S126: AN EU -- ARISE INITIATIVE GAP ANALYSIS APPROACH TO IMPROVING THE QUALITY OF LABORATORY SYSTEMS IN SUB-SAHARAN AFRICA.

Abstract

Background: Accurate and reliable laboratory results are critical to diagnostics in sickle cell disease (SCD) newborn screening. In sub-Saharan Africa, due to neglect of some national health laboratories, there has been persistently high levels of laboratory error, lack of functioning quality management systems and laboratory accreditation. ARISE (African Research and Innovative Initiative for Sickle Cell Education) is a research project funded by the EU. It involves a secondment plan across 8 work packages between institutions in EU (Italy, France, UK and Cyprus) and non-EU (Nigeria, Lebanon, Kenya and USA) countries, creating an interagency and multidisciplinary staff exchange programme to share best practices in newborn screening, diagnosis and treatment of SCD, leading to improved disease outcomes. Secondments include medical, nursing, laboratory, administrative, academic and research professionals. Led by the RCPath and INSERM, WP3 is tasked with improving laboratory diagnostics, capacity, and quality assurance systems for population screening, diagnosis, treatment and monitoring of SCD through assessments, training and mentoring of laboratory health professionals. This is facilitated by baseline, interim and final gap assessments Aims: To compare a baseline gap analysis at the commencement of the project in 2019 with an interim gap assessment 2 years into the project, following secondments to UK laboratories from Nigeria To identify areas of increased focus and support during planned secondments, workshops, and virtual lectures Methods: 6 partner organisation laboratories participated in the baseline gap assessment in 2019, while 10 laboratories participated in the interim gap assessment in 2021, due to new institutions joining the ARISE initiative. An electronic online questionnaire (40 questions) was sent to each laboratory lead. Results: Survey results of the 6 laboratories that undertook both the baseline and interim gap assessment were analysed. A sample of comparative results between 2019 and 2021 include the following: Working towards accreditation - 2/6 versus 3/6: There is the need for each laboratory to progress towards an application for accreditation. SOP’s available for tests and processes - 38 versus 32: This might suggest standardisation and rebranding of documents previously labelled as SOP’s. No schedule of SOP revisions in 0/6 laboratories versus 4/6 laboratories: This clearly demonstrates an understanding that SOP’s need to be updated via a document management system. Scientist certified competences - 22 versus 22. Self -assessed improvement targets - 18 versus 15. Laboratory lead for QA - 3/6 versus 6/6: The importance of QA leadership for each laboratory identified prior to interim assessment. Summary and Recommendations: Early evidence suggests that ARISE secondments have facilitated improved approaches to laboratory governance procedures and QA. Mentoring by EU partner laboratories will further enhance this. ARISE related workshops and train - the- trainer programmes will support capacity building and skills transfer. A final assessment will be undertaken at the end of the ARISE initiative. Conclusion: The ARISE initiative will build on the early success of improvement in laboratory systems, to further support service development and capacity building. The target for each partner laboratory will be a timeline of application to full accreditation