Functionality status and drivers of non-functionality of the standardised laboratory analysers in Tanzania mainland: Findings from a National Equipment Harmonisation and Standardisation Mapping Exercise

Introduction Reliable, well-maintained laboratory equipment is essential for timely, accurate and reliable laboratory results for patient care, surveillance, and health system resilience. Tanzania implemented the Standard Medical Laboratory Equipment Guideline (SMLEG-2018) to harmonise procurement and improve efficiency across a tiered laboratory system and network. However, equipment functionality gaps remain a critical challenge for healthcare delivery. This study determined the functionality status of standardised laboratory analysers in Tanzania mainland and identified the drivers of non-functionality. Methods We conducted a facility-based cross-sectional study to identify the causes of non-functionality of standardised chemistry, haematology, and urine analysers across mainland Tanzania. We assessed 3,044 analysers and used Pareto analysis to identify the primary drivers of non-functionality. Results Of the 3,044 standardised analysers assessed, 987 (32.4%) chemistry 1,308 (43.0%) haematology, and 749 (24.6%) urine) assessed; 397 (13.0%) were non-functional. Proportionally, urine analysers were the most non-functional (n=176/749, 23.5%), followed by chemistry (n=135/987, 13.7%), and haematology (n=86/1308, 6.6%) analysers, p<0.001. Urine analysers had significantly higher non-functional equipment (23.5%), followed by Chemistry analysers (13.7%), than Haematology analysers (6.6%), p<0.001. Equipment breakdown was the leading cause of non-functionality, accounting for 70.9% (61/86), 70.5% (124/176) and 60.0% (81/135) of the non-functional haematology, urine and chemistry analysers, respectively, among all causes identified for each analyser type. Conclusion Although the SMLEG 2018 implementation identified broad coverage of functional standardised laboratory equipment, persistent equipment breakdowns of more than 10% highlight a systemic, concerning gap that requires immediate corrective action to sustain high performance. Strengthening preventive maintenance, timely repair services and sustainable equipment lifecycle planning is critical to sustaining quality laboratory services for robust preventive and curative care.