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.

DIAGNOSTIC ERROR IN THE UNITED STATES: A SUMMARY OF THE REPORT OF A NATIONAL ACADEMY OF MEDICINE COMMITTEE.

This review article summarizes the conclusions of the National Academy of Medicine committee on diagnostic error. The committee deliberated during five in-person meetings and during numerous conference calls between April 2014 and April 2015. At three of the meetings, the committee invited multiple speakers to inform its deliberations. The 21 members of the committee represented a broad range of expertise related in some way to diagnostic errors, their potential causes, or their consequences. The members' specialized knowledge included patient safety, health care quality and measurement, patient engagement, health policy, health care professional education, cognitive psychology, health disparities, human factors and ergonomics, health information technology, decision analysis, nursing, radiology, anatomic pathology, laboratory medicine (clinical pathology), law, and health economics.

Intracellular receptor EPAC regulates von Willebrand factor secretion from endothelial cells in a PI3K-/eNOS-dependent manner during inflammation.

Coagulopathy is associated with both inflammation and infection, including infections with novel severe acute respiratory syndrome coronavirus-2, the causative agent Coagulopathy is associated with both inflammation and infection, including infection with novel severe acute respiratory syndrome coronavirus-2, the causative agent of COVID-19. Clot formation is promoted via cAMP-mediated secretion of von Willebrand factor (vWF), which fine-tunes the process of hemostasis. The exchange protein directly activated by cAMP (EPAC) is a ubiquitously expressed intracellular cAMP receptor that plays a regulatory role in suppressing inflammation. To assess whether EPAC could regulate vWF release during inflammation, we utilized our EPAC1-null mouse model and revealed increased secretion of vWF in endotoxemic mice in the absence of the EPAC1 gene. Pharmacological inhibition of EPAC1 in vitro mimicked the EPAC1-/- phenotype. In addition, EPAC1 regulated tumor necrosis factor-α-triggered vWF secretion from human umbilical vein endothelial cells in a manner dependent upon inflammatory effector molecules PI3K and endothelial nitric oxide synthase. Furthermore, EPAC1 activation reduced inflammation-triggered vWF release, both in vivo and in vitro. Our data delineate a novel regulatory role for EPAC1 in vWF secretion and shed light on the potential development of new strategies to control thrombosis during inflammation.

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.

EPAC regulates von Willebrand factor secretion from endothelial cells in a PI3K/eNOS-dependent manner during inflammation.

Coagulopathy is associated with both inflammation and infection, including infection with the novel SARS-CoV-2 (COVID-19). Endothelial cells (ECs) fine tune hemostasis via cAMP-mediated secretion of von Willebrand factor (vWF), which promote the process of clot formation. The e xchange p rotein directly a ctivated by c AMP (EPAC) is a ubiquitously expressed intracellular cAMP receptor that plays a key role in stabilizing ECs and suppressing inflammation. To assess whether EPAC could regulate vWF release during inflammation, we utilized our EPAC1 -null mouse model and revealed an increased secretion of vWF in endotoxemic mice in the absence of the EPAC1 gene. Pharmacological inhibition of EPAC1 in vitro mimicked the EPAC1 -/- phenotype. EPAC1 regulated TNFα-triggered vWF secretion from human umbilical vein endothelial cells (HUVECs) in a phosphoinositide 3-kinases (PI3K)/endothelial nitric oxide synthase (eNOS)-dependent manner. Furthermore, EPAC1 activation reduced inflammation-triggered vWF release, both in vivo and in vitro . Our data delineate a novel regulatory role of EPAC1 in vWF secretion and shed light on potential development of new strategies to controlling thrombosis during inflammation. KEY POINT: PI3K/eNOS pathway-mediated, inflammation-triggered vWF secretion is the target of the pharmacological manipulation of the cAMP-EPAC system.

The Value Proposition for Pathologists: A Population Health Approach.

The transition to a value-based payment system offers pathologists the opportunity to play an increased role in population health by improving outcomes and safety as well as reducing costs. Although laboratory testing itself accounts for a small portion of health-care spending, laboratory data have significant downstream effects in patient management as well as diagnosis. Pathologists currently are heavily engaged in precision medicine, use of laboratory and pathology test results (including autopsy data) to reduce diagnostic errors, and play leading roles in diagnostic management teams. Additionally, pathologists can use aggregate laboratory data to monitor the health of populations and improve health-care outcomes for both individual patients and populations. For the profession to thrive, pathologists will need to focus on extending their roles outside the laboratory beyond the traditional role in the analytic phase of testing. This should include leadership in ensuring correct ordering and interpretation of laboratory testing and leadership in population health programs. Pathologists in training will need to learn key concepts in informatics and data analytics, health-care economics, public health, implementation science, and health systems science. While these changes may reduce reimbursement for the traditional activities of pathologists, new opportunities arise for value creation and new compensation models. This report reviews these opportunities for pathologist leadership in utilization management, precision medicine, reducing diagnostic errors, and improving health-care outcomes.

Driving the route of laboratory medicine: a manifesto for the future.

The role of laboratory medicine is essential in healthcare, since in vitro diagnostic testing represents now an unavoidable part of reasoning and clinical decision making. Laboratory tests are an essential part of most care pathways, aimed at optimizing resource utilization and improving patient outcome. The activity of laboratory professionals is interconnected with all medical disciplines, and provides a crucial support for ordering the right test, for the right patient and at the right time, but also helps interpreting and using laboratory data. Although recent advancement in laboratory medicine, catalyzed by technical innovations and development of innovative tests, have promoted a substantial revolution in the organization of clinical laboratories, the future of this profession seems still ambiguous. We have hence developed a "manifesto" of laboratory medicine, meant to promote an innovative prospect of our discipline and encouraging the establishment of a new generation of laboratory professionals and managers.

A manifesto for the future of laboratory medicine professionals.

Laboratory medicine plays an increasingly essential role in modern healthcare systems, since it is integral to most care pathways and plays an essential role for optimizing patient flow, harmonizing procedures before and after analysis, improving harmonization and containing unnecessary testing. Nevertheless, recent changes in the nature of laboratory services, promoted by innovation and introduction of more complex tests in emerging diagnostic fields, more advanced diagnostics along with other "internal" and "external" drivers, will promote a paradigmatic transformation of current scenarios. The future of laboratory professionals remains hence uncertain, and is seems obvious that the role and figure of laboratory scientists and professionals shall evolve. We are hence proposing this 10-point "manifesto", which is aimed to encourage a new vision of the future of this discipline and should help supporting the development of a new generation of laboratory professionals and leaders, who shall be able to integrate specific technical and administrative skills with a broader vision of health care and patients needs.

Reducing Diagnostic Errors Worldwide Through Diagnostic Management Teams.

A major challenge facing most countries is the growing cost of healthcare. Laboratory testing costs constitute approximately 3% of all clinical costs, while waste of funds due to inappropriate admissions to clinical departments is reported to be as high as 15%. A frequently used approach to save money in healthcare is random reduction of laboratory budgets, focusing on decreasing the number of unnecessary laboratory tests. The World Health Assembly has approached this problem by publishing a list of essential in vitro diagnostic tests, to achieve a global rationalization of the problem. A much more thoughtful strategy to reducing healthcare expenditure is to improve the efficiency of the diagnostic process. Decreasing the time to a correct diagnosis provides considerable financial and clinical benefits. Additionally, reducing both overutilization and underutilization of laboratory tests while achieving the correct diagnosis is of great benefit to challenged healthcare budgets. Examining the situation in the United States and Italy, this review presents an opportunity for reducing diagnostic error and increasing the efficiency of diagnostic testing worldwide. One approach taken to achieve major savings in healthcare in the United States, which can be applied in Italy and other countries, is the creation of "diagnostic management teams," comprising experts in specialty areas of medicine, primarily based in the clinical laboratory, who can advise physicians on the selection of necessary tests and the interpretation of complex test results.

The Definition and Scope of Diagnostic Error in the US and How Diagnostic Error is Enabled.

BACKGROUND: The quality of healthcare in the US has been progressively addressed by 3 reports from the National Academy of Medicine, the latest of which, entitled "Improving Diagnosis in Health Care," was issued in 2015 from a 21-member panel (the author of this report was a member). The report is a review of the longstanding problem of diagnostic error. The infrastructure of healthcare delivery in the US has inadvertently made diagnostic error a major contributor to the high cost of care and preventable poor patient outcomes. CONTENT: This review describes the failures in US healthcare delivery that have led to the overwhelming number of deaths attributable to diagnostic error. Each failure is associated with recommendations to eliminate it. The review begins with a description of the scope of the diagnostic error problem and then discusses each of the issues that need to be addressed to reduce the number of misdiagnoses. SUMMARY: The problem of diagnostic error in the US is a large one. Some the contributing factors to this large problem can be resolved at a small expense and with modest change; others require a major overhaul of aspects of medical practice. For the first time, Americans have a "to-do list" to reduce our diagnostic error problem and be on par with other developed countries that are recognized as providing less costly care with better patient outcomes.

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.

BACKGROUND: Diagnostic error is extremely common in the USA and likely around the world. A major reason for the diagnostic error is both the overutilization and the underutilization of laboratory tests. Using a panel of two to four experts in coagulation, test selection was reviewed in clinical context and in real time, and consensus determinations were made to derive conclusions about the extent of overutilization and underutilization. METHODS: Two hundred cases of patients being evaluated for bleeding or thrombotic issues were presented at each daily meeting of the diagnostic management team, and a review of each case for appropriate utilization of tests was completed. RESULTS: Two hundred randomly selected cases revealed 77.5% diagnostic errors (155 cases). Sixteen percent were associated with overutilization of laboratory tests, 44% were associated with underutilization, and 17.5% were associated with both. The annual cost burden estimated for overutilization alone in one institution of 450 beds was on the order of $20,000. The cost burden for the delay in diagnosis or the misdiagnosis in cases with underutilization is orders of magnitude greater ($200,000 or more), but it is impossible to determine the cost of a misdiagnosis in an individual case because it can produce many different clinical outcomes. CONCLUSIONS: This was a rare opportunity for experts in a given field to review cases in real time and in clinical context and provide immediately a consensus answer about test utilization. The results of this study show errors in test selection in nearly 75% of the cases evaluated.

The new diagnostic team.

The National Academy of Medicine (NAM) in the recently issued report Improving Diagnosis in Health Care outlined eight major recommendations to improve the quality and safety of diagnosis. The #1 recommendation was to improve teamwork in the diagnostic process. This is a major departure from the classical approach, where the physician is solely responsible for diagnosis. In the new, patient-centric vision, the core team encompasses the patient, the physician and the associated nursing staff, with each playing an active role in the process. The expanded diagnostic team includes pathologists, radiologists, allied health professionals, medical librarians, and others. We review the roles that each of these team members will need to assume, and suggest "first steps" that each new team member can take to achieve this new dynamic.