Abstract
The South African National Accreditation System (SANAS) is the only national body responsible for carrying out accreditations in South Africa (SA) as mandated through the accreditation for Conformity Assessment, Calibration and Good Laboratory Practices Act 19 of 2006 (SANAS, 2019). Accreditation is an official recognition that a facility or laboratory is competent to perform specific tasks and has a documented Quality Management System (QMS) in place (Oliver, 2019). The International Organisation for Standardization (ISO) standard specific for medical laboratory accreditation is ISO 15189:2012 the current version.
Medical diagnostic laboratories contribute much toward the final decisions taken by clinicians to diagnose the patients or to start the treatment. Clinical laboratory testing plays an important role in patient diagnosis (Tucker, 2019). There is about 80% of South Africa (SA) population uses public laboratories of which are less accredited (Dabula, 2018). There is currently limited research done about accredited laboratories in SA, and literature had not revealed reasons for lesser number of accreditation in government own laboratories and lack of awareness to the outskirt’s areas. A quantitative cohort retrospective study of private and government sector accredited laboratories from 2010-2019 inclusive. The results were statistically analysed by means of Statistical Package for the Social Sciences (SPSS). The test for normality was done using Kolmogorov-Smirnova tests for sample size biggerthan fifty and the Shapiro-Wilk for sample size less than fifty (Mishra et al., 2019).
The P> 0.05 was not considered significant and indicated that data was normally distributed, P< 0.05 was considered statistical significance meaning data was not
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normally distributed (Pallant, 2007). The results indicated that there was a statistical difference on the overall distribution of accredited laboratories from 2010 to 2019.
In conclusion although accreditation is still a voluntary process in SA, mandating or regulating accreditation can eradicate the in-equality to access the quality health-care system.