Assessment of critical values policies in Italian institutions: Comparison with the US situation

Background: Critical value reporting is considered an essential tool to ensure the quality of medical laboratory services. Important issues include defining cut-off values, assessing responsibility for communication and adopting information technology solutions to improve notification. Here, we report the state of critical value reporting in a large cohort of Italian laboratories and comparison with Q-Probes surveys from the College of American Pathologists as representatives of the US situation. Methods: To compare critical value policies and procedures, formulation of critical values list with critical values limits and monitoring tools, a web-based questionnaire was formulated for 389 institutions participating in the External Quality Assessment Schemes of Veneto Region, in Italy. Results: A total of 90 clinical laboratories submitted data. Accredited laboratories represented 82.2% of participants, but written procedures for reporting were indicated by 70.5% of participants. Relevant differences between US and Italian policies have been observed, particularly regarding who provides the notification and on the formulation of the cut-off threshold for critical values. Conclusions: Accreditation according to international standards can decrease differences regarding the management of critical values across laboratories of different countries. However, the issues concerning critical limits should be debated and a consensus critical values list should be considered. Automated systems could offer improvements regarding some issues, such as who makes the notification, reducing the time spent in notification of critical values. Surveys for comparing and improving existing policies regarding critical values should be promoted at an international level.