A systematic approach to report, categorize and grade quality failures in clinical biochemistry laboratory – ‘single center analysis’

Introduction: Quality failures in clinical biochemistry laboratory have an adverse impact on patient care. Identification and correction of the quality failures are essential to decrease risk and improve patient safety in hospital. Materials and Methods: This study was assessed over 14 months from January 2017 to February 2018. A designed ‘Quality enquiry forms' were introduced to report quality failures which prioritize corrective action. Quality failures were categorized in three phases: preanalytical, analytical and postanalytical with subcategories in each phase. Quality failures were graded on the basis of actual (‘A' score) and potential (‘P' score) adverse outcome on patient care using 5 point scoring system. Results: The numbers of quality failures reported were 453 (0.53%) out of 84,569 requisites received by the clinical biochemistry laboratory, during this entire study period. Quality failures were reported as 50.3%, 5.1% and 44.6% in preanalytical, analytical and postanalytical phases respectively. Quality failure severity ‘A' score was tilted towards lower side: 58.5% allocated an ‘A' score of 1 (least severe grade), while for the ‘P' score towards higher side: 45.5% allocated a ‘P' score of 5 (most severe grade). Conclusion: Quality enquiry reporting system is an effective method for recognition of quality failures in clinical biochemistry laboratory. Systematic approach in this study encompasses a multifaceted strategy for error analysis based on error detection and prevention.