The reporting, classification and grading of quality failures in the medical laboratory.

Laboratory errors have a reported frequency of 0.012 to 0.6% of all test results and given the central role of the laboratory in diagnosis, may have a major adverse impact on patient care. Laboratories have been at the forefront of efforts to enhance patient safety through a range of improvements such as increased automation of manual processes and analytical quality control programmes. It is important that all laboratories have active systems in place to identify and monitor quality failures. This will be facilitated by a systems based approach to error which seeks to identify and correct weaknesses in policies/procedures rather than to apportion blame. Quality failures may be classified by cause [i.e., step in the testing pathway where the problem occurred] and graded by severity on a 5 point scale. The severity grading score measures both the Actual impact ['A' score] on patient outcome and the Potential impact ['P' score] i.e., the worst case possible outcome that might have resulted. 'A' scores tend to be skewed towards low adverse patient impact while 'P' scores are skewed towards high adverse impact. This confirms the need for ongoing vigilance by laboratories. This classification/grading system is easy to implement and represents a valuable additional tool for monitoring performance.