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1、EP15 A Vol 21 No 25 Replaces EP15 P Vol 18 No 22 User Demonstration of Performance for Precision and Accuracy Approved Guideline This document describes the demonstration of method precision and accuracy for laboratory analyte determinations utilizing a protocol designed to be completed within five
2、working days or less A guideline for global application developed through the NCCLS consensus process NCCLS Serving the World s Medical Science Community Through Voluntary Consensus NCCLS is an international interdisciplinary nonprofit standards developing and educational organization that promotes
3、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 NCCLS is based on th
4、e principle that consensus is an effective and cost effective way to improve patient testing and healthcare services In addition to developing and promoting the use of voluntary consensus standards and guidelines NCCLS provides an open and unbiased forum to address critical issues affecting the qual
5、ity of patient testing and health care PUBLICATIONS An NCCLS 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 unmodifi
6、ed 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 t
7、he user to fit specific needs Report A document that has not been subjected to consensus review and is released by the Board of Directors CONSENSUS PROCESS The NCCLS voluntary consensus process is a protocol establishing formal criteria for the authorization of a project the development and open rev
8、iew of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline Most NCCLS documents are subject to two levels of consensus proposed and approved Depending on the need for field evaluation or data collection documents may
9、also be made available for review at an intermediate i e tentative consensus level Proposed An NCCLS 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 ov
10、erall review of its scope approach and utility and a line by 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 pro
11、tocol 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 co
12、mments on earlier versions have been satisfactorily addressed and to identify the need for additional consensus documents NCCLS standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected competent and interested parties obtai
13、ned by following NCCLS s established consensus procedures Provisions in NCCLS 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 re
14、gulations COMMENTS 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 NCCLS committee that wrote the document All comments including those that result in a change to the document when publi
15、shed 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 NCCLS document Address comments to the NCCLS Executive Offices 940 West Valley Road
16、 Suite 1400 Wayne PA 19087 USA VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in NCCLS projects Please contact the NCCLS Executive Offices for additional information on committee participation Volume 21 EP15 A User Demonstration of Performance for Precision and Accuracy Approved Guideline Abstract NCCLS document EP15 A User Demonstration of Performance for Precision and Accuracy Approved Guideline describes the demonstration of method
