Evaluation of laboratory performance in consideration with quality indicators and rectification measures at clinical biochemistry laboratory

• Author Details:   
• Hasit Dalpatbhai LAD
• Umesh Manoj Kathiria
• DVSS Ramavataram
• Neeta Maheshchandra Rana ^*

Introduction and Objective: In laboratory, the errors related to the total testing process, affecting clinical decision making, may occur in all the phases. Quality Indicators are fundamental tool to assess the laboratory performance. The aim of this study is to observe the error types and rates for analytical and post analytical phase inorder to assess laboratory performance and rectify them. In addition to acrreditate laboratory as per international standards, it would also help to improve patient care and safety.
Materials and Methods: For a period of one year, errors were observed, recorded and analyzed at clinical Biochemistry laboratory, SMIMER, Surat by this retrospective study. Data analysis of total 907611 tests carried out on 317212 samples was done. Analytical and post analytical errors were identified; recorded and analysed taking into consideration certain related Quality Indicators.
Results: For analytical phase and post analytical phase error rates recorded were 7.51% and 8.57% of total samples respectively while it was observed to be as high as 46.71% and 53.28% respectively against total errors encountered for the phases. Highest (45.9%) error rate of analytical phase error was due to tests not in conformance with External Quality Assurance - Proficiency Testing scheme in a previously treated cause. 17.52% of post analytical phase error was due to low rate of critical call outs to clinicians. No records were maintained pertaining to (1) delayed delivery of reports due to insufficient reagents, (2) critical values call out time (min) and (3) staff training events. Also the laboratory was not equipped with Laboratory Informatics System.
Conclusion: Quality Indicators based high error rates warrant active intervention and strict supervision of both the phases of TTP under study. Strategic measures should be initiated to minimize the risk of errors. Ultimately it would be useful for betterment of patient care and safety.

Keywords: Total testing process, Errors in analytical and post analytical phase, Quality indicators, Rectification measures, Laboratory medicine.