1. I NTERVENTIONS TO REDUCE INAPPROPRIATE TEST UTILIZATION Diagnostic Error in Medicine 12 November 2012 Paul L Epner

2. T RENDS SUGGEST INCREASED DIAGNOSTIC ERRORS Aging population means more diagnoses Increasing chronic comorbidities mean increased diagnostic complexity Decreasing number of primary care physicians combined with emphasis on cost effectiveness means less time with patients Anecdotal evidence of reduced skills in taking history and conducting physical Diagnosis is an evolving term 2

3. D EFINITION OF DIAGNOSIS IS EXPANDING The cause of symptoms (traditional) The conditions subtype (for best treatment) Antimicrobial susceptibility testing Tumor typing The bodys likely response to treatments The stratification of risk 3 ©2012 Paul Epner LLC

4. T HE ROLE OF LABORATORY TESTING IN DIAGNOSIS IS LIMITED BUT IMPORTANT AND LIKELY INCREASING In a study of 248 hospitalized patients, 246 had definitive diagnosis within 3 months of hospitalization. The primary determinant of diagnosis for 215 with exact in-hospital diagnosis was: History and Physical – 48.4% Radiologic exam – 33.5% Blood test or culture – 9.8% Study limitations did not examine diagnostic error did not examine time to diagnosis did not examine appropriate use of diagnostic tools 4 Source: Wahner-Roedler, D. L.et al. (2007). Who makes the diagnosis? The role of clinical skills and diagnostic test results. Journal of evaluation in clinical practice, 13(3) ©2012 Paul Epner LLC

5. O LDER STUDIES YIELD COMPARABLE RESULTS 80 prospective outpatient cases Final diagnosis made Following history - 61 (76%) Following physical – 10 (12%) Following laboratory – 9 (11%) Confidence in diagnosis rose with more information Following history – 7.1 (scale of 1 to 10) Following physical – 8.2 Following laboratory – 9.3 Some evidence that skill in conducting history and physical is decreasing while reliance on data is increasing 5 Source: M.C. Peterson, J.H. Holbrook, D. Von Hales, N.L. Smith, and L.V. Staker, Contributions of the history, physical examination, and laboratory investigation in making medical diagnoses., The Western journal of medicine, vol. 156, Feb. 1992. ©2012 Paul Epner LLC

6. N= 583 Cases G. D. Schiff et al., Diagnostic error in medicine: analysis of 583 physician-reported errors., Archives of internal medicine, vol. 169, no. 20, pp. 1881-7, Nov. 2009. T HE ROLE OF TESTING IN DIAGNOSTIC E RRORS IS SIGNIFICANT 6 ©2012 Paul Epner LLC

7. U.S. MALPRACTICE CASES CONFIRM SIGNIFICANCE 7 Source: T. GANDHI, A. KACHALIA, E.J. Thomas, A.L. Puopolo, C. Yoon, T. Brennan, and D. Studdert, Missed and delayed diagnoses in the ambulatory setting: A study of closed malpractice claims., Annals of internal medicine, vol. 145, 2006. Of 307 closed cases (ambulatory) studied because they alleged missed or delayed diagnosis, 181 did involve diagnostic errors that harmed patients ©2012 Paul Epner LLC

8. T RADITIONAL LABORATORY QUALITY MEASURES ARE NOT SPECIFIC FOR PATIENT HARM OR DIAGNOSTIC ERRORS Prolonged turn-around time Error logs Missing ID, Hemolysis, Short fills, Interface error logs, Incomplete requisitions, uncollected samples, order entry errors, lost specimens, contaminated specimens Incident reports Corrected result reports 8 ©2012 Paul Epner LLC

9. A FRAMEWORK FOR LABORATORY - RELATED DIAGNOSTIC ERRORS HAS BEEN DEFINED * Inappropriate test is ordered Appropriate test is not ordered Appropriate test result utilization is delayed Appropriate test result is not properly utilized Knowledge deficit Failure of synthesis Misleading result Systematic failure Appropriate test result is wrong 9 *Adapted from P Epner and M Astion, Focusing on Test Ordering Practices to Cut Diagnostic Errors, Clinical Laboratory News, vol. 38, no. 7, July 2012 ©2012 Paul Epner LLC

10. T HE FRAMEWORK GUIDES INTERVENTIONS Inappropriate test ordered or appropriate test not ordered CPOE design and monitoring Algorithms, clinical pathways, guidelines Reflex testing Data mining Inter-physician variance analysis Resource utilization committee 10 ©2012 Paul Epner LLC

11. T HE FRAMEWORK GUIDES INTERVENTIONS Test result not utilized properly or fully Interpretive comments EMR interface Real-time triggers Test result delayed or not retrieved Process monitor Discharge monitor Appropriate test result is wrong Delta checks Controls/Calibrations Autoverification Second read (AP) 11 ©2012 Paul Epner LLC

12. R EQUISITION DESIGN 12 Design changes focused on medical necessity, reduction in panels, test groupings linked to specialty, etc. Reduction in tests per visit occurred No assessment of impact on Dx errors was made Source: J.F. Emerson and S.S. Emerson, The impact of requisition design on laboratory utilization, American Journal of Clinical Pathology, vol. 116, Dec. 2001.

13. C LINICAL DECISION SUPPORT / BEST PRACTICE ALERTS Source: Jones, Jay, Lab Enterprise Analytics, Executive War College 2009 13 ©2012 Paul Epner LLC

14. D IAGNOSTIC ALGORITHMS Clinical variables drive six distinct but potentially overlapping algorithms for prolonged PTT Evaluation preoperatively of an asymptomatic prolonged PTT Evaluation of a persistently prolonged PTT with bleeding Evaluation of a persistently prolonged PTT without bleeding Evaluation of an elderly patient without bleeding history accompanied by sudden development of soft tissue hematomas and/or persistent and significant gastrointestinal or genitourinary hemorrhage Evaluation of hospitalized newborn with prolonged PTT Evaluation of a unexplained prolonged PTT following multiple, appropriate workups; searching for rare diagnoses 14 Source: Tcherniantchouk, O., Laposata, M., & Marques, M. B. (2012). The isolated prolonged PTT. American journal of hematology. ©2012 Paul Epner LLC

15. 15 Developed by the Centers for Disease Control with the support of the Algorithm Subgroup of CLIHC

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18. R EFLEX AND REFLECTIVE TESTING Creating protocols for the sequential addition of tests based on earlier results reduces diagnostic delays and patient inconvenience while reducing test volume Reflex testing can improve diagnostic accuracy The improvement in diagnostic accuracy is linked to the threshold criteria and varies with the clinical scenario 18 Source: R. Srivastava, W. a Bartlett, I.M. Kennedy, A. Hiney, C. Fletcher, and M.J. Murphy, Reflex and reflective testing: efficiency and effectiveness of adding on laboratory tests., Annals of clinical biochemistry, vol. 47, May. 2010. ©2012 Paul Epner LLC

19. D ATA MINING Data mining is the process of nontrivial extraction of implicit, previously unknown and potentially useful information from data stored in repositories. 1 Strategies can be driven by published guidelines Retrospective study 2 of more than 450,000 HPV tests against new guideline published in 2004 HPV testing is contraindicated in women under age 21 HPV testing is contraindicated without positive cytology. Study showed multi-year improvements in compliance Data mining is a tool that identifies opportunities for education or other interventions 19 1 Lee, S.J. and Siau,K., A review of data mining techniques, Industrial Management & Data Systems, Vol. 101, January 2001. 2 B.H. Shirts and B.R. Jackson, Informatics methods for laboratory evaluation of HPV ordering patterns with an example from a nationwide sample in the United States, 2003-2009., Journal of pathology informatics, vol. 1, Jan. 2010. ©2012 Paul Epner LLC

20. P HYSICIAN - LEVEL PERFORMANCE FEEDBACK When physicians are given feedback on their test ordering patterns compared to colleagues or guidelines, test ordering behavior changes. In one study 1, clinicians were educated about the laboratory tests needed to monitor patients on antihypertensive medication. Additionally, they were given feedback on their testing patterns. Appropriate testing improved. In another study 2, quarterly feedback of practice requesting rates for nine laboratory tests, enhanced with educational messages were provided to primary care physicians which proved to be an effective strategy for reducing inappropriate testing 20 1 Lafata, J.E. et al, Academic detailing to improve laboratory testing among outpatient medication users., Medical care, vol. 45, Oct. 2007. 2 Thomas, R.E. et al, Effect of enhanced feedback and brief educational reminder messages on laboratory test requesting in primary care: a cluster randomised trial., Lancet, vol. 367, Jun. 2006. ©2012 Paul Epner LLC

21. R ESOURCE UTILIZATION COMMITTEE 21 Typically involves locally driven consensus One study is noteworthy for assessment of patient impact.* *Neilson, E. G., Johnson, K. B., Rosenbloom, S. T., Dupont, W. D., Talbert, D., Giuse, D. A., Kaiser, A., et al. (2004). The impact of peer management on test-ordering behavior. Annals of internal medicine, 141(3), 196–204. ©2012 Paul Epner LLC

22. F OCUS ON SYSTEMATIC ERROR REDUCTION Many laboratory professionals routinely drive initiatives to reduce systematic errors. Tools in use Lean 6 Sigma Root Cause Analysis Failure Mode & Effect Analysis Bias in problem selection may exist Within the laboratory walls Within the control or shared control of the laboratory Evidence for the use of these tools to eliminate diagnostic errors is difficult to find 22 ©2012 Paul Epner LLC

23. I NTERPRETIVE COMMENTS Criteria for providing interpretive comments have been described * a decision on treatment is indicated by the results in combination with the clinical details provided a result is unexpected a specific question has been posed but it is not obvious whether the results provide the answer a clinician has requested a test with which he/she is not likely to be familiar Areas where Interpretive reports are most relevant 23 * E. Piva and M. Plebani, Interpretative reports and critical values., Clinica chimica acta; international journal of clinical chemistry, vol. 404, 2009. ©2012 Paul Epner LLC

24. D IAGNOSTIC MANAGEMENT TEAMS AT V ANDERBILT ENSURE APPROPRIATE CONSULTATIVE SERVICES 24 ©2012 Paul Epner LLC

25. P ENDING LAB RESULTS : PROCESS MONITORING Shifts the focus from catching failures e.g., clinical event monitors to workflow process control Some efforts are ongoing: MSTART (Multi-Step Task Alerting, Reminding, and Tracking) 25 ©2012 Paul Epner LLC *Tarkan, S., Plaisant, C., Shneiderman, B., & Hettinger, A. (2010). Improving Timely Clinical Lab Test Result Management: A Generative XML Process Model to Support Medical Care.

26. P ENDING LAB RESULTS : DISCHARGE MONITOR Several attempts to create automated tools have been tried with limited success Positive results were obtained with a system of email notifications 1 A computer-based antimicrobial monitoring (CBAM) system has been used to ensure positive microbiology cultures receive attention with improved outcomes 2 Discharge systems need to alert both hospital-based and primary care physician 26 ©2012 Paul Epner LLC 1 Dalal, A. K., Schnipper, J. L., Poon, E. G., Williams, D. H., Rossi-Roh, K., Macleay, A., Liang, C. L., et al. (2012). Design and implementation of an automated email notification system for results of tests pending at discharge. Journal of the American Medical Informatics Association: JAMIA, 19(4), 523–8. 2 Wilson, J. W., Marshall, W. F., & Estes, L. L. (2011). Detecting delayed microbiology results after hospital discharge: improving patient safety through an automated medical informatics tool. Mayo Clinic proceedings. Mayo Clinic, 86(12), 1181–5. doi:10.4065/mcp.2011.0415

27. T OOLS EXIST ; PROVING VALUE IS MORE DIFFICULT Robust research on the role of laboratory services does not exist Research on the effectiveness of available tools is limited 27 ©2012 Paul Epner LLC

28. I MPROVEMENTS IN TEST SELECTION AND RESULTS INTERPRETATION (ITSRI) – A R ESEARCH A GENDA Strategic Intent Establish empirically the optimum role for laboratory medicines physicians and scientists to maximize positive patient outcomes Appropriate testing Appropriate interpretation Identify evidence-based interventions that support the optimum role 28 ©2012 Paul Epner LLC

29. ITSRI S TATUS Narrowed scope to diagnostic errors Seeking to catalyze research Diagnostic Process Variation Chief complaint specific Diagnosis specific Test domain specific Intervention effectiveness Building awareness Recruiting collaborators NorthShore University HealthSystem Virginia Commonwealth University Kaiser Permanente 29 ©2012 Paul Epner LLC

30. O THER EFFORTS ONGOING Diagnostic errors and the clinical laboratory AHRQ ACTION II CLIHC Significant challenges remain Lack of funding and resources Shifting the focus from laboratory costs 30 ©2012 Paul Epner LLC

31. AHRQ FUNDED RESEARCH Awarded to RTI in August, 2011; 18 month effort Developing risk assessment tools which will be tested in three sites: Vanderbilt Emory Seattle Childrens 31 ©2012 Paul Epner LLC

32. R EFERRAL L ABORATORY R ISK A SSESSMENT ©2012 Paul Epner LLC 32

33. I DENTIFICATION AND P RIORITIZATION OF R ISK ©2012 Paul Epner LLC 33

34. C LINICAL L ABORATORY INTEGRATION INTO HEALTHCARE COLLABORATIVE – CLIHC CDC sponsored Seeking to break down the barriers between care providers and laboratory professionals Key initiatives are moving forward A survey of medical schools to understand curricular changes since 1992 involving laboratory medicine A survey of pathology residency programs quantifying time spent teaching consultation A survey of primary care clinicians to quantify the barriers to appropriate laboratory utilization An initiative to define nomenclature issues and investigate technology strategies for addressing them An initiative that will develop and publish algorithms to guide clinicians in the use of complex tests (with iPhone app) An initiative that seeks to experimentally determine the effectiveness of laboratory interventions on diagnostic error reduction (ITSRI) 34 ©2012 Paul Epner LLC

35. K EY MESSAGES Diagnostic error is a major patient safety problem The total testing process is a significant source of diagnostic errors Laboratory-directed interventions are available and can be effective in reducing errors Laboratory physicians and scientists will realize other benefits from leading collaborative efforts Improve patient outcomes Strengthen relationships with clinicians Reduce the level of risk in the health system Become indispensable stewards of clinical data 35 ©2012 Paul Epner LLC

36. F INAL T HOUGHT : SHIFTING THE GOAL 36 T HE CLINICAL LAB S MISSION SHOULD NOT BE : To provide accurate, timely, low cost test results A LTHOUGH NECESSARY, IT IS NOT SUFFICIENT T HE CLINICAL LAB S MISSION SHOULD BE : To rapidly and efficiently enable the accurate diagnosis of conditions, the selection of appropriate treatments and the effective monitoring of health status* * Epner, Paul, Impact of Laboratory Services on Diagnostic Errors, ThinkLab 11 ©2012 Paul Epner LLC