From “panic” to “critical” values: which path toward harmonization?

Abstract

In the conventional “brain-to-brain loop” model, a body of evidence demonstrates that the risk of errors and patient harm is significantly decreased in processes that strictly develop inside the laboratory, whereas it remains relatively high at the beginning and at the end of the total testing process, which generally lie outside of the traditional laboratory environment [1, 2]. An increasing awareness of the need for standardizing and monitoring preanalytical activities has indeed generated positive revenues in terms of improved quality and decreased risk of errors [3]. Conversely, postanalytical processes are still more vulnerable to human error(s), noncompliance, and lack of harmonization, thus jeopardizing the quality of testing and – rather inevitably – posing serious risks for patient safety. Information technology (IT) has virtually eliminated the errors of manual data transcription, thus improving both efficiency and turnaround time between clinical laboratories and stakeholders. However, information overload can generate communication breakdowns, with delayed missed or even wrong diagnoses [4]. In postanalytical activities, critical values notification represents one of the main issues, but the complexity and importance of timely and safe delivery of this vital information require further efforts to improve harmonization throughout the process. In this issue of the journal, Zeng et al. [5] describe the results of a national survey on critical values notification in 599 Chinese institutions. The authors observed significant differences among laboratories, especially for limits and lists of the critical values as well as procedures for implementation. This reinforces the need for developing harmonization projects and developing best practice recommendations, which take into account correct definitions and terms [6, 7]. This should be achieved through projects based on consensus committees, professional groups (e.g., the ad hoc EFLM Working Group), published resources, or clinical studies. In particular, we need a general agreement on which tests and values should be considered “life-threatening”, and if – and how – we should harmonize decision levels and measurement units. Contextually, the harmonization of critical values may represent a cornerstone of educational and training process aimed to promote the culture of patient safety at medical schools. The genuine concept of “critical value”, originally described by George Lundberg [8, 9], has continued to be virtually unmodified for more than 40 years but merits some considerations. First, critical values, as already defined by Lundberg [8], identify some laboratory results that are so “extremely” abnormal and are considered life threatening because they may be associated with a significant dangerous event unless a medical action is promptly established. The term “panic value” should likewise be definitively abandoned, as Lundberg himself reasonably criticized this term because “physicians are not supposed to panic over anything” [10]. Second, “critical value” should be distinguished from “critical test”. The latter term, according to the Joint Commission, identifies all tests that require rapid communication of results, irrespective of being normal, abnormal, or critical [11]. Because this is a novel and poorly explained concept, it deserves some further explanatory discussion. A “critical test” (e.g., troponin, D-dimer, hemoglobin) implies an immediate impact on clinical decision making independently of result. Laboratory results for such tests may not be associated with a serious risk for the patient’s safety, but they require timely and safe reporting. From this point of view, although current technological equipments and IT may provide timely laboratory results with improved performances, there is the need to better define mutual duties and responsibilities. In particular, the physician who requests a critical test has the responsibility to verify the availability of the result within consensually defined times, whereas the laboratory professionals must ensure appropriate and timely reporting. Therefore, a consensus should be achieved by requesting physicians (namely those from emergency departments and intensive care units) on the reciprocal responsibilities to adopt when critical laboratory tests are requested and notified, although the list of critical tests and the notification/acknowledgment procedures may vary according to specific clinical settings and operational frameworks. The notification of critical tests should hence