Evaluation of Risk Management Parameters for Quality and Safety in a Clinical Biochemistry Laboratory of a Tertiary Health Care System: A Cross-sectional Study

Introduction: Clinical laboratory results play a crucial role in medical decision making and patient management. Accuracy and reliability of laboratory findings require systematic risk assessment and management across all phases of laboratory testing. Laboratory processes are broadly classified into preexamination or pre analytical, examination or analytical and post examination or post-analytical phases. Failure Mode and Effect Analysis (FMEA) is a risk assessment tool that helps identify potential failures, prioritise risks and improve quality management system in accordance with the standards of International Organisation for Standardisation (ISO) 15189: 2022. Aim: To evaluate risk management parameters affecting quality and safety in a Clinical Biochemistry Laboratory and prioritise them using FMEA assessment tool. Materials and Methods: The present cross-sectional study was carried out over a period of 12 months from January 2024 to December 2024 at the clinical biochemistry section, Central Diagnostic Laboratory Services, RL Jalappa Hospital and Research Centre attached to Sri Devaraj Urs Medical College Kolar, Karnataka, India. Laboratory incident reports were retrieved from audit logs and categorised into pre-examination, examination and post-examination phases. FMEA scoring based on severity, occurrence and detectability was applied to calculate Risk Priority Numbers (RPN). Corrective and Preventive actions (CAPA) were aligned with ISO 15189: 2022 guidelines. Results: A total of 14 incident events were identified and recorded. In the pre-examination phase, errors related to improper labelling, inadequate samples and delay in transport accounted for 3 (21.4%) of reported incidents. The examination phase accounted for the highest proportion of incidents 7 (50%) majorly due to Quality Control (QC) failures and equipment downtime that showed the highest RPN values. These risks were mitigated using Westgard QC rules, standby analysers and vendor service agreements. In the post-examination phase, Laboratory Information System (LIS) failures and delays in reporting contributed to 4 (28.6%) of the total incidents affecting Turnaround Time (TAT). Conclusion: Errors were identified across all the phases of the laboratory testing cycle. Implementation of an National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited quality system, combined with rigorous risk assessment through FMEA and CAPA, significantly contributes to improved patient safety and reliability of laboratory reporting.