Quality Assurance Program in Clinical Biochemistry Laboratory at a Multispeciality Teaching Hospital, with Special Reference to Quality Indicators

Abstract

Introduction: Clinical laboratories have made considerable progress in addressing the needs of quality control, to make a difference in patient care by giving reliable results. With high degree of dependence on the laboratory results for the healthcare management, the quality of laboratory testing and reporting has become crucial for the better outcome of the healthcare delivery system, particularly in case of tertiary care hospitals. The goal of effective quality assurance program is to ensure execution of all required activities in a proper, professionally acceptable manner. Aim: To evaluate the existing Quality Assurance Program (QAP) of the Clinical Biochemistry Laboratory and to assess the Quality Indicators (QI) in terms of pre-analytical, analytical and post-analytical phases. Materials and Methods: The retrospective study was conducted in a Clinical Biochemistry Laboratory of a Multispecialty teaching hospital, Mysuru, Karnataka, India. The QAP available in the Department of Clinical Biochemistry and the QI data from January 2017-December 2017 was collected. The QI data was assessed under pre-analytical/analytical/post-analytical phases. The data collected was analysed using Microsoft Excel and Microsoft data analysis pack tool. Results: A total of 29 parameters were evaluated to assess the execution of QAP being implemented in the clinical biochemistry laboratory. The existing QAP in the clinical biochemistry laboratory was assessed in terms of structure, process and outcome. We found that most of the processes were in place, as per the defined standards. The overall trend analysis of QI showed a consistent and good performance, though there were few areas where there was scope for improvement. Conclusion: Assessing the performance of QI provides an insight into the efficacy of the QAP. Identifying the gaps in the QAP opens up new avenues for continuous quality improvement.

Keywords

• analytical errors
• clinical laboratory
• compliances
• total quality management