C24 A3 American National Standards Institute-Books Pdf

C24 A3 American National Standards Institute
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This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Clinical and Laboratory Standards Institute, Setting the standard for quality in clinical laboratory testing around the world. The Clinical and Laboratory Standards Institute CLSI is a not for profit membership organization that brings. together the varied perspectives and expertise of the worldwide laboratory community for the advancement of. a common cause to foster excellence in laboratory medicine by developing and implementing clinical laboratory. standards and guidelines that help laboratories fulfill their responsibilities with efficiency effectiveness and. global applicability, Consensus Process, Consensus the substantial agreement by materially affected competent and interested parties is core to the. development of all CLSI documents It does not always connote unanimous agreement but does mean that the. participants in the development of a consensus document have considered and resolved all relevant objections. and accept the resulting agreement, Commenting on Documents. CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies. procedures methods and protocols affecting the laboratory or health care. CLSI s consensus process depends on experts who volunteer to serve as contributing authors and or as. participants in the reviewing and commenting process At the end of each comment period the committee that. developed the document is obligated to review all comments respond in writing to all substantive comments. and revise the draft document as appropriate, Comments on published CLSI documents are equally essential and may be submitted by anyone at any time on. any document All comments are addressed according to the consensus process by a committee of experts. Appeals Process, If it is believed that an objection has not been adequately addressed the process for appeals is documented in.
the CLSI Administrative Procedures, All comments and responses submitted on draft and published documents are retained on file at CLSI and are. available upon request, Get Involved Volunteer, Do you use CLSI documents in your workplace Do you see room for improvement Would you like to get. involved in the revision process Or maybe you see a need to develop a new document for an emerging. technology CLSI wants to hear from you We are always looking for volunteers By donating your time and. talents to improve the standards that affect your own work you will play an active role in improving public. health across the globe, For further information on committee participation or to submit comments contact CLSI. Clinical and Laboratory Standards Institute, 950 West Valley Road Suite 2500. Wayne PA 19087 USA, P 610 688 0100, F 610 688 0700.
www clsi org, standard clsi org, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Vol 26 No 25, ISBN 1 56238 613 1 Replaces C24 A2, ISSN 0273 3099 Vol 19 No 5. Statistical Quality Control for Quantitative Measurement Procedures. Principles and Definitions Approved Guideline Third Edition. Volume 26 Number 25, James O Westgard PhD Carl Garber PhD FACB. W Gregory Miller PhD Neil Greenberg PhD, Kathleen Allen MD Chandra P Jain. Donald Joe Boone PhD Kristian Linnet MD PhD, Patrick Caines PhD MBA Estelle Russek Cohen PhD.
Greg Cooper CLS MHA Jeffrey E Vaks PhD, Clinical and Laboratory Standards Institute document C24 A3 Statistical Quality Control for Quantitative Measurement. Procedures Principles and Definitions Approved Guideline Third Edition addresses the principles of statistical quality control. QC with particular attention to the planning of a QC strategy the definition of an analytical run and the application of. statistical QC in a healthcare laboratory While these principles are of interest to manufacturers this guideline is intended for use. by a healthcare laboratory to provide a QC procedure that employs control materials that are independent and external to a. reagent kit an instrument or analytical system This guideline is a revision of an earlier guideline and includes the original. definition for user defined run length Changes in the second edition included a strong emphasis on defining quality up front to. guide the selection of control rules and the number of control measurements The third edition adds example applications that. make use of a simple sigma metrics QC planning tool. Clinical and Laboratory Standards Institute CLSI Statistical Quality Control for Quantitative Measurement Procedures. Principles and Definitions Approved Guideline Third Edition CLSI document C24 A3 ISBN 1 56238 613 1 Clinical and. Laboratory Standards Institute 950 West Valley Road Suite 2500 Wayne Pennsylvania 19087 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 health care community is an ongoing process Users should expect revised editions of any. given document Because rapid changes in technology may affect the procedures methods and protocols in a standard or. guideline users should replace outdated editions with the current editions of CLSI documents Current editions are listed in. the CLSI catalog and posted on our website at www clsi org If your organization is not a member and would like to become. one and to request a copy of the catalog contact us at Telephone 610 688 0100 Fax 610 688 0700 E Mail. customerservice clsi org Website www clsi org, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Number 25 C24 A3, Copyright 2006 Clinical and Laboratory Standards Institute Except as stated below any reproduction of. content from a CLSI copyrighted standard guideline companion product or other material requires. express written consent from CLSI All rights reserved Interested parties may send permission requests to. permissions clsi org, CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of. this publication for use in its laboratory procedure manual at a single site To request permission to use. this publication in any other manner e mail permissions clsi org. Suggested Citation, CLSI Statistical Quality Control for Quantitative Measurement Procedures Principles and Definitions.
Approved Guideline Third Edition CLSI document C24 A3 Wayne PA Clinical and Laboratory. Standards Institute 2006, Proposed Guideline Approved Guideline Second Edition. March 1985 February 1999, Tentative Guideline Approved Guideline Third Edition. September 1986 June 2006, Approved Guideline, ISBN 1 56238 613 1. ISSN 0273 3099, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Volume 26 C24 A3, Committee Membership, Area Committee on Clinical Chemistry and Toxicology.
David A Armbruster PhD Richard R Miller Jr Harvey W Kaufman MD. DABCC FACB Dade Behring Inc Quest Diagnostics Incorporated. Chairholder Newark Delaware Lyndhurst New Jersey, Abbott Laboratories. Abbott Park Illinois Linda Thienpont PhD Gary L Myers PhD. University of Ghent Centers for Disease Control and. W Gregory Miller PhD Ghent Belgium Prevention, Vice Chairholder Atlanta Georgia. Virginia Commonwealth Hubert Vesper PhD, University Centers for Disease Control and David Sacks MD. Richmond Virginia Prevention Brigham and Women s Hospital. Atlanta Georgia and Harvard Medical School, John Rex Astles PhD FACB Boston Massachusetts. Centers for Disease Control and Advisors, Prevention Bette Seamonds PhD.
Atlanta Georgia Mary F Burritt PhD Mercy Health Laboratory. Mayo Clinic Swarthmore Pennsylvania, David M Bunk PhD Rochester Minnesota. National Institute of Standards and Dietmar St ckl PhD. Technology Paul D Orazio PhD University of Ghent, Gaithersburg Maryland Instrumentation Laboratory Ghent Belgium. Lexington Massachusetts, Neil Greenberg PhD Thomas L Williams MD. Ortho Clinical Diagnostics Inc Carl C Garber PhD FACB Nebraska Methodist Hospital. Rochester New York Quest Diagnostics Incorporated Omaha Nebraska. Lyndhurst New Jersey, Christopher M Lehman MD Jack Zakowski PhD FACB. Univ of Utah Health Sciences Uttam Garg PhD DABCC Beckman Coulter Inc. Center The Children s Mercy Hospital Brea California. Salt Lake City Utah Kansas City Missouri, Working Group on Statistical Quality Control.
James O Westgard PhD Chandra P Jain Jeffrey E Vaks PhD. Chairholder Beckman Coulter Inc Irvine California, University of Wisconsin Brea California. Madison Wisconsin Staff, Kristian Linnet MD PhD, Kathleen Allen MD Psychiatric University Hospital Clinical and Laboratory Standards. Quest Diagnostics Incorporated Risskov Denmark Institute. Pittsburgh Pennsylvania Wayne Pennsylvania, Estelle Russek Cohen PhD. Donald Joe Boone PhD U S Food and Drug Administration. John J Zlockie MBA, Centers for Disease Control and Rockville Maryland. Vice President Standards, Prevention, Atlanta Georgia Advisors Tracy A Dooley BS MLT ASCP.
Staff Liaison, Patrick Caines PhD MBA F Philip Anderson PhD. Ortho Clinical Diagnostics Virginia Commonwealth University. Patrice E Polgar, Rochester New York Richmond Virginia. Projects Coordinator, Greg Cooper CLS MHA Carl C Garber PhD FACB. Donna M Wilhelm, Bio Rad Laboratories Inc Quest Diagnostics Incorporated. Irvine California Lyndhurst New Jersey, Melissa A Lewis.
Assistant Editor, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Number 25 C24 A3, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Volume 26 C24 A3, Abstract i, Committee Membership iii. Foreword vii, 2 Introduction 1, 3 Standard Precautions 2. 4 Definitions 2, 5 Purpose of Statistical Quality Control 4.
6 Planning a Statistical Quality Control Procedure 5. 6 1 Define the Quality Specifications 5, 6 2 Select Control Materials 6. 6 3 Determine Method Performance 6, 6 4 Identify Candidate Statistical Quality Control Strategies 8. 6 5 Predict QC Performance 8, 6 6 Set Goals for QC Performance 8. 6 7 Select Appropriate QC Rules 9, 6 8 Example Applications of QC Planning 9. 7 Analytical Run 9, 7 1 Concept of Analytical Run 9.
7 2 Length of Analytical Run 9, 8 QC Applications 10. 8 1 Statement of QC Strategy 10, 8 2 Frequency of Control Measurements 10. 8 3 Location of Control Samples 10, 8 4 Decision Criteria for Control Rules 11. 8 5 Control Charts 12, 8 6 Setting Control Limits 12. 8 7 Out of Control Situations 13, 9 Interlaboratory QC Programs 14.
References 15, Appendix Selection of QC Procedures Examples Using Practical Tools 18. References for Appendix 25, Summary of Consensus Comments and Working Group Responses 26. Summary of Delegate Comments and Working Group Responses 27. The Quality System Approach 30, Related CLSI NCCLS Publications 31. This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Number 25 C24 A3, This is a preview of CLSI C24 A3 Click here to purchase the full version from the ANSI store. Volume 26 C24 A3, This document is the third edition of a guideline that has been in use by the clinical laboratory community.
for about fifteen years Statistical QC is still critically important in laboratories today to ensure the quality. of the test results produced by any measurement procedure The almost universal applicability of. statistical QC to quantitative measurement procedures provides laboratories with a quality management. tool that can be deployed whenever and wherever needed It also allows laboratories to verify and validate. independently the ongoing performance of in vitro diagnostic device manufacturers built in quality. control measures and monitors, When the first edition of this document was developed laboratories were experiencing changes in. measurement technology and instrument systems that made many of the conventional quality control. practices difficult to apply In response to those needs the first edition of this document clarified the. fundamental principles and definitions of statistical quality control that should be considered when. managing any laboratory measurement process, An example of an important concept in statistical quality control was the definition of an analytical. run which in the past often corresponded to the batch of specimens being analyzed for a particular. quantity With many modern analytical systems the definition of a run is not nearly as clear An. analytical run is better understood in terms of the time or number of measurements for which the. measurement procedure is stable, The second edition continued that tradition to appraise clarify and define concepts approaches and. practices that should be generally useful in developing a specific quality control strategy for testing with. quantitative measurements It maintained a focus on statistical quality control because of the capability of. this technique in monitoring the effects of many instrument reagent environment and operator variables. on the outcome of a measurement process, An example of an important approach was the planning of a quality control procedure The second. edition described the principles for developing a specific quality control strategy that takes into. account the quality requirements of the test the performance available from a method the error. CLSI document C24 A3 ISBN 1 56238 613 1 Clinical and Laboratory Standards Institute 950 West Valley Road Suite 2500 Wayne Pennsylvania 19087 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 health care community is an ongoing process Users should expect revised

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