The development of a system for the reporting, classification and grading of quality failures in the clinical biochemistry laboratory

Background: There is no agreed system for the reporting, classification and grading of the severity of quality failures in the clinical biochemistry laboratory. Methods: A 'Quality Query' reporting system was set up to log all quality failures identified by staff and service users. Quality failures were classified into three major groups of the preanalytical, analytical and postanalytical phases with appropriate subcategories in each group. The severity of each quality failure was graded using a five-point scoring system incorporating both actual (W) and potential ('P') score elements. The 'A' score measured the actual adverse impact of the quality failure on patient care, while the 'P' score measured the 'worst case' potential outcome that might have resulted. The system was assessed over a 19-month period. Results: Three hundred and ninety-seven Quality Query reports were completed (0.085% of all requests). Breakdown by cause: pre-analytical phase - 88.9%, analytical phase - 9.6%, post-analytical phase - 1.5%. The quality failure severity 'A' scores were skewed towards a low adverse impact on patient care: 72.7% allocated an 'A' score of 1 (least severe grade). The 'P' scores were skewed towards a high potential impact on patient care: 65.9% allocated a 'P' score of 5 (most severe grade). Conclusions: The Quality Query reporting system proved easy to integrate into routine laboratory practice. Although the great majority of quality failures had minimal adverse impact on patient care, the potential for adverse outcomes was much higher. This system generates important information on laboratory performance and helps inform risk management priorities.