Quality management system of level II laboratories providing CD4+ T cell count and AFB microscopy services in Addis Ababa, Ethiopia

Abstract

Abstract

Background: Delivery of high-quality patient care depends on reliable and actionable test results. Laboratories in developing settings are, however, often under-resourced resulting in poor performance. WHO-AFRO has established the Stepwise Laboratory (Quality) Improvement Process towards Accreditation (SLIPTA) to strengthen laboratory systems of its member states.

Objective: to assess the quality management system of level II clinical laboratories in Addis Ababa that perform CD4+ T cell counting and AFB microscopy as per ISO 15189 standard.

Methods: A cross-sectional health facility-based descriptive study was conducted between February 2013 and March 2013 using structured questionnaire (SLIPTA checklist) as well as observation to elicit information on quality management system of laboratories in intermediate referral facilities (Level II) that provide CD4+ T-cell count and AFB microscopy in Addis Ababa, Ethiopia.

Results: A total of 29 laboratories (13 government-owned, 13 private and 3 non-governmental hospitals) were assessed. The overall implementation of the 12 quality system essentials was <35% and values slightly over 50% were observed only for equipment, purchasing, inventory and information management. The average point obtained by the 29 level II (district) laboratories was 44.6% (115/258). Only 19 of the 29 laboratories were involved in an accreditation process, and only seven of these (four public and three private) had achieved star level 1 or above.

Conclusion and recommendations: The quality management system of level II laboratories performing CD4 count and AFB microscopy in Addis Ababa does not yet meet the ISO standard 15189. More intensive effort is needed to address quality while expanding laboratory services. [Ethiop. J. Health Dev. 2014;28(2):96-104]