The link between accreditation and quality laboratory services: public versus private laboratories in South Africa

Abstract

Background: The South African National Accreditation System (SANAS) is the only national body responsible for accreditations in South Africa as mandated by the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act 19 of 2006, which is specifically aimed at illustrating accredited services in medical laboratories. The limited information about accredited medical diagnostic laboratories in South Africa resulted in a lack of awareness on the value of accreditation. This study aimed to ascertain the ratio of the South African population who has access to ISO15189 accredited laboratory services as well as to show the distribution of ISO15189 accredited laboratories throughout the provinces of South Africa.
Methods: This was a retrospective cohort study that extracted data on public and private accredited laboratories from 2010–2019. Three databases were used to collect data; namely, the SANAS database to obtain the total number of accredited laboratories in South Africa, the Council of Medical Schemes (CMS) database regarding the populations with medical aid, and the Statistics South Africa (Stats SA) database to obtain the estimated population in South Africa. The collected data were tested for normality using the Shapiro–Wilk test and the Kolmogorov–Smirnov test.
Statistical analysis: The data were collected and statistically analysed using the Statistical Package for the Social Sciences (SPSS). The p-value < 0.05 was considered statistically significant and indicated that data were not normally distributed.
Results: The results showed that data of South African accredited laboratories were not normally distributed in eight of the nine provinces. Data were normally distributed only in Gauteng province indicating p = 0.474 for public laboratories and p = 0.420 for private laboratories.
Conclusion: The findings of this study showed that there was a biased distribution of accredited laboratories in South Africa in favour of private laboratories. There is a need for scaling up SANAS accredited laboratories for public healthcare facilities. The majority of the population who did not have medical aid also had access to unaccredited laboratories. The quality of results in these laboratories is not aligned to international ISO15189 laboratory quality standards.