Examining 7 years of implementing quality management systems in medical laboratories in sub‐Saharan Africa

Abstract

Background: Achievement of ISO15189 accreditation demonstrates competency of a laboratory to conduct testing. Three programmes were developed to facilitate achievement of accreditation in low-and middle-income countries: Strengthening Laboratory Management Towards Accreditation (SLMTA), Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) and Laboratory Quality Stepwise Implementation (LQSI). Objective: To determine the level of accreditation and associated barriers and facilitators among medical laboratories in the WHO-AFRO region by 2020. Methods: A desk review of SLIPTA and SLMTA databases was conducted to identify ISO15189-accredited medical laboratories between January 2013 and December 2020. Data on access to the LQSI tool were extracted from the WHO database. Facility and country characteristics were collected for analysis as possible enablers of accreditation. The chi-square test was used to analyse differences with level of significance set at <0.05. Results: A total of 668 laboratories achieved accreditation by 2020 representing a 75% increase from the number in 2013. Accredited laboratories were mainly in South Africa (n = 396; 55%) and Kenya (n = 106; 16%), two countries with national accreditation bodies. About 16.9% (n = 113) of the accredited laboratories were registered for the SLIPTA programme and 26.6% (n = 178) for SLMTA. Approximately 58,217 LQSI users were registered by December 2020. Countries with a higher UHC index for access to HIV care and treatment, higher WHO JEE scores for laboratory networks, a larger number of registered LQSI users, with national laboratory policy/ strategic plans and PEPFAR-priority countries were more likely to have an accredited laboratory. Of the 475 laboratories engaged in the SLIPTA programme, 154 attained ≥4 SLIPTA stars (ready to apply for accreditation) and 113 achieved ISO 15189 accreditation, with 96 enrolled into the SLMTA programme. Lower-tier laboratories were less likely to achieve accreditation than higher-tier laboratories (7.7% vs. 30%) (p < 0.001). The probability of achieving ISO 15189 accreditation (19%) was highest during the first 24 months after enrolment into the SLIPTA programme. Conclusion: To sustainably anchor quality improvement initiatives at facility level, national approaches including access to a national accreditation authority, adoption of national quality standards and regulatory frameworks are required.

Contexts for developing of national essential diagnostics list. Lessons from a mixed-methods study of existing documents, stakeholders and decision making on tier-specific essential in-vitro diagnostics in African countries

“…Quality requirements such as compliance to the ISO 15189 are reportedly not universally enforced in all clinical laboratory [ 21 ], let alone in testing sites outside conventional laboratory facility. For this reason testing activities taking place at community level, “point of care” or ‘‘point of need” often raise concerns about their compliance to quality assurance, or biosafety/biosecurity requirements such as waste management among other issues.…”

“…For this reason testing activities taking place at community level, “point of care” or ‘‘point of need” often raise concerns about their compliance to quality assurance, or biosafety/biosecurity requirements such as waste management among other issues. In the recently published ISO 15189:2022 the requirements and regulations for point-of-care testing (previously in ISO 22870) have been incorporated, opening the route for more quality and safety of community level testing [ 20 ], as part of national laboratory quality strategies [ 21 , 22 ].…”

“…For five countries they conducted interviews by Zoom conferencing; in two countries face-to-face (Kenya and Uganda). Respondents were staff from MoH national laboratory services (21); international partners (9); hospital laboratories (6); consultants for the Nigerian NEDL (3); professional associations (2); MoH Clinical Services Department (1); staff from regulatory body (1).…”

Quality and resilience of clinical laboratories in Rwanda: a need for sustainable strategies

“…The interventions of training of personnel in LQMS, mentorship, and assessments, as seen in the group two laboratories’ interventions in our study, also led to positive outcomes in Kenya [ 30 ]. A recently published study, collecting data spanning seven years starting in 2013, on medical laboratories implementing quality management systems in Sub-Sahara Africa, indicates that a national framework including laboratory policies and a strategic planning is likely to facilitate ISO 15,189 standard accreditation [ 31 ]. These three elements define priorities for laboratories, and similar attention was maintained in the case of the group two laboratories’ mentorship and assessment, yielding improved outcomes.…”