Diagnostic Safety in an EHR- Enabled Health Care System



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Diagnostic Safety in an EHR- Enabled Health Care System Mark L. Graber, MD FACP Senior Fellow, RTI International Professor Emeritus, SUNY Stony Brook School of Medicine Founder and President, Society to Improve Diagnosis in Medicine (SIDM) Gordon D. Schiff, MD Internist Associate Director, Center for Patient Safety Research and Practice Brigham and Women s Hospital Associate Professor of Medicine Harvard Medical School Hardeep Singh, MD MPH Chief, Health Policy, Quality and Informatics Program Houston VA Center for Innovations in Quality, Effectiveness and Safety, and Baylor College of Medicine PATIENT SAFETY AWARENESS WEEK DIAGNOSTIC ERROR WEBCAST SERIES

Introduction Mark L. Graber, MD FACP Senior Fellow, RTI International Professor Emeritus, SUNY Stony Brook School of Medicine Founder and President, Society to Improve Diagnosis in Medicine (SIDM) PATIENT SAFETY AWARENESS WEEK DIAGNOSTIC ERROR WEBCAST SERIES

Our vision: Diagnosis should be accurate, timely, efficient, and SAFE. To learn more: Annual conference: Diagnostic Error in Medicine Dx Error listserv New journal: DIAGNOSIS www.improvediagnosis.org 3

Diagnosis and Electronic Medical Records Its role in promoting diagnostic quality Gordy Schiff Its role in finding and studying diagnostic errors Hardeep Singh 4 4

Diagnostic Safety in an EHR-Enabled Health Care System Gordon D. Schiff, MD Internist and Associate Director Center for Patient Safety Research and Practice Brigham and Women s Hospital Associate Professor of Medicine Harvard Medical School PATIENT SAFETY AWARENESS WEEK DIAGNOSTIC ERROR WEBCAST SERIES

Schiff et al JAMA Intern Med 2013 6

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Sherlock Holmes Dr. Gregory House Marshal Wolf -Brigham 11

Don Berwick Former President and CEO Institute for Healthcare Improvement (IHI) Former Director Centers for Medicare & Medicaid Services 12

Genius diagnosticians make great stories, but they don't make great health care. The idea is to make accuracy reliable, not heroic Don Berwick Boston Globe 7/14/2002 13

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Safer practice can only come about from acknowledging the potential for error and building in error reduction strategies at each stage of clinical practice L. Leape 15

Micro environment: IT, staff, teamwork, support systems Time Pressures, Distractions, Interruptions Pt. Presentation Signal:Noise Ambient Conditions Difficult diagnoses Dx Errors Training Prior Experience Self-awareness limitations 16

1. Access/Presentation Denied care Delayed presentation 2. History Failure/delay in eliciting c ritical piece of history data Inaccurate/misinterpretation " Suboptimal weighing Failure/delay to follow-up 3. Physical Exam Failure/delay in eliciting critical physical exam finding Inaccurate/misinterpreted " Suboptimal weighing Failure/delay to follow-up 4. Tests (Lab/Radiology) Ordering Failure/delay in ordering needed test(s) Failure/delay in performing ordered test(s) Suboptimal test sequencing Ordering of unnecessary test(s) Performance 17

Clinician processing Failed/delayed follow-up of test Erroneous clinician interpretation of test 5. Assessment Hypothesis Generation Failure/delay in considering important diagnosis Suboptimal weighing/prioritizing Too much weight to low(er) probability/priority dx Too little consideration of high(er) probability/priority dx Too much weight on competing diagnosis Recognizing Urgency/Complications Failure to appreciate urgency/acuity of illness Failure/delay in recognizing complication(s) 6. Referral/Consultation Failed/Delayed in needed referral Inappropriate/unneeded referral Suboptimal consultation diagnostic performance Failed/delayed communication/followup of consultation 7. Followup Failure to refer patient to close/safe setting/monitoring Failure/delay in timely follow-up/rechecking of patient 18

Inaccurate/misinterpreted " Suboptimal weighing Failure/delay to follow-up 4. Tests (Lab/Radiology) Ordering Failure/delay in ordering needed test(s) Failure/delay in performing ordered test(s) Suboptimal test sequencing Ordering of unnecessary test(s) Performance Sample mixup/mislabeled (eg wrong patient) Technical errors/poor processing of specimen/test Erroneous lab/radiol reading of test Failed/delayed communication of test Clinician processing Failed/delayed follow-up of test Erroneous clinician interpretation of test 5. Assessment Hypothesis Generation Failure/delay in considering important diagnosis Suboptimal weighing/prioritizing 19

Preventing/Mitigating Diagnosis Errors Fertile Fields to Plow More reliable test result f/up Improving patient follow-up & feedback Re-engineered clinical documentation, EMR Learning from mistakes, recalibration Diagnosis time out Just-in-time knowledge, consultations Enhanced role for the patient 20

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El-Kareh Schiff BMJ QS 2013 22

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Priority to rapidly improve EHR usability and functionality 24

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Residents, rushing to complete numerous tasks for large numbers of patients, have sometimes pasted in the medical history and the history of the present illness from someone else s note even before the patient arrives at the clinic. Efficient? Yes. Useful? No. This capacity to manipulate the electronic record makes it far too easy for trainees to avoid taking their own histories and coming to their own conclusions about what might be wrong. Senior physicians also cut and paste from their own notes, filling each note with the identical medical history, family history, social history, and review of systems. Writing in a personal and independent way forces us to think and formulate our ideas. Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians thoughtful review and analysis. They may be efficient for the purpose of documentation but not for creative clinical thinking. 26

Although the intent may be to ensure thoroughness, in the new electronic sea of results, it becomes difficult to find those that are truly relevant. A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development. It s like Where s Waldo? he said bitterly. Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside....we have observed the electronic medical record become a powerful vehicle for perpetuating erroneous information, leading to diagnostic errors that gain momentum when passed on electronically 27

These problems, we believe, will only worsen, for even as we are pressed to see more patients per hour and to work with greater efficiency, we must respond to demands for detailed documentation to justify our billing and protect ourselves from lawsuits. Though the electronic medical record serves these exigencies, it simultaneously risks compromising care by fostering a generic approach to diagnosis and treatment. The worst kind of electronic medical record requires filling in boxes with little room for free text. Although completing such templates may help physicians survive a report-card review, it directs them to ask restrictive questions rather than engaging in a narrative-based, open-ended dialogue. Such dialogue can be key to making the correct diagnosis and to understanding which treatment best fits a patient s beliefs and needs. 28

Perhaps most important, we should be cautious in using templates that constrain creative clinical thinking and promote automaticity. We must be attentive to the shift in focus demanded by electronic medical records, which can lead clinicians to suspend thinking, blindly accept diagnoses, and fail to talk to patients in a way that allows deep, independent probing. The computer should not become a barrier between physician and patient; as medicine incorporates new technology, its focus should remain on interaction between the sick and the healer. Practicing thinking medicine takes time, and electronic records will not change that. We need to make this technology work for us, rather than allowing ourselves to work for it. 29

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Role for Electronic Documentation Providing access to information Recording and sharing assessments Maintaining dynamic patient history Maintaining problem lists Tracking medications Tracking tests Goals and Features of Redesigned Systems Ensure ease, speed, and selectivity of information searches; aid cognition through aggregation, trending, contextual relevance, and minimizing of superfluous data. Provide a space for recording thoughtful, succinct assessments, differential diagnoses, contingencies, and unanswered questions; facilitate sharing and review of assessments by both patient and other clinicians. Carry forward information for recall, avoiding repetitive pt querying and recording while minimizing erroneous copying and pasting Ensure that problem lists are integrated into workflow to allow for continuous updating. Record medications patient is actually taking, patient responses to medications, and adverse effects to avert misdiagnoses and ensure timely recognition of medication problems. Integrate management of diagnostic test results into note workflow to facilitate review, assessment, and responsive action as well as documentation of these steps. 31

Role for Electronic Documentation Ensuring coordination and continuity Goals and Features of Redesigned Systems Aggregate and integrate data from all care episodes and fragmented encounters to permit thoughtful synthesis. Enabling follow-up Providing feedback Facilitate patient education about potential red-flag symptoms; track follow-up. Automatically provide feedback to clinicians upstream, facilitating learning from outcomes of diagnostic decisions. Providing prompts Providing placeholder for resumption of work Provide checklists to minimize reliance on memory and directed questioning to aid in diagnostic thoroughness and problem solving. Delineate clearly in the record where clinician should resume work after interruption, preventing lapses in data collection and thought process. Schiff & Bates NEJM 2010 32

Open Loop System Water goes on the same time each day, regardless of whether it is raining or lawn is flooded Schiff A J Med 2008 33

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Diagnosis Essentials Checklist 1. Essential Data Elements - Elements of Hx, P.exam, tests data that should be reliably obtained for every pt presenting with given sx. In many situations can reliably be done w/ computer questionnaire. 2. Don t miss diagnoses - critical dx can present w/ sx that are fatal or have serious consequences if not recognized and rx promptly. These dx should be considered in every patient with that symptom. 3. Red flag symptoms - sx or findings (e.g. back pain with new urinary incontinence in cancer patient) that may indicate serious condition & should lead to heightened suspicion/evaluation for don t miss dx. Schiff & Leape Acad Med 2012 Schiff BMJ Safety & Qual 2012 35

Diagnosis Essentials Checklist 4. Potential drug causes - meds that can cause the symptom. High % sx med side effects, yet infrequently considered. 5. Required referrals - When is specialist expertise or technology needed to adequately and safely evaluate the patient? Includes possible rare conditions that only specialists have sufficient experience or where required testing (biopsy or endoscopy) 6. Patient follow-up instructions and plan - Warnings that patients should receive regarding specific symptoms that should lead them to return or call. These should be in writing and include a time frame. (e.g. call if you develop rash or fever, or if you are not improved in 48 hours) Schiff & Leape Acad Med 2012 Schiff BMJ Safety & Qual 2012 36

Prevalence Fatigue Checklist (27 diagnoses) Ely Acad Med 2010 Obstructive sleep apnea Depression, anxiety Deconditioning *Drugs (beta blocker, clonidine, alcohol) Chronic fatigue syndrome, fibromyalgia *Infections, infectious mononucleosis, hepatitis, pneumonia, mastitis Pregnancy *Anemia Vitamin D deficiency Hypothyroidism, hyperthyroidism Hypokalemia, hyponatremia *Myocardial infarction Celiac disease Disturbance of calcium, phosphorus, magnesium Polymyalgia rheumatica/temporal arteritis Parkinson disease Hypogonadism Myasthenia gravis *Heart failure, myocarditis Pulmonary, hepatic, renal failure Restless legs syndrome Multiple sclerosis Carbon monoxide Adrenal insufficiency, Addison s disease B12 deficiency Botulism Black widow spider bite Don t miss * Often missed 37

Role for Electronic Documentation Calculating Bayesian probabilities Goals and Features of Redesigned Systems Embed calculator into notes to reduce errors and minimize biases in subjective estimation of diagnostic probabilities. Providing access to information sources Provide instant access to knowledge resources through contextspecific info buttons triggered by keywords in notes that link user to relevant textbooks and guidelines. Offering second opinion or consultation Integrate immediate online or telephone access to consultants to answer questions related to referral triage, testing strategies, or definitive diagnostic assessments. Increasing efficiency More thoughtful design, workflow integration, easing and distribution of documentation burden could speed up charting, freeing time for communication and cognition. Schiff & Bates NEJM 2010 38

Summary Areas for Improvement Where EMR Could Help Tighten gaps so less likely to fall through cracks; safety nets for those that do. Operationalize, create safety around dx uncertainty Redesign follow-up; feedback Open door, pull systems for patients e-curbside just-in-time consults for clinicians Improve info access; decrease cognitive burden w/ smarter display. Learn from and share mistakes/pitfalls Engage the patient in all of above 39

Diagnostic Safety in EHR-based Healthcare: Missed Test Results Hardeep Singh, MD MPH Chief Health Policy Quality and Informatics Program, Houston Veterans Affairs Health Services Research & Development Center of Excellence Michael E. DeBakey VA Medical Center & BCM Director, Houston VA Patient Safety Center of Inquiry PATIENT SAFETY AWARENESS WEEK DIAGNOSTIC ERROR WEBCAST SERIES

Doctors sometimes miss electronic test results By Julie Steenhuysen CHICAGO Mon Sep 28, 2009 5:51pm EDT (Reuters) - Part of the appeal of electronic medical records is that they can help doctors keep track of test results and avoid medical errors, but a study released on Monday suggests that doctors sometimes ignore electronic warnings about abnormal test results. Researchers found doctors failed to follow up on nearly 8 percent of electronic alerts that a patient had something abnormal on an X-ray, mammogram, computed tomography or CT or magnetic resonance imaging or MRI scan that needed quick attention. "Just the fact that you can use technology to deliver a piece of information from the radiologist to a doctor doesn't mean it will be taken care of," said Dr. Hardeep Singh of the Baylor College of Medicine in Houston, whose study appears in the Archives of Internal Medicine. "The electronic health record system is a huge improvement from previous paper-based systems," but it is not perfect, Singh said in a telephone interview. President Barack Obama has made electronic medical records a centerpiece of his health reform efforts, promising nearly $1.2 billion to help doctors and hospitals make the switch from paper-based records. 41

Objective Discuss why we need a multi-faceted socio-technical approach to reduce missed tests results in EHRs Discuss examples of strategies to address missed test results in EHR-based health care 42

Objective Discuss why we need a multi-faceted socio-technical approach to reduce missed tests results in EHRs Discuss examples of strategies to address missed test results in EHR-based health care 43

Errors of Test Results Follow-up Failure to follow-up abnormal test results: up to 36% Communication breakdowns prevalent but also a problem IT can solve! Will technology eliminate failures to follow-up test results? Singh et al JGIM 2007 44

Case Study Alert in View Alert window 45

View Alert Window Example of an abnormal imaging alert 46

Case Study Background Hypothesized that unacknowledged alerts are indicators for missed test results (vs. acknowledged results that can serve as read receipts ) Queried an alert repository of abnormal imaging results Outcomes determined with assumption: Acknowledged took action Unacknowledged no action 47

Quantitative Data Assessment Outcomes: documented response /follow-up action on record review and phone calls Findings: Providers did not acknowledge receipt of 368 of 1,017 of transmitted alerts 45/368 unacknowledged alerts lost to follow-up at 4 weeks Next study hypothesis: Timely follow-up higher when providers acknowledge the alert Singh et al JAMIA 2007 48

Findings Evaluation of 1,163 outpatient abnormal lab & 1,196 abnormal imaging result alerts 7% abnormal labs lacked timely follow-up 8% abnormal imaging lacked timely follow-up Follow-up in acknowledged vs. unacknowledged alerts? Singh et al Am J Med 2010 & Singh et al Archives of Int Med 2009 49

Teamwork & Responsibility! 50

Digging Deeper Qualitatively One of the issues is just the sheer volume of alerts, and there s a number of alerts that in all honesty [you] really don t have any business seeing. 51

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Multiple Socio-Technical Issues Issue Software Content Usability Workflow Providers Organizational Examples no functionality for saving, tracking, and retrieving alerts too many unnecessary alerts poor signal to noise ratio on screen surrogate feature to forward alerts when providers out of office not used properly lack of knowledge/training policies for follow-up ambiguous Singh et al JAMA Int Med 2013 53

Lessons from Research EHR-based systems better than paper Not achieving full potential mostly due to nontechnological reasons! Need a sociotechnical model to improve safety Sittig and Singh JGIM 2012; QSHC 2010 54

8-Dimensional Socio-Technical Model of Safe & Effective EHR Use External Rules & Regulations Organizational Policies, Procedures, & Culture Workflow & Communication Content Hardware & Software Personnel Measurement & Monitoring Sittig Singh QSHC 2010 55

Objective Discuss why we need a multi-faceted socio-technical approach to reduce missed tests results in EHRs Discuss examples of strategies to address missed test results in EHR-based health care 56

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Experiences with National VA Policy Development Align with team-based model of care Leverage IT including for patient communication Standardize when possible especially in high-risk situations Give more hands-on guidance on workflow and processes Clarify roles/responsibilities 58

SAFER Guides ONC-sponsored Safety Assurance Factors for EHR Resilience (SAFER) project Proactive risk assessment and guidance Self-assessment; not meant to be regulatory Focused on high-risk areas Nine guides including Test Results Reporting and Follow-up http://www.healthit.gov/policy-researchers-implementers/safer Singh et al BMC Med Inf 2013 59

The Checklist is structured as a quick way to enter and print your self-assessment. Your selections on the checklist will automatically update the related section of the corresponding recommended practice worksheet. The Worksheet provides guidance on implementing the Practice. 60

Can EHR Triggers Help Us? Finding Needles in a Haystack and Creating Safety Nets! On a daily basis, thousands of patients have abnormal test results Can we electronically identify those likely to be experiencing diagnostic delays and intervene? Murphy et al BMJQS 2013 61

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Clinical laboratories must give patients access to their own lab-test results upon request, without going through the physician who ordered them, according to a new federal rule announced Monday by the Department of Health and Human Services. The rule, first proposed in 2011, is part of an Obama administration effort to give patients more control over their own health information. "Information like lab results can empower patients to track their health progress, make decisions with their health-care professionals and adhere to important treatment plans," said HHS Secretary Kathleen Sebelius. The final rule amends two existing federal laws, the Health Insurance Portability and Accountability Act, known as HIPAA, and the Clinical Laboratory Improvement Amendments, or CLIA, which regulates most of the clinical testing labs in the U.S. Patient advocacy groups had also pushed for the change. 63

In Closing Missed test results in EHRs related to both technical and non-technical reasons A sociotechnical approach is needed to improve safety & effectiveness of EHR-based test result follow-up Proactive risk-assessment, EHR-based triggers and patient engagement additional strategies to consider for reducing test result follow-up errors 64

Thank You Acknowledgements of Funding Support Veterans Affairs Health Services Research & Development Veterans Affairs National Center for Patient Safety National Institutes of Health/Agency for Healthcare Research and Quality Office of the National Coordinator for Health Information Technology No disclosures 65

Questions? 66

Free Diagnostic Error Tools Available Visit www.npsf.org/psaw to download free tools and resources for: Patients and Families Health Care Clinicians and Professionals Health Care Organizations 67

Please Join Us! Wednesday, March 26 2:00 3:00 pm ET How to Do a Root Cause Analysis of Diagnostic Error Learn more and register at www.npsf.org/psaw. PATIENT SAFETY AWARENESS WEEK DIAGNOSTIC ERROR WEBCAST SERIES

The Patient Safety Awareness Week Diagnostic Error Webcast Series has been made possible thanks to the generous sponsorship of the Cautious Patient Foundation.