Abstract

Background: In the modern era of tremendous automation in analytical processes, reporting errors have been reduced significantly. Therefore, the focus has been shifted to identifying the extra analytical causes of errors in the laboratory. Objectives: This study aimed to audit major clinical decisions affecting quality indicators (i.e., reporting errors and error prevention) by adhering to ISO 15189 (2012) and National Accreditation Board for Testing and Calibration Laboratories (NABL) (112) requirements. Methods: The records of the reporting errors were maintained from the biochemistry section of the central clinical laboratory (CCL) and analyzed based on the aim of this study. Then, the root cause analysis was performed, and the data was collected and audited from November 2015 to July 2020. Results: The total number of reporting errors between the mentioned periods were 132, with an incidence of 1 error per 384 processed samples on the day of observing the reporting error. In general, 22 (16.67%), 16 (12.12%), and 94 (71.21%) cases were pre-analytical, analytical, and post-analytical errors, respectively. The incidence of the post-analytical error was noted to be more since they were all typographical errors. Conclusion: Overall, transcriptional or typographical errors were found to be the main causes of reporting errors. In our clinical laboratory, we are attempting to minimize these errors by pre-validating the results by senior technicians and faculty prior to the typing and approval. These avoidable errors can be minimized by the continuous training of laboratory staff. Up-gradation to automated data collection information management systems are of great hope for preventing such errors.

Highlights

  • In the modern era of tremendous automation in analytical processes, reporting errors have been reduced significantly

  • The use of laboratory information management systems (LIS) as a recording mechanism for preanalytical errors is recommended as it is the easiest and most standardized mechanism of data capture [10]

  • Blood samples are Results The present study was conducted between November 2015 and July 2020, which included the auditing of the reporting errors with respect to the type of errors, frequency of errors, and the actual cause behind them

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Summary

Introduction

In the modern era of tremendous automation in analytical processes, reporting errors have been reduced significantly. Objectives: This study aimed to audit major clinical decisions affecting quality indicators (i.e., reporting errors and error prevention) by adhering to ISO 15189 (2012) and National Accreditation Board for Testing and Calibration Laboratories (NABL) [112] requirements. We are attempting to minimize these errors by pre-validating the results by senior technicians and faculty prior to the typing and approval. These avoidable errors can be minimized by the continuous training of laboratory staff. Laboratory systems are playing an important role as a pillar in the healthcare system for delivering quality patient care These new updated accredited laboratory systems have changed the traditional scene of healthcare systems into the more accurate and personalized healthcare delivery of services. Automated processing has recently replaced the manual testing of parameters in the field of laboratory medicine

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