The World Health Organization African Region Laboratory Accreditation Process

Abstract

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.

External quality assessment of national public health laboratories in Africa, 2002–2009

“…Only 340 diagnostic laboratories in Africa are accredited, with 312 (92%) in South Africa. 25 The commitment to strengthening African NATIONAL PUBLIC HEALTH LABORATORIEs [2][3][4][5] led directly to the development of the WHO-African Region stepwise approach to accreditation. 25 External quality assessment is among the 12 areas of laboratory quality evaluated by this approach, making participation in …”

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

“…All data points for DTS PT results that fell within or outside this range were graded as acceptable or unacceptable, respectively. Participants received a passing score if a minimum of four of the five panel members (80.0%) yielded an acceptable grade in a given PT testing cycle, on the basis of the criteria of the WHO Regional Office for Africa accreditation process (16). The results from participants who reported fewer than six PT results using a single assay or who used in-house VL assays in a given PT testing cycle were not graded, and results from these assays were combined into a group labeled "other assays."…”

Proficiency Test Feedback Utilization at Government Hospitals Laboratory, Addis Ababa, Ethiopia

“…So the aim of this study was to assess the utilization and challenges of PT feedback among participant laboratories in Addis Ababa governmental hospitals and to provide information on to optimize assessing the trend of laboratories PT performance and identify challenges for effective utilization, plus to this, it helps as an information source for the policy makers to take action for the effective utilization of PT in order to minimize hazards due to analytical error [10][11][12][13][14][15].…”