powell ventilator presentation 2007 03 16

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New York State Task Force on Life andamp; the Law

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New York State Task Force on Life andamp; the Law 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

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

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

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New York State Task Force on Life andamp; the Law Duty to Care Clinician must care for individual patient Autonomy not decisive factor Palliative Care

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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

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New York State Task Force on Life andamp; the Law 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

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

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

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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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 andgt;40%, severe inhalation injury ·End-stage organ failure: oCardiac: NY Heart Association class III or IV oPulmonary: severe chronic lung disease with FEV1** andlt; 25% oHepatic: MELD*** score andgt; 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 Clinical Evaluation Objective, clear, easily measured criteria Rule-in: severe respiratory compromise Rule-out: end-stage illness

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law SOFA Scoring Range from 0 -24 0 is the best possible score; 24 is the worst Milestone Scores andlt; 7 gains access andgt; 11 denied access

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New York State Task Force on Life andamp; the Law 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.

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New York State Task Force on Life andamp; the Law

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New York State Task Force on Life andamp; the Law

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New York State Task Force on Life andamp; the Law

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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

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

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New York State Task Force on Life andamp; the Law 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

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New York State Task Force on Life andamp; the Law 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.

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New York State Task Force on Life andamp; the Law Workgroup Co-chairs Gus Birkhead, MD New York State Department of Health Tia Powell, MD New York State Task Force on Life andamp; 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 andamp; 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.