Professional Documents
Culture Documents
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VOLUNTEER PARTICIPATION
Volume 26 Number 12
GP2-A5
ISBN 1-56238-600-X
ISSN 0273-3099
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guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents.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
May 1980
December 1996
Tentative Guideline
June 1981
April 2002
Approved Guideline
February 1984
March 2006
ISBN 1-56238-600-X
ISSN 0273-3099
ii
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GP2-A5
Committee Membership
Area Committee on General Laboratory Practices
Sheila M. Woodcock, MBA,
FCSMLS(D)
Chairholder
QSE Consulting
Rose Bay, Nova Scotia, Canada
Albert Rabinovitch, MD, PhD
Vice-Chairholder
Abbott Hematology
Santa Clara, California
Eric Arendash, MT(ASCP)
Centers for Medicare & Medicaid
Services
Philadelphia, Pennsylvania
Lucia M. Berte, MA, MT(ASCP),
SBB, DLM; CQA(ASQ)CQMgr.
Quality Systems Consultant
Westminster, Colorado
iii
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GP2-A5
Volume 26
GP2-A5
Contents
Abstract ....................................................................................................................................................i
Committee Membership........................................................................................................................ iii
Foreword ................................................................................................................................................ix
1
Scope..........................................................................................................................................1
Introduction................................................................................................................................1
Definitions .................................................................................................................................1
Path of Workflow.......................................................................................................................2
4.1
4.2
4.3
Preexamination Processes.............................................................................................2
Examination Processes .................................................................................................3
Postexamination Processes ...........................................................................................3
Title...............................................................................................................................4
Purpose or Principle......................................................................................................5
Process Flowchart or Table...........................................................................................5
Procedure Instructions ..................................................................................................5
Related Documents .......................................................................................................5
References.....................................................................................................................5
Appendixes or Attachments..........................................................................................6
Author ...........................................................................................................................6
Approval Signatures .....................................................................................................6
Benefits of Process Documents ....................................................................................6
Suggested Template for Process Documents ................................................................7
Preexamination Procedures...........................................................................................7
Examination Procedures .............................................................................................11
Postexamination Procedures .......................................................................................17
10
Form Documents......................................................................................................................19
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Contents (Continued)
12.4
12.5
12.6
12.7
12.8
12.9
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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GP2-A5
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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;
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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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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Scope
identify laboratory procedures using work processes in the laboratorys operational path of workflow;
and
Also, this edition of GP2 provides useful information about preparing, approving, maintaining, reviewing,
changing, and archiving laboratory documents.
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:
manufacturers; and
educators.
Definitions
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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.
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.
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
Test Ordering
Sample Collection
Examination Process
Sample Transport
Postexamination Process
Sample Receipt/Processing
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4.2
GP2-A5
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
Examination
Postexamination Process
Interpretation
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.
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5
5.1
GP2-A5
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
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.
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.
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:
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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
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:
text books;
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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
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
8.1
Process Documents
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
Examination
Examination Ordering
Automated instrument
Sample Collection and
systems
Labeling
Manual qualitative and
Blood samples
quantitative testing
Nonblood samples
Anatomic pathology
Sample Transport
Cytopathology
Sample Receipt and
Results
Review and FollowAccessioning
up
Preexamination Sample
Medical Review
Processing
8.2
Postexamination Processes
Results Reporting
Results Archiving
Sample Archiving
Blood samples
Tissues
Blocks, slides, etc.
Charging for examinations,
where applicable
A simple template for process documents can be created to include the following sections:
Title;
Purpose;
Process Flowchart or Table; and
Supporting Documents
9
9.1
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:
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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
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.
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;
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:
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9.1.2
GP2-A5
Where applicable, preexamination sample collection procedures need to include information about sample
collection techniques that are:
age-specific;
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 handling between the time of collection and time received by laboratory personnel (e.g.,
refrigeration, warming, immediate delivery).
placement of label on the sample (e.g., on the container, not the lid; position of bar code, etc.).
9.1.3
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:
bar-code readers
sample collection devices and materials (e.g., blood collection tubes, culture media, swabs);
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9.1.4
GP2-A5
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
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);
9.1.6
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;
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:
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9.1.8
GP2-A5
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
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;
Supplies;
Quality control;
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;
9.2.1.2
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:
special safety requirements (e.g., general category or class of hazard; special handling instructions);
degree of accuracy, and any special handling instructions for measuring devices;
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9.2.1.3
GP2-A5
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
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 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);
step-by-step instructions for performing the calibration, including expected instrument readings;
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Maintenance:
troubleshooting guidelines.
9.2.1.5
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:
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
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:
Volume 26
GP2-A5
explanation of control criteria (e.g., criteria for accepting or rejecting QC results and examination
data);
Proficiency testing samples (also known as external quality assurance) often need different handling
and preparation than patient samples. Therefore, separate instructions are needed for:
9.2.1.7
The examination method should be reflected in the title of the procedure document. For example:
Antibody Screen by Gel Technique;
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
The examination procedure needs to include information about the performance characteristics of the
examination method. Where applicable, this section needs to include the following:
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reportable range;
appropriate dilution and concentration protocols or reporting instructions if the reporting range is
exceeded;
analytic precision.
Quantitative examination procedures need to include the equations for calculations when they are
applicable to the examination. The calculation section needs to include:
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:
comparison of the results to the expected values or diagnostic findings to determine if the result is
normal, abnormal, or indeterminate;
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GP2-A5
recognition of results that fall outside the reportable range, and reference back to the Method
Limitations section; and
9.2.2
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);
making decisions based on the values of controls and patient examination results; and
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:
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sample retention.
9.3.1
GP2-A5
Prioritizing Results
are normal;
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.
Include instructions for supervisory and/or medical review of examination results, where such review is
required.
9.3.2
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:
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.
Volume 26
9.3.3
GP2-A5
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:
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 paperbased 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
Volume 26
GP2-A5
Creative applications of the document identification system can be used to link documents to:
who is responsible for the review (e.g., laboratory director, supervisors, senior staff);
Document management software systems often provide for electronic capture and tracking of approval
signatures.
revising the document and any related documents that also need to be changed;
archiving the new version of the document in its respective master file;
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providing working copies of the approved, revised document to all appropriate personnel.
Volume 26
GP2-A5
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.
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.
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Number 12
GP2-A5
References
1
ISO. Medical laboratoriesParticular requirements for quality and competence. EN/ISO 15189. Geneva: International Organization for
Standardization; 2003.
ISO. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:1999. Geneva: International
organization for Standardization; 1999.
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.
Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Pathology and Laboratory
Services. Oakbrook Terrace, IL: JCAHO. Published annually.
College of American Pathologists. Laboratory Accreditation Checklists. Northfield, IL: College of American Pathologists. Available at:
www.cap.org.
American Association of Blood Banks. Standards for Blood Banks and Transfusion Services. 23rd ed. Bethesda, MD: AABB; 2005.
ISO. Quality management systemsFundamentals and vocabulary. ISO 9000. Geneva: International Organization for Standardization;
2000.
Westgard JO. Basic Method Validation. 2nd edition. Madison, WI: Westgard QC Inc.; 2003.
10
Volume 26
GP2-A5
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Number 12
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This example was contributed by the Client Services Workgroup, Sutter Health Sacramento-Sierra Region, Sacramento,
California.
Volume 26
GP2-A5
Whos Responsible
Collection lists or
labels are generated
laboratory assistant
phlebotomist
clerk
technician
technologist
patient care technician
phlebotomist
laboratory technician
laboratory technologist
nurse
other healthcare
professional trained in
blood collection
patient care technician
phlebotomist
laboratory technician
laboratory technologist
nurse
other healthcare
professional trained in
blood collection
patient care technician
phlebotomist
laboratory technician
laboratory technologist
nurse
other healthcare
professional trained in
blood collection
patient care technician
phlebotomist
laboratory technician
laboratory technologist
nurse
other healthcare
professional trained in
blood collection
Patient is identified
Samples are
transported to
laboratory
Procedures
Generating a Collection List for Rounds
Generating Collection Lists and Labels for
Priority Draws
Reprinting Labels
Identifying Patients for Sample Collection
Identifying Patients for Emergencies
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GP2-A5
Whos Responsible
Procedures
Sample acceptability is
evaluated
Analyzer examinationready procedures are
performed
technician, or
technologist
technician, or
technologist
technician, or
technologist
Troubleshooting
procedures are
performed
Results are evaluated
technician,
technologist, or
supervisor
technologist, or
supervisor
Alert/critical values
called
Results are verified in
LIS
Samples are unloaded
and stored
technologist
technologist
technologist, or
technician
This example was contributed by the Central Clinical Laboratory of the Mayo Clinic Department of Laboratory of Medicine and
Pathology, Rochester, Minnesota.
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Number 12
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Sample is received in
microbiology lab
Is further
work needed?
Yes
No
- catalase
- coagulase
- etc.
No
Is
further work
needed?
Yes
End
This example was contributed by the Microbiology Technical Working group, Sutter Health Laboratory Integration Project,
Sacramento, California.
Volume 26
GP2-A5
Whos Responsible
Sample is received in
Microbiology
laboratory assistant,
technician, or
technologist
Sample is processed
laboratory assistant,
technician, or
technologist
laboratory assistant,
technician, or
technologist
Culture is set up
technician, or
technologist
technician, or
technologist
Susceptibility is performed
technician, or
technologist
technician, or
technologist
technician, or
technologist
Procedures
Changing Microbiology Sample
Status to Received in the LIS
Storing Microbiology Samples
Before Processing/Examining
Evaluating Microbiology Sample
Acceptability
Centrifuging Samples
Grinding Samples
Media selection table
Incubating cultures table
Streaking Agar Plates
Inoculating Tube Media
Making Sample Smears
Postinoculation Microbiology
Sample Storage
Urine Cultures: Reading and
Interpreting
Enteric Cultures: Reading and
Interpreting
[Additional procedures for reading
and interpreting other cultures]
[Instrument procedures]
[Examination-specific procedures
such as catalase, gram stain, etc.]
[Instrument and examination-specific
procedures]
Calling Alert Values
Generating Microbiology Reports:
Preliminary and Final
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Sample is centrifuged
- manual
- computer
- ABO/Rh
Type and screen
is performed
No
Is antibody
screen positive?
-D
- Antibody screen by tube technique
- Antibody screen by gel technique
Yes
Antibody identification
is performed
- antiglobulin panel
- gel panel
- rule-out cells
End
No
Is antibody
clinically significant?
Yes
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,
Sacramento, California.
Volume 26
GP2-A5
Whos Responsible
technician
technologist
laboratory assistant
technician
technologist
laboratory assistant
technician
technician
technologist
technician
technologist
Antibody identification is
performed, when
necessary
technologist
technologist
laboratory assistant
Procedures
Evaluating Blood Bank Samples
Batching Blood Bank Samples for Future
Examinations
Generating a Pending Log From the LIS
Checking Blood Bank Patient History Files
ABO and Rh by Tube Method
Weak D (Du Examination)
Antibody Screen by Gel Technique
Antibody Screen by Tube Technique
Identifying Antibodies by the Antiglobulin
Panel
Identifying Antibodies by the Gel Technique
Using Rule-Out Cells in Antibody Identification
[Additional specific antibody identification
procedures]
Reporting Blood Bank Results in the LIS
Antibody Identification Report Form
Storing Blood Bank Samples
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Number 12
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- labeling
- requisition
No
Is frozen section or
pathology consult
requested?
Yes
No
Sample is grossed
Is frozen
section indicated?
Yes
Case is
accessioned
Tissue is embedded
Pathologist
Interpretation
and Reporting
process
This example was contributed by the Department of Pathology and Laboratory Medicine, Elmhurst Memorial Hospital, Elmhurst,
Illinois.
Volume 26
GP2-A5
Case is delivered to
pathologist
Whos
Responsible
circulating
nurse
surgery
transporter
gross room
assistant
resident
pathologist
pathologist
pathologist
pathologists
assistant
resident
Histology
technician or
technologist
Histology
technician or
technologist
Histology
technician or
technologist
Histology
technician or
technologist
Histology
technician or
technologist
Histology
technician or
technologist
Procedures
Labeling Surgical Pathology Samples
Preparing Surgical Pathology Requisitions
Delivering Surgical Samples to the
Laboratory
Accessioning Routine Surgical Samples
Accessioning Frozen Section/Intraoperative
Consult Samples
Preparing Frozen Section Blocks
Processing Frozen Section Blocks
Cutting Frozen Section Blocks
Staining Frozen Section Slides
Reporting Frozen Section Results to Surgeon
Preparing Frozen Section Report
[guidelines for grossing different sample
types]
Labeling and Reconciling Samples
Preserving Cassettes in Formalin
Readying the ABC Tissue Processor
Loading the ABC Tissue Processor
Unloading the ABC Tissue Processor
Embedding Tissues
Cutting Tissue and Making Slides
Loading ABC Slide Stainer
Coverslipping With the ABC Instrument
Coverslipping by Manual Technique
Assembling Folders for Pathologist Case
Reading
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Number 12
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Purpose
This procedure provides instructions for correctly identifying patients for sample
collection.
Supplies
Procedure A:
Inpatients
Action
Ask the patient to state his or her last name when able.
Verify that the patient is wearing an identification band.
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
Match the ID band to the requisition, collection list, or labels.
The patients name and medical record number are required.
Exceptions are not allowed.
Proceed with sample collection only when patient identification is
verified.
Page 1 of 2
Volume 26
GP2-A5
Appendix F. (Continued)
Identifying the Patient for Sample Collection
Document #/version #
Procedure B:
Outpatients
3
4
Action
Ask the patient to
spell his/her first and last names, and
give his/her date of birth.
Verify the spelling and date of birth against the
label, and
requisition.
Proceed with sample collection only when patient identification
is verified. If identification cannot be verified, proceed to step 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
Proceed with sample collection only when patient identification
is verified.
Related
Procedures
Appendixes
End
Anytown Hospital Laboratory, Anytown USA 12345
[filename and path]
Page 2 of 2
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Number 12
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Purpose
Use the table below to select the correct rack for loading samples.
Procedure A:
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
10-20
Step
1.
2.
Action
Prioritize samples to be loaded
1. ER
3. Priority
2. Priority 1
4. Routine
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
Continued on next page
Page 1 of 3
Volume 26
GP2-A5
Appendix G. (Continued)
Loading Samples for Examinations on Instrument X
Document #/version #
Procedure B:
Loading
Samples
(continued)
Step
3
Procedure C:
Starting
Instrument X
Operation
Action
Load samples such as body fluids into red racks.
Program the samples. See Procedure ID. XXX, Manually
Programming Samples, if needed.
Load rack onto tray.
Load remaining samples into the appropriate racks with bar code
facing the open slot.
Load racks onto trays.
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.
Step
1
Action
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.
Continued on next page
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39
Number 12
GP2-A5
Appendix G. (Continued)
Loading Samples for Examinations on Instrument X
Document #/version #
References
Related
Procedures
Appendixes
None
End
Page 3 of 3
This example was contributed by the Central Clinical Laboratory of the Mayo Clinic Department of Laboratory Medicine and
Pathology, Rochester, Minnesota.
Volume 26
GP2-A5
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Number 12
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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
no growth
growth of 1-3
organisms
growth of 4 or more
organisms
Then
reincubate an additional day, and
enter a preliminary report of No growth at 24
hours.
(See Procedure ID. XXX: Generating Reports:
Preliminary and Final)
follow instructions in Appendix 1: Urine Culture
Workup Guidelines,
follow instructions in Appendix 2: Definitive
Identification and Susceptibility Criteria, and
enter a preliminary report.
report as (facility-specific comment on mixed flora),
and
enter a final report.
(See Procedure ID. XXX: Generating Reports:
Preliminary and Final.)
(follow facility-specific requirements for reporting.)
References
Related
Documents
Appendixes
Volume 26
GP2-A5
Appendix H. (Continued)
Urine Cultures: Reading and Interpreting
Document #/version #
Sex
F
all ages
WBC
No
< 10
or
Species
Single
(pure
isolate)
Multiple
M
< 5 years
Count
< 50 K
> 50 K
Workup
Descriptive ID
Definitive ID
Sensitivity
No
Yes
< 50 K
50
100 K
Descriptive ID
Definitive ID
predominant < 2
Descriptive others
and mixed flora
Definitive ID
predominant < 3
Descriptive others
and mixed flora
Descriptive ID
Definitive ID
No
Yes
> 100 K
Yes
> 10
Single
(pure
isolate)
Multiple
<1K
>1K
< 10 K
10
50 K
> 50 K
M
> 5 years
Suprapubic
puncture
All
N/A
N/A
Single
(pure
isolate)
Multiple
All
Any
count
Descriptive ID
Definitive ID
predominant < 2
Descriptive others
and mixed flora
Definitive ID
predominant < 3
Descriptive others
and mixed flora
Descriptive ID
Definitive ID
Descriptive ID
Definitive ID
predominant < 3
Descriptive others
and mixed flora
Definitive ID
No
Yes
No
No
Yes
No
Yes
No
Yes
No
No
Yes
No
Yes
No
Yes
Reference
Anytown Hospital Laboratory, Anytown USA 12345
[filename and path]
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Page 2 of 3
43
Number 12
GP2-A5
Appendix H. (Continued)
Urine Cultures: Reading and Interpreting
Document #/version #
Staphylococcus
Description
(Presumptive/Definitive
Identification)
Staphylococcus aureus
Staphylococcus
coagulase-negative
Staphylococcus
saprophyticus
Streptococcus
Gram-positive rods
Gram-negative rods
Yeast
Set Up Susceptibility?
yes
yes
s/p (facility-specific)
Beta streptococcus
no
Enterococcus
s/p (facility-specific)
Streptococcus viridans
no
Corynebacterium
ureolyticum
no
Diphtheroids
no
Lactobacillus
no
Presumptive identification
yes
Definitive identification
yes
(Facility-specific) presumptive
vs. definitive
no
Reference
Anytown Hospital Laboratory, Anytown USA 12345
[filename and path]
Page 3 of 3
Volume 26
GP2-A5
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45
Number 12
GP2-A5
Weak D (D ) Determination
Document #/version #
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
Isotonic saline
Anti-D Reagent
IgG Antiglobulin Reagent
IgG Sensitized Red Cells
Quality
control
Reagents must be evaluated each day of use with appropriate controls. Verify that reagent QC
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
1
2
3
4
5
6
Supplies
12 x 75-mm test tubes
control drop pipettes
test tube rack
Equipment
calibrated
centrifuge
automatic cell
washer
Action
Place one drop of anti-D serum into a clean, labeled examination tube.
Place one drop of 6% albumin control reagent into a second labeled tube.
Add one drop of a 2 to 5% suspension in saline of the red cells to be
examined to each tube.
Mix and incubate both tubes for 15 minutes at 37 C.
Centrifuge for the saline spin time of the calibrated centrifuge.
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
Continued on next page
Page 1 of 2
Volume 26
GP2-A5
Appendix I. (Continued)
u
Weak D (D ) Testing
Document #/version #
Procedure (Continued)
Step
7
8
9
10
11
12
13
14
15
Interpretation
Action
Control
0
0
+
Rh interpretation
D Positive
D Negative
Invalid
Perform and interpret the Direct
Antiglobulin Test Procedure ID. XXX
Result
Reporting
Enter results into the computer. Follow instructions for Entering results into the BBLIS
Procedure ID. XXX.
References
Related
Documents
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47
Number 12
GP2-A5
Purpose
This procedure provides instructions for how to manually stain slides for microscopic
examination with hematoxylin and eosin.
Materials
Equipment
Slide Holder
Timer
Procedure:
Follow the steps in the table below to manually stain slides with the HematoxylinEosin method.
Step
1
2
3
4
5
6
7
Reagents
Xylene
Iodine Solution
Sodium Thiosulphate 3%
Aqueous
Harris Hematoxylin
Acid Alcohol
Scotts Tap Water Substitute
95% alcohol
Eosin Staining Solution
Absolute alcohol
Supplies
Containers for Reagents
and Solutions
Action
Deparaffinize in two changes of xylene for a total of three minutes.
Immerse in absolute alcohol; three changes, ten dips each.
Immerse in 95% Alcohol; ten dips.
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.
Wash well in running water.
Stain in Harris hematoxylin for five minutes.
Wash well in running water.
Continued on next page
Page 1 of 2
Volume 26
GP2-A5
Appendix J. (Continued)
Hematoxylin and Eosin Staining: Manual Method
Document #/version #
Procedure
(Continued)
Step
8
9
10
11
12
13
14
15
16
Expected
Results
Action
Differentiate in acid alcohol three to six dips.
Wash well in running water.
Blue in Scotts Tap Water substitute for one minute.
Wash well in running water.
Rinse in 95% alcohol.
Stain one minute in eosin; make sure stain covers slides
completely.
Wash well in running water.
Dehydrate in 95% alcohol and three changes of absolute alcohol,
ten dips each.
Clear in three changes of xylene, ten dips each.
Cell Components
Nuclei
Cytoplasm and intercellular
substances
Cells with much RNA or acid
mucopolysaccharide
Expected Color
Blue
Shades of pink and red
Purplish
Related
Procedures
Reference
End
Page 2 of 2
This example was contributed by the Department of Paediatric Laboratory Medicine, Hospital for Sick
Children, Toronto, Ontario, Canada.
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49
Number 12
GP2-A5
Do not share your password with another employee passwords are confidential
information.
Policy
Procedure A:
New User
If you are a new user, follow the steps outlined below to sign on to the IDX for the first
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).
5
6
VERIFY
PASSWORD
Message: Password
Changed
Page 1 of 2
Volume 26
GP2-A5
Appendix K. (Continued)
Signing On To and Navigating IDX
Document #/version #
Procedure B:
Sign on with a
password.
Follow the steps below to sign on to the IDX when you know your
password.
Step
1
2
3
4
Prompt
USER NAME
PASSWORD
Action
Double click the IDX icon on the PC desktop
Enter the USER NAME <ENTER>
Enter the PASSWORD <ENTER>
Your MENU will be displayed.
End
Anytown Hospital Laboratory, Anytown USA 12345
[filename and path]
Page 2 of 2
This example was contributed by the Laboratory Services of Sutter Health Sacramento-Sierra Region,
Sacramento, California.
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51
Number 12
GP2-A5
Procedure
Pre- and Postexamination
X
X
X
Insert specific requirements at the place in the document where the reader
needs the information.
X
X
X
X
As needed
X
X
As needed
X
X
As needed
As needed
As needed
X
X
X
X
X
X
X
X
X
Other
procedures
As used
X
Other
procedures
As used
X
Other procedures
As used
NOTE: If there are separate procedures for any of these sections, then that section does not need
inclusion in the procedure.
Volume 26
GP2-A5
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53
Number 12
GP2-A5
CREATININE
Attribute
Principle
Clinical Utility
Sample Type
-Stability
-Volume
(Preferred)
(Minimum)
-Patient Prep
Reagents
Description
Colorimetric rate reaction. Creatinine forms a yellow-orange
complex with picrate in an alkaline solution.
Diagnosis and treatment of acute and chronic renal disease
Monitoring of renal dialysis
Serum; EDTA or sodium heparin plasma
7 days; centrifuged, at 2 to 8 C
0.5 mL
0.2 mL
None
Reagent #1: NaOH
Reagent #2: Picric Acid
Calculations
Interferences
Not applicable
Bilirubin
>25.0 mg/dL
Hemoglobin >150 mg/dL
Triglyceride >1000 mg/dL
Method Performance
Specifications
Reporting:
- Reference Range
Reporting:
-Alert Limits
Age
Creatinine Value, mg/dL
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
Continued on next page
Page 1 of 2
Volume 26
GP2-A5
CREATININE (Continued)
Reporting Results
Auto-release
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
Page 2 of 2
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55
Number 12
GP2-A5
XYZ Analyzer
Protime (PT)
Principle
Clinical Utility
Sample Type
-Stability
-Volume
(Preferred)
(Minimum)
-Patient Prep
Reagents
Calculations
Interferences
Method Performance
Specifications
Reporting
- Reference Range
Reporting
-Alert Limits
Continued on next page
Anytown Hospital Laboratory, Anytown USA 12345
[filename and path]
Page 1 of 2
Volume 26
GP2-A5
XYZ Analyzer
Protime (PT)
Reporting
Auto-release
Low Recheck
Dilutions
End
Page 2 of 2
NOTE: Additional columns can be added to the right for additional analytes, or the table could be
presented in landscape (sideways) format.
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57
Number 12
GP2-A5
SUBJECT
PROCESS
PROCEDURE
FORM
RESOURCE
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Volume 26
GP2-A5
Appendix N. (Continued)
PAGE
SUBJECT
Adding/Editing/Deleting Insurance in
IDX
Insurance (FSC) Listing
Registering Physician Office Collected
Specimens in IDX
Admitting an IDX non-Group 3, 4, 14
Patient into the LIS
Section C Test Ordering Process and
Procedures
Test Ordering Process Flowchart
Taking Verbal Orders From Physician
Verbal Order Follow-up Form
Accepting and Managing Standing Orders
Standing Order Form
Ordering Standing Orders in LIS
Ordering Tests In LIS
Standard SSR Laboratory Requisition
LIS Mnemonic Quick Reference
Using the SSR Laboratory Reference
Manual
Using the Quest Website as a Reference
Source
Ordering Confidential Tests in LIS
Adding an Order to an Accession Number
Canceling Test(s) in LIS
Cancellation Codes
Reprinting an LIS Collection Label
Managing Test Order Paperwork/Labels
Section D Sample Collection Process
and Procedures
Sample Collection Process Flowchart
Determining Specimen Requirements
Escorting Outpatients to Collection Area
Identifying Outpatients for Specimen
Collection
Collecting Specimens Following AgeSpecific Requirements
Collecting Blood Specimen by
Venipuncture
Collecting Blood Specimen by Capillary
Puncture
Collecting Blood Cultures
Collecting Stool and Urine Specimens
Labeling Blood Specimens at Collection
Managing Test Order Paperwork
Postcollection
Section E Sample Processing and
Handling Process and Procedures
Sample Processing Flowchart
PROCESS
PROCEDURE
FORM
RESOURCE
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ClinicalWannamaker
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59
Number 12
GP2-A5
Appendix N. (Continued)
PAGE
SUBJECT
PROCESS
PROCEDURE
FORM
RESOURCE
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
This example was provided by the Sutter Health Sacramento Sierra Laboratory Services Patient Service
Center, Sacramento, California.
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]
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61
Number 12
GP2-A5
Introduction
Types of Downtime
Scheduled Downtime
Unscheduled Downtime
Testing
Test Production
LIS Failure Plan Test Prioritization
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
Volume 26
GP2-A5
Appendix P. (Continued)
LIS and Automation Downtime Manual (Continued)
Section
6
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63
Number 12
GP2-A5
Appendix P. (Continued)
LIS and Automation Downtime Manual (Continued)
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
Transfusion Medicine
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
Volume 26
GP2-A5
Appendix P. (Continued)
LIS and Automation Downtime Manual (Continued)
Section
10
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65
Number 12
GP2-A5
Appendix P. (Continued)
LIS and Automation Downtime Manual (Continued)
Section
10
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.
Volume 26
GP2-A5
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67
Number 12
GP2-A5
No
New document?
Yes
Copy of current
Version is retrieved
New document
type is identified
Document is
edited
Document is
drafted
- policy
- process
- procedure
- form
Independent review/
verification is performed
Are
Adjustments
needed
No
Yes
Review signatures
are obtained
Documents
are edited
Checklist review
is completed
No
Is
training needed?
Yes
Training
Process
Staff notification
is made
Master-File
Maintenance
Process
This example was contributed by St. Joseph Mercy Hospital Blood Bank, Ann Arbor, Michigan.
Volume 26
GP2-A5
Whos
Responsible
anyone
OR
Need for changed
document is identified
anyone
assigned or
volunteer
author
supervisor
OR
Current version is edited
Independent review and
verification is performed
Review signatures are
obtained
Checklist review is
completed
Staff notification is made
Procedures
assigned staff
reviewer
supervisor
medical
director
quality function
(where
applicable)
supervisor
supervisor
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Number 12
GP2-A5
Document Name:
Document Number:
Version Number
Check one:
Requestor:
Date:
New Document
Changed Document
Description of Document:
______Yes
______No
Signature Approval
Signature
Date
Document Author
Supervisor
Director
Issue Date for Training
Effective Date for Use
Annual Review
Signature
Designee
Date
Page 1 of 1
Volume 26
GP2-A5
RULE
Read, acknowledge, and put into practice
the contents of all documents assigned to
you in a timely manner.
Go to the process and procedure documents
first when you are unsure of a step or
direction or need more information.
6
7
8
10
NOTE
Frequently check your LIS mailbox or
Laboratory Memos for a listing of new expired
documents
Asking a coworker to recall a detail may lead
to error. If the document does not have the
information you need, notify your supervisor
or team leader.
Do not use old versions of documents, forms,
labels, or tags that have been replaced by a
more current version or keep them in the work
areas. Remove and give these to your
supervisor or team leader.
A distribution list for each document indicates
where it should be. Do not move documents
unless a supervisor or team leader is involved.
Critical changes that affect the comprehension
of any type of document or performance of a
procedure will be made immediately. Typos
that do not affect comprehension or
performance may be held until the next
version is released.
See above
See above
Photocopies are no longer controlled. If a copy
is required for rewriting purposes, an
uncontrolled copy may be requested from the
document control coordinator or reprinted
from the document control system.
Uncontrolled copies are meant to be transient
or temporary in nature, hence the warning in
the document footer.
Do not share copies of approved documents
with other laboratories without director
approval.
This example was contributed by the Department of Laboratory Medicine and Pathology of the University of
Alberta Medical Center, Edmonton, Alberta, Canada.
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71
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.
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. GP2A5 is not a standard; that is, this guideline does not set requirements for laboratory documents and procedures. Instead, this
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.
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.
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.
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.
Procedures that describe the whole process are process documents. This guideline does not prevent users from
creating written process documents.
These examples were contributed by real laboratories that have realized the benefits of following the
recommendations provided in this guideline.
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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.
This section only relates to other procedures referred to in this procedure, not to tables or forms. Tables and forms
are appendixes (or attachments).
This statement has been modified, as no requirement for authors name could be found.
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.
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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GP2-A5
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.
This information was added to Section 9.1, second bullet on sample collection and labeling.
The items in ISO 15189 Section 5.4.3 have been edited into their respective sections (in Section 9.1.2) as suggested.
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.
A sentence has been added about having a separate written procedure for supplies.
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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.
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.
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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.
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.
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.
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.
A master file is not required; its only a recommendation for keeping better control of the history of each document.
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There is no requirement to determine what other documents may change, only a recommendation that this is a good
practice.
This editorial change has been incorporated in the text.
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.
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.
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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GP2-A5
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.
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.
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Equipment
Purchasing & Inventory
Process Control
Information Management
Occurrence Management
Assessment
Process Improvement
Service & Satisfaction
Facilities & Safety
X
GP26
HS1
GP26
HS1
GP21
GP26
HS1
GP26
HS1
GP26
HS1
GP26
HS1
M29
X
GP26
HS1
GP26
HS1
GP26
HS1
GP26
HS1
GP26
HS1
Facilities &
Safety
Service &
Satisfaction
Process
Improvement
Assessment
Occurrence
Management
Information
Management
Process
Control
Purchasing &
Inventory
Equipment
Personnel
Organization
Documents
& Records
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.
GP17
GP26
HS1
M29
Adapted from CLSI/NCCLS document HS1A Quality Management System Model for Health Care.
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GP2-A5
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
Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process;
therefore, readers should refer to the most current editions.
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NOTES
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NOTES
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NOTES
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NOTES
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85
Active Membership
(as of 1 January 2006)
Sustaining Members
Abbott Laboratories
American Association for Clinical
Chemistry
Bayer Corporation
BD
Beckman Coulter, Inc.
bioMrieux, Inc.
CLMA
College of American Pathologists
GlaxoSmithKline
Ortho-Clinical Diagnostics, Inc.
Pfizer Inc
Roche Diagnostics, Inc.
Professional Members
American Academy of Family
Physicians
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Chemistry
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Laboratory Accreditation
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Respiratory Care
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Laboratory Science
American Society for Microbiology
American Society of Hematology
American Type Culture Collection,
Inc.
ASCP
Assn. of Public Health Laboratories
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Italiani (AMCLI)
British Society for Antimicrobial
Chemotherapy
Canadian Society for Medical
Laboratory Science - Socit
Canadienne de Science de
Laboratoire Mdical
Canadian Standards Association
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Clinical Laboratory Management
Association
COLA
College of American Pathologists
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Technologists of Ontario
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of Saskatchewan
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Commission
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Chemistry
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Molecular Biology
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Laboratory Standards
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of Healthcare Organizations
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Biochemistry
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Authorities - Australia
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Histotechnology, Inc.
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Service
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PTY Limited
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Clinica y Patologia Molecular
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Clinicas
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Laboratory Standards (TCCLS)
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Laboratories
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Instrumentation Laboratory
International Technidyne
Corporation
I-STAT Corporation
Japan Assn. of Clinical Reagents
Industries
Johnson and Johnson Pharmaceutical
Research and Development, L.L.C.
K.C.J. Enterprises
LabNow, Inc.
LifeScan, Inc. (a Johnson & Johnson
Company)
Medical Device Consultants, Inc.
Merck & Company, Inc.
Micromyx, LLC
Nanogen, Point-of-Care Diagnostics
Div.
Nippon Becton Dickinson Co., Ltd.
Nissui Pharmaceutical Co., Ltd.
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Research
Olympus America, Inc.
Optimer Pharmaceuticals, Inc.
Ortho-Clinical Diagnostics, Inc.
(Rochester, NY)
Ortho-McNeil Pharmaceutical
(Raritan, NJ)
Oxoid Inc.
Paratek Pharmaceuticals
Pfizer Animal Health
Pfizer Inc
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Powers Consulting Services
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Inc.
QSE Consulting
Radiometer America, Inc.
Radiometer Medical A/S
Reliance Life Sciences
Replidyne
Roche Diagnostics GmbH
Roche Diagnostics, Inc.
Roche Diagnostics Shanghai Ltd.
Roche Laboratories (Div. HoffmannLa Roche Inc.)
Roche Molecular Systems
Sanofi Pasteur
Sarstedt, Inc.
Schering Corporation
Schleicher & Schuell, Inc.
Seneca Medical Lab, Inc.
SFBC Anapharm
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Streck Laboratories, Inc.
Sysmex Corporation (Japan)
Sysmex Corporation (Long Grove,
IL)
TheraDoc
Theravance Inc.
Third Wave Technologies, Inc.
Thrombodyne, Inc.
THYMED GmbH
Transasia Engineers
Trek Diagnostic Systems, Inc.
Vicuron Pharmaceuticals Inc.
Watin-Biolife Diagnostics and
Medicals
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XDX, Inc.
YD Consultant
YD Diagnostics (Seoul, Korea)
Trade Associations
AdvaMed
Japan Association of Clinical
Reagents Industries (Tokyo, Japan)
Associate Active Members
59th MDW/859 MDT/MTL (TX)
82 MDG/SGSCL (Sheppard
AFB,TX)
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(Belgium)
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Medical Center (NY)
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OFFICERS
Thomas L. Hearn, PhD,
President
Centers for Disease Control and Prevention
Robert L. Habig, PhD,
President Elect
Abbott Laboratories
Wayne Brinster,
Secretary
BD
Gerald A. Hoeltge, MD,
Treasurer
The Cleveland Clinic Foundation
Donna M. Meyer, PhD,
Immediate Past President
CHRISTUS Health
BOARD OF DIRECTORS
Susan Blonshine, RRT, RPFT, FAARC
TechEd
Maria Carballo
Health Canada
James A. Thomas
ASTM International
Kiyoaki Watanabe, MD
Keio University School of Medicine