SMILE

Johns Hopkins University

Baltimore, MD USA

Quality Manual Template

Jaclyn Madden, M.S. Document Effective
Author(s), Name &
Number Date
Title
International Laboratory QA/QC Doc10-15 22-Aug-08
Coordinator, SMILE
Review by Heidi Hanes Review date 10-Feb-20
SMILE Comments: This document is provided as an example only. It must be revised to accurately
reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to
countercheck facts when considering their use in other applications. If you have any questions contact
SMILE

Name, Title Signature Date

Approved SMILE 22-Aug-08

By

Name, Title Signature Date

Penny Stevens 22-Aug-08

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Annual
Review

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Quality Manual

Table of Contents Page

1. Introduction 4
2. Terms and Definitions 5
3. Purpose 5
4. Policy 5
5. Scope and Responsibilities 6
6. Procedures for the Quality System Essentials 6
6.1 Documents and Records 6
6.2 Organizational Structure 8
6.3 Personnel 9
6.4 Equipment 10
6.5 Purchasing and Inventory 11
6.6 Process Control 12
6.7 Information Management 13
6.8 Occurrence Management 14
6.9 Assessment 15
6.10 Process Improvement 16
6.11 Customer Service 17
6.12 Facilities and Safety 18
7. Appendices 19
8. References 20

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1. Introduction
In order to ensure the safety of patients and laboratory personnel and to ensure that accurate
results are obtained and reported, the laboratory needs to maintain quality throughout its pre-
analytical, analytical, and post-analytical path of workflow. The Quality Management Plan
described in this Quality Manual provides the infrastructure for maintaining quality in the
laboratory.

1.1 Description of the 12 QSEs

The Quality Management approach included in this Quality Manual is based on the 12 Quality
System Essentials (QSE) model developed by CLSI/NCCLS (refer to CLSI/NCCLS documents
GP26-A3, HS1-A2, and GP22-A2) and is mostly consistent with ISO standards (refer to ISO
15189). The 12 QSEs represent the most fundamental elements for maintaining quality, safety,
and efficiency throughout the laboratory’s path of workflow.
1.1.1 Documents and Records: This QSE describes the processes for creating and
maintaining standardized documents and records so that they are up-to-date and
accurate, readily accessible by laboratory staff, and protected from damage,
deterioration, and unauthorized use.
1.1.2 Organization: A strong commitment from top-level managers is essential for the
success of the overall laboratory quality program. This QSE describes how the
organizational structure and quality management system ensure that customer’
needs and regulatory requirements are met.
1.1.3 Personnel: The most important of the laboratory’s resources is its personnel. This
QSE describes how personnel are managed and provided with the tools needed to
perform testing so that accurate and reliable test results are obtained.
1.1.4 Equipment: This QSE describes how equipment is selected, installed, identified,
validated/verified, and maintained in order to ensure personnel safety and specimen
and testing result integrity.
1.1.5 Purchasing & Inventory: Availability of dependable and reliable test kits and
supplies is essential. This QSE describes how reagents and supplies are procured,
distributed, and managed.
1.1.6 Process Control: This QSE describes the activities and techniques that are carried
out to ensure that the testing procedures are correctly performed, the environment is
suitable for reliable testing, and the testing methods work as expected to produce
accurate and reliable results.
1.1.7 Information Management: This QSE describes how patient-related and testing
information are managed in order to maintain the accuracy, reliability, confidentiality,
and accessibility of the data.
1.1.8 Occurrence Management: This QSE describes how nonconforming events
(occurrences) are detected, investigated, resolved, and tracked.
1.1.9 Assessment: This QSE describes the internal and external assessments that are
conducted to evaluate the effectiveness of the laboratory’s quality management
system.

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1.1.10 Process Improvement: This QSE describes elements of a process improvement

program that identifies and addresses opportunities for improvement and problems
that impact patient care.
1.1.11 Customer Service: This QSE describes how the laboratory assesses and
addresses its ability to meet the needs of internal and external customers.
1.1.12 Facilities & Safety: This QSE describes how the physical space of the laboratory is
maintained in a manner that ensures efficient workflow, accurate test results, and
personnel safety. It describes how the laboratory supplies the materials and training
necessary to ensure the safety of all personnel.

2. Terms and Definitions

2.1 Document: The term document will refer to any written policy, process, procedure,
form, or job aid.
2.2 Record: Laboratory records may be paper or electronic. Laboratory records
include, but are not limited to: examination requisitions; worksheets and instrument
printouts; quality control results and actions taken; external quality assessment
(proficiency testing); equipment calibration and maintenance; examination method
verification; software verification; blood donation and transfusion; patient
examination reports; staff training and competence; internal and external audits and
inspections; and occurrence, nonconformance, and complaint records and actions
taken.
2.3 Referral Laboratory: Also known as a reference or backup laboratory.
2.4 OFI: Opportunities for Improvement
2.5 Internal Customers: Includes all laboratory personnel.
2.6 External Customers: Includes anyone to whom the laboratory provides services.
This includes the patient and his/her relatives, the patient caregivers, the ordering
physician, network personnel, and others.
2.7 Occurrence: An occurrence is a nonconforming event.
2.8 Include any other terms as necessary.

3. Purpose
The purpose of this Quality Manual is to describe the procedures necessary to ensure total
quality in the laboratory in all pre-analytical, analytical, and post-analytical activities throughout
its path of workflow.

4. Policy
The management of Laboratory Name is committed to providing laboratory testing services in
accordance with the principles of good clinical laboratory practices. The management is also
committed to providing accurate, reliable, and timely laboratory results. Management
periodically reviews the performance of the Quality Management System and quality objectives
to ensure their effectiveness and relevance. It is the responsibility of all laboratory personnel to
familiarize themselves with the requirements of the Quality Management System and to

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implement the relevant policies and procedures in all pre-analytical, analytical, and post-
analytical work processes.

5. Scope and Responsibilities

This Quality Manual applies to all management and personnel of Laboratory Name.

5.1 The Laboratory Director is responsible for to be determined by the laboratory.

5.2 The Laboratory Supervisor is responsible for to be determined by the
laboratory.
5.3 The Quality Manager is responsible for to be determined by the laboratory.
5.4 The Lead Technologist is responsible for to be determined by the laboratory.
5.5 The personnel of Laboratory Name are responsible for to be determined by
the laboratory. Further define personnel positions as needed for your
laboratory.

6. Procedures for the Quality System Essentials:

Note: The following is a template that can be used to describe instructions for all
aspects of a Quality Management System. If this template is used, revise each
requirement to include detailed, laboratory-specific instructions or include
references to other procedures that provide the required detail.

6.1 Documents and Records

6.1.1 Creating and Implementing New Documents:
6.1.1.1 The need for a new document is identified and documented.
6.1.1.2 The new document is drafted.
6.1.1.3 The document is reviewed and approved by the Laboratory Director
or designee before it is implemented.
6.1.1.4 The new document is assigned a unique identification number and
entered onto the Document Master List.
6.1.1.5 A Master File is created for the new document. The master copy of
the document is retained in this file.
6.1.1.6 Working copies of the document are made from the master copy
and distributed. A log is kept to track where working copies are
distributed.
6.1.1.7 Staff are notified of the new document and trained as necessary.
They review and sign the document before using it.
6.1.2 Revising Existing Documents:
6.1.2.1 The need for a change to an existing document is identified and
documented.
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6.1.2.2 Changes to related documents are identified and requested.

6.1.2.3 The document is edited.
6.1.2.4 The new version of the document is reviewed and approved. The
laboratory director or designee signs the new version before it is
implemented.
6.1.2.5 The Document Master List is updated.
6.1.2.6 The Master File is updated. The master copy of the obsolete
version is marked as retired and filed. Working copies of the
obsolete version are retrieved and destroyed.
6.1.2.7 Working copies of the new version are made from the new master
copy and distributed as necessary.
6.1.2.8 Staff are notified of changes to the document and trained as
necessary. Staff review and sign the document before they use it.
6.1.3 Document Control:
6.1.3.1 Each document is uniquely identified to ensure its traceability
throughout the document life cycle.
6.1.3.2 Information for each document is entered on the Document Master
List. The information is updated when there are changes to version
numbers or when a document is retired.
6.1.3.3 A Master File is maintained for each document. The Master File
includes the master copy of the current and all previous versions of
a document.
6.1.3.4 Working copies of documents are made from the master copy only.
All working copies are maintained in a controlled manner such that
there is a method for tracking the location of all working copies to
ensure that only the most current version of a document is in use.
Working copies are destroyed in a controlled manner.
6.1.3.5 Retention times for all retired documents are established. There is
a method for storing retired documents.
6.1.3.6 The laboratory director or designee reviews and signs each current
document at least annually.
6.1.3.7 There is a method for documenting staff’s knowledge of document
content.
6.1.4 Reviewing, Retaining, Storing, Retrieving, and Destroying Records:
6.1.4.1 Records are created. Records include the name of the individual
creating the record and the date it was created.
6.1.4.2 Records are listed in a Records Index.
6.1.4.3 Records are reviewed and signed by the laboratory director or
designee on a regular schedule (at least monthly).
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6.1.4.4 Records are labeled and stored in a manner that maintains patient
confidentiality, ensures only authorized individuals have access,
and maintains the physical integrity of the record.
6.1.4.5 Retention times for records are established. Destruction of records
is documented.
6.1.5 Modifying Records:
6.1.5.1 The need for a change to a record is identified.
6.1.5.2 Record is modified.
6.1.5.3 Appropriate individuals are notified of the modification, including
laboratory management and the ordering physician/other patient
caregiver.
6.1.5.4 Modification of records is documented. Documentation should
include the original record, the modified record, the individual who
modified the record, the date of the modification, and the
notification information.

6.2 Organizational Structure

6.2.1 Implementing a Laboratory Quality Management System
6.2.1.1 A Quality Manager is designated.
6.2.1.2 Internal and external customers’ needs are identified. Resources are
allocated for meeting those needs.
6.2.1.3 A Quality Manual is developed. All necessary policies, processes,
and procedures are identified and developed. Information in the
Quality Manual is communicated to all personnel. The Laboratory
Director or designee reviews the Quality Manual and other policies,
processes, and procedures prior to implementation and at least
annually thereafter.
6.2.1.4 The Quality Management System is reviewed at least annually.
6.2.1.5 Laboratory leadership works with leadership of other departments to
coordinate the laboratory quality management system with other
facility/institution quality management systems.
6.2.2 Organizational Chart:
6.2.2.1 Laboratory administration is identified.
6.2.2.2 Levels of authority and responsibility for all laboratory personnel are
identified.
6.2.2.3 The laboratory reporting chain of command is identified and
communicated to all personnel.
6.2.2.4 The organizational chart (organogram) is published and maintained.

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6.2.3 Identifying Referral Laboratories:

6.2.3.1 The need for referral laboratories is assessed.
6.2.3.2 Referral laboratory capabilities and performance are assessed.
6.2.3.3 A list of suitable referral laboratories and their test menus is
maintained.

6.3 Personnel
6.3.1 Maintaining Adequate Staff Resources:
6.3.1.1 The laboratory’s staffing needs are assessed/identified.
6.3.1.2 Personnel are recruited and hired to fulfill those needs.
6.3.2 Job Descriptions:
6.3.2.1 Job qualification requirements and duties are determined and
documented.
6.3.2.2 Job descriptions are developed and maintained so as to reflect these
qualification requirements and duties.
6.3.2.3 Personnel are familiarized with their job descriptions.
6.3.2.4 Job descriptions are signed by applicable staff and documented in
personnel files.
6.3.3 Documenting Personnel Qualifications:
6.3.3.1 Proof of licensure, certification, education records, and Curriculum
Vitae are maintained in personnel files.
6.3.4 Employee Orientation and Training:
6.3.4.1 New employees are oriented to the facility/institution.
6.3.4.2 New employees are oriented to the laboratory.
6.3.4.3 Personnel are trained for their duties.
6.3.4.4 Documentation of orientation and training is maintained in personnel
files.
6.3.5 Employee Competency Assessments:
6.3.5.1 Methods for competency training are documented.
6.3.5.2 Frequency of competency assessments is documented.
6.3.5.3 Competency performance is assessed as scheduled (i.e. following
initial training, at the end of the three month probation period, and
annually thereafter) and documented in personnel files.
6.3.5.4 Competency failures/deficiencies are addressed. Corrective and/or
preventive actions are documented in personnel files.

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6.3.6 Continuing Education:

6.3.6.1 Continuing education requirements are documented and
communicated to all personnel.
6.3.6.2 Opportunities for continuing education are available for personnel.
6.3.6.3 Completed continuing education is documented in personnel files.

6.4 Equipment
6.4.1 Equipment Selection, Acquisition, Installation, Identification, and
Inventory:
6.4.1.1 The need for new equipment is assessed.
6.4.1.2 Potential new equipment is evaluated.
6.4.1.3 New equipment is purchased and installed.
6.4.1.4 Equipment is assigned a unique identifier and included in an
equipment inventory.
6.4.1.5 Documentation related to each piece of equipment is maintained in
an equipment manual/file.
6.4.2 Instrument Validation Studies:
6.4.2.1 Validation study requirements are defined.
6.4.2.2 Validation studies are performed on new instruments prior to
implementing the instrument for patient testing, annually, or as
needed.
6.4.2.3 Before implementation, the laboratory director approves new
methods based on validation results.
6.4.2.4 Documentation of results of all validation studies is maintained.
6.4.3 Method Comparison Studies:
6.4.3.1 When two instruments/methods are used for the same testing,
comparison studies are conducted at least once every six months.
6.4.3.2 Comparison studies are statistically evaluated and approved by the
laboratory director. Documentation is maintained.
6.4.4 Carryover Studies:
6.4.4.1 Carryover study requirements are determined for each test method.
6.4.4.2 Schedules for instrument carryover studies are determined.
6.4.4.3 Carryover studies are performed and documented as scheduled.

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6.4.5 Preventive Maintenance:

6.4.5.1 A schedule for instrument/equipment preventive maintenance is
determined for each piece of equipment.
6.4.5.2 Instrument maintenance is conducted and documented.
6.4.5.3 Laboratory management reviews documentation of preventive
maintenance at least monthly.
6.4.6 Calibration:
6.4.6.1 Manufacturers’ recommendations are used to develop calibration
schedules and plans.
6.4.6.2 Calibration is conducted and documented as scheduled or for
troubleshooting purposes.
6.4.6.3 Calibration records for each piece of equipment are reviewed by
laboratory management as scheduled.
6.4.7 Equipment-Related Troubleshooting and Corrective Actions:
6.4.7.1 Troubleshooting schemes are developed, implemented, and
documented.
6.4.7.2 Corrective actions are documented.
6.4.7.3 Documentation is reviewed by laboratory management and filed.
6.4.8 Retiring Instruments:
6.4.8.1 The instrument is cleaned, decontaminated, packed, and removed
for shipment or storage.
6.4.8.2 Records from retired instruments are maintained and stored.

6.5 Purchasing and Inventory

6.5.1 Use of Referral Laboratory Services:
6.5.1.1 Referral laboratories are evaluated and selected for their ability to
meet regulatory and testing requirements.
6.5.1.2 The laboratory enters into contracts with referral laboratories.
6.5.1.3 The laboratory tracks samples sent to referral laboratories.
6.5.1.4 The laboratory reports results from referral laboratories. All required
elements are listed on the result reports.
6.5.2 Identifying and Selecting Vendors for Supplies and Reagents:
6.5.2.1 The supplies and reagents needed are determined using the
inventory list.
6.5.2.2 The ability of vendors to meet inventory needs is evaluated.
6.5.2.3 Vendors are selected for all supplies and reagents.
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6.5.3 Purchasing Supplies and Reagents:

6.5.3.1 An inventory of all supplies and reagents is maintained.
6.5.3.2 Order needs are identified using the inventory list.
6.5.3.3 Purchase orders are completed.
6.5.4 Handling Supplies and Reagents:
6.5.4.1 Supplies and reagents are received in the laboratory.
6.5.4.2 Receipt is documented on the inventory.
6.5.4.3 Acceptability of reagents and supplies is determined and
documented.
6.5.4.4 There are documented procedures for handling unacceptable
reagents and supplies.
6.5.4.5 Acceptable reagents/supplies are labeled, stored, and put into use.

6.6 Process Control

6.6.1 Process Identification and Validation:
6.6.1.1 The laboratory identifies and documents all processes in the path of
workflow and for each QSE.
6.6.1.2 Processes are validated prior to implementation.
6.6.1.3 Problems with processes are identified, and processes are revised to
correct problems.
6.6.2 Specimen Management:
6.6.2.1 Specimens are submitted, handled, and referred for additional
testing.
6.6.2.2 Tests are requested. Documentation of requests is maintained.
6.6.2.3 Specimen acceptability is determined, and unacceptable specimens
are handled.
6.6.2.4 Specimens are processed, stored, and tested.
6.6.3 Method Validation/Verification, Reportable Ranges, and Reference
Intervals:
6.6.3.1 All methods are validated/verified prior to implementation. This
includes accuracy, precision, linearity (analytic measurement range),
sensitivity (lower detection limit), analytic interferences (specificity),
reference intervals, and critical values.
6.6.3.2 Validation/verification studies are documented and approved by the
laboratory director prior to implementing the method..

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6.6.4 Internal Quality Control:

6.6.4.1 Internal quality control procedures exist for all analytic procedures.
6.6.4.2 Control materials are selected, obtained, and stored.
6.6.4.3 Acceptability criteria is established and documented.
6.6.4.4 Control materials are tested, and results are documented, monitored,
and evaluated for acceptability.
6.6.4.5 Corrective actions are performed and documented for any out of
range results.

6.7 Information Management

6.7.1 Patient Confidentiality:
6.7.1.1 Patient confidentiality is maintained.
6.7.1.2 Access to patient information is controlled.
6.7.2 Accessing and Using Electronic Information:
6.7.2.1 The computer system facilities meet environmental conditions and
safeguards for ensuring proper system operations.
6.7.2.2 Preventive maintenance for computer systems are conducted and
documented.
6.7.2.3 Access to electronic information is restricted to authorized personnel.
6.7.2.4 There are plans for disaster recovery, downtime, and backup of
information.
6.7.2.5 An audit trail is used to identify any individual who has accessed,
entered, or modified data.
6.7.3 Reporting Results:
6.7.3.1 Results are reported to authorized recipients.
6.7.3.2 Panic values and population normal ranges are established and
reported with results.
6.7.3.3 Ordering physicians and/or patient caregivers are notified of panic
results. Notification is documented.
6.7.3.4 Reported results are monitored for accuracy.
6.7.3.5 Result reports are stored in a manner that limits access to authorized
personnel only, maintains patient confidentiality, facilitates easy
retrieval, and maintains data integrity.
6.7.4 Result Modification:
6.7.4.1 An incorrectly reported result is identified. The correct result is
documented.

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6.7.4.2 Laboratory management and the ordering physician and/or clinic are
notified of the modified result. Notification is documented.
6.7.4.3 A revised report is generated. It should include the original result,
the modified result, the name of the individual who modified the
result, the date of the modification, and notification information (who
made the notification, who was notified, and when).
6.7.5 Reporting Delays:
6.7.5.1 Delays resulting from reporting or equipment failures are monitored,
documented, reported to the ordering physician/patient caregiver,
and communicated to appropriate DAIDS and network personnel.
6.7.6 Communicating Result Reporting Changes:
6.7.6.1 Changes in test methodology or reference ranges are communicated
to the ordering staff.
6.7.6.2 Changes in test methodology or reference ranges are communicated
to associated study administrators.
6.7.6.3 Changes in test methodology or reference ranges are communicated
to laboratory personnel.
6.7.7 Data Storage and Maintaining Data Integrity:
6.7.7.1 Data is labeled and stored in an area with controlled access and
appropriated environmental conditions.
6.7.7.2 Information is backed up.
6.7.7.3 Data integrity is verified after transmission and downtime.
6.7.7.4 Data integrity is verified by comparing it with the original input at
defined intervals.
6.7.7.5 Calculations performed by the computer system are regularly
verified.
6.7.7.6 Manual reports are regularly reviewed for correctness.

6.8 Occurrence Management

6.8.1 Identifying and Documenting Occurrences:
6.8.1.1 The laboratory identifies and documents occurrences, including:
6.8.1.1.1 Complaints from internal and external customers.
6.8.1.1.2 Recalls or notifications of nonconformances related to
materials, equipment, or software.
6.8.1.1.3 Nonconformances identified in internal or external audits.
6.8.1.1.4 QC, calibration, or EQA failures.
6.8.1.1.5 Information from management reviews.
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6.8.1.2 Occurrence information is referred for remedial and corrective

actions.
6.8.1.3 Occurrence information is referred for process improvement as
necessary.
6.8.2 Remedial Actions and Investigation of Occurrences:
6.8.2.1 Remedial actions are initiated in response to any occurrences that
result in immediate impact on patient or personnel safety.
Occurrences and remedial actions are documented.
6.8.2.2 Occurrences are investigated. Investigative steps are documented.
6.8.2.3 Additional corrective or preventive actions are performed and
documented.
6.8.2.4 Referral for process improvement is made as necessary.
6.8.3 Analyzing Occurrence Information and Referral for Process
Improvement:
6.8.3.1 Information regarding individual occurrences is tracked, categorized,
and organized in a manner that facilitates analysis of the collective
data.
6.8.3.2 The collective data is analyzed at least monthly for trends in
occurrence information.
6.8.3.3 Laboratory management reviews the occurrence data and allocates
resources for root cause analysis and process improvement as
necessary.

6.9 Assessment
6.9.1 Internal Quality Indicator Surveillance:
6.9.1.1 Quality indicators are selected.
6.9.1.2 Data regarding quality indicators is collected and analyzed.
6.9.1.3 Quality indicator data is presented to laboratory management.
6.9.1.4 Follow-up actions are initiated.
6.9.2 Internal Audits:
6.9.2.1 Internal audits are conducted according to a regular schedule (at
least annually).
6.9.2.2 Internal audit findings are developed into a report that is submitted to
laboratory management.
6.9.2.3 Follow-up actions are initiated.

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6.9.3 External Quality Assurance:

6.9.3.1 The laboratory participates in audits/assessments conducted by
external agencies. Information from audits is analyzed and
submitted for managerial review. Follow-up actions are initiated as
necessary.
6.9.3.2 The laboratory participates in external proficiency testing (EQA) for
all analytes tested. EQA results are analyzed and information is
submitted for managerial review. Follow-up corrective/preventive
actions are conducted as necessary.
6.9.4 External Benchmarks:
6.9.4.1 Quality indicators for external benchmarking are selected.
6.9.4.2 Performance data is collected.
6.9.4.3 Results are compared to external benchmarks and analyzed.
6.9.4.4 Information is presented for managerial review.
6.9.4.5 Follow-up actions are initiated as necessary.
6.9.5 Quality Assessment Report:
6.9.5.1 Data is collected from various sources, including quality indicator
surveillance, internal and external audits, EQA, external benchmark
performance, occurrences, and internal/external customer
suggestions and complaints.
6.9.5.2 Data is incorporated into a Quality Assessment Report.
6.9.5.3 The Quality Assessment Report is submitted to management for
review. Management makes any necessary referrals for root cause
analysis and process improvement.

6.10 Process Improvement

6.10.1 Identifying Opportunities for Improvement:
6.10.1.1 Problems within processes and opportunities for improvement are
identified and documented.
6.10.1.2 Problems within processes and opportunities for improvement are
prioritized according to the level of impact on customer needs or
patient care.
6.10.2 Root Cause Analysis and Corrective/Preventive Action Plans:
6.10.2.1 Problems and opportunities for improvement are addressed and
selected for additional analysis.
6.10.2.2 Root cause analysis is conducted.
6.10.2.3 Corrective and preventive action plans are developed and
implemented.
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6.10.3 Quality Improvement Evaluation:

6.10.3.1 The laboratory evaluates the effectiveness of actions taken to
improve performance.
6.10.3.2 The laboratory conducts any additional follow-up actions resulting
from the evaluation.

6.11 Customer Service

6.11.1 Provision of Laboratory Services:
6.11.1.1 Contracts are developed and maintained with all customers.
6.11.1.2 The laboratory provides services to customers.
6.11.2 Identifying and Managing Customer Needs:
6.11.2.1 Internal and external customers and their needs are identified.
6.11.2.2 The need for new processes or changes to existing processes to
meet customer needs is identified.
6.11.2.3 Referrals for process control and process improvement are made.
6.11.3 Managing Customer Complaints:
6.11.3.1 Internal and external customers submit complaints and
suggestions, including anonymous submissions.
6.11.3.2 Complaints/suggestions are received in the laboratory and
documented.
6.11.3.3 Complaints/suggestions are addressed appropriately.
6.11.3.4 Feedback is provided to the customer regarding how the
complaint/suggestion was addressed.
6.11.3.5 Complaints are tracked and analyzed. Referrals are made for
process improvement as necessary.
6.11.4 Monitoring Customer Satisfaction:
6.11.4.1 Customer satisfaction is evaluated by the laboratory.
6.11.4.2 Customer satisfaction surveys are conducted and collected.
6.11.4.3 Information from customer satisfaction surveys or other evaluations
is analyzed.
6.11.4.4 Referrals are made for process improvement as necessary.

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6.12 Facilities and Safety

6.12.1 Laboratory Design:
6.12.1.1 Laboratory work areas are designed to be sufficient in size,
comfortable for work processes, ergonomically correct, and suitable
for protection against chemical or biological hazards.
6.12.1.2 The laboratory is designed to meet governmental, accreditation,
and organizational requirements.
6.12.1.3 The laboratory work process is designed for efficiency and
ergonomics.
6.12.1.4 Laboratory-specific environmental requirements are met for energy
sources, water, lighting, ventilation, temperature control, humidity
control, noise control, and waste disposal.
6.12.1.5 Supplies, reagents, and samples are stored in a manner that
maintains their integrity.
6.12.1.6 Access to the laboratory is restricted, and information regarding
safety hazards is communicated on entrances to the laboratory.
6.12.1.7 Laboratory cleanliness is maintained.
6.12.1.8 Renovations to the laboratory are conducted in a manner that
meets the above requirements.
6.12.1.9 The laboratory is routinely inspected for safety, cleanliness, and
comfort. Any deficiencies are addressed.
6.12.2 Safety Procedures, Records, and Audits:
6.12.2.1 There is a laboratory-specific safety manual available to staff at all
times. Staff are familiarized with the content of the manual. The
manual is reviewed for relevance and content by the laboratory
director or designee at least annually.
6.12.2.2 There is a list of emergency phone numbers and contacts available
in the laboratory.
6.12.2.3 A documented chemical hygiene plan is available to staff at all
times.
6.12.2.4 Current MSDS for all chemicals in the laboratory are available to
staff at all times. MSDS are reviewed annually for content and
relevance.
6.12.2.5 Hazardous waste materials are stored and disposed of in a manner
that is compliant with all local and governmental regulations.
6.12.2.6 Staff can obtain emergency medical treatment. Staff are
familiarized with instructions for how to obtain medical treatment.
6.12.2.7 Safety-related records and safety incident reports are documented
and reviewed. Follow-up actions are taken as necessary.
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6.12.2.8 An internal safety inspection is conducted at least annually. Follow-

up actions are performed as necessary.
6.12.3 Safety Training:
6.12.3.1 All personnel read and document understanding of the safety
manual and other job-related safety documents.
6.12.3.2 New employees are trained in safety procedures and requirements
at hire. Safety training includes, but is not limited to, universal and
standard precautions, blood-borne pathogens, and fire safety.
6.12.3.3 All personnel receive safety training at least annually. Safety
training includes, but is not limited to, universal and standard
precautions, blood-borne pathogens, and fire safety.
6.12.3.4 All personnel are familiarized with emergency preparedness plans.
Drills are conducted regularly.
6.12.3.5 Safety training and competency are documented in personnel files.
6.12.4 Safety Equipment Availability and Use:
6.12.4.1 Personal Protective Equipment (PPE) including, but not limited to,
gloves, gowns, and face shields is available for all personnel. All
personnel are trained in the proper use of PPE.
6.12.4.2 All staff are familiarized with the location of First Aid supplies and
the procedures for obtaining emergency medical care in the
laboratory.
6.12.4.3 All personnel are familiarized with the location and correct use of
safety equipment. Safety equipment includes, but is not limited to,
eye wash stations, safety showers, and fire extinguishers.
6.12.4.4 Preventive maintenance and function checks are performed on all
safety equipment. Maintenance and checks are documented.
6.12.4.5 Hazardous materials are properly labeled. There are documented
safety instructions for handling and storing hazardous materials.

7. Appendices:

List and attach any appendices applicable to your Quality Manual. Some examples of
appendices that may or may not be included in your manual are listed below. Other documents
may be necessary for your procedures. SMILE can provide examples of these appendices
upon request.

7.1 Document Change Request Form

7.2 Document Master List Template
7.3 Signature Page Template
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7.4 Organogram
7.5 Job Descriptions
7.6 Orientation Checklist and Documentation Form
7.7 Training Documentation Form
7.8 Competency Assessment Documentation Form
7.9 Continuing Education Documentation Form
7.10 Equipment Inventory Template
7.11 Preventive Maintenance and Calibration Documentation Templates
7.12 Supply/Reagent Inventory Template
7.13 QC Testing Documentation Templates
7.14 Nonconformance Identification and Remedial Action Documentation Forms
7.15 Quality Indicator Performance Documentation Templates
7.16 Quality Assessment Report (QAR) Template
7.17 Opportunity for Improvement Identification and Tracking Forms
7.18 Root Cause Analysis Templates
7.19 Corrective/Preventive Action Plan Templates
7.20 Customer Satisfaction Survey
7.21 Customer Complaint Recording Forms
7.22 Safety Incident Documentation Forms

8. References
1. Berte, L. A World Wide Approach to Laboratory Quality Management – Session 1.
Teleconference sponsored by ASCP.
2. CLSI. Laboratory Design; Approved Guideline – Second Edition. CLSI document
GP18-A2. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute.
3. CLSI. Laboratory Documents: Development and Control; Approved Guideline – Fifth
Edition. CLSI document GP2-A5. Wayne, Pennsylvania: Clinical and Laboratory
Standards Institute.
4. CLSI. Management of Nonconforming Laboratory Events; Approved Guideline. CLSI
document GP32-A. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute.
5. ISO. Medical laboratories – Particular requirements for quality and competence.
EN/ISO15189. Geneva: International Organization for Standardization.
6. NCCLS. Application of a Quality Management System Model for Laboratory Services –
Approved Guideline – Third Edition. NCCLS document GP26-A3. Wayne,
Pennsylvania: NCCLS.
7. NCCLS. A Quality Management System Model for Health Care; Approved Guideline –
Second Edition. NCCLS document HS1-A2. Wayne, Pennsylvania: NCCLS.

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8. NCCLS. Continuous Quality Improvement: Integrating Five Key Quality System

Components; Approved Guideline – Second Edition. NCCLS document GP22-A2.
Wayne, Pennsylvania: NCCLS.
9. NCCLS. Clinical Laboratory Safety; Approved Guideline – Second Edition. NCCLS
document GP17-A2. Wayne, Pennsylvania: NCCLS.
10. NCCLS. Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS
document GP9-A. Wayne, Pennsylvania: NCCLS.
11. NCCLS. Training and Competence Assessment; Approved Guideline – Second Edition.
NCCLS document GP21-A2. Wayne, Pennsylvania: NCCLS.
12. College of American Pathologists (CAP) 2006. Commission on Laboratory
Accreditation, Laboratory Accreditation Program; Laboratory General Checklist.

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