Medical Laboratory Quality System at The Crown Prince Hospitals, Thailand

Abstract

       A policy of Department of Medical Sciences to facilitate and support laboratory quality system at each of the 21 laboratories of The Crown Prince Hospitals (CPH) in 2011 resulted in an achievement on ISO 15189:2012 accreditation of all laboratories since 2015. The policy has been continued with its ultimate goal for receiving accreditation of all testing being operated at each hospital laboratory. Our study was to determine factors associated with changes and improvement of quality system according to ISO 15189:2012 by collecting non-conformities (NC) received at 2 different time points: the first accreditation and reaccreditation. No significant differences on NC, classified as condition (C), were found (t-test, p > 0.05). Significant differences on NC, classified as observation (O), was, however, demonstrated (t-test, p < 0.05). It was shown that the most common NC of the initiation of accreditation clause 5.3: laboratory equipment, reagent and consumables, while the most common NC of reaccreditation was clause 5.5: examination processes. Moreover, the numbers of NC were decreased while the numbers of tests accredited were increased. In addition, a percentage of repeated NCs between 2 periods of our study was 95. It was suggested that a laboratory networking, knowledge and experiences sharing of NCs might be tools for facilitating and maintaining laboratory quality system towards ISO 15189:2012. Our study indicated that a model developed within CPH laboratory network could be useful for development of laboratory quality system at community hospitals of our nation.