Risk Assessment and Mitigation of Preanalytical Errors: A Quality Improvement Initiative at a National Accreditation Board for Testing and Calibration Laboratories-Accredited Diagnostic Laboratory.

Abstract

Preanalytical errors account for 60% to 70% of total laboratory errors and represent a significant threat to laboratory quality and patient safety. Despite their impact, systematic risk assessment approaches remain underutilized in clinical laboratories, particularly in resource-limited settings. To implement a structured risk assessment framework for identifying, evaluating, and mitigating preanalytical process vulnerabilities in a stand-alone diagnostic laboratory, and to measure the impact of targeted interventions on error reduction. A quality improvement initiative was conducted at Vedant Diagnostic Center, a National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited stand-alone diagnostic laboratory in Rajkot, Gujarat, India, processing approximately 4000 tests monthly. Nine critical preanalytical processes were systematically evaluated with a Severity × Probability risk matrix. Processes were classified as low (1-4), medium (5-9), high (10-15), or extreme risk (16-25). Corrective and preventive actions (CAPAs) were implemented. One process (11%) was classified as extreme risk, 2 (22%) as high risk, and 6 (67%) as medium risk. Baseline error rate was 1.0% (40 errors per 4000 tests monthly). Following CAPA implementation-including phlebotomist training, expiry verification, and temperature monitoring-error rate decreased to 0.3% (12 errors monthly), representing a statistically significant 70% reduction (χ2 = 21.8; P < .001). Systematic risk assessment combined with targeted corrective actions achieved substantial reduction in preanalytical errors. This reproducible, resource-appropriate methodology enables laboratories to enhance preanalytical quality and patient safety, particularly where NABL or other laboratory accreditation requirements drive continuous improvement.