Immunization Information Systems (AIRA)

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1.2 User Story Narrative
Immunization information systems (IIS) reflect a wide variety of user stories, or “story
boards,” which is a concept that is used in the HL7 organization.
The following 12 story boards were created by the American Immunization Registry
Association (AIR) as input into the HL7 Domain Analysis Model being developed by the
Public Health and Emergency Response (PHER) workgroup. They reflect the diverse
activities involved with immunization health information.
1.2.1 Goal
With our increasingly mobile society, families may move from one location to another
resulting in changing health care providers. Immunization information systems (IIS)
consolidate vaccinations from multiple providers into one reliable record. This saves time
and reduces paperwork associated with providing accurate immunization histories for
patients, schools, camps, day-care centers and colleges.
IIS also clarify complex and changing immunization schedules and emerging vaccine
combinations and provide patient-specific reminders of vaccine doses recommended, due
or overdue and invalid doses. This keeps a child’s vaccination schedule up-to-date and
prevents over-immunization.
IIS play a key role in public health and are used to track vaccination levels of children at
a population level and help guide interventions to control vaccine-preventable diseases.
Specific populations at high risk can be identified during a pandemic and the system can
manage vaccine usage and inventory.
In the interest of presenting as complete a story as possible, the next section describes in
detail the various story boards/user stories that should be considered.
1.2.2 Description of Data Reporting Events, Actors and Triggers
1. Record immunization history
Story Board:
Susan Q Public has moved from Portland, Maine to Augusta, Georgia. She brings her son
to his new pediatrician on 1/1/2011. The clinic staff enters his information into the office
EHR and requests an immunization history from the Georgia IIS (GRITS). No record is
found. Susan has a record from the previous pediatrician. The record includes the
following:
Date of birth: Feb 2, 2009
Vaccine
1
group
Hep B
2/2/2009
DTAP
4/2/2009
Polio
4/2/2009
HIB
4/2/2009
Rotavirus
MMR
2/1/2010
2
4/2/2009
8/3/2009
8/3/2009
8/3/2009
3
4
5
8/3/2009
Clinic staff enters this information into the EHR and transmits it to GRITS. They request
an evaluation of this history based on the ACIP schedule and request a forecast of what
doses are due next from GRITS. GRITS returns an evaluated history and forecast of next
doses due. They determine that they will administer a Pentacel (DTAP/HIB/IPV) dose,
Lot number Q234sw in the right deltoid. The manufacturer is Sanofi Aventis. This
administration is recorded in the EHR system. The EHR system transmits this to the IIS.
The IIS incorporates this new information into its data store.
Actors:





Clinician
Patient
Parent
IIS
EHR System
Actions/Interactions:





Request patient records
Record immunization history
Transmit immunization history
Request evaluation and forecast
Receive immunization history
Concepts:


Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Vaccine expiration date
o
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth




Evaluated history
Forecast
ACIP schedule
Historical immunization record
2. Manage Vaccine Inventory
Story Board:
The inventory clerk of a state Immunization Information System (IIS) orders 1000 doses
of MMR vaccine from the national distribution system (NDS). The order is received by
the NDS. Vaccine is packaged and shipped. An electronic packing slip is sent to the IIS.
When the IIS receives the vaccine, the inventory clerk examines the shipped vaccine and
determines that it is all there and intact. He uses that electronic packing slip to update the
IIS inventory system. (vaccine, lot number, expiration, number of doses)
A nurse in the state clinic administers a dose of MMR from this batch of vaccine and
records this in the IIS. The IIS updates the inventory management system, decrementing
one dose.
The inventory clerk responds to a request from a local health department and transfers 10
doses to them. The IIS inventory management system subtracts the doses from the state
inventory and adds it to the local public health inventory.
Actors:



IIS system manager
IIS System
Inventory clerk
Actions/Interactions:







Count doses used by vaccine
Inventory management system is implied
Transfer doses and inventory
Accept inventory
Record immunization
Decrement inventory
Increment inventory
Concepts:

Vaccination event
o Lot number
o Vaccine type
o Clinician
 Ordering




 Administering
Inventory clerk
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
Vaccine distributor
Packing slip (electronic)
3. Managing Publicly Funded Vaccine Inventory
Story Board:
Publicly funded vaccine usage must be tracked to assure appropriate usage and to
forecast future needs. Some IIS require that clinics which use EHR-S provide supporting
data when sending immunization records to the IIS. This story board describes some of
the possible interactions, but should not be considered definitive.
My Local Clinic receives 100 doses publicly funded MMR vaccine from the distributor.
The inventory clerk logs this into the EHR-S (including lot number, vaccine, expiration
date). Later in the day, Bob Nurse administers one dose of MMR vaccine from this lot of
publicly funded vaccine. He records this vaccination from that lot in the EHR-S. The
EHR-S sends the update immunization history to the IIS. Included in this information is
lot number and patient funding source for publicly funded vaccine. The record also
includes information about the patient’s eligibility for publicly funded vaccine. The IIS
updates its records with this data.
At the end of the month, the IIS runs a report for My Local Clinic comparing the funding
source and eligibility of all immunizations given at My Local Clinic for the month.
Actors:
Inventory clerk
EHR-S
IIS
Provider organizaton
Actions/Interactions:
Update inventory
Record immunization
Transmit immunization history
Create report
Concepts:



Vaccination event
o Lot number
o Vaccine type
o Clinician
 Ordering
 Administering
o Funding source
o Funding program eligibility
o Administering clinic
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
o Registry status
Vaccine distributor
4. Public Health-Lot Recall Outreach
Story board:
The Food and Drug Administration sends out a notice that lot number XYZ1123 of
Varicella vaccine has been identified as producing inadequate immunity. All persons
who have received vaccine from this lot need to be re-immunized immediately. In
addition, all remaining doses are to be counted and returned to the distributor for
replacement. The provider uses the Immunization information system (IIS) to create a
report listing all persons who they immunized with this vaccine lot. They send out a
notice to the responsible adult for each impacted patient. They track who responds. As
each patient is re-immunized at the clinic, this is recorded in the electronic health record
(EHR). The EHR sends this record to the IIS. Five of the patients get re-immunized at
the Public Health clinic. These records are added to the IIS. The provider runs a report on
the IIS and finds that 10 persons did not get the revaccination within 1 month. A public
health nurse makes a visit to assure they are aware of the need and to be sure they have
not moved. Two of these persons are not locatable. Their status in the IIS is changed to
Moved or Gone Elsewhere.
Remaining vaccine is sent back to the distributor for replacement. Inventory in system is
updated.
Actors:






National regulatory agency
Clinician
IIS
EHRs
Patients
Public health agency
Interactions:






Request list of persons receiving vaccine from one lot
Record immunizations administered in EHR
Record immunizations administered in IIS
EHR updates IIS immunization history
Generate report
o List of persons not re-immunized
Update vaccine inventory
o Track return shipment
Concepts:




Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
o Registry status
Vaccine distributor
National regulatory agency
5. Public Health—Deleting An Immunization Record
Story Board:
Sam Nurse reviews the immunization history for Tom Patient. He notes that the person
who entered immunization records on the last visit recorded an MMR for Tom. He
realizes that it should have been recorded for Tom’s twin brother, Tim. Tom had been
unable to go to the clinic at that time. Sam deletes the immunization record from the
EHR-S. He records the immunization for Tim. The EHR-S sends the delete request to
the IIS. The IIS updates Tom’s record.
Sam Nurse records a HIB vaccination on 10/1/2010. The clinic aide also records the HIB
vaccination on 10/1/2011. The EHR system sends the immunization records to the IIS.
The IIS identifies these 2 records as duplicate records and only saves one. Sam reviews
the EHR system record, realizes that there are duplicate immunization records and deletes
the second copy from the EHR system. The EHR system sends the delete request to the
IIS. The IIS identifies that this duplicate record did not get recorded in the IIS.
Note:Some systems remove deleted immunization records and others mask the “deleted”
record. The point here is to capture the need for synchronizing between systems.
Actors:



EHR-S
Clinician
IIS
Actions/interactions:





Request immunization history
Record immunization history
Delete immunization record
Send immunization history
Receive immunization history
Concepts:

Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o


Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
Duplicate immunization records
6. Public Health Outreach—Exposure
Story board:
A student at the local high school develops measles after returning from a trip to a
developing country. The student was not immunized against measles. Her onset of
symptoms was January 9. She was diagnosed and reported to the local health department
on January 10. Investigation showed that she had been at school on January 8 and
attended a movie at the local theater complex that evening. The state division of health
declared a health emergency. They determined the need to reach out to all unimmunized
students in the high school to assure that they got immunized. The state IIS generated a
list of all students in the high school needing an MMR, each was sent a letter. The local
health department collaborated with the school nurses to hold an immunization clinic.
Twenty seven students were immunized. These immunizations were recorded in the state
IIS. Ten students received immunizations at their physician’s office. The nurses at these
offices recorded these events in their EHR. The EHR updated the records in the IIS.
Public Health Nurses called all students who were at risk and did not attend the
immunization clinic to determine their immunization status. One high school student
developed measles. Investigators reviewed his record in the IIS and could find no
evidence of previous immunization against measles. Three people who were at the movie
theater at the same time as the index case saw the news and called public health asking if
they were at risk. The intake nurse at public health checked the IIS to see if they had a
history of immunization against measles. Two had a previous record of 2 doses of MMR,
the other lives in another state. That state IIS was queried and was able to furnish the
immunization record indicating previous immunization. The local health department
decided to assess the level of risk in the rest of the community. They generated a report
from the IIS indicating that the per cent of persons living in the community who were
fully immunized against measles was:
0-1 yr
1-5 yr
5-10 yr
5%
98%
99%
10-20 yr
96%
> 20 YR
93%
The overall immunization rate for all persons born since 1957 is 96.5%.
Actors:








National regulatory agency
Patient
Responsible Person
Clinician
EHRs
IIS
Public health agency
Distributor
Interactions:






EHR queries IIS for list of unimmunized patients
IIS returns response list of unimmunized patients
EHR requests immunization history for a patient
EHR sends immunization records to IIS
Reports generated from IIS
o List of unimmunized persons
o Aggregate coverage
Interstate IIS query and response for immunization history
Concepts:


Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult





Duplicate immunization records
Disease
o Name
o Onset
o Diagnosis
o Report
o Exposure
School
Investigation
Coverage report
7. Public Health pandemic response effort
Story board:
The WHO has identified a novel influenza outbreak in North America. A public health
emergency is declared. The plan is to attempt to immunize 70% of the population within
6 months. Initial vaccine will be targeted to college students and military recruits. As
more vaccine becomes available, pregnant women and postal workers will be the next
group. All other persons will be targeted in the 3rd wave of vaccination. Immunizations
will be administered in mass clinics lead by local and state public health agencies and
staffed with clinicians from both public and private organizations. Candidates will be
screened for risk category at the clinic. Immunizers will determine if the person has
previously received this vaccine. Eligible persons will be immunized, others will be
deferred. Screening information and immunization administration will be recorded in the
IIS. Vaccine availability will be monitored and balanced across provider organizations.
Weekly reports will be generated that track the number of persons screened, the number
immunized and the percent of the local population immunized will be shared with the
CDC.
The public health organization will track reports of adverse events and send to VAERS.
Actors:







International Public Health organization
National public health organization
Clinician
Local public health organization
EHR system
IIS
Inventory management system
Actions/Interactions:




Record immunization
Manage inventory
Create reports
Track adverse event
Concepts:









Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
Mass clinic
School
Investigation
Coverage report
Risk group
o Characteristics
Vaccine availability
Adverse events
o Onset
o Symptoms
o Report
8. Public Health Recall/Reminder
Story Board:
The Local Health Department is concerned because analysis shows the number of
children in schools up to date for MMR is only 84%. They decide that they want to reach
out to the parents of these children. They determine that they wish to send a post card to
the parents for all children that are overdue for the MMR. They enter the reference date
into the report request page and generate a set of mailing labels to be sent. Children who
are contraindicated for MMR vaccine are not included in the recall. Children who have
previously refused the vaccine are included in the recall.
Actors:



Public health agency
IIS
CDS service
Actions/Interactions:

Create report
o Reminder letters
o Request list of patients
 Overdue on a date
 Not contraindicated
Concepts:





Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
Coverage report
Recall/reminder
contraindication
9. Tracking funding program eligibility
Story Board:
George Pediatric, age 12, goes to MyClinic for a well-child visit. The nurse reviews his
immunization history in the EHR system and notes that he is due for a Tdap vaccine. In
addition, George’s mother reports that they will be travelling to a country with a risk of
yellow fever. After consulting with the travel specialist, the nurse administers a dose of
Tdap and a dose of yellow fever vaccine. The nurse determines that George is Native
American. The nurse records the child is eligible for vaccine funded by the Vaccines for
Children (VFC) due to his being Native American. The Tdap vaccine is eligible for VFC
funded vaccine, while the yellow fever vaccine is not. The nurse captures this in the
EHR. The EHR sends the updated immunization history, including the eligibility status to
the IIS. The IIS accepts the updated immunization history, tracking eligibility for each
immunization.
Note that VFC is a US vaccine funding program.
The IIS generates a report summarizing the number of immunization events where the
patient qualified for VFC.
Actors:
clinician
EHR-S
IIS
patient
Actions/Interactions:
Record immunization
Transmit immunization history
Accept immunization history
Concepts:



Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Clinician
 Ordering
 Administering
 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
o Funding program eligibility per immunization
Eligibility status report
10.
Public Health Tracking Vaccine Information
Sheet (VIS) Activity
Story Board:
The VIS is a document that providers are required to share with persons being
immunized. The document highlights why the immunization is important and lists
potential side effects. Providers must record the date the VIS was shared with the patient
and the version of the VIS document.
Suzy Patient (DOB 12/12/2009) is due for an MMR immunization. Her mother is shown
the VIS document (Version date 1/1/2010). The nurse reviews the contents to assure that
Mom understands the information. The Mom consents to allow Suzy to get immunized.
The nurse records the date the VIS was shared and the version date in the clinic’s EHR-s.
The EHR-s transmits the VIS information, along with the updated immunization record.
Two weeks later, Mom is concerned about a possible side-effect from the immunization.
The clinic determines which VIS sheet was given and the date. Mom is shown the VIS
again.
Actors:





Clinician
Patient
IIS
EHR
Parent
Actions/Interactions:




Record VIS date
Record consent
Request patient record
Review VIS date
Concepts:

Vaccination event
o Lot number
o Vaccine type
o Vaccination date
o Vaccine information sheet
 Version date
 Delivery date
o Clinician
 Ordering
 Administering

 Public health
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Patient address
o Responsible adult
11.
Public Health Vaccine Accountability
Story Board:
A provider organization must generate a report justifying how vaccine was used in the
previous year. They must separate usage of vaccine based on patient eligibility status.
The possible statuses are determined by characteristics of the patient and the vaccine
administered. The counts are grouped by eligibility reason and age. The report also
reports on the number of doses dispensed by age group and eligibility status. The
provider organization logs into the local IIS and generates the reports. They print these
for their records and electronically send the results to the state immunization program.
The clinician administers polio vaccine from lot xyz1234, expiration date 1/1/2012 in her
EHR system. The clinician records the eligibility category of the patient in the EHR. The
EHR system transmits the immunization record to the IIS. The IIS includes an inventory
management system which decrements the dose administered from appropriate lot.
The provider organization representative generates the annual usage report.
Actors:






Provider organization
Clinician
EHR
IIS
Patient
Vaccine inventory management system
Actions/Interactions:





Record immunization administered
Decrement inventory
Send immunization history
Receive immunization history
Create report
o Annual usage report by eligibility category
Concepts:

Vaccination event
o Lot number


o Vaccine type
o Vaccination date
o Vaccine expiration date
o
Patient/client
o Patient identifiers
 Id
 Name
 Date of birth
o Funding program eligibility
Usage report
12.
Requesting an Evaluated Immunization
History and Forecast
Note: There are a number of actors who wish to request an evaluated history and
forecast, including clinician, patient, EHRs, system doing reminders, system
populating data mart, etc. There are also several approaches. One is to request a
forecast from a source which has access to all pertinent data about the person in
question. Another is to populate the request Track vaccine usage and availability.
Story Board:
The manager of a state Immunization Information System (IIS) runs a report on vaccine
usage by vaccine and age group of recipient. She determines that an average of 1000
doses of MMR vaccine were administered per month over the previous year. She notes
that this average is similar to the average per month usage for the previous 5 years. She
projects her next years use and orders 12000 doses for the following year.
She notes that an average of 700 doses of Varicella vaccine were used per month over the
previous year. This different from the monthly average over the previous 5 years. On
investigation, she notes that the probable cause is low inventory levels of Varicella
vaccine (vaccine shortage) .
The IIS manager runs a report on Varicella vaccine inventory available by Provider
organization. She notes that The Big Clinic System has 200 doses of vaccine on hand.
She compares this to their usage per month over the past year and notes that they use an
average of 80 doses of vaccine in a typical month (range 49 to 100). Since this is
government funded vaccine she directs them to transfer 50 doses to The Other Clinic
system. They typically use 100 per month, but only have 25 doses on hand.
Actors:


IIS system manager
IIS System
Actions/Interactions:


Count doses used by vaccine
Inventory management system is implied
with the pertinent data. This story board covers the first case, though it may involve a
secondary request to a forecasting and evaluation service that includes the pertinent data.
For simplicity’s sake, we also do not address the issue of identity resolution in this
storyboard.
Story Board:
Dr Pediatrician prepares for an office visit with her patient, John Q Nuclear. She is
logged into her office EHR and gets the records on John. She causes the EHR system to
request an evaluation of John’s immunization history and recommendations on any
vaccines that John is due for. The EHR sends a request to the regional Immunization
Information System which is the source of consolidated immunization records for each
person living in the jurisdiction. The IIS uses its evaluation and forecasting service to
perform the tasks. The IIS returns the evaluated history, the forecast and any information
that indicates how and why the evaluation has arrived at these conclusions. (which rules
were violated causing doses to be not valid, reasons why schedule was altered from
standard schedule, etc)
Actors:





Clinician
Patient
EHR system
IIS
CDS service
Actions/Interactions:




Request forecast/evaluation
Send request for forecast/evaluation
Return forecast/evaluation
Receive forecast/evaluation
1.2.3 Data
The original Immunization Information Systems (IIS) core data items were prepared in
1995 by the National Center for Immunization and Respiratory Diseases (NCIRD) in
consultation with the Immunization Grantee Working Group. It was reviewed by the
National Vaccine Advisory Committee (NVAC), and recommendations of NVAC were
incorporated. Contributions were also made by public health representatives and private
providers. On February 5, 2007 NVAC approved a new set of core data items which were
developed in consultation with CDC and the American Immunization Registry
Association. Here is the listing of the current Required Data Elements for IIS:
http://www.cdc.gov/vaccines/programs/iis/stds/coredata.htm
Label
Status (Required/Optional)
Patient name: first, middle, last
Required
Patient alias name: first, middle, last
Optional
Patient address, phone number
Optional
Birthing facility
Optional
Patient Social Security number (SSN)
Optional
Patient birth date
Required
Patient sex
Required
**Patient race
Required
**Patient ethnicity
Required
Patient Primary language
Optional
**Patient birth order
Required
Patient birth registration number
Optional
Patient birth State/country
Required
Patient Medicaid number
Optional
Mother’s name: First, middle, last, maiden
Required
Mother’s SSN
Optional
Father’s name: first, middle, last
Optional
Father’s SSN
Optional
Vaccine Type
Required
Vaccine Manufacturer
Required
Vaccine dose number
Optional
Vaccine expiration date
Optional
Vaccine injection site
Optional
Vaccination date
Required
Vaccine lot number
Required
Vaccine provider
Optional
**Historical vaccination flag indicator
Optional
**VFC eligibility
Optional
**History of varicella disease indicator
Optional
**Patient status indicators that include active, inactive, MOGE, and other classifications
Optional
** Changes with the 2007 report.
Here is a link to the two HL7 guides for immunization exchange:
http://www.cdc.gov/vaccines/programs/iis/stds/standards.htm#hl7
1.2.4 Other information
Interoperability standards for immunization information are fairly mature, including the
following:
* HL7 v2 messages that are included in the ONC "Final Rule for Health Information
Technology: Initial Set of Standards, Implementation Specifications, and Certification
Criteria for Electronic Health Record Technology" (July, 2010), and HL7 v3 (POIZ)
messages.
* Inclusion of immunization information in both the CCD and CCR clinical document
specifications.
* Inclusion of immunization information in varies IHE profiles where appropriate,
including Immunization Content.
However, the diversity of standards makes it unclear how interoperability is to be
achieved. A key lesson of Meaningful Use Stage I in the U.S. has been that mismatched
sender and receiver capabilities have inhibited public health reporting objectives. What is
missing is something to tie the various standards together in an interoperable fashion to
satisfy the use cases above.
1.3 Stakeholder Commitment
The American Immunization Registry Association (AIRA) is committed to provide
leadership in all areas related to immunization information system activity, including
interoperability. Through its diverse membership of public health agencies, vendors, and
other stakeholders, AIRA will present any formal recommendations of the workgroup to
a review by its members for comment, and a formal vote of its members for endorsement.
If this user story is selected, AIRA will ensure that member representatives participate in
all workgroup activities.
1.4 Contact Information
Please contact the co-chairs of the AIRA Standards and Interoperability Steering
Committee, Emily Emerson (emily.emerson@state.mn.us) and Rob Savage
(robsavage@att.net), or the current AIRA president, Lora Santilli
(las09@health.state.ny.us).
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