CLSI EP18-A2 识别和控制实验室误差源的风险管理技术.pdf

EP18-A2 Vol. 29 No. 26 Replaces EP18-A Vol. 22 No. 28 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. Licensed to: Jill Runyen Abbott This document is protected by copyright. CLSI order # Subscription, id # 468452, Downloaded on 12/2/2009. Clinical and Laboratory Standards Institute Advancing Quality in Health Care Testing Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus— formerly NCCLS) is an international, interdisciplinary, “proposed” and “approved.” Depending on the need for nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be organization that promot