Abstract
Public health medical laboratories are a component of a healthcare sector where clinical pathology tests are performed on clinical samples. The results of these samples aid in the diagnosis, treatment, and monitoring of disease. Laboratory results greatly influence the outcome of patient management. Therefore, it is essential that the laboratories comply with internationally recognized standards to ensure the accuracy and reliability of results. The International standard specifically developed for the medical laboratories is the ISO15189 standard. The laboratories use it to implement and monitor the laboratory quality management system (QMS). Laboratories conduct annual internal audits to verify compliance with the standard. If the laboratory fulfils the requirements of this standard and is assessed by an external body to verify compliance, the laboratory is awarded an accreditation certificate that is recognized internationally. Out of the twenty-four laboratories in Gauteng, eight laboratories were ISO15189 accredited and sixteen laboratories were not accredited in 2018. There has been slow progress in the accreditation of laboratories throughout the years. The study aimed to determine the reasons for non-compliance with the ISO15189:2012 standard that prevented laboratories from being accredited. Internal audit non-conformances in the nonaccredited laboratories in the Gauteng Province of South Africa for the period 2015-2019 were reviewed to investigate the type of non-conformances recorded in these laboratories. The study was conducted in the three disciplines Haematology, Chemical Pathology, and Microbiology. A descriptive non-experimental quantitative research method design was used and a survey and quantitative data were collected. The survey data was collected through an online multiple response survey distributed to internal auditors that conducted audits in Gauteng. The auditors were asked to identify common non-conformances in these nonaccredited laboratories and to share reasons that contributed to the laboratories noncompliance with the ISO15189:2012 standard. They were asked to share recommendations for improvement based on their experience. The quantitative non-conformance data recorded for the period 2015-2019 was collected. Data was analysed using the SPSS program from STATKON. Descriptives were used to analyse data and frequencies and percentages were used to report results. Cross tabulations were done to compare frequencies and percentages observed for management...
M.Tech. (Biomedical Technology)