Laboratories have a major impact on patient safety as 80-90 % of all the diagnosis are made on the basis of laboratory tests. Laboratory errors have a reported frequency of 0.012-0.6 % of all test results. Patient safety is a managerial issue which can be enhanced by implementing active system to identify and monitor quality failures. This can be facilitated by reactive method which includes incident reporting followed by root cause analysis. This leads to identification and correction of weaknesses in policies and procedures in the system. Another way is proactive method like Failure Mode and Effect Analysis. In this focus is on entire examination process, anticipating major adverse events and pre-emptively prevent them from occurring. It is used for prospective risk analysis of high-risk processes to reduce the chance of errors in the laboratory and other patient care areas.
Keywords: FMEA; Incident reporting; Laboratory errors; Patient safety; Quality failure; Root cause analysis.