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ETHICAL FRAMEWORK

[ENTER FACILITATOR’S NAME AND CONTACT INFORMATION]

Developed by Troutman Sanders LLPDeveloped for the Virginia Department of Health

Funded by Centers for Disease Control and Prevention

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Toolkit Presentations Instructions for Use

Toolkit Presentations are intended to be a companion to the Hospital Implementation Guide and should not be used in isolation.

The Presentations are intended to serve as a starting point for the facilitator. The facilitator should thoroughly review the Presentation prior to use in Implementation Team, CRAG or Subcommittee meetings and customize the Presentation to meet the unique needs of the meeting participants.

Pay particular to attention to the information provided in brackets ([ ]), which must be completed by the facilitator prior to use.

Included in the “Notes” section of each slide are the following types of information:

• Slide Type, which indicates whether the slide is for information or discussion, serves as a placeholder, or is some combination thereof

• Planning Guide Section(s), which will direct the facilitator to the corresponding sections of the Planning Guide and Hospital Implementation Guide for further information

• Special Instructions, which provides directions for the facilitator to customize the slide for the intended audience

• Speaker’s Notes, which provides more detailed information to supplement the material on the slide

Refer to the Hospital Implementation Guide for further guidance and helpful hints on effectively completing the process described in the Planning Guide.

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CRAG Members

[Enter names and departments of each CRAG member]

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Add slides from Altered Standards Overview and/or Chapter 1 presentation, as needed, to re-introduce the CRAG to the concept of altered standards and critical resource shortage response planning, especially if new members are involved.

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Introduction

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Why Ethics?Decisions during a CRSE involve complex,

challenging ethical issues, including the allocation of scarce resources

An ethical framework will help ensure that the CRSRP and associated Protocols are developed in an ethical manner

Ideally, the application of an ethical framework will produce a CRSRP and Protocols that are accepted as ethically sound

While existing frameworks may be helpful, Planning Units should create their own framework which reflects their unique culture and values

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Strong Foundation

Operational Infrastructure

Education & Communication

Building the CRSRP

Protocol

Protocol

Protocol

Protocol

Protocol

Protocol

Protocol

Protocol

Ad Hoc

Ethical Framework

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Three Step Process

Step 1: Identify Ethical PrinciplesStep 1: Identify Ethical Principles

Step 2: Define the GoalStep 2: Define the Goal

Step 3: Determine Implementation SpecificationsStep 3: Determine Implementation Specifications

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Step 1: Step 1: Identify Ethical PrinciplesIdentify Ethical Principles

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Ethical Principles

Substantive Principles Individual Liberty Protection of the public from harm Proportionality Distributive justice and fairness Beneficence Non-maleficence Privacy Duty to provide care Reciprocity Respect for Autonomy Equity Trust Solidarity Stewardship

Procedural Principles Reasonable Open and Transparent Inclusive Responsive Accountable

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Prioritization of Ethical Principles

Substantive Individual Liberty Protection of the public from harm Proportionality Distributive justice and fairness Beneficence Non-maleficence Privacy Duty to provide care Reciprocity Respect for autonomy Equity Trust Solidarity Stewardship

Procedural Reasonable Open and transparent Inclusive Responsive Accountable

High Medium Low

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Ethical Principle Prioritization

High Priority Medium Priority Low Priority

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BREAK

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Step 2: Step 2: Define the GoalDefine the Goal

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Protecting the functionality of societyProtecting societal and community infrastructurePreventing morbidity and mortalityGreatest good for the greatest numberGreatest good for the greatest number with “side

constraints”Greatest number of people benefitedGreatest number of lives savedGreatest number of life years savedGreatest number of quality life years saved

Potential Goals

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“Protecting the Functionality of Society”

Modify practices and allocate resources to protect the societal infrastructure and prevent it from breaking down under the stress of the disaster

Prioritize for prophylaxis and treatment those people who are essential to preserving the functionality of society

Who is essential to protecting the functioning of society?• Health care providers?• Public Health Officials?• Legislators?• Police officers?• Truck drivers?• Janitors?• Sewage workers?

Will the answer depend on the disaster or the type of care that is being modified or allocated?

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“Prevent Morbidity and Mortality”

Modify practices and allocate resources to prevent illness and death

Prioritize for prophylaxis and treatment those people who are most likely to become ill, make others ill, or die without the intervention

Will the prioritization change based on the disaster or the type of care that is being modified or allocated?

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“Greatest Good for Greatest Number”

Widely used in critical resource shortage response planning literature

Not clear exactly what it means• Greatest number of lives saved?• Greatest number of life years saved?• Greatest number of quality life years saved?• Greatest number of people benefited?

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“Greatest Good for Greatest Number with Side Constraints”

Greatest good for the greatest number + Respect for persons + Non-maleficence + Justice

Greatest good for the greatest number + Refraining from harming individuals and communities + Providing equal opportunity to access resources to those in priority groups + Employing the least restrictive interventions likely to be effective

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Prophylaxis v. Treatment

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Choose a Goal

Protecting the functionality of societyProtecting societal and community infrastructurePreventing morbidity and moralityGreatest good for the greatest numberGreatest good for the greatest number with “side

constraints”Greatest number of people benefitedGreatest number of lives savedGreatest number of life years savedGreatest number of quality life years saved

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BREAK

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Step 3: Step 3: Determine Implementation Determine Implementation

SpecificationsSpecifications

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Withdrawal and Reallocation

Will providers be allowed to withdraw resources from one patient to give them to another patient?

If so, under what general circumstances?

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How will you decide who gets the ventilator?

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Minnesota’s Reallocation Criteria

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Consider that…

If you are not willing to withdraw treatment, then you are essentially providing care on a first come, first served basis.

If you are willing to withdraw care, will this be construed as valuing one person’s life more than another’s life?

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Withholding of Resources

Will providers be allowed to withhold a critical resource from one patient to conserve it for a future patient?

If so, under what general circumstances?

Is the answer different for durable v. consumable resources?

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Consider that …

If you are not willing to withhold care, you will essentially be providing care on a first come, first served basis.

If you are willing to withhold care, you may have unused, available resources that are not being provided to a patient in need.

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“Inclusion” and “Exclusion” Criteria

Many of the existing allocation algorithms include “inclusion” and “exclusion” criteria

Inclusion CriteriaThose patient

characteristics which indicate a need for the

Critical Resource

Exclusion CriteriaThose patient

characteristics that remove a patient from consideration

for the Critical Resource even when the inclusion

criteria are met

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Example Exclusion CriteriaOntario Health Plan for Influenza Pandemic

Christian MD, et al. (Nov 2006) “Development of a Triage Protocol for Critical Care During an Influenza Pandemic.” CMAJ, 175(11): 1377-1381. Available online at: http://www.cmaj.ca/cgi/reprint/175/11/1377 (last visited March 9, 2009).

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Example Exclusion CriteriaNew York Vent Allocation Guidance

Powell T, et al. (Mar 2008) “Allocation of Ventilators in a Public Health Disaster.” Disaster Medicine and Public Health Preparedness, 2(1): 20-26.

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Example Exclusion CriteriaTask Force for Mass Critical Care

Working Group

Devereaux A, et al. (2008) “Definitive Care for the Critically Ill During a Disaster: A Framework for Allocation of Scarce Resources in Mass Critical Care.” Chest, 133: 51S-66S. Available online at: http://www.chestjournal.org/content/133/5_suppl/51S.full (last visited March 9, 2009).

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Example Exclusion CriteriaUtah Pan Flu Hospital and ICU Triage

Utah Department of Health (Aug 2008) “Utah Pandemic Influenza Hospital and ICU Triage Guidelines.” http://www.uha-utah.org/Disaster%20Prep%20Materials/PANDEMIC%20FLU%20TRIAGE%2008-12-08.pdf (last visited March 9, 2009).

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CA’s Exclusion Criteria Guidance

Acceptable Likelihood of survival Change in quality of life Duration of benefit Urgency of need Amount of resources

required

InappropriateAbility to paySocial worthPatient contribution to

diseasePast use of resources

California Department of Public Health. (2007). “California Department of Public Health Standards and Guidelines for Healthcare Surge During Emergencies, Volume I: Hospitals.” Available online at:http://bepreparedcalifornia.ca.gov/NR/rdonlyres/0DB13C5F-89DC-4B94-850B-EF12EA221FF3/0/volume1_hospital_FINAL.pdf (last visited September 25, 2009).

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Inappropriate Exclusion Criteria

Ability to pay? Social worth? Race or ethnicity? Religion? Gender? Patient contribution to

disease? Past use of resources? Age? If so, what is the

cut-off?

Severe baseline cognitive impairment?

Known severe dementia? Metastatic malignant disease? End stage organ failure? Severe and irreversible

neurological event or condition?

Advanced and irreversible immunocompromise?

Advanced untreatable neuromuscular disease?

Known chromosomal or untreatable disorders fatal in first 2 years of life?

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Questions?Questions?