Part 2- Ethical Issues the Risk Manager Should Consider in a COVID-19 World: Rationing Healthcare

In Part 1 of the series on rationing services, we looked at the types of healthcare testing and treatment rationing (First Come, First Served; Maximizing Total Benefits; Priority to the Sickest; Social Usefulness; and Combination Approach), who should be the decision-maker and how those decisions are communicated, and some important takeaways for the risk manager. Part 2 will expand on more of the concepts and highlight additional elements of frameworks promulgated by states, clinical risk considerations, communication strategies, and risks of liability.

The language surrounding this pandemic is “war-like” in its bravado. Aggressive and war-like language used to describe a situation can decrease feelings of empathy, compassion, and concern; this emotional disconnect gives opportunity to decrease the considerations of patient rights, patient and family emotional needs, and self-care.[1] It is first important to realize that this is a worst-case scenario for healthcare providers and the medical establishment in aggregate. This is the living embodiment of an ethical thought experiment, fraught with the real “damned if you do, damned if you don’t” situations. Students learning ethical decision-making utilizing thought experiments often refer to them as “ghoulish” and disassociate their discomfort with what real world impacts would look and feel like. These conversations elicit memories of death panels and “playing God.” However, the reality and urgency of these decisions make this a painful truth. As a result, there is no way to ration healthcare in a manner that will leave people feeling “good” about the outcome. Support, structure, and consistency are the keys to moving forward in these trying times.

For the risk manager, there are two primary issues anecdotally discussed: (1) the ethical issues and (2) the operational issues. Ethically, there are a host of concerns that include rationing in light of the mission/values of the institution, managing staff burnout and moral distress, maintaining the physical and mental health of our providers, and the concerns of rationing care. The last topic is explored in this essay but take care to remember the other concerns. Adherence to the ethical foundation and framework of your institution and caring for your staff are critical ethical considerations. From an operational perspective, risk managers should be working with executive and medical leadership to address accessing capacity (human, space, and equipment), instituting disaster plans, communication of status and plans, and monitoring high-risk issues such as rationing, harm, and emergent or catastrophic systems failures. The Hastings Center noted that facilities are faced with the competing moral authorities of care to those in need and promoting equity and fairness but still have three important Duties: Plan (managing uncertainty), Safeguard (supporting workers and protecting vulnerable populations), and Guide (instituting contingency levels of care and crisis standards of care).[2]

Whatever the situation, the ethical consensus on responding to these types of crises is summed up very well by Alex London, Director of the Center for Ethics and Policy at Carnegie Mellon University: “Such agents might agree that in a pandemic, when not everyone can be saved, healthcare systems should use their resources to save as many lives as possible because that is the strategy that allows each person a fair chance of being able to pursue their life plan.”

Frameworks for Rationing Decision-Making. Making decisions in ethical and legal frameworks are critical to the defensibility of the patient outcomes. Since no comprehensive federal guidelines on rationing exist, states are either developing their own guidelines or are silent on the topic. This results in some state recommendations that do not always comport ethical guidelines or will conflict with institutional or community values. In an effort to assist with developing approaches to rationing, there are three principles to consider: (1) equal opportunity and access to care, (2) consistent methodology to utilizing resources, and (3) how and when to stop treatment.

Equal Opportunity/Access. Categorically excluding large groups of patients from receiving ventilator services (i.e. age; intellectual disability; insurance status; wealth or poverty; long-term prognosis; co-morbid conditions like ESRD, class 3 or 4 heart failure, or cognitive decline; etc.) should not be permitted and is fundamentally unethical. John Rawls referred to the act of equality as operating under a “veil of ignorance,” meaning you treat people fairly and do not penalize particular groups regardless of their circumstances. These factors may be considerations in a consistent methodological approach for allocation, but a blanket exclusion is fraught with ethical and legal ramifications.

Utilization of Resources. German philosopher Immanuel Kant asserted the ethical adage “ought implies can,” which means if you can do the right thing, you should. Obviously if you have scare resources, you cannot do what you are unable to do. This is important in the consideration of when you activate a rationing protocol. Rationing protocols should only be activated when a shortage actually occurs or is known to occur in the near future.

To activate this process/protocol, the institution should consider how the assessments are to be conducted and by whom. It is widely recommended that an outside party collaborate with the attending and the clinical team to assist or direct decision-making. One recognized approach is establishing a Triage Team, with a Triage Officer, who applies the allocation process/protocol and removes the attending physician and treatment team from the decision. This principally protects the therapeutic relationship and reduces the moral distress of the front-line providers.[3] Activating the triage team, the authority that team has over direct clinical care, and communication to stakeholders is decided on a facility-by-facility basis. 

Once the rationing process/protocol is initiated, utilize a multi-factored, scored, decision-making allocation framework to triage fairly and consistently the use of a given resource.[4] Some states have recommended or endorsed some methodologies that meet ICU criteria in which patients are triaged and assigned priority scores based on (1) likelihood of surviving the hospital discharge and (2) likelihood of “achieving longer-term survival” given comorbid conditions.[5] One example of this type of framework would be the Sequential Organ Failure Assessment (SOFA) scoring tool. However accomplished, ensure the tool is widely accepted and consistently implemented.

Determine how the team or outside decision-maker reviews the cases. One approach is a structured case presentation by the attending so that information is concise, consistent, and presented by someone capable of answering questions regarding clinical condition and prognosis. Having team member’s access the medical record could result in critical information not reviewed, reviewers going down “rabbit-holes” of information, and potentially increasing liability related to metadata showing who accessed the medical record.

Stopping Treatment. Even in a pandemic, there are basic ethical duties to beneficence (provide care beneficial to the patient) and nonmaleficence (avoiding something that will cause harm to the patient) when either limiting or withdrawing life-sustaining equipment. A key approach would be ensuring a process for ongoing reassessment of patients on ventilation by the Triage Team.[6] This process should include a methodology of reviewing individuals using a ventilator and those in immediate need. Be cautious of rapid cycling and give those started on a ventilator an opportunity to thrive.

Ensure there are appropriate weaning protocols in place and they can be adapted to the complexities of the situation in place.[7] The two common approaches to withdrawal is either immediate removal (extubation) or terminal weaning, both of which are case-by-case and those protocols clearly communicated to the providers and staff.[8] Once removed from ventilator or denied ventilator use, ensure there is appropriate palliative care in place to ease suffering.[9] Having palliative care and social work available during this time could be advantageous to offer support and ongoing clinical planning.

Ongoing monitoring of new and existing cases, care to not rapid cycle patients, access to palliative care, and protocols to weaning are key approaches to managing this difficult time.

Communication of Decisions. With this pandemic, we are in a new paradigm of surrogate decision-making and information sharing. In normal circumstances, surrogates are often at the bedside, speaking frequently with staff and physicians, and “come to a place” to make a difficult decision. Usually the family agrees, preparations made and goodbyes said. In these cases, shared decision-making is not possible, they have limited opportunities to speak with the patient, and often do not get the opportunity to say goodbye. This will increase the anger and confusion felt by the survivors, as well as create moral distress for the providers and staff caring for the patient. A clear and consistent line of communication is critical to effective and safe care as well as in decreasing the moral distress of the front-line providers.

Establishing Expectations. To establish expectations about ventilator use, attending physicians should initially discuss the use of a ventilator as a time-limited approach to meet specific clinical outcomes.[10] These expectations should be documented and clearly articulated to the patient, family, and treatment team. Expectations can be fluid as the clinical condition and the institutional needs change. If the parameters change or is modified based on the clinical presentation, then that should be communicated and documented as well.

Communication of Decisions. There is a variety of approaches to how this can be done and recommendations will vary based on the crisis standards of care you are reviewing. In general, the Triage Officer would notify the attending of the Triage Teams decision. If there is a conflict, this should be resolved before speaking with the patient or family. Conflict between team members can be very disruptive and increase the risks of distress and litigation. Once a decision is reached, the attending and Triage Officer should determine the best approach to communicate to the patient and family. Factors such as relationship with the family and comfort level should be discussed and situationally based.

Options. Option 1 would be the attending solely relaying the information. Even though the provider is not the decision-maker, it could create a situation in which the attending’s moral distress in delivering the news and the family’s response is significantly heightened. Option 2 would be the Triage Officer or a member of the Triage Team or Ethics Committee solely. Though they could effectively speak to the decision-making parameters, there may be a credibility issue in the mind of the patient and/or family since this was not the treating physician. Option 3 would be not having a physician deliver the news but rather a nurse, social worker, or psychologist. This is less than optimal because of both clinical credibility issues and unfair moral distress to the provider. Option 4, which is likely the most optimal, could be collaborative approach in which the attending explains the patient’s clinical condition and the Triage Officer/Representative explains the nature of the emergency and the decision-making process.[11]

Dispute resolution. As complex as the decisions are, so are the heightened emotions and concerns of injustice that will inevitably lead to disagreements and disputes. Having an open and transparent appeals process, defined ahead of time, to resolve conflicts between providers, patients, and families is important to ensure fairness and consistency for all of stakeholders.

Quality of Care Impact. The Hastings Center has warned that as the scarcity of staff, space, and equipment increases, quality of care and safety awareness declines.[12] Though it is not “business as usual,” awareness that short cuts and work-arounds are likely to increase and result in harm, confusion, and frustration when cohesion and alignment is crucial. Though the intent of relaxing some federal and state guidelines is meant to ease burdens placed on facilities and staff, they can affect patient safety and confuse those who are charged with ensuring compliance. Some examples include: allowing newly graduated and unlicensed medical professionals to perform tasks that generally require some level of competency verification, staff acting outside of their scope of practice, adapting equipment to do things they may not have been intended to do without ensuring safety measures and training is in place, staff making their own PPE due to limited supplies, and using hotels or non-healthcare sites as ancillary care sites.

           Awareness that these variations in normal operations exist should be discussed with physicians and staff, and appropriate safeguards instituted. Some states that allow unlicensed nursing school graduates to work on the floor, for example, require them to be supervised by a registered nurse. It is important to communicate that these variations are not the new normal and regular operations will return as soon as possible. In this process, more efficient and safer practices may be discovered. Review those when regular operations return and make policy changes as appropriate.  

           Do Not Resuscitate (DNR) Orders. There has been media coverage and even a mention from the White House Coronavirus Response Coordinator (Dr. Deborah Birx) of recommendations for institutions to initiate DNR orders for COVID-19 patients.[13] A blanket approach to this would certainly create a great deal of concern and distress and great consideration taken when revoking fundamental patient rights, especially when the potential of death exists. Prior to instituting such a policy, engage legal counsel to review the laws and liabilities, and engage your Ethics Committee to ensure that the organization’s values are maintained.  

Risk of Liability. There is a theoretical risk of medical negligence liability to the institution, provider, and members of a triage team and even criminal charges related to removing or withholding a patient from a ventilator.[14] The risks are very low and following approved guidelines and strategies is critical to mitigating these claims. Review the governance structure of the triage team. This team can be placed within the medical staff structure, probably as an ad hoc of an existing Medical Staff Committee under the Bylaws, which could provide some additional legal protections to the team and the provider. As a provider, if asked to participate in a triage team, it could beimportant to clarify with the institution if they will provide any malpractice coverage or premium reimbursement as part of the agreement.

Important Takeaways

·        Review the appropriate state and professional organization Crisis Standards of Care documents for guidance and recommendations.

·        Decide which rationing approach best fits the institutional values, community expectations and institutional capabilities.

·        Develop a decision-making process for the utilization of your limited resources.

·        Ensure your approach addresses: (1) equality opportunity to care, (2) utilization of resources, (3) ending treatment, and (4) ongoing reassessment.

·        Only activate rationing when needed.

·        Determine the decision-making allocation framework the facility wants to utilize.

·        Establish a triage team with a leader or note an independent reviewer.

·        Avoid rapid cycling through brief ventilator use. Ensure that the patient has had an appropriate amount of time of ventilator use to maximize chances of survival.

·        Establish a communication strategy for discussing decision-making.

·        Be vigilant about patient safety concerns that may arise during the situation.

·        Ensure that your Internal Disaster Plan reflects your rationing policy.

·        Develop care for the caregiver programs for your staff. Your team members are your most precious partner and customer and need as much attention as your patients. Assess the mental and physical needs of your team. Remember those who are working from home as well.

[1] Covington C, Williams P, Arundale J, & Knox J. (2002). Terrorism and War: Unconscious Dynamics of Political Violence. New York: Routledge. p77

[2] Berlinger N, Wynia M, et al. (2020). Ethical framework for health care institutions responding to Novel Coronavirus SARS-CoV-2: Guidelines for institutional ethics services responding to COVID -19. The Hastings Center.

[3] White DB & Lo B. (March 27, 2020). A framework for rationing ventilators and critical care beds during the COVID-19 pandemic. JAMA. Published online. https://jamanetwork.com/journals/jama/fullarticle/2763953

[4] University of Pittsburgh (March 30, 2020). Allocation of Scarce Critical Care Resource during a Public Health Emergency.

[5] White DB & Lo B. (March 27, 2020). A framework for rationing ventilators and critical care beds during the COVID-19 pandemic. JAMA. Published online. https://jamanetwork.com/journals/jama/fullarticle/2763953

[6] University of Pittsburgh (March 30, 2020). Allocation of Scarce Critical Care Resource during a Public Health Emergency.

[7]Jordan J, Rose L, Dainty KN, Noyes J, & Blackwood B. (2016). Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: A qualitative evidence-synthesis. Retrieved 04/08/20. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011812.pub2/epdf/full

[8] Szalados JE (2007). Discontinuation of mechanical ventilation at end-of-life: The ethical and legal boundaries of physician conduct in termination of life support. Critical Care Clinics. 23:2

[9] White DB & Lo B. (March 27, 2020). A framework for rationing ventilators and critical care beds during the COVID-19 pandemic. JAMA. Published online. https://jamanetwork.com/journals/jama/fullarticle/2763953

[10] Szalados JE (2007). Discontinuation of mechanical ventilation at end-of-life: The ethical and legal boundaries of physician conduct in termination of life support. Critical Care Clinics. 23:2

[11] University of Pittsburgh (March 30, 2020). Allocation of Scarce Critical Care Resource during a Public Health Emergency.

[12] Berlinger N, Wynia M, et al. (2020). Ethical framework for health care institutions responding to Novel Coronavirus SARS-CoV-2: Guidelines for institutional ethics services responding to COVID -19. The Hastings Center.

[13] Neale, S. (3/26/20). We are now on crisis footing: Healthcare providers weigh do-not-resuscitate protocols for coronavirus patients. Washington Examiner.

[14] Cohen IG, Crespo AM, White DB (April 2020). Potential legal liability for withdrawing or withholding ventilators during COVID-19. JAMA. Published online. doi:10.1001/jama.2020.5442