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1 Click to edit Master title Diagnostic Errors & Disclosure: Lessons style Learned Click to edit Master subtitle style Graham Billingham, MD, FACEP, FAAEM Chief Medical Officer, MedPro Group 5/30/2018 0

2 Diagnostic errors take center stage Increased awareness (advocacy, highprofile cases) Greater research focus Incentives (value-based care) Technology (clinical decision support, EHR alerts, etc.) Malpractice cases Barriers in Diagnostic Error Assessment The dispersed nature of care in ambulatory settings Potentially long gaps between error and detection Retrospective studies require timeconsuming and costly manual chart reviews Frequent disagreements about whether an error or delay occurred Source: National Academies of Sciences, Engineering, and Medicine, Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. 1

3 Malpractice claims data ( )

4 Claims: overall by location and allegation Note: A minimal number of cases fall into other allegation categories and are not shown here. Total dollars paid = indemnity + expense. 3

5 Claims: clinical severity Note: The other category includes allegations for which no significant claim volume exists. 4

6 Office-based claims: volume, frequency, and financial severity Note: Total not equaling 100% is the result of rounding. 5

7 Office-based claims: clinical diagnoses cited in claims Top Cancer Diagnoses Lung Colorectal Breast Prostate Oropharynx Skin 6

8 Contributing (risk) factors in diagnosisrelated malpractice claims

9 The diagnostic process: Where do mistakes occur? Initial diagnostic assessment Testing & results processing Follow-up & coordination Source: CRICO Strategies (2014). Annual Benchmarking Report: Malpractice Risks in the Diagnostic Process. 8

10 Top contributing factors in diagnosis-related claims Top clinical judgment issues: Patient assessment Narrow focus Inadequate assessment Failure to reconcile signs/symptoms Test ordering delay/failure Misinterpretation of test results Failure or delay in consult/referral Note: Totals do not equal 100% because more than one factor is most often present for each case. 9

11 Focus on clinical judgment Narrow focus Inadequate assessment Top clinical judgment factors Patient assessment Failure or delay in consult/referral Failure to reconcile signs/symptoms Test ordering delay/failure Misinterpretation of test results 10

12 The role of cognitive biases in clinical judgment Anchoring Under-adjustment Premature closure Confirmation bias Availability bias Overconfidence Relying too much on certain information often the initial information obtained Failure to revise a diagnosis based on additional clinical data Terminating the data-gathering process before all of the information is known Focusing on information that confirms an initial diagnosis or manipulating information to fit preconceptions Considering a diagnosis more likely because it is forefront in mind Overestimating your own knowledge and ability, which can prevent ample information gathering and assessment Affective Biases Gender Sexuality Socioeconomic status Race/ethnicity Age Physical characteristics 11

13 Case example Patient 47-year-old female Overview Outcome The patient presented to her family medicine physician with complaints of shoulder and back pain, nausea, dizziness, and chest discomfort. The previous day, the patient reported working in her garden and attending a family picnic. An ECG was ordered, and the results were negative. The patient was not referred for further cardiac testing because the family physician determined that muscle strain and acid reflux were the cause of the patient's symptoms. The patient was leaving for vacation several days later, and the doctor cleared her to go. Two days into the patient s vacation, she was found unresponsive and rushed to the hospital, where she died. An autopsy concluded that the cause of death was myocardial infarction (MI) due to atherosclerotic cardiovascular disease. 12

14 Diagnostic checklist Have I ruled out any must-not-miss diagnoses? Did I just accept the first diagnosis that came to mind? Was the diagnosis suggested to me by the patient, nurse, or another physician? Did I consider other organ systems besides the obvious one? Are data available about this patient that I haven t obtained and reviewed (e.g., older records, specialist records, etc.?) Does any information obtained not fit the current diagnosis? Source: Graber M, Sorensen A, Biswas J, Modi V, Wackett A, Johnson S, et al. Developing checklists to prevent diagnostic error in Emergency Room settings. Diagnosis. 2014;1(3): Retrieved from 13

15 Diagnostic checklist Did I read the X-ray myself? Was this patient handed off to me from another provider? Was this patient seen in the ED or clinic recently for the same problem? Was I interrupted/distracted excessively while evaluating this patient? Am I feeling fatigued or cognitively overloaded right now? Is this a patient I don t like for some reason, or like too much (e.g., a friend or relative)? Source: Graber M, Sorensen A, Biswas J, Modi V, Wackett A, Johnson S, et al. Developing checklists to prevent diagnostic error in Emergency Room settings. Diagnosis. 2014;1(3): Retrieved from 14

16 Focus on communication In office-based diagnosis-related claims: Risk mitigation Communication issues among providers occur in 19% of cases Communication issues between providers and patients/families occur in 15% of cases Handoffs Care coordination Consults/referrals Interruptions Hesitation to disclose information Lack of time Poor comprehension Access pertinent diagnostic information via: EHR structure that allows viewing of other providers notes Verbal communication of findings about the patient Review the health record Coordinate care (next steps belong to which provider?) Provide clear patient instructions Assess comprehension (e.g., teach-back method) 15

17 Focus on other risk factors Clinical system failures Lack of or inadequate processes for tracking test results, consults/referrals, and patient follow-up Insufficient maintenance of films from radiology studies Delays in, or failure to, receive test results Lack of established timeframes for follow-up Failure to assign responsibility for follow-up Failure of providers and staff to adhere to established protocols Behavior-related issues Noncompliance with follow-up calls and appointments Nonadherence to treatment plans Seeking other providers due to dissatisfaction with care 16

18 Focus on other risk factors Documentation Insufficient documentation (e.g., failure to document follow-up attempts, failure to document adequate details about the patient encounter or patient care, missing documentation in the patient s health record, etc.) Content-related issues (e.g., altered documentation, opinion stated as fact, copy/paste errors, and general inconsistencies in documentation patterns) Mechanics-related issues (e.g., inaccuracies in transcribing or writing orders, illegibility, delays in documenting, and failure to use an appropriate method for correcting documentation errors and making amendments Administrative issues Lack of staff training and education on office systems and processes Inadequate supervision of clinical and nonclinical staff Failure to verify patient identifiers Failure of clinical staff to contact a doctor when warranted 17

19 Focus on other risk factors Risk mitigation strategies Evaluate organizational processes and timeframes for test tracking, patient follow-up, and referrals/consults to identify gaps and implement safeguards. Ensure that staff and provider training is up to date with current systems and consistent with roles and responsibilities. Evaluate staff and provider competency with clinical systems and ensure appropriate supervision. Verify patient identifiers as part of information management processes. Include a review of clinical systems and administrative functions as part of your practice s quality improvement initiatives. Establish a policy defining the basic rights and responsibilities of each patient. Clearly explain the possible consequences of noncompliance with the agreed-upon treatment plan. Consider patients lifestyles and medication costs when developing treatment plans. 18

20 Focus on other risk factors Risk mitigation strategies Use comprehension techniques (e.g., teach-back) to ensure that patients fully understand information and instructions. Provide verbal and written patient education. Document a description of all clinical noncompliance. Avoid disparaging remarks or editorializing when documenting noncompliant behaviors. Consider using behavior contracts to address problematic patient behaviors. Review documentation policies to determine whether adequate information is being captured and appropriate timeframes for documenting patient care have been established. Ensure that documentation policies address issues unique to EHRs (e.g., copy/paste, form fields, check boxes, etc.) Consider whether documentation supports clinical judgment and decision-making. Understand and educate staff about the appropriate methods for correcting or amending documentation. 19

21 Diagnostic issues around the corner? Genetic testing Cancer, pre/antenatal decisions, rare significant disease EHRs and data volume New technologies Clinical decision support silver bullet? Reliance vs. adoption False positives move from underdiagnosis to overdiagnosis? Artificial intelligence Access mandate for underserved? Telehealth, mobile, wearable technology Informed consent for technical deficiencies Transgender issues Physician/provider burnout 20

22 Disclosure and communication and resolution programs

23 Disclosure vs. admission of liability Disclosure vs. admission of liability Understanding the difference Disclosure and apology I m sorry, Mrs. Jones, but your child became unresponsive and stopped breathing during the procedure. We had to resuscitate her. She is doing fine now, and we are going to closely watch her for the next several hours. Admission of liability I m sorry, Mrs. Smith, but it is my fault that your child became unresponsive during the procedure. I must have given her too much medicine. 22

24 States with apology laws In the United States, 36 states and the District of Columbia have apology laws. Sources: SorryWorks! (n.d.) States with apology laws. Retrieved from te.com/apology-laws-cms-143; National Conference of State Legislatures. (2014, January). Medical professional apologies statutes. Retrieved from 23

25 Disclosure expectations According to ECRI Institute, when an unanticipated outcome occurs, patients and families want a representative from the healthcare organization to: Acknowledge the event truthfully Express empathy Assume responsibility Apologize if an error occurred. (Note: Apology is appropriate only after an investigation has proven a mistake) State that corrective actions will be taken to prevent similar occurrences Source: ECRI Institute. (2012, November). Disclosure of unanticipated outcomes (Supplement A). Healthcare Risk Control, Incident Reporting and Management 5. 24

26 Is honesty always the best policy? Is honesty always the best policy? Error without harm The facts are in the medical record Disclosure can be used as a relationship builder There is a risk in not disclosing Admitting mistakes can be difficult and can force physicians to confront their own perceptions of inadequacy, fallibility, and guilt. It can be easier to avoid acknowledging mistakes, especially when the event or potential error has a perceived minimal or no-harm effect. Source: Chamberlain, C. J., et al. (2012, March). Disclosure of nonharmful medical errors and other events: Duty to disclose. Archives of Surgery, 147(3), Retrieved from 25

27 Full vs. partial disclosure Full vs. partial disclosure Full disclosure includes: Disclosure of all harmful incidents Acknowledgment of responsibility and apology (when a known error has occurred) An explanation of why the event happened How the effects of the event will be mitigated Steps the healthcare provider/organization will take to prevent similar occurrences In a survey of more than 2,600 medical and surgical physicians who were given scenarios depicting serious errors: 56% would partially disclose the event (mention adverse event but not error). 42% would fully disclose the error. 3% would provide no disclosure. Sources: AHRQ, Patient safety primer: Error disclosure; Gallagher, T. H., et al. (2006, August). Choosing your words carefully: How physicians would disclose harmful medical errors to patients. Archives of Internal Medicine, 166(15),

28 Barriers to disclosure Intrapersonal barriers Interpersonal barriers Institutional barriers Societal barriers Tangible sanctions for physicians Healthcare norms and attitudes toward medical error Causal uncertainty surrounding the error trajectory Physician weighing of harms and benefits of disclosure Sources: Perez, B., et al. (2014, March). Understanding the barriers to physician error reporting and disclosure: A systemic approach to a systemic problem. Journal of Patient Safety, 10, 45-51; Entwistle, M., & Kalra, J. (2014, October). Barriers to medical error disclosure: An organizing framework and themes for future research. Austin Journal of Pathology & Laboratory Medicine, 1(2), 6. 27

29 When does the disclosure process begin? Disclosure should begin with the informed consent process. Informed consent is: An opportunity for patients/families to develop reasonable expectations for their treatment results. An excellent reference point to begin the disclosure discussion (e.g., Remember when we discussed the possibility of [x] outcomes? ) Your opportunity to build a strong provider patient relationship, which can support future disclosure discussions. 28

30 Communication of an unanticipated outcome Who? When? Where? What? 29

31 Disclosure: Who should participate? The physician or other practitioner who is primarily responsible for the error or is familiar with the unanticipated outcome A representative from the healthcare practice or hospital, depending on the event Patient and family (consider the patient s desires and federal/state privacy regulations) The person who will be responsible for following up with the patient/family 30

32 Disclosure: When should it happen and where? When As soon as practical following the event As soon as basic facts about the event are known As soon as the patient and/or family is able to receive the message Where A quiet, comfortable room that provides privacy Make sure the room is not scheduled for something else Hang a Do Not Disturb sign on the door 31

33 Sample disclosure timetable 24 hours 48 hours 5 days Event Patient Stabilization Staff Briefing Secure Implicated Drugs, Equipment, Records ID Communicator/ Just-in-Time Training Patient Notice/Apology Patient Support Initiation MedPro Group Notice Billing Hold Analysis of Causation Documentation Patient Support Regulatory Reporting per State Requirements Staff Support 32

34 Disclosure: What should happen? Provide simple, concise facts in layman s terms. Discuss current medical status of the patient and anticipated treatment. Be empathic and offer an apology (if appropriate). Acknowledge that the information currently available is incomplete, and commit to further meetings with the patient/family as more details are known. 33

35 Communication tips Listen carefully and don t interrupt. Identify the emotion(s) observed in the patient/family (e.g., This must be very scary for you. ) Avoid saying: I know how you feel ; OR this is a blessing in disguise ; OR these things just happen. Do not assign blame or point fingers. Do not avoid the patient/family in hopes of avoiding questions. Establish direct eye contact, and sit when possible. Use I instead of we, and speak slowly and clearly. Be brief (avoid the tendency to over-explain). Try to anticipate questions the patient/family may have. 34

36 Disclosure: What else should happen? Solicit feedback from the patient/family throughout the disclosure discussion. Indicate that this can be an ongoing conversation, and provide the patient/family with the name and phone number of a contact person. Ask whether the patient/family has any immediate unmet needs. 35

37 Don t forget Healthcare providers and staff involved in the error or unanticipated outcome may require support counseling. Document the disclosure process, including: The time, date, and place. Who was present. The information that was communicated. The patient s/family s understanding of the event, any questions they had, and the responses given. Who is responsible for follow-up. The plan of action going forward. Stop patient billing until the details of the unanticipated event are analyzed. 36

38 Don t forget Consult your claims or insurance representatives when early resolution is indicated (as it relates to a medical error with damages). A discussion of monetary settlement is not recommended at the first meeting with the patient/family. Avoid absolute statements, such as We ll take care of everything. 37

39 When disclosing, remember... Identify the facts. Use a communication checklist to prepare yourself. Consult your professional liability carrier to review possible indicators for early resolution. Offer support counseling to healthcare providers and staff involved in the event. Saying I m sorry is okay. 38

40 Communication and resolution programs A comprehensive approach to the resolution of potentially compensable events (PCEs) Pioneered at the VA hospital in Lexington, Kentucky Currently in place at: The University of Michigan The University of Illinois Stanford University Several AHRQ-funded demonstration sites 39

41 Communication and resolution program elements Immediate reporting of unanticipated outcomes to risk management staff Rapid investigation and evaluation of the PCE Full disclosure Full apology (if appropriate) Full compensation (if appropriate) 40

42 The University of Illinois Medical Center approach Reporting Investigation Notifying patient safety or risk management personnel about unexpected outcomes involving patient harm Undertaking a rapid, detailed investigation using standard RCA techniques to determine whether an error was made Communication Creating programs for providing ongoing communication with patients/families after an unexpected outcome without regard to the cause of the event Apology and remedy Improvement In the event of an error, providing an apology and an appropriate remedy Linking process improvements identified in the RCA with patient/family involvement Source: Mayer, D., et al. (2011, September 12). Medical error calls for honest disclosure. American Medical News. Retrieved from 41

43 Stanford s PEARL Process for Early Assessment and Resolution of Loss (PEARL) Designed to address significant, unanticipated, or adverse medical outcomes Based on principles of open communication, transparency, and integrity Helps patients understand their care by addressing complex medical concerns in a comprehensive, compassionate, and confidential manner Between 2009 and 2014, Stanford's frequency of malpractice lawsuits dropped by 50% compared with the frequency from 2003 to Further, a 40% decrease occurred in the average cost of individual malpractice claims. Sources: Stanford Children s Health. (n.d.). PEARL: Process for early assessment and resolution program. Retrieved from The Advisory Board. (2016, February 3). How Stanford Hospital cut malpractice lawsuits in half. Retrieved from 42

44 AHRQ s CANDOR AHRQ s CANDOR Communication and Optimal Resolution (CANDOR) A process to help healthcare organizations and providers respond in a timely, thorough, and just way to unanticipated outcomes. Based on expert input and lessons learned from an AHRQ Patient Safety and Medical Liability grant initiative launched in Process and materials tested and applied in 14 hospitals across 3 U.S. health systems. Includes eight different modules that cover topics such as obtaining organizational buy-in; gap analysis; event reporting, investigation, and analysis; response and disclosure; second victim support; resolution; and more. Each module contains PowerPoint slides with facilitator notes. Some modules also contain tools, resources, or videos. Source: Agency for Healthcare Research and Quality. (2016, May). Communication and optimal resolution (CANDOR) toolkit. Retrieved from 43

45 Research: Tennessee health system Study Comparison of liability outcomes before and after collaborative communication resolution program (CRP) implementation at Erlanger Health System Timeframe Overall: ; pre-crp: ; post-crp: Results CRP protocol led to a 66% reduction in legal claims filed, 51% reduction in defense costs, and 53% reduction in the time required to close cases Sources: LeCraw, F. R., Montanera, D., Jackson, J. P., Keys, J. C., Hetzler, D. C., Mroz, T. A. (2018). Changes in liability claims, costs, and resolution times following the introduction of a communication-and-resolution program in Tennessee. Journal of Patient Safety and Risk Management, 23(1), 13-18; PRWeb. (2018, February 16). Another medical study confirms: Transparency, apology by hospitals after adverse medical outcomes sharply reduce litigation costs. Retrieved from 44

46 In summary When done properly, disclosure can reduce the impact of unexpected outcomes on patients AND healthcare providers 45

47 Questions What questions do you have? Thank You! 46

48 MedPro Resources Diagnostic errors: Clinical Judgment in Diagnostic Errors: Let s Think About Thinking Communication in the Diagnostic Process Diagnostic Errors: A Persistent Risk Risk Factors That Contribute to Diagnostic Errors Disclosure: Coping With Stress After an Adverse Patient Outcome Disclosure of Unanticipated Outcome (checklist) Disclosure of Unanticipated Outcomes (guideline) 47

49 Other Resources Clinical Reasoning Toolkit (Society to Improve Diagnosis in Medicine) Communication and Optimal Resolution (CANDOR) (Agency for Healthcare Research and Quality) Communication & Resolution Programs (Collaborative for Accountability and Improvement) Disclosure of Errors (Agency for Healthcare Research and Quality) Improving Diagnosis in Health Care (National Academies of Sciences, Engineering, and Medicine) Malpractice Risks in the Diagnostic Process (CRICO Strategies) Process for Early Assessment, Resolution and Learning (PEARL) (The Risk Authority, Stanford) 48