The current flu epidemic, with the attendant state of medical
emergency, reminds us of the critical role of hospitals and staff
in protecting public health. News reports describe the overwhelmed
hospital resources, from the numbers seeking emergency assistance
and the reduced hospital staff, who are themselves suffering from
the flu. These developments shed even more glaring light on recent
protests reported in the media, by hospital nurses refusing
mandatory immunization as well as wearing protective masks as a
barrier to disease transmission. Hospital administrators must
continue to enforce the immunization policy; it is a significant
and appropriate measure to protect patients, the public and in
fact, other staff, from substandard practices. Immunization and
regular testing of hospital staff for contagious disease is well
established as the standard of care in today's hospitals.
Massachusetts hospitals must provide the vaccines to staff free of
charge.1 To ignore these standards, or claim they are
not necessary, is to return the health care system to the days of
"Typhoid Mary," a prospect which no one welcomes.
These immunization policies are required on both the federal and
state levels. The United States government, still the standard
bearer for global health, through the Food and Drug Administration,
the Centers for Disease Control and the National Institutes of
Health, along with the World Health Organization and innumerable
other well-recognized international agencies, have all recognized
how invaluable vaccination can be. Preventing a disease or an
outbreak is simply preferable to treating it when it arrives.
There are persons for whom immunization is counter-indicated --
a small minority for whom the benefits of the vaccination are
outweighed by imminent risks to the patient -- those individuals
who have an allergy to the ingredients in the vaccine, those
receiving chemotherapy, those who have had an organ transplant and
the like. For the vast majority of individuals, particularly those
in the "vulnerable" group -- those over 60 and under 18, or those
with chronic conditions such as asthma and diabetes, the value of
the immunizations far outweighs the risks.
Additionally, there is a long-standing recognition that
hospitalization is the third leading cause of death in the United
States. This statistic does not refer to deaths which are the
expected outcome of disease or trauma and reflect the diagnosis or
condition for which the patient was admitted. The statistic refers
instead to iatrogenic disease -- disease that is actually caused by
or due to medical treatment. High on the list of iatrogenic disease
is nosocomial infection, which refers to infections transmitted to
patients already in the hospital.2 These findings
provide more than adequate support for the guidelines found in the
State Operations Manual. This manual, published by Centers for
Medicare and Medicaid Services, governs facilities receiving
Medicare and Medicaid funds. CMS, through the manual, requires
hospital administrators to evaluate staff for immunization status
for designated infectious disease, develop policies to screen staff
for infections likely to cause significant infectious disease or
other risks, and also to develop policies stating when infected
staff are restricted from providing direct patient care or required
to remain away from the facility entirely.3 Since
absences can disrupt patient care, preventative measures including
immunization, become more important.
The commonwealth has clearly articulated policies on vaccination
of healthcare personnel. The Massachusetts regulations require that
personnel be vaccinated, whether working in hospitals, clinics, or
long-term care facilities.4 Massachusetts hospitals are
required to provide or arrange for vaccination at no cost to any
personnel, as noted above. There are allowed exceptions to the
vaccine, where it is medically contraindicated, is against the
individual's religious beliefs, or if the individual declines the
vaccine, and in the case of refusal, the individual must
acknowledge in writing the consequences of such
refusal.5 The mandate does not violate individual
sovereignty, but does require a hospital take appropriate alternate
measures to protect staff, patients and the public.
Operating within the inoculation guidelines, medical staff is
the group most qualified to assess the benefits and risk of any
particular medication, including vaccines, for either the public at
large or for any specific individual. All medication approved by
the FDA is accompanied by the required labeling which is written
for the prescribing practitioner, not the patient. Labels contain
at a minimum, the risks, benefits, counterindications, and all
other relevant information which guide the prescriber in
determining whether or not a product is appropriate for a patient.
For those administering the medication, and not prescribing, the
label still has value, because it alerts the nurse or pharmacist
administering the dose to potential risks and side effects. All
medical practitioners are expected to report to FDA any
irregularities in the medication container, its color, and any
adverse event or problem experienced by the patient for follow
The progress made in fighting infectious diseases, the on-going
challenges in protecting hospitalized patients from adventitious
diseases and the continuing quest for improvement in the US health
care system require nothing less than universal and aggressive
health care standards for medical professionals. These requirements
are, in the author's opinion, among the most appropriate means to
protect patients, medical staff and the public at large.
2Starfield, Barbara MD, MPH. "Is US Health Really the Best in
the World?" JAMA 2000; Vol. 284 No. 4: 483-485; See also Grisanti,
Ronald, D.C., D.A.B.C.O.; MS, Iatrogenic Disease: The Third
Most Fatal Disease in the US, at www.yourmedicaldective.com/public/335.cfm;
accessed Dec. 11, 2012.
at pg 150ff; accessed Dec.11, 2012.
4See 105 CMR Secs 130, 140 and 150 respectively.
5105 CMR 130.325(F).
Josephine Babiarz is a member of the MBA Health Law
Section Council. She is solely responsible for the views expressed
in this article.