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Introduction: Poor quality health care is a serious silent public health problem worldwide, resulting in deaths, disabilities and long hospital stays with unnecessary costs. It affects patients in all countries regardless of their level of development. Estimations show that 64 million disability-adjusted life years are lost yearly worldwide due to unsafe health care, and this phenomenon is one of the top 10 causes of mortality and disability in the world. Four out of 10 patients are harmed while getting health care in primary and outpatient health care services. Most of this unsafe care is due to errors in diagnosis, prescriptions and use of medicines. Better management of patients could be accomplished with clearer diagnostics. Clinical laboratories play a central role in the quality of health care when they provide accurate and reliable test results for timely and evidence-based diagnostic for management of patients, surveillance and control of diseases. The aim of this dissertation was to study the quality of clinical laboratory services in Rwanda to contribute to the health care quality in Rwanda and other similar settings.

Methods: This dissertation is built on studies that used mainly primary data collected at five clinical referral laboratories and related hospitals (Papers I–III). To assess the quality performance of laboratories, the World Health Organization (WHO) Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist was used to score laboratories and to analyse the trend in quality performance (Paper I). The factors explaining the status of quality performance of laboratories were explored by using qualitative data, namely key informant interviews with thematic analysis (Paper II). Physicians’ satisfaction with laboratory services was assessed by using a structured questionnaire with a Likert scale and an open-ended question. All eligible physicians from four referral hospitals (N = 507) were invited to participate in the study (Paper III) and 91% provided their feedback. Descriptive statistics and ordered logistic regression were performed and qualitative data were analysed with a thematic approach. To identify pathogenic viruses circulating in Rwanda with no available diagnosis, we sampled 11 health centres for febrile patients with acute infections whose malaria test result was negative (n = 2313). Selected arboviruses were analysed from blood samples by using polymerase chain reaction (Paper IV).

Results and Discussion: In 2017, only one referral laboratory scored at the highest level, five stars, which was an increase from four stars in 2012. The other four laboratories had decreased in quality performance. The factors explaining this decrease were mainly insufficient coordination to ensure continuous quality improvement as well as lack of mentorship and regular external assessment of laboratory to identify and address gaps. Only 36% of physicians were satisfied with laboratory services in referral hospitals. Seventy per cent were satisfied with the reliability of test results, while only 19% were satisfied with the turnaround time, and improved virus diagnostics was sought. In general, paediatricians, internists and more experienced physicians were less satisfied. Over 2000 samples from acute, febrile patients were sampled in 11 health centres from different provinces of Rwanda and are now stored in a unique biobank for future analysis. The results so far show that o’nyong-nyong and Zika viruses are circulating in Rwanda.

Conclusion: Despite the improvement in quality performance with the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme, most laboratories showed decreased performance in their follow-up assessments compared with their exit assessment. Resuming external assessments as well as investing in leadership and planning would lead to high-quality laboratory performance, even reaching international accreditation. For sustainability, the SLMTA programme should be institutionalised, the laboratory quality management system should be integrated into the education of laboratory staff and in continuous professional development training. Extended diagnostics for infectious diseases should be considered. The achievement of quality health care, universal health coverage and global health security are not possible without quality laboratory services that guide the pathway through accurate and reliable tests results.