By: Giorgis Okubazgi, Ethiopia
Efficient and reliable laboratory services are essential to a functioning health system as quality laboratory testing plays a key role in patient care, surveillance and outbreak investigation (1). It is quality that is at the heart of all laboratories. A good quality control plan implies that the work being performed meets or exceeds some defined standards which can be measured or whose performance can be monitored (2).
The practice of both medical (calibration laboratory) and histopathology laboratories in Africa is mainly not traditional and not based on standards. Unreliable laboratory results are common occurrences and cause misdiagnosis of disease. It negatively affects clinical decision making and the effort to improve patient outcomes. It has caused prolonged illness or resulted in unnecessary or ineffective treatment regimens for many patients. With the wrong treatment, time and financial resources are wasted (3).
Organizations like ASCP and WHO are working to combat the lack of quality standards with programs such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) Program introduced by World Health Organization (WHO) in 2009. This program, and ASCP’s Partners for Cancer Diagnosis and Treatment in Africa focus largely on Sub Saharan African countries, which have only 8% of accredited laboratories in Africa, despite having a population of over 800 million. Sub Saharan African public health systems have long remained fragile due to fundamental limitations and lack of prioritization of human, financial and training resources; laboratory infrastructure; and resource and management capacity(7).
WHO’s SLMTA is a competency-based program that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training program spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization’s Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training program (1).
Compared to other laboratory disciplines, pathology laboratories in Africa have more limited access to certified or validated commercial procedures (e.g. ready-to-use diagnostic kits). Thus, a significant percentage of non-standardized, in-house methods must be implemented to meet the respective diagnostic requirements. Such methods are permitted by ISO, provided they are verified, validated and qualitative (4). The medical laboratories (Calibration laboratories) whose output is mainly quantitative are accredited according to ISO 17025 and the inspection body according to ISO 17020. The medico-laboratory processes of both must conform to ISO 15189, and this is why the latter standard is most broadly used in pathology laboratories (4).
1- Yao K, Maruta T, Luman ET, Nkengasong JN. The SLMTA program: Transforming the laboratory landscape in developing countries. Afr J Lab Med. 2014;3(1), 1-8
2- Vikash G, Geetika S, Narendra S. Total Quality Management in Pathological Laboratories: An Overview with Emphasis on Need for Structured National Policy, International Journal of Science and Research (IJSR), 2016;5(8),548-551
3- Linda A, Lawrence C, Mira J, Kenneth L, Danny M. Strengthening Laboratory Management Toward Accreditation, A Model Program for Pathology Laboratory Improvement, Clin Lab Med, 2017;
4- Alexandar T, Luigi T, Hands-On Experience: Accreditation of Pathology Laboratories according to ISO 15189, Pathobiology 2017;84:121–129
5- Giorgis O, Bereket B, Mesfin N, Aster T, Fatuma H. Status of Histopathology Services in Ethiopia, Am J Clin Pathol, 2015
6- Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Checklist For Clinical and Public Health Laboratories, WHO, 2015 (2)
7- Guide for the Stepwise Laboratory Improvement Process Towards Accreditation in the African Region (with checklist), WHO, 2009