Health Field Workers Upset by Mandatory Flu Inoculation Rules

The call for health care workers to get inoculated against the latest expected flu viruses is an annual event, happening just about this time every year, at the beginning of flu season. Health care providers are exposed to thousands of already vulnerable patients whose immune systems may be compromised, so it makes sense that they should be urged to take all the precautions they can to avoid infecting their charges. About 50% (give or take) generally opt not to.

Normally, health care workers are allowed to decide for themselves whether they will get a flu shot, but this year is different. One state has made inoculation against the H1N1 and other strains of flu mandatory, and several hospital systems have done the same. Those personnel who would have voluntarily gotten the inoculation may have few beefs with these policies, but many of those who would have chosen not to do so ' along with other groups and individuals who see the new rules as an impingement on personal liberty ' are up in arms.

New York's Rule

Part 66 of the Codes, Rules and Regulations of New York was amended in August of this year by the addition of Subpart 66-3, requiring annual flu vaccinations for almost all health care facility personnel. (Full name: Title 10, Subpart 66-3 Regulation for Hospitals, Diagnostic and Treatment Centers Licensed Under Article 28, Home Care Services Agencies Licensed Under Article 36 of the PHL, Hospice Programs Certified Under Article 40 of the PHL and County Health Departments.) The rule is not a one-year emergency change in response to the H1N1 virus (commonly referred to as swine flue). It is an ongoing rule change that will require New York's health care facility workers to receive flu shots each year, covering whichever types of flu the federal government recommends people receive inoculations for. This year, that means those affected by the New York law must get one shot for the seasonal flu as well as two more for the H1N1 virus.

The requirements of Subpart 66-3 apply to hospitals, diagnostic and treatment centers, home care services agencies, long-term home health programs and hospice programs. It does not apply to nursing homes, adult homes or adult day treatment facilities. Covered facilities are required to document that their existing staff have received their flu vaccinations by Nov. 30, and any personnel hired after that date must have these shots before they begin their employment.

The new rules apply not only to doctors and nurses, but also to anyone else in a health care facility who might come into regular contact with patients or with their health care providers, potentially passing on a flu virus to them. That means that volunteers and contract workers are included under the terms of the law. Those whose job sites are physically separate from patients and their caregivers are exempt. This category might include hospital administrators who do not visit the patient wards, cafeterias or other places where patients or health care workers convene. However, food service workers, maintenance workers and others who come into regular contact with health care providers will have to receive the same flu inoculations as direct health care providers. Some exceptions apply, as when a vaccine is medically contraindicated for a particular individual.

The Backlash

Many medical workers and their representative associations are making it clear that they are not happy with the imposition of the new flu shot requirements of the State of New York, or of individual employers.

The University of Iowa's attempt to impose a flu inoculation requirement on its employees was thrown off schedule in September when the union representing health care workers at the university's medical facilities filed for an injunction. The parties subsequently agreed to submit the issue to a mediator. Similar legal actions have been filed in other states, including Washington, where the large health care employer, MultiCare Health System, is trying to force its workers to get the H1N1 vaccine.

Soon after the law went into effect in New York, hundreds of health care workers marched in protest on the Capitol building in Albany, NY, carrying signs saying, “Stop selling fear! We don't need flu vaccines. My body, my choice!” and “Inmates Have More Rights Than Workers,” among others. At meetings over the summer of the New York State Hospital Planning and Review Council Codes and Regulations Committee the New York State Nurses Association referred to the new rules as a “scorched earth” approach to combating the spread of influenza in health care facilities. On Oct. 9, a group of New York health care providers went to court in Washington, DC, asking the judge to order the federal government not to distribute the H1N1 vaccine. Their claim is that the swine flu vaccine was approved without the legally required testing for safety and efficacy. As part of their suit, they are asking for an injunction against New York's mandated flu inoculations. Meanwhile, a lawsuit has been filed in New York State trial court against the state's health commissioner, brought on behalf of 60,000 New York health care facility workers.

For his part, New York State Health Commissioner Richard F. Daines, M.D., is trying to encourage compliance by allaying fears and appealing to health care providers' sense of duty to their patients. In September, he released an open letter to health care workers in New York State. Its first line reads, “As health care workers, we share one of the proudest traditions of all professions: we put our patients' interests ahead of our own.” He compares the precautions medical personnel are now being asked take with those they took in response to the HIV and SARS epidemics, and says that these precedents evidence a “tradition” that should be adhered to. Dr. Daines' open letter goes on to say:

Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination ' not the 40%-50% rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.

Not Unprecedented

In addition to the medical community, many in the general public are also concerned about their government's ability to require inoculations. Although they might be very happy to know that their medial caregivers are less likely to pass on the H1N1 virus to them, they worry that laws like this make it easier for government to take the next step and say, “Every state resident [whichever state that may be] must be inoculated.” However, allowing the current laws and hospital rules to go unchallenged will not necessarily help prevent this, as there is precedent for just such a mandate.

In Jacobsen v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), the defendant objected to a statewide law allowing local authorities to require all citizens over the age of 21 to be vaccinated when those authorities deemed it necessary. In accordance with the statutes, the board of health of Cambridge, MA, adopted a regulation requiring its adult citizens to receive smallpox vaccinations. The defendant claimed that compulsory vaccination rules were an assault on his liberty and, literally, an assault on his person. The state court nonetheless found him guilty of disobeying the law and fined him the amount set forth in the statutes: $5. The appeal went all the way to the U.S. Supreme Court.

The Supreme Court noted that “the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good.” In deciding that the Massachusetts law should stand, and that the defendant had no protected liberty interest in defying it, the Court concluded:

We are unwilling to hold it to be an element in the liberty secured by the Constitution of the United States that one person, or a minority of persons, residing in any community and enjoying the benefits of its local government, should have the power thus to dominate the majority when supported in their action by the authority of the state. While this court should guard with firmness every right appertaining to life, liberty, or property as secured to the individual by the supreme law of the land, it is of the last importance that it should not invade the domain of local authority except when it is plainly necessary to do so in order to enforce that law. The safety and the health of the people of Massachusetts are, in the first instance, for that commonwealth to guard and protect. They are matters that do not ordinarily concern the national government. So far as they can be reached by any government, they depend, primarily, upon such action as the state, in its wisdom, may take; and we do not perceive that this legislation has invaded any right secured by the Federal Constitution.

Although the Massachusetts law in question did not exempt from its requirements those who were deemed medically unfit to receive the smallpox inoculation, the Court refused to invalidate the law on that basis, because the Jacobsen defendant had shown no such disability. However, the Court reserved the right to invalidate the rule, or similar rules, if a case came before it involving a person who could show an inoculation would likely do him harm.

Conclusion

The flu inoculation requirements imposed by New York law and by individual hospitals and medical centers do exempt from their requirements those who, for medical reasons, should not receive them.

The debate does not stop there, however. Laws and job requirements like those we have discussed run counter to many Americans' idea of personal liberty rights. Although most of us have become accustomed to our schools' requirements that children receive their childhood immunizations before they can attend school, there is one glaring difference between these regulations and some of the new laws and rules pertaining to flu vaccines for health care providers. Schools generally permit un-immunized students to attend if they (or, more likely, their parents) have religious or moral objections to inoculations. Not so many of the newer rules, which could interfere with some people's ability to continue in their chosen profession. The New York State Nurses Association made this point in an open letter issued in response to the state health commissioner's open letter. In it, they said: “The [New York] regulation's impact on the state's shortage of nurses could be significant. There is no exemption for individuals with religious or cultural preferences regarding immunization. This rule effectively blocks these individuals from earning their livelihood as nurses. It's possible that nurses will leave the profession or choose another career because of this mandate; a serious threat at a time when the shortage of nurses in New York State is expected to reach 20,000 within a decade.”

Janice G. Inman is Editor-in-Chief of this newsletter.

The call for health care workers to get inoculated against the latest expected flu viruses is an annual event, happening just about this time every year, at the beginning of flu season. Health care providers are exposed to thousands of already vulnerable patients whose immune systems may be compromised, so it makes sense that they should be urged to take all the precautions they can to avoid infecting their charges. About 50% (give or take) generally opt not to.

Normally, health care workers are allowed to decide for themselves whether they will get a flu shot, but this year is different. One state has made inoculation against the H1N1 and other strains of flu mandatory, and several hospital systems have done the same. Those personnel who would have voluntarily gotten the inoculation may have few beefs with these policies, but many of those who would have chosen not to do so ' along with other groups and individuals who see the new rules as an impingement on personal liberty ' are up in arms.

New York's Rule

Part 66 of the Codes, Rules and Regulations of New York was amended in August of this year by the addition of Subpart 66-3, requiring annual flu vaccinations for almost all health care facility personnel. (Full name: Title 10, Subpart 66-3 Regulation for Hospitals, Diagnostic and Treatment Centers Licensed Under Article 28, Home Care Services Agencies Licensed Under Article 36 of the PHL, Hospice Programs Certified Under Article 40 of the PHL and County Health Departments.) The rule is not a one-year emergency change in response to the H1N1 virus (commonly referred to as swine flue). It is an ongoing rule change that will require New York's health care facility workers to receive flu shots each year, covering whichever types of flu the federal government recommends people receive inoculations for. This year, that means those affected by the New York law must get one shot for the seasonal flu as well as two more for the H1N1 virus.

The requirements of Subpart 66-3 apply to hospitals, diagnostic and treatment centers, home care services agencies, long-term home health programs and hospice programs. It does not apply to nursing homes, adult homes or adult day treatment facilities. Covered facilities are required to document that their existing staff have received their flu vaccinations by Nov. 30, and any personnel hired after that date must have these shots before they begin their employment.

The new rules apply not only to doctors and nurses, but also to anyone else in a health care facility who might come into regular contact with patients or with their health care providers, potentially passing on a flu virus to them. That means that volunteers and contract workers are included under the terms of the law. Those whose job sites are physically separate from patients and their caregivers are exempt. This category might include hospital administrators who do not visit the patient wards, cafeterias or other places where patients or health care workers convene. However, food service workers, maintenance workers and others who come into regular contact with health care providers will have to receive the same flu inoculations as direct health care providers. Some exceptions apply, as when a vaccine is medically contraindicated for a particular individual.

The Backlash

Many medical workers and their representative associations are making it clear that they are not happy with the imposition of the new flu shot requirements of the State of New York, or of individual employers.

The University of Iowa's attempt to impose a flu inoculation requirement on its employees was thrown off schedule in September when the union representing health care workers at the university's medical facilities filed for an injunction. The parties subsequently agreed to submit the issue to a mediator. Similar legal actions have been filed in other states, including Washington, where the large health care employer, MultiCare Health System, is trying to force its workers to get the H1N1 vaccine.

Soon after the law went into effect in New York, hundreds of health care workers marched in protest on the Capitol building in Albany, NY, carrying signs saying, “Stop selling fear! We don't need flu vaccines. My body, my choice!” and “Inmates Have More Rights Than Workers,” among others. At meetings over the summer of the New York State Hospital Planning and Review Council Codes and Regulations Committee the New York State Nurses Association referred to the new rules as a “scorched earth” approach to combating the spread of influenza in health care facilities. On Oct. 9, a group of New York health care providers went to court in Washington, DC, asking the judge to order the federal government not to distribute the H1N1 vaccine. Their claim is that the swine flu vaccine was approved without the legally required testing for safety and efficacy. As part of their suit, they are asking for an injunction against New York's mandated flu inoculations. Meanwhile, a lawsuit has been filed in New York State trial court against the state's health commissioner, brought on behalf of 60,000 New York health care facility workers.

For his part, New York State Health Commissioner Richard F. Daines, M.D., is trying to encourage compliance by allaying fears and appealing to health care providers' sense of duty to their patients. In September, he released an open letter to health care workers in New York State. Its first line reads, “As health care workers, we share one of the proudest traditions of all professions: we put our patients' interests ahead of our own.” He compares the precautions medical personnel are now being asked take with those they took in response to the HIV and SARS epidemics, and says that these precedents evidence a “tradition” that should be adhered to. Dr. Daines' open letter goes on to say:

Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination ' not the 40%-50% rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.

Not Unprecedented

In addition to the medical community, many in the general public are also concerned about their government's ability to require inoculations. Although they might be very happy to know that their medial caregivers are less likely to pass on the H1N1 virus to them, they worry that laws like this make it easier for government to take the next step and say, “Every state resident [whichever state that may be] must be inoculated.” However, allowing the current laws and hospital rules to go unchallenged will not necessarily help prevent this, as there is precedent for just such a mandate.

In Jacobsen v. Commonwealth of Massachusetts , 197 U.S. 11 (1905), the defendant objected to a statewide law allowing local authorities to require all citizens over the age of 21 to be vaccinated when those authorities deemed it necessary. In accordance with the statutes, the board of health of Cambridge, MA, adopted a regulation requiring its adult citizens to receive smallpox vaccinations. The defendant claimed that compulsory vaccination rules were an assault on his liberty and, literally, an assault on his person. The state court nonetheless found him guilty of disobeying the law and fined him the amount set forth in the statutes: $5. The appeal went all the way to the U.S. Supreme Court.

The Supreme Court noted that “the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good.” In deciding that the Massachusetts law should stand, and that the defendant had no protected liberty interest in defying it, the Court concluded:

We are unwilling to hold it to be an element in the liberty secured by the Constitution of the United States that one person, or a minority of persons, residing in any community and enjoying the benefits of its local government, should have the power thus to dominate the majority when supported in their action by the authority of the state. While this court should guard with firmness every right appertaining to life, liberty, or property as secured to the individual by the supreme law of the land, it is of the last importance that it should not invade the domain of local authority except when it is plainly necessary to do so in order to enforce that law. The safety and the health of the people of Massachusetts are, in the first instance, for that commonwealth to guard and protect. They are matters that do not ordinarily concern the national government. So far as they can be reached by any government, they depend, primarily, upon such action as the state, in its wisdom, may take; and we do not perceive that this legislation has invaded any right secured by the Federal Constitution.

Although the Massachusetts law in question did not exempt from its requirements those who were deemed medically unfit to receive the smallpox inoculation, the Court refused to invalidate the law on that basis, because the Jacobsen defendant had shown no such disability. However, the Court reserved the right to invalidate the rule, or similar rules, if a case came before it involving a person who could show an inoculation would likely do him harm.

Conclusion

The flu inoculation requirements imposed by New York law and by individual hospitals and medical centers do exempt from their requirements those who, for medical reasons, should not receive them.

The debate does not stop there, however. Laws and job requirements like those we have discussed run counter to many Americans' idea of personal liberty rights. Although most of us have become accustomed to our schools' requirements that children receive their childhood immunizations before they can attend school, there is one glaring difference between these regulations and some of the new laws and rules pertaining to flu vaccines for health care providers. Schools generally permit un-immunized students to attend if they (or, more likely, their parents) have religious or moral objections to inoculations. Not so many of the newer rules, which could interfere with some people's ability to continue in their chosen profession. The New York State Nurses Association made this point in an open letter issued in response to the state health commissioner's open letter. In it, they said: “The [New York] regulation's impact on the state's shortage of nurses could be significant. There is no exemption for individuals with religious or cultural preferences regarding immunization. This rule effectively blocks these individuals from earning their livelihood as nurses. It's possible that nurses will leave the profession or choose another career because of this mandate; a serious threat at a time when the shortage of nurses in New York State is expected to reach 20,000 within a decade.”

Janice G. Inman is Editor-in-Chief of this newsletter.