New York State Task Force on Life & the Law

1. New York State Task Force on Life & the Law

2. Ventilator Shortage in a Pandemic • Overview • Most severe scenario • Too few ventilators for patients • Too few staff for more ventilators • Rationing of ventilators needed • Ethical Framework for Allocation • Clinical Algorithm New York State Task Force on Life & the Law

3. Rationing: Ethical Implications • Limits patient autonomy • Limits physician autonomy • Doctor’s obligation to patient or to group? • Threat to doctor-patient relationship New York State Task Force on Life & the Law

4. Ethical Framework: • Allocation in Mass Casualty Scenarios • Duty to Care • Duty to Steward Resources • Duty to Plan • Transparency • Justice New York State Task Force on Life & the Law

5. Duty to Care • Clinician must care for individual patient • Autonomy not decisive factor • Palliative Care New York State Task Force on Life & the Law

6. Duty to Steward Resources • Disaster = Scarcity • Survival for greatest number • Three systems of prioritizing allocation • First come, first served • Most vulnerable • Best balance of resource use and survival New York State Task Force on Life & the Law

7. Duty to Plan • Predictable emergency • Government’s and health care system’s obligation to healthcare professionals and community • Lack of planning creates vulnerability for front-line providers • Flawed plan versus no plan New York State Task Force on Life & the Law

8. Transparency • Public communication • Disaster care different • Patient preference does not determine withdrawal or withholding of care • Objective criteria guide patients and professionals New York State Task Force on Life & the Law

9. Justice • Objective clinical criteria • Applied broadly and evenly • No differential access for special groups • No discrimination based on age, diagnosis ethnicity, perceived quality of life, or ability to pay New York State Task Force on Life & the Law

10. Triage Process •      Pre-triage requirements •      Patient categories •      Facilities •      Clinical Algorithm •      Triage decision-makers •      Palliative care •      Communication New York State Task Force on Life & the Law

11. Pre-triage Requirements • Decrease ventilator need • Elective surgery, preventive care • Increase vent supply • Stockpile • Collaborative arrangements • Use of OR, transport, additional vents New York State Task Force on Life & the Law

12. Patient Categories • Algorithm applies to all acute care patients • Not flu only • Includes patients on ventilator when triage starts New York State Task Force on Life & the Law

13. Patient Categories • No special priority for ventilators for health care workers or first responders • Group includes: • Allied HCW, EMT, Fire, Police • Home care, family caregivers • Return to work in pandemic unlikely • Assigning special access for this large group might mean: • Limited resources for community • Limited resources for children New York State Task Force on Life & the Law

14. Acute Care Facilities: • Triggering Triage • Pre-triage steps triggered in collaboration with public health authorities • Triage algorithm triggered with public health authorities • Regional differences in pandemic mean triage triggered only where and when needed • Coordinated end of triage after pandemic New York State Task Force on Life & the Law

15. Chronic Care Facilities • Balance protection for vulnerable patients with stewardship of resources • Many chronic patients likely to fail triage criteria • Not subject to acute care triage criteria • Patients who transfer into acute hospital subject to triage • Chronic care facilities to supply aspects of acute care in pandemic New York State Task Force on Life & the Law

16. Clinical Algorithm • Adapted from Ontario guidelines, 2006 • Only triggered when need overwhelms supply • Ventilator access based on patient’s score, objective criteria • NOT based on comparison to next patient • Ventilator treatment for timed period with periodic review New York State Task Force on Life & the Law

17. Clinical Evaluation • Objective, clear, easily measured criteria • Rule-in: severe respiratory compromise • Rule-out: end-stage illness Exclusion Criteria for Ventilator Access* ·Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrest ·Metastatic malignancy with poor prognosis ·Severe burn: body surface area >40%, severe inhalation injury ·End-stage organ failure: oCardiac: NY Heart Association class III or IV oPulmonary: severe chronic lung disease with FEV1** < 25% oHepatic: MELD*** score > 20 oRenal: dialysis dependent oNeurologic: severe, irreversible neurologic event/condition with high expected mortality *Adapted from OHPIP guidelines ** Forced Expiratory Volume in 1 second, a measure of lung function *** Model of End-stage Liver Disease New York State Task Force on Life & the Law

18. Measuring Clinical Status • SOFA criteria • Non-proprietary • Simple, reproducible • Evidentiary basis for estimating mortality • Points added based on objective measures of function in six key organs and systems: lungs, liver, brain, kidneys, blood clotting, and blood pressure New York State Task Force on Life & the Law

19. SOFA Scoring • Range from 0 -24 • 0 is the best possible score; 24 is the worst • Milestone Scores • < 7 gains access • > 11 denied access New York State Task Force on Life & the Law

20. Ventilator Time Trials • Initial Assessment • 48 hour Assessment • 120 hour Assessment • Patients may lose access to ventilators and other critical care resources if their SOFA score increases. • Patients may lose access if SOFA scores fail to improve within the allocated period. New York State Task Force on Life & the Law

21. New York State Task Force on Life & the Law

22. New York State Task Force on Life & the Law

23. New York State Task Force on Life & the Law

24. Case 1: Meets Triage Criteria • 58 year old man with asthma, weight 260 • Two day history fever, chills, cough, lethargy • Six hours increasing respiratory distress, waxing/waning mental status, temperature 103.6 • SOFA score: 6 New York State Task Force on Life & the Law

25. Case 2: Does NOT Meet Triage Criteria • 62 year old woman admitted with acute MI, CHF, drug-resistant pneumonia, acute renal failure requiring dialysis, ventilated 4 days • SOFA score: 12 New York State Task Force on Life & the Law

26. Triage Decision-making • Time trials, objective clinical criteria • Primary clinicians care for patients • Triage decisions made by triage officers • Role sequestration for decision-makers, clinicians New York State Task Force on Life & the Law

27. Palliative Care • Triage, not abandonment • Policies for end-of-life care • Continue non-ventilator treatments New York State Task Force on Life & the Law

28. Review of Triage Decisions • Option 1: • Appeals process • Separate team from triage • Health care professionals, additional expertise • Case by case review of decisions • Decision delayed during appeal New York State Task Force on Life & the Law

29. Review of Triage Decisions • Option 2 • Daily review of triage decisions • Different triage officer from decision maker • Maintains consistency, fairness • Prevents “gaming” of system • Permits monitoring of number, type of triage decisions New York State Task Force on Life & the Law

30. Liability • Altered standard of care for mass casualty • Government and professional support • Malpractice threat • Regulatory option • Legislative option New York State Task Force on Life & the Law

31. Conclusion • Guidelines address worst case scenario • Not possible to design system which preserves all lives • Draft guidelines • Comments invited • Goal is to revise and reissue New York State Task Force on Life & the Law

32. Sources • Ontario Health Plan for an Influenza Pandemic (OHPIP) Working Group on Adult Critical Care Admission, Discharge, and Triage Criteria, “Critical Care During a Pandemic,” April 2006. Available at http://www.health.gov.on.ca/english/providers/program/emu/pan_flu/flusurge.html. • Ferreira Fl, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001; 286(14): 1754-1758. • J. L. Hick, D. T. O’Laughlin, “Concept of Operations for Triage of Mechanical Ventilation in an Epidemic,” Academic Emergency Medicine, 2006;3(2):223-229. • University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group, “Stand on Guard for Thee: Ethical considerations in preparedness planning for pandemic influenza,” November 2005. New York State Task Force on Life & the Law

33. Workgroup Co-chairs Gus Birkhead, MD New York State Department of Health Tia Powell, MD New York State Task Force on Life & the Law New York State Department of Health Representatives Barbara Asheld, J.D.; Mary Ann Buckley, RN, MA, JD; Bob Burhans; Bruce Fage; Mary Ellen Hennessy, RN; Marilyn Kacic; John Morley, MD; Loretta Santilli; Perry Smith; Barbara Wallace, MD, MSPH; Dennis Whalen; Lisa Wickens, RN; Vicki Zeldin, M.S. New York State Task Force on Life & the Law Staff Michael Klein, J.D; Kelly Pike, M.H.S Outside Experts: Ron Bayer, Ph.D., Mailman School of Public Health, Columbia University; Kenneth Berkowitz, MD FCCP, NYU School of Medicine; Kathleen Boozang, J.D., L.L.M., Seton Hall University School of Law; David Chong, MD, NYU School of Medicine; Brian Currie, MD, Montefiore Medical Center; Nancy Dubler, L.L.B., Montefiore Medical Center; Paul Edelson, MD, Mailman School of Public Health, Columbia University; Joan Facelle, MD, Rockland County Department of Health; Joseph J. Fins, MD, New York Presbyterian Hospital-Weill Cornell Center; Alan Fleischman, MD, New York Academy of Medicine; Lewis Goldfrank, MD, New York University School of Medicine; Patricia Hyland, M.Ed., RRT, RT, Hudson Valley Community College; Marci Layton, MD, New York City Department of Health and Mental Hygiene; Kathryn Meyer, J.D., Continuum Health Partners, Inc.; Tom Murray, Ph.D, The Hastings Center; Margaret Parker, MD, FCCM, SUNY -Stony Brook; Lewis Rubinson, MD, Public Health Seattle King County; Neil Schluger, MD, Columbia University College of Physicians and Surgeons; Christopher Smith, Healthcare Association of New York State; Kate Uraneck, MD, New York City Department of Health and Mental Hygiene; Susan Waltman, J.D., MSW, Greater New York Hospital Association. New York State Task Force on Life & the Law