Clark G B
Uniformed Services University of the Health Sciences, Bethesda, MD.
Clin Lab Manage Rev. 1990 Jul-Aug;4(4):224-6, 228, 230-3 passim.
This is the second of a series of articles on medical laboratory quality assurance (QA). It provides a synopsis of the federal regulations and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards that are driving health-care QA at the laboratory level. The article also reviews the role of the College of American Pathologists (CAP) in laboratory accreditation and QA. This article explains the JCAHO ten-step process in detail. The Joint Commission model can be extremely helpful in designing a QA program and is a very practical template for a QA plan. Understanding the ten-step model, as well as the path of work flow, is essential to selecting meaningful laboratory indicators. Current concepts of quality, quality control (QC), and QA in the health-care industry are still in the developmental stage. Consequently, semantic differences of opinion exist among many laboratorians in regard to QA nomenclature and methods. These ambiguities have been generated, partly, by an extremely rapid evolution of federal and JCAHO guidelines. A major "gray" area exists in defining quality, QC and QA, and methods of quality management. The author has adhered closely to the definitions and nomenclature of the JCAHO to resolve some of the ambiguity. The reader also can review definitions that are presented in detail in the first part of this series (1). The source of most of the following information is federal, JCAHO, and CAP documentation. Some of the information in this article reflects personal managerial experience offered in the hope that it will be of some practical assistance to the reader.
这是关于医学实验室质量保证（QA）系列文章中的第二篇。它概述了推动实验室层面医疗保健质量保证的联邦法规和医疗保健组织认证联合委员会（JCAHO）标准。本文还回顾了美国病理学家协会（CAP）在实验室认证和质量保证中的作用。本文详细解释了JCAHO的十步流程。联合委员会的模式在设计质量保证计划时非常有用，并且是质量保证计划的一个非常实用的模板。理解十步模式以及工作流程路径对于选择有意义的实验室指标至关重要。医疗保健行业中当前的质量、质量控制（QC）和质量保证概念仍处于发展阶段。因此，许多检验人员在质量保证术语和方法方面存在语义上的意见分歧。这些模糊性部分是由联邦和JCAHO指南的极速演变产生的。在定义质量、质量控制和质量保证以及质量管理方法方面存在一个主要的“灰色”区域。作者严格遵循JCAHO的定义和术语来解决一些模糊性问题。读者也可以查阅本系列第一部分（1）中详细给出的定义。以下大部分信息的来源是联邦、JCAHO和CAP的文件。本文中的一些信息反映了个人管理经验，希望能对读者提供一些实际帮助。
