March 2010

GP33-A
Accuracy in Patient and Sample

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Identification; Approved Guideline

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This guideline describes the essential elements of systems and processes

required to ensure accurate patient identification. The principles in
this document may be applied to manual or electronic systems. Design
considerations covered include criteria for accuracy, differences in
inpatient vs outpatient settings that impact patient identification,
language and cultural considerations, and standardization of processes
across the health care enterprise.

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 clinical 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 clinical 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 addressed according to the consensus process by a committee of experts.

Appeals Process

If it is believed that an objection has not been adequately addressed, the process for appeals is documented in
the CLSI Standards Development Policies and Process document.
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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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 GP33-A
Vol. 30 No. 7
ISBN 1-56238-721-9 Replaces GP33-P
ISSN 0273-3099 Vol. 29 No. 13
Accuracy in Patient and Sample Identification; Approved Guideline
Volume 30 Number 7
Sheila M. Woodcock, MBA, FCSMLS(D)
Robert Bettinelli, BAppSc(Med Lab)

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Leslie A. Fedraw, MA, MT(ASCP)
Christian Fischer, MD
Walter H. Henricks, MD
Peggy Mann, MS, MT(ASCP)
Barbara Parsons, MA, MT(ASCP)
Merle B. Smith, MBA, MS, MT(ASCP)
Cecelia Wright, MBA, MT(ASCP)

Abstract
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Clinical and Laboratory Standards Institute document GP33-A—Accuracy in Patient and Sample Identification; Approved
Guideline describes the essential elements of systems and processes required to ensure accurate patient identification. The
principles in this document may be applied to manual or electronic systems. Design considerations covered include criteria for
accuracy, differences in inpatient vs outpatient settings that impact patient identification, language and cultural considerations,
and standardization of processes across the health care enterprise. Guidance on system implementation and user training is
included. Validation of patient identification systems/programs and ongoing monitoring as a quality measure are also covered.
This document is intended for health care providers who will design, select, implement, monitor, and evaluate patient
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identification systems.

Clinical and Laboratory Standards Institute (CLSI). Accuracy in Patient and Sample Identification; Approved Guideline. CLSI
document GP33-A (ISBN 1-56238-721-9). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500,
Wayne, Pennsylvania 19087 USA, 2010.

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: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:
[email protected]; Website: www.clsi.org.
Number 7 GP33-A

Copyright ©2010 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
[email protected].

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 [email protected].

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Suggested Citation

CLSI. Accuracy in Patient and Sample Identification; Approved Guideline. CLSI document GP33-A.

May 2009

Approved Guideline
March 2010
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Wayne, PA: Clinical and Laboratory Standards Institute; 2010.

Proposed Guideline
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ISBN 1-56238-721-9
ISSN 0273-3099

ii
Volume 30 GP33-A

Contents

Abstract ....................................................................................................................................................i 

Committee Membership........................................................................................................................ iii 

Foreword .............................................................................................................................................. vii 

1  Scope .......................................................................................................................................... 1 

2  Introduction ................................................................................................................................ 1 

3  Terminology............................................................................................................................... 2 
3.1  A Note on Terminology ................................................................................................ 2 

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3.2  Definitions .................................................................................................................... 2 
3.3  Abbreviations and Acronyms ....................................................................................... 3 
4  Designing a Patient and Sample Identification System ............................................................. 3 

5 

6 
5.1 
5.2 

6.1 
6.2 
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Preexamination Phase ................................................................................................................ 3 
Patient Identification ..................................................................................................... 4 
Sample Identification .................................................................................................... 7 
Examination Phase ................................................................................................................... 10 
Bar-coded Sample With Automated Sample Delivery System................................... 10 
Samples Without Bar Codes ....................................................................................... 11 
7  Postexamination Phase............................................................................................................. 11 
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7.1  Electronic Result Reporting ........................................................................................ 11 
7.2  Manual Result Reporting ............................................................................................ 12 
8  Training .................................................................................................................................... 12 

9  Validating a New System for Patient Identification ................................................................ 12 

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10  Reports of Incorrect Identification Incidents ........................................................................... 14 

10.1  Detection of Misidentification Errors ......................................................................... 15 
10.2  Correction of Misidentification Errors........................................................................ 16 
11  Audit Systems .......................................................................................................................... 16 
11.1  Patient Identification Audits ....................................................................................... 16 
11.2  Sample Identification Audits ...................................................................................... 17 
12  Technology Tools .................................................................................................................... 18 
12.1  Bar-code Technology .................................................................................................. 18 
12.2  Radiofrequency Identification Technology ................................................................ 19 
12.3  Biometrics ................................................................................................................... 20 
13  Point-of-Care Testing............................................................................................................... 21 
13.1  Ensure Accuracy in Patient Identification .................................................................. 21 
13.2  Prepare to Perform the Test ........................................................................................ 22 
13.3  Collect the Sample ...................................................................................................... 22 
13.4  Test the Sample ........................................................................................................... 22 
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Number 7 GP33-A

Contents (Continued)
13.5  Result Reporting ......................................................................................................... 22 
14  Conclusion ............................................................................................................................... 22 

References ............................................................................................................................................. 23 

Appendix A. Preexamination Phase Process for Hospital Patients....................................................... 25 

Appendix B. Sample Hospital Identification Band Policy.................................................................... 27 

Appendix C. Sample Inpatient Identification Procedure ...................................................................... 29 

Appendix D. Sample Procedure for Identifying Outpatients ................................................................ 31 

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Appendix E. Sample Procedure for Patient Identification in a Physician Office Laboratory ............... 32 

Appendix F. Sample Procedure for Identifying Neonates .................................................................... 33 

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Appendix G. Sample Labeling Policy and Procedures ......................................................................... 34 

Appendix H. Examples of Examination Phase Process ........................................................................ 37 

Appendix I. Postexamination Phase Process ........................................................................................ 39 

Appendix J. Sample Training Checklist Form ...................................................................................... 40 

Appendix K. Sample Policy for the Misidentified or Unidentified Patient .......................................... 41 
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Summary of Delegate Comments and Subcommittee Responses......................................................... 44 

The Quality Management System Approach ........................................................................................ 54 

Related CLSI Reference Materials ....................................................................................................... 55 

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Volume 30 GP33-A

Accuracy in Patient and Sample Identification; Approved Guideline

1 Scope
The identification (ID) process begins with the patient, either at the time of registration for admission to a
health care facility, or on presentation for sample collection, and ends with reporting the results of the
examination. This document outlines all points in the path of workflow related to patient and sample ID.

The essential elements of systems and processes required to ensure accurate patient ID are described. The
principles in this document are applicable to manual or electronic systems. Considerations covered
include criteria for accuracy, differences in inpatient vs outpatient settings that impact patient ID,
language and cultural considerations, and standardization of processes across the health care enterprise.
Guidance on system implementation and user training is included. Validation of patient ID

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systems/programs and ongoing monitoring as a quality measure are also covered.

This document is intended for health care providers (HCPs) who design, select, implement, monitor, and
evaluate patient ID systems or any individual responsible for specimen collection.

2 Introduction

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An accurate test result on the wrong patient is at best of no value and, at worst, could lead to incorrect or
harmful treatment or intervention. Accurate patient ID is the crucial first step to ensuring patient safety in
the delivery of health care processes. Failures in accurate patient ID can have serious and adverse
consequences for patients, including incorrect treatment, lack of treatment, injury, disability, and death.2

In recent years, data regarding rates of ID errors have become available. For example, data from a College
of American Pathologists Q-Probes study of ID errors in primary and secondary sample labeling
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involving clinical laboratories3 showed an overall ID error rate of 1 error per 2638 billable tests (379 per
million) and reported 345 adverse patient events during a five-week tracking period at 120 participating
institutions. A more recent Q-probes study of 147 laboratories showed a labeling error rate of 0.92 per
1000 labels.4
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In transfusion medicine,5,6 wrong blood in the tube (WBIT), in which a tube contains blood from a person
different from the person named on the tube submitted for pretransfusion compatibility testing, has
received increased attention because of the implications of transfusing incompatible blood components. A
survey of 27 United Kingdom hospitals for samples for pretransfusion testing showed a 3.2% rejection
rate, primarily for missing or incomplete information, and a WBIT rate of 1 in 1303 to 1501 samples.7 A
multicenter international study found a median international WBIT rate of 1 in 1986 collected samples.8

A College of American Pathologists Q-Tracks study involving quarterly ID band monitoring at 217
institutions found an initial median ID band error rate of 7.4% with the most common ID band error as
missing ID bands. Continuous monitoring of ID bands by program participants was associated with a
reduction in ID band error rate to 3.05%.9

It is important to recognize that any process involving human intervention, including bar coding and
radiofrequency identification (RFID), is still subject to error, so constant vigilance is required.

One hospital adopted a “zero tolerance laboratory sample labeling” process, which led to a 75% reduction
in labeling errors.10

©
Clinical and Laboratory Standards Institute. All rights reserved. 1
Number 7 GP33-A

3 Terminology

3.1 A Note on Terminology

CLSI, as a global leader in standardization, is firmly committed to achieving global harmonization

wherever possible. Harmonization is a process of recognizing, understanding, and explaining differences
while taking steps to achieve worldwide uniformity. CLSI recognizes that medical conventions in the
global metrological community have evolved differently in the United States, Europe, and elsewhere; that
these differences are reflected in CLSI, International Organization for Standardization (ISO), and
European Committee for Standardization (CEN) documents; and that legally required use of terms,
regional usage, and different consensus timelines are all important considerations in the harmonization
process. In light of this, CLSI’s consensus process for development and revision of standards and
guidelines focuses on harmonization of terms to facilitate the global application of standards and
guidelines.

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To align the use of terminology in this document with that of ISO, the terms preexamination,
examination, and postexamination were adopted in place of preanalytical, analytical, and postanalytical,
and the term sample replaces the term specimen where appropriate. The users of GP33-A should
understand that the fundamental meanings of the terms are identical in many cases, and are defined in the

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guideline’s Definitions section (see Section 3.2). The terms in this document are consistent with those
defined in the ISO 15189, ISO 17025, and ISO 9000 series of standards. The term “ID band” used in this
document is also known as “wristband.”

3.2 Definitions

analyte – component represented in the name of a measurable quantity (ISO 17511).11

examination – set of operations having the object of determining the value or characteristics of a
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property; NOTE: In some disciplines (eg, microbiology), an examination is the total activity of a number
of tests, observations, or measurements (ISO 15189).12

health care provider – individual authorized to deliver health care to a patient (ISO 17593)13; NOTE:
This is a global term used to describe a person obtaining the sample and can include physician, nurse,
medical technologist, laboratory assistant, respiratory therapist, care assistants, and phlebotomists.
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measurand – quantity intended to be measured (ISO/IEC Guide 99).14

postexamination procedures – processes following the examination, including systematic review;

formatting and interpretation; authorization for release; reporting and transmission of the results; and
storage of samples after the examinations (ISO 15189).12

preexamination procedures – steps starting, in chronological order, from the clinician’s request and
including the examination requisition, preparation of the patient, collection of the primary sample, and
transportation to and within the laboratory, and ending when the analytical examination procedure begins
(ISO 15189).12

reproducibility (measurement) – measurement precision (closeness of agreement between indications or

measured quantity values obtained by replicate measurements on the same or similar objects under
specified conditions) under reproducibility conditions of measurement (condition of measurement, out of
a set of conditions that includes different locations, operators, measuring systems, and replicate
measurements on the same or similar objects) (ISO/IEC Guide 99).14

2 ©
Clinical and Laboratory Standards Institute. All rights reserved.
Number 7 GP33-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 approach is based on the model presented in
CLSI document HS01—A Quality Management System Model for Health Care. 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:

Documents and Records Equipment Information Management Process Improvement

Organization Purchasing and Inventory Occurrence Management Customer Service
Personnel Process Control Assessment—External Facilities and Safety
and Internal

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GP33-A addresses the QSEs 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.
Purchasing and

Assessments—

Improvement

Facilities and
Organization

Management

Management

External and
and Records

Information

Occurrence
Documents

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Equipment
Personnel

Inventory

Customer
Internal
Control
Process

Process

Service

Safety
X
EP18 EP18 EP18 EP18
GP21
GP32 GP32
H03 H03 H03
H04
H11 H11 H11 H11 H11 H11
HS01 HS01 HS01 HS01 HS01 HS01 HS01 HS01 HS01 HS01 HS01 HS01
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MM13
Adapted from CLSI document HS01—A Quality Management System Model for Health Care.

Path of Workflow

A path of workflow is the description of the necessary steps to deliver the particular product or service that the
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organization or entity provides. For example, CLSI document GP26⎯Application of a Quality Management System
Model for Laboratory Services defines a clinical laboratory path of workflow, which consists of three sequential
processes: preexamination, examination, and postexamination. All clinical laboratories follow these processes to
deliver the laboratory’s services, namely quality laboratory information.

GP33-A addresses the clinical laboratory path of workflow steps 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.

Preexamination Examination Postexamination

receipt/processing
Sample collection

Results reporting
Sample transport

Results review
and follow-up

and archiving
Interpretation
Examination

Examination

management
ordering

Sample

Sample

X X X X
H03 H03 H03 H03 H03 H03
H04
H11 H11 H11 H11
MM13 MM13 MM13 MM13
Adapted from CLSI document HS01—A Quality Management System Model for Health Care.

54 ©
Clinical and Laboratory Standards Institute. All rights reserved.
Volume 30 GP33-A

Related CLSI Reference Materials∗

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.

GP21-A3 Training and Competence Assessment; Approved Guideline—Third Edition (2009). This guideline
provides background information and recommended processes for the development of training and
competence assessment programs that meet quality and regulatory objectives.

GP32-A Management of Nonconforming Laboratory Events; Approved Guideline (2007). This guideline provides
an outline and the content for developing a program to manage a health care service’s nonconforming events
that is based on the principles of quality management and patient safety.

H03-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—

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Sixth Edition (2007). This document provides procedures for the collection of diagnostic specimens by
venipuncture, including line draws, blood culture collection, and venipuncture in children.

H04-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved
Standard—Sixth Edition (2008). This document provides a technique for the collection of diagnostic

H11-A4

HS01-A2
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capillary blood specimens, including recommendations for collection sites and specimen handling and
identification. Specifications for disposable devices used to collect, process, and transfer diagnostic capillary
blood specimens are also included.

Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition
(2004). This document provides principles for collecting, handling, and transporting arterial blood specimens
to assist with reducing collection hazards and ensuring the integrity of the arterial specimen.

A Quality Management System Model for Health Care; Approved Guideline—Second Edition (2004).
This document provides a model for providers of health care services that will assist with implementation and
maintenance of effective quality management systems.
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MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved
Guideline (2005). This document provides guidance related to proper and safe biological specimen collection
and nucleic acid isolation and purification. These topics include methods of collection, recommended storage
and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic
acid type.
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∗
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. 55
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