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VENTILATOR ALLOCATION GUIDELINES

New York State Task Force on Life and the Law

New York State Department of Health

November 2015

Current Members of the New York State Task Force on Life and the Law

Howard A. Zucker, M.D., J.D. LL.M. Commissioner of Health, New York State

Karl P. Adler, M.D. Cardinal’s Delegate for Health Care, Archdiocese of NY

Donald P. Berens, Jr., J.D. Former General Counsel, New York State Department of Health

Rabbi J. David Bleich, Ph.D. Professor of Talmud, Yeshiva University, Professor of Jewish Law and Ethics, Benjamin Cardozo School of Law

Rock Brynner, Ph.D., M.A. Professor and Author

Karen A. Butler, R.N., J.D. Partner, Thuillez, Ford, Gold, Butler & Young, LLP

Yvette Calderon, M.D., M.S. Professor of Clinical Emergency Medicine, Albert Einstein College of Medicine

Carolyn Corcoran, J.D. Principal, James P. Corcoran, LLC

Nancy Neveloff Dubler, LL.B. Consultant for Ethics, NYC Health & Hospitals Corp., Professor Emerita, Albert Einstein College of Medicine

Paul J. Edelson, M.D. Professor of Clinical Pediatrics, College of Physicians and Surgeons, Columbia University

Joseph J. Fins, M.D., M.A.C.P. Chief, Division of Medical Ethics, Weill Medical College of Cornell University

Rev. Francis H. Geer, M.Div. Rector, St. Philip’s Church in the Highlands

Samuel Gorovitz, Ph.D. Professor of Philosophy, Syracuse University

Cassandra E. Henderson, M.D., C.D.E., F.A.C.O.G. Director of Maternal Fetal Medicine, Lincoln Medical and Mental Health Center

Letter from the Commissioner of Health

Dear New Yorkers,

Protecting the health and well-being of New Yorkers is a core objective of the Department of Health. During flu season, we are reminded that pandemic influenza is a foreseeable threat, one that we cannot ignore. In light of this possibility, the Department is taking steps to prepare for a pandemic and to limit the loss of life and other negative consequences. An influenza pandemic would affect all New Yorkers, and we have a responsibility to plan now. Part of the planning process is to develop guidance on how to ethically allocate limited resources (i.e., ventilators) during a severe influenza pandemic while saving the most lives.

As part of our emergency preparedness efforts, the Department, together with the New York State Task Force on Life and the Law, is releasing the 2015 Ventilator Allocation Guidelines, which provide an ethical, clinical, and legal framework to assist health care providers and the general public in the event of a severe influenza pandemic. The first guidelines in 2007 focused on the allocation of ventilators for adults, and were among the first of their kind in the United States. The 2015 version is also groundbreaking in that it includes two new detailed clinical ventilator allocation protocols – one for pediatric patients and another for neonates. The first Guidelines were widely cited and followed by other states. We expect these revised Guidelines to have a similar effect.

The Guidelines were written to reflect the values of New Yorkers, and extensive efforts were made to obtain public input during their development. While these Guidelines are comprehensive, they are by no means final. We will continue to seek public input and will revise the Guidelines as societal norms change and clinical knowledge advances.

It is my sincere hope that these Guidelines will never need to be implemented. But as a physician and servant in public health, I know that such preparations are essential should we ever experience an influenza pandemic. I want to thank the members and staff of the Task Force on Life and the Law for their efforts in creating these Guidelines, which once again demonstrate New York’s strong commitment to safeguarding the health of its citizens.

Sincerely,

Howard A. Zucker, M.D., J.D., LL.M. New York State Commissioner of Health

VENTILATOR ALLOCATION GUIDELINES

New York State Task Force on Life & the Law

New York State Department of Health

Preface

These Ventilator Allocation Guidelines (Guidelines) are an update to the 2007 draft guidelines, which presented a clinical ventilator allocation protocol for adults and included a brief section on the legal issues associated with implementing the guidelines. This update of the Guidelines consists of four chapters: (1) the adult guidelines, (2) the pediatric guidelines, (3) the neonatal guidelines, and (4) legal considerations. The adult guidelines were revised to reflect recent medical advances and further clinical analysis. The pediatric and neonatal guidelines are new and address important and previously overlooked segments of the population. Finally, the legal section provides a comprehensive examination of the various legal issues that may arise when implementing the Guidelines.

The underlying goal of this work is to provide a thorough ethical, clinical, and legal analysis of the development and implementation of the Guidelines in New York State. In addition to detailed clinical ventilator allocation protocols, this document provides an account of the logic, reasoning, and analysis behind the Guidelines. The clinical ventilator allocation protocols are grounded in a solid ethical and legal foundation and balance the goal of saving the most lives with important societal values, such as protecting vulnerable populations, to build support from both the general public and health care staff.

These Ventilator Allocation Guidelines provide an ethical, clinical, and legal framework that will assist health care workers and facilities and the general public in the ethical allocation of ventilators during an influenza pandemic. Because the Guidelines are a living document, intended to be updated and revised in line with advances in clinical knowledge and societal norms, the ongoing feedback from clinicians and the public has and will continue to be sought. In developing a protocol for allocating scarce resources in the event of an influenza pandemic, the importance of genuine public outreach, education, and engagement cannot be overstated; they are critical to the development of just policies and the establishment of public trust.

1 Executive Summary

VENTILATOR ALLOCATION GUIDELINES

Executive Summary

I. Introduction

Influenza pandemics occur with unpredictable frequency and severity. Recent influenza outbreaks, including the emergence of a powerful strain of avian influenza in 2005 and the novel H1N1 pandemic in 2009, have generated concern about the possibility of a severe influenza pandemic. While it is uncertain whether or when a pandemic will occur, the better prepared New York State is, the greater its chances of reducing associated morbidity, mortality, and economic consequences.

A pandemic that is especially severe with respect to the number of patients affected and the acuity of illness will create shortages of many health care resources, including personnel and equipment. Specifically, many more patients will require the use of ventilators than can be accommodated with current supplies. New York State may have enough ventilators to meet the needs of patients in a moderately severe pandemic. In a severe public health emergency on the scale of the 1918 influenza pandemic, however, these ventilators would not be sufficient to meet the demand. Even if the vast number of ventilators needed were purchased, a sufficient number of trained staff would not be available to operate them. If the most severe forecast becomes a reality, New York State and the rest of the country will need to allocate ventilators.

II. Development of the Ventilator Allocation Guidelines

In 2007, the New York State Task Force on Life and the Law (the Task Force) and the New York State Department of Health (the Department of Health) released draft ventilator allocation guidelines for adults. New York’s innovative guidelines were among the first of their kind to be released in the United States and have been widely cited and followed by other states. Since then, the Department of Health and the Task Force have made extensive public education and outreach efforts and have solicited comments from various stakeholders. Following the release of the draft guidelines, the Task Force: (1) reexamined and revised the adult guidelines within the context of the public comments and feedback received (see Chapter 1), (2) developed guidelines for triaging pediatric and neonatal patients (see Chapters 2 and 3), and (3) expanded its analysis of the various legal issues that may arise when implementing the clinical protocols for ventilator allocation (see Chapter 4).

To revise the adult clinical ventilator allocation protocol, a clinical workgroup comprised of individuals from the fields of medicine and ethics was convened in 2009 to develop and refine specific aspects of the clinical ventilator allocation protocol. To obtain additional public comment, the Task Force oversaw a public engagement project in 2011, which consisted of 13 focus groups held throughout the State. Furthermore, based on the results of these focus groups and its own analysis, the Task Force made additional recommendations to elaborate and expand certain sections and to include a more robust discussion of the reasoning and logic behind certain features of the protocol. These revisions appear as Chapter 1, the revised adult guidelines (the Adult Guidelines).

2 Executive Summary

The Task Force approached the pediatric ventilator allocation guidelines (the Pediatric Guidelines) in two stages. First, the Task Force addressed the special considerations for pediatric and neonatal emergency preparedness and the ethical issues related to the treatment and triage of children in a pandemic, with particular focus on whether children should be prioritized for ventilator therapy over adults. Second, the Task Force convened a pediatric clinical workgroup (including specialists in pediatric, neonatal, emergency, and maternal-fetal medicine, as well as in critical care, respiratory therapy, palliative care, public health, and ethics), to develop a clinical ventilator allocation protocol for pediatric patients. Chapter 2 presents these new Pediatric Guidelines.

The Task Force also organized a neonatal clinical workgroup, consisting of neonatal and maternal-fetal specialists, to discuss and develop neonatal guidelines (the Neonatal Guidelines), which appear as Chapter 3.

Finally, a legal subcommittee was organized in 2008, and the Task Force devoted substantial resources to exploring the various legal issues that may arise when implementing the clinical ventilator allocation protocols. Thus, the brief summary on legal issues from the 2007 draft guidelines is replaced with a substantial discussion in Chapter 4.

As a result of the Task Force’s efforts, the Ventilator Allocation Guidelines (the Guidelines) incorporate comments, critiques, feedback, and values from numerous stakeholders, including experts in the medical, ethical, legal, and policy fields. The Guidelines draw upon the expertise of clinical workgroups and committees, literature review, public feedback, and insightful commentary. Furthermore, in developing and revising the Guidelines, extensive efforts were made to obtain public input. For the public to accept the Guidelines, they must reflect the values of New Yorkers.

Because research and data on this topic are constantly evolving, the Guidelines are a living document intended to be updated and revised in line with advances in clinical knowledge and societal norms. The Guidelines incorporate an ethical framework and evidence-based clinical data to support the goal of saving the most lives in an influenza pandemic where there are a limited number of available ventilators.

III. Chapter Overviews

This report consists of four chapters, described below. Each chapter has an abstract that summarizes the chapter. While each chapter may stand alone, the underlying ethical framework and clinical concepts are discussed in more detail in Chapter 1, Adult Guidelines. For ease of reference, at the end of the report are the adult (Appendix A), pediatric (Appendix B), and neonatal (Appendix C) clinical ventilator allocation protocols (the Clinical Protocols for Ventilator Allocation). In addition, this report has a companion document, Frequently Asked Questions, which is intended to supplement the Guidelines and answer commonly asked questions.

4 Executive Summary

alternative forms of medical intervention, palliative care, communication about triage, real-time data collection and analysis, and future modification of the Neonatal Guidelines.

Chapter 4, Implementing New York State’s Ventilator Allocation Guidelines: Legal Considerations. This chapter addresses the various legal issues associated with effectively implementing the Guidelines and presents recommendations to encourage adherence to the Guidelines. This chapter begins with a discussion of the form of the Guidelines themselves as voluntary and non-binding. It then focuses on a number of constitutional considerations that may arise when implementing the clinical ventilator allocation protocols. It discusses the “trigger” for the implementation of the adult, pediatric, and neonatal clinical ventilator allocation protocols and enumerates the New York statutes that could interfere with adherence to the Guidelines in a pandemic influenza. This chapter then examines existing liability protections at the federal and State levels and recommends passage of legislation granting the New York Commissioner of Health authority to adopt a modified medical standard of care specific to the emergency, coupled with civil and criminal liability protections and professional discipline protections for all health care workers and entities who provide care in a pandemic emergency. This chapter also considers alternatives to legislation that would mitigate civil and criminal liability and encourage adherence to the Guidelines. The approaches include: (1) caps on damages; (2) expedited discovery and statutes of limitations; (3) alternative dispute resolution, including arbitration, pretrial review boards, and compensation pools; and (4) professional education. This chapter concludes with a consideration of the various approaches to an appeals process for those who object to decisions made pursuant to the clinical ventilator allocation protocols.

IV. The Guidelines’ Primary Goal: Saving the Most Lives

The primary goal of the Guidelines is to save the most lives in an influenza pandemic where there are a limited number of available ventilators. To accomplish this goal, patients for whom ventilator therapy would most likely be lifesaving are prioritized. The Guidelines define survival by examining a patient’s short-term likelihood of surviving the acute medical episode and not by focusing on whether the patient may survive a given illness or disease in the long- term (e.g., years after the pandemic). Patients with the highest probability of mortality without medical intervention, along with patients with the smallest probability of mortality with medical intervention, have the lowest level of access to ventilator therapy. Thus, patients who are most likely to survive without the ventilator, together with patients who will most likely survive with ventilator therapy, increase the overall number of survivors.

V. Ethical Considerations and Possible Methods to Allocate Ventilators

The clinical ventilator allocation protocols are based on an ethical framework which includes five components: duty to care, duty to steward resources, duty to plan, distributive justice, and transparency. First, duty to care is the fundamental obligation for providers to care for patients. Duty to steward resources is the need to responsibly manage resources during periods of true scarcity. Duty to plan is the responsibility of government to plan for a foreseeable crisis. Distributive justice requires that an allocation protocol is applied broadly and consistently to be fair to all. Finally, transparency ensures that the process of developing a clinical ventilator

5 Executive Summary

allocation protocol is open to feedback and revision, which helps promote public trust in the Guidelines.

To ensure that patients receive the best care possible in a pandemic, a patient’s attending physician does not determine whether his/her patient receives (or continues) with ventilator therapy; instead a triage officer or triage committee makes the decision. While the attending physician interacts with and conducts the clinical evaluation of a patient, a triage officer or triage committee does not have any direct contact with the patient. Instead, a triage officer or triage committee examines the data provided by the attending physician and makes the determination about a patient’s level of access to a ventilator. This role sequestration allows the clinical ventilator allocation protocol to operate smoothly. The decision regarding whether to use either a triage officer or committee is left to each acute care facility (i.e., hospital) because available resources will differ at each site.

The Task Force explored various non-clinical approaches to allocating ventilators, including distributing ventilators on a first-come first-serve basis, randomizing ventilator allocation (e.g., lottery), requiring only physician clinical judgment in making allocation decisions, and prioritizing certain patient categories (i.e., health care workers and patients with certain social criteria). However, the Task Force determined that these approaches should not be used as the primary method to allocate scarce resources because they are often subjective and/or do not support the goal of saving the most lives. Furthermore, advanced age was rejected as a triage criterion because it discriminates against the elderly. Age already factors indirectly into any criteria that assess the overall health of an individual (because the likelihood of having chronic medical conditions increases with age) and there are many instances where an older person could have a better clinical outlook than a younger person. Thus, the Task Force concluded that an allocation protocol should utilize clinical factors only to evaluate a patient’s likelihood of survival and to determine the patient’s access to ventilator therapy.

However, because of a strong societal preference for saving children, the Task Force recommended that young age may be considered as a tie-breaking criterion in limited circumstances. When the pool of patients eligible for ventilator therapy includes both adults and children (17 years old and younger), the Task Force determined that when all available clinical factors have been examined and the probability of mortality among the pool of patients has been found equivalent, only then may young age be utilized as a tie-breaker to select a patient for ventilator therapy. Thus, Guidelines that emphasize probability of mortality while incorporating the use of young age solely as a tie-breaker criterion acknowledge general societal values and advance the goal of saving the most lives.

Similarly, in its consideration to protect vulnerable populations, the Task Force determined that ventilator-dependent chronic care patients are subject to the clinical ventilator allocation protocol only if they arrive at an acute care facility for treatment. Once they arrive at a hospital, they are treated like any other patient who requires ventilator therapy. This policy balances the need to protect vulnerable populations with the principle of treating all patients in need of a ventilator equally. The unacceptable alternative would be to triage all stable, long-term ventilator-dependent patients, which may result in likely fatal extubations, and it would violate several principles of the ethical framework.

7 Executive Summary

discharge) are those who have a medical condition on the exclusion criteria list or those who have a high risk of mortality and these patients do not receive ventilator therapy when resources are scarce. Instead, alternative forms of medical intervention and/or palliative care are provided. However, if more resources become available, patients in the blue color category, or those with exclusion criteria, are reassessed and may be eligible for ventilator therapy. Red code patients (highest access) are those who have the highest priority for ventilator therapy because they are most likely to recover with treatment (and likely to not recover without it) and have a moderate risk of mortality. Patients in the yellow category (intermediate access) are those who are very sick, and their likelihood of survival is intermediate and/or uncertain. These patients may or may not benefit (i.e., survive) with ventilator therapy. They receive such treatment if ventilators are available after all patients in the red category receive them. Patients in the green color code (defer/discharge) are those who do not need ventilator therapy.

In some circumstances, a triage officer/committee must select one of many eligible red color code patients to receive ventilator therapy. A patient’s likelihood of survival (i.e., assessment of mortality risk) is the most important consideration when evaluating a patient. However, there may be a situation where multiple patients have been assigned a red color code, which indicates they all have the highest level of access to ventilator therapy, and they all have equal (or near equal) likelihoods of survival. If the eligible patient pool consists of only adults or only children , a randomization process, such as a lottery, is used each time a ventilator becomes available because there are no other evidence-based clinical factors available to consider. Patients waiting for ventilator therapy wait in an eligible patient pool. However, in limited circumstances, if: (1) the pool of patients eligible for ventilator therapy includes both adults and children , and (2) all available clinical data suggest that the probability of mortality among the pool of patients have been found equivalent (i.e., all patients are assigned a red color code), then young age (i.e., 17 years old and younger) may be utilized as a tie-breaker to select a patient for ventilator therapy.

In addition, there may be a scenario where there is an incoming red code patient(s) eligible for ventilator therapy and a triage officer/committee must remove a ventilator from a patient whose health is not improving. In this situation, first, patients in the blue category (or the yellow category if there are no blue code patients receiving ventilator therapy) are vulnerable for removal from ventilator therapy if they fail to meet criteria for continued ventilator use. If the pool of ventilated patients vulnerable for removal consists of only adults or only children , a randomization process, such as a lottery, is used each time to select the (blue or yellow) patient who will no longer receive ventilator therapy. However, in limited circumstances, if: (1) the pool of ventilated patients eligible for ventilator withdrawal includes both adults and children , and (2) all available clinical data suggest that the probability of mortality among the pool of ventilated patients has been found equivalent (i.e., all patients are assigned a blue (or yellow) color code), then young age (i.e., 17 years old and younger) may be utilized as a tie-breaker and the ventilator is withdrawn from the adult patient. A patient may only be removed from a ventilator after an official clinical assessment has occurred or where the patient develops a medical condition on the exclusion criteria list. However, if all ventilated patients are in the red category (i.e., have the highest level access), none of the patients are removed from ventilator therapy, even if there is an eligible (red color code) patient waiting.

8 Executive Summary

Patients who have a medical condition on the exclusion criteria list or who no longer meet the clinical criteria for continued ventilator use receive alternative forms of medical intervention and/or palliative care. The same applies to patients who are eligible for ventilator therapy but for whom no ventilators are currently available. Alternative forms of medical intervention, such as other methods of oxygen delivery and pharmacological antivirals, should be provided to those who are not eligible or waiting for a ventilator. In addition, actively providing palliative care, especially to patients who do not or no longer qualify for ventilator therapy, decreases patient discomfort and fulfills the provider’s duty to care, even when the clinician can no longer offer ventilator therapy.

Efforts will be made to inform and gather feedback from the public before a pandemic. Public outreach will inform people about the goals and steps of the clinical ventilator allocation protocols. Information should emphasize that pandemic influenza is potentially fatal, that health care providers are doing their best with the limited resources, and the public must adjust to a different way of providing and receiving health care than is customary. Instead, a protocol based only on clinical factors will be used to determine whether a patient receives (or continues with) ventilator treatment to support the goal of saving the greatest number of lives in an influenza pandemic where there are a limited number of available ventilators. Patients and families should be informed that ventilator therapy represents a trial of therapy that may not improve a patient’s condition sufficiently and that the ventilator will be removed if this approach does not enable the patient to meet specific criteria.

Finally, once the Guidelines are implemented, there must be real-time data collection and analysis to modify the Guidelines based on new information. Data collection and analysis on the pandemic viral strain, such as symptoms, disease course, treatments, and survival, are necessary so that the clinical ventilator allocation protocols may be adjusted accordingly to ensure that patients receive the best care possible. In addition, data collection must include real-time availability of ventilators so that triage decisions are made to allocate resources most effectively. Knowing the exact availability of ventilators also assists a triage officer/committee in providing the most appropriate treatment options for patients.

VIII. Legal Considerations

The Guidelines address many of the legal issues that may arise in the event that the clinical ventilator allocation protocols are implemented. The Department of Health is empowered to issue voluntary, non-binding guidelines for health care workers and facilities; such guidelines are readily implemented and provide hospitals with an ethical and clinical framework for decision-making. The complex legal issues raised by a modified medical standard of care in a public health emergency create vulnerabilities for individual facilities as they draft their own policies, and they have therefore requested detailed procedural advice from the State.

Among the most challenging legal questions related to a pandemic scenario is the issue of liability protection for clinicians and facilities that adhere to clinical ventilator allocation protocols in a public health crisis. Voluntary guidelines issued by the Department of Health for ventilator allocation provide evidence for an acceptable modified medical standard of care during the dire circumstances of a pandemic. However, there is no guarantee that a court will accept

10 Executive Summary

Members of the Task Force on Life and the Law

Howard A. Zucker, M.D., J.D., LL.M. Commissioner of Health, New York State

Karl P. Adler, M.D. Cardinal’s Delegate for Health Care, Archdiocese of NY

*Adrienne Asch, Ph.D., M.S. Director, Center for Ethics at Yeshiva University

Donald P. Berens, Jr., J.D. Former General Counsel, NYS Department of Health

*Rev. Thomas Berg, Ph.D., M.A. Professor of Moral Theology, St. Joseph Seminary

Rabbi J. David Bleich, Ph.D. Professor of Talmud, Yeshiva University Professor of Jewish Law and Ethics, Benjamin Cardozo School of Law

Rock Brynner, Ph.D., M.A. Professor and Author

Karen A. Butler, R.N., J.D. Partner, Thuillez, Ford, Gold, Butler & Young, LLP

Carolyn Corcoran, J.D. Principal, James P. Corcoran, LLC

Nancy Neveloff Dubler, LL.B. Consultant for Ethics, New York City Health and Hospitals Corporation Professor Emerita, Albert Einstein College of Medicine

Paul J. Edelson, M.D. Professor of Clinical Pediatrics, Columbia College of Physicians and Surgeons

Joseph J. Fins, M.D., M.A.C.P. Chief, Division of Medical Ethics, Weill Medical College of Cornell University Rev. Francis H. Geer, M.Div. Rector, St. Philip’s Church in the Highlands Samuel Gorovitz, Ph.D. Professor of Philosophy, Syracuse University Cassandra E. Henderson, M.D., C.D.E., F.A.C.O.G. Director of Maternal Fetal Medicine Lincoln Medical and Mental Health Center Hassan Khouli, M.D., F.C.C.P. Chief, Critical Care Section, St. Luke’s – Roosevelt Hospital Rev. H. Hugh Maynard-Reid, D.Min., B.C.C., C.A.S.A.C. Director, Pastoral Care, North Brooklyn Health Network, New York City Health and Hospitals Corporation John D. Murnane, J.D. Partner, Fitzpatrick, Cella, Harper & Scinto *Samuel Packer, M.D. Chair of Ethics, North Shore-LIJ Health System *Barbara Shack Health Policy Consultant Robert Swidler, J.D. VP, Legal Services St. Peter's Health Partners Sally T. True, J.D. Partner, True and Walsh, LLP

*indicates former member

Task Force on Life and the Law Staff

Susie A. Han, M.A., M.A. Project Chair of Guidelines, Deputy Director, Principal Policy Analyst

*Beth E. Roxland, J.D., M.Bioethics Former Executive Director

Valerie Gutmann Koch, J.D. Special Advisor, Former Senior Attorney

*Angela R. Star Former Administrative Assistant

*Tia Powell, M.D. Former Executive Director

• Carrie S. Zoubul, J.D., M.A. Former Senior Attorney

*indicates former staff

11 Executive Summary

Ventilator Allocation Guidelines

Chapter 1: Adult Guidelines ……………………………………………………………….........

Chapter 2: Pediatric Guidelines …………………………………………………………………

Chapter 3: Neonatal Guidelines ………………………………………………………………..

Chapter 4: Implementing New York State’s Ventilator Allocation Guidelines: Legal Considerations…………………………………………………………………………...

Clinical Ventilator Allocation Protocols

Appendix A: Adult Clinical Ventilator Allocation Protocol ...………………………………...

Appendix B: Pediatric Clinical Ventilator Allocation Protocol ……………………………….

Appendix C: Neonatal Clinical Ventilator Allocation Protocol …………………………….....

13 Chapter 1: Adult Guidelines Abstract

ventilator. The decision to use a triage officer or committee is left to each acute care facility (i.e., hospital) because available resources will differ at each site.

In addition, the Task Force recognized the pitfalls of an allocation system. These pitfalls include using emergency planning as a method to resolve long-standing disparities in health care access, rigid clinical protocols that are unable to adapt to real-time data, quality of life judgments that may impose on the rights of the disabled, and the reluctance to withdraw ventilators from patients.

In its consideration to protect vulnerable populations, i.e., ventilator-dependent chronic care patients, the Task Force determined that these individuals are subject to the clinical ventilator allocation protocol only if they arrive at an acute care facility for treatment. Once they arrive at a hospital, they are treated like any other patient who requires ventilator therapy. This policy balances the need to protect vulnerable populations with the principle of treating all patients in need of a ventilator equally. The unacceptable alternative would be to triage all stable, long-term ventilator-dependent patients, which may result in likely fatal extubations, and it would violate several principles of the ethical framework underlying the Guidelines.

The Task Force explored various non-clinical approaches to allocating ventilators, including distributing ventilators on a first-come first-serve basis, randomizing ventilator allocation (e.g., lottery), requiring only physician clinical judgment in making allocation decisions, and prioritizing certain patient categories (i.e., health care workers and patients with certain social criteria). However, the Task Force determined that these approaches would not be the best primary method to allocate scarce resources because they are often subjective and/or does not support the goal of saving the most lives. Furthermore, advanced age was rejected as a triage criterion because it discriminates against the elderly. Age already factors indirectly into any criteria that assess the overall health of an individual (because the likelihood of having chronic medical conditions increases with age) and there are many instances where an older person could have a better clinical outlook than a younger person. Thus, the Task Force concluded that a ventilator allocation protocol should utilize clinical factors only to give patients who are deemed most likely to survive with ventilator therapy an opportunity for treatment. After reviewing various clinical protocols, the Task Force developed New York’s clinical ventilator allocation protocol for adults.

Before the adult clinical ventilator allocation protocol is implemented, facilities must develop surge capacity to reduce the demand for ventilators when a pandemic is occurring. Steps must be taken to conserve scarce resources, such as equipment and staffing, by limiting elective procedures that require ventilators and by adjusting staff-to-patient ratios. Once the clinical ventilator allocation protocol is implemented, it should apply Statewide to reduce inequalities of ventilator access and distribution among facilities and to ensure that the same resources are available and in use at similarly situated facilities. Furthermore, the adult clinical ventilator allocation protocol applies to all acute care patients in need of a ventilator, whether due to influenza or other conditions.

The adult clinical ventilator allocation protocol applies to individuals 18 years old and older in acute care facilities Statewide and consists of three steps:

14 Chapter 1: Adult Guidelines Abstract

 Step 1 – Exclusion Criteria: A patient is screened for exclusion criteria, and if s/he has a medical condition on the exclusion criteria list, the patient is not eligible for ventilator therapy. Instead, a patient receives alternative forms of medical intervention and/or palliative care.

The purpose of applying exclusion criteria is to identify patients with a short life expectancy irrespective of their current acute illness, in order to prioritize patients most likely to survive with ventilator therapy. The medical conditions that qualify as exclusion criteria are limited to those associated with immediate or near-immediate mortality even with aggressive therapy. While selecting medical conditions that qualify as exclusion criteria is challenging, this list makes essential contributions to the goals of efficient ventilator distribution and saving the most lives. In the Draft Guidelines, resource utilization (i.e., renal dialysis) was a consideration, but the revised Adult Guidelines removed resource intensive medical conditions because of the lack of correlation to a patient’s likelihood of survival.

 Step 2 – Mortality Risk Assessment Using SOFA (Sequential Organ Failure Assessment): A patient is assessed using SOFA, which may be used as a proxy for mortality risk. A triage officer/committee examines clinical data from Steps 1 and 2 and allocates ventilators according to a patient’s SOFA score.

A clinical scoring system, SOFA, is used to assess a patient’s likelihood of survival. SOFA is simple to use, with few variables or lab parameters, and the calculation of the score is straightforward, which makes SOFA a good tool to provide a consistent, clinical approach to allocate ventilators. A SOFA score adds points based on clinical measures of function in six key organs and systems: lungs, liver, brain, kidneys, blood clotting, and blood pressure. A patient’s SOFA score determines the level of access (high, intermediate, or low) to ventilator therapy.

 Step 3 – Time Trials: Periodic clinical assessments at 48 and 120 hours using SOFA are conducted on a patient who has begun ventilator therapy to evaluate whether s/he continues with the treatment. The decision whether a patient remains on a ventilator is based on his/her SOFA score and the magnitude of change in the SOFA score compared to the results from the previous official clinical assessment.

Periodic evaluations are necessary to determine whether the therapy is effective for a patient while allowing for efficient allocation of scarce ventilators. Time trials are necessary because they provide as many patients as possible with sufficient opportunity to benefit from ventilator therapy. The use of time trials ensures uniform official assessments and provides valuable information about the status and real-time availability of ventilators. Until data about the pandemic viral strain and clarification of a more precise time trial period for adults become available during a pandemic, 48 and 120 hours were selected at this time.

A triage decision is made based on a patient’s SOFA score, which reveals: (1) the overall prognosis estimated by the patient’s clinical indicators, which is indicative of mortality risk by revealing the presence (or likelihood), severity, and number of acute organ failure(s), and