Evaluation of the performance of analytical quality indicators on the quality management system in a medical establishment
Authors:   , Hirjee Nishani 
Published: December 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 variables. 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 used. 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.