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

New York State Task Force on Life & the Law

Allocation of Ventilatorsin an

Influenza PandemicEthical Framework

&Clinical Decision Making

Tia Powell, MDExecutive Director



Ventilator Shortage in a PandemicOverview

•Most severe scenario•Too few ventilators for patients•Too few staff for more ventilators•Rationing of ventilators needed

•Ethical Framework for Allocation

•Clinical Algorithm


Rationing: Ethical Implications

•Limits patient autonomy •Limits physician autonomy•Doctor’s obligation to patient or to group?•Threat to doctor-patient relationship


Ethical Framework: Allocation in Mass Casualty

Scenarios

•Duty to Care•Duty to Steward Resources•Duty to Plan•Transparency•Justice


Duty to Care

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


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


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


Transparency

•Public communication•Disaster care different•Patient preference does not determine withdrawal or withholding of care•Objective criteria guide patients and professionals


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


• Pre-triage requirements• Patient categories• Facilities • Clinical Algorithm• Triage decision-makers• Palliative care• Communication

Triage Process


Pre-triage Requirements

•Decrease ventilator need•Elective surgery, preventive care

•Increase vent supply•Stockpile•Collaborative arrangements•Use of OR, transport, additional vents


Patient Categories

•Algorithm applies to all acute care patients •Not flu only•Includes patients on ventilator when triage starts


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


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


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


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


Exclusion Criteria for Ventilator Access*

Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrestMetastatic malignancy with poor prognosisSevere burn: body surface area >40%, severe inhalation injuryEnd-stage organ failure:

oCardiac: NY Heart Association class III or IVoPulmonary: severe chronic lung disease with FEV1** < 25%oHepatic: MELD*** score > 20oRenal: dialysis dependentoNeurologic: 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


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


SOFA Scoring•Range from 0 -24

•0 is the best possible score; 24 is the worst•Milestone Scores

•< 7 gains access •> 11 denied access

Sequential Organ Failure Assessment (SOFA) score

Variable 0 1 2 3 4O2/FiO2 mmHg >400 < 400 < 300 < 200 < 100

Platelets, x 103/µL(x 106/L)

> 150(>150)

< 150(< 150)

< 100(< 100)

<50(<50)

< 20(< 20)

Bilirubin, mg/dL(µmol/L)

<1.2(<20)

1.2-1.9(20 – 32)

2.0-5.9(33 – 100)

6.0-11.9(101 – 203)

>12(> 203)

Hypotension None MABP < 70mmHg

Dop < 5Dop > 5,Epi < 0.1,

Norepi < 0.1

Dop > 15,Epi > 0.1,

Norepi >0.1Glasgow Coma Score 15 13 - 14 10 - 12 6 - 9 <6Creatinine, mg/dL(µmol/L)

< 1.2(<106)

1.2-1.9(106 – 168)

2.0-3.4(169 - 300)

3.5–4.9(301 – 433)

>5(> 434)

Adapted From: Ferreira Fl, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome incritically ill patients. JAMA 2001; 286(14): 1754-1758.


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.


Critical Care Triage Tool(Initial Assessment)

Adapted from: Ontario Health Plan for an Influenza Pandemic (OHPIP) Working Group onAdult Critical Care Admission, Discharge, and Triage Criteria, “Critical Care During aPandemic,” April 2006.

ColorCode Criteria Priority/Action

Blue

Exclusion Criteria* or

SOFA > 11*Medical Mgmt

+/- Palliate & d/c

Red

SOFA < 7 or

Single Organ FailureHighest

Yellow SOFA 8 - 11 Intermediate

Green No significant organfailure

Defer or d/c,reassess as

needed

*If exclusion criteria or SOFA > 11 occurs at any time from the initial assessmentto 48 hours change triage code to Blue and palliate.d/c = discharge


Critical Care Triage Tool(48 Hour Assessment)


Blue

Exclusion Criteria or

SOFA > 11 or SOFA 8 – 11 no

Palliate & d/cfrom CC

Red

SOFA < 11 anddecreasing Highest

Yellow SOFA < 8 no Intermediate

Green No longer ventilatordependant

d/c from CC

= change, CC = critical care, d/c = discharge


Critical Care Triage Tool(120 Hour Assessment)


Blue

Exclusion Criteria* or

SOFA > 11* SOFA < 8 no

Palliate & d/cfrom CC

Red

SOFA score < 11 and decreasing progressively

Highest

Yellow

SOFA < 8 minimal decrease

(< 3 point decrease in past 72h)Intermediate

Green No longer ventilatordependant

d/c from CC

* If exclusion criteria or SOFA > 11 occurs at anytime from 48 – 120 hours changetriage code to Blue and palliate.CC = critical care, d/c = discharge


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

Variable ScorePaO2/FiO mmHg = 80 4Platelets, x 1000/microL = 135 1Bilirubin, mg/dL = 1.1 0Hypotension = borderline 110/60 0Glasgow Coma Score = 13, confused 1Creatinine, mg/dL = 1.1 0


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

Variable ScorePaO2/FiO2 mmHg = 80 4Platelets, x 1000/microL = 150 0Bilirubin, mg/dL = 1.2 0Hypotension = Dopamine 5 μg/kg/min 2Glasgow Coma Score = 9, obtunded 3Creatinine, mg/dL = 4.7 3


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


Palliative Care

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


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


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


Liability

•Altered standard of care for mass casualty•Government and professional support•Malpractice threat•Regulatory option•Legislative option


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


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.


Workgroup Co-chairs Gus Birkhead, MDNew York State Department of Health Tia Powell, MDNew York State Task Force on Life & the Law

New York State Department of Health RepresentativesBarbara 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 .

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