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New York State Task Force on Life & 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

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New York State Task Force

on Life & the Law

slide2

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

slide3

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

slide4

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

slide5

Duty to Care

  • Clinician must care for individual patient
  • Autonomy not decisive factor
  • Palliative Care

New York State Task Force

on Life & the Law

slide6

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

slide7

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

slide8

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

slide9

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

slide10

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

slide11

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

slide12

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

slide13

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

slide14

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

slide15

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

slide16

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

slide17

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

slide18

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

slide19

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

slide20

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

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New York State Task Force

on Life & the Law

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New York State Task Force

on Life & the Law

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New York State Task Force

on Life & the Law

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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

slide25

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

slide26

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

slide27

Palliative Care

  • Triage, not abandonment
  • Policies for end-of-life care
  • Continue non-ventilator treatments

New York State Task Force

on Life & the Law

slide28

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

slide29

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

slide30

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

slide31

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

slide32

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

slide33

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