PROCESS INNOVATION IN LABORATORY SERVICE SYSTEMS: ENHANCING OPERATIONAL PERFORMANCE AND RISK REDUCTION THROUGH FMEA

Abstract

This study aimed to conduct a prospective risk analysis of pre-analytical processes in a central laboratory to enhance patient safety. Failure Mode and Effects Analysis (FMEA) was conducted in the central laboratory of a private hospital in Türkiye. A multidisciplinary risk assessment team consisting of 10 members with expertise in laboratory, clinical, quality, and safety processes was established. The pre-analytical risk assessment process was examined under five main processes: specimen collection, analysis ordering, patient records, transport and temporary storage, and barcoding. Brainstorming, flowchart diagrams, and the multi-voting technique were used to identify and prioritize failure modes and their causes, assess severity, occurrence, and detectability, and propose corrective actions. Risk Priority Numbers (RPNs) were calculated by multiplying severity, occurrence, and detectability scores assigned by the team. A total of 36 potential failure modes were identified, and their causes, effects, and corrective actions were analyzed. The highest-risk failure modes included failure to order or incomplete ordering of tests by physicians (RPN: 80), blood sample collection using syringes (RPN: 80), incorrect test ordering (RPN: 64), registration under the wrong patient (RPN: 64), improper application of the tourniquet (RPN: 60), incorrect transfer of blood collected by syringe into tubes resulting in hemolysis or insufficient/excessive sample volume (RPN: 64), and loss of specimens (RPN: 64). Following the implementation of corrective actions, overall risk levels were reduced by 66.75%. This study demonstrates that FMEA is an effective and practical tool for identifying, prioritizing, and reducing risks in pre-analytical processes within a central laboratory of a hospital.