View PDF - Pathology Informatics Summit
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View PDF - Pathology Informatics Summit
DIAGNOSTIC ERROR AND IT STRATEGIES TO MITIGATE RISK Pathology Informatics 2012 Paul L Epner AGENDA Background Diagnostic Errors Diagnostic Errors and the Clinical Laboratory Diagnostic Errors, the Clinical Laboratory and IT Summary ©2012 Paul Epner LLC 2 Institute of Medicine. (2012). Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. (M. Smith, R. Saunders, L. Stuckhardt, & J. M. Mcginnis, Eds.) (p. 450). Washington DC: The National Academies Press. ©2012 Paul Epner LLC $750 BILLION 3 BACKGROUND: MACRO TRENDS U.S. healthcare costs continue to rise The aging population portends increases in demand for healthcare in general including laboratory services Prevalence of multiple chronic conditions will further increase demand Increases in longevity are linked to longer durations of poor health and will increase demand Shortages of primary care physicians will drive increased use of physician extenders, hospitalists and specialists with unclear impact Indicators of cost effectiveness are unfavorable for the US and will continue to put pressure on budgets ©2012 Paul Epner LLC 4 THE RISING COST OF DIAGNOSIS ©2012 Paul Epner LLC 5 J. K. Iglehart, “Health insurers and medical-imaging policy--a work in progress.,” The New England journal of medicine, vol. 360, no. 10, pp. 1030-7, Mar. 2009. THE LIKELY LABORATORY EXPERIENCE Increased test volume Fewer laboratory professionals More centralization (more remote) More automation Continually increasing focus on cost Less integration into the clinical situation ©2012 Paul Epner LLC The result is an increasingly factory-like experience: tube-in, number-out 6 THE “LAB-AS-FACTORY” MISSION STATEMENT ©2012 Paul Epner LLC To provide accurate, timely test results at the lowest possible cost What’s wrong with this? Where’s the why? 7 AN ALTERNATIVE VIEW OF THE LAB’S MISSION ©2012 Paul Epner LLC To rapidly and efficiently enable the accurate diagnosis of conditions, the selection of appropriate treatments and the effective monitoring of health status.* Where’s cost? 8 *P Epner, “Impact of Laboratory Services on Diagnostic Errors,” CLMA’s ThinkLab, Las Vegas 2011 WHERE DO WE FOCUS? Monitoring Screening ©2012 Paul Epner LLC Diagnosis/Treatment Selection/Risk Stratification Value 9 DIAGNOSTIC ERRORS DEFINED Diagnostic errors are defined as misdiagnosis, missed diagnosis, or delayed diagnosis1 Diagnostic errors occur in 10-15% of cases2 ©2012 Paul Epner LLC Diagnostic Errors Falls 1Graber, M. L. et al, “Diagnostic error in internal medicine,” Archives of internal medicine, vol. 165, July, 2005. 2Berner, E. S., & Graber, M. L, “Overconfidence as a cause of diagnostic error in medicine,” American Journal of Medicine, vol. 121, 2008, S2-S23. Rx Errors Wrong Site Surgery 10 IT COULD GET WORSE Aging ©2012 Paul Epner LLC population means more diagnoses Increasing chronic comorbidities mean diagnostic complexity Decreasing number of primary care physicians combined with emphasis on “cost effectiveness” means less time with patients Focus on overuse could mean less focus on appropriate use 11 DIAGNOSTIC ERRORS ARE CLASSIFIED INTO ONE OF THREE TYPES Cognitive Errors (74% in this study) Systematic Errors (65%) Technical failures and equipment problems Organizational flaws ©2012 Paul Epner LLC Faulty knowledge Faulty data gathering Faulty synthesis No Fault Errors (7%) Masked or unusual presentation of disease Patient-related error (uncooperative, deceptive) Source: M.L. Graber, N. Franklin, and R. Gordon, “Diagnostic error in internal medicine.,” Archives of internal medicine, vol. 165, Jul. 2005, pp. 1493-9. 12 HOW MANY OF YOU HAVE ENCOUNTERED DIAGNOSTIC ERRORS? ©2012 Paul Epner LLC 13 TO UNDERSTAND THE LABORATORY’S POTENTIAL TO REDUCE DX ERRORS, WE MUST UNDERSTAND ITS ROLE IN DIAGNOSIS 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: ©2012 Paul Epner LLC 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 14 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) OLDER STUDIES YIELD COMPARABLE RESULTS 80 prospective outpatient cases Final diagnosis made Confidence in diagnosis rose with more information Following history – 7.1 (scale of 1 to 10) Following physical – 8.2 Following laboratory – 9.3 ©2012 Paul Epner LLC Following history - 61 (76%) Following physical – 10 (12%) Following laboratory – 9 (11%) Some evidence that skill in conducting history and physical is decreasing while reliance on data is increasing 15 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. YET WE KNOW THAT DIAGNOSTIC ERRORS OCCUR ACROSS THE DIAGNOSTIC PROCESS ©2012 Paul Epner LLC N= 583 Cases 16 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. MALPRACTICE CASES PROVIDE FURTHER DATA 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 17 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. THE MECHANISMS FOR LABORATORY-RELATED DIAGNOSTIC ERRORS HAVE BEEN DEFINED* Inappropriate test is ordered Appropriate test is not ordered Appropriate test result is not properly utilized ©2012 Paul Epner LLC Knowledge deficit Failure of synthesis Misleading result Systematic failure Appropriate test result utilization is delayed Appropriate test result is wrong The impact is the same: Delayed diagnosis, delayed or inappropriate treatment, increased costs, patient harm *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 18 FAILURE TO RETRIEVE: “ORPHAN” TEST RESULTS Study1 of 2644 patients at 2 tertiary care hospitals of which 1095 had 2033 test results (lab, radiology) return after discharge 191 of results were potentially actionable (9%) 61% of respondents with potentially actionable results were unaware of results A systematic review2 found failure to follow-up was a significant problem for in-patients, for in-patients being discharged and for ED patients. ©2012 Paul Epner LLC 19 Roy, E.G. Poon, A.S. Karson, Z. Ladak-Merchant, R.E. Johnson, S.M. Maviglia, and T.K. Gandhi, “Patient safety concerns arising from test results that return after hospital discharge.,” Annals of internal medicine, vol. 143, Jul. 2005. 2Callen, J., Georgiou, A., Li, J., & Westbrook, J. I. (2011). The safety implications of missed test results for hospitalised patients: a systematic review. BMJ quality & safety, 20(2), 194–9. 1C.L. EXAMPLES OF CAUSATIVE FACTORS: TEST CHOICES ©2012 Paul Epner LLC “I may order 20 tests commonly and I may order an additional 10-20 tests [occasionally], so I may be using 40 tests that I feel comfortable that I’m not wasting time or money or resources.” 20 OTHER CAUSATIVE FACTORS: NOMENCLATURE High Sensitivity CRP synonyms Ultrasensitive CRP Cardiac CRP Test abbreviations: hsCRP, CRH, HSC Alkaline Phosphatase synonyms Alkaline Phos blood Alkaline phosphomonoesterase Alkaline phosphohydrolase Alkaline phenyl phosphatase Test abbreviations: ALP,Alk Phos, AP, AKP ©2012 Paul Epner LLC Within single physician office, multiple test synonyms exist driven by multiple payers “If I want Panel A it should look like Panel A in another lab and maybe you’ve ordered the right panel but now they’ve changed insurance and you’re ordering from a different lab. How [do you] identify what you’re getting?” 21 NOMENCLATURE : D 1,25 dihydroxy vitamin D2 1,25 dihydroxy vitamin D3 1,25 dihydroxy vitamin D Vitamin D 25 Hydroxy D2 Vitamin D 25 Hydroxy D3 Vitamin D 1,25 Dihydroxy Calcifdiol ©2012 Paul Epner LLC Vitamin D2 Vitamin D3 25-0H vitamin D2 25-0H vitamin D3 25-0H vitamin D 25 hydroxy vitamin D2 25 hydroxy vitamin D3 25 hydroxy vitamin D 1,25 (OH)2 vitamin D2 1,25 (OH)2 vitamin D3 1,25 (OH)2 vitamin D OPTIONS FOR VITAMIN Calcidiol Cholecalciferol “I was forced to look through all these panels and frankly I had no idea which one it was …I was totally frustrated. They had 6 different things that all looked the same to me. And if you called them to find out...that would be hopeless.” 22 THE FRAMEWORK SUGGESTS IT INTERVENTIONS Inappropriate test ordered or appropriate test not ordered Test result not utilized properly or fully ©2012 Paul Epner LLC CPOE design Algorithms, clinical pathways, guidelines Reflex testing Data mining Inter-physician variance analysis Interpretive comments EMR interface Trigger tools Test result delayed or not retrieved Process monitor Discharge monitor 23 CPOE DESIGN Many studies have shown requisition user interface is an effective way to change utilization. Most studies measure reduction in cost or test volume without examining patient harm. One study focused on impact of panels and future ordering, but assessed patient impact.* ©2012 Paul Epner LLC 24 *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. GEISINGER USES LOCALLY DEVELOPED GUIDELINES WITH CLINICAL DECISION SUPPORT ©2012 Paul Epner LLC 25 Source: Jones, Jay, “Lab Enterprise Analytics,” Executive War College 2009 ORDERING PATTERNS CHANGED ©2012 Paul Epner LLC Source: Jones, Jay, “Lab Enterprise Analytics,” Executive War College 2009 26 “SIMPLE” ALGORITHMS CAN EASILY BECOME COMPLEX 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 Source: Tcherniantchouk, O., Laposata, M., & Marques, M. B. (2012). The isolated prolonged PTT. American journal of hematology. ©2012 Paul Epner LLC 27 REFLEX TESTING IMPROVES EFFICIENCY AND EFFECTIVENESS 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 ©2012 Paul Epner LLC 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. 28 DATA 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 study2 of more than 450,000 HPV tests against new guideline published in 2004 ©2012 Paul Epner LLC 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 S.J. and Siau,K., “A review of data mining techniques,” Industrial Management & Data Systems, Vol. 101, January 2001. 2B.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. 1Lee, 29 PHYSICIAN-LEVEL PERFORMANCE FEEDBACK 1Lafata, ©2012 Paul Epner LLC When physicians are given feedback on their test ordering patterns compared to colleagues or guidelines, test ordering behavior changes. In one study1, 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 study2, 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 J.E. et al, “Academic detailing to improve laboratory testing among outpatient medication 30 users.,” Medical care, vol. 45, Oct. 2007. 2Thomas, 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. INTERPRETIVE Criteria for providing interpretive comments have been described1 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 ©2012 Paul Epner LLC COMMENTS 31 Piva and M. Plebani, “Interpretative reports and critical values.,” Clinica chimica acta; international journal of clinical chemistry, vol. 404, 2009. 1E. PENDING 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) ©2012 Paul Epner LLC 32 *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. PENDING 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 notifications1 A computer-based antimicrobial monitoring (CBAM) system has been used to ensure positive microbiology cultures receive attention with improved outcomes2 Discharge systems need to alert both hospital-based and primary care physician 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. 2Wilson, 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 ©2012 Paul Epner LLC 1Dalal, 33 SOLUTIONS ARE COMPLEX – EFFORTS ONGOING Significant challenges remain Lack of effectiveness and implementation research Unintended consequences Diagnostic errors (general) DEM SIDM Diagnostic errors and the clinical laboratory AHRQ ACTION II CLIHC™ ITSRI ©2012 Paul Epner LLC 34 ©2012 Paul Epner LLC 35 DIAGNOSTIC ERROR IN MEDICINE (DEM) November 11-14, 2012 – Baltimore AHRQ funded (partial) Agenda Highlights Sessions that are lab focused Sunday pre-conference workshop on clinical decision support Monday session on inappropriate testing Tuesday session on communicating test results ©2012 Paul Epner LLC Keynote by Carolyn Clancy, Director, AHRQ Featured presentation by Peter Pronovost For more information, visit Johns Hopkins CME: http://www.hopkinscme.edu/CourseDetail.aspx/80028747 Join our LinkedIn Group: Diagnostic Error in Medicine 36 ©2012 Paul Epner LLC • www.improvediagnosis.org • LinkedIn Group: Diagnostic Error in Medicine 37 AHRQ FUNDED RESEARCH ©2012 Paul Epner LLC Awarded to RTI in August, 2011; 18 month effort Preliminary literature search is complete Developing risk assessment tools which will be tested in three sites: Vanderbilt Emory Seattle Children’s 38 IDENTIFICATION AND PRIORITIZATION OF RISK ©2012 Paul Epner LLC 39 CLINICAL LABORATORY INTEGRATION INTO HEALTHCARE COLLABORATIVE 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) ©2012 Paul Epner LLC – CLIHC™ 40 IMPROVEMENTS IN TEST SELECTION AND RESULTS INTERPRETATION (ITSRI) – A RESEARCH AGENDA Appropriate testing Appropriate interpretation ©2012 Paul Epner LLC Strategic Intent Establish empirically the optimum role for laboratory medicine’s physicians and scientists to maximize positive patient outcomes Identify evidence-based interventions that support the optimum role 41 ITSRI STATUS Narrowed Diagnostic Process Variation Chief complaint specific Diagnosis specific Test domain specific ©2012 Paul Epner LLC scope to diagnostic errors Catalyzing research Intervention effectiveness Building awareness Recruiting collaborators NorthShore University HealthSystem Virginia Commonwealth University 42 KEY MESSAGES Diagnostic error is a major patient safety problem The total testing process is a significant source of diagnostic errors Pathology informaticians have an opportunity to A number of interventions have been tried and much has been learned about their effectiveness Choose your best fit and innovate ©2012 Paul Epner LLC Improve patient outcomes Strengthen relationships with clinicians Reduce the level of risk in the health system Become indispensable stewards of clinical data 43 FINAL THOUGHT: THE GOAL THE CLINICAL LAB’S MISSION SHOULD NOT BE: ALTHOUGH THE NECESSARY, IT IS NOT SUFFICIENT CLINICAL LAB’S MISSION SHOULD BE: ©2012 Paul Epner LLC To provide accurate, timely, low cost test results To rapidly and efficiently enable the accurate diagnosis of conditions, the selection of appropriate treatments and the effective monitoring of health status* 44 * Epner, Paul, “Impact of Laboratory Services on Diagnostic Errors,” ThinkLab ‘11 ©2012 Paul Epner LLC Questions? 45