Analysis of internal audit non-conformances at non-accredited public health laboratories in Gauteng province, South Africa

Background: The International Organisation of Standardisation (ISO) 15189:2012 standard specifies requirements for the competence and quality of medical laboratories and outlines criteria for the quality management system (QMS) within these laboratories. Among the 24 public health laboratories in Gauteng, only eight (33%) achieved ISO 15189:2012 accreditation by the end of 2018, leaving a notable 16 (67%) without this status. This study aimed to identify trends in non-conformances among the non-accredited laboratories in Gauteng, as well as strategies to improve compliance with the standard.
Methods: Non-conformances were collected in three disciplines (haematology, chemical pathology, and microbiology) over five years. They were categorised as pre-analytical, analytical, and post-analytical testing phases, and quality system essentials (QSE) for those non-conformances outside the testing phases. The distribution of non-conformances across the five years was compared. Non-conformances were categorised according to severity and compared. Pearson’s chi-square test evaluated differences (p < 0.05) between categories. Results: The findings showed a statistically significant difference between the years for the testing phases and QSE non-conformances (p < 0.001). Additionally, the severity of the non-conformances between these laboratories (p < 0.001) showed that medium severity non-conformances were less common than minor- or major-severity non-conformances. The majority (364, 57.6%) of non conformances were recorded for the QSEs (i.e. requirements outside the pre-analytical, analytical, and post-analytical phases). Gaps in the QMS were identified. Conclusion: Extensive knowledge and analysis of laboratory non-conformances are crucial for future improvement. This study showed that fulfilling the administrative requirements of the ISO standard is an area of concern. Strategies to overcome the challenges of the ISO 15189:2012 administrative requirements need to be explored, such as appointing quality assurance officers.