Collaboration with Clinical Laboratory Positively Impacts Proper Test Utilization and Decreases Diagnostic Errors.

BACKGROUND: Diagnostic errors in clinical laboratory testing are extremely common and are major roadblocks in providing timely patient care. The purpose of this project was to investigate whether collaboration between the clinical laboratory, a diagnostic management team (DMT), and physicians who are ordering tests for a patient, resulted in improved test utilization by choosing wisely and better patient care in an academic medical center. METHODS: A retrospective study for a period of 24 months between 2017 and 2019 evaluated whether improvement of test ordering was achieved by timely interventions from the clinical laboratory and the coagulation DMT, resulting in fewer test selection errors. RESULTS: The results showed about 54% improvement in diagnostic errors for coagulation test selection in 634 patients evaluated for bleeding or thrombotic disorders by DMT when compared to previous studies. Furthermore, a total of approximately 2,400 coagulation test orders for patients that were done from July 2017 to July 2018 required intervention in 12% of the cases in the initial six months. When physician education was provided, intervention was needed in only approximately 4% of the cases, an improvement of 67% that was statistically significant at p-value < 0.05. Only 28% of the cases were associated with underutilization or failure to order required initial tests. The generated cost savings from prevention of over and underutilization of laboratory tests was in the order of ~ $16,000. CONCLUSIONS: The clinical laboratory and a DMT can function as an effective decision support system in decreasing errors in diagnostic test selection and facilitate knowledge among care providers regarding test results and interpretation, that may help in proper evidence-based guidelines and disease management.

Overutilization and Underutilization of Thyroid Function Tests are Major Causes of Diagnostic Errors in Pregnant Women.

BACKGROUND: The failure to order the correct diagnostic test at the right time is one of the major contributing factors of diagnostic error. Excessive testing can lead to added economic burden and addressing underutilization is precarious as clinicians often fail to order the tests that would improve diagnosis, prognosis, and management. METHODS: A retrospective analysis of errors in test orders of thyroid function testing (TFT) in 321 pregnant women suspected of clinical and subclinical thyroid disorders was performed. Test selection was evaluated, and determinations were made about the extent of overutilization and underutilization of TFTs in reviewing each individual patient case by a Doctorate in Clinical Laboratory Science (DCLS) scholar. RESULTS: About 77% (247 cases) of the cases were found to have errors associated with test ordering for TFT. Of the cases reviewed, 18% cases were associated with overutilization, 53% of the cases were associated with underutilization, and 7% were associated with both (overutilization and underutilization). The annual cost burden because of ordering unnecessary tests was estimated to be approximately $13,000. The cost burden from errors resulting from not ordering a test would be of much greater magnitude but was difficult to estimate because underutilization has a ripple effect and may cause prolonged hospital stays, unnecessary medical bills, and delayed/ missed diagnosis leading to poor outcomes for patients. CONCLUSIONS: This study evaluated whether proper utilization of TFT were made at maternal health clinic locations of a large academic medical center in pregnant women to diagnose thyroid disorder and reported the issue of wastage of resources in the clinical laboratory. The study findings show significant errors in ordering of TFT for pregnant women in more than 75% of the cases that was based on evidence-based review of patient cases.

Addressing Low Scholarly Output in Residency With a Resident-Led Society for Innovation and Research.

PROBLEM: Research activity in residency develops skills essential for the practice of medicine and has many benefits for residents, residency programs, the community of medicine, and patients. However, resident participation in research and innovation remains limited, with several barriers that are difficult to address without significant overhead or changes to curriculum. APPROACH: In September 2021, the Society for Innovation and Research (SIR), a resident-led organization dedicated to promoting and supporting resident achievement in research and innovation, was founded. Using only 1 hour of protected didactic time a month, SIR workshops provide critical mentoring and feedback to make resident research a success as well as education on various topics of interest to residents. In addition, SIR celebrates and publicizes resident research success and lays the groundwork for interested residents to participate in innovation. OUTCOMES: The authors analyze the success of SIR in increasing resident research productivity by analyzing PubMed-indexed publications for 11 semesters from fall 2018 to fall 2023. After the launch of SIR, the mean (SD) total number of publications increased from 5.3 (2.4) to 13.3 (1.6) (P = .01), the total mean (SD) number of residents publishing increased from 3.7 (1.3) to 10.0 (1.2) (P = .009), and the mean (SD) total number of coauthored articles increased from 0.1 (0.3) to 2.8 (1.3) (P = .007). NEXT STEPS: The skill set acquired from participation in research during residency is more critical than ever in the wake of the COVID-19 pandemic. SIR initiatives are generalizable to most residency programs in most specialties and require little overhead in terms of physical space, digital resources, and staffing. The authors are currently exploring expanding the SIR program to other residencies at U.S. institutions and have set up processes for the mantle of SIR leadership to be passed down among the pathology resident body.

Impact of diagnostic management team on patient time to diagnosis and percent of accurate and clinically actionable diagnoses.

OBJECTIVES: Diagnostic management teams (DMT) are groups of experts with specialized knowledge to guide test selection and interpretation of results. They have been active in institutions over the past 20 years. To date, there are limited data on whether the presence of experts to advise healthcare providers on appropriate laboratory test selection and interpretation of complex test results positively impacts patient care. METHODS: A retrospective study at a regional healthcare system with 257,000 patient encounters between 2011 and 2022 reviewing test interpretations provided by clinical laboratory experts on a diagnostic management team. RESULTS: Cases reviewed by the coagulation DMT were 6 times more likely to have an established, scientifically based diagnosis compared to those without a DMT. Patients who have a coagulation DMT review were twice as likely to receive a diagnosis vs. having no diagnosis. CONCLUSIONS: This study demonstrates that for several objective clinical outcomes, specifically diagnostic conclusions and length of stay, a DMT of coagulation experts assessing patients' test results has had a major impact on outcomes and delivery of care.

Impact of an anemia diagnostic management team on follow-up test ordering by primary care providers.

BACKGROUND: Anemia is a complex condition with diverse causes and poses diagnostic challenges amid the expanding landscape of laboratory testing. Implementation of an anemia diagnostic management team (DMT) can aid health care providers in navigating this complexity. METHODS: This quasi-experimental study assessed the impact of an anemia DMT on laboratory test ordering by primary care providers for anemic patients. This study included adult patients (≥18 years) with anemia (hemoglobin <12.0 g/dL for nonpregnant women, hemoglobin <13.0 g/dL for men) presenting to a family medicine clinic. Cases reviewed by the DMT (n = 100) were compared with a control group (n = 95). RESULTS: The DMT recommended additional testing for 76 patients. Significantly more patients in the DMT group underwent follow-up tests compared with controls (59% vs 34%; P < .001). Moreover, the DMT group underwent a higher mean number of tests per patient (1.70 ± 2.2 vs 0.95 ± 1.9; P = .01). CONCLUSION: Implementation of an anemia DMT influenced follow-up testing patterns in anemic patients, potentially enhancing diagnostic thoroughness and patient care.

Analysis of hospital length of stay and cost savings with an in-house heparin-induced thrombocytopenia antibody assay at a midsized institution.

OBJECTIVES: Analysis of laboratory value often lacks assessment of the laboratory's impact on quality of care. In this study, we aimed to determine the impact of bringing a heparin-induced thrombocytopenia (HIT) antibody assay in-house on a quality metric-patient hospital length of stay (LOS)-and assess any associated cost savings. METHODS: A retrospective review of patient visits with a HIT antibody assay over a 7-year period determined the mean LOS in send-out vs in-house HIT antibody assay cohorts as well as cohorts of positive and negative results. Our systemwide mean LOS and metrics of acuity were analyzed. We performed a financial analysis of estimated cost savings. RESULTS: We found a mean LOS reduction of 3.97 days in the in-house cohort, with no evidence of a systemwide LOS decrease or a decline in patient acuity. This reduction was largely driven by a reduction in LOS among patients with a negative assay result. We found an estimated total cost savings of $3.9 million and an estimated mean savings per patient of $7,305, despite escalating health care costs over time. CONCLUSIONS: We demonstrated a reduction in LOS following the introduction of an in-house HIT antibody assay that cannot be attributed to either systemwide initiatives or reduced patient acuity and was driven largely by patients with negative assays. This reduction was associated with significant estimated cost savings.

How many mislabelled samples go unidentified? Results of a pilot study to determine the occult mislabelled sample rate.

BACKGROUND: Specimens with incorrect patient information are both a critical safety error and difficult to identify. Estimates of sample mislabelling rely on subjective identification of mislabelling, with the possibility that not all mislabelled samples are being caught. METHODS: We determined the blood type of two or more complete blood count specimens with the same patient label and assessed for discrepancies. We additionally determined the rate of identified sample mislabelling for the study period. RESULTS: We found a rate of 3.17 per 1000 discrepancies over the study period. These discrepancies most likely represent occult, or unidentified, mislabelled samples. In contrast, the rate of identified sample mislabelling was 1.15 per 1000. CONCLUSIONS: This study suggests that specimens identified as, or known to be, mislabelled represent only a fraction of those mislabelled. These findings are currently being confirmed in our laboratory and are likely generalisable to other institutions.

Multi-parametric thrombus profiling microfluidics detects intensified biomechanical thrombogenesis associated with hypertension and aging.

Arterial thrombosis, which represents a critical complication of cardiovascular diseases, is a leading cause of death and disability worldwide with no effective bioassay for clinical prediction. As a symbolic feature of arterial thrombosis, severe stenosis in the blood vessel creates a high-shear, high-gradient flow environment that effectively facilitates platelet aggregation towards vessel occlusion even with platelet amplification loops inhibited. However, no approach is currently available to comprehensively characterize the size, composition and platelet activation status of thrombi forming under this biorheological condition. Here, we present a thrombus profiling assay that monitors the multi-dimensional attributes of thrombi forming in conditions mimicking the physiological scenario of arterial thrombosis. Using this platform, we demonstrate that different receptor-ligand interactions contribute distinctively to the composition and activation status of the thrombus. Our investigation into hypertensive and older individuals reveals intensified biomechanical thrombogenesis and multi-dimensional thrombus profile abnormalities, demonstrating a direct contribution of mechanobiology to arterial thrombosis and endorsing the diagnostic potential of the assay. Furthermore, we identify the hyperactivity of GPIbα-integrin αIIbß3 mechanosensing axis as a molecular mechanism that contributes to hypertension-associated arterial thrombosis. By studying the interactions between anti-thrombotic inhibitors and hypertension, and the inter-individual variability in personal thrombus profiles, our work reveals a critical need for personalized anti-thrombotic drug selection that accommodates each patient's pathological profile.

A Case of Massive Fetal-Maternal Hemorrhage: Lessons Learned in Diagnosis and Treatment.

The use of Rho(D) immune globulin in Rh-negative pregnant women has become standard of care, but many practicing clinicians do not know the dosing recommendations for this essential medication. In this article, we describe a case of a 15-year-old girl who presented with intrauterine fetal demise and was found to have massive fetomaternal hemorrhage. Kleihauer-Betke testing results indicated nearly 460 mL of fetal blood in the maternal circulation. The patient ultimately received 4800 µg of Rho(D) immune globulin, a dose that required close coordination with the obstetrical service and pharmacy. Although this is an unusual case of large-volume, potentially chronic, fetomaternal hemorrhage, it is also an excellent illustration of the principles for diagnosing this condition, as well as providing dosing guidelines for Rho(D) immunoglobulin to prevent alloimmunization.

Cost-Effectiveness and Return on Investment Analysis of an In-house HemosIL Heparin-Induced Thrombocytopenia Antibody Assay at a Mid-Sized Institution.

CONTEXT.­: Laboratories face the challenge of providing quality patient care while managing costs and turnaround times (TATs). To this end, we brought the heparin-induced thrombocytopenia (HIT) antibody test in-house with the goal of reducing costs and the time to diagnosis. OBJECTIVES.­: To determine the cost-effectiveness and return on investment of our in-house HIT antibody test by comparing it to send-out assays with TATs of 2, 3, or 4 days. DESIGN.­: We performed a retrospective chart review of all patients with a HIT antibody assay and analysis of laboratory financial records. Analysis included the percentage of patients receiving alternative treatment, cost of treatment, startup costs of bringing the test in-house, and average TAT of the in-house test. RESULTS.­: We found significant reductions in the cost of treatment for patients and the overall cost to the health care system. The in-house assay became cost-effective at between 8 and 20 tests, with a return on investment of up to 298%. CONCLUSIONS.­: Bringing the HIT antibody assay in-house becomes cost-effective at a very low test volume with excellent return on investment. This novel analysis can provide a framework for other laboratory medicine professionals to analyze the benefits of bringing this and other assays in-house.

The Doctorate in Clinical Laboratory Sciences: A New Curriculum to Enhance the Connection of the Laboratory to Health Care Providers.

This report discusses the need for a Doctorate in Clinical Laboratory Sciences program and describes a curriculum to train Doctorate in Clinical Laboratory Sciences students. The Doctorate in Clinical Laboratory Sciences program was developed to help reduce diagnostic errors in patient care by enhancing connections between the clinical laboratory and health care providers. Data are presented from program implementation in 2016 to 2017 academic year to 2019 to 2020 regarding the faculty and student demographics, program statistics (eg, admissions and attrition rates), and effectiveness. Perceptions of program effectiveness were obtained via surveys from 28 faculty physicians who supervised Doctorate in Clinical Laboratory Sciences students during clinical service rotations. Another survey assessed the preferred type of practice after graduation of 33 students. Over the 4-year period, the program had a 50% rate of admission and a 21.8% attrition rate. As of December 2020, 15 students graduated from the program. The majority (69%-82%) of physician faculty who completed the survey agreed that Doctorate in Clinical Laboratory Sciences students contributed positively at clinical rounds. Approximately two-thirds of students reported a preference to lead a Diagnostic Management Team or serve as an advanced practice provider in a Diagnostic Management Team with leadership provided by an MD/DO or PhD. This report provides useful information for other institutions that may want to establish similar Doctorate in Clinical Laboratory Sciences programs. Early data suggest that our program effectively trains doctoral-level advanced practice medical laboratory scientists, who may play an important role in improving patient safety by reducing diagnostic errors and providing value-based, optimal patient care.

Overutilization and underutilization of autoantibody tests in patients with suspected autoimmune disorders.

OBJECTIVES: Diagnostic Management Teams (DMTs) are one strategy for reducing diagnostic errors. This study examined errors in serology test selection after a positive antinuclear antibody (ANA) test in patients with suspected systemic autoimmune rheumatic disorder (SARD). METHODS: This retrospective study included 246 patient cases reviewed by our ANA DMT from March to August 2019. The DMT evaluated the appropriateness of tests beyond ANA screening tests (overutilization, underutilization, or both) based on American College of Rheumatology recommendations and classified cases into diagnostic error or no error groups. Errors were quantified, and patient and provider characteristics associated with diagnostic errors were assessed. RESULTS: Among 246 cases, 60.6% had at least one diagnostic error in test selection. The number of sub-serology tests ordered was 2.4 times higher in the diagnostic error group than in the no error group. The likelihood of at least one diagnostic error was higher in males and African American/Black patients, although the differences were not statistically significant. Providers from general internal medicine, primary care, and non-rheumatology specialties were approximately two times more likely to make diagnostic errors than rheumatology specialists. CONCLUSIONS: Diagnostic errors in test selection after a positive ANA for patients with suspected SARD were common, although there were fewer errors when ordered by rheumatology specialists. These findings support the need to develop strategies to reduce diagnostic errors in test selection for autoimmunity evaluation and suggest that implementation of a DMT can be useful for providing guidance to clinicians to reduce overutilization and underutilization of laboratory tests.