Janet Brown 30 Complete

PERFORMANCE AN D PROCESS IMPROVEM ENT
measure of complications associated with joint-replacement operations, and data from federally
mandated patient-satisfaction surveys.
Truven 100 Top Hospitals Report
Truven analyzes data from approximately 5,000 hospitals in 16 adult and 10 pediatric specialties.
Truven also rates data on the best physicians, health plans, Medicare plans and nursing homes.
The resulting rankings are comprised of equally weighted measures of key organizational functions and
outcomes - financial stability, operational efficiency, patient safety, quality of inpatient and
outpatient care, and customer perception of care. Truven is also piloting rankings from other areas
such as the emergency department efficiency, extended outcomes, and the financial health of the
system. The health systems identified as the top 15 health care systems in 2015 were found to have a
lower cost per episode, better survival rates, fewer complications, and better patient safety and core
measures adherence than their peer systems.
There are other healthcare report card entities that can be identified, but it is suggested that facilities
identify one such entity that they will consistently utilize to show their progress towards inprovement
of quality and cost. The facilities can then explain more clearly to their customers how they are making
improvements and lowering costs.
PEOPLE IN THE PERFORMANCE IMPROVEMENT PROCESS
In the pursuit of quality care and services, we have stated that healthcare must build "quality
organizations" to be successful. The organization is really only as "quality" as its people. People
management is the personalization of strategic leadership and a corporate culture committed to
quality. Moreover, management that is truly "of, for, and by the people" is, by definition, participative.
This section of the chapter will focus on individuals who must be involved in the quality management
process in order to have a successful program.
There is a growing understanding of the impact and value in organizations of "networks of trust."
Networks represent the "collective cognitive capabilities" in the organization: the flow of tacit
knowledge (the circulation of information) between people who trust each other enough to engage.
Whereas the organization chart basically indicates the formal rules of authority, the human network is
how work actually gets done.
In high-trust cultures, people feel free to speak candidly together about their impressions of
organizational strategies, quality, safety, satisfaction, and ways to improve. Innovation opportunities
increase and costs associated with oversight management tend to decrease . Certain people play
critical networking roles, and they may not show up on the organizational chart .
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PERFORMANCE AND PROCESS IMPROVEMENT
If the power of networks is well understood, leaders place appropriate value on human exchange and
encourage the flow of knowledge and ideas. There are at least six core networks or layers of
knowledge in an organization's culture:
• Work (exchange of information in daily work)
• Social ("check-ins" inside and outside the workplace for information)
• Innovation (collaboration/sharing new ideas)
• Expert Knowledge (expertise and advice)
• Career Guidance/Strategic (advice about the future)
• Learning (improve existing processes or methods)
Managing Relationships
It is central to quality management knowledge that the quality of products and services provided to
external customers (non-employees) is determined in large part by the quality of the relationships
between internal organization customers, processors, and suppliers . The quality professional, along
with the organization, is responsible for facilitating relationships as much as systems and processes.
Relationships are considered "good" when there are long-term commitments, communications are
C:ea; and there is mutual trust that is operationalized. Good relationships are formed when people's
needs are known, understood, and respected; when conflict is resolved through negotiation; and when
honest attempts are made to meet and exceed those needs. Time spent in developing rapport and
solid working relationships with colleagues, QI team members, physicians, community, etc., will stand
the quality professional and others in the organization in good stead for successful quality
management.
There are always structural and cultural obstacles to overcome. When attempting to implement
interdepartmental or cross-functional quality improvement activities, several common obstacles may
be encountered. Often departments are organized traditionally, based on a professional discipline,
rather than organized by service line or flow of patient care. There is typically a lack of time to meet as
a team. There is often a traditional focus on individualized patient care, which can impede interest in
system and process issues. Likewise, physicians have been trained to think of patients as unique
individuals and not as cohorts of populations. The goal, and challenge, is to create an environment
where both foci are .:ippropriate: the patient is the center of quality improvement efforts, both at the
individual level (variances from clinical path, case-specific issues, etc.) and at the population/patient
flow level (clinical path or practice guideline development and process improvements).
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MOTIVATION THEORIES
There are many motivation theories that have been developed, with some better known than others.
While these theories are all widely accepted, no one theory fits all situations or individual. The
manager must be aware of the different major theories and apply them to the personnel they work
with, and for. Therefore, the quality professional also should be aware of these theories and how they
can affect the interaction and motivation of the various healthcare team members.
One of the most basic motivational theories is that of Maslow's Hierarchy of Need (Maslow, n.d.).
Maslow's theory states that the person's unsatisfied needs are the primary influences on an
individual's behavior, or the real motivators. The theory states that there is a hierarchy of needs, from
the most immature to the most mature, that must be at least partially fulfilled in ascending order
before behavior patterns change and mature (Figure 4). If the physiological needs are not met, then
the other four levels of need cannot be met. It is only until the first four levels of need are met that the
self-actualization level can be achieved. Maslow suggests that managers should seek to understand
employees' needs and need levels and use these to motivate behavior rather than assuming a
particular motivational theory or management style.
Figure 4: Maslow's Hierarchy of Need
Self-actualization
Esteem
Love/belonging
Safety
Theory X and Theory Y are two opposing management theories explained by Douglas McGregor
Theory X and Y (n.d.). Theory X assumes that employees have a dislike for work and only work for the
paycheck. These employees need to be directed and they avoid responsibility. They need to be
191
supervised at every step. Theory Y assumes that employees feel that the expenditure of physical and
mental effort in work is as much a need as is play or rest. They do not need much supervision, and seek
and accept responsibility. Table 33 displays the comparison of these two theories. The manager must
determine which theory of motivation pertains to which employees and then plan their management
techniques accordingly.
Table 33: Comparison of Theory X and Theory V

Comparison of Theory X and Theory V
Theory X Assumptions Theory V Assumptions
-··-
People dislike work and need to be threatened People are self-motivated
and controlled to work hard enough
People do not take responsibility and desire job People want responsibility and are
security committed to the organization
People like specialized and repetitive work People like work organized around wider
areas of skill and knowledge; Encouraged to
develop expertise & make suggestions for
improvements using imagination, creativity
and ingenuity
Management should be authoritarian with Management should be participative
centralized control; management controls all allowing involvement of employees in the
aspects of the job; Rigid policies and procedures, decision making process; Participative
job descriptions, work rules, and negative problem solving is encouraged
reinforcement are imposed without employee
input
Organizations use carrot and stick approach with Organization uses appraisal processes but is
performance evaluations for control and raises separate from organizational controls;
Frequent opportunities for promotion
Works well in large scale production operation Works well in organizations designed for
and unskilled production line work professional services work
Herzberg's Motivation-Hygiene Theory of job enrichment is another important motivation theory

(Herzberg, n.d.). Fredrick Herzberg studied the different aspects of satisfied and dissatisfied
employees. Drawing on Maslow's need hierarchy, Herzberg identifies work place satisfiers and
dissatisfiers. He determined that the factors that lead to satisfaction (motivation factors) are different
from the factors that lead to dissat isfaction (hygiene factors) . He contends that motivation is in the job
content (e.g., the work itself, achievement, recognition, responsibility, growth and advancement), like
Theory Y . However, if the hygiene factors, or job environment, are negative or dissatisfactory (e.g.,
company policy and administration, supervision, working conditions, interpersonal relations, safety, or
salary), morale and productivity suffer (Maslow need levels 1-3). Dissatisfiers must be removed, as
they are barriers to motivation, however removing them does not establish motivation. To motivate
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staff, you also have to focus on the satisfaction factors. Table 34 lists the factors for satisfaction and
dissatisfaction .
Table 34: Factors for Motivation-Hygiene Theory

Factors for Motivation-Hygiene Theory
Factors for Dissatisfaction Factors for Satisfaction
(eliminate) {build into work environment)
Company policies Achievement
Relationship with supervisor and peers The work itself
Work conditions Responsibility
Supervision Recognition
Security Advancement
Salary Growth
Status
EAMS & MEETING
In this section of the chapter, we will be discussing teams, team methodologies, meeting management
and documentation. Every organization regardless of size or organization type will need to apply this
information either to establish teams or to evaluate for opportunities to modify processes in these
several areas.
In the 1990s, the focus of quality in the institutional health care environment shifted from the
traditional segregated departmental practice to a multi-disciplinary team process. This mirrored the
increasingly popular view of holism and primary care in health care. For example, when children are
two or three years old, they may enjoy playing house. One child usually takes one role and another
takes another role. Observing this it seems as if they are interacting separately, or performing parallel
play. That is similar to many multidisciplinary groups. They are all in the same room, maybe focused on
the same process, but each member focuses on the contributions his or her discipline can make, and
not necessarily on the entire process. Critical care committees are an example of how this was done in
the past.
Following those 1990s teams, came the interdisciplinary team. With an interdisciplinary team,
members all work with the same focus. Again, as children grow older, when they play house, you can
observe that there is more give and take, discussion and collaboration with decision making. That is
the current preferred model of team collaboration. The concept of teams has expanded both globally
and beyond the focus of health care to many industrialized nations and their health care programs.
The concept of these teams is now in specific target populations, social work activities, and
reimbursement practices.
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The improvement of quality in healthcare organizations is d,ependent on teamwork, partly because

providing care and service is complex, with many handoffs between practitioners/workers, and partly
because healthcare workers like working with other people. How the organization and the quality
professional accept, lead, and participate in group process will determine the success of the
performance improvement strategy .
eamwork and Group Process!

[
This next section will describe 'what' teams are and what they can be expected to accomplish. A group is a
collection of ir··• · ,iduals who affect the character of the group and who are in turn affected by the group.
Group dynamics are determined by the various combinations of individual interests, abilities, and
personalities . Group success is inevitably tied to the organization's corporate culture, leadership's
commitment to quality as a key organization wide value, and the subsequent degree of empowerment
and resources given to the group. There should be 6 to 8 members of the team, but no more than 10,
whose membership is based on close work with the organizational function, processes, or topic.
!The Role of Teams in Quality Managemenq
A team is a group of people who perform interdependent tasks to work toward a common mission.
Some teams have a limited life: for example, a design team developing a new product, or a process
improvement team organized to solve a particular problem. Others are ongoing, such as a department
team that meets regularly to review goals, activities and performance . Understanding the many
interrelationships that exist between organizational units and processes, and the impact of these
relationships on quality, productivity and cost, makes the value of teams apparent (Teams, n.d.).
Quality Improvement (Qi) Teams must be comprised of appropriate clinical and non-clinical staff at
various levels in the organization. Teams may be temporary as in a task-associated team, or
permanent such as a team dealing with a specific topic such as medication management . If they are
permanent, they may be diagrammed on the organizational chart, along-side departments, services,
and committees.
Team members are the backbone to the success of the team. Teamwork involves the team members
working collaboratively ,through generation of ideas, discussions, utilizing understanding that the team
members bring different ideas and experiences to the team, and that only by working together will the
team be successful.
A team is needed to achieve a common purpose and better results than individuals working alone
would achieve (interdependence identified) . A team is utilized to maximize the expertise and
perspectives available in the organization, often when participative management is the leadership
style. When a planned change or new process design will impact current work practice, a team should
be utilized to help obtain buy-in from the staff. Teams play a large role when successful
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implementation of the problem solution or process design/redesign depends on buy-in from persons
across the organization. Teams are also valuable when resistance to change is high, but change is
inevitable.
All teams will move between four stages throughout the performance of their work: Forming;
Storming; Norming; and Performing. Psychologist Bruce Tuckman developed this sequencing in 1995
to describe the way most teams act on their way to completing their task (Forming, n.d.) (Improving,
n.d.).
In the Forming stage, team members are getting to know each other . The Team leader plays a large
role here in bringing the members of the group together and establishing the ground rules, etc. There
is little progress towards meeting the goal of the team during this phase. This phase may last a long
time as team members are oriented and educated on what the team's role is and how they fit into the
team. In this stage, the team leader should direct the team and establish clear objectives for the team.
In the Storming stage, team members begin to push against the boundaries, particularly when there is
a conflict between team members' working styles. The team members are beginning to realize that
there is _more to this task than they anticipated. In this stage, there could be challenges towards the
leader's authority, and the team roles, the goal of the team, resistance towards taking on certain tasks,
or challenges if the team members are uncomfortable with how the team is moving along. In this
stage, the team leader should work to build trust and good relationships, resolve conflicts, and remain
positive and firm.
In the Norming stage, the team members begin to come together, resolving their differences,
appreciating the strengths of other team members, and respecting the leader's authority. The team
members are moving to cooperation instead of competitiveness. The team members are more likely to
ask other team members for help, ask others for feedback or their opinion. The team members have
become committed to the team's goal and start to progress in that direction. The team leader could
attempt a team building exercise but should also step back a little and allow the team members to
begin taking on responsibility for the team's progress.
In the Performing stage, there is work toward the completion of the goal. There is minimal friction and
the team is working well together . The leader at this time is able to deleg.:itc work to the members and
feel assured that it will get completed . The team leader should delegate tasks and projects to the team
members, and begin focusing on the advancement of the team towards its outcome.
The team does not move straight from Forming to Performing, and then remain there. If there are any
changes to the team or their charge, then the team can go all the way back to the Forming stage again .
If someone leaves the team and is replaced, that new individual is definitely in the forming stage and
will pull the team in that direction. As new tasks are identified, the team may move back and forth
195
through the Storming and Norming phases before they move into the Performing phase for those
tasks.
frypes of QI Teams)
The word team is often used in many ways. In quality/performance improvement, teams are
frequently utilized to determine how to make improvements to processes that have been identified by
the organization. The team is brought together to make the improvements and then disbanded once
the improvements have been made. The use of work teams (or QI teams) to improve quality and
productivity is based on the knowledge that teams foster greater employee involvement and,
subsequently, commitment to the organization's success. Work teams vary widely in focus and degree
of autonomy from informal "ad hoc" groups assigned to resolve specific short-term problems to
permanent, "self-directed" teams.
Functional teams are organized to improve processes in a given important function, e.g., patient care,
medication management, infection control, environment of care, safety, or information management.
Cross-functional teams are organized to cross the boundaries of existing organizational structures, be
that functions, departments, or disciplines. Most "functional" teams are actually cross-functional because
they cross department or discipline lines, even though their focus is on one function, e.g., information
management.
Clinical teams are organized around a clinical condition, service line, DRG, diagnosis, or procedure, to
improve all associated processes of care and service on a prioritized basis, perhaps through a Strategic
Quality Initiative. Clinical path development is a common task performed by this team.
Operational teams are organized to improve management and support (nonclinical) services or
perhaps Strategic Quality Initiatives .
Ongoing teams can be functional, clinical, or operational, and are mostly cross-functional and
multidisciplinary in composition. These teams may replace committees, are permanent, and may be
self-managed, e.g.,the Quality Council.
Ad hoc teams are formed to address one important issue or task, e.g., a root cause analysis, a Strategic
Quality Initiative, a failure mode and effects analysis (FMEA), or a particular project. Ad hoc teams are
comprised of those with the most knowledge of, and information about, the issue under study and
includes those with subject matter expertise. Generally, once the project is complete and the process
change or new design has been implemented and been proven to work, the team disbands.
Self-Directed Work Teams share responsibility to complete a whole piece of work or service, are
trained cross-functionally, share many management responsibilit ies, and are given broad decision-
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making authority with access to all information needed to make good decisions. These teams have
more autonomy with the organization and thus have more responsibility than the other types of teams
listed above. Self-Directed teams do their own planning, setting of priorities, organizing and managing
the budget, scheduling and assigning work, coordinating with others, measuring their performance,
solving problems, taking corrective action, evaluating their effectiveness, and even hire/evaluate own
staff {depending on the organization).
Many of the above listed types are Interdisciplinary Teams . If one department forms a team,
department staff may be the only members on the team . Nevertheless, often the process being
improved has interdisciplinary individuals who have some ownership with the process.
!Roles within Quality Improvement Teams!
!selection of Team Members!
This section will discuss the 'how' of team processes and management. Among the initial tasks of
performance improvement initiatives is deciding who will be included on the team and establishing
their roles during the initiative. Individuals with intimate knowledge of the topic at hand are invaluable
to the team, especially staff members. Others who are stakeholders or process owners should also be
included. People with performance improvement methodology skills can guide the team through the
phases of process change. It could be beneficial to have someone with an unusual or different point of
view on the team to stimulate individual creative thinking and prevent team members from just
following the ideas of the leaders. Physicians or other champions are valuable members and can
communicate with others outside of the team to help achieve buy-in to the process changes .
Champions can often be found in any aspect of the organization, but these individuals are the ones
that support moving towards the goal of the team and sometimes are anxious to get moving in that
direction. They can add to the success of the team by communicating to others what is happening as
the team moves forward and why that is important. Physician champions should have a good working
relationship with colleagues and the day-to-day leader(s), and be interested in driving the change in the
system . A physician/provider who is an opinion leader in the organization makes an effective champion.
IRolesl
Great projects can be severely damaged when people do not understand their roles and how those
roles relate to the project deliverables . Healthcare quality professionals are frequently called upon to
lead and facilitate performance improvement teams. The project team leader must be crystal clear
about the expectations and requirements a re for each of the team members. The facilitator is basically
guiding the team in a manner that helps the team function easily and efficiently . The facilitator should
not have an interest in the outcome of the team. Table 35 lists the duties of the members of the team.
It is important that someone on the team, or the sponsor, be able to directly or indirectly engage the
financial support that will be needed by the team.
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Table 35: Team Roles and Basic Tasks

Team Roles and Basic Tasks
Role Basic Tasks
Sponsor Senior leader advisor to the team
Facilitator Assists the team leader in planning meeting and developing the
agenda; Ensures the participation of all team members,
monitoring the .lgcnda, and keeping track of time
• Make it simple for the team to function
• Keep team on task
• Guides activities such as brainstorming, cause mapping, risk
analysis, etc.
• Manage team dynamics
• Teach and support
• Help the team leader with assignments, needs between
meetings, plan changes, team tool techniques, prep for
presentations
• Seek opinions of all team members
• Coordinate ideas and test for consensus
• Assist team in applying QI tools and techniques
• Summarize key points
• Provide feedback to the team
Leader Fully understands the processes targeted for improvement and
the breath of the project in order to effectively lead the meetings
e Prepare for meetings
• Conduct meetings
• Assign activities to team members and participate in carrying
out assignments between meetings
• Provide direction
• Assess progress
• Interface with other teams and support resources
• Represent the team to management
• Follow up with team members as necessary
• Documentation (minutes, other records)
• Communicate with team, facilitator, sponsorichampion, and
the organization
Team member Agree to contribute their knowledge and insights to the project;
Agree to support suggested improvements; Facilitate 'buy-in' for
changes that result in improvement
• Attend regular meetings
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• Participate willingly
• Is engaged in working to reach the goals of the charter
• Treats others the way he/she would want to be treated
• Realize that the work of the team is accomplished outside of
the meetings
• Assist the team leader with documentation and meeting
management
• Help critique and improve the meeting process
• Share experience and knowledge
• Listen to others and remain open to all views and ideas
• Complete assignments between meetings
• Communicate effectively with colleagues regarding team's
work/progress and seek input/buy-in
• Participate in team QI/Pl process
• Understand role in implementation and monitoring
Champion Has influence within the organization; Should be credible with an
ability to persuade others; Is knowledgeable on the topic,
provides education, and supports staff; Acts as a liaison between
the unit and the process improvement team; Should have a strong
belief in patient safety and safety culture
• Participates as a member and sometimes subject matter
expert
• Encourages and supports team, particularly to the
organization and leadership
Time keeper • Keep the team within designated meeting time constraints
for discussions, brainstorming and other team tool sessions,
and ending times
Recorder • Keep minutes and other records to meet documentation
requirements and facilitate team recall
Ad hoc member • Comes and goes on the membership roster, as expertise is
needed by the team
!Facilitator/Coach!
The team facilitator serves as internal consultant or coach to the team. The facilitator does not care
about the outcome of the team, but rather about the team process itself. If the facilitator is involved in
the content of the process being changed, there is no objectivity to move the team along. For example,
for a clinical improvement team, a staff member facilitator who works in accounting would be
beneficial to this team .
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As a facilitator, teambuilding, listening skills, communication skills, organization skills, and data analysis
skills and knowledge of performance improvement methodologies are needed.The facilitator does not
have to come up with the answers to the questions at hand, but rather guides the team to do so.
There is a valuable comprehensive team facilitation tool kit (Facilitator, n.d.) produced by the
University of Wisconsin Madison.While the kit focuses on application in the university setting, it can
easily be used by he;:ilthcare as well. It is available as a free online download. See website list at the
end of this chapter. If your google 'Facilitator Tool Kit' you will find many other toolkits that you could
utilize.
\ream Leaded
One member is appointed team leader as the person who "owns" the process examined and has the
responsibility and authority to lead the improvement project. The team leader is an active member of
the team and is interested in the outcome of the team efforts. Many times, the leader is chosen and is
involved in choosing the other team members. The team leader establishes the content for the
meeting, runs the team meeting, and summarizes at the end of the meeting. If the team leader has
never held that position, a strong facilitator should be appointed to the team. The facilitator will run
the first several meetings as the leader learns the leadership role, and then the leader can gradually
take on the role with the support of the facilitator. The team leader is not responsible for the entire
decision-making and is not responsible for the team's success or failure. A team leader should have the
following ten skills: communication, organization, confidence, respectful, fair, integrity, influential,
delegation, facilitator, and negotiation (Scott, n.d.).
!ream Membe
The team members are responsible for working with the team leader to identify the opportunity for
improvement, identify the issues, process flows, and root causes of the problem. They are responsible
to collect and analyze the data and then to recommend corrective action/changes. Once approved by
the team sponsor, the team members are responsible to implement the action plan and to assure that
the monitoring is done and that a successful outcome can be achieved.
Team members need the skills of listening, sacrificing, sharing, respecting others views, questioning,
working hard, and persuading (Gaston, n.d.). The team member must understand what skills and ideas
they bring to the team and what they need others to bring to the team. The team member must also
be aware that in the beginning, the work will be done within the meeting itself. As the project
progresses, most of this work will be accomplished outside of the meeting and then reported at the
next meeting.
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!Recorder & Timekeeper Roles\
Both the recorder and timekeeper roles should be rotated throughout the team members. The person
who is taking notes, or watching the time, will not be able to participate in the discussions as muc h as
others on the team.
The recorder should be appointed to help document and maintain a record of the team's work. The
timekeeper is charged with maintaining the timeliness of meetings.
ponsod
The team sponsor is a key leader or clinician who is passionate about the need for improvement. The
sponsor reviews and supports the team's work, providing context, guidance, and direction. This
individual maintains the overall responsibility, authority, and accountability for the team effort. The
sponsor or the Quality Council will select/approve the project, facilitator/coach, team leader, and team
members. This includes ensuring that all stakeholders have appropriate input into the project and the
team process and outcomes. The sponsor continually monitors the decisions and planned changes of
the team and assures that they are in alignment with strategic goals. Ultimately, the sponsor
implements changes the team is not authorized to make.
Role of the Healthcare Quality Professional
The healthcare quality professional is predominantly a coordinator of the "team process." He or she is
the resource person, a centralized repository for both receipt and dissemination of information about
the organization's quality strategy, structure, processes, and outcomes. In team coordination, he or
she may oversee multiple teams and activities; orchestrate information flow to the Quality Council,
governing body, and organization; and may serve as trainer and/or facilitator for certain teams.
The quality professional may serve as a member on certain system-wide strategic initiative teams or
on the organization's strategic planning team. There are occasions when the healthcare quality
professional is asked to serve as team leader, but these should be rare requests, such as when the
organization wide quality strategy is being redesigned and the quality professional is the obvious
expert.
!Performance Improvement Team Establishment)
The performance improvement team will follow the performance improvement model selected by the
organization, such as the POCA model. Before the team is established, the need for such a team must
be recognized. This can occur in several fashions: There can be a request to the Quality Council for a
team; a department may join with another department to begin a performance improvement team; or
leadership may identify a need for the team. There must be a mechanism identified in the organization
as to who has the responsibility for the oversight of performance improvement teams and this
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group/department must be aware that a team is being formed. The Quality Council and leadership of
the organization should be involved to assist in the determination as to whether the team is truly
needed and if there are available resources .
Problem Statement/Charter
Once it has been identified that there is a need for a performance improvement team, a problem or
opportunity slalement should be developed. I he problem statement should indicate what the
problem is, who has the problem, when the problem occurs, how often it occurs, what causes it and its
overall impact. The problem statement should be concise, specific, and measurable and specify what is
impacted (Charter, n.d.). The statement should not mention either causes or remedies. However, be
cautious that the problem statement is not too simplistic, especially if the team members are aware of
the problem. Team members must understand the context and the significance of the issue. The
budget should be included in the problem statement, and the total cost will need to be considered
throughout the team's progress. There is a need for the team to have an open-minded approach to
discover root causes of problems.
Ground Rules
The ground rules are the code of conduct for the team. It is important to set and review the ground
rules at the beginning of the first team meeting and then briefly at each subsequent meeting. The
team members should establish the ground rules themselves . The ground rules may include: turn off
cell phones or put on vibrate; no side bar conversations; everyone's input is equally important; start on
time; end on time (or sooner); answer cal!s/pages outside of the meeting room; all membeis should
participate; respect everyone's ideas and opinions; it is OK to get up to meet your needs.
\orient/Educate the Teaml

The team needs to be able to work together successfully in order to address the problem statement. In
order to accomplish this, a sense of cohesion must be developed. The team must have a sense of
openness, where the group members get to know their teammates and understand that each member
brings new ideas and diverse viewpoints to the team. The team members must be willing to listen to
others and elicit their ideas. Trust and self-disclosure are critical for the team. These elements develop,
as every team member is willing to self-disclose and be honest and respectful with other members.
Group members must be willing to support one another as they work toward an action plan. A sense
of team loyalty and group support will need to be developed as they learn to collaborate with each
other (Pearsall & Venkataramani, 2014) (Center for Teaching Excellence, n.d.).
In addition to the orientation of the team members to each other, the team members will require Just-
in-Time training regarding the performance improvement tools that they will be utilizing within the
team process. There may be members of the team who have never utilized these tools and others who
are experienced users. There should be a need assessment completed and the beginning educational
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effort undertaken. As each tool is utilized for the first time, more education regarding that tool can
take place. There should be an ongoing analysis of the effectiveness of this training with additional
training provided as needed (Heathfield, 2017). Twelve tips for building a successful team are listed in
Table 36.
Table 36: Tips for Building a Successful Team

Tips for Building a Successful Team
Tips Comments
Clear Expectations Leadership communicates its expectations;
Team members understand why the team was created;
Team members have adequate time, resources of people, money;
Context Team members understand why they are on this team;
Team members understand why teams are utilized to make these
improvements;
Team members understand how what they are doing on the team affects the
organization's goals, principles, vision and values;
Commitment Team members want to participate on this team;
Team members feel the team's efforts are important;
Team members commit to accomplishing the teams mission;
Competence Team members feel they have the appropriate members on the team;
Team members feel the members have the knowledge, skill, and capability to
accomplish this mission;
Charter Team has developed their own mission, vision and strategies to accomplish
the mission;
Team has defined and communicated its goals, anticipates outcomes and
contributions, timeliness, and how it will measure the outcomes of the team's
efforts;
Control Team members have the empowerment and freedom to feel ownership to
accomplish the mission;
Team members understand their boundaries;
Limitations (monetary & time resources} are defined at the beginning of the
project;
Team members hold each other accountable for project timelines,
commitments, and results;
Collaboration Team understands team and group process;
Team members understand the stages of group development;
Team can approach goal setting, problem solving, and process improvement
together;
Communication Team members understand the priority of tasks;
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Team members communicate clearly and honestly with others;

Diverse ideas are brought into discussions;
Creative Innovation Organization values creative innovation with creative thinking, unique
solutions, and new ideas;
Organization rewards people who take reasonable risks to make
improvements;
Organiz;:ition provides training, education, and other such items to stimulate
new thinking;
Consequences Team members feel responsible and accountable for the team's
achievements;
Rewards and recognition to both the team and individuals are given when
teams are successful;
Coordination Teams are coordinated by a central leadership team (ie: Quality Council} that
assists groups with needed resources;
Cross-functional and multi-department teams are common and working
together effectively;
Organization is moving toward a customer-focused process-focused
orientation;
Culture Change Team-based, collaborative, empowering, and enabling culture change;
Organization plans to use failures for learning and support of reasonable risks;
··-·--- ·
Adapted from Heathfield, 2017
tteam Processl
At this point the team will begin the improvement process applying the improvement model utilized
within the organization itself (i.e.: PDCA, etc.). An excellent resource to use is The Team Handbook, by
Scholtes,Joiner, and Streibel, last published in 2003.
The team should develop a project timeline and determine what the deliverables may be. The role
each team member will assume can also be determined at this point. A JGantt chartl may be utilized to
plan the project and establish the timeline necessary. This timeline should be reviewed at every
meeting to determine if the team is progressing as planned. (See Chapter 4 Health Data Analytics).
Although the timeline is developed at the beginning of this process, it can be modified as needed
throughout the team process.
If there has not been data collected to indicate the extent of the problem, this must be undertaken
first. Once those data are obtained and analyzed,then the team can begin to identify what needs to be
done to improve the process and/or outcome .
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Choosing approaches to fix a situation can range from extremely simple and perhaps cost-free to very
complex and costly. A very effective tool is cause mapping. This tool and others can be found in
Chapter 4 Health Data Analytics. The team must keep in mind that interventions need to be specifically
chosen to address specific barriers to improvement. The intended target group that will receive or use
the intervention must be identified and then the intervention tailored for that group. Having a
multidisciplinary team select interventions provides input from a variety of vantage points. Ideally,
representatives from the target groups should also be able to provide the performance improvement
team with their input on the intervention selection.
Getting a team of people to come to a consensus on a subject or agree to a course of action to take
can certainly be challenging. It is possible that the entire group may not be in full agreement on every
single aspect of the issue at hand, but at least they are willing to be flexible enough to allow forward
momentum and progress with the initiative. Getting to consensus usually takes time and may include
clarifying sticking points, re-visiting the purpose and goals of the group, and then moving toward at
least some level of agreement. Sometimes it is inching toward the goal of consensus. Other times, the
participants can easily move forward. If there are many people involved in the decision-making, it may
impede progress. Voting can be accomplished in person, via email with voting buttons attached, or
even during conference calls. At times, multi-voting may be necessary to allow the committee
members to work through issues inch-by-inch rather than wholesale. Keeping the lines of
communication open and maintaining cool heads is important. It is very easy to get frustrated at this
stage. Keep moving toward the goals, even if progress is slow . Care must also be taken to prevent
strong personalities from dominating the group and manipulating others to agree with their position.
Throughout the team process, the team leader should be communicating with the team Sponsor to
assure that the team is processing in a manner acceptable to the organization. The team should never
be allowed to get to the action plan phase and have the leadership of the organization determine that
their action plan is not feasible to implement.
Once the action plan is formulated and approved for implementation, the team members must
determine how to implement it. Sometimes it is best to implement it on a pilot basis and then make
improvements before it is rolled out to the entire organization. The team must participate in the
monitoring of the project timelines and deliverables to ensure that the implementation is working
well. The team should coordinate the processes involves with the education, implementation and then
measurement of success of the efforts. The same measurement tools used in the beginning of the
team's work should be again utilized to determine if the desired outcome has been achieved. If the
desired outcome has not been achieved, the team must repeat the process and implement the revised
action plan, then measure again. Once the desired results have been obtained, the team's work is not
over. They must determine a way to sustain the results.
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In order to sustain the measures, monitors must be put in place to measure if the process/outcomes
are performing as desired. Potential measures that can be utilized, depending on the type of
improvement project, include but are not limited to: achieving project goals; raising awareness;
process change sustainability; enhanced patient safety; achieving benchmarks; leadership support;
data trends in the right direction; expanding the pilot into other units/areas; increased patient/staff
satisfaction; and a return on investments (ROI). It has to be determined who will conduct the ongoing
monitoring and analysis. If the process does not remain where it should be, and the results start to slip
back towards old habits, an intervention needs to be initiated as soon as possible to bring the process
back into compliance.
!Evaluation of Team Performance!
The simplest way to determine if the performance improvement team was effective is to ask these
three basic questions:
1. Did the team reach the goal(s) that were stated in the charter?
2. Did the team follow the performance improvement model?
3. Were individuals responsible in completing their assigned tasks?
If the answers to the questions were affirmative,then the team completed the task that it was charged
to do. !f not, there vvas a process failure somewheie along the way .
A more in-depth evaluation may be needed to be able to make improvements in how future teams
work together. There are numerous team effectiveness evaluation tools that can be found on the
internet.
Once such tool, 'Team Effectiveness Evaluation Summary', was developed by the University of
Minnesota in September 2013 . This tool examines the team in terms of the vision, team roles,
processes utilized, relationships, external influences, outcomes and team behaviors. It can be found in
the website list at the end of this chapter.
A second evaluation tool was developed by MindTools. This tool evaluates the team based on team
development, feedback, participation and articulation, managing conflict, group roles and structure,
team member development, and understanding and collaboration. The website for MindTools can be
found in the website list at the end of this chapter.
[Meeting Management!
The definition of meeting is, "a coming together of two or more people, by chance or arrangement"
(Lauby, 2015, p. ). Meetings that are productive and well organ ized are well accepted by staff,
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PERFORMANCE AND PROCESS I M PROVEM ENT
whereas meetings that are disorganized and not productive are determined unnecessary. Therefore, it
is up to the person holding the meeting to be sure that it is truly needed.
There are only three reasons to hold a meeting. The first reason is to provide information that cannot
be easily or effectively conferred by other means. The second reason is to create an opportunity for
decisions to be made. These types of meetings are held when decisions need to be made, when
information needs to be utilized to accomplish a goal or task. The last reason to hold a meeting is to
allow feedback and discussion, such as a focus group, or as a post implementation meeting to
determine what worked and what did not (Lauby, 2015).
It can be helpful to classify meetings or agenda items in a meeting by the type of communications
involved. This allows participants to have realistic expectations of their role and to be prepared. Table
37 lists three types of meetings/agenda items and examples of each.
Table 37: Meeting and Agenda Items by Type and Examples

Meeting and Agenda Items by Type and Examples
Type of Meeting I Agenda Item Examples
Information • Briefings
• Explain/present policy
• Nonnegotiable issues
• Some types of training
Discussion • Brainstorming
• Eliciting decision suggestions/input
• Planning
• Negotiating
Action • Planning for results
• Group decision making
• Problem solving
!Effective Meetings!
Meelings are more than just showing up at .:i ccrt.:iin time and sitting in a room until it is c:ompleted.
The leader's job is to be certain of the need for the meeting, conveying the need to the participants
and conducting the meeting in an organized and productive manner. However, no matter how well the
meeting planning is done, if the members in the meeting are not willing to participate, the meeting will
not be successful. Therefore, the meeting leader must have a set of skills that can be effective in
keeping participants engaged and also keeps the meeting moving through the agenda in a timely
manner.
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Preparing agendas, committee/meeting reports, and minutes should be more than just busy work.
They are the communication tools that need to be utilized effectively to communicate to the members
of the meeting and to others. They are documents that capture the work being done, and lay out the
framework for what comes next. They are the documentation that certain topics were discussed and
decisions were made. They are necessary for oversight agencies and others to examine to determine if
items were discussed as required and to determine where the group is in accomplishing their goals
and charter . Paying careful attention to the details in these documents is important.
The literature defines many essential steps to having an effective meeting. Neal Hartman (2014)
describes seven steps to an effective meeting.
• The first is that there must be a clear objective for the meeting. Standing meetings
without a clear reason for each meeting are not a good use of the participant's time.
• The second step is to consider who is invited to the meeting. It should be determined
who really needs to be at the meeting. The attendees should be determined based on
the need for the meeting and what the specific goals to be accomplished.
• The third rule is to stick to the agenda . The agenda should include the amount of time
allotted to each specific item. All participants should have a copy of the agenda.
• The fourth step is to keep the meeting moving. Do not allow one individual to
monopolize the conversation.
• The fifth step is to start on time and end on time. Do not delay the start if not all
attendees are there. Do not conduct the meeting for longer than 60 minutes if, at all
possible.
• The sixth step is to 'ban technology'. Do not allow attendees to use their phone or
computers unless it is directly involved with the information in the meeting. One
source suggests treating the technology issue as only allowing its use as if the
participants were 100 miles away from the facility .
• The seventh step that the leader must follow-up. It is important to send out the
minutes or the highlights of the meeting to all who attended and others that need to
have the information, including any team members who were not present, within 24
hours of the meeting. Document the responsibilities and tasks assigned, as well as the
deadlines.
!Before the Meeting!
Assure that everyone who is to attend the meeting is aware of the time and place. Ask attendees to let
you know ahead of time if they are not going to be able to attend the meeting. When you send them
the reminder notice about the meeting, include the agenda so that they are also reminded about what
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they are to bring or discuss at the meeting. This allows attendees to be prepared for the meeting so
that they can be actively engaged.
When preparing the agenda, the chair of the meeting should be notified as to what is on the agenda
and determine if the chair wishes to add or clarify any items. Also, assure that those individuals
responsible for presenting items are prepared to present them. The flow of the agenda will differ
depending on the type of meeting. If there has been a previous meeting, then the first item on the
agenda should be the approval of the minutes from the last meeting. Corrections, additional items or
deleted items can be clarified prior to the approval. Putting the most important items at the beginning
of the agenda assures that they will be addressed in the meeting. Should the meeting run overtime
and the important items are left till the end, then they may not be effectively a ddressed. G'-:nerally, old
business is discussed before the new business, but sometimes this can lead the participants into the
discussion of some new business. The leader should not let this happen, and should bring the
discussion back to the current item and the agenda . As mentioned previously, there should be time
limits for each item on the agenda. This will help keep the meeting on track. An additional annotation
on the agenda could be an indication, if the item is for information only for discussion or if a decision is
needed.
!During the Meetingl
Begin the meeting on time even if individuals are not there yet. Assure that the attendees all have a
copy of the agenda or that it is posted so that they can all see it. If you have a quorum, you can start
with the approval of the previous meetings minutes. If there is not a quorum, then start with an item
on the agenda that requires discussion and then move back to the top of the agenda when a quorum is
present. Begin the meeting by stating the purpose, sharing what the goals are, and then review the
agenda. Clarify your role in the meeting as the leader.
If this is the first meeting of the group, ground rules should be established . Four ground rules should
always be followed, with the addition of others deemed as appropriate. The four ground rules are a
must and apply to all attendees. They are: (1) participate, (2) focus, (3) maintain momentum, and (4)
reach closure. A ground rule about confidentiality may also be appropriate . The ground rules should be
posted at all times during the meeting.
As you move through the agenda items, keep the momentum and keep to the established timeline in
the agenda. If the conversation is wandering off the topic, bring it back by announcing to the group
that they need to get back on topic. If there are sidebar conversations, ask those in the conversation if
they would like to share what they were discussing with the group. If the planned time on the agenda
is not sufficient to close a topic, ask the group what they wish to do. It may result in some out of
meeting work on the topic that can be carried over to the next meeting.
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Many resources suggest that at the end of every meeting, the agenda should include a 5 to 10minute
period for feedback to evaluate the meeting. Other resources suggest obtaining the feedback after the
first meeting and after every so many meetings as established by the organization. Of course, the
feedback can also be conducted throughout the meeting,if so desired.
Always end the meeting on time and if possible, on a positive note. The leader should review the
actions taken and the assignments and set the time for the next meeting. This again reminds all
attending of their responsibilities between meetings so that the next meeting can run smoothly.
Meeting Minutes & Documentation
Following the meeting,the best practice is to send the attending members, and others as appropriate,
a summary of the meeting or the meeting's minutes within 24 hours. In reality, a more manageable
time frame for the minutes would be within a week. Dispensing the minutes in a timely fashion
ensures shaper memory and greater accuracy.
The minutes should stand by themselves. Whenever someone asks you for a copy of the minutes, they
are given only the minutes and not all the attachments. Therefore, if the minutes are vague, the reader
cannot tell what really happened. The golden rule to follow when writing minutes is to "close the
loop". If the reader can read the minute sections and then say to themselves "and?", then the loop has
not been closed. The minutes may state that something was discussed - And? What was the discussion
about and what was the result of the discussion? If the minutes state that the item was presented, the
remaining question is and what happened? Every item should have a short statement that ties up the
loose ends. There does not have to be a detailed discussion about what happened but it should be
clear what did happen. Table 38 lists some examples of inappropriate and appropriate phrases for the
minutes.
At the time the minutes are completed, items that need follow up should be added to the agenda for
the next meeting. The agenda outlines for each meeting can be developed for the entire year. When
an item needs to appear on a certain meeting agenda, it can be placed there when the minutes of a
meeting are written. For example, if it is determined at a meeting that there needs to be follow-up of a
report from a Pl team at the next meeting, (see Table 38), then the item is placed on the next agenda
when the minutes of this meeting are produced. If this meeting was held in July and the item needs to
be discussed in a meeting 3 months away (October), then it can be placed on the October agenda
when the July minutes are written. This helps to prevent items being dropped from the agenda due to
someone forgetting to include it. Accreditation surveyors often follow the items in agendas/minutes
through to the resolution of the item. If something is not in the minutes when it should be, it raises
questions that would not need to be raised if this technique is used.
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Table 38: Examples of Closing the Loop in Minutes

Examples of Closing the Loop in Minutes
Agenda Item Inappropriate Minutes Appropriate Minutes
Quality Dashboard Quality dashboard was Quality dashboard was presented.
presented. See attached . See attached. There was no
discussion concerning the
dashboard.
OR
The quality dashboard was
presented. See attached.
Discussion concerning the fall rate
being above the benchmark.
Continue to monitor and discuss
again at the October meeting.
Pl Team - The team presented their The team reported that they have
Turnaround OR Time report - see attached. They implemented their interventions
are working on the process. and are now collecting data to
determine the effectiveness. Will
report on progress at the next
meeting.
Pl Team - Patient The team presented their The team presented their report
Flow report and the results of the and the results of the
implementation. See implementation. See attached. The
attached. result shows that the time from the
admission order to bed assignment
was reduced from over an hour to
less than 30 minutes. The team is
commended for all their hard work.
Infection Prevention The infection prevention rates The minutes were presented from
Committee Minutes were presented - see the last meeting. Important issues
attached. include infection rates in the ICU,
MRSA outbreak, and flu
immunization progress. The
Infection Prevention Committee
has developed an action plan for
reducing the infection rates and
handling the MRSA outbreak .
Further reports will be presented at
the next committee meeting and at
this meeting.
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THE PRACTITIONER APPRAISAL PROCESS
The medical staff bylaws, rules, and regulations establish a framework for medical/professional staff
activities and accountability and are subject to governing body approval. They relate to all licensed
independent practitioners with clinical privileges in the care of inpatients, emergency care patients,
and patients in home care, ambulatory care, and long-term care. Membership on the medical staff
requires an application process, including credentialing, privileging, and appointment.
The credentialing and privileging processes are extremely important in that there are legally required
processes that protect the patient, physician and the organization. The credentialing and privileging
processes are utilized in healthcare to assure that licensed professional practitioners have the
credentials required for the position and the ability to perform the tasks or privileges required. The
credentialing and privileging processes will be described in an overview in this section, however, if you
have a position such as a Medical Staff Coordinator, then you will need to explore other avenues to
obtain the knowledge necessary to function in that position. In addition, if you would like to learn
more about what happens when credentialing is not done correctly, purchase the book Blind Eye, by
James B. Stewart. This nonfiction book is about Michael Swango who was allowed to practice without
a medical license, and the patients who suffered the consequences. Michael Swango is an American
serial killer and a former physician. It is estimated that Swango has been involved in as many as 60
fatal poisonings of patients and colleagues, though he only admitted to causing four deaths (Montaldo,
2017). He was sentenced in 2000 to three consecutive life terms without the possibility of parole, and
is serving that sentence at the ADX Florence supermax prison near Florence, Colorado.
All of the processes described in this section pertain to the physician and other Licensed Independent
Practitioners (LIP) including allied health practitioners who are credentialed and privileged through the
medical staff. This includes dentists, podiatrists, psychologists, chiropractors, advanced practice
nurses, CRNAs, nurse practitioners, midwives, physician assistants, mental health providers, and other
such specialties. Some accreditation organizations such as The Joint Commission may allow an
equivalent process to the medical staff credentialing and privileging processes for the allied health
professionals, but the processes have the same principles as will be discussed here.
The extent to which the credentialing and privileging processes are carried out will also vary with the
type of healthcare facility where the practitioner applies to practice. For example, in home health,
there is no credentialing or privileging done except for the verification of the physician's license in the
state where the patient resides. Managed care organizations only credential the practitioners and do
not award any privileges since these practitioners do not care for patients at the managed care offices.
The practitioners will be credentialed and receive privileges at the locations where they see patients.
At the other end of the spectrum, the hospital credentialing and privileging processes are very specific
and complex.
212
Appointment/Reappointment
Medical Staff Membership
The medical/professional staff includes fully licensed physicians (doctors of medicine and osteopathy)
and may include other licensed individuals permitted by law and the organization to provide
independent patient care services (e.g., psychologists, podiatrists, dentists). Healthcare organizations
and their medical staffs make the determ ination regarding what types of licensed independent
professional practitioners will be allowed to practice at a specific organization . This decision must be
defined in writing and applied equally to all applicants . Certain types of facilities do not require the
services of certain types of practitioners. For example, if the organization does not deliver babies,
there will be no need for neonatal practitioners at that organization. An ambulatory surgery center
would not require an intensivist to be on staff. Some hospitals will employ midwives to help deliver
vaginal births, but other facilities may determine not to use midwives. Some organizations determine
that they will utilize groups of specific practitioners, and if a practitioner in that specialty, such as
Anesthesia, is not a member of that specific anesthesia group practice, the application for that
practitioner will not be accepted .
Process Leading to Appointment
Applicants begin by submitting an application for appointment. The application itself may be created
by the state, the organization, or other sources as defined by law within that state. Applicants supply
requested information, consent to the inspection of pertinent records and documents, agree to be
bound by the bylaws, rules and regulations, and request specific clinical privileges.
Once credentialing is completed and specific clinical privileges are granted, the appropriate
department recommends appointment to the Medical Executive Committee, which then sends their
recommendation to the governing body. The appointment requires approval of the governing body or
a designated committee of the governing body.
Initial Appointment
The full appointment period is determined by the bylaws, but cannot exceed three years in managed
care organizations or two years in other organizations such as those accredited by The Joint
Commission. At the time of appointment, the practitioner is awarded a specific category of
membership depending on the categories listed in the medical staff bylaws. Each organizalion and
medical/professional staff determines the number and type of categories available and specifies the
privileges associated w ith each category. Table 39 demonstrates categories of the medical staff that
are common ly utilized. Allied Health professionals are not appointed into any of the categor ies listed in
Table 39 . For a new privilege, a practitioner undergoes a focused professional practice evaluation
based on the guidelines set by the medical staff. The Focused Professional Practice Evaluation will be
addressed later in this chapter.
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Table 39: Categories of Medical Staff Membership

Categories of Medical Staff Membership
Category Definition
Active Members providing most of the medical services and performing
most of the administrative functions of the medical staff.Criteria for
Active staff status vary, but usually the member must admit at least
a specified number of pi:lticnts annually, may vote, hold office, and
serve on committees .
Courtesy Members whose practice at the institution is limited but who have
the privilege to admit on an occasional basis (defined in the medical
staff bylaws). Sometimes members choose Courtesy status to avoid
the Active staff requirements to serve on committees, etc.,
relinquishing prerogatives to vote and hold office.
Consulting Members who serve as consultants to other admitting physicians
and are not members in any other staff category. They do not vote
or hold office.
Affiliate Members who do not actively practice at the institution (perhaps
due to the use of hospitalists) but are important resource
individuals for medical staff quality management/improvement
activities. They may serve on ad hoc committees or provide peer
review, but do not vote or hold office.
Community I Members who do not practice in the facility, but who want/need
affiliation with the facility. They do not vote or hold office. I
Honorary/retired Members who rarely practice at the facility, but who are well
respected by their peers and are so honored or formerly Active
members who have retired. They do not vote or hold office.
Re!appointment
Reappointment includes reappraisal of the activity of the practitioner over the time period from last
appointment, including both credentialing and privileging. Reappointment is granted for the time
period specified in the bylaws or policies/procedures, but never for longer than two years for acute
care hospitals and other healthcare organizations. The time period is three years for a managed care
organization .
Re-credentialing consists of submission of an application as previously occurred during the initial

credentialing, and updating the information concerning current activity, licensure and
certifications/registrations, liabilities/claims leading to judgments against the practitioner, and
malpractice insurance coverage. All information that was reviewed at the time of appointment, except
214
information that does not expire, such as education achieved, must be re-verified at the time of
reappointment. In addition, if any new credentials, education, or other information has been obtained
since the last appointment, it must also be verified at this time.
Re-privileging consists of a review of the current competency, quality management activities, and peer
review activities of the practitioner. It also includes a review of other reasonable indicators of
continuing qualifications, peer and departmental recommendations, review and renewal of specific
clinical privileges, and compliance with continuing medical education requirements. Some
organizations also review attendance at medical/professional staff, department, and assigned
committee and team meetings. Again, following the re-credentialing and re-privileging processes, the
information is sent to the appropriate department who recommends reappointment to the Medical
Executive Committee, which then sends their recommendation to the governing body. Reappointment
requires approval of the governing body or a designated committee of the governing body.
Credentialing of Licensed Independent Practitioners
Credentialing and privileging are two distinctly different processes. The credentialing process occurs
before the privileging process is begun. A Licensed Independent Practitioner (LIP) is any individual who
is professionally licensed by the state (U.S.) and permitted by the organization to provide patient care
services without direction or supervision, within the scope of that license. Medical doctors (MDs),
doctors of osteopathy (DOs), dentists (DDSs), podiatrists (DPMs), and doctors of chiropractic (DCs) are
LIPs in all U.S. states. Certain Allied Health Professionals are also Licensed Independent Practitioners
who are credentialed in a manner the same as the medical staff LIPs or through an equivalent process
if allowed by the accrediting organization utilized by the facility .
Credentialing is the verification of the practitioner's right and competency to provide patient care in
the appropriate setting. The credentialing and re-credentialing process involves verification of
compliance with pre-determined standards and criteria concerning:
• Current, valid (state in U.S.) license to practice

• Drug Enforcement Agency (DEA) registration or Controlled Dangerous Substances (CDS)
certification
• Relevant training and education
• Current competence
• Board certification, if so stated
• Work history
• History of loss of license and felony conviction; history of loss or limitation of privileges
or disciplinary actions; challenges to, or voluntary and involuntary relinquishment of,
licensure or registration
215
• Voluntary and involuntary limitation, reduction, or loss of clinical privileges or

termination of membership
• Professional liability claims history resulting in settlements or judgments paid; evidence
of unusual pattern or excessive number of professional liability actions resulting in final
judgment against the applicant
• Current malpractice insurance coverage
• Evidence of physical ability to perform the requested privilege (or) inability to perform
essential functions of the position
These and other items may be different for certain types of organizations and their accrediting bodies.
The accrediting body's standards should be reviewed to determine exactly what is required by the
accrediting organization your facility utilizes. There must be a written process that is followed during
the credentialing process, which describes the actions that the facility must undertake to credential an
individual practitioner. The credentialing information obtained must be maintained in a confidential
manner to assure that the files are only available to authorized individuals. However, the credential
files are considered discoverable in a court of law.
!Primary source verification! is required at the time of initial credentialing and re-credentialing for all
elements required by the state or the applicable accreditation organization. This means that direct
contacts must be made with licensing states, certifying agencies, educational institutions, insurance
carriers, state medical boards, and perhaps other institutions where the practitioner has privileges.
Copies of these documents are not allowed to be accepted as verification since these copies could be
digitally altered. However, there are some, nationally recognized organizations (Table 40) that have
been identified as "primary source" which means that they are designated equivalent sources in
verifying specific items during the credentialing process: Utilizing these organizations eliminates
unnecessary time and money being spent on this process.
Centralized credentialing is another attempt to refine this verification process to streamline the
demands on practitioners to complete multiple applications, credentialing and privileging processes,
and perhaps medical staff appointments. If a practitioner is practicing at several sites within a
healthcare system, the practitioner would have to be reappointed at each facility, but it may not occur
at the same time throughout the organization . This would necessitate the practitioner completing
multiple re-appointment applications and each facility having to absorb the costs of each
reappointment credentialing. By utilizing a centralized credentialing process, healthcare organizations
have one center that completes all the credentialing verification for a given practitioner at one time for
all facilities within the system. The practitioner has one reappointment date, which is the same
throughout the organization. The essence of the system is one credentialing (and perhaps
appointment) application and one-time primary source verification for all providers, and then one
reapplication and information collection process, including profiling for current competency for re-
216
credentialing and perhaps reappointment. A secure-access Intranet site is utilized for systems seeking
to centralize the application and credentialing processes.
Instead of organizations performing this centralized credentialing themselves, many organizations

delegate the credentialing/re-credentialing function to credentials verification organizations (CVOs).
CVOs are accredited themselves by accreditation organizations, so they must meet identified
standards. The contracting organization however must provide sufficient oversight of the CVO and
process to ensure accuracy, timeliness, and completeness.
Table 40: Nationally Recognized Primary Source Organizations for Medical Staff Credentialing
Nationally Recognized Primary Source Organizations for Medical Staff Credentialing
• American Medical Association (AMA) Physician Masterfile-primary source; {medical
school and residency completion plus additional profile information)
• American Osteopathic Association (AOA) Physician Database (pre-doctoral education);

AOA Council on Postdoctoral Training; Osteopathic Specialty Board Certification-
primary sources
• American Board of Medical Specialties (ABMS)-primary source (board certifications)
• Educational Commission for Foreign Medical Graduates (ECFMG)-primary source
• Federation of State Medical Boards (FSMB) Disciplinary Data Bank-primary source

(actions against a physician's medical license)
Credentialing in Managed Care Settings
There are multiple accreditation agencies that accredit managed care organizations, but they basically
have the same types of credentialing requirements. The credentialing function may be performed by
the health plan or may be delegated to participating medical groups and independent practice
associations (IPAs). At the health plan level, if not delegated to a CVO, the credentialing function may
be housed in the quality management department, case management department, provider services,
or contracting department . Managed care credentialing standards requires that a physician be directly
responsible for the credentialing function and that a designated committee, generally called the
Credentialing Committee, make recommendations regarding credentialing decisions, using a peer
review process.
Managed care credentialing standards apply to licensed independent practitioners with whom the
Managed Care Organization (MCO) contracts or whom it employs who treat members outside the
inpatient setting and who fall within its scope of authority and action. Certain hospital-based
physicians with independent contracts to treat MCO members (e.g., anesthesiologists providing pain
management) must also be credentialed. In behavioral health, in addition to physicians, those who
must be credentialed include all practitioners who are licensed, certified, or registered by the state to
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practice independently. Managed care organizations do not award privileges to its practitioner
members, since no actual patient care is provided at the managed care organization . Privileges are
only awarded at the facility where the practitioner practices.
Privileging of Licensed Independent Practitioners
Once the applicant's credentialing process is completed, it is time to move into the privileging process.
Once the centralized credentialing office or CVO has completed the credentialing, the application and
file are returned to the specific facility where the applicant wants to practice. While the credentialing
process can be outsourced from the facility, each individual facility must award privileges to the
practitioner for use in that facility. This process must always be setting-specific, based on services
available, so it has to be accomplished at each provider site. If the facility does not perform a specific
procedure, does not have patients with certain diagnoses, or does not have the staff or equipment to
perform a procedure, the practitioner may not receive privileges for that procedure or to treat that
group of patients.
"Privileging" is granting permission to provide specific medical or other patient care services in the
organization, within well-defined limits, based on the individual's professional license and his or her
experience, scope of practice, competence, ability, and judgment and on the organization 's ability to
provide and support the service. The granting/renewing of clinical privileges (and basic credentialing) is
performed regardless of medical/professional staff membership status, if applicable.
Delineation of Privileges
Clinical privileges are granted individually, based on criteria established by the organization, usually
using privilege lists or groupings that are specific to each department, section, service, or specialty. The
criteria are established by the medical staff to determine the level of competency appropriate for each
privilege, e.g., the number of procedures that must be performed every reappointment cycle for the
practitioner to be considered currently competent and to retain the privileges. Core privileges focus on
a criteria-based core set of basic privileges that a practitioner within a certain specialty should be able
to perform competently based on the education, residency, and internship received. Any privilege
beyond those basic privileges must be individually selected and the practitioner must show
competency in order to receive those privileges. Any licensed independent practitioner given the
privilege to admit patients must be a member of the medical staff .
Privileges are granted for the time period specified in the bylaws or policies and procedures, but for no
more than three or two years as defined by the accrediting organization. Upon initial application, the
information concerning the competency of the practitioner is obtained through the credentialing
process review of education, malpractice findings, reference checks, and other such information.
During the periodic reappraisal process set by the organization, the privileges must be re-requested
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and be renewed, revised, a dded, or deleted, based on information from the practitioner's practice
patterns and review for the reappointment period.
A practitioner may also apply for a new privilege at any time during the reappointment cycle.
However, when this occurs, the practitioner must demonstrate the competencies required for that
privilege. For example, when bariatric surgery first became accepted surgery, the practitioner who
requested this privilege had to meet the criteria established by the medical staff. This frequently
required a set number of didactic trainings and a set number of proctored procedures to demonstrate
the competency. The practitioner would then reapply for this privilege at the time of reappointment,
even if the time period is less than a full reappointment cycle.
Advanced practice practitioners may be awarded clinical privileges as defined by the medical staff
bylaws, yet they are not members of the medical staff. Many times, allied health practitioners have
standing guidelines that define their scope of practice rather than clinical privileges. It is very
important that each facility utilizing advanced practice allied health practitioners understand the scope
of practice that is permitted by the state licensing organization and the resulting clinical privileges
awarded by the facility . The facility does not have to allow the practitioner to receive privileges for all
that the state organization has within their scope of practice, however the facility may not award
privileges that are beyond that scope of practice. These individuals often have medical staff sponsors
who are responsible for the standard of care provided by these individuals.
There may also be primary care community physicians who are members of the medical staff but who
do not have any privileges, and do not admit or care for patients in that setting. These practitioners
may order outpatient tests and services even though they do not have hospital privileges . In fact, any
medical practitioner can order outpatient tests and procedures even if not a member of the medical
staff if they meet the following CMS §482.54 Condition of Participation requirements:
• Practitioner is licensed in the state where the patient receives the care (including Home
Health Services)
• Practitioner is acting w ithin his/her scope of care
• Practitioner is acting in accordance with state law and polices of the medical staff to
order such outpatient tests or care
• Practitioner is responsible for the care of the patient as an outpatient
Practitioner Continuing Education (CE) is required by most states for renewal of the professional
license. Many accreditation organizations also require continuing education for renewal of clinical
privileges. There is a move within the healthcare industry to require that the continuing education be
in the areas of the requested privileges, but this is not required in most cases.
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Special Privilege Statuses
The majority of the time privileges are awarded for the three or two year period, or until the next
reappointment time. However, there are two exceptions to this rule, and these are based on the
clinical needs of the facility.
Temporary Privileges
Temporary privileges are awarded to practitioners in only two circumstances . Both types of temporary
privileges may only be awarded for a period of up to a total of 120 days. If the practitioner is needed
for a longer period of time, the practitioner must apply for membership in the medical staff of the
facility. The length of time that a practitioner can provide patient care under temporary privileges
should be closely monitored, as should the care provided.
The first type of temporary privileges is those given to a locum tenens practitioner. Locum tenens
privileges are given to a practitioner who will be working at the facility to either meet an identified
clinical need or to replace a practitioner who will be absent from the facility for a period of time. For
example, if an anesthesiologist takes a 30 day vacation, the facility will need to find a temporary
physician to fill in for the practitioner so that the number of surgeries can continue in the facility's
anesthesiologist's absence. The locum tenens anesthesiologist will stop practicing there when the staff
anesthesiologist returns. A separate example would be if a hospital does not have a neurologist on
staff, but a patient with a clinical need for a neurologist is admitted, then a locum tenens neurologist is
brought on staff. The neurologist would stop practicing at that facility when that specific patient no
longer requires the neurologist's care. Both of these types of locum tenens practitioners would have to
go through credentialing and privileging process, but in an abbreviated format as defined in the
medical staff bylaws that provides a minimum amount of verified information and w ith the approvai of
the hospital CEO and the Medical Staff president or designee.
The second type of temporary privileges are awarded to applicants to the medical staff who have been
through the credential ing and privileging processes and who are needed or wish to practice in that
facility prior to the completion of the approval process. The application must have no red flags, or
indications that there may be a question about any of the content in the application. Red flags could
include gaps on a physician's resume, resignations from healthcare facilities, multiple reports to the
National Practitioner Data Bank (NPDB), a high number of malpractice suits, or insurance reduction in
coverage over a period of time, and resignations for reasons other than relocation, illness, and/or
retirement. Red flags also include withdrawals of applications for joining a rnedicaIstaff, and receiving
weak or minimal inquiries from other hospitals with very limited information. The application must be
reviewed per medical staff bylaws for the temporary privileges.
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Emergency & Disaster Privileges
Emergency privileges are awarded during an emergency to existing members of the medical staff that
allow them to perform tasks outside of their delineated privileges to save a patient's life, limb or
organ. When a practitioner with the appropriate privileges arrives, the emergency privileges are
relinquished by the first practitioner.
In a disaster, any volunteer independent licensed practitioner who has a picture identification badge
demonstrating membership in a hospital medical staff, and/or membership on one or more disaster
management teams, or other specific organizations, may be allowed to practice at a healthcare facility
during the disaster. Any volunteer practitioner is permitted to do everything possible to save a life or
protect a patient from further or serious harm within the scope of his/her license, regardless of
membership status, credentialing status, or approval of specific privileges. Once the disaster has been
declared as being over, or if a practitioner on the medical staff of the facility arrives to take over, then
the volunteer practitioner must relinquish those privileges. The facility should make every attempt to
verify at a minimum the license, and must provide oversight of the care provided by the practitioner.
Specific requirements for the Emergency and Disaster privileges can be found in the standards of the
accreditation agency utilized by the facility.
!Evaluation of the Practice of Licensed Independent Practitioners!
The evaluation of Licensed Independent Practitioners is an ongoing process that begins when the first
privileges are delineated and continues until the individual no longer practices at the facility. There are
multiple means that are utilized to accomplish this ongoing evaluation. Not all types of organizations
utilize all these methods discussed here, but each could be applicable to multiple healthcare settings.
!Practitioner Profilin
At the time of reappointment, these data from the various methods of evaluation to be discussed here
are utilized to provide information to assist the Medical Executive Committee in the determination of
the privileges to be renewed, discontinued, and so forth with each practitioner.
At the time of reappointment, a practitioner profile should be developed that summarizes the
practitioner's practice during the reappointment cycle. Profiles are practitioner-specific data and
information summaries are used in the reappraisal process, usually in conjunction with re-
credentialing and re-privileging activities. All independent practitioners and other practitioners with
delineated clinical privileges, whether or not they are medical staff members, are profiled, and based
on an ongoing measurement process. Department chairs, section chairs, medical/clinical directors, or
chief medical officers, depending on the setting and structure, must review the profile data for both
positive findings and any areas of concern.
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Practitioner profiles offer the opportunity to summarize all measurement and assessment activities for
each privileged practitioner and should be compared to aggregate information when applicable .
Practitioner profiles represent a "closing of the loop" for performance monitoring and analysis, helping
to effectively communicate appropriate findings to those leaders who need to know.
This profile should be constructed utilizing the information from the Ongoing Professional Practice
Evaluation (OPPE), the Focused Professional Practice Evaluation (FPPE), the peer review that has been
completed, and other such indicators monitored by the facility and the practitioner departments and
groups. Ideally, profiling should be as concurrent as possible, with review, analysis, and reporting at
least quarterly, to identify better practices, as well as permit appropriate intervention in quality of care
and patient safety issues.
In tracking the "WHO" of care as well as the "WHAT" and "HOW," we owe it to our practitioners to
document current competency and care well done-the positive outcomes of the measurement and
analysis activities-and "best practices", along with any significant, confirmed negative variations.
The content in the practitioner profile will differ by the type of practitioner and the type of facility that
is completing the re-credentialing/re-privileging process. Table 41 lists the types of elements that
could be included within the practitioner profile.
Practitioner profiles must be maintained in a strictly confidential environment, electronic or hard copy.
The Practitioner profile and other practitioner practice information should NOT be kept in the
Credentials file. The credentials file is discoverable, while the performance improvement information is
protected from discovery in most cases. The Quality file, which should include the practitioner profile,
cannot be kept in a separate file immediately behind the credentials file as it is then considered part of
the credentials file. It should at a minimum, be kept in a different locked file drawer, or better yet in a
different locked file cabinet, or even better in another room. If the file is kept electronically, it must be
password protected. The Quality information should be released only in accordance with bylaws, rules
and regulations, and/or policy, to authorized individuals or committees, within the limits of the law.
The practitioner profile should be reviewed and signed off by, Medical directors and/or peer review
committee chairs in managed care organizations/health plans or networks and by Department chairs,
at the time of reappraisal for reappointment to the medical staff and re-privileging in hospitals; or by
the Chairperson of the Interdisciplinary Practice Committee, which may be responsible for
recommending to the governing body privileges for allied health professionals.
Table 41: Potential Items for a Practitioner Profile

Potential Items for a Practitioner Profile
Findings from all applicable department-specific and organization-wide required measurement
processes
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PERFORMANCE AN D PROCESS I MPROVEM ENT
Aggregate Peer review findings

Monitoring of clinical processes, e.g., mortality review findings; complications and other peer-
reviewed events with ratings below standard of care; performance on core measures compared
to aggregate
Monitoring of clinical outcomes
Use of operative and other procedures placing patients at risk, e.g., unplanned return to
operating room
Use of medications
Use of blood and blood products, e.g., usage not meeting criteria after peer review (inpatient
and outpatient)
Significant infection surveillance findings, e.g., total inpatients w/verified clean wound
infections; total verified inpatient healthcare-associated infections
Utilization management findings, e.g., readmissions related to previous hospitalization w/in 30
days; total inpatient stays and average length of stay (ALOS); separate total inpatient and
outpatient procedures
Information concerning patient care activity in the organization, e.g., numbers of patients
admitted or treated, numbers and types of procedures performed
Outpatient activity, e.g., unscheduled inpatient admissions due to adverse outcome from
outpatient procedure
Pharmacy and therapeutics function
Patient safety findings, including adverse events, root cause analyses
Risk management findings
Medical record review
Pertinent findings/successes resulting from QI Team activities
Pertinent findings from external review, including the Quality Improvement Organization (QIO),
State Department of Health, private review and case management companies, and managed
care organizations/health plans
Information concerning fulfillment of administrative responsibilities, e.g., meeting attendance,
committee membership, QI team participation, productivity, etc.
Other items identified by the medical staff in the facility/organization/medical group
longoing Professional Practice Evaluation (OPPE)i
Ongoing Professional Practice Evaluation (OPPE) is the ongoing measurement and analysis of each
practitioner's performance relative to existing privileges, including licensed independent practitioners
and others with clinical privileges granted by the organization. All practitioners require that OPPE be
done, not just those with performance issues. OPPE was first required by only The Joint Commission
(TJC), but is now also required by the Healthcare Facilities Accreditation Program (HFAP) accreditation
standards. However, any number of types of healthcare organizations can undertake programs such as
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OPPE with the licensed independent professional practitioners. The specifics of each accreditation
program's OPPE standards should be reviewed when establishing or modifying the OPPE process.
The purpose of OPPE is to provide an ongoing evaluation of the practitioner's performance to assist
the practitioner in making improvements in his/her practice and patient safety. Conceptually it is
similar to the report cards that students receive throughout the year. Elementary and secondary
students receive a report card every six weeks . The parents then encourage the students to mnke
improvements before the next report card is issued. In OPPE, it is designed for the practitioner to
identify his/her weak spots and then undertake efforts to improve those areas of care and
performance. The Joint Commission and HFAP expectations are that hospitals use data to evaluate
practitioners and, if necessary, intervene if there are issues that impact the provision of safe patient
care. This intervention could include additional focused review, proctoring for a period of time, up to
limiting or revoking existing privileges for that practitioner (OPPE, 2017).
The OPPE reports must be completed more than once a year . The TJC considers once a year to be a
periodic evaluation rather than an ongoing evaluation. Therefore, to meet the intent of the standards,
the OPPE reports should be completed no less than every nine months, leading to at least three
reports every two years. However, the Joint Commission's Frequently Asked Questions for OPPE
caution about not having the third OPPE completed before the reappointment is conducted. TJC
suggests that three, six, or eight months should be the time periods to be considered when
establishing or modifying this prog;am (OPPE-FAQ, 2017). In order to accompiish this, many
organizations have determined to spread the different department OPPE reports throughout the
rotating cycle, due to the number of medical staff, advanced practice professionals and the others that
must be evaluated throughout the facility.
The medical staff defines the exact processes to be utilized at that facility to meet the OPPE standards .
Each department and specialty determines the type of data to be collected. Each specialty must have
objective measureable measures that relate to the practice and privileges of that specialty. There may
also then be objective measureable indicators that can be utilized by other specialties within the
facility. For example, the Gastroenterologists who perform moderate sedation may want to identify an
indicator regarding the use of reversal agents. They may also determine an indicator to look at the
length of stay of a certain type of patient population. The indicator data may be obtained by direct
observation, periodic chart review, monitoring practice patterns, or by discussions with other
caregivers.
The information obtained from the OPPE process should then be integrated into performance
improvement activities, including educational efforts for the entire department or specialty. The
department chair should review the information from all members of the department/specialty and
can then identify areas of needed improvement or education for the entire department or specialty .
The department cha ir may be able to identify a specific practitioner(s) who is/are providing the best
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care and can then utilize that person(s) to help educate others within the department/specialty. The
information in the OPPE report must also be reviewed with each individual practitioner to assist that
practitioner in making improvements to his/her care.
At the time of reappointment, the information from the ongoing professional practice evaluation
should be included in the reappointment process. This can be accomplished through the practitioner
profile and/or by including the OPPE reports in the reappointment file. After the reappointment
process is completed, the information MUST return to the quality file and be kept separate from the
credentialing file, as previously discussed.
!Focused Professional Practice Evaluation (FPPE)[
Focused Professional Practice Evaluation (FPPE) is a privilege-specific, time-limited process to validate

practitioner competency when there is no current performance documentation for the requested
privilege(s) at the organization, or when concerns arise about a practitioner's ability to provide safe,
high quality patient care. FPPE was first required by only The Joint Commission (TJC), but is now also
required by the Healthcare Facilities Accreditation Program (HFAP) accreditation standards. However,
any number of types of healthcare organizations can undertake programs such as FPPE with the
licensed independent professional practitioners. The specifics of each accreditation program's FPPE
standards should be reviewed when establishing or modifying the FPPE process.
The FPPE process must be defined before it is utilized in an organization to be sure that it is applied
evenly across the organization. There are four components that must be utilized when developing this
process: Criteria for conducting performance evaluations; method for establishing the monitoring plan
specific to the requested privilege(s); method to determine the duration of performance monitoring;
and circumstances under which monitoring by an external source is required (FPPE-FAQ, 2017). When
conducting the FPPE, only activities performed at that organization may be utilized to evaluate the
practitioners' ability to perform a specific privilege. The process must include when external peer
review may be required, and how that will be accomplished . More information about this portion of
the FPPE process will be discussed below in the Peer review section .
There are two related parts to the FPPE process. The first part is directly related to the privileges
requested by a practitioner . It applies to both new applicants and to existing practitioners who request
a new privilege. When a new privilege is requested, the practitioner must demonstrate competency
regarding the performance of that privilege (FPPE -FAQ, 2017). There is no exception for practitioners
who are board certified, or have documented experience or reputation. There could be a tiered
approach utilized. The type and length of the review can be different due to different privileges, the
type of the practitioner, and experience of the practitioner. For example, if a resident performs his/her
residence at a certain facility and then applies for membership to that facil ity, the time period for the
focused review of the privileges delineaed many be different from a resident who performed his/her
residency elsewhere but then determine to apply for membership at this facility.
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The second part of FPPE addresses what has been previously called Peer Review. The standards
require medical staff to develop criteria to be utilized to determine if practitioner performance issues
can be identified that may affect the provision of safe care (FPPE-FAQ, 2017). This part of FPPE states
that the medical staff should develop triggers that indicate a need for performance monitoring of a
practitioner's care for the provision of safe, and quality patient care. These triggers can be either a
single incident or patterns or trends that are identified. Triggers include sentinel events, complaints,
undesired patterns or trends, or other obvious events. The OPPE results m;:iy ;:ilso indicate a need for a
more focused review of a practitioner's practice. Incident reports may also lead to the need for FPPE of
a practitioner's practice.
!Peer Review\
Peer review is intensive, in-depth review involving either an individual practitioner or patient or group
of identifiable patients. It may result from the findings of ongoing performance measure data
collection and initial analysis, utilization review, infection surveillance activities, occurrence or event
reporting, a sentinel event, team QI/Pl activities, and/or data aggregation with internal or external
comparisons (averages or benchmarks) . It is a significant component of practitioner appraisal.
The purpose of peer review is to identify patterns outside recognized standards, behavior problems, or
other circumstances, which endanger the safety or care of patients. It is also used for upgrading the
practitioner's clinical knowledge, enhancing his/her medical practice, reducing medical errors and
improving patient safety and care. Peer review is used to protect patients, assure due process to the
practitioner under investigation and preserve the immunity of the medical facility and medical staff.
The analysis of cases should be reviewed for the following factors: clinical management, timeliness of
medical interventions, adherence to a facility's clinical pathways and/or established guidelines for
medically appropriate care, medical record documentation, professional conduct, and other reasons as
requested by the facility.
Documentation of the peer review must be maintained in the practitioner's quality file, not their
credentialing file. Peer review information is protected by law from discovery. If it is kept in the
credentials file, it loses that protection. Federal statutes and state laws have determined how much
protection is given to keep this information undiscoverable. The HealthCare Quality Improvement Act
and the Patient Safety & Quality Improvement Act are two such federal statutes. These acts basically
state that any actions that are handled appropriately by the health care facility through the facility's
peer review committee are protected under the peer review process. This would include the
documents, evaluations, minutes, and other such materials
If the medical staff bylaws, and written peer review policies and procedures are not followed, the
information can become discoverable. If the peer review information is discussed outside of the peer
review process, there is a loss of protection. The peer review protection can also be waived by any
which individual committee member in informal discussions with colleagues. Physicians should not
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place any notations in a patient's chart regarding peer review activities. The physicians should also not
involve or discuss the peer review actions w ith the patient or others outside of the peer review
process.
In the provider organizations, peer review is the responsibility of the appropriate department, section,
or specialty and generally is delegated to a committee. Some hospital medical staffs and medical
groups now use a multidisciplinary physician peer review committee to provide case-specific review
and evaluate all physician care, obtaining specialist peer review for specific physicians as deemed
necessary. In managed care, health plans may describe the required peer review activities under the
Quality Management Committee. Regardless of where the peer review is completed, the committee
must consider their conflict of interest policy, possible actions based on findings, corrective action
plans, and any required reporting to the state medical board, to the National Practitioner Data Bank
(NPDB) (www.npdb.hrsa.gov), and to other contracted entities.
The peer review process typically results in a rating of the care provided by the practitioner. Peer-
reviewed findings generally are ranked, e.g., by following a simple four-point scale, such as the one
listed below:
1= Peers would have managed care in the same manner
2 = Patient outcome unaffected by the variance
3 = Peers would have managed care differently
4 = Negative outcome resulted from the variance
Organizations will implement their own language for the above ranking that supports the processes at
that facility. There is even discussion in the literature to use a three ranking system. The specific
system that is utilized must be consistent throughout the facility for all peer review that is conducted.
At the time of reappointment, the aggregate number of peer review findings is typically included in the
practitioner profile. When this occurs, the number recorded on the practitioner profile must include a
denominator value of the total number of cases that were reviewed, which were rated 1to 4.
Typically, peer review begins w ith an initial screening of data to determine if the medical staff
established criteria for a process has been met. The established criteria must be approved by the
medical staff before it is utilized for this purpose. If the criteria have not been met, then the file is sent
to the peer review process established for the appropriate review. Some examples of initial screening
indicators but not limited to these, would be Radiology film and Pathology slides over read; EKG over
reads; Blood usage review; and Operative and invasive procedure reviews. Other types of reviews
would include reviews of house-based physicians and single specialists. If the criteria are met, the peer
review case is scored utilizing a value of 1. When a value of 3 or 4 may be assigned to a peer review
case, the practitioner(s) involved must be invited to come to the next meeting and present his or her
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side of the story. If a score of 3 or 4 is assigned to the case, then there must be action taken to address
the issue with the practitioner involved. The medical staff will determine the appropriate action to be
taken. Throughout this review process, there must be documentation to support every step in the
process.
INTERACTING WITH CONSULTANTS
The quality professional is called upon to develop, implement, direct, coordinate, facilitate, and
manage over time so many different slices of the organization's quality pie. For this reason,the quality
professionals are in a unique position to recognize if and when external consultative support may be
necessary. Consultants may help relieve pressures stemming from knowledge, time, or staffing gaps.
The critical success factor, however, is getting the right person.
Word of mouth tends to be the best method of obtaining a good consultant or consulting firm.
References for consultants do not have to be as restrictive as when referring an employee. The rules
for fulltime employee references do not apply to a reference for an independent consultant. The
Request for Proposal (RFP) process can be very cumbersome when multiple RFPs are received. If RFPs
are utilized, they should be a closed RFP, which is sent to a small number of consultants. The RFP
should be as explicit as possible by clearly defining the project and the requirements of the consultant
(Proposal, n.d.).
Selection of a Consultant
The key to a successful association with consultants is a strong working relationship. A contract is
important, but a relationship of mutual respect, trust, and confidence is the basis for getting the work
done on time and in accordance with your specifications. The organization must decide the type of
consultant they desire. Consultants are frequently utilized for interim managers, interim staffing
needs, and for project management. Within project management, there are again three types of
consultants. The project management consultants can point out problems and give recommendations
for improvements, or complete both of those and then assist with actually accomplishing the product
or improvements. Table 42 lists the steps that should be taken during the discovery and hiring process
for consultants.
Table 42: Consultant Selection Process Steps

Consultant Selection Process Steps
Consultant Selection Process Steps:
• Set goals for the project. What exactly do you want the consultant to do for you?
• List everything you need done. Can the consultant deliver?
• Decide, on the basis of the goals and needs, what type of consulting you want:
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- Project management, with a team approach?
- One highly organized consultant to complete the project on time, then leave?
- What type of expertise and resources do you expect the consultant to have or
have access to?
- What is the budget? How much can you spend to get the job done?
• Network: Talk to colleagues: [Word of mouth referrals are valuable references.}
- Which consultants/companies do they recommend and why?
- Which do they not recommend and why?
• Check out the advertising (mail, email, web sites, and journals): Do they promise to
deliver the services you need?
• Make a list of the positives and negatives for each consultant/company. On that basis,
narrow the list to no more than four or five.
• Interview the "finalists" by telephone, presentation, or proposal.
• Ask for references (or the last three clients) and call each one to get their opinion of
the company and people.
• Ask for disclosure and explanation of any relationships the consultant/company has
with vendors.
Communication with Hired Consultants
Once the consulting company is hired, it should be an immediate priority of both the organization and
the consulting agency to each identify a team leader. Any communication between the organization
and the consulting team must flow through the respective team leaders. If this chain of
communication is not maintained, several issues may arise. A staff member from the organization may
ask a specific consultant to send him/her a policy that can be modified for the specific setting. The
consultant team member sends the policy to the organization team member. If the team leaders are
not informed of this action, they may assign the same activity to two other individuals within each
organization. This leads to confusion and misunderstandings.
Deliverables
It is incumbent on the hiring organization to identify what is expected of the consultant with r egard to
time, material, staff, and expertise (knowledge, problem solving, creativity, innovative ideas). The
relationship between the consultant(s) and the organization must be explained and accepted. This
includes what the organization expects, the accessibility of the consults, if the consultants will remain
onsite or off site, and how the communication between the two organizations will be handled.
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The exact deliverables must be identified prior to the contract being signed. The details of the
deliverables will frequently drive a portion of the cost of the consultation. For example, if the client
requires a verbal report versus a detailed written report, the cost of the consultation may be different.
The time frames and deadlines that are required must be stated and agreed upon. The consultant
should have the ability to execute quickly, to produce value, and to bring speed to value. These
expectations and deliverables become the basis upon which the organization monitors the
consultant(s)' performance, progress and results.
The organization must confirm in the contract that all information or knowledge gained while working
on a project either belongs to the organization or can be used and modified by the organization on an
ongoing basis. The respective team leaders must meet together and participate, or have designated
participants in all consultant activities for ongoing deployment; monitor all deliverables to hold
consultant accountable.
!OM/Pl/PS/ACCREDITATION ORIENTATION, TRAINING, AND EDUCATION!
In the age of quality/performance improvement, education is the 11name of the game" for the entire
organization, and the quality professional must assume the role of facilitator, educator and consultant,
more than the role of doer. The quality professional must understand both performance improvement
and educational concepts and their implications within the organization and be able to teach them to
others. The quality professional must have good teaching skills and workable plans to implement new
ideas. The quality professional must also evaluate the effectiveness of the educational training,
especially if it concerns utilizing performance/quality training for teams.
!orientation of Quality, Risk, Patient Safety, Accreditation, and Utilization Management!
Every individual who works for the organization requires three stages of orientation : the organization,
the department, and the job. As is commonly known, the organizational orientation is quick
information loaded in several days. The new staff members are not going to remember much of the
material introduced to them during those first few days.
As such during the first organization orientation program, an overview of the quality arena in macro
concepts should be presented. The organization's commitment to quality of care and patient safety
should include all pertinent statements, such as quality management philosophy, continuous quality
improvement concepts, performance improvement model and how these fit with the mission, vision,
and values of the organization. This should also include an introduction to the roles of risk and
utilization management.
When the new employees move to their department, a more in-depth orientation should occur.
Typically, a departmental orientation feels like a scavenger hunt to find items such as the fire hydrants,
exits, utility rooms, nutrition rooms, supply rooms, equipment, and such are located. Within that
230
department orientation however, should be the identification of how the specific department applies
the performance improvement principles to identify and to improve processes within the clinical and
non-clinical departments . This should include employee and visitor safety processes. It should be
emphasized that all staff members of the department are to be actively involved in improving quality
and patient safety, reducing risk, and as appropriate the utilization aspects of the department. This
could include display of Pl materials for staff and others to see within the department, attendance at a
department quality meeting, and so on. It also could include the process used when the employee
identifies opportunities for improvement within the department. It is important to emphasize early on
that all members of the department are involved in the performance improvement process. If this is
not accomplished in the departmental orientation, it must be introduced in the job specific
orientation.
As the new employee begins the orientation to their specific jobs, the orientation should include
aspects of quality, risk, patient safety, accreditation, and as appropriate utilization . It is important to
note that performance improvement is not limited to only clinical areas, but should be ingrained
throughout all departments of the facility. What the employee does in their work filters into quality
improvement and even the quality control processes. Most new employees have an orientation
checklist to complete, especially if it is a clinical position. This orientation checklist could include some
aspect of data collection, analysis, improvement, etc., or simply meeting with the individual{s) who are
doing those jobs on the unit. It is important for the new employee to recognize that performance
improvement can be as simple as changing a form, moving equipment around in the department, or
other relatively easy changes to improve work processes and patient care.
!orientation and Training Topicsl
Different levels of positions need different levels of quality, performance, risk and utilization
orientation and training. Table 43 contains a list of topics that could be utilized at all levels of the
organization.
Table 43: Example of Potential Orientation Topics

Example of Potential Orientation Topics
• QI/Pl philosophy, management, and methods
• Organizational culture, mission, vision, and values
• Patient- and other customer-centered performance improvement
• Important organization functions
• Teams, team process, and team process tools, as applicable
• Shared expertise, information, and ownership
• Change process
• Confidentiality and conflict of interest
• The organization's QM/Pl approach and methodologies
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• Statistical process control, data collection and analysis, as applicable

• Specific current Pl activities :
- Strategic quality initiatives and alignment with strategic goals
- Performance measures-organization wide (e.g., a balanced scorecard), cross-
functional, and relevant department-specific, as applicable
The governing board, senior administrative leaders and medical staff leadership, (as well as all others
in the organization), require an understanding of the quality, performance improvement, risk, patient
safety, accreditation, and utilization activities and processes conducted within the organization. These
individuals are less likely to be involved in the detailed improvement efforts, but are held responsible
to assure that these activities are occurring as needed. These individuals will be more responsible for
the identification, prioritization, and resolution of the issues and opportunit ies for improvement. At
this level, the orientation and training should include:
• The required accreditation orientation topics
• The specific organizational application of quality
• QM structure, system, processes, and improvement "approach"
• Strategic goals and initiatives
• Organization wide performance measures, e.g., balanced scorecard
• QI teams (Ad hoc and ongoing/cross-functional) and empowerment of teams to make

decisions
• Linkages between measurement and analysis activities and QI team contributions
• Communication linkages between governing body, administration, practitioners
• Development, facilitation, and leadership of QI teams
The directors and department managers are the individuals who must motivate their employees to
identify opportunities for improvement, participate on teams, make improvements, and most
importantly, sustain the gain from improvement efforts. Licensed independent practitioner
department and committee leaders also will be involved at this level to some degree . These individua ls
should receive the orientation and training of the leaders of the organization as listed above. Directors,
managers, and licensed independent practitioner leaders should also receive training regarding the
corporate mission, vision, values, and cultural philosophy about people; the patient population served
and type and nature of care provided; and the individual staff/practitioner member needs. Topics that
may be included in the departmental leader level are shown in Table 44 . In addition, it is important to
assure that they are competent in assisting their staff about how to carry out improvement activit ies
and how to engage their staff in the processes of identifying and making improvements.
232
Table 44: Director/Manager/Department Level and Above Orientation and Training

Director/Manager/Department Level and Above Orientation and Training
For:
- QM/Pl staff, including all reviewers
- Department managers and medical directors
- Administrative leaders
- Medical staff/practitioner leaders, members, panel, or group
- Governing body
Orientation should include information about;
- Organizational mission, vision, and values
- Governance, policies, and procedures
- Department/service policies and procedures
- The individual's job description
- Performance standards/expectations
- The organization's plant, technology, and safety management programs, and the
individual's safety responsibilities
- The organization's quality management/performance improvement activities and the

individual's role in these activities
- The organization's infection control program and the individual's role in preventing
infection, if applicable
Staff and licensed independent practitioner orientation, training, and education are based on the
identification of opportunities for improvement, participating in making the improvements and
sustaining the gains from the improvement efforts. Specific training such as data collection, analysis,
and data display may be essential for specific members of the department staff and practitioners, but
remember that if the information is not utilized, then it is often not remembered when it is needed.
Just-in-time training should occur when the improvement teams are established based on the needs of
the team members and the improvement opportunity. All of the tools and other processes that could
be utilized within the team should be included. This will serve as a refresher for some and as new
education for others.
233
!Education/Training Program Development Process!
The educational program development process is very similar to the performance improvement
process. The concepts of Plan, Do, Check, and Act can be identified. There are three tables included
here that contain additional information for an effective teaching/learning process.
Plan: The plan dimension begins with a needs assessment of the topics requiring education. It also
includes the identification of who needs what training, how will they best learn, what are the
necessary outcomes of the training, and what resources are available.
Once the needs assessment is completed, the goals and learning objectives are identified. It is also
important to determine how the goals and objectives will be measured. The leadership must also
support this educational plan.
The learner characteristics are identified. Learners have different expectations and learning styles. An
auditory learner learns best by hearing, so a lecture would be appropriate . A visual learner learns best
by seeing and being able to draw a picture of what is being described or discussed. A tactile learner
learns best by touching and doing. It is likely that any group will be composed of all three types of
learners, and appropriate instructional strategies should be utilized. Lecture, demonstrations, and
discussions are all effective tools.
The educational course is then developed. The course materials are selected and the instructors are
selected and trained. A pilot test course should be done, and the appropriate revisions made, before
the actual course is conducted.
Do: The course is administered.
Check: Two types of checks should be conducted. The first is an evaluation to determine if the goals,
objectives, and outcomes were accomplished . This might include fewer falls, lower use of restraints,
more medication error reporting, more immunizations being given on time, etc., depending on the
type of improvement project. The second check should be the gathering of input from the class
attendees to determine what worked well and what did not.
Act: Changes should be made to the educational program before it is administered again. This can
include the exclusion or revision of the topics presented, the addition of supplemental information, a
change in Lhe setting in which the education was held, or other such activities .
Tables 45, 46, and 47 provide other information about adult education, and teaching tactics that the
quality professional may find useful.
234
Table 45: Adult Learning Concepts

Adult Learning Concepts
Adults:
• Are motivated to learn when THEY identify they have a need to learn
• Are motivated by societal or professional pressures that require a particular learning

need
• Can be motivated to learn when the benefits of a learning exper ience outweigh the
desire to resist
• Use their knowledge from years of experience as a filter for new information and do
not change readily
• Learn best from their own experiences
• Prefer to determine their own learning experiences
• Like some lectures.All lectures won't be liked by alladults
• Like small group discussion
• Want practical answers for today's problems
• Enjoy practical problem solving
• Hate to have their time wasted
• Like physical comfort
• Like tangible rewards and benefits from training
• Refreshments and breaks establish a relaxed atmosphere and convey respect to the
learner
235
Table 46: Dimensions of Effective Teaching
Dimensions of Effective Teaching

Instructor knowledgeable
• Being accurate, factual, and up-to-date in
healthcare quality
• Directing staff, physicians, administration to

useful research and references
• Objectively identifying and analyzing concepts,

principles, and problems
Ir.t ::,,action skills • Establishing and maintaining :.:.pport

• Controlling interaction to meet the objectives
• Creating a climate of mutual respect
• Stimulating active participation
• Eliciting lively exchange/discussion
• Reading body language to determine if minds
are being turned off or on
Organization and clarity • Getting the message across
• Making oneself understood
• Systematically and effectively:
- Stating learning objectives
- Presenting ideas in a logical progression
- Placing emphasis where appropriate
- Summarizing succinctly and timely
- Using well chosen examples and illustrations
Enthusiasm and stimulation • Awakening interest and stimulating response
• Using movement, humor, voice inflection to
prevent boredom
• Conveying charisma,self-confidence, and an
enjoyment of teaching
236
Table 47: Teaching Tactics
Teaching Tactics
• Involve learners in the lesson:
- Identify their needs
- Ask questions
- Role play, discussion, writing
• Provide reinforcement/feedback to the learners:

- Smiling, gestures
- Knowledgeable answers to questions
• Utilize effective questioning techniques

• Exhibit enthusiasm:
- Focus on the audience
- Act enthusiastic, even if not feeling like it at the moment
• Be a professional role model:
- Practicing skills, standards, and values to be developed by others

- Being accessible
- Providing opportunities to discuss practical applications of knowledge and skills
and apply problem solving approaches
- Being self-confident and self-critical
- Assuming responsibility
- Recognizing one's own limitations
- Showing respect for others
• Utilize appropriate teaching methods/learning activities:
- Lecture
- Discussion
- Discovery or inquiry-oriented discussion, case study
- Socratic (asking questions)
- Independent study units, small groups, case study
- Demonstration
- Practice
- Role playing (scenario)
- Simulation (script)
- Testing
237
This chapter presented an overview of performance and process measurement.The information in this
chapter is key in establishing and maintaining performance improvement for the organization. Without
strong, committed leaders, the chances of having a strong robust improvement program is decreased
even with the information provided here. The leadership must support and communicate that support
to all in order for an improvement program to be able to sustain its efforts overtime. As a
Quality/UM/RM/PS/accreditation manager you are also a leader, and while you may not have
positional power, you have expertise and influence that is key to your organization's success.
238
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WEBSITES
PERFORMANCE AND PROCESS IMPROVEM ENT
Agency for Healthcare Research and

http://www.ahrq.gov
Quality (AHRQ)
AHRQ Community Quality https://ahrq.gov/professionals/quality-patient-
Collaboratives safety/quality-resources/tools/l ocalnetworks/index.html
AHRQ Effort to Prevent and reduce https://www.ahrq.govIresearch/findings/factsheets/erro
Health Care Associated Infections rs-safety/ha iflyer/index. htmI
AHRQ Health Care Report Card
https://caha ps.ahrq.gov/apps/rcc.aspx
Compendium
Case Management Society of America
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(CMSA)
Center for Disease Control (CDC) http://www.cdc.gov
CDC National Healthcare Safety
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Network
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Patient-Assessment-
CMS - Strategy
lnstruments/QualitylnitiativesGenlnfo/CMS-Quality-
Strategy.html
Consumer Assessment of Healthcare
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Providers and Systems (CHAPS)
Consumer Reports Healthcare Rankings http://www.consumerreports.org/cro/hea lth/index.htm
Department of Veteran Affairs Clinical
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Practice Guidelines
https://www.medicare.gov/dialysisfacilitycompare/searc
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FDA's Reduce Medication Errors http://www.fda .gov/Drugs/Reso urcesForYou/Consu mers
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Focused Professional Practice http://www.jointcommission.org/jc_physician_blog/ oppe
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http://www.ihi.org/resources/Pages/Tools/lHIGlobalTrigg
Global Trigger Tool
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Harvard Business School (HBS) http://www.hbs.edu
Health & Human Services (HHS) http://www.hhs.gov
Health & Human Services (HHS)
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Measure Inventory
http://www.healthpolicyohio.org/wp-
Health Data Transparency Basics
content/ uploads/2014/01/transpa rencybasics.pdf
249
Health Grades http://www.healthgrades.com

http://www .ncqa.org/HED ISQualityMeasurement/HEDIS
HEDIS
Measures.aspx
Home Health Compare https://www.medicare.gov/homehealthcompare
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Grievances Certification/SurveyCertificationGenlnfo/downloads/SCLe
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Inpatient Rehabilitation Facility (IRF) https://www.medicare.gov/inpatientrehabilitat ionfacility
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(IHI)
Institute for Safe Medication Practices
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Insurance Coverage https://healthcare.gov
The Josie King Story http://www.josie king.org/thejosiekingstorydvd
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Reporting e/
I Managed Care COPs for Co- plaints http://www.cms.gov/Regulations-and-
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tm
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250
Evaluation (OPPE) _fppe_tools_privi leging_decisions

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ml
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Standards Categories
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Transition of Care
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Triple Aim
efault.aspx
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US News Healthcare rankings http://health.usnews.com
World Health Organization http://www.who.int
251
HEALTH DATA ANALYTICS
CHAPTER 4
Susan Mellott, Kathleen Tornow Chai
CPHQ Examination Content Outline Task Statements For This Chapter

Organizational Leadership
1.A.7 Assist in evaluating or developing data management systems (e.g., data bases,
registries)
1.B.1 Assist the organization in maintaining awareness of statutory and regulatory
requirements (e.g., CMS, HIPAA, OSHA, PPACA)
Health Data Analytics
2.A.1 Maintain confidentiality of performance/quality improvement records and reports
'
2.A.2 Design data collection plans:
a. measure development (e.g., definitions, goals, and thresholds)
b. tools and techniques
c. sampling methodology
2.A.3 Participate in identifying or selecting measures (e.g., structure, process, outcome)
2.A.4 Assist in developing scorecards and dashboards
2.A.5 Identify external data sources for comparison (e.g., benchmarking)
2.A.6 Collect and validate data
2.B.1 Use data management systems (e.g., organize data for analysis and reporting)
2.B.2 Use tools to display data or evaluate a process (e.g., Pareto chart, run chart,
scattergram, control chart)
2.B.3 Use statistics to describe data (e.g., mean, standard deviation, correlation, t-test)
2.B.4 Use statistical process control (e.g., common and special cause variation, random
variation, trend analysis)
2.B.5 Interpret data to support decision-making
2.B.6 Compare data sources to establish benchmarks
2.B.7 Participate in external reporting {e.g., core measures, patient safety indicators,
HEDIS bundled payments)
Performance and Process Improvement
3.A.2 Assist with establishing priorities
3.A.3 Facilitate development of action plans or projects
3.B.2 Use a range of quality tools and techniques (e.g., fishbone diagram, FMEA, process
map)
3.B.3 Participate in monitoring of project timelines and deliverables
3.B.6 Document performance and process improvement results
253
Patient Safety
4.A.3 Participate in risk management assessment activities (e.g., identification and
analysis}
4.8.3 Use safety principles:
b. high reliability
c.systems thinking
4.B.4 Participate in safety and risk management activities related to:
a. incident report review (e.g.,near miss and actual events}
b. sentinel/unexpected event review (e.g., never events)
Words and titles of sections that refer to task statements from the CPHQ Exam Content Outline are
indicated throughout the Handbook with a ox around the texq.
For many individuals when they hear the terms quality improvement and performance improvement
they only think of the clinical aspects of a healthcare facility. This view is as limiting as a driver only
looking at whether or not the car needs gas. Eventually the car breaks down because no attention was
paid to the oil light or the tire inflation light. Information management in healthcare is more than
simply analysis of the patient medical record. The information within a healthcare system
encompasses all aspects of the business. All of this information should be utilized for performance
improvement throughout the facility.
There are many instances where participants have little or no information management knowledge or
ability to use this knowledge to its fullest potential in performance improvement. The level of
Information Literacy (IL) of the individuals who are trying to make improvements and decisions is
important. Understanding Information Literacy is to understand all its components . From a research
perspective, Information Literacy involves having the following skills: 0Be able to identify, evaluate, and
select search tools; Have thorough knowledge of search strategies; Be able to evaluate and select
sources accordingly; Adhere to legal and ethical practices when using IL skills" (Robertson & Felicilda-
Reynaldo, 2015, p. S26). Another source, the American Library Association, describes an information
literate individual as one who knows what information is needed, knows where and how to abstract
that information efficiently and effectively, critically evaluates the information and its source, adds the
selected information to one's own database, uses the information effectively to accomplish the
desired purpose and understands the economic, legal, and social issues surrounding the use of
information, and accesses and uses information ethically and legally (ACRL, 2000) .
Many years ago, all the information one needed to run a hospital was kept in detailed logs or ledgers:
financial data, patient data, staffing data, and so forth. However, more and more of the data are kept
in computer systems. The utilization of these computer systems evolved over time, with little
recognition that both clinical and non-clinical data often need to be combined to get to the necessary
information that will guide organizational decision-making.
254
What follows in this chapter are several sections on information management. The first section
describes data, including definitions and sources, data collection techniques, ethical and legal issues
when dealing with data, and the use of information technology. Next this chapter discusses processes
used to transform the data into information, including measurement and display. The final portion of
the chapter deals with using the data as information to demonstrate optimal outcomes or effect
changes needed for improvement.
DATA
In today's quality driven health care environments, valid data is needed to provide support for
changes. Statistically valid data, that assists in identifying better and best practices, and in explaining
patterns of care, are valuable in identifying problems in the provision of care.
Two definitions are important to understand information management: "Data" is the collection of
uninterrupted observations or facts. "Information" is what happens when data are aggregated
together, analyzed, and interpreted into a form useful for decision-making. For instance, suppose a
medical surgical unit had three patients who experienced falls with injury in the last month. That is
data. It becomes information when you apply statistics to define the rate, severity, and outcomes. This
additiona l information will allow the user to understand not only the severity of the issue, but also
what actions may need to be taken. The goal of information management is to utilize data to support
decision-making to improve processes and outcomes.
There are pressures to produce reliable and valid information to improve aspects of healthcare. These
pressures are both internal and external to healthcare organizations. Quality improvement leads one
to utilize information that is reliable and valid. Deming's Total Quality Management principles presume
the need to base decisions on timely and accurate data, not on wishes or hunches. Statistical quality
control demands use of factual information.The integration of clinical and financ ial data is increasingly
important for financial surviva l in this age of diminished reimbursement . The transparency of data on
the internet allows consumers to be aware of how a healthcare organization operates, how the
practitioners practice, and what outcomes and costs are associated.
Where are these data found?
Healthcare information is used in clinical/service decision-making, organizational/strategic decision-

making, performance improvement efforts, education, and research. There are at least three types of
information systems utilized in healthcare to assist with decision-making and the care of patients:
Administrative Information System; Clinical Information System; and the Decision Making Information
System. The Administrative Information System includes the financial, billing, inventory, supplies
management, human resources, risk management, and quality management, information, as well as
policies and procedures. The Clinical Information System includes the electronic medical record,
pharmacy, and laboratory data. The risk and quality management utilize the Clinical Information
255
System to gather the patient data that are needed to identify opportunities for improvement. The
Decision Making System, sometimes known in business as decision support, takes information from
the other two systems and additional information and uses it to assist the organization in the decision-
making processes. Most organizations and practitioners utilize Administ rative and Clinical Information
Systems, but decision-making systems are seldom used because the coordination, leadership, and
integration required involves many individuals and layers within an organization (Byrne et al., n.d.).
Prior to integration of information in larger software systems organizations had two basic data
keepers; Finance and the Health Information Management (HIM) Department or the Medical Record
Department. However, it has been suggested that, "HIM could be headed for the C-suite. Corporate
HIM directors-an emerging role that is expected to grow by 2025-are beginning to form within
integrated health systems with multiple hospitals. These corporate HIM directors manage a set of
functions being carried out by HIM professionals within various hospital departments, rather than
managing HIM within the traditional HIM department structure" (Dimick, 2012, para 25).
!Aggregate Datal
Information comes from data which must be collected and aggregated. The organization must have a
process for aggregation and summarization of data that is consistent with its nature and will impact
patient care. During the development of the collect ion process, it should be determined what groups
or persons are responsible for the treatment of data. There should be time frames established for
tabulation, display of raw data, statistical analys is, and reporting. The data must be aggregated and
displayed, summarizing and trending over time. This allows the users to determine the type, cause,or
extent of problems, and to determine the type and cause of best practices. The data must be
summarized in ways to permit meaningful interpretation and formulation of accurate conclusions
regarding the quality of patient care and services. Since many individuals are visual learners, graphic
displays shou ld be used whenever reasonable to enhance understanding of analyses.
When data are collected, it is just that: a set of data points that have been collected. It is not until we
aggregate and summar ize the data points that we have information about what is happening,and then
we can determine what needs to be done, if anything, to make improvements. If a picture is taken
outside in a town on a certain day, it only shows what the weathe r was like at that point in time. It
cannot be used to describe or predict the weather at any other point in time; it is a piece of data.
However, if the pictures are arranged in a photo album, with one for every day in the month, the user
can begin to descr ibe what the weather is like in that town for that month. The data points have
become information. Information can then be utilized to make decisions about whether one is likely to
need a coat when going outside during the particular month.
If we are to make appropriate decisions to truly improve care and services over time, we must collect
quality data that converts into understandable, useful information:
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DATA c:>c:> leads to c:>c:> INFORMATION c:> c:> leads to c:>c:> KNOWLEDGE
c:>c:> leads to c:> c:> DECISION MAKING
Without good data, we rely upon our opinion, logic, intuition, rationalization, rumor, and/or hearsay to
lead us to recommendations and hopefully appropriate action to improve the quality of care and
service. In essence, we had no defined process for decision-making. In a database model of decision-
making, the information management function closely resembles the scientific method, as shown in
Figure 1. In this figure, work flows from the design to knowledge. The design is based on the
proposal/hypothesis, which leads to data collection, and then through statistical analysis, leads to
information. Information then must be interpreted and understood to lead to knowledge and
knowledge leads to both appropriate decision-making and to additional hypotheses to be tested by
this cycle.
Figure 1: Decision-Making Process
Decisions
Interpretation I Knowledge Proposal /

Understanding
thesis
INFOR MATION
Information MANAG EM ENT Design
CYCLE
Statistical
Coflection
Analysis Data
Quality professionals must collaborate with other collectors, analyzers, and users of data to learn of all
information resources available. Issues with data collection include: Access to the data/information
(authority, securities, etc.); Availability of data/informat ion in the form/format needed; and Timeliness
of data/information access (how close to real time is data collected, downloaded, etc.).
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!Data Definitions!
When developing a questionnaire or other data collection tool,there are certain terms that need to be
understood and considered, especially if clinical performance measures are being collected.
ensitivit: The ability of a measure, test, or tool (study design, screening tool, or lab test) to
identify and select all positive cases or specified variations or deviations (all cases in the category),
with few "false negatives". This means that the creator includes all of the appropriate descriptors of
the data to be gathered. The developer must determine how sensitive/inclusive the measure should
be. For example, if the collection tool just asks for the number of falls, then that is all the data
provides.The recipient would not be able to determine what shift the fall occurred, where the fall
occurred, and so
on. However, if the collection tool was inclusive enough to ask for the number of falls, the unit on
which the fall occurred, and the shift it occurred on, then the tool is more sensitive and the data can
be analyzed in ways that provides more information.
peci ficit : The ability of a measure, test, or tool to differentiate between the cases wanted and
those similar, but not in the desired category, and to exclude those negative cases - fewer "false
positives". The question to be asked is what do you want and not want to include. However, if the
question is too specific, it may not be sensitive enough. The tool may specifically address the patient
who is 65 years of age or older. No one who is younger than 65 will be asked to answer the questions.
llitratificationl : The classification of data into homogeneous groups or subsets. If the user wants to
stratify the results, then the collection tool must be able to gather all the needed information to allow
for the stratification of the data. An example would be the study of Urinary Tract Infections (UTls) by
organism, by catheterization, by surgical procedure, and by nursing unit. All this information must be
captured within the collection tool.
lusabifit: The relative ease with which the indicator can be understood or the tool can be used. Have
you ever taken one of those surveys or tests that states "If you answered yes, go to question 23. If you
answered no, go to question 42"? This type of collection tool can be very confusing and thus not very
easy to complete.
IRecordabilit : The ability of the indicator or tool to identify, capture, and measure the needed
information. When answering questions on a Scantron form, the bubbles must be completely filled in.
If a mistake is made, the marking in the bubble must be completely erased without tearing the form.
This represents difficulty in recording the answers to the questions.
!Goal A numerical value that defines the significance level of the data that is desired for decision-
making.
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: A numerical point at which there should be some action taken (see Chapter 3 Performance
and Process Improvement).
jrhresho/: A numerical point below which the data should not fall or the point or level at which
something begins or changes.
!Benchmarhl: A standard or point of reference against which data may be compared or assessed.
Indicators and tools that are developed and utilized must be both reliable and valid. Reliability is
defined as the ability of the indicator or collection tool to measure in a reproducible way what it is
supposed to measure. Validity is defined as the capability of the indicator or collection tool to measure
what it is supposed to measure; its predictive value as a measure of quality. There are numerous ways
to determine reliability and validity and these will be discussed here.
!Reliability and Validit
!Reliability!:
Reliability is the ability to reproduce the same results if there are no interventions or changes between
measurements. Also, if there is an intervention between measurement, then the results should move
in the direction that is desired. There are two different kinds of measurement of reliability: Test/Retest
and lnterrater Reliability .
Test/Retest Reliability is simply what it sounds like. A question, survey, test or other such tool can be
used to measure an indicator or collection tool twice. If there is no change then the indicator or tool is
said to be reliable. If there is a change and it is in the desired direction, that also indicates reliability.
For example, if a class was given a pretest on ceramics, then sat through a lecture that was on
ceramics, when they were post-tested you would expect their score to rise on the posttest about
ceramics. If the lecture was about quality, and the post-test was the same or similar to the pretest,
there should be no change in the student scores. That would indicate that the ceramic test is not a
reliable tool to utilize to measure the effects on a lecture about quality. So, in one case it would be
reliable (ceramic lecture) but in the other case it would not (quality lecture).
The other kind of reliability can be determined through lnterrater Reliability test. This is utilized when
you have more than one person utilizing an indicator or data collection tool and you need each
individual to interpret and apply the indicator or tool in the same manner. To obtain lnterrater
Reliability, the indicator/tool should be developed and then the data collectors must be educated as to
how to apply the indicator and/or utilize the data collection tool. Once that has been completed, each
data collector must complete a data collection experience on several records or other items being
examined. For example, there are three individuals who are going to collect data on the completeness
of the medical record documentation. Each of the three individuals could possibly interpret where and
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how to collect the data differently from the other two individuals. This could result in incomplete data.
With lnterrater Reliability, the data collection tool would be developed and the individuals educated as
discussed. The first of the three individuals would be given three records and instructed to collect the
data utilizing the tool that was developed. When that individual is done, the second individual is asked
to collect the same data on the same medical records utilizing the tool, and so on until all the
individuals have completed the extraction of the data . The data collected by all three individuals is
then compared together and a rate of agreement determined. An interrater rate of 95% agreement
should be the goal to have 'reliable' data collected. If there is not a 95% agreement, then there is
either something unclear about the tool or the education that was given.Changes should be made and
then the testing repeated until there is at least a 95% agreement.
&a1idit
Validity is the ability to measure what is really desired to be measured. If the data collection occurs
utilizing a topic that is not correct, then there will be data that is not usable for that project. For
example, the ceramic test discussed in the Reliability text above is a reliable tool,but it is not valid to
utilize for a lecture on quality. There must be reliability of an indicator/tool before there can be validity
of that indicator/tool. There are three types of validity that will be discussed here: Face
validity, Criterion validity, and Construct validity.
Face Validity is the least valuable and precise of the validity tests. Face validity simply means that the
indicator/tool "looks" like it covers the topic. It is clear that the ceramic test does not apply to the
quality lecture, but the quality test look like it does apply. Unfortunately, face valid ity may be
misleading. Continuing with the quality lecture example, while the test has face validity one must
determine if it includes the topics include in the lecture or is it just general quality information. Relying
on face validity is not good enough in healthcare.
Criterion Validity is the type of validity that should be utilized for most of the healthcare definition and
collection tools. Criterion validity utilizes some criteria that have been developed previously to write
the indicators or the content of the tools. This could be as simple as utilizing the policy and/or
procedure requirements for the measurements. The items in those documents would be the criteria to
utilize to ask the questions. Also, the criteria of what you want to know could be developed and then
the questions written from that criteria. For example, if the Outpatient Surgery department would like
to know how their Day Surgery patients are doing after they go home, the department could
determine what it is that they want to know. This could include if the patient is having pain, any
bleeding, any difficulty getting medications, and so forth. These would then form the basis for the
questions to be asked.
Construct Validity is an even higher level of validity, but this type of validity is difficult to determine.
Constructs are defined as an idea or theory. It is a subjective versus objective measure, is not based on
empirical evidence and thus can be elusive to measure. Patient satisfaction is a construct and thus
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hard to measure. Your personality type, how happy or hungry you are, and how excited you are to see
someone are all constructs and thus hard to measure. This has led to most healthcare organizations
utilizing tools from organizations such as Press Ganey, Gallop, and NRG Picker to measure the patient
satisfaction of their patients. Without research and statistical measures, healthcare facilities would
often not be able to develop these types of measurements.
!Data Inventor
Many healthcare organizations know that data is being collected throughout the organization.
However, many do not know where the data is coming from, what definitions are utilized, how the
data is being analyzed, or where it is reported. A database application can be utilized to maintain this
information for use throughout the organization. The purpose of a data inventory is to identify the
data that individuals actually need so that the information can be accessed without duplication of
efforts. "If you're going to undertake a data inventory, your output should be structured so that the
next person doesn't have to repeat your work . Identify the data that is moving across various systems,
as this indicates key information that is being shared. Categorize this data by subject area . You will
inevitably find that there are inconsistent versions of the data, enabling you to identify data
disparities. You can then begin to develop a catalog of key corporate data that will form the basis of
your data dictionary" (Levy, 2010).
A data inventory can be utilized to keep track of all data and related documentation and information
that is being created or acquired. The data inventory consists of what the data means, how and where
it was collected, what definitions were utilized, how the data was analyzed, who owns the data, who
has access to the data, who manages the data, and how the data can be used and shared.
Since the data inventory will be utilized by many different individuals, the departments that will be
involved should be included in the design and implementation, including someone from the IT
department who will be involved in creating the database . Involving all these individuals can
encourage them to be part of the maintenance of the data inventory system. To begin this process, all
of these individuals will collect the information that is needed to be entered into the project. The
success of this project will depend on the quality and accuracy of the information input into the
system . In order to obtain high quality and accuracy, the team members must be trained as to how to
collect the data. The team must determine exactly what is to be collected and in what format. The
team must also determine if they are going to collect data used for internal and/or external purposes.
The organization and the team must determine what information to include in the data inventory. It
must be determined what data is currently being used and by whom . During this collection process, it
will be noted if there is duplication in the use of the data being collected throughout the organization.
An example of this duplication would be if the ED is a designated Chest Pain Center, they must send
data in monthly to the Chest Pain Center Accred itation Agency. The Emergency Department may
collect their data from the ED and Cardiac-Cath Lab logs. Many of these measures are the same or
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similar to those collected for CMS Core Measures, which are collected from the medical record itself.
The organization may determine that these two measure sets are very similar and could be collected
by one group and shared with the other instead of being collected in two different parts of the
organization .
The reason that the data are being collected must also be determined. There is often data that are
collected because it "always has been collected". There may not be any current need for the data or
information produced from those data. This is called the DRIP principle or "Data Rich but Information
Poor" when data is collected but not analyzed into information. It may also be determined that the
data were once useful in the form it was collected, but now it needs to be collected differently in order
to have better information about a process or system. It must also be determined with whom the data
and information must be shared for use in decision-making processes. Once the scope of the data
needed is determined, it can be collected and maintained in the data inventory. This must be
maintained over time, so the data inventory process must be repeated frequently as determined by
the organization. An individual in the quality department should be assigned the task of keeping data
updated. The inventory should be updated on an annual basis or when major changes are
implemented.
!Potential Data Sources!
The potential sources of healthcare data are numerous and vary depending upon the type of facility
and the type of care given. Data sources can be internal or external to the organization. In Tables 1and
2 are listed potential internal and external sources of healthcare data.
Data that comes from internal sources have many benefits but there are also weaknesses. One of the
benefits is that data are available for analysis and use as soon as it is collected. Internal data are best
utilized when there is a desired change to a process or an outcome. One of the weaknesses is that there
frequently is little reliability of the data collection method and thus the data may not be correct.
Table 1:Internal Example of Data Sources

Internal Example of Data Sources
• Patient/client records
• Ongoing quality control/measurement summaries
• Patient surveys, interviews, questionnaires
• Staff surveys
• Direct observation
• Clinical reports/profiles (pharmacy, lab, blood bank,etc.)
• Medication records
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• Clinical review findings, e.g.:

- Operative/other procedures
- Medical record review
- Medication use
- Blood/blood component use
- Pharmacy and therapeutics function
- Mortality reports
- Autopsy reports
- Functional outcome status
• Variance reports, e.g., clinical paths
• Demographics/registration data
• Indexes, registers, and logs
• Infection control reports

• Occurrence/other generic screening reports/summaries, including sentinel events and root
cause analyses
• Risk management/claims reports

• Utilization/case management reports
• QI team reports
• Patient safety reports and \FMEA\s
• Environmental safety reports
• Patient bills
• Case mix reports
• Financial reports
• Clinical research reports
• Department/service QM reports and minutes (physician/LIP, nursing, and ancillary/support
services)
• Self-assessment/pre-survey reports
Data which comes from external sources also has benefits and weaknesses. One of the benefits is that
the data from the organization can be combined with the data from other facilities. This gives the
facility an opportunity to benchmark with other facilities that are similar to the one submitting the
data. Several weaknesses include the fact that the data are frequently not available for months after it
is collected. This makes the data less useful when attempting to change processes or outcomes, as
these may have changed since the time the data were collected.
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Another weakness is the fact that the different organizations collecting and reporting data may not
have used data definitions in the same manner. This could result in data that are not similar to that in
the facility that will be utilizing the comparison results. Another weakness is the fact that external data
can be old when published for use and infrequently updated. Data from the Center for Disease Control
(CDC) that is posted online is often two or more years old. In 2016, the CDC posted its 2014 National
and State Healthcare-Associated Infections Progress Report online. In this report, the data is from 2014
and is compared to the national baseline obtained in 2008-2009 (CDC, 2016).
Table 2: External Example of Data Sources

External Example of Data Sources
• Reference databases/performance measure report systems/compilations (e.g., CMS
National Quality Initiatives, Maryland Quality Indicator Project, HED1s , etc.) (see also
Transparency and Public Reporting in Chapter 3 Performance and Process Improvement)
• Accreditation reports
• State inspection/licensure reports
• Third party payer and employer reports
• CMS and QIO reports
• Registry reports
• CDC reports
• Recent scientific, clinical, and management literature (e.g.,MEDLINEPlus)
• Sentinel event alerts (e.g.,The Joint Commission)
• Evidence-based practice guidelines and clinical algorithms/protocols (medical colleges

and boards; National Guideline Clearinghouse)
• Well formulated/updated performance measures (e.g., National Quality Measures

Clearinghouse)
• Validated clinical pathways
• Identified best practices
• State/regional/national rates and thresholds
• Comparative report cards
An example of how data are processed when sent from an external source is the process used by The
Joint Commission and CMS with their Core Measure sets. Data are collected for a quarter (for example,
January, February, and March) and then sent to a vendor, usually in the month following the quarter
(April). The vendor then 'scrubs' the data. The vendor will apply statistical processes to determine if
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there are errors in the data. If it is not "clean", the data may be sent back to the facility for correction.
Some vendors select certain patient records to be abstracted by a second person at the facility to
determine if it has been extracted correctly (inter-rater reliability), as another source of data
verification . Once the vendor has completed this process, the data from different facilities are
combined in the database for analysis. The reports are then produced and sent to facilities for their
utilization. This process will typically take one to two months, or more. Results are then sent to The
Joint Commission or CMS by the end of the fourth month (July) after the initial quarterly data
collection was complete. It is at this point that the Joint Commission and CMS again repeat data
scrubbing and the combination of all data into the database for the measures. It is then sent to
facilities and posted on the internet, usually 1-2 months after it was received by the vendor
(September). By this time, many healthcare facilities have already begun to r11ake changes to processes
and the data have lost some usefulness .
In order to make healthcare data more accessible and useable, the government and other agencies
have established programs that will help them obtain aggregated data. Although many such programs
exist, meaningful use, ICD-10, indexes, and registers will be discussed.
!Benchmarking!
The term "benchmark" was defined above. It is very useful when using data since a benchmark sets
the standard the organization wishes to achieve and gives guidance to the usefulness of its own data.
Sometimes the benchmark is O or 100%. For instance, Medicare and Medicaid (CMS) implemented
regulations in 2010 regarding payment for healthcare acquired infections. When these preventable
infections occur, CMS imposes financial penalties for them. Thus, the benchmark is 0. Other
benchmarks are not so strict and allow an organization to move toward improvement without an all or
nothing approach. For instance, patient/customer satisfaction is required to be measured in many
organizations, and the data are usually aggregated, analyzed and sent back to the organization by an
external vendor who provides benchmarking data from organizations who perform well.
However, there are several factors that need to be considered when using internal or external data to
compare outcomes. The first is similarity between institutions. Comparing data related to patient falls
should be done between similar institutions. It would not be reasonable to compare an acute care
hospital's rate of falls with that of a skilled nursing facility, or even a mental health facility that offers
acute care. The populations of each organization are not similar so the findings would not be
comparable. The same caution would apply when fall data are being compared internally. The critical
care unit or the medical surgical unit should not have the same goals, as the care that is given to
patients in each of these areas is very different, as a re the patients.
Secondly, when comparing data between one place and another, it is useful to compare only ra te
based information. Going back to falls, unit A & B in the acute care hospital may both be medical
surgical units. However due to the building structure one unit houses 30 patients and the other unit
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houses 15 patients. There needs to be a way to compare them but it is not the number of falls. 5 falls
in one month on the unit that houses 30 patients is not the same as 5 falls the same month on the other
unit. So how do we compare? The literature describes 2 different ways, one being more accurate than
the other. The unit that has 30 beds may have a monthly census of 150 patients. Therefore, the rate
of falls for that unit is 5/150 or 3.3% of the patient fell. The unit that houses 15 patients had a total of
100 patients so that unit's fall rate is 5/100 or 5%. An even more accurate denominator is the number
of patient days. Patient days are calculated by multiplying the number of patients, by the number of
days each stayed. Therefore, the unit with 30 beds and 150 patients has 450 patient days, and 5
falls/450 patient days equals 0.011 falls per patient day. The smaller unit with 100 patients had 200
patient days. 5/200 means that this unit had 0.025 falls per patient day. Which unit has more falls?
Benchmarking is something that is frequently done but beware of the pitfalls related to comparing
apples and oranges. Sometimes the answer is not clear and you may end up with fruit salad.
!GENERAL DATA COLLECTION METHODOLOG
Timeframes
Data can be collected in several different timeframes .
jProspectivej data collection occurs prior to care being rendered. Before a patient is accepted in a
Rehabilitation or Home Health facility, someone from the receiving facility goes to the patient to
assess if the patient meets the requirements for admission. For an acute Rehabilitation facility, for
example, the patient must be able to tolerate three hours of physical therapy a day.
jconcurrentj data coiiection occurs while care is being rendered. Medical record review is best
conducted while the patient is still receiving care. If nothing has been done, it can be corrected while
the patient is still being treated. For example, AMI (Acute Myocardial Infarction) data is often collected
while the patient remains in the hospital. In many organizations, this process serves as a checklist and
reminds individuals to make sure the process is in place, improving data as it is collected.
jRetrospectivej data collection occurs after the care is rendered. For example, mortality data can only
be collected retrospectively. Sometimes quality monitoring occurs retrospectively as a chart review to
determine if there are patterns and trends in the data.
jFocusedl data collection occurs when only cert.:iin topics are the focus of the data collection. The data
are based on predetermined priorities (nonprobability sampling), rather than measuring the entire
population (100%). Infection control and prevention utilizes focused data collection based on the types
of infections that occur in the facility. Focused monitoring occurs with predetermined, high priority
(high frequency/volume, high risk, problem-prone) issues, based on previous study, mandated criteria
(e.g., CMS, accrediting body), or other baseline information. Issues, processes, or even practitioners
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"focused out" may require periodic measurement by the representative sampling method in order to
verify that improvement is maintained or to validate current competency.
Once the time frame of the data collection is determined, the type of data collection must be selected.
The data collection methods can be accomplished through the review of paper records or through an
automated method such as an electronic health record. The types of data collection methods listed in
Table 3 are only a sample of those which can be utilized.
Table 3: Data Collection Methods

Data Collection Methods
--
Type of Collection Method Description of Method
Continuous or periodic measurement Routine, systemat ic collection of information over
time, either concurrently or retrospectively, e.g.,
utilization review; tracking of structure, process, or
outcome indicators (performance measures); blood
or medication use reviews, etc
Targeted studies or audits Generally retrospective, criteria-based assessments
of care, using document review (or a combination of
document and encounter/claims data), focusing on
structure, process, and/or outcome
Service-specific studies Based on the major services provided, functions
performed, and problems identified or suspected
(usually document review or check sheets/logs for
processes)
Generic screening Reporting each occurrence (retrospective) of a
(events/occurrences/incidents) predetermined list of possible untoward events,
typically used for actual or potential adverse and
sentinel events and tracking over time for
patterns/trends
Medical records Concurrent (preferred) or retrospective review of
inpatient, outpatient, emergency, home health
medical records, etc.
Summary reports Retrospective of patient and staff occurrences
(incidents or critical events), clinical complications,
infections, utilization, services, committees,
research, organizat ional evaluations, credentialing,
special studies
Daily logs Concurrent review of surgical, neonatal, emergency,
cancer registry,urgent care, clinic, etc.
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Monthly data logs, check lists, etc. Statistical data to be tracked over time, e.g., number
of encounters/admissions, referrals or transfers, C-
Sections/ VBACs, radiology procedures, deaths,
newborns <500 gms, etc. Rates can also be
calculated and tracked, then summarized and
displayed in graph form
Financial reports Concurrent and retrospective d.ita including case
mix, claims, reimbursements, denials, costs per
case, etc.
Direct observation and referral Informal or criteria-based surveillance (concurrent)
of process of care and compliance with established
procedures or standards
Surveys or interviews Patients, staff (concurrent or retrospective) written
or face-to-face questions concerning perception of
care delivery, outcomes, and problems
--
Reports from external agencies or Retrospective data, which are usually received
reference databases months after the data, has been collected
!Population & Samplin
One of the steps in developing the design of a data collection project is to determine the population to
be studied and to determine if sampling is required. Unless the population is small in number,
sampling will be utilized. The type of sampling utilized has a great effect on what can be done with the
data and information obtained. The population can be static (not changing) or dynamic (changing) and
this will affect the type of sampling that is utilized.
The population is defined as 100% of the possible group to be studied, whether they are individuals,
objects, events and so on. Some examples of populations include:
• All cases encountered/admitted for a particular diagnosis
• All cases with a particular treatment or procedure performed
• All cases with a particular complication identified
• All physicians/licensed independent practitioners, or from a certain department or discipline
• All the patients who received care in a clinic during the month
• All cases with a particular medical device ordered
When the total population is small, such as in a small rural or critical access hospital where only 10
units of blood were transfused in a year, then all of the population (units of blood) should be reviewed.
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There is power in having a larger sample size, but in healthcare, it does not necessarily make sense to
wait until you have a larger number of transfused units of blood before the units are monitored.
Sampling is not appropriate with very small populations. In most cases, the population is larger and
sampling will need to be used.
A sample in statistics is a subset of a population or a group drawn from a larger population. The
purpose of sampling is to measure only a portion of a total group or population for high volume
aspects of care and service in order to achieve an accurate representation of the entire target
population (such as all ambulatory patients, a specific procedure, diagnosis, DRG, or all cardiologists),
and to generalize the results to the larger population based on sample findings.
In determining the type of sampling to utilize, there are several factors to consider. The first factor to
consider is the characteristics of the population that the sample must represent. You want to have a
sample that is representative of the characteristics of this specific population which you are studying.
Another factor that must be considered is the location and time period from which the sample must be
drawn. If the sample must be obtained within a short period of time, or if travel to collect the sample is
prohibitive, this will affect which type of sampling is utilized. The type of sampling technique utilized
must assure that the sample accurately represents the population. If you are looking at patients with
Pneumonia and you only select your sample from those patients seen in three months out of the year,
you are not accounting for the effects the weather and other factors that might affect these patients.
The selection of a sample also must not introduce a bias. Selecting your sample to assure that your
assumptions are supported is introducing a bias into the study.
There are two types of sampling: Probability and Nonprobability sampling. The names tell you whether
you can generalize your findings to the population or others. Probability sampling increases the
probability that the findings can be generalized to other populations. Nonprobability sampling lessens
the probability that the findings can be generalized to others. In healthcare, we typically use a
combination of probability and nonprobability sampling. The more probability sampling is used, the
higher the opportunity to generalize the findings. Probability sampling introduces statistical techniques
into the selection process, thus permitting the reviewer to draw inferences about a population. It
assures that each case in the population has an equal and independent (random) chance of being
selected, therefore, the final sample is "representative" of the entire population.
[ypes of Probability Sampling Techniques)
imple Random) sampling that uses a Table of Random Digits (available in all statistical software)
to select the persons/cases from a list of every case in the defined population, with each case having
an equal chance of being selected. This is similar to putting all the names into a hat and pulling out
one name to receive a door prize. Everyone present has an equal chance of being chosen to be included
in the sample .
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Wtratifled Random! sampling utilizes two or more homogeneous categories or dimensions of a

population and samples an appropriate number of persons/cases that are representative of the
category. The studies regarding the signs and symptoms of heart attacks needed to study women and
men since heart attacks appear different in each group. Equal numbers of the women and the men
would be chosen randomly and then included in the study .
Wystematic Randoml sampling utilizes a system to select the sample. All of the population is !isled and
then the first case is randomly selected; and then selecting every nth case, thereafter, based on
standard/fixed intervals, e.g., every 5th referral to a specialist by a primary care physician in an HMO
after random selection of the first case.
ypes of Nonprobability Sampling Techniquesl

[
Nonprobability sampling is an intentionally-biased way to sample, involving qualitative judgment about

an issue that is suspected to be common or widespread. Examination of a relatively few cases is
assumed to be enough to reveal the nature of the problem and its probable causes. However, since
this methodology does not include techniques to estimate the probability that each case will be
included, the results cannot be generalized to the entire population without further study.
lconveniencel sampling utilizes data that is most readily available, e.g., all patients seen in the
Emergency Department (ED) in a given week . If convenience sampling is utilized, the findings could not
be generalized easily to patients that come to the ED at any other time.
!auotal sampling utilizes portions or percentages of persons/cases in a stratified population (subset),

e.g., 10% of male patients with both diabetes and heart disease. A quota sample limits the ability to
draw conclusions outside of those studied because there may be differences between those who were
chosen and not chosen . In the example provided, 10% of the male patients do not assure that the
entire population is similar to those selected due to the small number sampled.
IPurposiv sampling selects persons/cases/issues because they demonstrate a desired characteristic

that can be measured against specific, predetermined criteria, e.g., all patients over age 60 with total
hip replacements. Purposive sampling was utilized in the first heart attack studies, which were only
conducted utilizing male heart attack patients because they came to the ED with a heart attack more
often than the women. As we now know, women experience different symptoms than men when
experiencing a heart attack .
!sampling Size!
There are ways to determine the necessary sample size in research, but there are no such rules for to
determining the best sample size of quality monitoring and performance improvement projects.
However, there are several general guidelines. In general, the larger the sample size the more
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predictive the findings will become. For example, if there are 20 people in a room and you ask the first
four people how many children they have, you may get answers such as zero, one, two, and one. If you
were to ask the people to raise their hands if they have the same number of children (zero - one), a
number of hands will go up. The small number of four people sampled usually does not yield findings
that describe the entire group. However, if you were to ask ten people (50%) there should be fewer
hands raised when asked if they do have more children than those that were polled. There may be one
person who is different and has the highest number of children among this group.
A general rule of thumb that has been followed by many organizations is 5% or 30, whichever is
greater in the population being studied . If this rule is followed, thirty records, events, etc., can be
measured and deemed adequate. It is not until there is a population of 600 to choose from that 5%
equals 30. How the apply the 5% or 30 rule is a matter of choice. If there is a large population to be
studied every month, then 30 records a month should be audited. If there is a small population to be
studied every month, then 30 records a quarter would be a better sample size. Several of the
accreditation organizations, such as The Joint Commission and NCQA, have established their
requirements for sample size and these should be utilized as appropriate.
Other considerations in determining the sample size and type of sampling utilized will depend on what
is being studied. If licensed independent practitioners are being studied, a representative sample of
the medical records of all the practitioners should be studied, which is not usually considered
completely random. For example, if blood utilization is being monitored, every practitioner who
ordered blood should be included in the review of the records over time.
Successive samples can be measured, an average (arithmetic mean) calculated for each sample and a
frequency distribution made of these means. The data will approximate a normal distribution that is a
symmetrical bell-shaped curve (See the discussion of a standard deviation later in this chapter).
If there is only one sample, then use "N" to designate that sample; if samples are taken from each of
several populations or groups, use a small "n" for each sample. For example, if the total number in the
sample is 50, the sample size would be represe_nted as N = 50. If a portion of the sample are men and
some are women, they would be represented as "Males n = 30", and "Females n = 20" (HyperStat,
n.d.).
\Data Collection Tools!
The type of tool used to collect data will depend upon what you are trying to measure. When selecting
a tool to utilize or develop, you want to keep the tool as short and simple as possible. However, you
need to make sure you include all the data elements that you want to measure. The data definitions
previously discussed must be considered in the selection of the tool that will be used. Computerizing
the data collection tool should always be considered. This will enable the data to be analyzed easily
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and decrease the chance of data entry errors that occur when someone inputs the data from paper
into the computer. All tools have pros and cons you need to choose the tool that best fits your needs.
!Data Sheets/Work Sheets! are frequently utilized for extracting data from the medical record. If
developing the tool yourself, you need to pilot it before it is used for data collection. If the data sheets
are created elsewhere, you need to determine if extra columns or rows are required to assure you
capture all of the data you need. One of the drawbacks of using this a collection tool that is on paper,
is that it runs the risk of data entry errors.
!check Sheets/Tally Sheets! are other forms for recording data. These tools are designed to facilitate
interpretation directly from the form. These tools are useful when you are counting something to see
how often it occurs . These tools limit the detail collected to that which is listed on the forms and limits
the amount of analysis that can be done with the data collected .
!surveys/Questionnaires! are frequently used to get feedback from a large group, e.g., assessment of
how patients feel about the care they have received. Surveys are also used in employee and physician
satisfaction measurement. An educational needs assessment is often conducted in the form of a
survey. This tool is best for assessment of customer needs, expectations, or satisfaction. The
survey/questionnaire can include open ended questions for the person to enter text as answers to
questions. This limits the data analysis that can be done since this is considered qualitative data (see
Data Types iater in this chapter). The survey or questionnaire could also utilize yes or no responses or
use of a Likert scale to broaden the scope of possible answers and allow the responder greater choice
in how the question is answered . One of the drawbacks of surveys is the low level of response typically
received. If there is a return of 30%, the data collection is considered successful. Frequently though a
smaller percentage of responses is received. While this does not negate the purpose of the data
collection, the small numbers received will hinder the probability of generalizing the results. Another
drawback of the use of surveys is the time frame over which the survey is distributed to the
responders. The closer to the time of the experiences in question to when the survey is distributed,
the greater the response will be. The method of delivering the survey (paper vs. computerized), the
length of the survey, and the difficulty in completing the survey, all contribute to whethe r the survey is
completed or discarded by the responder . The language of the survey must also coincide with the
primary language of the responder. The surveys that are produced by companies such as Press Ganey,
Gallop, and NRC Picker will have construct validity, while those developed otherw ise will only have
criterion validity at best (see Validity discussion in this chapter) .
A JFocu!> _ Groupl is frequently used to determine how a particular group of representative individua ls
feels about a certain topic, product, etc. Focus groups are often utilized in qualitative studies. A focus
group is used to generate ideas and help formulate interview questions to be utilized later. Focus
Groups use open-ended questions to obtain qualitat ive input from those in attendance (Schmidt &
Brown, 2015). Groups consist of six to twelve participants with a common interest. The persons in the
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focus group should not know each other well. The researcher or data collector can act as the facilitator
of the group or as an observer who listens and takes notes. A focus group is typically audio or visually
recorded. There can be multiple groups that are asked the same questions in the same order in each
group. Upon completion of all the groups, the responses are transcribed and reviewed and the
answers given separated into groups during the analysis. Since the answers received are qualitative
data, the analysis is limited, but can be very valuable . The focus group can be helpful in that it brings all
the participants to one location for the data collection, and usually the participants who agree to
attend are willing to voice their opinions and insights with the group. One of the barriers to the use of
focus groups is that the recording, transcription and analysis can be very expensive and time
consuming. In addition, since participants were purposively selected, the findings are not very
generalizable.
!collection Principles and Concepts!
Data collection is a process that begins with assessing what data are needed, and whether or not it is
possible to collect. If the organization has developed a data inventory, as previously discussed, this
assessment will be expedited . If time and resources are scarce, one might want to start by seeing what
data are available and then retrofitting the needed information to information available.
Data collection support organizational functions that require performance measures/indicators .

Organizational leaders identify interdisciplinary quality teams to oversee the design of data collection
methods, maximize the use of data already being collected, minimize duplication of effort, maximize
accuracy, maximize the organization's computer capabilities, and coordinate data collection efforts
across departments, services, and QI Team activities . The group (department, service, committee) or
QI Team with the most knowledge of the process being measured will be best able to set triggers for
further analysis, identify sources for data collection, and determine the most appropriate data-
collection methodology . The collection methodology can be paper based, automated or a hybrid of
both of these (Figure 2).
Figure 2: Data Collection Continuum
Hybrid of Manual
Automated
manual and
Cost Efficient automated Resource Intense
Automatic Scheduled
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In deciding what data to collect, you need to determine what data adequately describes actual patient
care provided or service rendered (point of care). In addition, it is important to use accurate measures,
including, as necessary, generic screens, rate-based indicators, objective criteria, survey or interview
results, and feedback from patients, families, staff, and vendors. The data must also be applicable to
the specific measure/indicator that is utilized. Detailed criteria may be necessary, either to obtain
adequate data for a specific measure/indicator or to provide objective evaluation of a process or
pattern.
The individuals selected to collect the data will depend on the type of data being collected, their
knowledge of the issues, the method of collection, and other factors. The data should be collected at a
frequency and duration sufficient to evaluate effectively the care and service under consideration. For
example, patient/customer satisfaction data are important measures that can change quickly, so the
organization wants to make sure data are collected at least monthly, and reported and analyzed with
minimal delay. Waiting for quarterly data would delay intervention and might put the organization at
risk of having to "catch up." Base the frequency and duration of data collection/compilation on the
number of patients affected by the care and service being measured, the degree of risk involved in the
care or service and the regularity with which the aspect of care or service is rendered.
!Data Collection Process!
!coordinate Data Collection!

When it is time to collect the data, it is best to review the processes described to this point. The
purpose for the performance measure should have been determined and the population of interest
defined. The sampling method(s) of the population established and the measures determined
(including the numerator and denominator. If you need a refresher on numerator and denominator,
try the Khan Academy quick tutorial (found in the website list at the end of this chapter).
How the data are to be analyzed must be determined up front. Determine the appropriate statistical
and non-statistical tools for data analysis (see Data Analysis later in this chapter). Determine how you
will want to display the information obtained from the data. This will assure that all the necessary and
desired data will be collected in the correct format to do the desired analysis.
Collect a baseline sample to determine the usefulness of the collection tool. This needs to be done to
assure that the tool collects the required data and the ease of recording the collected data. Once the
tool has been verified for this project, the personnel who will collect the data must be trained. This will
assure inter-rater reliability of the data collectors and assure that the data is collected in the same
manner every time (see Reliability discussed later in this chapter). If software is not used to collect the
data, the personnel must be trained on how to enter the data correctly into the computer database.
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!validate Data lntegrit
Once the data is collected, it must be organized and scrubbed (validated), before it can be analyzed.
Many times, there are mistakes in the data, so it is important that you review the data looking. Check
for obviously incorrect (out-of-range) numbers. For instance, maybe the math is done wrong and it
adds up to more or less than 100%. Are the answers scored correctly? Validate a few to see.
One way to validate the data collection is to have someone not involved with the first data collection
recollect data for a small portion of the sample already collected. The second collection should yield
the same results as the first data collection. If it does not, then the data collected is suspect, and a
larger sample should be studied. Data that are not the same on both collections should not be utilized,
unless validated on a third try.
!using Excel to Validate Data Col/ecte
This is best done in an electronic format such as Excel or Access (for more information about Excel, a
spreadsheet program, and Access, a database program, go to the website list at the end of this
chapter). Most often, Excel is used. It is best to keep all of your data on a single worksheet. Each piece
of information you have been collecting data on or variable should have its own column and
correspond to just on piece of information. Do not utilize a zero if there are no data available for a cell.
The zero becomes a value that will be utilized by the statistical software. Instead, be sure that there
are data for every cell. If you are using numerators and denominators to figure percentages, ratios,
etc., utilize two columns, one for each variable and a third column for the derived variable
(percentage, ratio, etc.). If you are going to utilize codes for data, put the codes in a separate
worksheet. If you think that you will remember the codes when you return to the data, you may be
mistaken. You can also write notes about the data, but that should also be in a different worksheet.
You should note for each variable if it is nominal, ordinal, interval, or ratio since this information might
be needed for data analysis . You also need to be consistent with how you enter the data. If the data
requires a 'No' response, do not use 'negative' or 'neg'. If everything is in CAPS, keep it all CAPS. If you
are using UpPeR and LoWeR cAsE, keep it the SaMe. Also, assure that there are no spelling errors or
typos. It is best to restrict the number of people who will enter the data, or make certain they
understand the data entry standards that are being utilized. Enter the data exactly as collected and do
not guess, approximate, or round up/down.
It is best to make a copy of the original data and use the copy to scrub the data. You can call the
original data "original" or "raw data". To "scrub the data" means to examine the data for obvious
errors. If you make a mistake in scrubbing the data, you can refer back to the original data. Table 4 lists
the type of items to look for when scrubbing your data. Excel also has formulas that can be utilized to
assist with cleaning the database. Make sure terms are used consistent ly .
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Table 4: Items to Look for When Scrubbing Data

Items to Look for When Scrubbing Data
• Obvious errors as you look over the data
• Check for difference in how dates are entered
• Blank cells
• Negative numbers when there should only be positive numbers
• Positive numbers when there should only be negative numbers
• Numerator larger than Denominator it this should not be possible
• Variables expressed differently within a column
• Numbers that are greater than zero if they should not be greater than zero
• Calculate the minimum, mean, and maximum for each column looking for errors or
erroneous outliers
LEGAL AND ETHICAL CHALLENGES WHEN DEALING WITH DATA
[Protected Health Information[
The Health Information Management department (which today has many other titles including
Medical Records, HIM, Heaith Information Technology, etc.) has a critical role in information
management. It is in this department that medical records are transcribed, coded and stored (unless
the records are electronic), and all components verified and data transmitted to external agencies as
required by law. There is a close relationship between the Health Information Management
department, the Quality Management department, and the Information Technology department.
These departments may fall under the same umbrella and report to the same department head or
manager. They must work together to assure there is the required technology and software in place to
meet the information needs of the organization. There are currently national initiatives that make this
collaboration a necessity. The regulations and rules requiring the use of ICD-10, meaningful use of
certified electronic health record (EHR) technology, and common data formats are currently driving
this collaboration.
In August 2003, the Institute of Medicine (IOM) and the Department of Health and Human Services
started a movement toward electronic medical records (EHR capabilities, 2003). A committee of the
Institute of Medicine of the National Academies identified a set of eight core care delivery functions
which the electronic health records (EHR) systems (also called electronic medical record - EMR)
should be capable of performing in order to promote greater safety, quality and efficiency in health
care delivery. The eight core functions of an EHR are: (1) health information and data; (2) result
management; (3) order management; (4) decision support; (5) electronic communication and
connectivity; (6) patient support; (7) administrative processes and reporting; and (8) reporting and
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population health. This list of key capabilities was used by Health Level Seven (HL7), one of the world's
leading developers of healthcare standards, to devise a common industry standard for EHR
functionality that would guide the efforts of software developers. The report was sponsored by the
U.S. Department of Health and Human Services as part of a public and private collaborative effort to
advance the adoption of the EHR systems.
In January 2015, the Office of National Coordinator for Health Information Technology of the
Department of Health and Human Services released a report called Connecting Health and Carefor the
Nation, A Shared Nationwide Interoperability Roadmap for achieving EHR secure information exchange
and use of EHR's in healthcare systems (ONC, 2015). This report focuses on actions that need to be
taken to enable individuals and providers throughout the continuum of care to send, receive, find and
use a common set of electronic healthcare information nationally by the end of 2017 (Conn, 2015). The
common data sets consist of 20 basic elements including patient demographics, lab test results, and
identifiers for a patient's care team members. The plan also includes a call for both the government
and private sector to provide additional incentives for interoperability.
Common Formats
In 2005, the Patient Safety and Quality Improvement Act (Patient Safety Act) and the Patient Safety
and Quality Improvement Final Rule (Patient Safety Rule) (PSA, n.d.) authorized the use of common
formats for information so that patient information can be sent from one computer system to another.
This is different from meaningful use in that this encompasses the entire electronic patient record and
not just certain quality measures. The common format was specifically developed for use with Patient
Safety Organizations (PSO) and adverse event reporting. The common formats were developed by the
Agency for Healthcare Research and Quality (AHRQ) for use in acute care hospitals and nursing homes.
The common formats are divided into two categories: generic formats that apply to all patient
safety events; and event-specific formats that relate to certain high-frequency event types. These
include patient safety events that reached the patients (incidents), patient safety events that did
not reach the patient (near misses), and unsafe conditions that increase the probability of a
patient safety event occurring (PSA, n.d.).The Common format is currently utilized in the hospital and
long-term care facilities.
These common formats include common definitions (as defined by the National Quality Forum) and
reporting formats to allow the PSOs to obtain data concerning adverse events from multiple settings,
and then utilize the large sample of information to determine trends, patterns of care and best
practices in the participating organizations . This format will allow the aggregation of data that has to
be de-identified (organization and patient information removed from the data) in order to determine
new opportunities for safety improvements, increase healthcare practitioners working together in
such initiatives, and to help with the understanding of how to improve patient safety (Common
Format, 2017).
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The event-specific formats currently include Blood or Blood products, Device or Medical/Surgical
Supply, HIT, Falls, Healthcare Associated Infections, Medication or other Substance, Perinatal, Pressure
Ulcer, Surgery or Anesthesia, and Venous Thromboembolism. Other common formats are being
developed and are open for public review and comment at the NQF website.
!Health Information Exchange (HIE)!
Health lnformc1lion Exchange allows both health care professionals and patients to appropriately access
and securely share vital medical information electronically. Practitioners can share the results of a visit
with the patient and the patient can access their medical record from the computer in their home.
Hospital, clinic and other such records can be shared in the same manner. Sharing of the medical record
through a secure connection allows for better decision making at the point of care, and allows providers
to avoid readmissions, avoid medication errors, improve diagnoses, and decrease duplicate testing.
Where one practitioner used to have to fax lab results to another practitioner treating the patient,
results can now be accessed through a health information exchange. There are currently three key forms
of health information exchange:
• Directed Exchange - ability to send and receive secure information electronically between
care providers to support coordinated care
• Query-based Exchange - ability for providers to find and/or request information on a

patient from other providers, often used for unplanned care
• Consumer Mediated Exchange - ability for patients to aggregate and control the use of
their health information among providers
These exchanges provide a method for improving quality and safety of patient care by reducing
medication and medical errors, stimulating consumer education and patient involvements in their own
health care, increasing efficiency in documentation management, eliminating redundancy, improving
public health reporting, reducing health related costs, and many other factors. Health Information
Exchanges are currently operating in many states including Maryland, Colorado, Delaware,
Massachusetts, New Hampshire, Maine, Pennsylvania, Indiana, Missouri, Utah, and others.
he Medical Record!
[
The medical, clinical, or health record is the primary legal document, as well as the primary data
source (either electronic or paper) for recording and ascertaining the quality of healthcare delivery to
patients. The purpose of the medical record is multifold. The medical record provides for: continuity of
care: communication among practitioners; legal protection for the patient, practitioner, and the
organization; and data/information for quality/performance measurement, assessment, and
improvement. It also confirms the identity of the patient, supports the diagnosis and justification of
need for treatment, documents the course and results of treatment, and is used to determine the
reimbursement rate and justification of claims.
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The contents of the medical record must be sufficiently detailed and well-organized to enable the
practitioner responsible for the patient to provide continuing care to the patient, know the condition
of the patient at a specific time, and review the diagnostic and therapeutic procedures performed and
the patient's response to treatment. The medical record documentation is where a consultant will
render an opinion after examination and review of the medical record. Other practitioners use the
information in the medical record when assuming the care of the patient at any time. The information
in the medical record is also used for the retrieval of pertinent information required for utilization and
quality management activities.
The type of facility where the patient is receiving care determines the exact contents in the medical
record. The patient in a clinic will have different content than one in a hospital setting, long-term care
facility and so on. In many facilities, the documentation in the medical record is driven by some form
of accreditation and/or licensure. The Centers for Medicare and Medicaid Services (CMS) has laid out
required content for organizations that treat Medicare and Medicaid patients. Accreditation
organizations and the type of facility drive the need for certain types of documentation. The
documentation in a rehabilitation facility and an outpatient behavioral health facility will be different
based on the type of patients that utilize those services . There are, however, some common elements
in all medical records . A history and physical examination, laboratory and radiology reports, progress
notes, discharge information and other items are usual common items.
The medical record is used as a monitoring or review tool in the electronic or paper format. The
medical record review is best accomplished in a concurrent manner while the patient is receiving
services from the organization. With concurrent review, items that have been missed can be
completed and any over use or under use can also be remedied on the spot. Concurrent review is
often used for Core Measures and reviews where the data will be sent outside of the organization and
aggregated by others then analyzed. There are cases when prospective and retrospective reviews are
useful. When a patient is discharged from a hospital setting and going to a rehabilitation or home
health setting, an individual from those settings comes to the hospital and reviews the medical record
prospectively to determine if the patient is a candidate for rehabilitation or home health services.
Monitoring for mortality review obviously cannot be done concurrently and is an example of when
retrospective monitoring is appropriate. Both concurrent and retrospective monitoring are commonly
utilized in research studies. The content that is reviewed depends on the type of information being
monitored. This will be discussed later in this chapter.
!confidentiality and Security of Patient Information!
Confidentiality in healthcare deals with the patient's personal right to privacy and with the need for
the organization to maintain the confidentiality of all information pertaining to !peer review!. In
addition, the measurement and analysis of the quality of patient care provided by licensed
independent practitioners is held in a secure and confidential manner.
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lcon[identia/ lnformationl is information that one keeps or entrusts to another with the understanding
that it will be kept private and not shared. Webster defines confidential as secret or private; trusted
with secret or private information (Confidential, n.d.). An example of confidential data is your Social
Security number. You give it out as needed, but it can under certain circumstances become
discoverable by others.
!Protected Information! is information that cannot be obtained by others or used in a court of law.
Webster defines protected as to cover or shield from exposure, injury, damage, or destruction . At
times in healthcare, this type of information is called privileged information. Webster defines
privileged communications as those statements made by a client to his counsel, attorney, or solicitor in
confidence. Such communication cannot be disclosed without the consent of the client (Privileged
Communication, n.d.). The amount of protection given to patient specific quality information has
become less clear with the advent of collaborative QI, since the emphasis is on total organizational
involvement in the process, involving the sharing of pertinent information so improvement can be
made and sustained. In addition, QI adds the dimension of improving services that are nonclinical and
administrative (governance, management, and support processes). It is very likely that courts of law
will not agree that state "evidence codes" protect such information from legal discovery. \Peer reviewl
data (see Chapter 3 Performance and Process Improvement for more information on Peer Review) is
protected data, but state regulations have weakened the protection afforded in some states such as
California and Florida.
It is the intent of every healthcare organization to prevent unauthorized access to individually-

identifiable health information. Individually-identifiable health information is any information that can
be tracked back to an individual patient. The Health Insurance Portability and Accountabi lity Act of
1996 (HIPAA), Sections 261-264 ("Administrative Simplification" legislation), requires health plans,
providers, and healthcare clearinghouses ("covered entities") that transmit any protected health
information (PHI) electronically, to protect the privacy and security of health information. A primary
principle of HIPAA is that it is unlawful to use patient information in ways that are inconsistent with
the patient's original authorization. With that said, the law does permit both use and disclosure for
treatment, payment, or health operations, as long as the privacy of the information is maintained and
use or disclosure is limited to the "minimum necessary" to accomplish the intended purpose (HIPAA,
2017).
In general, HIPAA requirements that impact most healthcare entities in the U.S. include, but are not
limited to: ensuring the confidentiality, integrity, and availab ility of all electronic protected health
information (ePHI) that the covered entity creates, receives, maintains, or transmits; protection
against any reasonably anticipated threats or hazards to the security or integrity of ePHI; protection
against reasonably anticipated uses or disclosures of ePHI not permitted under the HIPAA Privacy Rule;
and to ensure compliance to these rules and regulations.
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The HIPAA regulations concerning privacy and security add both clarity and complexity to the handling
of patient information. The HIPAA "minimum necessary" rule means that, access to "protected health
information" (PHI) is to be limited to those persons or classes of persons who have a need to know in
order to carry out their roles and responsibilities; and for each person or class of persons, the
organization must identify the category or categories of information to which access is needed and
conditions appropriate to such access.
In October 2017, the HHS Office for Civil Rights clarified that HIPAA regulations allow health
professionals to share health information with a patient's loved ones in emergency or dangerous
situations. The patient's loved ones should be informed as they are crucial to preventing or lessoning
serious events and imminent threat to patient. Healthcare workers misunderstandings to the contrary
persist and create obstacles to family support that is crucial to the proper care and treatment of
people experiencing a crisis situation, such as an opioid overdose. Health care providers have broad
ability to share health information with patients' family members during certain crisis situations
without violating HIPAA privacy regulations {HIPAA-Opioid, 2017).
Well-defined policies must be in place regarding the use and disclosure of medical information,
encompassing all patient-identifiable record systems maintained within the organization. These
systems generally include the medical record, as well as abstracts, studies, registers,etc.,in any form,
e.g., paper, electronic, audio, or Internet. It is a HIPAA requirement that with psychiatric cases,
psychotherapy information is maintained separately and made available as necessary. While it is not a
HIPAA requirement, often, the electronic and other media files from radiologic exams and other such
studies are not kept in the medical record, but should be considered a part of the medical record.
The provider is responsible for safeguarding both the record and the informational content against
loss, defacement, tampering, and unauthorized use. Written policy must stipulate just how the provider
complies with state statutes and accreditation standards. The patient is considered the "owner" of the
information in the U.S. and can access and copy that information by signing a release form. HIPAA
and laws in most states recognize the patients' reasonable right to access, inspect, and copy their
health information. The organization's policy should address the release of records to patients or their
representatives. The HIPAA privacy regulations give patients access to their health information, the
right to amend (add corrections, but not delete) their medical records, and the right to a rewr u of
disclosures of their information.
!consent and Use of Patient Information!
In most healthcare settings in the United States, patients give advance written consent (assent;
agreement) when registering, for medical and surgical treatment, and for release of information for
payment even though such consent is optional under HIPAA. The consent for others to view the
patient's medical records for medical and surgical treatment includes the provision, coordination, or
management of healthcare services by one or more providers, consultation between providers, and
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referrals from one provider to another. Consent also typically includes the release of sufficient medical
information to the payer to assure payment (including information necessary to confirm benefits
entitlement) establish the necessity for treatment, and validate orders and charges.
)tnformed Conseng
In addition to the consent and use of patient information discussion above, patients are also required
by law to be well informed concerning the care they receive. Adequate information is provided to the
patient or legal representative in order for the patient or legal representative to make a rational,
informed decision to permit medical-surgical treatment. The patient is free to reject recommended
treatment . The law in most states in the U.S. requires that consent must be obtained from the patient
or from a person authorized to consent on the patient's behalf before any medical or surgical
procedure can be performed. Touching a patient without authorization to do so may be considered a
legal wrong called a "battery." Certain exceptions apply in emergency situations.
Two types of consent forms should be obtained: a general admission or treatment consent, as
applicable (information provided by the organization, but not necessarily by the practitioner); and a
special consent form for highly technical testing, medical, or surgical treatment (information provided
by the practitioner). The exact requirements for informed consent for the testing or medical/surgical
treatment varies by state.
The principles supporting informed consent stem from the patient's right of self-determination
espoused in the 1972 court case, Canterbury v. Spence (See Chapter 7 Legislation Initiatives). In this
case, a 19-year-old male was experiencing back pain. When medications did not control the pain, Mr.
Canterbury went to the hospital to have a laminectomy performed by Dr. Spence. After surgery, the
patient was fine on the first post-op day until he fell getting out of bed in the hospital, and was
paralyzed from the waist down. Mr. Canterbury stated that Dr. Spence never informed him or his
mother that the surgery could result in paralysis. Following the lawsuit and appeals, it was determined,
that Dr. Spence and the hospital were at fault for not disclosing all the possible information about the
risks connected with this surgery. In 1975, the Patient's Bill of Rights was published by the American
Hospital Association, which included the patient's right to know information vital to participating in
making his or her own treatment decisions (Canterbury, n.d.).
Information for special procedures must be provided by the practitioner performing the procedure and
must include the full extent of the treatment plan; the extent of the side effects and risks involved;
alternative treatments available; and the risks of non-treatment. To constitute proof of consent a
written consent must contain certain elements. These elements include: (1) the exact name of the
procedure for which the patient is consenting; (2) the consenter's understanding of the nature of the
procedure, alternatives, risks and benefits involved and the probable consequences of non-treatment;
(3) the date of consent; (4) the patient's signature prior to the procedure, and the signature of a
witness. There may be different requirements established by individual states, so more information
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than this may be required. The procedures that require consents are also established by individual
states.
Such written consent may or may not be obtained in primary and specialist care office practices .
Patients give separate informed consent prior to performance of specific surgical, radiological, and
other invasive and high-risk procedures.
llnternal Usel
Generally, written authorization by patients is not required for use of the patients' personal health
information by the provider organization. The consent for treatment completed at the time of
registration provides the consent for PHI access for many internal activities. Because of HIPAA,
standard practice in the U.S. is to provide the patient with a "Notice of Privacy Practices", to inform
them of possible intended uses of identifiable health information and their right to restrict use or
disclosure, and to get a written acknowledgement of receipt of the Notice, if possible. A notice of this
information is often posted in a prominent location in the facility. Table 5 lists who and when PHI is
utilized in healthcare organizations without the specific written authorization of the patient. Most
organizations require a signed Confidentiality Agreement from all employees, as well as from
designated committee members and individual licensed independent practitioners who are involved
with reviewing medical record information and/or participating in clinical quality management
activities. All information about these activities must be screened to be sure that legal mandates and
organizational policies concerning confidentiality and "minimum necessary" access are followed.
Table 5: Internal Use of PHI Without Specific Written Authorization

Internal Use of PHI Without Specific Written Authorization
Allowed Access to PHI Without Patient PHI Utilized in These Healthcare Functions
Authorization
Governing body, and designees, to ensure quality Quality, patient safety, accreditation, Pl,
of patient care utilization, and risk management, including
case management and care coordination
Chief Executive Officer (CEO) Competency assurance activities, e.g., staff
performance evaluation, Licensed
Independent Practitioner (LIP) credentialing
and reappraisal, and jpeer reviewl
Physicians and healthcare personnel involved in Infection surveillance and control
the care
Chiefs of clinical services and clinical department Patient safety
directors, along with designated committees, for
performance measurement and/or individual
performance evaluation, including lpeer reviewl
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Duly appointed committees/QI teams of the Education of patients' families

organization, in determining the quality of care
and requisites for accreditation, and all support
staff
Health information management/medical record Other auditing, legal, insurance, business,
personnel and general administrative activities
Designees of the CEO as needed reearding legal
and risk management concerns or health services
planning
)External Us
Written authorization (permission) by the patient or his/her legal representative is required for release
of medical record information (all "protected health information") in individual-identifiable form
outside of the organization that is responsible for the record, unless permitted or required by law or
regulation. The HIPAA Privacy Rule requires a valid "Authorization to Disclose" for all protected health
information, except as otherwise permitted in the privacy rule as described in Table 6. Each
Authorization to Disclose must contain at least the information provided in Table 7.
Table 6: Written Authorization is Not Required for External Disclosure of PHI

Written Authorization is Not Required for External Disclosure of PHI
'--------··---
• Pursuant to law or statutory regulation, e.g.:
- Reporting of communicable diseases, births, deaths, etc.
- Disclosures to the Department of Health and Human Services (DHHS) to enforce HIPAA,
I e.g., investigating complaints regarding preventing access oi improper use of patient

information for marketing
- Fraud and abuse detection and compliance
• To medical personnel to the extent necessary to address a genuine medical emergency
• Permitted under certain circumstances for the conduct of research
• To other covered entities or providers for treatment, payment, or healthcare operations
when the recipient has a healthcare relationship with the individual
• To share health information with a patient's loved ones in emergency or dangerous
situations such as Opioid abuse
Table 7: Authorization to Disclose - Core Elements

Authorization to Disclose - Core Elements
!--
• Specific information to be used or disclosed
• Identification of person(s) or class of persons authorized to use or disclose the information
• Identification of person(s) or class of persons to whom the use/disclosure is made
• Description of purpose(s) of the requested use or disclosure (or "at the request of the
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individual" if patient-initiated)
• Expiration date, event, or statement related to purpose for use or disclosure
• Signature of individual and date (if legal representative, description of authority)
• Right of individual to revoke the authorization in writing and procedure
• Whether covered entity will or will not alter treatment, payment, enrollment, or eligibility of
benefits
• Statement of possible re-disclosure by recipient without federal privacy protection
!Meaningful Usej
Meaningful use is a qualification in order to receive federal funding for health information techno logy .
Implementing provisions of the American Recovery and Reinvestment Act of 2009 (Recovery Act), the
Medicare EHR incentive program was designed to provide payments to eligible professionals (EPs),
hospitals, and critical access hospitals (CAHs) that are meaningful users of certified EHR technology.
The Medicaid EHR incentive program provides incentive payments to eligible professionals and
hospitals for efforts to adopt, implement, upgrade or meaningfully use certified EHR technology
(Meaningful Use, 2017).
Meaningful Use (MU), in a health information technology (HIT) context, defines minimum U.S.
government standards for using electronic health records (EHR) and for exchanging patient clinical
data between healthcare providers, between healthcare providers and insurers, and between
healthcare providers and patients.
There are three parts of the meaningful use portion of this act:
1) Using certified electronic health records in a meaningful way such as e-prescribing
2) Using certified electronic health record technology to electronically send and receive
health information to improve quality of care
3) Using certified electronic health records technology to send clinical quality and other
measures to required organizations
In order to accomplish these parts of meaningful use, the Office of the National Coordinator for Health
Information Technology developed and issued Standards and Certification Criteria for Electronic Health
Records (CEHRT). These have become the standards and certification criteria which met for with
meaningful use certification.
Hospitals and clinical practices are required to utilize electronic health records and to have their
technology certified for meaningful use. This requirement includes hospitals that are paid under the
Inpatient Prospective Payment System (IPPS), Medicare Advantage hospitals, and Critical Access
hospitals (CAH), as well as children's hospitals, physicians,dentists, chiropractors, nurse practitioners,
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certified mid-wives, and physician assistants. The requirements for hospitals are different from those
for practitioners, but similar in intent.
Meaningful use is divided into three stages. Stage 1,which began in 2010, focused on promoting
adoption of EHRs. Stage 2, finalized in late 2012, increases thresholds of criteria compliance and
introduces more clinical decision support, care-coordination requirements and rudimentary patient
engagement rules. Stage 3, focuses on robust health information exchange as well as other more fully
formed meaningful use guidelines introduced in earlier stages. All three stages have been updated
after the dates mentioned above. Stage 3 was finalized in October 2015. Healthcare providers can only
prove compliance with meaningful use while using government-certified EHR technology, CEHRT,
mentioned above. Meaningful use criteria for healthcare providers are written by CMS, with input
from the Office of the National Coordinator for Health IT (ONC). EHR vendors, however, get their
systems certified under rules written by the ONC, which currently are updated yearly. Some years
CEHRT rules are voluntary, in other years they are mandatory (Meaningful Use, 2017).
The reporting of compliance began in 2011. Hospitals and practitioners have to attest to fulfillment of
criteria established for each stage of meaningful use. There are three stages of compliance where the
measures established must be attested. Hospitals and providers must achieve meaningful use under
the Stage 1criteria before moving to Stage 2, and meet Stage 2 criteria before moving to Stage 3. The
CMS, in August 2017, has moved the requirements for hospitals to meet Stage 3 requirements until
2019.
On November 4, 2016, CMS established the Medicare Access and CHIP Reauthorization Act of 2015
(MACRA) (see Chapter 3 Performance and Process Improvement). MACRA includes the Merit-based
incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician
Fee Schedule, and Criteria for Physician-Focused Payment Models. The new MIPS program is for
certain Medicare-enrolled practitioners and it consolidates components of three existing programs,
the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and
the Medicare EHR Incentive Program for Eligible Practitioners. The Medicare EHR Incentive Program
replaces the meaningful use rules discussed above for physicians. MIPS focuses on quality - utilizing a
set of evidence-based, specialty-specific standards and practice based improvement activities, cost,
and use of CEHRT. MIPS was developed to support interoperability and advanced quality objectives in
a single, cohesive program for practitioners that avoids redundancies (CMS-Physician, 2017).
The ICD-9-CM (Clinical Modification) coding scheme has been used in the United States since 1979 .
Since that time, many things have changed in healthcare. The ICD-9-CM coding scheme no longer is
clinically accurate so the ICD-10-CM (U.S. diagnoses) coding scheme was released on October 1, 2015.
The release of the ICD-10-CM coding scheme had been delayed twice. However, the ICD-10 coding
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scheme, developed and published by the World Health Organization (WHO), has been used in most
other developed countries for morbidity applications for years (ICD-10, 2017).
All healthcare organizations that are required to adhere to the Health Insurance Portability and
Accountability Act (HIPAA) must convert to ICD-10-CM. The diagnostic codes have been adopted for all
healthcare settings and their use with HIPAA. In ICD-10-CM a "provider" is defined as a physician or
any qualified health care practitioner who is legally accountable for establishing the patient's
diagnosis. The ICD-10-CM/PCS codes will be updated annually each October (ICD-10, 2017).
The ICD-10-CM coding system has several distinct advantages over the ICD-9-CM coding scheme. In the
ICD-10 -CM coding, there are 69,823 codes compared to 14,035 ICD-9-CM codes. The ICD-9-CM codes
are five characters long and all numerals. The ICD-10-CM codes are up to seven characters of letters
and numbers. These additional codes are relevant to ambulatory and managed care encounters . They
allow for sub-classifications, laterality, greater clinical detail, increased level of specificity, and a more
specific code assignment. The ICD-10-PCS (Procedure Codes) are for hospital inpatient procedures
only. They do not affect the Current Procedural Terminology (CPT) codes for the outpatient
procedures.
The World Health Organization offers ICD-10 training materials online. The website can be located in
the web list at the end of this chapter. This training can be used for self-learning or classroom
education . The site includes a User Guide, Full ICD-10 training modules and the Cause of Death
Certificate Version. The website also provides a link for interaction with a group of specialists.
Once the transition has occurred, there are implications for the resulting data and on quality
measures. ICD-10 codes can impact the quality measures utilized in the Meaningful Use eMeasures.
Definitions of certain indicators will change with the revision of the coding system. Examples of
changes include fractures, pressure ulcers, and myocardial infarctions. In ICD-9 fractures were
considered only in the sense that one happened. In ICD-10, laterality and specificity of the type of
encounter are now coded. Pressure ulcers in ICD-9 had two codes: location of the ulcer (only 9
locations to choose from) and the stage of the ulcer. In ICD-10, location and stage are combined into a
single code, and additional codes address laterality and other information regarding Stage 3 and 4
ulcers. Myocardial infarction was coded in ICD-9 as acute if it had duration of eight weeks or less. With
ICD-10, the time period was reduced to four weeks or less, and other codes are added to indicate if a
second acute infarction occurred within those four weeks (ICD-10 - Quality, 2017).
Annual additions and/or changes in definitions and the addition of new codes will make it difficult to
compare data for a while after implementation of ICD-10. Some of the data will not be compatible
with data obtained through JCD-9 coding. Users of data must be trained to understand the differences,
so that the information is not misinterpreted during analysis and reporting. Changes will affect both
internal and external data. The Quality practitioner should examine the effect that these changes in
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definition and coding specificity will have on data the organization is currently collecting. Those who
are going to collect data must also be educated as to how their data collection plan needs to change
with this implementation.
Indexes
Indexes are permanent collections of medical record data required by state laws. They refer to
collections of different types of data based on specific topics. The Indexes are used to locate cases for
record maintenance, statistics, and research. Think of the old paper card indexes used in libraries. By
looking at a paper card index, you could determine the location of the book you were looking for. In
the current library environment, many of these Indexes are maintained on a computer instead of on
paper.
Healthcare uses a number of different indexes, but the most common one is the Master Patient Index
(MP!). This is a permanent file of all patients seen in the organization, with dates, names of the
attending physicians, and medical record numbers. The Master Patient Index is considered the most
accurate index of patient information in most organizations.
Other common indexes include the Physician Index, Disease index, and Surgery Index. The Physician
index lists cases attended by individual physicians and are maintained for a minimum of ten years. The
Disease Index contains the principle and some secondary diagnosis codes with individual patient
information and it is also maintained for ten years . The Surgery Index contains the principle and some
secondary procedures in a manner similar to the Disease Index.
Registers
Registers are the permanent chronological listings for maintaining certain statistics. A common
Register is the Emergency Department Register listing each patient who came to the Emergency
Department for treatment, the order of arrival, and other information about the patient. Information
contained in this type of register would be the patient's identification, medical record number,
diagnosis, tests performed, name of physician who saw the patient, and the discharge site (whether it
was at a home, an outpatient setting, admission to a hospital, or some other location).
Other Registers that are commonly used in healthcare settings include, but are not limited to: patient
registers for inpatients or outpatients; Deaths/Autopsies/Coroner's cases/Fetal deaths; births;
deliveries; Surgical/Procedure logs; Cancer and other disease registers; and medical device implant
logs (mandatory under the FDA).
These registers are useful in the studying of diseases and disease prevalence. Registries have been
shown to lead to improved health outcomes and reduced costs of health care. For example, if a
physician in a private practice keeps a registry of patients with chronic diseases, the data obtained
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from this registry can be aggregated by disease and the most effective interventions could be
identified. If there is a multi-practitioner practice, then the outcomes of patients with a specific disease
could be compared between practitioners and the best practice among these practitioners could be
identified. This examination of such data could lead to improved care for all the patients in the practice
with that particular disease. In a study by Stefan Larsson (Anonymous, 2011) described in the editorial
section of The Lancet, a registry for cystic fibrosis in Sweden was reviewed. This registry is estimated to
have averted about 500 patient years of Pseudomonas infection and a cost of $230 million from 2000
to 2009. This cost savings accounted for about 2% of the total costs for care of cystic fibrosis.
Information Technology and Systems
An information system is the sum of all manual and/or automated systems . These systems are
designed to provide and coordinate information that can be used in decision-making. Manual
information systems have been utilized in healthcare settings, but the current movement is to
automate the process into the electronic health systems to meet the needs of the organization. Health
records, billing and charge records, medical record coding, surgery data, admissions data, infection
data, and other vital information are all being computerized. Over the past ten years, the United States
government has passed laws, rules and regulations that encourage healthcare entities such as
hospitals, long-term care facilities, and practitioner offices to implement computerized information
systems .
The goal of this movement is to encourage use of integrated electronic information systems that link
quality, utilization, risk management, patient safety activities and infection control data with existing
patient, clinical, management, and financial databases. Eventually these systems will allow for the flow
of information not only within a facility, but also to other facilities and organizat ions, including the
federal government, insurance companies, and research databases. There are a number of health
systems have an electronic medical record that all acute hospitals within that system utilize. There are
many differences in the programs used by different departments. For example, inpatient-nursing
records may be housed in one system, while operating room and emergency room records, physical
therapy treatments, and pharmacy data may be housed in another system.
Unfortunately, most of these systems do not yet allow transfer of patient information to other acute
care hospitals, nor do they allow information to flow throughout the particular facilities. All of this is
changing, but not rapidly enough.
Information Management Functions
The information management function is shared by all entities of the organization. Typically, this is
spearheaded by the Information Systems Management department and the Health Information
Management department (which used to be called the Medical Records). In organizations that are
highly automated, the oversight of the maintenance of the systems may fall under a Chief Information
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or Technology Officer. Information Management may or may not include clinical people. In addition,
due to the inclusion of financial information, this area often falls under the purview of the CFO.
Framework for Enterprise Information Management
Information management is a dynamic process. There are a number of key elements that need to be
included. They are laid out in the following table that comes from AHIMA, the American Health
Information Management Association. Table 8 lists the latest, though still evolving, characteristics and
functions of Health Information Management (HIM) in an enterprise information management
environment.
Table 8: Health Information Management Roles

Health Information Management Roles
Information Building EIM Goals Key Functions
Blocks
1. Information To continuously improve the • Architecture, definitions, and
Integrity value of the information relationships, including metadata
asset by ensuring that data • Data accuracy audit, structured
and content are accurate, and unstructured data
reliable, up-to-date, • Data provenance or lineage
consistent and "fit for use" • Error correction/amendments
• Interface and upgrade assurance
2. Information Use To correlate and cross- e Clinical applications
reference data and content • Quality measurement and
requirements to the range of improvement
clinical and business needs • Patient access
and ensure that those who • Information exchange
rely on information have the • Business applications
requisite tools and skills to
• Research and secondary uses
use it effectively
3. Confidentialityand To ensure that personal • Access controls
Protection health information and • Confidentiality/privacy
business information are • Security
available only to authorized • Authentication
persons and used only for • Business continuity
authorized purposes and that • Audits of compliance
security risks and
vulnerabilities are proactively
managed
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4. Life Cycle To develop a common • Retention policies and practices

understanding of the life
• Disposition policies and practices
cycle of patient medical
• Audit of records, clinical and
record and other key corporate
business records and explicit
plans and processes for their
retention and disposition,
accounting for clinical and
business needs and legal and
regulatory requirements for
creation and maintenance
5. Information To ensure that the • Transparency of policies,
Governance organization has the procedures, and standards
leadership and • A culture of ethical stewardship
organizational structures, • Compliance with applicable laws,
policies, procedures, regulations, other requirements
technology, and controls for • Enhance the value of managed
enterprise information information assets
management that represent • E-discovery
the highest standards for
legal, ethical, and business
practice serving patients and
stakeholders and advancing
the public good
Adapted from Kloss Strategic Advisors LTD (Retrieved from Dimick, 2012)
Within the next 5-10 years, information management will take on a new approach. Linda Kloss (2013)
for the Iron Mountain Incorporated predicts that the next generation for information management
and governance will (Kloss, 2013):
1. View information as an asset that must be deliberately managed

2. Encompass patient records and other clinical and business data, information and
records, files, and reports
3. Put in place and continuously improve on the component functions reflected in the
model
4. Encompass the life cycle of information and records
5. Be guided by effective governance and stewardship values and policies, focusing on
getting it right where it matters most
6. Strive for measurable and sustainable improvement
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!computerization & Software Selection and lmplementationl
Computers and automation have been utilized in healthcare for many years, but it has been only in the
last 15 years or so that the automation has moved into the arena of bedside care. Computerization has
been utilized in finance and administration, but the electronic health record has brought this
technology to patient care. It is now more important than ever that all the members of the healthcare
team be involved in the selection of computer systems and software programs for the organization.
There are multiple aspects of selecting a computer system and software for use in the organization. It
is not a process to be undertaken quickly and requires a team effort to assure that the computer
system and software are applicable and usable with the information system already in use in an
organization. All parties who could be affected by the choice should be represented in considerations
of the appropriate equipment and software for the organization.
An automated information system should organize data sources in useful formats. The user inputs data
that is then manipulated by the computer software . The output of the data must be in a format, such
as Excel, that can be easily utilized by the requester of that data. Integration of data from several
sources is also important. For example, it may be necessary that data from the medical record and the
billing software be combined . There should be a short time between data collection and report
availability. The closer to the point of collection that the data is used, the more meaningful it will be.
Programs must also be written to condense information to allow meaningful analysis. Too much
information can slow or even prohibit decision-making .
One of the challenges when choosing automated systems is that, as much as a number of departments
think they "own" the system, it is the responsibility of the leaders of the organization. For instance, the
Pharmacy system is important to the Pharmacy, the Chief Information Officer, the billing department,
the clinical users including nurses, doctors, a_ llied health professionals, the compliance department,
those who review recalls, materials' management, the quality department, medical records, infection
control and risk management, and those who credential practitioners. If the system is selected without
the input of these areas, problems can be expected. Ideally, senior leadership should mandate that all
players who may be involved in the input, throughput or output of the automated system be present
at system acquisition discussions .
There are several key issues to be considered in selecting a computerized quality management system.
The present performance and future computer needs of the organization-wide quality strategy should
be the starting point for discussions. If the organization is part of a larger healthcare system, there may
be a need for all the facilities to utilize the same quality management system so that the data can
easily be shared. Senior leaders of the organization will also have strategies and concerns that must be
incorporated into the decision making process.
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Financially, the cost/benefit and cost/effectiveness analysis of purchasing commercial software versus
developing the software in-house using available business and database packages must be considered
by the senior leaders of the organization. If commercial software is purchased, the software company
will maintain and provide updates to the software. However, if the software is written in house, it may
better meet the needs of the organization, but then the organization must maintain and update the
software. Other important financial issues to consider include data storage (both on-site and off-site),
data back-up, and system downtime to make the necessary updates. The organization must also
consider the computer knowledge, capability, and training needs of staff. This will influence the choice
of software.
In this discussion; consideration of selection of a computerized quality management system is the

example. The same issues apply to the selection of any computerized system. The quality management
system does not stand alone, but is linked to the other software systems in the organization.
Depending on the type of healthcare facility and the capabilities of the organization, necessary
elements of a quality management information system may include coordinated monitoring, analysis,
and improvement processes, including performance measures/indicators, criteria, screen selection, as
well as data collection.
!Evaluating and Selecting Software to Support QM/Pli
Software to meet organization-wide quality/performance improvement needs varies tremendously in

terms of capabilities, comprehensiveness, and price. The process required to appropriately evaluate
organizational needs and priorities, evaluate the many varied software products as to their adequacy
and applicability in meeting specified needs, and then determ ine whether and what to buy, takes time,
energy, and a team approach. This selection process is organized in six steps consisting of: (1)
obtaining a commitment from senior leadership, (2) selecting a team, (3) identifying system
requirements, (4) evaluating potential vendors, (5) evaluating and selecting the software, and (6)
negotiating a contract. While it is usually a team of organizational leaders and departments that select
the software and computer equipment necessary, the quality professional must be involved in these
processes, ifthe system being selected is a quality management system .
The requirements of system features are extremely important to consider. In one organization, a new
CFO wanted to purchase a new billing software system. The CEO gave him permission to do so,and the
CFO purchased the system. Once it was installed however, it was discovered that the software would
not communicate with the laboratory software, the pharmacy software, and multiple other software
utilized within the facility. There was not a team effort in the selection of the software, and as a result,
the facility did not have a functioning information management system.
Organization issues which are unique to a quality system management software selection include an
assessment of the current automation of the various users,such as the number,types of computers,
locations, and the ability of them to interface with each other and with any new software. Overall
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information system goals and needs must be identified. It is best to look toward an organization-wide,
comprehensive, fully-integrated database and reporting system. Real or perceived barriers to
implementation of an integrated or interfaced system need to be identified for: Quality,
Case/Utilization, Risk Management operations; performance measurement; case review;
medical/professional staff management and credentialing; and data/information exchange, analysis,
and reporting. Current and future data and report needs must be identified. Corporate requirements
or proposed system upgrades/changes should also be determined.
User needs include the need for real time/timely, accurate information, and ease of system use. This
information can be identified through questionnaires/checklists, specific user group sessions for
brainstorming, and "Wish lists". These user needs must be prioritized as essential, desired - but not
required, or as optional (the nice extras). Table 9 lists items to consider in the evaluation of necessary
system features.
Table 9: System Features to Consider in Selecting Software

System Features to Consider in Selecting Software
1) Ability to use current hardware
2) Ability to interface with current software
3) Ability to download information from a mainframe or cloud
4) Ability to permit easy/timely access to information by specified users
5) Ability to integrate, process, and produce reports as required or desired (without
requiring a programmer)
6) Flexibility in changing indicators, criteria, screens, data collection method, report
formats, etc.
7) Statistical data analysis
8) Graphic and tabular data display
9) Capacity to network personal computers or terminals in all locations
10) Potential for interface with severity systems and other mandated systems
11) Data storage and data exchange capabilities
12) Electronic (Web-based) capabilities for operational and clinical decision support
13) Human Factors issues
14) Ease of use
!Evaluate Potential Vendors!
Vendors who have software that meet the requirements discussed above must be carefully evaluated
based on satisfactory performance with other organizations, product history and implementations,
product, maintenance, education and training of users, help desk response time, and upgrade service
capabilities .
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!Evaluate and Select Softwarel
Based on a comparison of each product against the identified organizational requirements,

comparison of vendor software products against those requirements will take place. Decide in advance
which specifications cannot be compromised and what is the time frame for development and
installation necessary for project success.
Often a Request for Information (RFI) will provide an initial way to compare vendors, as will an internet
search, contacts with colleagues at similar organizations, and attendance at conferences. The team
must develop clear, objective criteria for software evaluation. They must also compare potential
software with respect to, the ability to meet requirements, compatibility with existing and desired
hardware or other software, cost (purchase price, maintenance fee to vendor, and internal cost of
implementing, deploying, and maintaining) and extent of service.
Representatives of the team should conduct enough site visits in similar institutions with the software
already in place to evaluate each vendor software. Visits to present and past users is one of the best
ways to determine the features, and issues with the software or vendor.
The team will then perform a cost/benefit analysis for all products, being evaluated. This includes
review of vendor contract agreements to determine which vendor will provide the software.
Lastly, the team and the senior leaders of the organization will enter final negotiations with at least
two vendors to maintain some type of comparison. The lawyers of the organization should also be
involved for legal advice regarding purchase or maintenance contracts and warranty provisions, as well
as distribution of financial risks appropriately between the user and the vendor.
M EASUREMENT
Once data has been collected and verified, it is time to begin statistical and other analysis of the data.
Before we get to that part, it is important to understand the various sorts of data that might be
available.
!Data Basics!
There are two basic types of data: Categorical data and Continuous data. There are distinct
characteristics, uses, and statistical processes associated with each type. This part of the chapter will
discuss the similarities and differences between these two types of data.
!categorical datal (sometimes called Attribute data) are data that have been categorized and counted.
Nominal and Ordinal data fall into this type of data. Categorical data basically consists of how many
things have the same name and thus in the same category. If you are in a classroom, you can count
how many people are named Susan, Fred, Terry, and so on. You will then know the total number of
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individuals who have each of the names you counted. For example, in healthcare you can count how
many patients have Congestive Heart Failure or Pneumonia.
Categorical data is not measured. It is based on counts of members of discreet categories, therefore
this sort of data is also known as "discrete" data. Categorical data exists only as whole numbers, (e.g.,
number of procedures performed, members, patients, births, deaths, occurrences) . The data can then
be expressed in a percentage, such as, Congestive Heart Failure patients are 20% of <111 the patients
treated. Categorical data is qualitative data in that it relies on specific descriptions of qualities to
establish categories, such as blood type, intensity of burn, or physician specialty. Qualitative data can
also include statements about observations, such as data drawn from case studies, focus groups, or
interviews.
If you are counting things that simply have different names, you are creating nominal data. If the
things you are counting have a sense of order, you are using ordinal data. Ordinal data consists of
scores that exist on an ordered scale, i.e., an arbitrary numerical scale where the numerical value of a
particular category has no significance beyond its ability to establish an ordering of a set of data points.
An example might be the number of patients in the pre-op unit, the number in the surgery suites, and
the number in the post-op unit. There is a sense of order here in that the patient will have to register,
then go to pre-op, and then to surgery, and then to post-op.
\Continuous data! (sometimes called Variable data) is measured on a continuous scale rather than
discreet categories. Continuous data is expressed in specific measurement units (whole and/or
fractionaij indicating the amount or quantity of what is being measured. Continuous data is also called
quantitative data because of the measurement of the interval between any two points as a quantity.
Blood glucose and oxygen consumption are examples of quantitative data.
Measures that have an equal interval between each integer form interval data. However, in interval
data there is no true zero point and thus ratios are not meaningful. An example of an interval scale is
temperature . The difference between 40 and 80 degrees is the same as that between 60 and 100.
However, it is not true that 80 is twice as hot as 40 since the zero point is set arbitrarily, and measures
below zero are as meaningful as those above. If the data have equal intervals between each integer,
and zero is absolute (a value cannot go below zero), then this type of continuous data is called ratio
data. It is meaningful to say that twenty pounds is twice as heavy as 10 pounds, and something
weighing less than zero is meaningless. Examples of ratio data include scores on a test, infection rates,
respiration rates, height, weight, and voiume.
As seen in Table 10, the type of data that you are dealing with determines what you can do with those
data. If you are using Categorical data, you can determine if there are significant differences between 2
groups by using the Chi Square test, but if you have Continuous data, you would utilize the t-Test to
determine the difference between 2 groups of scores. Throughout the remainder of this section of the
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chapter, we will be returning to this table as we explain data analysis. It is recommended that you copy
this figure and keep it at your desk as you work with different data so that you will utilize the proper
tools for the type of data that you have obtained.
Table 10: Types and Uses of Data

Types and Uses of Data
Type Categorical I Count Continuous I Measured
Also Known As Attribute Variable
(AKA) Discrete Quantitative
Nominal Interval
Ordinal Ratio
Qualitative
Examples # Members, Patients, Births, Age, Height, Weight, Temperature,
Procedures, Occurrences, Time, Charges (money), LOS
Gender
Usually Reported as % in each category Mean
(whole numbers) Median
Minimum
Maximum
Percentiles
(whole and fractional units)
Usual statistical test of Chi Square T test
difference between 2
groups
Usual display tools Table Run chart
Scorecard Control chart
Histogram Scorecard (not the best to use)
Pareto Data display over time = use run or
control chart
Basic Statistics (Mom, Baseball, Apple Pie, Statistics)
This section looks at statistics in two ways . First will be a conceptual view of each type of statistical
measure so that the reader can understand what each statistical test is, when to use it, and what it
tells us. The second will be an explanation of the calculations for those who do not have a computer to
do the calculations for the test .
!Descriptive Statistics!
Table 11describes the basic statistics that can be used with descriptive data. This table should be used
as a reference for when you use descriptive data.
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Table 11:Type of Descriptive Statistics That Can Be Utilized with Categorical/Continuous Data
Type of Descriptive Statistics That Can Be Utilized with Categorical/Continuous Data
Data Type Distribution Central Tendency Variability
Nominal Frequency, Mode
Percentage
Ordinal Frequency, Median, Mode Range, Minimum/Maximum
Percentage
Interval/Ratio Mean, Median, Range, Minimum/Maximum,
Mode Standard Deviation, Variance
Adapted from Houser, 2012
!central Tendency - Mean, Median, Mode, Weighted Mean!
The term Central Tendency describes a set of measures that indicate what the 'middle' value is or the
typical value of data. The statistical measures that display central tendency are the mean, the median,
and the mode (Central tendency, n.d.). Each one is utilized for a different purpose and with different
types of data. When an individual is asked to calculate measures of central tendency, it is sometimes
helpful to organize the numbers from lowest to highest, especially if the math is to be done by hand.
For example, the set of numbers given may be: 375, 109, 663, 29, 390, 56, 110, and 444. If these are
rearranged from lowest to highest ( 29, 56, 109, 110, 375, 390, 444, and 663) it is often easier to
visualize the median and the mode without having to do much math.
The \M eanl is frequently referred to as the average . To determine what the mean is, you simply add all
the numbers together and divide by the number of integers in the set of numbers.
For example, the mean of 2, 4, 6, 8, and 10 is equal to 6. The mean is used with interval and ratio types
of data.
Astronomical numbers overly influence the mean. Astronomical numbers, or outlier data, are numbers
that are very different from the remaining numbers. When one or more numbers are very different
from the other numbers, the mean is 'pulled' toward these astronomical numbers. In the numbers
below, 100 is astronomically different from the other numbers listed.
For example, with numbers such as 2, 4, 6, 8, and 100, the mean is 24.
As is apparent from this example with a mean of 24 it is very different from the first example. Thus,
with astronomical or outlier data, the mean does not really indicate the middle of the data. Therefore, it is
better to utilize the \medianj .
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Sometimes it is necessary to give more weight to certain data points. In this case a !weighted M ean! is
utilized. This will be discussed later in this section .
The !Median! is the 'middle number' with an equal number of values above and below the median. The
median can be used with the ordinal and interval data types. Arranging your numbers from lowest to
highest facilitates the determinat ion of the median - the middle number.
For example, in the seven number series 29, 56, 109, 110, 375, 390, and 444, you can place your
fingers on the outer numbers (29 and 444) and then walk them in. This results with both fingers on top
of each other on the number 110, which is the median or middle of these numbers .
When there is an even number of numbers, such as 23, 55, 66, 79, 83, 98, you can again walk your
fingers in and they will land next to each other rather than on top of each other . You then must take
these two numbers (66 and 78 in this example) add them together and divide by 2. With this set of
numbers the median is 72.
As previously stated, when there is an astronomical value, such as in the numbers 2, 4, 6, 8, 100, it is
better to use the median for the measure of central tendency. The mean of these numbers is 24, but
the median is 6. This better describes the middle of the data. This is useful for example when
calculating the length of stay that has several patients staying longer periods of time than the rest of
the patients.
The !Model is the most frequently appearing number. The data may have one or more modes. No math
is required to determine this value. This measure of central tendency is best utilized with nominal
data . It can also be used with ordinal, interval, and ratio data; but there may be no identifiable mode
due to the spread of the data.
Utilizing the numbers 2, 4, 4, 6, and 8, there are two 4's and so the mode is 4.
In the numbers 23, 23, 34, 45, 45, 56, and 88, the values 23 and 45 both appea r twice so 23 and 45 are
both the mode.
With the numbers 3, 3, 4, , ' S, 6, and 8, the value 5 occurs th r ee Li mes so it is the mode.
However, w ith the numbers 29,56, 109, 110, 375, 390, 444, and 663, each number appears only once,
so there is no mode in this data set.
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!tmportant Facts to Remember about the Mean, Median, & ModeJ
• In a 'normal' unimodal symmetrical distribution, the values of the mean, median and the mode
are the same.
• In an asymmetrical or skewed distribution or curve, the mode falls at the highest point, the
mean falls somewhere towards the tail of the distribution, and the median lies between the
mean and the mode (Figure 3) .
• In an asymmetrical or skewed distribution or curve, it is better to utilize the median than the
mean to indicate the middle of the values.
• With repeated samples of the same type, the mean is a more stable value from sample to
sample, and the mode is the least consistent value.
Figure 3: Mean, Median, & Mode
Mode
Mean
I I
I I
I
I
I
I
:\ Outliers
I :
I
I
II
II
I
I
i
!weighted Meanl
There are times when some numbers are worth more, or carry more weight, than others carry. One
example in healthcare is the annual reimbursement that hospitals receive. A certain portion of the
reimbursement is calculated on the quality data submitted and the remainder is calculated based on
HCAHPS patient satisfaction scores . The quality data portion counts more than the patient satisfaction
portion.
When calculating the weighted mean, there are two numbers per set of data. The first number is the
value of what was measured, and the second is the weight assigned to the measure as a portion of the
whole. Table 12 shows the way to calculate the weighted mean utilizing the following example :
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Table 12:Weighted Mean

Weighted Mean
Domains Score Weight (%) Multiply S X W
Clinica l Process of 82 10 I I
820
Care I
I
-
, I
I
Pt. Experie nce of 58 25 I 145 0 I

Ca re I I
I I
Outcome 92 40 I 3680 I
I I
Efficiency Measure 67 25 I 1675 I

"+' "+'
TOTAL 100 7625
Total Performa nce

Score
- (7625/100)
The CMS Fiscal Year 2016 Hospital Value Based Purchasing (VBP) Percentage Payment Summary
Report states that there are four quality domains. In Table 12, those measures are represented in the
first column on the left. The Scores in column 2 (not real scores) are the calculated values (CMS - VBP,
2015) of each of these domains. The Weight is the proportion of the whole that each domain was
worth in FY 2016. The score and weight for each domain are multiplied together as seen in column 4.
The weight column (column 3) is now added to the total line (100) and the multiply column (column 4)
figures are added together to the Total line (7625). The total of the Multiply column (7625) is then
divided by the total of the Weight column (100) giving you the weighted mean, in this case, the Total
Performance Score of 76.25.
!Dispersion of Data - Range, Frequency, Standard Deviation!
The term !Dispersion! refers to how variable, scattered, or spread the data is in a distribution. Common
measures of dispersion in statistics are the range, frequency distribution, and the standard deviation
(Dispersion, n.d.).
The !Range! is the simplest of dispersion statistics . The range tells you the lowest and highest numbers in
a set of numbers, but it does not tell you anything about the numbers between those two values. The
range is frequently cited as the smallest number, a comma, and then the largest number . Another way
to calculate the range is to subtract the smallest number from the highest number in the range of
values . The number obtained demonstrates the number of integer spaces between the lowest and
highest numbers.
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For example, if the numbers include 2, 4, 6, 8, and 10, then the range can be expressed as 2, 10 or as 8
(10-2=8). However, if we also look at the range of 102, 104, 106, 108, and 110, that range can be
expressed as 102, 110 or also as 8 (110-102=8).
The 2, 10 and the 102, 110 are more expressive of where the data lies, and if readers wish, they can
easily calculate the number of integers between the two numbers.
!Frequenc y Distribution are a logical and systematic arrangement ("rank-ordering"} of numerical data from
the highest to the lowest, or lowest to highest, values. Frequency distributions are commonly seen in
three formats: Simple, grouped, and cumulative frequency distributions . In a simple frequency
distribution (f = frequency), all possible values between the highest and lowest reported measures
(range) are listed in one column. The number of times each numerical value appears in the set of data
is listed in an adjacent column.
SIMPLE FREQUENCY DISTRIBUTION TABLES
Individual Test Scores t

(Ranked highest to lowest)
125 1
124 3
123 2
122 2
121 3
120 4
119 0
118 4
117 1
116 2
115 5
etc.
N = 27
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A Grouped frequency distribution (i = width of class interval), is utilized when the range of values from
highest to lowest (or lowest to highest) is wide . The single measures are grouped together in blocks
(class intervals), each containing an equal number of possible values {width of the class interval).
Generally, between 10 and 20 intervals should be used. Interval (i) is the width of a class of grouped
data, including both high and low values . The "i" for the class of data, 116-125, is 10.
GROUPED FREQUENCY DISTRIBUTION TABLE
Grouped Test Scores 1

(Ranked lowest to highest)
56-65 42
66-75 70
76-85 99
86-95 74
96-105 52
106-115 40
116-125 22
i = 10 N = 399
With a Cumulative frequency distribution, at each value or point in the distribution column, the
cumulative frequency is calculated as the sum of the frequency of that value or point (or class of
values) the frequencies of all points or classes of smaller value .
CUMULATIVE FREQUENCY DISTRIBUTION TABLE
Grouped Test Scores 1

(Ranked lowest to highest)
56-65 42 42
66-75 70 112 {42 + 70)
76-85 99 211 (42 + 70 + 99)
86-95 74 285
96-105 52 337
303
106-115 40 377
116-125 22 399
N = 399
!Relative Frequency/Percentage! is defined as a calculation of proportion, or a part-to-whole relationship.

It can also be stated as the percent of the total number of individuals, objects, or events occurring at
each value or group cf values. The percentage is calculated by dividing the part-the single individual,
object, or event (or one group of individuals, objects, or events)-by the whole, the total number (N) of
cases in the group, study or collection of data, and multiplying by 100:
Part [individual case or group] X 100

Whole [N; total cases]
A !Ratio! is also defined as a proportion - a fixed relation in number, degree, etc., between two similar
things. An example is a ratio of surgical site infections (numerator) to surgical procedures performed
(denominator) for general abdominal surgeries (the group). A mathematical ratio is usually expressed
as a decimal. A ratio can also be used to express relations between group, such as One Group: Similar
Group.
In a proportion, the quantity in the numerator is also a part of the denominator (part of the whole) . If
calculating the difference between two ratios, e.g., 50:1,000 versus 200:5,000, you must first seek a
common denominator (the higher of the two: 5,000). Then multiply both numerator and denominator
of the lower ratio by 5 (since 5,000 is 5 times greater than 1,000):
50 X 5 and 1,000 X 5 = 250:5,000
Then subtract the lowest numerator from the highest:
The difference between 250:5000 and 200:5,000 is 50.
futandard Deviation! is another measure of the spread of a distribution - a computed value describing
the amount of variability in a particular distribution. The more the values cluster around the mean, the
smaller the amount of variability or deviation. The standard deviation is the square root of a measure
called the variance. The variance is the arithmetic mean of the squared differences between each
value and the mean value. Now that we have lost you, let us make this simpler and then retl,Jrn to the
more statistical interpretation.
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All of the students who have gone to school are familiar with the bell curve. Most data with a strong
central tendency look like this when plotted. The bell-shaped curve typically has a mean drawn as a
line through the middle of the curve. Unfortunately, we do not often find a perfect 'normal' bell curve
in reality, but we often assume that our data approximate a 'normal' bell curve. If the standard
deviation is not at the center of the curve, it is said to be skewed to one side or another. If the left side
gets drawn out further to the left, it is sa id to be negatively skewed, and if the right side gets drawn
out further to the right, it is said to be positively skewed. When skewed, the mean will be pulled to one
side or the other depending on how it is skewed (see previous discussion of Mean and Median). For
the sake of the discussion at this time, we will assume that we have a normal bell bell-shaped
distribution of values in the dataset, as in Figure 4.
In Figure 4, the lines to the immediate left, and right of the mean indicate 1standard deviation away
from the mean. The (J symbol stands for standard deviation. In a normal distribution 68.2% of all
values will fall between these two lines. The next set of lines outside the first standard deviation line
represents two standard deviations away from the mean and accounts for 95.4% of all the data. The
third lines away from the mean are three standard deviation from the mean, and 99.7% of all data lie
between these third set of lines. There remains 0.3% of values that are unaccounted for w ithin 3
standard deviation.
Figure 4: Standard Bell Curve
13.6% 2.1%
· la x +la +20" +3a

1 68.2% -' I
l
-2a
-- - 95.4% J
99,7%-
-- - - - -
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Let's explain this in another way with the bell curve often used for assigning grade in schools (called
"grading on the curve") (Figure 5).
Figure 5:Grade Bell Curve
F D C \ B A
-2a la
I x
13.6%
+ la +2a
2.2%
+3a
-
-
-
I
-
I.....---£
t:. ,Q• ,..-.,,.010
0
-95.4%- -
I
_......
, --1 I
99.7%-------
In school, there are times when an exam is too difficult and the students all score very iow. Grading on
the basis of each student's percent correct score would be too severe - too many students would fail.
The alternative is to grade on the curve - the bell curve. This process uses the mean and standard
deviation of the distribution of the entire class's actual scores to determine grades. As in Figure 5,
everyone scoring 2 standard deviations above the mean gets an A, 1standard deviation above gets a
B, and so forth. For example, if the test mean was only 45 and the standard deviation 15, everyone
scoring at or above 75 gets an A (45 + [2x15]), everyone at or above 60 (45 + 15) and below 75 gets a B,
etc. If it is desired that more than 2.2% of the class gets an A, then the cutoff might be lowered to 1.5
standard deviations, i.e., 67 .5 (45 + [1.5x15]). Grading on the curve assumes that the actual scores on
the test are distributed like the bell-shaped curve in Figures 4 and 5, which may not be the case .
However, this process can be used - and is often used - when the distribution of measures (e.g., test
scores) is not exactly bell shaped.
Understanding what the standard deviation and the bell curve tell you is very important for the
healthcare quality professional. The principles of this statistical tool are applicable in many settings.
For example, in a Nursing Home or other Long Term Care setting, the length of stay (LOS) of patients
will vary. It can be determined what the mean LOS is, and then the standard deviation can be
determined. Knowing what types of patients stay the shortest time vs. the longest time may be
306
information that can help identify what factors are contributing to the longer LOS. Look at Figure 5,
68.2% of the patients would be around the mean (in the portion where the grade C is). The further
away to the right or the left would be those patients who have notably longer and shorter LOS. So, the
facility should look at those patients who come and go quickly (the 5% at the left of the graph) to
determine if the Long Term Care setting is appropriate for that type of patient . Similarly, the 5% to the
right might be the focus of concern regarding adequacy of intervention.
In an outpatient clinic or physician practice, the practice may wish to determine the time patients
spend in the office when they come for an appointment. The clinic/office collects the data for a month,
and then determines the mean and standard deviation of the data. The data can then be used to
determine what is making the difference in the length of time spent at appointments. In ti'1is case, the
outpatient clinic would examine the nature of the patients that are in the sections furthest away from
the middle to see why they are different than the 68 .2% in the middle. We will return to the use of the
standard deviation as we explain other tools described in this chapter.
When creating a pathway or guideline, it is understood that not all patients will be able to stay on that
pathway or guideline . However, these care tools need to be written for the more homogenous group
of individuals that account for the 68.2% of individuals who are included within +/- 1 SD from the
mean (See the C area in Figure 5). Patients who are outside of the first standard deviation may be able
to begin on the pathway or guideline, but due to comorbidities, complications, and so forth,
differences will need to be accounted for outside of the pathway or guideline (these would be the
patients who are represented in Figure 5 as the A's, B's, D's and F's).
For example, if there is a pathway or guideline for a patient having a hip replacement, approximately
68% of the patients (the C's) should be able to stay on that pathway. However, perhaps a patient with
a history of CHF develops symptoms of CHF after the surgery due to being overloaded with fluids
during the surgical process. This patient cannot remain on the pathway or guideline (would appear in
the A, B, D, or F portions of Figure 5). With trending of these types of patients who are not in the
middle C section, the organization may be able to determine if a sepa rate pathway or guideline could
be developed for hip replacement patients who have a history of CHF which limits the fluids in surgery
and includes a bifurcation for those patients that do develop CHF post operatively .
Calculating the Standard Deviation (SD) from the Mean
Before the SD can be determined, the mean (M ) is found (the average of all scores) . Then the deviation,
or distance, of each score {X) from M must be calculated . Each deviation ("x" ) is obtained by
subtracting M from each score ("x" = X - M ). A small "x" means little deviation. The variance is found
by squaring each " x", then finding their sum and dividing by the total number of scores (N). The
Standard Deviation {SD) is the square root of the variance.
Summar y of how to find the SD:
307
1. Find M (Sum raw scores and divide by N);

2. Subtract M from each raw score to obtain each "x";
3. Square each "x" value;
4. Find the variance or SD2 (Sum the "x" squares and divide by N);
5. SD = square root of the variance.
6. SD tells the "average" number of score units by which individuals, objects, or events
deviate from the mean.
The number of Standard Deviation units each score is from the Mean can be used as an alternate unit
of measurement instead of the raw score.
What this means:

• = 65; and the SD = 10.
If a Test is given and the mean exam score ( M )
• The "average" amount by which individuals deviate from M = 10 units.
• If a score = 85 (20 points > M), the n, the score's deviation from M is 2 Standard
Deviation better (+2 SD) better than the "average" and is therefore very good (in the
upper 2.2%).
• If a score = 35 (30 points below M), the score is 3 Standard Deviation worse (-3 SD) than
the "average" and is a very poor performance (worse than over 99% of other scores).
We will return to the use of the standard deviation as we explain other tools described in this chapter.
Parametric & Non-Parametric Statistical Tests
There are two broad categories of statistical tests which are utilized in determining what information
the results of the tests are telling us: Parametric and Nonparametric tests (Polit & Beck, 2012).
Parametric tests assume that the distribution of the data is normal (i.e., a bell-shaped curve) and then
estimate its parameters. Parametric tests require that the data be interval or ratio. Parametric tests
are more powerful in describing data than nonparametric tests. If the sample size is large, the
assumptions of normal distribution is likely to be true and small violations will not affect statistical
decision-making based on the results of the tests. However, if the sample size is small the distribution
may not be normal, it is better to utilize nonparametric tests for the data even if it is interval or ratio
data.
Nonparametric tests do not involve the same assumptions about the data as the parametric tests do.
The parameters of the data are not estimated, and there is less concern about the actual distribution
of the data. Nonparametric tests are best utilized when the data are not interval or ratio data, when
the distribution of the data is not normal,and/or when the sample size is small.
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Table 13 shows which tests are parametric and nonparametric and with which type of data they are
best used.
Table 13: Parametric & Nonparametric Tests

Parametric & Nonparametric Tests
Level of Group Group Correlational Analysis
Measurement Comparison Comparison
2 Groups 3 Groups
Nonparametric Nominal x2 x2 Phi Coefficient
tests Ordinal x2 x2 Spearmen's Rho
Parametric tests Interval I Ratio t Test ANOVA Pearson's r
Adapted from Polit & Beck, 2012
NOTE: If sample size is very small or distribution of the data is non-normal, use nonparametric tests.
Chi Square (X 2) & t-Test - Tests of Statistical Significance
As shown in Table 10 Types and Use of Data, the Chi Square and t-Test are utilized to determine the
difference between two groups. The Chi square is used with the categorical data and the t-Test is used
with the continuous data. Both of these test result in a 'p' score. This p-score indicates if there is
statistically significant difference between the two groups. While both tests produce a p-score, the
methodology utilized to obtain the p-score varies with each test. It is best to describe what the
statistical significance looks like before we explain each test. This description is a conceptual
description designed to help the reader understand what the p-score represents. The statistical
calculations of the p-score will follow each of the tests described below (Saint-Germain, 2001).
Figure 6: p-Score Results
309
O 0.05 0.25 0.5 1.0
The p-score will be a number between O and 1. When the p-score is between O and 0.05 (shaded area
in Figure 6) the difference between the two groups/scores is said to be statistically significantly
different. This means if measured again, the p-score will remain between O and 0.05 unless there has
been an intervention. If the p-score is between 0.05 and 1.0 then the difference between the two
groups/scores is said to have occurred by chance. This means that if measured again, the p value may
310
be different ( NOTE: Refer to this Figure as you read about the Chi Square and the t-test in the next few
pages).
A good conceptual example of this is marriage and divorce. When two individuals get married, they
feel as if they complement each other and together they feel they make a better whole. This concept is
a depiction of a test result where the p value is 1.0 and where the two groups are exactly, the same.
However, if these individuals get a divorce, it is often because they have grown apart and feel very
different from the other person. In many cases, they have nothing in common (represented by the O in
this figure) . However, there are some times when the two individuals will never be 100% different,
such as when there is a child involved. Each individual will be connected together by the child
therefore; they will never be 100% different. However, the remaining difference is so great that it can
be said they are two very different individuals with very little in common. This is represented in Figure
6 by the shaded area between O and 0.05. The individuals are statistically significantly different but not
100% different. However, every married couple has days when they feel closer or further apart from
the spouse. Often, this is the result of something one of them said or did. The difference between
them is not statistically significantly different and can change when one says I am sorry, or brings
flowers and/or other gifts to the other. This is represented by the line from 0.05 to 1.0 where there are
differences noted by the individuals but they are not significant differences.
The Chi Square (X2) test is used to determine if the distribution of two variables differ from one
another. The Chi Square test can only be utilized on the actual numbers obtained and not with the
percentages that are calculated. The question asked should be: Is there a significant difference
between the groups or conditions being compared with respect to the counts or rates of a particular
occurrence, event, or outcome?
An example of how the Chi Square test is utilized is the Comparison of long-term care facilities A and B
(Table 14) on the number of healthcare-associated lower respiratory infections (Refer to Figure 6 as
needed). The numbers in each box represent the patients with each outcome in two different 6-month
samples :
Table 14: Long Term Care Example of Chi Square

Long Term Care Example of Chi Square
January - June July - December
Facility A Facility B Facility A Facility B
Infection 5 4 12 2
No Infection 95 96 88 98
Total (N) 100 100 100 100
xi xi = 0.116 X = 7.680, p = <.01
2
No difference Significant difference
311
In July - December time period in this example, the difference between infections in Facility A and
Facility B is statistically significant as indicated by the p=<.01. However, in the January to June data,
there is no statistical difference between the two facilities. This means that from July - December
something has happened to make the two facilities so very different. If that cause is not uncovered
and removed then there will continue to be statistically significant differences between the infection
rates in these two facilities.
To calculate the Chi Square, the data must be placed in a 2x2 table similar to the one utilized in the
below example . In this case, we will use data from two facilities identified as a, b, c, and d. The total (n)
is then calculated (n = a + b + c + d).
Facility A Facility B
a b
C d
The formula for calculating the X 2 is:

X2 = n(ad-bc)2
(a+b)(c+d)(a+c)( b+d)
Once X 2 is determined, the degrees of freedom must be determined . In the above example, the
degrees of freedom (df) is 1. The degrees of freedom is calculated as:
Degrees of Freedom (df) = (# rows - 1) (# columns - 1)
A Chi Square Distribution Table is then utilized to look up the X 2 value utilizing the degrees of freedom
to determine the level of significance (p-value) of the observed x2, which will be between the values of
0 to 1.0.
The t-Test is utilized to compare two groups on the same measured variable using means (averages) of
each group to see if they indicate real (significant) difference, or a difference likely to have occurred by
chance (refer to Figure 6 as needed). The example that demonstrates this statistical test is comparing
the average number of cigarettes smoked per month by smokers who had a heart attack (Ml) before
age 65 (Group A) vs. smokers who did not have a heart attack (Ml) before 65 (Group B). In order to
calculate the t-Test value, the number in the group (N), the mean of the group (M), and the sld ndard
deviation of the group (SD) must be determined for each group separately.
Ml < 65 (Group A) No Ml < 65 (Group B)

Total (N) 13 9
Mean ( M ) 27.1 15.0
Standard 7.3 12.5
Deviation (SD)
310
The formula utilized to calculate the t value is:
t= M(a) - M(b)
SD(a) 2 + SD(b) 2
N(a) N(b)
So, in this example:
t= 27 .1 - 15.0
7.32 + 12.52
13 9
t = 2.61; df = (13-1) + (9-1) = 20 so, p = <.02
The difference between the average number of packs of cigarettes smoked per month for the two
groups (27.1 vs. 15.0) is a significant difference and not likely to be due to chance.
Type Iand Type II Errors
When calculating the relationship of one variable to another there is always a chance of making a
mistake regarding the relationship between the variables in the real world beyond your sample . If a
mistake is made, it will be either a Type I or a Type II error (Types of error, 2017).
A Type I error occurs when one assumes that there is a relationship between the two variables when
there in fact is no relationship. The probability of making a Type I error is called alpha. Typically, in the
social sciences, an acceptable alpha is 0.05. This means that there is a 5% chance of making a Type I
error. However, in public health, the acceptable alpha is frequently set at 0.01. This indicates the very
small likelihood of assuming that there is a relationship between the two variables when there really is
no relationship.
A Type II error occurs when one assumes that there is no relationship between two variables when
there in fact is a relationship. The probability of making a Type Ii error is called beta. Unfortunately,
reducing the likelihood of one of these types of errors increases the chances of the other type of error.
A Type I error, where a relationship is thought to exist, when it really does not, is the worse of the two
errors. Therefore, Type I errors should be avoided, if possible. The level of alpha is affected by the size
312
of the samples. If there is a weak relationship between two variables or the alpha is set very small, a
larger sample size will be needed to be able to reach statistical significance.
\Regression Analysis - Scatter Diagrams\
Regression Analysis is a statistical technique that allows one to compare the entire distribution of
observations of one measurement (or variable) with the entire distribution of another measure in
order to determine how strongly the two sets of variables are interrelated (correlated).
A Correlation Coefficient (r) is the value computed in regression analysis that expresses the strength of
the relationship between the two sets of measures. The numbers associated with r range between 0
and plus or minus l.
An r approaching +1.0 indicates a strong positive relationship between the measures, with both sets of
measure either increasing or both decreasing together. An r approaching -1.0 indicates a strong
negative relationship, with the numbers of one of the measures increasing as the numbers of the other
measure decrease. Measures with no significant relationship will have an r of approximately zero (O) .
-1.0 +----------- 0 -
---
---
----+1.0
Strong Negative - ---- No Relationship ----- Strong Positive

Relationship Relationship
(One set increases/ (Both sets increase
one set decreases) or decrease)
The cotter Diagram) is one way to display the possible relationship between two sets of
data (variables), looking at how closely they correlate. This assists in the data analysis and
outcome evaluation. The correlation may represent a possible cause-and-effect relationship,
depending on the nature of the variables . The two variables utilized are called either the
independent variable or the dependent variable. The independent variable is the one that is varied or
manipulated and presumably has some effect on the dependent variable. The independent variable is
often referred to as the 'cause' and the dependent variable is the presumed 'effect'.
Graphically, the correlation coefficient (r) expresses the degree to which the dots on the scatter
diagram form a straight line. A regression equation is the formula for the line that best fits the dots of
the scatter diagram. The regression equation can be used to predict the expected value of one variable
based on a particular value of the other variable. In the example scatter diagram with a strong
correlation, the dots nearly form a line; with a moderate correlation, the dots roughly form a line; and
313
with no correlation, the dots cannot be said to form a line at all. On the scatter diagram, the
Dependent variable should be on the Y-axis and the Independent variable displayed on the X-axis.
Let's look at some Scatter Diagrams to illustrate these points:
1'1 Example - (Figure 7): "Strong Positive Relationship" [r = +.80]
Both the heart rate as measured by the nurse and as measured by the monitor correlates positively
(both sets of numbers increase or decrease together, as you would hope). The relationship is strong;
the points approximate a straight line (each point = a comparison of two heart rate measures on the
same patient at approximately the same time). This relationship represents a correlation that is
expected, but is not one of possible cause and effect.
Figure 7: Scatter Diagram - Strong Positive Relationship (r = + .80)
120
,;
Variable 2:
100
Point = 1Comparison of Measures
Heart Rate by
Nurse
80
60
40
40 60 80 1 00 1 20
Variable 1: Heart Rate by Monitor
2"d Example - (Figure 8): "Moderate Negative Relationship" [r = -.45]
The average number of medication errors made by each nurse in a critical care unit did not correlate
positively with an increase in the number of hours worked per week over a six-month period. In fact,
there were more errors generally by those with the fewer number of hours worked. The relationship
between measures here is considered moderate (r is not too far towards -1.0), and "nega tive" (as the
number of hours increased, the number of errors tended to decrease). Here there may be a cause and
effect relationship given the nature of these variables).
314
Figure 8: Scatter Diagram - Moderate Negative Relationship (r = - .45)
10
8 Point = 1Nurse
Variable 2:
Average #
6
Med Errors 4
2
0
20 30 40 50 60
Variable 1:Average # of Hrs. Work I Week
3rd Example - (Figure 9); "No Relationship" [r = approx. OJ
There is no relationship between the number of confirmed adverse patient occurrences (APOs) per
year and age of physician.
Figure 9: Scatter Diagram - No Relationship (r = .00)
10 -
0
8 - 0
0o 0 Point = 1Physician
Variable 2: 6 0
# of confirmed
0 0
APOs I Year 4 0 g oo
0
2
1---
0 0
O 20 30 40 5 60 70 80
Variable 1:Age of Physician
An important point is that if there is a 'Positive Relationship' found, it does not mean that the
relationship is what you want or do not want to happen. Conversely, a 'Negative Relationship' is also
not necessarily negative or positive. It is simply the way in which the lines go. For example, a scatter
diagram of the Independent va riable of calories consumed vs. the amount of weight someone gains is
a positive relationship . However, to most individuals an increase in weight is not positive.
While the Scatter Diagram is a pictorial representation of a Regression Analysis, the analysis itself is more
stringent because it is mathematically calculated.
315
Multiple Regression Analysis
A Multiple Regression Analysis is similar to a simple regression analysis except that it includes multiple
independent variables that are predicting (or potentially affecting) the dependent variable. An
example of a multiple regression would be a determination of how much a diabetic diet, medication,
and activity affect the HAlc value. The HAlc value is the dependent variable and the diet, exercise,
and medication are the independent variables. A multiple regression will calculate how much effect
the diet has on the HAlc, how much effect the exercise has on the HAlc, and how much effect the
medication has on the HAlc. It will also calculate how much effect a combination of these
independent variables has on the HAlc.
The outcome of a multiple regression analysis is expressed as a multiple correlation coefficient or R.

Unlike the regression analysis where the calculated value ranges from -1 to +1, in the multiple
correlation coefficient does not have any negative values. The R ranges from O to 1.00 which
demonstrates the strength of the relationship between several independent variables and the
dependent variable, but it cannot demonstrate the direction of the relationship (positive or negative)
(Polit, & Beck, 2012).
Confidence Interval
A confidence level represents the level of probability that a sample parameter is truly representative
of the population. It is usually set at 95% (the ".05 level"). Calculations using this standard assume that
there is a 95% chance or probability that the sample mean and standard deviation are the same as the
population, and that the results are not due to chance, but can be replicated. Most statistical packages
have the capability to calculate the confidence interval.
A confidence level, statistically calculated, involves a test for significance, and is generally represented
by the p-value, e .g., p = <.05. As the p-value decreases, significance increases-i.e., the % probability
increases.
A p-value of p = < .05 means that relationships in the data are "significant" statistically; therefore, the
team members have more "confidence" that they can trust the data and make decisions accordingly. If
the p-value is p = < .01, confidence in decision making is even higher (99%); relationship in the data are
more significant, and even better represents the whole population and results are even less likely due
to chance.
lnterpercentile (Interquartile Range - IQR) Measure
The interpercentile or interquartile range refers to the variation of the data between the first quartile
(251h percentile) and the third quartile (751h percentile), or somet imes described as the middle 50% of
the data values. This assists the evaluation of extreme outliers, but is not often reported in studies.
316
The most commonly utilized interquartile range is the baby growth chart utilized to determine the
distribution of selected body measurements in children.
Statistical Process Control
One concept that should be explored is that of statistical process control. It is defined as the use of
measurements to study a process with the goal of making it perform in a certain way, conform to
standards, and continuously improve (developed by Walter A. Shewhart in the 1920s to improve
processes at AT&T). The objective is to distinguish common from special causes of variation to make good
management decisions (Shewhart, 1931).
According to Webster's New World Dictionary, variation is "change or deviation in form, condition,
appearance, extent, etc., from a former or usual state, or from an assumed standard." Variation
generally refers to the whole process or a step in the process. A variance is "a changing or tendency to
change; degree of change or difference; divergence; discrepancy" . This term generally refers to specific
data or information (Variation, n.d.).
It is true that all processes vary and no process functions exactly the same way over a period of time.
Some variation is desirable, some is wasteful, and some may be harmful. So how do we meet the
demands for accountability and improvement when processes always vary? First, we must understand
the variation.
According to Walter Shewhart (1931), process variation is of two types: Random or Common Cause,
and Assignable or Special Cause Variation.
)Random or Common Cause) variation is intrinsic to the process itself; naturally occurring "noise" in the
process; "inliers". For example, patient response to medication will always vary within the cohort of
patients, and even for one patient over time. "Common causes" refer to situations, usually within
patient care systems and processes that are more ongoing, chronic, and persistent. These common
causes contribute to the "normal range of variation" within a process. The goal of quality improvement
is not to eliminate, but to reduce variation in a process enough to produce and sustain "stability".
Common causes may also contribute to what are considered the less than desirable parts of a process.
Usually finding and resolving common causes of problems or variation is more time-consuming and
may be more difficult for departments, services, or quality improvement (QI) teams. The resolution of
common causes of problems is often considered to be key, to continuous, incremental improvement
of the quality of care and services rendered to patients. In this case, there needs to be no focused or
case-specific review. Process redesign or improvement is necessary .
317
ssignable or Special Causel variation is extrinsic to the usual process; related to identifiable patient
or clinical characteristics, idiosyncratic practice patterns, or other factors that can be tracked
("assigned") to root causes. "Special causes" refer to sentinel events, one-time occurrences, or other
unique, out- of-the-ordinary circumstances that give rise to a variation from what is normally
expected. Special causes are usually more easily identified and resolved, either by departments or by
QI teams. Special causes account for the majority of what we call "outliers" - those problems that
generally contribute to the "tails" of a normal, bell-shaped curve representing a particular process.
When a special cause variation is identified, case-specific focused review and root cause analysis are
needed to identify the cause and take action. Such variations, if negative, can be fairly quickly changed,
or eliminated . Positive variations should be analyzed for possible replication as better or best practice.
tatistica/ thinkin understands and views work as a process. It recognizes that the processes and
the measurement data they produce will exhibit variation, and that the variation should be
appropriately responded to reduce the variation to improve quality (Shmula, 2017).
A process is in good statistical control when the it is (1) stable over time (demonstrated through
measurement data); (2) operated in a stable, consistent manner with no arbitrary changes in process
steps or conditions; (3) the "process aim" is set and maintained at the proper level, based on quality
control specifications or target values; and (4) the average or normal process variation (control limits)
falls within the specification limits (expectations) . See Control Charts under Display Techniques, in this
chapter.
Walter Shewhart's understanding of causes of variation led him to develop a methodology to chart a
process and quickly determine when a process is "out of control." This ongoing measurement and
analysis is known as Statistical Process Control (SPC). As long as assignable or special causes of
variation exist, we cannot make accurate predictions about process performance and probable
outcome. Once assignable causes are eliminated, we can call the process "stable" and can measure the
"capability of the process" by rates of deficiencies or rates of achievement of desired outcomes. At this
point, we have the data we need to perform the in-depth analysis that leads to improvement. For
example, a diabetic tracking his/her daily blood sugars would want them to remain in statistical
process control.
Display and Statistical Tools are used to measure performance, and collect and display data different
variables. Commonly utilized display and statistical Laois include Tables, Pie Charts, Frequency
Distributions, Histograms, Bar Charts, Pareto Charts, Run Charts and Control Charts. The appropriate
display of information is a key responsibility of the Quality Professional. How data is presented may
determine whether an appropriate decision is made and appropriate action taken. Since measurement
and assessment are more and more dependent on the analysis of patterns and trends, how data is
aggregated and displayed is critical to the outcome and ultimate effectiveness of the process.
318
There are many Quality Improvement Tools which are used for different reasons. Tools are developed
to be utilized when identifying a problem, for data analysis, solution planning, and outcome
evaluation. Table 15 displays the tools and when they are best utilized. Each of these tools will be
described in this section. The emphasis will be on what the tool is, when it should be utilized, and what
it tells you. This portion of the chapter will be divided into two sections: Statistical Tools and Process
Tools. The Scatter Diagram, a statistical tool, was previously discussed (see Regression Analysis), so it
will not be repeated here.
Table 15: Quality Improvement Process Tool Selection Matrix
Problem Data Solution Outcome
I Identification Analysis Planning Evaluation
Check Sheet ./ ./ ./
Run Chart ./ ./ ./
Control Chart ./ ./ ./
Bar Chart/ Histogram ./ ./
Scatter Diagram ./ ./
Pareto Chart ./ ./ ./
Brainstorming ./ ./ ./ ./
Nominal Group Technique ./
Delphi Technique ./
Multivoting ./ ./ ./
Cause-and- Effect (Fishbone) ./ ./ ./
Interrelationship Diagram ./ ./ ./
Lotus Diagram ./ ./ ./ ./
Affinity Diagram ./ ./ ./
Flowchart ./ ./ ./
· Value Stream Map ./ ./ ./
Process Map ./ ./ ./
319
A3 Problem Solving Tool ._/' ._/' ._/'
Force Field Analysis ._/'
Task List ._/' ._/' ._/' ._/'
Gantt Chart ._/' ._/' ._/' ._/'
Prioritization Matrix ._/' ._/'
Quality Improvement Tools
ables!
[
Organized and summarized data for a sample, population, a given set of criteria, screens, etc., can be
displayed by using tables (see the example in Table 16) . Infection Control surveillance data or other
specific measurement data (e.g., medication usage or wait times) can also be viewed over time with
the use of tables, though graphic display may prove more interesting (Table 17) .
Table 16: Demographic Information Table

Demographic Information Table
Newly Diagnosed Medical Conditions in Children Participating in a Community Health ·
Program
CODE # SEX AGE RACE INITIAL
(pt-school)
01-01 M 7 w Impetigo, Conjunctivitis
02-01 F 8 w Blepharitis, Malnutrition
03-04 F 8 B Urinary tract infection
04-07 F 7 A Heart murmur
05-01 M 9 w Enlarged tonsils
06-04 M 8 B Hearing deficit, Eczema
07-07 M 9 L Myopia, Heart murmur, URI
There are several issues with the use of tables displaying data over time. First, if the information
displayed is without any guidance as to what is important within the table (Table 17), then it will be
difficult for the reader to tell easily what is important within the table.
320
Table 17: Table with Information Over Time

Table with Information Over Time
I
Goal Actual Aver.
Jan Feb Mar Apr May Jun Jul
Nosocomial
<7 7.1 6.9 5.1 6.2 7.1 3.4 4.4 5.7
infection
Nosocomial
<2.0 0.8 0.9 0.0 1.9 2.3 3.3 2.5 1.7
decubitus
Patient fall
with
0 0.0 0.0 0.2 0.2 0.0 0.1 0.5 0.1
significant
injury
".0.'. Medication
0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
+,I
IU
error harm
.!::!
'a
Mortality 21.20
-'iii
C
Rate
24.20% 27.50% 7.80% 26.00% 26.00% 16.20% 20.90%
%
·c
u Restraint
utilization <8% 6.0% 13.0% 6.0% 10.0% 8.0% 5.0% 15.0% 9.0%
(%)
Many organizations use traffic light coloring to indicate where to focus on the table. The red, yellow,
and green colors (shown here with shading) of the traffic light indicate that the organization needs to
stop and focus on the red data, use caution with the yellow data, and be confident that the green data
is where the organization wants it to be. The main problem with this type of table is the arbitrary
boundaries that are set to distinguish between the different colors. Table 18 displays an example. In
this table, the values of the colors are set for each measure. With the Mortality rate, there is no goal so
there is no color provided for those results. While this gives the reader an idea of whether the data are
acceptable or not, it does not demonstrate the common cause variation of the data over time. The
data value may be in the green zone one month, the yellow next, and then back to the green during
the third month. This does not indicate that action be taken to change this outcome, even though it
has been changing color zones. It does not indicate that there is a pattern or trend, but rather is
321
expected variation . There are better tools that can be utilized with data that is aggregated over time,
and those tools, run and control charts, are discussed later.
Table 18: Table with Color Coding of Information

Table with Color Coding of Information
Goal Goal Actual Aver.
Acceptable
Unacceptable Jan Feb Mar Apr May Jun Jul
Nosocomia
<7
infection 7.1 6.9 5.1 6.2 7.1 3.4. 4.4 5.7
Nosocomial
<2.0
decubitus 0.8 0.9 0.0 1.9 2.3 2.5 1.7
Patient fall
with significant 0 o.o .o.o 0.2 0.2 0.0 0.09 0.5 0.14
injury
Medication
0
error harm '0.0 o.o 0.0 o.o 0.01 ' 0.0 ,
Mortality
Rate
Restraint
<8%
utilization
Pie Graph
A Pie Graph is a display of relative frequency (percentages) of the proportional relationships within a
dataset when there are only a few divisions or categories and the total of all categories is 100% (Figure
10).
A Pie Graph is usually used to display parts of the whole in percentages . The full "pie" or circle
represents 100%, and each segment calculated as a percent of 360 degrees, e.g., 10% percent is
calculated as 36 degrees. The Pie Graph is not frequently used in healthcare as other depictions of the
data display the information in a better format, such as a Bar Chart (see Figure 14 below).
322
Figure 10:Pie Graph - Surgical Site Infection by Section
Surgical Site Infections

Percent of Total by Section
January • June
Urology
22%
GenSurg
Ortho 46%
11%
Gyn
21%
Frequency Plots
A Frequency distribution is a graph, designed to display the location, spread, and shape of the data.
The frequency plot has two axes: The horizontal baseline (X axis or abscissa) covers the elements of
interest and the vertical axis (Y or ordinate) indicates the frequency of this element in the data. Other
names for a frequency plot include a dot plot, a stem-and-leaf plot, and a histogram. These tools can
best be utilized to assist in data analysis and outcome evaluation. The frequency plots reveal one of
two types of curves of the data. In a Symmetrical curve, the two sides of the curve are identical if the
graph is folded in half perpendicular to the baseline (e.g., bell-shaped or rectangular). In a Skewed
curve, the curve is positively skewed if it tails off to the right side of the midline and negatively skewed
if it tails to the left side of the midline (Provost, & Murray 2011).
A Dot plot is a graph that utilizes a dot for each unique value. This frequency distribution is best
utilized when there are a small number of sample values (Figure 11).
Figure 11: Dot Plot - Length of Stay for CVA (Stroke)
ORH
# of cases (N) = 55
LOS Days
.
1
J
2 3
. Ll_LL - -·
4 5 6 8 9 10
_,,,...__,,..
11 12
-'
13
• _ ...
14 15
323
A Stem-and-Leaf Plot is more like a table where each data value is split into a stem and a leaf. The stem
value is the first number(s) in the value (Provost, & Murray 2011). The leaf is the remaining number in
the value. When graphed, the stem values are listed down and the leaf values are listed appear to the
right of the stems (Table 12).
Figure 12: Stem-and-Leaf Plot of Patient Weights
Patients Weights (lbs.)
STEM LEAF
10 9
11 2 25
12 59
13 2 57
14 9
15
16 3 58
17 2 46
18 5
19 2
20 9
This stem-and-leaf plot shows that there is one patient who weighs 109 lbs. and one patient who
weighs 209. It also shows two patients who weigh 112 lbs. each.
A !Histogram! is a bar graph of the frequency of one continuous variable. Because frequency is actually
a continuous variable, the bars are "blended" by connecting them at the frequency midpoints so the
bars are no longer discrete (Figure 13).
324
Figure 13: Histogram of Body Mass Index (BMI) of Patients Receiving Home Health Services
HISTOGRAM
0-16 17-30 31-50 51-65 >65
Body Mass Index
General procedures for graphing dot and histogram frequency distributions:
• Horizontal baseline (X axis) = scores or measures

• Vertical (Y axis) = frequencies or percent of cases
• The length of the vertical axis is 60-75% of the baseline length
• Label each axis very carefully, including:
What each element represents (captions)
The numerical values of each element (with consistent intervals)
• The lowest values for each axis start at the lower left of the graph
• In frequency histograms label midpoints of intervals
• Label each graph, including:
A concise title
Time period
Total number of observations
Number of observations for each subgroup (if appropriate)
Keys/legends as appropriate
325
!Bar Charci
A Bar Graph or Bar Chart is a display of comparisons between different groups or a collection of
discrete objects or events that cannot be ordered so it is not considered a frequency distribution, but looks
very similar to a Histogram. It emphasizes the groups' discreteness w.ith respect to two or more
categorical variables. Each set of bars represents a category. In Figure 14 for example, the number of
surgical site infections are displayed for each of four sections . In the figure, a Clean wound refers to a
wound produced by uncontaminated sharp objects, such as glass or a surgical incision. A Clean-
Contaminated (Cl-Cont) wound refers to a wound that is a dirty wound that may have been
contaminated.
Figure 14: Bar Chart - Surgical Site Infections - Rate by Section
Clean and Clean-Contaminated
Surgica l Site Infections

Rate by Section
January - June
*-
c
0 -
-
- -· -
·;;
u
.l!!
-
--
· ---
...0
!_:
..
CII
ta
a::
0 .
Section
labeling a Line or Bar Graph:
In general-though there are exceptions-labeling the graph involves the follow ing guidelines:
The independent variable, such as trials, groups, conditions, time period, age, etc. (categorical data), is
plotted along the baseline-X (horizontal) axis.
The dependent variable-the response measure of the characterist ic being measured, e.g., average
responses, time, percentages, or magnitude of response, etc. (continuous data)-is indicated on the Y
(vertical) axis.
326
!Pareto!
A Pareto Diagram is a special form of vertical bar graph with bars in rank order of occurrence from
highest to lowest. It offers a comparison of causes of problems, characteristics of a product or service,
or variables in a process and rank-orders (prioritizes) them, with the most common cause or most
frequently occurring characteristic or variable graphed first (on left side of graph). Each bar represents
a different problem, characteristic, or variable. The Pareto chart is best used in problem identification,
data analysis, and outcome evaluation.
The purpose of a Pareto Diagram is to determine where to focus improvement efforts, looking for the
"vital few" from the "useful many" to determine where to start to make improvements. The Pareto
Principle of 20% of the whole represent 80% of the problem is the theory behind this tool.
Typically, in healthcare, a Simple Pareto Diagram (Figure 15) can be utilized to determine where to
begin improvement efforts. However, at times, a more Complex Pareto Diagram (Figure 16) needs to
be utilized to determine mathematically where the largest portion of the problem lies.
Root Causes of Sentinel Events

60
so
.".' 40
C
GI
-...
>
w
0
C
GI
30
u
....GI.........20
c..
10
If you were to develop a Pareto of all the DRGs that your organization utilizes, you would probably not
be able to visually identify the 80% problem. Therefore, the Advanced Pareto chart should be used .
The Advanced Pareto looks like the usual Pareto, but with more information which statistically
identifies the 80% where the performance improvement efforts need to begin. The Advanced Pareto
327
includes a percentage line on the right vertical axis that corresponds to the values on the left axis. This
left vertical axis should be based on the total number of observations in the data being analyzed. In
Figure 16 the total amount of data is 75, so the left axis includes all possible data should they be
displayed in one column, which would be 100% of the data (right vertical column). Fifty percent of the
data (right vertical column) is equal to 37.5 (left vertical column), and so on. The values of each column
are then added together with a notation made above each column. In Figure 16, the first column (30)
is added to the second column (20) to get a value of 50, or 66.7% of the data The third column is
added to that value to show that the first 3 columns encompass 80 % of all the data. This continues
until all of the columns are added together for 100% of the data. The notations are then joined
together by a line as shown in the figure. At this point, the 80% level is located on the right vertical axis
and a line drawn to the left over to the right vertical axis. The point at which this line crosses the line
connecting the notations indicates that 80% of the data is to the left of that point, and that is where
improvement efforts should focus .
Figure 16: Pareto Diagram - Advanced
Pareto Chart
,--
(As an example of Cumulative Frequency)
- ---- --- -- , !
Reasons for Patient Dissatisfaction
70.0%
66.7% '
.. _:. . 60.0%
5 0 .0 %
& 30 T 40.0%
'o
'It
20 - 30.0%
20.0%
10
--2----2 ---2- ·0.0%

·
- 10.0%
4
Q
Appointment Attitude Wait Time Report Delays Billing Communication Refills Cleanliness
L Type of Dissatisfaction ------ ------- J
328
Pareto Drill Down
In healthcare, more information is needed to be able to better identify exactly where to start to make
improvements. Pareto Diagrams provide the ability to drill down to the finer details of the problem.
This allows the team to identify where the largest part of the problem truly lies.
For example, one hospital which has an active surgical schedule is finding that there are too many
delays in getting patients out of the PACU. The delay in PACU is causing a delay in surgeries. The
hospital tracked PACU discharge delays greater than 1 hour from August through November, which
showed some improvement (Figure 17), but not any significant improvement. It was determined that
the data needed to be utilized to drill down to identify the reasons for the delay, and a Pareto was
developed (Figure 18).
Figure 17: Percent of Patients Recovering > 1 hour in PACU
Percent of Patients Recovering > 1 Hour in

PACU
25 ········--·······-·····.................................................. ..........
20
-
15 ·····-···· ··············· -·-···················· ········ ··········-····-······· · ·········-·-·············-· ············· · ·.............................. ...... . . . . . . ................. ···········-···-····-···... . . . ....................... ._..................................... .......-............................
10 --- --------·------ ----.....-------
0 -----·----.---··--·---
Aug Sept Oct Nov
329
HEALTH DATA ANALVTICS
Figure 18: Reasons for Prolonged PACU Recovery Time
Reasons for Prolonged

PACU Recovery Time
250
200
150
100
50
0
Clinical Non-clinical
While this was a good first attempt, the Pareto does not really tell the team anything. Everyone
already knows that there are clinical and non-clinical issues attributing to these delays, so more drill
down is required. It was determined to drill down on the clinical issues first with another Pareto chart
(Figure 19).
Figure 19: Clinical Delay in PACU Time
Clinical Delay in PACU Time

80
70
60
50
40
30 --·--------------------
20
10
0
330
It is clear from this Pareto that pain and hypothermia are the main reasons for the delays in
discharging the patients from PACU. Thus, these are the areas where the team should start in
determining how to make improvements . Two teams were assembled, one for each of these issues.
When the Pain team met for the first time, they determined that 'pain' was a large issue and that
perhaps another drilldown on pain would be helpful (Figure 20).
Figure 20: Pain Delay in PACU
Pain Delay in PACU

30
Not reassessed Pt not medicated Med did not work Pt not assessed Pt not complain
With the information provided from this last Pareto, it is now clear to the pain team that the patients
are not being reassessed for the effectiveness of the pain medication, or the patient was not even
medicated for the pain if they were assessed. These areas are where the team will focus their efforts
to decrease the delay in the PACU.
!Run Chart!
The Line Graph or Run (Trend) Chart is a display of performance changes with systematic increases or
decreases in the value of some variable over time. It can be either a comparison within one group
when conditions change over time or a comparison between two groups in the same study. Each data
point, plotted horizontally, is a measurement of an output from a process (Figure 21).
33
1
Figure 21: Surgical Site Infections Run Chart

Rate by Month for Urology Section
January - June
10
9
8
.IllC..ll.
a::
7
6 ! Cl-Cont l
C 5
0
·.
u
-2!
4
3
-1----------' =- L--.-c1ean J
C
2 Mean
1
0
Month
A §un Chard provides a running record of a process over time and it can be used with any kind of data.
It is the tool of choice for continuous or measured data, and should be utilized with categorical or
count data if the data is to be displayed over time. !t is best utilized in problem identification, data
analysis, and outcome evaluation. It requires no statistica l calculations. It often includes a horizontal
mean or median !ine.
A Run Chart iincluding the control charti heips to answer the following questions:
• What is baseline performance for the process over time?

• How much variation is there in the process?
• What kind of variation is it, special or common cause?
• Is the process changing over time?
• Was the change really an improvement?
• What predictions can be made about the process from the data?
The Run Chart should start as soon as there are data available, and then continue to add data as it
becomes available. After there .:ire 10 data points, then a mean or median line can be added, and this
will provide more data to help interpret the Run Chart.
There are three probability-based rules that can be used to interpret the data on the Run Charts: a
Shift, a Trend, and an Astronomical value. The first of these rules is based on a probability of 5% or
p=0.05 indicating that there is a very small probability that chance has made the data act in this
332
manner. The second and third rules are based on comparison to random patterns of data. All three of
these rules should each be applied to a set of data, but not all three rules have to be met to indicate
that there has been a change in the data (Provost, & Murray 2011) .
A occurs when six or more points consecutively appear above or below the mean or
median. Values that fall on the mean/median itself do not count in terms of the start, break, or end
of a shift, and are not included in the count for a shift (Figure 22).
Figure 22: Run Chart - Shift
Shift - Dot on Mea n
A ITren consists of five or more consecutive data points (some people count six or more points) gQ!!) g
up or going down. This rule does not care whether the consecutive dots are above or below, or
crossing the mean/median . However, if two or more consecutive data points are the same, one of
them is not counted (Figure 23).
Figure 23: Run Chart - Trend
Trend - Dot Next To Each Other
333
An stronomical Value! occurs when there is one value which is greatly different from the other
data values on the run chart. It would be a va lue that is highly unlikely to occur again, and would
appear as an outlier (Figure 24).
Figure 24: Run Chart - Astronomical Value
Astronomical Value
!control Chart!
A control chart is a line graph/run chart that compares actual performance or change over time to the
mean and includes both upper (UCL) and lower control limits (LCL). It is a display of normal variations
and special cause variations over time. It is best utilized with continuous or measured data; and can
assist w ith problem identification, data analysis, and outcome evaluation. The Control Limits provide
the basis for determining the capability of the process (the degree of control) and to identify special
causes (Figure 25).
Figure 25: Surgical Infections Control Chart

January - June
10
UCL
:
> - -·
--.
-
Mean
2 -L. _
___
LCL
-J-
1-
0
I -+-Cl-Cont
·
c... ---+-Clean
_
Month
334
Control charts are more precise than run charts in identifying special cause variation in the process
being measured. Data that falls between the control limits are deemed to represent a predictable
variation in a "common cause," controlled system. This variation in the data will form a normal
distribution, which is the bell-shaped curve. The upper and lower control limits represent the end-
most "tails" of the curve. While mathematically different, they can conceptually be thought of as
being l, 2, or 3 standard deviations (sigma) away from the mean (see Standard Deviation previously
discussed in this chapter). The upper and lower control limits are usually set at ± 3 SD (standard
deviations), or 3 sigma, from the mean, representing that 99.7% of the data should fall within those
limits. Most national organizations as CMS and The Joint Commission utilize this control limits. Two
sigma limits (95.4% of data will fall between these limits) can serve as "early warning signs" if
clinicians are uncomfon:able with waiting until a data point exceeds 3 sigma before taking action.
There are many special cause rules that indicate a special cause variation, but three are utilized most
often in healthcare (Provost, & Murray 2011). These special cause rules are similar to the probability-
based rules utilized with Run Charts . These three rules are (1) a shift, (2) a trend, and (3) any value
outside of the upper or lower control limits. If any of these properties are found in the data, then it
represents special cause variation necessitating intensive analysis.
The first rule is a hif4 which consists of eight or more consecutive points in a row above or below
the mean. As in the rule for the Run Chart, a point exactly on the mean does not count or cancel the
shift because it is neither above nor below the mean (Figure 26).
Figure 26: Control Chart - Shift
Shift - Dot on Mean
The second rule, la trendl consists of six consecutive points going up or coming down. This rule is
also similar to the Run Chart rule where two or more consecutive dots of the same value, only the first
one
counts since the dots do not go up or down, but remain the same. Again, the mean does not figure
into this rule at all (Figure 27).
335
Figure 27: Control Chart - Trend
Trend - Dot Next To Each Other
-
-
-
--· ·--·-- --·- -----
--
The last rule is exactly as it sounds, any data point !outside of the up per or lower control limid (Figure
28).
Figure 28: Control Chart - With Dot Outside Upper Control Limit

January • June
iO
UCL
8
6 Mean
4
2 - - LCL
0 ----·----
-·-·-
1
-·· --- i
_._ Cl-Cont
-+-Clean !
.
-
L -
-
- - - - !
Month
336
Process Tools
Process tools are utilized in quality improvement and quality planning to generate ideas, understand
current process and root causes, and prioritize improvements. These tools are not discussed in any
particular order, but are grouped together with other similar tools.
Brainstorming
Brainstorming is a structured group process used to create as many ideas as possible in as short a time
as possible, (e.g., one session), and to elicit both individual and group creativity. Lists generated in this
process may relate to problems or topics, components of a process, indicators, criteria, elements for
data collection, and possible solutions. Brainstorm ing can be structured, unstructured, or rapid
brainstorming. With structured brainstorming, everyone in the group gives an idea in rotation or
passes until the next round (a type of "nominal group process"). With unstructured brainstorming, the
participants in the group give ideas as they come to mind. Finally, with rapid brainstorming, small
groups have two minutes to generate ideas using flip charts and scribes who rotate, and then sha ring
each group's ideas with the other groups. This process is repeated two or three times.
There are six steps of brainstorming: Definition of the subject and direction of the session; allowing
time for initial, individual thought; establishment of a time limit for the entire session; requesting ideas
according to the predetermined structure; keep circling the issue until all ideas are recorded (using a
flip chart or overhead projector so all can see); and clarification of all ideas are generated to assure
accuracy and understanding.
Nominal Group Technique
Nominal Group Technique is a similar technique used to give everyone on the team/group an equal
voice in brainstorming, problem selection, or resolution (Sample, 1984). When the team/group is new,
or some members are more vocal, or the issue is controversial, ideas and/or the most important issues
are brainstormed in silence, written down, then shared one idea per person at a time, and recorded on
a flip chart. In this process ideas are clarified, but not criticized.
Each idea is then rated by each participant, e.g., top five ranked from 5 points down to 1 point
independently and anonymously. Votes within the team/group are tabu lated, and a report prepared
or discussed with the large group in a structured brainstorming format.
Multivoting
Multivoting is a technique used to prioritize a long list of possibilities or alternatives and to move a
team toward consensus. The goal is to end up with the "critical few" ideas upon which to focus the
team's attention. Multivoting begins with a brainstorming of ideas as previously discussed . The group
then considers similarities, redundancies, etc., on a brainstormed list of ideas in order to eliminate any
overlap. Each team member is asked for input to prevent wrongful tampering with an idea. If the team
337
agrees, then combine duplicate or similar ideas, being certain the team agrees on new wording.
Number each item on the new list. Determine how the group wishes to rate each of the items that are
on the list. There are multiple ways to do this. One method is to ask the participants to pick a certain
number of items (for example 10) on the list that the participant feels are the most important items on
the list. Another method would be to give each participant dots of a different color that represent a
differenf number of points. The participants then place the dots, one dot per item, on the list next to
the items they feel are important.
Once the votes are counted or the dots are placed, someone adds up the number of points for each
item. The items with the most selections or points are determined and the others are deleted. The
group again individually votes for a lower set number (now maybe 5), or placement of dots (less dots
than before), and the calculation of points is again done. This continues until a reasonable number of
items a re left that the group can work on.
Delphi Technique
The Delphi Technique is a tool used to reach team consensus concerning a particular goal or task . The
technique can be used whether or not the team is in session or if members are in different locations. A
questionnaire or listing of possible options is drafted by the team or the team leader to tap each
individual's views or attitudes, possibly including a requirement to vote, concerning the team goal,
task, or project. The questionnaire or listing is circulated anonymously , during, before, after, or in
place of team meetings. After each round, the questionnaire or listing is revised and recirculated until
consensus is reached. Each round includes a request for comments, questions, objectives, criteria, etc.,
that participants deem most appropriate. Verbal discussion is used at each team meeting to review the
results and gain consensus.
!cause & Effect Diagram (Ishikawa)!
The Cause & Effect Diagram (Figure 29) is a display of the relationship between some "effect" and all
the possible "causes" impacting it. It is also often ca lled a "fishbone" or "Ishikawa" diagram . It is a tool
generally used to gather all possible causes as an overview. The ultimate goal is to uncover the root
cause(es) of a problem. The specific problem can be stated as a negative or positive outcome ("effect")
of a process. A negative effect could be the late transfer of patients from the skilled nursing facility to
home health facilities . A positive effect could be the need to develop a new service, or educational
program. The diagram is a visualization of relationships between the outcome of a particular system or
process, the major categories of that system or process (the cause; main branches), and sub-causes
(sub-branches off main branches).
The Cause-and-Effect diagrams can be built to analyze dispersion (Why does a particular cause or
dispersion happen?); classify processes (identify all steps); or enumerate causes (same as dispersion,
338
except that all possible causes are first organized in list form, then placed in the main cause
categories).
Figure 29: Cause & Effect Diagram
Cause & Effect Diagram
l
''
- 1 1 Effect !
/ Cause
/
''
''
..
'
'
',
To construct a Cause & Effect diagram, begin with the outcome/effect on the right of the paper,
halfway down. Draw a horizontal line across the middle of the paper with an arrow pointing to the
outcome. Draw diagonal lines angled from the horizontal line away from the outcome . There needs to
be at least two lines, but limit the number of lines to less than 6-8 as more would become too
complicated and the ideas diluted. These lines will be used to display the causes of the effect that is
being studied. Brainstorm to identify possible main causes of the outcome and add them to the chart
using horizontal lines (parallel to the main outcome line) touching the appropriate diagonal line.
Possible sub-causes of main causes can be identified by using the "Five-Why" technique described in
the !Root Cause Analysis\ process in Chapter 5 Patient Safety. The team then needs to evaluate the draft
diagram to determine the accuracy of the placement of issues and lines.
You can label the diagonal lines before or after the brainstorming. However, if you label them before
the brainstorming, the pa rticipants may be blinded to other possibilities as they will focus on the
categories listed in the drawing. If there is a good facilitator to record the brainstorming ideas, the
facilitator can group like ideas together and then name the diagonal line based on what is
brainstormed and grouped on that line. If it is determined that the diagonal lines should be pre-labeled
prior to the brainstorming, there are conventional labels that can be applied. Industry utilizes the 5
M's: Manpower, Materials, Machines, Methods, and Management. In healthcare, there are the 5 P's:
People, Provisions {supplies), Policies, Procedures, and Place (environment).
Once the diagram seems appropriate to the team, evaluate the diagram for obvious improvement
options, causes already resolved or eliminated, causes easily resolved or eliminated, issues raised
which require more in-depth assessment to be understood, significance, etc. Use whatever statistical
tools are necessary to collect data, draw accurate conclusions, and pursue appropriate solutions. It is
339
very important to study the relative frequencies of the different causes before acting to change the
process.
Once all of these factors are considered, the team should determine which of the diagonal lines could
be improved easily and quickly. That diagonal line should be circled and numbered (#1). Change theory
demonstrates that there should be quick wins when possible so that those involved can see that there
are improvements being made. This will help those that are unsure to see that there is positive
movement in this area. Then identify the diagonal line that will take the most work and the longest
time to make the changes and sustain them. Circle this line and number it as the last one to be tackled.
For example, if there are four diagonal lines, this line should be #4; if there are five diagonal lines, this
one should be labeled #5. Next move to the remaining diagonal lines and determine which ones should
be numbered #2, etc., up to the last number already labeled. By the time improvement processes
reach the last diagonal line, some of the items will already have been improved based on the gains
made with the other diagonal lines.
Interrelationship Diagram
An Interrelationship Diagram is a tool that allows a team to analyze all the interrelated cause-and-
effect relationships and factors involved in a complex problem, distinguish between issues that serve
as drivers and those that are outcomes, as well as describe desired outcomes. It should be used to help
a team understand the relationships among issues within a process. It can also be utilized to assist in
identifying root causes (Interrelations hip, 2015).
In order to create an interrelationship diagram, a problem statement should be developed and then
issues related to the problem. These issues may be identified through brainstorming or with the use of
other tools discussed in this book.The items are then each placed into a circle pattern. Using any issue
to start with, identify if there are any cause-and effect relationships with each issue in a circle. It needs
to be determined whether there is no relationship, a weak relationship, or a strong relationship
between the two issues. If a cause & effect issue is identified, determine which of the two issues is the
cause and which is the effect. An arrow is then drawn from the issue that is the cause to the issue
which is the effect. If there is a strong relationship, the line drawn should be a solid line. If there is a
weak relationship, the line drawn shou ld be a dotted line. Lines are not to be bi-directional. If both
issues affect the other, then draw two lines, with one going in each direction. Once this has been
completed for all the issues, count the number of arrows pointing to an issue and the number leaving
an issue. The issues with the high number of arrows leaving it are considered a driver. A high number
of arrows going into an issue indicate that the issue is an outcome. The driver issues are usually
addressed first, and then the outcome issues.
An Interrelationship Diagram can be used to analyze the dynamics of a meeting to determine - who
talks a lot and who is quiet during the meeting. When a person talks, the arrow line goes from the
person talking to the person to whom the dialog is intended. By the end of the meeting, it can be
340
determined if someone dominates the meeting and if one person is being shut down by another
(Figure 30).
Figure 30: Interrelationship Diagram
Affinity Diagram
An affinity diagram is an organizational tool most often used at the beginning of a team 's work to
organize large volumes of ideas or issues into major categories. The ideas may have come from the
group's initial brainstorming session. "Affinity" means close relationship or connection or similarity of
structure. Therefo re, when developing an Affinity Diagram, it is most important to determine the
primary issue and major related subgroups in order to grasp the appropriate relationships, links, or
connections .
There are only three kinds of supplies, which are needed: a wa ll, sticky notes, and markers. All of the
participants will have some of the Post-It notes and a marker. A pen or pencil will not be readable from
far away. Once the primary issue is defined in broad terms, the participants brainstorm ideas, listing
one per Post-It note, and posting those on the wall. After all the brainstorming has been completed,
two or three individuals go up to the wall and without talking to each other, sort the sticky notes into
categories of similar or like ideas. The group then discusses the groupings and provides a concise title
for each one. The Affinity diagram is then drawn on paper, based on the major groupings, linking the
ideas related to each group (Figure 31).
341
Figure 31: Affinity Diagram
Quality Education Objectives J
Leadership Teams j j Orientation
Lotus Diagram
The Lotus Diagram is a tool to expand thinking around a single topic. The expansion may include types,
categories, details, or questions around a theme. It is one simple, but effective way to organize output
from Brainstorming. It is also a useful way to organize discussion during planning, e.g., Strategic or
Quality Planning. The identification of a topic is the first step to be accomplished and recorded in the
center box. Next, the team needs to determine the type of expansion of the topic that needs to be
accomplished. The responses are copied into the boxes around the Lotus (center) box. The responses
are then placed into the center box of the 8 peripheral 3x3 cubes as displayed in Figure 32.
342
Figure 32: Lotus Diagram
New
Orientation X
Teams
New
Orientation X
Teams
w w EDUCATION y y
Leadership z Physicians
Leadership z Physicians
IFlowchar
A flowchart is a pictorial representation displaying all the steps in a process and their
interrelationships . It displays the actual sequence of steps and their interrelationships in a specific
process in order to identify hand-offs (appropriate and inappropriate), inefficiencies, redundancies,
inspections, and waiting steps. It can also be utilized to display the ideal sequence of steps, once the
actual process is known.
Flowcharts can be used to identify and describe a current process; to proactively look for potential
process weaknesses or failures, e.g., !Failure Mode and Effects Analysis (FMEAJI; to analyze problems to
determine causes, e.g., !Root Cause Analysis (RCA)!; to redesign the process as part of improvement
action; and to design a new process. It can also be used to identify whether there is a process and
when questioning whether the actual process meets current policy/procedure.
There are several steps to be utilized in developing a flow chart. First the team must determine the
boundaries (the start and stop points) of the process under review. These may change later as the
process is studied in more depth. The team must then brainstorm to identify all activities, hand-offs,
and decision points in the process. Once these have been identified, they are placed in sequence,
paying attention to repetitions, disconnections, etc. Figure 33 demonstrates such a flowchart.
343
Figure 33: Flowchart
Get out of bed
YES
Get Dressed Eat Then
Get Dressed
In developing the flowchart there are certain established shapes that have meaning in the flowchart.
The start and stop points are always an ova l. A box or rectangle represents the action steps or activity
in the process. Each time a decision needs to be made it is represented by a diamond. Every diamond
must have two or more exit points from the diamond itself which must be clearly labeled. Arrows
connect the ovals, boxes, and diamonds throughout the diagram. If there is more than one "output"
arrow from an activity box, it probably requires a decision diamond. All of these symbols are utilized in
Figure 33.
Once the flowchart has been developed, it can be used to determine what changes might be needed.
Analyze the flowchart, looking for process "glitches" such as inefficiencies, omissions/gaps,
redundancies, barriers, etc. Also, look for the smooth parts of the process to use as models or "best
practices" for improvement . Decide whether to correct steps within the current process, design a new
process, or do corrections first then redesign in the future. If utilizing the flowchart with an IFME,look
for places where there is a potential for failure that could result in a patient care or other problem.
344
Value Stream Map
A Value Stream Map is utilized at a high level to identify the value and non-value steps in a process
from start to end of the process. Once the areas of non-value are identified, a process map may be
used to provide more detail about the area that has less value. It is then from the process map that the
identification areas of needed improvements can be made and an action plan developed and
implemented.
The Value Stream Map typically contains a SIPOC table, which stands for Supplier, Input, Process,
Output, and Customer (see Table 19) . In each of the columns of the table (boxes in the table below),
the high level data are placed, including upstream and downstream links. The team requires a narrow
charter (focus) of what is to be mapped, being specific to the process being mapped. The team must
be composed of the individuals who do the work, understanding the inputs and outputs of the
process. The team members must also be able to identify the resources that will be needed to perform
the tasks, and the demands of the outputs (Mclnnes & Dean, 2012).
Table 19: Value Stream Map

Total Lead Time .-=. 60·128 days {to evafuation)
Total Value Added Time = 3.2 hours (to evaluation)
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345
Before the columns in the table can be filled, the team must identify what the demands of customers
are, the maximum demand (what the system can tolerate), the historical demand (what the usual
demand is), predicted market changes in demand (what the future may bring), and how the product or
services may evolve over time. Once these have been determined, the team can begin to identify the
SIPOC column contents. In order to complete this step, the team should use sticky notes so that the
ideas or steps in the process can be rearranged based on the teams input. The actual process being
mapped should be observed and interviews should be conducted with those actually doing the
process. The process should be recorded with the sticky notes without making any judgments as to
what is happening. The time it takes to complete each part of the process should be captured, and
determine if the steps are completed one at a time or batched together. The team members should
record what resources are required before each step in the process is undertaken. The amount of time
that patients, staff, and/or others have to wait in line, or wait for something, needs to be included, as
well as how things are prioritized and sequenced. Once this step is completed, the Value Stream Map
can then be constructed utilizing the standard icons for this tool. These icons can be found on the
internet or in printed materials such as The Lean Memory Jogger (Mcinnes & Dean, 2012) for
Healthcare. Aftei the map is constructed, a lead-time chart is completed below each portion of the
value stream map utilizing the time data gathered . After this step, the team is ready to identify where
improvements are needed. There may be need for a further drill down on particular steps and that is
where the process map can be a valuable tool. It can be used to identify the waste and unnecessary
steps that should be removed.
Process Map
A process map is a series of detailed steps or actions performed to achieve a specific process. It is very
similar to a Flowchart. Process maps are utilized to document processes, identify areas of rework, and
to generate ideas for improvement. After the improvements are made, a new graph can then be
utilized to illustrate how the process was improved. Process maps can be used in brainstorming
possible changes to the process, to revise or create policy and procedures for processes, to identify
possible outcomes of a process, and to orient/educate staff members. The symbols utilized in a
process map are the same as those utilized in a flow chart.
A3 Problem Solving Tool
The A3 tool is a problem solving approach built around the POCA model previously discussed in
Chapter 3 Performance and Process Improvement. This tool is a method of structuring thinking, and a
communication tool for reporting problems and improvement suggestions to management. !t is a
concise summary of the problem and a possible solution. Several formats may be utilized for the A3
tool, and these can be found on the internet and in Lean and Six Sigma books and articles. Work is
done on one 11 x 17 form that includes: Background, Current Conditions, Goal, Analysis, Proposal,
Plan, and Follow Up (Figure 34) .
346
Figure 34: A3 Tool
PDMAI The A3 Problem Solving Process

Issue
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The background consists of why is this important to examine at this time. What is the business case
that you are trying to solve or analyze? It should be stated concisely and communicate to others why
you are addressing this issue. The current conditions consist of where is the process at this time. What
is going on? What is the symptom that brings this issue to the organization's attention? How often
does it happen? In addition, is there a pattern of occurrence? This area should include data, facts,
charts, graphs and other such tools.
The goal is stated as succinctly as possible with the target that is desired. What is the spec ific change
you want to accomplish? How will you measure success? The graph must be stated in measureable or
identifiable terms. Many times, this is the outcome of a !Root Cause Analysis (RCA)) as discussed in
Chapter 5 Patient Safety. It should include why you are experiencing this problem and what constraints
are preventing you from reaching your goal or target. You can utilize fishbones and other quality tools
to display this information and state the analysis as simply as possible.
The proposal is the countermeasures you feel are needed to reach your goal or target. What
alternatives should be considered? How will you choose the option and what criteria will you utilize to
do so? How will your choice impact the root cause to change the current situation and achieve the
goal/target? The .P.@.!'.l is what spec ifically needs to be implemented and who will be responsible for the
implementation .This should include a timeline with who, what, when, where, and how. The follow up
then consists of how you will know if the desired impact has occurred. What issues or remaining
problems can be anticipated? it wiii also identify any failure modes that have been identified that will
require further action.
Force Field Analys is
A Force Field Analysis is used by a team when a proposed solution to a problem will require significant
change, and it is important to analyze the potential impact and chances of success. The team can, thus,
be proactive, anticipating both possible resistance to change and ways to minimize it. Kurt Lewin, an
American social psychologist, developed this technique to look at both the "driving forces" that move a
situation toward change and the "restraining forces" that block the movement. If no change occurs, it
is because the opposing forces are equal, or the restraining forces are too strong. Sometimes the two
sides are title strengths and weaknesses . It is the goal to 'strengthen' the strengths, and to 'weaken or
remove' the weaknesses . Figure 35 represents a template for a Force Field Analysis.
348
Figure 35: Force Field Analysis - Integrating Quality, Utilization, and Risk Functions
Force Field Analysis - Integrating Quality, Utilization, and Risk Functions
Driving Forces (Strengths) Restraining Forces (Weaknesses)
Shared mission and vision for quality in the
Loss of autonomy
organization
Reduced duplication of effort; staff efficiency Changes in job descriptions and workload
Balanced approach to decision making regarding
Loss of focus on specialty area
cost, quality, risk
Shares Staff (cross training) Staff turnover with leadership change
In order to create a Force Field A nalysis in a template (such as Figure 35), list in two columns all the
dr iving (strengths) and restraining (weaknesses) forces affecting a desired change . Discuss the overall
value of the proposed change and then the team comes to a consensus about priorities for effecting
change. Include in the planned solution actions to diminish or eliminate the restraining forces while
strengthening the driving forces.
Checklist/Task List
A checklist or task list is a listing of things to do or obtain in order to keep the team on schedule, to
help team members remember commitments (e.g., the Safety Surgical Checklist), or to inventory
information. Joseph Juran ca lled it a "memory jogger". A task list ca n be converted to a detailed action
plan if appropriate . In Figure 36, the checklist is designed to inventory information and to display how
often something occurs or does not occur.
Figure 36: Checklist

Errors Jan Feb Mar Apr May June TOTAL
Type 1 1111 II II 1111 111 1 II 18
Type 2 II Ill II 7
Type 3 I I Ill 1111 1111 13
Type 4 1111 1111 8
TOTA L 4 3 7 8 11 12 46
!Gantt Chartl
A Gantt chart is a !project-planning tool! for developing schedules. It is a graphic display (a type of bar
chart) of the individual parts of a quality improvement process a s bars on a horizontal sca le. The Gantt
chart includes a list of tasks (process steps) and estimates of time and/or people resources required to
complete the quality improvement effort. Most project-planning software includes Gantt charts.
Figure 37 displays a Gantt chart that shows the estimated time of a project from initiation to
presentation. Instead of columns representing time, you could also use the Gantt chart to assign who
is responsible for what steps in the process.
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Figure 37: Gantt Chart

Month Month Month Month Month
Task/Time
1 2 3 4 5
Collect
Data
Analyze
Data
Display
Data
Preset
Data
iPrioritization Matrix!
A Prioritization Matrix is a tool used to select one option from a group of alternatives whether
problems or solutions, or to put options into priority order if all need to be done. it promotes decision-
making and consensus (Figure 38).
First, the matrix must be prepared with options, problems or solutions down the left side and criteria
and total score coiumns across the top of the matrix. List the items that need to be improved or
decided upon down the left side of the matrix. They do not have to be listed in any certain order. Next,
determine the criteria to be utilized to help make the decision regarding the priority order . The criteria
should all be phrased either positively or negatively so that the rating can be applied consistently. A
point system must then be developed. Typically,a 1to 5 Likert Scale is utilized with one being of low
significance/importance and five being of high significance/importance based on the criteria. A zero
should never be utilized.
In order to apply the criteria equally to each of the options/problems/solutions, the user should not
take an item from the left column and apply the ranking horizontally across all criteria . Instead, each
criteria should be taken and applied vertically down each of the items in the left column. This will allow
the rater to apply the criteria in the same manner to each of the items. There does not have to be only
one use of a number per column. In Figure 38,the cost column contains two items rated a two in cost.
The value placed there is independent for each item in the left column. Once each of the items have
been rated utilizing each criteria, each row is added horizontally and the total placed in the last column
in the appropriate cell. Once all rows have their totals displayed, the course of action will become
clear. The items in the left column will be rank ordered with the highest score determining the first
item to be addressed. Also in Figure 38, "longer hours" has the highest score, and thus should be
undertaken first in order to improve patient access to the clinic. The physician numbers should be
350
addressed second or maybe even at the same time as addressing the longer hours. Adding a toll-free
number can then be done after the other two items have been accomplished.
In order to create this Prioritization Matrix, one of two methodologies is usually applied. The entire
team in one meeting can brainstorm together to determine the numbers to go into each cell. This will
allow the team members to hear and hopefully understand the rational and viewpoints of the other
members on the team. The alternative, and sometimes-easier, approach is prior to the meeting, to
have each member of the team independently, enter their own numbers and submit the Prioritization
Matrix to the team leader, who then combines all the individual scores into the final sheet. Then the
results are presented at the team meeting and everyone will have had input as to what the desires
should be.
Figure 38: Prioritization Matrix
PRIORITIZATION MATRIX
PROJECT: IMPROVE PATIENT ACCESS TO CLINIC
Clinic Access Quality Impact Criteria Total
Options Safety Pt. Pt. Satisfaction Cost Score

Outcome
Toll-Free # 1 3 5 2 11
Longer Hours 3 5 4 4 16
Physician Numbers 5 5 1 2 13
Likert Scale = 1(lowest), 5 (highest)
THE DATA IS COLLECTED AND DISPLAYED. NOW WHAT?
The entire point to performing measurement is to give the leaders and others involved in the
improvement process information that will be the basis for decision making - strategic, operational,
clinical, and education decisions. However, doing what we have already discussed is not enough.
Frequently, the individual presenting the information must analyze the data (which is discussed
following this section) and create a report that provides analyzed data (information) and potential
actions that should be ta ken.
Analysis and Interpretation
Analysis is the process of studying and interpreting aggregated and displayed data and drawing valid
conclusions leading to a decision. Initial Analysis and Interpretation of data usually is the responsibility
of those persons closest to the process being measured, or perhaps the team that is chartered to
351
design/redesign or improve the process. It may be performed by one or more persons participating at
appropriate stages of the QM cycle/Pl process and may involve one or more of the following steps :
• "Eye-balling" the data in its current form (raw or aggregated)
• Comparing the data to triggers, thresholds and benchmarks
o [riggers\ are tools to find clues about adverse events. The Institute for
Healthcare improvement has developed "trigger tools" in areas such as
medication administration and global trigger tools. For instance, some
organizations ana lyze the use of Narcan, a medication that is used to reverse
the effect of narcotics, to identify overdosing. Many other tools are available
on the IHI website
o [hresholds\ are levels of improvement expected and if that level is not reached,
it is expected that action will be taken. An example would be an organization that
requires its patient satisfaction to be 90% or above. Any time patient satisfaction
is below that level, action must be taken
o A lbenchmarkl is a standard one compares to what has been achieved by

another organization that one wishes to emulate . In the example immediately
above, the organization achieves 85% patient satisfaction but cannot seem to
get any higher. They find that a similar hospital using the same patient
satisfaction tool achieves 95% regularly. They plan a visit to the organization to
see what processes they have in place to achieve that level, identifying which
processes to copy in order to achieve this benchmark of patient satisfaction
• Coordinating some or all aggregation tasks (tabulation, summarizat ion, statistical

testing, display) to clarify the data
• Validating accuracy, validity, and reliability
• Comparing to other known, related data to determine need for intensive analysis
• Identifying and sepa rating issues for lpeer review\ from process issues
Intensive Analysis is the responsibility of those persons with the knowledge, expertise, and experience
to study the process issue in-depth: those who know which questions to ask, and how to best interpret
the resulting information . The outcomes of such analysis include determ ination of degree, type, and
possible causes of process variation, and if validated, whether process improvement is necessary .
Regardless of who is to analyze the data, there must be certain questions asked (Table 20). These
questions are essentia l in that they will help to determine the type of analysis to be utilized. These
analysis methods include the identification of patterns, trends, and variation; group analysis by teams;
analys is by peers; and special analysis for root cause analysis.
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Table 20: Analysis Process Questions

Analysis Process Questions
• Does the accumulated data adequately represent the group being measured? Are all
predefined diagnoses, conditions, procedures, tests, events, locations, time frames,
etc., included?
• Is the sample size large enough to render fair interpretation?
• Is the accumulated data accurate? Have adequate validations been performed or

crosschecking measures been taken?
• For each indicator measured, has the trigger (if applicable) for intensive analysis been
reached?
• If comparison levels are used how does actual performance compare to the previous
year; internal, regional, or national norms; internal or external benchmarks, etc.?
• Is demonstrated performance consistent with the stated indicator/expected

outcome/standard?
• Is there a gap between demonstrated performance and the stated indicator that
identifies a need for action to effect change? Is the gap based on an isolated case or on
a pattern or trend? Is change needed?
A pattern is an identifiable arrangement of data (a grouping or distribution) suggesting a systematic or

predictable relationship. An example of a pattern would be a positive correlation between patients'
heart rate taken by a nurse and that taken by a monitor and plotted on a scatter diagram.
A trend is a key type of pattern indicating a general tendency or direction of events or conditions,
usually over a significant period of time . An example of a trend might be decreasing infections from
surgeries over a period of six months.
Looking for patterns and trends in data over a period of time is an attempt to understand variation in
the process being measured. Part of the responsibility of participating in analysis is to assure that the
data is appropriately displayed so that patterns and trends can be detected.
There are basically two approaches for depicting variation. A static display (like snapshots with a
camera) describes the process and occurs with simple tabulation, calculations of measures of central
tendency (Mean, Median, Mode) and measures of dispersion (e.g., Range, Variance, Standard
Deviation), and aggregated forms, (e.g., Tables, Pie Charts, Histograms, Pareto Charts). A dynamic
display (like pictures with a video camera) shows variance over time (Common and Special Cause) and
occurs when data are plotted on Run or Control Charts.
353
Each approach helps convert data to information. The person or team must decide when to use each
approach and how to move from information to knowledge and decision.
Analysis by interdisciplinary teams or peers, as applicable, includes the determination of the degree of
success in meeting the "standard" or expected outcome for each performance measure for which data
are collected in a process of care or service. The data can indicate an "acceptable" range of variation,
current performance level, a trigger for intensive analysis, a brer1ch in acceptable performance rather
than an appropriate "exception", and a need for change, or opportunity to improve, a particular
process. If a "clinically relevant" issue or concern suggesting real or potential adverse patient impact is
identified by a performance improvement team, and specific individuals or cases are involved, the
issue must be referred to the appropriate peer group for further review.
!Peer Review! is the key to fair interpretation of practitioner-specific or case-specific information

collected in the assessment process. Those with professional experience, expertise, and judgment in
the particular healthcaie specialty must determine what constitutes current competency for
practitioners, and must perform any necessary peer review . Clinically relevant findings with real or
potential adverse patient impact require a commitment to take corrective action or initiate change.
This type of review was discussed in Chapter 3 Performance and Process Improvement.
!Root Cause Analysis Process! which may also be utilized in the analysis of the data, will be described in
Chapter 5 Patient Safety .
iviore information on the analysis of data/information can be found in Chapter 3 Performance and
Process Improvement.
!Documentation, Reports & Meeting Minutes!
jManagement of Quality Information Documentation!
Documentation of information is critical. There are many ways that information is documented in a
healthcare organization . Of course, there is the patient's medical record, which was discussed earlier
in this chapter . It is impossible to list all possible types of documentation, but several are listed in Table
22 .
Table 21: Types of Documentation

Types of Documentation
Documentation includes, but is certainly not limited to:
• Medical record (manual and electronic)
• Minutes of meetings
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• QI team project descriptions/p lans
- Quality Initiative teams (e.g., pneumonia or asthma care; new community-based

clinic)
- Key function teams (e.g., information management-new Internet applications)
- Ad hoc teams (e.g., diabetes clinical path or hypertension disease management)
- Organizational process teams (e.g., patient safety)
• QI team project progress reports
• QI team project summary reports
• QI project "storyboards"
• Performance measure trend reports
• Ongoing measurement/quality control summary reports/"function reports"
• Special study reports
Confidential lpeer review! worksheets and reports
• Practitioner profiles
• Report cards (see Healthcare Effectiveness Data and Information Set (HEDIS®) in
Chapter 3 Performance and Process Improvement)
• Annual quality, utilization, risk management program evaluations (as applicable)
!Action Plans[
Once the data have been analyzed to produce the information required, and actions that need to be
taken to make improvements or to sustain the gain has been identified, then an action plan needs to
be developed and implemented. After the implementation, there needs to be another collection of
data to determine if the desired results were obtained (See PDCA and similar information presented in
Chapter 3 Performance and Process Improvement) .
The action plans should include a statement concerning what is to be improved, what the goals of the
improvement effort are, and the various steps to be completed to achieve the goals. There should also
be a timeline dnd an assignment of who will be involved in each step. It is also an absolute necessity
that the outcome of each step be something that can be utilized to move to the next step, or which
contributes to the overall desired goal. As the team moves through the action plan, there should be
commun ication with the senior level sponsor of the team. This is to assure that the team stays on
course and does not wander into an area that the administ ration of the organization cannot/will not
accept as a result of the action taken. There should also be a team commitment to be mutually
accountable to assure that the timeline and the deliverables are completed within the planned time
frame.
355
!Management of Documentation of Meetings and Reports!
It is the responsibility of every member of a QI Team, committee, or service who has participated in
quality management activities to review and approve both the accuracy and the completeness of the
documentation of those activities. Documentation includes, but is certainly not limited to: Minutes of
meetings; QI team project descriptions/plans; QI team project progress and summary reports; QI
project "storyboards"; Performance measure trend reports, including those sent to external agencies;
Ongoing measurement/quality control summary reports/"function reports"; Confidential peer review
worksheets and reports; Practitioner profiles; Dashboards & Balanced Scorecards; and Annual quality,
utilization, risk management program evaluations (as applicable).
The documentation must be easy to read and displayed in a fashion that the reader will understand
what is being conveyed in the report. If there is a graphic presentation of the information, there are
various means to identify points of interest on the graphs. Some of these include the use of arrows,
comment clouds, circling the important information, the use of color, and many more. Refer back to
the graphic tools described in this chapter to identify how these methods can be utilized.
Above all, when the information is ready to be presented to individuals in the organization, it needs to
be tailored to the individual levels in the organization. For example, information presented to the
Governing Board should be a condensed version of what is presented at the department level where the
information is to actually be utilized to make improvements. The information should be reported to all
areas of the facility which may benefit from the information, not just the area that collected the data.
For example, if data is collected after an action plan has been implemented regarding the use of
antibiotics in the emergency department with adults who present with pneumonia, the findings should
also be presented to the Pediatrics department who may also be able to utilize the information for
their patients. In all cases, the information must be returned to the individual users/departments/units
where the data are to be utilized to make the improvements required, or for sustaining successful
improvement efforts. All quality information that does not pertain to one specific individual should
also be communicated to the Quality Council (see Chapter 3 Performance and Process Improvement)
for their use.
\Meeting Minutes!
Minutes from meetings and other activities are important information that leads to decision-maki ng at
all levels. It is important that the minutes stand by themselves and do not depend on attachments to
explain what happened at the meeting. There should be enough information in the minutes
themselves to demonstrate what was discussed in the meeting and the outcome of the discussion (See
Chapter 3 Performance and Process Improvement for more information).
The content of minutes, in general, should include the meeting date, the time meeting was called to
order and adjourned, attendance and who was not in attendance, old business that is a follow up from
356
a previous meeting or outstanding issues, new business related to performance improvement activities
and operations, and an authorized signature approving the content. Both the old and new business
sections should each include a summary of discussion, conclusion, and action and should also include a
timeframe in which the action is scheduled to be taken. Actions that need to occur can then be carried
over to the next meeting's agenda as old business.
There is no one format that is acceptable . Each organization must determine a format that is best for
their organization to utilize. The format should include the agenda items, which then lead to the
information that was discussed for each item, recommendations or actions needed, and follow up that
needs to occur at the next meeting. The discussion and action items include an evaluation of how
effective the action taken was and if more improvements are needed. The same numbering system
should be used in the minutes as was used in the agenda for the meeting.
Key Elements that need to be Addressed:
• The agenda items should include all topics to be discussed, where the meeting will be
held, and the time for the meeting. The agenda should be created from the outstanding
items from previous meetings, plus any new business for the meeting. The items listed
in the agenda should all be included in the minutes of the meeting, w ith the same
numbering and ordering as the agenda.
• Meeting minutes should stand by themselves and give the reader all of the information
needed to "know" what happened at the meeting. The minutes should list who
attended, who was excused from the meeting, those who were absent, and any guests
that were present .
• When someone asks for a copy of the minutes, any attachments presented at the
meeting are usually not included. If the minutes simply say 'see attachments' then the
reader will not have any idea about what happened during the meeting regarding that
item. For every item that is on the agenda, there should be something in the minutes to
describe what was presented, any discussion that followed and the results of that
discussion, what conclusions were made, what actions need to be taken, and who is
responsible to assure that those actions occur .
• The minutes should be distributed as soon as possible after the meeting so that the
attendees and those who missed the meeting will have the information they need to
follow up prior to the next meeting.
In conclusion, the best way for a healthcare organization to demonstrate improvement is using data.
Gone are the days when your reputation as a hospital, HMO or insurance company was based on the
"word of mouth" informat ion shared in the community. Today, the organization's reputation is based
on very specific information: Publicly reported data on clinical and service outcomes, accreditat ion
status and reports including Magnet status, newspaper articles detailing events that are brought to the
357
attention of the public, financ ial reports that make their way into the public purview, publicly reported
data on physicians and mid-level practitioners, and in some organizations local or state information
made public. What we do with the data is essential. We cannot ignore it now or in the future. It is the
basis of reputation, reimbursement, and solvency.
358
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WEBSITES
Access, a database program https://products.office.com/en-us/access

Chest Pain Center Accreditation
http://www .scpcp.org/Services/CPC.aspx
Agency
Common Formats http://www.qualityforum.org
https://www.psoppc.org/psoppc_web/publicpages/commonForma
Common Formats
tsHV2.0
http://www.hea Ithit.gov sites/default/fiIes/aeds-lesson s-in-cds-
Decision Making Systems
implementation-deliverablev2 .pdf
Dispersion of Data http://www.quickmba.com/stats/dispersi on
Dot Plot of Length of Stay (LOS)
http://www .qimarcos.com
for CVA (Stroke)
Excel, as spread sheet program http://products .office.com/en-us/excel
Finance and the Health I
Information Management (HIM) http://library.ah ima.org/xpedio/groups/public/docu ments/ahima/b

Department or the Medical ok1_049692. hcsp?dDocName=bokl_049692
Record Department
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Histogram of BM!
m-25-162-g002&req=4
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Meaningful Use http://www.cms.gov/EHRlncentiveProgra ms
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WHO ICD-10 Interactive Self
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Learning Tool
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PATIENT SAFETY
CHAPTER 5
Jacque Cole, Michelle Franklin, Susan Mellott, Kathleen Tornow Chai

Patient Safety
4.A .1 Assess the organization's patient safety culture
4.A.2 Determine how technology can enhance the patient safety program (e.g.,
electronic health record (EHR), abduction/elopement security systems,
smart pumps, alerts)
4.A.3 Participate in risk management assessment activities including
identification and a nalysis
4.B .1 Facilitate the ongoing evaluat ion of safety activit ies.
4.B.2 Integrate safety concepts throughout the organization.
4.B.3 Use safety principles:
a . human factors engineering
b. high reliability
c. systems thinking
4.B.4 Participate in safety and risk management activities related to:

a. incident report review (e.g., near miss and actual events)
b. sentinel/unexpect ed event review (e.g., never events)
c. root cause analysis
d. fa ilure mode and effects analys is
indicated throughout the Handbook with a lbox around the tex.
"So long as it involves humans, health care will never be free of errors...but it can be free of injury".
Donald Berwick
During the 1990s the push was on to build a quality culture in our healthcare organizations. Then in
1999, a groundbreaking report, To Err is Human: Building a Safer Health System was published. It set
all of healthcare on a different path, a patient safety culture (IOM, 2015). The Institute of Medicine
(IOM) published To Err is Human, and soon thereafter, Crossing the Quality Chasm, laying the
groundwork for a patient safety culture.The race is st ill going, but at a tortoise's pace.
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In the To Err is Human report, it was estimated the number of hospital deaths related to preventable
medical errors was possibly as great at 98,000 per year . This became headline news and thus the
current patient safety movement was born. This report also resulted in a series of congressional
hearings with governmental agencies, professional groups, accreditation organizations, insurers, and
others, who responded swiftly with plans to develop reporting systems . By imposing reporting
requirements, people and organizations were thought to be held accountable. However, reporting
requirements alone do not make systems safer.
We have seen advances in reporting of errors, and the Agency for Healthcare Research and Quality
(AHRQ) annual reports continue to indicate death related to error remain similar to the statistics cited
in 1999 (Clancy, 2009). However, as reported in 2016, "While it is clear that the frequency of adverse
events declined substantially from 2010 to 2014, it is less clear why this improvement occurred"
(Kronick, Arnold, & Brady, 2016). The authors in this article discuss the problems with inconsistent data
definitions and other challenges but also identified four possible reasons for the improvement that has
been seen. One of the first reasons given was that evidence based improvement methods had been
introduced by AHRQ in error reporting for areas such as central line associated blood stream infections
and the implementation of that evidence had reduces errors in particular areas. A second reason that
the numbers decreased may have been that tools and technical assistance were developed by those
who were studying medical errors with which to implement consistent processes for improvement
that may have had an effect on improvement. For example, "The Centers for Medicare & Medicaid
Services Partnership for Patients initiative p;ovided extensive technical assistance, reaching more than
80% of acute care hospitals throughout the country" (Kronick, Arnold, & Brady, 2016). Next, with the
focus on medical errors, hospitals needed data to demonstrate their progress and error rates and th is
data was beginning to be mandated so outside agencies were used to generate and display data that
was consistent and used consistent data definitions. Finally, hospital leadership, including chief
financia l officers became very attentive when the Centers for Medicare and Medicaid (CMS) began to
impose fines for certain medical errors. It then became an issue important across the organizat ion.
The goal in quality and patient safety is to prevent death and injury from preventable medical errors
through system wide changes. By developing strategies to recognize, prevent and mitigate harm from
errors inherent in complex systems, we have the greatest potential to affect outcomes for our
patients. Learning from events,and using that information to improve or prevent new events, is critical
to develop ing these strategies. However, the process is undermined by the difficulty health care
professionals have in adm itting or discussing these events.
Not all errors result in harm or injury. Every day physicia ns, nurses, pharmacists and other care team
members recognize and correct errors, usually preventing harm. The key is to differentiate between
individual factors and factors attributed to the system or process design, and then redesign the
process to reduce or eliminate errors and latent conditions. Health care often consists of large,
complex problems that require thoughtful, multifaceted responses by individuals and teams . This
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chapter has highlighted some of the ways we can redesign systems for safety, through technical
processes, understanding likely sources of error and being committed to finding effective ways to
reduce errors in our organizations.
This chapter will look at the comprehensive work done to address overall quality and safety of care
and the associated outcomes since the release of the IOM To Err is Human report. This report will be
presented as a foundation, followed by what has been done and what is currently being done to
improve patient safety. By the end of this chapter, the reader should be able to examine their own
organization and implement ideas to help their organization decrease errors and improve patient
safety .
WHAT IS PATIENT SAFETY?
Before we get into the To Err is H uman report, there is a need for some definition and discussion about
basic patient safety concepts. The assumption of safety in the provision of healthcare is as
fundamenta l as care itself. Primum non nocere-fi rst , do no harm-is the main phrase we all know
from the Hippocratic Oath taken by physicians (Hippocrates, n.d.). Safety is the most basic dimension
of performance necessary for the improvement of healthcare quality. Safety is the underlying reason
for risk management, infection control, and environmental management programs. It is the reason we
insist on qualified clinical practitioners and support staff.
Patient safety is a subset of safety. Organizations must be aware of all safety risks throughout the
facility. Safety was discussed in the Environment Safety Programs and Risk Management sections of
Chapter 3 Performance and Process Improvement. The safety of all individuals in a healthcare setting
is ultimately important. However, patient safety is the current activity of safety and is focused more on
the individual's safety within clinical areas, rather than the overall safety of the organization. As
facilities move toward a Highly Reliability Organization (Chapter 2 Organizational Leadership) to drive
out error and decrease the variability of practice, patient safety is a major area of importance.
According to the AHRQ, patient safety is defined as:
"Patient safet y is a discipline in the healthcare sector that applies safet y science methods
toward the goal of achieving a trustworthy system of healthcare delivery. Patent safety
is also an attribute of health care systems; it minimizes the incidence and impact of, and
maximizes the recovery from, adverse events." (Emanuel, et al., 2009, p. 6)
This definition states patient safety is both an emergent discipline, and a way of doing things. Patient
safety seeks high reliability of a system filled with risk. Therapeutic interventions are where medical
errors occur, and where patient safety must be focused .
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PATIENT SAFETY
Grober and Bohnen (2005) define a medical error as "an act of omission or commission in planning or
execution that contribute or could contributes to an unintended result" (p. 42). This definition contains
the key domains of error causation of omission (failure to do the right thing) and commission (doing
the right thing wrong), as well as planning and completing a process. It also indicates faulty processes
can result in error, even if there is not an adverse outcome; such as when a patient receives the wrong
medication but there is no harm to the patient.
Grober and Bohnen (2005) go on to define an adverse event as the "unintended injur y to patients
caused by medical management ... that results in measureable disability, prolon ged hospitalization, or
both" (p. 40). Since not all adverse events are a result of error, many prefer to use the term
preventable adverse events.
The Joint Commission defines a sentinel event as "...an unexpected occurrence involving death or
serious ph ysical or psychological injury or the risk thereof. The phrase 'or the risk thereof' includes any
process variation for which a recurrence would carry a significant chance of a serious ad verse outcome"
( l-lAS Glossary, 2012, GL-35). 'v'v'ith every sentinel event, a Root Cause Analysis must be completed in a
timely manner with implementation of an action plan. Another name for a sentinel event is a never
event. A never event is an event that should never happen and if it does, immediate invest igat ion and
remediation is required. The Centers for Medicare and Medicaid (CMS) defined 28 never events in
2008.
In 2011, the list was modified and expanded to 29 events and the National Qua lity Forum (NQF)
changed the 'never event' term to 'Serious Reportable Events (SRE j'. The iist of locations and facilit ies
this applies to has been expanded beyond hospitals to ambulatory and office based surgery centers,
skilled nursing facilities and doctors' offices and clinics (Torrey, 2017) .
A near miss is defined as a potential medical error, which is caught prior to the administration to a
patient. For a near miss, it is best to complete a Failure Mode Effectiveness Analysis (FMEA) or a Root
Cause Analysis (RCA) even though it did not reach the patient. An example of a near miss is: the
pharmacy fills an IV order and sends it to the nursing unit for a patient. Prior to administer ing the IV,
the nurse double checks the order and identifies the mixed IV solution is not correct . The IV bag is sent
back to the pharmacy and another bag with the correct ingredients is obtained for the patient. This
would be a major medical mistake should it have reached the patient (Grober & Bohnen, 2005, p. 41).
One basic safety concept becoming fa irly well known is the Swiss Cheese Modei developed by John
Reason (Figure 1). The concept behind this model is one where catastrophic errors do not occur in
isolation. Rather there are multiple opportunities for errors to occur. It is only when the systems align in
a certain way, and the fa il-safe mechanisms all fail, therefore creating the opportun ity for the
catastrophic event to occur (Reason, 2000).
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Each slice of Swiss cheese has holes in it, but as demonstrated in Figure 1,the hole location will not be
consistent to allow a straight line to be drawn from the front to the back. There is a barrier preventing
further passage through the cheese. One failure (hole) occurs but does not contribute to another
failure (Duke, 2016). For example, the wrong patient is brought into the OR suite and prepped. Before
the surgery starts, a time out is called and someone realizes it is the wrong patient in the suite for the
procedure. This stops further errors from occurring. It is only when the holes all line up one after
another, a catastrophic event occurs. Continuing with our surgery example, a patient is brought into
the surgery suite but no one checks the patient's arm band, so they do not know if this is the correct
patient. The su rgeon is in a hurry to start and rushes through the time out. The OR staff are not really
ready to start, but no one speaks up and the surgery starts. The surgeon begins the surgery to remove
the cataract in the right eye and is upset when the lens available is not the correct one to be inserted
in that eye. Someone runs to get the correct lens, which the surgeon implants. When the patient is
taken to the recovery room, the staff realizes the surgery should have been performed on the left eye.
All of these errors (holes) had to line up perfectly for this adverse event to occur.
Figure 1:James Reason's Swiss Cheese Model
Reason's Swiss Cheese Model
--
"a trajectory of
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Emanuel et al. (2009) describes several other basic principles of patient safety . The first principle is
patient safety emerges from systems design. Patient safety depends on systems which make risky
interventions reliable. The more complex a system is, the more chance there is for error, especially
when there a re different systems work ing together. Safety systems have many components . The
safety systems are comprised of procedures, the environment, the design of the material used, the
training, and the culture of the team caring for the patient. All of these can contribute to errors.
A second principle is patient safety is designed for the nature of illness. When a patient comes to a
healthcare setting and is already ill,then something in their body has a lready gone wrong, so failu re to
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provide the correct care causes further harm to the patient. This can happen with a missed diagnosis,
or with underuse or inappropriate use of tests and or treatments . Most conditions are common and
thus patients can be treated with standardized protocols and/or guidelines to help minimize error. The
standardization decreases the opportunities for errors.
A third principle is patient safety is dependent on open learning. There must be a culture of openness
among all team members so learning can occur when errors arise. Patient safety combines principles
of adult education and effective behavioral learning with traditional approaches to caring for patients.
When errors occur, the team should learn from those errors. Patient safety depends on organizational
and personal accountability, but it also recognizes most errors are caused by flaws in the process
rather than the person.
The last principle is trustworthiness is essential to the concept of patient safety. The members of the
healthcare team must trust each other to speak up when an error or a potential error is identified.
fWHAT DOES THE IOM REPORT STATE WE SHOULD DO?[
The IOM (2000), To Err is Human Report was released to stimulate the healthcare industry to develop
a patient safety culture and thus to decrease medical errors and preventable adverse events. The
report states one of the causes of medical errors is the decentralized and fragmented nature of health
care delivery. Patients are seen by a number of different practitioners who do not have information
from their other practitioners. The primary practitioner completes the annual physical and lab work,
assures immunizations are up to date, and treats the patient for common illnesses. The cardiologist
sees the patient for heart disease, but focuses only on the cardiovascular system. The
gastroenterologist sees the patient when there is a gastrointestinal illness, or a need for a
colonoscopy, and so forth. These three practitioners do not routinely share information, even though
all three are treating the same patient. This results in overuse of diagnostic tests, possible duplication
of medications, and confusion for the patient and family. The cardiologist may prescribe a medication
for high cholesterol, but the primary practitioner may decide to change the medication. When the
patient returns to the cardiologist, he/she may not have all of the current information needed to treat
the patient. The patient may forget about changes in medications or forgets about the changes have
occurred between cardio logy visits.
Other deterrents to patient safety, according to the report, include practitioners' concerns about
medical liability, lack of preventative services, and a lack of incentives from third-party purchasers of
health care to provide the financial incentives to health care organizations to improve patient safety
and quality.
The IOM (2000) report lays out a comprehens ive strategy that government, health care providers,
industry, and consumers can use to begin reducing medical errors. The authors contend what is
needed to improve patient safety is already known, and if utilized, can decrease medical errors
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without other interventions being developed. The IOM felt if these known improvements were
utilized, 50% of medical errors would have been reduced by 2004, five years after the report was
released. As stated earlier in this chapter, this has not occurred, even over fifteen years later.
The IOM (2000) report recognizes the majority of medical errors are not results of 'individual
recklessness' or actions of an individual or group intent on doing harm. More often, the errors are
results of faulty systems, processes, and conditions lead individuals to make mistakes, or at least fail to
prevent mistakes . As a result of these conclusions, health systems need to be designed to make it
harder for an individual to make a mistake, and easier to do the correct thing. When an error occurs,
the individual who made the error should not be reprimanded, as this has not shown to be effective in
making the system better nor preventing someone else from making the same error. The focus should
be on the process itself and the individual who made the error should learn from the mistake.
Four categories of errors were identified in the IOM report: communication, treatment, preventative,
and other. The communication errors include an error or delay in the diagnosis, failure to order
indicated tests, use of outmoded tests or therapies, and/or the failure to act on the results of
monitoring or testing. The treatment errors include an error in the performance of a procedure or test,
an error in the administration of the treatment, an error in the dose or method of using a drug,
avoidable delay in treatment or responding to a test result, and/or inappropriate care. Preventative
errors include failure to provide prophylactic treatment and/or inadequate monitoring or follow-up of
treatment . And lastly, other errors include failure of communication, equipment failure, and other
system failures . Healthcare organizations must be aware of these categories of error as they examine
the patient safety risks in their organization.
The !OM (2000) laid out a four-tiered approach to developing a strategy to improve patient safety :
• Establish a national focus to create leadership tools, research, and protocols to increase
the knowledge base about patient safety
• Identify and learn from errors by developing a nation-wide public mandatory reporting
system as well as encouraging healthcare staff, practitioners, and the organizat ion to
participate in voluntary reporting systems
• Raising performance ex pectations and standards for improvements in patient safety

through the professional organizations, group purchasers, and so forth within
healthcare
• Implementing patient safety systems in healthcare organizations and systems to ensure

safe practices at the delivery area
The IOM report also called on Congress to create a Center for Patient Safety which would set national
patient safety goals and track the progress being made in meeting those goals. The Center for Patient
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Safety would then be charged to implement research, identify prototype safety systems, provide tools
for identifying and analyzing errors, and recommend additional improvements. The IOM report
suggested this center should be housed within the Agency for Healthcare Research and Quality
(AHRQ), which already had a large infrastructure for quality and patient safety.
With the development of a mandatory reporting system, the states would be required to develop a
process to collect information regarding adverse events which result in death and serious harm. The
reporting system should start with hospitals and then progress to other healthcare organizations . This
system would hold healthcare organizations accountable for these errors and lead to transparency to
the public and others. At the time of the 1999 report, about one third of the states already had such a
system in place.
Voluntary reporting systems would complement the mandatory reporting. These voluntary systems
should focus on a much broader set of errors and issues, especially those which do not result in major
harm or death. The voluntary reporting systems should be utilized to examine the processes producing
these errors before there is harm or death. in order for this to be possible, Congress would have to
enact laws to protect the confidentiality of the information collected.
The definition of minimum performance levels for health professionals and healthcare organizations
should be established through regulatory and other means such as licensing, certification, and
accreditation.The values and culture of healthcare professionals and healthcare organizations, as weii
as professional organizations, should also be utilized to establish standards regarding patient safety
and what is expected from practitioners and staff. Larger purchasers of healthcare, healthcare
insurance and individual consumers can also assist in changing the environment to increase patient
safety.
The healthcare organization must develop a culture of patient safety. The workforce and processes
should focus on improving reliability and safety of care for patients. Patient safety should be an
organizational goal and an initiative all healthcare organizations strive to improve . Systems for
continuously monitoring patient safety must be developed and utilized to make improvements. Simply
collecting the data does not improve a process or system. The data must be used to identify areas for
improvement and then to measure if improvements have occurred and are sustained.
jWHAT HAVE WE DONE & HOW EFFECTIVE HAS IT BEEN?!
Very soon after the To Err is Human (IOM, 2000) report was released the government and the private
sector responded. Congress launched a series of hearings on patient safety, and then in December
2000 allocated $50 million to the AHRQ to manage the many patient safety projects and initiatives.
Between December 1999 when the report was first published and the time of publication of the
Report Brief in 2000, less than a year later, AHRQ had already implemented the items found in Table 1
(IOM, 2000). In addition to the AHRQ, other groups such as the National Academy for State Health
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Policy, National Quality Forum, Leapfrog Group, the Council on Graduate Medical Education, and the
National Advisory Council on Nurse Education and Practice, were all involved in activities to increase
patient safety.
Table 1: AHRQ Initial Activities After To Err is Human was Published

AHRQ Initial Activities After To Err is Human was Published
• Developing and testing new technologies to reduce medical errors
• Conducting large-scale demonstration projects
• Supporting multidisciplinary teams to develop new knowledge to be utilized in

the demonstration projects
• Supporting projects for better understanding of how the environment affects the
ability of providers to improve safety
• Funding researchers and organizations to develop, demonstrate, and evaluate

approaches to education of providers and others in order to reduce errors
• Developing in a booklet for consumers to utilize to improve the quality of care

they receive
In 2013, the AHRQ published a report based on the examination of published research regarding
Patient Safety Practices that had been completed between 1999 and 2011 (AHRQ, 2013). AHRQ
defines a Patient Safety Practice (PSP) as a process or structure that reduces the probability of adverse
events occurring in the healthcare system across a range of diseases and procedures. The PSPs were
evaluated on the evidence of the outcomes of the safe practices and on the factors that influence their
use and effectiveness. A systematic review of 18 studies was conducted (Table 2). Another brief review
was conducted for 23 additional studies that were already well established. The materials were divided
into: Adver se Drug Events; Infection Control; Surgery, Anesthesia, and Perioperative.
Table 2: Patient Safety Practices Recommended for Implementation by AHRQ

Patient Safety Practices Recommended for Implementation by AHRQ
Strongly • Hand hygiene
encourage • Barrier precautions to prevent healthcare-associated infections
implementation • "Do Not Use" list of hazardous abbreviations
• Preoperative checklists and anesthesia checklists
• Use of real-time ultrasound for central line placement
• Bundles include checklists for central line insertion and care
• Bundles include head-of-bed elevation, sedation vacations,
oral care with chlorhexidine and subglottic-suctioning
endotracheal tubes
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• Interventions to reduce urinary catheter use, including

catheter reminders, stop orders, or nurse-initiated removal
protocols
• Multicomponent interventions to reduce pressure ulcers
• Interventions to improve prophylaxis for VTE
Encourage • Multicomponent interventions to reduce falls

implementation • Use of clinical pharmacists to reduce adverse drug events
• Computerized provider order entry
• Medication reconciliation
• Obtaining informed consent to improve patients'
understanding of the potential risks of procedures
• Use of surgical outcome measurements and report cards such
as the American College of Surgeons National Surgical Quality
Improvement program
8 Practices to reduce radiation exposure from fluoroscopy and
computed tomography scans
• Documentation of patient preferences for life-sustaining
treatment
• Rapid response systems
• Utilization cf complementary methods for detecting adverse
events/medical errors to monitor for patient safety problems
• Team training
• Use of simulation exercises in patient safety efforts
I
Healthcare organizations and practitioners readily acknowledge errors occur in the provision of care. It
is known the longer a patient occupies a bed in a healthcare facility,the more likely the development
of infection or other complication. Yet what is implicitly known does not reduce risk or increase patient
safety. Therefore, further actions are necessary to reduce the risk of errors.
Government & Accreditation Efforts
Patient safety has become an initiative involving the federal government as well. The Patient Safety
and Quality Improvement Act of 2005 (PSQIA, 2005) established confident iality and privilege
protections for patient safety. It is associated with quality of care and freedom from accidental injury
or harm from a failed process or procedure. The act states, no matter how it is defined, an
organization must have a culture of safety. This means certain actions surrounding patient safety
improvement activ ities are protected and confidential. It helps those involved in an improvement
project associated with patient safety to work as transparently as possible. It encourages the reporting
and discussion of an adverse event, near miss,or other dangerous condition.
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The PSQIA also established Patient Safety Organizations (PSOs) to standardize event data collection
and reporting to the PSO without the fear of legal discovery or disciplinary action. PSOs were approved
by ARHQ beginning in 2008 and began accepting data in 2009 (Clancy, 2009). The PSO Privacy
Protection Center (PSOPPC) was created by AHRQ to assist the PS0s in rendering the data non-
identifiable as to the organizat ion, patients, practitioners and others mentioned. The PSOPPC also
maintains the "common formats" (see Chapter 4 Health Data Analytics) software the PSO utilizes,
which contains common definitions and reporting formats to make data comparable (PSO, 2017).
Thus, if a healthcare organization joins a PSO, they can benefit from comparative results at the
national level, across PSOs, and across a larger group of provider types . The PSO data can assist
healthcare organizations to discover underlying causes of incidents, near misses, and unsafe conditions
in healthcare delivery. The PSO also provides expertise to work with healthcare organizations to
decrease events and improve quality, and to identify patterns of rare events (PSO, 2017). A listing of
Patient Safety Organization Programs can be found at the PSO website in the list at the end of this
chapter . This website is routinely updated with those organizations working under the confidentiality
and privilege protections of the PSQIA.
The Centers for Medicare and Medicaid Services (CMS) began withholding Medicare reimbursement
October 2008 for 10 healthcare-acquired conditions (HACs) (CMS - HACs, 2017). These conditions
were not present on admission (POA), but developed during the time the patient was under the care
of the hospital, nursing home, etc. HACs are usually high cost or high volume or both, and could
reasona bly have been prevented through the application of evidence based guidelines . For current
HACs, see the Hospital Acquired Conditions website listed at the end of the chapter. In 2015, the
number of conditions was increased to 14. The website for that list can be found in the table at the
end of the chapter.
Accreditation Standards
In response to the IOM To Err is Human Report, accreditation bodies like The Joint Commission,
National Committee for Qua lity Assurance (NCQA) and URAC modified their Quality Management
standards to meet the call for "regulators and accreditors to require health care organizations to
implement meaningful patient safety programs", and to focus greater attention on performance
measures of patient safety for both health care organizations and health care professionals.
In 2014, The Joint Commission (TJC) moved all ot their patient safety standards into a chapler enlitled
Patient Safety Systems, in the hospital manual effective January 1, 2015. No new standards were
added. The chapter describes how leaders and others can utilize the standards to improve quality of
care and patient safety. It also demonstrates how the hospital systems must be integrated to achieve
compliance with the standards .
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!Patient Safety Goals and Safe Practicesl
In 2003, The Joint Commission established National Patient Safety Goals for all healthcare
organizations they accredited. Soon after, other entities established patient safety goals or safety
practices. These different organizations' safety goals and practices will be covered in this section.
IWHO Collaborating Centre for Patient Safety Solutionsl
The World Health Organization (WHO) Collaborating Centre for Patient Safety Solutions was
established in 2005 to identify, evaluate, adapt, coordinate, disseminate and accelerate improvements
in patient safety worldwide (WHO, 2017) . The Collaborating Centre has built an international network
composed of key organizations and individuals with expertise in patient safety, such as accrediting
bodies, national patient safety agencies, professional societies, and others. The Joint Commission and
The Joint Commission International are partnered with the WHO to contribute to the endeavor .
In 2009, the WHO developed a 19-item Surgical Safety Checklist to decrease errors and adverse events
during surgery . It is also designed to increase teamwork and communication (W HO, n.d.). Use of this
checklist has shown a decrease in morbidity and mortality. It is being used for many types of surgery
around the world, and can be customized to meet specific needs. In 2015 they came out with the Safe
Childbirth Checklist and Implementation Guide (WHO, 2015). This checklist "targets the major causes
of maternal and newborn complications and deaths, including post-partum hemorrhage, infection,
obstructed labor, preeclampsia and birth asphyxia".
!National Quality Forum (NQF)!
The National Quality Forum (NQF), a not-for-profit membership organization, was incorporated in May
1999, and has been focusing on patient safety for over 10 years. One of its charges was identifying a
core list of preventable, serious adverse events . The NQF has identified measures for medication
safety, healthcare-associated infections, falls, pressure ulcers, surgical complications, workforce issues,
and other subjects (NQF-1, 2015). Because gaps still exist, the NQF changed their approach and
developed a standing committee to examine measures and determine what should be kept, added,
and deleted, based on established criteria . The Patient Safety Committee's work to oversee the NQF
Patient Safety measures has been divided into phases . In Phase one, published in January 2015, they
endorsed eight measures and rejected another eight measures. The endorsed measures are displayed
in Table 3.
Table 3: NQF's Phase 1Endorsed Patient Safety Measures
NQF's Phase 1Endorsed Patient Safety Measures

(0138) National Healthcare Safety Network (NHSN) Catheter-associated Urinary Tract Infection
(CAUTI) Outcomes Measure
(0139) National Healthcare Safety Network (NHSN) Central Line-associated Bloodstream
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Infection (CLASBI) Outcomes Measure

(0555) INR Monitoring for Individuals on Warfarin
(0556) INR for Individuals Taking Warfarin and Interacting Anti-infective Medications
(0541) Proportion of Days Covered (PDC) : 3 Rates by Therapeutic Category
(0684) Percent of Residents with a Urinary Tract Infection (Long-Stay)
(2337) Antipsychotic Use in Children Under 5 Years Old
(2371) Annual Monitoring for patients on Persistent Medications
Phase two will be evaluating topics including, but not limited to: fall screening and risk management ;
medication reconciliation; measures from applicable settings such as skilled nursing facilities and
inpatient rehabilitation facilities; unplanned admission-related measures from non-hospital settings; all-
cause and condition specific admission measures; condition-specific readmission measures; and
measures examining length of stay (NQF - 2, n.d.). Currently, NQF has prioritized five measures that
have demonstrated the need for more measurement . This effort is based on the National Quality
Strategy that was last revised in January, 2017. These five areas include: Adult Immunization,
Alzheimer's Disease and Related Dementias, Care Coordination, Health Workforce, and Person-
Centered Care and Outcomes (Nationa l Quality Strategy, 2017).
he Institute for Healthcare Improvement (IHl)j

[
The IHI has been work ing to improve patient safety for many years (IHI - Pt. Safety, 2015). The IHI had
a tool called 'The Improvement Map', but they are no longer utilizing or supporting the tool. They now
provide a website for their patient safety resources, which can be found in the website list at the end
of this chapter. The IHl's goal for patient safety is to work with others "to build safety into every
system of care, ensuring patients receive the safest, most reliable care across the continuum" (IHI - Pt.
Safety, 2015, p. 1). The IHI focuses on innovations which will create the system level changes across
organizations at a ll levels. They work with organizations to move from separate silos to system level
reliability for patient safety, and to build measures and early warning systems for patient safety, as
well as for transparency. They have published How-To guides which include evidence-based care
components, along with how to implement the components and measure the resulting improvements.
Some of the areas of these guides include medication reconciliation, high alert medications, surgical
site infections, and others.
The tool IHI utilizes to accurately identify adverse events and to measure their rate over time is called
the Global Trigger Tool (IHI - Pt. Safety, 2015) . By tracking adverse events over time, the organization
can determine if the changes being made are improving patient safety. The IHI also has Leadership
Guides to assist leaders in these processes, and numerous other resources free. For individuals to learn
more about patient safety, the IHI Open School has nine free and quick online courses available by
subscript ion.
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At this time, the Institute for Healthcare Improvement (IHI) and the National Patient Safety Forum
have joined to make further patient safety improvements (IHI 2017). There are four areas in the
spotlight: A New Emergency Checklist for Office-Based Surgery, Closing the Loop: A Guide to Safer
Ambulatory Referrals in the EHR Era, Collaborative Improvement Positively Impacts Culture Change to
Improve AMI Care, and The Link Between Physician Wellness and Patient Safety.
lfilj RQ PatiE!nt Safety Indicators!
The AHRQ Patient Safety Indicators (PSls) are a set of risk-adjusted measures which screen for
potential in-hospital complications and adverse events following surgeries, procedures, and childbirth
(AHRQ - Pt. Safety, n.d.). They are part of a set of software modules for AHRQ and were originally
released in 2003. The indicators are divided into two domains, hospital-level indicators and area-level
(county, state) indicators. They are free to utilize and the user receives comparison data from similar
facilities. The Patient Safety Indicators can be downloaded from the website list at the end of this
chapter. AHRQ states the indicators are useful not only to improve patient safety, but also for
comparative public reporting, pay-for-performance initiatives, and to identify potentially avoidable
complications. At this point there are 26 indicators including 18 provider level indicators developed for
hospitals (AHRQ-Fact Sheet, 2017). This is an ongoing collaborative process.
!National Patient Safety Goals!
The Joint Commission's National Patient Safety Goals (NPSG) are based on past sentinel event
information, and they include specific recommendations and/or approved alternative approaches (TJC-
NPSG, 2015). The goals are included in accreditation decisions, as appropriate for each type of entity
surveyed. The Joint Commission uses a panel of practitioners and patient safety experts to oversee the
development and annual updating of the National Patient Safety Goals {NPSGsj and requirements for
all accreditation programs, and the Disease-Specific Care Certification Program. Changes for 2018
include NPSG.07.03.01 - multidrug-resistant organisms (MDROs) : Has been applicable to hospitals
and critical access hospitals and is now applicable to nursing care centers and NPSG .07.04.01 - central
line-associated bloodstream infections (CLABSls): The elements of performance (EPs) for hospitals and
critical access hospitals have been reordered, and the goal has been modified to allow organizations to
·determine the appropriate time frame for educating staff and licensed independent practitioners.
Each year the goals are evaluated for compliance. Other aspects of patient safety, such as reported
sentinel events, and nationally reported issues are identified for possible new goals. For 2015, no new
goals were added, but the goal on the use of oxygen in the home (Home Health) was modified. When a
goal has been implemented successfully for the majority of the accredited organizations, or for other
reasons, the patient safety goal is moved into the standards, making way for new goals to be adapted .
The current National Patient Safety Goals can be downloaded from the Joint Commission website
indicated in the website list at the end of this chapter.
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Patient Safety Management - The Program
Up to this point, there really is not a good user-friendly guide to setting up a patient safety program.
The following is a starting point and not an all-inclusive list. This information is also helpful if you
assume a new position or need to review your current program to identify areas for improvement. As
with any organization, one must have the support of the senior leadership. In some organizations, this
starts with the Board of Directors and the executive leadership team. Without the support of senior
leadership, no program, no matter how well planned and developed, will survive.
Leadership
Patient safety must be considered a strategic priority by the leaders of the organization . The leaders
must be educated about patient safety, be given ongoing safety briefings, understand how processes
must be embedded with patient safety goals, and measure harm levels over time.
In 2006, the Institute for Healthcare Improvement (IHI) developed a white paper, Leaders in Patient
Safet y, to assist health care leaders in the development of the patient safety program. The IHI
considers leadership to be the critical success factor for an effective patient safety program. This
responsibility cannot be delegated to others. This white paper (Botwinick, Bisognano, Haraden, 2006)
recommends the following eight steps for leaders to follow to achieve patient safety and high
reliability in their organizations .
1. !Establish Patient Safet y as a Strategic Priorit Every healthcare organization must have patient
safety as one of the organization's strategic priorities. This strategic priority then should be
found in all of the plans of the organization, especially the Patient Safety Plan and the Quality
Improvement Plan (See Chapter 3 Performance and Process Improvement). The leadership
must assess and establish a supportive patient safety culture, address the organization's
infrastructure, and learn about patient safety and improvement methods.
2. !Engage Key Stakeholders! These key stakeholders include the Governing Board, leaders,
physicians, staff, patients and families (See Chapter 2 Organizational Leadership) . These
individuals need to be educated about patient safety, and engage in discussions about patient
safety. The agenda of meetings should give patient safety the same amount of time as
finr1nr.ial issues on the agenda.
3. . !communicate and Build Awareness! The leaders should routinely engage in leader
rounds throughout the organization, engaging staff, practitioners, patients and others in
discussions about patient safety (See Chapter 3 Performance and Process Management).
Within the departments, there should be education and other activities to address patient
safety directed towards the functions of the department. This could include safety briefings,
huddles, utilizing
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SBAR (Situation, Background, Assessment , Recommendation), and the utilization of Crew

Management (see below in this chapter).
4. [Establish, Oversee, and Communicate System-Level Aim[ The leaders should develop a strategic
plan with identified system-level goals (see Chapter 2 Organizational Leadership). These goals
then need to be communicated throughout the organization, as appropriate, so the
organization can meet these goals. For example, the quality plan should include the patient
safety strategic objectives. The education and IT departments should include organization
goals regarding implementation of new software.
5. [Measure Harm Over Tim The leaders should utilize a dashboard or balanced scorecard to
observe data over time for important factors identified for the organizat ion. This might include
mortality rates, triggers for adverse events, Root Cause Analyses (RCAs) and Failure Mode and
Effects Analyses (FMEAs), and other such patient safety information (See Chapter 3
Performance and Process Improvement and Chapter 4 Health Data Analytics for more
information. See information presented below for RCAs & FMEAs).
6. fuupport Staff and Patients/Families Impacted by Medical Errors and Harm! The patient and family,
as well as the staff who made an error, will all require support after a medical error occurs. The
appropriate disclosure of information and an apology to the patient/family are discussed later in
this chapter.
7. lign System StrategY, Measures, and Improvement Project.sj The organization must align
their strategic initiatives between various parts of the organizatio n, such as between
quality improvement and financial plans. There should be oversight of improvement
projects, with monitoring and revising if changes are not forthcoming. The national
initiatives must also be integrated in this process. (See Chapter 3 Performance and
Process Improvement for information on the Quality Council).
8. !Redesign Care Processes Increase Reliabilit Reliability is the key concept imbedded in
patient safety. Reliability ensures the patient receives the appropriate test, treatment, or
medication at the appropriate time (see Chapter 4 Health Data Analytics for information on
reliability). This can be accomplished by the use of rapid response teams, CPOE systems with
decision support, and many other means. Another concept utilized is the decrease of
variability. The standardization of care with guidelines and pathways leads to decreased
variability and thus increased reliability of care (See Chapter 3 Performance and Process
Improvement for information on guidelines & pathways).
Another leadership resource from IHI is the Governance Leadership of Safety and Improvement. It
states the governing board's responsibility for ensuring and improving care. This cannot be completely
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delegated to the medical staff and executive leadership. Rather the ensuring safe and harm-free care
to the patients is the Board's job and is at the very core of their fiduciary responsibility (IHI-Pt. Safety,
2015).
!Gener ic Components of the Program!
The healthcare organization is complex, with many systems and processes impacting the quality and
safety of patient care. The specific patient safety program includes at least:
• Infrastructure: senior leaders roles, patient safety officer, governance teams, software
• Clear linkage with the quality strategy; Integration of all related functions and safety
programs; Alignment with strategic goals (See Chapter 2 Organizational Leadership and
• Policies, procedures, and education to reduce and control risk to patients and staff (See
• An occurrence/event/incident reporting process
• Mechanisms to participate in national patient safety initiatives (see above in this

chapter)
• Proactive activities to identify high-risk processes and implement actions to reduce

avoidable risk (e.g., FMEA, clinical risk and environmental assessments) (see below in
this chapter)
• A process for immediate response to medical errors and sentinel events
• Performance measurement, tracking, and analysis (see Chapter 4 Health Data Analytics)
• Improvement activities (see Chapter 3 Performance and Process Improvement)
• Documentation and reporting (see Chapter 4 Health Data Analytics)
All healthcare organizations across the continuum are expected to implement specific patient safety
programs, as defined by CMS and accreditation standards. A general overview of the major
components is listed in Table 4. All organizations should review the appropriate standards for their
type of healthcare organization. The information in this table is taken from select accreditation
standards.
Table 4: General Components in a Patient Safety Program

General Components in a Patient Safety Program
1. The patient safety program is an organization wide program implemented by the
leadership.
2. Individuals leading the interdisciplinary group to manage the patient safety program
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include, but are not limited to, directors, managers, safety officers, and clinical
leadership including practitioners, nurses, ancillary personnel, and other frontline
clinical staff.
3. The scope of the patient safety program includes the full range of patient safety issues,
from potential or no-harm errors to hazardous conditions and sentinel events.
4. All departments, programs, and services within the organization should participate in
the patient safety program.
5. As part of the patient safety program, the leaders create procedures for responding to
system or process failures. Note: Responses may include continuing to provide care,
treatment, and services to those affected, containing the risk to others, and presenting
factual information for subsequent analysis.
6. The organization leaders provide and encourage the use of systems for blame-free
internal reporting (culture of safety/Just Culture) of a system or process failure, or the
results of a proactive risk assessment.
7. The organizat ion leaders define "sentinel event" and communicate the definition
throughout the organization.
8. The organization conducts thorough and credible root cause analysis in response to
sentinel events.
9. The organization leaders make support systems available for staff who ·have been
involved in an adverse or sentinel event. Note: support systems recognize
conscientious health care workers who are involved in sentinel events are themselves
victims ("second victims") of the event and require support . Support systems provide
staff with additional help and support as well as additional resources through the
human resources funct ion or an employee assistance program. Support systems focus
on the process rather than blaming the involved individuals.
10. Selecting one high-risk process and conducting a proactive risk assessment (FMEA)
should occur at least every 18 months.
11. The organization should analyze and then use information about system or process
failures (and the results of proactive risk assessments) to improve patient safety and to
reduce the risk of medical errors.
12. . The lessons lea rned from root cause analys is, system or process fa ilures, and
the results of proactive risk assessments should be shared with all staff providing
services for the specific situation,and up the chain of command to the governing body.
13. Annual written reports to the governing body might include things like:
1. All system or process failures
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PATIENT SAFETY
2. . The number and type of sentinel events

3. Whether the patients and the families were informed of the event
4. All actions taken to improve patient safety, both proactively and in response to
actual occurrences
5. The determined number of distinct improvement projects to be conducted
annually
6. . All results of the analyses related to the adequacy of staffing
14. The leaders encourage external reporting of significant adverse events, including
voluntary reporting programs in addition to mandatory programs. ( Note: Examples of
voluntary programs include, but are not limited to, The Joint Commission Sentinel
Event Database and the U.S. Food and Drug Administration (FDA) MedWatch.
Mandatory programs are often state initiated) .
!Physician Participation\
In addition to the physician leader participation in the development and implementation of the patient
safety program as a strategic initiative, there are specific ways in which all physicians and other
practitioners can facilitate patient safety/clinical risk management efforts. These include, but are not
limited to, the following:
• Identify general areas of potential risk in clinical aspects of patient care/safety
• Participate in identified patient safety initiatives such as hand hygiene, time out, and so
forth
• Report any medical error to Risk Management or other designated department
• Help design programs to reduce risk in clinical aspects of patient care
• Develop criteria for identifying specific cases with potential clinical and safety risk
• Evaluate specific cases identified as having potential or real clinical risk
• Participate on teams to correct problems in the clinical aspects of patient care and
patient safety identified through performance improvement and risk management
!Patient Safety Officer!
The Patient Safety Officer (PSO) has primary responsibility to coordinate and serve as a resource for
the development, implementation, review, and ongoing refinement of the patient safety program. The
Patient Safety Officer must also encourage leadership performance measurement and staff incentive
programs which support patient safety improvement. The PSO acts as a liaison for patient safety issues
to and between the CEO, senior leaders, governing body, Patient Safety Team/Comm ittee,
organization, and external organizations.
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The PSO coordinates patient safety education and activities which support the patient safety program
(e.g., governing body presentations and leadership rounding) (IHI, 2017). While the PSO is not always
the team leader, the PSO will coordinate activities of the Patient Safety Team/Committee and how
they integrate with other relevant teams such as QI/Pl, RCA, and FMEA teams. The coordination of the
development and periodic review and revision of patient safety policies and procedures is another role
of the PSO. The PSO also establishes and facilitates proactive risk assessments and risk reduction
activities, and the changes necessary to improve patient safety throughout the oreanizat ion.
Communication is a major responsibility for the PSO. The PSO must develop mechanisms for
organization wide communication and dissemination of patient safety information, including
educational activities, to promote organization wide understanding of and commitment to patient
safety practices. The PSO promotes a computerized, non-punitive error reporting process throughout
the organization and participates in the trend analysis, review, and investigation of identified patient
safety issues as warranted. The PSO also has the responsibility to review and facilitate the use of
medical error information, including internal trend reports and external reporting programs and
resources. Some resources include The Joint Commission Sentinel Event Alerts, FDA Safety Alerts, ISMP
Medication Safety Alertt (biweekly email newsletter), ECRI Institute Alerts Tracker, NPSGs, Leapfrog,
AHRQ, IHI, and many others (see the last part of this chapter and website list at the end of this
chapter).
Other responsibilities of the Patient Safety Officer include but are not limited to the estabiishment and
facilitation, appropriate response and investigation processes for adverse events, including front-line
response, intervention with patient/farnily and support of involved staff, and root cause analysis. The
PSO works closely with Risk Manager and Quality Manager as the domains of all three frequently
coincide with patient safety issues and concerns .
!Role of the Quality Professional!
The Quality Professional is often designated as the Patient Safety Officer (PSO) because of the integral
part patient safety plays in the effectiveness of the overall quality strategy and the similarity of roles.
Even if not designated the PSO, the Quality Professional must have knowledge of, and be able to help
facilitate and coordinate, all of the leadership and program activities described above.
The Quality Professional must be knowledgeable of all related safety activities in the organization and
must participate as necessary to maximize patient safety efforts, e.g.:
• Facilitate integration with related organization functions, including infection

surveillance, control,and prevention and environmental safety processes
• Minimize duplication of effort in policy/procedure development, education of staff and

patients, data collection and aggregation, and communications
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• Coordinate event/occurrence reporting and performance measurement and prioritize

available patient safety data and information for analysis, reporting, and decision
making
• Ensure reactive activities, such as root cause analysis (RCA), and proactive activities,
such as failure mode and effects analysis (FMEA), are conducted timely, efficiently, and
effectively
• Coordinate the flow of information to all who need to know
Patient Safety Plan
To have a successful patient safety program, there should be a written patient safety plan. The goals
and objectives of the plan are then utilized to move the patient safety program forward. The Patient
Safety Plan should define and describe the organization's commitment and approach to providing a
safe environment. The patient safety plan may be written as a major component of the performance
improvement plan itself. Often this is the best way to insure clear integration. Table 5 lists the general
components, which should be included in a Patient Safety Plan. As you can see, many of the
components are very similar to those in the performance improvement plan.
Table 5: Written Patient Safety Plan General Components

Written Patient Safety Plan General Components
• Purpose
• Mission, Vision, Values (organization) and Commitment
• Goals (strategic) and Objectives
• Scope
• Responsibilities: Board of Directors; Quality Council/Patient Safety Team; Medical

Staff; Patient Safety Officer; Hospital and Medical Staff Department Directors and
Chairs; Employees, Medical Staff Members, and Volunteers; Patients
• Important Processes: Identification of patient safety issues; response to a patient

safety incident; event/incident reporting; managing serious, potentially serious, and
sentinel events; communication of unanticipated outcomes; non-punitive reporting;
E!motional support of individuals involved in an incident; external reportine
requirements; proactive risk assessment; National Patient Safety Goals; IHI
Improvement Map; design and redesign of processes; patient safety education
• Confidentiality
• Program Evaluation, at least annually
Important Processes and Reports to include:
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PATIENT SAFETY
• Regulatory agencies and accrediting bodies w ith oversight authority, listing of their
standards and how the organization documents the compliance with those
standards. These may include Occupational Safety and Health (OSHA), National
Patient Safety Goals, Patient Safety Organizations, Sentinel Event Reporting, FDA
Recall Alerts
• Update of the policy noting how risk is addressed by the organization, including who
shares Lhe r isk (i.e., insurance, patient, etc.)
• Reassessments of the program due to changes in legislation, insurance policy, or

additional exposure due to a change in the programs and services offered by the
organization
• Education efforts related to safety and risk reduction and prevention
• Quarterly reports to the Board related to safety issues
!Documenting How You Incorporate Patient Safety Throughout the Organization!
In addition to the Patient Safety Plan, other documentation must be maintained to reflect how the
organization addresses the following items (Table 6). This can be a part of the Patient Safety Plan, or in
policies and procedures. The documentat ion can be maintained in various parts of the organization.
For example, the liability information could be in the Risk Management Plan instead of the Patient
Safety Pian. Piease note this is not an all-encompassing list, but rather it should serve as an initial
effort only.
Table 6: Documentation of Incorporation of Patient Safety throughout the Organization

Documentation of Incorporation of Patient Safety throughout the Organization
A. Basic Duties of Care
a. Basic Duties of Care and Liabilities
i. Basic duties of direct providers (independent practitioners)
1. Comply with statutory duties such as drug laws
2. Obtain proper consent for medical care
3. Render care not substantially inferior to like providers
ii. Liabilities of physicians/ independent practitioners
1. Lack of documentation of treatment
2. Inadequate work-up (based on accepted standards)
3. Acts of others (e.g., nurses) if exercising control ("borrowed servant"

or "captain of the ship" doctrine)
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PATIENT SAFETY
4. Failure to attend or follow up
5. Mistaken identity (along with the institution)
6. Misdiagnosis, if based on inadequate examination and testing
7. Wrong diagnosis followed by improper treatment causing injury
8. Wrong treatment, procedure, surgical site, based on diagnosis
9. Treatment outside field of competence

10. Abandonment (neglect or failure to follow up after the acute stage
of illness -- unilateral termination of the physician-patient
relationship without notice to the patient)
11. Failure to obtain informed consent
12. Failure to seek consultation or refer to a medical/surgical specialist
13. Use of unprecedented procedures, unless approved by a

respectable minority of medical opinion
14. Failure to order diagnostic tests considered to be a "matter of

common knowledge"
15. Failure to obtain results of diagnostic tests ordered
16. Infections resulting from failure to utilize proper

procedures/precautions
17. Aggravation and/or activation of a preexisting condition if injury

results
18. Premature dismissal or discharge
iii. Liabilities of nurses
1. Adm inistration of drugs inconsistent with prevailing statutes, nurse

practice acts, or institutional policies
2. Failure to follow physician/ independent practitioner orders
3. Failure to report significant changes in a patient's condition
4. Failure to take con ed verbal or telepho11e orders
5. Operating room sponge/instrument miscounts
6. Patient burns
7. Patient falls
8. Failure to report defective equipment
9. Failure to follow established nursing procedures
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10. Negligent handling of patient valuables
b. Create a process with safety in mind
i. Near miss reporting
ii. Coach the reporter; positive reinforcement for future reporting
c. Risk Management vs. Risk Avoidance vs. Risk Mitigation
i. Find the oops before it happens
d. Educate staff regarding patient safety issues
i. "It starts before the offer letter" - how safety is addressed in the interview
ii. Annual education efforts
B. Incorporating Patient Safety into the Quality Management Processes
a. Assess and Plan
i. Assess the organization's patient safety culture
ii. Determine how technology can enhance the patient safety program
1. Automated audits
2. Computerized physician order entry (CPOE)
3. Barcode medication administration (BCMA)
4. Electronic medical record (EMR)

5. Abduction/elopement security systems
6. Human factors engineering
b. Monitor to determine current status and need for improvement
c. Implementation and Evaluation
i. Assist with implementation of patient safety activities
1. Education of staff regarding patient safety issues
2. For every implementation there is a monitor for ongoing

evaluation
ii. Facilitate the ongoing evaluation of patient safety activities
1. Near Misses
iii. Participate in patient safety activities
1. Patient safety goals review
2 . Incident report review
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PATIENT SAFETY
3. Sentinel/unexpected event review
4. Root cause analysis (RCA)
5. Failure mode and effects analysis {FMEA) (proactive risk

assessment)
6. Identification of reportable events for accreditation and

regulatory bodies
C. Prevention
a. Sentinel Event Alerts from Joint Commission
b. Reports and findings leading to focus on patient safety
c. Risk Management vs. Risk Avoidance vs. Risk Mitigation
i. Internal review of processes to prevent future events
D. Reportable Events
a. Levels of events
b. Steps
i. Notification of Administration of a POSSIBLE reportable even
ii. Development of a fast track investigation
iii. Report
iv. Follow-up
v. Dealing with the media
Patient Safety Management
!safety Culture!
A generally accepted definition of Safety Culture is a paraphrase of several organization's and

dictionary references: The safety culture of an organizat ion is comprised of values, attitudes,
perceptions, competencies, and behaviors, which determine the commitment to, and proficiency of,
an organization's health and safety management. An organization's safety culture is characterized by
communication founded on mutual trust, by shared perceptions of the importance of safety, and by
confidence in the efficacy of preventive measures. The outcomes of these efforts may be reflected
positively or negatively.
All healthcare organizations should periodically assess where the organization is in terms of their
patient safety culture. The culture of the organizat ion impacts the culture of the organization . An
organization with a culture of fear of retribution, for example, will not be very open to reporting errors
or potential errors. On the other hand, an organization with a recognized 'Just Culture' leads to
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process changes, not individual retribution, and has a better patient safety culture (see next section of
this chapter).
The safety culture assessment helps identify and measure conditions in healthcare organizations which
lead to adverse events and patient harm. The assessment diagnoses the current safety culture and
tracks change over time. It raises patient safety awareness, helps prioritize quality strategies, and
provides an opportunity for internal and external benchma rking. The survey is the baseline from which
action planning and system/process changes can begin (AHRQ - Assessment, 2015). The survey has
sound psychometrics, is free to use.
The Agency for Healthcare Research and Quality (AHRQ) released the Hospital Survey on Patient
Safet y Culture in November 2004 with the first Comparative Database Report released in 2007. The
2010 Report has grown and was based on voluntary data submission from 885 hospitals. Currently,
there are forms of the Patient Safety Culture Survey available for hospitals, medical offices, nursing
homes, community pharmacies, and ambulatory surgery centers (AHRQ - Assessment, 2015). The
surveys in each of these types of healthcare organizations are staggered with surveys occurring every
two years. All organizations who submit the survey receive the corresponding Comparative Database
Report. This report can be used to:
• Raise staff awareness about patient safety
• Diagnose and assess the current status of patient safety culture
• Identify strengths and areas for patient safety culture improvement
• Examine trends in patient safety culture change over time
• Evaluate the cultural impact of patient safety initiatives and interventions
• Conduct internal and external comparisons
If a healthcare organization does not qualify to utilize the AHRQ surveys, the organization can develop
their own survey, but are then not able to obtain comparative results from other organizations. In this
case, the organization should consider what is important to their environment in terms of a patient
safety culture. The survey forms themselves are available on the AHRQ website so the organization can
pick and choose questions from these different surveys and then analyze the data and benchmark with
themselves.
One word of caution is required here. Do not bite off more than the organization can chew. This means
the organization will be expected to address the areas which indicate improvement is needed. In a
large organizatio n, this may be too labor and resource intensive for the leadership to approve . It may
be better to identify the high-risk areas first . For example, in a hospital, high-risk areas include but are
not limited to, the ICU, the ER, Labor and Delivery, and Surgery. One year, the survey could be focused
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PATIENT SAFETY
on one or more of these high-risk areas. Then two years later, when the survey is repeated, these
areas should again complete the survey, but other areas should also be selected to participate. In this
manner, the organization can measure progress made and identify the improvement needs in other
areas of the organization. It may even be found the improvements made in the high-risk areas can also
be implemented in other areas of the organization.
µust Culture!
People can and will make mistakes. It does not matter who the person is, what they do for a living, or
how much they are paid. We all make mistakes. Most of the time the mistakes are not premeditated
errors. The healthcare system, based on the type of work done, must attempt to eliminate as much
error as possible from its culture. In a 'Just Culture' all employees, practitioners and others understand
the mission and the vision of the organization guides them to do the best they can in completing their
job. Just culture is obtained in organizations where everyone knows the company's values and how
they are expected to make choices to protect those values. Everyone has a job to protect the patient
and others and to be part of the solutions to reduce the risk of errors. "Most serious medical errors are
committed by competent, caring people doing what other competent, caring people would do"
(Berwick, n.d., p.1).
Most errors are a result of a process and not necessarily the individual. The processes somehow
enable mistakes to happen. Of course, human factors (later in this chapter) play an important factor in
whether an error occurs. The Just Culture structure defines what behavior should be undertaken for
the individual who directly makes the error. The previously mentioned Swiss cheese model
demonstrated errors do not occur in isolation, but are associated with a number of smaller errors
leading up to a catastrophic error. Just culture recognizes this to be a true statement (Just Culture,
n.d.).
Just culture defines three possible behavior choices that an individual makes and needs to manage
(Just Culture, n.d.). A 'human error', which is an inadvertent action, a lapse or a mistake, is the first
behavior choice. When a human error is made, the individual should be consoled regarding the
mistake. The process should be examined and managed through changes in choices, processes,
procedures, training, and so forth. An example of this might be starting an operative procedure
without a time out.
An 'At-Risk Behavior' is the second behavior choice (Just Culture, n.d.). With this behavior, the
individual chooses to do something that may unintentionally lead to a situation where harm occurs.
The person does not necessarily recognize the possible risks and results of their actions, or feel the
risks are insignificant or justified. An example of this risk would be looking at a billboard while driving a
car. With this beh;:ivior, the individual should be coached as to the consequences of the actions and
where better choices should have been made. The organization should remove incentives for at-risk
behaviors, incentivize healthy behaviors, and increase situational awareness.
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PATIENT SAFETY
The last behavior choice is 'Reckless Behavior' where the individual consciously chooses to put
themselves and/or others in harm's way (Just Culture, n.d.). The risk is identified but is ignored. It is
with this type of behavior there should be severe consequences related to the behavior, such as
remedial action or punitive action.
To achieve just culture the organization must have reasonab le values and expectations, knowing there
will be mistakes made (Just Culture, n.d.). There must be good system design to catch and recover
from human errors and equipment failures. The company must direct and manage the behavioral
choices of its employee, practitioner, and so forth, as described above. There must be learning systems
in place to allow the organization to learn from the errors and to make improvements in the processes
to prevent further mistakes from occurring if possible. Lastly, the organization must treat every
individual and event with accountability and justice . There must be an unbiased and fair manner
utilized regardless of the severity of the error.
Establish Learning Boards
One tool of many to be used on a unit is the Learning Board (Figure 2). This tool is frequently used with
the CUSP program, which is described toward the end of this chapter. The learning board is posted on
the unit and utilized to display safety concerns identified by staff, practitioners, and others. It is up to
each organization as to where this learning board is displayed on each unit, and thus determines if
patients and/or others may also view the board. Any person may place safety concerns on the
'Identified' section of the board. Through staff meetings, leadership WalkRounds and other such
activities, the prioritization of the safety concerns is determined and the appropriate individuals
assigned to each initiative.
A designated individual on the unit is appointed to aggregate the data and to report the data to the
appropriate individuals. The learning board promotes visibility of specific concerns and what is being
done to resolve the concerns/issues. This transparency demonstrates to the staff and others their
input is critical to having a well-function ing patient safety program. Being able to anonymously report
concerns in this manner may be valuable for the staff and others to report the safety concerns without
fear of reprisal.
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PATIENT SAFETY
Figure 2: Learning Board

Learning Board
--
Active
.
Visual
--
Identified
-- --
Resolved
Measures # of defects # of defects # defects

identified/ Month without action > resolved in
30 days past 30 days
Data collection: Data collection: Data collection:
Count on the first Monitor and Count on the first
day of each move day of each month
month
Patient Safety Leadership Rounds
Patient Safety Leadership Rounds or WalkRounds was developed by Allan Frankel, MD, to increase
awareness of safety issues by all clinicians (HRET, 2010) . Dr. Frankel, Director of Patient Safety at
Partners Healthcare, spent three years working with the Health Research & Educational Trust to study
the implementation of these types of rounds and identified staff and practitioners developed new
insights into patient safety . The WalkRounds occur in patient care areas of the organization and
demonstrat e to staff the organization is committed to patient safety . The WalkRounds also provide an
informal method for leaders to talk to staff and encourage reporting of errors as well as reporting to
staff the accomplishments of the organization in eliminating or decreasing the effect of the errors (IHI-
WalkRound, 2017). Table 7 lists the objectives to be gained by utilizing these leadership WalkRounds.
Table 7: Twelve Objectives of Patient Safety Leadership WalkRounds

Twelve Objectives of Patient Safety Leadership WalkRounds ·
• Increase awareness of safety issues by all clinicians
• Engage senior leadership with frontline staff about patient safety issues
• Provide opportunity for leadership to openly discuss operational failures, safety
and harm from front line staff
• Educate staff about patient safety concepts such as Just Culture
• Encourage frank & open discussion in a unit setting
• Obtain information collected from staff about barriers to safety
• Assure the information collected affects actions or resource allocation
• Utilize the Learning Board
• Elicit information to be collected and aggregated in a useful manner
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PATIENT SAFETY
WalkRounds cannot simply start without preparation of senior leadership and unit participants . The
leadership must have buy-in with the concept and agreement of the need to be consistent with the
WalkRounds . The WalkRounds should consist of a senior leader, a scribe, the Patient Safety Officer
and/or Quality Professional, and the manager/director of the unit. The scribe captures comments,
concerns, and safety events. There must be a plan to provide feedback from the rounds to other
leaders of the organization (HRET, 2017; IHI-WalkRounds, 2017).
The WalkRounds should be scheduled based on the staff's schedule and not the leaders' schedules. It
is common knowledge the nursing staff are the busiest at certain times during the day,depending on
the type of unit or department. The first thing in the morning is not a good time for rounds due to the
patient care to be accomplished in the morning or after shift change . The WalkRounds should occur on
all shifts so all staff members have opportunities to voice their concerns and have buy-in with the
process. The WalkRounds should occur weekly for at least a year to reinforce to the staff and others
the commitment from the leadership is not a one-time occurrence . Some organizations announce
when the WalkRounds wil! be occurring and others do not. Some organizations assign specific leaders
to specific units/depa;tments which can build trust between all who participate (HRET, 2017; IHI -
WalkRounds, 2017).
The manager of the unit/department should know several days in advance the WalkRounds will be
done on their unit/department. When the WalkRound team arrives in the area, a brief opening
statement/introduction should occur. This opening introduction should be scripted so that all of the
senior leaders make the same statement, and set the stage for open discussion. The senior leaders
should be given some potential general questions in advance they may ask to get the discussion
started. Table 8 contains a sample list of questions provided by the Institute for Healthcare
improvement. The patient safety discussions can occur in a variety of ways. They can be informal
discussions in the hallways, individual conversations, conversations with employees in a specific
position {such as all Patient Care Assistants (PCA) on a unit), and or conversations in the same location
every week. It is also important for leadership to elicit concerns from patients and families during
these WalkRounds . It is important to take a camera along on the WalkRounds so that others can 'see'
issues. At the end of the session,there should be a scripted closing statement to indicate there will be
work done to examine the information provided, and identify and prioritize the improvements to be
made.The participants should be asked to talk with others in the unit/department about the concepts
discussed during the meeting. It is important there is follow up and feedback to the staff about the
issues discussed during the WalkRounds . Regular safety briefings or other meetings should also be
conducted throughout the organi1ation regarding the issues raised, and to communicate what is being
done to improve patient safety (HRET, 2017; IHI-WalkRounds, 2017).
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PATIENT SAFETY
Table 8: Sample WalkRound Questions

Sample WalkRound Questions
Question Examples
Can you think of any events in Appointments, treatments, procedures scheduled
the past day or so which but missed
resulted in prolonged Miscommunications
hospitalization of a patient? Delayed or omitted medications or treatments
Have there been any near Finding the wrong drug sent up from Pharmacy and
misses that almost caused harm almost administered but caught before it was
to the patient but didn't? IV pump mis-programmed, but the alarm sounded
prior to the infusion beginning
Physician wrote orders on the wrong patient and the
nursing staff caught the error before anything was
done to the patient
Have there been any incidents Infections
lately where you think a patient Surgical complications or errors
was harmed? Complications from medications
What aspects of the Consider the movement of patients throughout the
environment are likely to lead to organization
patient harm? Consider communication
Consider computer issues and EHR issues
Is there anything we could do to What information would help?
prevent the next adverse event? Consider environment and workflow
Consider interactions between clinicians
Can you think of a way in which Not enough information
a system or the environment Requirements don't make sense
does not work consistently? Requirements are unnecessary and time-consuming
What specific intervention from Organize interdisciplinary teams to evaluate specific
leadership would make your problems
work with patients safer? Assist in changing the attitude of certain groups
Facilitate interaction between specific groups
What would make WalkRounds Informal hallway conversations instead of group
more effective? meetings
Individual conversations
Enough time to really discuss issues
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PATIENT SAFETY
How are we actively promoting Do not penalize individuals for inadvertent errors
a blame-free culture and Employees who report potential or actual errors and
working on developing a blame- adverse events in a timely manner are provided
free reporting policy? immunity
Adapted from IHI-WalkRounds, 2017
/\t the conclusion of the WalkRounds, the da la collected must be trended and improvement tracked.
The Health Research & Educational Trust (HRET, 2017) has developed a database in Microsoft Access
to allow information to be tracked beginning at the time it is gathered during the WalkRounds. The
database is free and can be downloaded from the WalkRounds Database listed in the website links at
the end of the chapter.
[ethnology and Its Effects on Patient Safet
Technology has been expanding in healthcare at an exponential speed. Many of the new technologies
were thought to be the answer to patient safety and quality issues. While new technology has
remedied many issues, it has also created new ones now needing to be addressed. Several of these
technology advances will be discussed here with the positives and negatives resulting from their use.
Top Patient Safety Issues and Hazards - 2017/2018
Beginning in 2014 the Emergency Care Research institute's ( ECR i i Patient ·safety Organization (PSO)
issued the first 'Top 10 Patient Safety Concerns for Healthcare Organizations' for multiple healthcare
settings, such as hospitals, ambulatory care centers, doctor's offices and nursing homes (ECRI, 2017).
The ECRI also releases the 'Top 10 Health Technology Hazards' every Fall. The Top 10 lists are designed
as a starting point for healthcare organizations to identify any of the risks and to begin to prioritize the
issues at their organization. Organizations contribute data to the PSO in a protected manner, as
discussed previously in this chapter, as a result of the Patient Safety and Quality Improvement Act. This
information is then compiled and analyzed to create these lists.
In 2017 there are two recurring patient safety issues and seven new issues (ECRI, 2017) (Table 9). It is
also interesting to note there are four concerns/issues the same on both the Patient Safety and
Hazards lists. These lists were compiled by two different teams and yet these same concerns surfaced
on both lists. This should cause organizat ions to place additional attention on these items. More
information about these lists can be found on the ECRl's website listed in the website list at the end of
this chapter.
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PATIENT SAFETY
Table 9: ECRl's Top Ten Patient Safety and Hazards Lists, In Rank Order of Significance
ECRl's Top Ten Patient Safety and Hazards Lists, In Rank Order of Significance
Top 10 Patient Safety Concerns 2017 Top 10 Health Technology Hazards 2018
1. Information management in EHRs 1. Ransomware & other cybersecurity
threats to healthcare delivery can
endanger patients
2. Unrecognized patient deterioration 2. Endoscope reprocessing failures continue to
expose patients to infection risk
3. Implementation and use of clinical 3. Mattress & covers may be infected by
decision support body fluids and microscopic contaminants
4. Test result reporting and follow-up 4. Missed alarms may result from
inappropriately configured secondary
notification devices and systems
5. Antimicrobial stewardship 5. Improper cleaning may cause device
malfunctions, equipment failures, and
potential patient injury
6. Patient identification 6. Unholstered electrosurgical active
electrodes can lead to patient burns
7. Opioid administration and 7. Inadequate use of digital imaging tools
monitoring in acute care may lead to unnecessary radiation
exposure
8. Behavioral health issues in non- 8. Workarounds can negate the safety
behavioral-health settings advantages of bar-code medication
administration systems
9. Management of new oral 9. Flaws in medical device networking can lead to
anticoagulants delayed or inappropriate care
10. Inadequate organization systems 10. Slow adoption of safer enteral Feeding
or processes to improve safety and connectors leaves patients at risk
quality
!computerized Physician/Provider [AHRQ]/Prescriber [NQF] Order Entry (CPOE)i
A computerized physir:i;in order entry (CPOE) system allows the clinician to enter directly an order into
the computer rather than writing on paper. The order entered through the CPOE is electronically
transmitted directly to the pharmacy or other department where it is then linked to the patient's other
information in the electronic health record. Most systems interface with clinical decision support
systems (CDSSs), which include suggestions or default values for drug doses, routes, and frequencies
and may also check for drug allergies, drug-drug interactions, drug- laboratory values, drug guidelines,
or prompt for corollary lab tests. CPOE was recommended to be implemented in the To Err is Human
report and was one of Leapfrog's first standards (AHRQ - CPOE, 2014).
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PATIENT SAFETY
Another impetus for CPOE comes from the CMS Meaningful Use regulations. The measure for Stage 1
is: "More than 30 percent of all unique patients with at least one medication in their medication list
seen by the EP {Eligible Practitioner } have at least one medication order entered using CPOE" (CMS -
CPOE, 2017, p. 1). In Stage 2 the measure for CPOE is "More than 60% of medication, 30% of
laboratory, and 30% of radiology orders created by the EP {Eligible Practitioner} or authorized providers
of the EH's {Eligible Hospital} or CAH {Critical Access Hospital} inpatient or emergency department
during the EHR reporting period are recorded using CPOE" (CMS - Stage 2, 7014, p. 1). On November
14, 2016, CMS published a final rule with comment period that included changes responsive to
stakeholder feedback and will result in continued advancement of certified EHR technology. The
finalized changes will also utilize and result in a program result in more focused on supporting
interoperability and data sharing for all participants under the Medicare and Medicaid EHR Incentive
Programs (CMS - CPOE, 2017).
While CPOE has been shown to be quite effective in reducing error related to the prescribing of the
medication, it has not been effective in errors occurring at the dispensing and administration stages of
the medication process. Its effectiveness in reducing ciinicai adverse events is iess clear. Several
studies have shown CPOE does not reliably prevent patient harm with a persistence of high rates of
adverse drug events (AHRQ - CPOE, 2017). Other studies have seen the CPOE implementation be
effective in preventing these types of events (Leapfrog, 2016). There is postulation the Clinical Decision
Support Software (COSS) may account for the difference.
!Bar Code Medication Administration (BCMA) Systems!
The use of wireless, mobile (handheld) barcode medication administrat ion safety systems (BCMA) is
now a community standard in hospitals. Barcode scanning is the oldest machine-readable identification
system. Its use in BCMA sys_tems to reduce medication error rates and improve patient safety has been
recommended by several organizations, including the Institute of Medicine and the National Patient
Safety Foundation. The barcoding system has been utilized to assure the medication is administered
correctly with the five rights of medication administration. It has reduced medication errors as much as
65% to 86% and adverse drug events have also decreased (PA, 2008).
The barcode is applied to each unit dose (item-specific identification) and scanned by nurses at the
bedside to connect the right medication with the right patient. The BCMA system is useful on patient
units for medication administration and laboratory specimen collection, in preoperative and
postoperative areas, radiology, and emergency departments. Benefits for any inpatient setting include:
• Accuracy in confirming the "five rights" of medication administration: right patient,

medication, time,dosage, and route
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PATIENT SAFETY
• Seamless integration with an electronic medication administration record (eMAR),

pharmacy system, and the organization's information system, using an industry
standard HL7 interface
• Comprehensive data for performance measurement and improvement
Studies have shown medication administration errors can be reduced if the barcode system is utilized
correctly (PA, 2008). However, when first implemented, nurses and others found ways to "work-
around" the proper use of the barcoding system . The work-arounds have led to unanticipated
consequences when administering medications. One work-around was related to how the system
documents the medication given when the scan is done. Some nurses identified they had been trained
to give the medication before documentation so it circumvented the system. Retraining was needed.
Another issue was the barcode on the patient's armband was too lightly printed or the armband
reflected light so the barcode could not be read. There was also user error in operating the new
equipment and there were equipment failures (Voshall, Piscotty, Lawrence, & Targosz, 2013).
Leapfrog, an organization of payers and others that look at Patient Safety and rate hospitals on specific
indicators developed in collaboration with hospital leaders and vendors, recently published a Leapfrog
standard with which they sill measure hospitals (Leapfrog, 2016). The four components of this
measurement will include: 1. "Measurement of the extent of a hospital's BCMA implementation
throughout the hospital with a focus on medical and/or surgical units (adult and pediatric) and
intensive care units (adult, pediatric, and neonatal)"; 2 . "A hospital's compliance with both patient and
medication scans at the bedside prior to administering medications"; 3. "The types of decision support
that the hospital's BCMA system offers"; and 4. "A hospital's structures to monitor and reduce
workarounds" (Leapfrog, 2016).
In a 2014 study, Seibert, Maddox, Flynn, and Williams examined how the use of the electronic medical
record and barcode medication administration affected the accuracy of medication administration
rates within two hospitals. They found after the implementation of the BCMA-eMAR system the
accuracy rate of medication administration did increase, especially when wrong time medication
errors were removed from the calculations . In hospital 1,the accuracy rate improved from 92% to 96%
(P=0.000008) after the BCMA-eMAR was implemented. In hospital 2, the accuracy rate did improve
significantly, (p=0.015) but not as significantly.
The above study is important because the use of barcoding, or similar technology, is required for
hospitals under Stage 2 Meaningful Use's core measures. The objective is to automatically track
medications from order to administration using technology and an electronic medication record. The
Stage 2 Meaningful Use definition is "More than 10% of medication orders created by authorized
providers of EH's {Eligible Hospitals} or CAH's {Critical Access Hospitals} inpatient or emergency
department (POS 21 or 23} during EHR {Electronic Health Record} reporting period for which all doses
are tracked by eMAR" (CMS - Stage 2, 2014, p. 4).
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PATIENT SAFETY
!Radio Frequency Identification (RFID)I
Radio Frequency Identification (RFID} is a type of automatic identification system, using digital memory
chips embedded on tags to track medical devices, drugs, staff, patient, and so forth. The tag may
contain information about the lot number and expiration date for medical supplies and drugs or
allergies and blood type for patients, or the physical location of equipment and patients in real time. It
comes in a variety of shapes and sizes and it has both read and write capability, whereas barcoding is
rc;:id only. Each chip has a unique electronic product code. Data can be read by sensors trom a distance
and through materials like clothing, wristbands, boxes, and paint, and can be transmitted to a host
computer for processing and tracking. RFID tags do not apply or read well on metal or in fluids.
Systems are more expens ive than barcoding but may be more viable in the long term (RFID, 2007).
In healthcare, RFID is utilized for three purposes: asset management, patient care, and inventory
management (RFID, 2007). The RFID is utilized in asset management to help the organization know
where equipment is located throughout the building. The tags are utilized on IV pumps, surgical carts,
and other such equipment to decrease a time lag in trying to locate needed equipment. It also helps to
find the equipment when it is due for preventative maintenance, thus meeting the standards for
equipment management, and assur ing the patient safety of the equipment. In inventory control, RFID
is utilized to track supplies from receiving through the location whe re it is to be used. When it comes to
the patient care uses, there are multiple uses from tracking patients who wander, or leave the unit for
testing, surgery, treatments and so forth, to patient identification, to surgical sponge and instrument
tracking when closing a surgical incision, and so forth. The RFID tags can also be utilized in abduction
and elopement systems to let you know when an infant has left the unit.
A disadvantage of RFID is the expense of the equipment, both hardware and software. Also, in the
past, there were questions as to whether the RFID frequency interferes w ith equipment, such as
anesthes ia equipment, but further advancements seem to have resolved the interference issue.
!Abduction/Elopement Security Systems!
According to the most recent available data, there were zero infant abductions from healthcare
facilities between 2013 and May 2015. However, from 1983 - October 2017 there were 323
abductions from healthcare facilities with 15 of these abductions unsolved (NCMEC, 2017). Of these
infant abductions, 72.53% were individuals personating a nurse or other healthcare worker while these
infants were a patient in the hospital. Hospitals and other health care facilities must remain vigilant.
Active RFID technology is used increasingly for infant and pediatric security to prevent abduct ion.
Abduction prevention systems usually have a soft self-adjusting bracelet placed around the infant or
child's wrist or ankle. If the bracelet is removed or cut off, an alarm signals the nursing station and
computer software, alerting the healthcare staff. Usually the facility incorporates door and elevator
locks, and goes into "lockdown mode", if a bracelet is removed or if someone attempts to take the
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PATIENT SAFETY
infant/child through the door or down the elevator with the bracelet still on the child. Some systems
utilize a mother/infant matching system, where the mother is given a tag or band with the same code
as her infant's, to serve as an additional and automatic identification (Wyld, 2009).
Unfortunately, most healthcare facilities only utilize these systems on newborns/infants, when in fact
children of all ages can be abducted from a facility . More than 350,000 family abductions occur in the
U.S. each year, with 47% of these cases involving the concealment of a child, transporting out of state,
or intent to keep the child permanently. The same type of abduction prevention systems can be
utilized on pediatric units, clinics, emergency rooms, or other areas where children might be left alone.
Unlike infants, children are usually abducted by family members ( NCMEC, 2017).
It has been estimated between 25% and 70% of adults with dementia but still living at home will
wander at least once. Of nursing home residents, 31% will be found wandering . In a 2006 study, it was
estimated one in five people with dementia will wander (Lester, Ga rite, & Kohen, 2012). RFID is also
useful to prevent elopement by wandering patients or residents, while still allowing more freedom for
both patients and healthcare staff. This is generally helpful in settings where patients/residents are
ambulatory, have short-term or long-term cognitive impairment, and may stray away from a location
(wandering) or try to leave the unit without permission/needed supervision (elopement). As described
above w ith infant and pediatric security systems, RFID devices can be linked to door locking
mechanisms . The patient/resident wears a tag and strap designed to prevent removal. It works with
systems which monitor and control specified exit doors. If a patient or resident approaches an exit, the
door controller locks the door; if the door is open, an alarm sounds. Certain alert systems include
options for central reporting, integration with other security systems, and real-time patient/resident
locating.
!Human Factors!
Human Factors include how people interact with tasks, devices/machines (e.g., computers), the
environment, other individua ls, related groups and teams, and the organization . Human Factors also
include capabilities and limitations. According to the World Alliance for Patient Safety (WAPS), the
science of human factors is the "study of the interrelationship between humans, the tools, and
equipment they use in the workplace and the environment in which they work" (WAPS, 2009).
Understanding these dynamics helps improve, through better design, the usability, reliability,
efficiency, usefulness, and effectiveness of technology in meeting process outcome objectives,
reducing errors, and ultimately improving patient safety and outcomes. While most root cause
analyses (see information below) focus on the processes leading to a never event, the human factors
a re not often studied. The aviation industry was one of the first industries to incorporate human
factors it into their analyses of never events.
In a study by Th iels et a l. (2015), they identified alarming figures that detail how important human
factors are in preventing never events in the surgical areas. Over 5 years they studied 69 never events
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PATIENT SAFETY
which occurred in the OR, endoscopy and radiology areas. Thiels et al. (2015) utilized the Human
Factors Analysis and Classification System (HFACS), which was developed for aviation and utilized by
several industries, including medicine, to code the human factors during those never events. The
human factors were then divided into 4 categories for analysis: unsafe actions, preconditions for
unsafe actions, oversight/supervisory factors, and organizational influences. Table 10 defines what is
included in each of these categories. The rate of never events during this timeframe was 1in 22,000
procedures of which 35% were wrong procedure, 30% were wrong side/site errors, 28% were retained
foreign object, and 7% were wrong implants. There was a mean of nine human factors attributed to
each event. The results demonstrated 47% of the human factors were attributed to preconditions for
unsafe actions, 41% to unsafe actions, 7.5% to oversight and supervisory actions, and 4% to
organizational factors.
Table 10: Human Factors Categories

Human Factors Categories
Category for Analysis Analysis of Cause
Unsafe actions Issues with failure to follow institutional policies and
procedures/standards; bending/breaking the rules
Errors
1) Percetual errors = inaccurate information;
confirmation bias; misinterpretation of information
2) Decisional errors = honest errors in cognitive thought;
inadequate treatment
3) Action-based errors = errors in thinking without
s1gnifican .. consc1ous thought; failure 1.0 foJlot/\. a
1
verification process
Preconditions for Environmental such as inadequate operation room lighting,
unsafe actions construction, technology issues, etc
Patient such as obesity, complex anatomy, etc
Situational such as poor patient handoffs, emergent

situations, etc
Behavioral factors such as inadequate communication,

attention on a single issue, overconfidence, inadequate
vigilance, distractions, personal behaviors, etc
Oversight/supervisory Supervisor oversight
factors Planning difficulties
Problem correction deficiencies
Staffing difficulties
Supervisor noncompliance
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PATIENT SAFETY
Organizational Inadequacies in organizational culture

influences Inadequacies in operational processes
Resources management
Adapted from Thiels et al., 2015
From this study by Thiels et al. (2015), it can be reasoned the same types of human factor errors are
occurring in other parts of the healthcare organization. There are multiple actions undertaken to begin
to mitigate these errors. The first is to utilize system-based strategies focused on mitigating the
cognitive and perceptual errors. Cognitive errors are problems with the way humans think at an
unconscious level. Perceptual errors are crucial to the way humans organize and interpret their
sensory impressions. Since individual human factors are substantial to preventing errors, there must
be focus on individuals, in addition to focus on the system. In the Thiels et al. (2015) study, the top
three factors contributed to the errors were cognitive factors . Communication failures ranked fourth .
Cognitive factors and communication failures are therefore the highest priority areas of focus when
working to mitigate these types of errors.
Historically human factor error was known as an unwanted incident and resulted in an incident report.
Some organizations have started to update their terminology to Human Factor Error Reporting or
Human Error Reporting. No matter what your organization calls the process, reporting of errors is very
important to determine if there are trends to be investigated and potential process changes needing
to be implemented. Some not all errors may be escalated to a Sentinel Event.
\RED RU LES\
Red Rules have been utilized in healthcare to signify when there is to be no bending of the rules. They
are to be utilized to reduce the possibility of harm to patients through work-arounds. The Red Rules
should be used selectively with the acts that could cause the highest probability of harm to patients.
staff members, or others. One example of this use of the rule would be with a Time Out before surgery
or a procedure is begun. If someone is violating a Red Rule, the staff should feel free to "Stop the Line"
and not allow the process to continue until the issue has been corrected. According to Jones, &
O'Connor (2016), Red Rules should be few in number, clear and obvious, identify the consequences for
not utilizing the rule correctly, and focus on the decision-based (such as the Time Out) rather than the
skill-based activities. There should be an emphasis on communication throughout the organization,
especially as the Red Rules are being implemented.
\sentinel Event Process\
Sentinel events and what the IOM report calls "adverse events" fall under the category of medical
errors. They probably constitute a relatively small percentage of medical errors. However, they may
compound to result in an adverse impact on patients, even if a specific "event" is never identified.
Sentinel events are considered a special cause variation, falling outside the normal control limits of the
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process of care. As such, intensive analysis must be performed in each case, whether the sentinel
event occurs in the organization or is associated with services provided by or for the organization.
Careful investigation and analysis of all sentinel events, as well as evaluation of corrective actions, is
essential to reduce risk and prevent patient harm. When a sentinel event occurs, a Root Cause Analysis
(RCA) should be conducted to find the true root cause of the event. From analysis, an action plan is
initiated and implemented. The RCA is conducted to identity whc1t really caused the event to occur ,:ind
the action plan is developed to eliminate or minimize the root-cause so the event does not occur
again. The RCA process is discussed later in this chapter.
In 1996, The Joint Commission (TJC) implemented its sentinel event policy. The policy was created to
assist hospitals that experience serious adverse events improve safety and learn from the events. Since
then, the policy has been part of the accreditation standards for all types of organizations accredited
by The Joint Commission (TJC - Sentinel, 2017). Other accreditation agencies and CMS have similar
standards which apply to the same type of analysis of sentinel events. For information on these
standards of accreditation agencies and others, refer to Chapter 6 Regulatory, Accreditation, and
External Recognition.
There are no complete, accurate databases with the information of all sentinel events. Several states
and governmental agencies require sentinel and other adverse event reports to be sent to them. The
Joint Commission has a database of the events voluntarily reported to them. This database does not
contain all the sentinel events in healthcare organizations accredited by TJC because reporting is not
required. However, the data from TJC represents a iarge sample of the types of events in various
healthcare organizations. From 2013 through the first half of 2017 (latest data available at the time of
this writ ing), the top four root causes were human factors, leadership, communication, and
assessment (TJC - Sentinel, 2017). All types of healthcare organizations should focus their patient
safety improvements with these four factors in mind.
pology & Disclosure!
When an adverse or sentinel event occurs, the patient deserves to know a serious unanticipated
outcome/error occurred and the related details about the occurrence . As a practitioner, it may be
difficult to admit to a patient something did not go as expected. All healthcare organizations must have
a formal process for disclosing this information to the patient and as appropriate to family members,
and to those responsible for patient safety within the organization. The organization process must
determine whom the individual should be to make the disclosure to the patient. Some organizations
require a licensed independent practitioner and others require the risk m.inager be present. The type
of adverse event may determine who the individual should be to make the apology and disclosure. The
process should also include how the information from the adverse event should be utilized to foster
transparency and performance improvement efforts (NQF - Disclosure, 2009).
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In 2009, the National Quality Forum (NQF) published the Safe Practices for Better Healthcare 2009
Update: A Consensus Report, which addresses the need for the apology and disclosure, and measures
to be taken to create such practices in a healthcare organization (NQF - Disclosure, 2009). The report
also addresses some of the difficulties in carrying out this disclosure. If the organization has
determined the Licensed Independent Practitioner (LIP) be the one to apologize to the patient,
however the practitioner was not involved in the adverse event occurrence, the LIP may not have all
the facts about the incident, or may fear an increased liability as a result of the disclosure. Support
systems to assist the patient and providers with this process must be in place. According to the report,
communication with the patient should be timely, within 24 hours of the event if possible. It should
include the facts about what happened, empathic communication of those facts and expression of
regret, a commitment to investigate and, as possible, to prevent future occurrences of the event, and
emotional support of the patient and family will be provided.
In addition to the apology and disclosure, the 2009 report (NQF-Disclosure, 2009) also discusses the
care of the providers/caregiver(s) involved in the error as well as support staff and others involved.
Caregivers are often called the "second victim" of the event. The number of second victims will vary
from one to many. Due to the complexity of care and technology, and the knowledge about the Swiss
cheese model (discussed earlier in this chapter), there may be multiple individuals who directly and
indirectly contributed to the adverse event occurrence, due to system failures or human error. The
harm to caregiver(s) and others involved in the event may manifest itself as increased depression,
anxiety about future errors, loss of confidence, sleeping difficulties, reduced job satisfaction, and harm
to their reputation. As a result of this harm, the caregiver may have loss of work time, may decide to
change their profession, ,;1nd it may cause a disruption to their family and many other results.
The NQF report {NQF - Disclosure, 2009) further addresses specific guidance concerning the events
that should occur concerning the second victims . Caregivers, according to this report, are considered
clinica l providers, staff, and administration who are "involved" in the adverse events, either directly or
indirectly. Indirect involvement includes those involved in the chain of errors or system failure. The
report indicates there must be a formal evidence-based process in place to identify what happened in
the event and the role of the individuals involved. The individuals involved in the event either directly
or indirectly should be treated with respect and dignity. These individuals may be under extreme stress
and discomfort . Those involved should be considered innocent of intentional harm until proven
otherwise and should be treated by those interacting with them as if they themselves were in this
position. A formal process should be utilized for the individual's co-workers to be able to express their
personal feelings about what happened, and to receive help with forgiveness and personal support for
those involved in the error. There should be a formal process where a designated team or individual is
responsible to assure those involved in the error receive the care they need and to determine if they
are "fit to work" for the protection of them and others. The individuals involved in the event should
also be invited to be a part of the RCA or other investigation of the event. The exception would be if
they were found to be under the influence of drugs, or alcohol, or if their behavior indicated they may
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have intentionally contributed to the error. The requirement for disclosure did not change in the NQF
Safe Practices for Better Healthcare (NQF-2010) but the document describes opportunities for further
research and linkages to other safe practices within the organization.
[Root Cause Analysis (RCA)[
A root cause is defined as a factor that caused an adverse event and should be permanently eliminated
through process improvement. A Root Cause Analysis (RCA) is defined as the approach, tools and
techniques utilized to determine what the root cause of a problem is (ASQ, n.d.). The RCA can be
utilized for multiple purposes. American Society for Quality (ASQ, n.d.) has identified five possible uses
for the RCA, listed in Table 11. For more information on these uses of RCAs, they are detailed in the
book Root Cause Analysis: The Core of Problem Solving and Corrective Action, which can be obtained
from ASQ.
Table 11: Different Uses for RCAs

Different Uses for RCAs
-
Approaches to RCAs Purpose
Events & Causal Factor Use with major, single event problems; Uses evidence
Analysis gathered quickly and methodically to determine a
timeline of what happened; Once established then
causal and contributing factors can be identified
Change Analysis Use w ith situations when a system's performance has
shifted significantly; Examines changes in people,
information, equipment, etc. which may have
I contributed to the change in performance
Barrier Analysis Focuses on what controls are in place to prevent or
detect problems and failures
Management and Oversight Use of a tree diagram to examine what occurred and
and Risk Free Ana lysis why it might have occurred
Kepner-Trgoe Problem Solving Four phases of problem solving: Situation analysis;
& Decision Making Problem analysis; Solution analysis, and Potential
problem analysis
Most healthcare organizations are utilizing the RCA mainly after an adverse event occurs, and
occasionally when there is a near miss. The RCA process should be used every time there is a sentinel
event, without exception. In some organizations, an RCA is required when every event, such as the
development of a pressure ulcer, is identified. The immediate analysis of the situation can result in
changes to the systems involved before the event occurs again. Other organizations use the RCA for
every near miss identified. The tool is not designed to be used before such an event occurs. In those
situations, the organization would use the FMEA,which is the next topic in this chapter.
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The RCA uses the '5 Whys' approach to identifying the root cause. With this approach, the team asks
'Why' five successive times, to systematically drill down to the real root cause. There may be times
when less than 5 Whys are needed and other times when more are needed to identify the root
cause(s). There may be more than one root cause . (Remember the Swiss cheese model discussed
previously in this chapter) . In utilizing the 5 Whys, it is important not to leave any loose ends. If there is
more than one answer to a Why question, the team must continue to drill down on both of those
answers. The time to stop asking Why is clear, when you have identified a process, policy, or person as
the root cause (Vidyasgar, 2015).
The root cause analysis should begin as soon as possible after the event occurs and is reported. It is
important to have all involved either be interviewed individually or to write what happened from their
point of view . This must be done as close to the event occurrence as possible. The longer the delay to
this first step, the more detail will be lost from the participants' memory. Typically, a flow chart of
what happened can be constructed with the information provided by these interviews/reports. The
emphasis should be placed on identifying what happened, with less intent on who made the error.
The Joint Commission (TJC) provides a RCA tool on their website . This is a very comprehensive tool and
it can be used in all healthcare settings, whether or not the setting is TJC accredited. The tool is divided
into three parts: the incident itself, facility wide contributing factors, and the action plan based on the
root causes. In the first part, the incident itself, the tool provides the areas of human factors,
equipment factors, controllable environmental factors, uncontrollable external factures, and other
factors for evaluation. Information needs to be gathered from prior to the event, as well as what
happened during the event. In this part the information obtained from those involved in the incident
should be used in the analysis of contributing factors. Part two, facility wide contributing factors,
includes information from the entire organization which may have contributed to the event occurring,
and which if not changed, could happen elsewhere in the facility . The areas examined in this part of
the tool include human resources/staffing issues, information management/communication issues,
environmental management issues, technology issues, and leadership issues . Leadership issues consist
of corporate culture/risk reduction, encouragement of communication and clear communication of
priorities. The third part, the action plan, defines the actions to be taken based on each root cause
identified. The action plan must specify time frames and who is responsible for each part of the plan.
The key here is the action must be implemented, have follow-up and assurances to compliance and
sustainment occurring.
A couple of actual examples may help clarify these parts of the evaluation . The first example is a
hospital with an outpatient Dialysis department in the hospital. A chronic patient receiving dialysis
asked to be disconnected to go to the restroom. The patient returned to their bed and when the nurse
came to reattach the patient to the dialysis machine, she found the patient with no pulse and not
breathing. CPR was started and a Cold Blue was called. This is where it all started to go wrong. The
crash cart in the department did not have a bed board attached so compressions were being done on
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PATIENT SAFETY
the bed rather than a hard surface. The suction equipment was also not with the crash cart. The nurses
in the unit had never had an actual Code Blue before and were not familiar with the contents of the
crash cart. The Code Blue team were not aware of where the department was now located since it had
recently moved (Part 1). When the hospita l wide factors were examined (Part 2), it was found there
never had been Code Blue drills conducted throughout the faci lity, and especially in the outpatient
services area. It was identified there were environmental issues of moving the patient out of the
Dialysis unit and through the hospital. It was also identified the new locations of moved units were not
communicated effectively to those on the Code Blue team. All of these finding could be the root
causes of why this event occurred.
In another healthcare organization, the individual who was responsible for conducting the RCAs and
assuring the action plans we re implemented and sustained left the organization for other
employment. The organization chose not to replace the position but to assign the duties elsewhere
within the organization. However, this role was never assigned to another individual. As a result, the
organization realized about 18 months later that no one was completing the RCAs and/or
implementing the action plans. As a result, over 20 incomplete RCAs were sitting in a file cabinet . Upon
examination, one of the early RCAs concerned a patient who fell and had a head injury. An action plan
was developed, but it was never implemented. As a result, in the rest of the RCAs were two patient
falls with injury. These may have been prevented, or at least occurred without injury if the action plan
had been implemented house wide .
The National Patient Safety Foundation (NPSF, 2015) recently released their new recommendations for
conduct ing a RCA. This document is called Root Cause Analysis and Action, or RCA2 (RCA squared)
which emphasizes the actions taken once the root cause has been identified. This new model can be
utiiized to prioritize events, hazards and vulnerabilities in the systems of care. If actions resu!ting from
the RCA are not implemented, then change cannot occur and the adverse event will likely occur again.
This document can be found on the National Quality Forum (NQF) website listed in the website list at
the end of this chapter.
!Failure Mode Effectiveness Analysis (FMEA)I
The Failure Mode Effectiveness Analysis is a tool designed to proactively and systematically evaluate a
process to determine where and how it might fail, the effects of those failures, and to identify the
portion of the process the most in need of change. Once the areas are identified, an action plan can be
developed and implemented to prevent the failures from occurring or to reduce the effects should an
event occur (FMEA, 2004). One of the main differences between the FMEA and the RCA is the FMEA is
proactive (before an adverse event occurs) and the RCA is reactive (after an adverse event occurs). The
steps in the FMEA are easy to do, but sometimes more difficult to understand when first utilized
(FMEA, 2004) .
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PATIENT SAFETY
Step 1 is to identify a process to evaluate with FMEA. If the team is utilizing a FMEA for the first time, it
is best to choose a process without a lot of sub-processes. For example, medication administration has
several processes including ordering, dispensing and administering the medication. As a novice to the
FMEA, the team may want to only examine the administration portion of the overall process. When
the members of the team have experience with the FMEA when the more complicated processes can
be examined .
Step 2 entails establishing an interdisciplinary team. The team should include everyone involved in the
process being studied. Some of the members of the team can participate only when their portion of
the process is being examined. For instance, continu ing with the medication example, when discussing
how a medication is delivered from the Pharmacy to the nursing unit, it is important the transporters
are involved in the discussion.
Step 3 consists of the team members developing a flowchart of all the steps in the process to
be studied (FMEA, 2004). Every step in the process should be numbered from top to bottom, from 1to
whatever number of step there are in the process. Once the process is flowcharted, the team needs to
come to a consensus about the steps and their numbering. At this point, the team should begin using a
table such as Figure 3 to record the information in the rest of the steps. The IHI has an interactive FMEA
tool available for use instead of Figure 3 for this step onward, which will simplify the process for the
team.
Step 4 the team will list all possible 'failure modes'. Failure mode is defined as anything that could go
wrong, including items minor and/or rarely occur. Once this is completed, each failure mode should be
examined to identify what would cause each failure mode to occur.
Step 5 is where the team will determine how likely it is the occurrence will occur, how likely it is the
failure would be detected, and how severe the failure would be (FMEA, 2004). The resulting numbers
of these rankings is called the Risk Priority Number, or RPN. For occurrence, the team will assign a
score of 1to 10, with 1 meaning "very unlikely to occur" and 10 meaning "very likely to occur". For
detection, the team will assign a score of 1to 10, with 1meaning "very likely to be detected", and 10
meaning "very unlikely to be detected" . For severity, the team will assign a score of 1to 10, with 1
meaning "very unlikely that harm will occur", and 10 meaning "very likely that harm will occur" .
In Step 6, the RPNs for each failure mode are multiplied together . The failure modes with the highest
numbers are the ones the team should begin to work on improving first (see Figure 3).
Step 7 entails utilizing the RPNs for each of the high priority failure modes to develop an action plan
for improvement (FMEA, 2004). To do this, the team members look at the scores (RPNs) for the
occurrence, detection, and severity of each failure and develop the action plan from there. The team
should analyze each potential cha nge to determine how much it might change the RPN if it were
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PATIENT SAFETY
implemented. Then a goal for improvement should be set and monitored to see if the goal is met. For
example, the team may determine there should be a decrease of 25% of the baseline RPN total for one
of the failure modes identified.
Figure 3: FMEA Calculation Table
wrote me 1cation atient cou ave a

for wrong patient reaction to the
to severe
e 1cation
administered, but
should have been 2
pills so med not as
C:!ffective
rong me
administered
medication from little
to severe
X X
As with many of the tools we utilize in healthcare, the FMEA was used originally in industry. The FMEA
has been adapted by the Veterans Administration to a version entitled Healthcare Failure Mode
Effectiveness Analysis (HFMEA), which they felt was a better fit for healthcare (VA, 2015). This model
streamlines the hazard analysis steps in the FMEA with the use of a decision tree, and with a hazard
score rather than a risk priority number. Table 12 represents a comparison of the FMEA and the
HFMEA.
Tab!e 12: Comparison of FMEA and HFMEA Steps

Comparison of FMEA and HFMEA Steps
FMEA HFMEA
Identify a process to evaluate Identify a process to evaluate
Establish a multidisciplinary team Establish a multidisciplinary team
Flowchart of all the steps in the process Flowchart of all the steps in the
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PATIENT SAFETY
process
List all possible 'failure modes' List all possible 'failure modes'
Determine and rate occurrence, detection, Determine severity rating and
and severity probability rating from separate tables
Multiply RPNs for each failure mode Identify hazard score from hazard
score matrix
Develop action plan Decision: continue or stop based on
hazard score and dec ision tree
Develop action plan
Patient Safety Tools & Resources
There are many patient safety tools and resources to be utilized to help build and maintain a Patient
Safety program. Several of these tools w ill be discussed here, but it is impossible to discuss all the sites
available to help organizations improve patient safety .
Josie King Foundation
The Josie King Foundation was founded by a mother following the death of her 18 month old daughter.
The child, Josie King, was admitted to a hospital with first and second degree burns from a hot bath.
She healed from the burns and was getting ready to go home. Instead, she died from dehydration and
a wrongly administered narcotic medication (IHI - Josie, 2015).
The Josie King Foundation is a non-profit organization whose mission is to prevent patients from dying
or being harmed by medical errors (Josie, 2012). This foundation has programs and resources to tell
Josie's story and educate healthcare workers, community members, patients, families, and others
about patient safety. One very effective resource is a video of Josie's mother telling the story of Josie's
care and her subsequent death. For more on this Foundation, go to the website list at the end of this
chapter.
Institute for Healthcare Improvement - Open School
The Institute for Healthcare Improvement (IHI) developed the Open School to provide education to
healthcare professionals interested in quality, patient safety, and other related topics (IHI-Open,
2017). Currently there are 253,725 students and residents registered on IHI.erg and 244,710 students
and residents have completed an IHI Open School online course. Almost 50,000 students and residents
have earned the basic Certificate of Completion by completing online courses in Improvement
Capability, Patient Safety, Leadership, Person-and Family-Centered Care and Quality, Cost and Value
modules. Participants in the Open School can also earn continuing education contact hours for
completing the modules. The courses are free to students, residents, and professors. All others are
charged a modest annual subscription. The Open School also provides a free library of activities the
healthcare professional can use to educate others about the covered topics. Currently, the available
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PATIENT SAFETY
Open School courses are listed in Table 13. To learn more about the IHI Open School, go to we bsite list
at the end of this chapter.
Table 13: IHI Open School Available Courses

IHI Open School Available Courses
Course # of Modules in Course
Patient SafP.ty 9 modules
Improvement Capability 8 modules
Quality, Cost, and Value 2 modules
Person- and Family-Centered Care 3 modules
Triple Aim for Populations 2 modules
Leadership 1module
Graduate Medical Education 7 modules
TeamSTEPPS
TeamSTEPPS is a teamwork system developed by the Agency for Healthcare and Quality (AHRQ) to
help healthcare teams increase patient safety and make quality improvements. TeamSTEPPS has been
described in Chapter 3 Performance and Process Improvement. The Crew Resource Management
system is frequently utilized in combination with TeamSTEPPS.
Crew Resource Management
Crew Resource Management (CRivij is defined as a management system which makes optimum use of all
available human factor and other resources to promote safety and enhance the efficiency. Kanki,
Helmreich, Anca, (2010) has been used to improve the operations of flight crews since a 1979 NASA
workshop. It is used primarily for improving aviation safety. CRM focuses on interpersonal
communication, leadership, and decision making in the cockpit, which were identified as the most
common factors leading to errors. In healthcare, like aviation, human error can cause devastating
results.
CRM is a team training program, emphasizing the role human factors play in high-stress, high- risk
environments. Safety, efficiency, and morale are considered to be the three primary outcomes of
effective crew management. CRM is not as concerned about the technical knowledge and skills of the
individual, as with the areas of cognitive and interpersonal skills needed to manage within a complex,
critical environment such as healthcare .
In CRM, cognitive skills are the mental processes used for gaining and maintaining situational
awareness, for solving problems and for making decisions . Interpersonal skills are considered the
communication and behavioral activities associated with teamwork. It has been found the
communication and behavioral activities often overlap with each other, and with the required
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PATIENT SAFETY
technical skills. Furthermore, they relate to single individuals and groups of individuals, which
invariably need to interface with others in the healthcare arena. If you would like more information
concerning Crew Resource Management, there is a tutorial available (7 modules) on the Crew
Resource Management website listed in the website list at the end of this chapter
Comprehensive Unit-based Safety Program (CUSP)
The Comprehensive Unit-based Safety Program (CUSP) is a part of the AHRQ's Healthcare-Associated
Infections Program focusing on generating evidence for the development and implementation of
interventions to reduce healthcare associated infections (CUSP, 2017). The CUSP is a combination of
teamwork, communications, and techniques to improve safety culture, and uses a checklist of proven
practices. CUSP was first utilized to reduce central line-associated bloodstream infections, but can be
used with any safety problem.
AHRQ has developed a Toolkit updated in 2017, for organizations to use in learning how to implement
CUSP, and has numerous other resources to go along with training (CUSP, 2017). The CUSP is designed
to be the foundation for physicians, nurses, and others to work effectively as a team. The Toolkit
teaches participants how to combine clinical best practices and the science of safety. It is modular
based and each module includes faci litator notes (proposed script), slides, videos and tools. When first
learning the CUSP model, the new users complete six online modules to learn the core principles. After
this training, the team can use the AHRQ tools specifically designed to apply the CUSP framework to
decrease healthcare-associated infections . More information about the CUSP system can be obtained
from their website, which is listed at the end of this chapter.
Centers for Medicare and Medicaid - Partnership for Patients: Better Care, Lower Costs
The Partnership for Patients: Better Care, Lower Costs was launched in April 2011 by the CMS
Innovation Center and the Department of Health and Human Services (HHS) (CMS-Partnership, n.d.). It
is a public-private partnership of 3,700 hospitals to make healthcare safer, more reliable and less
costly. The Partnership currently provides resources regarding hospital-acquired conditions, healthcare-
associated infections and hospital leadership and organizational culture. These may be obtained from the
website list at the end of this chapter.
The Joint Commission - Sentinel Event Alerts, and Quick Safety Issues
The Joint Commission (TJC) provides Sentinel Event Alerts, Quick Safety Issues, and other information
and resources, such as the Speak Up campaign on their website (TJC-Sentinel, 2017). Anyone can
subscribe to receive the Sentinel Event Alerts via email when a new alert is issued. They are free to all
whether or not the organization is accredited by TJC. Each organization is encouraged to review all of
the Sentinel Event Alerts and to review their own organization to determine if the event could happen
there. An FMEA may be appropriate to assist with this risk assessment .
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The Joint Commission Center for Transforming Healthcare
Established in 2008, the Center for Transforming Healthcare works with leading hospitals and health
systems, using a systematic approach, to analyze care breakdowns, discover underlying causes, and
develop targeted solutions to complex problems (CFTH, 2015). The ultimate goal is to consistently
provide quality healthcare in high reliable organizations. The Center is utilizing Robust Process
Improvement (RPI®) tools such as Six Sigma, lean, and change management tools. At the time of this
writing, the Center's initiatives are geared towards hand hygiene, hand-off communications, safe
surgery, surgical site infections, heart failure hospitalizations, safety culture, falls, sepsis, insulin safety,
and C.diff infections. There are currently 36 healthcare organizations/systems working on various
aspects of these initiatives. The results of these initiatives are available as Targeted Solutions Tool®,
which are available to Joint Commission accredited organizations .
Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is a non-profit organization formed 20 years ago to
focus on preventing medication errors (ISMP, 2017). Through the work of ISMP, there have been
changes in clinical practice, drug labeling and packaging, public policy, and in many more areas. The
ISMP provides a voluntary national error reporting program and is also a Patient Safety Organization
(PSO) in order to learn about the causes of medication and vaccine errors.
ISMP has many resources available to assist healthcare practitioners to prevent medication errors
(ISM P, 2017). It has five medication safety newsletters for healthcare practitioners and consumers .The
ISMP Nurse Advisor ERR® is published monthly providing nurses with detailed error reports, checklists,
error reduction strategies, and more. This newsletter is free to nurses. The ISMP also publishes two
ISMP Medication Safety Alerts®; one for acute care and one for community/ambulatory care. The
remaining newsletters include an ISMP Long-Term Care Advise ERR® and a Safe Medication®
newsletter. In addition to the newsletters, ISMP has medication safety tools and resources, webinars,
guidelines, FDA Medication Safety Alerts, and much more. All these resources can be found at the
ISMP website found in the website list at the end ofthis chapter .
!Agency for Healthcare Research and Quality - Patient Safety Netl
The Agency for Healthcare Research and Quality (AHRQ) has developed a section on its webs ite
focused solely on patient safety information. The web -based resource is called the Patient Safety Net
(PSNet) and contains the latest news and resources on patient safety (PSNet, 2017). The topics are
retrieved from other sections of AHRQ, for easy access in one location. There are a iso resources
provided by other organizations .
There are two main sections within this website (PSNet, 2017). The first one is the AHRQ PSNet
Collection and it is comprised of resources pertaining to the patient safety community, based on set
criteria. The resources must meet these criteria to be included. Resources consist of literature,
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PATIENT SAFETY
research, tools, and websites. The second section is the AHRQ PSNet Classics Selection, which contains
review articles, empirical studies, reports and books with relevance to the patient safety arena. There
are established criteria for this collection also. For more information concerning PSNet, go to the
The Veterans Administration National Center for Patent Safety
The Veterans Health Administration (see website list at the end of this chapter) has made all of their
resources available to the public: TIPS newsletter, Patient Safety Handbook, HFMEA, RCA, external
patient safety reporting system.
Pennsylvania Patient Safety Authority
The Pennsylvania Patient Safety Authority (PPSA) was developed in 2002 and is one of the oldest state
data repositories for collection of patient safety data (PPSA, 2017). The PPSA's job is to reduce and
eliminate medical errors by identifying problems and recommending solutions. This charge is related
to hospitals, ambulatory surgery facilities, nursing homes, birthing centers, and certain abortion
facilities. The PPSA is a non-regulatory and non-punitive agency.
In addition to the collection and analysis of patient safety data, the PPSA develops and implements
tools to assist facilities in the reduction of medical errors (PPSA, 2017). On their website, the PPSA
publishes Patient Safety Advisorys, patient and consumer tips, news and information, and a long list of
patient safety tools. See the website list at the end of this chapter to get more information. Recent
reviews and analyses include Near-Miss Event Analysis Enhances the Barcode Medication
Administration Process, Preparing for Unplanned Admissions to the NICU, Medication Errors in
Outpatient Hematology and Oncology Clinics, and Warming Blankets and Patient Harm (PPSA, 2017).
WHAT REMAINS LEFT FOR HEALTHCARE TO DO?
It is obvious there is still a lot to be done to increase patient safety and reduce medical errors. There is
'
no one set of actions that will work for everyone . Utilization of the resources above is a starting point,
but each organization must determine what it needs to move forward. The Quality Professional and
the Patient Safety Officer are two key individuals who can steer the organization in the direction of a
patient safety culture, but they cannot do it alone. The leadership is critical. It must set the strategic
goals and initiatives to integr.:itc p.:itient sa fety as an important part of the culture of the organization.
It is a long road, but it can be traveled, with new paths to be discovered along the way .
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REFERENCES
PATIENT SAFETY
AHRQ (2013). National Healthcare Quality Report, 2013 . Agency for Healthcare Research and Quality.
Retrieved from http://www .ahrq.gov/research/findings/nhqrdr/nhqr13/chap4.html
AHRQ - Assessment (2015). Surveys on patient safety culture™. Agency for Healthcare Research and
Quality. Retrieved from http://www.ahrq.gov/professionals/quality-patient-
safetyIpatientsafetycu lture/
AHRQ - CPOE (2017). Computerized Provider Order Entry. Agency for Healthcare Research and Quality.
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WEBSITES
PATIENT SAFETY
https://archive .ahrq.gov/news/newsroom/press-
AHRQ's Patient Safety Practices
releases/2013/ptsafetypr .html
http://www.qualityindicators.ahrq.gov/Moduies/psi_resources
AHRQ's Patient Safety Indicators
.aspx
AHRQ's PSNet https://psnet.ahrq.gov/
Center for Transforming
www .centerfortransforminghealthcare.org
Healthcare
CMS - The Partnership for
http://partnershipforpatients.cms.gov/
Patients: Better Care, Lower Cost
https://www.ems.gov/Regulations-and-
CPOE - Stage 1 Guidance/Legislation/EHRlncentivePrograms/downloads/l _CP
OE_for_Medic ation_Orders.pdf
Crew Resource Management http://www.crewresourcemanagement.net/
http://www.ahrq.gov/professionals/ed ucation/curricuIum-
CUSP
tools/ cusptoolkit/index.htm I
https://www.ecri.org/com ponents/AlertsTracker /Pages/defa uI
ECRI Institute Alerts Tracker
t.aspx
ECRl's Top Ten Patient Safety https://www.ec ri.org/Pages/To p-10-Patie nt-Safety-
Concerns List Concerns.aspx
ECRl's Top Ten Technology
https://www.ecri.org/Pages/201 8-Hazards.aspx
Hazards List
FMEA Interactive Tool http://app.ihi.org/Workspace/tools/fmea
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http://www.c ms.gov/Medicare/Medicare-Fee-fo r-Service-
Hospital Acquired Conditions
Payment/Hospita IAcqCond/Hospita 1-Acq uired_Conditions. htmI
IHI Governance Leadership of
http://www.ihi.org/Topics/GovernanceLeadership/Pages/defa
Safety and Improvement White
ult.aspx
Paper
IHI Leaders in Patient Safety http://www.ih i.org/resources/Pages/1 HIWhitePapers/Leadersh
White Paper ipGuidetoPatientSafetyWhitePaper.aspx
http://www.ihi .org/education/ihiopenschool/Pages/default.as
IHI Open School
px
IHI Patient Safety http://www.ihi.org/Topi cs/PatientSafety/Pages/ default.aspx
ISMP Biweekly Newsletter http://www.ismp.org/NEWSLETTERS/acutecare/default.aspx
ISMP Resources http://www.ismp.org/tools/
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PATIENT SAFETY
Joint Commission Center for

www.centerfortransfo rminghealthcare .org
Transforming Healthcare
Josie King Foundation http://josieking.org/
httQS:LLwww.outco me-eng.comLdavid-ma rx-introduces-just
Just Culture
culture/
http://www .ahrq.govIresearch/findings/ evidenee-based-
Making Health Care Safer II
reports/services/ qu<1 Iity/ptsafetys um.htmI
Patient Safety Organization
http://www .pso.ahrq.gov/listed
Listings
Pennsylvania Patient Safety
http://patientsafetya uthority.org/Pages/default.aspx
Authority
'
RCA2 http://www.npsf.org/page/rca2
Root Cause Analysis: The Core of
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Action
http://www.jointcomm ission.org/topics/spea k_ up_campaigns.
Speak Up Campaign
aspx
http://patientsafetyed .duhs.duke .edu/module_e/sw iss_chees
Swiss Cheese Model
e.html
TeamSTEPPS http://teamstepps.ahrq.gov/about-2cl _ 3.htm
The Joint Commission http://www .jo intcommission.org
The Joint Commission National http://www .jointcommi ssion.org/standards_ information/npsg
Patient Safety Goals s.aspx
The Joint Commission RCA Tool http://www .joi ntcommission.org/sentinel_ event.aspx
http://www.nationalacademies.org/hmd/-/media/Files/Repor
t%20Files/1999/To-Err-is-
To Err is Human
Human/To%20Err%20is%20Human%20 1999%20%20report%2
Obrief.pdf
Top 10 Health Technology
http://www.ec ri.org/Pages/2015-Hazards .aspx
Hazards for 2015
Top 10 Patient Safety Concerns
http://www.ec ri.org/PatientSa fetyToplO
for Healthcare Organizat ions
VA National Center for Patient
http://www.patientsafety .va .gov
Safety
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WalkRound Database
database.sht ml
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WHO - Multi-Professional Patient http://www.who.int/patientsafety/educa tion/curriculum/Cur ri
Safety Curriculum Guide culum_Tools/en/
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REGULATORY, ACCREDITATION, AND EXTERNAL RECOGNITION
CHAPTER 6
Jacque Cole, Susan Mellott, Sarah Yelton, Michelle Franklin

Organizational Leadership
requirements (e.g., CMS, HIPPA, OSHA, PPACA)
1.B.2 Identify appropriate accreditation, certification, and recognition options (e.g.,
AAAHC, CARF, DNV GL, ISO, NCQA, TJC, Baldrige, Magnet)
1.B.3 Assist with survey or accreditation readiness
1.B.4.c Participate in the process for evaluating compliance with internal and external
requirements for: Documentation
1.B.S Facilitate communication with accrediting and regulatory bodies
1.C.4 Develop/provide survey preparation training (e.g., accreditation, licensure, or
equivalent)
Words and titles of sections referring to task statements from the CPHQ Exam Content Outline are
indicated throughout the Handbook with a ox around the tex.
All healthcare organizations, regardless of setting, are subject to constant scrutiny. The organization
striving for high quality seeks to continuously improve their care and services, aiming for full
compliance with state law, federal law, interpretive regulations (see Chapter 7 Legislation Initiatives),
and volunteers for accreditation under the appropriate agency . In addition, some healthcare
organizations increasingly are looking at other industry recognized achievements and awards,
including, but not limited to: 150 9001 registration, the Baldrige Performance Excellence Program, and
the ANCC Magnet Recognition Program or Pathway to Excellence.
ACCREDITATION CONCEPTS
Accreditation is a voluntary survey process used by various non-governmental, independent, external

agencies to assess the extent of a healthcare organization's compliance with applicable pre-established
performance standards set by the agency. Accreditation involves both self-assessment and external
peer review, focusing on organizational, not individual practitioner, performance . Many programs now
include comparative performance measurement with like organizations, and the results are publicly
reported on the agency's website .
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The purpose of accreditation is to improve the systems and processes of care and, in so doing, improve
patient outcomes. The healthcare organization must be prepared to provide adequate evidence of its
compliance with each standard applicable to its operations. Accreditation surveys are common in the
U.S. and they are increasing internationally .
The Centers for Medicare and Medicaid Services (CMS) is the United States of America's federal
agency operating the Medicare program for elderly and disablP.ci indiv iduals, as well as the other
programs we administer including: Medicaid, the Children's Health Insurance Program (CHIP), and the
Health Insurance Marketplace. CMS is under the Department of Health and Human Services (HHS) and
receives its oversight from the Office of the Inspector General (OIG). In addition, CMS works with
states to manage the Medicaid program. Among CMS's goals is to ensure beneficiaries in these
programs receive high-quality healthcare (CMS, 2017).
The Medicare Conditions of Participation (CoPs) originated in 1966, and underwent major revisions in
1986, to serve as the foundation for accreditation. The CoPs were first developed using the Avedis
Donabedian theory which notes a good structure (e.g. safe, sanitary building and qualified personnel)
would increase the likelihood of good processes for patient care and ultimately lead to good outcomes
for the patient. The current CoPs and the CMS survey process focuses on prescribed structural
elements, patient-focused performance, and functions of the organization from a federal compliance
perspective. Table 1 lists the common threads, in no particular order, woven through the CMS
regulations for different types of healthcare organizations.
Table 1:CMS Common Accreditation Threads

CMS Common Accreditation Threads
• Patient rights (advance directives, complaints and grievances, informed consent,
dignity, support person,etc.)
• Preventing healthcare-associated conditions (falls, blood stream infection from vascular
catheters, urinary tract infections from bladder catheters)
• Pain control
• Safe environment of care
• Care delivery (restraining of patients, sedation, waived testing, peri-operative care)
• Quality improvement
• Leadership involvement
• Disaster and emergency preparedness
• Individualized care planning (updating the plan as the patient's condition changes)
• Individualized education for the patient and caregiver
• Medication safety (medication reconciliation, high risk medication safety)
• Qualified care givers (verifying licensure for practitioners as well as ongoing continuing
education and competency for licensed and unlicensed personnel)
424
• Preventive care (immunizations)

• Coordination of care (proper discharge planning, coordinating special needs,
commun ication between care providers, timely sharing of medical records, etc.)
• Preventing overuse, underuse, and misuse of health care (i.e.: radiation safety,
unneeded repeated tests, fraud, waste, abuse (FWA)
• Private and secure protected health and individually identified information
In the U.S., healthcare organizations must be certified as complying with the CMS Conditions of
Participation . This is necessary in order to receive approval for payment for Medicare and Medicaid
patients. In addition, many insurance carriers and self-insured employers, as well as many managed
care plans contracting for healthcare services, require accreditation for providers to treat their
patients. Those insurers requiring accreditation as a contracting issue may accept agencies other than
The Joint Commission (TJC), Det Norske Veritus GL (DNV), or the National Committee for Quality
Assurance (NCQA), depending on the type of organization (e.g., osteopathic hospital, rehabilitation
hospital, ambulatory surgery center, medical group, managed care or home care).
In addition to the accreditation of provider organizations and health plans, within the last several
years, external agencies have developed accreditation or certification standards for specific programs
(e.g. disease management or ca re management, and certain functions, such as credentialing).
!Deemed Status!
For a healthcare organization to participate in and receive payment from the CMS or Healthcare
Insurance Marketplace programs, it must be certified as complying with the standards, called
Conditions of Participation, set forth in federal regulations . This certification is usually based on an
onsite survey conducted by a state agency on behalf of CMS or the CMS regional office . However, if a
national accrediting organization enforces standards meeting the federal Conditions of Participation,
CMS may grant the organization "deeming" authority to conduct these types of surveys and "deem"
each subsequent ly accredited health care organization as meeting the CMS certif ication requirements.
The health care organization would have "deemed status" and would not be subject to a routine,
separate survey and certification process conducted by the state or regional CMS office. If an
organization selects the deemed status option and their accreditation survey is successful, the CMS
approved accreditation agency then recommends to CMS the organization should receive certification.
CMS makes the final determination on whether or not the organization will be Medicare certified. CMS
retains the authority to conduct random validation surveys and complaint investigations for certified
organizations. CMS has planned for 5% of the hospitals and organizations receiving federal
reimbursement for healthcare will still require validation by CMS after an onsite accreditation survey
by a deemed agency. This number has increased since 2014 (ASHE, n.d.).
425
Subsequent and ongoing legislation and regulations define requirements for accrediting agencies
wishing to grant deemed status to accredited organizations. The regulations provide a mechanism by
which accrediting agencies may apply to become authorized to confer deemed status. The accrediting
agencies release survey information to CMS after each survey if deemed status is granted. CMS may
release information from accreditation surveys if applicable to an enforcement action; otherwise, CMS
keeps survey reports confidential.
All accreditation programs in the U.S. and internationally are "voluntary," as they are not a condition
of licensure to operate a hospital or other healthcare organizations . Motivations to participate in
accreditation include a true commitment to improvement in quality of patient care and services, and
the willingness to be held accountable and be compared to like organizations . Other motivations
include: to enhance confidence of the public/consumers, as a condition of payment for U.S. federal
programs, to undergo a Conditions of Participation survey, as a requirement for contracting to provide
services and receive reimbursement (most insurers, health plans, self-insured employers), and/or as a
requirement for residency programs in academic medical centers (ASHE, n.d.).
!Healthcare Licensure in the u.s.j

Licensure is the mandatory act of granting and receiving a license to provide healthcare services in a
state in the United States. A governmental regulatory entity, usually the state Department of Health
Services or Division of Insurance, grants the license for the healthcare entity. Based on an onsite
survey, sometimes requiring several visits, and compliance with all applicable state and federal laws
and regulations, the agency grants and monitors the license. Corporate compliance plans can be
important tools in maintaining licensure.
State and federal laws determine the type of facilities mandated to be licensed to operate. Typically,
the following types of healthcare facilities are licensed : Acute care hospitals (medical and psychiatric),
long-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, ambulatory surgery
centers, skilled and subacute care, long term care, home care, hospice care, resident behavioral,
mental retardation/developmentally disabled healthcare, rural health clinics, and assisted living
facilities. The license specifies the number and type of beds permitted: acute, skilled, subacute, long-
term, etc. If used for other types of patients or care, the organization must be able to convert all beds
to the appropriate licensed number within 24 hours.
Most Managed Care Organizations (MCOs) are licensed or certified by their state Department of
Corporat ions, Department of Insurance, or Department of Managed Care rather than the Department
of Health Services. MCOs cannot contract with unlicensed providers or practitioners if a license is
required.
Financial incentives in contracts (e.g., end-of-year profit and/or risk sharing, capitated payment,
discounted charges or daily rates, controlled access) are beginning to impact the "same level of care"
426
standard in acute facilities . There are external pressures to use acute beds as holding beds for patients
who are waiting to "transition" to skilled, subacute, or long-term care. There are also internal
pressures to move less stable patients to lower levels of care. Use of beds and staffing in patterns
noncompliant with the license will place the organization at risk for losing their license.
Compliance with Standards
Compliance with standards has become two-pronged with the advent of performance measures, in
addition to the traditional written standards, as ways to measure accreditation appropriateness. The
current prescribed, approved, and accepted, written standards in healthcare accred itation and
certification have become or are becoming more practical in the sense of assessing actual
performance ("performance-based") rather than capacity to perform. They also focus on processes
and outcomes, not simply structure, patient care issues related to quality and safety, and the
organization's efforts to manage patient care and to support process improvements resulting in good
patient outcomes . Most agencies will accredit an organization if it is in "substantial" or "full"
compliance with the standards overall, even if not with each individual standard.
The integration of comparative performance measure data into the accreditation process (e.g., NCQA's
HEDIS Joint Commission's Core Measures, OASIS, Minimum Data Set (MDS), etc.) adds another set of
0
,
standards. The better an organization meets the performance measure expectation compared to peer
organizations, the higher the rating for the related portion of the process.
Achieving compliance with the accreditation/regulatory standards and then maintaining survey
readiness is the goal for healthcare organizations. After all,the regulations are minimum requirements
for quality and safe patient care. Virtually all of them are based on best practices, with the intention of
providing the best possible healthcare for individuals. It can be challenging at times to meet the "letter
of the law" of some regulations and accreditation standards, particularly when dealing with older
buildings, with long established ways of doing things, and with the human factors adding complexity to
care settings. If the organization is accredited or seeking to be, consider readiness a daily organization
wide responsibility, regardless of setting. Survey readiness is not a once every 2-3 year proposition.
Gone are the days when preparations occurred during the 10-12 months prior to the expiration of the
accreditation certificate. For the quality and safety of the patients served, upholding the minimum
standard of care is a daily and year-round endeavor .
If a surveyor finds any condition existing posing a threat (potential or actual) to public or patient health
or safety, the surveyor may notify the chief executive officer of the organization and recommend
denial of accreditation. Any recommendation of denial is reviewed by the accrediting agency before a
final decision is made. The organization is offered an opportunity to discuss a reas of noncompliance, to
submit jdocumentationl to demonstrate compliance or progress, and, with some accrediting agencies,
to request a face-to-face interview or even a "validation" resurvey.
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CCREDITATION SURVEY READINESS\
As you prepare for a survey, determine who will be the main points of contact with the surveyors . The
main points of contact are the condu it for the survey team to work w ith through the preparatory,
onsite and post review activities . Using and limiting yourself to one or two people helps keep
communication in control and organized at all times.
There ore two main avenues for your communicalions: documentation preparation and logistics. If the
communication is related to logistics (dates, time, hotel, and local transportation) more than the
standards, utilizing an administrative assistant can work very well. This relieves the other person,
usually a manager or above, to concentrate on the documentation preparations. Also, the
administra tive assistant can manage the team meeting times and locations; meals during preparations,
onsite and post review activit ies; assisting with copies of the final prepared documentation, etc.
\Preparedness/Continuous Readinessl
W hether preparing for a routine accreditationireguiatory survey or a disease specific certification

survey, the process is basically the same. To begin, the individuals who are coordinating the effort
must be very familiar with the regulatory requirements and elements of performance. Deemed
accrediting agencies make available the standards and rationale to organizations choosing this
method. Online and paper handbooks are available for purchase. The CMS regulations are online for
download. There are seminars and educat ional meetings conducted by va rious organizat ions. Read the
guidelines very carefully and look for time related words such as annual, months, and minutes. The
organization is either in compliance or out of compiiance. For ex ample, The Joint Commission has a
regulation in the Comprehensive Stroke Regulations stipulating the time in minutes to get a patient
from the helipad to the emergency department. When you see such regulations, do not leave things to
chance . Take a timer and actually measure the time it takes, to be sure you are meeting the standard.
The organization is held to the standard, the element of performance, the interpretive statement, the
state code, expectations of expert agencies such as National Fire Protection Agency ( NFPA), and the
policies as set by the local organization. This section contains some practical suggestions and tips on
how to navigate the survey process, which have been developed during actual healthcare surveys.
Most accreditation agencies use one or more of the following mea ns to assess compliance with
applicable standar ds:
e Accred itation/Regulatory Readiness Te;im
• Review of documents demonstrating compliance
• Onsite observations by surveyors
• Verbal information gained by surveyors through interviews
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• Examples of standards implementation
• Review of medical/health records
• Assessment of service/support systems
• I ntegration of performance measure data into scoring
!Delegated Entitie
Of note, if you are an organization which contracts with another organization to cover all or part of
your services, you are still the accountable organization to a regulator. Your contracted entities,
whether they are a delegated service or delegate entity, should be doing readiness activities prior to
your review. As the main organization, you are responsible to review your delegates' activities as if
they were your own departments and you are held accountable to any external regulatory oversight
audit/review. There are some areas which can be deemed. If your contracted entity is accredited by a
recognized accrediting organization you MAY be able to streamline your delegate oversight review.
!Accreditation/Regulato ry Readiness Teaml
Each organization should have an Accreditation/Regulatory Readiness Team or committee to create

and implement a survey preparedness plan. This group is responsible for the implementation and
improvement of processes in terms of existing and new accreditation and regulatory standards. This
team most often consists of key leaders and managers who coordinate and oversee continuous
readiness and survey planning efforts. The team members must have decision-making authority in the
organization . The Quality Council, the administrative council, or a senior leadership survey team
includes key QM/Pl leaders and sponsors/champions. Routine meetings are set to review
environmental rounds, to establish a method of inspecting and following patients and processes
through the care settings, to communicate accrediting agency and regulatory information, and to plan
for dissemination of information. For example, in 2014 The Joint Commission (TJC) issued a new
patient safety goal regarding the use of monitors with alarms . TJC has given organizations two years to
implement this patient safety goal before they will begin to survey it in January 2016. The
Accred itation/Regulatory Team's job is to assure implementation has been completed prior to the
January 2016 deadline.
Specific senior leaders (president, vice presidents, chief nursing officer, and administrative directors)
should be designated to ensure compliance with the standards applicable to the areas for which they
are responsible . In provider organizations, these leaders participate in regularly scheduled (announced
or unannounced) environmental rounds.
The organization also needs to identify a medical/professional staff, Chief Medical Officer, or medical
team of Licensed Independent Practitioner (LIP) leaders who have authority for quality and peer
review and/or are required to participate in the survey process as medical directors, department
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chairs, etc. They review quality, patient safety, utilization, and risk reports related to compliance with
applicable standards.
\Accreditation/Regu latory Readiness Team Activities/Process Improvements\
The Accreditation/Regulatory Readiness Team should establish ongoing interdisciplinary teams (or use
appropriate existing teams) at each site. These teams will be assigned portions of the standards for
which they are responsib le. This is an ongoing effort and not a pre-survey effort to make
improvement s . Each interdisciplinary team will consist of three to five members from clinical and
administrative areas (e.g., senior leadership/leadership council perso1nel, as well as staff responsible
for quality, performance improvement, case management, patient safety, and environment). Each
team meets routinely, such as quarterly, to review compliance with the appropriate
standards/regulations, improvements, and policies. The team members conduct patient and
organizational tracers to identify areas of weakness or areas for improvement related to the standards.
The team leaders and members are well versed in the pertinent standards, operational policies,
procedures, and practices and are able to identify compliance deficiencies. System problems found
during environmental rounds, tracer activities (patient or process), or data tracking linked to standards
should be followed up by the leader responsible for compliance. The administrative team (leadership)
is the most effective in performing periodic walk-around inspections of all settings, departments, and
services, focusing on selected standa rds each time. Provide a grid or log sheet outlining, for each
standard, where/in what form appropriate \documentation\ may be found to prove compliance. This log
will serve the administrative and clinical teams, but also will provide support to each person
participating in the survey. If non-compliance issues arise, decisions can be made on the spot. A good
a lternative or addition to the walk-around is to establish interview/focus groups for each important
function or category of standards and each organization-wide required review process.
System changes often require the work of a quality improvement team over time, unless the problem
involves simply failure to comply with an established clinical pathway, clinical practice guideline,
protocol, or other standard operating procedure. The team will set priorities and recommend solutions
to achieve compliance and provide leadership for implementing recommended solutions.
Communication to organization leadership and appropriate staff concerning compliance is imperative.
\Learning the Regulations\
Once the team members have been identified, the initial steps involve compiling a listing of the
requirements and then performing a gap analysis (self-assessment) to clarify what is in place and what
has yet to be compiled or developed. Next, assign people to help fill the gaps. Using a series of
notebook binders is one way to organize the information and required documents. A neatly organized
and labeled binder (or series of binders) conveys attention to detail and helps the surveyor find all of
the items easily and quickly. Handling of the documents electronically has also been successful.
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External surveyors appreciate receiving information in a succinct and organized manner. Your
organization's ability to achieve this will set the tone for success for the whole survey process.
All through the preparation process, it is wise to build in educational opportunities with leaders,
managers, physicians, staff members, and patients when possible . Maximize teachable moments.
Presenting the material in a variety of ways also helps the learners retain the information and makes it
more interesting. Group meetings and 1:1talks both have their merits. Mock surveys help everyone to
become more familiar with the survey process and be more relaxed and ready when the real survey
occurs. The mock survey also provides the organization with a road map of identified issues to build
action steps for improvement.
If it is planned to have an outside agency conduct a mock survey, it should be scheduled to allow the
maximum time possible for implementation of their recommendations. As much as possible, the mock
survey should incorporate all standards in effect at the time of the actual survey. However, most
organizations do not need to hire a consultant or other group to perform the mock survey . Different
departments in the organization could survey other departments . It is important to not have staff
survey their own department, as a "new set of eyes" will see what the staff would miss. If the
organization is part of a larger healthcare system, then like facilities in the system could be utilized to
survey another facility .
It is also important to have each staff member educated on the rules, regulations and accreditation
standards which are specific to their particular job. Most accreditat ion standards are noting this as an
educational element to be completed. When individual members of the staff area trained, prefera bly
on an annual basis, related to their particular job specific areas, additional training just prior to an
audit/review becomes less daunting.
Oversight agencies want to see you access and evaluate the effectiveness of the training. Education
and Tra ining are areas which can be coordinated with your Human Resources and Education
Departments . They are very good about having tools which can computerize the key elements and
areas needing to be taught with an electronic evaluation at the end of the session . Most education has
been standardized and will need edits as regulations, rules and accreditation standards change.
!Document Preparation\
There are some specific documents surveyors will w ant to see during the visit. The accreditation and
regulatory agencies typically provide Survey Activity Guides listing the spec ific documents . These will
need to be collected prior to the survey. CMS or other oversight agencies also have document lists
noting documents to be available during their visits.
Some healthcare entities organize their documents in an annually updated file box or notebook binder
categorized with labeled dividers. Either way, the goal is to be able to present the documents in an
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organized and timely manner. It is a good practice to have two identical boxes or binders - one to give
to the surveyor for review and the other one to keep in the command center so the organization
survey team sees exactly what the surveyor has been given to review. Note: It is also important the
staff person compiling the documents accesses the most current policies, data, etc. which must be
updated as changes are made. Review of the document box or binder prior to the survey by a senior
leader, manager, or risk manager is necessary to prevent outdated or potentially inappropriate
materials from seeping into the document compilation. Be aware the preparation of documents is an
ongoing process. The ability of the organization to provide the documents immediately to surveyors
upon arrival is a first step in demonstrating your organization's working continual readiness program
to the survey team.
racersl
[
A tracer is a record used to assess the movement of a patient through the health system . From entry
to discharge the record is reviewed for completeness, individualized care planning, pain assessments,
individualized education, patient involvement in goal setting, communication with the care team,
discharge planning, and other components pertinent to the patient. A surgery patient, for example,
would need a signed informed consent form, history and physical, anesthesia evaluation, airway
assessment, time out procedure, and so on. For a patient who entered via the Emergency Department,
a tracer might include assessing the time it took to be seen by a physician, how long it took to be
admitted, and anything else delaying their care. The surveyors will visit the locations where the patient
has traveied through the organization. They will review with staff at the spec ific location what did, or
should have occurred in the specific area of review.
Tracers examining system processes such as medication use and information flow will a!so occur
during the survey process . There should be a concerted effort by the healthcare organization to
examine these processes and others stated in the Survey Guides. Again, there should be tracers
performed moving through the organization as indicated by the process flow of the event.
When conducting mock surveys and tracers, use fresh eyes to look at your organization as if you had
never seen it before. Put yourself in the place of the surveyor . Ask questions of the staff members;
look around the environment. Search the electronic medical record for specific elements . Fine-tune
and focus the training as the time frame for survey draws closer .
\Education of Staff, Leaders, and Practitionersl
The surveyors increasingly want to talk to the staff more so than to managers, but both must be
prepared to answer questions. When making rounds and conducting tracers ask staff to 'show you' the
specific activity, so they know the answers . For example, staff frequently will answer a question about
a resource saying they can find it on the computer; but when put to the test, they cannot actually find
it. If the staff depends on computer super users in the clinical areas to locate information on a routine
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basis, and then ensure you have super users available during the survey process to identify the
location of requested electronic charting.
Using quality tools for communication, such as eight times eight ways and affinity of like items, will
assist in bringing information to the users understandably.
Slide presentations are particularly helpful to teach regulatory compliance information. Hearing and
seeing the information can help the learners retain the key messages . If possible, take steps to attend
a variety of committee meetings in order to share regulatory updates. Increased visibility of the
regulato ry compliance staff can provide the organization with much needed support in their regulatory
readiness activities.
Presenting regulatory compliance information via printed materials allows the reader to refer back to
the document . Newsletters on the subject are available via many sources. A particularly good free
monthly newsletter developed by a vendor containing both CMS and TJC information can be accessed
online through the Patton website listed in the webs ite list at the end of this chapter. Organizations
can also develop their own printed materials. Medical staff and employee newsletters can be
developed and distributed throughout the organization .
Many other educational media are available or can be developed by the organization. While email is
used frequently to send out updates, there is no guarantee emails are even opened. The organization's
electronic education system is a wonderful means of conveying information if the system is used.
Crossword puzzles, fill in the blank. games, and scrabble puzzles are easy to make or can be purchased
from multiple sources. If the education is fun, even if mandated, more individuals will participate.
Cafeteria tables can be used for education by adding tent cards with the patient safety goals or other
such information. Colorful posters can be placed throughout the organization . The key to both the tent
cards and the posters are changed out (using different color paper) on a regular basis to stimulate an
individual to notice what is new.
With a little creative brainstorming, it is easy to find other fun and inexpensive educational ideas. One
hospital chose the theme of a train going down the tracks. Every bit of information sent out in
preparation for the survey had a picture of a train on a track depicting their journey. Another
organization chose a Wizard of Oz theme. As the team members were talking with staff throughout
the organization, they would ask the staff questions. If the staff member got the correct answer, or
could find the correct information in their department/unit, they were awarded with a sticker. The
sticker was placed on a card with a Yellow Brick Road on it (Figure 1). When the card was full of
stickers, the staff member turned the card into the Risk Management office and received a reward.
Once a month, one completed card was drawn for a larger reward (e.g., two movie tickets or a free
meal in the cafeteria) .
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Figure 1:Yellow Brick Road Card
------ ---
! -·
TJC Wizard Lottery
Follow Iha ye.llow
brick road...
Name:
Dept: -- -
·-
· -
-
Phone:---,--,..-,,,--.,---
Multiple Elf\!ri"" may be submiltoo for <tl\'.fe chances ro
wh Please •ubmit '1ll compla!ed cards ro Rls!<. Mgmt.
(x.521;5).
!Regulatory Compliance Leaders Meetings!
Conducting ongoing monthly or bi-monthly regulatory compliance meetings keeps the regulatory
emphasis in the forefront with department leaders as well as sen ior leadership. This approach provides
another layer of staff involvement in the survey preparation process. During the meetings, section
leaders provide a short presentation for the group on a particularly challenging or troub lesome
regulation and lead a discussion on how to approach adherence to the requirement. The results of the
above listed activities can also be discussed at these meetings.
!Preparations for the Days of Survey!
Preparing the governing board, senior leaders, survey team, physicians, and staff members for the
actual survey day activities is very important. Before the survey, establish the following:
• Who is on the core survey team?
• Compile the requested documents.
• Who is to be contacted when the surveyors arrive? Compile a list with cell phone
numbers, pagers, etc.
• Where will the command center be located?
• Where will the surveyor's home room be located? There must be computer access in
this room, and assure the door can be locked for security purposes.
• Who will tour with the surveyor?
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• Who will scribe and take notes during the survey?
• Who will be readily available in the command center?
• What supplies w ill be needed in the command center?
• Consider having a rolling computer case outfitted ahead of time with office supplies,
laptop, power cord, flip chart markers, self-adhesive flip chart pages, organization
directory, etc.
• For the governing board and members of expected interviews, prepare example
proceedings such as questions and answers. Running practice interviews ahead of time
is recommended.
SURVEY PROCESS
The actual survey process will vary with different accreditation agencies, but many of the activities are
similar . Surveys for all accreditation agencies with deemed statuses are unannounced, which is
becoming the industry standard. The number of surveyors is determined by the accrediting
organization, w ith consideration of facility's size, types of patients, and services provided. Most
surveys are conducted at least once every three years, but this is not the standard for all types of
healthcare organizations and accrediting bodies. Information unique to each type of accreditation
program can be found on their websites.
Surveyor Arrival
Any overseeing agency can visit an organization at any time. Any day of the week may be a survey day,
even on the weekends, unless otherwise stated by the agency. A surveyor might visit at any time of
day, even during the night shift . When it becomes known that the surveyor is on site or on the way, it
is important to immediately begin notifying the key members of the survey team and activate the
survey plan.
Surveyors may enter an organization via any entrance . Sometimes they are easy to spot as they will be
in business dress with rolling computer cases wearing lanyards with identification. Ideally, staffs at
information desks are prepared to greet surveyors. The surveyors should be asked to have a seat while
the administration or designated individual is notified, or they can be escorted to the execut ive office. It
is customary for surveyors to have identification for themselves and the organization they represent .
They may also share their business cards with identifying and contact information. There are specific
standards with deemed survey teams to verify the surveyors online by viewing photographs and
background information of the surveyors onsite. If there is any question as to whether the person
claiming to be a surveyor is actually a surveyor, it is best to verify through the agency.
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Notify the senior leaders of the organization right away. In addition, it is common for the senior
leaders to notify the governing board chairman. The governing board members are expected to be
aware of and participate as possible during the survey .
At the time of arrival, there should be an announcement to the organization such as, "We welcome
{accreditation/regulatory agency name} to our facility for their {# of days or type of} survey." This
alerts all the staff and practitioners that there are surveyors in the building. This should be done for
any type of survey/surveyor who is in your building, not just for the major accreditation surveys . If the
organization chooses not to make the overhead announcement, then the staff and physicians need to
be alerted, by some means, that surveyors are in house. Everyone needs to be on his or her best
behavior during a survey, but patient safety processes need to be hard wired into their everyday
practice. Being regulatory compliant needs to be how business is done all the time, whether a surveyor
is watching or not. It is natural for staff and physicians to experience some level of stress having a
surveyor in house. Regardless of the oversight entity, patient care should not be interrupted or unduly
affected by the survey .
Entrance Interview
The surveyor or team will usually want to sit down for a few minutes with the organization's
designated individuals, to go over why they are at the organization (triennial survey, complaint survey,
revisit, disease specific certification, initial survey, etc.) and what the schedule of the day will be. It is
very helpful for the surveyor to have an attendance iist with the names and titles of the attendees so
he/she can refer back to it throughout the survey. The surveyor leads this meeting but usually allows
questions from the group . This meeting is efficient, lasting 15 to 45 minutes, as the surveyor w ill want
to begin the survey process as soon as possible.
A typical schedule for the day at an acute care hospital might include visiting clinica l units, observing
medication administration, watching a time-out in surgery, assessing moderate sedation, reviewing
prepared documents, visiting an outpatient care area, and touring the Emergency Department. A
schedule for the specific type of survey and type of organizat ion being surveyed will be supplied by the
accreditation or regulatory agency. Time is built in for lunch and document review. Typically, the
survey day ends about 4:30 p.m., but this could vary depending on the circumstances surrounding the
visit .
If the survey team is from a state agency or CMS, the expectation is they should not be allowed to
move through the facility without being accompanied by a staff member. There should be a designated
escort for each surveyor to guide them through the faci lity. Deemed agency surveyors and other
accreditors may prefer their surveyors not be accompanied, but the organization has the right to
assign someone as a guide . Ensure the survey team members have a private area for their computer
set up and document review. Provision of information on the closest restrooms and exit doors is
essential.
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Surveyor Work Room
Escort the survey team to their home room for the duration of the survey. The ideal room for a survey
team should be locked (to keep their items safe and protect the confidentiality of their notes), and
conta ins: a telephone, the ability to connect to the internet, a printer connection, and a table large
enough to accommodate several people. Some surveyors prefer to have an empty folder with their
name on it for them to use during the survey . Some healthcare organizations make it a practice to
provide a few basic office supplies and Kleenex in the home room. If only one surveyor is in-house, a
smaller empty office can be used. It is a nice touch to provide creature comforts such as coffee, ice
water, and light refreshments. Keep in mind, CMS employees may not be able to accept food unless it
is being provided for the staff as well.
Command Center
There should be a command center established for the organization's accreditation/regulatory leaders,
similar to what is utilized during a disaster. Bring the rolling computer case with supplies into the
room. Be sure the command center staff has access to the regulations either online or in hard copy.
Get the document boxes or binder housing the prepared survey documents. One or two people are
usually enough to staff the command center. The ideal room is private, quiet, has a computer,
conference phone, wall space for flip chart sheets, multi-person table, and located within or close to
the executive offices . Flip chart sheets on the walls will be used to keep track of any issues identified,
themes of scrutiny, potential citations, surveyor requested items, and the surveyor's positive
comments, suggestions, and best practices.
If the surveyor asks for a form, policy, or procedure, the scribe with the surveyor should contact the
command center to obtain the requested information. This will prevent the surveyor from getting
duplicate information . Sometimes old, retired policies and procedures seem to surface during the
survey. The organization should pay particular attention to assuring the documents given to the
surveyor are the most up-to-date and current copies.
Staff Interviews with the Surveyor
There should be a scribe with the surveyor to note the surveyor's questions, what policies/forms are
received, areas surveyed, staff and physicians addressed, and which patient records are reviewed. In
virtually every survey staff members will be involved in talking with surveyors. The surveyor will ask
caregivers specific questions to assess their care provided, practices, communication, and adherence
to policies. Staff members may ask a surveyor to re-state a question if they do not understand what
the surveyor is asking. Most surveyors are very happy to clarify what they are asking for and try very
hard to put staff members at ease during interviews.
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Patient Interviews with the Surveyor
Another valuable source of information for surveyors comes from the patients and their families. Who
better to interview than someone who is experiencing the care first hand? Because of personal
healthcare information confidentiality, the surveyor will ask permission to speak to the patient. Topics
expected to be addressed during the interview include pain control, communication, medication
reconciliation, and individualized education .
End of the Survey Day
It is typical for the survey team to hold a debriefing meeting at the end of each day or at the beginning
of the next day to discuss how the survey is going. Managers and others should then be informed of
what was found and what was troublesome to the surveyor. This will allow the staff to be more
prepared and obtain needed information for the next day.
In some organizations, a senior leader will send a summary email communication to selected members
of the leadership team at the end of each survey day. This keeps the leadership apprised of the dai!y
findings, helps educate, and provides a means of support and encouragement for the team. Stress
levels are naturally high during the survey process and this is one way to alleviate some of the stress
and maintain connectivity with one another . It also assists with correcting any issues as soon as
possible prior to the survey team's departure. The immediate correction may, in some cases, prevent
additional action plans once the surveyors have left and com leted their reporting.
At the End of the Survey
When the survey has been completed, the surveyor or survey team will hold an exit conference with
the organizatio n's leadership team to review preliminary findings. The CEO is typically asked who
he/she wants at the exit conference . The official findings and citations will be provided in a written
report from the surveying agency in approximately 10 days.
After the exit conference is over and the surveyors leave, a summary of the preliminary findings should
be communicated as appropriate throughout the facility. It is common for a senior leader to send out a
summary email to selected members of the leadership team. In addition, it is common to hold a
leadership meeting to discuss the survey, what could have been improved, and what was learned. This
keeps people apprised of the situation, helps educate, and provides a means of support and
encouragement for the team. Stress levels are naturally high during the survey process and this is one
way to alleviate some of the stress and maintaining connectivity with one another.
Regardless of the results, the organization should celebrate . If there is still more to be done, celebrate
the work done so far, then in the next few days continue the journey to accreditation or regulatory
compliance.
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Unfortunately, after the survey is over, staff tends to relax and go back to old habits. However,
sustainment of the high level of performance required by the survey standards is imperative to make
permanent improvements. This sustainment will be a great accomplishment when the next survey rolls
around and there is less work to be done.
After the Surveyors Leave
The day after the surveyor leaves, a meeting to review 'lessons learned and 'debriefing' is. very
educational for all concerned. During this meeting with all who participated in the survey, note
everything from atmosphere to what documents needed to be obtained, from surveyor comments on
improvements needed to suggestions for best practice, etc. Nothing is off limits. The subjects should
not be limited to just regulatory but also include perception irnms. The key to the day after meeting is
the comments and suggestions are fresh in everyone's mind. Some items may not ever be noted on
the offic ial report or become an action item; but, if a reviewer sees and says something, your
patients/families/visitors are seeing it too.
Once the fina l reporting is done and any action plans completed, make sure to share with staff through
meetings, newsletters, posters, etc. both the positive and the 'needs work' items.
For a CMS or state survey, the organization receives a Statement of Deficiencies also known as a 2567
form . The organization then completes a detailed corrective action plan identifying the changes to be
made, who is responsible for oversight, timelines, monitoring of the performance, and reporting
structure within the organization. Other types of surveys have their equivalent type of report form.
Begin drafting corrective action plans for suspected citations as soon as possible. There is a tight
timeframe for response associated with citations. The time varies with the accreditation/regulatory
agency. Usually there is a set number of calendar days specified, in which the organization must
submit action plans. Do not miss submission dates.
There are common elements to address in a corrective action plan regardless of the
accreditation/regulatory agency. Table 2 includes some of the questions to ask and answer when
writing the correction plan.
Table 2: Common Correction Plan Questions to Answer

Common Correction Plan Questions to Answer
• What was the main issue identified by the surveyor?
• What was the underlying cause of noncompliance?
• What specific steps will be taken to prevent this from happening in the future?
• Who is the senior leader responsible to monitor the action plan to completion?
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• What timeframe is being established?
• What data w ill be collected to assess compliance?
• What are the data numerator and denominator definitions?
• What are the inclusion and exclusion criteria?
• What is the % goal for performance?
• Will a sample be monitored or will there be 100% monitoring?
• If a sample is used, how will the sample be chosen?
• How will progress toward compliance be monitored?
• Are progress reports going to be made to organizational committees or leaders?
• What steps are in place to ensure sustainability of improvements?
When noncompliance is noted, it can usually be traced back to leadership oversight. While a citation
might be in one category, it is common to also receive also a connected leadership citation.
In any healthcare setting, patient care is more and more complex these days. Regulations are
increasingly detailed, sometimes resulting in a greater number of citations than in the past. In addition,
patients and visitors are savvy and they can file their own complaints directly with various oversight
agencies. Sometimes agencies become aware of adverse situations at a healthcare organization
through news media.
If CMS determines patients are not being cared for properly by a healthcare facility, and they find
actual or potential patient harm, they have the power to declare an immediate jeopardy situation. This
is extremely serious! It means there is a severe safety condition happening and the surveyor perceives
is causing patient harm, or has the potential to do so . This puts the organization at risk of losing
Medicare funding, which could be financially catastrophic, and could open the door to large legal
liabilities.
Continuous Improvement and Sustainability
Identifying the root causes of a process fa ilure, implement ing changes, and monitoring the success of
those interventions necessitates the use of an ongoing and structured performance improvement
model (e.g., plan, do, check, and act). Making changes can be done quickly in some instilnces, but
maintaining performance improvement is more challenging . It would be a shame to develop a process
that leads to desired outcomes, then to later slide back into old inferior patterns and habits that
caused the underlying problems in the first place. Being able to sustain improvements is imperative .
More information can be found on this topic in Chapter 3 Performance and Process Improvement and
Chapter 4 Health Data Analytics.
440
!u.s. HEALTHCARE ACCREDITING AGENCIE@
There are numerous healthcare accreditation agencies. Table 3 lists many of the U.S. healthcare
accreditation organizations. Not all of the accrediting organizations can be described here. Websites
are listed for more information and updates.
The most recent addition to the accrediting body list has arisen due to the electronic safety and
security needs for healthcare. CAQH-Core is for the oversight related to the activities associated with
healthcare information technology. Council for Affordable Quality Healthcare (CAQH) Committee on
Operating Rules for Information Exchange {CORE) was established in 2005 as a national initiative. In
2012, CAQH CORE was named by the Secretary of the U.S. Department of Health and Human Services
as the author of three phases of operating rules for Hf PAA-mandated standards for electronic
transactions. Organizations that create, use or transmit administrative healthcare data (such as plans,
providers and vendors) can earn CORE certification.
CAQH CORE® (Committee on Operating Rules for Information Exchange) is an industry-wide

collaboration committed to the development and adoption of national operating rules for electronic
business transactions. Technical standards and the supporting operating rules specify the business
actions required for each party to ensure a high volume of reliable electronic transactions {CAQH,
2017).
Implementation of the Phase I, II, and Ill CAQH CORE Operating Rules is mandated for all HIPAA-
covered entities by the ACA (with the exception of requirements pertaining to acknowledgments).
Implementation of the Phase IV CAQH CORE Operating Rules is currently voluntary. HHS will determine
if the Phase IV CAQH CORE Operating Rules will be included in any regulatory mandates. CAQH CORE
offers CORE Certification for Phases I, II, Ill, a·nd IV.
Table 3: Partial List of U.S. Healthcare Accreditation Agencies*

Partial List of U.S. Healthcare Accreditation Agencies
Organization Accreditation Website
Accreditation Association Ambulatory Surgery Centers, Medical and www.aaahc.org
for Ambulatory Health Care Dental Group Practices, Community and
(AAAHC): University Student Health Centers,
Diagnostic Imaging Centers
Accreditation Commission Home Care Services www .achc.org
for Health Care, Inc.
(ACHC):
American Association for Ambulatory Surgery Facilities www.aaaasf .org
Accreditation of
Ambulatory Surgery
Facilities (AAAASF):
44
1
American Associat ion of Standards for Blood Banks and www.aabb.org

Blood Banks (AABB): Transfusions Services
American College of Radiation, Oncology and Mammography www.acr.org
Radiology (ACR) :
American College of Cancer Treatment Programs in Hospitals, www.facs.org/quality-
Surgeons - Outpatient Centers and Freestanding programs/cancer/accredi
Commission on Cancer Facilities ted/benefitscoc/seekinga
(ACS-Co(): ccred
American Correctional Minimum Correctional Facility www.aca.org
Association (ACA): Requirements
American Lithotripsy Lithotripsy www.lithotripsy .org
Society (ALS):
American Society for Histocompatibility and lmmunogenetics www .ashi-hla.org
Histocompatibility and
lmmunogenetics (ASHI}:
Center for Improvement in Acute Care Hospitals www.cihq.org
Healthcare Quality (CIHQ):
College of American Clinical Laboratories www.cap.org
Pathologists (CAP),
Commission on Inspections
and Accreditation:
Commission for Hospital-based or Freestanding Medical www.carf.org
..
Rehab1lltat1on Centers, Adult Day
Accred1tat1on of
I (CARF}:
Rehabilitation Facilities Services, Assisted Living
Commission on Home Care and Community Health www.caas.org

Accreditation of Organizations
Ambulance Services
(CAAS):
Commission on Office Office Laboratory www.cola.org
Laboratory Accreditation
(COLA):
Community Health Home Care and Community Health www.chapinc.org
Accreditation Program, Inc. Organizat ions
(CHAP}, a subsidiary of the
National League of Nursing
(NLN):
Continuing Care Continuing Care Retirement Communities www.elderweb.com
Accreditation Commission
442
(CCAC):
Council on Accreditation Outpatient Mental Health, Residential www.coanet.org
(COA): Treatment Centers, Alcohol and other
Substance Abuse Treatment Centers,
Therapeutic Foster Care
Det Norske Veritas Hospital Accreditation with ISO and CMS www.dnvusa.com/indust
Healthcare, Inc. (DNV) - CoPs ry/hea Ithca re/index.asp
National Integrated
Accreditation for
Healthcare Organizations
(NIAHO):
Electronic Healthcare Entities that send or receive HIPAA- www.ehnac.org
Network Accreditation Regulated Transactions or
Commission (EHNAC): Transport/Process EDI Transactions
Health Facilities Osteopathic Hospitals and Clinical www.hfap.org
Accreditation Program Laboratories
(HFAP) of the American
Osteopathic Association
(ADA) :
National Commission for Correctiona I Healthcare facilities www .ncchc.org
Correctional Health Care
(NCCHC): QM Standards
National Committee for Managed Care Organizations www.ncqa.org
Quality Assurance (NCQA):
Public Health Accreditation National Voluntary Accreditation for www.phaboard.org
Board (PHAB), Centers for Public Health Departments (new Fall
Disease Control and 2011)
Prevention (CDC), and
national partners:
The Joint Commission Multiple Accreditation Programs www.jointcommission.or
(TJC) : g
Utilization Review Voluntary Accreditation for Private UM www.urac.org
Accreditation Commission Organizations, Case Management
( URAC)/American Organizations, Health Plans and
Accreditation Health Care Networks, Worker's Compensation UM,
Commission (AAHCC): and Network Organizations and Three
others
*not a complete list of healthcare accreditation agencies
44
3
[Disease Specific Certification[
Becoming certified as a disease specific provider is very popular and can do much to enhance a
healthcare organizations' reputation in the community. Several agencies, as described below, offer
certifications including in areas such as stroke, acute myocardial infarction, heart fa ilure, hip/knee
replacements, vascular disease, dialysis, and many more. Also, some state agenc ies offer certifications
in stroke care and ST-elevated myocardial infarction care. Specific information on the certification
standards con be found on the appropriate certificalion agency's website. Some of the basic elements
needed for disease specific certifications include:
• Eligibility related to treatment volumes
• Practitioner competency
• Ongoing professional educational requirements
• Use of clinica l practice guidelines or evidence-based practices
• Individualized care planning for the patient
• Team communication
• Data to evaluate processes and outcomes
• Ongoing Performance Improvement
• Comparison database
• Protection of personal health information
• Individualized patient education
• Community involvement
[Hospital Accreditation Organizations with Deemed Status[
At the time of this writing these four (4) CMS approved hospital accreditation organizat ions can
provide deemed status. They are each discussed in detail below.
1. The Joint Commission (TJC)
2. . Det Norske Veritas GL Healthcare (DNV GL Healthcare)
3. American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP)
4. Center for Improvement in Healthcare Quality (CIHQ)
[
he Joint Commission (TJC}[
The Joint Commission is an independent, not-for-profit organization that accredits and certifies more
than 20,500 health care organizations and programs in the United States. The Joint Commission
444
accreditation and certification is recognized as a symbol of quality that reflects an organization's

commitment to meeting certain performance standards (TJC, 2017). The Joint Commission surveys the
types of organizations listed in Table 4.
Table 4: Healthcare Organizations Accredited/Certified by The Joint Commission (TJC)

Healthcare Organizations Accredited/Certified by The Joint Commission (TJC)
Accreditation Certifications
• Hospitals • Comprehensive Cardiac Center
• Critical Access Hospitals • Disease Specific Care Programs
• Behavioral Healthcare • Palliative Care
• Ambulatory Health Care • Healthcare Staffing Services
• Office-Based Surgery • Integrated Care
• Home Care • Medication Compounding
• Laboratory Services • Perinatal Care
• Nursing Center Care • Primary Care Medical Home (PCMH)
• Patient Blood Management
The Joint Commission accreditation process is a three-year cycle, with one survey every three years,
and a self-assessment, known as the Intra-Cycle Monitoring (ICM), done annually. On-site surveys are
unannounced and generally conducted by a team including physicians, nurses, generalists, and life
safety specialists. The Joint Commission Standards include elements of performance detailing the
specific expectations required to meet the goal of a standard. There is an emphasis on data collection
and analysis, but the actual quality management process is left up to the organization. The survey
process includes patient and process/system tracers, where the surveyors follow a patient or process
as it would/occur through the organization.
Over the past 10 years, the Joint Commission standards have been revised multiple times and ongoing
changes are made to better align TJC standards with Medicare Conditions of Participation (CoPs).
Some standards are considered more critical than others. An organization's final score, based on ability
to meet the standards, is calculated at the Joint Commission Central Office where the final
determination of accreditation category is decided.
The Joint Commission has additional requirements. Since 2003, all accredited organizations must meet
all applicable approved National Patient Safety Goals (NPSGs). More information on the National
Patient Safety Goals can be found in Chapter 5 Patient Safety. Hospitals are required to submit a set
number of the Core Measures, as they are applicable to the organization. Other types of organizations
44
5
are required to submit other quality measures. The Joint Commission recommends a facility reports
sentinel events, and TJC maintains statistics concerning occurrences of sentinel events . TJC publishes
Sentinel Event Alerts, and makes recommendations for appropriate action to be taken to prevent the
occurrence of those alert topics at another healthcare organization . The Sentinel Event Alerts are free.
All healthcare quality practitioners, whether utilizing accreditation by TJC or not, should subscribe to
these alerts. Once an alert is received, the organization should evaluate whether such an event could
occur in their facility, conduct a gap analysis, and then take appropriate actions to prevent it from
occurring.
Fees for accreditation include the direct cost of the survey, based on the size and complexity of the
organization, and indirect costs related to the purchase of standards manuals, staff education, and the
use of external consultants to assist with survey readiness. More information concerning The Joint
Commission can be found at their website (see webs ite list at the end of this chapter).
!n 2016, the Joint Commission's multiphase process improvement project REFRESH has completed
Phase II with additiona l deletion of hospital elements of performance in the EP Review Project. Phase
Ill focuses on the evaluation of the elements of performance from the remaining accreditation
programs. Following the completion of this phase the consolidations of existing requirements across
accreditation programs (REFRESH, 2016).
The REFRESH project includes developing a different approach for identifying and communicating risk
levels of deficiencies identified during a survey. The Survey Analysis for Evaluating Risk (SAFER)
approach was developed to provide organizations with additional information related to risk of
deficiencies in order to help prioritize and focus corrective actions. The development of this approach
was driven by the Joint Commission's desire to allow organizations to see at an aggregate level area of
noncompliance which will demonstrate for the organization significant components of risk analysis
including the likelihood to harm and the scope of a cited deficiency (SAFER, 2016). All accreditation
and certification programs are utilizing this matrix in their survey reports.
!Det Norske Veritas Healthcare (DNV GL Healthcare)[
DNV GL (Det Norske Veritas) Healthcare is a global risk management foundation headquartered in
Oslo, Norway. DNV GL was granted deeming authority by the Centers for Medicare and Medicaid
(CMS) for acute hospitals in September 2008 and for critical access hospitals in November 2010. There
are currently over 500 hospitals that are DNV GL accredited . DNV GL utilizes a set of standards called
National Integrated Accreditation for Healthcare Organizations (NIAHO) standards, which are closely
aligned with CoPs, and designed to drive quality transformation into the core processes of running a
hospital. These standards are less prescriptive than TJC standards and include compliance with the
International Standardization Organization (ISO) 9001 certification by the fourth year of survey . NIAHO
helps healthcare organizations meet their national accreditation obligations and achieve ISO 9001
compliance in the same seamless program . The hospital may choose to obtain ISO 9001 certification,
446
but not required in order to be surveyed by DNV GL (DNV GL, 2017). Table 5 lists the types of facilities
that are accredited or certified by DNV GL.
Table 5: Healthcare Organizations Accredited/Certified by DNV GL

Healthcare Organizations Accredited/Certified by DNV GL
Accreditation Certifications
• Hospitals • Primary Stroke Center (PSC)
• Critical Access Hospitals • Comprehensive Stroke Center (CSC)
• Ancillary Services • Acute Stroke Ready (ASR)
• Managing Infection Risk Certification (MIR)
• Hip & Knee Replacement Program

Certification ( HKRC)
DNV GL also has five certifications that combine elements from the hospital accred itation standards
with other organizations (Table 5). The Primary Stroke Center (PSC) Certification program for
organizations providing stroke treatment includes the NIAHO standards as well as the Guidelines of the
Brain Attack Coalition and Recommendations of the American Stroke Association. The Comprehensive
Stroke Center (CSC) Certification utilizes the standards as the Primary Stroke Center Certification, but
this certification is designed for stroke centers that utilize the most advanced stroke treatment
available. The Acute Stroke Ready (ASR) Certification is designed for smaller and rural hospitals that
perform initial treatment of stroke patients. The Managing Infection Risk Certification (MIR) enables
hospitals to reduce their risk of infection utilizing innovative assessments of risk. The Hip & Knee
Replacement Program Certification (HKRC) recognizes facilities providing excellence in orthopedic
surgery for hip and knee replacement and related procedures.
DNV GL has formed an alliance with the Accreditation Commission for Health Care (ACHC) for
accreditation of ancillary services provided by DNV accredited facilities. The ACHC has deemed status
for home health, hospice, DMEPOS, and other ancillary healthcare services. These will be discussed
later in this section
The DNV GL accred1tat1on cycle is for 3 years. However , DNV performs annual, unannounced survey
to help the -facility make continuous improvements . DNV attempts to have the same surveyors each
time to facilitate teamwork and collaboration with the facility. The lead surveyor will consistently be
the same. The survey team is comprised of physicians, nurses, administrators and life safety specia lists.
The focus is on improving healthcare quality and delivery while managing risk. Accreditation decisions
take into consideration whether nonconformance with a standard can directly impact patient care or
safety. All deficiencies require a written plan of correction.
44
7
Accreditation fees are based on the size of the facility, the average daily census, and the number of
Full Time Equivalents (FTE's). The surveys include the annual survey, ISO assessment, and any follow-
up activities. Standards and other materials are provided at no charge. The integration of ISO 9001 is
unique to DNV. It is thought by some authors that the adoption of ISO 9001 structure and processes
are associated with better employee productivity and safety as well as quality, market share, and
financial outcomes. More information concerning DNV GL can be found on their website listed at the
end of this chapter .
!ISO 9001 Standards!
The International Organization for Standardization in Geneva, Switzerland, issued the first version of
the ISO 9000 series of standards and guidelines in 1987. The ISO is a worldwide certification agency
focusing on the quality management systems of an organization. The European Common Market, now
the European Commission (EC), requested a way to harmonize the various quality assurance standards
from the different member countries. The word iso is Greek for harmonize. The goal was to eliminate
redundant and perhaps conflicting requirements between customers and vendors across country
boundaries . The basic assumption underlying the standards is that a good quality management process
will satisfy the customer by reducing nonconformance in products and services (ASQ, 2017).
The original sets of five documents, standards ISO 9000 - 9004, were written primarily for the
manufacturing industry. The 2000 and 2005 version language was much more generic and therefore
more applicable to service industries like healthcare . ISO certification has been utilized in industry for
many years and only recently has been applied to healthcare. In September 2015, the ISO 9001:2015
standards were released. The most significant difference is an update for Risk Management (ASQ,
2017).
ISO focuses on a process approach when establishing and utilizing a quality program. This approach
emphasizes understanding and meeting requirements, the need to consider the added value of
processes, and continual, ongoing improvement of the processes.
ISO 9001 standards (ASQ, 2017) are basically a Quality Management System focused on effectively
meeting customer needs is the focus of the quality management system . The organization must
consistent ly provide service/products meeting customer needs and enhance customer satisfaction
through continual improvement of the system. The ISO standards are based on five components:
• Quality Management System - general and !documentation! requirements
• Management Responsibility
• Resource Management
• Service/Product Realization
448
• Measurement, Analysis, and Improvement
he Healthcare Facilities Accreditation Program (HFAP)[

[
HFAP was originally created in 1945 by the American Osteopathic Association (ADA) to conduct an
objective review of the unique services provided by osteopathic hospitals. HFAP has had deemed
status from CMS since 1965. Their standards and accreditation program are now no longer limited to
osteopathic healthcare organizations. Their standards are closely aligned to CoPs, as well as patient
safety and quality of care standards. Approximate ly 80% of the HFAP standards can be cross-walked
with the CoPs. The standards are provided free of charge to HFAP clients, and the standards change
infrequently. Table 6 lists the types of faci lities accredited by HFAP (HFAP, 2017).
Table 6: Healthcare Organizations Accredited/Certified by HFAP

Healthcare Organizations Accredited/Certified by HFAP
Accreditation Certification
• Acute Care Hospitals (General, Specialty, • Stroke Ready

Long Term Acute Care)
• Primary Stroke
• Critical Access Hospitals
• Comprehensive Stroke
• Behavioral I Mental Health Facilities
• Ambulatory Care I Office-based Surgery
Facilities
• Ambulatory Surgery Centers
• Clinical Laboratories
The survey process is a three-year cycle with unannounced surveys done by a team of three people,
general ly a physician, a nurse, and an administrative representative. The survey is designed to be
educational and is based on the facility's ability to correct deficiencies during the survey process. The
team scores each standard, which is weighted based on its impact on patient care. At the end of the
survey, the organization is given a deficiency report and is expected to provide the HFAP central office
with a corrective action plan. The corrective action plan must be approved by oversight body (HFAP)
before the accreditation status can be determined.
The direct cost for the survey includes survey materials, online standards, newsletters, and
publications of standard changes. Indirect costs include outside consulting for survey readiness
preparation. More information concerning HFAP can be found on their website in the website list at
the end of this chapter.
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9
Center for Improvement in Healthcare Quality (CIHQ)
As of August 9, 2013, the Center for Improvement in Healthcare Quality (CIHQ), a privately held
company, became the nation's fourth accreditation provider approved by CMS to deem acute care
hospitals as meeting Medicare Conditions of Participation . The CIHQ accreditation is available to
hospitals and all services and sites of care listed on their license. At the end of 2017, the CIHQ website
states that 48 acute care hospitals have been accredited through CJHQ. Other services such as home
health and long-term c.:irc services are not surveyed by CIHQ. The sldndards are based on the CoPs
plus areas of patient safety and quality care. The CIHQ also provides disease specific certification for
Stroke Ready, Comprehensive Stroke Center, Heart Failure, and Joint Replacement (Table 7). These
certification surveys occur at the time of the hospital's main survey (CIHQ, 2017). CIHQ also awards
program recognition via Center of Excellence designation to Long Term Acute Care, Rehabilitation
Services in the acute care hospitals and for Environmental Health & Safety. The designations survey
occurs during the organization's accreditation survey.
Table 7: Healthcare Organizations Accredited/Certified by CIHQ

·
Healthcare Organizations Accredited/Certified by CIHQ

• Acute Care Hospitals • Stroke Ready
• Comprehensive Stroke
• Heart Failure
I • Joint Replacement
The CIHQ survey length depends on the size and complexity of the organization. The surveyors
typica lly are a team of 2 - 4 individuals with one being a facilities specialist. A full survey is conducted
every three years, with a focused mid-cycle survey a pproximately 18 months after the full survey. The
focused survey is generally one day with one surveyor .
The cost for the survey is dependent on the size and complexity of the organization, billed annually or
quarterly, whichever the hospital prefers. Additionally, CIHQ provides standa rds, monthly audio
conferences, templates for policies, forms and other such material, complementary attendance for
two at their annual conference, a web-based reference library, and alerts to changes in the standards
and CMS regulations. More information concerning CIHQ can be found on their website in the webs ite
list at the end of this chapter.
450
Accr editation for Health Plans and other Managed Care Organizations, especially those actively
involved in the Health Insurance Marketplace, Medicare or Medicaid
At the time of this writing there are three CMS approved health plan and managed care accreditation
organizations are used for deemed status :
• National Committee for Quality Assurance (NCQA)
• Utilization Review Accreditation Commission (URAC)
• Accreditation Association for A mbulatory Hea lth Care (AAAHC)
iNational Committee for Quality Assurance (NCQA)j
The National Committee for Quality Assurance (NCQA) is a private, not-for-profit organization
established in 1990 by the then Group Health Associat ion of America (now America's Health Insurance
Plans) and the Ame rican Managed Care Review Associatio n. The organization works to improve
healthcare quality via evidence-based standa rds, measures, programs, and accreditation . It operates
on the formula of measure, analyze, and improve. It provides an evidence-based program for case-
management accreditat ion ava ilable for uses in payer, provider, and community based organizations .
The NCQA works with policymakers, employers, doctors, patients, and health plans, with the aim of
building consensus in the industry. Table 8 lists the types of organizations acc redited by NCQA (NCQA,
2017) .
Table 8: Healthcare Organizations Accredit ed/Certified by NCQA

Healthcare Organizations Accr edited/Certified by NCQA
Type Programs
Healthcare Accreditation
• Accountable Care Organiz ations (ACO)
Programs
• Health Plan (HP) (HMO, MCO, PPO, and POS
plans)
• Wellness & Health Promotion (WHP)
• Case Management (CM)
• Managed Behavioral Healthcare Organizations

(MBHO)
• New Health Plans (NHP)
• Disease Management (DM)
• Accreditation Users Group (AUG)
Certification • Accredita tion and Certificat ion Users Group

(ACUG)
45
1
• Certification Ver ification Organizations (CVO)
• Disease Management (DM)
• Health Information Products (HIP)
• Multicultural Health Care (MHC)
• PCMH Content Expert Certification (CEC)
• Physician and Hospita l Quality (PHQ)
• Utilization Management and Credentia ling

(UM/CR)
• Wellness & Health Promotion (WHP)
Distinction • Behavioral Health Integration (BHI)

Recognition • Diabetes Recognition Program (DRP)
Government Recognition Initiative
• Heart/Stroke Recognition Program (HSRP)
• Oncology Medical Home
• Patient-Centered Connected Care
• Patient-Centered Medical Home (PCMH)
I• Patient-Centered Soecialtv Practice PCSP
I• School-Based Medical Home Program (SBMH)
Other • Special Needs Plans Structure & Process

Measures
• Specia l Needs Plans Model of Care Review

Process
NCQA offers a three-year accreditation to health plans with managed care organizations. Healthcare
Effectiveness Data and Information Set (HEDIS) performance measure data is required annually with the
accreditation status reevaluated based on those results. NCQA began incorporating HEDIS data into the
0
accreditation process in July 1999. HEDIS effectively evaluates the structure and functions of medical and
quality management systems in M,maged Care Organizations (MCOs) (see Chapter 3 Performance and
Process Improvement).
The Health Plan accreditation standards cover: Quality Management and Improvement; Utilization
Management; Credentialing and Recredentialing; Members' Rights and Responsibilities, and Member
Connections . Health Plan performance is based on selected audited measures from HEDIS and adult 0
452
survey results from HEDIS/CAHPS 0

which are both then combined with the standards compliance
score, to determine the final score for the organization . The score determines the accreditation status
of the organization. Audited HEDIS results are submitted annually and the accreditation status is
0
recalculated by product line based on those results. The changes are not subject to reconsideration .
NCQA's standards for Quality Management and Improvement of health plans include the program
structure, program operations, health serv ices contracting, availability of practitioners, accessibility of
services, member satisfaction, complex case management, disease management, clinical practice
guidelines, continuity and coordination of medical care, continuity and coordination between medical
and behavioral healthcare, and delegation of QI. Further information can be found in the standards for
the specific program of interest. More information on NCQA can be found on their website in the
Utilization Review Accreditation Commiss ion (URAC)
The Utilization Review Accreditation Commission was previously known as the American Accreditation
Health Care Commission (AAHCC) when founded in 1990 to establish standards for the healthcare
industry. Its membership includes employer, consumer, regulator, provider, health plan, and workers'
compensat ion representatives . The organization's initial focus was on voluntary accreditation of
private external utilization management companies. As of this publication, URAC offers 24
accreditation and certification programs ( URAC, 2017).
All accredited organizations must meet "Core Accreditation" standards . Table 9 lists the types of
accreditation programs offered through URAC. Organizations performing the functions listed in Table 9
may apply for accreditation . This includes hospitals, health maintenance organizat ions, preferred
provider organizations, third-party administrators, and provider groups.
Table 9: Healthcare Functions Accredited by URAC

Healthcare Functions Accredited by URAC
• Health and Dental Plan Programs
• Healthcare Management Programs
• Healthcare Operations Programs
• Pharmacy Quality Management Programs
• Provider Integration & Coordination Programs
The accreditation process includes a desktop review conducted by the accreditation team to identify
compliance with the URAC standards. Documentation is submitted by the facility requesting
accreditation . The required documents are outlined in the standards. This is followed by an on-site
review where the survey team compares the desktop review with the on-site review. URAC surveyors
453
also conduct audits and other such activities while onsite. The Accreditation Committee makes the
determ ination of the accreditation status based on the report from the survey team . More information
regarding URAC can be found on their website in the website list at the end of this chapter.
Accreditation Association for Ambulatory Health Care (AAAHC)
The Accreditation Association for Ambulatory Health Care (AAAHC) is a private, non-profit organization
formed in 1979. The association, with a flexible collaborative approach, accredits more than 6,000
organizations in a wide variety of ambulatory health care settings. Known in the industry as "Triple A
HC", the AAAHC is the official accrediting organization for the US Air Force and the US Coast Guard.
Tab le 10 lists some of the types of facilities accredited by AAAHC (2017).
Table 10: Healthcare Organizations Accredited/Certified by AAAHC

Healthcare Organizations Accredited/Certified by AAAHC
• Ambulatory Surgery Center e Orthopedic Specialty
• Community Health Centers • Orthopedic Advanced

Specialty
• Health Plans/OHPs/FEHB plans
• Indian and Student Health Centers
• Medical Home
• Network
• Office-based Surgery Centers
• Primary Care
Surveys are conducted every three years. Differences in the manuals and surveys depend on the type
of facility, and whether or not the survey is for Medicare deemed status. Medicare deemed status
surveys are unannounced. Random surveys between the 3-year cycles are also unannounced and
typically have one surveyor for one day. Fees for the surveys are calculated based on the size, type,
and range of services provided by the organization. Standard manuals may be purchased at an
additional cost from the AAAHC website. Further information regarding AAAHC can be found on their
website in the website list at the end of this chapter.
Commission on Accreditation of Rehabilitation Facilities (CARF)
The Association of Rehabilitation Centers (ARC) and the National Assoc iation of Sheltered Workshops
and Homebound Programs (NASWHP) established the Commission on Accreditation of Rehabilitation
Facilities (CARF) in 1966 to accredit rehabilitation facilities. CARF promotes the quality, value, and
optimal outcomes of services utilizing a consultative accreditation process and continuous
454
improvement services, in organizations internationally . The CARF International group of companies

currently accredits more than 50,000 programs and services at 23,000 locations. Table 11 lists the
CARF Accreditation Programs (CARF, 2017).
Table 11: Healthcare Organizations Accredited by CARF

Healthcare Organizations Accredited by CARF
• Aging Services
• Behavioral Health
• Continuing Care Retirement Communities (CCRC)
• Child and Youth Services
• DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies)
• Employment and Community Services
• Medical Rehabilitation
• Opioid Treatment Programs
• Vision Rehabilitation Services
Each CARF accreditation program has a standards manual including quality standards for business
practices, service processes, and specific programs and services . CARF updates its standards manuals
annually, frequently providing clarification of standards based on feedback from users. Midyear
changes are posted on their website. Facilities are surveyed every three years. Facilities may choose to
become accredited in more than one standards area and as a result will have a blended survey . The
organization may apply for accreditation in adult care and or pediatric care. CARF also offers specialty
care certifications such as Stroke/Brain Attack. It is not required that a facility be accredited in every
service area. CARF accreditation programs and services can also be utilized to survey any business
entity such as an individual, sole proprietorship, partnersh ip, etc. Survey findings detail the standards
for which the provider has not satisfactorily demonstrated conformance . Standards not met are
addressed through a Quality Improvement Plan. The number of surveyors needed is determined by the
number of persons served, number of sites to be visited, number of service areas to be accredited, and
the geographic area to be covered. More information about CARF can be found on their website in the
Other Healthcare Accreditation Agencies (not an inclusive
list) Accreditation Commission for Health Care, Inc. (ACHC)
The Accreditation Commission for Health Ca re was established in 1986 by the home care and alternate
healthcare providers. The accreditation process is designed to improve business operations, quality of
patient care, and services. All major third-party payers recognize ACHC. ACHC also awards 5
455
Distinctions awards, most though deal with medications . Table 12 displays the organizations
accredited/distinctions by ACHC (ACHC, 2017).
Table 12: Healthcare Organizations Accreditation/Distinctions by ACHC

Healthcare Organizations Accreditation/Distinctions by ACHC
Accreditation Distinctions
• Ambulatory Care • Behavioral Health
• Behavioral Health • Hazardous Drug Handling (USP

Chapter 800)
• DMEPOS (Medicare Deeming Authority)
• Infectious Disease Specific to
• Home Health (Medicare Deeming HIV (medications)
Authority)
• Oncology (medications)
• Hospice (Medicare Deeming Authority) • Palliative Care
• Hospital (alliance with DNV GL)
• Pharmacy (Specialty, Infusion,

Compounding)
• Private Duty
• Sleep Lab/Center
ACHC has developed service specific standards, and have personal advisors to assist organizations in
obtaining accreditation. The surveyors offer evidence-based practices to the organizations to assist
them in making improvements. ACHC is an ISO 9001 certified organization since 2004. in 2008, the
ACHC executives received training on the Baldrige criteria to assist them in achieving company-wide
quality and sustainability . They continue to utilize Baldrige practices within the organizat ion. ACHC has
formed an alliance with DNV for accreditation of many services within a health system . Fees for the
accreditation process are all inclusive, with no added fees for surveyor travel, etc. The standards are
downloadable from the website in the website list at the end of this chapter. After a five-day trial
period, the organization can purchase unlimited access for all ACHC's service-specific standards.
Community Health Accreditation Program, Inc. (CHAP)
The Commun ity Health Accreditation Program accredits a range of home and community-based health
services. CHAP has Medicare deemed authority for the accreditation of home health, hospice, and
home medical equipment services. Table 13 lists the types of programs accredited by CHAP (2017).
456
Table 13: Healthcare Organizations Accredited by CHAP

Healthcare Organizations Accredited by CHAP
• Home Health (Medicare Deeming Authority)
• Hospice (Medicare Deeming Authority)
• Home Medical Equipment Services (Medicare Deeming Authority)
• Pharmacy
• Private Duty
• Public Health
• Infusion Therapy Nursing
The CHAP standards are built on standards of excellence, which look at the four following principles of
an organization: the organization's structure and function consistently support its consumer-oriented
mission; it consistently provides high-qual ity services and products; it has adequate human, financial
and physical resources to accomplish its stated mission and purpose; and it is positioned for long-term
viability. These standards of excellence support the scope and complexity of the programs CHAP
accredits. The standards of excellence and service-specific standards of excellence are customized to
the different accreditation programs.
The accreditation process includes a se lf-study of how the organization meets the CHAP standards and
then a site visit by the surveyors. The site visit is usually unannounced and lasts 2 - 5 days, based on
the organization size. The surveyors are assigned to the services where they have specific experience .
They are required to have a minimum of 5 years of experience in one of the healthcare fields CHAP
accredits. They must have at least a bachelor's degree in a related specialty, and at least 5 years
management experience in a home or community-based health care organization. For more
information concerning CHAP, refer to the website list at the end of this chapter.
External Quality Awards
Quality Professional Role
The role of the Quality professional in obtaining external awards is to:
• Determine goals to be achieved with obtaining the award
• Determine current state of compliance with the criteria
• Discuss current state and action needed with the leadership
• Determine action plan to meet criteria and timeline
• Develop and submit the application
457
!Baldrige Performance Excellence Program (U.S.)[
The National Institute of Standards and Technology (NIST) is the agency of the U.S. Department of
Commerce managing the Baldrige award and program (Baldrige, 2017). Leaders in the United States
realized during the 1980s American companies needed to focus on quality in order to be competit ive
in the global market. The Secretary of Commerce, Malcolm Baldrige, was an advocate of quality
management as a key to U.S. prosperity and sustainability . Congress named an award in recognition of
his contributions ;:iftcr his sudden death in 1987.
The goal of the Malcolm Baldrige National Quality Award i•,:tially was to enhance the competitiveness
of U.S. businesses. Congress created the award program to identify and recognize role- model
businesses, to establish criteria for evaluating improvement efforts, and to dissem inate and share best
practices. In subsequent years, it has been expanded to include health care and education
organizat ions as wel l as nonprofit and government organiza tions. In April 2003, SSM Health Care
became the first healthcare organization to receive the Award.
The Health Care Criteria for Performance Excellence, under the Baldrige Program, offers both a self-
assessment framework and an optional award component. An organization must work on the criteria
for a number of years before applying for the award. Table 14 lists the seven categories of criteria, the
core set of values and concepts on which they are built. More information can be found on their
website in the website list at the end of this chapter .
Table 14: Baldrige Award Criteria and Values

Baldrige Award Criteria and Values
Categories of Criteria Core Sets of Values and Concepts
1. Leadership
• Visionary leadership
2 . Strategic Planning • Patient-focused excellence
3. Customer Focus
• Organizational and personal learning
4. Measurement, Analysis, and
Knowledge Management
• Valuing workforce members and partners
• Agility (capacity for rapid change and
5 . Workforce Focus flex ibility)
6. Operations Focus • Focus on the future
7. Results • Managing for innovation
e Management by fact
• Societal responsibility and commun ity health
• Focus on results and creating value

• Systems perspective
458
When an organization submits an application for the Malcolm Baldrige Award, the applicant receives a
detailed feedback report from an independent, external assessment panel of experts. Some
applications will lead to a site visit and ultimately to the award.
If chosen for a site visit, the organization undergoes a comprehensive evaluation of their processes and
results. "Processes" refer to the methods used by the organization to address Categories 1-6 (refer to
Table 14). These categories are scored with four factors known as ADLI:
Approach - the methods used to accomplish the process, the appropriateness of the methods to the
organization's environment, the effectiveness of the methods, and the degree to which the approach
is repeatable and based on reliable data and information;
Deployment - the extent to which an approach is applied in addressing items relevant and important
to the organization, applied consistently, and used/executed by all appropriate work units;
Learning - refinement through cycles of evaluation and improvement, encouraging change through
innovation, and sharing refinements and innovations with other relevant work units within the
organization;
Integration - the extent to which an approach is aligned with the organizational needs identified in the
organizational profile, the measures, information, and improvement systems are complementary
across processes and work units to support organization-wide goals.
Category 7, "Results," refers to the organization's outputs and outcomes, and is scored with four
factors known as LeTCI:
Levels - the current level of performance;

Trends - the rate of performance improvements or the sustainability of good performance;
Comparisons - performance relative to appropriate comparisons, such as competitors or similar
organizations, and/or performance relative to benchmarks or industry leaders;
Integration - the extent the organization's results measures address important customer, product,
market, process, and action plan performance requirements identified in the organizational profile;
results include valid indicators of future performance; and results are harmonized across processes
and work units to support organization-wide goals.
Annually, Baldrige Award winners are chosen from applicants whose scores are determined sufficiently
high by a Board of Governors. The scoring system is at:
http://www.ba Idrige21.com/Baldrige%20Scoring%20System .htmI.
/Magnet Recognition Program"!
The Magnet Recognition Program· was developed by the American Nurses Credentialing Program to
recognize health care organizations for excellence as evidenced by quality patient care, nursing
excellence, and innovations in professional nursing practice. Developed by The American Nurses
Credentialing Center (ANCC), Magnet is the leading source of successful nursing practices and
459
strategies worldwide. As of April 2017, there are 456 Magnet recognized healthcare organizations in
the United States with 37 of those being Pediatric organizations (Magnet, 2017). A new manual is due
to be published in 2019 and may contain information that is different from what is presented here.
The Magnet recognition program has three goals: promoting qua lity in a setting supporting
professional practice; identifying excellence in nursing service delivery; and disseminating "best
practices" in nursing services. Evidence-based criteria must be utili1ed to have a positive work
environment for nurses and others in the healthcare organization.
There are 14 Forces of Magnetism that fit into five model components. The five model components
are Transformational Leadership, Structural Empowerment, Exemplary Professional Practice, New
Knowledge, Innovations, and Improvements, and Empirical Quality Results. Transformational
Leadership is defined as being able to transform organizational values, beliefs, and behaviors to meet
the demands and achieve the vision of the future. Structural Empowerment includes influential
leadership to develop structures and processes supporting innovation through strategic planning,
systems, policies, and programs. Exemplary Professional Practice refers to a comprehensive
understanding and application of the nursing role with patients, families, communities, and the
interdisciplinary team, and application of new knowledge and evidence. New Knowledge, Innovation,
and Improvements are the contributions to patient care, the organization, and the profession. Lastly,
Empirical Quality Results pertain to striving for benchmark and clinical outcomes data related to
nursing, workforce, patient and consumer, and organizational outcomes.
Table 15 lists the 14 Forces of Magnetism and the 5 modei components. The model components are
the primary basis for achieving magnet recognition. The Forces of Magnetism remain the foundation of
the Magnet program. More about the Forces of Magnetism can be found on their website in the
Table 15: Magnet Program Forces of Magnetism & Model Components

Magnet Program Forces of Magnetism & Model Components
Model Components
Transformational Structural Exemplary New Empirical
Forces of Magnetism Leadership Empowerment Professional Knowledge, Quality
Practice Innovations, Results
Improvement
#1 Quality of X
Nursing Leadership
#2 Organizat ional X
Structure
#3 Management X
460
Style
#4 Personnel X
Policies & Programs
#5 Professional X
Models of Care
#6 Quality of Care X
#7 Quality X
Improvement
#8 Consultat ion & X
Resources
#9 Autonomy X
#10 Community & X

the Healthcare
Organization
#11 Nurses as X
Teachers
#12 Image of X
Nursing
# 13 Interdisciplinary X
Relationships
#14 Professional X
Development
Pathway to Excellence
In 2003, the Texas Nurses Association (TNA) established the Nurse Friendly designation aimed at
improving the quality of patient care and the professional satisfaction of Texas nurses. In 2007, the
American Nurses Credentialing Center (ANCC) acquired the program and in 2009 renamed it as the
Pathway to Excellence Program. In 2010, the ANCC expanded the program to long-term care facilities .
As of this writing, there are 155 healthcare organizations with this designation, of which 5 are in
Switzerland, Thailand and Australia (Pathway, 2017) . In 2016, an Ohio hospice was the first hospice to
become Pathway to Excellence certified.
ANCC's Pathway to Excellence® Program recognizes health care and long-term care organizations for
positive practice environments where nurses excel. Any size healthcare facility may apply for the
award. The benefits of the Pathway to Excellence designation include improvement to nurse
461
satisfaction, retention of nursing staff and leaders, inter-professional teamwork, high quality nursing
practice, and supported business growth.
To qualify, organizations meet 6 practice standards (Table 16) essential to an ideal nursing practice
environment. In the long-term care arena, additional standards are included (see Table 16). The
organization conducts a process review to document their compliance with the standards. Three ANCC
nursing experts review the documentation to determine if the standards are met. This is followed by
an independent confidential survey completed by the organization's nursing staff, to validate the
information submitted. This validation is designed to give the nurses a voice in the process.
Nurses are attracted to Pathway-designated institutions and respect their contributions, support for
professiona l development, and nurturing work settings. Organizat ions may hold the Pathway to
Excellence and the Magnet Recognition designat ions concurrently. More information regarding the
Pathway to Excellence can be found on their website in the website list at the end of this chapter .
Table 16: Pathway to Excellence Hospital and Long-Term Care Standards

Pathway to Excellence Hospital and Long-Term Care Standards
All facilities:
• Practice Standard 1: Shared Decision-Making

• Practice Standard 2 : Leadership
• Practice Standard 3: Safety
• Practice Standard 4: Quality
• Practice Standard 5: We ll-Being
• Practice Standard 6: Professional Development
Long Term Care facilities - Additional Standards:
• Certified Nurse Assistants (CNAs) are included in the nursing community

• Educational standards are temporarily established for Directors of Nursing (DON)
• Standards about staff education regarding zero tolerance of resident abuse and neglect;
policies/procedures on the use of restraints and prevention of falls
• A person-centered model of care is understood
This chapter presented an overview of regulatory, accreditation and external reward programs. The
responsibilities as well as perspectives on these topics from experts is key in quality improvement.
Organizations without strong, committed leaders often find themselves missing something in the
programs and processes as well as receiving accreditation/certification status for their organization . As
a Quality/UM/RM/PS/accreditation manager you are also a leader, and while you may not have
positional power, you have expertise and influence that is key to your organization's success.
46
2
REFERENCES
AAAHC (2017). Home Page. Accreditation Association for Ambulatory Health Care. Retrieved from
http://www.aaahc.org/
ACHC (2017). Home Page. Accreditation Commission for Health Care. Retrieved from
http://www.achc.org/
ASHE (n.d.) . Deemed Status. American Society for Healthcare Engineering. Retrieved from
http://www.ashe.org/advocacy/orgs/deemedstatus.shtml
ASQ (2017). Home Page. American Society for Quality. Retrieved from http://www.asq.org
Baldrige (2017). Baldrige Performance Excellence Program. National Institute of Standards &
Technology. Retrieved from https://www .nist.gov/baldrige
CAQH (2014). Administrative Simplification : Certification of Compliance for Health Plans; Proposed
Rule [PDF file). Federal Register, 79(1), 298-324. Retrieved from
https://www.gpo.gov/fdsys/pkg/FR-2014-01-02/pdf/2013-31318.pdf
CARF (2017). Home Page. Commission for Accreditation of Rehabilitation Facilities. Retrieved from
http://www.carf.org
CHAP (2017). Home Page. Community Health Accreditation Partner. Retrieved from
http://www.chapinc .org
CIHQ (2017}. Home Page. Center for Improvement in Healthcare Quality. Retrieved from
http://www.cihq .erg/home.asp
CMS (2017). About CMS. Centers for Medicare & Medicaid Services. Retrieved from
https://www.cms .gov/About-CMS/ About-CMS .html
DNV GL (2017). Home Page. Det Norske Veritas. Retrieved from http://dnvglhealthcare.com/
HFAP (2017). Home Page. Healthcare Facilities Accreditation Program. Retrieved from
http://www.hfap.org
Magnet (2017). ANCC Magnet Recognition Program®. American Nurses Credentialing Center. Retrieved
from http://nursecredentialing.org/Magnet
NCQA (2017). Home Page. National Committee for Quality Assurance. Retrieved from
http://www.ncqa.org/
Pathway (2017). ANCC Pathway to Excellence® . American Nurses Credentialing Center. Retrieved from
http://nursecredentialing.org/Pathway .aspx
463
REFRESH (2016). Project REFRESH: Phase II of EP Review Project [PDF file]. Joint Commission
Perspectives, 36 (11), 1-6. Retrieved from
https://www.jointcommission.org/assets/1 /6/REFRESH_Phase_2 .pdf
SAFER (2016). The SAFER Matrix: A New Scoring Methodology [PDF file]. Joint Commission
Perspectives, 36(5), 1-3. Retrieved from
https://www.jointcommission .org/assets/1/6/SAFER_Matrix_New_Scoring_Methodology.pdf
TJC (2017). Home Page. The Joint Commission. Retrieved from https://www.jointcommission.org/
URAC (2017). Home Page. Utilization Review Accreditation Commission. Retrieved from
http://www.urac.org
46
4
WEBSITES
Accreditation Commission for

http://www.achc.org
Health Care (ACHC)
Accreditation Concepts http://www.med icare.gov
Accred itation Association for
http://www.aaahc.org
Ambulatory Health Care (AAAHC)
American Association for
http://www.ashe.org
Healthcare Engineering ( ASHE)
Baldrige Performance Excellence
https ://www .nist.gov/baldrige
Program (U.S.)
Baldrige Scoring System http://baldrige21.com/Ba1drige%20Scoring%20System .html
Center for Improvement in
http://www.cihq .org/home .asp
Healthcare Quality {CIHQ)
Commission for Accreditation of
http://www.carf.org
Rehabilitation Facilities (CARF)
Committee for Affordable
http://caqh.org
Healthcare (CAQH)
Community Health Accreditat ion
http://www.chapinc.org
Partner (CHAP)
Deemed Status http://www.ashe .org/advocacyIorgs/deemedstatus.shtm I
Det Norske Veritas (DNV GL) http://www.dnvglhealthcare.com/
Healthcare Facilities Accreditation
http://www.hfap .org
Program (HFAP)
ISO 9001 http://www.iso.org
International Society for Quality
http://www.isqua.org
(ISQua)
Joint Commission International
http://www.jointcommissioninternational.org/
(JCI)
Magnet Recognition Program http://nursecredentialing.org/M agnet
National Committee for Quality
http://www.ncqa .org
Assurance (NCQA)
Pathway to Excellence http://nursecredentia Iing.org/Pathw ay.as px
Patton Healthcare Education
https://pattonhe.com/patton-hea Ithcare-cons uILing-newsletters/
Newsletter
The Joint Commission (TJC) http://www.jointcommission.org
Utilization Review Accreditation
http://www.urac.org
Center (URA()
465
LEGISLATION INITIATIVES
CHAPTER 7
Jacque Cole, Susan Mellott

Quality Leadership and Structure
1.A.13 Recognize quality initiatives impacting reimbursement (e.g., pay for
performance, value-based contracts)
requirements (e.g., CMS, HIPAA, OSHA, PPACA)
1.B.5 Facilitate communication with accrediting and regulatory bodies
indicated throughout the Handbook with a ox around the textj.
Throughout this chapter there will be references to specific laws and cases which have shaped the
healthcare industry. There are two basic types of laws which will be referenced, public laws and case
laws. The public laws will have the initials "P.L." within the naming convention of the law. Case laws
will note the two parties who were in court together such as Darlin g v. Charleston Community
M emorial Hospital .
The website links are in the text itself, but can also be found in the website list at the end of the
chapter.
Editor's note: The future of healthcare insurance coverage is expected to be changing with the new
Presidential Administration. This chapter is reflective of the current industry as of December 2017.
There are several tentative legislative and presidential orders in draft; but nothing absolute. Examples
of tentative subjects includ e; Repeal Replace and Removal of Insurance M andates.
CORPORATE LIABILITY IN THE U.S.
From the very beginning of recorded evidence of the provision of medical care (Code of Hammurabi,
around 2,000 B.C.), the responsibility for quality care rested solely with the individual who provided
the care. There were, of course, no institutions with which physicians could share this responsibility.
When Benjamin Franklin founded the first U.S. hospital in 1752, the accountability of the governing
body was limited to fundrais ing. For the next 200 years, the hospital operated legally as an
"innkeeper," a place where physicians, totally independent ("independent contractors"), could bring
467
and treat their patients. Hospitals operated with "charitable immunity" from prosecution until 1939. In
1876, the Supreme Court of Massachusetts was the first American court to indicate a charitable
institution is not responsible for its torts ( McDonald v. Massachusetts General Hospital, 120 Mass. 432)
(McDonald, 1876). In 1942, the United States Court of Appeals for the District of Columbia revealed
"the charity immunity doctrine was built on a foundation of sand" (Georgetown College v. Hughes, 130
F.2d 810) (Georgetown, 1942). After the 1957 New York Court of Appeals' case of Bing v. Thunig,
N.Y.2d 656 (Bing, 1957) the charitable immunity began to crumble. Until the malpractice cases of
Leneris v. Haas (1955) and Bing v. Thunig (Bing, 1957), hospital governing bodies were seen to be
responsible only for facilities, services, equipment, and supplies. In Leneris v. Haas, the court held the
hospital liable for the negligence of employees under the doctrine of " Respondeat Superior". In the
Bing case, the New York Court of Appeals ruled the doctrine of charitable immunity no longer applied.
For more information on the historical cha ritable immunity provision, see page 498 - 500 of the
Flagiello v. Pennsylvania Hospital case (Flagiello, 1965).
Then, in the landmark case Darling v. Charleston Community Memorial Hospital (Darling, 1965), the
governing body and the hospital 1,vere found to have a "duty of care" to patients and were held
accountable for the selection of medical staff and the quality of care rendered in the hospital. Both
state licensure laws and The Joint Commission standards subsequently began to reflect this legal
mandate. Since then, responsibility for patient care, as well as organizational authority over
administration and the medical staff, has been vested with the governing body. In a subsequent
landmark case, Elam v. College Park Hospital ( E!a m, 1982), corporate liability was further expanded to
include the obligation to ensure effective medical staff peer review. The governing body divides and
delegates these responsibilities to administration and the medical staff as appropriate.
In addition to the legai pressures for governing body accountability based on malpractice case law,
there are now very strong financial pressures, supported through federal and state legislation. These
financial pressures range from capitated reimbursement to fines and fees associated with regulatory
compliance. Post World War II legislation brought the Hill-Burton Program (P.L. 79-725) (English &
Knowledge Service Groups, 1946) with hospital capital expansion and increasingly high-tech medicine.
Public policy created the insurance industry with all costs and charges covered without question. The
ultimate "third party payment" program came with the Medicare/Medicaid Program (P.L. 89-87,
1965), with its open-ended "indemnity" reimbursement.
Accountability and Liability Pressures
Corpor.:itc and governing body responsibilities for the quality of healthcare services provided by their
organization(s) increased dramatically due to pressures from Federal and State Government
regulations and strategies, business, healthcare professionals and respective organizations and
societies, and legal atmosphere and decisions.
468
Liability, according to the Oxford Dictionary is being "legally responsible for something" (Liability, n.d.).
In some states, there are monetary limitations to a liability. There are four main types of liability in
healthcare.
• Contractual liability obligates the practitioners or organization to perform according to what is

promised or advertised. A person takes on contractual liability when he accepts liability for the
acts of another in a written agreement or contract. A "breach of contract" may be affected if a
promised treatment or result is not performed or obtained, regardless of any negligence
involved. Claims made by product manufacturers generally fall under contractual liability .
• Tort liability is legal responsibility for civil wrongs, including invasion of privacy, lack of
consent, defamation of character, fraud and deceit, assault and battery, and
negligence/malpractice. Tort liability litigation most often includes monetary compensation for
both actual and punitive damages assessed by the courts, particularly if the tort is determined
to be intentional. There are three types of torts : Strict Liability, Intentional and Negligence
Torts. These are discussed more thoroughly in the next portion of this chapter.
• Corporate liability replaced charitable immunity as the doctrine dictating healthcare

organizations' legal responsibility to patients. The doctrine of Respondeat Superior ("let the
master be responsible") also known as vicarious liability (Respondeat Superior, n.d.) assumes
organizational liability for the negligent acts of its employees and of "ostensible agents" .
The doctrine of "ostensible agency" (vicarious liability) holds organizations liable for the
professional conduct of licensed independent practitioners and other workers who are not
employees (but may be under contract) when the patient associates the professional/worker
with the organization and is not privy to contractual arrangements (Worsham, 2017). For
example, physicians are presumed to be ostensible agents of a hospital unless there is clear
evidence that the patient was informed, in advance of treatment, of the independent
contractor status of the physician. Other examples include: a dialysis organization that sends
their staff in to a facility to do dialysis treatments, or a lithotripsy truck that visits once a
month to do lithotripsy.
• Criminal liability is legal responsibility for actions in violation of criminal law and punishable by
fine and/or imprisonment.
• Duty of care/duty to act was developed from the Darling v. Charleston Community Memorial
Hospital case previously discussed. There is an organizational liability for direct duties owed to
the patient and for the quality of medical care. The organization is liable for negligence in the
selection and monitoring of physicians . There is also organizational liability for breach of its
duty to the patient to prntect him or her from acts of malpractice by an independent physician
469
(and now other licensed independent practitioners}, if the organization knew, had reason to
know, or should have known of incompetence. The organization cannot defend itself on
grounds that medical and other professional staffs are independent and self-governing.
Consistent with duty to act or duty of care, the healthcare organization has a direct and
independent responsibility to patients for ensuring the competency of its licensed
independent practitioners and the quality of medical care provided. Elam v. College Park
Hospital, 1982, added the hospital's obligation to set up effer.tive medical staff peer review for
ongoing evaluation in order to identify otherwise unsuspected substandard practice.
• The doctrine of Res lpsa Loquitur ("The thing speaks for itself") refers to organizational or
personal liability due to circumstantial proof of negligence. The existence and nature of the
injury obviously proves a breach in standard of care or duty owed the patient, such as a
sponge or clamp left in the abdomen, or removal of the wrong body part (Res lpsa Loquitur,
n.d.).
Torts
There are three types of torts:intentional torts; negligence; and strict liability. Tort cases stem from a
failure of the 'duties' noted above. They are defined by the intent of the duty failure . Generally,
liability because of a tort only arises where the defendant either intended to cause harm to the
plaintiff or in situations where the defendant is negligent. However, in some areas, liability can arise
even when there is no intention to cause harm or negligence.
An intentional tort is a civil wrong that occurs when the person engages in intentional conduct that
results in damages to another (Torts, n.d.). Striking another person in a fight is an intentional act that
would be the tort of battery. Striking a person accidentally would not be an intentional tort since there
was not intent to strike the person. It is the intent to do harm that makes the act an intentional tort.
Strict liability or absolute liability results from cases of defective products or se rvices . For example,
cars recalled due to defective air bags. Any activity that is so dangerous to the public that there must
be liability qualifies as strict liability (Liability, n.d.).
Negligence
Negligence is careless conduct that results in damage to another . It is the failure to follow the degree
of care that would be followed by a reasonably prudent person in order to avoid foreseeable harm. It
is behavior that is less than the standards of behavior established by law for the protection of others
against unreasonable harm (Negligence, 2015).
In healthcare, a negligence lawsuit is referred to as Malpractice. Malpractice is a failure by a physician

or other professional to use the care and skill that other members of their profession would use under
470
similar circumstances . When an accountant, doctor, attorney, or some other professional contracts to
perform services, there is a duty to exercise skill and care as is common within the community for
persons performing similar services. Failure to fulfill that duty is malpractice (Torts - Negligence, n.d.).
The reasonable person standard specifies that to the degree of care required of a person is that which
an ordinarily prudent person would exercise under similar circumstances even though this standa rd
degree of care might not have prevented the harm from occurring. This degree of care will vary in
every situation. The "reasonable person" clause of this definition of negligence is what distinguishes
negligence from assault and battery (Negligence, 2015).
The elements required for a person to establish negligence are: there was a presence of duty; there
was a failure to act (breach of duty) according to the required standards of conduct/care; there was
proximate causation of harm; and the harm was caused by the breach of duty. All four of these
elements must be in place for the actions to be called negligent. For example, a physician driving by an
accident has no duty to stop and offer medical assistance so the doctor would not be negligent if he
keeps on driving.
Torts involve duties created by law. Just because someone is hurt does not mean that someone else
must pay for the harm. There must have been a duty, which has been broken. A plaintiff will not be
allowed to recover from a defendant if the defendant did not break a duty that was owed to the
plaintiff. For example, if a burglar breaks into a house and trips over an item of furniture, the
homeowner is not liable to the burglar because he had no duty to him. However, if a guest in a
person's home trips over a piece of furniture, the homeowner may have a duty to that guest. The
breach of duty must result from a voluntary act or failure to act.
In order for someone to be legally responsible for damages, it is necessary to show that the breach of
duty was the cause of the harm. The term used here is proximate cause, which means that the person
who has a breach of duty could foreseeably know that natural or probable consequences/harm could
be caused (Negligence, 2015). The plaintiff must prove that any negligence of which the defendant is
accused is the natural or probable cause of the plaintiff's injury. There may be an intervening cause,
which comes after the original negligence of the defendant, which may reduce the amount of the
defendant's liability. If this intervening cause is the substantial reason for the injury, then the
defendant will not be li:ible at al l (Torts - Negligence, n ct )
The final element of negligence is damages. A plaintiff may recover monetary damages to compensate
for the multiple things such as the economic losses of lost wages and medical expenses, and the
noneconomic losses of pain and suffering. Punitive damages designed to punish the defendant for his
wrongdoing may also be appropriate . The punitive damages are generally only appropriate if the
plaintiff can prove gross negligence or willful misconduct by the defendant . Many states have
undergone tort reform, which limits the damages the plaintiff may receive.
471
REGULATORY AND LEGAL HINTS
All federal laws, regulations, final rules, and interim rules are published in the Federal Register. They
can be found through the following government website. Under the section, "Federal Register
Publications and Online Services" is a link to the Federal Register 2.0., (www.federalregister.gov). The
most current issues are in a shortcut bar across the top of the web page.
New documents available for review ;:ind comment can be found at www.regulalions.gov.
Public Laws (P.L.) (Found under "Bill Searches and Lists")
• Congress www.congress.gov
Federal Bills and Reports
• House of Representatives www.house.gov
• Senate www.senate.gov
State Bills and Reports
• Each State Government has a website for bills, administrative rules and laws. Hint: Add your
state's website to your favorites.
Regulations associated with the Social Security Administration
• www.socialsecurity.gov/OP Home/comp2/comp2toc.html
Case Law Resources
To find specific case laws there are several sources available on the internet:
• Justia U.S. Law http://law.justia.com
o Case, Codes and Statutes, Regulations, Federal and State Laws.

o This resource may have city codes where they are available.
• Several paid resources include:
o Lexis Nexis http://www.lexisnexis.com

o Westlaw http://www.westlaw .com
472
U.S. HISTORICAL REVIEW - SAMPLE OF LAWS INVOLVING HEALTHCARE
1935
• Social Security Act of 1935 (www.ssa .gov/history/35act.html) On August 14, 1935, the Social
Security Act established a system of old-age benefits for workers, benefits for victims of
industrial accidents, unemployment insurance, and aid for dependent mothers and children,
the blind, and the physically handicapped.
1955
• Leneris v. Haas: Established hospital liability for employee and agent acts.
1965
• P.L. 89-97: Social Security Act (Titles XVIII and XIX: Medicare/Medicaid legislation for the
aged, permanently disabled, and the indigent). This amendment referred to as Old-age,
Survivors and Disability Insurance (OASDI). See the archives for more information on this
amendment at www.ssa.gov/po1icy/docs/ssb/v28n9/v28n9p3.pdf
• Darling v. Charleston Community Memorial Hospital: Established institutional liability for

the quality of medical care provided by physicians.
1972
• P.L. 92-603: Amendments to Social Security Act
• Professional Standards Review Organizations (PSROs);

www.ssa.gov/policy/docs/ssb/v36n3/v36n3p3.pdf
• Section 1160, quality assurance requirements for health care practitioners .
1973
• Health Maintenance Organization (HMO) Act (P.L. 93-222) required that HMOs accepting
federal funds have a QA program. (www.ssa.gov/policy/docs/ssb/v37n3/v37n3p35.pdf)
1974
• Department of Health, Education, and Welfare (HEW) released U.R. Standards for PSRO
review.
1975
• Diagnostic-Related Groups (DRGs) devised as a patient classification system by John

Thompson and Robert Fetter at Yale .
1979
• Quality Assurance Strategy for HMOs published by the Federal Office of HMOs required that
federally certified HMOs operate an internal QA program addressing both inpatient and
ambulatory care, and participate in external reviews.
47
3
1982
• Tax Equity and Fiscal Responsibility Act (TEFRA) (P. L. 97-248), Amendment to Section 143,
Part B of the Social Security Act, provided incentive for effective UR:
• Set cost-per-case limits for Medicare patients;
• Authorized incentive payments to hospita ls keeping costs below set targets .
• www .socialsecurity .gov/OP Home/comp 2/F097-248. html
• TEFRA Title I, Subtitle C, S. 2 142 entitled the "Peer Review Improvement Act"
• Replaced the PSRO program with the Utilization and Quality Control Peer Review
Organization (PRO) program;
• Required Medicare providers to release patient information to a PSRO or PRO for both
utilization and quality review .
• Elam v. College Park Hospital: Expansion of hospital corporate liability.
1983
• Title VI of Socia l Security Amendm ents (P.L. 98-21) - Prospective Payment System:
• Medicare reimbursement changed from reasonable cost to a pre-determined fixed

price per discharge;
• Set deadlines for implementation;
• Set limits for determination of hospital cost base and for routine nursing costs;
a Expanded PRO review to include all Medicare providers.
• www .ssa.gov/OP Home/comp2/F098-021.h tml
1985
• Consolidated Omnibus Budget Reconciliat ion Act (COBRA)
• Joint Commission began the Agenda for Change to reformulate standards, redesign
the survey process, and develop performance measures.
• www.soc ialsecur ity.gov/policy/docs/ssb/v49 n8/v49n8p22.pdf
1986
• Omnibus Budget Reconciliation Act (OBRA 86) ( P.L. 99-509)
• www.socia lsecurity.gov/ OP Home/comp2/ F099-509.html
• Health Care Quality Improvement Act (P.L. 99-660)
• www.socialsecurity.gov/OP Home/comp2/ F099-660 .html
• False Claims Amendment Act (P.L. 99-562)
• www.gpo .gov/fdsys/pkg/STA TUTE-100/pdf/STATUTE-100- Pg3153 .pdf
474
• Patrick v. Burget: A physician under review may file a federal antitrust claim against a
hospital and physicians for their medical staff disciplinary action.
1987
• Omnibus Budget Reconciliation Act (OBRA 87) (P.L. 100-203)
• www.socialsecurity.gov/OP Home/comp2/F100-203.html
• Medicare and Medicaid Patient and Program Protection Act (MMPPPA)
• JCAHO: Name change to Joint Commission on Accreditation of Healthcare

Organizations and implementation of Agenda for Change
1988
• Medicare Catastrophic Coverage Act (MCCA) (P.L. 100-360) enacted, then repealed, effective
1/1/90.
• Clinical Laboratory Improvement Act (CUA) enacted; most regulations effective 9/1/92
1989
• Total quality management (TOM) and continuous quality improvement (CQI) concepts
began to be applied to healthcare.
1990
• Patient Self-Determination Act (PSDA) (P.L. 101-508, Part of OBRA 90), effective 12/1/91
• Americans with Disabilities Act (ADA)
• Safe Medical Device Act (SMDA) (P.L. 101-629)
• www .gpo.gov/fdsys/pkg/STATUTE-100/pdf /STATUTE-100-Pg3153.pdf
1993
• www .socialsecurity.gov/OP _Home/comp2/F103-066. html
1996
• Health Insurance Portability and Accotmtability Act (HIPAA) (P.L. 104-191)
47
5
1997
• Balanced Budget Act (BBA) (P.L. 105-33). Established Medicare+Choice, Part C of Title XVIII of
Social Security Act, and State Children's Health Insurance Program (SCHIP) .
• www.socialsecurity .gov/OP Home/comp2/F105-033.html
1999
• Balanced Budget Refinement Act (BBRA): Program modifications.
• Institute of Medicine report on medical error, "To Err is Human" (11/99).
• ( iom.nationa lacademies.org/Im edia/Files/Report%20Fi Ies/ 1999/To-Err-is-

Human/To%20Err% 20is%20H uman%201999%20%20re port%20brief. pdf
2000
• Benefits Improvement and Protection Act (BIPA): BBA program modifications (Medicare,
Medicaid, and SCHIP).
2001
• Institute of Medicine report on the status of healthcare delivery in the U.S., "Crossing the
Quality Chasm," released 3/1/01.
• iom.nationalacademies .org/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-
System-for-the-21st-Century.aspx
2003
• Medicare Prescription Drug, Improvement, and Modernization Act (MMA) (P.L. 108-173)
www .socialsecurity.gov/OP Home/comp2iF108-173.html
2005
• Patient Safety and Quality Improvement Act (PSO Act) (P.L. 109-41):
• Created Patient Safety Organizations (PSOs) and Network of Patient Safety Database ( N PSD).
• Deficit Reduction Act (DRA) (P.L. 109-171) Impacted inpatient and dialysis PPS, Medicare
demonstration projects, DME, physician fee schedule, therapy services, federally qualified
health centers, home health, PACE, drug payments, Medicaid utilization data, administration,
long-term care, false claims recovery, payment.
• www.socialsecurity .gov/OP Home/comp2/F109-171.html
2006
• Tax Relief and Health Care Act (TRHCA) (P.L. 109-432) Established physician quality reporting
system, with incentive payment.
476
2008
• Medicare Improvements for Patients and Providers Act (MIPPA) (P.L. 110-275) For mental
health, increased provider payments, Medicare co-payment parity (80-20 from 50-50) with
other medical services; PQRI bonus payment increase.
2009
• American Recovery and Reinvestment Act (ARRA) (P.L. 111-5) Economic jumpstart support
for Community Health Centers, Medicaid and prescription drug funding, immunization grants,
National Institutes of Health medical research, state Health IT.
• Health Information Technology for Economic and Clinical Health (HITECH) Act,
enacted as part of the American Recovery and Reinvestment Act of 2009, to promote
the adoption and meaningful use of health information technology. Subtitle D of the
HITECH Act addresses the privacy and security concerns associated with the electronic
transmission of health information, in part, through several provisions that strengthen
the civil and criminal enforcement of the HIPAA rules.
• Omnibus Rulemaking to strengthen the privacy and security protections for health
information established under the Health Insurance Portability and Accountabi lity Act
of 1996 (HIPAA).
• Children's Health Insurance Program Reauthorization Act (CHIPRA) (P.L. 111-3): Reauthorized
CHIP and funded through 2013.
2010
• Patient Protection and Affordable Care Act (PPACA) or (ACA) (P.L. 111-148) Signed 23 March,
2010. Expanded health care coverage to 2/3 of uninsured Americans through a combination of
cost controls, subsidies and mandates.
• (www.socialsecurity.gov/OP Home/comp2/F111-148.html)
• Health Care and Education Reconciliation Act (P.L. 111-152) Signed 30 March, 2010. Changed
some healthcare provisions in PPACA and added the Student Aid and Fiscal Responsibility Act
as a rider.
• (www.congress .gov/111/plaws/publ148/PLAW-111publ148.pdf)
47
7
LEGAL FOUNDATIONS FOR QUALITY PRACTICE
Federal Program Participation and Quality Improvement Organizations
There are numerous federal regulations governing healthcare, and they continue to increase and
expand on an annual basis. Federal healthcare legislation is developed, massaged, and eventually
passed by the United States Congress. It is then interpreted and implemented by the Department of
Health and Human Services (HHS) and its subsidiary, the Centers for Medicare and Medicaid Services
(CMS).
On June 14, 2001, U.S. Health Secretary Tommy Thompson announced a name and structure change
for the Health Care Financing Administration (HCFA) to the Centers for Medicare and Medicaid
Services (CMS). The federal agency, was split into three main divisions (CMS, 2017):
• The Center for Medicare Management: Fee-for-service program administration
• The Center for Beneficiary Choices: Beneficiary education and Medicare Advantage
managed care programs administration
• The Center for Medicaid and State Operations: Oversight of programs administered by
states, including Medicaid, the State Children's Health Insurance Program (SCHIP), and
insurance regulation
Medicare and Medicaid
Medicare and Medicaid are two governmental programs that provide medical and health-related
services to specific groups of people in the United States. In 1965, The Social Security Act (P.L. 89-97)
was passed by Congress and signed by President Johnson. Titles XVI Ii and XIX of the Act established the
Medicare and Medicaid Programs, healthcare legislation for the aged, permanently disabled, and the
indigent. Both Medicare and Medicaid are managed by the Centers for Medicare and Medicaid
Services, a division of the U.S. Department of Health and Human Services .
CMS developed and administers the Conditions of Participation {CoPs) and Conditions for Coverage
(CfCs), that health care organizations must meet in order to begin and continue participating in the
Medicare and Medicaid programs. These health and safety standards are the foundation for improving
quality and protecting the health and safety of beneficiar ies . For example, the Conditions of
Participation for Hospitals are part of the Code of Federal Regulations. Hospitals must meet all of the
Conditions established by Medicare and Medicaid to receive reimbursement for treating Medicare
beneficiaries. CMS also ensures that the standards of accrediting organizations recognized by CMS
(through a process called "deeming") meet or exceed the Medicare standards set forth in the
CoPs/CfCs (COP, 2013).
478
Revisions to the Conditions of Participation and Conditions for Coverage: Retrieved from
http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index .html accessed July 8,
2015.
Medicare System
The Medicare program is an insurance program financed through taxes paid by employees and
employers. The primary purpose of the program is to provide a health care safety net for individuals
retired from the workforce. The three groups that are eligible for Medicare are individuals aged 65 and
older who have paid into the system, certain individuals under age 65 who have disabilities, and
individuals with End-Stage Renal Disease.
The Centers for Medicare and Medicaid Services (CMS) is given the responsibility by the Department of
Health and Human Services to establish guidelines and regulations to implement federal legislative
mandates concerning the Medicare Program. State or regional Quality Improvement Organizations
(QIOs) are under contract with CMS to monitor the care provided to Medicare patients.
Medicare has four parts, A, B, C, and D. These parts can be subscribed to independently or in various
combinations. The most commonly known part is Part A, which is the insurance for hospitalization,
skilled nursing, certain home health services and other services . It is available without cost to
individuals who paid Medicare taxes and certain other individuals. Medicare Part B is the medical
insurance. There is a monthly premium and enrollees must be eligible to receive Medicare Part A. The
Medicare Part C is also known as, the Medicare + Choice, or Medicare Advantage plans. These plans
are additional coverage plans obtained from private insurance agencies to pay for the things not
included in the Medicare Parts A and B. Medicare Part D, established in 2006, is a prescription drug
plan purchased from private insura ce agencies. Part D requires a premium and deductibles. The
purpose of Part D is to cover the gap when Medicare does not cover the cost of the medications. Table
1lists the items covered under Medicare Part A and Part B.
Table 1: Coverage for Medicare Part A and Part B

Coverage for Medicare Part A and Part B
Medicare Part A Medicare Part B
• Hospitalization for illness or injury • Medical and other services such as non-
routine doctor visits, medical equipment,
• Inpatient psychiatric care
outpatient therapies
• Care in a skilled nursing facility
• Home health care for individuals with an illness

• Clinical lab services
or 'injury and meeting certain conditions. This • Home health care for individua ls with an
benefit provides part time limited skilled illness or injury and meeting certain
nursing care and other therapeutic services. conditions. This benefit provides part time
limited skilled nursing care and other
. .
.l.l,·,-.-..._=:''"j
47
9
• Hospice care for individuals meeting certain therapeutic services.

conditions (must be terminal within 6 months
• Outpatient hospital services for diagnosis
as determined by a physician)
and treatment of injury
• Blood given at a hospital or skilled nursing
• Blood
facility
• Preventative Services including bone mass
measurement, colorectal cancer screening,
diabetes monitoring, annual mammogram
screening, pap smears and pelvic exams,
prostate cancer screening and vaccinations
Medicaid System
The U.S. Federal Medicaid Program was established in 1965 under the same legislation as Medicare.
Changes to the Medicaid laws come just as Medicare changes do-through budget-related legislation,
e.g., the Balanced Budget Act (BBA) of 1997, Balanced Budget Refinement Act ( BBRl1) of 1999, and
Benefits Improvement and Protection Act (BIPA) of 2000. Medicaid is a federal-state assistance
program rather than an insurance program like Medicare (Medicaid, n.d.).
The Centers for Medicare and Medicaid Services (CMS) has overall responsibility for the program, with
the day-to-day administration delegated to each state through its own Department of Health, based
on federal policy guidelines, limits, and payment rates. On the average, the Federal Government pays
for approximately 57% of Medicaid expenditures, and the states pay for 43%.
!n most states, the program is offered to those individuals and families meeting certain iow- or no-
income criteria who generally own no property, though home ownership is permitted in some states.
Medicaid e ligibility includes children, parents, pregnant women, seniors and people with disabilities
who need the health coverage to get healthy and stay healthy. Employment is not necessarily a
determinant, but many who receive Medicaid have at least one person in the household who is
working. Generally, Medicaid coverage has no co-payment requirements, deductibles, or premiums,
and there is freedom of choice of provider, though eligibility requirements may be complex.
Approximately 50% of all Medicaid expenditures have been for long-term care at both skilled and
intermediate levels or for care of the developmentally disabled. Another 26% has been for general
hospital care. Medicaid reimbursement systems are established by each state, with federal approval,
so they vary greatly. Variations include managed care capitated options, discounted charges, flat daily
rates (regardless of level of care) and experiments with DRG reimbursements (Medicaid, n.d.).
Since it is a program where both the Federal Government and the State Government pay for the
program, Medicaid continues to be the center of debate as states continue to wrestle with the pros
480
and cons of expanding their programs in response to the options available under the PPACA legislation
(see PPACA legislation later in this chapter). The fifty states each have to decide if their state will
participate in this program or not, and currently not a ll fifty are participating.
The positive outcomes of a Medicaid expansion would be to cover individuals up to 138% of the
Federal Poverty Level (FPL). In 2013, this would have equated to households of one receiving $15,856
per year and for households of four receiving $32,499 per year. According to the PPACA rules,
individuals between 100-138% of the FPL could access tax subsidies to purchase insurance through the
exchange. The expansion would have also required coverage of the Essential Health Benefits (EHB).
EHB include: Ambulatory Patient Services, Emergency Services, Hospitalization, Maternity and
Newborn Care, Mental Health and Substance Use Disorder Services, Prescription Drugs, Rehabilitative
and Habilitative Services & Devices, Laboratory Services, Preventive and Wellness Services and Chronic
Disease Management, and Pediatric services, including oral and vision care. Most of these were
already covered under the Medicaid plans.
The negative side is the costs to be incurred by the states . The first three years the Federal
Government pledged to cover 100% of the cost difference . After the first three years, the percentage
of cost different ial dropped incrementally adding the cost burden for the expansion to state budgets.
)Prospective Payment System (PPS)j
In 1983, Congress adopted the Social Security Amendments of 1983, which included measures to
establish a prospective payment system for Medicare inpatient hospital services (Scott, 1984) . The
prospective payment system was designed to make reimbursements for care in a predetermined, fixed
amount. CMS has created separate perspective payment systems since 1984 for acute inpatient
hospitals, home health agencies, hospice, hospital outpatient, inpatient psychiatric facilities, inpatient
rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and federally qualified health
centers (CMS - PPS, 2015). Each of the separate PPS's can be found at this CMS website :
www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/ProspMedicareFeeSvcPmtGen/index.html
A fee schedule is a complete listing of fees used by Medicare to pay doctors or other
providers/suppliers. This comprehensive listing of fee maximums is used to reimburse a physicia n
and/or other providers on a fee-for -service basis. CMS develops fee schedules for physicians,
ambulance services, clinical laboratory services, and durable medical equipment, prosthetics,
orthotics, and supplies.
Quality Improvement Organization and Medicare Scopes/Statements of Work
History of Professional Standar ds Review Organizations (PSRO)
481
Professional Standards Review Organizations (PSRO) established by Public Law 92-603, Ame ndment to
Social Security Act, in 1972, were physician-sponsored and established to assure services provided to
Medicare and Medicaid patients worked and employed concurrent utilization review, including
admission and continued stay review . The PSRO's have performed medical care evaluation studies and
profile analyses, and have functioned like government agencies with annual federal grants as their
funding source .
In 1982, Peer Review Organizat ions (PROs) were established by the Tax Equity and Fiscal Responsibility
Act (TEFRA), 1982, in the "Peer Review Improvement Act" (S.2142, P.L. 97-248). This law replaced the
federal PSROs and initiated contract bidding by competing review organizations, either nonprofit or for-
profit (one per state), created geographic consolidation (QIO boundaries coincident with statewide or
regional boundaries), and did not have delegated review .
In January 2002, the Peer Review Organizations (PRO) changed their name and focus to Quality
Improvement Organizations (QIO). In 2014, the QIOs were split into two separate entities under the
Q!O umbrella in order to improve the efficiency of their activities : Beneficiary and Family Centered
Care (BFCC - QIO); and Quality Innovation Network (QIN - QIO) (CMS-QIO, 2017).
The primary purpose of the original PRO program was quality-protected cost containment. The current
QIO Program is dedicated to improving health quality for Medicare beneficiaries . The QIO is an integral
pa rt of the U .S. Department of Health and Human (HHS) Services' National Quality Strategy for
providing better care and better health at lower cost. By law, the mission of the QIO Program is to
improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare
beneficiaries.
The QIO Program changes include separating case review from quality improvement, extending the
contract period of performance from three (3) to five (5) years, removing requirements to restrict QIO
activity to a single entity in each state/territory , and opening contractor consideration to a broad
range of ent ities to perform the work. With the removal of the state restrictions, the number of QIOs
w as reduced and all QIOs now represent more than one state. Now, one group of QIOs will handle
complaints while another group will provide assistance to support providers and suppliers in improving
their care and services (Table 2) .
Benefic iary and Family Centered Care (BFCC) -QIOs perform statutory review functions, including
complaints and quality of care reviews for people with Medicare. They ensure consistency in the case
review process while considering the local factors and needs. This will include general quality of care,
medical necessity, and readmissions. There are also five Beneficiary and Family Centered Care areas
w ith eight or more states and territories . There are only two agencies which have the contracts for
these five areas (Table 2) (QualityNet, n.d.).
482
Quality Innovation Network (QIN)-QIOs provide to healthcare organizations education, outreach, and
sharing practices that have worked in other areas. The QIN will utilize data to measure improvement,
and will work with patients, families and community partners through communication and
collaboration. QIN-QIOs also focus on targeted health conditions and priority populations to reduce
the incidence of healthcare-acquired conditions . There are currently 14 Quality Innovation Networks,
w ith each responsible for three to six states and/or territories. For example, Texas Medical Foundation
is now the QIO for Arkansas, Missouri, Oklahoma, Puerto Rico, and Texas (QualityNet, n.d.).
Table 2: QIO Group Functions

QIO Group Functions
Beneficiary and Family Centered Care (BFCC) Quality Innovation Network {QIN)
• Quality of Care Reviews (includes Essential Functions:

compla ints) • Cham pion local-level, results-oriented
change
• Medical Necessity Reviews
• Higher Weight DRG Reviews • Facilitate learning and action networks
• Readmission Reviews • Teach and Advise as technical experts
• EMTALA Reviews • Integrated Communicat ions
• Focused Reviews Triple Aim (SoW):

• Recommendations for Quality Improvement • Better Health
Initiatives (Oil's) & Technical Assistance
• Better Care
• Discrimination Referrals
• Lower Costs
• Patient and Family Engagement
Adapted from CMS-QIO, 2017
QIOs are not federal agencies and are exempt under the Freedom of Information Act. The government
contracts with the QIOs for their services. Data submitted to or used by the QIO is not discoverable .
The QIO maintains the author ity to revoke or rebut waiver of liability transferred from the Fiscal
Intermediaries to QIO's. Confidential information must be shared upon request of a state licensing
agency, a certifying agency, and/or a national accreditation body, but only when that information is
necessary for those agencies to conduct their certification/accreditation activities. Non-confidenlici l
information must be supplied to anyone requesting and paying for such information.
Scope of Work
QIO activities with both beneficiaries and the medical communities in the state have increased in
recent years. The activities of the QIO are known as the "Scope of Work" (SoW). They are numbered
consecutively every 4 years. Each Scope of Work is outlined in the Federal Register and is based on
483
analysis of the previous SoW. The current 11th Scope of Work will be in place from August 1, 2014
through July 31, 2019. Table 3 contains the main focus of this SoW, which is based on the Triple Aim.
Table 3:CMS 11th Scope of Work

CMS 11th Scope of Work
AIM Goal Focus
Healthy People, Promote effective prevention and • Improving cardiac health and
Healthy treatment of chronic disease reducing cardiac healthcare
Communit ies: disparities
Improving the
Health Status of
• Reducing disparit ies in diabetes care
Communities • Using immunization information

systems to improve prevention
coordination
• Improving prevention coordination

through meaningful use of HIT and
collaborating with regional extension
centers
Better Healthcare 1. Make care safer by reducing • Reducing healthcare-associated

for Communit ies: harm caused in the delivery infections
Beneficiary- of care
I•
Reducing healthcare-acquired
Centered,Reliable, I conditions in nursing homes
Accessible, and
Safe Care I I
2. Promote effective • Coordination of care
communication and
coordination of care
Better Care at a Make care more affordable • Quality improvement through
Lower Cost physician value-based modifier and
physician feedback reporting
program
• QIN-QIO proposed projects that

advance efforts for better care at
I
I lower cost
Other technical assistance • Quality improvement initiatives

projects
A dapted from Stratus Health,(n.d.)
484
American Recovery and Reinvestment Act (ARRA) of 2009 (P.L. 111-5)
On February 13, 2009, in direct response to the economic crisis and at the urging of President
Obama, Congress passed the American Recovery and Reinvestment Act of 2009 -- commonly referred
to as the "stimulus" or the "stimulus package" (AARA, 2009) . This act encompassed many individual
provisions including education benefits, home buying credits, new vehicle credits and home energy
credits, to name a few. However, this law also added provisions for health care like the HITECH Act and
Health Information Technology upgrades and grants to improve medical record connectivity and
stimulate the adoption of an electronic medical record. Some states also took advantage of the
additional funding available for Medicaid program expansions.
The Health Information Technology for Economic and Clinical Health (HITECH) Act, Division A: Title XIII
of the American Recovery and Reinvestment Act (ARRA) of 2009 (P.L. 111-5), provided incentives for
development and adoption of national health information technology (HIT) standards toward a fully
interoperable health information system and "improved" the HIPAA privacy and security provisions
(Subtitle D) (HITECH, 2009).
Medicare and Medicaid Health Information Technology, Division B: Title IV of the ARRA, provided
incentive programs to eligible professionals, hospitals, and critical access hospitals to allow them to
adopt, implement or upgrade electronic health records (CMS - EHR, 2017). The Incentive Programs
allocated over $22 billion to stimulate adoption of (EHR) systems by designated practitioners, from
2011 through 2016. Physicians and other qualified practitioners in outpatient clinic settings apply for
health information technology (HIT) stimulus money, up to $44,000 total over five years in the
Medicare Incentive Program and up to $63,750 over six years in the Medicaid Program. Eligible
hospitals and critical access hospitals that begin the Medicare or Medicaid Program between 2011and
2016 receive a $2 million base payment. By January 2015, more than 400,000 eligible hospitals and
professionals had adopted or were meaningfully using EHRs. The CMS is currently working on adapting
the EHR incentive programs to account for the changes that have occurred since this begun in 2011
(ARRA, 2009) .
!Patient Protection and Affordable Care Act (PPACA)i
The Patient Protection and Affordable Care Act (P.L. 111-148), commonly referred to as "Obamacare",
"Healthcare Reform", "Affordable Care Act", and "ACA", was signed into law March 23, 2010. It was
immediately amended by the Health Care and Education Reconciliation Act (HCERA) (P.L. 111-152),
signed March 30, 2010, included changes to the PPACA by adding the Student Aid and Fisca l
Responsibility Act (PPACA, 2015).
Provisions
The bill is divided into 10 main areas, which are shown in Table 4. Most of the health-related
provisions took effect between 2010 and 2014, with a few extending to 2018. Provisions include:
485
expanded Medicaid eligibility for those states which elected to accept the expansion; expanded
Medicare Part D by closing the coverage gap ("donut hole") by 2020; a pilot program for tort reform;
subsidization of insurance premiums; incentives for businesses to provide health care benefits;
support for medical research, initiated the development of accountable care organizations; initiation
of the health insurance exchange (marketplace); and several health insurance mandates. Since 2010,
the PPACA has been modified many times. The U.S. Health and Human Services website at
http://www.hhs.gov/healthcare/facts/timeline/timeline-text .html contains a list of changes year by
year for your reference . The required preventive services mandated are based on the category A and B
services by the Preventive Services Taskfo rce. The exact list is updated frequently and is found at:
http://www.uspreventiv eservicestaskforce.org/Page/Name/uspstf-a-and-b-recommendations -by-
date/.
Table 4: Ten Areas of PPACA

Ten Areas Of PPACA
• Eliminating the underwriting of pre-existing conditions
• Eliminating lifetime and annual limits on benefits
• Requiring coverage of preventive services, immunizations and coverage for pregnancy

regardless of gender
• Extending dependent coverage up to age 26 on a parent's plan with the parent's permission
• Developing uniform coverage documents for health insurance comparisons
• Capping medical loss ratios
• Expanding the appeals process
• Creating the Health Insurance Exchange (renamed Health Insurance Marketplace) to assist
the identifying of coverage options: www.HealthCare.gov
• Creating a re-insurance and Premium Stabilization Program
• Facilitating administrat ive simplification to lower health system costs
!Accountable Care Organizations!
Accountable Care Organizations (ACOs) are groups of doctors, hospitals, and other health care
providers, who work together to give coordinated high-quality care to their patients, at lower costs.
The ACO comes from the PPACA as one of the ways to increase coordination of care and reduce costs.
An ACO is not a Medicare Advantage plan or an HMO. The goal of coordinated care is to ensure that
patients, especially the chronically ill, get the care they need and at the right time, without
unnecessary duplication of services and while preventing medical errors. The ACO members will then
share in the savings obtained through their coordinated efforts (CMS - ACO, 2017).
486
With managed care, the patient pays the health plan and holds it accountable for care delivery. In an
ACO ,the provider's accountability will still be through the contract with the health plan but the health
plan will reimburse the ACO as a who le and not the individual provider. The ACO will then be
responsible for dividing the reimbursement between all of the practitioners and facilities who
participated in the ca re of the patient.
Medicare currently offers three ACO programs:
• Medicare Shared Savings Program is a program that helps Medicare fee-for-service program
providers become an ACO and share the savings. The Shared Savings Program aims to improve
patient outcomes and increase value of care by providing better care for individua ls, better
health for populations, and lowering growth in expenditures (CMS - MSSP, 2017). The ACOs in
this program will receive the savings when they lower their growth in health care costs, while
meeting performance standards on quality of care, and putting patients first.
• Advance Payment ACO Model is a supplementary incentive program for selected participants
in the Shared Savings Program. Selected participants in the ACO receive upfront and monthly
payments, which they can use to make important investments in their care coordination
infrastructure . This is usually for small ACOs who have a lack of ready access to the capital
needed to invest in infrastructure and staff for care coordinat ion (CMS-AP, 2017).
• Pioneer ACO Model is a program designed for early adopters of coordinated care who already
have experience in coordinating care for patients across care settings. These provider groups
can then move more rapidly from a shared savings payment model to a population-based
payment model. The population-based payment model is consistent with, but separate from,
the Medicare Shared Services Program. The population-based payment model is designed to
work in coordination with private payers by aligning provider incentives. This in turn will
improve quality and health outcomes for patients across the ACO, and achieve cost savings for
Medicare, employers and patients. CMS is no longer accept ing applications for this kind of
payment model (CMS - PACO, 2017).
LEGAL FOUNDATIONS FOR PATIENT PROTECTION
Patient Self-Determination Act (PSDA) of 1990
The Patient Self-Determination Act (P.L. 101-508), part of OBRA '90, took effect on December 1, 1991.
The law requires that providers develop policies and procedures addressing a patient's right to refuse
treatment and to execute an "advance directive" in accordance with individual state laws. The
requirements apply to hospitals, nursing facilities, health plans, home care and hospice programs
(Kelley, 1995). Section 1395cc(f) of the PSDA defines an advance directive as a written instruction, such
as "a living will or durable power of attorney for healthcare, recognized under State law ( whether
statutory or as recognized under State law (either statutory or case law) and relating to the provision of
such care when the individual is incapacitated" (Kelley, 1995).
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There are six requirements of the law:
1. Written policies and procedure for living wills and durable power of attorney
2. Written information to adult patients concerning their rights
3. Documentation in the medical record concerning existence of advance directive
4. Care not to be conditioned on whether or not the patient signed an advance directive
S. Ensure compliance with advance directives, once executed
6. Provide education for staff and the community on issue _oncerning advance
directives
Patient Rights and Responsibilities Legislation
Patients' Rights are established by federal law (e.g., Patient Self-Determination Act), state legislation,
by professional organizations, such as the American Hospital Association, and by accrediting agencies,
such as The Joint Commission and the National Committee for Quality Assurance. Patients'
Responsibilities are generally defined in case law and by accrediting agencies, and include: following
the instructions of their physicians and nurses, providing accurate and complete information, keeping
appointments, and considering the rights of others. The Medicare, Medicaid, and Hill-Burton programs
prohibit discriminat ion on the basis of race, creed, or color as a condition for receiving funds. A patient
may not be detained in the hospital for inabl!ity to pay ("false imprisonment"), nor can a patient be
discharged without his/her agreement. Patients with communicable diseases can be held by a health
officer to prevent spread of infection. Psychiatric patients can be detained if they are considered to be
dangerous to themselves or others.
!Health Insurance Portability and Accountability Act (HIPAA) of 199@
The Health Insurance Portability and Accountability Act of 1996 (H.R.1303, P.L. 104-191) was a major
health insurance reform bill. The provisions generally were effective on July 1, 1997, though many
have taken years to implement. The bill was updated in the Section 1104 of the PPACA in 2010 with
new and expanded provisions. It requires health plans to certify compliance with standards and
healthcare rules, and other items. The latest addition to the HIPAA compilation is the HIPAA OMNIBUS
FINAL RULE, released by HHS on January 17, 2013 (HIPAA, 2017).
In summary, The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S.
Congress in 1996. The Act is massive in scope. Title II of HIPAA, known as the Administrative
Simplification Provisions, requires the establishment of national standards for electronic health care
transactions and national identifiers for providers, health insurance plans, and employers. The
Administrative Simplification Provisions also address the security and privacy of health data. The
standards are meant to improve the efficiency and effectiveness of the nation's health care system by
encouraging the widespread use of electronic data interchange (HIPAA, 2013). The HIPAA Privacy Rule
48
8
provides federal protections for individually identifiable health information held by covered entities
(healthcare providers, health plans, and healthcare clearinghouses) and their business associates . The
rule also gives patients an array of rights regarding their personal health information. The Privacy Rule
permits the disclosure of health information needed for patient care and other important purposes.
The Security Rule specifies a series of administrative, physical, and technical safeguards for covered
entities and their business associates to use to assure the confidentiality, integrity, and availability of
electronic protected health information.
Americans with Disabilities Act (ADA) of 1990
The Americans with Disabilities Act was enacted on July 26, 1990. It prohibits discrimination on the
basis of disability in employment, public accommodations, state and local government services, public
transportation, and telecommunications. The act prohibits discrimination on the basis of race, color,
religion, sex, or national origin. In 1973, Section 504 of the Rehabilitation Act designated the ADA as an
"equal opportunity" law for people with disabilities. The provisions dealing with employment and
public accommodations are of the greatest interest to healthcare organizations and physicians (ADA,
n.d.). Any person who has a record of having or is regarded as having a physical or mental impairment
that substantially limits one or more of the person's major life activities, is covered by this act. The Act
does not cover persons with sexual behavior disorder, bisexuality, compulsive gambling, use of illegal
drugs, exhibitionism, gender identity disorders, homosexuality, kleptomania, pedophilia, psychoactive
substance abuse disorders, pyromania, transsexualism, transvestitism, and voyeurism.
The Department of Justice's revised regulations for Titles II and Ill of the Americans with Disabilities
.Act of 1990 were published in the Federal Register on September 15, 2010. These regulations adopted
revised, enforceable accessibility standards called the 2010 ADA Standards for Accessible Design,
"2010 Standards." On March 15, 2012, compliance with the 2010 Standards was required for new
construction and alterations under Titles II and fil. March 15, 2012, is also the compliance date for
using the 2010 Standards for program accessibility and barrier removal (ADA - Title II, 2010) (ADA -
TITLE 111, 2010).
LEGISLATION IMPACTING ORGANIZATIONAL ACTIVITIES
Corporate Compliance
Compliance with law and government reg1il;:itions is an expectation for all healthcare organizations.
The impetus here has come from onerous penalties applied for violat ions in U.S. Federal and State
healthcare programs. For most organizations, however, compliance is an intent arising from its heart:
its organizational values and ethics and the commitment of its leaders.
In many organizations, a Chief Compliance Officer is responsible to establish and oversee processes
necessary to prevent or quickly identify any inaccurate billing practices or actual misbehavior that
might result in errors being investigated as fraudulent practice by the Office of Inspector General
489
(OIG). Quality professionals and risk management professionals are likely candidates for this role. In
many smaller organizations, the Quality Professional will also have the Compliance responsibilities in a
combined position.
The definition of compliance is to act in accordance with another's command, request, rule, or wish
(Compliance, 2017). In healthcare, this translates to providing billing, reimbursing and monitoring
services according to the laws, regulations, administrative rules and guidelines governing the
organization.
In 1997, the Columbia/HCA Company was part of a fraud investigation initiated by a number of
governmental departments in the United States. Later that year, Rick Scott resigned as Chairman. In
May 2000, Columbia/HCA Healthcare Corporation agreed to pay the U.S. Government $745 million to
resolve most of several Medicare fraud allegations, including home healthcare issues and laboratory
claims billing. The probe first became public in March 1997. The case was settled in 2003 at a reported
cost of $2 billion to HCA. This made it the largest fraud settlement in U.S. history (U.S. Dept. of Justice,
2010).
False Claims Act (FCA) of 1863 and 1986
Since the Columbia/HCA case, issues of compliance by healthcare organizations with federal and state
regulations, particularly those related to billing and business relationships, has been a top priority for
healthcare organizations and the government. The top compliance associated issues prior to the
Patient Protection and Affordable Care Act are the False Claims Act (1863) and the False Claims
Amendment Act of 1986 (P.L. 99-562) which are the basis for much of the current focus on fraud and
abuse. There have been three additional amendments since the 1986 amendments (False Claims Act,
2011).
The Federal False Claims Act (FCA) was signed into law by Abraham Lincoln in 1863 to encourage
private persons to report fraud against the Union, particularly war profiteers. Specific intent to defraud
was necessary to prosecute. The False Claims Amendment Act of 1986 (P.L. 99-562) allows any citizen
to file suit in federal district court against anyone who "knowingly presents" a false or fraudulent claim
to the Federal Government (False Claims Act, 2011).
The law has been in effect since Civil War days, but was amended to increase incentives and
protections for citizens who report, "crooked government contractors ." Legislators became very
interested in using the act to reduce false Medicare and/or Medicaid claims. There are those who see
the act as an ideal way for healthcare personnel to report fraud when frustrated with the
organization's failure to act. The FCA has determined that a pattern or practice that results in
overbilling to the Federal Government is sufficient to prosecute a healthcare provider. A person who
makes a mistake in the submission of false information does not violate the FCA (False Claims Act,
2011).
490
The FCA Provisions note that the information provided by insiders is essential for the government in
bringing a fraud action. The 1986 FCA amendments entitle the reporting individual(s) to 15 to 25%
when the government intervenes in any litigation. If the government does not intervene and there is a
judgment or settlement, the individual(s) is entitled to 25 to 30% of the recovery. The FCA provides for
mandatory civil penalties of $5,500 - $11,000 per false claim, plus damages, government costs, and
attorneys' fees (False Claims Act, 2011) .
To report fraud, the hotline phone number is 1-800-HHS-TIPS (1-800-447-8477) or the individual can
go to the website at https://forms.oig.hhs .gov/hotlineoperations/nothhsemployeeen.aspx.
Stark Law
The Stark Law, in three separate provisions, governs physician self-referral for Medicare and Medicaid
patients. The law is named for United States Congressman Pete Stark, who sponsored the initial bill.
Physician self-referral occurs when a physician refers a patient to another healthcare site or
practitioner in which he/she has a financial relationship, such as ownership, investment, or structured
compensation arrangement (Stark Law, 2013).
The Omnibus Budget Reconciliation Act of 1989 (OBRA 1989) (P.L. 101-239), known as Stark I, barred
self-referrals for clinical laboratory services under the Medicare program, and was in effective as of
January 1, 1992. The Omnibus Budget Reconciliation Act of 1993 (OBRA 1993) (P.L. 103-66), known as
Stark II, expanded the restriction to a range of additional health services and applied it to both
Medicare and Medicaid. Stark II also contained clarifications and modifications to the exceptions in the
original law. Minor technical corrections to these provisions were included in the Social Security
Amendments of 1994 (P.L. 103-432).
The Stark Ill final rule was published on September 5, 2007, at 72 FR 51012 in the Federal Register, and
it became effective December 4, 2007 . This rule added more clarification as to what referrals are
allowed and which ones are prohibited. More specific information regarding the Stark law can be
found at www.starklaw.org.
Medicare and Medicaid Patient Protection Act of 1987 (P.L. 100-93)
The Medicare and Medicaid Patient Protection Act of 1987 (MMPPA) (P .L. 100-93) is referred to as the
Anti-kickback Statute. The statute provides criminal penalties for certain acts impacting Medicare and
Medicaid reimbursable services . Particularly, the statute prohibits the offer (solicitations) or receipt of
certain remuneration in return for referrals for or recommending purchase of supplies and services
reimbursable under government health care programs. The remuneration offer itself may entice an
individual to refer a patient or recommend particular services or supplies to a patient, and is illegal.
The Secretary of the Department of Health and Human Services is allowed to establish exceptions,
491
called safe harbors, to this rule to identify practices that do not violate the Anti-kickback Statute,
which can be found at 42 C.F .R. §1001.952.
Compliance Programs
The best source for compliance program templates and guidance is on the Office of Inspector General
website (oig.hhs.gov). The most recent addition to the OIG materials for Health Care Boards was
published on April 20, 2015, by a collJboration of the OIG, Association of Hec1lthcare Internal Auditors,
Healthcare Compliance Association and American Health Lawyers Association,
(http://oig.hhs.govIcompl iance/ compliance-guidanee/docs/Practica 1-Guidanee-far-Hea Ith-Care-
Boards-on-Complianee-Oversight .pdf).
OIG Compliance Program Guidance
The OIG began publishing guidelines for establishing healthcare compliance programs with clinical
laboratories in the Federal Register in March 1997. Subsequently compliance program guidance for
specific areas (hospitals, home health agencies, third party payers, Medicare Advantage, managed care
organizations, durable medical equipment suppliers, physicians in solo and small group practices,
nursing homes, hospice, the pharmaceutical industry, and ambulance services) were developed.
According to the OIG, the plan must be unique to the individual entity's needs, exposures, and
resources and to its particular corporate structure, mission, and employee composition. Canned or
generic compliance programs are not acceptable to O IG (Matos, Heimer, Martin, Michalski, Roach, and
Teplitzky, 2015). The Health Care Compliance Association is the professional organization to assist with
this aspect of the compliance role. It offers training, certification, and publications committed to
improving the quality and recognition of the healthcare compliance indust;y (http://www.hcca-
info.org).
Elements of Compliance
To have a truly effective compliance program, organizations will need to create a culture of
compliance. This is a top-level commitment, which is part of organizational values, ethics, and
infrastructure. It is noteworthy that soon after the initial fraud investigation, Columbia/HCA replaced
its chief executive officer, hired a corporate ethics officer, and initiated restructuring of its acquisitions
nationwide (U.S. Dept. of Justice, 2010).
The OIG's document defines a comprehensive compliance program consisting of seven mandc1tory
elements. Table 5 lists these elements.
492
Table 5: OIG Comprehensive Compliance Program Essential Elements

OIG Comprehensive Compliance Program Essential Elements
1. Conducting internal monitoring and auditing
2. Implementing compliance and organizational standards
3. Designating a Compliance Officer (not general counsel or CFO) who reports direct ly to the
CEO and governing board
4. Conducting appropriate training and education
5. Responding appropriately to detected offenses and developing corrective action
6. Developing open lines of communication
7 . Enforcing disciplinary standa rds through well-publicized guidelines
Self-Disclosure
If in the event the organization has an issue of non-compliance which could be found during an
internal investigation, which could otherwise be reported by a whistle blower, the OIG strongly
suggests the organizat ion to do a self-report. The Office of Inspector General (OIG) has several self-
disclosure processes that can be used to report potential fraud in Department of Health and Human
Services (HHS) programs. Self-disc losures are voluntary and it has helped to decrease the Civil and
Monetary Penalties (fines and fees) against an organization (OIG, n.d.).
Note: When self-disclosing, it is important to have your data available and an action plan in place.
More information on self-disclosure can be found at http://oig.hhs .gov/compliance/self -disclosure-
info/index.asp.
Healthcare Quality Professionals & Compliance Information
Three initial documents for a Healthcare Quality Professional to review are noted below. They focus on
the education of the Board of Directors of a healthcare entity. They also give the new quality
professional a nice overview of the interconnectivity between the compliance and quality specialties.
From the corporate duties of care to monitoring of indicators, these will be good resources to have
readily available in your web browser favorites.
• Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards
of Directors, OIG and American Health Lawyers Association, 04-02-2003,
http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf
• Corporate Responsibility and Health Care Quality - A Resource for Health Care Boards of
Directors, O IG and American Health Lawyers Association, 09-13-2007,
http://oig.hhs.gov/fra ud/docs/complianceguida nce/CorporateResponsibi lityFina 1%209-
4-07. pdf
493
• Practical Guidance for Health Care Governing Boards on Compliance Oversight, OIG,
Association of Healthcare Internal Auditors, American Health Lawyers Association and
Health Care Compliance Association, 04-20-2015,
http://oig.hhs.gov Icomplianee/comp Iiance-guidanee/docs/P ractica 1-Guida nce-for-
HeaIth-Care-Boards-on-Compliance-Oversight .pdf
The newest guide to assist in the measurement of Compliance was released in 7017. This guide is to
help assess the effectiveness of the compliance program.
• Measuring Compliance Program Effectiveness: A Resource Guide

Issue Date: March 27, 2017 by HCCA-OIG Compliance Effectiveness Roundtable
Meeting: January 17, 2017 I Washington, DC
https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide .pdf
National Practitioner Data Bank (NPDB)
The National Practitioner Data Bank (NPDB) is an electric confidential information clearinghouse
dedicated to improving healthcare quality, promoting patient safety and preventing fraud and abuse.
It contains information submitted from various sources regarding malpractice payments and certain
adverse events concerning practitioners, providers, suppliers, and entities such as insurance
companies. The reports from the NPDB are utilized by authorized organizations to make licensing,
credentialing, privileging, and/or employment decisions . The information provided through the NPDB
should be utilized to alert organizations that there may be a problem with the performance of a
practitioner, entity, provider, or supplier. Additional information should be sought regarding the issue
before a fina l decision is based on this information. Reports are confidential and are only released to
organizations as specified in the NPDB regulations. Organizations and individuals who are subjects of
these reports are allowed access to their information if they so desire (NPDB, 2015).
Title IV of P.L. 99-660 (HCQIA) led to the NPDB establishment. The HealthCare Quality Improvement
Act of 1986 (HCQIA) was designed to protect peer review bodies from damage liability and to prevent
incompetent practitioners from changing employers without disclosure of issues with care provision.
The final NPDB regulations (45 CFR part 60) were published in the Federal Register in 1989, and
opened in 1990 to support peer review and credentialing. Electronic queries were begun in 1992. In
1993, the National Committee for Quality Assurance (NCQA) (see Chapter 6 Regulatory, Accreditation,
and External Recognition) adopted standards requiring the HMOs to query the NPDB (NPDB, 2014).
The Healthcare Insurance Portability and Accountability Act of 1996 created the Healthcare Integrity
and Protection Data Bank (HIPDB) in order to collect data similar to the NPDB, but concerning fraud
and abuse in health insurance and health care delivery. In 1997, the law changed to have the NPDB
and the HIPDB coordinate their operations, since the reports received were similar at times. In 2010,
the NPDB under Section 1921 expanded information received and distributed to include all licensure
494
actions taken against all healthcare practitioners and healthcare entities. In 2013, the HIPDB merged
into the NPDB, creating one organization with all information collected and transmitted through the
NPDB (NPDB, 2014).
The reporting obligations apply to federa l and state agencies, but also include "health plans," broadly
defined to include all plans, programs, and organizations that provide health benefits directly or
through insurance, reimbursement, or otherwise, including self-insured employers. The required
reporting needs to occur on the website within 30 days of the final action, or the close of a monthly
reporting cycle, whichever is the later. The information is confidential and access is limited. Table 6
lists the availab le information which may be conveyed to approved entities who query this
information. However, hospitals, other health agencies, professiona l societiP.s, and QIOs are not
authorized to receive certain adverse action reports as listed in Section 1921.
Table 6: Information Available through Queries to the NPDB (not including exceptions in Section
1921)
Information Available through Queries to the NPDB (not including exceptions in Section 1921}
• Medical malpractice payments

• Certain adverse licensure actions taken by State medical and dental boards
• Certain adverse clinical privileges actions
• Certain adverse professional society membership actions
• DEA controlled-substance registration actions
• Exclusions from Medicare, Medicaid, and other Federal health care programs
• Negative actions or findings by peer review organizations
• Negative actions or findings by private accreditation organizations
• State licensure and certification actions
• Federal licensure and certification actions
Clinical Laboratory Improvement Act (CUA) of 1988
Final regulations were issued for the Clinical Laboratory Improvement Act (CLIA) Legislation (42 U.S.C.
263a) on 2/28/92, most effective on 9/1/92. The Act resulted from a series of Wall Street Journal
articles in 1987, exposing lab inaccuracies and fraud, untouched by regulation. The Clinical Laboratory
lmprovemenl Amendments of 1988 (CUA) regulations include federal standards applicable to all ll.S.
facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat
disease. The latest changes in the law occurred in 2012 with the passing of The Taking Essential Steps
for Testing Act of 2012 (TEST Act). This act, addressed the requirements and enforcement of
proficiency testing referral, with an amendment to the CUA 1988's certificate as stated in section 353
of the Public Health Service Act (42 U.S.C. 263a) (CUA, 2017).
495
Major components of the CUA include requirements and oversight by the Department of Health and
Human Services (DHHS), and certification with submission of data on operations and quality activities .
Accreditation is obtained through deemed organizations such as the College of American Pathologists
(CAP) . The regulations require entities to follow standards involving physical facilities, equipment,
quality monitoring policies, and qualifications of lab personnel. DHHS may invoke various penalties for
noncompliance.
CMS works a long with the Centers for Disease Control (CDC) and the Federal Drug Administration
(FDA) to assure clinical lab qua lity. The CDC's responsibilities for the national CLIA program include
(CLIA-CDC, 2017) :
• Providing analysis, research, and technical assistance
• Developing technical standards and laboratory practice guidelines, including standards

and guidelines for cytology
• Conducting laboratory quality improvement studies
• Monitoring proficiency testing practices
• Developing and distributing professional information and educationa l resources
• Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC)
The most significant aspect of the law is the authorization of DHHS to require proficiency testing for
most types of procedures performed in labs. DHHS approves such programs, including that of CAP.
DHHS requires an 80% standard, meaning that each test must be accurate in four of five challenges.
Previously, C.A.P only required two cha!!enges.
Safe Medical Device Act (SMDA) of 1990 and FDA Safety and Innovation Act (FDASIA) of 2012
The Safe Medical Device Act of 1990 was an update to the Federal Food, Drug and Cosmetic Act
(FFDCA) of 1938 and 1976. This act requires reporting within ten (10) work days of any information
that reasonably suggests that a medical device has caused, or may have caused, or contributed to a
death, serious illness, or serious injury, either to the Food and Drug Administration or the
manufacturer. Summary reports must be sent to the FDA on a semi-annual basis; January 31 for the
preceding July through December, and July 31 for the preceding January through June (Samuel, 1991)
(MDA, 1996).
A device user facility is defined as a hospital, ambulatory surgical fac ility, nursing home, outpatient
treatment facility, or outpatient diagnostic facility, which is not a physician's office.
A medical device is any item (other than a drug or biologic) used to diagnose, treat, or prevent a
disease, injury or other condition. If failure of diagnostic equipment results in a misdiagnosis or lack of
496
diagnosis that contributes to a death or serious illness or injury, the diagnostic equipment failure must
be reported.
Serious illness or injury means either life-threatening, or resultant permanent impairment, and/or
required medical or surgical intervention to prevent permanent impairment.
The primary impact of the 1992 Amendments on user facility reporting was to establish a single
reporting standard for user facilities, manufacturers, and importers (MDA, 1992) . The medical device
reporting rule published in the December 11, 1995, Federal Register Medical Device Reporting (MDR)
added further definition to the law (MDA, 1996). This act was last updated in 2012 with the FDA Safety
and Innovation Act (FDASIA), and includes the Medical Device User Fee Amendments of 2012 (MDUFA
Ill) as well as other medical device provisions. MDUFA Ill will be in effect until September 30, 2017. It
inc ludes performance goals and user fees paid to the Food and Drug Administration (FDA) by medical
device companies when they register and list with the FDA and when they submit an application to
market a medical device in the U.S. Other provisions of FDASIA begin immediately. These new
amendments change the way the FDA approves clinical trials, provide a new de novo pathway for risk-
based classification of devices, expand FDA's post-market surveillance capabilit ies, shorten the
timelines for scheduling appeals and issuing decisions, and change the process for reclassification of
dev ices (FDA, 2012).
Resources for the Full Federal Food, Drug and Cosmetic Act (FFDCA):
• 1938 and 1976. Chapter V: Drugs and Devices
https://www .fda.gov/Regulatorylnformation/LawsEnforcedbyFDA/FederalFoodDrugand
CosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm
• 1990 Amendment
http://thomas.loc .gov/cgi-
bin/bdguery/z?d10l:HR03095 :@ @ @ D&summ2=1& ITOM :/bss/dlOlguery.html
• Medical Device Amendments of 1992
https://www.congress .gov/b iIl/102nd-congress/senate-bi 11/2783
• 1995 Amendment
http://www.gpo.gov/fdsys/pkg/FR-1995-12-11/html/95-29906 .htm
• 2012 Amendment
http://www.gpo.gov/fdsys/pkg/PLAW - 112 pubI144/pdf /PLAW-112 publ144 .pdf
497
Federal Occupational Safety and Health Act (OSHA) of 1970
The Federal Occupationa l Safety and Health Act (OSHA) of 1970 required employers to establish
occupat ional safety and health programs and ensure safe and healthful working conditions for
employees (OSHA, 2017). Assuring safe and healthful workplaces by setting and enforcing standards,
a nd by providing training, outreach, education and assistance is the mission of OSHA. The main
component of OSHA law is the General Duty Clause (29 USC 654) that applies to every employer and
employee regardless of the type of workplace. It encompasses Lhe basic responsibilities of the
employer and the employee .
Each employer: (1) shall furnish to each of his employees emplo yment and a place of
employment, which are free from recognized hazards that are causing or are likely to cause
death or serious ph ysical harm to his emplo yees; (2) shall compl y with occupational safet y
and health standards promulgated under this Act.
Each employee shall compl y with occupational safety and health standards and all rules,
regulations, and orders issued pursuant to this Act, which are ap plicable to his own actions
and conduct (OSHA - General Clause, 2015, Sec. 5 . Duties).
Table 7 displays the top ten OSHA healthcare citations and the amount of penalty fines that were
occurred between October 2016 and September 2017 . The figures for other industries can be found on
the OSHA website (NAICS, 2017).
Table 7: Top 10 NAICS Code: 62 Health Care Citations: October 2016 through September 2017
Top 10 NAICS Code: 62 Health Care Citations: October 2016 through September 2017
!
Standard Citations Inspections Penalty Description
All Standards cited for Health
Tota l 807 245 $1,663,355
Care and Social Assistance
19101030 298 93 $656,120 Bloodborne pathogens
19101200 115 63 $95,836 Hazard Communication
19100132 27 20 $62,852 General requirements
19040039 25 25 $81,435 No Description Found
The control of hazardous
19100147 23 9 $100,603
energy ( lockout/tagout)
19100134 22 8 $ 20,565 Respiratory Protection
19101048 20 7 $59,719 Formaldehyde
19100303 19 16 $51,750 General requirements
Wir ing methods, components,
19100305 18 14 $11,209
equipment for general use
19040032 15 11 $5,868 Annual Summary
498
Adapted from Occupational Safety & Health Administration, NAICS Code: 62 Health Care and Social
Assistance Citations (NAICS, 2017)
Most OSHA programs provide free consultation and training in key safety and illness-prevention issues
pertinent to the workplace . Some states, including California, administer their own occupational health
and safety programs in accordance with provisions of the Federal OSHA. OSHA establishes program
structure and operations requirements (e.g. to post the injury logs for 3 months every year starting in
February), but permits the state to manage the program, with federal monitoring. These states receive
part of program funding from the Federal OSHA agency.
In July 2015, OSHA announced a new initiative that will focus on hospitals and nursing homes to
evaluate work-related injuries and illnesses through inspections . The inspectors will focus on
musculoskeletal disorders related to patient or resident handling, workplace violence, bloodborne
pathogens, tuberculosis, and slips, trips and falls. OSHA considers all of these types of events as mostly
preventable (OSHA's Office of Communications, 2015).
This chapter presented an overview of the Legislation that has impacted healthcare through the years.
Legislation knowledge involvement is key in quality improvement, and organizations without strong,
committed efforts to follow the regulations often find themselves missing something in the programs
and processes. As a Quality/UM/RM/PS/accreditation manager you are also must have a working
knowledge about the legislative requirements so that you can utilize that expertise and influence that
is key to your organization's success .
REMEMBER: The future of healthcare insurance coverage is expected to be changing with the new
Presidential Administration. This chapter is reflective of the current industry as of December 2017.
There are several tentative legislative and presidential orders in draft; but nothing absolute. Examples
of tentative subjects include; Repeal Replace and Removal of Insurance M andates.
499
REFERENCES
LEGISLATIVE INITIATIVES
AARA (2009). Public Law 111- 5 - American Recovery and Reinvestment Act of 2009 . U.S. Government
Publishing Office. Retrieved from http://www.gpo.gov/fdsys/pkg/PLAW-1 11publ5/content-
detail.html
ADA-Title Ill (2010). Introduction to the ADA. Americans with Disabilities Act. Retrieved from
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Bing (1957). Bing vs . Thunig. 2 N.Y.2d 656, Court of Appeals of the State of New York ., Decided May
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506
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Prospective Payment System
Westlaw (Case Law Resources) http://www.westlaw .com/
507
Certified Professional in Healthcare Quality
Detailed Content Outline
(Adapted from http://cphq.org/UPLOADS/certification/CPH(l_Content_out!ine_-_effective_01-2018.pdf)
1. Organizational Leadership (35 items)
A. Structure and Integration

1. Suppo rt organizational commitment to quality
2 . Participate in organization-wide strategic planning related to quality
3 . Align quality and safety activities with strategic goals
4. Engage stakeholders to promote quality and safety (e.g., emergency preparedness,
corporate compliance, infection prevention, case management , patient experience,
provider network, vendors)
5. Provide consultative support to the governing body and clinical staff regarding their roles
and responsibilities (e.g., credentialing, privileging, quality oversight, risk management)
6. Facilitate development of the quality structure (e.g., councils and committees)
7. Assist in evaluating or developing data management systems (e.g., data bases, registries)
8 . Evaluate and integrate externa l best practices (e.g., resources from AHRQ, IHI, NQF, WHO,
HEDIS, outcome measures)
9. Participate in activities to identify and evaluate innovative solutions and practices
10. Lead and facilitate change (e.g., change theories, diffusion, spread)
11. Participate in population health promotion and continuum of care activities {e.g.,
handoffs, transit ions of care, episode of care, outcomes, healthcare utilization)
12. Communicate resource needs to leadership to improve quality (e.g., staffing, equipment,
technology)
13. Recognize quality initiatives impacting reimbursement (e.g., pay for performance, value-
based contracts)
B. Regulatory, Accreditation, and External Recognition

1. Ass ist the organization in maintaining awareness of statutory and regulatory requirements
(e.g., CMS, HIPAA, OSHA, PPACA)
2. . Identify appropriate accreditation, certification , and recognition options (e.g.,
AAAHC, CARF, DNV GL, ISO, NCQA, TJC, Baldrige Magnet)
3. . Ass ist with survey or accreditation readiness
4. Participate in the process for evaluating compliance with internal and external
requirements for :
509
a. clinical practice guidelines and pathways (e.g., medication use, infection
prevention)
b. service quality
c. documentation
d. practitioner performance evaluation (e.g., peer review, credentialing, privileging)
e. gaps in patient experience outcomes (e.g., surveys, focus groups, teams,
grievance, complaints)
f. identification of reportable events for accreditation and regulatory bodies
5. Facilitate communication with accrediting and regulatory bodies
C. Education, Training, and Communication
1. Design performance, process, and quality improvement training
2. Provide education and training on performance, process, and quality improvement (e.g.,
including improvement methods, culture change, project and meeting management)
3. Evaluate effectiveness of performance/quality improvement training
4. Develop/provide survey preparation training (e.g. accreditation, licensure, or equivalent)
5. Disseminate performance, process, and quality improvement information within the
organization
2. Health Data Anaiytics (30 items)
A. Health Data Analytics

1. Maintain confidentiality of performance/quality improvement records and reports
2 . Design data collection plans:
a. measure development (e.g., definitions, goals, and thresholds)
b. tools and techniques
c. sampling methodology
3. Participate in identifying or selecting measures (e.g., structure, process, outcome)
4. Assist in developing scorecards and dashboards
5. Identify external data sources for comparison (e .g., benchmarking)
6. Collect and validate data
B. Measurement and Analysis
1. Use data management systems (e.g., organize data for analysis and reporting)
2. Use tools to display data or evaluate a process (e.g., Pareto chart, run chart, scattergram,
control chart)
3. Use statistics to describe data (e.g., mean, standard deviat ion, correlation, t-test)
510
4. Use statistical process control (e.g., common and special cause variation, random
variation, trend analysis)
5. . Interpret data to support decision-making
6. Compare data sources to establish benchmarks
7. Participate in externa l reporting (e.g., core measures, patient safety indicators, HEDIS
bundled payments)
3. Performance and Process Improvement (40 items)
A. Identifying Opportunities for Improvement

1. Facilitate discussion about quality improvement opportunities
2 . Assist with establishing priorities
3. . Facilitate development of action plans or projects
4. Facilitate implementation of performance improvement methods (e.g., Lean, PDCA, Six
Sigma)
5. Identify process champions
B. Implementation and Evaluation

1. Establish teams, roles, responsibilities, and scope
2. Use a range of quality tools and techniques (e.g. fish bone diagram, FMEA, process map)
3. Participate in monitoring of project timelines and deliverables
4. Evaluate team effectiveness (e.g., dynamics, outcomes)
5. Evaluate the success of performance improvement projects
6. Document performance and process improvement results
4. Patient Safety {20 items)

A. Assessment and Planning
1. Assess the organization's culture of safety
2. . Determine how technology can enhance the patient safety program (e.g., electronic
health record (EHR), abduction/elopemen t security systems, smart pumps, alerts)
3. . Participate in risk management assessment activities (e.g., identification and analysis)
B. Implementation and Evaluation
1. Facilitate the ongoing evaluation of safety activit ies

2. . Integrate safety concepts throughout the
organization 3 . Use safety principles:
a. human factors engineering
511
b. high reliability
c. systems thinking
4. Participate in safety and risk management activities related to:
a. incident report review (e.g., near miss and actual events)
b. sentinel/unexpected event review (e.g., never evets)
c. root cause analysis
d. failure mode and effects analysis
512
ACRONYMS AND ABBREVIATIONS
The following acronyms and abbreviations are used throughout the 301H Edition of THE Janet A. Brown
HEALTHCARE QUALITY HANDBOOK:A PROFESSIONAL RESOURCE AND STUDY GUIDE.
ACRONYM FULL NAME

AAAHC American Association for Ambulatory Health Care
AABB Association of Blood Banks
AA HCC American Accreditation Health Care Commission
ABMS American Board of Medical Specialties
ABQAURP Healthcare Quality & Management Certification
ACA Affordable Care Act shortened from Patient Protection and Affordable Ca re
Act
ACE Array of Clinical Evidence (ACE Star Model)
ACHC Accreditation Commission for Health Care
ACO Accountable Care Organization
ACS American College of Surgeons
ACTION Ill Accelerating Change & Transformation in Organizations & Networks Ill
ACUG Accreditation and Certification Users Group
ADA Americans with Disabilities Act
ADE Adverse Drug Event
ADL Activities of Daily Living
ADLI Approach, Deployment, Learning, Integration
AE Adverse Event
AHIMA American Health Information Management Associat ion
AHRQ Agency for Healthcare Research and Quality
ALOS Average Length of Stay
AMA Against Medical Advice
AMA American Medical Assoc iation
AMI Acute Myocardial Infraction
ANA American Nurses Association
ANCC American Nurses Credential ing Center
ANSI American National Standards Institute [ISO]
AOA American Osteopathic Association
AORN Association of Operating Room Nursps
AP Advance Payment ACO Model
APM Advanced Alternative Payment Model
APO Adverse Patient Occurrence
AQA Ambulatory Care Quality Alliance
ARRA American Recovery and Reinvestment Act (2009)
ASC Ambulatory Surge ry Center
ASH RM Amer ican Society for Healthcare Risk Management
ASPE Assistant Secretary for Planning and Evaluation
513
ASQ American Society for Quality
ASR Acute Stroke Ready
AUG Accreditation User Group
BBA Balanced Budget Act (1997)
BBRA Balanced Budget Refinement Act (1999)
BCMA Bar-Code Medication Administration
BFCC Beneficiary and Family Centered Care
BHI Behavioral Ilealth Integration
BIPA Benefits Improvement and Protection Act (2000)
BPMN Business Process Modeling Notation
BPOC Barcode Point Of Care (alternative to BCMA)
BPRP Back Pain Recognition Program
CABG Coronary Artery Bypass Graph
CAC Children's Asthma Care
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems Survey
CAHQ Council for Affordable Healthcare
----
CAP College of American Pathologists
CAPS CAPITAL LETIERS
CARF Commission on Accreditation of Rehabilitation Facilities
CAUTI Catheter-associated Urinary Tract Infection
CCA Care Area Assessment
C-CDA Consolidated-Clinical Document Architecture
CCMC Commission for Case Manager Certification
CCRC Continuing Retirement Communities
CDC Centers for Disease Control and Prevention
C. diff Clostridium difficile
CDS Controlled Dangerous Substances
CDSS Clinical Decision Support System
CE Continuing Education
CEC Content Expert Certification
CEHRT Certified Electronic Health Record Technology
CEO Chief Executive Officer
CfCs Conditions for Coverage [CMS]
CFO Chief Financial Officer
CFTH Center for Transforming Healthcare
CG-CAHPS CHAPS Clinician & Group Survey
CHAC Community Health Accreditation Commission
CHAP Community Health Accreditation Program
CHCQM Health Care Quality and Management Certification
CHF Congestive Heart Failure
CHIP Children's Health Insurance Program
CHIPRA Children's Health Insurance Program Reauthorization Act (CHIPRA)
CHIRI Child Health Insurance Research Initiative
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CHNA Community Health Needs Assessment
Cl Confidence Interval
CIHQ Center for Improvement in Healthcare Quality
CIO Chief Information Officer
CLABSI Central Line Associated Blood Stream Infection
CLIA Clinical Laboratory Improvement Act (1988)
CM Care Management or Case Management
CMHC Community Mental Health Center
CMO Chief Medical Officer
CMQ/OE Certified Manager of Quality/Organizational Excellence
CMS Centers for Medicare and Medicaid Services
CMSA Case Management Society of America
CNA Certified Nursing Assistant
CNO Chief Nursing Officer
coo Chief Operations Officer
COPD Chronic Obstructive Pulmonary Disease
COPQ Cost OF Poor Quality
CoPs Condition of Participation [CMS]
COQ Cost Of Quality
CORE Committee on Operating Rules for Information Exchange
CORF Comprehensive Outpatient Rehab Facility
CPA Critical Path Analysis
CPG Clinical Practice Guideline
CPHQ Certified Professional in Healthcare Quality
CPK Core Body of Knowledge
CPM Critical Path Method
CPOE Computerized Physician Order Entry
CPR Cardio-Pulmonary Resuscitation
CPT Current Procedural Terminology
CQI Continuous Quality Improvement
CR Credentialing
CRM Crew Resource Management
CRNA Certified Registered Nurse Anesthesiolog ist
csc Comprehensive Stroke Center
C-Suite Chief Officers Offices (CEO, CNO, COO, etc.)
CT Clinical Trial
CTO Chief Technology Officer
CTQ Critical To Quality [Six Sigma]
CUSP Comprehensive Unit-based Safety Program
cvo Credentials Verification Organization
CY Calendar Year
DC Doctor of Chiropractic
DDS Dentist
DEA Drug Enforcement Agency
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df Degrees of Freedom
DHHS Department of Health and Human Services
DM Disease Management
DMAIC Define, Measure, Analyze, Improve, Control [Six Sigma]
DME Durable Medical Equipment
DMEPOS Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
DNR Do Not Resuscitate
DNV GL Det Norske Veritas
DO Doctor of Osteopathy
DoD Department of Defense
DON Director of Nursing -
DPM Doctor of Pediatric Medicine (Podiatrist)
DRA Deficit Reduction Act (2005)
DRG Diagnostic Related Group
DRIP Data-Rich, Information-Poor
DRP Diabetes Recognit ion Program
EBP Evidence-Based Practice
EC European Commission
ECFMG Educational Commission for Foreign Medical Graduates
ECHO Experience of Care and Health Outcomes [Behavioral Health CAHPSJ
eCQM Electronic Communication of Quality Measures
ECRI Emergency Care Research Institute
ED Emergency Department
EDI Electronic Data Interchange
EEOA Equal Employment Opportunity Act
EEOC Equal Employment Opportunity Commission
EFQM European Foundation for Quality Management
EH Eligible Hospital
EHB Essential Health Benefits
EHDI Early Hearing Detection and Intervention
EHR Electronic Health Record
EIM Electronic Information Management
EM Emergency Medicine
eMAR Electronic Medication Administration Record
EMR Electronic Medical Record
EOC Environment of Care
EP Eligible Professional
EPC Evidence-based Practice Center
ePHI Electronic Protected Health Information
ERM Enterprise Risk Management
ESRD End-Stage Renal Disease
f Frequency
FCA False Claims Act (1863) and Amendments (1986)
FDA Food and Drug Administration
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FDASIA FDA Safety and Innovation Act of 2012
FFDCA Federal Food, Drug and Cosmetic Act
FMEA Failure Mode and Effects Analysis
FOCUS-POCA Find, Organize, Clarify, Understand, Select-POCA
FPL Federal Poverty Level
FPPE Focused Professional Practice Evaluation
FSMB Federation of State Medica l Boards
FTE Full-Time Equivalent
FY Fiscal Year
F/U Follow-Up
GB Govern ing Body
GI Gastrointestinal
GPRO Group Practice Reporting Option
HAC Healthcare/Hospital-Acquired Condition
HAI Healthcare-Associated Infection
HBIPS Hospital Based Inpatient Psychiatric Services
HBS Harvard Business School
HCA Healthcare Corporation of America
HCAHPS Hospital Consumer Assessment of Healthcare Providers and Systems Survey
HCBS Home & Community-Based Services
HCERA Health Care and Education Reconciliation Act
HCFA Health Care Financing Administration
HCQIA Health Care Quality Improvement Act (1986)
HCQM Health Care Quality Management
HEDIS Healthcare Effectiveness Data and Information Set
HEW Health Education and Welfare
HFACS Human Factors Analysis and Classification Systems
HFAP Healthcare Facilities Accreditation Program
HFE Human Factors Engineering
HFMEA Healthcare Failure Mode and Effects Analysis
HHA Home Health Agency
HHCAHPS Home Health Consumer Assessment of Healthcare Providers and Systems
Survey
HHS Health and Human Services
HIE Health Information Exchange
HIM Health Information Management
HIO Health Information Organization
HIP Health Information Products
HIPAA Health Insurance Portability and Accountability Act
HIPDB Healthcare Integrity and Protection Data Bank
HIT Health Information Technology
HITECH Health Information Technology for Economic and Clinical Health (HITECH) Act
HKRC Hip & Knee Replacement Certification
HL7 Health Level Seven: international healthcare standards for electronic
517
information interchange between computer systems
HMO Health Maintenance Organization
HP Health Plan
HPS Healthcare Personnel Safety
HQ Healthcare Quality
HQCC Healthcare Quality Certification Commission
HR Human Resources
HRET Health Research and Educational Trusl
HRSA Health Resources and Service Administration
HSRP Heart/Stroke Recognition Program
IAP International Accreditation Program [ISQua]
IC Infection Control
ICD-10 International Classification of Diseases - 10
ICD-10 CM ICD-10 Care Management Codes
ICD-10-PCS ICD-10 Procedure Codes
ICF/IID Intermediate Care Facility for Individuals with Intellectual Disabilities
ICM Intra-cycle Monitoring
-
IC&P Infection Control & Prevention
ICU Intensive Care Unit
ID Identification
IDN Integrated Delivery Network
IDS Integrated Delivery System
IHI Institute for Healthca re Improvement
IM Information Management
IMM Immunization
IOM Institute of Medicine
IPA Independent Practice Association
I-PASS Illness severity, Patient summary, Action list, Situation awareness and
Contingency planning,Synthesis by receiver
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
IQR Interquartile Range (lnterpercentile)
IRF Inpatient Rehabilitation Facility
IRO Independent Review Organization
IRS Internal Revenue Services
IS Information System
ISBAR Introduction, Situation,Background,Assessment, Recommendation
ISMP Institute for Safe Medical Practices
ISO International Organization for Standardizat ion
ISQua International Society for Quality in Health Care
IT Information Technology
IV Intravenous
JCAHO See TJC
KSA Knowledge, Skill, & Attitude
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LASA Look-Alike, Sound-Alike [medication names]
LCL Lower Control Limit
LO Leadership
LeTCI Levels, Trends, Comparisons, Integration
LIP Licensed Independent Practitioner
LOC Level of Care
LOS Length of Stay
LPN Licensed Practical Nurse
LTC Long-Term Care
LTCH Long Term Care Hospital
LVN Licensed Vocational Nurse
LWOBS Left Without Being Seen
M Mean
MACRA Medicare Access & CHIP Reauthorization Act of 2015
MBHO Managed Behavioral Healthcare Organization
MCCA Medicare Catastrophic Coverage Act (MCCA)
MCD Managed Care Organization
M&E Monitoring and Evaluation
MD Medical Doctor
MDA Medical Device Act
MOR Medical Device Reporting
MORO-CO i Mulitdrug-Resistant Organism - Clostridium difficile Infection
MOS Minimum Data Set
MEC Medical Executive Committee
MHC Multicultura l Health Care
MIP Merit-based Incentive Payment System
MIPPA Medicare Improvements for Patients and Providers Act (2008)
MIR Managing Infection Risk
M&M Morbidity/Mortality
MMPPA Medicare and Medicaid Patient Protection Act of 1987
MPC Measurement Policy Council
MPFS Medicare Part B Physician Fee Schedule
MPI Master Patient Index
MRSA Methicillin-Resistant Staphylococcus Aureus
MS Medical Staff
MSO Management Services Organization
MSSP Medicare Shared Savings Programs
MU Meaningful Use
n Number in the Sample
N Total Number
NAHQ National Association for Healthcare Quality
NAICS North American Industry Classification System
NASWHP Nationa l Association of Sheltered Workshops and Homebound Programs
NCC MERP National Coordinating Council for Medication Error Reporting and Prevention
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NCMEC National Center for Missing and Exploited Children
NCPS National Center for Patient Safety [VA]
NCQA National Committee for Quality Assurance
n.d. No date
NDNQI National Database of Nursing Quality Indicators
NFPA National Fire Protection Agency
NGC National Guidelines Clearinghouse
NHIN National Health Information Network
NHP New Health Plans
NHPPD Nursing Hours Per Patient Day
NHQI Nursing Home Quality Initiative
NHSN National Healthcare Safety Network [CDC]
NIST National Institute of Standards and Technology
NLC National Learning Consortium
NLN National League for Nursing
NLRB The National Labor Relations Board
NPDB National Practitioner Data Bank
NPSD Network of Patient Safety Databases [AHRQ]
NPSF National Patient Safety Foundation
NPSG National Patient Safety Goal
NPUAP National Pressure Ulcer Advisory Panel
NQF National Quality Forum
NQMC National Quality Measures Clearinghouse
NQS National Quality Strategy
NTOCC National Transitions of Care Coalition
OAS CAHPS Outpatient Ambulatory Surgery
OASDI Old Age, Survivors, and Disability Insurance
OASIS Outcome and Assessment Information Set
OBRA Omnibus Budget Reconciliation Acts (1980s and 1990s)
ODPHP Office of Disease Prevention and Health Promotion
OIG Office of Inspector General
OP Outpatient
OPPE Ongoing Professional Practice Evaluation [TJC]
OPS Organ Procurement Organization
OR Operating Room
ORYX Joint Commission's Core Measures Program
OSHA Occupational Safety and Health Act (1970)
OT Occupational Therapist
P4P Pay For Performance (also VBP)
PACE Programs for All-Inclusive Care for the Elderly
PACU Post Anesthesia Care Unit
PAR Post Anesthesia Room
PBRN Public Care Practice Based Research Networks
PC Perinatal Center
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PCA Patient Care Assistant
PCE Potentially Compensable Event
PCMH Patient-Centered Medical Home
PCP Primary Care Practitioner
PCS Primary Stroke Center
PCSP Patient-Centered Specialty Practice
PDC Proportion of Days Covered
POCA Plan-Do-Check-Act
PDC/SA Plan Do Check/Study Act
PDSA Plan-Do-Study-Act
PERT Program Evaluation Review Technique
PHAB Public Health Accreditation Board
PHF Public Health Foundation
PHI Protected Health Information
PHO Physician-Hospital Organization (joint venture)
PHQ Physician and Hospital Quality
PHR Personal Health Record
Pl Performance Improvement
PICO Problem, Intervention, Comparison, Outcome
PICOT Problem, Intervention, Comparison, Outcome, Time
PITL Point Interval Temporal Logic
PIV Peripheral IV
p.L. Public Law
POA Plan Of Action
POA Present On Admission
POS Point of Service
PPACA Patient Protection and Affordable Care Act
PPO Preferred Provider Organization
PPS Prospective Payment System (Medicare in USA)
PPSA Pennsylvania Patient Safety Authority
PQRI Physician Quality Reporting Initiative [CMS]
PQRS Physician Quality Reporting System
PRO Peer Review Organizations
PS Patient Safety
PSDA Patient Self-Determination Act (1990)
PSI Patient Safety Indicator (AHRQ)
PSNet Patient Safety Network (AHRQ)
PSO Patient Safety Officer
PSO Patient Safety Organization
PSOPPC Patient Safety Organization Privacy Protection Center
PSP Patient Safety Practice
PSQIA Patient Safety and Quality Improvement Act of 2005
PSRO Professional Standards Review Organizations
P&T Pharmacy and Therapeutics Committee
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PT Physical Therapist
PVBP Physician and other Professional Services Value-Based Purchasing (PVBP)
Plan [CMS]
QA Quality Assurance
QA & I Quality Assurance and Improvement
QAO Quality Asse ssments Only
QAPI Quality Assessment and Performance Improvement (QAPI) Program (CMS)
QI Quality Improvement
QIN Quality Innovation Network
QIO Quality Improvement Organization
QI/Pl Quality Improvement/Performance Improvement
QM Qua lity Management
QM/Pl Quality Management/Performance Improvement
QM/QI/Pl Quality Management/Quality Improvement/Performance Improvement
QM/RM Qua lity Management/Risk Management
Q/PI* Quality/Performance Improvement
QPS Quality and Patient Safety
Q/R/U Quality/Risk/Utilization
QRM Quality Resource Management
QRP Quality Reporting Program
OSEN Quality & Safety Education for Nurses
r Correlation Coefficient
RAI Resident Assessment Instrument
RCA Root Cause Analysis
-
RCA 2 RCA Squared
RCT's Random Control Trials
RFI Request For Information
RFID Radio Frequency Identification
RFP Request For Proposal
RHICs Regional Health Improvement Collaboratives
RHIO Regional Health Information Organization
RM Risk Management
RN Registered Nurse
ROI Return on Investment
RPI Robust Process Improvement
RPN Risk Priority Number [FMEA]
RWJF Robert Wood Johnson Foundation
SAFER Survey Analysis for Evaluating Risk
SBAR Situation, Background, Assessment, Recommendation
SBMH School Based Medical Home Program
SCHIP State Children's Health Insurance Program
SCIP Surgical Care Improvement Project
SD or 1 Standard Deviation
SE Sentinel Event
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SIMS Surgical Indications Monitoring [lnterQual criteria]
SIPOC Supplier, Input, Process, Output, and Customer
SMDA Safe Medical Devices Act (1990)
SNA State Nurses Association
SNF Skilled Nursing Facility
SOP Standard Operating Procedure
sow Scope of Work (CMS Contract with QIO's)
SPC Statistical Process Control
SRE Serious Reportable Event
SSM Summary Survey Measures
STEMI Segment Elevation Myocardial Infarction
STK Stroke
SUB Substance Use
SWOT Strengths, Weaknesses, Opportunities, Threats
t t-Test
TB Tuberculosis
TeamSTEPPS Team Strategies and Tools to Enhance Performance and Patient Safety
TEFRA Tax Equity and Fisca l Responsibility Act (TEFRA)
Test Act Taking Essential Steps for Testing Act of 2012
TJC The Joint Commission
TNA Texas Nurses Association
TOB Tobacco Treatment
TQM Total Quality Management
TR HCA Tax Relief and Health Care Act
TPS Total Percentage Score
UAP Unlicensed Assistive Personnel
UCL Upper Control Limit
UM Utilization Management
UM/CR Utilization Management and Credentialing
UMLAD Unified Modeling Language Activity Diagram
URAC Utilization Review Accreditation Commission
U.S . United States
USP United States Pharmacopeia
UTI Urinary Tract Infection
VA Veterans Affairs / Veterans Administration
VA/DoD Veterans Affairs/Department of Defense
VAP Ventilator Associated Pneumonia
VBAC Vaginal Birth After Caesarian (Section)
VBP Value-Based Purchasing (also P4P)
VHA Veterans Health Administrat ion
VTE Venous Thrombosis
WAPS World Alliance for Patient Safety
WHP Wellness & Health Promotion
WHO World Health Organization
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1 x2 j Chi-Square
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GLOSSARY:
HANDBOOK TERMS AND WORKING DEFINITIONS
The following terms are used throughout this 30TH Edition of THE Janet A. Brown HEALTHCARE
QUALITY HANDBOOK: A PROFESSIONAL RESOURCE AND STUDY GUIDE.
Accountable Care Organization (ACO): Groups of doctors, hospitals, and other health care providers,
who work together to give coordinated high quality care to their patients, at lower costs.
Accreditation: A voluntary survey process used by various independent, non-governmental external
agencies to assess the extent of a healthcare organization's compliance with applicable pre-established
performance standards set by the agency. Accreditation involves both self-assessment and external
peer review, focusing on organizational, not individual practitioner, performance. Purpose: Improve
the systems and processes of care (performance) and, in so doing, improve patient outcomes.
Adverse Event: Unintended injury to a patient resulting from a medical intervention [IOM Report To
Err is Human], generally with lesser degree of severity that may be a precursor to a sentinel event.
Affinity Diagram: An organizational tool most often used at the beginning of a team's work to organize
large volumes of ideas or issues into major categories.
Aggregation: Combining standardized data; gathering into a mass, sum, or whole.
Alignment: The translation of the work of each person into its proper relative position with the
organization's strategic goals. Alignment in healthcare means that all the systems, functions,
processes, process steps, departments, units, and people in the organization are working together, in
synchrony with mission, vision, values, and strategic direction, to serve the key customer-the patient.
Ambulatory Care: All healthcare that is provided to patients who are not residing in healthcare
institutions at the time the care is rendered.
Analysis: The translation of data collected during the monitoring process, through aggregation and
interpretation, into information about the organization's level of performance along many dimensions,
over time, and, where possible, compared to similar organizations, that can be used to change
processes and improve performance.
Appeal: A request to change a previous decision made by the organization.
Application Software: A program, such as a word processor or spreadsheet that performs some
specific useful task; an application of the computer to a particular area or need.
Appointment: Selection for membership in a medical/professional staff (e.g., hospital or medical
group) or to a practitioner panel (e.g., preferred provider organization).
Appraisal: Initial evaluation by peers of a practitioner's competency to provide care and services to
patients in or for a healthcare organization . Appraisal may include credentialing, privileging,
proctoring, and appointment [See this Glossary for definitions].
Appropriateness: The degree to which care is "correct" and relevant to the patient's clinical needs,
given the current state of knowledge.
Availability: The degree to which appropriate care is accessible and obtainable to meet the patient's
needs.
"Balanced Scorecard": A performance measurement system based on and organized around the
organization's strategic plan; a translation of mission, vision, and strategy into a balanced set of top-
level-approved financial and non-financial measures that drive organ;zational change and
improvement.
Baldrige Performance Excellence Program: An award program to identify and recognize role-model
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businesses, to establish criteria for evaluating improvement efforts, and to disseminate and share best
practices.
Benchmark: A comparative "best" as levelfor improvement .
Benchmarking: The continual process of measuring practices and services against the performance of
recognized leaders at a particular function, regardless of "industry standard".
Beneficiary and Family Centered Care (BFCC) : Division of the QIO that performs statutory review
funct ions, including complaints and qua lity of care reviews for people with Medicare.
Best Practice:
• A process, technique, or innovation producing superior results and driving best performance,
with demonstrated improvement in quality,cost, safety, or other key organizat ion measures.
• The methods or steps used in a process, the outputs of which best meet customer
requirements.
Brainstorming: A structured group process used to create as many ideas as possible in as short a time
as possible,e.g., one session, and to elicit both individual and group creat ivity.
Breakthrough: Any sudden or significant solution to a problem that leads to further advances. It may
be used in healthcare as a synonym for innovation or significant improvement, progress, or advance.
Capitation: Prepayment for services with a fixed number of dollars per member per month (PMPivi) on
a per-person rather than a per-procedure basis, regardless cf the amount of care the member/patient
receives.
Catheter-associated Urinary Tract Infection (CAUTI): A urinary-track infection resulting from an
indwelling foley catheter.
Cause-and-Effect Diagram: A tool generally used to gather all possible causes as an overview,
the ultimate goal being to uncover the root cause(es) of a problem.
Center for Improvement in Healthcare Quality (CIHQ): Accreditatio n agency with deemed status that
accredits hospitals and other types of healthca re facilities.
Central Line Associated Blood Stream Infection (CLABSI) : A laboratory confirmed bloodst ream
infection in a patient with a central line.
Central Processing Unit (CPU): The brain of the computer that processes instructions and manages the
flow of information through a computer system .
Checklist/Task List: A listing of things to do or obtain in order to keep the team on schedule, to help
team members remember commitments, or to inventory information.
Clinical Path: A prospective, detailed, strategic treatment regimen, or daily/intermittent protocol for
patient care, designed to identify and integrate key activities, interventions, and services for certain
patient conditions. Clinical paths are applicable across the continuum of care, e.g., in acute care from
pre-admission and pre-operative treatment through the hospital stay to discharge and post-discha rge
phases of care, including home care. Clinical/critical paths are designed to include clinical
performance criteria for specified time periods or intervals,organized by categories of care needs, e.g.,
diagnost ics, treatments, activity, medications, psychosocial, etc. They are useful tools for measuring
actual performance.
Commission for Accreditation of Rehabilitation Facilities (CARF): Accreditation agency with deemed
status that accredits rehabilitation hospitals and other types of healthcare facilities.
Communication: The act and art of giving and/or receiving information;a message.
Community Health Information Networks (CHINs) : Networks forming to exchange data electronical ly
among computer systems of various healthcare financing and delivery organizations in a defined
geographic region.
Comorbidities: "Specific patient conditions that are seconda ry to the patient's primary diagnosis and
526
require treatment during the stay....Comorbid conditions must co-exist at the time of admission,
develop subsequently, and affect the treatment received, the length of stay, or both treatment and
length of stay." [Centers for Medicare and Medicaid Services (CMS)]
Competence: Job knowledge (understanding of facts and procedures), skills (performance of specific
actions), and related behaviors (e.g., ability to work in teams).
Competency: The individual's ability to produce both the health and satisfaction of patients, as
applicable, and meet the needs and expectations of other customers; the performance equivalent to
stated requirements and to professional standards of care and practice.
Complaint: An oral or written expression of dissatisfaction. A person "registers" a complaint.
Complex Adaptive System: "... a dynamic network of many agents...constantly acting and reacting to
what the other agents are doing.... The overall behavior of the system is the result of a huge number of
decisions made every moment by many individual agents." [John J. Holland in Complexity: The
Emerging Science at the Edge of Order and Chaos by M. Mitchell Waldrop].
Compliance: To act in accordance with another's command, request, rule, or wish. In healthcare, this
translates to providing, billing, reimbursing and monitoring services according to the laws, regulations,
administrative rules and guidelines governing the organization.
Complications: Concurrent diseases, accidents, or adverse reactions that aggravate the original disease
not present on admission that may or may not have been pr_eventable.
Conditions for Coverage (CfCs): Requirements that CMS has established that healthcare organizations
must meet to participate in the Medicare and Medicaid programs.
Conditions of Participation (CoPs): Requirements that CMS has established that healthcare
organizations must meet to participate in the Medicare and Medicaid programs.
Confidentiality: An organizational (facility/staff) and/or patient right, to the fullest extent of the law,
to personal and informational privacy, including all identifiable health information and all identifiable
quality management information.
Continuity of Care: The coordination of needed healthcare services for a patient or specified
population among all practitioners and across all involved provider organizations over time.
Continuous Quality .Improvement: A term used interchangeably with "Quality Improvement" to mean a
management process or approach to the ongoing study and improvement of the processes of providing
health care services to meet the needs and expectations of patients and others.
Copayment: A fixed amount (generally $10-$30) paid by the patient for each visit to a health plan
clinician or for a specified service; the remaining cost is paid by the patient's insurance.
Core Measures: Sets of measures required of acute care hospitals for CMS and TJC accreditation.
Cost-Benefit Analysis: The process of placing monetary values (dollars in U.S.) on all costs associated
with outputs (actual and predicted) and on all benefits (to patient/member and organization) to assist
in comparing and setting priorities across different interventions and selecting which, if any, programs
or services to provide. The analysis looks at costs and benefits both with and without the program or
service, to the patient and organization, so an appropriate decision can be made.
Credentialing: The process of obtaining, verifying, and assessing the qualifications of a healthcare
practitioner to provide patient care services in or for a healthcare organization or network.
Crisis management: 1) Forecasting potential crisis and planning how to deal with them (proactive) and
2) When a crisis occurs, identifying its full nature, intervening to minimize damage, and recovering
(reactive).
Criterion/Criteria: A statement(s) of a specific level of achievement against which performance or care
can be measured. A criterion further defines and explains, for measurement purposes, a standard, a
527
policy or procedure, or a clinical practice guideline or protocol. For example, in ANA Standards of
Professional Performance, the Quality of Practice standard states: The registered nurse systematicall y
enhances the quality and ef fectiveness of nursing practice." Specific measurement criteria define what
sk ills and tasks are to be measured & assessed. [ Nursin g: Scope and Standards of Practice, ANA, 2004]
(-Suite: A term used to describe corporate officers and directors. The term is derived from the use of the
letter C in most high-level positions, such as Chief Operating Officer.
Culture: A basic set of assumptions about people, how people work together, and how work gets
done.
Customer: One who receives a product or service, a "dependent" of the one providing the product or
service (the supplier).
Data: Uninterrupted clinical observations, facts, or material, usually collected as a result of assessment
activities.
Database: A collection of information arranged into individual records to be searched by computer.
Decision Making: Choosing from among alternatives to determine a course of action. There must be
at least two options, or there is no decision, only forced choice.
Deductible: A fixed amount the patient pays per year before the insurer begins paying for covered
costs of care . Deductibles are not required for most managed care plans. High-deductible (perhaps
$5,000 per year) "consumer-driven" health plans are linked to Health Reimbursement Accounts or pre-
tax Health Savings Accounts.
Delphi Technique: A tool used to reach team consensus concerning a particular goal or task.
Design: The intentions, plans, or stated expectations for systems and processes of care and service
delivery, incorporating organizational mission, vision, and strategic plan; customer needs and
expectations; knowledge-based information; and current performance in the field.
Det Norske Vertis (DNV): Accreditation agency with deemed status that acCiedits hospitals and critical
access hospitals - originating in Norway.
Documentation: Information recorded, or the process of recording such information, in the medical
record, meeting minutes, or other source document. The accuracy and completeness of the
information, and the timeliness of recording, are quality issues related to documentation .
Effectiveness: The degree to which a desired outcome is reached; the degree to which care is provided
in the correct manner, given the current state of knowledge, to meet the expected outcome.
Efficacy: The potential, capacity, or capability to produce the desired effect or outcome, as already
shown, e.g., through scientific research (evidence-based) findings.
Efficiency: The delivery of a maximum number of "units" of healthcare for a given unit of health
resources; "the relationship of outputs (services produced) to inputs (resources used to produce those
services)." [JCI]
Electronic Data Interchange (EDI): The computer-to-computer transmission of business data in a
standard format, which replaces a traditional paper business document.
Empowerment: Giving employees the authority and information they need to make wise
recommendations or decisions and solve problems.
Evaluation: To determine the worth of or to appraise. !n performance improvement, evaluation is
included in the analysis process.
Event: An occurrence thcJt is either deemed to be, or results in, a significant problem, e.g., an adverse
event or sentinel event [both defined above], or is a "near miss" (almost happened).
Evidence-based: The best external evidence available, e.g., scientific research findings.
Failure Mode: The way that a process or sub-process can fail to function or fail to provide the desired
result; an undesirable variation in a process.
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Failure Mode and Effects Analysis (FMEA): A team-based quality improvement tool that prospectively
assesses, identifies, and improves steps in a process to reasonably ensure a safe and clinically desirable
outcome [NCPS]; a systematic mechanism to identify and prevent product and process failures before
they occur.
Financial management: The study and control of money resources, including their acquisition,
distribution, disbursement, and investment, to meet the goals and objectives of the organization .
Flowchart: a pictorial representation displaying the actual sequence of steps and their inter-
relationships in a specific process in order to identify hand-offs (appropriate and inappropriate),
inefficiencies, redundancies, inspections, and waiting steps and/or the ideal sequence of steps, once
the actual process is known.
Focused Professional Practice Evaluation (FPPE): A privilege-specific, time-limited process to validate
practitioner competency when there is no current performance documentation for the requested
privilege(s) at the organization or when concerns arise about a practitioner's ability to provide safe,
high quality patient care.
Force Field Analysis: A tool used by the team when a proposed solution to a problem will require
significant change, and it is important to analyze the potential impact and chances of success.
Forecasting: Forecasting is the process of predicting what will happen in the future. The ability to
forecast accurately and timely will prove to be a highly valued step in ensuring the strategies are set
with clarity of purpose.
Function: A key area of responsibility and activity of healthcare organizations, such as leadership or
performance improvement .
Gantt Chart: a project-planning tool for developing schedules; a graphic display of the individual parts
of a quality improvement process as bars on a horizontal time scale.
Global Trigger Tool: IHI developed tool that uses triggers (clues) to identify adverse events through
retrospective review of patient's medical records.
Goal: A numerical value that defines the level of the data that is desired to be obtained.
Grievance: A formal expression of dissatisfaction, usually written but may be oral. A person "files" a
grievance.
Healthcare-Associated Infection (HAI): "An infection acquired concomitantly by an individ ual receiving
or who has received care, treatment, or services by a health care organization . The infection may or
may not have resulted from the care, treatment, or services ." Results from medical treatment and
generally has been synonymous with "hospital-acquired".
Healthcare-Associated Infection Rate: The ratio describing the number of individuals w ith a healthcare-
associated infection [numerator] divided by the number of individua ls at risk of developing the
healthcare-associated infection [denominator] . Rates may be stratified by specifying groups predisposed to
infection risk, e.g., surgical site infections further stratified by type of procedure.
Healthcare Effectiveness Data and Information Set (HEDIS): Sets of measures required of facilities
accredited by NCQA.
Healthcare Facility Accreditation Program (HFAP): Accreditation agency with deemed status that
accredits hospitals and other types of healthcare facilities.
High Reliability Organizat ion: Those that achieve zero defects in quality outcomes .
Improve: "To take actions that result in the desired measurable change".
Indicator: A measure used to determine, over time, the performance of functions, processes, and
outcomes of an organization. The term "indicator" now means "performance measure", addressing an
important governance, management, support, or clinical function or process. Indicators may be based
on practice guidelines . Indicators include data definitions, as well as numerator and denominator
529
statements, to accurately specify what is being measured.
Information: Data transformed through analysis and interpretation into a form useful for decision-
making.
Information Management: A function (set of processes) focused on meeting the organ ization's needs
for information for decision-making.
Integration: The systematic coordination of key management functions concerned with the planning and
design of quality processes, as well as the measurement, analysis, and improvement of patient care
and services provided by the organization.
Interrelationship Diagram: A tool that allows a team to analyze all the interrelated cause-and-effect
relationships and factors involved in a complex problem; distinguish between issues that serve as
drivers and those that are outcomes; and describe desired outcomes .
Joint Commission International (JCI): Accreditation agency with deemed status that accredits
internationalhospitals and other types of healthcare facilities.
Just Culture: An organization culture that defines what behavior should be undertaken for an
individua lwho directly made a medical error.
Leadership: (1) The direction, guidance, and example given to others to get quality work done and
achieve intended object ives. (2) The ability to take others where they otherwise would not go or to get
others to do what they otherwise would not do.
Learning Organization: Organizations that are continually learning through the use of personal
mastery, shared vision, mental models, team learning, and systems thinking.
Liability: The state of being legally responsible for something.
Licensed Independent Practitioner (LIP): Any individual who is professionally licensed by the state
(U.S.) and permitted by the organization to provide patient care services without direction or
supervision, within the scope of that license .
Licensure: The mandatory act of granting and receiving a license to provide healthcare services in a
state in the U.S.A governmental regulatory entity grants and monitoring the license to operate.
Lotus Diagram: A tool to expand thinking around a single topic. The expansion may include types,
categories, details, or questions around a theme.
Magnet: A program to recognize health care organizations for excellence as evidenced by quality
patient care, nursing excellence, and innovations in professional nursing practice.
Managed Care: The careful planning and delivery of coordinated healthcare services in an integrated
delivery system or network for an entire episode of illness and/or for wellness and health
maintenance. Ideally, well-managed care maximizes value, integrating concerns for cost, quality, and
access.
Management: The sum of the activities of planning, organizing, staffing, directing, coordinating, and
working to improve human and material resources toward the achievement of stated goals.
Measurement: The planned, systematic process of quantifiable data collection, at a single point in
time or repeated over time.
"Medicaid" :The U.S. Federal Government health insurance for persons meeting low-income or certain
other need requirements, managed by each state.
"Medicare": The U.S. Federal Government health insurance program for persons age 65 and over,
those with permanent kidney failure, and those meeting certain requirements as disabled, managed
by the federal Centers for Medicare and Medicaid Services.
Medical Error: An act of omission or commission in planning or execution that contribute or could
contribute to an unintended result.
530
Minimum Data Set (MDS): Assessment of patients in long-term care settings, which also provides a set
of performance improvement measures.
Mission: The written expression of the organization's overall, broad purpose and role (what/who the
organization is). In a quality improvement environment, it is expected that the statement of mission
will express a high-priority, comprehensive commitment to patient care, to quality in all activities, and
to service to the community. The mission statement is the basis for the formation of organizational
vision, values, goals, and objectives.
Monitoring: Keeping track systematically in order to collect information; keeping close watch.
Monitoring and Evaluation: Historically, a data collection process that focused on high-priority quality-
of-care issues and was designed to facilitate problem solving and the identification of opportunities to
improve.
Multivoting: A technique used to prioritize a long list of possibilities or alternatives and to move a
team toward consensus.
National Committee for Quality Assurance (NCQA): Accreditation agency with deemed status that
accredits managed care and other health plan services.
Near Miss Events: A potential medical error, which was caught prior to the administration or use for a
patient or others.
Negligence: Lack of proper care, as judged by peers.
Negligent Conduct: Doing what a reasonable person would not do; failure to do what a reasonable
person would do (based on set standards and under like circumstances and training). Gross negligence
is failure to act if there is known or suspected risk resulting in adverse impact or death.
Negotiation: The art of conferring, discussing, or bargaining to reach agreement.
Never Event: An event that should never happen and if it does, immediate investigation and
remediation is required. (Also, commonly called a sentinel event).
Nominal Group Process: A technique used to give everyone on the team/group an equal voice in
brainstorming, problem selection, or resolution.
Nonprobability Sampling: Sampling design, which decreases the probability that the findings can be
generalized.
Ongoing Professional Practice Evaluation (OPPE): Ongoing measurement and analysis of each
practitioner's performance relative to existing privileges, including licensed independent practitioners
and others with clinical privileges granted by the organization .
Organizationleaders: The group of individuals that sets expectations, develops plans, and implements
procedures to assess and improve the quality of the organization's governance, management, clinical,
and support functions and processes.
Organizational Ethics: Management of relationships with patients and the public under a set of
principles of right conduct; conduct of business with patients and the public with respect, honesty, and
integrity; and recognition and acceptance of responsibilities under law.
Outcome: The result(s) or effect(s) of the performance or non-performance of one or more functions
or processes. An outcome represents the cumulative effect of one or more processes on a patient at a
defined point in time.
Outcome and Assessment Information Set (OASIS): Assessment of patients in home health care
settings, which also provides a set of performance improvement measures .
Patient-Centered Medical Home (PCMH): "a model of the organization of primary care that delivers
the core functions of primary health care"-patient-centered, comprehensive, coordinated, accessible,
continuously improved [Agency for Healthcare Research and Quality (AHRQ)].
Patient Safety: "Freedomfrom accidental injury caused by medical care" [Institute of Medicine].
531
Patient Safety Organization (PSO): An organization that receives deidentified patient health
information for use in population health and in improving patient outcomes.
Patient Safety and Quality Improvement Act of 2005 (PSQIA): Federal law that provides privilege and
confidential protections for patient safety work products .
Pattern: An identifiable arrangement of data (a grouping or distribution) suggesting a systematic or
predictable design or behavior. Example: A positive correlation between patient's heart rate taken by
nurse and that taken by monitor as demonstrated on a scatter diagram.
Peer Review: Review of an individual practitioner by a "like" practitioner with similar training ,rnd
expertise.
Peer Review Organizations (PRO): Established to assure services provided to Medicare and Medicaid
patients worked and employed concurrent utilization review. PROs were replaced by QIOs in 2002.
Performance: The effective execution or accomplishment of important functions and processes, with
particula r focus on those that increase the probability of desired outcomes; what is done and how well
it is done to provide healthcare.
Performance Measure: A quantifiable process and outcome indicator used to monitor performance .
Performance Improvement :
• "The continuous study and adaptation of a healthcare organization's functions and processes
to increase the probability of achieving desired outcomes and to bettei meet the needs of
individuals and other users of services." {Past Glossary, CAMH, TJC]
• "Data collection and analysis for the purpose of providing an indication of the organization's
performance on a specified process or outcome. " {Current Glossary, CAMH, TJC]
Plan: The written document describing a particular program and all associated structures, processes,
and activities. Plans discussed in the Handbook include those related to quality management,
utilization management, risk management, information management, the organizational plan for
patient care services, and the corporate compliance plan.
Planning: A systematic, organizationwide approach to the design, monitoring, analysis, and
improvement of performance .
Practice Guideline: A generally accepted principle for patient management, with care specifications
based on the most current scientific findings (evidence of effect iveness, hence "evidence-based"),
clinical expe rtise, and community standards of practice. "Clinical practice guidelines are systematically
developed statements to assist practitioner and patient decisions about appropriate health care for
specific clinical circumstances. " [Institute of Medicine]
Present on Admission (POA): Conditions that a re present upon admission to a healthcare fac ility.
Preventable Event: Unintended injury to patients not caused by an error.
Primary Care: The point of entry into the healthcare system for non-emergency care, the point of first
contact w ith the system, and the point of most frequent contact.
Prioritization Matrix: A tool used to select one option from a group of alternatives, be they problems
or solutions, or to put the options into priority order if all need to be done, to promote objective decision-
making.
Privileging: Permission to provide specific medical or other patient care services in the granting
organization, within well-defined limits, based on the individual's professiona l license and his or her
experience, competence, ability, and judgment and on the organization's ability to provide and
support the service.
Probability Sampling: Sampling design which increases the probability that the findings can be
generalized.
Problem: A deviation from an expected occurrence that cannot be justified as appropriate under the
532
given circumstances .
Process: In performance improvement, a goal-directed, interrelated series of actions, activities, events,
mechanisms, or steps related to a function of care or service; a sequence that transforms inputs into
outputs or outcomes.
Productivity: "That bafance between aff factors of production that wiff give the greatest output for the
smaffest effort" [Peter F. Drucker].
Profiling: Ongoing documentation, tracking, and compilation of practitioner clinical activities and
services (e.g., performance measure and peer review data and information), as well as QI/Pl activities
(e.g., teams, committees, leadership) for reappraisa l [See this Glossary].
Program: A pre-arranged outline of work to be done; a logical sequence of operations to be
performed; a composite of all activities associated with improvement of organizational performance .
Prospective Payment System: A method of reimbursement that provides healthcare providers-
facilities and licensed independent practitioners-with a pre-negotiated fixed set of payment rates for
each type of patient or group of services. The payment rate remains unchanged regardless of
operating costs.
Quality: Measurable: Compliance with, or adherence to, standards (or performance measures).
Appreciative: The comprehension and appraisal of excellence beyond minimal standards and
criteria, based on training and expertise.
Perceptive: The degree of excellence that is perceived by the recipient or observer of care
rather than by the provider.
An organizational definition: "Quality is meeting or exceeding expectations at a cost that
represents value to the customer."
Quality Improvement Organization (QIO): As part of the DHHS national Quality Strategy, replaced the
PROs and is dedicated to improving health quality for Medicare beneficences.
Quality Innovation Network (QIN): Division of the QIO that provides healthcare organizations
education, outreach, and sharing practices that worked in other areas. The QIN utilizes data to
measure improvement, and works with patients, families, and community partners.
Quality Management: A planned, systematic, organizationwide (or networkwide) approach to the
monitoring, analysis, and improvement of organization performance, thereby continually improving
the quality of patient care and services provided and the likelihood of desired patient outcomes.
Quality Management is the quality umbrella, including quality planning, quality control/measurement,
and quality improvement, based on the Juran Quality Management Cycle, also known as the Quality
Trilogy.
Rapid Cycle Improvement: Utilizing traditional quality tools but expediting the change and the results.
Reappointment: Selection for continued membership in a medical/professional staff (e.g., hospital or
medical group) or to a practitioner panel (e.g., preferred provider organization), based on reappraisal.
Reappraisal: Periodic reevaluation by peers of a practitioner's competency to provide care and
services to patients in or for a healthcare organization. Reappraisal may include recredentialing,
reprivileging, proctoring for a new privilege, profiling, peer review, and reappointment [See this
Glossary for definitions].
Reliability: The ability of the indicator or collection tool to measure in a reproductive way
what it is supposed to measure (interrater reliability).
Risk: The possibility of loss or injury; peril; a dangerous element or factor.
Risk Management: Clinical and administrative activities developed and implemented to prevent and
533
reduce, or identify, evaluate, and intervene with, risk of injury or loss to patients, staff, visitors, and
the organization.
Risk Register: a listing of identified risks and its components, usually in table format, that supports the
governing body, leadership, management, and teams seeking to develop, organize, implement, and/or
maintain ERM or another new strategic initiative, function, process, or project. It is a tool for
documenting priorities; summarizing and succinctly describing risks to be managed, based on
probability and impact scores, by category; listing prevention or mitigation strategies; responsibility;
timeline.
Root Cause Analysis (RCA): A systematic process for identifying the most basic or causal factor(s)
under lying variation in performance, including the occurrence or possible occurrence of adverse
events that might be prec1.;, :;ors to a sentine l event; the intensive, in-depth analysis of a problem
event, e.g., a sentinel event, to learn the most basic reason(s) for the problem, which, if corrected, will
minimize recurrence of that event.
Safety: The degree to which the healthcare environment is free from danger or hazard; the degree to
which the healthcare intervention minimizes risks of adverse outcome for both patient and provider.
Scope of Work (SoW): QIO activities determined by CMS with both beneficences and medical
communities in the state.
Sensitivity: The ability to measure, test, or tool (study design, screen ing tool, otr lab test) to identify
and select all positive cases or spec ified variations or deviations (all cases in the category), using
var iables to be examined - fewer false negatives.
Sentinel Events: "An unexpected occurrence involving death or serious ph ysical or ps ychological injur y,
or the risk thereof. The phrase "of the risk thereof" includes any process variation for which a
recurrence would carry a significant chance of a serious ad verse outcome." [TJC Glossary]
Severity of Illness: The degree of risk of immediate death or permanent loss of function due to a
disease. Clinical findings are used to assign a severity rating, ranging from "no risk" (0) to "death" (5),
depending on the system.
Specificity: The ability to measure, test, or tool to differentiate between cases wanted and those
similar, but not in the desired category, and to exclude those negative cases.
Standard of Care: A predefined outcome of patient care that the patient can expect from the
encounter and that is accepted within the community of professionals, based upon the best scientific
knowledge, current outcome data, and clinical expertise.
Standard of Practice: An acceptable level of performance or an expectation for professional
intervention or behavior, generally formulated by practitioner organizations based upon clinical
expertise and the most current research findings. Standards of care and practice are the building
blocks of practice guidelines, critical/clinical paths, patient care policies and procedures, and indicators
for quality management activities.
Statistical Process Control: The use of measurements to study a process with the goal of making it
perform in a certain way, conform to standards, and continuously improve.
Storyboard: a visual display of the team and pertinent data/ information, analyses, and decisions
made during the improvement process.
Strategic Leadership: Guidance or direction that is essential to meeting intended objectives or
successfully implementing a plan of action.
Strategic Planning: An organizationwide/systemwide, ongoing look into the future.
Strategic Quality Initiative: A statement of intent and a strategy to improve care and services in a
specific way; a high-level, leadership-driven, organizationwide decision, resulting from, or incorporated
into, the strategic planning process.
534
Stratification: To break the whole down into its parts.
Structure: The arrangement of parts of a care system or elements that facilitate care; evidence of the
organization's capacity to provide care to patients. Structure is causally related to process and
outcome: structure leads to process and process leads to outcome.
System: "A perceived whole whose elements 'hang together' because they continually affect each
other over time and operate toward a common purpose." [Senge]
Systems Theory: Systems theory is a way of looking at an organization holistically and breaking it down
into a series of individual elements that interact with each other.
Systems Thinking: The belief that the behavior of all systems follows certain common principles, the
nature of which can be discovered, articulated, understood, and used to make change. [Senge]
Team: A group of people working toward a common purpose for which they are interdependent and
mutually accountable.
Threshold: A numerical point below, which the data should, not fall or the point or level at which
something begins or changes
Timeliness: The degree to which care is provided to the individual at the most necessary or beneficial
time and in accordance with the patient's perception of promptness.
To Err is Human: IOM groundbreaking report on the presence of medical errors in healthcare.
Tort: Legal cases that result from civil wrongs including invasion of privacy, lack of consent, defamation
of character, fraud and deceit, assault and battery, negligence/malpractice.
Total Quality Management (TQM): A broad management philosophy, espousing quality
and leadership commitment that provides the energy and the rationale for implementation of the
process of Continuous Quality Improvement (CQI) within the organizationwide Quality Management
Strategy. Tracer: A framework used to assess the movement of a patient through the healthcare
system and the quality of care received.
Transparency: Enabling consumers to compare the quality and price of healthcare services and make
informed choices. [U.S. Department of Health and Human Services)
Trend: A key type of pattern indicating a general tendency or direction of events or conditions, usually
over a significant period of time. Example: The correlation between heart rates taken separately by
nurse and monitoring device over a period of six months.
Trigger : A numerical point at which there should be some action taken.
Triple Aim: A framework developed by IHI that describes the approach to optimizing health system
performance through population health, experience of care, and per capita cost of care.
Us: A term used to describe corporate officers and directors. The term is derived from the use of the
letter C in most high-level positions, such as Chief Operating Officer .
Utilization Management: The examination, evaluation, and appropriate use of organization resources;
an organizationwide, interdisciplinary approach to balancing cost, quality, and risk concerns in the
provision of patient care.
Validity: The capability of the indicator or collection tool to measure what it is supposed to measure.
Value Statements: A listing of organizational values that support the mission and vision statements
and guide strategic planning, decision-making, and the provision of all services.
Variation: A "change or deviation in form, condition, appearance, extent, etc., from a former or usual
state, or from an assumed standard" [Webster's New World Dictionary].
Vision Statement: The organization's intent and aspirations for the future (what the organization
strives to be). It should espouse forward thinking goal'.; for quality and customer service.
535
WalkRound: Leadership rounds throughout the healthcare organization in an informal manner to
demonstrate to staff the organization's commitment to patient safety and talking with staff and
patients encouraging them to report errors as well as accomplishments.
536
INDEX
Abduction/Elopement 400
Accountable Care Organizations (ACO) 451,486-487, 500, 513, 525
Accreditation 99, 125, 173,423-466, 525
Accreditation Commission for Health Care 447,455,465, 513
(ACHC)
Advance Payment ACO Model (AP) 487, 513
Adverse Event 147-149,525
Agency for Healthcare Research and Quality 38,85,107, 120, 124,186,277,366,372,390, 414,
(AHRQ) 513
American Association for Ambulatory Health 441, 451,453-454,463,465,513
Care (AAAHC)
American Recovery and Reinvestment Act 477,485,504,513
(ARRA)
American Society for Quality (ASQ) 24,26, 514
Americans with Disabilities Act (ADA) 475,489, 513
Amory Cadman 1-2, 30
Analysis 176-180
Anti- kickback 491-492
Appointment 213
Approval 212-213
Baldrige 458-459,525
Bar-code 397,419,420
Benchmarking 114,526
Beneficiary and Family Centered Care (BFCC) 482-483, 514,526
Categorical Data 295-296
Catheter-Associated Urinary Tract Infection 155, 376, 514, 526
(CAUTI)
Cause Mapping 198, 205
Center for Improvement in Healthcare 24,444,450,465,515, 526
Quality (CIHQ)
Centers for Medicare & Medicaid Services 58-59, 515
(CMS)
Certification 22, 31, 60
Certified Manager of Quality/Organizational 24, 26,515
Excellence (CMQ/OE)
Certified Professional in Healthcare Quality 24, 515
(CPHQ)
Champions 197, 199,429
Change Management 62
Charter 202
537
Chi Square 296-297,309-311
Children's Health Insurance Program 477
Reauthorization Act (CHIPRA)
Central Line Associated Blood Stream 376-377,515,526
Infection (CLABSI)
Clinical Laboratory Improvement Act (CLIA) 475,495,515
Commission for Accreditation of 442,454,465,514,526
Rch.:ibilitation Facilities (CARF)
Common Format 277,359
Communication 64-65
Community Health Accredita tion Program 442,456,514
(CHAP)
Competencies 19-24,60,527
Comprehensive Unit-based Safety Program 413,515
(CUSP)
Conditions for Coverage [CMS] (CfCs) 58,478,514,527
Conditions of Participation 58,71,78,94,98, 136,139,152, 164-165,424-426,
445,450,478-479,504,527
Conditions of Participation [CMS] (CoPs) 58,80,185-187,446,465,467-468,471-472,500,
515,523,527
Confidence Interval 316
Confidentiality 279-280,527
-·-··- -
Confidentiality Agreement 283
Consent for Treatment 283
Consulting 228-229,345,449,465
Continuous Data 295-296,298,309,326
Continuous Qua lity Improvement (CQI) 1,8,11-12,30,81,475,515
Core Measures 173,445
Corporate Compliance 489-499
Credentialing 212-217,525
Crew Resource Management 412-413,418, 421
Culture of Safety 389-390
Customer 14,528
Data Collection 266,274
Data Display 295
Data Inventory I 261-262
Deemed Status 425-426
Descriptive Statistics 297-298
Det Norske Vertis (DNV) 9,445-447,465-466,468-470,478,485-487,516,528
Disclosure 404-406,419,489,493-494,502,507
DMAIC (Define, Measure, Analyze, Improve, 90-91,516
Control [Six Sigma])
538
Donald Berwick 1,4, 30-31,365
Education 18-27, 202
Edward Deming 2, 29, 31
Evidence- Based Practice (EBP) 21,118, 538
Facilitation 198-199
Failure Mode Effectiveness Ana lysis (FMEA) 368, 408, 517, 529
False Claims Act (1863) and Amendments 512-513, 523, 516
(1986) (FCA)
FDA Safety and Innovation Act (FDASIA) of 496,517
2012
Federal Food, Drug and Cosmetic Act 496-497, 517
(FFDCA)
Federal Occupational Safety and Health Act 22, 172, 275, 408, 445, 489, 520-521, 524
of 1970 (OSHA)
Federal Poverty Level (FPL) 481, 517
Fish Bone Diagram 338-339
Focused Professional Practice Evaluation 222, 225, 243, 517, 529
(FPPE)
Food and Drug Administrat ion (FDA) 383, 497, 517
Forecasting 52-53, 66, 529
Governance 40
Health Care Financing Administration (HCFA) 478, 517
Health Care Quality and Management 24-25, 514
Certification (CHCQM)
Health Information Technology for Economic 477, 485,517
and Clinical Health (HITECH) Act
Health Insurance Portability and 287,475, 488, 505, 517
Accountability Act (HIPAA)
Healthcare Corporation of America (HCA) 490, 512, 517
Healthcare Effectiveness Data and 175,452,529
Information Set (HEDIS)
Healthcare Facility Accreditation Program 444, 449, 465, 529
(HFAP)
Healthcare Infrastructure 38-40, 379-380
Healthcare Quality Essentials 19
Healthy People 2020 143-144, 243
Herzberg's Hygiene Theory 192
High Performance Organization 47
High Reliability Organization 42
Human Factors 401-402
Indexes 288
Inferential Statistics 269-270
539
Informed Consent 282-283, 374,387, 424, 432
Institute for Healthcare Improvement (IHI) 4, 13, 143, 377-379, 411
Institute for Safety Medication Practice 250,414,518
(ISMP)
Institute of Medicine {IOM) 4, 19-20, 124, 143, 251,276, 365, 518
International Disease Code (ICD-10) 286,287, 518
International Society for Quality 465,518
Accreditation Program (ISQua)
Interval 296-299,303,308-309,31 6
Joint Commission International (JCI) 465,530
Joint Commission on Accreditation for See The Joint Commission (TJC)
healthcare Organizations (JCAHO)
Jos ie King 156,244, 250,411,418,422
Just Culture 389,391-393,416,418,422
Kaora Ishikawa 11-12, 338-339
Leadership 34,36,47,55, 530
Leadership Development Model 60
Leadership Styles 47,49,61,67
LEAN 88-89, 242-243, 245,346,360,414
Learning Board 392-393
Learning Organization 43,46,67,69
Liability 93,96, 144,146,149, 370,386,467-471,473-474,
483,494,502-503, 530
Licensure 426,530
Magnet 459-460, 465, 530
Manager 49-50
Maslow's Hierarchy of Need 191
Mean 298
Meaningful Use 285-287,360,362, 477,484
Median 297-300, 332-333, 353
Medicaid 58,480, 530
Medical Device Act {MDA) 496,519
Medical Device Reporting (MDR) 497,519
Medicare 58, 413, 478-479, 491, 530
Medicare and Medicaid Health Information 485
Technology
---
Medicare and Medicaid Patient Protection 491,519
Act of 1987 (MMPPA)
Medicare Catastrophic Coverage Act (MCCA) 475,519
Medicare Shared Savings Program (MSSP) 509,519
Minimum Data Set (MDS) 169,427, 519,531
540
Mode 298-300
Monitoring 152-153, 531
Motivation - Herzberg's Hygiene Theory 191-192
Motivation Theories 191-192
Multiple Regression 316
National Association for Healthcare Quality 19, 24, 60, 519
(NAHQ)
National Committee for Quality Assurance 93, 125, 175, 246, 375, 425, 451, 465, 494, 520, 531
(NCQA)
National Learning Consortium (NLC) 31, 520
National Practitioner Data Bank (NPDB) 220, 227, 250, 494
National Quality Forum (NQF) 107, 250, 362, 368, 376, 405, 408, 520
National Quality Strategy (NQS) 13, 520
Near Miss Events 368, 531
Negligence 470, 502-503, 531
Never Event 368, 401
Nominal 295-299, 309, 319, 337
Non-Parametric Tests 308
Nonprobability Sampling 266, 269-270, 531
Office of the Inspector General (OIG) 424,520
OIG Compliance Program Guidance 492, 506
Omnibus Budget Reconciliation Act of 1989 475, 491, 506, 520
(OBRA)
Omnibus Budget Reconciliation Act of 1993 475, 491, 506
(OBRA)
Omnibus Budget Reconciliation Acts of 474, 506
1980s (OBRA)
Omnibus Budget Reconciliation Acts of 475, 506
1990s (OBRA)
Ongoing Professional Practice Evaluation 222-224, 250-251, 520, 531
(OPPE)
Ordinal 296, 309
Outcome 178, 531
Outcome and Assessment Information Set 168, 241, 521, 531
(OASIS)
Parametric Tests 308-309
Pareto Analysis 327-331
Patient Protection and Affordab le Care Act 185,477, 485, 521
(PPACA)
Patient Rights and Responsibilities 488
Patient Safety 367, 422, 531
Patient Safety and Quality Improvement Act 374, 521, 532
541
-
of 2005 (PSQIA)
Patient Safety Goals 376-379, 385- 388, 422, 433, 445
Patient Safety Organization (PSO) 375,414, 419, 521
Patient Self- Determination Act (PSDA) 475, 487, 506, 521
Peer Review Organizations (PRO) 482, 521, 532
Performance Improvement 75-77, 85, 94-96, 101, 189, 532
Periodic Performance Review 224-225, 266
Philip Crosby 1,3
Pioneer ACO Model (PACO) 487, 509
Plan-Do-Check-Act (POCA) 86, 521
Plan-Do-Study-Act (PDSA) 86, 246, 521
Predictive Analysis 53, 69
Present on Admission (POA) 375, 521, 532
Prioritization 52-53, 350-351,392
Privileging 33, 73, 132, 212, 214-216, 218, 220-222,532
Probability Sampling 269, 532
Process 435, 519
Professional Organizations 60
Professional Standards Review Organizations 481-482, 521
(PSRO)
Prospective Payment System (PPS) 481, 521,533
1-----·-· -- ,
Protected Information 280

Public Health 142
Quality and Safety Education for Nurses 20-21, 522
(QSEN)
Quality Assessment and Performance 94, 522
Improvement (QAPI)
Quality Improvement Organization (QIO) 387-390, 504-506, 522, 533
Quality Innovation Network (QIN) 483, 503, 522, 533
Quality Management Principles 92, 533
Quality Professionals Role 15, 17-19, 60-61, 77, 99, 197, 384
Rapid Cycle Improvement 88, 103, 239, 533
Ratio 296-299, 304
Reappointment 213 -222, 224-225, 227, 533
Registers 288
Regression Analysis 313, 315-316, 319
Reliability 259, 533
Radio Frequency Identification (RFID) 400, 522
Root Cause Analysis (RCA) 343, 348, 368,385, 389, 404, 406, 416, 522, 534
Safe Medical Devices Act (SMDA) of 1990 497, 523
Safety Culture 389-390
542
Utilization Review Accreditation Commission 451,453, 523
(URAC)
Va lidity 260,535
Value 6-7, 345
WalkRound 393-395, 536
World Health Organization (WHO) 287,376,523
'I
544
Sampling 268
Satisfaction 155-162
Scope of Work (SoW) 483, 523, 534
Sensitivity 258, 534
Sentine l Event 368, 403-404, 406, 534
Sigma 3-4, 74, 90-92, 239, 346, 414
Six Sigma 3-4, 74, 90-92, 239, 346, 414
Social Security Amendments of 1994 491
Spec ificity 258, 287-288, 534
Standard Deviation 301, 304-308, 311,316, 335, 353, 363
Stark Law 491, 503, 507
Statistical Process Control (SPC) 318, 523, 534
Strategic Leadership 36-37, 69, 71, 534
Strategic Planning 51-55, 534
Strategic Priority 379
Stratification 258, 535
Structure 78,105, 535
Survey 272-274, 434-438, 445-450, 453-455
Swiss Cheese Model 368-369, 407, 422
Systems Theory 34-35, 535
Systems Thinking 35, 46, 365
Taiichi Ohno 11, 30
Tax Equity and Fiscal Responsibility Act 474, 482, 507, 523
(TEFRA)
Tax Relief and Health Care Act (TR HCA) 476, 523
TeamSTEPPS 412, 422, 523
Technology 289, 396
The HealthCare Quality Improvement Act of 494, 517
1986 (HCQIA)
The Joint Commission (TJC) 173-174, 444-445, 523
{changed in 2007 from Joint Commission on
Accreditat ion of Healthcare Organizations
[JCAHO]}
Theory X 191-192, 248
Theo ry Y 191-192, 248
To Err is Human 365- 367, 370, 372, 375, 416, 418,476, 535
Tort 469-471,486, 535
Tota l Quality Management (TQM) 11, 523, 535
Trace r 432, 535
Transpa rency 184-186, 535
T-Test 309-311
543

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PERFORMANCE AN D PROCESS IMPROVEM ENT

Truven 100 Top Hospitals Report

PEOPLE IN THE PERFORMANCE IMPROVEMENT PROCESS

• Work (exchange of information in daily work)

• Social ("check-ins" inside and outside the workplace for information)

• Innovation (collaboration/sharing new ideas)

• Expert Knowledge (expertise and advice)

• Career Guidance/Strategic (advice about the future)

• Learning (improve existing processes or methods)

Figure 4: Maslow's Hierarchy of Need

Table 33: Comparison of Theory X and Theory V

Herzberg's Motivation-Hygiene Theory of job enrichment is another important motivation theory

Table 34: Factors for Motivation-Hygiene Theory

EAMS & MEETING

The improvement of quality in healthcare organizations is d,ependent on teamwork, partly because

eamwork and Group Process!

!The Role of Teams in Quality Managemenq

!Roles within Quality Improvement Teams!

!selection of Team Members!

Table 35: Team Roles and Basic Tasks

!Recorder & Timekeeper Roles\

Role of the Healthcare Quality Professional

!Performance Improvement Team Establishment)

\orient/Educate the Teaml

Table 36: Tips for Building a Successful Team

Team members communicate clearly and honestly with others;

!Evaluation of Team Performance!

2. Did the team follow the performance improvement model?

3. Were individuals responsible in completing their assigned tasks?

Table 37: Meeting and Agenda Items by Type and Examples

!Before the Meeting!

!During the Meetingl

Meeting Minutes & Documentation

Table 38: Examples of Closing the Loop in Minutes

THE PRACTITIONER APPRAISAL PROCESS

Medical Staff Membership

Process Leading to Appointment

Table 39: Categories of Medical Staff Membership

Re-credentialing consists of submission of an application as previously occurred during the initial

Credentialing of Licensed Independent Practitioners

• Current, valid (state in U.S.) license to practice

• Voluntary and involuntary limitation, reduction, or loss of clinical privileges or

Instead of organizations performing this centralized credentialing themselves, many organizations

• American Osteopathic Association (AOA) Physician Database (pre-doctoral education);

• American Board of Medical Specialties (ABMS)-primary source (board certifications)

• Educational Commission for Foreign Medical Graduates (ECFMG)-primary source

• Federation of State Medical Boards (FSMB) Disciplinary Data Bank-primary source

Credentialing in Managed Care Settings

Privileging of Licensed Independent Practitioners

• Practitioner is acting w ithin his/her scope of care

• Practitioner is responsible for the care of the patient as an outpatient

Special Privilege Statuses

Emergency & Disaster Privileges

!Evaluation of the Practice of Licensed Independent Practitioners!

Table 41: Potential Items for a Practitioner Profile

Aggregate Peer review findings

longoing Professional Practice Evaluation (OPPE)i

!Focused Professional Practice Evaluation (FPPE)[

Focused Professional Practice Evaluation (FPPE) is a privilege-specific, time-limited process to validate

1= Peers would have managed care in the same manner