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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.

BACKGROUND: The quality of laboratory services is crucial for quality of patient care. Clinical services and physicians' decisions depend largely on laboratory test results for appropriate patients' management. Therefore, physicians' satisfaction with laboratory services is a key measurement of the quality service that stresses impactful laboratory service improvement to benefit patients. OBJECTIVE: To assess physicians' satisfaction and perspectives on the quality of services in clinical referral laboratories in Rwanda. METHODS: A cross-sectional survey among physicians from four referral hospitals with closed-ended questionnaire and one general open-ended question. A five-point Likert scale rating was used to measure satisfaction. Descriptive, ordered logistic regression, and thematic analysis were used. RESULTS: In total, 462 of 507 physicians (91% response rate) participated in the study. Overall mean satisfaction was 3.2 out of 5, and 36.2% of physicians were satisfied (satisfied and strongly satisfied) with laboratory services. In four service categories out of 17, the physicians' satisfaction was over 50%. The categories were: reliability of results (69.9%), adequacy of test reports (61.9%), laboratory staff availability (58.4%), and laboratory leadership responsiveness (51.3%). Lowest satisfaction was seen for routine test turnaround time (TAT) (19.3%), in-patient stat (urgent) test TAT (27%), communication of changes such as reagent stock out, new test (29%), and missing outpatient results (31%). Eighty-four percent answered that test TAT was not communicated, and 73.4% lacked virology diagnostics. Pediatricians, internists, and more experienced physicians were less satisfied. While ineffective communication, result delays, and service interruption were perceived as dissatisfying patterns, external audits were appreciated for improving laboratory services. CONCLUSION: Availing continuously laboratory tests, timely result reporting, and effective communication between laboratories and clinicians would increase physicians' satisfaction and likely improve the quality of health care. Laboratory staff participation in clinical meetings and ward rounds with physicians may address most of the physicians' concerns.

Objectives: To explore challenges explaining the decrease in quality performance and suggest strategies to improve and sustain laboratory quality services. Methods: Twenty key informants' interviews from laboratory personnel were conducted in five laboratories. Four had previously shown a decrease in quality performance. Interviews were transcribed verbatim and analyzed using inductive thematic analysis. Results: Two themes emerged: (1) insufficient coordination and follow-up system towards accreditation, where lack of coordination, follow-up, and audits explained the decrease in performance; (2) inadequate resource optimization, where insufficient knowledge in Laboratory Quality Management System (LQMS), ownership by laboratory workforce, and insufficient stakeholders' communication contributed to low-quality performance. Conclusions: The coordination, follow-up, and assessments of LQMS, in conjunction with training of laboratory workforce, would establish an institutional culture of continuous quality improvement (CQI) towards accreditation and sustainment of quality health care. To achieve CQI culture, routine gap checking and planning for improvement using a system approach is required.

Two decades ago, the genocide against the Tutsis in Rwanda led to the deaths of 1 million people, and the displacement of millions more. Injury and trauma were followed by the effects of a devastated health system and economy. In the years that followed, a new course set by a new government set into motion equity-oriented national policies focusing on social cohesion and people-centred development. Premature mortality rates have fallen precipitously in recent years, and life expectancy has doubled since the mid-1990s. Here we reflect on the lessons learned in rebuilding Rwanda's health sector during the past two decades, as the country now prepares itself to take on new challenges in health-care delivery.