DOD/MEDCOM HEALTH CARE LAW SYMPOSIUM

1. DOD/MEDCOM HEALTH CARE LAW SYMPOSIUM September 2014 Barbara I. Moidel Special Assistant for Healthcare Resolutions 301-295-5434 Barbara.i.moidel.civ@mail.mil BB 301-219-8823

2. Military medicine has been at the forefront of transparency following unanticipated/adverse outcomes of care since The Joint Commission disclosure standard was established in July 2001. That same month we instituted a Healthcare Resolutions Program that includes disclosure training for providers, real time disclosure coaching during specific events and a resolution process that seeks equitable resolutions for patients, for providers and for the organization. Transparency has gained tremendous momentum throughout the Military Health System and is supported by the Assistant Secretary of Defense for Health Affairs and Surgeons General of the Army, the Navy and the Air Force. My staff and I remain committed to a culture of transparency, the trust it engenders, the integrity it represents and the value it places on our staff and those we are privileged to serve—our patients. Brigadier General Jeffrey B. Clark Director Walter Reed National Military Medical Center

3. Promote openness and transparency in patient and family – centered care philosophy by learning from events, healing psychologically, showing healthcare’s humanism and working out issues of distrust.

4. YEAR # 14 LESSONS LEARNED • Transparency is always the right thing to do by providers who delivered the care • There is only one truth; no clinical vs. legal truth • Transparency in military medicine is not driven by cost-containment • Transparency is appropriate even when claim is likely to be forthcoming • Transparency drives change; lessons learned are lessons applied. • Venue for resolution option that no other military medicine system addresses. • Resolution process is totally separate from claims system; no compromise • Resolution process is totally separate from Patient Safety/Risk Management/Quality and protects integrity of Title 10 USC 1102; no compromise • Not everyone seeks resolution; repeal Feres

5. Serious preventable injury is a medical emergency with two victims - patient and caregiver ~ Lucian Leape, M.D.

6. “When this first happened, I was out of school for about 2 years. I thought my career was over. I assumed I would not be in this profession any more. I thought I was going to get fired. I remember having to write an incident report about it, talk to the family and get my supervisor involved and it just became a whole day's worth of work. I was totally exhausted. I was totally drained and thought I was going to lose my job. I have this degree and I will never be able to use it again.” Anonymous Quality and Safety in Health Care Journal

7. 2011 INSTITUTE FOR HEALTHCARE IMPROVEMENT WHITE PAPER "Every day, clinical adverse events occur within our health care system, causing physical and psychological harm to one or more patients, their families, staff (including medical staff), the community, and the organization. In the crisis that often emerges, what differentiates organizations, positively or negatively, is their culture of safety; the role of the board of trustees and executive leadership; advanced planning for such an event; the balanced prioritization of the needs of the patient, family, staff, and organization; and how actions immediately and over time address integrated elements of empathy, disclosure, support (including reimbursement), assessment, resolution (including compensation), learning, and improvement. The risks of not responding to these adverse events in a timely and effective manner are significant, and include loss of trust, absence of healing, no learning and improvement, the sending of mixed messages about what is really important to the organization, increased likelihood of regulatory action or lawsuits, and challenges by the media."

8. TRUTHS • “Patients will often forgive honest mistakes when they’re disclosed promptly, fully and compassionately “ • “They become enraged when they think they’re being stone walled. Even with serious errors, when a lawsuit may be inevitable, disclosure and apology is still the best course of action. It can mitigate the patients anger. It demonstrates that you had the patient’s best interests at heart. • An appropriate apology doesn’t mean admitting liability.

9. PROGRAM OVERVIEW • Early intervention process at time of service delivery; prior to claims being filed • Non-legal venue to resolve healthcare issues following unexpected outcomes of care or quality of care concerns. Unanticipated outcome triggers our involvement. • Does not exist to prevent claims yet provides an alternative resolution process; patients retain legal rights. Withdraw if a claim is filed

10. PROGRAM OVERVIEW • Separate from Patient Safety/Risk Management/Quality in managing adverse medical events to preserve integrity of 10 USC 1102 • Separate from Staff Judge Advocate, Customer Service/Patient Relations • Serve as Special Assistant to the Director and Chief of Staff to maintain autonomy and neutrality • 24/7 availability

11. PROGRAM FUNCTIONS • Assists organization in “doing the right thing” when there are unanticipated outcomes of care, treatment and/or services • Promotes organizational transparency and integrity with full disclosure, recognition of system vulnerabilities and a commitment to process improvements • Resolves complex healthcare issues and disputes starting at the time of service delivery, in a neutral setting, with equitable resolutions for patients, providers and the organization

12. PROGRAM FUNCTIONS • Provides disclosure training and coaching for medical staff, ensuring compliance with The Joint Commission standard RI 01.02.01 and hospital policy; respect boundaries of Title10 USC 1102 • Provides training on patient-centered communication. • Opportunity to restore trust following adverse outcomes, preserve patient/provider relationship • Support providers following unanticipated outcomes of care; providers are second victims • Conducts mediation sessions surfacing issues from all parties to facilitate resolutions; stays involved from disclosure through case resolution.

13. ADVERSE EVENT MANAGEMENT SAFETY HEALTHCARE QUALITY RESOLUTIONS RISK ADVERSE MEDICAL EVENTS UNANTICIPATED OUTCOMES QUALITY OF CARE CONCERNS

14. REFERRAL ISSUES • Disclosure issues – coaching, follow-up, maintain open communication • Unanticipated outcomes of care • Delayed diagnosis/misdiagnosis • Medical/medication errors • Sentinel events/wrong site/wrong patient procedures • Elevation of care caused by hospital/nosocomial infections • Expected or unexpected deaths • Patient dissatisfaction with treatment outcomes or quality of care • Poor patient-provider interaction/communication • Appropriate patient disengagement without abandoning patient care • Follow up patients who leave AMA Early referral is the key!

15. ADVANTAGES OF DISCLOSURE Patients strongly support the disclosure of unanticipated outcomes, especially those due to medical errors. Patients want to know about errors even when the harm is minor, and to be told the facts concerning the event; they want a full explanation and an apology. In the aftermath of an unanticipated outcome due to error, patients want acknowledgement of their pain and suffering and reassurances that steps will be taken to prevent the error from happening again. www.anesthesia-analgesia.org 2012

16. The only risk greater than disclosure… is the risk to know something and not disclose it.

17. DO NOT DISCLOSE • Disciplinary actions • Peer review materials • Results of root cause analysis or quality assurance reviews • Morbidity and mortality conference proceedings • Information protected by Title 10 USC 1102. • Refrain from admission of personal or institutional liability. • Do not say: There was negligence. We are liable Standard of care was not met. Military medicine should compensate you. • Patients may inquire about whether or not a review is being conducted.

18. Apologizing may assuage the patient’s feelings of anger by subtracting the insult from the injury and it may also ease the physician’s feelings of guilt for causing harm. Annals of Emergency Medicine 2006

19. DEFINITION OF SECOND VICTIMS "Second victims are healthcare providers who are involved in an unanticipated adverse patient event, in a medical error and/or a patient related injury and become victimized in the sense that the provider is traumatized by the event. Frequently, these individuals feel personally responsible for the patient outcome. Many feel as though they have failed the patient, second guessing their clinical skills, knowledge base and career choice." • Excellent clinicians may leave the profession prematurely when involved in a preventable error. These are often career-jolting events, causing a devastating personal and professional toll similar to posttraumatic stress disorder. • Second victim phenomenon may be described as life-altering, leaving a permanent imprint on involved providers. * MAKING AN ERROR THAT HARMS A PATIENT MAY BE THE GREATEST DISTRESS THAT CLINICIANS EXPERIENCE, THEIR DARKEST HOUR * Providers may recall meticulous details of these events years later * Often affects subsequent patient care as they may be depressed and are likely to make additional errors (third victim)

20. COORDINATION WITH THE STAFF JUDGE ADVOCATE • Briefs the Staff Judge Advocate on healthcare cases of concern. • SJA serves in an advisory capacity. • Potential claims against the government that come to our awareness are reported to legal counsel. • SJA is consulted in the event that acceptance of specific cases may be questionable. • SJA shall review all written correspondence prepared by Healthcare Resolutions. • Refer any written correspondence prepared by providers. • Notify SJA if patient retains legal counsel. • Patients retain the integrity of their legal rights. • Any subpoenas related to services of Healthcare Resolutions are referred to SJA. • No attorneys participate in disclosure or mediation sessions. • Healthcare Resolutions is not authorized to intervene once a claim has been filed.

21. COORDINATION WITH PATIENT SAFETY/RISK/QUALITY • No information is soughtfrom Patient Safety/Risk/Quality reviews. • Event reporting to Healthcare Resolutions may be through providers and should not be directly from the Patient Safety/Risk Management staff. • Healthcare Resolutions does not make any determination regarding negligence, medical error or any breach in standard of care. There is no direct reporting to Professional Affairs. • No PSR’s are completed by Healthcare Resolutions. • Provide one-way venue for input from patients to Quality

22. CONFIDENTIALITY • NEUTRALITY • DISCOVERABILITY • DOCUMENTATION /CASE FILES • PERSONAL WORKING NOTES • SHREDDING • SIGNED AGREEMENTS • PATIENTS WITH LEGAL COUNSEL • CLAIMS • SUBPOENA

23. OFFICE MANAGEMENT PRACTICES Refrain from: • Accepting legal or service of process notice for organization • Obtaining signed waivers or confidentiality statements • Maintaining individual case files (keep personal working notes only) • Obtaining written statements from providers • Referring to peer review • Being involved with QA reviews or securing copies of any documentation protected by Title 10 USC 1102 • Attending morbidity and mortality conferences, Quality Council, Patient Safety forums.

24. OFFICE MANAGEMENT PRACTICES Refrain from (continued): • Documenting in medical record • Writing case reports • Tape recording of sessions • Including legal counsel in sessions (patient's or hospital's) • Drafting policy with the exception of disclosure policy • Engaging with attorneys of patients

25. RATIONALE FOR OFFICE MANAGEMENT PRACTICES • No providers would engage with us if we maintained discoverable files • Program involvement is exclusively upon resolution process based upon facts of the case. We have no independent knowledge, do not conduct a risk analysis and do not draw conclusions regarding standard of care, medical error, negligence, malpractice or liability • Legal initially wanted program placed under Quality with 1102 protection; however, there would be no opportunity for open communication and potential resolution. Office practices were determined by Legal • We have no independent medical information.

26. RATIONALE FOR OFFICE MANAGEMENT PRACTICES • We do not conduct discovery for Legal, Risk or Quality • We do not establish or maintain any official system of government records • Neutrality - while working for the government , “neutrality” is evidenced by ensuring that the resolution process is fair for patients and families, for providers and for the organization. We are neutral to the dispute. • Not neutral to attempt to prevent claims • Not neutral to collate discoverable documents • Could not have access to providers, medical records or process owners if we did not work for the government/hospital. Providers would not trust us.

27. PROGRAM GROWTH SINCE 2012 PRESENTATION • Healthcare Resolutions Program was incorporated into the Department of Defense Manual, 6025.13, Medical Quality Assurance and Clinical Quality Management in the Military Health System. • Four of eight healthcare resolutions specialists are DOD employees • Disclosure training has been conducted at eight Army Medicine medical treatment facilities • Second cycle of disclosure training is scheduled at ten Air Force medical treatment facilities • Air Force has proposed hiring four healthcare resolutions specialists • Army has proposed hiring five healthcare resolutions specialists • Disclosure training presented to The Joint Commission Quality Improvement Program, February 2014

28. PROGRAM IMPACT/OUTCOMES • Opportunity to achieve resolution for patients and providers to complex healthcare needs • Skilled communicator in adversarial situations with acknowledgement of value of personal relationships, effective communication, sharing emotions • Opportunity to restore trust following adverse outcomes; preservation of patient/provider relationship; lessons learned/applied from cases • Organization shows integrity and respect to patients and public: promotes culture of full disclosure • Provider support following unanticipated outcomes of care • Providers meet professional, moral, ethical obligations via disclosure. • Information-sharing of meaningful feedback while protecting quality assurance process

29. CURRENT LOCATIONS FOR HEALTHCARE RESOLUTIONS PROGRAM • Walter Reed National Military Medical Center • Fort Belvoir Community Hospital • Naval Medical Center Portsmouth • Naval Medical Center San Diego • Naval Hospital Jacksonville • Naval Hospital Okinawa • Current Hiring action: • Travis Air Force Base • Army anticipates hiring five healthcare resolutions specialists • Air Force anticipates hiring four healthcare resolutions specialists

30. Barbara I. Moidel Special Assistant for Healthcare Resolutions 301-295-5434 Barbara.i.moidel.civ@mail.mil BB 301-219-8823