Faculty of Health Sciences
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Item Evaluation of the performance of analytical quality indicators on the quality management system in a medical establishment(2022-09-29) Hirjee, Nishani; Mkhize, B. T.; Pillay, P.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.Item The effect of human factors on the implementation of accreditation in the medical laboratories in KwaZulu-Natal(2021-05-27) Ngubo, Mbalenhle Audrey; Pillay, Pavitra; Phili, Rogerio; Cele, LindiweBackground: The National Health Laboratory Service (NHLS) provides pathology laboratory services to approximately 80% of the population in South Africa (SA). Despite being the main provider of laboratory service, the NHLS continues to struggle in preparing and ensuring the accreditation of its laboratories. In SA, the SA National Accreditation System (SANAS) is the platform through which laboratories are assessed and granted the accreditation status that certify their adherence to quality and performance standards. The process of preparing and ensuring laboratory accreditation in the NHLS is currently slow. The infrastructural and weak quality management systems are generally the universal barriers to the accreditation of laboratories. However, there is inadequate knowledge of human factors affecting the accreditation of laboratories. This quantitative descriptive study aims to explore the influence of staff motivation, practices and management support to the achievement of SANAS accreditation and to routine laboratory performance. Methods: A modified Likert-Scale employee motivation and management support assessment questionnaire was administered to 438 purposively-sampled NHLS employees in selected laboratories in KwaZulu-Natal (KZN). Employee attitudes, practice and behavioural questions as well as cumulative percentages of leadership index questions were used to assess the employee motivation and level of support provided by laboratory management, respectively. Retrospective data of two selected routine indicators of laboratory performance were subsequently evaluated against the employee motivation categories of the laboratories. The laboratories were stratified into accredited and non-accredited streams. Univariate analysis on employee motivation and management support and bivariate analysis on laboratory performance was performed using the SPSS Software. Chi-Square tests were used for comparisons, odds ratios (ORs) and 95% confidence intervals were calculated. Statistical significance was defined as p < 0,05 and any variables that achieve a pvalue of <0.05 were analysed using multivariate logistic regression. The study findings were applied to the Stages of Change (SOC) Theoretical Model or Transtheoretical Model (TTM). Results: This study included 249/296 participants, resulting in a response rate of 84%. Accredited laboratories had twice the number of staff compliment when compared with non-accredited laboratories. The results indicated that 98% of employees regard NHLS as the employer of choice; they believe they are a critical resource for the organization; they see themselves still working for the NHLS in two years’ time and they can recommend NHLS as a great place to work at. Forty-seven percent of the participants did not believe that they have good career opportunities at the NHLS. Most of the participants (82%) stated that there is no work recognition for good performance and 77% of employees indicated that management decisions do not regard quality as the top priority, instead this was turnaround time. About 94% agreed that they believe that laboratory accreditation is necessary and they know their role in accreditation. However, most participants strongly disagreed about the NHLS management motivating them to go beyond what they would in a similar role elsewhere. It was found that 51% of employees did not believe that managers are great role models to the employees. Majority of NHLS employees were not satisfied with financial incentives, with the existing staffing in their laboratories, with the work infrastructure especially in rural settings and with the lack of management support. Conclusion: The SOC/ TTM model has five stages: pre-contemplation, contemplation, preparation, action, and maintenance. This model is based on the assumption that behaviour change among people occurs continuously through a cyclical process. This model is also based in the premise that people are at distinct points along the five stages and have different informational needs. In the present study it was found that human factors have an effect on the implementation of accreditation in medical laboratories of KwaZulu-Natal. It was also found that the areas of concern in the NHLS that are likely to be the main cause of the slowness in implementation of accreditation are: inadequate management support and leadership and poor staff morale/ lack of motivation among NHLS employees. It is recommended that the NHLS provide strengthened and ongoing training for employees focusing on the importance of laboratory accreditation. Managers also need to be capacitated so that they are able to better support staff in gaining and maintaining laboratory accreditation.