WEBCAST TRANSCRIPT

Transcript of "Smallpox Vaccine Clinic Operations and Management"\
Presented by Glen Koops, 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/clinic-op.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/clinic-op.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/clinic-op.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/clinic-op.pdf).)

Glen Koops, MPH, Director, State and Local Preparedness Program, Office
of Terrorist Preparedness and Response, CDC

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

# KOOPS:

In this segment, I will cover a variety of issues related to organizing
and implementing vaccination clinic operations. My comments are
primarily intended for public health staff who will be responsible for
setting up and operating the clinics. I will also address issues
concerning individuals who potentially will receive smallpox vaccine in
the clinics. These individuals will comprise the public health response
teams responsible for investigating smallpox cases and conducting
broader vaccination operations. They will also include the
hospital-based healthcare response teams that will be responsible for
treating and caring for people infected with smallpox in the event that
such a terrible event would occur in our country.

## Slide 3

Before discussing the operational issues related to clinic operations, I
would like to go over several concepts that are basic to the vaccination
program we are preparing for. First, vaccination will be limited to
individuals who volunteer for public health smallpox response teams and
hospital-based healthcare smallpox response teams. Next, the location
and number of clinic sites will depend on several factors, such as
population density, hospital location and clustering, judicious use of
the vaccine and the availability of suitable clinic facilities. States
and in some case, local health departments have the responsibility for
coordinating this vaccination program. These agencies will determine the
number and location of vaccination clinics based on the factors given
above, but in general, clinic operations should be as centralized as
possible to maximize the efficiency that comes with higher volume
operations. A major issue related to selection of clinic sites is the
fact that the vaccine is packaged in 100-dose vials, which have a
limited shelf life once the vial has been open and reconstituted with
diluent.

## Slide 4

Vaccinators should be vaccinated before clinic operations begin. CDC
will work with the coordinating state and local health departments to
develop a system to vaccinate the vaccinators. There will be significant
emphasis on safety. Careful medical screening must be done to prevent
adverse events caused by the vaccine. Last, we must provide good
management of clinic operations to ensure control of the interrelated
processes of planning, clinic operations, records management, and
communications involving multiple agencies, health care organizations
and clients. These processes require a substantial level of planning and
management and are far too complex to figure it out as you go along.

## Slide 5

Another important preclinic consideration is the selection of the
hospitals that will participate and the identification of the individual
health care workers within those hospitals. The public health
departments responsible for coordinating the vaccination program will
initiate this process by contacting hospitals to determine their
interest and willingness to provide care for smallpox cases should they
occur. Hospitals will be given the opportunity to self-identify as
treatment centers and offer vaccine to appropriate staff. The types of
staff who may be considered for vaccination are described in another
section of this broadcast by Dr. Jane Siegel. Participating hospitals
will then give staff an opportunity to volunteer to be vaccinated as
part of a smallpox response team.

## Slide 6

In addition, potential volunteers will be prescreened by providing them
with educational material that describes the risk factors associated
with vaccine adverse events. This will permit persons with
contraindications about which they have privacy concerns to withdraw if
they wish. Arrangements should be made for evaluating vaccine "takes",
since potentially this can occur at the hospitals participating in the
program with appropriate staff training. Alternatively, "take"
evaluations can be conducted at the vaccination clinics or at other
locations arranged by the coordinating state or local public health
agency. In connection with this, it will be critical for arrangements to
be made for transmitting the vaccine "take" information for each
vaccinee to a designated point for data entry into the information
management system. We\'ll talk more about data management systems in the
next broadcast segment.

## Slide 7

Moving on to issues more directly related to the vaccination clinics, in
many, if not most cases, local health departments or other existing
clinical facilities will probably be used. If existing suitable clinic
space is not available in an area where a smallpox vaccination clinic is
needed, arrangements must be made to find alternative venues that are
suitable. In any case, the clinics should be, first of all, large enough
to handle the staff and the expected client volume, with all of the
obvious amenities such as restrooms, waiting areas and so on. The space
should be well lighted and ventilated. In addition, a separate room or
screened area should be available for persons that have become sick
while in the clinic either as a result of the vaccination or for
unrelated incidental reasons. The facility should have separate doors
for entry and exit to maximize a smooth flow of people through the
clinic process. The clinic should have good access to transportation and
parking.

## Slide 8

Other important characteristics of the ideal clinic include a layout
that facilitates delivery and receipt of clinic supplies and vaccine,
and does so without disrupting the clinic. A central geographic location
that is convenient to potential vaccinees. However, given the
constraints related to the site selection factors mentioned earlier, it
may not be possible for all vaccinees to have a clinic as close as they
would like. Lastly, it may be necessary to establish formal arrangements
for using clinic space through signed memoranda of understanding or
agreements MOUs or MOAs, or through contracts.

## Slide 9

Before and during clinic operations, it will be necessary to create a
schedule for vaccinees to come in for vaccination. To make this
possible, participating hospitals will need to submit a list of all
response team volunteers to the state or local health department that
will in turn provide these lists to specific vaccination clinics. The
response team volunteers will be scheduled for vaccination individually
or in small groups. In most cases, scheduling vaccination appointments
for all volunteers, both public health and hospital workers, will
probably be and should be handled at the clinic level. However, during
this process, clinic schedulers should work closely with the hospitals
to make sure that the hospitals do not have requirements related to
staggering their workers\' vaccinations at different times. Persons not
on the list submitted by the hospitals should not be vaccinated without
special authorization by the designated hospital liaison.

## Slide 10

At this time, I\'d like to explain the clinic process that must be in
place before vaccinations can occur. Upon entry to the clinic,
appropriate security staff should be present to limit entry to staff and
clients. The clinic entrance should have appropriate signs so that
clients know they are at the right place. A staff member should be
assigned as a greeter to direct clients to the clinic area, if
necessary. And answer general questions about things like clinic hours
and parking. This is also the best time to distribute a pack of
information and documents to each client. This packet will have, at
minimum the following contents \-- a patient history form with a
check-off list of potential contraindications. This form also includes a
consent line for the clients\' signature and it will become part of the
medical record. Next, a Vaccine Information Statement that provides
information about the risks and benefits of the vaccine and a
vaccination card for the client to take home. Also, an informational
sheet about the contraindications and potential adverse events
associated with the vaccine. And lastly, instructions on care of the
vaccine site, what a normal and abnormal site looks like and who to call
if they have questions or concerns. CDC is in the process of finalizing
these documents, which will be provided electronically to the
coordinating public health agencies as soon as possible.

## Slide 11

The next step in the process is the client briefing. This can be
conducted with clients individually or in groups. The briefing should
include, first, a general overview of the process, a verification of
each client\'s appointment, time for clients to read the information in
the packet, completion of the documents by the clients, including
signing of the consent form and an opportunity for clients to ask
questions and have those questions answered.

## Slide 12

The next step in the clinic process is medical screening. Each client\'s
medical history must be reviewed by a medical professional who has been
trained on the specific contraindications related to smallpox vaccine.
The medical screeners will determine or verify medical eligibility of
each client. Persons who are determined to be eligible and who have
consented can proceed to the vaccination station.

## Slide 13

Very briefly, let\'s review the contraindications that would make a
person ineligible for smallpox vaccination. First, immunosuppression of
any kind or having household contact with immunosuppression. Next,
pregnancy or having a pregnant household contact; a history of eczema or
atopic dermatitis or having household contact with these conditions. If
the medical screener is uncertain about the medical eligibility of any
client, the client should be reserved to the physician who serves as the
screening team manager for that person to make a final decision.

## Slide 14

Persons who are determined to be medically ineligible or who opt out for
any reason terminate the clinic process at this time. The topic of
medical screening will be covered in a different segment of this
broadcast by Dr. Bill Atkinson.

## Slide 15

Having gone through the briefing process, completion of forms, and
medical screening, the response team volunteer, our client, finally
arrives at the vaccination station to accept vaccination. What are the
issues to be concerned with at this time? First, vaccinators should
observe all of the standard precautions to prevent transmission of
bloodborne pathogens. Arms do not need to be cleaned before they\'re
vaccinated unless there are excessive contaminants on the skin at the
vaccination site. Use a bifurcated needing to administer the vaccine,
then discard the needle. Place a dressing on the vaccination site.
Briefly give the client site care and basic information about potential
reactions. Give a preliminary message about the need to schedule a
"take" evaluation.

## Slide 16

After each client is vaccinated, clinic staff will again need to deal
with issues related to forms and data collection. Staff should be
assigned to review all forms for completeness. The peel-off sticker that
come with the vaccine should be placed on the patient\'s medical record
and any other documents that require information about the vaccine, such
as the vaccine manufacturer and the lot number. Ensure that the date of
vaccination and other critical information is on the client\'s
vaccination card to authenticate it. Again, review site care and
reaction information sheet with the client. And verify that the client
has his or her vaccination card, vaccine information sheet, other fact
sheets and the site care instruction sheet with the important phone
numbers. Make sure that the signed consent form, however, is retained at
the clinic.

## Slide 17

Two final post-vaccination items. Each client must be given clear
instructions as to when and where they should report to have their
vaccine "take" evaluated. And second, information from the clinic forms
must be entered into CDC data system or an equivalent system established
by the state or local health department. Additional information about
the CDC data system will be provided in the next presentation by Vicki
Kipreos.

## Slide 18

The response team volunteer has completed the vaccination process and is
ready to leave the clinic. Clinic staff should be assigned to a station
near the exit to ensure that all is well with each client and to monitor
the flow of clients as they leave. If the flow of clients is noticeably
uneven, this should be brought to the attention of the clinic manager so
that staffing at the various stations can be adjusted appropriately.

## Slide 19

During another segment of the broadcast, Dr. Joanne Cono will discuss
evaluating vaccine "takes" in some detail. However, I would like briefly
go over some vaccination "take" issues as they relate to clinic
operations. First, if the "take" is successful, this should be noted on
the patient\'s vaccination card. Therefore, clients should be reminded
to bring their vaccination card with them when they have their
vaccination "take" evaluated. This may or may not occur at the clinic,
depending on the system arranged by the state or local health
department. As I mentioned earlier, if some or all of the vaccine
"takes" will be evaluated at locations other than the clinic where the
client is vaccinated, it is important that arrangements be made for
transmitting the vaccine "take" information to a designated point for
entry into the information system. When the client comes in for "take"
evaluation, this is a good time to review site care and adverse reaction
information with him or her. If the take is determined to be not
successful, the client should be referred for revaccination. And lastly,
if a second vaccination is unsuccessful, medical referral will be
necessary before another vaccination is attempted.

# KOOPS:

Before we go on to discuss additional issues directly related to
clinics, I would like to take a few moments to give a little background
information about why we are so focused on vaccine safety and medical
screening of our patients.

## Slide 20

Here are some data about adverse events related to smallpox
vaccinations. In unimmunized populations, inadvertent inoculation will
occur in 25 to 529 persons per million. Between 10 and 39 persons per
million will have eczema vaccinatum. 1 or 2 persons per million will
suffer progressive vaccinia. 3 to 12 persons per million will suffer
post-vaccinial encephalitis and 1 or 2 people per million will die as a
result of complications from the vaccine. This will be covered in detail
by Dr. Gina Mootrey in another one of our segments.

## Slide 21

Getting back to operational issues, implementing the smallpox
vaccination program will require substantial commitments in terms of
personnel resources. This slide provides some estimates of the number of
staff that will be required to staff a vaccination clinic capable of
vaccinating approximately 150 persons per day. Bear in mind these
staffing patterns are designed for the current circumstances where we
are conducting vaccinations in the absence of smallpox disease and are,
therefore, taking extra care to prevent vaccine adverse events. In a
large-scale mass scale vaccination effort where smallpox has occurred,
the per day ratio of staff to vaccinees would increase dramatically. The
estimates for clinic staffing are as follows: you will need one clinic
manager, one appointment scheduler, one health care educator to brief
clients, five or six medical screeners and one supervisory screener.
This is the most time-consuming part of the process. You will need two
vaccinators.

## Slide 22

In addition, you will need two vaccinator assistants. One supply
specialist will be needed to monitor supply inventories and to order
more when necessary. Two roamers to monitor and assist with clinic
traffic flow and to do other duties as assigned. Two data entry
personnel, two monitors, one at the clinic entrance and another at the
exit. And finally, two security personnel, perhaps one outside the
clinic and one inside. The total number of staff required for this
configuration is 22 or 23 FTEs (full time equivalents). It is possible
that this level of staffing could be reduced after the clinic has been
operating for several days, but for planning purposes, care should be
taken to avoid underbudgeting in this critical area. It should also be
pointed out this level of staffing can and should be adjusted to reflect
the actual client flow scheduled for each clinic.

## Slide 23

Because this is an initiative that has drawn a lot of national and
international attention in the context of the war on terrorism, the
vaccination clinics may draw more people than we would like. And not all
of them may there be for helpful reasons, therefore, a few comments and
reminders about security issues may be in order. Clinic parking should
be adequate, close and protected. The clinic entrance should be well
marked. It is advisable that one of the security staff be stationed
outside the front entrance. Internal traffic monitors should be alert
for disruptions. And finally, make sure the security staff have the
telephone numbers for fire, police, utility companies and the owner or
manager of the facility.

## Slide 24

Worker safety is another significant consideration. Security staff
should be on duty when the staff arrive and easily accessible and
responsive to the staff. Again, clinic facilities should be secure, well
lighted and functional.

One special concern relates to handling the vaccine, which contains live
virus. Great care must be taken to prevent needle sticks with the
bifurcated needles. In this connection, vaccinators should not hold the
vaccine vial in their hand while inserting the bifurcated needle into
the vial. This probably should also be avoided because this practice
will cause the vaccine to become warm. Care should also be taken that
the vaccine is not spilled. Because of this concern, along with the
vaccine, CDC will include special holders to prevent the vaccine vials
from being tipped over accidentally. These holders will also insulate
the vaccine to help keep it cool while it is being used.

## Slide 25

To assure worker safety, workers should be given adequate initial job
training. They should be given occasional work breaks so they can
maintain attention to detail. They should be cross-trained to relieve
the stress of repetitive motion. And backup personnel should always be
available.

## Slide 26

On November 22, 2002, CDC distributed a supplemental guidance document
to all recipients of federal funding through the bioterrorism
cooperative agreement. Annex three of this guidance document includes a
list of suggested supplies for use in a smallpox vaccination clinic.
This slide provides additional suggestions about clinic supplies. First,
start with a minimum two day supply of clinic supplies as you begin your
operations. Keep the supplies in a secure place, separated from the
clinic traffic flow. Conduct a daily, more frequently if necessary,
inventory and track supplies for use and resupply and finally, dispose
of wasted supplies in accordance with pertinent regulations and accepted
policies and procedures.

## Slide 27

Earlier Dr. Sue Gorman discussed the logistical considerations related
to receiving and storing vaccine. To reiterate some of this information
briefly: when the vaccine arrives, it should be inspected, logged in and
refrigerated immediately. Vaccine should be stored at 35 to 46 degrees
Fahrenheit or 2 to 8 degree Centigrade until it is needed in the clinic.
Temporarily storing the vaccine in coolers with ice or cold packs is
acceptable, but you should avoid placing the vaccine directly on ice.
Put a sheet of plastic or cardboard between the vaccine and the ice.

## Slide 28

In addition, you should reconstitute vaccine just before use. Do not
reconstitute more vaccine than is needed. Remember that when
reconstituted, each vial contains 100 doses. One person - probably the
supplies manager - should be designated to receive and do a daily
vaccine inventory and ensure the security of the vaccine. The
responsibility for reconstituting the vaccine and bringing it to the
vaccination station should also be specialized. Probably this would be
an appropriate role for one of the assistant vaccinators.

## Slide 29

In handling the smallpox vaccine use standard precautions, including
bloodborne pathogen precautions. Clean all vaccine spills with a
tuberculocidal agent. Materials contaminated with smallpox vaccine, for
example as the result of a spill, should be considered and disposed of
as medical waste. Bifurcated needle should be discarded in a sharps
container

## Slide 30

Some final notes on vaccine handling. If stored appropriately at 35 to
46 degrees Fahrenheit or 2 to 8 degrees Centigrade, vials of
reconstituted vaccine can be kept for up to 30 days. This includes vials
that have been partially used. Be sure to note the date on each vial
when it is opened and reconstituted. Do not use inappropriately stored
vaccine -- dispose of it as medical waste and document the estimated
number of doses that are being discarded. Finally, ensure security of
vaccine. This means that the refrigerator must have a lock on it.

# KOOPS:

In conclusion, I would like to emphasize a few last points. We are
preparing to implement the first large scale smallpox vaccination
program in the United States since routine smallpox vaccination was
discontinued in the 1970s. This program will require substantial
commitment in terms of management and personnel resources. It is
critical that clinic operations be implemented efficiently so that we
can succeed in offering vaccine to all those who are potential response
team members. And effectively so we can expeditiously vaccinate all of
the volunteers who are eligible, most importantly, safely to keep to an
absolute minimum the adverse events that can result from the vaccine.
Since this vaccination program could prove to be the beginning of a much
wider, possibly ongoing vaccination program, it is important that we
develop an operational infrastructure that can be built upon and
expanded as necessary. Thank you for your hard work and commitment in
preparing for this smallpox vaccination program and thank you for your
attention this afternoon.

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)