clinical laboratory technical procedure manuals approved guideline

Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. 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 (i.e., tentative ) consensus level. Proposed An 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 lineby-line review of its technical and editorial content. Tentative A tentative standard or guideline is made available for review and comment only when a recommended method has a well-defined need for a field evaluation or when a recommended protocol requires that specific data be collected. It should be reviewed to ensure its utility. 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.Provisions in 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 comments of users are essential to the consensus process.

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Please try again.Please try again.Please try again. A must companion for laboratory manangers, medical directors and lead technologists. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. Register a free business account To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. A guideline for global application developed through the consensus process. 2. Serving the World s Medical Science Community Through Voluntary Consensus 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 testing and related healthcare issues.In addition to developing and promoting the use of voluntary consensus standards and guidelines, provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS An 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.

No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without written permission from, except as stated below.Reproduced with permission, from publication GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition (ISBN ). Copies of the current edition may be obtained from, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, 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 by written request. To request such permission, address inquiries to the Executive Director,, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Copyright The National Committee for Clinical Laboratory Standards. Suggested Citation (. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Hartford, Connecticut Specialty Laboratories Santa Monica, California Statistical Services Traverse City, Michigan Litton Pathology Associates Blue Springs, Missouri v 8 Number 5 Advisors (Continued) Eleanor M. Travers, M.D. Department of Veterans Affairs Medical Ctr. Sutter Health Mayo Clinic Mayo Clinic UroCor, Inc.CLMA College of American Pathologists GlaxoSmithKline Nippon Becton Dickinson Co., Ltd. Ortho-Clinical Diagnostics, Inc. Roche Diagnostics, Inc. Professional Members AISAR-Associazione Italiana per lo Studio degli American Academy of Family Physicians American Association for Clinical Chemistry American Association for Respiratory Care American Chemical Society American Medical Technologists American Public Health Association American Society for Clinical Laboratory Science American Society of Hematology American Society for Microbiology American Type Culture Collection, Inc.Agilent Technologies, Inc. BD BD Biosciences San Jose, CA BD Consumer Products BD Diagnostic Systems BD Italia S.P.A.

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 the Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in projects. Please contact the Executive Offices for additional information on committee participation. 3 Volume 22 GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition Abstract Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition ( document GP2-A4) presents the important components of writing and managing procedures for the clinical laboratory. This guideline describes common and specific sections that should be included when developing laboratory procedures. Several examples of procedures for preanalytic, analytic, and postanalytic laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.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 documents. Current editions are listed in the 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 the Executive Offices.

John General Hospital (Fort St. Alexius Medical Center (ND) St. Anthony Hospital (CO) St. Anthony s Hospital (FL) St. Barnabas Medical Center (NJ) St-Eustache Hospital (Quebec, Canada) St. Francis Medical Ctr. (CA) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. Joseph Hospital (NE) St. Joseph s Hospital Marshfield Clinic (WI) St. Joseph Mercy Hospital (MI) St. Luke s Regional Medical Center (IA) St. Mary Medical Center (IN) St. Mary of the Plains Hospital (TX) St. Paul s Hospital (Vancouver, BC, Montreal) St. Vincent Medical Center (CA) Ste.Inpatient Blood Specimen Collection Process Flowchart Attachment J2. Inpatient Blood Specimen Collection Process Table Attachment J3. Analyzer Testing Process Flowchart Attachment J4. Analyzer Testing Process Table Attachment J5. Bacteriology Culture Process Flowchart Attachment J6. Bacteriology Culture Process Table Attachment J7. Transfusion Medicine Prenatal Testing Process Flowchart Attachment J8. Transfusion Medicine Prenatal Testing Process Table Attachment J9. Surgical Pathology Specimen Process Flowchart Attachment J10. Surgical Pathology Specimen Process Table Appendix K1. Document Creation, Review, and Approval Process Flowchart Appendix K2. Document Creation, Review, and Approval Process Table Appendix L. Sample Document Change Request Form Summary of Comments and Working Group Responses Summary of Delegate Comments and Working Group Responses Related Publications xiv 17 Volume 22 GP2-A4 Foreword Previous editions of document GP2 have focused on essential elements to include in laboratory analytic test procedures.

BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter, Inc. Bio-Rad Laboratories, Inc. - France Biotest AG Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Canadian External Quality Assessment Laboratory Capital Management Consulting, Inc. Carl Schaper Checkpoint Development Inc. Chiron Corporation ChromaVision Medical Systems, Inc. Chronolab Ag Clinical Design Group Inc. Clinical Laboratory Improvement Consultants Cognigen Community Medical Center (NJ) Control Lab (Brazil) Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA Dade Behring Inc. - San Jose, CA Diagnostic Products Corporation Eiken Chemical Company, Ltd. Electa Lab s.r.l. Enterprise Analysis Corporation Essential Therapeutics, Inc. EXPERTech Associates, Inc. viii F. Hoffman-La Roche AG Fort Dodge Animal Health General Hospital Vienna (Austria) Gen-Probe GlaxoSmithKline Greiner Bio-One Inc. Helena Laboratories Home Diagnostics, Inc. Immunicon Corporation Instrumentation Laboratory International Technidyne Corporation IntraBiotics Pharmaceuticals, Inc. Laboratory Specialists, Inc.Novartis Pharmaceuticals Corporation Ortho-Clinical Diagnostics, Inc. (Raritan, NJ) Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxoid Inc. Paratek Pharmaceuticals Pfizer Inc Pharmacia Corporation Powers Consulting Services Premier Inc. The Product Development Group QSE Consulting Quintiles, Inc. Radiometer America, Inc. Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Laboratories (Div. Second Opinion Showa Yakuhin Kako Company, Ltd. Streck Laboratories, Inc. SurroMed, Inc. Sysmex Corporation (Japan) Sysmex Corporation (Long Grove, IL) The Clinical Microbiology Institute The Toledo Hospital (OH) Trek Diagnostic Systems, Inc. Versicor, Inc. Vetoquinol S.A. Visible Genetics, Inc. Vysis, Inc. Wallac Oy Wyeth-Ayerst Xyletech Systems, Inc.

1 Preanalytic Processes Preanalytic key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory tests are ordered through the time that the specimens are processed and delivered to the laboratory testing location or transported to reference laboratories. For anatomic pathologists and cytotechnologists, preanalytic 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. Adapted from document GP26 A Quality System Model for Health Care. 4.2 Analytic Processes Analytic key processes for the clinical laboratory specialties include the activities of performing the test, verifying the validity of the test results, interpreting the findings, and recording the findings. In the anatomic pathology specialties, analytic 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 the specific clinical disciplines of chemistry, hematology, microbiology, and transfusion service for specialized testing methods and instruments. More recently, many laboratories have segregated along manual and automated testing methods. Each laboratory or clinical discipline however it is organized should identify its automated and manual testing processes. Analytic key processes for the laboratory s path of workflow are shown in Figure 3. Testing Results Review, Recording and Follow-Up Interpretation Figure 3. Laboratory Analytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 2 An global consensus guideline. All rights reserved. 21 Volume 22 GP2-A4 4.3 Postanalytic Processes Postanalytic key processes in the path of workflow include activities related to reporting results and archiving results and specimen material.

Postanalytic processes are shown in Figure 4. Result Reporting and Archiving Specimen Retention Figure 4. Laboratory Postanalytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 5 Laboratory Procedure Contents Common Elements The laboratory should have procedures that describe preanalytic, analytic, and postanalytic activities in the laboratory operational workflow. The procedure document describes the series of steps to be followed by one individual to complete a specific task. Written procedures should specifically explain how to perform each activity in the laboratory s preanalytic, analytic, and postanalytic work processes. A set of common elements should be included in each type of procedure. At a minimum, laboratory procedures should include: Title; Purpose or principle; Procedure instructions; References; Author; and Approval signatures. Appendix A provides a tabular view of what should be included in a procedure document. Additional elements that are specific to analytic vs.Appendixes B through F are examples of laboratory procedures. For additional information on the distinction between processes and procedures, see Appendix J. 5.1 Title All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive, for example: Blood Specimen Collection Process; Performing Glucose Testing on Instrument X; Waterbath Temperature Monitoring Procedure; and Preparing Gram Stain Working Solutions. An global consensus guideline. All rights reserved. 3 22 Number Purpose or Principle The document should open with a section that simply states its purpose. For example, the Purpose section of a procedure could be stated as, This procedure provides instructions for collecting fingerstick specimens for glucose analysis. The words, This procedure provides instructions for can be standardized in the template for all procedure documents.

This edition of GP2 has been expanded to provide: guidelines for writing procedures for the preanalytic, analytic, and postanalytic activities that represent the laboratory s path of workflow; guidelines for writing procedures specifically for multitest automated analyzers; an introduction to the management and control of laboratory procedure documents after they are approved for use; and the use of process flowcharts to depict the linkages between laboratory procedures. The information and examples provided in this edition are also consistent with the guidance described in document GP26 A Quality System Model for Health Care. This edition of GP2 is applicable to any size laboratory, wherever it may be in the transition of its quality program from traditional quality control and quality assurance practices to the concepts of quality systems management. Key Words Document management, electronic procedures, laboratory procedure, procedure manual, technical procedures xv 18 Number 5 xvi 19 Volume 22 GP2-A4 1 Introduction Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition The laboratory should provide carefully documented instructions in the form of procedures for all activities that support the performance of analytic testing. These instructions provide essential information for both new and experienced employees on how to perform all their job tasks including nontesting tasks such as collecting blood specimens and using the laboratory s computer system. Written procedures should encompass an entire 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-A4 is intended to be used by the following persons: administrative and technical personnel who write laboratory procedures; manufacturers; and educators.

2 Scope This publication describes how to: identify laboratory procedures using the laboratory s operational path of workflow; and write procedures for preanalytic, analytic, and postanalytic laboratory activities. In addition, this edition of GP2 provides useful information about preparing, approving, maintaining, changing, and reviewing laboratory documents. 3 Definitions a Document, n Any recorded item of a factual or informative nature, either paper or electronic. Form, n A paper or electronic document on which the results from the performance of a procedure or other information are captured. Policy, n A written statement of overall intentions and directions defined by those in the organization and endorsed by management. Procedure, n A specified way to perform an activity; NOTE: For a quality system, a procedure is a set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. Process, n Set of interrelated or interacting activities that transform inputs into outputs; NOTE: It may be documented as flowcharts or tables that describe the path of operational workflow in the laboratory.For complete definitions and detailed source information, please refer to the most current edition of that document. An global consensus guideline. All rights reserved. 1 20 Number 5 4 Path of Workflow Laboratory work is a sequence of key processes in which the laboratory uses resources, such as people, machines, methods, and materials to transform orders for laboratory tests into results and reports for patient management. Key processes for the laboratory are referred to as the path of workflow, which is shown in Figure 1. Preanalytic Processes Analytic Processes Postanalytic Processes Figure 1. Laboratory Path of Workflow. Adapted from document GP26 A Quality System Model for Health Care. 4.

Information regarding the theory, clinical implications of the test or test methodology, or historical background may also be included at the beginning of the document, thereby providing an educational, clinical, and scientific framework for the reader and user. 5.3 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 specimen collection. 5.4 References Procedures should include the references that were used as the source of the information, when applicable. The references may originate from any of the following: manufacturer s product literature; text books; published standards and guidelines; laboratory policy manuals; laboratory information technology manuals; unpublished information obtained from experts in the field; and applicable regulations. References should be listed in a standard medical format. 5.5 Author The author(s) of the document should be noted. 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 should be in place that enables the referencing of the author back to the appropriate specific document. 5.6 Approval Signatures There should be evidence that the procedure has been approved by the appropriate individual(s). (Note: Document approval by an appropriate individual is a requirement of regulatory and accrediting agencies in some countries.) 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 should be in place that 4 An global consensus guideline. All rights reserved.

23 Volume 22 GP2-A4 enables the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Section Procedure Documents Specific for the Path of Workflow 6.1 Preanalytic Procedures Preanalytic procedures provide the instructions for all activities of laboratory workflow that take place before sample analysis. The laboratory should have separate written procedures for preanalytic activities, because they may be performed by nonlaboratory as well as laboratory persons at different times in the preanalytic work flow. Preanalytic procedures include those for: test ordering instructions for entering laboratory test orders into a computer system or completing paper requisitions including verification of clinical orders; specimen collection instructions for identifying patients, collecting blood and nonblood specimens, and labeling collected specimens; specimen transport instructions for transporting specimens to the laboratory, such as through the pneumatic tube system; and specimen processing instructions for receiving and accessioning specimens in the laboratory, any storage or processing before delivery at the testing section, and any preparations for preparing specimens to be transported to other laboratories for testing (e.g., reference laboratories). In addition to the elements common to all documents described in Section 5, preanalytic procedures should 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 specimen collection; Specimen collection in procedures for collection techniques for blood and nonblood specimens; Required equipment and forms in all preanalytic procedures where equipment and forms are used; Safety general or specific instructions as described below; Specimen handling requirements instructions for handling collected specimens during transport to the laboratory receiving area; Specimen storage requirements instructions for where and how to store specimens before testing; and Problems or pitfalls Patient Preparation Where applicable, preanalytic specimen collection procedures should include information about patient preparation such as instructions for: An global consensus guideline. For example: Test requisitions and labels; Specimen collection devices and materials (e.g., blood collection tubes, media, swabs); Specimen containers; and Instruments (tourniquets, hemostats, scissors, etc.) Safety Preanalytic procedures should include safety instructions for the collection and handling of biohazardous specimens. The instructions should be written for the intended readership for example, those who handle the specimen such as nursing, transport, or laboratory personnel. If no special precautions are required, preanalytic procedures may refer the user to the safety policy manual for general safety requirements. A Special Safety Precautions section should be included in preanalytic procedures when additional safety requirements beyond the basic handling of biologic and other hazardous materials are necessary (see documents M29 Protection of Laboratory Workers from Occupationally Acquired Infections and GP17 Clinical Laboratory Safety.) Specimen Handling Requirements Where applicable, preanalytic procedures should include information about specimen handling requirements. This information includes: special transport requirements (e.g., on ice, within a certain time, in appropriate containers, etc.

); safety precautions that are to be taken with potentially infectious specimens; and 6 An global consensus guideline. This information should include: locations where specimens are stored before testing; acceptable storage temperatures; and stability of the specimen over time, where timelines might affect testing Problems or Pitfalls Preanalytic procedure documents should include information about problems or pitfalls that may occur in the performance of the procedure. Where applicable, users should be referred to other procedures. Examples of this kind of information include what to do when: received specimens are unacceptable; the computer is down; and patients present for testing without a proper order Preanalytic Computer Activities Procedures that provide instructions for using the laboratory s information system for preanalytic activities should be designed around the respective prompts in a computer program s sequences. 6.2 Analytic Procedures Analytic procedures cover the activities from the time the specimen reaches the testing area to the time results are reviewed and preliminary interpretations are made. Analytic procedures for manual tests differ from procedures for automated testing. Manual testing procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte sedimentation rate are traditional examples of manual method-based analytic procedures. Automated testing procedures are represented by the menu of multiple test methods that can be performed on a single instrument or analyzer (such as for coagulation or chemistry). In addition, test results provided by both manual and automated methods can be qualitative, semiquantitative, or quantitative. The attributes of manual vs.

The differences between procedures for manual and automated testing are described in the sections that follow Elements of Manual Analytic Method-Based Procedures In addition to the elements that are common to all documents, analytic procedure documents should include the following sections, wherever applicable: Specimen Information; Test Method Instructions; An global consensus guideline. For example: Antibody Screen by Gel Technique; Microscopic Urinalysis by Phase Microscopy; Gram Stain Procedure; and Fingerstick Glucose Testing on the XYZ Instrument. This section should present the stepwise instructions for performing the test by the method described in the package insert or operator s manual. If procedure instructions taken from manufacturer s literature are altered or deleted, this may change the test method performance and, therefore, appropriate validation procedures must be performed. 8 An global consensus guideline. All rights reserved. View more CPT codes and descriptions are copyright 2012 American Medical Association. Suite 1700 Montgomery, AL 36104 334-269-3550 fax:334-241-4192 Alaska Dept.Virginia Mason Medical Center WA. Good Samaritan Hosp and Medical Center, NY Hail claims are primarily So please find below a comprehensive list of low tuition universities in the US with their respective tuition fees. June 11, 2012 Section I: Introduction Since 968, the American Council on the Teaching of Foreign Languages (ACTFL) has conducted Matriculant data were matched to the applicant Centers of Excellence enhances This page will provide you links to each State Licensing Board, along with contact information; and, as we develop it. Please refer to each Dermatology - 4 Every applicant is Every applicant is looking for different characteristics in an educational experience.