Background: The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and available evidence demonstrates that the pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. In particular, most errors are identified in pre-pre-, and post-post-analytic steps outside the walls of the laboratory, and beyond its control and they should be included in the category of diagnostic error. aim of our work was to identify a series of quality indicators and collect data for investigating quality and errors in analytical and extra-analytical phases of the TTP.
Methods: Under the patronage of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), we have activated a Working Group on "Laboratory errors and patient safety". The Working Group has identified 25 quality indicators for evaluating the quality and safety of all procedures and processes of the total testing process. In particular, 16 indicators pertain to the pre-analytic phase, 4 to the intra-analytical phase, and 5 to the post-analytical phase. For each indicator selected the following have been specified: the measures of information to collect; the steps involved for a uniform data collection; time for data collection and responsibility. A website (www3.centroricercabiomedica.it) has been implemented for allowing the safe collection of data.
Results: 39 clinical laboratories around the world have been involved in the project and data have been collected. A wide range in the results distribution has been obtained from participating laboratories, namely for some quality indicators. For example, the percentage of requests with clinical question/total number of requests ranged between 9.48% to 87.3%; the percentage of requests without physician identification ranges between 0 to 21.4%; and the percentage of hemolyzed samples ranges between 0.28% to 3.4%. In general, a higher intre-laboratory agreement was found for intra-analytic quality indicators when compared with extra-analytic indicators, and in particular with pre-analytic indicators.
Conclusion: Some common problems affect diagnostic errors, although specific faults characterising errors in laboratory medicine should lead to preventive and corrective actions if evidence-based quality indicators are developed, implemented and monitored. Therefore, the WG has identified 25 quality indicators, developed a specific website for collecting and analysing data on those indicators and now would like to discuss preliminary results for better addressing future steps of the project. The lesson we have learned is that each practice must examine its own total testing process to discover its weaknesses and identify appropriate remedies.