Introduction
Introduction
Introduction
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Read this chapter first to understand the Laboratory Accreditation Program and the
structure and content of the CAMLAB. After you have a better understanding of the
value of accreditation in improving and maintaining the quality of care, treatment, or
services, maximizing patient safety, and stimulating performance improvement, read
“The Accreditation Process” (ACC) chapter to understand The Joint Commission’s
accreditation process, including eligibility for accreditation; the application process;
accreditation surveys and what to expect before, during, after, and between surveys;
accreditation decision rules; and review and appeal procedures.
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Figure 1. The Joint Commission’s Laboratory Accreditation Program is designed to help laboratories
achieve, maintain, and demonstrate consistent excellence in the services they provide to patients. The
program has several key components designed to work collectively to better power your overall performance
improvement efforts.
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Following the direction provided in these standards and focusing on the patient will
allow staff to begin to explore ways to improve care, treatment, or services to help
patients in attaining the most favorable outcomes possible. A self-assessment using the
Intracycle Monitoring (ICM) process (discussed in more detail in “The Accreditation
Process” [ACC] chapter) and the information on your Joint Commission Connect
extranet site can help you focus on organization-specific problem areas. An understand-
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ing of the complex issues addressed by these standards will help you assess just how
ready for accreditation your organization is and will allow you to continually assess your
organization’s readiness going forward.
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Changes to the standards, which occur for a variety of reasons, are developed with input
from accredited organizations, health care professionals, providers, internal and external
subject matter experts, consumers, government agencies, and/or employer groups and
are informed by the scientific literature. New standards are added only if they relate to
patient safety or quality of care and/or have a positive impact on health outcomes, can
be accurately and readily measured, and relate to important issues that clearly support
high-quality care, treatment, or services. Standards may also be revised in response to law
and regulation changes.
Although The Joint Commission may announce revisions to accreditation standards
throughout the year, those changes are made to E-dition generally only twice a year: in
the spring (with changes applicable July 1) and in the fall (with changes applicable
January 1 of the following year). Accredited organizations receive one complimentary
subscription to E-dition as long as they maintain accreditation. The print version of the
CAMLAB is published once a year in the fall; it is available for purchase at https://
www.jcrinc.com/store/publications/manuals/. The “What’s New” table, provided with
each print manual and accessible from the blue navigation bar across the top of E-dition,
offers a summary of the changes made since the CAMLAB was last published or posted.
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Acronym Meaning
DA Denial of Accreditation
EP element of performance
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Table 2. (continued)
LD “Leadership” chapter
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Accreditation Requirements
The first section of this manual contains the accreditation standards for the Laboratory
Accreditation Program, which consists of Joint Commission standards, EPs, and other
requirements applicable to all organizations accredited in the Laboratory Accreditation
Program.
This manual contains the following standards chapters:
“Accreditation Participation Requirements” (APR): Consists of specific requirements
for participation in the accreditation process and for maintaining an accreditation
award.
“Document and Process Control” (DC): Contains a comprehensive set of requirements
for the pre- and post-analytical phases of testing and describes the procedures for
specimen collection, ordering of laboratory tests, and step-by-step description of the
performance of each test.
“Environment of Care” (EC): Describes how to maintain a safe, functional, and
effective environment for patients, staff, and other individuals in the organization.
Includes requirements that address fire safety.
“Emergency Management” (EM): Ensures that the organization has a disaster plan in
place.
“Human Resources” (HR): Outlines requirements for personnel roles required for
nonwaived testing as listed in the Clinical Laboratory Improvement Amendments of
1988 and processes for staff orientation, training, competency, and management.
“Infection Prevention and Control” (IC): Helps organizations identify and reduce the
risk of acquiring and transmitting infections.
“Information Management” (IM): Directs organizations to obtain, manage, and use
information to provide, coordinate, and integrate care, treatment, and services.
“Leadership” (LD): Reviews structure and relationships of leadership and the
maintenance of a culture of safety, quality, and operational performance.
“National Patient Safety Goals” (NPSG): Includes specific actions that organizations are
expected to take to prevent medical errors, such as harm associated with inaccurate
patient identification, delayed communication on critical test results, and health care–
associated infections.
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“Standards Applicability Grid” (SAG): Provides a list of the standards that are
applicable to laboratories. The user-friendly format allows you to quickly identify the
services, as you identified them in your E-App, and the related standards that apply to
your laboratory.
“Sentinel Event Policy” (SE): Contains information on The Joint Commission’s
Sentinel Event Policy, including the definition of a sentinel event, the goals of the
policy, the adverse events that constitute sentinel events, sentinel event–related
standards, and the various activities that surround the policy.
“The Joint Commission Quality Report” (QR): Provides an overview of publicly
viewable accreditation information provided in the form of Quality Reports. It describes
what Quality Reports are, how and when they are developed, how organizations can
respond to them, and how the public and organizations can access and use them. It also
includes information about The Joint Commission’s Quality Check® website, guide-
lines for submitting commentary, and marketing and communications guidelines for
using Quality Reports.
“Required Written Documentation” (RWD): Lists the standards that require written
documentation beyond that required in the medical record—that is, all the EPs marked
with a icon throughout the standards chapters. This chapter can be used as a
checklist by accredited organizations to maintain continuous compliance with documen-
tation requirements or by organizations seeking accreditation to verify compliance with
those requirements.
“Appendix A: Retention Times for Records, Reports, and Specimens” (AXA): Lists
the minimum required retention times for various records, reports, and specimens. In
instances where state or local regulations require longer retention periods, the laboratory
must conform to those.
“Appendix B: Laboratory Developed Tests” (AXB): Lists the standards and EPs that, in
addition to those found in the Molecular Biology column of the SAG chapter, may be
applicable to laboratories performing Laboratory Developed Tests (LDTs) in a
particular specialty or subspecialty.
“Appendix C: Individualized Quality Control Plan–Eligible Requirements” (AXC):
Contains the general and specialty/subspecialty quality control requirements eligible for
the Individualized Quality Control Plan (IQCP) approach. Laboratories that choose to
implement IQCP are still required to follow all other non–IQCP eligible Joint
Commission quality control requirements.
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Standards for the following 10 Joint Commission accreditation programs are available
on E-dition (the names of the corresponding print or PDF manuals, if available, are
indicated in parentheses):
1. Ambulatory Care (Comprehensive Accreditation Manual for Ambulatory Care):
Surgery centers, community health centers, group practices, imaging centers, sleep
labs, rehabilitation centers, student health centers, urgent care clinics, and other
ambulatory providers
2. Assisted Living Communities (Comprehensive Accreditation Manual for Assisted
Living Communities): Organizations that provide residency and services to residents,
which may include assistance with activities of daily living, medication adminis-
tration, and dementia care
3. Behavioral Health Care and Human Services (Comprehensive Accreditation Manual
for Behavioral Health Care and Human Services): Organizations that provide mental
health services, substance use disorder treatment services, foster care services,
programs or services for children and youth, child welfare, services for individuals
with eating disorders, services for individuals with intellectual/developmental
disabilities of various ages and in various organized service or program settings, case
management services, peer-based recovery services, prevention and wellness pro-
motion services, corrections-based services, opioid treatment programs, and psychi-
atric rehabilitation/community support services
4. Critical Access Hospital (Comprehensive Accreditation Manual for Critical Access
Hospitals): A hospital that offers limited services and is located more than 35 miles
from a hospital or another critical access hospital, or is certified by the state as being a
necessary provider of health care services to residents in the area. It maintains no
more than 25 beds that could be used for inpatient/swing bed care. A critical access
hospital provides acute inpatient care for a period that does not exceed, on an annual
average basis, 96 hours per patient. A critical access hospital can also have a
psychiatric and/or rehabilitation distinct part unit; each unit can have up to 10 beds.
5. Home Care (Comprehensive Accreditation Manual for Home Care): Organizations
that provide home health services, personal care and support services, pharmacy
services including infusion services and/or mail order and specialty pharmacies, long-
term care pharmacies and freestanding infusion centers, durable medical equipment
services, and hospice services
6. Hospital (Comprehensive Accreditation Manual for Hospitals): General, acute
psychiatric, pediatric, medical/surgical specialty, long-term acute care, and rehabili-
tation hospitals
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Figure 2. Components of a standards chapter in the print manual. The components are further
described in the “Understanding the Icons Used in the Manual” section.
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■ Create or use a checklist to evaluate compliance for each standard, or turn each
standard into a question. For example: Is our interdisciplinary team consulted when
necessary to determine whether a prospective patient is eligible for admission? Does
my organization assess the patient’s risk for falls?
■ Monitor The Joint Commission’s website for free tools and resources provided,
such as workplace violence prevention resources (https://www.jointcommission.
org/resources/patient-safety-topics/workplace-violence-prevention/).
■ Use the manual to perform mock tracers or a mock survey. Plot your compliance on
a Survey Analysis for Evaluating Risk® (SAFER®) Matrix. (For more details on
plotting your compliance, see “The Scoring Process” section in “The Accreditation
Process” [ACC] chapter or the SAFER Matrix scoring process fact sheet at https://
www.jointcommission.org/resources/news-and-multimedia/fact-sheets/facts-about-
safer-matrix-scoring-process/.)
■ Use the worksheets at the end of each standards chapter to track compliance with
the standards in the chapter and to trace progress for coming into compliance.
■ Turn accreditation standards into PowerPoint presentations, handouts, study aids,
posters, or other staff education materials. They also can be rewritten as quizzes,
tests, or worksheets to determine staff understanding.
■ Compile information on your performance improvement activity for discussion
during your survey.
■ Form a team to develop creative ways to assess, achieve, and maintain standards
compliance, such as the following:
❏ Question of the week or month
❏ Standards-related posters
❏ Column in a weekly all-staff newsletter or electronic bulletin board
■ Speak to other accredited program coordinators. To find other accredited programs,
go to https://www.qualitycheck.org and search by organization, service/setting,
state, city, or zip code.
■ Conduct a gap analysis for the activities required by the standards and evaluate your
organization against each standard. Identify whether the standard is being (or has
been) met or not met.
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KEY MILESTONES IN THE ACCREDITATION PROCESS
Stimulate Improvement
-6 -3 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Application Year One Year Two
Organization Organization
Organization completes
completes and submits ESC Organization
and submits ICM profile
submits E-App updates and
(including selected FSA
* Activities The Joint Commission completes appear above the time line; activities conducted by the organization appear below the time line.
FSA, Focused Standards Assessment; SIG, Standards Interpretation Group; POA, Plan of Action; E-App, electronic application; ICM, Intracycle Monitoring;
ESC, Evidence of Standards Compliance.
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organization complies with Joint Commission standards and meets the needs of your
After a standards assessment has been completed, there likely will be follow-up action
needed to bring your organization into compliance. Following are tips to make sure your
■ Teach leaders and management staff how to access the standards on E-dition so that
they can reference them frequently for help in maintaining compliance.
■ Create an online Joint Commission electronic bulletin board on your organization’s
internal website to give staff updates about compliance, allow them to check
standards, and post questions about the accreditation process. Be sure to include
any links to outside sources that can help staff understand why a standard is
important to safe care.
■ Use an internal online discussion board to help staff recognize existing compliance
processes and to integrate new processes into everyday work.
■ Use the ACC chapter to access accreditation policies and information about what
happens before, during, after, and between surveys.
■ Take note of any standards you need assistance with, and make an action plan to
achieve compliance. You can use the Action Planning Worksheets at the back of
each standards chapter to track your progress. (See the “Assess Compliance with the
Standards” section for more information.) Take advantage of the ICM FSA tool (or
another preferred resource) that allows the organization to score each standard and
EP, develop an action plan, assign a responsible party, set goal dates, run reports,
and monitor progress toward achieving full compliance with all the standards.
■ Obtain answers to standards compliance questions online using the Standards
Interpretation frequently asked questions (FAQs) at https://www.jointcommission.
org/standards/standard-faqs/.
❏ Save the link on your intranet or add it to your favorites list and encourage staff
to regularly check the FAQs for laboratories or search by keyword.
❏ When an FAQ provides helpful information that clarifies an intended rationale
or requirement, consider including it in an online discussion board or
electronic accreditation portal accessible to staff or print it out and insert a
copy of the FAQ in your print manual or an accreditation binder.
❏ If you are unable to find the answer you need, accredited organizations may
submit their own question using the online submission process on the FAQ
page via your Joint Commission Connect extranet site (see the “Standards
Questions” section for more information).
■ Use resources and tools provided to all organizations on your Joint Commission
Connect extranet site. In addition to E-dition, tools available on the site include the
following:
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work e-mail address in a location with a valid domain that matches the HCO ID domain
on file. For staff using a computer without the HCO’s domain, a message will be sent to
the primary accreditation contact at the organization for approval.
In addition to reading Perspectives, there are several other ways to keep track of standards
changes:
■ Check The Joint Commission’s website (https://www.jointcommission.org
/accreditation-and-certification/health-care-settings/laboratory-services/) regularly
for any revisions to laboratory standards published in Perspectives.
■ Sign up for news and alerts, including standards changes, by clicking on “Subscribe
to E-Alerts” on The Joint Commission’s home page at https://www.jointcommis-
sion.org.
■ Use the “What’s New” feature (see Figure 4, below) found on the blue navigation
bar running along the top of E-dition or at the front of the print manual to become
familiar with changes that occurred since the last E-dition or print release. You can
also sort by new and changed EPs as of the selected effective date by clicking on the
“Filters” feature on the blue navigation bar.
■ Check e-Alerts subscriptions on The Joint Commission’s website for new content
or updates. Sign up for or update e-Alerts subscriptions at https://www.joint
commission.org/e-alerts/.
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Account Executive
Accredited organizations can call their assigned account executive at 630-792-3007 for
information or with questions about the following:
■ Scheduling of surveys
■ Survey agenda or survey process
■ Status of a Final Accreditation Report
■ Content of a Final Accreditation Report
■ ESC submission process
■ Other survey activities
■ Accessing and completing the Focused Standards Assessment
The name and contact information for your assigned account executive can be found on
the home page of your Joint Commission Connect extranet site.
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Standards Questions
Should you have a question about a standard, check the frequently asked questions
(FAQ) repository online at https://www.jointcommission.org/standards/standard-faqs/.
If you don’t see your question addressed, please note that applicant and accredited
organizations can submit a question via http://web.jointcommission.org/sigsubmission/
sigquestionform.aspx using the online submission process described on the FAQ page or
via your Joint Commission Connect extranet site (under “Resources and Tools”).
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