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Q. Many laboratories, including ours, stopped repeating critical values after literature favored the expediency of initial critical value results, given the precision of state-of-the-art instrumentation. Nurses and physicians in our system now prefer that we release critical values for inpatients to the LIS before achieving successful critical value verification/call/documentation, which can take considerable time. Is there expert opinion on or standard practice for the release of preliminary critical values (denoted as such in the LIS lab results field) pending subsequent technologist or technician verification and documentation?

A. Some of the confusion in reporting critical values can be obviated by recognizing that there are three distinct activities: 1) verifying the critical value, 2) releasing the critical value, and 3) notifying a responsible provider, which is often by phone and includes documenting “read back” for laboratory records.

The first step is to verify the critical value, which, depending on laboratory policy, may or may not require retesting of the sample. There is no regulatory requirement to retest a sample when a result falls within the laboratory-defined critical range. On the contrary, the improved analytical precision and reproducibility of modern analyzers has made retesting of samples largely unnecessary. This is particularly true for modern chemistry and hematology analyzers, which generate the majority of critical results. The analytical performance of the test method dictates the level of confidence in any value, whether the result obtained is normal, abnormal, or critical. Thus, repeating tests may be unnecessary from a quality perspective and may only delay the reporting of a critical test result. Although the time needed to repeat automated testing is relatively short, delayed critical result reporting can cause adverse events.

Releasing a critical value renders that laboratory result viewable to providers within the patient’s chart. The result may be released or transmitted to the laboratory information system or the electronic health record. If laboratory policy requires verification of critical results by repeating the test, then the first result should not be released until it is verified by retesting. Releasing the value and notifying the provider are independent actions that can be performed in any order. There is no requirement that a critical value be held (i.e. not released) until notification is completed. However, the standard practice for many laboratories is to release the result once they have both verified the result and completed notification. (See “Sequence of information flow in critical value reporting: standard.”) The main reason many laboratories do not release critical values until they have notified the provider is they are worried the technologist will forget to follow up and complete notification once the value is released when their initial attempt to notify is unsuccessful. Thus, the main reason to hold the result is operational and based on the limitations of computer systems that make documenting provider notification difficult once the result is released. The limitations can be traced to the way the LIS interacts with or is interfaced with the EHR and the processes laboratories use to report critical values.

The practice of holding critical results until successful provider notification may not be in the best interest of patient care with the widespread adoption of the EHR, which has led to the rapid dissemination of and increased accessibility to patient information. An alternative flow of information may be more suitable (see “Sequence of information flow in critical value reporting: alternative”), in which the critical result is released after it is verified but before notification. This is analogous to instances that already occur in the standard model in which a laboratory releases a result to the EHR when it is unable to complete notification after one or more attempts. In the inpatient setting, released critical results are often recognized by a nurse, advanced provider, or another doctor before the ordering provider or a licensed caregiver is contacted. In either circumstance, the laboratory remains responsible for follow-up and verification of result receipt after the value is released and transmitted to the EHR. Follow-up systems can be developed within the EHR that help to close the communication loop and to ensure notification after the results are transmitted electronically.

We recommend avoiding the use of the term “preliminary critical value” because once a value is released—whether preliminary or final—providers may act on that value. Again, the value should be verified before it is released, and there is no requirement that precludes releasing a critical result before successful notification. The most important rule for laboratories to follow is to have clear policies and procedures for critical value reporting that are approved by the laboratory medical director and hospital or health system committees, when applicable. Audits should be performed to ensure these procedures are followed and that they effectively provide critical results to caregivers in a timely and efficient manner.

  1. College of American Pathologists. GEN.43825 Result verification. In: Laboratory general checklist. Aug. 22, 2018.
  2. College of American Pathologists. COM.30000 Critical result notification. In: All common checklist. Aug. 22, 2018.
  3. College of American Pathologists. COM.30100 Critical result read-back. In: All common checklist. Aug. 22, 2018.
  4. Lehman CM, Howanitz PJ, Souers R, Karcher DS. Utility of repeat testing of critical values: a Q-Probes analysis of 86 clinical laboratories. Arch Pathol Lab Med. 2014;138(6):788–793.
  5. Valenstein PN, Wagar EA, Stankovic AK, Walsh MK, Schneider F. Notification of critical results: a College of American Pathologists Q-Probes study of 121 institutions. Arch Pathol Lab Med. 2008;132(12):1862–1867.
  6. Meier FA, Souers RJ, Howanitz PJ, et al. Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 1999–2011. Arch Pathol Lab Med. 2015;139(6):762–775.
  7. Deetz CO, Nolan DK, Scott MG. An examination of the usefulness of repeat testing practices in a large hospital clinical chemistry laboratory. Am J Clin Pathol. 2012;137(1):20–25.
  8. Niu A, Yan X, Wang L, Min Y, Hu C. Utility and necessity of repeat testing of critical values in the clinical chemistry laboratory. PLOS One. 2013;8(11):e80663.

Peter L. Perrotta, MD
Medical Director of Clinical Laboratories, West Virginia University Hospital
Professor of Pathology and Chair, Department of Pathology, Anatomy, and Laboratory Medicine
West Virginia University School of Medicine, Morgantown
Chair, CAP Quality Practices Committee
Member, CAP Council on Scientific Affairs

Christopher M. Lehman, MD
Clinical Professor of Pathology, University of Utah School of Medicine
Medical Director of Clinical Laboratories, University of Utah Health Hospitals, Salt Lake City
Chair, CAP Standards Committee
Member, CAP Checklists Committee

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