Sponsoring Offices: National Center for Ethics in Health Care

1. Critical Thinking about Institutional Disclosure of Adverse Events to Patients August 6, 2012 (Call 2 of 2) Sponsoring Offices: National Center for Ethics in Health Care Office of Quality, Safety and Value, Risk Management Program

2. Welcome • Materials from this call as well as the call from May 21, 2012 (Clinical and Institutional Disclosure of Adverse Events) are available on these websites: • National Center for Ethics in Health Care (slides only) http://vaww.ethics.va.gov/index.asp • Office of Quality, Safety, and Value, Risk Management Program (slides and audio) http://vaww.oqsv.med.va.gov/functions/mindfulness/rm/rmLearning.aspx

3. Learning Objectives After participating in this conference, the participant will be able to: • Identify the trigger for institutional disclosure of adverse events to patients • Describe the responsibilities of VHA facility staff and leadership in institutional disclosure of adverse events to patients • Discuss the format of an institutional disclosure meeting with a patient (or personal representative/family) • Evaluate scenarios to determine whether the adverse events described warrant institutional disclosure

4. Questions Carried Over from theMay 21, 2012 Call

5. Do harmful adverse events require both a clinical disclosure and an institutional disclosure? • Depends on the nature and circumstances of the event • Disclosure may involve a series of conversations • The trigger for disclosure is harm to the patient resulting from an adverse event • Institutional disclosure: serious harm to the patient, or potentially serious harm. • May involve multiple conversations • Clinical disclosure: minor harm to the patient • May be the first step in a process which might result in institutional disclosure after more information is discovered • Some adverse events may only warrant a clinical disclosure, while others, in which the patient sustained a serious harm, may involve both a clinical and institutional disclosure, or only an institutional disclosure

6. Do you have to wait for the findings of an investigation to conduct an Institutional Disclosure? • No. Facility leadership should not wait to find out the results of the review or investigation before proceeding with the disclosure • Institutional disclosure must be initiated as soon as reasonably possible generally within 24 hours to 72 hours • The patient and family can be informed that a review or investigation of the circumstances is ongoing • Conducting an investigation is important to understand what happened and to prevent it from happening again • What is important about the adverse event from the perspective of disclosure is not its cause, but its effect on the patient

7. Disclosure of Adverse Event (VHA Handbook 1004.08*) • An institutional disclosure is a formal process in which organizational leaders (Director, Chief of Staff, and/or Nurse Executive) disclose adverse events that have resulted in serious injury or death to the patient, or those involving reasonably expected serious injury • A patient’s personal representative is any person(s) who, under applicable law, has the authority to act on behalf of the individual when making decisions related to health care or to act on behalf of a deceased individual • Has the ability to exercise the individual’s rights • A personal representative is usually but not always the patient’s surrogate for the informed consent . (See VHA Handbook 1605.01 for details on personal representatives)

8. Disclosure vs. Reporting • Requirements regarding clinical adverse event and close call reporting • VHA Handbook 1050.01: VHA NATIONAL PATIENT SAFETY IMPROVEMENT • “Reporting” an adverse event (or close call) means communicating information up the chain of command through incident reporting. • Requirements regarding clinical adverse event disclosure • VHA Handbook 1004.08: DISCLOSURE OF ADVERSE EVENTS TO PATIENTS* • “Disclosure” of an adverse event means communicating information to the patient (or the patient’s personal representative and/or family members)

9. Communicating Information About a Serious Adverse Event to Facility Leadership • Incident reporting is the mechanism by which providers and others inform facility leadership that an adverse event has occurred. • Facility staff must understand the local incident reporting process • If staff are unsure about the about the process, or unsure whether an occurrence warrants reporting, they should bring the issue to their supervisor

10. Steps in the Institutional Disclosure Process • The adverse event occurs • Staff complete an incident report and/or communicate information about incident to supervisor or facility leadership • Facility leadership consult with Regional Counsel • Regional Counsel and facility leadership address: • What information is to be communicated in the disclosure • Who will communicate the information • How the information will be communicated • Note: Facility leadership, not Regional Counsel, ultimately decides whether institutional disclosure is necessary • Institutional leaders authorize the disclosure • The Risk Manager often coordinates the meeting arrangements between facility leadership and patient/personal representative, and extends the invitation

11. Steps in the Institutional Disclosure Process • The setting should be a quiet, private place, with adequate time and no interruptions • The provider may or may not be present (this is a local determination) • Request by the patient/family to bring an attorney must be honored • Facility leadership should offer • an apology • an explanation of the facts to the extent that they are known • One person, usually the Risk Manager or Quality Manager is designated to document the institutional disclosure in the dedicated CPRS note template

12. Case 1 – Mr. B While getting out of bed with the nurse’s assistance following a hernia repair, Mr. B fell to the floor. Other than the hernia, he has been in good health and was not at risk for falls. The nurse called for assistance and she and another nurse placed the patient back on his bed. As the nurses were readying Mr. B for transport to X-ray, Mr. B’s daughter arrived at Mr. B’s room for a planned visit. She found the nurses there with her father, who was now showing signs of pain and agitation. Later, the X-ray showed a hip fracture.

13. Case 1, Question 1 To whom should the institutional disclosure be made? a. Mr. B’s daughter b. Mr. B’s personal representative c. Mr. B Mr. B and anyone he would like to include (see Notes section below for answer explanation) e. The event should only be reported in an incident report d.

14. Case 1, Question 2 Who should conduct the institutional disclosure? a. The attending physician after consultation with Regional Counsel b. The nurses Facility leadership after consultation with Regional Counsel (see Notes section below for answer explanation) d. The nurses and attending physician c.

15. Case 1, Question 3 During the pre-disclosure consultation with Regional Counsel, facility leadership should address: a. What information is to be communicated in the disclosure b. Who will communicate the information c. How the information will be communicated All of the above (see Notes section below for answer explanation) d.

16. Case 1, Question 4 Should an apology be offered during the institutional disclosure? a. No Yes (see Notes section below for answer explanation) c. I don’t know b.

17. Questions from the Audience?

18. Question from the Audience In addition to an apology, what other information should be provided to the patient during an institutional disclosure? •  An outline of treatment options. • Arrangements for a second opinion, additional monitoring, expediting clinical consultations, bereavement support, or whatever might be appropriate depending on the adverse event. • Notification that the patient or personal representative has the option of obtaining outside legal advice for further guidance. • Information to ensure that the patient or their personal representatives are made aware of their rights under 38 U.S.C. Section 1151 claims as well as the federal tort claim process and provided the SF-95 claim form. • The patient or personal representative should be told that information about their right to file a claim is not a guarantee of payment or a successful lawsuit • Contact information for follow-up or ongoing conversations.

19. Question from the Audience Why is the Risk Manager doing the documentation? Why not someone from Leadership? • It is not a requirement that the Risk Manager complete the documentation. • Facility leadership should decide who they want to complete the documentation of the institutional disclosure. • In many facilities, leadership has assigned the Risk Manager with the responsibility to document.

20. Question from the Audience Must an institutional disclosure by conducted for all inpatient falls with fractures? • In VHA, we have an ethical obligation to disclose adverse events that harm the patient. • As noted in a 2008 book chapter on “Fall and Injury Prevention” in Patient Safety and Quality: An Evidence-Based Handbook for Nurses, “Traditional hospital-based incident reports deem all inpatient falls to be avoidable, and therefore falls are classified as adverse events. Indeed, falls are the most frequently reported adverse events in the adult inpatient setting.” • According to VHA Patient Safety Handbook (1050.01), falls are identified as some of the more common adverse events that require reporting and Aggregated Review • The need for institutional disclosure in falls with fracture should be determined on a case-by-case basis, but an inpatient who falls and sustains a facture (which is a serious harm), should, in most cases, receive an institutional disclosure. • VHA has a responsibility to maintain a safe environment for patients within its jurisdiction and it is not necessary for the patient’s harm to be a result of an error in order for a disclosure to be required.

21. Question from the Audience Why would we provide an SF-95 claim form if the patient just had an accident – independently fell – and no provider was at fault? • The purpose is to meet our ethical obligation. • To meet our ethical obligation, we also need to inform the patient about their right to bring a legal claim. • Inpatient falls with fractures are not always open and shut cases and it isn’t the provider’s decision to make a legal judgment. • When the patient suffers a serious harm, we owe the patient information about that happened, why we think it happened, and their right to submit a claim.

22. Question from the Audience What about hospital acquired infections – do they require institutional disclosure? • As with inpatients falls, the need for institutional disclosure in hospital acquired infections is determined on a case-by-case basis. • The trigger for an institutional disclosure is an adverse event that caused serious harm to the patient. • In most cases, if those two criteria are met, in the case of a hospital acquired infection, then the situation would likely warrant an institutional disclosure.

23. Case 1 – TEACHING POINTS • Institutional disclosure is an ethical obligation that we have to patients who are seriously harmed as a result of an adverse event related to their VA care. • Institutional disclosure is a formal process conducted by institutional leaders. • After an adverse event, an incident report should be provided to facility leadership through local processes. • Prior to any institutional disclosure, facility leadership should consult with Regional Counsel. • During a pre-disclosure consultation with Regional Counsel, facility leadership addresses: • What information is to be communicated in the disclosure • Who will communicate the information • How the information will be communicated • If the patient has decision-making capacity, the institutional disclosure should be made to the patient and anyone else the patient chooses to include. • During the institutional disclosure, facility leadership should offer an apology including an explanation of the facts to the extent that they are known. • In most instances, an inpatient who falls and sustains a fracture – which is a serious harm – should, in most cases, receive an institutional disclosure.

24. Case 2 – Ms. D (Part 1) During the informed consent discussion for decompressive laminectomy and cervical thoracic fusion C3-T5, the surgeon described the risks, benefits, and alternatives of the recommended surgery to Ms. D. Among those risks were common complications such as post-operative neck swelling, and rare complications such as death. Ms. D consented to the recommended surgery and developed post-operative neck swelling that required re-intubation to protect her airway.

25. Case 2, Question 1 What type of disclosure is required as a result of the post-operative neck swelling? a. Clinical b. Institutional c. Both clinical and institutional None (see Notes section below for answer explanation) e. I don’t know d.

26. Case 2 – Ms. D (Part 2) Despite appropriate management, Ms D’s neck swelling worsens and she dies. Autopsy reveals a nicked artery.

27. Case 2, Question 2 Is institutional disclosure required as a result of the patient’s death? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

28. Case 2, Question 3 Is institutional disclosure required for every surgical death? a. Yes No (see Notes section below for answer explanation) c. I don’t know b.

29. Case 2, Question 4 Why is Regional Counsel involved in institutional disclosures? a. To provide counsel to the patient/personal representative/family To advise facility leadership regarding legal implications of the adverse event (see Notes section below for answer explanation) c. To provide counsel to the surgeon d. All of the above b.

30. Case 2, Question 5 Does VHA policy require the provider to be present at the institutional disclosure meeting? a. Yes No (see Notes section below for answer explanation) d. I don’t know b.

31. Case 2, Question 6 Institutional disclosures must be documented using the dedicated CPRS note template? True (see Notes section below for answer explanation) b. False c. I don’t know a.

32. Institutional Disclosure of Adverse Event Note Template (1004.08 , Appendix A)

33. Questions from the Audience?

34. Question from the Audience Can we use the CPRS template to document both clinical and institutional disclosures? • In VHA Handbook 1004.08 (issued October 2, 2012) there is a new requirement that the CPRS template be used only for institutional disclosure. • The Handbook explains that facilities are not required to establish a “template” note or a note title for documenting clinical disclosures. • Requiring documentation of clinical disclosure for all minor events would create a barrier to making such disclosures as a part of routine practice. • As a general rule, documentation of a clinical disclosure is required when harm is more than minor, as evidenced by the face that an incident report or local equivalent has been created. That documentation can be done in a progress note as part of routine care.

35. Question from the Audience How can we get Regional Counsel on board with institutional disclosure? They often say “don’t disclose” when the facility wants to disclose. • The decision to make an institutional disclosure is a leadership decision • Role of Regional Counsel is in an advisory capacity – they are not the decision makers. • There should be consultation with Regional Counsel and then leadership ultimately makes the determination as to whether they have a professional, clinical, and ethical obligation to disclose. • The decision to disclosure should not be based on whether there may be legal exposure for the medical center is the patient files a claim.

36. Question from the Audience Regarding the need for re-intubation in the case of the post-operative neck swelling, is documentation of the discussion (rather than disclosure) as part of ongoing care required? • Documentation of the discussion would fall into the usual documentation of any kind of progress note where the practitioner documents the treatment plan and the conversation that occurred with the patient regarding that treatment plan • Documentation of that conversation is not part of the requirements of the Disclosure of Adverse Events to Patients policy

37. Question from the Audience Does leadership know they are to be involved in institutional disclosures? • Responsibilities for leadership involvement are laid out in national policy in VHA Handbook 1004.08, Disclosure of Adverse Events to Patients. • Bring the policy to their attention or consult with your IntegratedEthics Council.

38. Question from the Audience Can the Risk Manager discuss an adverse event investigation with the patient, patient’s personal representative or family? • The Risk Manager or organizational leaders should engage in ongoing communication with the patient or personal representative to keep them apprised, as appropriate, of information that emerges from investigation of the facts of the adverse event. • Documents that are considered protected, such as RCAs and Peer Reviews, cannot be disclosed. • The Risk Manager may provide the results of an Administrative Board of Investigation (AIB), but should contact the VA Freedom of Information Act (FOIA) officer before releasing any documents related to an AIB.

39. Question from the Audience Is there a quota for institutional disclosures that VACO expects a facility to meet? Having a quote seems to send the wrong message when the goal is to work really hard to prevent and reduce harmful adverse events. • No, there is not an expected quote that you should aspire to reach. There is no reason to believe that a quota could be accurate or useful. It would likely be counterproductive. • It does seem unusual that many facilities, especially the clinically complex 1a and 1b facilities, have been able to go one or more fiscal years without having an event in which a patient sustained farm of the level that would warrant institutional disclosure. • If institutional disclosures that should be made are not being made, there may be two contributing factors: underreporting of incidents (information about adverse events that cause serious harm is not getting to leadership) OR facilities are setting the threshold for institutional disclosure so high that clinical disclosures are being used for adverse events that cause minor as well as serious harm.

40. Question from the Audience Response to quota question continued • To address under-reporting, staff need to understand that the terms “adverse event,” “error,” and “harm” are not synonymous. Staff should be encouraged to report all adverse events that have resulted in a serious or potentially serious harm – while recognizing that not all adverse events are the result of errors, not all adverse events cause harm to the patient, and not all patient harm is the result of adverse events. • A recent comprehensive report published by the DHHS OIG reviewing adverse event reporting practices in hospitals in 25 states and the District of Columbia identified significant underreporting of adverse events – showing that this problem is not unique to VA. • The OIG noted that nearly all of the unreported events went undetected by internal hospital reporting systems, suggesting “the low rate of reporting to State adverse event reporting systems is due largely to hospital staff not identifying incidents of harm as reportable events.” We do not know if this finding is transferable to our VA health care systems, but we do not believe facility leadership should assume that the absence of reporting always indicates the absence of harmful events. [Summarized from DHHS OIG Report – Hospital Incident Reporting Systems Do Not Capture Most Patient Harm, Jan 2012] • Institutional disclosure is an ethical obligation that we have to patients who are seriously harmed as a result of an adverse event related to their VA care. We fail in our obligation if we hide information about adverse events or errors or purposely set the threshold for disclosure so high as to avoid liability.

41. Question from the Audience How detailed do you have to be when arranging an institutional disclosure meeting? The patient or family always want to know what is the meeting is about. • Explain that there is something important that you need to discuss and that a face-to-face discussion would be better. • If the patient or family has no idea as to what the meeting will be about, give enough information to make the patient and/or family feel comfortable and so they can understand why they need to meet face-to-face. • Don’t give all of the details. • You don’t want to give the institutional disclosure over the phone.

42. Question from the Audience What is the role of the Risk Manager in an institutional disclosure? • The Risk Manager is present during an institutional disclosure meeting to answer any questions that the patient/personal representative /family has about the tort claim process. • The Risk Manager cannot recommend an attorney or fill out the SF-95 claim form. • The Risk Manager cannot recommend that the patient’s representative file a claim.

43. Case 2 – TEACHING POINTS • Complications that were discussed in the informed consent process are generally not considered adverse events that require disclosure UNLESS analysis of the event determines that the complication was untoward or preventable. • Institutional disclosure is an ethical obligation that we have to patients who are seriously harmed as a result of an adverse event related to their VA care. • If a patient has died as the result of an adverse event, the institutional disclosure should be made to the patient’s personal representative and others desired by the personal representative. • The need for institutional disclosure should be determined on a case-by-case basis by facility leadership based on whether there has been an adverse event, whether the patient experienced harm from the adverse event, and the seriousness of the harm. • Regional Counsel represents the government, not the patient, the patient’s representative or the provider. • The CPRS Institutional Disclosure of Adverse Event Note Template must be used to document institutional disclosure. • Risk managers need to understand their role in institutional disclosure and what information may and may not be provided to the patient/personal representative/family.

44. For more information: • Please access VHA Handbook 1004.08: DISCLOSURE OF ADVERSE EVENTS TO PATIENTS at: http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2800

45. Course Faculty & Planning Committee National Center for Ethics in Health Care Karen M. Rasmussen, MD, Chief, Ethics Policy Virginia Ashby Sharpe, PhD, Medical Ethicist Samantha Johnson, MSW, LICSW, MBE, Ethics Policy Specialist Office of Quality, Safety and Value Yuri N. Walker, RN, JD, MPH, Director, Risk Management Program Karen Maudlin BSN, MS, LHRM, VHA-CM, Health Systems Specialist Barbara Rose, PhD, RN, Clinical Program Specialist, Risk Management Lisa Stiles, RN, MA, CPHRM, Clinical Program Specialist, Risk Management Employee Education System Constance Singleton, Project Manager Derek Pringle, Program Support Assistant Shannon Trammell, Program Support Assistant