™ Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 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 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 customerservice@clsi.org 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 Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Volume 26 Number 12 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: customerservice@clsi.org; Website: www.clsi.org Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Number 12 GP2-A5 This publication is protected by copyright No part of it may be reproduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute, except as stated below Clinical and Laboratory Standards Institute hereby grants permission to reproduce limited portions of this publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in educational programs provided that multiple copies of such reproduction shall include the following notice, be distributed without charge, and, in no event, contain more than 20% of the 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 ISBN 1-56238-600-X ISSN 0273-3099 ii Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Volume 26 GP2-A5 Committee Membership Area Committee on General Laboratory Practices Sheila M Woodcock, MBA, FCSMLS(D) Chairholder QSE Consulting Rose Bay, Nova Scotia, Canada Albert Rabinovitch, MD, PhD Vice-Chairholder Abbott Hematology Santa Clara, California Eric Arendash, MT(ASCP) Centers for Medicare & Medicaid Services Philadelphia, Pennsylvania Lucia M Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ)CQMgr Quality Systems Consultant Westminster, Colorado 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 Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 iii Number 12 iv Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 GP2-A5 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 Contents Abstract i Committee Membership iii Foreword ix Scope Introduction Definitions Path of Workflow .2 4.1 4.2 4.3 Preexamination Processes Examination Processes Postexamination Processes Process – The Sequence of Laboratory Activities .4 5.1 5.2 Key Work Processes .4 Process as a Basis for Training and Competence Assessment Procedure – How to Do It Elements Common to Process and Procedure Documents 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 Process Documents 8.1 8.2 Title .4 Purpose or Principle Process Flowchart or Table Procedure Instructions Related Documents .5 References Appendixes or Attachments Author Approval Signatures .6 Benefits of Process Documents Suggested Template for Process Documents Procedure Documents – Specific for the Path of Workflow 9.1 9.2 9.3 Preexamination Procedures 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 Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn v C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 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 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 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 Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn vii C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 viii Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 Section 7, Elements Common to Process and Procedure Documents 12 Other industries use policy/procedure with a flowchart (diagram) on page one of the procedure Some processes are so complex that they 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.” • This editorial change has been incorporated in the text 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 • This editorial change has been incorporated in the text 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 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 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 © 74 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 Section 9.1, Preexamination Procedures 21 Add the following bullet to the beginning of the list of bullet items: “patient identification.” • Patient identification at the time of sample collection is already included in the second bullet 22 Modify the fourth bullet to read: “criteria for unacceptable samples and follow-up action.” • This editorial change has been incorporated in the text 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) • This editorial change has been incorporated in the text 26 ISO 17025 clauses 5.7.2, 5.7.3, and 5.8.3 are about client-requested deviations… and samples that 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…) • A sentence has been added about having a separate written procedure for supplies © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 75 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 Section 9.2.1.4, Equipment Calibration and Maintenance 30 Under Calibration: Include a new bullet for “services.” ISO 17025, Clauses 4.6.1 and 4.6.2: qualifications required to perform calibrations, e.g., ISO 17025 accredited calibrating laboratory or employee passed competence testing See also ISO 15189, Clause 4.6.4 • Section 9.2.1.4 is about written instructions for laboratory personnel to perform calibrations The information in the ISO 17025 and ISO 15189 sections quoted is about qualifying suppliers of calibration services, which does not take place at the time of examination and therefore, does not apply to this section 31 Under Maintenance: Delete “…and storage requirements for maintenance records” from the last bullet This information falls under “Documents and Records,” not equipment procedures • This editorial change has been incorporated in the text 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 This editorial change has been incorporated in the text 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) • This editorial change has been incorporated in the text © 76 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 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.” • This editorial change has been incorporated in the text 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.” © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 77 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 • GP2-A5 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 • This editorial change has been incorporated in the text 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) • This editorial change has been incorporated in the text 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 • This editorial change has been incorporated in the text 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 • This editorial change has been incorporated in the text References 52 Include ISO 17025 in the reference list • This editorial change has been incorporated in the text 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 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 © 78 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 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 • This editorial change has been incorporated in the text 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 • This editorial change has been incorporated in the text 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 © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 79 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 The Quality System Approach Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the development of standards and guidelines, which facilitates project management; defines a document structure via a template; and provides a process to identify needed documents The approach is based on the model presented in the most current edition of CLSI/NCCLS document 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 © 80 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 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 © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 81 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 NOTES © 82 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 NOTES © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 83 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Number 12 GP2-A5 NOTES © 84 Clinical and Laboratory Standards Institute All rights reserved Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Volume 26 GP2-A5 NOTES © ClinicalWannamaker and Laboratory Standards Institute All rights reserved Licensed to: Cameron This document is protected by copyright CLSI order # 71377, id # 477046, Downloaded on 12/11/2009 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn 85 C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Active Membership (as of 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 (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 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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 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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 Licensed to: Cameron Wannamaker This document is protected by copyright CLSI order # 71377, id # 477046, 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