New York State Ventilator Allocation Guidelines: Legal and Ethical Dilemmas in the Materialization of Policy

ELIZA YADAV

Introduction 

     COVID-19, a new deadly virus which attacks the human respiratory system, has rapidly spread to 210 countries and over 2 million people worldwide since the first confirmed outbreak in Wuhan, China [1]. Externalities of the virus have included economic recession, unemployment, and medical resource scarcity, among many others. One of the largest issues currently concerning policymakers and medical workers is that ventilators are running out in New York City, the epicenter of the COVID-19 outbreak in the United States [2]. 

    Ventilators serve a life-saving function for individuals who cannot breathe on their own by taking over the work of breathing through mechanical ventilation [3]. Without them, thousands in critical care may face preventable deaths during the ongoing pandemic. In light of this medical emergency, policymakers and medical workers are questioning the ethical and legal implications behind ventilator allocation. Implications include who creates policy, who makes the decisions on allocation, and what legal form such protocol should take. This paper delves into some of those issues and investigates the ethics, justification, and feasibility of the New York State Ventilator Allocation Guidelines, a source of “soft law.” This paper asks what is the ethical and logical reasoning behind ventilator allocation, and how should this reasoning concretely materialize to save lives during the COVID-19 pandemic? 

What are the New York State Ventilator Allocation Guidelines and how do they work?

     In 2015, the New York State Task Force on Life and the Law in the Department of Health created a set of Ventilator Allocation Guidelines (the Guidelines) in anticipation for a flu epidemic that may infect thousands and overload the city’s health system. In light of the ongoing pandemic, some New York City hospitals have begun considering the implementation of this system. With the primary goal of “[allocating] limited resources … while saving the most lives” the Guidelines include neonatal, pediatric, and adult criteria to make it easier for medical professionals to decide who gets a ventilator and who does not during a crisis [4].

     The Guidelines achieve their primary goal through prioritization of ventilator therapy to patients for whom it would be most lifesaving. In adults, the guidelines involve three steps: (1)application of exclusion criteria, (2)assessment of mortality risk, and (3)periodic clinical assessments [4]. In the first step, patients who have a medical condition that will result in immediate or near-immediate mortality, despite medical therapy, are excluded from receiving a ventilator. Examples include an individual who reports to the emergency room with a severe head injury and COVID-19, and will most likely die in the next couple hours, despite everything doctors can do for him. In the second step, patients who have a moderate risk of mortality and for whom ventilator therapy would be most-likely lifesaving are prioritized. Risk of mortality is measured through the Sequential Organ Failure Assessment {SOFA}, which is used to determine the survival rate of patients in critical care. The SOFA score tracks a patient’s organ function or rate of failure by providing a quantitative score of the patient’s lung, heart, kidney, liver, brain, and blood-clotting functionalities. A low score means the patient has a higher risk of mortality, and is therefore allocated a ventilator. Finally, the third step involves periodic clinical assessments at the 48 and 120 hour-marks during which a patient is in medical care. The Guidelines call for a SOFA at each mark to determine whether the patient should stay on ventilation or be removed so that another patient may receive the therapy. 

What are some of the ethical and legal implications of the Ventilator Allocation Guidelines?

     A major component of the Guidelines is not in line with the fundamentals of bioethics, a widely used ethical framework to guide medicine and related research. This is because the Guidelines misplace responsibility of allocation from policymakers to healthcare workers. They also incorrectly assume that non-maleficence involves picking and choosing who gets to live or die.

     The Guidelines are structured on five components: duty to care, distributive justice, transparency, duty to steward resources, and duty to plan [5]. Some of these components loosely follow the four fundamentals of bioethics: autonomy, justice, beneficence, and non-maleficence [6]. Duty to care represents the fundamental obligation that healthcare providers have to care for their patients. This is in line with beneficence, the need for healthcare providers to do good for their patient. It is absolutely crucial that the duty to care be included in the Guidelines because this component encourages medical personnel to treat the ill to the best of one’s ability, a baseline responsibility for all who practice medicine –  pandemic or not. 

     Transparency means the Guidelines are a “living” document, and should be constantly updated according to the public opinion of New Yorkers. This is in line with autonomy, the requirement that patients have freedom of thought regarding their own healthcare. The Guidelines were designed to represent the best interest of New Yorkers, so ongoing collaboration with these targeted beneficiaries is fundamental in keeping it that way. Still, questions surrounding how policymakers and the New York public will collaborate to restructure the Guidelines in a time of medical emergency do arise.

     Distributive justice is the requirement that allocation protocol be applied broadly and consistently to ensure fairness for all. It lightly engages with justice, the idea that the burdens and benefits of new therapies be distributed equally amongst all groups [6]. While distributive justice borders on the bioethical concept of justice, it does encourage equal treatment for all, a concept that many medical practitioners and researchers have tried to implement even prior to the Coronavirus. This principle is the last ethically-sound reasoning in the Guidelines, as the prescriptive force of the document soon becomes disjointed through the duty to steward resources.   

     Duty to steward resources is not in line with the fundamentals of bioethics. This duty is the need to manage resources in periods of “true scarcity.” Perhaps the intuition behind inclusion of this component was to instill non-maleficence, the principle of “doing no harm” [6].  However, choosing who gets to live or die through allocation of lifesaving therapy is arguably an extension of “pulling the plug,” a direct contradiction to the aforementioned principle. The main distinction between “pulling the plug” in the context of COVID-19 versus non-pandemic scenarios is that in this crisis, the Guidelines ask healthcare professionals to remove ventilators from patients who are in non-vegetative states and possibly even recovering (but at a slower rate than desired).   

     Further, the third step of the Guidelines specifically asks hospitals to remove ventilators from patients who perform poorly on SOFAs at 48 and 120-hour intervals. While there may be no difference between allocating ventilators to patients and removing ventilators from patients from a public health perspective, there is a massive difference between the two emotionally. Removing a ventilator from an individual to simply allocate it to another during a pandemic in which thousands are suffering a similar plight can be mentally taxing on both the patient’s family and the patient’s medical team. What is the determinate proof that another patient will do better with ventilation therapy when h/she only has a marginally better clinical outcome? The heart of the issue is that these Guidelines are undeniably subjective: while the SOFA is impartial, it is performed by human beings who have flaws. 

     As well, SOFA is only performed at two intervals. The duration and frequency of these intervals is inadequate in relation to COVID-19. The Guidelines state that the 48 and 120-hour intervals were specifically chosen because they reflect the “duration of beneficial treatment for acute respiratory distress” [5]. Doctors at various universities such as Hofstra and Johns Hopkins have found that patients in acute care due to contraction of the Coronavirus take much more time to recover from the illness and therefore require extended intervals [7]. 

What are the concerns behind real-world application of the Ventilator Allocation Guidelines?

     The reality of the Guidelines is that they recommend concrete policy with lethal outcomes in a crisis that could never have been planned for. The Guidelines are outdated, not specific enough to the ongoing pandemic, allocate too much responsibility to busy healthcare workers, and have no concrete form of implementation. The first concern behind the Guidelines is who should decide the policy for resource allocation in times of medical crisis. A positive of the Guidelines is that they were designed by a diverse team of professors, doctors, ethicists, policymakers, and attorneys. This plurality of opinions led to an incredibly detailed and comprehensive plan for dealing with an infectious disease outbreak in New York City. A downside of the Guidelines is that they were written five years ago as a precautionary measure in a world before COVID-19. A reconfiguration of the Guidelines is undoubtedly in order. These changes should include greater flexibility in the determination of a medical crisis, separate allocation guidelines for chronically ill and impaired patients, and a separate protocol for removal of ventilators from patients to minimize patient extubation. In general, as COVID-19 unfolds and real-time data on the pandemic viral strain becomes available, the Guidelines should be regularly updated by some sort of re-writing committee in order to reflect the unique and changing nature of this virus [8].

     The second concern behind ventilator allocation is who should have the authority to make decisions and implement medical supply allocation to patients in times of shortages. The Guidelines rightfully assign this responsibility to individual hospitals and their triage teams but wrongfully privilege healthcare workers with the task of apportion. The triage teams are to be made of healthcare professionals who do not directly treat the COVID-19 patients and solely administer SOFAs [8]. However, in hospitals with existing staff shortages, this may be impossible to do. In addition, it is a stretch to ask healthcare professionals to allocate ventilators when their main priority is to take care of their patients. Many doctors and nurses are already exhausted and overburdened in this pandemic. Calling upon some of them to join triage teams and instead pick and choose which patients live or die on a daily basis may contribute to the burnout and widen the scarcity of medical professionals. 

     A preliminary alternative to ventilator allocation implementation is to have triage teams be made of health statisticians and medical researchers. These people are equipped to analyze data and make objective decisions. This solution will encourage qualified people to join the pandemic response effort instead of bothering busy healthcare workers. 

     The third concern is what legal form ventilator allocation should take. Currently, the Guidelines are voluntary and non-binding [9]. This means that hospitals can choose to follow them or adopt their own protocol. The outcome is a variety of ventilator allocation protocol being implemented across New York City. One implication of this lack of harmonization is the creation of local “medical tourists.” These are people who may opt to go to specific New York City hospitals for the treatment of their COVID-19 because their chances of getting a ventilator at one facility may be higher than at another. Lawsuits regarding preferential access to healthcare and failure to treat may ensue.    

     Ethically, the pre-existing enforcement protocol of the Guidelines is also contradictory to the principle of distributive justice. The allocation protocol of the Guidelines cannot be applied broadly and consistently to ensure fairness for all if different hospitals are following different allocation plans. One solution is a blanket restriction policy, but this has its own weaknesses. Mainly, hospitals and their leadership will have no individual sovereignty. Some debate and contestation are likely, and this is precious time taken away from the COVID-19 response effort.

Conclusive remarks and considerations

     The main ethical reasoning behind the Guidelines is an institutional duty to save lives. Logically, this duty is meant to be fulfilled by healthcare workers and hospitals. In terms of materialization, the Guidelines may be just what the world needs to fight COVID-19 but will first have to be thoroughly edited and ethically re-assessed before being implemented in New York City and beyond. In addition, these Guidelines do not exist in isolation: they have to be complemented with precautionary public health measures such as social distancing and closure of non-essential facilities. These measures should be strictly enforced and publicly adhered to for an extended period of time. Of course, this has not been the case in the United States where many individuals have recently engaged in mass protests against government mobility restrictions and stay-at-home orders [10]. Denmark, Austria, Norway, and Germany have already begun lifting their pandemic lockdowns [11].   

     Still, if the world does not win against COVID-19 in this first and current battle, the virus will most likely return again for a second and even more deadly rematch [12]. Yes, the protocol being used to tackle the pandemic right now is crucial. However, most relevant is the fact that policymakers and governmental leaders learn from this crisis for better management of medical crises in the future. 

 

References

[1] World Health Organization. (2020). “Coronavirus (COVID-19).” World Health Organization. Retrieved from https://covid19.who.int/

[2] Johns Hopkins University. (2020).  “COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.”  Johns Hopkins University. Retrieved from https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

[3] American Thoracic Society. (2020). “Mechanical Ventilation, ATS Patient Education Series.” American Journal of Respiratory and Critical Care Vol. 196, P3-4. Retrieved from  https://www.thoracic.org/patients/patient-resources/resources/mechanical-ventilation.pdf

[4] Zucker, Howard; Adler, Karl; Bleich, Rabbi; et al. (2015). “Ventilator Allocation Guidelines.” New York State Task Force on Life and the Law, New York State Department of Health. Retrieved from https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines.pdf

[5] New York State. (2020). “Frequently Asked Questions: New York State Task Force on Life and the Law and the New York State Department of Health’s Ventilator Allocation Guidelines.” New York State. Retrieved from https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines_faqs.pdf

[6] Beauchamp, T; Childress, J. (2013). “Principles of Biomedical Ethics, 7th edition.” Oxford University Press. 

[7] Hamilton, John. (2020). “Ventilators Are No Panacea For Critically COVID-19 Patients.” NPR. Retrieved from https://www.npr.org/sections/health-shots/2020/04/02/826105278/ventilators-are-no-panacea-for-critically-ill-covid-19-patients

[8] Zucker, Howard; Adler, Karl; Bleich, Rabbi; et al. (2015). “Ventilator Allocation Guidelines.” New York State Task Force on Life and the Law, New York State Department of Health. Retrieved from https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines.pdf

[9] Foggatt, Tyler. (2020). “Who Gets a Ventilator?” The New Yorker. Retrieved from https://www.newyorker.com/magazine/2020/04/20/who-gets-a-ventilator

[10] Rose, Joel. (2020). “Protesters Across the Country Demand COVID-19 Restrictions be Lifted.” NPR. Retrieved from https://www.npr.org/2020/04/20/838297652/protesters-across-the-country-demand-covid-19-restrictions-be-lifted

[11] Bradon, Simon. (2020). “These European countries are starting to lift their coronavirus lockdowns.” World Economic Forum. Retrieved from https://www.weforum.org/agenda/2020/04/these-european-countries-are-starting-to-end-their-lockdowns/

[12] Leung, Kathy; Wu, Joseph; Liu, Di; Leung, Gabriel. (2020). “First-wave COVID-19 transmissibility and severity in China outside Hubei after control measures, and second-wave scenario planning: a modelling impact assessment.” The Lancet. Vol 395, Issue 10233. Pp. 1382-93. DOI: 10.1016/S0140-6736(20)30746-7.