Targeting Sample Reception Errors: A Failure Reporting Analysis and Corrective Action System (FRACAS)-Based...

Approximately 70% of clinical decisions depend on laboratory test results, underscoring the critical importance of examination accuracy. Among the phases of the total testing process, the pre-examination phase accounts for the highest proportion of errors; therefore, interventions aimed at reducing these errors can significantly enhance overall laboratory quality. This study aims to evaluate the effectiveness of risk assessment and corrective strategies through the implementation of the Failure Reporting, Analysis, and Corrective Action System (FRACAS) by comparing Risk Priority Number (RPN) scores before and after implementing corrective strategies.

This retrospective observational quality-improvement study obtained approval from the institutional ethics committee. It analyzed two years of data from a clinical biochemistry laboratory. A total of 573 samples were rejected in a NABL-accredited, ISO 15189-compliant tertiary-care hospital in South India. Each nonconformance (NC) was categorized, and its frequency, percentage distribution, and RPN were calculated for both study periods. The effectiveness of risk assessment and corrective strategies was evaluated by comparing pre- and post-corrective RPN values and percentage reductions in NCs.

Data from 573 rejected samples (216 pre-corrective in 2021; 357 post-correctives in 2022) were analysed. Mean RPN decreased from 18.0 ± 16.1 to 10.9 ± 15.3 (mean difference 6.0, 95% CI 2.0-24.0, p = 0.041); paired Bayesian t-test showed BF10 = 1.15, evidence for effectiveness. Four NCs were eliminated; however, three new NCs emerged post-STAT lab launch.

FRACAS-guided interventions reduce pre-examination NCs and lower RPNs for high-risk processes, supporting their use for pre-examination quality improvement.