WEBCAST TRANSCRIPT

Transcript of "Data and Information Management of the Smallpox Vaccine
Program"\
Presented by Victoria Kipreos, 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/data-mgmt.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/data-mgmt.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/data-mgmt.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/data-mgmt.pdf).)

Victoria Kipreos, PMP, Lead IT Specialist, Information Resources
Management Office, CDC

(Slides 1 and 2-3 are title and objectives, respectively)

# KIPREOS:

I appreciate the time today to be a representative for the information
resource management office. I\'d like to talk with you about the PVS
system and the security surrounding that and the importance of the data
you\'ll be collecting as this program moves forward.

## Slide 4

So to begin with, I\'d like to talk a little bit about the importance of
vaccination data. Number one, most importantly, we need to support the
vaccination strategy and program itself. It\'s important to be aware
that the vials of vaccine are being used appropriately, that clinic flow
is working efficiently and effectively as referred to by Mr. Koops and
also that vaccination verification is taking place and that we\'re able
to track adverse events as they take place. This data will provide us
baseline information on vaccine safety. We do want to know if "takes"
are actually happening and if adverse events are occurring. Finally, and
probably most importantly for the states, we want to be able to be aware
that personnel are protected and that they\'re able to participate in
smallpox response efforts should there be a need for response teams to
reply.

## Slide 5

Let\'s talk a little bit about data reporting activities. The data
reporting activities that surround this particular program not only fall
into the hands of the CDC, but they also are very important for states.
The first of those for states is the pre-event vaccination system or the
PVS system. One of the things we have looked to is to be able use the
PVS system with patient identification or without. There also is a
possibility of being able to use a certified alternative state system,
be that state developed or commercial. I\'ll talk more after this part
of the presentation about those actual systems and give you a little bit
of a broader understanding of their functionality and what we\'re
expecting from our end. CDC is responsible for aggregate unnamed data
collection and analysis. It\'s important for us to be able to respond to
our Administration as well as the Department, HHS, and understand how
many people have been vaccinated, the number of vaccine "takes" that
have taken place, the number of adverse events that are happening and
the actual usage of the vials of vaccine. And, again, the CDC will be
responsible for collecting this in an aggregate format.

## Slide 6

Let\'s talk about the functionality of the PVS system. It\'s been in
development for approximately the last five months. As part of that
development process, we worked very closely with the National
Immunization Program to understand how clinic operations will take place
so that the system actually supports the flow of people through a
vaccination clinic and then the data into the system. So we\'ve been
modeling it after the clinic process as well as the management of it.
The PVS system itself includes forms, such as the medical history form.
That very first form has most of the data entry form on it that we will
need for the PVS system. Also important in this whole process are the
unique vaccination event numbers. These unique numbers actually tie the
patient to their records within the database so that we can understand
where and when and with what batch they had been vaccinated. Also
regarding that are the PVN stickers, the patient vaccination number
stickers that Glen Koops alluded to earlier. These stickers will be
distributed via the National Pharmaceutical Stockpile and available for
states to use, whether they use or system or not, to keep track of the
individuals who are vaccinated. Finally, just to make sure that the PVS
system flows with the work flow of the clinic so they\'re not
interruptions and trying to capture the data, but to make sure the
patient or the volunteer can flow through the clinic without being
hindered by our data collection efforts.

## Slide 7

Included in the PVS system is what we call the vaccination roster. It
includes the name of the clinic, the vaccination batch, which includes
the manufacturer, the lot numbers, date of reconstitution and the date
that the vial will no longer be viable, as well as the ability to import
data from external systems. We have not mentioned this yet in this
presentation, but VAERS which is the adverse events reaction reporting
system, is a system that we will be connected to. We will be able link
to these individuals to their adverse events with their patient
vaccination numbers. This is a web-based application that will run
either through Internet Explorer or through Netscape. It\'s a secure
data exchange over a secure data network. We need to make sure we are
able to secure this data and make it available to the appropriate
individuals only.

## Slide 8

Since PVS is a web-based application, there are data input screens. Some
of the data input screens that we have available for those working at
the clinics are the vaccinee information screen, the vaccine batch
information, again which includes your vaccine lot, diluent manufacturer
and reconstitution dates. Also, "take" response recording information,
adverse events recording and organizational information about the actual
clinics that are doing those vaccinations.

## Slide 9

It\'s also important to not only put data into the system, but also to
retrieve it from the system. We have a number of reports at the clinic,
state, and federal levels that will be available as well as data exports
that will be available to the state so they can do their own data
analysis. Some of those reports include a "take" callback report to
ensure that six to eight days from date of vaccination, the individual
can be called and asked to return for their "take" check. The
vaccination report by date, so that the individuals working within the
clinic can understand how many people actually passed through the clinic
itself. Finally, it includes the medical history form, which can be
preprinted at the beginning of the day as the patients are scheduled to
come in so that the batch that is being used to vaccinate that
individual is preloaded into that form. For more information on the
reports, for clinic, state and federal levels, you can refer to the
annex of the state guidance document that was distributed last week.
Also, one of the things we provide through the PVS system are data
loads. We work closely with the National Pharmaceutical Stockpile here
at CDC. We are privy to the vaccine lots and diluent lots that will be
used for this program. We\'ve been able to preload that information into
the system so that when data entry is done, there are fewer data entry
mistakes in trying to enter the numbers into the system. Finally, we can
load organizational data before the actual program begins so that you
don\'t have to enter this while you are working in the clinic.

## Slide 10

Since this is a computer program, there are going to be PC requirements
that go along with it. Internet Explorer, 5.0 or above, and Netscape 6.0
or above, are the two browsers that we\'re looking to use. Windows 98 or
above should work just fine with this program. Your computer monitor
resolution should be 800 by 600. We\'re looking for a PC or a laptop
that has a Pentium 2 or above processor to allow for ease and speed of
getting the data into the system.

## Slide 11

You\'re also going to be concerned depending on where you\'re located
about your internet speed. We wanted to assure you that a 56k modem or
faster will work. A T1 line is always good, would be good for your
internet speed to be able to send the data through the PVS. In terms of
personnel requirements we recommend at least two administration and data
management people per clinic. You can\'t ever be aware of how many forms
you\'ll have to put in at certain points of the day, as well as the fact
that one of those individuals may not be specific on an available day
and you need to make sure you have a backup. We\'ve been asked through a
number of webcasts that we\'ve done previously what the cost of the
system is. We\'re happy to say we are providing this free of charge for
use during this program. That also includes not only the software
itself, but the digital certificate that you will need to be able to
come in securely through the secured data network to load the data.
Since PVS is on the web, it\'s available 24 hours a day, 7 days a week.

## Slide 12

Now that we\'ve talked about the pre-event vaccination system created by
CDC, I want to make you aware of the fact that state-developed and
commercial systems can be used if you so choose. But there are criteria
that must be passed before it\'s deemed compliant to work with the PVS
system and be in the program. Number one, the basic system functionality
must be met. In the annexes of the guidance document there\'s a full set
of functional specifications and you should be able to meet those basic
system functionalities. Most importantly, data exchange will be tested
and verified for insertions, deletions and updates to make sure that as
that data is sent through the secure data network, it\'s appropriately
updating the database. And finally, the use of PVN or patient
vaccination numbers or an equivalent is extremely important because that
is our one link to be able to identify that individual as having been
vaccinated as well as a link back to any adverse events that may occur
for that patient that may come in through the VAERS system.

## Slide 13

CDC will be providing an upload utility to assist the states when they
want to exchange the data files. In your guidance material you\'ll find
a package that includes the requirements. These have been identified and
published. They include the availability of the state to use the system
either in a named or unnamed identifying fashion. Two important notes,
these last two bullets on this slide refer to your submission of your
plans that are due on Monday. We would require that you identify whether
you\'re going to be using the PVS system within your state or whether
you plan to go for certification for a state developed or commercial
system, as well as the identification of system contacts within your
state. It\'s important for us to understand who will be using these data
systems so that we can get the digital certificates assigned
appropriately and make sure we have a contact to go back to and talk
with to make sure the certification process goes smoothly if that\'s
that you choose to do.

## Slide 14

Let\'s talk about the people now - the people that are involved and have
roles in all of this data management and information management
collection. First there are the clinic system users that will be
collecting patient and vaccination information and also entering that
information into the support system. It\'s important to maintain the
vaccine and diluent batch data, to maintain vaccination records, to
record the take responses and adverse events and to have someone who has
the ability to generate reports for your clinic, as well as your clinic
managers and state governments.

## Slide 15

Also within the state are your principle and co-principle investigators
who will want to be able to look at the data for your state and all the
clinics. An important note, I\'ll talk more about this in the securities
section is that the information or data that is input into the system
will be separated according to states. You will be able to view your
state\'s data and analyze it, but you will not be able to view the data
of other states and their clinics. Finally, a local administrator. It\'s
important to note that someone will have to be responsible for
understanding whether records have to be deleted and make that decision
as well as being the person responsible for the data extract if you
decide to use a state certified system.

## Slide 16

The states have roles, but so does the CDC. In terms of data management
roles, our largest role in this whole process is to accumulate aggregate
data. We will receive data from certified state systems and work through
PVS for the states who choose to use that and most importantly, will be
entering the manufacturer and the lots, the clinic data, organizational
data and roles. We\'ll also be responsible for that second layer of
security and authentication into the patient vaccination system by
identifying user IDs and passwords for those users. Finally, we will
have SDN administrators, security data network administrators who will
create, approve and distribute certificates. I\'ll talk more about this
later. We wanted to provide the best user support that we can.

## Slide 17

So, moving on to data security. The secure data network that we\'ll be
using is through the CDC. It will encrypt and exchange the data with
strong security for either a PVS system or data uploads. No matter which
option your state chooses, you will still need to have digital
certificates to do this data exchange. Within the PVS system, there\'s
selective access to data by jurisdiction, according to the states. Named
data, if the state so chooses to send that through PVS, will be
available for state purposes only. CDC will not be using the name data,
but will be interested in the aggregate data information. There is a
possibility that at some point there may be an active surveillance
program that could be put into place and if that indeed is true, then
the states would be confirmed that their name data, they would like to
have that used with that particular program and that information would
be shared with the active surveillance program.

## Slide 18

As a service organization the Information Resource Management Office
most importantly wants to provide the appropriate support for these
systems. So we have established a CDC Help Desk with individuals who are
well aware of the data exchange requirements as well as the capabilities
of the pre-event vaccination system, all of the stickers that go with it
as well as any information or questions that you might have. We have on
a website some webcasts of some PVS demonstrations that we have done.
That website is www.genesis.com. And that particular website, again, has
archived webcasts of previous demonstrations we\'ve done of PVS, as well
as documents that we have within the annexes in the state guidance,
review of the PVS system, and listings of reports. The data exchange
information and then finally, training. One of the things we are going
to do above and beyond this particular program is to provide several
webcasts along with training materials in PDF format that will allow the
data entry people within clinics to take a class before the system comes
to them for their use.

# KIPREOS:

In conclusion, what I\'d like to remind you that the plans are due on
Monday, December 9th. The most important criteria within those plans are
the decision that you\'re going to make as a state as to whether you\'re
going to use the PVS system, whether that\'s with identifiers or without
and then as well, if you\'re going to choose a state certified system.
We also need your clinic contacts and are looking forward to offering
you training opportunities, which we will communicate to you through
e-mails and websites. We want to give you the support that you need to
make this a successful program. I appreciate your time. 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)