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Title: Evaluation of the performance of analytical quality indicators on the quality management system in a medical establishment
Authors: Hirjee, Nishani 
Keywords: Performance;Analytical quality;Quality management;Medical laboratories
Issue Date: 29-Sep-2022
Since laboratory results are used to diagnose, monitor, and evaluate patient outcomes,
a medical laboratory is an essential component of health care. It is therefore the
responsibility of a medical laboratory to maintain the quality of their analytical
procedures and to implement a quality management system to improve the
effectiveness and efficiency of their tests. Medical laboratories use quality indicators to
monitor and control the quality of their laboratories.
Quality indicators identify risks that may lead to errors, which may cause harm to
patients. In order to comply with the International Organisation for Standardisation
(ISO) quality standard for medical laboratories, quality indicators must be implemented
and monitored. To assess a laboratory's competence, medical laboratories use quality
indicators from the ISO 15189:2012 checklist. Each year, the laboratory monitors a
maximum of three quality indicators covering pre-analysis, analysis, and post-analysis
A study that compared the performance of selected analytical quality indicators
between three main laboratories and ten peripheral laboratories over a two-year period
was designed to assess the quality management system of a medical establishment.
Furthermore, the study evaluated quality reports for the selected analytical quality
indicators between January 2017 and January 2019. To determine whether the
conventional method of choosing only one out of nine quality indicators is sufficient to
maintain quality in the laboratory, analytical quality indicators were compared. The study consisted of a retrospective component and a prospective component. The
retrospective aspect involved the evaluation of laboratory quality reports over a twoyear period, from January 2017 to January 2019. The prospective aspect consisted of
administering a questionnaire to 80 medical technologists in order to assess their
knowledge, attitudes, and practices regarding quality indicators. The Institutional
Research and Ethics Committee (IREC) of the Durban University of Technology
provided ethical clearance. To analyse the data collected, SPSS 26.0 version was
The analysed data depicted a gender composition amongst the participants, with
females predominant in the medical laboratory establishment. The overall ratio of
males to females was approximately 3:7. The results revealed that more than half of
the participant population had working experience of greater than nine years post –
qualification. It was deduced that the pre-selected quality indicator is not sufficient to
maintain the quality management of the medical establishment. The study identified a
suggested list of analytical quality indicators in this medical establishment where the
problem areas can be identified and improved by decreasing analytical errors and
improving patient care. The correlation of the level of knowledge has a direct impact
on the attitudes and practices of medical technologists on the current use of quality
indicators (p<0.001).
The levels of knowledge practises and attitudes of medical technologists were
assessed and further training was suggested to improve the quality management
system. The key findings noted were that the medical technologists in this
establishment had adequate knowledge on document control and instrument
maintenance. Another key finding was that knowledge directly affects the practises and
attitudes. The pre-selected quality indicator is not sufficient to maintain the quality
management system of this medical establishment.
Dissertation submitted in fulfilment of the requirements for the Degree Masters of Health Sciences in Medical Laboratory Science at Durban University of Technology, Durban, South Africa, 2022.
Appears in Collections:Theses and dissertations (Health Sciences)

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