|
The Smallpox Vaccination Plan: Challenges and Next
Steps
Bill Number: Oversight Hearing
Hearing Date: January 30, 2003
Witness:
William J. Schuler, CEO
Portsmouth Regional Hospital
on behalf of the Federation of American Hospitals
Portsmouth, NH
Testimony:
Good morning, I am William Schuler, President and
CEO of Portsmouth Regional Hospital, of HCA, Hospital
Corporation of America. I would like to take this
opportunity to thank Chairman Gregg, Ranking Member
Kennedy, and others on the Senate Health, Education,
Labor and Pensions Committee for providing me this
opportunity to discuss with you the implications and
concerns raised by the Federal Government’s
smallpox vaccination plan from the perspective of
a community hospital.
Portsmouth, HCA and our trade association, The Federation
of American Hospitals, fully support the Administration’s
decision to provide voluntary smallpox vaccinations
for healthcare workers. We particularly applaud the
Chairman, the Ranking Member and others on the Committee
for their continued advocacy of voluntary vaccinations.
There seems to be widespread recognition that proper
implementation and safeguards will produce an environment
where our nation’s hospitals can provide the
safest patient care and work setting for our patients,
our employees and their families.
We believe that advanced voluntary vaccinations will
provide the best protection to our providers in an
identified smallpox outbreak, and will strengthen
the ability of nurses, doctors and others throughout
the nation to deliver the care that would be needed–care
that would likely stretch for weeks and months following
a smallpox epidemic. By vaccinating these core caregivers,
we enable them to step forward with the assurance
of their own immunity to provide this vital care.
Portsmouth’s Role in Vaccinations
Portsmouth Regional Hospital, a 209-bed full service
facility, is the seventh largest hospital in New Hampshire.
In 1998, we served as one of the four facilities in
the country chosen by the US Department of Justice
to participate in Operation TOPOFF, a nationwide exercise
to test healthcare preparation for mass casualties.
Under the President’s smallpox vaccination
plan, the Department of Health and Human Services
(HHS) will work with state and local governments to
form volunteer Smallpox response teams comprised of
healthcare workers and first responders. Understandably,
much of the efforts have filtered to the hospital
level. As I describe how this vaccination plan is
proceeding, I will highlight the critical issues facing
a community hospital, how we are handling them, and
where we feel further guidance and assistance is needed.
These issues include: 1) Staffing;
2) Treatment of vaccine-related adverse effects; 3)
Communication, Planning and Funding;
4) Liability and Compensation; and 5) Regulatory Requirements.
Allow me to begin by describing the stages of the
vaccination initiative:
Pre-Event Preparations
Stage I
- Step 1 – One “pilot” clinic
that will consist of a very small group of clinical
individuals from two hospitals in the central region
of the state, as well as five to seven members of
the Public Health department vaccination team. (Imminent)
- Step 2 – Five or six vaccination clinics
at sites that have not yet been designated. Approximately
forty core, prescreened healthcare workers from
Portsmouth Regional Hospital will be vaccinated
at this time, twenty nurses and twenty physicians.
(March)
Stage II – Vaccinations will be offered to
all healthcare workers, EMS, First Responders, including
Firefighters and Police. We are not aware of any policy
or guidance from any level of government on this step
or how many workers will be vaccinated. (End of summer
if plan progresses)
Stage III – Vaccinations will be offered to
General Public. Public would, at that time, receive
vaccine from their primary care providers.
Post-Event Preparations
Community Clinics – A collaborative effort led
by the state Office of Emergency Management (OEM),
facilitated by a community team of Fire, Police, State
Department of Health and Human Services employees,
and hospital representatives. This team is charged
with the formulation of a workable plan in which vaccination
of an entire community, consisting of fifty to one
hundred thousand people in our catchment area could
be achieved in ten days following a smallpox outbreak
in the United States.
At Portsmouth Regional Hospital, recruitment of volunteer
physicians and clinical staff, including nurses, radiology
technologists, respiratory therapists, and others
began in our facility in mid-November, 2002. Physicians
were the first to be invited to a classroom-style
presentation by the Chief of Staff, Infectious Disease
Physician, Infection Control Practitioner, Emergency
Room Medical Director and myself. The physicians assumed
the leadership role in the development and implementation
of the voluntary vaccination plan. Educational booklets
and volunteer rosters were distributed to the 150
physician attendees. Approximately twenty-five physicians
volunteered immediately. A similar presentation was
offered the following week to hospital nursing and
ancillary staff, as well as staff from physician offices,
local nursing homes and visiting nurse associations.
An additional thirty clinicians were added to the
volunteer roster. From our volunteer roster, we arrived
at a core group of forty providers for Stage I vaccination,
all from the hospital’s Inpatient and Emergency
Department staff. These volunteers were chosen because
they had previously been vaccinated against smallpox,
screened for contraindications and provided with additional
educational resources. In March, we anticipate that
this core staff will visit area clinics at staggered
intervals to receive the vaccination.
Staffing
As the smallpox vaccination process proceeds into
Stages II and III, Portsmouth faces increasing medical
and staffing challenges. According to a study recently
reported on by the CDC, 36% of adults receiving the
vaccine for the first time will likely be sufficiently
ill to miss work, school, or recreational activities
or have trouble sleeping. Nationwide, this amount
of absenteeism, superimposed on winter illnesses and
a critical nationwide nursing shortage, will surely
exacerbate an already tenuous staffing shortage. Provisions
must be allowed for staggered vaccination schedules
of clinical staff to ensure support of normal hospital
operations. Although our core team of forty staff
has all previously received the smallpox vaccine without
complications, we anticipate that approximately ten
employees may require some time away from their duties.
At this stage, we should be able to cover this level
of absenteeism without impacting patient care. However,
in future stages, as additional staff members are
vaccinated, including those who have not had the vaccine
before, these staffing issues will become of major
significance.
According to the CDC guidelines, hospital responsibilities
include not only program education, screening for
contraindications, and identification of healthcare
workers to be offered vaccine, but also daily vaccination
site assessment and management, and evaluation of
‘takes’. Such site assessment means that
hospitals must provide daily staffing for a twenty-one
day vaccine site assessment clinic. At this stage
of vaccinations (Stage I) at Portsmouth, we would
likely be able to absorb the financial and staffing
burden. However, such a burden might not be so easily
managed in a much larger hospital with a much larger
pool of vaccinees.
Furthermore, in a Stage II setting, when a greater
number of healthcare workers, EMT’s, firefighters
and police are vaccinated, the logistics for staffing,
education, site care, assessment and record keeping
will require state and federal support. They are not
activities that a local community hospital can absorb
with existing staffing. Consideration for extra funding
to State Public Health departments would enable them
to play a much greater role than we have seen to date
in education, screening and post-vaccination site
care, and will ease the vaccination-related staffing
issues which are currently expected to be shouldered
by the hospitals.
Treatment of Vaccine-Related Adverse Effects
If and when mass vaccination (Stage III) within the
community occurs, it is important to recognize that
community health care systems will be severely stressed.
Using published rates of vaccine related complications,
the 50,000 vaccinees in our designated service area
could potentially lead to 5,000 office visits and
up to 500 hospital admissions -- an untenable demand
for a medical community and a 200 bed hospital like
our own. We anticipate the need to coordinate a system
where specialists would help in the evaluation of
the more severe vaccine reactions, discussing and
coordinating homecare for all but the most ill. This
system has been discussed at a State level in theory
only, but has yet to be developed. We will hardly
be unique in this regard. Mass vaccination will create
a volume of ill patients that in most communities
will be unprecedented and profoundly difficult to
manage.
Communication, Planning and Funding
Major issues remain regarding communication and division
of labor. Communication between the State OEM and
local emergency personnel has been sub-optimal. In
the early stages of Community Clinic planning, local
emergency personnel (fire and police) were not adequately
informed about the CDC vaccination plans, or their
responsibilities in such a plan. Initially, hospital
and community responsibilities were stated to be quite
limited. As planning unfolded, responsibilities originally
assigned to the OEM were given to the hospital and
community.
We have communicated this issue to State leaders,
and have learned that the New Hampshire OEM, like
many other states in the country, has received no
additional funding from FEMA. The New Hampshire OEM
remains funded only through the Bioterrorism Grant
and the New Hampshire Department of Health and Human
Services. At a time when state and municipal budgets
are already stressed, there is an understandable reluctance
to take on additional responsibilities without funding.
Furthermore, as is happening nationwide, New Hampshire
is looking for millions of dollars in cuts from the
Department of Health and Human Services in order to
balance the State’s budget. As a result, the
state’s OEM is relying too heavily on the staffing
resources at a local hospital level for planning and
initiation. In order to strengthen overall post-event
planning, the State OEM requires additional funding,
staffing, and resources.
Liability and Compensation
We, as a nation, must ensure that healthcare workers
are protected from personal expense and lost wages
as a result of adverse reaction to voluntary vaccination.
Initially, hospitals and affiliated organizations,
such as physician offices, had significant concerns
about their protection from liability in the case
of adverse outcomes from vaccination, or the rare,
yet potentially devastating, inadvertent spread of
the vaccinia virus to other healthcare workers or
patients. We understand and appreciate the recent
clarification of Section 304 of the Homeland Security
Act that appears to have resolved many of these liability
concerns. The guidance clarified that a hospital participating
in the vaccination program is a covered entity, regardless
of where its smallpox response team is vaccinated.
The declaration goes a step forward by clarifying
that all members of a participating hospital's team
are covered, whether employees or not, such as non-employed
medical staff.
However, further clarification of liability may be
needed on the “scope of employment" issue.
Specifically, it is not clear if the current guidance
provides protection for vaccinated persons who inadvertently,
and outside of the scope of one’s employment,
spread the infection caused by the smallpox vaccine
outside the participating hospital. We look forward
to working with the Congress and the Administration
to achieve the full protection intended under Section
304.
Significant concerns also remain regarding first party
compensation claims for health care workers and first
responders. The only avenue to address compensation
as a result of illness, under current law, would be
through State Workers’ Compensation Law, which
provides coverage after three days of vaccine-related
absence. However, since the vaccination is voluntary,
and not a condition of employment, it remains unclear
whether this would be an option for our employees.
Furthermore, our hospital does not feel that our volunteer
health care workers should be asked to absorb the
first three days of absence from their own sick leave
banks, nor should hospitals be responsible for payment
of this sick time directly. In addition, not all private
practice physicians subscribe to workers’ compensation.
Therefore, we would suggest that Congress develop
an additional fund, similar to the National Vaccine
Injury Compensation Program, to ensure that no volunteer
health care worker goes without compensation due to
smallpox vaccine-related complications. Providing
such compensation would help us significantly in the
recruitment of additional health care workers.
Regulatory Requirements
Finally, in a time of national emergency requiring
the implementation of mass immunizations, health care
resources will be severely strained. In these limited
circumstances, certain aspects of current healthcare
laws and regulations may not be in the best interest
of the patients and health care workers in our hospitals.
For example, in response to anthrax exposures occurring
in Florida, New York, Washington, D.C. and other states,
some state departments of health issued directives
regarding the handling of patients who feared they
had been exposed to anthrax or other biological agents.
One hospital was instructed to put a sign outside
of the emergency department directing patients to
an alternative site. In another instance, a state
health department told asymptomatic patients who feared
anthrax exposure that they did not need medical screening
until laboratory results from source letters or packages
were received. As you know, EMTALA requires hospitals
to provide medical screening to all patients requesting
medical treatment. In the event of mass vaccinations
or potential smallpox exposures, hospital emergency
departments could be overwhelmed by the “worried
well.” Any hospital following the recommendations
in the two examples above would have been subject
to potential liability under EMTALA.
In addition, when hospitals are coping with mass
vaccination clinics and the potential complications
generated, the completion of the usual complement
of hospital forms such as notices of HIPAA privacy
rights and Advance Beneficiary Notices may not be
possible or practical. We hope that the committee
will consider how to mitigate the consequences of
these regulatory dilemmas in a time of national crisis.
Conclusion
In closing, I would like to commend the Committee
for its commitment to the safety and well being of
first responders and their families. Portsmouth Regional
Hospital, HCA and the Federation of American Hospitals
look forward to working with the Committee to implement
the Administration’s voluntary smallpox vaccination
plan.
I would like to emphasize four key points--first,
as the immunization program progresses to Stage II
and Stage III, staffing shortages are likely to become
particularly acute. Extra funding to State Public
Health departments would enable them to play a much
greater role than has been seen to date in education,
screening and post-vaccination site care, and will
ease the vaccination-related staffing issues which
are currently expected to be shouldered by the hospitals.
Second, further clarification on hospital liability
as it pertains to “scope of employment”
issues may be necessary. Third, Congress should consider
developing an additional fund, similar to the National
Vaccine Injury Compensation Program, to ensure that
all volunteer health care workers have access to compensation
in the event of smallpox vaccine-related complications.
Fourth, although not the primary focus of today’s
hearing, Congress may want to review the consequences,
in limited national emergency circumstances, of regulatory
issues such as EMTALA and completion of the paperwork
requirements for HIPAA and Advanced Beneficiary Notices.
Thank you for providing me this opportunity to testify.
I will be happy to answer any questions the Committee
may have.
|
