# Presentation: 502462

## VHA Ethical Guidance on Triage and the Allocation of Scarce Life-Saving Clinical Resources in Pandemic InfluenzaNational Conference Call - June 13, 2008

- <footer>

**VHA Ethical Guidance on Triage and the Allocation of Scarce Life-Saving Clinical Resources in Pandemic Influenza**National Conference Call - June 13, 2008

## Goals of the Call

- <footer>

- To brief VHA clinical staff, managers, and leaders on the draft guidance from the National Center for Ethics in Health Care pertaining to allocation of scarce critical care resources in a pandemic influenza.
- To enable a dialogue on this draft guidance.
- To assist facilities with the “allocation of scarce resources/altered standards of care” portion of the national pandemic flu exercise (June 23-27)

## Overview/Agenda

- <footer>

- Introduce faculty
- Describe the VHA Pan Flu Ethics Initiative
- Describe _draft_ guidance
- Describe _draft_ guidance re. the ethical _framework_, the team-based decision _structure, _and the specific _protocol_ for allocation of scarce life-saving resources for use in national exercise
- Identify questions

## Faculty for the Call

- <footer>

**Virginia A. Sharpe, PhD**., Lead, VHA Pandemic Influenza Ethics Initiative, National Center for Ethics in Health Care
**Kenneth Berkowitz, MD, FCCP**, Chief, Ethics Consultation, National Center for Ethics in Health Care. (Member, ACCP Task Force for Mass Critical Care and the New York State Workgroup on Ventilator Allocation in an Influenza Pandemic)
**James Geiling, MD, FCCP**, White River Junction VAMC (Steering Committee Member, ACCP Task Force for Mass Critical Care)

## The National Center for Ethics in Health Care (10E)

- <footer>

- The National Center for Ethics in Health Care (10E)

- VHA's primary office for addressing the complex ethical issues that arise in patient care, health care management, and research.

**Notes:**
A current focus on the VHA pandemic influenza ethics initiative

## The VHA Pandemic Influenza Ethics Initiative

- <footer>

**Goal:**
- To provide resources to support VHA leaders, clinicians, staff in meeting the ethical challenges of pandemic influenza planning and response.

## The VHA Pandemic Influenza Ethics Initiative 

- <footer>

- The VHA Pandemic Influenza Ethics Initiative

**What Resources Has the Initiative Produced?**
- _Staff Discussion Forums_ On Ethics Issues In Pandemic Influenza Preparedness including a slide set: Tough Decisions: Preparing VA for the Ethical Challenges of Pandemic Influenza. Available at: _[http://vaww.ethics.va.gov/activities/pandemic_influenza_preparedness.asp](http://vaww.ethics.va.gov/activities/pandemic_influenza_preparedness.asp)_
- _Guidance_: Meeting the Challenge of Pandemic Influenza: Ethical Guidance for VHA Leaders and Clinicians. Available at: _[http://www1.va.gov/EMSHG/page.cfm?pg=132](http://www1.va.gov/EMSHG/page.cfm?pg=132)_

**Notes:**
Will only be talking about the Guidance in this presentation

## Draft Guidance: Meeting the Challenge of Pandemic Influenza: Ethical Guidance for VHA Leaders and Clinicians.

- <footer>

**Draft Guidance: ****Meeting the Challenge of Pandemic Influenza: Ethical Guidance for VHA Leaders and Clinicians.**

- Draft submitted into concurrence 5/1/08. Comments from program offices now being incorporated. The guidance will not be approved in time for the national exercise, though it should be distributed/used/tested in this activity.

## Goal of the Guidance

- <footer>

- To provide VHA leaders and clinicians with an ethical framework to meet challenges concerning:
- Rationing
- Restrictions
- Responsibilities

**Notes:**
Will only be talking about the guidance on rationing in this presentation

## Rationing (Assumptions)

- <footer>

- In a severe influenza pandemic, it is expected that need will outstrip resources and consequently that it will not be possible to provide everyone the care that they require to survive.
- A shift to altered standards is predicated upon 2 conditions: (1) a declared state of emergency, and (2) conditions of severe scarcity.
- The pandemic triage protocol is an altered standard of care.
- Even under a declared state of emergency, initiation of the pandemic triage protocol should only occur when demand for life-saving resources exceeds supply.

**Notes:**
Clinical disease attack rate of 30% or higher in the overall population; Severe 1918-like scenario:1 ventilator for every 2 influenza patients who need one, 1 non-ICU bed for every 2 influenza patients who need one, one ICU bed for every 4 to 5 influenza patients who need one.

## Why Guidance on Rationing During Pandemic?

- <footer>

- Pandemic-related policies and procedures are especially important when practitioners are required to deviate from normal practice and follow alternate standards of care.  If a practitioner can demonstrate that his or her actions are in accordance with institutionally promulgated policy, guidance and/or rules, his or her liability exposure and moral distress will be diminished.

## Preparing the VHA Community

- <footer>

- In advance of a pandemic, political leaders, VHA
- leaders, and health officials must emphasize
- publicly:
- That pandemic influenza is potentially fatal,
- That altered standards of care and associated protocols for allocation of scarce life-saving resources may be implemented by health care organizations.
- That everyone will need to adjust to a different way of providing and receiving health care than is customary.

## Rationing (Guidance)

- <footer>

**The Guidance Provides:**
- An ethical _framework_ for allocation of scarce life saving resources that is fair, transparent, reasonable, and consistent.
- A team-based decision _structure_ for allocation of scarce life saving resources that prevents *ad hoc* bedside rationing decisions.
- A specific _protocol_ for allocation of scarce life-saving resources (e.g., ventilators, ICU beds, and medications for critically ill patients).

## Allocation “Inject” – Exercise Day 2

- <footer>

- 0624L058: "The ICU is full. All ventilators, including back up and portable ventilators are in use. The ER calls the command center reporting 2 patients in severe respiratory distress. Both are in imminent need of intubation and ventilatory support. Who decides and how should the decision be made?"
-   (See: Local Master Scenario Event List (MESL) at _[http://www1.va.gov/EMSHG/page.cfm?pg=140](http://www1.va.gov/EMSHG/page.cfm?pg=140)_)

## Initiation of Triage Protocol – Assumption for the Exercise

- <footer>

- For the exercise, we are assuming that initiation of the triage protocol has been triggered by the Network Director and generally will be applied throughout an affected VISN. Application of pandemic triage algorithms will apply only at the point that demand for the life-saving resource exceeds supply. This will follow a shift to altered standards of care, triggered usually by a declared state of emergency. (See draft Guidance Section 3.2)

## Ethical Framework for Allocation

- <footer>

- Ethical Framework for Allocation

**When Resources Are Scarce:**
- Allocation (rationing) is necessary to ensure the greatest good for the greatest number (principle of _utility_).
- Allocation must be fair - applied consistently across groups of people according to specified criteria (principle of _fairness_).
- Allocation criteria must be transparent, reasonable, legal, feasible and practical.
- VHA pandemic triage protocol for scarce life-saving resources is based on 2 rank-ordered criteria:
- 1. _Survivability_: Priority is given to those for whom treatment has the highest probability of medical success/survival.
- 2. _First-come, first served_: (Assuming resources are still insufficient) For those who meet survivability criteria, resources will be made available on a first-come, first-serve basis.

## Team-Based Decision Structure for Allocation

- <footer>

- Team-Based Decision Structure for Allocation

**Scarce Resource Allocation Team (SRA) (**part of** **Incident Command Structure (ICS)/Hospital Incident Command Structure (HICS)/Emergency Operations**):**
- Formally oversees operations with regard to resource availability within each VAMC .
- Assists Director/Chief of Staff in determining the shift to altered standards of care.
- Via subgroup, Triage Review team (TR), responsible for tertiary triage decisions based on the allocation protocol and regional conditions.

**Notes:**
Ideally, the primary clinicians treating a patient should have neither the sole nor main responsibility for deciding to institute or remove a patient from life-saving resources. If resources permit, the clinicians directly caring for the patient will assess the patient’s condition, note the existence or absence of exclusion criteria, and, if no exclusion criteria are present, assign the patient to an appropriate priority category (per Table 10).  The Triage Review team will make triage decisions based on the allocation protocol and regional conditions as determined by the Scarce Resource Allocation (SRA) team or comparable structure. Upon learning of the Triage team’s decision, the primary clinician will implement a treatment plan consistent with its decision. Such role sequestration will enhance the capacity for maintaining professionalism by allowing primary clinicians to fulfill their obligation to care for their individual patients without facing a conflict of interest about triage.  The use of a TR team may help decrease burnout and stress for clinicians providing critical care during the finite duration of the pandemic.  Placing responsibility for triage with a team that is not involved in a particular patient’s care will help to sustain, post-pandemic, the ordinary obligations that define the physician-patient relationship.  Finally, placing responsibility with a team that has the best information on the current balance of need versus supply would ensure consistency of triage decision making across a group of patients. 

## Evaluating the Exercise

- <footer>

- Had your VAMC established a clear relationship between SRA functions and ICS/HICS/Emergency Operations?
- Did the SRA (or comparable structure) have sufficient information about resource availability?

## Table 9 - Exclusion Criteria for Access to Scarce Life-Saving Resources

- Criteria based on : New York State Task Force on Life and the Law. Allocation of Ventilators in an Influenza Pandemic: Planning Document - Draft For Public Comment, March 15, 2007; Ontario Health Plan for Influenza Pandemic (OHPIP). Working Group on Adult Critical Care Admission, Discharge and Triage Criteria. Critical Care During a Pandemic. April 2006; Devereaux AV and the Task Force for Mass Critical Care. Definitive care for the critically ill during a disaster: A framework for allocation of scarce resources in mass critical care. Chest 2008; 133:51S-66S and comments from additional VHA reviewers and critical care experts

| 
1.	Confirmed presence of any advanced disease with average life expectancy of 6 months or less (e.g., advanced cancer or end-stage organ failure with less than 6 months average survival).
2.	Recent cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; trauma-related arrest.
3.	Confirmed severe irreversible cognitive impairment (e.g., Persistent Vegetative State (PVS) or advanced dementia). |
| --- |

## Protocol for Allocation of Scarce Life-Saving Resources

- <footer>

**Exclusion Criteria** (Table 9):
- If an exclusion criterion is present, the patient is no longer a candidate for scarce life-saving resources.  A DNR order should be entered into their record, the patient and/or surrogate notified of this action, and palliative care and other appropriate care should be offered.  If life-saving resources are in use, they should be withdrawn.

## Evaluating the Exercise

- <footer>

- Did either patient in the “inject” meet exclusion criteria?
- Were there obstacles in clinicians making determinations based on exclusion criteria?
- Did clinicians communicate adequate information to the TR team?
- Were there any problems in the TR’s use of the allocation protocol to determine which patients are eligible for life-saving resources?

## Protocol for Allocation of Scarce Life-Saving Resources

- <footer>

**Inclusion Criteria:**
- Patients who are not excluded will be placed in categories based on a SOFA score (Table 10), and assigned a color-coded priority category based on initial, 48-hour, 72-hour, and subsequent assessments. (SOFA score adapted based on VHA patient population)

## Table 10 - Sequential Organ Failure Assessment (SOFA) Score* 

| Variable | SOFA Score |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  | 0 | 1 | 2 | 3 | 4 |
| PaO2/FiO2 mmHg  | > 400  | 301 – 400  | 201 – 300   | 101 – 200  | < 100  |
| Platelets, x 103/μL or x 106/L  | > 150  | 101 – 150  | 51 – 100  | 21 – 50  | < 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 < 70 mmHg  | Dop < 5  | Dop 6 – 15 or 
Epi < 0.1 or 
Norepi < 0.1  | Dop 6 – 15 or 
Epi < 0.1 or 
Norepi < 0.1 |
| Glasgow Coma Score  | 15  | 13 - 14  | 10 - 12  | 6 - 9  | < 6  |
| Creatinine, 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) 
or anuric |
| Note: Clinicians will determine the total SOFA score for each patient by summing the scores for each variable.  Dopamine [Dop], epinephrine [Epi], norepinephrine [Norepi] doses in ug/kg/min.  SI units are noted in parentheses ( ). 
*Adapted from: Ferreira et al., Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001;286(14):1754-1758.2001. Explanation of variables: PaO2/FiO2 indicates the level of oxygen in the patient’s blood. Platelets are a critical component of blood clotting. Bilirubin is measured by a blood test and indicates liver function. Hypotension indicates low blood pressure; scores of 2, 3, and 4 indicate that blood pressure must be maintained by the use of powerful medications that require ICU monitoring, including dopamine, epinephrine, and norepinephrine. The Glasgow coma score is a standardized measure that indicates neurologic function; low score indicates poorer function. Creatinine is measured by a blood test and indicates kidney function.  |  |  |  |  |  |

## Initial and Subsequent Triage Assessments 

- <footer>

- Initial and Subsequent Triage Assessments

- Clinical assessment and calculation of a SOFA score by
- the primary clinicians at the designated time intervals will result in
- patients being assigned to a color coded priority category at initial assessment,
- 48 hours later, and subsequently at ongoing 72-hour intervals. NOTE:  There is
- a specific triage tool for each predetermined assessment time. In conformity
- with other existing protocols, the following color coding categories will
- be used:
- Blue – Patients with very poor expected outcomes even if life-saving resources are used.
- Red – Patients who require life-saving resources and are most likely to recover by receiving those resources.
- Yellow – Patients who require life-saving resources and are less likely than patients in the Red category to recover by receiving those resources.
- Green – Patients who do not require life-saving resources to recover.
- Triage tools adapted from: New York State Task Force on Life and the Law. Allocation of Ventilators in an Influenza Pandemic: Planning Document - Draft For Public Comment, March 15, 2007; Ontario Health Plan for Influenza Pandemic (OHPIP). Working Group on Adult Critical Care Admission, Discharge and Triage Criteria. Critical Care During a Pandemic. April 2006

## Life-Saving Resources Triage Tool for Initial Assessment

| Life-Saving Resources 
Triage Tool for Initial Assessment |  |  |  |
| --- | --- | --- | --- |
|  | Initial Criteria | Priority | Action |
| B  | Exclusion Criteria 
or 
SOFA > 11 | None | Do not use life-saving resources
Use other resources including palliative measures |
| R  | SOFA < 7 
or 
Single Organ Failure  | Highest  | Use lifesaving resources, as available, per the direction of the Triage Review team |
| Y  | SOFA 8 - 11  | Intermediate  | Use life-saving resources, as available, per the direction of the Triage Review team |
| G | No requirement for life-saving resources | None | Use other medical management
Reassess as needed |

## Life-Saving ResourcesTriage Tool for 48-Hour Assessment

| Life-Saving Resources
Triage Tool for 48-Hour Assessment |  |  |  |
| --- | --- | --- | --- |
|  | 48 Hour Criteria  | Priority | Action |
| B | Exclusion Criteria 
or
SOFA > 11 
or 
SOFA 8 – 11 no change  | None | Discontinue life-saving resources
Use other resources including palliative measures |
| R | SOFA < 11 and decreasing
or 
Single Organ Failure  | Highest  | Continue life-saving resources, as available, per the direction of the Triage Review team |
| Y  | SOFA < 8 no change | Intermediate  | Continue life-saving resources, as available, per the direction of the Triage Review team |
| G | No longer requiring life-saving resources | None | Discontinue life-saving resources. Reassess as needed |

## Life-Saving Resources Triage Tool for 72- Hour Assessments After the Initial 48 Hours

| Life-Saving Resources 
Triage Tool for 72- Hour Assessments After the Initial 48 Hours |  |  |  |
| --- | --- | --- | --- |
|  | Ongoing Criteria | Priority | Action |
| Bl | Exclusion Criteria

or 
SOFA > 11
or 
SOFA < 8 no change  | None | Discontinue life-saving resources
Use other resources including palliative measures |
| R | SOFA score < 11 and decreasing progressively (>3 points in past 72 h) | Highest  | Continue life-saving resources, as available, per the direction of the Triage Review team |
| Y | SOFA < 8 with minimal decrease (< 3 points in past 72h) | Intermediate  | Continue life-saving resources, as available, per the direction of the Triage Review team |
| G | No longer requiring life-saving resources | None | Discontinue life-saving resources. Reassess as needed |

## Review and Appeals Process for Triage Decisions 

- <footer>

**Review and Appeals Process for Triage Decisions**** **

- To ensure fairness and accountability for the
- quality of triage decisions, the triage process
- must include mechanisms for review and
- appeal.

## Review and Appeals Process for Triage Decisions

- <footer>

**Review and Appeals Process for Triage Decisions**

**During a Pandemic:**
- _Daily retrospective_ of all triage decisions by the Triage Review team.
- _Real-time appeals process_ to consider only whether applicable standards are being followed consistently and correctly (e.g., an appeal based on an error in calculating SOFA score, or based on a challenge to the timing of reassessment).
- Ideally personnel involved in the appeals process would be different from personnel on the Triage Review team.

**Notes:**
Daily retrospective: would provide a regular mechanism to ensure consistency and fairness in the application of triage criteria and would present an opportunity for correcting the guidelines or their implementation as needed.
Real-time appeals process: is also needed to ensure process accountability for triage decisions.  The assumption behind such a process is that the established triage protocol meets conditions of fairness and efficiency such that any appeal is based on claims of failure to adhere to established triage processes (e.g., an appeal based on an error in calculating SOFA score, or based on a challenge to the timing of reassessment).
	During the period of scarcity only, all other established VHA dispute resolution processes will be suspended and will not be used to resolve specific triage decisions.

## Evaluating the Exercise

- <footer>

- Was there an appeals structure in place?
- Were there appeals from either of the two patients?
- How were appeals resolved?

## Resuscitation Status for Patients Excluded from Scarce Life-Saving Resources

- <footer>

**Resuscitation Status for Patients Excluded from Scarce Life-Saving Resources**

- 	During rationing of scarce life-saving resources, normal decision making about resuscitation status should be suspended in patients who are excluded from scarce life-saving resources.  If a patient who is not a candidate for life-saving resources suffers a cardiopulmonary arrest, he/she should not be resuscitated.  Patients who are identified in advance as being excluded from scarce life-saving treatment should have DNR orders entered in their records *during the period of scarcity only.*

## Application of Triage Algorithms to Patients Already Receiving Life-Saving Treatments

- <footer>

**Application of Triage Algorithms to Patients Already Receiving Life-Saving Treatments**

**In Circumstances of Extreme Resource Scarcity:**
- Critical care triage algorithms _will_ apply to all patients receiving care _in acute care facilities_, regardless of their illness or their current treatment modalities. This applies to patients already in acute care facilities at the start of pandemic or transferred to acute care facilities.
- Critical care triage algorithms will _not_ apply to VHA patients _residing in long-term care facilities or at home_ (e.g., those who are chronically dependent on life-saving resources for their daily maintenance) – unless and until they are transferred to an acute care facility.

## Evaluating the Exercise

- <footer>

- Were there acute care admissions of patients chronically dependent on life-saving resources for their daily maintenance?
- Were these patients subject to the life-saving resources allocation protocol?

## Sponsors of the National Conference Call:

The National Center for Ethics in Health Care (10E) Pandemic Ethics Initiative Team http://vaww.ethics.va.gov/

The VHA Office of Public Health and Environmental Hazards (13) http://www.publichealth.va.gov/flu/pandemicflu.htm

The National Exercise Planning Group, Emergency Management Strategic Health Care Group (13C)
http://www1.va.gov/EMSHG/page.cfm?pg=136

- <footer>

**Sponsors of the National Conference Call:**
**The National Center for Ethics in Health Care (10E) Pandemic Ethics Initiative Team **_**[http://](http://vaww.ethics.va.gov/)**__**[vaww.ethics.va.gov](http://vaww.ethics.va.gov/)**__**[/](http://vaww.ethics.va.gov/)**_
**The VHA Office of Public Health and Environmental Hazards (13) **_**[http://](http://www.publichealth.va.gov/flu/pandemicflu.htm)**__**[www.publichealth.va.gov/flu/pandemicflu.htm](http://www.publichealth.va.gov/flu/pandemicflu.htm)**_
**The National Exercise Planning Group, Emergency Management Strategic Health Care Group (13C)**
- _[http://www1.va.gov/EMSHG/page.cfm?pg=136](http://www1.va.gov/EMSHG/page.cfm?pg=136)_