Quick Links



Meeting Schedule



Edit SidebarRight
Edit PageTabs

Edit PageTabs

User Story: Immunization Information Systems (AIRA)


Contact Info:

Emily Emerson (emily.emerson@state.mn.us) -- AIRA Standards and Interoperability Steering Committee Co-Chair
Rob Savage (robsavage@att.net) -- AIRA Standards and Interoperability Steering Committee Co-Chair
Lora Santilli (las09@health.state.ny.us) -- AIRA President

Date Received:

11/18/2011

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 Group
1
2
3
4
5
Hep B
2/2/2009
4/2/2009
8/3/2009


DTAP
4/2/2009
8/3/2009



Polio
4/2/2009
8/3/2009



HIB
4/2/2009
8/3/2009



Rotavirus





MMR
2/1/2010




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
    • Lot number
    • Vaccine type
    • Vaccination date
    • Vaccine expiration date
  • Patient/client
    • 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
    • Lot number
    • Vaccine type
    • Clinician
      • Ordering
      • Administering
  • Inventory clerk
  • Patient/client
    • 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
    • Lot number
    • Vaccine type
    • Clinician
      • Ordering
      • Administering
    • Funding source
    • Funding program eligibility
    • Administering clinic
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • Responsible adult
    • 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
    • List of persons not re-immunized
  • Update vaccine inventory
    • Track return shipment

Concepts:
  • Vaccination event
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • Responsible adult
    • 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
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • 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 5%
1-5 yr 98%
5-10 yr 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
    • List of unimmunized persons
    • Aggregate coverage
  • Interstate IIS query and response for immunization history

Concepts:
  • Vaccination event
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • Responsible adult
  • Duplicate immunization records
  • Disease
    • Name
    • Onset
    • Diagnosis
    • Report
    • 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
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • Responsible adult
  • Mass clinic
  • School
  • Investigation
  • Coverage report
  • Risk group
    • Characteristics
  • Vaccine availability
  • Adverse events
    • Onset
    • Symptoms
    • 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
    • Reminder letters
    • Request list of patients
      • Overdue on a date
      • Not contraindicated

Concepts:
  • Vaccination event
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • 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
    • Lot number
    • Vaccine type
    • Vaccination date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • Responsible adult
    • 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
    • Lot number
    • Vaccine type
    • Vaccination date
    • Vaccine information sheet
      • Version date
      • Delivery date
    • Clinician
      • Ordering
      • Administering
      • Public health
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • Patient address
    • 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
    • Annual usage report by eligibility category

Concepts:
  • Vaccination event
    • Lot number
    • Vaccine type
    • Vaccination date
    • Vaccine expiration date
  • Patient/client
    • Patient identifiers
      • Id
      • Name
      • Date of birth
    • 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

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) 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.

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.

Supporting Files:

Description
File
This document contains the initial draft user story submission.


Comments:

Please comment on this User Story using the "Discussion" tab at the top of the screen.