OSHA strongly opposes feds move to mandatory flu shots for HCWs
OSHA strongly opposes feds move to mandatory flu shots for HCWs
'Could be fired for refusing a flu vaccine that provides little protection'
By Gary Evans, Executive Editor
In a stunning setback to a federal move to mandate seasonal flu shots for health care workers, the Occupational Safety and Health Administration (OSHA) said there is insufficient evidence to warrant such policies and openly questioned the longstanding perception that they make patients safer, Hospital Infection Control & Prevention learned.
"OSHA believes that there must be a very high burden of proof that mandatory programs are not just desirable, but also necessary to protect the public health before the government promotes such a controversial policy that may result in employment termination," stated a letter signed by Jordan Barab, OSHA Deputy Assistant Secretary "While we support the Healthy People 2020 goal of 90% health care personnel (HCP) vaccination as an aspirational goal, we are troubled that some have tried to convert the goal into a mandate. High HCP influenza vaccination rates are generally desirable, but we are unaware of any evidence to support the notion that such a high influenza vaccination rate is also essential to protect patients, and should thus be mandatory."
The OSHA comments were submitted in response to National Vaccine Advisory Committee (NVAC) recommendations drafted by its Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS). (See box, below) An advisory committee to the Department of Health and Human Services (HHS), NVAC was scheduled to meet Feb. 7, 2012. The comment period ended Jan. 16th on the recommendations, but the HHS declined a request by HIC to release all the submitted documents.
Nevertheless, comments obtained from various key sources reveal there is considerable controversy about the NVAC recommendation, which essentially puts mandatory vaccination on the table at the federal level. Presented as sort of a "final option" in a tiered approach, NVAC recommends that facilities "that cannot achieve the 90% influenza goal in an efficient and timely manner, should strongly consider an employer requirement for influenza immunization. HCPIVS also recommends that the Assistant Secretary of Health assure that this recommendation is implemented in HHS facilities and services (including the Public Health Service, HHS staff and Federally Qualified Health Centers) and urge all other healthcare employers to do the same."
As more individual facilities and states began discussing and implementing mandatory flu vaccinations in health care settings, Assistant HHS Secretary of Health Howard Koh asked NVAC to explore the issue and make a recommendation. They have — at least in an initial draft — but OSHA urged that the mandatory recommendation be stricken from the text. "OSHA believes the report should clearly state that HCP should not be terminated from employment for refusing the influenza vaccine," Barab noted.
Moreover, OSHA's firm opposition to the provision will further embolden health care unions, several of which questioned the legality of the policy in comments to NVAC.
"Such a premature action would undermine the public's trust in federal vaccine policy," argued William Borwegen, Occupational Health and Safety Director for the Service Employees International Union (SEIU). "The practical effect of voting to adopt [the mandatory policy recommendation] would in essence be to make flu vaccination a mandate for millions of healthcare workers, without NVAC or HHS ever having to go through the typical rulemaking procedures as stipulated under the Administrative Procedures ACT."
SHEA, IDSA back mandatory policy
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. "Several studies demonstrate that immunizing HCP against influenza reduces the risk of patients acquiring the virus from HCP, reducing both morbidity and mortality," the groups noted in a joint statement.1-8
Moreover, the 90% goal is unlikely to be achieved in the absence of such policies, so NAVAC's "tiered recommendations will only result in delays in achieving higher vaccination rates and may result in failures if facilities merely `consider' an employer requirement and do not implement one," the SHEA joint statement read.
"Some critics have argued that employer mandates will lead to a false sense of security and decreased adherence to infection prevention programs," the joint statement reads. "Our Societies strongly support comprehensive influenza educational efforts for HCP and continuation of comprehensive infection prevention and control programs, in addition to employer mandates. Such programs would include identification and isolation of infected patients, adherence to hand hygiene and cough etiquette, the appropriate use of personal protective equipment, and restriction of ill healthcare workers and visitors in the facility."
Strongly concurring in separate comments was the Association for Professionals in Infection Control and Epidemiology.
"We strongly support the report's recommendations and the underlying Healthy People 2020 Annual goal [of 90%]," stated APIC comments signed by current President Russell Olmsted. "As you may know, in January 2011 APIC recommended that acute care hospitals, long term care, and other facilities that employ health care personnel (as defined in the August 2009 MMWR) require annual influenza immunization as a condition of employment unless there are compelling medical contraindications."
However, APIC can expect to fight an uphill battle on the vaccination issue now, including its recommendation that unvaccinated employees wear a surgical mask for patient care. (See related story, below) With OSHA balking, the national momentum toward mandatory seasonal flu shots may stall, though many infection preventionists argue that it is the only way to overcome historically abysmal immunization rates in the 50% range. That, despite a standing Centers for Disease Control and Prevention recommendation for more than 25 years that HCP be immunized. According to the NVAC draft report, "In the 2010-11 influenza season, CDC found that approximately 13% of HCP reported that their employers required influenza vaccination as a condition of employment. Among this group, vaccination coverage was 98.1%, compared to 58.3% among those without an employer requirement."
OSHA would be the likely regulatory agency charged with enforcing any such federal requirement, which may partly explain its forceful comments at the onset. Other federal initiatives are moving forward in any case, with the Centers for Medicare and Medicaid Services (CMS) using its considerable leverage to have HCP influenza immunization rates reported as a quality infection prevention measure to the CDC's National Healthcare Safety Network (NHSN). According to APIC, a new NHSN module has recently been endorsed by the National Quality Forum and is expected to be available for use in August 2012.
"APIC supports use of NHSN to capture HCP influenza vaccination rates in order to capture regional trends on the yearly uptake of the vaccine, prophylaxis and treatment for HCP, and the elements within yearly influenza campaigns that succeed or require improvement," Olmsted said.
Minority Report: OSHA questions integrity'
While the patient safety and ethical justification for such policies is widely embraced in the infection prevention community, OSHA cited studies that raise questions about the efficacy of the vaccine in any given year and the seemingly sacrosanct connection between worker immunization and patient safety. The agency cited a recent study that found only an overall efficacy of 59% for seasonal flu vaccination.9 OSHA observed that there is great variability in the effectiveness of the influenza vaccine in preventing infection, as well as preventing life-threatening illnesses. The vaccine also requires annual reformulation and revaccination, the agency reminded, noting that every year there are numerous circulating strains of influenza that are not included in the vaccine. In years where the antigenic match is good, the vaccine only provides protection against the three strains in the formulation. In years when the antigenic match is poor, the vaccine may provide limited or no protection at all, OSHA argued. The limits of current influenza vaccine technology are especially problematic in the context of a mandatory influenza vaccination program that results in job loss, the agency warned.
"OSHA believes that the [NVAC] report should specifically address the implication of the limitations of current influenza vaccine technology on HCP mandatory vaccination (e.g., that, in some cases, a worker could be fired for refusing the influenza vaccine that provides little protection.)," Barab stated.
In the comments to NVAC, OSHA expressed concern "that minority comments describing insufficient evidence of a link between worker vaccination against influenza and patient safety have not been adequately addressed in the draft report. In order to prevent any allegations concerning the scientific integrity of this report, OSHA requests that the final report include appropriate minority comments."
OSHA cited three recent studies to support its concerns:
- Jefferson, et al.10 states "There is no evidence that they [influenza vaccinations] affect complications, such as pneumonia, or transmission." The evidence-based review also concluded that "At best, vaccines might be effective against only influenza A and B, which represent about 10% of all circulating viruses [that cause influenza or ILI symptoms]."
- Michiels, et al.11 concluded "There is a striking lack of sound evidence for the effect of vaccination on influenza complications such as pneumonia, hospitalization and mortality among individuals with comorbidities."
- Thomas, et al.12 determined that "there is no evidence that vaccinating HCP prevents influenza in elderly residents in LTCFs."
"The scientific literature clearly supports offering the influenza vaccine to workers for the protection of the workers themselves, however OSHA does not believe that at this time the scientific literature adequately supports the notion that vaccinating HCP also provides a significant measure of protection for the patients for whom they care," Barab stated.
Urging that these issues must be "substantively addressed" in the final NVAC report, Barab's comments imply the NVAC subcommittee tried to finesse the issue by giving it short shrift in the report.
"We are concerned that the subgroup has obscured the issues of insufficient evidence of a link between worker vaccination against influenza and patient safety, by addressing the issue at the end of the section on mandatory vaccination and just before the conclusion," Barab stated in the comments. "The strength of association (or lack thereof) between worker vaccination and patient safety is a central and necessary element before contemplating whether mandatory influenza vaccination is an appropriate remedy. Additionally, the ethical and legal arguments associated with mandatory influenza vaccination also rely upon the integrity of the scientific evidence."
While OSHA expressed serious policy concerns about promoting "mandatory-taking" influenza vaccination programs, the agency supported "mandatory-offering" the vaccine in conjunction with education and the use of declination statements. OSHA cited its declination statement used for HCP hepatitis B vaccinations as a best-practice model.
Influenza vaccination exemptions should be allowed for HCP with valid medical contraindication to vaccinations, or religious and/or personal objections," Barab concluded. "In addition, a signed declination statement should indicate that: the HCP has been educated regarding influenza; is aware of the risk and benefits of influenza vaccination; has been given the opportunity to be vaccinated at no charge; and can receive the influenza vaccine in the future, at no cost, should they change their mind. We believe declination statements are an appropriate way that healthcare settings can document employee refusal and employer actions to encourage vaccine acceptance."
References
- Carman WF, et al. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet 2000;355:93-7.
- Salgado CD et al. Preventing nosocomial influenza by improving the vaccine acceptance rate of clinicians. Infect Control Hosp Epidemiol 2004;25(11):923-8.
- 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.
- 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.
- 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.
- 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.
- vanden Dool C et al., Modeling the effects of influenza vaccination of health care workers in hospital departments, Vaccine 2009;27:6261-7.
- Hayward AC, et al. Effectiveness of influenza vaccination of staff on morbidity, and mortality of residents of long term care facilities for the elderly, Vaccine 2011;29(13):2357-8.
- 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.
- Jefferson T, et al. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2010;(7)(7):CD001269.doi: 10.1002/14651858.CD001269.pub4.
- Michiels B, et al. A systematic review of the evidence on the effectiveness and risks of inactivated influenza vaccines in different target groups. Vaccine 2011;29(49):9159-9170.eoi:10.1016/j.vaccine.2011.08.008.
- Thomas RE, et al. Influenza vaccination for healthcare workers who work with the elderly: Systematic review. Vaccine 2010;29(2):344-356.doi:10.1016/j.vaccine.2010.09.085.
NVAC issues five recommendations The National Vaccine Advisory Committee (NVAC) flu recommendations were drafted by its Healthcare Personnel Influenza Vaccination Subgroup. NVAC is an advisory committee to the Department of Health and Human Services (HHS). The key recommendations in the draft are summarized as follows:
Editor's note: To review the full NVAC draft and/or comment on the guidelines go to: http://1.usa.gov/yoIe5W |
Mask policies: Pt safety or punitive measure? Unions object to 'illogical' policy As part of its mandatory flu vaccination policy, the Association for Professionals in Infection Control and Epidemiology recommends that health care workers that cannot be immunized should wear surgical masks when caring for patients or working with susceptible staff. This practice, which is already in place at some hospitals, was singled out for criticism by worker union officials in comments to National Vaccine Advisory Committee (NVAC) regarding new flu recommendations. The committee did not take a position on such masking policies, deferring to individual facilities to adopt the specifics of mandatory vaccination policies.
Robbins coalition is comprised of 28 local unions representing some 95,000 frontline employees of the Kaiser Permanente health system. Since the flu vaccine is typically only 59% effective in a given flu season, and since there are many influenza like illnesses (ILI) that cannot be prevented by the flu vaccine, then many workers who are vaccinated can and will get the flu or other ILIs, Robbins argued. "The logic of the situation tells us that it is not 'just' unvaccinated workers who are at risk of being a pre-symptomatic case of ILI (one of the justifications we've been given for such policies)," she said in comments to NVAC. "Both vaccinated and unvaccinated HCW could be a pre-symptomatic ILI case. By this logic every health care worker should be masked every day during flu season. We are not claiming this is a path that should be followed, but this is the direction logic leads us if we accept that the vaccinate-or-mask policy makes sense." Robbins also expressed concern that the masking policies actually could contribute to transmission if a worker never changes the mask throughout the course of patient care. "We wish the report and recommendations had reviewed and commented upon the safety and appropriateness of this type of requirement for vaccine refusal," she noted. |
"The 'vaccinate or mask' option some hospitals and county health departments (including San Francisco, Sacramento and Yolo counties in California) are requiring is not based on evidence of effectiveness," stated Margaret Robbins, MPH, National Director of the Occupational Safety and Health Coalition of Kaiser Permanente Unions, in comments to NVAC. "There is no scientific evidence that the routine wearing of surgical masks by unvaccinated healthcare workers protects either patients or the wearer of the mask from getting the flu. We believe this practice is intended to coerce and intimidate workers into getting vaccinated, and is not grounded in thoughtful analysis of whether the practice of daily mask wearing protects anyone."Subscribe Now for Access
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