Evaluation of non-conformities identified in accredited medical laboratories in Uganda and experiences of laboratory personnel during processes of identifying these non-conformities

Abstract

Introduction: Identification, control, analysis of trends and management, of non-conformities in medical laboratories is one of the management requirements that laboratories accredited to ISO 15189 must implement as part of continual improvement to ensure quality tests are released. The objective of this study was to profile the frequency, types and trends of non-conformities identified against ISO 15189:2012 in the quality management systems of SANAS accredited laboratories in Uganda during the period 2017-2021. The study also explored the experiences of laboratory personnel on non-conformities identification processes by SANAS during accreditation assessments.

Methods: It was a retrospective and cross-sectional study design, involving mixed research methods and stratified sampling technique were employed. Data analysis and reporting were performed using Microsoft excel and Power BI softwares.

Results: Findings from this study revealed that 64% of the identified non-conformities were against the technical ISO 15189:2012 requirement compared to 33% against the management requirement (n=261). By categorization, 71% of the identified non-conformities were major compared to 21% minor non-conformities (n=261). The study also showed that most non-conformities occurred in the testing-phase (77%) compared to 20% and 3% in pre-testing and post-testing phases respectively (n=261). Overall, there was a steady decrease in the number of non-conformities identified during initial assessments compared to follow up and surveillance assessment at 6-12 months and at 24 months respectively. Across the twenty-five clauses of ISO 15189:2012, most non-conformities were identified against clause 5.6, followed by clause 5.3, clause 4.14 and clause 5.5. In relation to the experiences of laboratory personnel, most of them indicated that it was motivating to be working in an internationally accredited laboratory although a some of them expressed sentiments of more fatigue and pressure arising from increase in responsibilities associated with accreditation works. Most challenges encountered by the laboratories during accreditation journey included among other inadequate human resources, limited funding to the laboratory sector, facilities' limited management commitment towards accreditation processes and complexity nature of the identified non-conformities.

Conclusion: More non-conformities categorized as major were identified against the technical requirements of ISO 15189:2012 compared to management requirement amongst SANAS accredited medical laboratories in Uganda during the period 2017-2021 with of the technical non-conformities were mainly identified clauses 5.6, 5.3 and 5.5 of ISO 15189:2012. There was a general decline in the number of identified non conformities by the end of the surveillance assessment at 24 months as compared to initial assessment which signifies improvement the laboratories quality management system. Pertaining to laboratory personnel’s experience in identification of non-conformities during the laboratory accreditation journey and for being part of this process, they generally articulated that it improved their motivation, self-esteem while providing good learnings.

Recommendations: Based on finding from this study, it is recommended to stakeholders to establish accreditation sustenance program, need to recruit more staff, address logistics and equipment gaps, consider expanding external quality assessment schemes among others in order to sustain the accreditation program and minimize occurrence and re-occurrence of non-conformities.