Ensure Flu Vaccine Policies, Exemptions Are Clear, Equitable
Hospital pays $74k to settle religious exemption vaccine dispute
By Gary Evans, Medical Writer
After a bad flu season last year, experts are emphasizing the importance of vaccinating healthcare workers as the 2019-2020 season begins. Employee health professionals were rolling out their flu immunization programs as this report was filed.
“It’s that time of year, and we are starting our annual campaign,” says Lydia Crutchfield, MA, BSN, RN, director of employee health at Atrium Health in Charlotte, NC, and president of the Association of Occupational Health Professionals in Healthcare (AOHP).
“The ultimate goal is to protect the patient, your co-workers, as well as yourself and your family,” she tells Hospital Employee Health. “That ends up protecting the community.”
Influenza virus is mutable and unpredictable — thus, the adage in public health that “if you’ve seen one flu season, you’ve seen one flu season.”
Likewise, conventional wisdom holds that the bottom-line measure of vaccine efficacy is keeping people out of the hospital and the morgue. William Schaffner, MD, professor of preventive medicine at Vanderbilt University, drove this point home recently at the annual flu season press conference at the National Foundation for Infectious Diseases (NFID) in Washington, DC.
“It’s critical that we emphasize the importance of partial protection,” he said. “We need to remember that even if you get influenza after having received the vaccine, you are likely to benefit by having a less severe and shorter illness. More important, you are less likely to suffer the complications, including pneumonia, hospitalization, and dying. This part of the story has not been sufficiently told.”
In a separate interview with HEH, Schaffer says the seasonal flu vaccine for 2019-2020 contains strains well matched to circulating virus. “Given the viral strains that were circulating in the Southern Hemisphere — our summer, their winter — we’ve got a pretty good match,” he says. “We need as good a match as we can get for maximum protection. We start out knowing that influenza is an imperfect vaccine. It is good, but not perfect.”
The CDC estimates vaccine efficacy over the last 15 flu seasons as low as 10% in 2004-2005 to a high of 60% in 2010-2011.1 The 2018-2019 vaccine was 29% effective overall after a strain of H3N2 influenza A emerged that was a mismatch with the vaccine.
“The beginning of the flu season was dominated by H1N1 viruses, where we had a pretty good match,” Schaffner says. “Then, all of a sudden, the latter half of the season was dominated by H3N2 viruses. We had a double barrel flu season, and that contributed to its being long. The match was not as good with the H3N2; it never is. That is unfortunate because H3N2 usually causes more severe disease.”
To get the best H3N2 match possible this season, public health officials delayed adding that component to the vaccine from February until March this year. The delay allowed identification of a distinct strain of H3N2 that was growing in the United States. “H3N2 viruses have presented an increasing challenge for vaccine virus selection due to frequent changes in the viruses and difficulties in generating optimal candidate vaccine viruses for use in manufacturing,” the CDC stated in explaining the delay.2
The H3N2 vaccine component in this season’s vaccine is A/Kansas/14/2017. The CDC also added a new H1N1 strain, A/Brisbane/02/2018. Both B/Victoria and B/Yamagata virus components from the 2018-2019 flu vaccine remain the same for the 2019-2020 flu vaccine.
Hospital immunization rates have improved in recent years, driven in part by mandatory policies, education about myths and misinformation, and overall awareness of how vaccines are critical to protect vulnerable patient populations. Hospitals with mandatory requirements immunized 95% of workers in the 2017-2018 flu season, according to a CDC survey.3 However, the same survey showed that one-third of long-term care workers were not vaccinated. (See related story in this issue.)
“It is a patient safety issue,” Schaffner says. “That’s the principal reason healthcare workers should get immunized. I think it is both a professional and ethical obligation for us to be vaccinated.” Vaccination also is critical to ensure healthcare teams can stay on the job and care for a potential upsurge in patients, he says.
As more facilities adopt mandatory vaccination policies, they have to decide whether to allow exemptions. Some require influenza vaccination as condition of employment, while others allow specified exemptions. Medical exemptions may include allergy to vaccine components or a history of Guillain-Barré syndrome.
“We have had a mandatory flu vaccination policy for four years now,” Crutchfield says. “We allow medical and religious exemptions here. If someone completes an exemption form, that’s perfectly fine and makes them compliant with the program. But when flu season is declared by our epidemiologist, if an [unvaccinated] team member is within six feet of a patient, they are required to wear a mask.”
One key to these policies appears to be consistency in making equitable arrangements, as workers denied religious exemptions have successfully sued through the federal Equal Employment Opportunity Commission (EEOC). Memorial Healthcare in Owosso, MI, recently paid $74,418 to settle a lawsuit brought by the EEOC on behalf of a newly hired medical transcriptionist who claimed religious exemption to vaccines.
“Memorial refused to accommodate the sincerely held religious requirement of the transcriptionist, whose Christian beliefs require her to forgo inoculations,” the EEOC stated.4 “The transcriptionist offered to wear a mask during flu season. This was an acceptable alternative under hospital policy for those with medical problems with the flu shot, but Memorial refused to extend it to her. It then rescinded her offer of employment.”
Under the consent decree settling the suit, Memorial will permit those with religious objections to wear masks in lieu of receiving a flu vaccine, the EEOC reported. “The hospital also will train managerial staff participating in the accommodation process on the religious accommodation policy,” the EEOC stated. “In addition, the transcriptionist will receive $34,418 in back pay, along with $20,000 in compensatory damages and $20,000 in punitive damages.”
Considering such cases, healthcare facilities should carefully consider exemption policies and seek legal advice in developing a mandated flu shot program. The EEOC cited the case as a violation of Title VII of the Civil Rights Act of 1964, which requires employers to “provide reasonable accommodations for religious observances and beliefs, absent undue hardship.”
“Employees should not have to check their religious beliefs at the workplace door,” EEOC attorney Dale Price said in a statement. “The transcriptionist’s objection could have been easily accommodated by allowing her to use the mask option utilized by other employees. Nevertheless, Memorial’s revision of its policy is a welcome change that will provide broader accommodations for applicants and employees.”4
Douglas Opel, MD, assistant professor of pediatrics at the University of Washington School of Medicine in Seattle, outlined legal strategies in a review article on flu vaccine mandates and exemptions.5
“In our analysis, we found that hospitals prevailed in lawsuits when they developed ways to accommodate their employee’s religious views and still protect patients,” he tells HEH. It makes sense for hospitals to tailor this accommodation based on where in the hospital employees work, he adds.
“For example, for employees with patient contact, reasonably accommodating them might mean having them wear a mask to prevent them spreading influenza to their patients,” Opel says. “But for an employee without patient contact, it might be reasonable to simply require her to stay home if she had symptoms.”
In general, avoid the appearance of arbitrary or inconsistent vaccination policies that could be perceived as discriminatory by a healthcare worker seeking an exemption, he recommends.
“Influenza vaccination mandates for healthcare workers represent good policy, but heavy-handed, context-free implementation does not,” Opel and colleagues concluded in the paper.
The EEOC’s definition of “religion” includes “moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.” Courts are not bound by the definition, but it is broad enough to create uncertainty about the line between religious and philosophical objections, Opel notes.
In the paper, Opel cited a case involving an employee who sued after being denied a vaccination exemption on the basis of strongly held beliefs in a vegan diet. The hospital filed to dismiss the suit, but agreed to settle after a court ruled it would allow the plaintiff “to try to show that veganism constituted a religious belief.”
“Though the belief need not be theistic, it must relate to ultimate questions, not just vaccines,” Opel and colleagues wrote. “At a minimum, hospitals should feel fairly confident in rejecting mere anxieties about vaccine safety. Providing a religious-belief definition in vaccination policies and explaining what does and doesn’t qualify should also help reduce misguided requests and lawsuits.”
Some hospitals require signoff by clergy regarding a religious exemption, although there have been legal challenges in some of these cases.
“This raises the metaphysical question of ‘What is a religion?’” Schaffner says. “My understanding is that, other than Christian Science, there is no tradition of vaccine avoidance in any of the major religious traditions in the United States. These religious traditions and doctrines were established long before vaccines were developed.”
Amy Behrman, MD, FACP, FACOEM, director of occupational medicine at the Hospital of the University of Pennsylvania in Philadelphia, concurs. “My own opinion is that religious exemptions are rarely justified by scripture,” she says.
While emphasizing that he is a doctor and not a lawyer, Schaffner notes the contrast between religious exemptions in healthcare and the requirements for children to be vaccinated for childhood diseases to attend schools. This issue has come to the fore in recent years due to outbreaks of measles. “When it comes to school vaccination requirements, there are several states now that have eliminated religious exemptions,” he says. “I’m just a lay person, but I don’t quite understand the distinction here.”
The issue is complicated on several levels, including the fact that the flu vaccine changes every year and has varying levels of efficacy. Regarding the religious exemption issue, it also is fair to reiterate the moral imperative of protecting frail patients.
“I am perfectly comfortable managing medical exemptions and certainly think it is crucial to be as evidence-based as possible,” Behrman says. “Religious exemptions are much more challenging.”
There is considerable work involved in exemption reviews to ensure they are performed fairly and to ensure that any administrative policies like wearing a mask are enforced.
“There is a huge amount of work — shout-out to human resources, who need to actually operationalize the administrative policies to make the program work,” Behrman says. “Effective mandates should take you close to 100% [flu vaccination rates]. In our institution, we have just over a 98% vaccination rate every year with about a 1.5% exemption rate.”
Mandatory flu vaccination policies vary, going from work reassignment for the non-immunized, formal declination forms, masking, and immunization simply as a condition of employment.
“My own reading of the literature, primarily in acute care, is that any requirement is a huge and powerful tool for improving immunization rates, and in my view, normalizing them,” Behrman says. “We should normalize the concept of healthcare worker vaccination while acknowledging that there is a spectrum of immunization requirements.”
- Centers for Disease Control and Prevention. Seasonal Flu Vaccine Effectiveness Studies. Available at: https://bit.ly/2lJWv5B.
- Centers for Disease Control and Prevention. Frequently Asked Influenza (Flu) Questions: 2019-2020 Season. Available at: https://bit.ly/2mJwPpS.
- Centers for Disease Control and Prevention. Influenza Vaccination Coverage Among Health Care Personnel — United States, 2017-18 Influenza Season. MMWR Morb Mortal Wkly Rep 2018;67:1050-1054.
- Equal Employment Opportunity Commission. Memorial Healthcare to Pay $74,418 to Settle EEOC Religious Discrimination Lawsuit. June 25, 2019. Available at: https://bit.ly/2kAFhHm.
- Opel DJ, Sonne JA, Mello MM. Vaccination without litigation — Addressing religious objections to hospital influenza-vaccination mandates. N Engl J Med (Perspective) 2018;378:785-788.
As more facilities adopt mandatory vaccination policies, they have to decide whether to allow exemptions. Some require influenza vaccination as condition of employment, while others allow specified exemptions. Medical exemptions may include allergy to vaccine components or a history of Guillain-Barré syndrome. One key to these policies appears to be consistency in making equitable arrangements, as workers denied religious exemptions have successfully sued through the federal Equal Employment Opportunity Commission.
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