Ethical & Legal Guidelines

The principles of humanitarianism require both saving lives and prevention and alleviation of human suffering as essential parts of a humanitarian healthcare response during a crisis. The consequences of a public health crisis like COVID-19 vary greatly depending on the causes, location, and vulnerability of the population they affect, but the consequences often include extensive loss of life and physical, psychological, social, and spiritual suffering on a massive scale.

The ethical legal framework for making end of life decisions has not changed during COVID-19.  Public Health Law governs MOLST decisions for the general population, depending on the presence of a valid health care proxy. If a person does not have a valid health care proxy and does not have an intellectual/developmental disability (I/DD), Family Health Care Decisions Act (FHCDA) applies. If a person has an I/DD, Surrogate Court Procedures Act (SCPA) 1750-b applies.

Specific ethical and legal requirements for MOLST decisions apply and have not changed during COVID-19.

• Adults

• I/DD

• Pediatrics

• Authority of a Health Care Agent and Surrogate

Ventilator Guidelines

While much is being written about the appropriate use of ventilators, ethical principles should guide the allocation of scarce resources, particularly ventilators during COVID-19. State laws, regulations and guidance vary and may not align with these principles.

Reviewing current MOLST orders with the patient, or their health care agent or surrogate if they lack capacity is an important step being taken now to deal with a potential surge. For those who do not want to be hospitalized or placed on a ventilator, an appropriate care plan is needed. <<link to Respiratory Support

If there is a shortage of ventilators, large populations of patients from access to scarce intensive care unit (ICU) resources. Decisions should not be made based on patient race, ethnicity, religion, insurance, I/DD or other unrelated issues.

DOH and the New York State Task Force on Life and the Law (Task Force) released updated guidelines for allocating ventilators during an influenza pandemic in New York in 2015. The Ventilator Allocation Guidelines provide an ethical, clinical, and legal framework that aims to assist health care workers and facilities and the general public in the ethical allocation of ventilators during an 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.

The 2015 Guidelines rely upon both ethical and clinical standards in an effort to offer the best possible care under gravely compromised conditions to support the goal of saving the most lives in an influenza pandemic where there are a limited number of available ventilators. In 2015, DOH and the Task Force concluded the Guidelines will assist a triage officer/committee as they evaluate potential patients for ventilator therapy, but decisions regarding treatment should be made on an individual (patient) basis, and all relevant clinical factors should be considered. A triage decision is not performed in a vacuum; instead, it is an adaptive process, based on fluctuating resources and the overall health of a patient. Examining each patient within the context of his/her health status and of available resources provides a more flexible decision-making process, which results in a fair, equitable plan that supports the goal of saving the most lives where there are limited resources.

The Ventilator Allocation Guidelines  establish a protocol that consists of three steps (each of which are discussed in greater detail in the Guidelines):

• 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.
• Step 2 – Mortality Risk Assessment Using SOFA: 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. The sequential organ failure assessment score (SOFA score) is used to track a person’s status during the stay in an intensive care unit (ICU) to determine the extent of a person’s organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
• 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 results from the previous official clinical assessment.

The Ventilator Allocation Guidelines are under review amid COVID-19 but the same ethical and clinical standards apply.  Thus far in NY, there is no evidence that the legislature or the governor intend to delegate reallocation decisions to physicians. In the interim, see current guidelines:

References

• AMA Code of Ethics Crisis standards of care: Guidance from the AMA Code of Medical Ethics
• Bagenstos, Samuel R., May Hospitals Withhold Ventilators from COVID-19 Patients with Pre-Existing Disabilities? Notes on the Law and Ethics of Disability-Based Medical Rationing (March 24, 2020). 130 Yale Law Journal Forum ___ (2020, Forthcoming). Retrieved March 31, 2020
• Coronavirus: Extraordinary Decisions For Italian Doctors – The Atlantic
• de Grooth, H., Geenen, I.L., Girbes, A.R. et al. SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care 21, 38 (2017). https://doi.org/10.1186/s13054-017-1609-1
• DOH and NYS Task Force on Life and the Law Ventilator Allocation Guidelines (2015)
• DOH and NYS Task Force on Life and the Law Update Ventilator Allocation Guidelines Press Release (2015)
• DREDF re Illegality of Medical Rationing on Basis of Disability
• FAQs on the Ventilator Allocation Guidelines (2015)
• HHS directive (March 28, 2020) OCR Bulletin: Civil Rights, HIPAA, and the Coronavirus Disease 2019 (COVID-19)
• Sequential Organ Failure Assessment (SOFA) severity of illness score for hospital mortality Calculator
• Waldman E, Glass M. (2019) A Field Manual for Palliative Care in Humanitarian Crises. Oxford University Press Print Publication Date: Nov 2019 Print ISBN-13: 9780190066529 Published online: Nov 2019 DOI:10.1093/med/9780190066529.001.0001.
• White, D. B., Lo B. (2020). A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic. JAMA. Published online March 27, 2020. doi:10.1001/jama.2020.5046