Date of Award

10-31-2024

Degree Type

Thesis

Degree Name

Master of Health Policy and Management

First Advisor

Dr Rozina Mistry

Second Advisor

Dr Shifa Habib

Third Advisor

Dr Hasan Nawaz

Department

Community Health Sciences

Abstract

Background: Clinical laboratories are significant in hospitals since 60 to 70% of diagnoses are based on test results. A quality assurance system is the key to maintaining the reliability and accuracy of the test results. National and international regulatory organizations have given guidelines to maintain and improve the quality of laboratories. According to those guidelines, laboratory equipment requires regular maintenance to ensure the accuracy and reliability of test results, which can reduce diagnostic errors. Misdiagnosis can lead to an increase in the cost of health care services. Abnormal test results are among the main issues in clinician satisfaction with laboratories and can increase the cost of healthcare services. In Pakistan, relevant ministries developed policies and guidelines for good laboratories to ensure the quality of laboratory test results. There is a need to explore the quality assurance processes of equipment in clinical laboratories of public and private health hospitals that are currently being followed to identify the gaps in quality management systems and have a continuous improvement method.
Objective: To assess the current quality assurance process of diagnostic equipment at clinical laboratories of tertiary care public and private hospitals in Karachi, Pakistan. This study aims to obtain stakeholders’ perspectives on the barriers to following diagnostic equipment quality assurance guidelines at clinical laboratories of tertiary care public and private hospitals in Karachi, Pakistan.
Method: It is an observational qualitative study. A purposive sampling technique was used to conduct in-depth interviews with 11 participants working in the clinical laboratories of hospitals in Karachi. The interview was based on a semi-structured interview guide developed using the WHO Laboratory standard checklist and concept framework of a study conducted in Africa for equipment maintenance. Consent was obtained from the organisations and participants. The interviews were conducted and recorded at the hospital. The recordings were transcribed in Urdu and translated into English for data analysis. The English transcription was coded according to the selected theme and then analysed for findings. Results: Three themes were selected, which were divided into subthemes and further categories. Planning, implementation, and monitoring and evaluation. These themes showed that in terms of planning, most laboratories have all the critical components in place to follow the Quality Management system. Still, there is a need for guidelines for implementing the policy given by regulatory authority, as the findings show many variations in procedures that are followed, while in implementation, there needed to be more training sessions and unmaintained maintenance logbooks. Regarding monitoring and evaluation, there were many gaps related to a lack of record maintenance, external QC verification, and no accreditation. At the same time, participants believe that barriers are related to a lack of resources, awareness, training, and a few behavioural problems.
Conclusion: Knowing the current situation is the key to improving the implementation of the quality management system. These findings reveal that most of the components required to implement an effective quality management system are in place. However, there is a need for standard guidelines for implementation with training sessions in quality assurance and equipment handling. The monitoring and evaluation process should be more thorough, and the policy should be revised after identifying gaps. With a few additions to the regulatory process, the development of standard guidelines and the improvement of the quality of monitoring and evaluation criteria can improve the overall quality management system of laboratories in Karachi.

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