key: cord-0696006-41ivhwm5
authors: Bowen, Raffick A.R.
title: Ethical and organizational considerations for mandatory COVID-19 vaccination of health care workers: a clinical laboratorian's perspective
date: 2020-08-07
journal: Clin Chim Acta
DOI: 10.1016/j.cca.2020.08.003
sha: af80924c4ceaa24a0b3809fa28260888d15bd370
doc_id: 696006
cord_uid: 41ivhwm5

nan

Dear Editor,

The 2019 novel coronavirus pandemic has inflicted substantial disease and economic harm on the world [1] . Clinical laboratory personnel are essential workers and must continue to generate high-quality test results for diagnosis, monitoring, and treating patients. A risk assessment for the clinical laboratory is vital to provide comprehensive information to stakeholders to implement the most effective measures for mitigation of COVID-19 infection among laboratory staff [2] . When a vaccine becomes available, this will raise many ethical questions such as, who should receive the vaccine first? Health care workers (HCWs), including clinical laboratory personnel, will likely be given priority. To ensure high rates of COVID-19 vaccination, healthcare facilities may mandate vaccination, but this should be enacted only after significant ethical and organizational considerations have been weighed. In this letter, I provide a simplistic overview of the ethical theories and principles for mandatory COVID-19 vaccination of HCWs with a focus on clinical laboratorians. The reader is encouraged to seek additional references for a more in depth understanding of this topic [3] . Furthermore, a discussion of legal, religious, economic, political, and regulatory aspects of mandatory COVID-19 vaccination of HCWs is beyond the scope of this letter.

Deontology asserts that a person should adhere to his or her obligations and duties when making an ethical decision, "end/outcomes may not justify the means" [3] . One could argue that HCWs have a fiduciary duty to protect the health of their patients, particularly when precautions are available to prevent the transmission of COVID-19 virus, which would support compulsory 2 COVID-19 vaccination. However, it can also be argued that a HCW's obligations should be overridden when the risk of harm to the HCW is certain, significant, and cannot be adequately mitigated.

Utilitarianism is a form of consequentialism that suggests that the right action is the one that will bring about the greatest amount of good for the largest number of people, "the ends justify the means" [3] . Hence, if all HCWs are required to be vaccinated, this would dramatically reduce the spread of COVID-19 to patients, family members, and the public, and many people would be spared from this illness, and society would benefit. Clinical laboratory personnel, such as phlebotomists, typically collect blood specimens from numerous patients, so they are in a unique position to be infected and transmit the virus to many people. However, mandating vaccination of HCWs would mean that it is acceptable to violate HCW autonomy in exchange for societal good, but this action could erode respect for autonomy, which is a central principle in medical ethics [3] .

Ethical principlism is a widely used moral framework for guiding conduct in healthcare and is relevant to the issue of mandatory COVID-19 vaccination of HCWs. Autonomy, which focuses on an individual's right to self-determination, would argue that competent adults have the right to make their own healthcare decisions, including the right to accept or reject medical intervention [3] . Mandatory vaccination policies would force HCWs to receive a largely unproven vaccine that might not be safe and efficacious and may even increase the severity of the disease [1] . Therefore, strong evidence-based justification would be needed before the infringement of HCW's autonomy with a vaccine that may be potentially harmful [1] . Increased absenteeism of clinical laboratory staff due to the adverse effects of the mandatory vaccine against COVID-19 will be devastating on the healthcare system due to problems with reporting 3 of test results.

Justice focuses on the equitable distribution of benefits, risks, and costs [3] . The principle of justice supports the mandatory vaccination of HCWs to benefit the least advantaged in society [3] . In this way, vaccination of HCWs could offset the disadvantaged individuals like the immunocompromised or those who have medical contraindications to the COVID-19 vaccine. In addition, justice prioritizes equitable treatment for all citizens regardless of socioeconomic factors [3] . Therefore, any mandated COVID-19 vaccination should be widely available and at no cost to HCWs. However, the principle of justice would support an individual's right to refuse vaccination. This is important because mandatory vaccination of HCWs against COVID-19 may carry significant risks. Moreover, if phlebotomists are one of the first individuals in society to receive the COVID-19 vaccine, they may unknowingly spread the virus to patients if the vaccine is shown not to be protective. The COVID-19 virus might mutate in ways that would make prior vaccination of HCW ineffective [1] . If HCWs are severely affected because of mandatory vaccines against COVID-19, this would be unjust due to the unequal distribution of burden to HCWs. A vaccine injury compensation program to address adverse events should be implemented for COVID-19 vaccination of HCWs.

The ethical principles of beneficence and nonmaleficence should be considered when discussing compulsory COVID-19 vaccination. Beneficence requires the individual to only do good to others, and the burden must be low relative to the benefit [3] . Laboratorians apply this principle to ensure that accurate, reliable, and timely test results are produced from all the specimen received in the clinical laboratory. The benefits of mandatory vaccination of HCWs are that patients are less likely to contract and transmit the virus within the healthcare organization, and laboratory staff staying home due to COVID-19 infection is minimized. However, applying 4 beneficence to HCWs is paternalistic because the government's or hospital's external judgment of the best outcome may contradict the HCW's wishes not to be vaccinated [3] . Nonmaleficence means to do no harm [3] . HCWs who are not vaccinated may be indirectly causing harm because they are increasing the risk of COVID-19 infection to patients. However, the principle of nonmaleficence could oppose a vaccine mandate if vaccination carries a risk of significant adverse effects (e.g., respiratory failure requiring ventilation, long-term respiratory deficits) or death [1] . Disclosure of risk or side-effects of COVID-19 vaccination is necessary, especially when the long-term adverse effects of the vaccine may be unknown [1] . Thus, a risk/benefit analysis is needed to justify compulsory COVID-19 vaccination of HCWs. Deciding on mandatory COVID-19 vaccination requires a broad viewpoint and input from many stakeholders. At the hospital level, a multidisciplinary team should be created that 5 includes a representative from the board of trustees, the chief executive officer, a hospital administrator, a director of nursing, a staff nurse, a physician, a virologist and/or microbiologist, an epidemiologist, a member of the clergy (or other religious personnel), a social worker, an attorney, a union representative, a health economist, an ethicist, a layperson from the community, and representatives from different patient advocacy groups. The interests of all parties involved in the hospital should be considered in the ethical assessment of mandatory vaccination of HCWs.

Hospital personnel must use an orderly, systematic, and objective approach to find the best solution for HCW vaccination [6] . Ethical decision-making tools exist to aid in this process, including ethical matrices that provide a standard process for weighing and integrating values, ethical decision-making models, and checklists to identify and analyze the ethical problems. The multidisciplinary team should identify the issues surrounding mandatory COVID-19 vaccination, the available options, and all stakeholders. The team should carefully evaluate this information, set priorities among the options, and consider the consequences of the decisions that they make in the context of organizational ethics [6] . After completing these steps, the team must choose among the various options and act. Once the plan is implemented, the team must evaluate the consequences with both short-and long-term follow-up.

My recommendations for ethically mandating COVID-19 vaccination for HCWs are as follows: organizations should ensure that HCWs fully understand both the empirical and moral rationale for the mandatory vaccination program. Simply imposing a mandate without laying the ethical groundwork is likely to encounter strong resistance. The hospital should adhere to the mandatory public health intervention framework of Kass [6] , which includes the following tenets: (1) there are compelling patient safety concerns; (2) the least restrictive approaches to 

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