Medical error is an extremely large problem in health systems around the world. Annual fatality estimates in US alone from medical errors are greater than 200,000 (1). As a subset of medical error and an area of increasing interest in the laboratory community, diagnostic error is the inability to establish an accurate or timely diagnosis. A few years back, the National Academy of Medicine has determined that American adults suffer from at least one diagnostic error during their lifetime (2). These diagnostic errors are extremely common in a clinical laboratory setting and are major roadblocks in providing timely patient care.
Laboratory testing recommendations and interpretation can, and often is, a challenging portion of the diagnostic process for many clinicians. In fact, the American Board of Family medicine surveyed their members and found that physicians are unsure what laboratory tests to order 14.7% of the time and unsure how to interpret those results 8.3% of the time (3). Studies show that where laboratories’ assistance have been asked resulted in better guideline adherence and reduced unnecessary testing (4,5,6). One principal reason for this is that clinical laboratory test menus have exploded in the past few years making it extremely difficult for clinicians to order appropriate tests. We started this project to investigate whether collaboration between the clinical laboratory, a diagnostic management team (DMT) specific to a laboratory discipline comprising of pathology faculty/ residents/ fellows/ laboratory staff, and physicians who are ordering tests for a patient, resulted in improved test utilization and better patient care in an academic medical center.
In 2017, Sarkar et al., showed that about 78% of cases had an error in coagulation test selection evaluated by DMT in real time, in an academic medical center with 450 beds (7). These findings begged to ask one critical question: should the clinical laboratory be consulted before ordering tests/ test panels if there is any doubt? Clinical laboratorians go through a rigorous curriculum and a certification examination (primarily from ASCP) that make them ideal ‘GO TO’ persons to understand the many facets of clinical lab tests. This study was conceptualized and then endeavored to involve a multi-tiered approach to address laboratory test errors by: (a)develop special test panels and educate physicians, (b) the coagulation clinical laboratory to coordinate with the coagulation DMT and intervene if any errors in test orders were made, (c) Intervention will be by communications between the clinical lab and the ordering physicians/ care givers to explain the error, and correct test order appropriately, (d) Pathology resident on coagulation service notified and the case discussed in coagulation DMT.
Initially, a retrospective study was performed to look at all clinical interventions done between July, 2017- June, 2018, and if they resulted in fewer test selection errors for patients who presented with bleeding or thrombotic disorders. Between, July-Dec, 2017, we found that 12% of the cases required interventions by the clinical laboratory on coagulation tests. The errors were directly communicated to the ordering physicians, which also involved educating them on the correct usage of diagnostic algorithms and test panels. Over the period of Jan-June, 2018 we saw a reduction in interventions to about 5% that was found to be statistically significant at p-value < 0.05. Furthermore, between July, 2018 – June, 2019, a retrospective analysis of coagulation cases that were evaluated by the coagulation DMT in real time, was undertaken to measure the impact of measures taken to standardize coagulation testing and whether physicians were making the right choice. A total of 634 cases of patients was evaluated by diagnostic experts in coagulation. The results revealed significant improvement of diagnostic errors in coagulation test selection with error rate at only 36% compared to error rate seen in the previous study by Sarkar et al (7).This also resulted in significant cost savings for the healthcare center.
One significant finding was that only 28% of the cases were associated with underutilization, which translates to inadequate use of laboratory resources. This was again a significant improvement when compared to previous studies (7,8). However, in the same time frame (July,2018-June,2019) when we examined whether percentage of interventions remained the same as the previous 6 months, decreased or increased, it was found that the laboratory was again correcting test errors at a rate of about 12%! During this time, no education was provided to physicians/ residents regarding correct usage of test panels. Thus, interventions from the clinical laboratory were found to be the key deterrent to lab test errors.
Medicine today is witnessing a transformation towards a more patient-centered care for each individual. In this scenario, the clinical laboratory is poised to play a crucial role as Medicare transitions from a ‘volume’ to ‘value’ based reimbursement that rewards providers for better coordination of care, improved outcomes and reduced costs. Hence, the clinical laboratory and a DMT can function to meet these goals by working as an effective decision support system to choose wisely for test ordering, facilitate knowledge among care providers regarding test results and interpretation, that may help in proper evidence-based guidelines and disease management.
- Makary, M. A., & Daniel, M. (2016). Medical error—the third leading cause of death in the US. Bmj, 353, i2139. doi:10.1136/bmj.i2139
- Medicine Io. Improving diagnosis in health care. Balogh EP, Miller BT, Ball JR, editors. Washington, DC: The National Academies Press, 2015. 450 p.
- Hickner, J., Thompson, P., Wilkinson, T., Epner, P., Sheehan, M., Pollock, A., . . . Taylor, J. (2014). Primary care physicians' challenges in ordering clinical laboratory tests and interpreting results. Journal of the American Board of Family Medicine, 27(2), 268-274. doi:10.3122/jabfm.2014.02.130104
- Laposata, M., Laposata, M., Van Cott, E., Buchner, D., Kashalo, M., & Dighe, A. (2004). Physician survey of a laboratory medicine interpretive service and evaluation in the influence of interpretations on laboratory test ordering.(Original articles.). Archives of Pathology & Laboratory Medicine, 128(12), 1424–1427.
- Wiencek, J., Colon-Franco, J., Bissonnettee, S., Utz, A., & Woodworth, A. (2017). The endocrine diagnostic management team pilot study.147(suppl_2), S21-S22. doi:10.1093/ajcp/aqw191.033
- Seegmiller, A., Kim, A., Claudio, A. Shaver, A., Thompson, M., Shaoying, H., David R., and Zutter, M. (2016). Data-driven iterative refinement of bone marrow testing protocols leads to progressive improvement in cytogenetic and molecular test utilization. American Journal of Clinical Pathology 146, (5), 585–593
- Sarkar MK, Botz CM, Laposata M. (2017) An assessment of Overutilization and Underutilization of laboratory tests by Expert Physicians in the Evaluation of Patients for Bleeding and Thrombotic Disorders in Clinical Context and in Real-Time. Diagnosis: Vol.4(1):21-26.
- Zhi, M., Ding, E. L., Theisen-Toupal, J., Whelan, J., & Arnaout, R. (2013). The landscape of inappropriate laboratory testing: a 15-year meta-analysis. PLoS One, 8(11), e78962. doi:10.1371/journal.pone.0078962