WEBCAST TRANSCRIPT

Transcript of "Considerations for Hospitals: Developing a Smallpox
Healthcare Response Team"\
Presented by Dr. Jane Siegel and Dr. David Fleming, 5 December 2002, on
the satellite broadcast of "CDC Bioterrorism Update: Smallpox
Preparedness"

(Associated graphics can be found at
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/hospital-consider.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/hospital-consider.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/hospital-consider.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/hospital-consider.pdf).)

Jane Siegel, MD, Co-Chair, CDC Healthcare Infection Control Practices
Advisory Committee (HICPAC) and Professor of Pediatrics, University of
Texas Southwestern Medical Center and Children's Medical Center, Dallas,
Texas

David W. Fleming, MD, Deputy Director for Science and Public Health, CDC

(Slides 1 and 2 are title and objectives, respectively)

# SIEGEL:

It is a pleasure for me to be here this afternoon with you and to
represent the Healthcare Infection Control Practices Advisory Committee.
During the next 30 minutes I'm going to review with you the current
recommendations and rationale for those recommendations for selection
and management of hospital based vaccinated healthcare workers. I will
also be discussing issues to be considered by hospitals in order to
ensure a safe and successful implementation of the healthcare worker
smallpox vaccination program.

## Slide 3

First let\'s start with how the recommendations were actually developed.
During a meeting on September 23rd and 24th of this year, the options
for selection of healthcare workers for smallpox vaccination and
post-vaccination management were developed by the smallpox vaccine
working group, which is compromised of various stakeholders including
representative members of three federal advisory committees: the ACIP,
the Advisory Committee on Immunization Practices that works with the
National Immunization Program; NVAC, the National Vaccine Advisory
Committee of the Department of Health and Human Services; and HICPAC,
the Healthcare Infection Control Practices Advisory Committee of the
Division of Healthcare Quality Promotion in the National Center for
Infectious Diseases at CDC. Recommendations were then developed and
approved by the ACIP and HICPAC at their meetings in October 2002 and
are posted on their respective websites.

## Slide 4

The goal in creating a hospital-based smallpox healthcare response team
is to provide uninterrupted medical care for smallpox patients in acute
care hospitals that will be providing care for both smallpox patients
and patients without smallpox. In order to do this, we would need to
vaccinate a team of healthcare workers who will be protected and feel
comfortable managing smallpox patients in the emergency room and
providing direct primary medical care for the first patients with
suspected or confirmed smallpox admitted to acute care hospitals. This
would essentially be creating a "ready-to-go" team of individuals who
would be able to provide care immediately in those days after the first
smallpox patients are identified when vaccine is being deployed and
administered to large numbers of individuals.

## Slide 5

There are several underlying principles that have guided the formulation
of the current recommendations for selection of healthcare workers for
vaccination. And they are as follows: First of all, we feel that only
immune healthcare workers should care for patients with
vaccine-preventable diseases. Protection provided to susceptible
healthcare workers by protective equipment such as respirators, gowns,
gloves, could be overwhelmed by an exposure to a very large inoculum of
virus or misuse of equipment. And finally, unvaccinated, non-essential
personnel must be restricted from entering areas where smallpox patients
are present.

## Slide 6

What would be the requirements of a smallpox healthcare response team?
First of all, there must be voluntary willingness to be vaccinated. No
healthcare worker would be vaccinated against their will or be coerced
into accepting vaccination. However, vaccination is required for all
members of the healthcare response team. There will be a preference for
revaccinees, that is providing vaccination for those individuals who
have had vaccine in the past, which in most cases are those who are 32
years of age or older.

## Slide 7

Next, this team must be able to have enough members of the appropriate
category \-- categories of healthcare workers needed to deliver medical
care 24 hours a day 7 days a week for the first 7 to 10 days following
the initial appearance of smallpox patients. Seven to 10 days was chosen
as an estimate because that is the time that would allow us to determine
how many of the individuals vaccinated during the first round of mass
vaccination efforts would have a take and be protected and be
appropriate for providing care to smallpox patients. The categories and
number of healthcare workers per hospital will be based on several
factors. One factor would be the composition of the patient population,
what types of patients are cared for in that institution. Another is the
type of medical care delivered in the institution, intensive care units,
specialized care units and general medical patients. And then work
schedules, vacations and anticipated workload. These are recommendations
made to guide hospitals, but it\'s clear that individual hospitals and
health departments may modify the recommendations in order to meet their
needs.

## Slide 8

Let\'s look at the suggested composition of healthcare response teams.
First of all, if we look at the emergency room staff, the intention
would be to have selected numbers of physicians and nurses from the
emergency room who would be able to provide care. There could also be
some selected emergency medical technicians who would be needed for
transport as determined by individual hospitals. The goal is not to
vaccinate the entire emergency room staff, but rather those selected in
order to have sufficient numbers to provide care in the first week. Then
if we look at the intensive care unit, again, it would be selected
physicians and nurses. And for these two areas, it is important for
hospitals that provide care to infants and children to include those
professionals who have training in pediatrics.

## Slide 9

Now, if we look at the general medical unit, it is likely that in
hospitals where there are appropriate types of negative pressure or
airborne infection isolation rooms that would be appropriate to care for
patients with smallpox, that there would be general medical units and
the individuals to staff those units would be selected nurses and
physicians. Those physicians may be hospitalists, internists,
pediatricians, obstetricians and in certain centers, where family
physicians are the main physicians who are the essential providers of
primary medical care, those individuals would be included. Similarly, in
hospitals that depend on the housestaff for providing primary, direct
medical care, there would be selected medical, pediatric, obstetric and
when essential, family physician housestaff.

## Slide 10

If we look at the specialists needed in this situation, I think it is
reasonable to believe that the infectious disease specialist will be
certainly called upon to assist in diagnosis and management. Surgery and
anesthesia teams may be indicated in order to provide the supportive
care, but not for the primary care. There are a variety of specialists
that would be needed and perhaps creating regional teams for
consultation would be the most efficient way to make certain there are
enough specialists available rather than each hospital having their own
specialists vaccinated. The types of specialists that we would include
would be: within a community, there may be consultants who have had
first-hand experience with smallpox disease or vaccine and adverse
effects from vaccine. Those individuals would provide very valuable
perspective and information for us. Dermatologists may be called upon to
perform diagnostic skin biopsies. Ophthalmologists may be needed to
assist in the management of eye complications. Pathologists may also be
needed to assist in assessing tissue and assisting us in that way. There
may be other specialists as defined by individual institutions.

## Slide 11

Another group of individuals that would be very important to vaccinate
for primary healthcare response is the infection control staff. The
infection control staff certainly provides valuable input in terms of
management of patients, of implementation of infection control
recommendations and assistance in contact investigation as well.
Respiratory therapists and radiology technicians would also be important
to provide the supportive care and diagnostic care for smallpox patients
and the group of security personnel in the hospital would be very
important in order to maintain a calm and safe environment.

## Slide 12

Another group of workers are the property services or housekeeping group
of workers. These individuals are required, selected individuals would
be required to maintain the environment and decrease the risk of fomite
transmission. These individuals are present throughout the hospital and
it would be difficult to restrict all housekeeping individuals from
areas where smallpox patients are present. Therefore, they should be
offered the opportunity to be protected with vaccine. One group of
workers that is not included in this first round of healthcare worker
vaccinations are the clinical microbiology laboratory workers. It is
important when considering lab workers to make the distinction between
the risk of exposure in research labs where very high concentrations of
virus are being handled as compared with the exposure in clinical
microbiology labs where the actual viral load in the usually submitted
clinical specimens, the body fluids would be quite low. Adherence to
standard precautions and to the ASM, American Society of Microbiology
and CDC protocols would prevent exposure of clinical lab workers to
virus present in lab specimens.

## Slide 13

Once we\'ve selected our individuals \-- our healthcare workers for
vaccination, we need to be prepared to manage these individuals. And
before we go on to that, I\'d like to review with you some background
considerations that were helpful in formulating the current
recommendations. First of all, historically, we know that there\'s a low
risk of transmission of vaccinia virus to healthcare worker hospital
contacts from recently vaccinated healthcare workers. This information
has been reviewed very nicely in a publication by John Neff and
colleagues in the October 15th, 2002, JAMA issue. We know when
transmission did occur, it was more likely to be in the home setting,
where there was a much closer type of contact and also more from primary
vaccinees. We also have a tool available to us now that was not
available in past years when we used smallpox vaccine. That is the use
of semi-permeable dressings. From two publications, we know there\'s a
100% virus containment in 97% to 100% of cultures obtained from the
outside of the semi-permeable transparent dressing over folded gauze;
that is, no virus was recovered from 100% and 97% of outside dressing
cultures in the two studies, respectively. I\'ve listed the citations
for you here on the slide. In addition, we know these dressings are very
well tolerated when they are changed, as soon as exudate begins to
appear at the site, which is approximately every three to five days.
This experience has been published in the spring of 2002 in the New
England Journal of Medicine.

## Slide 14

Another consideration is that we have a hospital-wide distribution of
high risk patients. We\'re all familiar with the risk associated with
patients in specialized units, in intensive care units, bone marrow
transplant units and burn units. But if we think about the risks such as
immunosuppression either to secondary to primary disease processes or
secondary to treatment modalities, we know many at risk patients are
distributed throughout the hospital. In addition, we know there are
patients throughout the hospital who have disruption of the normal
protective skin barrier, such as the patients with atopic dermatitis,
with burns, with other extensive skin eruptions and the use of medical
devices such as central venous catheters and ostomies that further break
down the normal skin barriers. It would be difficult to reassign
healthcare workers who have been vaccinated to areas where there are no
"at risk" patients. The final consideration is the severe nursing
shortage that hospitals in our country are facing. We know it\'s been
very well reported in recent publications that these nursing shortages
are associated with adverse outcomes. Adverse patient outcomes including
shock, cardiac arrest, increase length of stays and increased rate of
healthcare associated infections. In hospitals that are experiencing
these types of shortages, it would be very difficult to tolerate
substantial numbers of healthcare workers being on administrative leave
for the time following receipt of the smallpox vaccination, especially
in critical areas such as ICUs and the ER.

## Slide 15

Therefore, in light of these considerations, administrative leave is not
required for newly vaccinated healthcare workers unless certain
circumstances are present. One is if an individual is physically unable
to work. That is, we know that a small number of individuals at about 8
to 10 days following vaccination will have sufficient systemic signs to
not feel well enough to be able to work. Secondly, if there\'s an
extensive reaction at the vaccination site that cannot be completely
covered by the dressing, that individual should not work either.
Finally, if the healthcare worker is unable to adhere to the infection
control recommendations that would prevent potential transmission of
virus, especially consistently practicing proper hand hygiene, that
individual should not be allowed to work. Although administrative leave
is not required for newly vaccinated healthcare workers, it is true that
individual institutions may choose to make individual reassignments or
if feasible in that institution to place on leave. Those are individual
decisions that must be made. However, based on the information that
I\'ve reviewed with you, we do not feel administrative leave is
necessary.

## Slide 16

What are the components of a hospital-based program? One is education.
Certainly there will be an educational pre-vaccination day that will be
part of the vaccination program, but we think it\'s important for
hospitals to begin education as soon as possible so that healthcare
workers may make informed choices in accepting the vaccine. Then we have
identification of candidates without contraindications. The use of
semi-permeable dressings over folded gauze is a necessary component as
is a vaccination site monitoring program.

## Slide 17

I know that you can\'t read this algorithm on the slide. This summarizes
the steps in care of the vaccination site. It begins with the decision
of what type of product to use based on the presence or absence of tape
sensitivity. There are various steps that are outlined here, most of
which I will discuss in the next few slides. This algorithm will be
available to you. I think it may be a useful tool to help individuals
see how the site care should be managed.

## Slide 18

If we look at the components of site care, number one is to observe
thorough hand hygiene, hand washing with anti-microbial soap and water
or the use of approved alcohol-based handrubs. Remember that if there is
visible soiling on the hands, then handwashing with antimicrobial soap
and water is recommended. In the absence of visible soiling, the use of
alcohol-based handrubs is preferred and this is described very well in
our recently published guideline for hand hygiene in healthcare
settings. Hand hygiene should be observed after contact with the
vaccination site or any materials that have been in contact with that
site, after removal of gloves that have been in contact with
contaminated materials and, as always, before and after patient contact.

## Slide 19

Another important point is to keep the site covered with folded gauze or
similar absorbent material overlaid by a single semi-permeable dressing
until the scab has separated, approximately 21 days after vaccination.
When the healthcare worker is at work, it\'s important to cover the
dressing further with clothing and probably a long-sleeved item of
clothing with a cuff or something to keep that sleeve in place. This
would provide maximum protection.

## Slide 20

At home, showering is allowed, but again, to improve the margin of
protection, the site should be covered with plastic wrap. The
vaccination site should be the last site dried. The towels should be
kept separate and should be ideally washed with hot water that is at
least 160 degrees Fahrenheit, and soap. This is most likely only
possible in commercial hospital laundries, but is not achievable in the
home. In the home, contact time of 10 minutes at 20-25 degrees C (68
degrees F), using a standard detergent, followed by a hot air drying
cycle would be sufficient to inactivate vaccinia virus. The dressing
should be changed at the place of work, when the exudate first begins to
accumulate, usually every three to five days. Gloves should be changed
between removing the old dressing and applying the new dressing.

## Slide 21

Finally, contaminated dressing materials should be discarded as
regulated medical waste in a healthcare setting or in a sealed bag at
home.

## Slide 22

I\'d like to look at the components of a site monitoring program. We
think this is important to safely carry out this smallpox vaccination in
hospitals. There would be a daily monitoring at the local institution
prior to beginning the day\'s work assignment. There would be site
inspection by a vaccinated staff number and the dressing would be
changed when indicated as I described earlier. There would be an
assessment of fitness for duty. Are there any contraindications for that
individual to assume duty? Also, the site monitoring would provide an
opportunity to triage adverse reactions that may need treatment and make
sure the appropriate individuals are contacted for that. In addition,
there would be a reporting of the experience and a capturing of the
individual healthcare worker\'s daily diary to an active surveillance
system. There\'s an internet-based surveillance tool that is currently
being developed through the efforts of staff members in the National
Immunization Program and the Division of Healthcare Quality Promotion.
Finally, this daily site monitoring would afford an opportunity for
educational reminders to vaccinated healthcare workers concerning hand
hygiene and proper infection control practices in order to minimize the
risk of transmission.

## Slide 23

In the final two slides, I\'ll summarize the steps involved in
implementation of a healthcare worker vaccination program for smallpox
preparedness. The first step would be to identify a planning and
monitoring team. Each hospital now has a terrorism preparedness team and
has members on the team who would be appropriate to oversee this
project. There would be infection control and hospital epidemiologists
involved, administrative staff and other members designated by the local
institution as appropriate to carry out this program. Next, a hospital
would need to identify the categories and number of healthcare workers
to be vaccinated. And it would be helpful to identify liaisons within
each care area who would assist in identifying appropriate candidates,
as well as providing education and support to those healthcare workers.
Providing education is absolutely essential. We want healthcare workers
to make informed choices.

## Slide 24

We would identify the suitable volunteer candidates without
contraindications and it would be helpful, I think, to plan to stagger
these vaccinations by approximately one to three weeks within a clinical
area. That is, we would prefer to not vaccinate all of our intensive
care unit staff that we\'ve identified as appropriate at one time, so
that if there were systemic effects at 8 to 10 days, they would not all
be absent at the same time. Finally, we would develop and maintain a
site monitoring program.

This concludes my presentation on the considerations for hospitals. I
hope that you have found this information useful and will be able to use
it as you begin planning your local program. It\'s important for members
of the healthcare community to know and to understand the rationale for
the current recommendations and to know that there are many resources
available to address questions as they arise.

# MODERATOR:

Thank you, Dr. Siegel. We know that a lot of you working in hospitals
and healthcare facilities have pressing questions about the possible
liabilities for your facilities when deciding whether or not to
administer the smallpox vaccine. As a part of this section on
Considerations for Hospitals, with us today is Doctor David Fleming.
Doctor Fleming is the Deputy Director for Science and Public Health at
the Centers for Disease Control and Prevention. Dr. Fleming, welcome.

# FLEMING:

I want to assure you we\'re aware hospitals, healthcare providers, and
others have raised IMPORTANT concerns about potential liability for
involvement in a smallpox vaccination program. Section 304 of the
recently passed Homeland Security Act is intended to alleviate these
liability concerns, and therefore to ensure that vaccine is available
and can be administered.

Section 304 of the Homeland Security Act provides an exclusive remedy
against the United States pursuant to the Federal Tort Claims Act for
injury or death attributable to smallpox vaccine, other substances used
to treat or prevent smallpox, or vaccinia immune globulin.

CDC is working with other federal partners to answer the many specific
questions related to these issues. We very much understand their
importance and urgency. As soon as this additional guidance is
available, we will provide it to you. We appreciate your patience during
this interim period. Thank you.

END

For more information, visit
[www.cdc.gov/smallpox](http://www.cdc.gov/smallpox), or call the CDC
public response hotline\
at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646
(TTY)