The World Health Organization African Region Laboratory Accreditation Process Improving the Quality of Laboratory Systems in the African Region
The World Health Organization African Region Laboratory Accreditation Process Improving the Quality of Laboratory Systems in the African Region
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DOI：
10.1309/ajcptuuc2v1wjqbm
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发表时间：
2010-09-01
影响因子：
3.5
通讯作者：
Nkengasong, John N.
中科院分区：
文献类型：
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作者：
Gershy-Damet, Guy-Michel;Rotz, Philip;Nkengasong, John N.
很少有发展中国家制定了负担得起、易于执行和监测的实验室质量标准。为了应对这一挑战，世界卫生组织非洲区域办事处（世卫组织非洲区域办事处）制定了一个逐步的方法，使用0到5-星星等级，以识别不断发展的ISO 15189标准的履行情况，而不是通过-不通过分级。未能达到至少55%的评估分数的实验室将不会被授予星星排名。达到95%或以上的实验室将获得5星星评级。这种循序渐进的方法承认实验室的现状，通过一系列评估来支持他们以证明改进，并认可和奖励他们的进步。世卫组织非洲区域办事处的认证程序并不是要取代既定的ISO 15189认证计划，而是为实现国际实验室标准提供一个临时途径。将大力鼓励在世卫组织-非洲区域办事处进程中表现出色的实验室参加既定的ISO 15189认证计划。我们认为，世卫组织-非洲区域办事处的实验室认证方法是负担得起的、可持续的、有效的和可扩展的。
Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating.This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO's accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.