CLSI Laboratory Documents Development and Control Approved Guideline NAT L COMM CLINICAL LAB STANDARDS 2006 PDF

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Clinical and Laboratory Standards Institute
Advancing Quality in Healthcare Testing
Clinical and Laboratory Standards Institute (CLSI Most documents are subject to two levels of consensus
formerly NCCLS) is an international, interdisciplinary, proposed and approved. Depending on the need for
nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be
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cost-effective way to improve patient examination and
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In addition to developing and promoting the use of
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reviewed to assess the utility of the final document, to
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GP2-A5
ISBN 1-56238-600-X
Volume 26 Number 12 ISSN 0273-3099
Laboratory Documents: Development and Control; Approved
GuidelineFifth Edition
Lucia M. Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ)CQMgr
Donald R. Callihan, PhD
Joan Carlson, MLT(CSMLA), BSc(MLS), MT(ASCP)
Beverly J. Charlton, CLC(AMT)
Christine D. Flaherty, MHA, MT(ASCP)
Mary H. Hopper, MA, MT(ASCP)
Barb Kirkley, MT(ASCP)
Oliver Ndimbie, MD, FCAP
Jennifer Schiffgens, MBA, MT(ASCP)
Peggy J. Stupca, MS, CLSp(CG)
Nita Sudderth, MT(ASCP), CQMgr(ASQ)
Joyce I. Wilson, MS, MT(ASCP)
Shelia M. Woodcock, MBA, FCSMLS(D)
Abstract
Clinical and Laboratory Standards Institute document GP2-A5Laboratory Documents: Development and Control; Approved
GuidelineFifth Edition presents the important components of writing and managing documents for the clinical laboratory. This
guideline describes common and specific sections for inclusion in laboratory documents. Several examples of process and
procedure documents for preexamination, examination, and postexamination laboratory activities are provided in the form of
appendixes; such appendixes are simply illustrative, and not prescriptive.
Clinical and Laboratory Standards Institute (CLSI). Laboratory Documents: Development and Control; Approved Guideline
Fifth Edition. CLSI document GP2-A5 (ISBN 1-56238-600-X). Clinical and Laboratory Standards Institute, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.
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 healthcare 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/NCCLS documents. Current editions are
listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. 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: customerservice@clsi.org; Website: www.clsi.org

Number 12 GP2-A5
This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system,
transmitted, or made available in any form or by any means (electronic, mechanical, photocopying,
recording, or otherwise) without prior written permission from Clinical and Laboratory Standards
Institute, except as stated below.
Clinical and Laboratory Standards Institute hereby grants permission to reproduce limited portions of this
publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in
educational programs provided that multiple copies of such reproduction shall include the following
notice, be distributed without charge, and, in no event, contain more than 20% of the documents text.
Reproduced with permission, from CLSI publication GP2-A5Laboratory Documents:

Development and Control; Approved GuidelineFifth Edition (ISBN 1-56238-600-X).
Copies of the current edition may be obtained from Clinical and Laboratory Standards
Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA.
Permission to reproduce or otherwise use the text of this document to an extent that exceeds the
exemptions granted here or under the Copyright Law must be obtained from Clinical and Laboratory
Standards Institute by written request. To request such permission, address inquiries to the Executive Vice
President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA.
Copyright 2006. Clinical and Laboratory Standards Institute.
Suggested Citation
(Clinical and Laboratory Standards Institute. Laboratory Documents: Development and Control;
Approved GuidelineFifth Edition. CLSI document GP2-A5 [ISBN 1-56238-600-X]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2006.)
Proposed Guideline Approved GuidelineThird Edition

May 1980 December 1996
Tentative Guideline Approved GuidelineFourth Edition

June 1981 April 2002
Approved Guideline Approved GuidelineFifth Edition

February 1984 March 2006
Approved GuidelineSecond Edition

July 1992
ISBN 1-56238-600-X
ISSN 0273-3099
ii
Volume 26 GP2-A5
Committee Membership
Area Committee on General Laboratory Practices

Sheila M. Woodcock, MBA, Theresa D. Billups, MBA, Steven I. Gutman, MD, MBA
FCSMLS(D) MT(ASCP)DLM FDA Ctr. for Devices/Rad. Health
Chairholder Remel Inc. Rockville, Maryland
QSE Consulting Lake Charles, Louisiana
Rose Bay, Nova Scotia, Canada Stephen J. Sarewitz, MD
Margaret M. Grimes, MD Valley Medical Center
Albert Rabinovitch, MD, PhD Virginia Commonwealth University Renton, Washington
Vice-Chairholder Richmond, Virginia
Abbott Hematology Jennifer Schiffgens, MBA,
Santa Clara, California Bruce David Tually, BAppSc, MT(ASCP)
MAppSc California Pacific Medical Center
Eric Arendash, MT(ASCP) Hunter Area Pathology Service San Francisco, California
Centers for Medicare & Medicaid New South Wales, Australia
Services Daniel W. Tholen, MS
Philadelphia, Pennsylvania Advisors American Association for
Laboratory Accreditation
Lucia M. Berte, MA, MT(ASCP), Kay M. Creed Traverse City, Michigan
SBB, DLM; CQA(ASQ)CQMgr. St. Marys Hospital
Quality Systems Consultant Richmond, Virginia Marla Thomas
Westminster, Colorado Litton Pathology Associates
Dennis J. Ernst, MT(ASCP) Blue Springs, Missouri
Center for Phlebotomy Education
Ramsey, Indiana Eleanor M. Travers, MD, MHA
State of Connecticut Dept. of Public
Health
Hartford, Connecticut
Working Group on Technical Procedure Manuals
Lucia M. Berte, MA, MT(ASCP), Mary H. Hopper, MA, MT(ASCP) Joyce I. Wilson, MS, MT(ASCP)
SBB, DLM: CQA(ASQ)CQMgr Mayo Clinic University of Alabama-Birmingham
Chairholder Rochester, Minnesota Hospital
Quality Systems Consultant Birmingham, Alabama
Westminster, Colorado Barb Kirkley, MT(ASCP)
The Cleveland Clinic Foundation Sheila M. Woodcock, MBA,
Donald R. Callihan, PhD Cleveland, Ohio FCSMLS(D)
BD Diagnostic Systems QSE Consulting
Sparks, Maryland Oliver Ndimbie, MD, FCAP Rose Bay, Nova Scotia, Canada
Abbott Diagnostics
Joan Carlson, MLT(CSMLS), Irving, Texas Staff
BSc(MLS), MT(ASCP)
University of Alberta Hospital Jennifer Schiffgens, MBA, Clinical and Laboratory Standards
Edmonton, Alberta, Canada MT(ASCP) Institute
California Pacific Medical Center Wayne, Pennsylvania
Beverly J. Charlton, CLC(AMT) San Francisco, California
University of Pittsburgh Medical John J. Zlockie, MBA
Center Peggy J. Stupca, MS, CLSp(CG) Vice President, Standards
Pittsburgh, Pennsylvania Mayo Clinic
Rochester, Minnesota Jennifer K. McGeary, MT(ASCP),
Christine D. Flaherty, MHA, MSHA
MT(ASCP) Nita Sudderth, MT(ASCP), Staff Liaison
Sutter Health CQMgr(ASQ)
Sacramento, California UroCor, Inc. Donna M. Wilhelm
Oklahoma City, Oklahoma Editor
Melissa A. Lewis
Assistant Editor
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Contents
Abstract ....................................................................................................................................................i
Committee Membership........................................................................................................................ iii
Foreword ................................................................................................................................................ix
1 Scope..........................................................................................................................................1
2 Introduction................................................................................................................................1
3 Definitions .................................................................................................................................1
4 Path of Workflow.......................................................................................................................2
4.1 Preexamination Processes.............................................................................................2
4.2 Examination Processes .................................................................................................3
4.3 Postexamination Processes ...........................................................................................3
5 Process The Sequence of Laboratory Activities .....................................................................4
5.1 Key Work Processes .....................................................................................................4
5.2 Process as a Basis for Training and Competence Assessment......................................4
6 Procedure How to Do It ..........................................................................................................4
7 Elements Common to Process and Procedure Documents ........................................................4

7.1 Title...............................................................................................................................4
7.2 Purpose or Principle......................................................................................................5
7.3 Process Flowchart or Table...........................................................................................5
7.4 Procedure Instructions ..................................................................................................5
7.5 Related Documents .......................................................................................................5
7.6 References.....................................................................................................................5
7.7 Appendixes or Attachments..........................................................................................6
7.8 Author ...........................................................................................................................6
7.9 Approval Signatures .....................................................................................................6
8 Process Documents ....................................................................................................................6
8.1 Benefits of Process Documents ....................................................................................6
8.2 Suggested Template for Process Documents ................................................................7
9 Procedure Documents Specific for the Path of Workflow......................................................7
9.1 Preexamination Procedures...........................................................................................7
9.2 Examination Procedures .............................................................................................11
9.3 Postexamination Procedures .......................................................................................17
10 Form Documents......................................................................................................................19
11 Procedures Manuals .................................................................................................................20
12 Document Management ...........................................................................................................20

12.1 Document Identification .............................................................................................20
12.2 Master File ..................................................................................................................21
12.3 Review and Approval of New Documents .................................................................21
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Contents (Continued)
12.4 Review and Approval of Changes to Approved Documents ......................................21
12.5 Job Aid Documents.....................................................................................................22
12.6 Periodic Review of Unchanged Documents ...............................................................22
12.7 Master Index ...............................................................................................................22
12.8 Distribution .................................................................................................................23
12.9 Archiving, Storage, and Retention of Documents ......................................................23
13 Summary ..................................................................................................................................23
References.............................................................................................................................................24
Appendix A1. Inpatient Blood Sample Collection Process Flowchart ................................................26
Appendix A2. Inpatient Blood Sample Collection Process Table .......................................................27
Appendix B1. Analyzer Examination Process Flowchart....................................................................28
Appendix B2. Analyzer Examination Process Table...........................................................................29
Appendix C1. Bacteriology Culture Process Flowchart ......................................................................30
Appendix C2. Bacteriology Culture Process Table ..............................................................................31
Appendix D1. Transfusion Medicine Prenatal Examination Process Flowchart ..................................32
Appendix D2. Transfusion Medicine Prenatal Examination Process Table ........................................33
Appendix E1. Surgical Pathology Sample Process Flowchart..............................................................34
Appendix E2. Surgical Pathology Sample Process Table.....................................................................35
Appendix F. Sample Preexamination Procedure ..................................................................................36
Appendix G. Sample Analyzer Procedure ............................................................................................38
Appendix H. Sample Microbiology Procedure.....................................................................................42
Appendix I. Sample Transfusion Service Procedure ............................................................................46
Appendix J. Sample Histology Procedure ............................................................................................48
Appendix K. Sample Computer Procedure...........................................................................................50
Appendix L. Suggested Contents of Laboratory Procedures ...............................................................52
Appendix M1. Attributes for a Single Analyte on the ABC Analyzer .................................................54
Appendix M2. Attributes for Multiple Analytes on the XYZ Analyzer ...............................................56
Appendix N. Sample Table of Contents for a Preexamination Procedures Manual .............................58
Appendix O. Sample Table of Contents for the ABC Analyzer Procedures Manual ...........................61
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Contents (Continued)
Appendix P. Sample Table of Contents for a Computer Downtime Manual........................................62
Appendix Q1. Document Creation, Review, and Approval Process Flowchart ...................................68
Appendix Q2. Document Creation, Review, and Approval Process Table .........................................69
Appendix R. Sample Document Change Request Form.......................................................................70
Appendix S. Ten Rules for Document Control.....................................................................................71
Summary of Delegate Comments and Working Group Responses ......................................................72
The Quality System Approach..............................................................................................................80
Related CLSI/NCCLS Publications ......................................................................................................81
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Foreword
Previous editions of CLSI document GP2 have focused on essential elements to include in laboratory
examination procedures.
This edition of GP2 has been renamed and reorganized to provide:
the use of process flowcharts to depict the linkages between laboratory procedures;
guidelines for writing process and procedure documents for the preexamination, examination, and
postexamination activities that represent the laboratorys path of workflow;
guidelines for writing process and procedure documents specifically for multitest automated
analyzers;
guidelines for writing procedures for laboratory information systems; and
an introduction to the management and control of laboratory documents after they are approved for
use.
The information and examples provided in this edition are also consistent with the guidance described in
CLSI/NCCLS document GP26Application of a Quality Management System Model for Laboratory
Services.
This edition of GP2 is applicable to any size, scope, or specialty of laboratory, including point-of-care
testing, wherever the laboratory may be in the transition of its quality program from traditional quality
control and quality assurance practices to the concepts of quality management systems.
GP2-A5 is a guideline for how to implement requirements that have been established by regulatory and
accrediting organizations and international standards for laboratory documents and procedures manuals.
GP2-A5 is not a standard; that is, this guideline does not set requirements for laboratory documents and
procedures. Instead, this guideline describes what laboratories need to do to meet published
regulations and accreditation requirements and international standards.1-7
The words must and shall reflect language used in the requirements of regulatory and accreditation
organizations; therefore, these words do not appear in the text of this guideline. Instead, the guideline text
reads, the laboratory needs to, followed by a description of the activity(ies) that will fulfill
requirements. If a laboratory follows the guidance described herein, it will provide better and clearer
communications and instructions for laboratory staff, in addition to experiencing better performance on
regulatory and accreditation inspections and certification audits (for international standards).
A Note on Terminology
Clinical and Laboratory Standards Institute (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, ISO, and CEN documents; and that legally required use of terms,
regional usage, and different consensus timelines are all obstacles to harmonization. In light of this, CLSI
recognizes that harmonization of terms facilitates the global application of standards and is an area of
immediate attention.
In order to align the use of terminology in this document with that of ISO, the terms preexamination,
examination, and postexamination have been adopted in place of pretest, test, and posttest, and the term
sample replaces the term specimen where appropriate. The users of GP2-A5 should understand that the
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Number 12 GP2-A5
fundamental meanings of the terms are identical in many cases, and are defined in the guidelines
Definitions section (see Section 3). The terms in this document are consistent with those defined in the
ISO 15189, ISO 17025, and ISO 9000 series of standards.
Key Words
Computer procedure, document, document management, electronic procedures, laboratory procedure,

laboratory process, procedures manual, technical procedures
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Laboratory Documents: Development and Control;

Approved GuidelineFifth Edition
1 Scope
This publication describes how to:
identify laboratory procedures using work processes in the laboratorys operational path of workflow;
and
write procedures for preexamination, examination, and postexamination laboratory activities.
Also, this edition of GP2 provides useful information about preparing, approving, maintaining, reviewing,
changing, and archiving laboratory documents.
2 Introduction
The laboratory needs to provide carefully documented instructionsin the form of proceduresfor all
activities that support the performance of laboratory examinations.1-7 These instructions provide essential
information for both new and experienced employees about how to perform all their job tasksincluding
nonexamination tasks, such as collecting blood samples and using the laboratorys computer system.
Written procedures should encompass a single task from start to finish. Therefore, it makes sense to write
separate instructions for tasks that are performed at different times by different people.
GP2-A5 is intended for use by the following:
administrative and technical personnel who develop laboratory documents;
manufacturers; and
educators.
3 Definitions
conformance fulfillment of a requirement (ISO 9000).8
document any recorded item of a factual or informative nature, either paper or electronic.
examination set of operations having the object of determining the value or characteristics of a property
(ISO 15189)1; NOTE 1: In some countries and disciplines (e.g., microbiology), an examination is the
total activity of a number of tests, observations, or measurements (ISO 15189)1; NOTE 2: In this
document, the term examination replaces the term test; however, for the purposes of this guideline,
readers can consider the terms equivalent.
form a paper or electronic document on which the results from the performance of a procedure or other
information are captured, and after which becomes a record.
policy a documented statement of overall intentions and directions defined by those in the organization
and endorsed by management.

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Number 12 GP2-A5
procedure a specified way to carry out an activity or a process (ISO 9000)8; NOTE: For a quality
system, a procedure is a set of instructions that describe the stepwise actions taken to complete activities
identified in processes.
process set of interrelated or interacting activities that transform inputs into outputs (ISO 9000)8;
NOTE: A process may be documented as a flowchart or table that describes operations in the laboratorys
path of workflow.
sample one or more parts taken from a system and intended to provide information on the system, often
to serve as a basis for decision on the system or its production (ISO 15189)1; NOTE 1: For example, a
volume of serum taken from a larger volume of serum (ISO 15189)1; NOTE 2: In this document, the term
sample replaces the term specimen; however, for the purposes of this guideline, readers can consider
the terms equivalent.
4 Path of Workflow
Laboratory work is a sequence of key processes in which the laboratory uses resources such as people,
instruments, methods, and materials, to transform orders for laboratory examinations into results and
reports for patient management. Key processes for the laboratory are referred to as the path of
workflow or total testing process, which is shown in Figure 1.
Figure 1. Laboratory Path of Workflow. From CLSI/NCCLS document GP26Application of a Quality

Management System Model for Laboratory Services.
4.1 Preexamination Processes
Preexamination key processes in the path of workflow for the anatomic and clinical laboratory specialties
include all activities from the time the laboratory examinations are ordered through the time that the
samples are processed and delivered to the laboratory examination location or transported to referral
laboratories. For anatomic pathologists and cytotechnologists, preexamination activities extend from the
time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic
assessment and interpretation. The preexamination portion of the laboratorys path of workflow is shown
in Figure 2.
Preexamination Process Examination Process Postexamination Process
Test Ordering Sample Collection Sample Transport Sample Receipt/Processing
Figure 2. Laboratory Preexamination Key Processes. From CLSI/NCCLS document GP26Application of

a Quality Management System Model for Laboratory Services.

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Volume 26 GP2-A5
4.2 Examination Processes
Examination key processes for the clinical laboratory specialties include the activities of performing the
examination, verifying the examination results, interpreting the findings, and recording the findings. In
the anatomic pathology specialties, examination key processes include the diagnostic assessment of the
slides, peer review, and recording the findings.
Traditionally, laboratories have been functionally and often physically divided into specific clinical
disciplines, such as chemistry, hematology, microbiology, and transfusion service for specialized
examination methods and instruments. More recently, many laboratories have segregated along manual
and automated examination methods. Each laboratory or clinical disciplinehowever it is organized
needs to identify all of its automated and manual examination processes.
Examination key processes for the laboratorys path of workflow are shown in Figure 3.
Preexamination Process Examination Process Postexamination Process
Examination Results Review and Follow-up Interpretation
Figure 3. Laboratory Examination Key Processes. From CLSI/NCCLS document GP26Application of a

Quality Management System Model for Laboratory Services.
4.3 Postexamination Processes
Postexamination key processes in the path of workflow include activities related to reporting results and
archiving results and sample material. Postexamination processes are shown in Figure 4.
Figure 4. Laboratory Postexamination Key Processes. From CLSI/NCCLS document GP26Application

of a Quality Management System Model for Laboratory Services.

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5 Process The Sequence of Laboratory Activities
5.1 Key Work Processes
The laboratorys key work processes interlink to transform an examination order into a result report for a
patients health record. The laboratory should document its key processes, because these documents
describe the sequence of specific activities that take place across time and identify the specific
organizational units (departments, services, sections) and job titles involved. Process documents can be
created for all aspects of preexamination, examination, and postexamination laboratory operational
workflow. They provide the means to identify problematic activities that can be improved to help prevent
medical errors.
The main information in a process document depicts or describes how something happensfor
example, the interrelated sequential activities involved in the automated examination process. Flowcharts
or tables are usually used to present process information. Process flowcharts and their respective tables
are provided in Appendixes A1 through E2.
5.2 Process as a Basis for Training and Competence Assessment
All work happens as a sequence of activities known as a process. In a persons professional training or
prior experience, he or she has learned work processes as they are performed in the training facilities.
However, each different facility in which a person works is likely to have different work processes.
Training involves familiarizing new employees with their new work processes. Competence assessment
determines if employees know and can successfully accomplish their assigned work processes. Therefore
it makes sense to understand and document a laboratorys work processes and use the process documents
in training programs and competence assessment exercises. CLSI/NCCLS document GP21Training
and Competence Assessment provides information on how to design and deliver work-process-based
training and competence assessment programs.
6 Procedure How to Do It
Whereas process documents depict or describe how related activities are sequenced across time,
procedure documents present step-by-step instructions that a single individual needs to take to
successfully complete one activity in the process. Therefore, one process document refers to a number of
supporting procedure documents. Examples of procedures have been provided as Appendixes F through K.
7 Elements Common to Process and Procedure Documents
The elements described in this section are common to documents that capture process and procedure
information. However, process documents will contain only the process flowchart or table, not the
procedure instructions, and procedure documents will contain only the procedure instructions. Appendix L
presents a table that suggests which sections in addition to the common elements should be included in
process and procedure documents.
7.1 Title
All documents need to have a title that clearly states the intent of the document. The title should be
concise and describe the document type (i.e., process or procedure). Examples include:
Blood Sample Collection Process;
Performing Glucose Examinations on Instrument X;

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Waterbath Temperature Monitoring Procedure; and
Preparing Gram Stain Working Solutions.
The word process should appear in the title of a process document. The gerund form of a verb (i.e.,
ing) can be used to replace the word procedure in the title of a procedure document.
7.2 Purpose or Principle
The document should open with a section that simply states its purpose. For example, the Purpose
section of a process could be stated as, This process describes how [name of process here, e.g., sample
accession] happens in this laboratory. The Purpose section of a procedure could be stated as, This
procedure provides instructions for collecting fingerstick samples for glucose analysis. The words, This
process describes how and This procedure provides instructions for can be standardized in the
template and therefore included in each process and procedure document.
Information regarding the theory, clinical implications of the examination or examination methodology,
or historical background may be included at the beginning of a procedure document to provide an
educational, clinical, and scientific framework for the reader and user. However, because this information
can be technical and lengthy, it may also be placed at the end of a procedure document. Analyte-specific
information may be placed in analyte attribute tables, such as those provided in Appendixes M1 and M2.
7.3 Process Flowchart or Table
The primary focus of a process document is to describe the sequence of activities that leads to the correct
outcome. For example, the blood sample collection process presents the activities (i.e., the procedures)
that need to be correctly sequenced and performed to obtain a blood sample for a specified laboratory
examination.
7.4 Procedure Instructions
The primary focus of a procedure is to provide instructions for how to do a particular task in a stepwise
fashionfor example, the steps involved in verifying patient identification at the time of blood sample
collection.
7.5 Related Documents
If used, this section provides a listing of other procedures that were referred to in this procedure. For
example, Step 1 of a procedure might say, Log onto the laboratory computer system. See procedure
#XXX, How to Log On to the LIS. The Related Documents Sections would list: Procedure XXX: How to
Log On to the LIS.
7.6 References
Process documents do not need references because the sequence of activities is usually facility-specific.
Procedures need to reference the source of the information, where applicable. The references may
originate from any of the following:
manufacturers product literature, such as package inserts and operators manuals;
text books;

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published standards and guidelines;
laboratory policy manuals;
laboratory computer system manuals;
unpublished information obtained from experts in the field; and
applicable regulations.
References should be listed in a standard medical format, using the style of the Journal of the American
Medical Association or the Archives of Pathology and Laboratory Medicine.
7.7 Appendixes or Attachments
Examples of completed forms, labels, or tags should be included as appendixes or attachments in

procedure documents. Additional information contained in a table or list may be best presented as an
appendix or attachment, rather than in the body of the procedure. Appendix H demonstrates how
important information needed by the reader to make decisions can be captured in tables that are used as
appendixes to the procedure. Appendixes M1 and M2 show how analyte-specific information may be
presented as appendixes in procedures for operating automated analyzers.
7.8 Author
The author(s) of the document should be recorded. The laboratory has the option of including author
information directly on the document, or on another document that can be referenced to the specific
document. If the laboratory chooses to use a separate document to record the author, a mechanism is
needed to enable the referencing of the author back to the appropriate specific document.
7.9 Approval Signatures
Evidence that the document has been approved by the appropriate individual(s) is a requirement of
regulatory and accrediting agencies, and international standards. The laboratory has the option of
including signature approval information directly on the document, or on another document that can be
referenced to the specific document. If the laboratory chooses to use a separate document to record
signature approvals, a mechanism is needed to enable the referencing of the approval signature back to
the specific document. Guidance for this approach to approval signatures is provided in Sections 12.2 and
12.3.
8 Process Documents
8.1 Benefits of Process Documents
Although there is no governmental or accreditation requirement for the laboratory to document its work
operations processes, doing so provides the following valuable benefits:
creation of a common understanding of who does what and when for laboratory activities both
inside and outside the laboratorys walls;
visualization of the sequence of work across the laboratorys entire path of workflow;

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the opportunity to identify where improvements in efficiency (i.e., use of resources) and effectiveness
(i.e., meeting requirements) in work processes can be made; and
identification of the tasks for which documented instructions (i.e., procedures) are needed.
At a minimum, the laboratory should document the preexamination, examination, and postexamination
processes shown in Table 1 (expanded from Figures 2, 3, and 4).
Table 1. Key Processes in the Laboratory Path of Workflow

Preexamination Processes Examination Processes Postexamination Processes
Examination Ordering Examination Results Reporting
Sample Collection and Automated instrument Results Archiving
Labeling systems Sample Archiving
Blood samples Manual qualitative and Blood samples
Nonblood samples quantitative testing Tissues
Sample Transport Anatomic pathology Blocks, slides, etc.
Sample Receipt and Cytopathology Charging for examinations,
Accessioning Results Review and Follow- where applicable
Preexamination Sample up
Processing Medical Review
8.2 Suggested Template for Process Documents
A simple template for process documents can be created to include the following sections:
Title;
Purpose;
Process Flowchart or Table; and
Supporting Documents
The contents of the first three sections were described in Section 7.
The additional section after the process flowchart or table, titled Supporting Documents, is
recommended. This section lists the procedures manual(s) or the individual procedures that support this
process, thus referring the reader to where the instructions for carrying out the process may be found.
9 Procedure Documents Specific for the Path of Workflow
9.1 Preexamination Procedures
Preexamination procedures provide the instructions for all activities in laboratory workflow processes that
take place before sample analysis. The laboratory should have separate written procedures for
preexamination activities, because they are often performed by nonlaboratory as well as laboratory
persons at different times in the preexamination workflow.
Preexamination procedures are the instructions that support the following preexamination processes:
examination orderinginstructions for entering laboratory examination orders into a computer

system or completing paper requisitions, including verification of clinical orders and provision of
necessary clinical information;

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sample collection and labelinginstructions for identifying patients (to include two different
identifiers and any other local requirements), collecting blood and nonblood samples, and labeling
collected blood and nonblood samples;
sample transportinstructions for transporting samples to the laboratory, such as through the
pneumatic tube system; and
sample processinginstructions for receiving and accessioning samples in the laboratory:

instructions for handling client-required deviations, additions, or exclusions from the laboratorys
procedures; criteria for unacceptable samples and follow up action; any storage or processing before
delivery to the examination location; and any preparations for samples transported to other
laboratories for examination (e.g., referral laboratories).
In addition to the elements common to all documents described in Section 7, preexamination procedures
should also contain the following types of information; however, this information should be included only
where it is needed to perform that procedure.
patient preparationin procedures for sample collection;
sample collection informationin procedures for collection techniques for blood and nonblood
samples;
sample labeling informationinstructions for labeling blood and nonblood samples and providing for
any special labeling (e.g., blood bank labels);
required equipment and formsin all preexamination procedures where equipment and forms are
used;
safetygeneral or specific instructions as described below and in Section 9.1.4;
sample handling requirementsinstructions for handling collected samples during transport to the
laboratory receiving area;
sample storage requirementsinstructions for where and how to store samples before examination;
and
problems or pitfalls.
9.1.1 Patient Preparation
Where applicable, preexamination sample collection procedures need to include information about patient
preparation, such as instructions for:
dietary requirements (e.g., fasting and special diets);
timed examination (e.g., glucose tolerance, therapeutic drug monitoring); and
aseptic techniques (e.g., when drawing blood cultures).

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9.1.2 Sample Collection and Labeling
Where applicable, preexamination sample collection procedures need to include information about sample
collection techniques that are:
age-specific;
sex-specific (e.g., clean-catch urine); and
collection-site-specific (e.g., the presence of intravenous lines, and alternatives to the antecubital
collection site [capillary puncture, arterial puncture, line draw, etc.]).
Sample collection procedures need to include instructions for how to record the identity of the person who
collected the sample.
In addition, prepare procedures for patient-collected samples that provide information and instructions to
the patient about:
special preparation (see Section 9.1.1 above);
type and amount of sample to collect;
how to do the procedure (e.g., collect a clean-catch urine);
special timing of collection (e.g., 24 hour urine);
labeling of the sample; and
special handling between the time of collection and time received by laboratory personnel (e.g.,
refrigeration, warming, immediate delivery).
Labeling procedures need to include clear instructions about:
required label information, and
placement of label on the sample (e.g., on the container, not the lid; position of bar code, etc.).
9.1.3 Required Equipment and Forms
Where applicable, preexamination procedures need to include information about the required equipment
used, and forms and the use of forms needed for the procedure. For example:
examination requisitions and labels;
bar-code readers
sample collection devices and materials (e.g., blood collection tubes, culture media, swabs);
sample containers; and
instruments (tourniquets, hemostats, scissors, etc.).

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9.1.4 Safety
Preexamination procedures need to include or reference applicable safety instructions for the collection
and handling of biohazardous samples. The instructions should be written for the intended readership
for example, those who handle the sample such as nursing, transport, or laboratory personnel. If no
special precautions are required, preexamination procedures may refer the user to the safety manual for
general safety requirements (e.g., standard precautions).
A Special Safety Precautions section should be included in preexamination procedures when additional
safety requirementsbeyond the basic handling of biologic and other hazardous materialsare
necessary. The current editions of CLSI document M29Protection of Laboratory Workers From
Occupationally Acquired Infections and CLSI/NCCLS document GP17Clinical Laboratory Safety
provide valuable information on laboratory safety and special requirements.
9.1.5 Sample Handling Requirements
Where applicable, preexamination procedures need to include information about sample handling
requirements. This information includes:
special transport requirements (e.g., on ice, within a certain time, in appropriate containers);
safety precautions taken with potentially infectious samples; and
special transport requirements for dangerous or hazardous materials.
9.1.6 Sample Storage Requirements
Where applicable, preexamination procedures need to include requirements for sample storage before
examination. This information includes:
locations where samples are stored before examination to protect the condition and integrity of
samples, including any security requirements;
acceptable storage temperatures; and
stability of the sample over time, where timelines might affect the quality of the examination results.
9.1.7 Problems or Pitfalls
Preexamination procedure documents should include information about problems or pitfalls that may
occur in the performance of the procedure. Where applicable, users may refer to other procedures.
Examples of this kind of information include what to do when:
patients present for laboratory examinations without a proper order;
received samples are unacceptable; and
the computer is down.

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9.1.8 Preexamination Computer Activities
Procedures that provide instructions for using the laboratorys information system for preexamination
activities should be designed around the respective prompts in a computer programs sequences.
Appendix K provides an example of a laboratory computer system procedure.
9.2 Examination Procedures
Examination procedures cover the activities from the time the sample reaches the examination area to the
time results are reviewed and preliminary interpretations are determined.
Procedures for manual examinations differ from procedures for automated examinations. Manual
examination procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte
sedimentation rate are examples of traditional manual method-based examination procedures.
Examination results provided by both manual and automated methods can be qualitative or quantitative.
The attributes of manual versus automated examination, and qualitative versus quantitative results,
influence the sections that should be included in each type of procedure. The differences between
procedures for manual and automated examinations are described in the sections that follow.
9.2.1 Elements of Manual Examination Method-Based Procedures
In addition to the elements presented in Section 7 that are common to all documents, examination
procedure documents should include the following sections, wherever applicable. These sections are
listed below in the order in which the reader would logically need the information. More information on
each section is provided after the list.
Sample information;
Reagents and/or media;
Supplies;
Equipment calibration and maintenance;
Special safety precautions;
Quality control;
Instructions for performing the examination method;
Method performance specifications;
Calculations (for quantitative procedures only);
Expected values; and
Interpretation of results.
9.2.1.1 Sample Information
The examination procedure needs to include the following information regarding the sample required for
the examination:

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sample type;
sample source;
amount of sample required, including minimum requirements;
acceptable collection containers and sterility requirements;
sample stability and storage requirements; and
criteria for unacceptable samples and follow-up action.
9.2.1.2 Reagents and Media
The procedure needs to include a list of the reagents or media used in performing the procedure.
An examination procedure should provide instructions for preparing reagents only when the reagents are
prepared each time the procedure is performed. Instructions for stock and working solutions of reagents
and stains that are prepared at times other than performance of the actual procedure should be written into
separate procedures. For example, the Reagents section in a procedure that provides instructions for
performing a Gram stain should only list the reagents used to stain smear samples. There should be
separate procedures for preparing, labeling, and storing the different stock and working solutions. This
reduces the length of the examination procedure and allows for keeping reagent recipes in a separate
place where they can be easily referenced and located.
Receipt of reagents and materials in the laboratory does not take place at the time of performing
examinations; therefore, a separate procedure is needed for receiving, inspecting, and appropriately
evaluating laboratory reagents and examination kits before use.
Procedures for reagent and media preparation should include the following:
list of required reagents and/or media;
reagent name or chemical formula;
acceptable reagent grade;
special safety requirements (e.g., general category or class of hazard; special handling instructions);
step-by-step instructions for reagent or media preparation;
degree of accuracy, and any special handling instructions for measuring devices;
QC of reagents or media (e.g., pH testing or visual assessment);
labeling requirements, including expiration;
storage requirements, including containers and stability; and
regulatory classifications where applicable.

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9.2.1.3 Supplies
Receipt of supplies and other materials in the laboratory does not take place at the time of performing
examinations; therefore, a separate procedure is needed for receiving, inspecting, and appropriately
evaluating laboratory supplies and materials before they are used in examination procedures.
The examination procedure needs to include a list of the supplies used to perform the procedure.
Examples of supplies that could be listed include:
disposable pipettes;
pipette tips;
gauze;
bibulous paper;
immersion oil;
test tube rack;
test tubes;
scissors; and
other applicable supplies.
9.2.1.4 Equipment Calibration and Maintenance
Instructions for calibration and maintenance should be included in the examination performance
procedure only when these activities are performed each time the procedure is done. Instructions for
equipment calibration, calibration verification, and maintenance that are performed at a time remote from
the use of such equipment in the performance of an examination procedure should be written as separate
procedures. Directions for the preparation of calibration standards should be included in a separate
calibration procedure.
Procedures for equipment calibration and maintenance need to include the following information:
Calibration:
schedule for performing calibrationdaily, weekly, monthly, semiannually, etc.;
schedule for performing calibration verifications (which are the assaying of calibration materials in
the same manner as patient samples to confirm that the calibration of the instrument, kit, or
examination system has remained stable throughout the laboratorys reportable range for patient
examination results);
source of the calibration material;
calibration material specifications;
calibration material preparation and storage;
step-by-step instructions for performing the calibration, including expected instrument readings;
troubleshooting guidelines; and
documentation methods and storage requirements for calibration records.

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Maintenance:
schedule for performing maintenancedaily, weekly, monthly, semiannually, annually, etc.;
step-by-step instructions for performing maintenance activities; and
troubleshooting guidelines.
9.2.1.5 Special Safety Precautions
All laboratory personnel need to receive training about precautions taken when handling biologic and
other hazardous materials. Because all laboratory examinations use biologic samples, it is redundant to
repeat routine safety precautions, such as the requirement for wearing of gowns and gloves, in every
procedure. If no special precautions are required, the examination procedure may refer the user to the
safety manual for general safety requirements.
The examination procedure needs to include a special safety precautions section when additional safety
requirementsbeyond the basic handling of biologic and other hazardous materialsare necessary. The
special safety precautions section should include the following:
engineering controls (e.g., use of a biohazard cabinet);
personal protective equipment (e.g., respirators, special gloves, face shields); and
work practice controls (e.g., beginning a step only after certain conditions have been met or
precautions have been taken).
9.2.1.6 Quality Control (QC)
Instructions for QC should be included in the examination performance procedure only when QC is
performed each time the examination procedure is performed. Instructions for performing QC when it is
performed at a time remote from the performance of the examination procedure should be written as a
separate procedure. For example, the instructions for performing the positive and negative controls for a
rheumatoid factor examination need to be in the rheumatoid factor examination procedure, because these
controls are included every time a batch of samples is examined. On the other hand, the instructions for
performing the QC of anti-A, anti-B, and anti-D reagents should be in a procedure separate from that of
determining patient ABO and Rh types, because reagent QC examination is performed and recorded
separately from patient examinations.
QC procedures need to include the following information:
frequency with which controls should be examined;
number of levels of controls to use;
type of quality control material to use;
instructions for preparation and handling of control materials;
the expected QC values and/or ranges;

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explanation of control criteria (e.g., criteria for accepting or rejecting QC results and examination
data);
corrective action to take if controls exceed expected criteria;
instructions for documentation of QC data; and
alternate QC measures, such as procedural controls or clinical correlation.
Proficiency testing samples (also known as external quality assurance) often need different handling
and preparation than patient samples. Therefore, separate instructions are needed for:
receiving proficiency testing samples in the laboratory;
distributing and rotating samples for examination;
handling and preparing proficiency testing samples;
transcribing and submitting results;
reviewing reports; and
taking and documenting any necessary follow-up action.
9.2.1.7 Instructions for Performing the Examination Method
The examination method should be reflected in the title of the procedure document. For example:
Antibody Screen by Gel Technique;
Microscopic Urinalysis by Phase Microscopy;
Gram Stain Procedure;
Fingerstick Glucose Examinations on the XYZ Instrument.
This section should present the stepwise instructions for performing the examination by the method
validated in the laboratory (before use on patient samples) that was derived from the manufacturers
package insert, or operators manual or reference method. When procedure instructions in the validated
method are altered or deleted, the examination method performance may change and, therefore,
appropriate verification that the changed method provides the expected results needs to be performed and
documented.
See Appendixes F through K for examples of how to present procedure instructions.
9.2.1.8 Method Performance Specifications9
The examination procedure needs to include information about the performance characteristics of the
examination method. Where applicable, this section needs to include the following:
analytic sensitivity (lower limit of detection, biological limit of detection);

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analytic specificity (including effect of interfering substances, such as chemicals [preservatives],

drugs, cold agglutinins);
reportable range;
appropriate dilution and concentration protocols or reporting instructions if the reporting range is
exceeded;
analytic accuracy (bias); and
analytic precision.
Appendixes M1 and M2 provide a means to present analyte-specific information by analyte or analyzer in

a tabular format for easier comprehension. These tables can serve as useful references when answering
questions about examinations and methods.
9.2.1.9 Calculations for Quantitative Procedures
Quantitative examination procedures need to include the equations for calculations when they are
applicable to the examination. The calculation section needs to include:
the full equation;
step-by-step instructions to solve the equation; and
an example of how to solve the equation.
This section is not needed for qualitative examination procedures (e.g., dipstick examinations, slide
examinations, immunohematology examinations).
A separate documented procedure is needed for periodically verifying calculations performed by the
laboratory information system, because verification of calculations made by the computer does not take
place at the time of performing examinations.
9.2.1.10 Expected Values
The examination procedure needs to include the range of expected values for the analyte or examination
result. The expected values encompass the reference range relevant to the following:
sample type; and

demographic variables, such as sex, age, and race.
9.2.1.11 Interpretation of Results
The examination procedure needs to include guidelines for interpreting examination results when
applicable. This section should include:
comparison of the results to the expected values or diagnostic findings to determine if the result is
normal, abnormal, or indeterminate;
follow-up for indeterminate results;

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recognition of results that fall outside the reportable range, and reference back to the Method
Limitations section; and
recognition of results that exceed critical limits (see Section 9.3.1).
9.2.2 Procedures for Automated Instruments and Manufacturers Operators Manuals
Multitest, random-access analyzers require documents that reflect the instructions for readying the
analyzer for examinations; performing scheduled QC, calibration, or calibration verification; performing
required maintenance and function checks; and troubleshooting problems.
Automated examinations are centered on:
preparing the instrument for examinations (e.g., start-up diagnostics, reagent sufficiency);
loading patient and nonpatient samples for examinations;
selecting the analytes to examine;
making decisions based on the values of controls and patient examination results; and
handling instrument problems.
Therefore, it is important that procedures clearly and accurately describe what the operator needs to do
and how to do it.
The laboratory may write its own procedures for performing these activities or may use those in the
instrument operators manuals. The laboratory needs to review the manufacturers manuals to determine
if the procedures match the laboratorys practice. Where there are differences, revise the procedures to
reflect actual practice and verify to ensure expected performance. When manufacturer procedures
manuals are adopted as the laboratorys procedures (after proper validation and documentation of
validation), the guidance provided herein for revision and approval should be followed.
In addition to the common elements described in Section 7 for all documents, procedures for automated
examinations need to cover all of the information discussed in Sections 9.2.1.1 through 9.2.1.11.
Important information about analytes that are examined on analyzers can be presented in one or more
tables that summarize analyte-specific information for easy reference. Examples of these types of tables
are presented in Appendixes M1 and M2.
9.3 Postexamination Procedures
Postexamination procedures address the activities from reporting patient examination results to archiving
results and samples. In addition to the common elements described in Section 7 for all documents,
postexamination procedures need to include the following, where applicable:
how results are prioritized;
entry of results into the laboratory reporting system;
guidelines for notification of appropriate individuals of examination results;

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archiving results and report documents; and
sample retention.
9.3.1 Prioritizing Results
Postexamination procedures need to include instructions for prioritizing results that:
are normal;
fall outside the reference range;
exceed the critical limits;
fall outside the reportable range (e.g., the use of greater than [>] and less than [<]); and
use interpretative text. NOTE: Examples of such text should be included in the procedure.
Instructions are also needed for:
rounding numbers; and
the acceptable units for reporting (e.g., mL, mmol, g).
Include instructions for supervisory and/or medical review of examination results, where such review is
required.
9.3.2 Entry of Results Into the Laboratory Reporting System
The laboratory needs to have postexamination procedures for result reporting that describe all electronic
and manual methods that are used. These postexamination procedures need to include instructions for
reporting results:
by electronic transfer of data from an instrument or analyzer into a computer system;
by manual entry of data into a computer system; and
manually, on paper report forms.
Procedures that provide instructions for entering patient examination results into the laboratorys
information system (whether manually or by electronic transfer) should contain instructions for the user at
each prompt in the computer program sequence. Appendix K provides an example of a template that can
be used for writing computer procedure instructions.
A separate procedure is needed for periodically verifying the accuracy of electronic transmission of
laboratory examination results, because this verification does not take place at the time of performing
patient examinations.
A separate procedure is needed for how to change results that have been erroneously entered into the
reporting system (for whatever reason) and are thus available for review and use by clinicians and
caregivers.

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9.3.3 Guidelines for Notification of Appropriate Individuals of Examination Results
Postexamination procedures need to include guidelines for notifying the appropriate individual(s) of
results that exceed critical clinical limits. Instructions are also needed for documentation of the
notification and verification that the results and notification have been received. If the laboratory has a
separate procedure for notification and documentation of notification, the postexamination procedure may
refer the user to that procedure.
9.3.4 Archiving Results
The laboratory needs to have postexamination processes and procedures that address the archiving of
patient results. The processes and procedures need to provide the activities and instructions for electronic
and/or paper identification collection, indexing, access, filing storage maintenance and disposal of patient
records. Data storage procedures need to provide instructions for storing patient records so as to prevent
loss, damage, or unauthorized access, and promote easy retrieval.
In addition, the laboratory needs to have a schedule for the duration of patient record retention, as defined
by regulatory or accreditation requirements, and organizational needs. CLSI/NCCLS guideline GP26
Application of a Quality Management System Model for Laboratory Services provides an example of a
laboratory record retention schedule.
9.3.5 Sample Retention
Postexamination procedures for sample retention need to include step-by-step instructions for archiving
sample material, such as compatibility testing samples, hematology slides, and histology and cytology
tissue blocks and slides in such a way as to be readily retrievable when needed.
In addition, the laboratory needs to have a schedule for the duration of sample retention as defined by
regulatory or accreditation requirements, and organizational needs. CLSI/NCCLS guideline GP26
Application of a Quality Management System Model for Laboratory Services provides an example of a
laboratory record retention schedule.
The laboratory also needs to have instructions for disposal of samples after they have exceeded their
established retention times.
10 Form Documents
Forms are the blank documents (or computer screens) onto which the results generated from the
performance of a given procedure are recorded. Form documents need to include:
a title that describes the forms purpose;
facility name and location;
effective date;
fields in which to record information generated from performing the procedure (e.g., results,
interpretations, date, time, initials); and
a means to link the form to its respective procedure document (e.g., through the document numbering
system).

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Examples of properly completed forms, labels, tags, and registers should be included with their respective
procedures in the procedures manual. These examples can be placed in the Appendixes (or Attachments)
section of their respective procedures.
11 Procedures Manuals
Procedures manuals should be organized in a way that can be easily followed by laboratory personnel and
should contain the following elements:
table of contents;
process descriptions (optional, but strongly recommended; see Appendixes A1 through E2);
procedures; and
associated forms.
Appendixes N and O provide examples of procedures manual content. These Appendixes suggest that
procedures can be organized into subgroups that represent the sequence of work activities (i.e., work
processes), rather than arranging in alphabetical order, but that is entirely at the discretion of each
laboratory. However, the organization of procedures by work processes makes information much easier
for staff to find and also provides a useful training tool for orienting new employees to how we do it in
our laboratory. An alphabetized or topic index could also be included in the manual for easy location of
individual procedures. Appendix P is an example of the table of contents for a laboratory information
system computer downtime manual.
12 Document Management
The laboratory needs to have a document management system in place to ensure that all documents in use
are written in the approved formats, reflect the current version, and are reviewed and approved by the
appropriate individual(s) in a timely manner. The document management system may be either paper-
based or electronic-based; however, an extensive review of electronic systems is beyond the scope of this
guideline. Although this guideline contains information primarily about the paper-based systems used in
many laboratories, the document management concepts may be handled differently by the different
electronic systems. Readers are encouraged to review the key features about electronic document control
systems.10
12.1 Document Identification
To facilitate the document management system, it is recommended that the laboratory have a document
identification system that enables the reader to determine the type of document, its location, and how it is
used.
Document identification tells the individual what type of document it is (e.g., policy, process, procedure,
or form). A combination of alpha and numeric characters can be used to identify appropriate placement or
ordering of the document within the laboratory operational workflow. In addition, version identification
provides a means to ensure that only the latest approved version of a laboratory document is in use.
Version identification also enables the tracking of changes to documents over time. Document names and
effective dates can also serve as identification of documents stored electronically.

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Creative applications of the document identification system can be used to link documents to:
laboratory location (e.g., in a region or system);
laboratory section (e.g., a clinical discipline or division);
work bench (e.g., microbiology enterics, anaerobes, respiratory);
instrumentation (e.g., chemistry, hematology, or coagulation); or
operations process (e.g., sample collection, compatibility testing).
12.2 Master File
Each document should have a master file that contains the current and all previous versions of the
document. Documents can be stored either as electronic files in virtual folders or as the original paper
copy in a paper file folder. The master file serves as the original paper or electronic source from which
working copies of the current version are generated. The master file is the historic record of the document
and includes master copies of previous versions as required. The laboratory may decide to include in the
master file the signature file for all the author, reviewer, and approval signatures for each version.
12.3 Review and Approval of New Documents
Laboratories need to establish a process for the timely review and approval of new documents before they
are placed into use. This process needs to specify:
who is responsible for the review (e.g., laboratory director, supervisors, senior staff);
who has the approval authority; and
how the review is recorded.
Document management software systems often provide for electronic capture and tracking of approval
signatures.
12.4 Review and Approval of Changes to Approved Documents
Laboratory services need to have a process for the timely revision, review, and approval of formerly
approved documents. This process needs to include the following activities:
establishing the need for revision;
revising the document and any related documents that also need to be changed;
reviewing the revised document;
approving the revisions and recording the approval;
archiving the new version of the document in its respective master file;
notifying staff of the changes; and

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providing working copies of the approved, revised document to all appropriate personnel.
Laboratory control over changes to documents provides a means to ensure that:
only authorized changes are made to approved documents;
all changes are reviewed and approved before use; and
all copies of the document in use reflect the change.
All signed approvals of new and changed documents need to be dated.
Appendixes Q1 and Q2 provide an example of the document control process as a flowchart and as a table.
When changes to a particular procedure document are made, the laboratory service should also determine
what other documents will be affected by the change. This is facilitated by review of the appropriate
process flowchart or table and the procedures Related Documents and Appendixes (or Attachments)
sections. If additional procedure documents need revision, the change process described above needs to
be initiated for those documents, as well. One mechanism that can facilitate this is to adopt the use of a
document change request form. The completed document change request form is kept with the changed
document in its respective master file.
Appendix R is an example of a document change request form for approving new documents or changing
previously approved documents.
NOTE: This change request form has a place for signature approval of the document. When this type of
form is used and retained for each document, working copies of the document do not need signature(s),
because the document change control process is such that only approved current versions are available to
staff.
Document management software systems can electronically track changes and revisions to provide a
documented audit trail.
12.5 Job Aid Documents
If any additional job aids are used (e.g., index card files; posted diagrams, forms, or instruction sheets;
wall charts), they also need review to be sure that they are current, complete, correct, and traceable to the
parent document, and that the effective date is listed. If changes are needed, initiate the document
change process.
12.6 Periodic Review of Unchanged Documents
When documents are managed using a document control process, such as that described in this guideline,
periodic review of unchanged documents may be useful to detect errors, oversights, or work practices that
have diverged from the formal procedures. In the absence of an effective document control process,
however, annual review of documents is required.
12.7 Master Index
The master index is a spreadsheet, database, or hard copy log that lists all documents currently in use in
the laboratory. The master index can be organized for the entire laboratory, or it can be subdivided into
the laboratorys defined work units.

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At a minimum, the elements of the master index need to include document name and effective date. The
document number and version, and the locations of each working copy of the document.
The master index provides laboratory staff with the means to identify the most current version of the
document. Whenever a document is changed and updated to a new version, update the master index.
12.8 Distribution
Revised documents need to be available to all appropriate personnel. The laboratory uses the document
master index to locate the active working copies of the documents. Where paper copies or nonlinked
electronic copies of the document are used, the master copy is used to make new working copies that are
distributed to the locations listed on the master index. Old working copies can be destroyed because the
current and previous master copies of each document have been retained in the master file.
12.9 Archiving, Storage, and Retention of Documents
Store the current version and all previous versions of a laboratory document in the documents respective
master file. When a document is changed, the new version becomes the new master document, and the
previous version is retired and archived in the master file. A notation or stamp indicating the retirement
date is needed to identify the document as obsolete and prevent its unintended use.
Store document master files in a manner that prevents loss, damage, or unauthorized access, and promotes
easy retrieval. Duration of retention of archived laboratory documents is defined in regulations,
accreditation requirements, and by the organization. The laboratory must have documented processes for
short-term and long-term storage for both on-site and off-site locations.
A summary of useful document control rules is presented in Appendix S.
13 Summary
Process documents provide valuable information to staff about how the work operations processes
sequence work through the laboratory. Procedure documents provide the staff with instructions for how to
perform the individual tasks that comprise the work processes.
When process and procedure documents are used as the basis for the laboratorys training and
competence assessment programs, personnel can become functional in the actual work operations
environment more quickly. Staff can more easily identify where process problems exist and which
documents need revision.
A document management process is vital for ensuring that staff access and use only the most current
versions of documents, and that everyone is following the same process sequence and procedure
instructions. In so doing, performance variations that can affect the quality of laboratory services and
results are greatly reduced or actually eliminated.

ClinicalWannamaker
Number 12 GP2-A5
References
1
ISO. Medical laboratoriesParticular requirements for quality and competence. EN/ISO 15189. Geneva: International Organization for
Standardization; 2003.
2
ISO. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:1999. Geneva: International
organization for Standardization; 1999.
3
Centers for Medicare and Medicaid Services. Department of Health and Human Services. Part 493Laboratory Requirements: Clinical
Laboratory Improvement Amendments of 1988. 42 CFR, Parts 430 to end. U.S. Government Printing Office. Published annually.
4
Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Pathology and Laboratory
Services. Oakbrook Terrace, IL: JCAHO. Published annually.
5
College of American Pathologists. Laboratory Accreditation Checklists. Northfield, IL: College of American Pathologists. Available at:
www.cap.org.
6
American Association of Blood Banks. Standards for Blood Banks and Transfusion Services. 23rd ed. Bethesda, MD: AABB; 2005.
7
COLA. Laboratory Accreditation Manual. Columbia, MD: COLA; 2001.
8
ISO. Quality management systemsFundamentals and vocabulary. ISO 9000. Geneva: International Organization for Standardization;
2000.
9
Westgard JO. Basic Method Validation. 2nd edition. Madison, WI: Westgard QC Inc.; 2003.
10
Woodcock SM. Quality management software. Lab Medicine. 2005;36(6):333-336.

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ClinicalWannamaker
Number 12 GP2-A5
Appendix A1. Inpatient Blood Sample Collection Process Flowchart
This example was contributed by the Client Services Workgroup, Sutter Health Sacramento-Sierra Region, Sacramento,
California.

26
Volume 26 GP2-A5
Appendix A2. Inpatient Blood Sample Collection Process Table

Inpatient Blood Sample Collection Process
What Happens Whos Responsible Procedures
Collection lists or laboratory assistant Generating a Collection List for Rounds

labels are generated phlebotomist Generating Collection Lists and Labels for
clerk Priority Draws
technician Reprinting Labels
technologist
Patient is identified patient care technician Identifying Patients for Sample Collection
phlebotomist Identifying Patients for Emergencies
laboratory technician
laboratory technologist
nurse
other healthcare
professional trained in
blood collection
Blood samples are patient care technician Collecting a Blood Sample by
collected phlebotomist Venipuncture
laboratory technician Collecting a Blood Sample by Capillary
laboratory technologist Technique
nurse Collecting a Blood Sample by Arterial
other healthcare Puncture
blood collection
Blood samples are patient care technician Labeling Collected Blood Samples
labeled phlebotomist Using the Blood Bank Armband/Labeling
laboratory technician System
laboratory technologist Following Chain of Custody
nurse
other healthcare
blood collection
Samples are patient care technician Tubing Samples to the Laboratory
transported to phlebotomist Transporting Samples to the Laboratory
laboratory laboratory technician
laboratory technologist
nurse
other healthcare
blood collection

ClinicalWannamaker
Number 12 GP2-A5
Appendix B1. Analyzer Examination Process Flowchart

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Volume 26 GP2-A5
Appendix B2. Analyzer Examination Process Table

Analyzer Examination Process
Sample acceptability is technician, or Evaluating Sample Acceptability

evaluated technologist
Analyzer examination- technician, or Starting Up the ABC Analyzer
ready procedures are technologist Performing Daily Maintenance on the ABC
performed Analyzer
Performing and Evaluating Daily Calibration on the
ABC Analyzer
Performing and Evaluating Controls on the ABC
Analyzer
Samples are loaded technician, or Generating an LIS Pending Log for the ABC
and examined technologist Analyzer
Programming Patient Samples on the ABC
Analyzer
Loading Routine and Stat Racks on the ABC
Analyzer
Troubleshooting technician, [Troubleshooting procedures from the
procedures are technologist, or manufacturers manual]
performed supervisor
Results are evaluated technologist, or Evaluating Patient Results
supervisor Following Up on Delta Checks
Following Up on Technical Limit Flags
Alert/critical values technologist Calling Alert Values
called
Results are verified in technologist Verifying Results in the LIS
LIS
Samples are unloaded technologist, or Storing Patient Examination Samples
and stored technician
This example was contributed by the Central Clinical Laboratory of the Mayo Clinic Department of Laboratory of Medicine and
Pathology, Rochester, Minnesota.

ClinicalWannamaker
Number 12 GP2-A5
Appendix C1. Bacteriology Culture Process Flowchart
Bacteriology Culture Process
Start
- status as received in LIS

Sample is received in
- preexamination sample storage
microbiology lab
- determining microbiology sample acceptability
Culture is set up and incubated
First read is performed
Is further Yes
work needed?
- catalase
Further ID is performed. Susceptibility - coagulase
No performed, if needed - etc.
Preliminary report is generated
Critical values are called
Additional read is performed
Is
further work
No Yes
needed?
Further ID and susceptibility

Final report is generated are performed
Critical values are called

Next read is performed
End
This example was contributed by the Microbiology Technical Working group, Sutter Health Laboratory Integration Project,
Sacramento, California.

30
Volume 26 GP2-A5
Appendix C2. Bacteriology Culture Process Table

Bacteriology Culture Process
Sample is received in laboratory assistant, Changing Microbiology Sample

Microbiology technician, or Status to Received in the LIS
technologist Storing Microbiology Samples
Before Processing/Examining
Evaluating Microbiology Sample
Acceptability
Sample is processed laboratory assistant, Centrifuging Samples
technician, or Grinding Samples
technologist
Culture is set up laboratory assistant, Media selection table
technician, or Incubating cultures table
technologist Streaking Agar Plates
Inoculating Tube Media
Making Sample Smears
Postinoculation Microbiology
Sample Storage
First read is performed technician, or Urine Cultures: Reading and
Second read is performed technologist Interpreting
Enteric Cultures: Reading and
Interpreting
[Additional procedures for reading
and interpreting other cultures]
Further identification is made technician, or [Instrument procedures]
technologist [Examination-specific procedures
such as catalase, gram stain, etc.]
Susceptibility is performed technician, or [Instrument and examination-specific
technologist procedures]
Critical values are called technician, or Calling Alert Values
technologist
Preliminary report and technician, or Generating Microbiology Reports:
final report are issued technologist Preliminary and Final

ClinicalWannamaker
Number 12 GP2-A5
Appendix D1. Transfusion Medicine Prenatal Examination Process Flowchart
Transfusion Medicine
Prenatal Examination Process
Sample is received in blood bank/transfusion service
Sample is centrifuged
Sample acceptability is determined
Sample is held for batching
Pending log is generated from computer
- manual
Previous record check is performed
- computer
- ABO/Rh
u
Type and screen -D
is performed - Antibody screen by tube technique
- Antibody screen by gel technique
No Is antibody Yes
screen positive?
- antiglobulin panel
Results are reported Antibody identification - gel panel
is performed - rule-out cells
End
No Is antibody Yes
clinically significant?
Results are reported Results are reported
End
Specimens are held pending
order for titer
Order for
titer is received
This example was contributed by the Blood Bank Technical Work Group, Sutter Health Laboratory Integration Project,

32
Volume 26 GP2-A5
Appendix D2. Transfusion Medicine Prenatal Examination Process Table

Transfusion Medicine Prenatal Examination Process
Sample acceptability is technician Evaluating Blood Bank Samples

determined technologist
Sample is held for laboratory assistant Batching Blood Bank Samples for Future
batching technician Examinations
technologist
Computer pending log is laboratory assistant Generating a Pending Log From the LIS
generated technician
Previous record check is technician Checking Blood Bank Patient History Files
performed technologist
Type and screen is technician ABO and Rh by Tube Method
performed technologist Weak D (Du Examination)
Antibody Screen by Gel Technique
Antibody Screen by Tube Technique
Antibody identification is technologist Identifying Antibodies by the Antiglobulin
performed, when Panel
necessary Identifying Antibodies by the Gel Technique
Using Rule-Out Cells in Antibody Identification
[Additional specific antibody identification
procedures]
Results are reported technologist Reporting Blood Bank Results in the LIS
Antibody Identification Report Form
Samples are stored laboratory assistant Storing Blood Bank Samples

ClinicalWannamaker
Number 12 GP2-A5
Appendix E1. Surgical Pathology Sample Process Flowchart
Surgical Pathology Sample Process
Start
Surgeon extracts sample
Circulating nurse prepares sample for - labeling

transport to laboratory - requisition
Surgery transporter brings sample to

laboratory
Is frozen section or
No pathology consult Yes
requested?
No Is frozen
Case is received and accessioned
section indicated?
Sample is grossed
Yes
Frozen section block is prepared

Case is
Cassettes are preserved in formalin
accessioned
Frozen section block is processed

Tissue is processed
Slides are read and surgeon

notified by pathologist
Tissue is embedded
Tissue is cut and slides made Frozen section report is prepared
Slides are stained
Slides are coverslipped

Pathologist
Interpretation
Case delivered to pathologist and Reporting
process
This example was contributed by the Department of Pathology and Laboratory Medicine, Elmhurst Memorial Hospital, Elmhurst,
Illinois.

34
Volume 26 GP2-A5
Appendix E2. Surgical Pathology Sample Process Table

Routine Surgical Pathology Sample Process
What Happens Whos Procedures

Responsible
Surgical sample is circulating Labeling Surgical Pathology Samples
prepared for transport to nurse Preparing Surgical Pathology Requisitions
laboratory
Sample is brought to surgery Delivering Surgical Samples to the
laboratory transporter Laboratory
Case is received and gross room Accessioning Routine Surgical Samples
accessioned assistant Accessioning Frozen Section/Intraoperative
resident Consult Samples
Frozen section block is pathologist Preparing Frozen Section Blocks
prepared and processed Processing Frozen Section Blocks
into slides Cutting Frozen Section Blocks
Staining Frozen Section Slides
Pathologist reads frozen pathologist Reporting Frozen Section Results to Surgeon
section slides and prepares Preparing Frozen Section Report
report
Routine samples are pathologist [guidelines for grossing different sample
grossed pathologists types]
assistant Labeling and Reconciling Samples
resident
Cassettes are preserved in Histology Preserving Cassettes in Formalin
formalin technician or
technologist
Tissue is processed Histology Readying the ABC Tissue Processor
technician or Loading the ABC Tissue Processor
technologist Unloading the ABC Tissue Processor
Tissue is cut and slides Histology Embedding Tissues
made technician or Cutting Tissue and Making Slides
technologist
Slides are stained Histology Loading ABC Slide Stainer
technician or
technologist
Slides are coverslipped Histology Coverslipping With the ABC Instrument
technician or Coverslipping by Manual Technique
technologist
Case is delivered to Histology Assembling Folders for Pathologist Case
pathologist technician or Reading
technologist

ClinicalWannamaker
Number 12 GP2-A5
Appendix F. Sample Preexamination Procedure

Identifying the Patient for Sample Collection Effective Date: mm/dd/yy
Document #/version #
Identifying the Patient for Sample Collection
Purpose This procedure provides instructions for correctly identifying patients for sample
collection.
Supplies Patient identification band (see example in Appendix 1)
Procedure A: Follow the activities in the table below to properly identify inpatients.
Inpatients
Step Action
1 Ask the patient to state his or her last name when able.
2 Verify that the patient is wearing an identification band.
3 Follow the directions in the table below for identifying the patient.
If Then
there is no ID band do not proceed, and
anywhere in the room notify the patients nurse.
Note:
During disasters or codes, refer to the
emergency identification procedure.
the ID band is attached do not proceed,
to the bed ask the patients nurse to identify the patient,
and
ask the nurse to document the verification on
the collection list, labels, or requisition.
the ID band is present do not proceed, and
but not attached to the notify the patients nurse.
patient
4 Match the ID band to the requisition, collection list, or labels.
The patients name and medical record number are required.
Exceptions are not allowed.
5 Proceed with sample collection only when patient identification is
verified.
Continued on next page
Anytown Hospital Laboratory, Anytown USA 12345 Page 1 of 2

[filename and path]

36
Volume 26 GP2-A5
Appendix F. (Continued)
Identifying the Patient for Sample Collection Effective Date: mm/dd/yy
Procedure B: Follow the activities in the table below to properly identify outpatients.
Outpatients
Step Action
1 Ask the patient to
spell his/her first and last names, and
give his/her date of birth.
2 Verify the spelling and date of birth against the
label, and
requisition.
3 Proceed with sample collection only when patient identification
is verified. If identification cannot be verified, proceed to step 4.
4 Follow the directions in the table when activities 1 and 2 cannot
be followed.
If Then
the patient is unable to get the information from a family
provide information member or caregiver, if present, or
for whatever reason if not present, notify the person in
charge.
the identifiers do not contact the registration desk, and
match resolve the discrepancies before
proceeding.
the ID band is present do not proceed, and
but not attached to the notify the patients nurse.
patient
5 Proceed with sample collection only when patient identification
is verified.
Related Procedure ID. XXX: Emergency Identification Procedure

Procedures
Appendixes Appendix 1: Example of Patient Identification Band
End

[filename and path]

ClinicalWannamaker
Number 12 GP2-A5
Appendix G. Sample Analyzer Procedure

Loading Samples for Examinations on Instrument X Effective Date: mm/dd/yy
Loading Samples for Examinations on Instrument X
Purpose This procedure provides instructions for prioritizing and loading the samples to be run
on Instrument X.
Procedure A: Use the table below to select the correct rack for loading samples.
Rack Selection
Sample Type Rack Color Rack ID Details
Calibrator Black C
Quality control White Q
Serum/plasma/body Red (stat) 10-50 Most often used for
fluid (not urine) exceptional samples.
Serum/plasma/body Gray (routine) 21-200 Most often used for:
fluid (not urine) stat
routine
CSF Red with blue stripes 1-9
CSF Gray with blue stripes 1-9
Urine Gray with yellow stripes 10-20
Procedure B: Follow the activities in the table below to load samples.

Loading Samples
Step Action
1. Prioritize samples to be loaded
1. ER 3. Priority
2. Priority 1 4. Routine
2. Load ER and Priority 1 samples into a gray rack with bar code
facing the open slot.
Load ER/Priority 1 rack onto Instrument X.
If Instrument X is Then
in operation load the rack into the stat
position.
Note:
The stat position is located on
the left side of the instrument.
Standby or Rack Supply load racks to the front of the
Complete tray

[filename and path]

38
Volume 26 GP2-A5
Appendix G. (Continued)
Procedure B: Step Action
Loading 3 Load samples such as body fluids into red racks.

Samples Program the samples. See Procedure ID. XXX, Manually
(continued) Programming Samples, if needed.
Load rack onto tray.
4 Load remaining samples into the appropriate racks with bar code
facing the open slot.
Load racks onto trays.
5 Load the tray into an open position on Instrument X.

- Lift the metal flap
- Remove the empty tray
- Load sample tray
- Lower the metal flap
Note:
If the instrument is taking samples from track 2, the instrument will
not go to track 1 when finished with 2. Wait for rack supply
complete to restart.
Procedure C:
Starting Follow the activities in the table below to start operation of Instrument X.
Instrument X
Operation
Step Action
1 Check the status of the instrument in the upper left corner of the
monitor screen.
If the status is Then
in operation continue to load samples onto the
instrument.
Standby or Rack Supply touch the Start button on the
Complete monitor screen and the Start button
on the following screen.
Note:
If the instrument is taking samples
from track 2, the instrument will not
go to track 1 when finished with 2.
Wait for rack supply complete to
restart.

[filename and path]

ClinicalWannamaker
Number 12 GP2-A5
Appendix G. (Continued)
References Daily Operations Guide for Instrument X
Related
Procedures Procedure ID. XXX Manually Programming Samples
Appendixes None
End

[filename and path]
This example was contributed by the Central Clinical Laboratory of the Mayo Clinic Department of Laboratory Medicine and
Pathology, Rochester, Minnesota.

40
Volume 26 GP2-A5

ClinicalWannamaker
Number 12 GP2-A5
Appendix H. Sample Microbiology Procedure

Urine Culture: Reading and Interpreting Effective Date: mm/dd/yy
Urine Cultures: Reading and Interpreting
Purpose This procedure provides instructions for reading and interpreting a urine culture.
Policy Examine the first read of all cultures that were set up before midnight.
For cultures set up after midnight (enter facility-specific directions here).
Procedure Follow the activities in the table below to read and interpret urine cultures.
If there is Then
no growth reincubate an additional day, and
enter a preliminary report of No growth at 24
hours.
(See Procedure ID. XXX: Generating Reports:
Preliminary and Final)
growth of 1-3 follow instructions in Appendix 1: Urine Culture
organisms Workup Guidelines,
follow instructions in Appendix 2: Definitive
Identification and Susceptibility Criteria, and
enter a preliminary report.
growth of 4 or more report as (facility-specific comment on mixed flora),
organisms and
enter a final report.
(See Procedure ID. XXX: Generating Reports:
Preliminary and Final.)
a urine screen policy (follow facility-specific requirements for reporting.)
References Essential Procedures for Clinical Microbiology, ASM, (year)
Related Procedure ID. XXX: Generating Reports: Preliminary and Final

Documents
Appendixes Appendix 1: Urine Culture Workup Guidelines

Appendix 2: Definitive Identification and Susceptibility Criteria

[filename and path]
This example was contributed by the Microbiology Technical Work Group, Sutter Health Laboratory Integration Project,

42
Volume 26 GP2-A5
Appendix H. (Continued)
Urine Cultures: Reading and Interpreting Effective Date: mm/dd/yy
Appendix 1: Urine Culture Reading and Interpreting Guidelines
Sample Sex WBC Species Count Workup Sensitivity

Voided F No Single < 50 K Descriptive ID No
all ages < 10 (pure > 50 K Definitive ID Yes
Clean catch isolate)
Catheterized or Multiple < 50 K Descriptive ID No
50 Definitive ID Yes
M 100 K predominant < 2
< 5 years Descriptive others No
and mixed flora
> 100 K Definitive ID Yes
predominant < 3
Descriptive others No
and mixed flora
Yes Single <1K Descriptive ID No
> 10 (pure >1K Definitive ID Yes
isolate)
Multiple < 10 K Descriptive ID No
10 Definitive ID Yes
50 K predominant < 2
and mixed flora
> 50 K Definitive ID Yes
predominant < 3
and mixed flora
M N/A Single Descriptive ID No
> 5 years (pure Definitive ID Yes
isolate)
Multiple Descriptive ID No
Definitive ID Yes
predominant < 3
and mixed flora
Suprapubic All N/A All Any Definitive ID Yes
puncture count
Reference
Anytown Hospital Laboratory, Anytown USA 12345

[filename and path] Page 2 of 3

ClinicalWannamaker
Number 12 GP2-A5
Appendix H. (Continued)
Urine Cultures: Reading and Interpreting Effective Date: mm/dd/yy
Appendix 2: Urine CulturesDefinitive Identification and Susceptibility Criteria
Organism Group Description Set Up Susceptibility?

(Presumptive/Definitive
Identification)
Staphylococcus Staphylococcus aureus yes
Staphylococcus yes
coagulase-negative
Staphylococcus s/p (facility-specific)
saprophyticus
Streptococcus Beta streptococcus no
Enterococcus s/p (facility-specific)
Streptococcus viridans no
Gram-positive rods Corynebacterium no

ureolyticum
Diphtheroids no
Lactobacillus no
Gram-negative rods Presumptive identification yes
Definitive identification yes
Yeast (Facility-specific) presumptive no

vs. definitive
Reference

44
Volume 26 GP2-A5

ClinicalWannamaker
Number 12 GP2-A5
Appendix I. Sample Transfusion Service Procedure

u
Weak D (D ) Determination Effective Date : mm/dd/yy
Weak D (Du) Determination
Purpose This procedure provides instructions for performing the weak D (Du) determination.
Weak forms of the Rho(D) antigen can be detected only after incubating the red cells with the
anti-D reagent and using the antiglobulin technique.
Sample Red cells for examination can be either anticoagulated (e.g., EDTA), or from a clot.
Materials Reagents Supplies Equipment

Isotonic saline 12 x 75-mm test tubes calibrated
Anti-D Reagent control drop pipettes centrifuge
IgG Antiglobulin Reagent test tube rack automatic cell
IgG Sensitized Red Cells washer
Quality Reagents must be evaluated each day of use with appropriate controls. Verify that reagent QC
control has been performed. If not, see Procedure ID. XXX: Daily Reagent Quality Control.
Procedure NOTE: If the original direct examination with the anti-D was performed by tube method, the
same tube may be used for the weak D examination, provided the manufacturers directions so
state. In this case, proceed directly to step 4, after recording the original anti-D tube examination
as negative.
Step Action
1 Place one drop of anti-D serum into a clean, labeled examination tube.
2 Place one drop of 6% albumin control reagent into a second labeled tube.
3 Add one drop of a 2 to 5% suspension in saline of the red cells to be
examined to each tube.
4 Mix and incubate both tubes for 15 minutes at 37 C.
5 Centrifuge for the saline spin time of the calibrated centrifuge.
6 Gently resuspend the cell button and examine for agglutination.
If the examination red cells Then:
are:
strongly agglutinated in the record the examination
anti-D tube but not in the sample as D-positive, and
control tube, do not proceed with the
antiglobulin examination.
not agglutinated, or results are proceed with step 7.
doubtful


46
Volume 26 GP2-A5
Appendix I. (Continued)
u
Weak D (D ) Testing Effective Date : mm/dd/yy
Procedure (Continued)
Step Action
7 Wash the cells three times in the automatic cell washer.
8 Add two drops of anti-IgG reagent.
10 Resuspend each cell button and examine for agglutination.
11 Grade and record the results.
12 To each tube with a negative result, add one drop of IgG-sensitized (check)
cells.
14 Resuspend each cell button and examine for agglutination.
15 Grade and record the results.
NOTE: Agglutination of the check cells confirms the presence of active
antiglobulin reagent and indicates that the results obtained in step 14 are valid.
Interpretation + = agglutination of the red cells

0 = no agglutination
Anti-D Control Rh interpretation

+ 0 D Positive
0 0 D Negative
+ + Invalid
Perform and interpret the Direct
Antiglobulin Test Procedure ID. XXX
Result Enter results into the computer. Follow instructions for Entering results into the BBLIS
Reporting Procedure ID. XXX.
References Manufacturers package insert for anti-D

AABB Technical Manual, current edition
Related Procedure ID. XXX: Entering Results into the BBLIS

Documents Procedure ID. XXX: Direct Antiglobulin Test
Procedure ID. XXX: Daily Reagent Quality Control
End

ClinicalWannamaker
Number 12 GP2-A5
Appendix J. Sample Histology Procedure

Hematoxylin and Eosin Staining Procedure: Manual Method Effective Date: mm/dd/yy
Hematoxylin and Eosin Staining Procedure: Manual Method
Purpose This procedure provides instructions for how to manually stain slides for microscopic
examination with hematoxylin and eosin.
Materials Equipment Reagents Supplies

Slide Holder Xylene Containers for Reagents
Timer Iodine Solution and Solutions
Sodium Thiosulphate 3%
Aqueous
Harris Hematoxylin
Acid Alcohol
Scotts Tap Water Substitute
95% alcohol
Eosin Staining Solution
Absolute alcohol
Procedure: Follow the steps in the table below to manually stain slides with the Hematoxylin-
Eosin method.
Step Action
1 Deparaffinize in two changes of xylene for a total of three minutes.
2 Immerse in absolute alcohol; three changes, ten dips each.
3 Immerse in 95% Alcohol; ten dips.
4 Determine if treatment is necessary.
If Then
sections are B5 fixed treat with iodine for five minutes
wash, and
treat with sodium thiosulphate for one
minute.
Otherwise go to step five.
5 Wash well in running water.

6 Stain in Harris hematoxylin for five minutes.

[filename and path]

48
Volume 26 GP2-A5
Appendix J. (Continued)
Hematoxylin and Eosin Staining: Manual Method Effective Date: mm/dd/yy
Procedure Step Action

(Continued)
8 Differentiate in acid alcohol three to six dips.
10 Blue in Scotts Tap Water substitute for one minute.
12 Rinse in 95% alcohol.
13 Stain one minute in eosin; make sure stain covers slides
completely.
15 Dehydrate in 95% alcohol and three changes of absolute alcohol,
ten dips each.
16 Clear in three changes of xylene, ten dips each.
Expected Cell Components Expected Color

Results Nuclei Blue
Cytoplasm and intercellular Shades of pink and red
substances
Cells with much RNA or acid
Purplish
mucopolysaccharide
Related Iodine Solution Preparation Procedure

Procedures Sodium Thiosulphate 3% Aqueous Preparation Procedure
Harris Hematoxylin Stain Preparation Procedure
Acid Alcohol Preparation Procedure
Scotts Tap Water Substitute Preparation Procedure
Eosin Stain Preparation Procedure
Reference Bancroft JD, Gamble M. Theory and Practice of Histological Techniques.

5th ed. Churchill Livingstone; 2001.
End
[filename and path]
This example was contributed by the Department of Paediatric Laboratory Medicine, Hospital for Sick
Children, Toronto, Ontario, Canada.

ClinicalWannamaker
Number 12 GP2-A5
Appendix K. Sample Computer Procedure

Signing On To and Navigating IDX Effective Date: mm/dd/yy
Signing On to and Navigating the IDX System
Purpose This procedure provides instructions for signing on to the IDX system.
Do not share your password with another employee passwords are confidential
Policy information.
Do not sign on to a computer using another employees password.
Procedure A: If you are a new user, follow the steps outlined below to sign on to the IDX for the first
New User time.
If you are not a first-time user, go to Procedure B.

Step Prompt Action
1 Double click the IDX icon on the PC desktop

2 USER NAME Type in GENERIC USER NAME <ENTER>
3 PASSWORD Type in GENERIC PASSWORD <ENTER>
*First-time users will then get a message that
his/her password has expired and will be
prompted to enter a user-specified password.
4 NEW PASSWORD Enter NEW password that has a
minimum of 6 characters (letters or
numbers), and a
maximum of 26 characters (letters or
numbers).
NOTE: Your password cannot be duplicated

or you will get the message Password already
in use.
<ENTER>
5 VERIFY Re-enter NEW password
PASSWORD <ENTER>
6 Message: Password NONE
Changed

[filename and path]

50
Volume 26 GP2-A5
Appendix K. (Continued)
Signing On To and Navigating IDX Effective Date: mm/dd/yy
Procedure B: Follow the steps below to sign on to the IDX when you know your
Sign on with a password.
password.
Step Prompt Action
1 Double click the IDX icon on the PC desktop

2 USER NAME Enter the USER NAME <ENTER>
3 PASSWORD Enter the PASSWORD <ENTER>
4 Your MENU will be displayed.

End

[filename and path]
This example was contributed by the Laboratory Services of Sutter Health Sacramento-Sierra Region,

ClinicalWannamaker
Number 12 GP2-A5
Appendix L. Suggested Contents of Laboratory Procedures
Procedure
Examination Pre- and Postexamination
Quantitative Qualitative
Section
Purpose X X X
Policy Insert specific requirements at the place in the document where the reader
needs the information.
Reagents X X
Equipment X X As needed
Supplies X X As needed
Sample X X
Special safety As needed As needed As needed
precautions
Quality control X X
Procedure X X X
Calculations X X
Interpretation/ X X
Results/Alert
Values
Reference X X
intervals
Method X X
performance
specifications
References X X X
Related Other Other Other procedures
documents procedures procedures
Appendixes As used As used As used
(forms, labels,
tags, tables)
NOTE: If there are separate procedures for any of these sections, then that section does not need
inclusion in the procedure.

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Volume 26 GP2-A5

ClinicalWannamaker
Number 12 GP2-A5
Appendix M1. Attributes for a Single Analyte on the ABC Analyzer

Creatinine Attributes for the XYZ Analyzer Effective Date: mm/dd/yy
CREATININE
Attribute Description
Principle Colorimetric rate reaction. Creatinine forms a yellow-orange
complex with picrate in an alkaline solution.
Clinical Utility Diagnosis and treatment of acute and chronic renal disease
Monitoring of renal dialysis
Sample Type Serum; EDTA or sodium heparin plasma
-Stability 7 days; centrifuged, at 2 to 8 C

-Volume
(Preferred) 0.5 mL
(Minimum) 0.2 mL
-Patient Prep None
Reagents Reagent #1: NaOH
Reagent #2: Picric Acid
Calculations Not applicable

Interferences Bilirubin >25.0 mg/dL
Hemoglobin >150 mg/dL
Triglyceride >1000 mg/dL
Method Performance Linear range of detection:

Specifications 0.1 to 25.0 mg/dL
Reporting: Male Age (Years) mg/dL Female Age (Years) mg/dL

- Reference Range 1 2 0.2 0.6 13 0.3 0.6
3 4 0.3 0.7 45 0.4 0.7
5 9 0.4 0.8 68 0.5 0.8
10 11 0.5 0.9 >9 0.6 0.9
12 13 0.6 1.0
14 15 0.7 1.1
> 16 0.8 1.2
Reporting: Age Creatinine Value, mg/dL

-Alert Limits 1 day 30 days >1.5 mg/dL
1 month 23 months >2.0 mg/dL
2 years 11 years >2.5 mg/dL
12 years 15 years >3.0 mg/dL
> = 16 years >10.0 mg/dL

[filename and path]

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Volume 26 GP2-A5
Appendix M1. (Continued)

CREATININE (Continued)
Reporting Results
Auto-release 0.4 to 25.0 mg/dL: Release results.
Low Recheck <0.4 mg/dL:

Check for clots and bubbles.
Instrument will rerun as volume and calculate results.
Dilutions >25.0 mg/dL:

Instrument will rerun as volume and calculate results.
Rerun dilution < 50.0 mg/dL: Report result.
Rerun dilution >50.0 mg/dL: Make manual dilution (0.9%

NaCl) and rerun.
Document calculations and report.
End

[filename and path]

ClinicalWannamaker
Number 12 GP2-A5
Appendix M2. Attributes for Multiple Analytes on the XYZ Analyzer

XYZ Analyzer Protime (PT) Partial Thromboplastin Time

(PTT)
Principle
Clinical Utility
Sample Type
-Stability
-Volume
(Preferred)
(Minimum)
-Patient Prep
Reagents
Calculations
Interferences
Method Performance
Specifications
Reporting
- Reference Range
Reporting
-Alert Limits

[filename and path]

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Volume 26 GP2-A5
Appendix M2. (Continued)

XYZ Analyzer Protime (PT) Partial Thromboplastin Time

(PTT)
Reporting
Auto-release
Low Recheck
Dilutions
End

[filename and path]
NOTE: Additional columns can be added to the right for additional analytes, or the table could be
presented in landscape (sideways) format.

ClinicalWannamaker
Number 12 GP2-A5
Appendix N. Sample Table of Contents for a Preexamination Procedures Manual

Patient Service Center Procedures Manual
Table of Contents
PAGE SUBJECT PROCESS PROCEDURE FORM RESOURCE

Section A General Information
STAT Test Menu X

Courier Schedules/Phone Number
Turnaround Times
Acceptable Test Panels
Critical Values
Rejected Specimens
Reflex Testing
Standing Orders
Managing Inquiries
Reference Laboratory Testing
Ambiguous Test Orders
Events Requiring Immediate
Notification
Medicare Approved Panels - Appendix
A
Immediate Contact List X
Section B Registration Process and

Procedures
Patient Registration Process Flowchart X
Greeting the Customer at the Patient X
Service Center
Determining an Outpatients Eligibility X
for Service
Conditions of Registration Form X
Checking for Verbal, Standing, or X
Computer Orders
Verifying the Completeness and Accuracy X
of the Laboratory Requisition
Standard SSR Laboratory Requisition X
Ambiguous Test Order - Action Summary X
Request for Diagnosis Clarification X
Assigning ICD-9 Codes To Diagnostic X
Information
Completing and Managing MSP Forms X
MSP Form X
Providing Advanced Beneficiary Notice X
ABN Form X
Patient Refusal of Testing Form X
Signing On and Navigating Within IDX X
Registering Workers Comp (WC) in IDX X
Registering a New Patient in IDX X
Verifying Correct Patient Information in X X
IDX

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Volume 26 GP2-A5
Appendix N. (Continued)
Adding/Editing/Deleting Insurance in X
IDX
Insurance (FSC) Listing X
Registering Physician Office Collected X
Specimens in IDX
Admitting an IDX non-Group 3, 4, 14 X
Patient into the LIS
Section C Test Ordering Process and
Procedures
Test Ordering Process Flowchart X
Taking Verbal Orders From Physician X
Verbal Order Follow-up Form X
Accepting and Managing Standing Orders X
Standing Order Form X
Ordering Standing Orders in LIS X
Ordering Tests In LIS X
Standard SSR Laboratory Requisition X
LIS Mnemonic Quick Reference X
Using the SSR Laboratory Reference X
Manual
Using the Quest Website as a Reference X
Source
Ordering Confidential Tests in LIS X
Adding an Order to an Accession Number X
Canceling Test(s) in LIS X
Cancellation Codes X
Reprinting an LIS Collection Label X
Managing Test Order Paperwork/Labels X
Section D Sample Collection Process
and Procedures
Sample Collection Process Flowchart X
Determining Specimen Requirements X
Escorting Outpatients to Collection Area X
Identifying Outpatients for Specimen X
Collection
Collecting Specimens Following Age- X
Specific Requirements
Collecting Blood Specimen by X
Venipuncture
Collecting Blood Specimen by Capillary X
Puncture
Collecting Blood Cultures X
Collecting Stool and Urine Specimens X
Labeling Blood Specimens at Collection X
Managing Test Order Paperwork X
Postcollection
Section E Sample Processing and
Handling Process and Procedures
Sample Processing Flowchart X

ClinicalWannamaker
Number 12 GP2-A5
Appendix N. (Continued)
Processing Physician Office-Collected X
Specimens
Physician Collected Specimen Transport X
List
Receiving Specimens in LIS X
Processing and Storage of PSC-Collected X
Specimens
Operating the Centrifuge X
Preparing Specimen Aliquots X
Generating a Batch Tracking List From X
LIS
PSC Tracking List X
Preparing Transport Batch for Courier X
Pick-up
Section F Special Procedures
Opening and Closing the PSC X

Patient Data Sheet X
Laboratory
Glucose Tolerance Testing X
Glucose Tolerance Test Collection Form X
Recognizing and Responding to Adverse X
Reactions to Venipuncture
Managing and Reporting Client Injuries X
Telephone Use
Using the Fax Machine X
Operating/Answering the Phone X
Telephone Quick Reference Guide X
Computer Systems
Opening a Help Desk Ticket X
Managing Workflow During Computer X
Downtime
IDX Downtime X
Safety
Responding to an Outpatient Emergency X
Responding to a Fire X
Fire Extinguisher Inspection and Service X
Fire Extinguisher Inspection and X
Maintenance Record
Quality Management
Quality Assessment Record X
This example was provided by the Sutter Health Sacramento Sierra Laboratory Services Patient Service
Center, Sacramento, California.

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Volume 26 GP2-A5
Appendix O. Sample Table of Contents for the ABC Analyzer Procedures Manual
Section 1. ABC Analyzer Set-up and Run Process
Analyzer Set-up and Run Process Flowchart
Analyzer Set-up and Run Procedures
Starting Up the ABC Analyzer
Performing Daily Maintenance on the ABC Analyzer
Performing and Evaluating Daily Calibration on the ABC Analyzer
Performing and Evaluating Controls on the ABC Analyzer
Generating an LIS Pending Log for the ABC Analyzer
Programming Patient Samples on the ABC Analyzer
Loading Routine and Stat Racks on the ABC Analyzer
Evaluating Patient Examination Results
Calling Alert Values
Following Up on Delta Checks
Following Up on Technical Limit Flags
Verifying Results in the LIS
Storing Patient Examination Samples
Section 2. Analyte-Specific Information Table (see example in Appendixes M1 and M2)

Analyte-Specific Information Table(s)
Section 3. Troubleshooting Process

Troubleshooting Process Flowchart (from manufacturers manual)
Troubleshooting Process Procedures
(Troubleshooting Procedures from the manufacturers manual in the order in which they are
performed)
Section 4. Preventive Maintenance Process

Preventive Maintenance Schedule (from manufacturers manual)
(Preventive Maintenance Procedures from the manufacturers manual in the order in which they
are performed)
Section 5. Calibration Process

Calibration Schedule (from manufacturers manual)
Calibration Procedures
[Calibration Procedures from the manufacturers manual
Installation Calibration
Periodic Calibration
Recalibration After Service or Repair]
Ideas for this example were contributed by:

Client Services Workgroup, Sutter Health Laboratory Integration Project, Sacramento, California; and
Central Clinical Laboratory, Mayo Clinic Department of Laboratory Medicine and Pathology, Rochester, Minnesota.

ClinicalWannamaker
Number 12 GP2-A5
Appendix P. Sample Table of Contents for a Computer Downtime Manual
LIS and Automation Downtime Manual

Table of Contents
Section
1 Introduction
2 Types of Downtime
Scheduled Downtime
Unscheduled Downtime
3 Testing
Test Production
LIS Failure Plan Test Prioritization
4 LIS Failure
Introduction
Sequence of Events
Forming the Control Team
Control Team Assessment
Implementation of Failure Plan
Triage Specimens
Notification of the Labor Pool
Labor Pool Deployment
Failure Plan Transition Between Shifts
Postdowntime Plan
Postdowntime Labor Pool
Postdowntime Operations
Termination of Failure Plan
Labor Pool
Definition
Laboratory Contributions to Labor Pool
Training
Drills
5 Laboratory Information Services Communication

Communication to LIS
Communication From LIS
Types of Failures/Impact
Misys (Sunquest) Processors
Servers
Interfaces
MULHOS Connection
ROE Connections
Laboratory Instruments
Network Hardware
Automation
LIS Failure Plan Communication
LIS Start Up Protocol

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Volume 26 GP2-A5
Appendix P. (Continued)
LIS and Automation Downtime Manual (Continued)
Section
6 LIS Scheduled Downtime Preparation Checklists

Laboratory Information Support Team (LIST)
Laboratory Information Services (LIS)
Manual Laboratory
Automated Laboratory
Clinical Microbiology
Client Services/Distribution/Reference Laboratory
Central Processing Area
Phlebotomy Transport Services
7 Downtime Operational Plan

Full Impact Downtime Plan
Short Downtime
Specimen Collection
Accessioning
Processing
Resulting
Reporting
Long/Extended Downtime
Sample Collection
Accessioning
Processing
Test Areas
Testing Areas
Resulting
Reporting
Moderate Impact Downtime Plan
Sample Collection
Accessioning
Processing
Testing Areas
Resulting
Reporting
8 Automation Downtime Plan

POSD Alpha
Preanalytics
Analytics
PSD Beta
DIU
Total System Managers (TSM)

ClinicalWannamaker
Number 12 GP2-A5
Section
9 Miscellaneous Information
Appendix A: LIS Failure Plan Manager and Supervisor On-Call Schedule

Assignment numbers, Names and Home Phone Numbers
Weekly On-Call Assignments
Calling Procedure
Appendix B: Labor Pool Sign-In Sheet

First Shift Regular Weekday
All Other Shifts
Appendix C: LIS Failure Plan

Documentation and Checklist
First Shift Regular Weekday Checklist
All Other Shifts Checklist
Appendix D: Volunteer and Standby List

Volunteer List
Standby List
Appendix E: Employee Phone List

Manual Laboratory
Clinical Microbiology
Automated Laboratory
Central Processing
Send-Outs
Problem Resolution
Phlebotomy and Transport Services (PTS)
Appendix F: LIS Downtime Training

Checklist
Appendix G: LIS Failure Flowcharts

First Shift Regular Weekday Flowchart
All Other Shifts Flowchart
Postdowntime Flowchart
10 Laboratory Areas Specific Downtime Procedures
Appendix H: Phlebotomy & Transport Services (PTS)

Inpatient Downtime Procedures
Communication of Downtime
HIS Downtime
LIS Downtime

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Volume 26 GP2-A5
Section
10 Appendix H: Phlebotomy and Transport Services (PTS) (Continued)

Outpatient Downtime
Interface Downtime
HIS Downtime
LIS Downtime
All Systems Down
Printers Down
Appendix I: Central Processing Area (CPA)

Scheduled
Unscheduled
Operations
Short Downtime
Extended CID Downtime
Downtime Labels
Off-Campus Specimens
Labor Pool
Startup after a Downtime
Additional Startup
Appendix J: Automated Laboratory

Scheduled
Unscheduled
Operations
Acute Care Laboratory
Deployment of Labor Pool
Appendix K: Manual Laboratory

Online Instruments
Manually Entered Tests
Appendix L: Transfusion Medicine

Principle
Patient Inquiry and Testing
Component Preparation
Bank Area
Blood Bank Inventory

ClinicalWannamaker
Number 12 GP2-A5
Section
10 Appendix M: Clinical Microbiology

Labor Pool Selection
Labeling and Specimen Processing
Result Inquiries
Startup
Microbiology Audit Trail
Bench Work
Postdowntime
Appendix N: Reference Laboratory

Principle
Procedure
Appendix O: Client Services

Client Notification
Client Notification List
Appendix P: Accessing LIS Laboratory Results Inquiry
This example was contributed by the Department of Clinical Pathology of the Division of Pathology and
Laboratory Medicine at the Cleveland Clinic Foundation, Cleveland, Ohio.

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Volume 26 GP2-A5

ClinicalWannamaker
Number 12 GP2-A5
Appendix Q1. Document Creation, Review, and Approval Process Flowchart

Document Creation, Review, and Approval Process
Need for new or changed

documents is identified
No Yes
New document?
- policy
Copy of current New document - process
Version is retrieved type is identified - procedure
- form
Document is Document is
edited drafted
Independent review/
verification is performed
Are
No Yes
Adjustments
needed
Review signatures
Documents
are obtained
are edited
Checklist review
is completed
No Is Yes
training needed?
Staff notification Training

is made Process
Master-File
Maintenance
Process
This example was contributed by St. Joseph Mercy Hospital Blood Bank, Ann Arbor, Michigan.

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Volume 26 GP2-A5
Appendix Q2. Document Creation, Review, and Approval Process Table

Document Creation, Review, and Approval Process
What Happens Whos Procedures

Responsible
Need for new document is anyone Selecting the Correct Document Type
identified Selecting the Correct Document Format
New/Changed Document Request Form
OR anyone Retrieving Current Document Version for
Need for changed Editing
document is identified New/Changed Document Request Form
New document is drafted assigned or Writing Policy, Process, and Procedure
volunteer Documents
OR author Designing Form Documents
Current version is edited supervisor Editing Documents in Microsoft Word
2000
Independent review and assigned staff Reviewing and Verifying New or Changed
verification is performed reviewer Documents
Review signatures are supervisor New/Changed Document Request Form
obtained medical
director
quality function
(where
applicable)
Checklist review is supervisor New/Changed Document Request Form
completed
Staff notification is made supervisor Notifying Staff of Document Changes

ClinicalWannamaker
Number 12 GP2-A5
Appendix R. Sample Document Change Request Form

QSE: Documents and Records Effective Date: mm/dd/yy
Change #:_________________
Document Change Request Form
Document Name:
Document Number: Requestor:
Version Number Date:
Check one: New Document Changed Document
Description of Document:
Rationale for new or changed document:
Are any related documents affected? ______Yes ______No

If yes, list here. Also, prepare additional Document Change Request Forms, if needed.
Is process validation affected? ______Yes ______No

Why or why not?
Signature Approval
Signature Date
Document Author
Supervisor
Director
Issue Date for Training
Effective Date for Use
Annual Review
Designee Signature Date
Anytown Hospital Laboratory, Anytown, USA 12345


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Volume 26 GP2-A5
Appendix S. Ten Rules for Document Control

# RULE NOTE
1 Read, acknowledge, and put into practice Frequently check your LIS mailbox or
the contents of all documents assigned to Laboratory Memos for a listing of new expired
you in a timely manner. documents
2 Go to the process and procedure documents Asking a coworker to recall a detail may lead
first when you are unsure of a step or to error. If the document does not have the
direction or need more information. information you need, notify your supervisor
or team leader.
3 Notify your supervisor or team leader if Do not use old versions of documents, forms,
more than one version of a document is labels, or tags that have been replaced by a
found in a work area. more current version or keep them in the work
areas. Remove and give these to your
supervisor or team leader.
4 Keep controlled copies of documents (ones A distribution list for each document indicates
with controlled copy numbers on the page) where it should be. Do not move documents
in the bench manuals where they have been unless a supervisor or team leader is involved.
placed.
5 Notify your immediate supervisor or team Critical changes that affect the comprehension
leader when a change to a document is of any type of document or performance of a
required. procedure will be made immediately. Typos
that do not affect comprehension or
performance may be held until the next
version is released.
6 Do not write on controlled copies of See above
documents.
7 Do not white out on controlled copies of See above
documents.
8 Do not photocopy controlled copies of Photocopies are no longer controlled. If a copy
documents. is required for rewriting purposes, an
uncontrolled copy may be requested from the
document control coordinator or reprinted
from the document control system.
9 Do not print uncontrolled copies of Uncontrolled copies are meant to be transient

documents for prolonged use at the or temporary in nature, hence the warning in
workstation. the document footer.
10 Do not release documents outside the Do not share copies of approved documents
Laboratory Department without approval with other laboratories without director
of the Administrative Director or Medical approval.
Director.
This example was contributed by the Department of Laboratory Medicine and Pathology of the University of
Alberta Medical Center, Edmonton, Alberta, Canada.

ClinicalWannamaker
Number 12 GP2-A5
Clinical and Laboratory Standards Institute consensus procedures include an appeals process that
is described in detail in Section 8 of the Administrative Procedures. For further information,
contact CLSI or visit our website at www.clsi.org.
Summary of Delegate Comments and Working Group Responses

GP2-A5: Laboratory Documents: Development and Control; Approved GuidelineFifth Edition
General
1. I particularly noticed that GP2-A5 references ISO 15189, and so believe that it needs to follow its standards more closely.
ISO 17025, as the basis for all testing laboratories, is very similar (though not identical) and GP2-A5 should encompass it,
as well.
Concepts from ISO 15189 have been included in GP2-A5. Because ISO 15189 is based on ISO 17025, those concepts
are included, as well. ISO 17025 has been added as a reference.
2. I can see that you may have a great deal of resistance to your suggestion to (once again) completely rewrite the Procedures
manual. This is a lengthy and often painful process, and is not a favorite of any manager or supervisor that I have ever
known. At the same time, so much of it makes such perfect sense, that once the manuals are rewritten and documented, they
will be so much easier to use at the bench level, and much more easily modified at the management level.
Are you planning on having (or suggesting) a time frame for implementing these admittedly terrific suggestions? I dont
know the process between CLSI suggesting guidelines like this one, and CAP and other regulatory agencies demanding their
implementation, but I would suggest at least a few years.
Many of the charts, flowcharts, and procedures in tabular form have some pretty fancy formatting. Im no slouch at Word,
Excel, Powerpoint, etc., but I would have no idea how to set up some of these documents. Im sure you have the master
copies in some sort of format. Would you plan to make these available to laboratories worldwide? If you were to have a CD
burned with the blank formats, so that the laboratories could just modify the contents with a click of a mouse, this would
make the transition from the old procedures manual form to the new much easier. If you have Microsoft Publisher, this is
what I have in mind.
Because this is a guideline and not a standard, following the recommendations for flowcharting and formatting are
optional to all laboratorieslaboratories can choose how to document the required information as they see fit.
However, when this guideline says, The laboratory needs to have instructions for, laboratories must have a
written document because this statement stems directly from a regulatory or accreditation requirement. The
formatting of the documents still remains optional to each laboratory. This CLSI guideline is only recommending
formats that are based on research and actual best practice. It is unlikely that CAP and CMS will demand the
formatting of flowcharts and procedures, but, as mentioned above, they do already have requirements for the
presence of the documents this guideline describes as needs to have.
To get started in this transition, the working group recommends that the laboratory start with one processperhaps
the sample collection process, or the next new test, or changes to an existing testing platform. After one complete
process has been converted, it can serve as a model for other laboratory processes and then more processes can be
converted. Yes, it may take some time to do this; however, regulatory and accrediting organizations understand that
the laboratory is always preparing and changing documents and as long as the required documentation is present
and complete, there are no deficiencies for format.
CLSI already has a product offering called the GP2 Toolkit, which was introduced with the GP2-A4 guideline in
2002. This toolkit contains templates in MS Word for both flowcharting and procedures, as shown in the guideline. A
new toolkit will be released with GP2-A5 in 2006.
Foreword
3. I recommend incorporating the following text into the fourth paragraph of the Foreword: specifically ISO 9001, ISO
17025, and ISO 15189. Therefore, the text would read: GP2-A5 is a guideline for how to implement requirements that
have been established by regulatory and accrediting organizations for laboratory documents and procedures manuals. GP2-
A5 is not a standard; that is, this guideline does not set requirements for laboratory documents and procedures. Instead, this

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Volume 26 GP2-A5
guideline describes what laboratories need to do to meet published regulations and accreditation requirements, specifically
ISO 9001, ISO 17025, and ISO 15189.
A modified version of this recommendation has been incorporated into the Foreword; however, the working group
chose not to include ISO 9001 because the vast majority of medical laboratories will not be seeking ISO 9001
certification. Laboratories that seek ISO 9001 certification will need to follow that specific standard, as well.
Section 1, Scope
4. I recommend modifying the second paragraph to read as follows: Also, this edition of GP2 provides useful information
about preparing, approving, maintaining, reviewing, changing, and archiving laboratory documents.
This editorial change has been incorporated in the text.
Section 2, Introduction
5. The recommendations provided in the second paragraph break procedures up too much. It is more effective to simply define
who does which part or have several subprocedures in one document.
Combining several subprocedures into one document results in a text version of a process document, which is what
this guideline is trying to caution against because they become too long and hard to follow. However, users can
choose to combine documents if they wish.
Section 3, Definitions
6. I recommend modifying the definition for form as follows: form a paper or electronic document on which the results
from the performance of a procedure or other information are captured, and becomes a record.
7. Sample replaces the term specimen. Why? To me, specimen is more specific.
As described in the Note on Terminology that appears after the Foreword, the use of sample instead of
specimen is to ensure consistency with international terminology.
Section 4, Path of Workflow
8. The laboratory uses resources such as people, machines, methods Maybe its just me, but I prefer the word instrument
to machine. To me, an instrument implies something to use for precision measuring, whereas a machine is just a machine.
This editorial change was made to Section 4, line 2.
Section 5.1, Key Work Processes (and many times in the document), Appendixes
9. Many years ago, I learned that the proper way to spell this word was appendices. I looked it up, and apparently, both ways
are acceptable, but as we are scientists, and are using many Greek- and Roman-based words on a regular basis, we should
use the most grammatically correct word. My vote would be for appendices, for what its worth.
CLSI editorial policy requires the use of the word Appendixes.
Section 6, Procedure How to Do It
10. We have tried to implement the recommendations in Section 6 and found it extremely cumbersome. We have now written
procedures that describe the whole process (where reasonable). This provides better flow and better training.
Procedures that describe the whole process are process documents. This guideline does not prevent users from
creating written process documents.
11. These are great!
These examples were contributed by real laboratories that have realized the benefits of following the
recommendations provided in this guideline.

ClinicalWannamaker
Number 12 GP2-A5
Section 7, Elements Common to Process and Procedure Documents
12. Other industries use policy/procedure with a flowchart (diagram) on page one of the procedure. Some processes are so
complex that they do stand alone, but this is often not the case.
Many industries use the word procedure to mean process. In this guideline, the working group has separated the
concepts of sequential activities (process) from step-wise instructions (procedure) and encourages the use of separate
documents. This guideline does not prevent users from creating written process documents.
Section 7.1, Title
13. Explain that in the examples, ing replaces the word procedure.
Section 7.5, Related Documents
14. Tables that provide information or instruction only are Related Documents. Forms that gather information are records, and
therefore, are appendixes or attachments.
This section only relates to other procedures referred to in this procedure, not to tables or forms. Tables and forms
are appendixes (or attachments).
Section 7.7, Appendixes or Attachments
15. This should be Appendices (the correct plural of appendix). Check for the need to replace elsewhere in the document.
CLSI editorial policy requires the use of the term Appendixes.
16. Title the section appropriately, i.e., Appendixes or Attachments.
Section 7.8, Author
17. This section recommends that the author(s) of the document needs to be noted. Why? Work area must be noted, not
necessarily the name of the person.
This statement has been modified, as no requirement for authors name could be found.
Section 8.1, Benefits of Process Documents
18. Section 8.1 states: Although there is no governmental or accreditation requirement for the laboratory to document its work
operations processes, doing so provides the following valuable benefits This is wrong. Refer to ISO 9001, Clause 4.1 (a),
(b), etc.
The working group chose not to include ISO 9001 requirements in this guideline because accreditation and
regulatory requirements do not require it and the vast majority of medical laboratories will not be seeking ISO 9001
certification. Laboratories that seek ISO 9001 certification will have to document their work processes.
19. Table 1. I recommend including the following bullet at the end of the list under the heading of Preexamination Processes:
sending sample to another laboratory (e.g., reference laboratory).
Sending samples to another laboratory is included in Sample Processing. See Section 9.1, fourth bullet.
Section 8.2, Suggested Template for Process Documents
20. For better continuity, I recommend changing Supporting Documents to Related Documents in the last paragraph.
Procedures (instructions) support process documents. Related Documents are other procedures referred to within a
given procedure. Therefore, within these definitions, Supporting Documents and Related Documents are not the
same.

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Volume 26 GP2-A5
Section 9.1, Preexamination Procedures
21. Add the following bullet to the beginning of the list of bullet items: patient identification.
Patient identification at the time of sample collection is already included in the second bullet.
22. Modify the fourth bullet to read: criteria for unacceptable samples and follow-up action.
Section 9.1.1, Patient Preparation
23. Add a new Section 9.1.1 on Patient Identification followed by two bullets as follows: minimum two identifiers and
follow local Health Act. Then, renumber subsections accordingly.
This information was added to Section 9.1, second bullet on sample collection and labeling.
Section 9.1.2, Sample Collection and Labeling
24. This section needs expansion. See ISO 15189, Clause 5.4.3.
The items in ISO 15189 Section 5.4.3 have been edited into their respective sections (in Section 9.1.2) as suggested.
Section 9.1.3, Required Equipment and Forms
25. I recommend modifying the first sentence to read: about the required equipment used and forms and use of forms
needed for the procedure. Also include text on completion of required information; see ISO 17025, Clause 5.7.2
(deviations, additions or exclusions); Clause 5.7.3 (all relevant data); and, Clause 5.8.3 (record all discussions).
26. ISO 17025 clauses 5.7.2, 5.7.3, and 5.8.3 are about client-requested deviations and samples that do not meet requirements.
Instructions for how to handle these deviations need inclusion in procedures for sample receiving and processing and have
been added to the appropriate parts of Section 9.1.
Add a new second bullet that reads as follows: sample identification (two identifiers) must match requisition.
This information was added to the second bullet of Section 9.1.
Section 9.1.6, Sample Storage Requirements
27. Add a new second bullet that reads, security. See ISO 17025, Clause 5.8.4 (held secure).
This information was added to the first bullet of Section 9.1.6.
Section 9.1.7, Problems or Pitfalls
28. I recommend modifying the section title to read: Criteria for Unacceptable Samples and Follow-up.
Section 9.1.7 covers more than just unacceptable samples.
Section 9.2.1.3, Supplies
29. A separate written procedure is needed for ensuring that supplies, reagents, and consumable materials that affect the quality
of the test are not used until inspected or verified that they comply with specifications. See ISO 17025, Clause 4.6.2; see
also ISO 15189, Clause 5.3 (includes consumables and reagents); Clause 5.3.2 (shall comply with specifications relevant
to the examinations concerned); and Clause 4.6.2 (suppliesshall not be used until they have been verified).
A sentence has been added about having a separate written procedure for supplies.

ClinicalWannamaker
Number 12 GP2-A5
Section 9.2.1.4, Equipment Calibration and Maintenance
30. Under Calibration: Include a new bullet for services. ISO 17025, Clauses 4.6.1 and 4.6.2: qualifications required to
perform calibrations, e.g., ISO 17025 accredited calibrating laboratory or employee passed competence testing. See also ISO
15189, Clause 4.6.4.
Section 9.2.1.4 is about written instructions for laboratory personnel to perform calibrations. The information in the
ISO 17025 and ISO 15189 sections quoted is about qualifying suppliers of calibration services, which does not take
place at the time of examination and therefore, does not apply to this section.
31. Under Maintenance: Delete and storage requirements for maintenance records from the last bullet. This information
falls under Documents and Records, not equipment procedures.
Section 9.2.1.6, Quality Control (QC)
32. Second paragraph on proficiency testing: For laboratories subject to CLIA88, penalties for not following the CLIA
regulations on handling PT specimens and results can be severe. Thus I recommend that 1) the statement that PT samples
are handled as regular patient specimens *be deleted, because this is not true in all instances; and 2) that a statement be
added such as, Laboratories need to be certain that PT samples are handled in accordance with applicable government
regulations. (*In certain situations, patient specimens may be referred for analysis/consultation to a laboratory with a
different CLIA number. CLIA88 forbids this practice for PT samples.)
The statement has been modified as appropriate to the comment.
Section 9.2.1.7, Instructions for Performing the Examination Method
33. The second paragraph states: When procedure instructions taken from manufacturers literature are altered or deleted, the
examination method performance may change and, therefore, appropriate verification that the changed method provides the
expected results needs to be performed and documented. Note: Test method validations need to be performed and
documented for all methods.
The section has been modified to reflect this comment.
Section 9.2.1.8, Method Performance Specifications
34. This section actually is partially addressing method performance specifications (which include method limitations). I
suggest renaming this section Method Performance Specifications and revising as follows: The examination procedure
needs to include information about performance characteristics of the examination method. When applicable, this section
needs to include the following:
analytic sensitivity (lower limit of detection, biologic limit of detection);

analytic specificity (including effect of interfering substances, such as chemicals [preservatives], drugs, cold
agglutinins);
reportable range;
appropriate dilution and concentration protocols, or reporting procedures if the reportable range is exceeded;
analytic accuracy (bias); and
analytic precision.
35. If not already present in the References section of the guideline, I suggest adding as a reference for this section, Basic
Method Validation by James O. Westgard, 2nd edition, Westgard QC Inc., 2003.
This reference was added.
Section 9.2.1.11, Interpretation of Results
36. Delete and follow-up from the last bullet. Also delete the cross-reference to Section 9.3 (follow-up is in Section 9.3).

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Volume 26 GP2-A5
Section 9.2.2, Procedures for Automated Instruments and Manufacturers Operators Manuals
37. Include the following text as the last sentence of the fourth paragraph: Test method validation needs to be performed and
documented.
The concept was edited into the existing text.
Section 9.3.2, Entry of Results Into the Laboratory Reporting System
38. This section needs to include test report content control (see ISO 17025 and ISO 15189). Also needs to include audit trail.
Information about test report content control and audit trail is needed at the time of designing the reporting
processnot at the time workers are entering results into the reporting system. Report content and auditing is
covered in CLSI/NCCLS GP26Application of a Quality Management System Model for Laboratory Services.
Section 9.3.4, Archiving Results
39. Postexamination procedures for archiving results should address identification, collection, indexing, and disposal (see ISO
17025, Clause 4.12.1.1).
Section 9.3.4 has been modified as appropriate.
Section 9.3.5, Sample Retention
40. Postexamination procedures for sample retention should address identification, collection, indexing, and disposal.
Section 9.3.5 has been modified as appropriate.
Section 10, Form Documents
41. Include a new fourth bullet authorization.
Forms are authorized as part of the process for design and development of a given process or procedure document.
Approval signatures are captured at the time of document approval.
42. The last sentence in the second paragraph should read: These examples can be placed in the Appendixes (or Attachments)
section of their respective procedures.
Section 11, Procedures Manuals
43. Ive always heard them called in the singular Procedures manuals. Any reason for the change? Or is it a typo?
Each manual has more than one procedure, so it is more grammatically correct to say procedures manuals.
44. The paragraph under the bullets, and relating to the forms alluded to in the Appendixes: I like this good idea. Thanks for
the suggestions. Would be much more user-friendly for the bench tech, and would help management give a stronger this is
how we want it to be done approach, versus the teaching Tech teaching the newbie how he/she has done it for years.
These examples were contributed by real laboratories that have realized the benefits of following the
recommendations provided in this guideline.
Section 12.2, Master File
45. Modify the first sentence to read: Each document needs to have a master file
A master file is not required; its only a recommendation for keeping better control of the history of each document.
Section 12.4, Review and Approval of Changes to Approved Documents
46. I recommend modifying text in the third paragraph as follows: When changes to a particular procedure document are made,
the laboratory service needs to also determine what other documents will be affected by the change. This is facilitated by
review of the appropriate process flowchart or table or Related Documents and Attachments.

ClinicalWannamaker
Number 12 GP2-A5
There is no requirement to determine what other documents may change, only a recommendation that this is a good
practice.
47. Regarding Appendix R: This is an excellent way of allowing all of the staff to have input into the procedures and processes.
Additionally, it allows management to have a better idea as to what is really happening at the bench level, and to better
control the documents pertaining thereto. Additionally, it allows everyone involved in the process to follow the process, as it
proceeds.
This example was contributed by a laboratory that realized the benefits of following the recommendations provided
in this guideline.
Section 12.6, Periodic Review of Unchanged Documents
48. Modify the first sentence as follows: When documents are managed using a document control process, such as that
described in this section, periodic review is necessary. See ISO 17025, Clause 4.3.2.2 b (i.e., documents are periodically
reviewed) and ISO 15189, Clause 4.3.2 d.
Section 12.7, Master Index
49. Modify the second paragraph, second sentence as follows: In addition, the master index needs to include a version number
and the locations of each working copy of the document. See ISO 17025, Clause 4.3.2.1 (master list identifying
current revision status and distribution shall be established) and ISO 15189, Clause 4.3.2 b (similar).
Section 12.9, Archiving, Storage, and Retention of Documents
50. Modify the first paragraph, last sentence as follows: A notation or stamp indicating the retirement date is needed to identify
the document See ISO 17025, Clause 4.3.2.2 d and ISO 15189, Clause 4.3.2 f.
51. Modify the second paragraph, last sentence as follows: The laboratory must have documented processes Archived
documents are actually records and so must follow ISO 17025, Clause 4.12 and ISO 15189, Clause 4.13.
References
52. Include ISO 17025 in the reference list.
53. Why the small font?
CLSI style dictates formatting requirements.
Appendixes - Flowcharts
54. In the flowcharts, in many cases it would be appropriate to add additional step(s) for confirmation of the identity of the
sample before testing or reporting the result. For example, in Appendix E1, the box slides are read and surgeon notified by
pathologist can be broken down into slides are read, then pathologist confirms patient identification with surgeon, and
then pathologist communicates frozen section diagnosis to surgeon. Confirmation of specimen identification may be
appropriate for the transfusion medicine process chart and flow chart, in particular.
Confirmation of the identity of the sample is a step in the testing or reporting procedure (e.g., Step 2. Verify the
identity of the sample before proceeding). The laboratory does not have to have a separate set of instructions for
how to verify the identity of a sample, but it could if it wishes.

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Volume 26 GP2-A5
Appendix A2, Inpatient Blood Sample Collection Process Table
55. Insert phlebotomist in the Whos Responsible boxes for the following What Happens categories:
Collection list or labels are generated

Patient is identified
Blood samples are collected
Blood samples are labeled
Samples are transported to the laboratory
In certain states, phlebotomists must be licensed or certified, and I think the title should be recognized in this process table
to make it more universal.
Thank you for this observation. The word phlebotomist was inadvertently omitted from the entire Whos
Responsible column. This editorial change has been incorporated in the text.
Appendix B1, Analyzer Examination Process Flowchart
56. Add a box between the Results are evaluated and Results are verified in the LIS that says Critical Values are called,
similar to the flowchart in Appendix C1.
Appendix B2, Analyzer Examination Process Table
57. Similar to the above comment, add a box between the Results are evaluated and Results are verified in the LIS that says
Critical Values are called, similar to the chart in Appendix C2.
Appendix C2, Bacteriology Culture Process Table
58. Example. Technicians are included in reading and interpreting cultures. In Canada, this can only be done by technologists.
This is simply an example that can be adjusted as appropriate in your setting. In the Whos Responsible column,
your laboratory would list only those personnel who are qualified to perform that activity based on national,
regional, or local requirements.
Appendix D2, Transfusion Medicine Prenatal Examination Process Table
59. Example: Technicians are included in performing type and screen. In Canada, this can only be done by technologists. Are
these necessary to be included in the example or can the technician be left off to make this a more international standard?
See response to comment 58.
Appendix M2, Attributes for Multiple Analytes on the XYZ Analyzer
60. Pages 53, 54, 55: the Watermark stating these are examples is missing.
Watermarks have been superimposed on all examples as recommended.
Appendix N, Sample Table of Contents for a Preexamination Procedures Manual
61. Appendix N chart: Patient Refusal of Testing Form has an X in Resource. Should this not be a form? Verifying Correct
Patient Information in IDX has an X in both a procedure and resource. Is it possible to be both?
These editorial changes have been made.
Appendix P, Sample Table of Contents for a Computer Downtime Manual
62. LIS and Automated Downtime, Section 7: Add Testing Areas under Downtime Operational Plan/Full Impact Downtime
Plan/Short Downtime. Change Testing to Testing Areas under the same paragraph, Moderate Impact Downtime
Plan.
These editorial changes have been incorporated in the text.

ClinicalWannamaker
Number 12 GP2-A5
The Quality 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 the
most current edition of CLSI/NCCLS document HS1A 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 healthcare services path of workflow (i.e., 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 managers guide. The quality system essentials (QSEs) are:
Documents & Records Equipment Information Management Process Improvement

Organization Purchasing & Inventory Occurrence Management Service & Satisfaction
Personnel Process Control Assessment Facilities & Safety
GP2-A5 addresses the quality system essentials (QSEs) indicated by an X. For a description of the other
documents listed in the grid, please refer to the Related CLSI/NCCLS Publications section on the following page.
Purchasing &
Improvement
Organization
Management
Management
Information
Satisfaction
Assessment
Facilities &
Occurrence
Documents
Equipment
& Records
Service &
Personnel
Inventory
Control
Process
Process
Safety
X GP26 GP21 GP26 GP26 GP26 X GP26 GP26 GP26 GP26 GP17
GP26 HS1 GP26 HS1 HS1 HS1 GP26 HS1 HS1 HS1 HS1 GP26
HS1 HS1 M29 HS1 HS1
M29
Adapted from CLSI/NCCLS document HS1A Quality Management System Model for Health Care.

80
Volume 26 GP2-A5
Related CLSI/NCCLS Publications*

GP17-A2 Clinical Laboratory Safety; Approved GuidelineSecond Edition (2004). This document contains general
recommendations for implementing a high-quality laboratory safety program, which are provided in a
framework that is adaptable within any laboratory.
GP21-A2 Training and Competence Assessment; Approved GuidelineSecond Edition (2004). This document
provides background information and recommended processes for the development of training and
competence assessment programs that meet quality/regulatory objectives.
GP26-A3 Application of a Quality Management System Model for Laboratory Services; Approved Guideline
Third Edition (2004). This guideline describes the clinical laboratorys path of workflow and provides
information for laboratory operations that will assist the laboratory in improving its processes and meeting
government and accreditation requirements.
HS1-A2 A Quality Management System Model for Health Care; Approved GuidelineSecond Edition (2004).
This document provides a model for providers of healthcare services that will assist with implementation and
maintenance of effective quality management systems.
M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline
Third Edition (2005). Based on U.S. regulations, this document provides guidance on the risk of transmission
of infectious agents by aerosols, droplets, blood, and body substances in 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.
*
Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process;
therefore, readers should refer to the most current editions.

ClinicalWannamaker
Number 12 GP2-A5
NOTES

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Volume 26 GP2-A5
NOTES

ClinicalWannamaker
Number 12 GP2-A5
NOTES

84
Volume 26 GP2-A5
NOTES

ClinicalWannamaker
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OFFICERS BOARD OF DIRECTORS
Thomas L. Hearn, PhD, Susan Blonshine, RRT, RPFT, FAARC J. Stephen Kroger, MD, MACP
President TechEd COLA
Centers for Disease Control and Prevention
Maria Carballo Jeannie Miller, RN, MPH
Robert L. Habig, PhD, Health Canada Centers for Medicare & Medicaid Services
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Immediate Past President
CHRISTUS Health
Glen Fine, MS, MBA,

Executive Vice President



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Licensed to: Cameron Wannamaker

Reproduced with permission, from CLSI publication GP2-A5Laboratory Documents:

Copyright 2006. Clinical and Laboratory Standards Institute.

Proposed Guideline Approved GuidelineThird Edition

Tentative Guideline Approved GuidelineFourth Edition

Approved Guideline Approved GuidelineFifth Edition

Approved GuidelineSecond Edition

Area Committee on General Laboratory Practices

Working Group on Technical Procedure Manuals

Licensed to: Cameron Wannamaker iii

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

7 Elements Common to Process and Procedure Documents ........................................................4

11 Procedures Manuals .................................................................................................................20

12 Document Management ...........................................................................................................20

Appendix A1. Inpatient Blood Sample Collection Process Flowchart ................................................26

Appendix A2. Inpatient Blood Sample Collection Process Table .......................................................27

Appendix B1. Analyzer Examination Process Flowchart....................................................................28

Appendix B2. Analyzer Examination Process Table...........................................................................29

Appendix C1. Bacteriology Culture Process Flowchart ......................................................................30

Appendix C2. Bacteriology Culture Process Table ..............................................................................31

Appendix D1. Transfusion Medicine Prenatal Examination Process Flowchart ..................................32

Appendix D2. Transfusion Medicine Prenatal Examination Process Table ........................................33

Appendix E1. Surgical Pathology Sample Process Flowchart..............................................................34

Appendix E2. Surgical Pathology Sample Process Table.....................................................................35

Appendix F. Sample Preexamination Procedure ..................................................................................36

Appendix G. Sample Analyzer Procedure ............................................................................................38

Appendix H. Sample Microbiology Procedure.....................................................................................42

Appendix I. Sample Transfusion Service Procedure ............................................................................46

Appendix J. Sample Histology Procedure ............................................................................................48

Appendix K. Sample Computer Procedure...........................................................................................50

Appendix L. Suggested Contents of Laboratory Procedures ...............................................................52

Appendix N. Sample Table of Contents for a Preexamination Procedures Manual .............................58

Appendix R. Sample Document Change Request Form.......................................................................70

Appendix S. Ten Rules for Document Control.....................................................................................71

Summary of Delegate Comments and Working Group Responses ......................................................72

The Quality System Approach..............................................................................................................80

Related CLSI/NCCLS Publications ......................................................................................................81

Licensed to: Cameron Wannamaker vii

This edition of GP2 has been renamed and reorganized to provide:

guidelines for writing procedures for laboratory information systems; and

Computer procedure, document, document management, electronic procedures, laboratory procedure,

Laboratory Documents: Development and Control;

write procedures for preexamination, examination, and postexamination laboratory activities.

GP2-A5 is intended for use by the following:

administrative and technical personnel who develop laboratory documents;

Figure 1. Laboratory Path of Workflow. From CLSI/NCCLS document GP26Application of a Quality

4.1 Preexamination Processes

Preexamination Process Examination Process Postexamination Process

Test Ordering Sample Collection Sample Transport Sample Receipt/Processing

Figure 2. Laboratory Preexamination Key Processes. From CLSI/NCCLS document GP26Application of

4.2 Examination Processes

Preexamination Process Examination Process Postexamination Process

Examination Results Review and Follow-up Interpretation

Figure 3. Laboratory Examination Key Processes. From CLSI/NCCLS document GP26Application of a

4.3 Postexamination Processes

Figure 4. Laboratory Postexamination Key Processes. From CLSI/NCCLS document GP26Application

5 Process The Sequence of Laboratory Activities

5.1 Key Work Processes

5.2 Process as a Basis for Training and Competence Assessment

7 Elements Common to Process and Procedure Documents

Blood Sample Collection Process;