Giving It Your Best Shot: Maintaining a Compliant Vaccination Program in the Healthcare Sector

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Workplace vaccination programs are not new. While many focus on influenza, healthcare employers often impose more robust requirements to protect employees and vulnerable patient populations. The Centers for Disease Control and Prevention (CDC) recommends healthcare workers receive several vaccinations, including: hepatitis B; influenza; measles, mumps, and rubella (MMR); varicella (chickenpox); tetanus, diphtheria, and pertussis (Tdap); and meningococcal. Many states have enacted laws requiring such vaccinations for healthcare workers. (The CDC maintains a list of state requirements.) Indeed, because healthcare workers can be at a heightened risk for both exposure and transmission of disease to patients, families, and coworkers, prominent medical groups such as the Infectious Diseases Society of America (IDSA) recommend mandatory vaccinations consistent with CDC recommendations as part of an effective infection prevention and control program.

Recent outbreaks of vaccine-preventable diseases, such as measles and pertussis, have focused public attention on the need for employee vaccine programs. For example, the CDC reports that between January 1, 2019 and August 8, 2019, there were a total of 1,215 confirmed cases of measles in the United States, the highest number since 1994. This is despite the fact that measles was eliminated in the United States in 2000, due to an effective MMR vaccination program. The World Health Organization (WHO) reports that the rise of measles cases is likely due to a decline in people getting the vaccine. (The CDC has additional information about measles and the safety and efficacy of the MMR vaccine.)

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Healthcare institutions are increasingly mandating that employees receive vaccinations, such as Tdap and MMR. But, while mandatory vaccination programs are on the rise, so are challenges from employees. Employee objections to vaccines (strengthened by misinformation about vaccines such as MMR), and thus litigation, have increased in recent years. While employers may not always have to accommodate generalized or unfounded objections to vaccinations, employees do have legally cognizable objections to being vaccinated under certain circumstances. Specifically, the Equal Employment Opportunity Commission (EEOC) takes the position that Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act (ADA) require employers to provide exemptions from mandatory vaccination policies or other accommodations to employees with religious objections and disabilities.

Just as wise employers seek to immunize their workforces from harmful pathogens, employers may also seek to immunize their vaccination programs from common legal claims. Employers may want to take into consideration the following issues:

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Is the vaccination program mandatory?

Will the vaccination program be voluntary, mandatory, or a hybrid based on employee classification and work setting? Voluntary programs are attractive from the standpoint of avoiding employee objections and ADA/Title VII accommodation issues, but compliance rates may be inadequate or the healthcare setting may favor a mandatory program for some or all healthcare workers. Employers may want to consult the CDC’s recommendations, review applicable state vaccination laws, and assess the risks posed in their facilities in coordination with their infection prevention and control programs.

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Is the workforce unionized?

Are nurses or other employees represented by a labor union? Employers with unionized workforces generally must bargain with the unions before imposing mandatory vaccination programs.

Who is covered?

In deciding whether to adopt a mandatory program, what is the scope of the mandate? Is it necessary to require vaccines for all employees (including clerical workers, etc.), or is it more appropriate to reserve the mandatory program for healthcare workers involved in direct patient contact or healthcare workers in vulnerable patient settings, such as the neonatal intensive care unit (NICU), pediatric intensive care unit (PICU), emergency department, or operating room? Some employers may find it more effective to implement a mandatory program with respect to a subset of healthcare workers in patient-contact roles, while offering an incentivized voluntary program to others.

Will the program permit exceptions or accommodations?

What accommodations will be permitted, and what is the process for evaluating such requests? In particular, employers should consider having a process to receive and evaluate employee requests for exemption or accommodation due to disability or sincerely held religious beliefs.

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  • Under the ADA, a reasonable accommodation may be required for an employee with a disability, unless it would result in an undue hardship or a direct threat to the safety of the employee or the public. In these cases, employers can work with their infection-control team to determine the risks of exposure and transmission. For example, with employees objecting to a Tdap or MMR vaccine, the risk for a nurse working in the NICU may be very different than that of an office assistant in the back office. The ADA analysis for undue hardship and direct threat are fact specific and complicated.
  • Under Title VII, an accommodation may be required for sincerely held religious beliefs, unless doing so would pose an undue hardship. Employers should be aware that the EEOC and courts interpret “religion” broadly, and the term is not limited to major faiths but may include “religious beliefs that are new, uncommon, not part of a formal church or sect, only subscribed to by a small number of people, or that seem illogical or unreasonable to others.” Under Title VII, an undue hardship may exist where there is more than a de minimis cost or burden. The EEOC has considered several factors when determining whether an undue hardship exists, such as (1) the assessment of the public risk at that time, (2) the availability of other means of infection control, and (3) the number of accommodation requests.
  • Employers must maintain medical information and vaccination records collected from employees as confidential files in accordance with ADA requirements.
  • State vaccination laws—including where certain vaccines are mandatory for certain categories of healthcare workers—may also be relevant in designing and implementing a workplace vaccination policy.

What types of accommodations would be permitted?

Where an employer decides, after a case-by-case analysis, that an accommodation is required, it may consider is viable in the healthcare setting. Some common options include the following:

  • Requiring an employee to wear a mask, gown, or other safety gear. This option may depend on the nature of the risk, as a mask may be a reasonable accommodation for influenza in some settings, but it may not be sufficient in a setting with particularly vulnerable patients or with other pathogens that have multiple means of transmission.
  • Modifying an employee’s duties to remove at-risk activities, such as direct patient contact.
  • Temporary or permanent transfers to other positions or work areas that do not contain the same risks to patient safety.
  • Providing alternative vaccines. For example, some employees might have religious objections based on the contents of a vaccine itself, such as its use of swine products or fetal cell lines. In some cases, it may be possible to provide an alternative vaccine from a different manufacturer that does not contain the objectionable ingredient.

Healthcare employers may have legitimate reasons for requiring employee vaccinations and may want to give thoughtful consideration to federal and state employment law protections, as well as the objective medical risks applicable to specific employee groups, healthcare settings, and patient populations, before imposing sweeping mandatory policies. Such organizations may consider reviewing their vaccination programs to avoid unnecessary exposure to discrimination claims.

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© 2019, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
For more vaccination legal considerations see the National Law Review Biotech, Food, Drug law page.

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