Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation

Abstract

BackgroundThe increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program.SLIPTA implementation processWHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1–5 stars were issued.Preliminary resultsBy March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62–77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%.ConclusionThe WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

Diagnosis of Human Immunodeficiency Virus Infection

“…The scale-up of VL testing and EID has led to the decentralization of molecular laboratories in order to meet country needs (220). These laboratories are encouraged to participate in strengthening laboratory management toward accreditation to improve laboratories and then be enrolled into the WHO/Stepwise Laboratory Quality Improvement Process towards Accreditation for formal recognition using the 5-star grading system (304)(305)(306). Furthermore, some laboratories are aiming for international ISO15189 accreditation and ensuring compliance to standards in the laboratory (307,308).…”

Clinical Referral Laboratories in Rwanda

“…In addition to the quality improvement registered between baseline and exit audits, laboratories are recommended to continuously apply laboratory quality systems to achieve international accreditation. 27 To be eligible for international accreditation, a laboratory in the SLMTA program is required to score 95% or more out of 275 points on the SLIPTA checklist audit. 22 , 28 This score is equivalent to five stars on the WHO grading scale of 0 (<55%) to five stars (≥95%), and the awarded score in this WHO system is valid for 2 years.…”

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: long way to go

“…Predisposition to the observed low quality is neither well studied nor understood; however, as earlier studies indicated, laboratory size and staff training may be some of the determinants [ 14 , 16 ]. Although we did not study the effect of staffing and their training, the observed low scores for these laboratories concedes the fact that medical laboratory training may not suffice, but rather it ought to be augmented with more comprehensive quality management systems as earlier reported [ 11 , 17 ]. Additionally, as the research laboratory scored the lowest acceptable accreditation level, it had clinical trials at the time of this survey, suggesting that this may have set certain quality needs.…”

“…SLIPTA is a framework for improving quality of public health laboratories in developing countries to achieve the requirements of the ISO 15189 standard [ 6 ]. The WHO AFRO SLIPTA program has been recommended for low resource set up [ 11 ]. The SLIPTA checklist is based on collection of patient samples, interpretation of test results, acceptable turnaround times, testing in medical emergency, routine internal quality control (IQC) and an 80%, 2-cycle pass rate on external quality control (EQC).…”