Laboratory Documents: Development and Control; Approved Guideline

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Clinical and Laboratory Standards Institute Advancing Quality in Healthcare Testing Clinical and Laboratory Standards Institute (CLSI formerly NCCLS) is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient examination and related healthcare issues. Our process is based on the principle that consensus is an effective and cost-effective way to improve patient examination and healthcare services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient examination and health care. PUBLICATIONS A document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.

Most documents are subject to two levels of consensus— “proposed” and “approved.” Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level. Proposed A consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line-by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following CLSI’s established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS

The CLSI voluntary consensus process is a protocol establishing formal criteria for:

The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA.

•

the authorization of a project

VOLUNTEER PARTICIPATION

•

the development and open review of documents

•

the revision of documents in response to comments by users

•

Healthcare professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at [email protected] or +610.688.0100 for additional information on committee participation.

the acceptance of a document as a consensus standard or guideline.

Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS


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GP2-A5 ISBN 1-56238-600-X ISSN 0273-3099

Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition Lucia M. Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ)CQMgr Donald R. Callihan, PhD Joan Carlson, MLT(CSMLA), BSc(MLS), MT(ASCP) Beverly J. Charlton, CLC(AMT) Christine D. Flaherty, MHA, MT(ASCP) Mary H. Hopper, MA, MT(ASCP) Barb Kirkley, MT(ASCP) Oliver Ndimbie, MD, FCAP Jennifer Schiffgens, MBA, MT(ASCP) Peggy J. Stupca, MS, CLSp(CG) Nita Sudderth, MT(ASCP), CQMgr(ASQ) Joyce I. Wilson, MS, MT(ASCP) Shelia M. Woodcock, MBA, FCSMLS(D)

Abstract Clinical and Laboratory Standards Institute document GP2-A5—Laboratory Documents: Development and Control; Approved Guideline—Fifth 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: [email protected]; Website: www.clsi.org


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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 document’s text. Reproduced with permission, from CLSI publication GP2-A5—Laboratory Documents: Development and Control; Approved Guideline—Fifth 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 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.)

Proposed Guideline

Approved Guideline—Third Edition

May 1980

December 1996

Tentative Guideline

Approved Guideline—Fourth Edition

June 1981

April 2002

Approved Guideline

Approved Guideline—Fifth Edition

February 1984

March 2006

Approved Guideline—Second Edition July 1992

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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

Theresa D. Billups, MBA, MT(ASCP)DLM Remel Inc. Lake Charles, Louisiana Margaret M. Grimes, MD Virginia Commonwealth University Richmond, Virginia Bruce David Tually, BAppSc, MAppSc Hunter Area Pathology Service New South Wales, Australia Advisors Kay M. Creed St. Mary’s Hospital Richmond, Virginia Dennis J. Ernst, MT(ASCP) Center for Phlebotomy Education Ramsey, Indiana

Steven I. Gutman, MD, MBA FDA Ctr. for Devices/Rad. Health Rockville, Maryland Stephen J. Sarewitz, MD Valley Medical Center Renton, Washington Jennifer Schiffgens, MBA, MT(ASCP) California Pacific Medical Center San Francisco, California Daniel W. Tholen, MS American Association for Laboratory Accreditation Traverse City, Michigan Marla Thomas Litton Pathology Associates Blue Springs, Missouri Eleanor M. Travers, MD, MHA State of Connecticut Dept. of Public Health Hartford, Connecticut

Working Group on Technical Procedure Manuals Lucia M. Berte, MA, MT(ASCP), SBB, DLM: CQA(ASQ)CQMgr Chairholder Quality Systems Consultant Westminster, Colorado Donald R. Callihan, PhD BD Diagnostic Systems Sparks, Maryland Joan Carlson, MLT(CSMLS), BSc(MLS), MT(ASCP) University of Alberta Hospital Edmonton, Alberta, Canada Beverly J. Charlton, CLC(AMT) University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Christine D. Flaherty, MHA, MT(ASCP) Sutter Health Sacramento, California

Mary H. Hopper, MA, MT(ASCP) Mayo Clinic Rochester, Minnesota Barb Kirkley, MT(ASCP) The Cleveland Clinic Foundation Cleveland, Ohio Oliver Ndimbie, MD, FCAP Abbott Diagnostics Irving, Texas Jennifer Schiffgens, MBA, MT(ASCP) California Pacific Medical Center San Francisco, California Peggy J. Stupca, MS, CLSp(CG) Mayo Clinic Rochester, Minnesota Nita Sudderth, MT(ASCP), CQMgr(ASQ) UroCor, Inc. Oklahoma City, Oklahoma

Joyce I. Wilson, MS, MT(ASCP) University of Alabama-Birmingham Hospital Birmingham, Alabama Sheila M. Woodcock, MBA, FCSMLS(D) QSE Consulting Rose Bay, Nova Scotia, Canada Staff Clinical and Laboratory Standards Institute Wayne, Pennsylvania John J. Zlockie, MBA Vice President, Standards Jennifer K. McGeary, MT(ASCP), MSHA Staff Liaison Donna M. Wilhelm Editor Melissa A. Lewis Assistant Editor


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Contents Abstract ....................................................................................................................................................i Committee Membership........................................................................................................................ iii Foreword ................................................................................................................................................ix 1

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

2

Introduction................................................................................................................................1

3

Definitions .................................................................................................................................1

4

Path of Workflow.......................................................................................................................2 4.1 4.2 4.3

5

Preexamination Processes.............................................................................................2 Examination Processes .................................................................................................3 Postexamination Processes ...........................................................................................3

Process – The Sequence of Laboratory Activities .....................................................................4 5.1 5.2

Key Work Processes .....................................................................................................4 Process as a Basis for Training and Competence Assessment......................................4

6

Procedure – How to Do It ..........................................................................................................4

7

Elements Common to Process and Procedure Documents ........................................................4 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9

8

Process Documents ....................................................................................................................6 8.1 8.2

9

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

Procedure Documents – Specific for the Path of Workflow......................................................7 9.1 9.2 9.3

Preexamination Procedures...........................................................................................7 Examination Procedures .............................................................................................11 Postexamination Procedures .......................................................................................17

10

Form Documents......................................................................................................................19

11

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

12

Document Management ...........................................................................................................20 12.1 12.2 12.3

Document Identification .............................................................................................20 Master File ..................................................................................................................21 Review and Approval of New Documents .................................................................21


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Contents (Continued) 12.4 12.5 12.6 12.7 12.8 12.9 13

Review and Approval of Changes to Approved Documents ......................................21 Job Aid Documents.....................................................................................................22 Periodic Review of Unchanged Documents ...............................................................22 Master Index ...............................................................................................................22 Distribution .................................................................................................................23 Archiving, Storage, and Retention of Documents ......................................................23

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 vi Licensed to: Cameron Wannamaker This document is protected by copyright. CLSI order # 71377, id # 477046, Downloaded on 12/11/2009.

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Contents (Continued) Appendix P. Sample Table of Contents for a Computer Downtime Manual........................................62 Appendix Q1. Document Creation, Review, and Approval Process Flowchart ...................................68 Appendix Q2. Document Creation, Review, and Approval Process Table .........................................69 Appendix R. Sample Document Change Request Form.......................................................................70 Appendix S. Ten Rules for Document Control.....................................................................................71 Summary of Delegate Comments and Working Group Responses ......................................................72 The Quality System Approach..............................................................................................................80 Related CLSI/NCCLS Publications ......................................................................................................81


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Foreword Previous editions of CLSI document GP2 have focused on essential elements to include in laboratory examination procedures. This edition of GP2 has been renamed and reorganized to provide: •

the use of process flowcharts to depict the linkages between laboratory procedures;

•

guidelines for writing process and procedure documents for the preexamination, examination, and postexamination activities that represent the laboratory’s path of workflow;

•

guidelines for writing process and procedure documents specifically for multitest automated analyzers;

•

guidelines for writing procedures for laboratory information systems; and

•

an introduction to the management and control of laboratory documents after they are approved for use.

The information and examples provided in this edition are also consistent with the guidance described in CLSI/NCCLS document GP26—Application 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 Licensed to: Cameron Wannamaker This document is protected by copyright. CLSI order # 71377, id # 477046, Downloaded on 12/11/2009.

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fundamental meanings of the terms are identical in many cases, and are defined in the guideline’s Definitions section (see Section 3). The terms in this document are consistent with those defined in the ISO 15189, ISO 17025, and ISO 9000 series of standards.

Key Words Computer procedure, document, document management, electronic procedures, laboratory procedure, laboratory process, procedures manual, technical procedures

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Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition 1

Scope

This publication describes how to: •

identify laboratory procedures using work processes in the laboratory’s operational path of workflow; and

•

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

Also, this edition of GP2 provides useful information about preparing, approving, maintaining, reviewing, changing, and archiving laboratory documents.

2

Introduction

The laboratory needs to provide carefully documented instructions—in the form of procedures—for 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 tasks—including nonexamination tasks, such as collecting blood samples and using the laboratory’s computer system. Written procedures should encompass a single task from start to finish. Therefore, it makes sense to write separate instructions for tasks that are performed at different times by different people. GP2-A5 is intended for use by the following: •

administrative and technical personnel who develop laboratory documents;

•

manufacturers; and

•

educators.

3

Definitions

conformance – fulfillment of a requirement (ISO 9000).8 document – any recorded item of a factual or informative nature, either paper or electronic. examination – set of operations having the object of determining the value or characteristics of a property (ISO 15189)1; NOTE 1: In some countries and disciplines (e.g., microbiology), an examination is the total activity of a number of tests, observations, or measurements (ISO 15189)1; NOTE 2: In this document, the term “examination” replaces the term “test”; however, for the purposes of this guideline, readers can consider the terms equivalent. form – a paper or electronic document on which the results from the performance of a procedure or other information are captured, and after which becomes a record. policy – a documented statement of overall intentions and directions defined by those in the organization and endorsed by management. ©

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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 laboratory’s path of workflow. sample – one or more parts taken from a system and intended to provide information on the system, often to serve as a basis for decision on the system or its production (ISO 15189)1; NOTE 1: For example, a volume of serum taken from a larger volume of serum (ISO 15189)1; NOTE 2: In this document, the term “sample” replaces the term “specimen”; however, for the purposes of this guideline, readers can consider the terms equivalent.

4

Path of Workflow

Laboratory work is a sequence of key processes in which the laboratory uses resources such as people, instruments, methods, and materials, to transform orders for laboratory examinations into results and reports for patient management. Key processes for the laboratory are referred to as the “path of workflow” or “total testing process,” which is shown in Figure 1.

Figure 1. Laboratory Path of Workflow. From CLSI/NCCLS document GP26—Application of a Quality Management System Model for Laboratory Services.

4.1

Preexamination Processes

Preexamination key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory examinations are ordered through the time that the samples are processed and delivered to the laboratory examination location or transported to referral laboratories. For anatomic pathologists and cytotechnologists, preexamination activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic assessment and interpretation. The preexamination portion of the laboratory’s path of workflow is shown in Figure 2.

Preexamination Process

Test Ordering

Sample Collection

Examination Process

Sample Transport

Postexamination Process

Sample Receipt/Processing

Figure 2. Laboratory Preexamination Key Processes. From CLSI/NCCLS document GP26—Application of a Quality Management System Model for Laboratory Services.

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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 discipline—however it is organized— needs to identify all of its automated and manual examination processes. Examination key processes for the laboratory’s path of workflow are shown in Figure 3.

Preexamination Process

Examination Process

Examination

Postexamination Process

Results Review and Follow-up

Interpretation

Figure 3. Laboratory Examination Key Processes. From CLSI/NCCLS document GP26—Application of a Quality Management System Model for Laboratory Services.

4.3

Postexamination Processes

Postexamination key processes in the path of workflow include activities related to reporting results and archiving results and sample material. Postexamination processes are shown in Figure 4.

Figure 4. Laboratory Postexamination Key Processes. From CLSI/NCCLS document GP26—Application of a Quality Management System Model for Laboratory Services.

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Process – The Sequence of Laboratory Activities Key Work Processes

The laboratory’s key work processes interlink to transform an examination order into a result report for a patient’s 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 happens”—for example, the interrelated sequential activities involved in the automated examination process. Flowcharts or tables are usually used to present process information. Process flowcharts and their respective tables are provided in Appendixes A1 through E2.

5.2

Process as a Basis for Training and Competence Assessment

All work happens as a sequence of activities known as a process. In a person’s 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 laboratory’s work processes and use the process documents in training programs and competence assessment exercises. CLSI/NCCLS document GP21—Training and Competence Assessment provides information on how to design and deliver work-process-based training and competence assessment programs.

6

Procedure – How to Do It

Whereas process documents depict or describe how related activities are sequenced across time, procedure documents present step-by-step instructions that a single individual needs to take to successfully complete one activity in the process. Therefore, one process document refers to a number of supporting procedure documents. Examples of procedures have been provided as Appendixes F through K.

7

Elements Common to Process and Procedure Documents

The elements described in this section are common to documents that capture process and procedure information. However, process documents will contain only the process flowchart or table, not the procedure instructions, and procedure documents will contain only the procedure instructions. Appendix L presents a table that suggests which sections in addition to the common elements should be included in process and procedure documents.

7.1

Title

All documents need to have a title that clearly states the intent of the document. The title should be concise and describe the document type (i.e., process or procedure). Examples include: •

“Blood Sample Collection Process”;

•

“Performing Glucose Examinations on Instrument X”; ©


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“Waterbath Temperature Monitoring Procedure”; and

•

“Preparing Gram Stain Working Solutions.”

GP2-A5

The word “process” should appear in the title of a process document. The gerund form of a verb (i.e., “ing”) can be used to replace the word “procedure” in the title of a procedure document.

7.2

Purpose or Principle

The document should open with a section that simply states its purpose. For example, the “Purpose” section of a process could be stated as, “This process describes how [name of process here, e.g., sample accession] happens in this laboratory.” The “Purpose” section of a procedure could be stated as, “This procedure provides instructions for collecting fingerstick samples for glucose analysis.” The words, “This process describes how…” and “This procedure provides instructions for…” can be standardized in the template and therefore included in each process and procedure document. Information regarding the theory, clinical implications of the examination or examination methodology, or historical background may be included at the beginning of a procedure document to provide an educational, clinical, and scientific framework for the reader and user. However, because this information can be technical and lengthy, it may also be placed at the end of a procedure document. Analyte-specific information may be placed in analyte attribute tables, such as those provided in Appendixes M1 and M2.

7.3

Process Flowchart or Table

The primary focus of a process document is to describe the sequence of activities that leads to the correct outcome. For example, the blood sample collection process presents the activities (i.e., the procedures) that need to be correctly sequenced and performed to obtain a blood sample for a specified laboratory examination.

7.4

Procedure Instructions

The primary focus of a procedure is to provide instructions for “how to do” a particular task in a stepwise fashion—for 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: •

manufacturer’s product literature, such as package inserts and operator’s manuals;

•

text books;

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•

published standards and guidelines;

•

laboratory policy manuals;

•

laboratory computer system manuals;

•

unpublished information obtained from experts in the field; and

•

applicable regulations.

References should be listed in a standard medical format, using the style of the Journal of the American Medical Association or the Archives of Pathology and Laboratory Medicine.

7.7

Appendixes or Attachments

Examples of completed forms, labels, or tags should be included as appendixes or attachments in procedure documents. Additional information contained in a table or list may be best presented as an appendix or attachment, rather than in the body of the procedure. Appendix H demonstrates how important information needed by the reader to make decisions can be captured in tables that are used as appendixes to the procedure. Appendixes M1 and M2 show how analyte-specific information may be presented as appendixes in procedures for operating automated analyzers.

7.8

Author

The author(s) of the document should be recorded. The laboratory has the option of including author information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record the author, a mechanism is needed to enable the referencing of the author back to the appropriate specific document.

7.9

Approval Signatures

Evidence that the document has been approved by the appropriate individual(s) is a requirement of regulatory and accrediting agencies, and international standards. The laboratory has the option of including signature approval information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record signature approvals, a mechanism is needed to enable the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Sections 12.2 and 12.3.

8 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 laboratory’s walls;

•

visualization of the sequence of work across the laboratory’s 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

Suggested Template for Process Documents

A simple template for process documents can be created to include the following sections: • • • •

Title; Purpose; Process Flowchart or Table; and Supporting Documents

The contents of the first three sections were described in Section 7. The additional section after the process flowchart or table, titled “Supporting Documents,” is recommended. This section lists the procedures manual(s) or the individual procedures that support this process, thus referring the reader to where the instructions for carrying out the process may be found.

9 9.1

Procedure Documents – Specific for the Path of Workflow Preexamination Procedures

Preexamination procedures provide the instructions for all activities in laboratory workflow processes that take place before sample analysis. The laboratory should have separate written procedures for preexamination activities, because they are often performed by nonlaboratory as well as laboratory persons at different times in the preexamination workflow. Preexamination procedures are the instructions that support the following preexamination processes: •

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examination ordering—instructions for entering laboratory examination orders into a computer system or completing paper requisitions, including verification of clinical orders and provision of necessary clinical information;


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sample collection and labeling—instructions 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 transport—instructions for transporting samples to the laboratory, such as through the pneumatic tube system; and

•

sample processing—instructions for receiving and accessioning samples in the laboratory: instructions for handling client-required deviations, additions, or exclusions from the laboratory’s procedures; criteria for unacceptable samples and follow up action; any storage or processing before delivery to the examination location; and any preparations for samples transported to other laboratories for examination (e.g., referral laboratories).

In addition to the elements common to all documents described in Section 7, preexamination procedures should also contain the following types of information; however, this information should be included only where it is needed to perform that procedure. •

patient preparation—in procedures for sample collection;

•

sample collection information—in procedures for collection techniques for blood and nonblood samples;

•

sample labeling information—instructions for labeling blood and nonblood samples and providing for any special labeling (e.g., blood bank labels);

•

required equipment and forms—in all preexamination procedures where equipment and forms are used;

•

safety—general or specific instructions as described below and in Section 9.1.4;

•

sample handling requirements—instructions for handling collected samples during transport to the laboratory receiving area;

•

sample storage requirements—instructions for where and how to store samples before examination; and

•

problems or pitfalls.

9.1.1

Patient Preparation

Where applicable, preexamination sample collection procedures need to include information about patient preparation, such as instructions for: •

dietary requirements (e.g., fasting and special diets);

•

timed examination (e.g., glucose tolerance, therapeutic drug monitoring); and

•

aseptic techniques (e.g., when drawing blood cultures).

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Sample Collection and Labeling

Where applicable, preexamination sample collection procedures need to include information about sample collection techniques that are: •

age-specific;

•

sex-specific (e.g., clean-catch urine); and

•

collection-site-specific (e.g., the presence of intravenous lines, and alternatives to the antecubital collection site [capillary puncture, arterial puncture, line draw, etc.]).

Sample collection procedures need to include instructions for how to record the identity of the person who collected the sample. In addition, prepare procedures for patient-collected samples that provide information and instructions to the patient about: •

special preparation (see Section 9.1.1 above);

•

type and amount of sample to collect;

•

how to do the procedure (e.g., collect a clean-catch urine);

•

special timing of collection (e.g., 24 hour urine);

•

labeling of the sample; and

•

special handling between the time of collection and time received by laboratory personnel (e.g., refrigeration, warming, immediate delivery).

Labeling procedures need to include clear instructions about: •

required label information, and

•

placement of label on the sample (e.g., on the container, not the lid; position of bar code, etc.).

9.1.3

Required Equipment and Forms

Where applicable, preexamination procedures need to include information about the required equipment used, and forms and the use of forms needed for the procedure. For example: •

examination requisitions and labels;

•

bar-code readers

•

sample collection devices and materials (e.g., blood collection tubes, culture media, swabs);

•

sample containers; and

•

instruments (tourniquets, hemostats, scissors, etc.).

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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 requirements—beyond the basic handling of biologic and other hazardous materials—are necessary. The current editions of CLSI document M29—Protection of Laboratory Workers From Occupationally Acquired Infections and CLSI/NCCLS document GP17—Clinical Laboratory Safety provide valuable information on laboratory safety and special requirements. 9.1.5

Sample Handling Requirements

Where applicable, preexamination procedures need to include information about sample handling requirements. This information includes: •

special transport requirements (e.g., on ice, within a certain time, in appropriate containers);

•

safety precautions taken with potentially infectious samples; and

•

special transport requirements for dangerous or hazardous materials.

9.1.6

Sample Storage Requirements

Where applicable, preexamination procedures need to include requirements for sample storage before examination. This information includes: •

locations where samples are stored before examination to protect the condition and integrity of samples, including any security requirements;

•

acceptable storage temperatures; and

•

stability of the sample over time, where timelines might affect the quality of the examination results.

9.1.7

Problems or Pitfalls

Preexamination procedure documents should include information about problems or pitfalls that may occur in the performance of the procedure. Where applicable, users may refer to other procedures. Examples of this kind of information include what to do when: •

patients present for laboratory examinations without a proper order;

•

received samples are unacceptable; and

•

the computer is “down.”

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Preexamination Computer Activities

Procedures that provide instructions for using the laboratory’s information system for preexamination activities should be designed around the respective prompts in a computer program’s sequences. Appendix K provides an example of a laboratory computer system procedure.

9.2

Examination Procedures

Examination procedures cover the activities from the time the sample reaches the examination area to the time results are reviewed and preliminary interpretations are determined. Procedures for manual examinations differ from procedures for automated examinations. Manual examination procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte sedimentation rate are examples of traditional manual method-based examination procedures. Examination results provided by both manual and automated methods can be qualitative or quantitative. The attributes of manual versus automated examination, and qualitative versus quantitative results, influence the sections that should be included in each type of procedure. The differences between procedures for manual and automated examinations are described in the sections that follow. 9.2.1

Elements of Manual Examination Method-Based Procedures

In addition to the elements presented in Section 7 that are common to all documents, examination procedure documents should include the following sections, wherever applicable. These sections are listed below in the order in which the reader would logically need the information. More information on each section is provided after the list. •

Sample information;

•

Reagents and/or media;

•

Supplies;

•

Equipment calibration and maintenance;

•

Special safety precautions;

•

Quality control;

•

Instructions for performing the examination method;

•

Method performance specifications;

•

Calculations (for quantitative procedures only);

•

Expected values; and

•

Interpretation of results.

9.2.1.1

Sample Information

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sample type;

•

sample source;

•

amount of sample required, including minimum requirements;

•

acceptable collection containers and sterility requirements;

•

sample stability and storage requirements; and

•

criteria for unacceptable samples and follow-up action.

9.2.1.2

Reagents and Media

The procedure needs to include a list of the reagents or media used in performing the procedure. An examination procedure should provide instructions for preparing reagents only when the reagents are prepared each time the procedure is performed. Instructions for stock and working solutions of reagents and stains that are prepared at times other than performance of the actual procedure should be written into separate procedures. For example, the “Reagents” section in a procedure that provides instructions for performing a Gram stain should only list the reagents used to stain smear samples. There should be separate procedures for preparing, labeling, and storing the different stock and working solutions. This reduces the length of the examination procedure and allows for keeping reagent “recipes” in a separate place where they can be easily referenced and located. Receipt of reagents and materials in the laboratory does not take place at the time of performing examinations; therefore, a separate procedure is needed for receiving, inspecting, and appropriately evaluating laboratory reagents and examination kits before use. Procedures for reagent and media preparation should include the following: •

list of required reagents and/or media;

•

reagent name or chemical formula;

•

acceptable reagent grade;

•

special safety requirements (e.g., general category or class of hazard; special handling instructions);

•

step-by-step instructions for reagent or media preparation;

•

degree of accuracy, and any special handling instructions for measuring devices;

•

QC of reagents or media (e.g., pH testing or visual assessment);

•

labeling requirements, including expiration;

•

storage requirements, including containers and stability; and

•

regulatory classifications where applicable.

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Supplies

Receipt of supplies and other materials in the laboratory does not take place at the time of performing examinations; therefore, a separate procedure is needed for receiving, inspecting, and appropriately evaluating laboratory supplies and materials before they are used in examination procedures. The examination procedure needs to include a list of the supplies used to perform the procedure. Examples of supplies that could be listed include: • • • • • • • • •

disposable pipettes; pipette tips; gauze; bibulous paper; immersion oil; test tube rack; test tubes; scissors; and other applicable supplies.

9.2.1.4

Equipment Calibration and Maintenance

Instructions for calibration and maintenance should be included in the examination performance procedure only when these activities are performed each time the procedure is done. Instructions for equipment calibration, calibration verification, and maintenance that are performed at a time remote from the use of such equipment in the performance of an examination procedure should be written as separate procedures. Directions for the preparation of calibration standards should be included in a separate calibration procedure. Procedures for equipment calibration and maintenance need to include the following information: Calibration: •

schedule for performing calibration—daily, weekly, monthly, semiannually, etc.;

•

schedule for performing calibration verifications (which are the assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument, kit, or examination system has remained stable throughout the laboratory’s reportable range for patient examination results);

•

source of the calibration material;

•

calibration material specifications;

•

calibration material preparation and storage;

•

step-by-step instructions for performing the calibration, including expected instrument readings;

•

troubleshooting guidelines; and

•

documentation methods and storage requirements for calibration records.

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Maintenance: •

schedule for performing maintenance—daily, weekly, monthly, semiannually, annually, etc.;

•

step-by-step instructions for performing maintenance activities; and

•

troubleshooting guidelines.

9.2.1.5

Special Safety Precautions

All laboratory personnel need to receive training about precautions taken when handling biologic and other hazardous materials. Because all laboratory examinations use biologic samples, it is redundant to repeat routine safety precautions, such as the requirement for wearing of gowns and gloves, in every procedure. If no special precautions are required, the examination procedure may refer the user to the safety manual for general safety requirements. The examination procedure needs to include a special safety precautions section when additional safety requirements—beyond the basic handling of biologic and other hazardous materials—are necessary. The special safety precautions section should include the following: •

engineering controls (e.g., use of a biohazard cabinet);

•

personal protective equipment (e.g., respirators, special gloves, face shields); and

•

work practice controls (e.g., beginning a step only after certain conditions have been met or precautions have been taken).

9.2.1.6

Quality Control (QC)

Instructions for QC should be included in the examination performance procedure only when QC is performed each time the examination procedure is performed. Instructions for performing QC when it is performed at a time remote from the performance of the examination procedure should be written as a separate procedure. For example, the instructions for performing the positive and negative controls for a rheumatoid factor examination need to be in the rheumatoid factor examination procedure, because these controls are included every time a batch of samples is examined. On the other hand, the instructions for performing the QC of anti-A, anti-B, and anti-D reagents should be in a procedure separate from that of determining patient ABO and Rh types, because reagent QC examination is performed and recorded separately from patient examinations. QC procedures need to include the following information: •

frequency with which controls should be examined;

•

number of levels of controls to use;

•

type of quality control material to use;

•

instructions for preparation and handling of control materials;

•

the expected QC values and/or ranges;

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explanation of control criteria (e.g., criteria for accepting or rejecting QC results and examination data);

•

corrective action to take if controls exceed expected criteria;

•

instructions for documentation of QC data; and

•

alternate QC measures, such as procedural controls or clinical correlation.

Proficiency testing samples (also known as “external quality assurance”) often need different handling and preparation than patient samples. Therefore, separate instructions are needed for: •

receiving proficiency testing samples in the laboratory;

•

distributing and rotating samples for examination;

•

handling and preparing proficiency testing samples;

•

transcribing and submitting results;

•

reviewing reports; and

•

taking and documenting any necessary follow-up action.

9.2.1.7

Instructions for Performing the Examination Method

The examination method should be reflected in the title of the procedure document. For example: • “Antibody Screen by Gel Technique;” •

“Microscopic Urinalysis by Phase Microscopy;”

•

“Gram Stain Procedure;”

•

“Fingerstick Glucose Examinations on the XYZ Instrument.”

This section should present the stepwise instructions for performing the examination by the method validated in the laboratory (before use on patient samples) that was derived from the manufacturer’s package insert, or operator’s manual or reference method. When procedure instructions in the validated method are altered or deleted, the examination method performance may change and, therefore, appropriate verification that the changed method provides the expected results needs to be performed and documented. See Appendixes F through K for examples of how to present procedure instructions. 9.2.1.8

Method Performance Specifications9

The examination procedure needs to include information about the performance characteristics of the examination method. Where applicable, this section needs to include the following: • ©

analytic sensitivity (lower limit of detection, biological limit of detection);


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analytic specificity (including effect of interfering substances, such as chemicals [preservatives], drugs, cold agglutinins);

•

reportable range;

•

appropriate dilution and concentration protocols or reporting instructions if the reporting range is exceeded;

•

analytic accuracy (bias); and

•

analytic precision.

Appendixes M1 and M2 provide a means to present analyte-specific information by analyte or analyzer in a tabular format for easier comprehension. These tables can serve as useful references when answering questions about examinations and methods. 9.2.1.9

Calculations for Quantitative Procedures

Quantitative examination procedures need to include the equations for calculations when they are applicable to the examination. The calculation section needs to include: •

the full equation;

•

step-by-step instructions to solve the equation; and

•

an example of how to solve the equation.

This section is not needed for qualitative examination procedures (e.g., dipstick examinations, slide examinations, immunohematology examinations). A separate documented procedure is needed for periodically verifying calculations performed by the laboratory information system, because verification of calculations made by the computer does not take place at the time of performing examinations. 9.2.1.10 Expected Values The examination procedure needs to include the range of expected values for the analyte or examination result. The expected values encompass the reference range relevant to the following: • •

sample type; and demographic variables, such as sex, age, and race.

9.2.1.11 Interpretation of Results The examination procedure needs to include guidelines for interpreting examination results when applicable. This section should include: •

comparison of the results to the expected values or diagnostic findings to determine if the result is normal, abnormal, or indeterminate;

•

follow-up for indeterminate results;

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recognition of results that fall outside the reportable range, and reference back to the Method Limitations section; and

•

recognition of results that exceed critical limits (see Section 9.3.1).

9.2.2

Procedures for Automated Instruments and Manufacturers’ Operator’s Manuals

Multitest, random-access analyzers require documents that reflect the instructions for readying the analyzer for examinations; performing scheduled QC, calibration, or calibration verification; performing required maintenance and function checks; and troubleshooting problems. Automated examinations are centered on: •

preparing the instrument for examinations (e.g., start-up diagnostics, reagent sufficiency);

•

loading patient and nonpatient samples for examinations;

•

selecting the analytes to examine;

•

making decisions based on the values of controls and patient examination results; and

•

handling instrument problems.

Therefore, it is important that procedures clearly and accurately describe what the operator needs to do and how to do it. The laboratory may write its own procedures for performing these activities or may use those in the instrument operators’ manuals. The laboratory needs to review the manufacturers’ manuals to determine if the procedures match the laboratory’s 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 laboratory’s procedures (after proper validation and documentation of validation), the guidance provided herein for revision and approval should be followed. In addition to the common elements described in Section 7 for all documents, procedures for automated examinations need to cover all of the information discussed in Sections 9.2.1.1 through 9.2.1.11. Important information about analytes that are examined on analyzers can be presented in one or more tables that summarize analyte-specific information for easy reference. Examples of these types of tables are presented in Appendixes M1 and M2.

9.3

Postexamination Procedures

Postexamination procedures address the activities from reporting patient examination results to archiving results and samples. In addition to the common elements described in Section 7 for all documents, postexamination procedures need to include the following, where applicable: •

how results are prioritized;

•

entry of results into the laboratory reporting system;

•

guidelines for notification of appropriate individuals of examination results;

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archiving results and report documents; and

•

sample retention.

9.3.1

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Prioritizing Results

Postexamination procedures need to include instructions for prioritizing results that: •

are normal;

•

fall outside the reference range;

•

exceed the critical limits;

•

fall outside the reportable range (e.g., the use of greater than [>] and less than [ 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 < 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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Appendix H. (Continued) Urine Cultures: Reading and Interpreting Document #/version #

Effective Date: mm/dd/yy

Appendix 2: Urine Cultures—Definitive Identification and Susceptibility Criteria Organism Group

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]

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Appendix I. Sample Transfusion Service Procedure u

Weak D (D ) Determination Document #/version #

Effective Date : mm/dd/yy

Weak D (Du) Determination Purpose

This procedure provides instructions for performing the weak D (Du) determination. Weak forms of the Rho(D) antigen can be detected only after incubating the red cells with the anti-D reagent and using the antiglobulin technique.

Sample

Red cells for examination can be either anticoagulated (e.g., EDTA), or from a clot.

Materials

Reagents • 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 manufacturer’s 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

Anytown Hospital Laboratory, Anytown USA 12345 [filename and path]

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Appendix I. (Continued) u

Weak D (D ) Testing Document #/version #

Effective Date : mm/dd/yy

Procedure (Continued) Step 7

Wash the cells three times in the automatic cell washer.

8 9 10 11 12

Add two drops of anti-IgG reagent. Centrifuge for the saline spin time of the calibrated centrifuge. Resuspend each cell button and examine for agglutination. Grade and record the results. To each tube with a negative result, add one drop of IgG-sensitized (check) cells. Centrifuge for the saline spin time of the calibrated centrifuge. Resuspend each cell button and examine for agglutination. Grade and record the results. NOTE: Agglutination of the check cells confirms the presence of active antiglobulin reagent and indicates that the results obtained in step 14 are valid.

13 14 15

Interpretation

Action

+ = agglutination of the red cells 0 = no agglutination Anti-D + 0 +

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

• Manufacturer’s package insert for anti-D • AABB Technical Manual, current edition

Related Documents

Procedure ID. XXX: Entering Results into the BBLIS Procedure ID. XXX: Direct Antiglobulin Test Procedure ID. XXX: Daily Reagent Quality Control End


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Appendix J. Sample Histology Procedure Hematoxylin and Eosin Staining Procedure: Manual Method Document #/version #


Hematoxylin and Eosin Staining Procedure: Manual Method

Purpose

This procedure provides instructions for how to manually stain slides for microscopic examination with hematoxylin and eosin.

Materials

Equipment • 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 • Scott’s 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


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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 Scott’s 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

• Iodine Solution Preparation Procedure • Sodium Thiosulphate – 3% Aqueous Preparation Procedure • Harris Hematoxylin Stain Preparation Procedure • Acid Alcohol Preparation Procedure • Scott’s Tap Water Substitute Preparation Procedure • Eosin Stain Preparation Procedure

Reference

Bancroft JD, Gamble M. Theory and Practice of Histological Techniques. 5th ed. Churchill Livingstone; 2001.


End 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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Appendix K. Sample Computer Procedure Signing On To and Navigating IDX Document #/version #


Signing On to and Navigating the IDX System Purpose

This procedure provides instructions for “signing on” to the IDX system. •

Do not share your password with another employee – passwords are confidential information.

•

Do not sign on to a computer using another employee’s password.

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

NOTE: Your password cannot be duplicated or you will get the message “Password already in use.” <ENTER> Re-enter NEW password <ENTER> NONE

VERIFY PASSWORD Message: “Password Changed”

Continued on next page Anytown Hospital Laboratory, Anytown USA 12345 [filename and path]

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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]

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This example was contributed by the Laboratory Services of Sutter Health Sacramento-Sierra Region, Sacramento, California.

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Appendix L. Suggested Contents of Laboratory Procedures Examination Quantitative Qualitative Section Purpose Policy Reagents Equipment Supplies Sample Special safety precautions Quality control Procedure Calculations Interpretation/ Results/Alert Values Reference intervals Method performance specifications References Related documents Appendixes (forms, labels, tags, tables)

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

X

X

X

X Other procedures As used


X


NOTE: If there are separate procedures for any of these sections, then that section does not need inclusion in the procedure.

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Appendix M1. Attributes for a Single Analyte on the ABC Analyzer Creatinine Attributes for the XYZ Analyzer Document #/version #

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

Linear range of detection: 0.1 to 25.0 mg/dL

Reporting: - Reference Range

Male Age (Years) mg/dL 1 –2 0.2 – 0.6 3 –4 0.3 – 0.7 5 –9 0.4 – 0.8 10 – 11 0.5 – 0.9 12 – 13 0.6 – 1.0 14 – 15 0.7 – 1.1 > 16 0.8 – 1.2

Reporting: -Alert Limits

Female Age (Years) mg/dL 1–3 0.3 – 0.6 4–5 0.4 – 0.7 6–8 0.5 – 0.8 >9 0.6 – 0.9

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


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Appendix M1. (Continued) Creatinine Attributes for the XYZ Analyzer Document #/version #


CREATININE (Continued) Reporting Results Auto-release

0.4 to 25.0 mg/dL: Release results.

Low Recheck

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


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Appendix M2. Attributes for Multiple Analytes on the XYZ Analyzer Creatinine Attributes for the XYZ Analyzer Document #/version #

XYZ Analyzer


Protime (PT)

Partial Thromboplastin Time (PTT)

Principle Clinical Utility Sample Type -Stability -Volume (Preferred) (Minimum) -Patient Prep Reagents Calculations Interferences Method Performance Specifications Reporting - Reference Range Reporting -Alert Limits Continued on next page Anytown Hospital Laboratory, Anytown USA 12345 [filename and path]

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Appendix M2. (Continued) Creatinine Attributes for the XYZ Analyzer Document #/version #

XYZ Analyzer

Protime (PT)


Partial Thromboplastin Time (PTT)

Reporting Auto-release Low Recheck Dilutions

End


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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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Appendix N. Sample Table of Contents for a Preexamination Procedures Manual Patient Service Center Procedures Manual Table of Contents PAGE

SUBJECT

PROCESS

PROCEDURE

FORM

RESOURCE

Section A – General Information

X

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

X

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

X X X X X X X X X X X X X X X X X X X

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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

X


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Appendix N. (Continued) PAGE

SUBJECT

PROCESS

Processing Physician Office-Collected Specimens Physician Collected Specimen Transport List Receiving Specimens in LIS Processing and Storage of PSC-Collected Specimens Operating the Centrifuge Preparing Specimen Aliquots Generating a Batch Tracking List From LIS PSC Tracking List Preparing Transport Batch for Courier Pick-up Section F – Special Procedures

PROCEDURE

FORM

RESOURCE

X X X X X X X X X

Opening and Closing the PSC Patient Data Sheet Laboratory Glucose Tolerance Testing Glucose Tolerance Test Collection Form Recognizing and Responding to Adverse Reactions to Venipuncture Managing and Reporting Client Injuries Telephone Use Using the Fax Machine Operating/Answering the Phone Telephone Quick Reference Guide Computer Systems Opening a Help Desk Ticket Managing Workflow During Computer Downtime IDX Downtime Safety Responding to an Outpatient Emergency Responding to a Fire Fire Extinguisher Inspection and Service Fire Extinguisher Inspection and Maintenance Record Quality Management Quality Assessment Record

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.

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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 manufacturer’s manual) Troubleshooting Process Procedures (Troubleshooting Procedures from the manufacturer’s manual in the order in which they are performed) Section 4. Preventive Maintenance Process Preventive Maintenance Schedule (from manufacturer’s manual) (Preventive Maintenance Procedures from the manufacturer’s manual in the order in which they are performed) Section 5. Calibration Process Calibration Schedule (from manufacturer’s manual) Calibration Procedures [Calibration Procedures from the manufacturer’s manual • Installation Calibration • Periodic Calibration • Recalibration After Service or Repair]

Ideas for this example were contributed by: • Client Services Workgroup, Sutter Health Laboratory Integration Project, Sacramento, California; and • Central Clinical Laboratory, Mayo Clinic Department of Laboratory Medicine and Pathology, Rochester, Minnesota.

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Appendix P. Sample Table of Contents for a Computer Downtime Manual LIS and Automation Downtime Manual Table of Contents Section 1

Introduction

2

Types of Downtime Scheduled Downtime Unscheduled Downtime

3

Testing Test Production LIS Failure Plan Test Prioritization

4

LIS Failure Introduction Sequence of Events Forming the Control Team Control Team Assessment Implementation of Failure Plan Triage Specimens Notification of the Labor Pool Labor Pool Deployment Failure Plan Transition Between Shifts Postdowntime Plan Postdowntime Labor Pool Postdowntime Operations Termination of Failure Plan Labor Pool Definition Laboratory Contributions to Labor Pool Training Drills

5

Laboratory Information Services Communication Communication to LIS Communication From LIS Types of Failures/Impact Misys (Sunquest) Processors Servers Interfaces MULHOS Connection ROE Connections Laboratory Instruments Network Hardware Automation

LIS Failure Plan Communication LIS Start Up Protocol

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Appendix P. (Continued) LIS and Automation Downtime Manual (Continued) Section 6

LIS Scheduled Downtime Preparation Checklists Laboratory Information Support Team (LIST) Laboratory Information Services (LIS) Transfusion Medicine Manual Laboratory Automated Laboratory Clinical Microbiology Client Services/Distribution/Reference Laboratory Central Processing Area Phlebotomy Transport Services

7

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

8

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

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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

Laboratory Areas Specific Downtime Procedures Appendix H: Phlebotomy & Transport Services (PTS) Inpatient Downtime Procedures Communication of Downtime HIS Downtime LIS Downtime

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Appendix H: Phlebotomy and Transport Services (PTS) (Continued) Outpatient Downtime Interface Downtime HIS Downtime LIS Downtime All Systems Down Printers Down Appendix I: Central Processing Area (CPA) Scheduled Unscheduled Operations Short Downtime Extended CID Downtime Downtime Labels Off-Campus Specimens Labor Pool Startup after a Downtime Additional Startup Appendix J: Automated Laboratory Scheduled Unscheduled Operations Acute Care Laboratory Deployment of Labor Pool Appendix K: Manual Laboratory Online Instruments Manually Entered Tests Appendix L: Transfusion Medicine Principle Patient Inquiry and Testing Component Preparation Bank Area Blood Bank Inventory

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Appendix M: Clinical Microbiology Labor Pool Selection Labeling and Specimen Processing Result Inquiries Startup Microbiology Audit Trail Bench Work Postdowntime Appendix N: Reference Laboratory Principle Procedure Appendix O: Client Services Client Notification Client Notification List Appendix P: Accessing LIS Laboratory Results Inquiry

This example was contributed by the Department of Clinical Pathology of the Division of Pathology and Laboratory Medicine at the Cleveland Clinic Foundation, Cleveland, Ohio.

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Appendix Q1. Document Creation, Review, and Approval Process Flowchart Document Creation, Review, and Approval Process Need for new or changed documents is identified

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.

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Appendix Q2. Document Creation, Review, and Approval Process Table Document Creation, Review, and Approval Process What Happens Need for new document is identified

Who’s Responsible • anyone

OR Need for changed document is identified

• anyone

New document is drafted

• 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

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Procedures • • • • • • • •

“Selecting the Correct Document Type” “Selecting the Correct Document Format” New/Changed Document Request Form “Retrieving Current Document Version for Editing” New/Changed Document Request Form “Writing Policy, Process, and Procedure Documents” “Designing Form Documents” “Editing Documents in Microsoft Word 2000” “Reviewing and Verifying New or Changed Documents” New/Changed Document Request Form

• assigned staff reviewer • supervisor • medical director • quality function (where applicable) • supervisor

•

• supervisor

• “Notifying Staff of Document Changes”

•

• New/Changed Document Request Form


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Appendix R. Sample Document Change Request Form QSE: Documents and Records Document #/version #

Effective Date: mm/dd/yy Change #:_________________ Document Change Request Form

Document Name: Document Number: Version Number Check one:

Requestor: Date: New Document

Changed Document

Description of Document:

Rationale for new or changed document:

Are any related documents affected? ______Yes ______No If yes, list here. Also, prepare additional Document Change Request Forms, if needed.

Is process validation affected? Why or why not?

______Yes

______No

Signature Approval Signature

Date

Document Author Supervisor Director Issue Date for Training Effective Date for Use Annual Review Signature

Designee

Anytown Hospital Laboratory, Anytown, USA 12345 [filename and path]

Date

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Appendix S. Ten Rules for Document Control # 1

2

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.

3

Notify your supervisor or team leader if more than one version of a document is found in a work area.

4

Keep controlled copies of documents (ones with controlled copy numbers on the page) in the bench manuals where they have been placed. Notify your immediate supervisor or team leader when a change to a document is required.

5

6 7 8

9

10

Do not write on controlled copies of documents. Do not white out on controlled copies of documents. Do not photocopy controlled copies of documents.

Do not print uncontrolled copies of documents for prolonged use at the workstation. Do not release documents outside the Laboratory Department without approval of the Administrative Director or Medical Director.

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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Clinical and Laboratory Standards Institute consensus procedures include an appeals process that is described in detail in Section 8 of the Administrative Procedures. For further information, contact CLSI or visit our website at www.clsi.org.

Summary of Delegate Comments and Working Group Responses GP2-A5: Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition General 1.

I particularly noticed that GP2-A5 references ISO 15189, and so believe that it needs to follow its standards more closely. ISO 17025, as the basis for all testing laboratories, is very similar (though not identical) and GP2-A5 should encompass it, as well.

•

Concepts from ISO 15189 have been included in GP2-A5. Because ISO 15189 is based on ISO 17025, those concepts are included, as well. ISO 17025 has been added as a reference.

2.

I can see that you may have a great deal of resistance to your suggestion to (once again) completely rewrite the Procedures manual. This is a lengthy and often painful process, and is not a favorite of any manager or supervisor that I have ever known. At the same time, so much of it makes such perfect sense, that once the manuals are rewritten and documented, they will be so much easier to use at the bench level, and much more easily modified at the management level. Are you planning on having (or suggesting) a time frame for implementing these admittedly terrific suggestions? I don’t 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. I’m no slouch at Word, Excel, Powerpoint, etc., but I would have no idea how to set up some of these documents. I’m 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 laboratories⎯laboratories 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 process⎯perhaps 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

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guideline describes what laboratories need to do to meet published regulations and accreditation requirements, specifically ISO 9001, ISO 17025, and ISO 15189.” •

A modified version of this recommendation has been incorporated into the Foreword; however, the working group chose not to include ISO 9001 because the vast majority of medical laboratories will not be seeking ISO 9001 certification. Laboratories that seek ISO 9001 certification will need to follow that specific standard, as well.

Section 1, Scope 4.

I recommend modifying the second paragraph to read as follows: “Also, this edition of GP2 provides useful information about preparing, approving, maintaining, reviewing, changing, and archiving laboratory documents.”

•

This editorial change has been incorporated in the text.

Section 2, Introduction 5.

The recommendations provided in the second paragraph break procedures up too much. It is more effective to simply define “who does which part” or have several subprocedures in one document.

•

Combining several subprocedures into one document results in a text version of a process document, which is what this guideline is trying to caution against because they become too long and hard to follow. However, users can choose to combine documents if they wish.

Section 3, Definitions 6.

I recommend modifying the definition for “form” as follows: “form – a paper or electronic document on which the results from the performance of a procedure or other information are captured, and becomes a record.”

•


7.

“Sample” replaces the term “specimen.” Why? To me, specimen is more specific.

•

As described in the “Note on Terminology” that appears after the Foreword, the use of “sample” instead of “specimen” is to ensure consistency with international terminology.

Section 4, Path of Workflow 8.

“The laboratory uses resources such as people, machines, methods…” Maybe it’s just me, but I prefer the word “instrument” to “machine.” To me, an instrument implies something to use for precision measuring, whereas a machine is just a machine.

•

This editorial change was made to Section 4, line 2.

Section 5.1, Key Work Processes (and many times in the document), Appendixes 9.

Many years ago, I learned that the proper way to spell this word was appendices. I looked it up, and apparently, both ways are acceptable, but as we are scientists, and are using many Greek- and Roman-based words on a regular basis, we should use the most grammatically correct word. My vote would be for appendices, for what it’s worth.

•

CLSI editorial policy requires the use of the word “Appendixes.”

Section 6, Procedure – How to Do It 10. We have tried to implement the recommendations in Section 6 and found it extremely cumbersome. We have now written procedures that describe the whole process (where reasonable). This provides better flow and better training. •

“Procedures” that describe the whole process are process documents. This guideline does not prevent users from creating written process documents.

11. These are great! •

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Section 7, Elements Common to Process and Procedure Documents 12. Other industries use policy/procedure with a flowchart (diagram) on page one of the procedure. Some processes are so complex that they do stand alone, but this is often not the case. •

Many industries use the word “procedure” to mean “process.” In this guideline, the working group has separated the concepts of sequential activities (process) from step-wise instructions (procedure) and encourages the use of separate documents. This guideline does not prevent users from creating written process documents.

Section 7.1, Title 13. Explain that in the examples, “ing” replaces the word “procedure.” •


Section 7.5, Related Documents 14. Tables that provide information or instruction only are Related Documents. Forms that gather information are records, and therefore, are appendixes or attachments. •

This section only relates to other procedures referred to in this procedure, not to tables or forms. Tables and forms are appendixes (or attachments).

Section 7.7, Appendixes or Attachments 15. This should be Appendices (the correct plural of appendix). Check for the need to replace elsewhere in the document. •

CLSI editorial policy requires the use of the term “Appendixes.”

16. Title the section appropriately, i.e., Appendixes or Attachments. •


Section 7.8, Author 17. This section recommends that “the author(s) of the document needs to be noted.” Why? Work area must be noted, not necessarily the name of the person. •

This statement has been modified, as no requirement for author’s name could be found.

Section 8.1, Benefits of Process Documents 18. Section 8.1 states: “Although there is no governmental or accreditation requirement for the laboratory to document its work operations processes, doing so provides the following valuable benefits…” This is wrong. Refer to ISO 9001, Clause 4.1 (a), (b), etc. •

The working group chose not to include ISO 9001 requirements in this guideline because accreditation and regulatory requirements do not require it and the vast majority of medical laboratories will not be seeking ISO 9001 certification. Laboratories that seek ISO 9001 certification will have to document their work processes.

19. Table 1. I recommend including the following bullet at the end of the list under the heading of Preexamination Processes: “sending sample to another laboratory (e.g., reference laboratory).” •

Sending samples to another laboratory is included in “Sample Processing.” See Section 9.1, fourth bullet.

Section 8.2, Suggested Template for Process Documents 20. For better continuity, I recommend changing “Supporting Documents” to “Related Documents” in the last paragraph. •

Procedures (instructions) support process documents. Related Documents are other procedures referred to within a given procedure. Therefore, within these definitions, Supporting Documents and Related Documents are not the same.

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Section 9.1, Preexamination Procedures 21. Add the following bullet to the beginning of the list of bullet items: “patient identification.” •

Patient identification at the time of sample collection is already included in the second bullet.

22. Modify the fourth bullet to read: “criteria for unacceptable samples and follow-up action.” •


Section 9.1.1, Patient Preparation 23. Add a new Section 9.1.1 on Patient Identification followed by two bullets as follows: “minimum two identifiers” and “follow local Health Act.” Then, renumber subsections accordingly. •

This information was added to Section 9.1, second bullet on sample collection and labeling.

Section 9.1.2, Sample Collection and Labeling 24. This section needs expansion. See ISO 15189, Clause 5.4.3. •

The items in ISO 15189 Section 5.4.3 have been edited into their respective sections (in Section 9.1.2) as suggested.

Section 9.1.3, Required Equipment and Forms 25. I recommend modifying the first sentence to read: “…about the required equipment used and forms and use of forms needed for the procedure.” Also include text on completion of required information; see ISO 17025, Clause 5.7.2 (…deviations, additions or exclusions); Clause 5.7.3 (…all relevant data); and, Clause 5.8.3 (…record all discussions). •


26. ISO 17025 clauses 5.7.2, 5.7.3, and 5.8.3 are about client-requested deviations… and samples that do not meet requirements. Instructions for how to handle these deviations need inclusion in procedures for sample receiving and processing and have been added to the appropriate parts of Section 9.1. Add a new second bullet that reads as follows: “sample identification (two identifiers) – must match requisition.” •

This information was added to the second bullet of Section 9.1.

Section 9.1.6, Sample Storage Requirements 27. Add a new second bullet that reads, “security.” See ISO 17025, Clause 5.8.4 (…held secure). •

This information was added to the first bullet of Section 9.1.6.

Section 9.1.7, Problems or Pitfalls 28. I recommend modifying the section title to read: “Criteria for Unacceptable Samples and Follow-up.” •

Section 9.1.7 covers more than just unacceptable samples.

Section 9.2.1.3, Supplies 29. A separate written procedure is needed for ensuring that supplies, reagents, and consumable materials that affect the quality of the test are not used until inspected or verified that they comply with specifications. See ISO 17025, Clause 4.6.2; see also ISO 15189, Clause 5.3 (includes consumables and reagents); Clause 5.3.2 (…shall comply with specifications relevant to the examinations concerned); and Clause 4.6.2 (…supplies…shall not be used until they have been verified…). •

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Section 9.2.1.4, Equipment Calibration and Maintenance 30. Under Calibration: Include a new bullet for “services.” ISO 17025, Clauses 4.6.1 and 4.6.2: qualifications required to perform calibrations, e.g., ISO 17025 accredited calibrating laboratory or employee passed competence testing. See also ISO 15189, Clause 4.6.4. •

Section 9.2.1.4 is about written instructions for laboratory personnel to perform calibrations. The information in the ISO 17025 and ISO 15189 sections quoted is about qualifying suppliers of calibration services, which does not take place at the time of examination and therefore, does not apply to this section.

31. Under Maintenance: Delete “…and storage requirements for maintenance records” from the last bullet. This information falls under “Documents and Records,” not equipment procedures. •


Section 9.2.1.6, Quality Control (QC) 32. Second paragraph on proficiency testing: For laboratories subject to CLIA’88, penalties for not following the CLIA regulations on handling PT specimens and results can be severe. Thus I recommend that 1) the statement that PT samples “are handled as regular patient specimens” *be deleted, because this is not true in all instances; and 2) that a statement be added such as, “Laboratories need to be certain that PT samples are handled in accordance with applicable government regulations.” (*In certain situations, patient specimens may be referred for analysis/consultation to a laboratory with a different CLIA number. CLIA’88 forbids this practice for PT samples.) •

The statement has been modified as appropriate to the comment.

Section 9.2.1.7, Instructions for Performing the Examination Method 33. The second paragraph states: “When procedure instructions taken from manufacturer’s literature are altered or deleted, the examination method performance may change and, therefore, appropriate verification that the changed method provides the expected results needs to be performed and documented.” Note: Test method validations need to be performed and documented for all methods. •

The section has been modified to reflect this comment.

Section 9.2.1.8, Method Performance Specifications 34. This section actually is partially addressing method performance specifications (which include method limitations). I suggest renaming this section “Method Performance Specifications” and revising as follows: The examination procedure needs to include information about performance characteristics of the examination method. When applicable, this section needs to include the following: • • • • • • •

analytic sensitivity (lower limit of detection, biologic limit of detection); analytic specificity (including effect of interfering substances, such as chemicals [preservatives], drugs, cold agglutinins); reportable range; appropriate dilution and concentration protocols, or reporting procedures if the reportable range is exceeded; analytic accuracy (bias); and analytic precision.


35. If not already present in the References section of the guideline, I suggest adding as a reference for this section, Basic Method Validation by James O. Westgard, 2nd edition, Westgard QC Inc., 2003. •

This reference was added.

Section 9.2.1.11, Interpretation of Results 36. Delete “…and follow-up…” from the last bullet. Also delete the cross-reference to Section 9.3 (follow-up is in Section 9.3). •


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Section 9.2.2, Procedures for Automated Instruments and Manufacturers’ Operator’s Manuals 37. Include the following text as the last sentence of the fourth paragraph: “Test method validation needs to be performed and documented.” •

The concept was edited into the existing text.

Section 9.3.2, Entry of Results Into the Laboratory Reporting System 38. This section needs to include test report content control (see ISO 17025 and ISO 15189). Also needs to include audit trail. •

Information about test report content control and audit trail is needed at the time of designing the reporting process—not at the time workers are entering results into the reporting system. Report content and auditing is covered in CLSI/NCCLS GP26—Application of a Quality Management System Model for Laboratory Services.

Section 9.3.4, Archiving Results 39. Postexamination procedures for archiving results should address identification, collection, indexing, and disposal (see ISO 17025, Clause 4.12.1.1). •

Section 9.3.4 has been modified as appropriate.

Section 9.3.5, Sample Retention 40. Postexamination procedures for sample retention should address identification, collection, indexing, and disposal. •

Section 9.3.5 has been modified as appropriate.

Section 10, Form Documents 41. Include a new fourth bullet “authorization.” •

Forms are authorized as part of the process for design and development of a given process or procedure document. Approval signatures are captured at the time of document approval.

42. The last sentence in the second paragraph should read: “These examples can be placed in the Appendixes (or Attachments) section of their respective procedures.” •


Section 11, Procedures Manuals 43. I’ve always heard them called in the singular Procedures manuals. Any reason for the change? Or is it a typo? •

Each manual has more than one procedure, so it is more grammatically correct to say “procedures” manuals.

44. The paragraph under the bullets, and relating to the forms alluded to in the Appendixes: I like this – good idea. Thanks for the suggestions. Would be much more user-friendly for the bench tech, and would help management give a stronger “this is how we want it to be done” approach, versus the teaching Tech teaching the newbie how he/she has done it for years. •

These examples were contributed by real laboratories that have realized the benefits of following the recommendations provided in this guideline.

Section 12.2, Master File 45. Modify the first sentence to read: “Each document needs to have a master file…” •

A master file is not required; it’s only a recommendation for keeping better control of the history of each document.

Section 12.4, Review and Approval of Changes to Approved Documents 46. I recommend modifying text in the third paragraph as follows: “When changes to a particular procedure document are made, the laboratory service needs to also determine what other documents will be affected by the change. This is facilitated by review of the appropriate process flowchart or table or Related Documents and Attachments.” ©


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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.

Section 12.6, Periodic Review of Unchanged Documents 48. Modify the first sentence as follows: “When documents are managed using a document control process, such as that described in this section, periodic review is necessary.” See ISO 17025, Clause 4.3.2.2 b (i.e., documents are periodically reviewed) and ISO 15189, Clause 4.3.2 d. •


Section 12.7, Master Index 49. Modify the second paragraph, second sentence as follows: “In addition, the master index needs to include a version number and the locations of each working copy of the document.” See ISO 17025, Clause 4.3.2.1 (…master list… identifying current revision status and distribution… shall be established) and ISO 15189, Clause 4.3.2 b (similar). •


Section 12.9, Archiving, Storage, and Retention of Documents 50. Modify the first paragraph, last sentence as follows: “A notation or stamp indicating the retirement date is needed to identify the document…” See ISO 17025, Clause 4.3.2.2 d and ISO 15189, Clause 4.3.2 f. •


51. Modify the second paragraph, last sentence as follows: “The laboratory must have documented processes…” Archived documents are actually records and so must follow ISO 17025, Clause 4.12 and ISO 15189, Clause 4.13. •


References 52. Include ISO 17025 in the reference list. •


53. Why the small font? •

CLSI style dictates formatting requirements.

Appendixes - Flowcharts 54. In the flowcharts, in many cases it would be appropriate to add additional step(s) for confirmation of the identity of the sample before testing or reporting the result. For example, in Appendix E1, the box “slides are read and surgeon notified by pathologist” can be broken down into “slides are read,” then “pathologist confirms patient identification with surgeon,” and then “pathologist communicates frozen section diagnosis to surgeon.” Confirmation of specimen identification may be appropriate for the transfusion medicine process chart and flow chart, in particular. •

Confirmation of the identity of the sample is a step in the testing or reporting procedure (e.g., “Step 2. Verify the identity of the sample before proceeding”). The laboratory does not have to have a separate set of instructions for how to verify the identity of a sample, but it could if it wishes.

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Appendix A2, Inpatient Blood Sample Collection Process Table 55. Insert “phlebotomist” in the “Who’s Responsible” boxes for the following “What Happens” categories: • • • • •

Collection list or labels are generated Patient is identified Blood samples are collected Blood samples are labeled Samples are transported to the laboratory

In certain states, phlebotomists must be licensed or certified, and I think the title should be recognized in this process table to make it more universal. •

Thank you for this observation. The word “phlebotomist” was inadvertently omitted from the entire “Who’s Responsible” column. This editorial change has been incorporated in the text.

Appendix B1, Analyzer Examination Process Flowchart 56. Add a box between the “Results are evaluated” and “Results are verified in the LIS” that says “Critical Values are called,” similar to the flowchart in Appendix C1. •


Appendix B2, Analyzer Examination Process Table 57. Similar to the above comment, add a box between the “Results are evaluated” and “Results are verified in the LIS” that says “Critical Values are called,” similar to the chart in Appendix C2. •


Appendix C2, Bacteriology Culture Process Table 58. Example. Technicians are included in reading and interpreting cultures. In Canada, this can only be done by technologists. •

This is simply an example that can be adjusted as appropriate in your setting. In the “Who’s Responsible” column, your laboratory would list only those personnel who are qualified to perform that activity based on national, regional, or local requirements.

Appendix D2, Transfusion Medicine Prenatal Examination Process Table 59. Example: Technicians are included in performing type and screen. In Canada, this can only be done by technologists. Are these necessary to be included in the example or can the technician be left off to make this a more international standard? •

See response to comment 58.

Appendix M2, Attributes for Multiple Analytes on the XYZ Analyzer 60. Pages 53, 54, 55: the Watermark stating these are examples is missing. •

Watermarks have been superimposed on all examples as recommended.

Appendix N, Sample Table of Contents for a Preexamination Procedures Manual 61. Appendix N chart: Patient Refusal of Testing Form has an X in Resource. Should this not be a form? Verifying Correct Patient Information in IDX has an X in both a procedure and resource. Is it possible to be both? •

These editorial changes have been made.

Appendix P, Sample Table of Contents for a Computer Downtime Manual 62. LIS and Automated Downtime, Section 7: Add “Testing Areas” under “Downtime Operational Plan/Full Impact Downtime Plan/Short Downtime.” Change “Testing” to “Testing Areas” under the same paragraph, “Moderate Impact Downtime Plan.” • ©

These editorial changes have been incorporated in the text.


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The Quality System Approach Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the development of standards and guidelines, which facilitates project management; defines a document structure via a template; and provides a process to identify needed documents. The approach is based on the model presented in the most current edition of CLSI/NCCLS document HS1—A Quality Management System Model for Health Care. The quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any healthcare service’s path of workflow (i.e., operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide. The quality system essentials (QSEs) are: Documents & Records Organization Personnel

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 HS1—A Quality Management System Model for Health Care.

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Related CLSI/NCCLS Publications* GP17-A2

Clinical Laboratory Safety; Approved Guideline—Second 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 Guideline—Second 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 laboratory’s 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 Guideline—Second Edition (2004). This document provides a model for providers of healthcare services that will assist with implementation and maintenance of effective quality management systems.

M29-A3

Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline— Third Edition (2005). Based on U.S. regulations, this document provides guidance on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents.

*

Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process; therefore, readers should refer to the most current editions. ©


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Active Membership (as of 1 January 2006) Sustaining Members Abbott Laboratories American Association for Clinical Chemistry Bayer Corporation BD Beckman Coulter, Inc. bioMérieux, Inc. CLMA College of American Pathologists GlaxoSmithKline Ortho-Clinical Diagnostics, Inc. Pfizer Inc Roche Diagnostics, Inc. Professional Members American Academy of Family Physicians American Association for Clinical Chemistry American Association for Laboratory Accreditation American Association for Respiratory Care American Chemical Society American Medical Technologists American Society for Clinical Laboratory Science American Society for Microbiology American Society of Hematology American Type Culture Collection, Inc. ASCP Assn. of Public Health Laboratories Associazione Microbiologi Clinici Italiani (AMCLI) British Society for Antimicrobial Chemotherapy Canadian Society for Medical Laboratory Science - Société Canadienne de Science de Laboratoire Médical Canadian Standards Association CISMEL-SIMel Clinical Laboratory Management Association COLA College of American Pathologists College of Medical Laboratory Technologists of Ontario College of Physicians and Surgeons of Saskatchewan ESCMID Hong Kong Accreditation Service Innovation and Technology Commission Int’l Federation of Clinical Chemistry Italian Society of Clinical Biochemistry and Clinical Molecular Biology Japanese Committee for Clinical Laboratory Standards Joint Commission on Accreditation of Healthcare Organizations National Academy of Clinical Biochemistry National Association of Testing Authorities - Australia National Society for Histotechnology, Inc. Ontario Medical Association Quality Management Program-Laboratory Service RCPA Quality Assurance Programs PTY Limited Sociedad Espanola de Bioquimica Clinica y Patologia Molecular Sociedade Brasileira de Analises Clinicas Taiwanese Committee for Clinical Laboratory Standards (TCCLS) Turkish Society of Microbiology World Health Organization Government Members Armed Forces Institute of Pathology Association of Public Health Laboratories BC Centre for Disease Control Caribbean Epidemiology Centre Centers for Disease Control and Prevention Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services/CLIA Program Chinese Committee for Clinical Laboratory Standards Department of Veterans Affairs

Deutsches Institut für Normung (DIN) FDA Center for Biologics Evaluation and Research FDA Center for Devices and Radiological Health FDA Center for Veterinary Medicine FDA Division of Anti-Infective Drug Products Iowa State Hygienic Laboratory Maryland Dept. of Health & Mental Hygiene Massachusetts Department of Public Health Laboratories National Center of Infectious and Parasitic Diseases (Bulgaria) National Health Laboratory Service (South Africa) National Institute of Standards and Technology National Pathology Accreditation Advisory Council (Australia) New York State Department of Health Ontario Ministry of Health Pennsylvania Dept. of Health Saskatchewan Health-Provincial Laboratory Scientific Institute of Public Health; Belgium Ministry of Social Affairs, Public Health and the Environment Industry Members AB Biodisk Abbott Diabetes Care Abbott Laboratories Access Genetics Acrometrix Corporation AdvaMed Advancis Pharmaceutical Corporation Affymetrix, Inc. Agilent Technologies, Inc. Ammirati Regulatory Consulting Anna Longwell, PC A/S ROSCO AstraZeneca Pharmaceuticals Axis-Shield Diagnostics Axis-Shield POC AS Bayer Corporation - Elkhart, IN Bayer Corporation - West Haven, CT BD BD Diabetes Care BD Diagnostic Systems BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter K.K. (Japan) Bio-Development S.r.l. Bio-Inova Life Sciences International Biomedia Laboratories SDN BHD bioMérieux, Inc. (IL) bioMérieux, Inc. (MO) Biometrology Consultants Bio-Rad Laboratories, Inc. Bio-Rad Laboratories, Inc. – France Bio-Rad Laboratories, Inc – Irvine, CA Bio-Rad Laboratories, Inc. – Plano, TX Black Coast Corporation – Health Care Systems Consulting Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Cepheid Chen & Chen, LLC Chi Solutions, Inc. Chiron Corporation The Clinical Microbiology Institute Comprehensive Cytometric Consulting Control Lab Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Cumbre Inc. Dade Behring Inc. - Cupertino, CA Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA David G. Rhoads Associates, Inc. Diagnostic Products Corporation Digene Corporation Eiken Chemical Company, Ltd. Elanco Animal Health Electa Lab s.r.l. Enterprise Analysis Corporation

F. Hoffman-La Roche AG Future Diagnostics B.V. Gavron Group, Inc. Gen-Probe Genzyme Diagnostics GlaxoSmithKline Greiner Bio-One Inc. Immunicon Corporation 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. Novartis Institutes for Biomedical 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 Pharmacia Diagnostics AB Powers Consulting Services Predicant Biosciences Procter & Gamble Pharmaceuticals, 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 Sphere Medical Holding 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 Wyeth Research 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) Academisch Ziekenhuis -VUB (Belgium) ACL Laboratories (WI) Alexandria Hospital (IL) All Children’s Hospital (FL) Allina Health System (MN) Allina Labs Alton Memorial Hospital (MN) American University of Beirut Medical Center (NY) Anaheim Memorial Hospital (CA)

Antwerp University Hospital (Belgium) Arkansas Department of Health Arnett Clinic, LLC (IN) Aspirus Wausau Hospital (WI) Associated Regional & University Pathologists (UT) AZ Sint-Jan (Belgium) Azienda Ospedale Di Lecco (Italy) Barnes-Jewish Hospital (MO) Barnes Jewish West County Hospital (MO) BayCare Health System (FL) Baystate Medical Center (MA) Bbaguas Duzen Laboratories (Turkey) BC Biomedical Laboratories (Surrey, BC, Canada) Bo Ali Hospital (Iran) Boone Hospital Center (MO) Broward General Medical Center (FL) Calgary Laboratory Services (Calgary, AB, Canada) California Pacific Medical Center Cambridge Memorial Hospital (Cambridge, ON, Canada) Canterbury Health Laboratories (New Zealand) Capital Health System Fuld Campus (NJ) Capital Health System Mercer Campus (NJ) Carolinas Medical Center (NC) Central Baptist Hospital (KY) Central Ohio Primary Care Physicians Central Texas Veterans Health Care System Children’s Healthcare of Atlanta (GA) Children’s Hospital (NE) Children’s Hospital Central California Children’s Hospital Medical Center (Akron, OH) Childrens Hospital of Wisconsin Christian Hospital/Northeast/ Northwest (MO) Christus St. John Hospital (TX) City of Hope National Medical Center (CA) Clarian Health - Methodist Hospital (IN) Clendo Lab (PR) Clovis Community Hospital (CA) CLSI Laboratories (PA) Commonwealth of Kentucky Community Care 5 (OH) Community College of Rhode Island Covance Central Laboratory Services (IN) Creighton University Medical Center (NE) Dekalb Memorial Hospital (IN) Detroit Health Department (MI) DFS/CLIA Certification (NC) Diagnostic Accreditation Program (Vancouver, BC, Canada) Diagnósticos da América S/A (Sao Paulo) Dianon Systems (OK) Dr. Everett Chalmers Hospital (New Brunswick, Canada) Emory University Hospital (GA) Evangelical Community Hospital (PA) Faith Regional Health Services (NE) Firelands Regional Medical Center (OH) Fisher-Titus Memorial Hospital (OH) Florida Hospital East Orlando Focus Technologies (VA) Fresno Community Hospital and Medical Center Gamma-Dynacare Laboratories (Brampton, Ontario) Gamma Dynacare Medical Laboratories (Ontario, Canada) Geisinger Medical Center (Danville, PA) Geisinger Wyoming Valley Medical Center (Wilkes-Barre, PA) General Health System (LA) Hamad Medical Corporation (Qatar) Harris Methodist Fort Worth (TX) Health Network Lab (PA) Health Partners Laboratories (VA) High Desert Health System (CA) Hoag Memorial Hospital Presbyterian (CA)


Hôpital Maisonneuve - Rosemont (Montreal, Canada) Hospital Consolidated Laboratories (MI) Hospital for Sick Children (Toronto, ON, Canada) Hotel Dieu Grace Hospital (Windsor, ON, Canada) Hunter Area Pathology Service (DE) Hunterdon Medical Center (NJ) Indiana University International Health Management Associates, Inc. (IL) Island Hospital (WA) Jackson Health System (FL) Jackson South Community Hospital (FL) Jacobi Medical Center (NY) John H. Stroger, Jr. Hospital of Cook County (IL) Johns Hopkins at Bayview (MD) Johns Hopkins Howard County General Hospital (MD) Johns Hopkins Medical Institutions (MD) Kaiser Permanente (CA) Kaiser Permanente (MD) Kantonsspital Aarau AG (Aarau, AG) Karolinska University Hospital King Abdulaziz Medical City – Jeddah (Jeddah, WR, Saudi Arabia) King Faisal Specialist Hospital (Saudi Arabia) Kosciusko Laboratory (IN) LabCorp (NC) Laboratoire de Santé Publique du Quebec (Canada) Laboratório Fleury S/C Ltda. (Brazil) Laboratorio Manlab (Argentina) Laboratory Corporation of America (NJ) Lakeland Regional Medical Center (FL) Lawrence General Hospital (MA) Lewis-Gale Medical Center (VA) L’Hotel-Dieu de Quebec (Quebec, PQ) Long Beach Memorial Medical Center (CA) Long Island Jewish Medical Center (NY) Manipal Acunova Pvt., Ltd. (India) Martin Luther King/Drew Medical Center (CA) Massachusetts General Hospital (Microbiology Laboratory) MDS Metro Laboratory Services (Burnaby, BC, Canada) Medical Centre Ljubljana (Slovinia) Medical College of Virginia Hospital

Medical University of South Carolina (SC) Memorial Medical Center (Napoleon Avenue, New Orleans, LA) Memorial Regional Hospital (FL) Montreal General Hospital (Canada) Mount Sinai Hospital (NY) MRL Europe (Zaventem) National Healthcare Group (Singapore) National Serology Reference Laboratory (Australia) National University Hospital (Singapore) NB Department of Health & Wellness (New Brunswick, Canada) The Nebraska Medical Center Nevada Cancer Institute New Britain General Hospital (CT) New England Fertility Institute (CT) New York University Medical Center NHG Diagnostics (Singapore) Nichols Institute Diagnostics (CA) NorDx (ME) North Bay Hospital North Carolina State Laboratory of Public Health North Coast Clinical Laboratory (OH) North Shore Hospital Laboratory (Auckland, New Zealand) North Shore - Long Island Jewish Health System Laboratories (NY) Northern Plains Laboratory (ND) Northwestern Memorial Hospital (IL) Onze Lieve Vrouw Ziekenhuis (Belgium) Orange Coast Memorial Medical Center (CA) Orlando Regional Healthcare System (FL) The Ottawa Hospital (Ottawa, ON, Canada) Parkland Health Center (MO) Pathology and Cytology Laboratories, Inc. (KY) Pathology Associates Medical Laboratories (WA) Pathology Associates of Boone (NC) Penn State Hershey Medical Center (PA) The Permanente Medical Group (CA) Phoenix College (AZ) Piedmont Hospital (GA) Pitt County Memorial Hospital (NC) PPD (KY) Presbyterian Hospital of Dallas (TX) Prince George Medical Lab (Prince George, BC)

Providence Health Care (Vancouver, BC, Canada) Provincial Health Services Authority (Vancouver, BC, Canada) Provincial Laboratory for Public Health (Edmonton, AB, Canada) Quest Diagnostics, Inc (San Juan Capistrano, CA) Quintiles Laboratories, Ltd. (GA) Regional Health Authority Four (NB, Canada) Regions Hospital Rhode Island Department of Health Laboratories Riyadh Armed Forces Hospital (Riyadh) SAAD Specialist Hospital (Saudi Arabia) SAE – Laboratorio Medico (Brazil) St. Agnes Healthcare (MD) St. Anthony’s Hospital (FL) St. Barnabas Medical Center (NJ) St. Christopher’s Hospital for Children (PA) St-Eustache Hospital (Quebec, Canada) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. John’s Hospital & Health Center (CA) St. Joseph’s Hospital (FL) St. Joseph’s Hospital-Marshfield Clinic (WI) St. Jude Children’s Research Hospital (TN) St. Louis Children’s Hospital (MO) St. Margaret Memorial Hospital (PA) St. Michael’s Hospital (Toronto, ON, Canada) St. Vincent’s University Hospital (Ireland) San Francisco General Hospital (CA) Santa Clara Valley Medical Center (CA) Shands at the University of Florida SJRMC Plymouth Laboratory (IN) Sonora Quest JV (AZ) South Bend Medical Foundation (IN) South Florida Baptist Hospital (FL) South Texas Laboratory (TX) South Western Area Pathology Service (Australia) Southern Maine Medical Center Specialty Laboratories, Inc. (CA) Starke Memorial Hospital Laboratory (IN) State of Washington Department of Health Stormont-Vail Regional Medical Center (KS)

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

Sunnybrook & Women’s College Health Sciences Centre (Toronto, Ontario) Sunnybrook Health Science Center (ON, Canada) Taiwan Society of Laboratory Medicine Tan Tock Seng Hospital (Tan Tock Seng) Texas Department of State Health Services (TX) The Children’s University Hospital (Ireland) The Permanente Medical Group (CA) Tri-Cities Laboratory (WA) Tripler Army Medical Center (HI) Tuen Mun Hospital (Hong Kong) Tuttle Army Health Clinic (GA) UCLA-Brentwood Lab (CA) UCLA Medical Center (CA) UCSD Medical Center (CA) UNC Hospitals (NC) Union Clinical Laboratory (Taiwan) United Laboratories Company (Kuwait) Universita Campus Bio-Medico (Italy) University Medical Center (CA) University of Chicago Hospitals (IL) University of Colorado Hospital University of Debrecen Medical Health and Science Center (Hungary) University of Medicine & Dentistry, NJ University Hospital University of MN Medical Center Fairview University of the Ryukyus (Japan) University of Virginia Medical Center University of Washington US LABS, Inc. (CA) USA MEDDAC-AK UZ-KUL Medical Center (Belgium) Valley Health (VA) Vejle Hospital (VA) Virginia Beach General Hospital (VA) Wellstar Health Systems (GA) West China Second University Hospital, Sichuan University (P.R. China) William Beaumont Army Medical Center (TX) William Beaumont Hospital (MI) Winn Army Community Hospital (GA) Women’s Health Laboratory (TX) Woodlawn Hospital (IN) York Hospital (PA)

BOARD OF DIRECTORS Susan Blonshine, RRT, RPFT, FAARC TechEd

J. Stephen Kroger, MD, MACP COLA

Maria Carballo Health Canada

Jeannie Miller, RN, MPH Centers for Medicare & Medicaid Services

Kurt H. Davis, FCSMLS, CAE Canadian Society for Medical Laboratory Science

Gary L. Myers, PhD Centers for Disease Control and Prevention

Russel K. Enns, PhD Cepheid

Klaus E. Stinshoff, Dr.rer.nat. Digene (Switzerland) Sàrl

Mary Lou Gantzer, PhD Dade Behring Inc.

James A. Thomas ASTM International

Lillian J. Gill, DPA FDA Center for Devices and Radiological Health

Kiyoaki Watanabe, MD Keio University School of Medicine

Glen Fine, MS, MBA, Executive Vice President


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