A house divided: A muddled mandate on health care worker flu shots goes to HHS

Infection control, occ health renew historic clash

By Gary Evans, Executive Editor

After considerable controversy that included strong objections by the nation's leading occupational health agency, a federal vaccine committee has approved a recommendation that health care facilities strongly consider mandatory flu immunization of workers if voluntary efforts fail to achieve high vaccination rates.

However, in doing so, the National Vaccine Advisory Committee (NVAC) made it perfectly clear that individual facilities can broadly define exemptions to their mandated flu shot policy. As a result, while occupational health groups and worker unions originally feared and fiercely resisted draconian policies, it is the infectious disease community — which has long favored mandates in the name of patient safety — that is left to assess a lost opportunity.

William Schaffner, MD"I thought it was very unfortunate," says William Schaffner, MD, chairman of the Department of Preventive Medicine at Vanderbilt University Medical Center. "To me, either it's mandatory or it ain't. This actually stops one step short of mandatory. If you start issuing exemptions and some institutions [include] 'personal beliefs' — that's an exception you can drive a truck through. I saw this as a weakening of NVAC's resolve."

NVAC is an advisory committee to the Department of Health and Human Services (HHS), which now is considering action on the approved committee recommendations. Drafted by NVAC's Healthcare Personnel Influenza Vaccination Subgroup (HPIVS) the recommendations included the language that lit the fuse — that facilities failing to reach a 90% immunization level "in an efficient and timely manner, should strongly consider an employer requirement for influenza immunization." The full panel approved the draft recommendations with some word-smithing and revisions at a Feb. 8 meeting, but as this issue of HIC went to press neither NVAC nor the HHS had released the exact wording of the final recommendations. The issue has been divisive, as evidenced by the comments submitted to the committee.

Though the end result was too equivocal for his taste, Schaffner emphasizes that the NVAC action still puts the mandatory policy option on the table as a federal-level recommendation.

"There are a growing number of institutions around the country that have successful mandatory programs," he says. "It will be that local pressure more than anything else that will drive institutions in this direction. However, having these kind of 'green lights' at a national level will provide the advocates of mandatory immunization further rationale and ammunition to use in their local discussions."

Committee favored local options

Julie Morita, MDIn terms of the exemption issue, the committee felt it was beyond its charge to specifically define a mandated policy at the local level, says Julie Morita, MD, co-chair of HPIVS subcommittee.

"There are a lot of issues that need to be considered when employers are considering mandates regarding who can be exempted," she tells HIC. "Beyond medical exceptions is there a need for religious, philosophical or personal belief exemptions? Also if people don't accept the vaccine what is the consequence? Do they lose their job, are they required to wear a mask, or are they taken off patient care responsibilities? Also bargaining with unions has to be done at the local level, so for us to make an overarching statement that fit all [facilities] would be inappropriate. We really felt like there should be some local discretion in terms of how these mandates are implemented."

Still, with the support of a cadre of major infectious disease and infection control groups behind it, NVAC voted 12-2 (1 abstention) in favor of the conditional mandate recommendation. Despite the perceived dilution of the policy, HHS approval would give hospitals considering mandatory vaccination policies a top-level federal recommendation to proceed if other methods are not working. In that regard, the vaccination component is only part of a comprehensive flu prevention program recommended by NVAC, says Morita, deputy commissioner of the bureau of public health and safety at the Chicago Department of Public Health.

"We really felt that the healthcare employers and the facilities need to establish a comprehensive influenza infection control program, including education," she says. "Our charge was to come up with evidence-based strategies. If you look at the strategies, there is great value in having comprehensive flu infection control programs. Those programs that can do that often are effective at raising their coverage levels."

Such programs could include education and training about influenza and flu transmission, respiratory hygiene protocols, and screening and isolation of health care personnel and patients with acute respiratory infection, she says. NVAC recommended that such targeted programs be incorporated within the facilities overall infection prevention program.

"The vaccine is just one component of a comprehensive program," Morita says. "This really needs to be incorporated into other aspects of infection prevention. We recognize that this is a patient safety issue."

Standard measures, reporting likely

NVAC also approved a recommendation urging the HHS to support ongoing public health efforts to standardize a method of measuring staff immunization rates. This could eventually lead to comparisons of flu shot coverage between different facilities, something that would probably drive high immunization rates even in the absence of mandates.

"Facilities are going to be under increasing scrutiny, including from the Joint Commission," Schaffner says. "I think the local availability of [flu immunization] data will eventually play a larger role than this NVAC action."

In the interim, though many hospitals have been struggling with this issue for years, NVAC does not want facilities to consider mandatory immunization until they have fully implemented the voluntary options.

"If those things aren't successful in achieving the 90% coverage in a sustained manner or in a timely fashion, then health care facilities really need to think about mandating the vaccine," Morita says. "It is important to realize we are not saying just jump to a mandate right away. People should attempt to use the other methods or other strategies first."

Despite this measured approach, the mandatory option drew strong opposition from the Occupational Safety and Health Administration (OSHA), which urged NVAC to drop the language. OSHA said in comments to the committee that there is insufficient evidence to warrant such policies, even questioning the longstanding perception that worker vaccinations can be definitively linked to improved patient safety.1-3 OSHA's objections were considerably more forceful than the agency's position in 2009, when it issued a "letter of interpretation" regarding mandatory flu shot policies. At that time, OSHA ruled that employers may mandate the vaccination as long as they don't retaliate against employees who have "a reasonable belief" that they would have a serious medical reaction to the vaccine. There was no mention of philosophical or religious beliefs, but if a worker claims to be at risk of "a serious reaction" to the flu vaccine, OSHA says they may be protected under "whistleblower" statutes. However, OSHA appeared to be swayed by new data in its comment to NVAC, particularly a study that showed that the annual seasonal flu vaccine has an average efficacy of only 59%.4 In that regard, OSHA raised the point that workers could be fired for not taking a vaccine that was not even effective.

"While the committee looked at some flu vaccine efficacy data, that wasn't really what we were asked to do," Morita says. "We were asked to come up with recommendations regarding evidence based strategies for achieving the goal of 90% [immunization]. We believe the flu vaccine is an effective tool that can prevent disease among health care workers and can prevent transmission to other workers and patients. Our [final] recommendation is to make a better vaccine so we are acknowledging that the currently available vaccine is not perfect. It is still a good tool and we want to optimize and maximize it."

While OSHA urged dropping the mandatory option in the recommendations, a joint statement by several major infectious disease groups said NVAC should make the mandate even more forceful. The Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS) cited studies that show a protective effect for patients in a joint statment.5-12 Strongly concurring in separate comments was the Association for Professionals in Infection Control and Epidemiology. Many of the infectious disease groups are increasingly making ethical appeals for immunization in the name of patient safety. (See related story below.) Though neither OSHA nor the infectious disease groups got what they wanted, the local exemption policy was seen by some observers as a concession to occupational health.

Mandatory flu shots an ethical obligation

"As strong case in terms of duties and obligations."

Is it unethical as a medical professional to refuse vaccination against influenza? One of the nation's leading bioethicist says it is, indeed, outlining the key issues to be considered in a provocative commentary.1 Arthur Caplan, PhD, professor of medical ethics and health policy at the University of Pennsylvania Center for Bioethics in Philadelphia makes his case via the following arguments:

"First, every code of ethics adopted by physicians, nurses, nurses' aides, social workers, pharmacists, and other health-care professionals states very clearly, succinctly, and loftily that the interests of patients must come ahead of anyone else's. … Whatever one's views about personal rights to choose, unless a valid medical reason exists to not vaccinate, the best interests of the patient trumps personal choice in the hierarchy of self-imposed professional values.

"Second, all health-care workers are obligated to honor the core medical ethics requirement of 'First Do No Harm.' Given the evidence that vaccination prevents disease transmission to the vulnerable and maintains the health of health-care providers which allows them to work, the most fundamental moral requirement in all of health care demands that those in care-giving roles treat influenza vaccination as obligatory. It also requires that those who run health-care institutions and programs act on and implement that principle in the form of making vaccination against influenza a mandatory condition of employment or volunteering.

"Lastly, health-care workers have a special duty towards the vulnerable who cannot protect themselves. This is a duty that is widely acknowledged in professional codes of ethics. Newborn babies, infants, and the seriously immunocompromised can do little to protect themselves against acquiring diseases in hospitals, nursing homes, and home-care settings. Few people pick their health-care providers or even know to ask if they have been vaccinated. Health-care providers have an absolute duty to do what can be done to ensure they do not transmit diseases to those at grave risk who cannot protect themselves. Vaccination against influenza and other communicable diseases is an important step in fulfilling this duty to protect the vulnerable. It takes obvious moral priority over one's personal choice not to be vaccinated or individual delusions about why vaccination is not necessary in dealing with patients who are of necessity highly vulnerable to influenza.

"The case from professional ethics for influenza vaccination mandates is as strong a case as can be built in terms of duties and obligations. However, there is yet still another powerful moral reason to mandate vaccination for all professionals working in health care. By not vaccinating themselves, health-care workers feed vaccine fears, reinforce anti-vaccine sentiments, and set a dismally poor example for the public. Invoking personal choice in the face of obvious patient need for protection and ignoring the overwhelming safety of vaccination simply feeds public distrust of vaccination. At a time when epidemics of measles, whooping cough, and mumps are sweeping through many nations as a result of parental decisions not to vaccinate their children, is it not the duty of every health-care worker to provide a role model of what the right course of action is to take with respect to vaccination?

Reference

  1. Caplan, A. Time to mandate influenza vaccination in health-care workers. Lancet 2011; 378: 310-311.

The IC — Occ Health impasse

"I was not entirely surprised by [OSHA's opposition]," says Schaffner, a longtime infection control and flu vaccine advocate who received the IDSA's Walter E. Stamm Mentor Award last year. "OSHA has never been very interested in influenza immunization let alone mandates. They regard influenza as seasonal and as something that is not distinctively occupational. It's very hard to determine where an employee — and that's their interest of course — acquires an infection."

Dr. Melanie Swift, MDIn a broader view, the controversy reflects the longstanding philosophical rift between health care epidemiology and occupational health, which has been evidenced in previous disputes like OSHA's pursuit of a tuberculosis standard and during the emergence of SARS. At the risk of oversimplification, it is the friction that occurs when patient safety and employee health are perceived at cross purposes. What arises, as observed by former CDC director Julie Gerberding is a "conflict between the traditions and views of two disciplines" anchored in distinctly different paradigms.13 "We have that in microcosm right here at Vanderbilt," Schaffner says. "There are a number of us who are strong advocates of influenza immunization of health care workers. We have spoken nationally and written in favor of mandates if other things don't work. At our same institution we have a valued colleague, Dr. Melanie Swift, who is very skeptical of mandates. We have had some informed discussions about this. There are split opinions about this by highly intelligent and well-intentioned people."

To precisely that point, Swift and some of her occupational health colleagues saw the flexibility lamented by Schaffner as a favorable outcome.

"At first blush, it may seem to people that if you can't get to 90% you should mandate flu vaccine," says Swift, MD, medical director of the Vanderbilt Occupational Health Clinic. "That's really not what it says if you read it closely. The definition for employer requirement that the group created is pretty broad and allows the employer to determine what their requirement and consequences are going to be. I think that flexibility is absolutely crucial."

Swift participated in the NVAC discussions as a liaison member of the subcommittee representing the American College of Occupational Health.

"There are places where a mandatory vaccine program can work," she says. "That's fine for those places. There are places that have different organizational cultures and different organizational structures where that's just not feasible at all. There are variable levels of desire to mandate a vaccine, given the limitations of the current vaccine."

For example, the Mayo Clinic in Rochester, MN, attained an 88% vaccination rate by early January of this year. Mayo has mandatory compliance — but not mandatory vaccination. Employees must receive their vaccine or view an education module and electronically sign a declination statement by the end of January.

"The [NVAC recommendations] were sufficiently vague, and I think appropriately so, to allow each institution to determine what they consider to be a requirement," says Bill Buchta, MD, MPH, medical director of Mayo's Occupational Health Service. "I don't think we can be nationally prescriptive on this."

Writer Michelle Marill contributed to this story

References

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  4. Osterholm MT, et al. Efficacy and effectiveness of influenza vaccines: A systematic review and meta-analysis. Lancet Infect Dis 2012;12(1):36-44. doi:10.10116/S1473-3099(11)70295-X.
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  7. Hayward AC, et al. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ 2006;333(7581):1241-6.
  8. Shugarman LR, et al. The influence of staff and resident immunization rates on influenza-like illness outbreaks in nursing homes. J Am Med Dir Assoc 2006;7(9):562-7.
  9. van den Dool C, et al. The effects of influenza vaccination of health care workers in nursing homes: insights from a mathematical model. PLoS Medicine 2008;5:1453-1460.
  10. Lemaitre M, et al. Effect of influenza vaccination of nursing home staff on mortality of residents: a cluster-randomized trial. J Am Geriatr Soc 2009;57(9):1580-6.
  11. vanden Dool C et al. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine 2009;27:6261-7.
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  13. Gerberding, JL. Occupational Infectious Diseases or Infectious Occupational Diseases? Bridging the Views on Tuberculosis Control. Infect Control Hosp Epi 1993; 14: pp. 686-688.