Ethical Disclosure of Adverse Events to Patients: Clinical & Institutional Guidance

1. Clinical and Institutional Disclosure of Adverse Events to Patients Call 1 of 2 Delivered May 21, 2012updated to reflect directive’s reissue (October 31, 2018) Sponsoring Offices: National Center for Ethics in Health Care Office of Quality, Safety and Value, Risk Management Program

2. Welcome • Slides* from this call, as well from the call on August 6, 2012, (Critical Thinking About Institutional Disclosure of Adverse Events to Patients), are available on these websites: • National Center for Ethics in Health Care http://vaww.ethics.va.gov/index.asp • Office of Quality, Safety, and Value, Risk Management Program 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 ethical basis for disclosure of adverse events to patients. • Identify the features of an adverse event that may require clinical and/or institutional disclosure. • Describe the difference between clinical and institutional disclosure. • Evaluate scenarios to determine whether the adverse events described warrant clinical or institutional disclosure or both. • Describe the responsibilities of VHA facility staff in clinical and institutional disclosure of adverse events to patients.

4. Disclosure of Adverse Events to Patients: Ethical Basis • Patient’s right to know • Professional duty of truth-telling • Respecting patient autonomy • Establishing and maintaining patient trust • Utilitarian ethics: Disclosure produces the greatest balance of benefit over harm • Good for patients • Good for providers • Good for health care organizations

5. Adverse Event (as defined in VHA Directive 1004.08 and VHA Handbook 1050.01) • An adverse event is an untoward incident, diagnostic or therapeutic incident, iatrogenic injury, or other occurrence of harm or potential harm directly associated with care or services delivered by VA providers. • In other words, an adverse event is an adverse occurrence in the patient’s care that was unexpected or unanticipated.

6. Disclosure of Adverse Event (VHA Directive 1004.08) • For the purpose of this directive, the phrase “disclosure of adverse events” refers to the forthright and empathetic discussion of clinically significant facts between providers or other VHA personnel and patients or their personal representatives about the occurrence of a harmful adverse event, or an adverse event that could result in harm in the foreseeable future.

7. Disclosure vs. Reporting of Adverse Events • DISCLOSURE • VHA Directive 1004.08: Disclosure of Adverse Events to Patients • Trigger is unanticipated harm or potential future harm (or event that is perceptible) • Obligation of honesty and respect to specific patients • Disclosure is to patients (or their personal representatives) • REPORTING • VHA Handbook 1050.01: VHA National Patient Safety Improvement • Trigger is an adverse event (that may or may not have caused harm) • Obligation to ensure patient safety and continuously improve the delivery of care in general based on information about the occurrence of an adverse event or close call • Reporting is to oversight bodies, e.g., VHA’s National Center for Patient Safety, regulatory agencies, Joint Commission

8. Types of Disclosure (VHA Directive 1004.08) • Clinical disclosure of adverse events. An informal process for informing patients (or their personal representatives) of harmful adverse events related to the patient’s care. This type of disclosure is considered a routine part of clinical practice. (In general, clinical disclosure should be immediate, and should be carried out by the person involved in the event, such as a nurse, physician, physical therapist, or the like. Clinical disclosure should be documented in CPRS as a normal note, not a templated note). • Institutional disclosure of adverse events. A formal process required in cases resulting in serious injury or death, or those involving reasonably expected serious injury. (A decision that an institutional disclosure is appropriate involves a decision at the facility leadership level and the disclosure is made by facility leadership and others.  Documentation of institutional disclosures in CPRS is made on a templated note). • Large-scale disclosure of adverse events. For adverse events involving multiple patients, collaboration with Department of Veterans Affairs (VA) Central Office is required for evaluation and planning. Decisions regarding large scale disclosure of adverse events are made by the Principal Deputy Under Secretary for Health.

9. Case 1 – Mr. A Mr. A has been in the CLC for over a year. He is not a high-risk for falls but lacks decision-making capacity and is sometimes confused and disoriented. The nurses heard the bed alarm and came in the room and found that the patient had fallen out of bed. He had minor cuts and scrapes, but no serious injury from his fall. Mr. A’s son arrived at Mr. A’s room for a planned visit and found the nurse there with his father.

10. Case 1 – Mr. A Is this an adverse event? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

11. Case 1 – Mr. A Does this adverse event need to be reported? Yes(see Notes section below for answer explanation) b. No c. I don’t know a.

12. Case 1 – Mr. A If I report the adverse event, have I satisfied the disclosure requirement? a. Yes No (see Notes section below for answer explanation) c. I don’t know b.

13. Case 1 – Mr. A Is a disclosure required? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

14. Case 1 – Mr. A What type/s of disclosure is/are required? Clinical (see Notes section below for answer explanation) b. Institutional c. Both clinical and institutional a.

15. Case 1 – Mr. A To whom should the disclosure be made? a. Only the patient, Mr. A b. Only Mr. A’s son Both Mr. A and his son (see Notes section below for answer explanation) d. Mr. A’s surrogate c.

16. Case 1 – Mr. A Is a clinical disclosure required if the patient has no cuts or scrapes from this fall, that is, the patient didn’t suffer even a minor injury? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

17. Question from the Audience Why was the bed alarm on if the patient was not a fall risk? Most newer beds come with a bed alarm, and some cannot be disabled. In addition, the local facility policy may mandate that patients with diminished capacity of any degree must have the alarm activated. These local policies may govern the setting of the alarm.

18. Case 1 – Mr. A Summary Of Teaching Points SUMMARY OF TEACHING POINTS: (1) Reporting and disclosure are separate requirements that are fulfilled separately and that are governed by separate policies. (2) The trigger for disclosure is an adverse event that results in harm (or risk of future harm) to the patient or that has a clinical effect that is perceptible to the patient or others. (3) Clinical disclosure is appropriate for minor harms. (4) If an adverse event results in a minor harm to a patient who lacks decision making capacity, the clinical disclosure should be made to the patient (if the patient is able), a family member(s) involved in the patient’s care, or the patient’s personal representative/surrogate and others desired by the personal representative/surrogate.

19. Case 2 – 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 disorientation. Later, the X-ray showed a hip fracture.

20. Case 2 – Mr. B Is this an adverse event? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

21. Case 2 – Mr. B Does this adverse event need to be reported? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

22. Case 2 – Mr. B If I report the adverse event, have I satisfied the disclosure requirement? a. Yes No (see Notes section below for answer explanation) c. I don’t know b.

23. Case 2 – Mr. B Is a disclosure required? Yes (see Notes section below for answer explanation) b. No c. I don’t know a.

24. Case 2 – Mr. B What type/s of disclosure is/are required? a. Clinical b. Institutional Both clinical and institutional c.

25. Case 2 – Mr. B To whom should the clinical disclosure be made? a. Only the patient, Mr. B b. Only Mr. B’s daughter Both Mr. B and his daughter d. Mr. B’s surrogate c.

26. Case 2 – Mr. B To whom should the institutional disclosure be made? a. Only the patient, Mr. B b. Only Mr. B’s daughter c. Both Mr. B and his daughter Mr. B (if able) and Mr. B’s surrogate/personal representative d.

27. Question from the Audience Q: Why does this need to be disclosed if the nurses did nothing wrong? (Is a disclosure required if the patient’s fall and fracture were not the result of an error?) A: The trigger for disclosure of an adverse event is harm or potential harm to the patient, that is, its effect on the patient. Mr. B sustained a hip fracture, which means that disclosure is required. Although the cause of the adverse event is important for purposes of quality improvement, peer review, liability etc. What is important about the adverse event from the perspective of disclosure is not its cause, but its effect. So, it is not necessary for the patient’s harm to be the result of an error in order for a disclosure to be required.

28. Question from the Audience Q: How would you handle a disclosure if Mr. B (whose decision-making capacity is not in doubt) does not want his daughter notified of the event? A: If you are aware that this patient—who has decision-making capacity—does not want his health information to be shared with a his daughter, then you have an ethical obligation to respect the wishes of the patient.

29. Question from the Audience Q: I heard during the presentation today that we need to do an institutional disclosure when someone has a fracture. Currently we only do Root Cause Analyses (RCA)s on patients who fall, fracture and require surgery. Are we to understand that we need to do an institutional disclosure for all falls with fracture?  A: Remember that the triggers and rationales for disclosure and reporting (and RCAs) are different. The trigger for a disclosure is harm to the patient. In most instances, a patient who sustains a fracture related to a fall would, therefore, require an institutional disclosure. An RCA is conducted to ensure patient safety and continuously improve the delivery of care in general. An institutional disclosure may be required regardless of whether an RCA is required and vice versa. One does not always preclude or necessitate the other.

30. Case 2 – Mr. B Summary Of Teaching Points (1) Reporting and disclosure are separate requirements that are fulfilled separately and that are governed by separate policies. (2) The trigger for disclosure is an adverse event that results in harm (or risk of future harm) to the patient or that has a clinical effect that is perceptible to the patient or others. (3) Not all adverse events are the result of an error. It is not necessary for the patient’s harm to be the result of an error in order for disclosure/s to be required. (4) Disclosure may be a process involving a series of conversations, beginning with a clinical disclosure and, after more facts are known, requiring an institutional disclosure. (5) Institutional disclosure is required for a serious harm. (6) If an adverse event affects a patient whose decision-making capacity is uncertain, the initial clinical disclosure should be made to the patient (if the patient is able) and either a family member(s) involved in the patient’s care or the patient’s personal representative/surrogate and others desired by the personal representative/surrogate. (7) If the patient has decision-making capacity, the institutional disclosure should be provided to the patient and anyone the patient desires.

31. Question from the Audience If the harm that the patient experienced was a known complication of surgery, is it still an adverse event? There may be times when a complication/side effect that was anticipated and discussed in the informed consent process will occur. When such complications/side effects occur, they need to be discussed with the patient (or patient’s representative) as part of ongoing clinical care. In general, an adverse event is an event that was unexpected or unanticipated. Since “disclosure” suggests revealing or exposing information that is otherwise not known, complications/side effects that were discussed in the informed consent process are not considered adverse events that require disclosure under policy, UNLESS the event is deemed to be untoward or preventable. We will discuss this in more detail on our second call on August 6, 2012.

32. For more information • Please access VHA Directive 1004.08: DISCLOSURE OF ADVERSE EVENTS TO PATIENTS at: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8120

33. Course Faculty and Planning Committee National Center for Ethics in Health Care Karen M. Rasmussen, M.D., Chief, Ethics Policy Virginia Ashby Sharpe, Ph.D., Medical Ethicist Samantha Johnson, LSW, 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