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White Paper Healthcare Organizations Do Not Have the Right to Mandate Flu Vaccines Roger Anderson, Leslie Burgy, Margie Pokorski, and Carolyn SucaetSiena Heights University LDR 650 Medical LawShanna R. Reed, Esq.March 13, 2014 Healthcare Organizations Do Not Have the Right to Mandate Flu VaccinesAs healthcare leaders we enforce the policies and procedures of our organization to ensure compliance and to meet performance standard expectations. In 2012, leaders in our healthcare organization were advised to administer corrective actions for those employees who did not receive a flu vaccine. The corrective action, depending upon the circumstances, could result in termination. This mandate raised questions of both ethical and legal concerns for leaders and the employees that they lead. “Whether vaccination against flu should be mandatory for healthcare workers has been intensely debated since the influenza A (H1N1) pandemic in 2009” (Kong, 2011, p. 9). The opposition declares that “. . . overwhelming scientific, ethical, and legal justifications support mandating healthcare worker vaccination” (Ottenberg, et al., 2011, p. 212). Our position upholds that healthcare organizations should not mandate flu vaccines for their employees. The employee has the right to choose. The premise for which we stand is based upon law which upholds freedom of choice, the right to privacy, and the right to be free from harm. We will support our position and provide justification to reverse hospital mandates for employee flu vaccines by presenting applicable laws, regulatory agency positions, research, and ethical theories. Healthcare organizations need to reverse their mandatory stance on flu vaccines and give employees a choice.History of Flu Vaccines, Mandates, and PrecedentsIn 1796 Dr. Edward Jenner first introduced the vaccination and “he successfully prevented a young English boy from getting smallpox” (Childs & Kansagra, 2007). During the period 1923-1927 additional vaccines were discovered for diphtheria, whooping cough, tuberculosis, and tetanus. “In the 1950s, medical breakthroughs resulted in new vaccines to combat such diseases as polio and measles. States responded by requiring mandatory immunization for schoolchildren. One result was the near eradication of diseases that had previously been crippling or fatal. A second, unforeseen result was adverse side effects of the vaccines, which led to lawsuits against drug companies. Jacobson v. Massachusetts “is considered the seminal case in immunization and public health law” (Randall, Curran, & Omer, 2013, p. 1772).A mandatory vaccination policy first withheld constitutional scrutiny by the Supreme Court in Jacobsen v. Massachusetts, wherein the Court held that four elements should be considered in determining whether a mandatory immunization was justified in the name of public health namely: necessity, reasonable means, proportionality, harm avoidance. (Williams, 2013) The court found that the state’s need to protect the public health took precedence over an individual’s freedom of choice. In 2009, the H1N1 flu pandemic heightened awareness of the need for flu vaccines. “The concern that novel 2009 H1N1 influenza A would spark a particularly severe influenza season in 2009-2010 spurred several institutions and one state to institute mandatory vaccination policies for healthcare workers, and several new mandates have been introduced since then” (Randall, Curran, & Omer, 2013, p. 1771). In 2009, healthcare workers “filed suit against New York State, claiming that the mandate deprived them of liberty without due process and violated their right to free exercise of religion, rights guaranteed by the Fourteenth and First Amendments” (Ottenberg, et al., 2011, p. 212). The suit was halted due to a shortage of the vaccine. Government Agencies Government agencies do not mandate nor do they recommend that hospitals implement mandatory flu vaccines for their employees. “The Joint Commission released an R3 Report, a complimentary publication that provides detailed information about a July 1, 2012, requirement that all Joint Commission accredited healthcare organizations establish an annual influenza vaccination program for licensed independent practitioners and staff” (Newswire, 2012, p. 8). “The Joint Commission standard will not mandate influenza vaccination for staff as a condition of accreditation.” (p. 8). The Center for Disease Control (CDC) provides that the vaccine can enhance patient safety: “However, CDC does not issue any requirements or mandates for state agencies, health systems, or health care workers regarding infection control practices, including influenza vaccination” (Center for Disease Control). In an informal discussion letter dated March 5, 2012 from the U.S. Equal Employment Opportunity Center (EEOC), the EEOC addressed the question of whether or not an employer may compel all of its employees to take the flu vaccine regardless of their medical or their religious beliefs during a pandemic. The EEOC responded “no” and further stated “Generally, ADA-covered employers should consider simply encouraging employees to get the influenza vaccine rather than requiring them to take it” (Mastroianni, Peggy R, 2012, p. 1). The Occupational Safety and Health Administration (OSHA) strongly support the effort to increase the number of healthcare workers vaccinated against influenza in accordance with the Healthy People 2020 goals. However, at this time, “OSHA believes that there is insufficient scientific evidence from the federal government to promote mandatory influenza vaccination programs that do not have an option for healthcare workers to decline for medical, religious and/or personal philosophical reasons” (“NVAC”, 2011, p.25). The position held by OSHA is twofold; first “the limits of current influenza technology is problematic in the context of a mandatory influenza vaccination that results in job loss” and second “a reliance on a mandatory influenza policy may provide healthcare workers…management and patients with an unwarranted sense of security and results in poor adherence to other infection control practices that prevent all types of infection, not just influenza” (“NVAC”, 2011, p.25). Why Mandate? If the Joint Commission, EEOC, CDC, and OSHA do not recommend mandating flu vaccines than what is the motivation for hospital mandates? According to the CDC the effectiveness rate of the 2012/2013 influenza vaccine was reported to be 56% (Williams, 2013). “In comparison, other vaccines which are commonly mandated for health care workers are measles which has a 99% effectiveness rate … and rubella which has a 95% to 99% effectiveness rate (Williams, 2013, p. 3). Although the CDC encourages employers to obtain a 90% influenza vaccination rate of their employees, there are very few studies which investigate the actual incidence of transmittal of the influenza virus to patients from workers in a healthcare setting. A study which reviewed the effects of the vaccine on transmittal from health care workers to elderly patients in five different long term care settings found that there was no evidence that the vaccination of the health care workers protected the elderly patients in their care (Williams, 2013, para. 2). The combination of a low rate of vaccine effectiveness as well as a lack of evidence supporting that health care workers who have been vaccinated indeed prevent their patients from acquiring illness does not support the mandating of the influenza vaccine for health care workers. In spite of actual proof regarding the effectiveness of a mandate to prevent disease transmission, another reason hospitals may choose to mandate employee vaccination is to protect the organization from liability in regards to infection control. Under the doctrine of respondeat superior, a hospital could be found negligent should a patient contract influenza during a hospital stay (Coughlin, King, & Kemper, 2010, p. 5).Employee PerspectiveAnother issue with mandating vaccination for health care workers is the doctrine of informed consent. “Informed consent is a bedrock principle of patient care” and provides that “every human being of adult years and sound mind has a right to determine what shall be done with his own body” (Coughlin et.al., 2010, p. 6). Additionally the doctrine states “it is wrong to force another to act against his or her will” (Coughlin et. al., 2010, p. 6). In order for consent to be valid it must not only be informed, but also voluntarily given: “When an employee is faced with choosing between vaccination and loss of employment; consent to vaccination is coerced and cannot be considered voluntary” (Coughlin et. al., 2010, p. 7). “Employers should recognize that coercion in medicine is antithetical to the patient-centered movement, and that therefore, forcing employees into the patient role is inherently contradictory” (Coughlin et. al., 2010, p. 9). This is why most forms which employees are required to sign prior to receiving the vaccination are only an acknowledgement that the employee has received documentation regarding the risks of the vaccine.The issues of HIPAA relevance are likely not applicable, however this does not preclude other issues of privacy violation. Health systems that offer alternatives to the vaccine such as masks or other external indications have, de facto, identified the confidential health information of their employees. While this is not a violation of their exemption under HIPAA, it is still a violation of the individual’s protected information in a specific form. Violation of Personal Freedom and ChoiceEveryone including healthcare workers have the right to make an informed, voluntary choice regarding vaccines. The choice of submitting to a vaccine “should be an inalienable human right because it involves taking a risk with a pharmaceutical product that could cause harm or even death” (Mercola, 2012, para.18). The National Vaccine Information Center (NVIC), which has a long history of representing the vaccine injured and consumers concerned with vaccine safety, does not advocate for or against the use of vaccines but defends the human right to exercise informed consent to medical risk-taking, including the right for everyone to have access to full information about infectious diseases and vaccines and the freedom to make voluntary decisions about vaccination. (Mercola, 2012, para.1) The Institute of Medicine (IOM) in 2011 published a report, Adverse Effects of Vaccines: Evidence of Causality, which acknowledged “an increased susceptibility for individuals, who have unidentified genetic or other biological high risk factors for adverse responses to vaccination that can lead to permanent injury or death” (Mercola, 2012, para. 3). Because of the IOM statement regarding vaccinations, the NVIC states “a mandatory one-size fits all approach to vaccinations punishes those at greater genetic and biological risk for suffering harm from vaccines” (Mercola, 2012, para. 3). The NVIC also states that:Mandatory vaccination policies without exemption also penalize those holding religious or conscientious belief objections to vaccination. Therefore it is unfair, irresponsible and unethical for employers to force healthcare workers to choose between their health, their deeply held spiritual or conscientious beliefs or their jobs. (Mercola, 2012, para. 3) Federal equal opportunity laws prohibit discrimination on the basis of religion or disability. These laws require that “employers make exceptions to generally applicable work rules to accommodate for an employee’s conflicting religious belief or practice or qualifying mental or physical impairment, unless the accommodation would cause a hardship on the employer’s business” ( Perry & Prenkert, 2013, para. 10). Because of these federal laws healthcare workers objections to mandatory vaccinations must be given adequate consideration, preferably on a case-by-case basis. Even where mandated by state law, provisions have been made for exemption from immunization in a number of manners and by law. Under Title VII of the Civil Rights Act of 1964, most institutions have a pathway in place for exemption based on religious belief, practice, or observance. This is one facet of the class action suit filed January 2, 2014 in Michigan by nurse Karen Bashista who was terminated from her position for refusing the influenza vaccine. She also claimed “health grounds”, referring the questionable efficacy of the vaccine, as well as unfair treatment since she stated that exemptions were granted in some cases (Law Offices of James Elsman, 2014). Other fear of harm cases have emerged. A Pennsylvania pregnant nurse was fired on December 17, 2013 after she refused to be vaccinated for fear of a miscarriage (Malloy, 2013).ConclusionAs the many facets of this discussion have demonstrated, the legal status of mandatory influenza vaccination for healthcare workers remains tenuous. Employee challenges have been presented on the grounds of civil rights and religious freedom violations, questionable efficacy, and rights to privacy. Given such challenges – and the lack of a legal mandate in most states for the vaccinations to occur - one is forced to consider the remaining incentive for hospitals and similar organizations to mandate such steps. This incentive, unfortunately, is financial loss. Under the Values-Based Purchasing provisions of the Affordable Care Act, one performance standard used in determination of a hospital’s incentive payments is the vaccination of healthcare personnel (Health Impact News, 2013). The question then becomes one of dollars versus personal freedom, with the dollars winning thus far. Should dollars trump employee freedom of choice? No, healthcare organizations need to give employees back their freedom of choice and rescind mandatory flu vaccines.ReferencesCenter for Disease Control. (n.d.). Influenza vaccination information for health care workers. Retrieved from , D., & Kansagra, S. (2007, September 20). 10 health advances that changed the world. abc News. Retrieved from , C. N., King, N. M., & Kemper, K. (2010). When doctors become "patients": Advocating a patient-centered approach for health care workers in the context of mandatory influenza vaccinations and informed consent. Wake Forest Law Review. Wake Forest Law Review Association, Inc.Health Impact News. (2013). Are Mandatory Flu Vaccines for Healthcare Workers part of Obamacare and Linked to Financial Reimbursement to Healthcare Facilities? Retrieved February 25, 2014, from Health Impact News: Are Mandatory Flu Vaccines for Healthcare Workers part of Obamacare and Linked to Financial Reimbursement to Healthcare Facilities?Kong, S. (2011). A winter predicament global uptake of the flu jab is low but, argues susie kong, compulsory vaccination is not the answer to cutting infection. Nursing Management, 18(7), 9.Law Offices of James Elsman. (2014, January 24). PR Newswire. Retrieved February 12, 2014, from PR Newswire Services: , A. (2013, December 29). Pregnant nurse: I was fired for refusing flu vaccine. CNN Health. Retrieved from , Peggy R. (2012, March 5). Title vii: Religious Accomodation. EEOC informal discussion letter, 1-5. Retrieved from , J. (2012). Tell your doctor: If you don’t show me this, you’re breaking the law. Retrieved from Vaccine Advisory Committee (NVAC). (2011, September 13-14). National Vaccine Advisory Committee (NVAC) September 13–14, 2011, Meeting Minutes . Retrieved February 25, 2014, from United States Department of Health and Human Services: . (2012). Joint commission r3 report explains new flue vaccine requirements. Healthcare Purchasing News, 36(7), 6.Ottenberg, A., Wu, J., Poland, G., Jacobson, R., Koenig, B., & Tilburt, J. (2011, February). Vaccinating health care workers against influenza: The ethical and legal rationale for a mandate. American Journal of Public Health, 101(2), 212-216.Perry, J., & Prenkert, J. (2013). Clarifying the ethics and law of healthcare employee flu shot refusals. Retrieved from , L., Curran, E., & Omer, S. (2013). Legal considerations surrounding mandatory influenza vaccination for healthcare workers in the united states. Vaccine, 31, 1771-1776.Showalter, J. S. (2012). The law of healthcare administration (6th ed.). Chicago, Illinois: Health Administration Press.Williams, K. L. (2013, May). The variable efficacy of current influenza vaccines result in mandatory flu vaccination policies for heatlh care workers being difficult to justify. Health Law Perspectives: University of Houston Law Center. Retrieved from ................
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