Laboratory critical values: Automated notification supports effective clinical decision making
Introduction
The original definition of “laboratory critical value” (formerly panic value), introduced by George D. Lundberg more than 40 years ago, is a laboratory result that is life-threatening unless some corrective action is undertaken, for which interventions are possible [1].
In the post-analytical phase of laboratory testing, the issue of critical values continues to be of crucial importance in safeguarding patient safety. Since Lundberg's pioneering work, many laboratories worldwide have implemented systems for notifying critical values, whereas the International Standard for laboratory accreditation, the ISO 15189:2012, has included written procedures for reporting critical values as a requirement, and related lists of quality indicators are also needed to verify the process [2], [3]. In 2005, with the aim of improving upon patient safety, the Joint Commission released a laboratory accreditation program, in which the reporting of laboratory critical values became a National Patient Safety Goal [4]. However, the different terminologies used, and variations in practices and policies that have been described in literature, indicate the need for a more harmonized and systematic approach in notifying critical results [5]. Harmonization initiatives should take into consideration the following: a) reliable value limits should be chosen for true “life-threatening” analytes, according to the definition; b) critical values should be formulated while considering patients' characteristics (i.e. age, gender and ethnic origin); c) notification should be made with the most efficient reporting and communication tools; d) policies should be laid down to identify the person who should be in charge of notifying critical values, and the caregiver who should be responsible for receiving these values; and e) technological tools should allow the acknowledgment of the critical values, facilitate feedback and data recording, and ensure that the indicators control and monitor the critical value process.
The efficacy of laboratory critical values, namely their impact on the clinician's decision-making process, including treatments and related patient outcomes, has been poorly investigated and represents the missing link in the cycle of critical result communication. The aim of the present study is therefore to assess the effectiveness of automated critical value notification on clinical decision making, related patient management issues, and outcomes.
Section snippets
Study setting
The University-Hospital of Padua in north-east Italy, a healthcare institution with 1600 beds and a research center of national and international relevance, provides specialty care in surgical and medical areas, including transplantation, cardiology, hepatology, gastroenterology, immunology, hematology, pediatrics, gynecology, oncology, traumatology, and orthopedics.
For the year 2012 a 16.3% increase is estimated in highly complex cases, defined according to the Diagnosis Related Group system,
Inpatients
The number and the relative frequency of critical values evaluated for inpatients are shown in Table 1, and the more important associated diseases are summarized in Fig. 1. Medical actions undertaken following the notification of critical values are shown in Fig. 2. As reported by physicians, the principal action taken was a change of therapy, due to the clinical need to modify dosage and/or to treat patient with new drugs. The notification of critical values led to a change of treatment in
Discussion
Quality in laboratory testing includes all aspects of the so-called “Brain-to-brain loop”, from the “pre-pre-analytical” phase (“Right test choice at the Right time on the Right patient”) through analytical steps (“Right results in the Right forms”) to the “post-post-analytical” phase (“Right interpretation, at the Right time with the Right advice as to what to do next with the result”) [8], [9].
A body of evidence demonstrates that the initial and final steps of the total testing process (TTP)
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