By Brandy D. Gunsolus, DCLS, MLS(ASCP)CM, ASCLS Patient Safety Committee

Within the healthcare professional competencies outlined by the 2003 report “Health Professions Education – A Bridge to Quality”, effectiveness is listed as one of the five necessary competencies1. While this could be interpreted as individual competence and effectiveness, it could also be interpreted as the effectiveness of our practice in producing positive patient outcomes. Historically, clinical laboratory professionals have focused on its internal processes and fine-tuned procedures and protocols to minimize analytical error. What we have missed is not ‘have we run the test correctly and reported a correct result?’, but ‘is the test result going to positively impact patient care and contribute to effective evidence-based healthcare practice. To quote the character Ian Malcolm in the film Jurassic Park: “Your scientists were so preoccupied with whether they could, they didn’t stop to think if they should.” 2

Recent concerns over patient outcomes from laboratory testing, also known as clinical utility, have begun to surface with the discussions of appropriate laboratory test utilization3. Performing laboratory tests unnecessarily leads to increased costs and potentially additional unnecessary testing4. However, treating patients based on the results of tests with poor or unproven clinical utility could result in patient harm3. Even Center for Medicare & Medicaid Services (CMS) and private insurance companies are denying reimbursement for tests that lack sufficient proof of clinical utility, especially in the area of molecular diagnostics5.

Why has proof of clinical utility not been standard practice in test development?

First, the FDA does not require studies of clinical utility in their approval process for new test methodologies6. Without this requirement, researchers and manufacturers have simply not performed clinical utility studies resulting in new tests coming to market that may cause patients to receive treatments unnecessarily, threatening patient safety. This has been most evident in molecular diagnostics and precision medicine, with studies identifying genetic variants once hailed as markers of disease, being quite prevalent in patient populations without the disease7. Other laboratory areas have seen similar aftermarket evidence of poor clinical utility. Procalcitonin, for example, originally marketed as the ideal biomarker for sepsis, has now had its clinical utility disvalued in post-market studies showing that its use does not improve septic patient outcomes8,9.

What are our professional responsibilities in assessing clinical utility?

Unfortunately, since clinical utility studies have not been performed on much of the laboratory testing we perform today, it is up to us as laboratory professionals to address the situation. We must 1) research and identify when clinical utility has not been demonstrated for a test, 2) take steps to aid in research of testing clinical utility, and 3) communicate with clinicians when a particular test’s clinical utility is questionable.

We must assure that appropriate evidence-based research on clinical utility is completed when new tests are being evaluated. Do not take the manufacturer’s information at face value, as they likely have not performed a clinical utility study. Do your own literature research in scientific journals and critically review the studies that are published on the test. What was the study population? What was the size of the study population? Was the study population similar to your patient population? Was the study a randomized-controlled trial or a model-based study? Was the study funded by an organization that may imply bias in the results (for example: did the test manufacturer pay to have the study done or was it funded by an independent entity)? Next, determine if your facility would be interested in performing a clinical utility study. If you are not sure what a clinical utility study would look like, a basic outline of one is shown in Figure 1.

While not all clinical utility studies will look like this, it is a starting point for you and your facility to develop your own. Additional information on performing clinical utility studies is supplied by Pletcher et al (2011) “Evaluating the clinical utility of a biomarker: a review of methods for estimating health impact”10. Finally, communicate with your clinicians if you have identified a test with minimal clinical utility. Most clinicians appreciate documented evidence, so it is good practice to provide copies of the clinical utility studies that support your assessment and conclusions regarding the test being evaluated.

We, as medical laboratory professionals, must not only ensure that the information we generate is correct, but that it is evidence-based and aids in providing effective healthcare to our patients. We have done an excellent job in ensuring the data is correct; now it is time to ensure the information we provide is effective in improving patient outcomes and not detrimental to patient safety.


1.            Institute of Medicine (U.S.). (2003). Health Professions Education: A Bridge to Quality. Washington, D.C., National Academies Press.

2.            Jurassic Park. Directed by Steven Speilburg, Universal Pictures, 1993. Film.

3.            Bossuyt PM, Reitsma JB, Linnet K, and Moons KG. Beyond Diagnostic Accuracy: The Clinical Utility of Diagnostic Tests. Clinical Chemistry. 2012;58(12):1636–1643.

4.            Zhi M, Ding E, Theisen-Toupal J, Whelan J, Arnaout R. The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis. Plos One, 2013:8,e78962.

5.            Peabody JW, Shimkhada R, Tong KB, Zubiller MB. New Thinking on Clinical Utility: Hard Lessons for Molecular Diagnostics. Am J Manag Care. 2014;20(9):750-756.

6.            Institute of Medicine (US). Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary. Washington (DC): National Academies Press (US);2010. Regulation of Predictive Tests. (accessed 12/24/18).

7.            Van Driest SL, Wells QS, Stallings S, et al. Association of Arrhythmia-Related Genetic Variants With Phenotypes Documented in Electronic Medical Records. JAMA. 2016;315(1):47–57. doi:10.1001/jama.2015.17701

8.            Khan F. High serum procalcitonin – interpret with caution. Clin Microbiology. 2017;6:e141.

9.            Rotman et al. Clinical utility of serum procalcitonin level and infection in the neurosurgical intensive care unit. World Neurosurg. 2018;112:e368-374.

10.          Pletcher MJ, Pignone M. Evaluating the clinical utility of a biomarker: a review of methods for estimating health impact. Circulation. 2011;123(10):1116-24.

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