October 2011

EP23-A™
Laboratory Quality Control Based on Risk

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Management; Approved Guideline

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This document provides guidance based on risk management for

laboratories to develop quality control plans tailored to
the particular combination of measuring system, laboratory
setting, and clinical application of the test.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
Clinical and Laboratory Standards Institute
Setting the standard for quality in medical laboratory testing around the world.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings
together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a
common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory
standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global
applicability.

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Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the
development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the
participants in the development of a consensus document have considered and resolved all relevant objections

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and accept the resulting agreement.

Commenting on Documents

CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies,

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procedures, methods, and protocols affecting the laboratory or health care.

CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants
in the reviewing and commenting process. At the end of each comment period, the committee that developed
the document is obligated to review all comments, respond in writing to all substantive comments, and revise the
draft document as appropriate.

Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on
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any document. All comments are managed according to the consensus process by a committee of experts.

Appeals Process

When it is believed that an objection has not been adequately considered and responded to, the process for
appeals, documented in the CLSI Standards Development Policies and Processes, is followed.
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All comments and responses submitted on draft and published documents are retained on file at CLSI and are
available upon request.

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standard@clsi.org
Volume 31 ep23-a

ISBN 1-56238-767-7 (Print) EP23-A

ISBN 1-56238-768-5 (Electronic) Vol. 31 No. 18
ISSN 1558-6502 (Print) Replaces EP23-P
ISSN 2162-2914 (Electronic) Vol. 30 No. 4

Volume 31 Number 18
Laboratory Quality Control Based on Risk Management;
Approved Guideline
James H. Nichols, PhD, DABCC, FACB Ronald H. Laessig, PhD Wadid Sadek, PhD
Sousan S. Altaie, PhD Ronalda Leneau, MS, MT(ASCP) Mitchell G. Scott, PhD

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Greg Cooper, CLS, MHA Jacob (Jack) B. Levine, MBA Ann E. Snyder, MT(ASCP)
Paul Glavina W. Gregory Miller, PhD Liz Walsh, CLS, NCA
Abdel-Baset Halim, PharmD, PhD, DABCC Robert Murray, JD, PhD Gitte Wennecke
Aristides T. Hatjimihail, MD, PhD Valerie L. Ng, PhD, MD Marcia L. Zucker, PhD
Devery Howerton, PhD Nils B. Person, PhD, FACB
Ellis Jacobs, PhD, DABCC, FACB

Abstract
PL Arleen Pinkos, MT(ASCP)

Clinical and Laboratory Standards Institute document EP23-A—Laboratory Quality Control Based on Risk Management;
Approved Guideline provides guidance to laboratories on the development of quality control plans for measuring
systems. Regulatory requirements, information provided by the manufacturer, information pertaining to the laboratory
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environment, and medical requirements for the test results are evaluated, using risk management principles, to develop
a quality control plan tailored to the particular combination of measuring system, laboratory environment, and clinical
application. The effectiveness of the laboratory quality control plan is monitored to detect trends, identify corrective
actions, and provide continuous quality improvement. The advantages and limitations of various quality control
processes are considered.
Clinical and Laboratory Standards Institute (CLSI). Laboratory Quality Control Based on Risk Management; Approved
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Guideline. CLSI document EP23-A (ISBN 1-56238-767-7 [Print]; ISBN 1-56238-768-5 [Electronic]). Clinical and Laboratory
Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2011.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document
through two or more levels of review by the health care community, is an ongoing process. Users should expect
revised editions of any given document. Because rapid changes in technology may affect the procedures, methods,
and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI
documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org.

If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at:

P: 610.688.0100 F: 610.688.0700 E: customerservice@clsi.org W: www.clsi.org

© Clinical and Laboratory Standards Institute. All rights reserved. 1

Number 18 ep23-a

Copyright ©2011 Clinical and Laboratory Standards Institute. Except as stated

below, any reproduction of content from a CLSI copyrighted standard, guideline,
companion product, or other material requires express written consent from
CLSI. All rights reserved. Interested parties may send permission requests to
permissions@clsi.org.

CLSI hereby grants permission to each individual member or purchaser to make a

single reproduction of this publication for use in its laboratory procedure manual
at a single site. To request permission to use this publication in any other manner,
e-mail permissions@clsi.org.

Suggested Citation
CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline.
CLSI document EP23-A™. Wayne, PA: Clinical and Laboratory Standards Institute;

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2011.
Proposed Guideline
January 2010

Approved Guideline
October 2011

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ISBN 1-56238-767-7 (Print)

ISBN 1-56238-768-5 (Electronic)
ISSN 1558-6502 (Print)
ISSN 2162-2914 (Electronic)

2
ii © Clinical and Laboratory Standards Institute. All rights reserved.
Volume 31 ep23-a

Contents
Abstract i
Committee Membership iii
Foreword vii

Chapter 1: Introduction 1
1 Scope 2
2 Introduction 2
2.1 Quality Control Plan 2
2.2 Risk Management 5
3 Standard Precautions 7
4 Terminology 8
4.1 A Note on Terminology 8
4.2 Definitions 9

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4.3 Abbreviations and Acronyms 17

Chapter 2: Path of Workflow 18

5 Process Flow Chart 19
6 EP23 Path of Workflow 20

6.2 Process Mapping

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6.1 Information Gathering for Risk Assessment

6.3 Developing the Quality Control Plan

6.4 Postimplementation Monitoring of the Quality Control Plan

Chapter 3: Quality System Essentials

7 Quality System Essentials
7.1 Organization
7.2 Documents and Records
20
26
31
40

43
44
44
44
7.3 Nonconforming Event Management 45
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7.4 Assessments 45
7.5 Continual Improvement 45

Chapter 4: Conclusion 46

Chapter 5: Supplemental Information 47

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References 48

Appendix A. The Quality Control Toolbox 50

Appendix B. Quick Guide Checklist for Establishing a Quality
Control Plan Based on Risk Management 61
Appendix C. The Laboratory Risk Assessment: Example Glucose
Measurement Using an Automated Measuring System 64
Appendix D. Summary of Laboratory Risk Assessment Table. Example:
Glucose Measurement on an Automated Measuring System 89
Appendix E. The Quality Control Plan Developed From the Individual
Components of the Quality Control Strategies From Appendixes C and D.
Example: Glucose Measurement on an Automated Measuring System 96
Appendix F. Example of Failure Investigation and Corrective Action for
Glucose Measurement on an Automated Measuring System 98

The Quality Management System Approach 104

Related CLSI Reference Materials 105

© Clinical and Laboratory Standards Institute. All rights reserved. v5

Volume 31 ep23-a

Foreword

Although the manufacturer is responsible for

quality in design of its measuring system and
reagents, the laboratory and, ultimately, the
laboratory director are accountable for the
quality of test results. To establish effective
quality control (QC), laboratories should

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process an array of information (regulatory
requirements, manufacturer-provided

and the medical applications of tests PL

information, the laboratory’s environment,

performed) through a risk assessment process.

This process identifies potential weaknesses in the measuring system

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and environment that are weighed against the probability for error, the
effectiveness of control processes built into the measuring system, and
the laboratory’s assessment of risk in consideration of the clinical use
of a laboratory result. This document provides guidance to laboratories
for establishing a quality control plan (QCP). Once developed, the QCP
key words
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is monitored for effectiveness and modified as unanticipated failure

modes or underestimated risks of error are discovered or as particular Quality Control
control procedures are no longer required once sufficient objective
data demonstrating reliable performance have been established. The
Risk Assessment
advantages and limitations of a variety of QC measures are discussed to Risk Management
help the laboratory develop a QCP that is appropriate for its particular
measuring system, laboratory, and clinical environment.

Compliance with EP23 may not satisfy the requirements of all regulatory,
accreditation, or certification bodies. Laboratories need to comply with
all applicable requirements in the development of their QCPs.

© Clinical and Laboratory Standards Institute. All rights reserved. vii7

 Volume 31 ep23-a

Chapter 1
Introduction
In this document, you will learn how to create a quality control plan (QCP)

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that is customized for your institution, facility, and laboratory, so that you can
run your tests in an effective and efficient manner, improving patient care.

You will learn:

 ow to compile information into
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a QCP

 he many types of tools in the QC

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can cause harm

 ow to help prevent errors from

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toolbox, and which are most effective occurring
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for your situation
How to ensure your QCP is effective
How to detect potential errors
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1
© Clinical and Laboratory Standards Institute. All rights reserved. 1
Number 18 ep23-a

Laboratory Quality Control Based on Risk

Management; Approved Guideline

1 Scope
This document describes good laboratory practice for developing
note: and maintaining a QCP for medical laboratory testing using
internationally recognized risk management principles. An individual
This document QCP should be established, maintained, and modified as needed
for each measuring system. The QCP is based on the performance

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may not satisfy the
required for the intended medical application of the test results.
requirements of all
Risk mitigation information obtained from the manufacturer and
regulatory, accreditation,
identified by the laboratory, applicable regulatory and accreditation
or certification bodies. requirements, and the individual health care and laboratory setting
Laboratories need
to comply with all
applicable requirements
in the development of
their QCPs.
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are considered in development of the QCP. This document is intended
to guide laboratories in determining QC procedures that are both
appropriate and effective for the test being performed.

This document may not satisfy the requirements of all regulatory,

accreditation, or certification bodies. Laboratories need to comply
with all applicable requirements in the development of their QCPs.
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2 Introduction
2.1 Quality Control Plan
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Health care providers need test results that are relevant, accurate,
and reliable for patient care. A number of factors can adversely
affect the quality of test results and present a risk of harm to the
patient, from failures of the measuring system, to operator errors,
to environmental conditions. Failure is used in this document in the
context of risk management and means, in the broadest sense, a
case when the system does not meet the user’s expectation. Failure
includes the inability of a measurement process to perform its
intended functions satisfactorily or within specified performance
limits, errors of a measuring system that may produce an incorrect
result, and incorrect use of a measuring system that may cause an
incorrect result. Risk management is the systematic application
of management policies, procedures, and practices to the tasks

2 © Clinical and Laboratory Standards Institute. All rights reserved.

Number 18 ep23-a

The Quality Management System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the
development of standards and guidelines, which facilitates project management; defines a document structure via a
template; and provides a process to identify needed documents. The quality management system approach applies a
core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path
of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the
framework for delivery of any type of product or service, serving as a manager’s guide. The QSEs are as follows:

Organization Personnel Process Management Nonconforming Event Management

Customer Focus Purchasing and Inventory Documents and Records Assessments
Facilities and Safety Equipment Information Management Continual Improvement

EP23-A addresses the QSE indicated by an “X.” For a description of the other documents listed in the grid,
please refer to the Related CLSI Reference Materials section on the following page.

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Information Management
Purchasing and Inventory

Documents and Records

Continual Improvement
Nonconforming Event
Process Management
Facilities and Safety
Customer Focus

Management
Organization

Assessments
Equipment
Personnel

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C24
EP18 EP18 EP18 EP18
GP02 GP02
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GP21
GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26
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Path of Workflow
A path of workflow is the description of the necessary processes to deliver the particular product or service that the
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organization or entity provides. A laboratory path of workflow consists of the sequential processes: preexamination,
examination, and postexamination and their respective sequential subprocesses. All laboratories follow these
processes to deliver the laboratory’s services; namely, quality laboratory information.
EP23-A addresses the clinical laboratory path of workflow steps indicated by an “X.” For a description of the
document listed in the grid, please refer to the Related CLSI Reference Materials section on the following page.

Preexamination Examination Postexamination

Sample management
Sample collection

Sample transport

Results reporting
Sample receipt/

Results review

Interpretation
and follow-up

and archiving
Examination

Examination
processing
ordering

X X X
GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26 GP26

104 © Clinical and Laboratory Standards Institute. All rights reserved.

Volume 31 ep23-a

Related CLSI Reference Materials*

C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions;
Approved Guideline—Third Edition (2006). This guideline provides definitions of analytical
intervals, planning of quality control procedures, and guidance for quality control applications.

EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved
Guideline—Second Edition (2009). This guideline describes risk management techniques that will
aid in identifying, understanding, and managing sources of failure (potential failure modes) and
help to ensure correct results. Although intended primarily for in vitro diagnostics, this document
will also serve as a reference for clinical laboratory managers and supervisors who wish to learn
about risk management techniques and processes.

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GP02-A5 Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition (2006).
This document provides guidance on development, review, approval, management, and use of
policy, process, and procedure documents in the medical laboratory community.

GP21-A3

GP26-A4
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Training and Competence Assessment; Approved Guideline—Third Edition (2009). This
document provides background information and recommended processes for the development
of training and competence assessment programs that meet quality and regulatory objectives.

Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth

Edition (2011). This document provides a model for medical laboratories that will assist with
implementation and maintenance of an effective quality management system.
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M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline—Third Edition (2005). Based on US regulations, this document provides guidance on
the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in
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a laboratory setting; specific precautions for preventing the laboratory transmission of microbial
infection from laboratory instruments and materials; and recommendations for the management
of exposure to infectious agents.

* CLSI documents are continually reviewed and revised through the CLSI consensus process; therefore, readers
should refer to the most current editions.

© Clinical and Laboratory Standards Institute. All rights reserved. 105

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