Elsevier

Clinical Biochemistry

Volume 47, Issues 13–14, September 2014, Pages 1163-1168
Clinical Biochemistry

Laboratory critical values: Automated notification supports effective clinical decision making

https://doi.org/10.1016/j.clinbiochem.2014.05.056Get rights and content

Highlights

  • We investigate laboratory critical value notification and the patient's outcomes.

  • We assess the effectiveness of the automated critical value notification.

  • Critical value notification leads to a change in patient's management and outcomes.

  • Automated notification is an efficient way of critical value communication.

  • Automated notification supports effective clinical decision making.

Abstract

Objective

Failure to adequately communicate a laboratory critical value (CV) is a potential cause of adverse events. The harmonization of CV reporting is increasingly recognized as a key issue in ensuring patient care and minimizing harm. With ongoing improvements in CV reporting, the patient's outcome should be audited to assess the effectiveness of CV notification.

Design and methods

We report the data audited throughout a six month-period during which an analysis was made of CVs, and we describe the approach of clinicians and general practitioners (GPs), and their decision making following CV reporting.

Results

CV notification led to a change of treatment in 98.0% of patients admitted to surgical and in 90.6% of those admitted to medical wards. Clinicians made a further evaluation of new complications in patients in 70.0% and 60.4% of cases, in surgical and medical wards respectively. In more than 40.0% of cases, CVs were unexpected findings. In the primary care setting, critical hyperkalemia was managed by GPs in 55% of patients, thus sparing patient's hospitalization. For all outpatients with critical INR (international normalized ratio), the GPs changed or stopped warfarin dosage. Twenty-four percent of patients were checked for an additional INR, whereas a further medical examination by a consultant in the hospital setting was requested for 5% of patients.

Conclusions

The laboratory plays a key role in ensuring patient safety, especially in CV reporting. An evaluation should be made of the patient's outcome and clinical decision making in order to assess the effectiveness of the CV process.

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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