1. TM 1 Vaccine Doses Administered Exercise 2008 September 10, 2008 Presented by: Immunization Services Division National Center for Immunization and Respiratory Diseases and Division of Emergency Preparedness and Response National Center for Public Health Informatics

2. TM 2 Agenda Background Exercise Summary Option Specific Information BioSurveillance Credit Requirements DAX Status Next Steps Questions and Answers

3. TM 3 Background The National Strategy for Pandemic Influenza: Implementation Plan calls for monitoring appropriate use of scarce pre-pandemic/pandemic influenza vaccine To accomplish this, Project Areas are expected to track pandemic influenza (PI) vaccine doses administered at the individual patient level and then send a subset of data (minimum data set) on a weekly basis to the CDC; Project Areas are the 50 states, 4 large cities and 8 territories CDC’s CRA system has been modified to provide flexible ways for Project Areas to report vaccine doses administered

4. TM 4 HHS Proposed Pandemic Priority Groups http://www.pandemicflu.gov/vaccine/allocationguidance.pdf

5. TM 5 Proposed Pandemic Priority Doses Administered - Category and Tiers Homeland and National Security Tier 1 (HNSt1) Tier 2 (HNSt2) Tier 3 (HNSt3) Health Care and Community Support Services Tier 1 (HCCSSt1) Tier 2 (HCCSSt2) Tier 3 (HCCSSt3) Critical Infrastructure Tier 1 (CIt1) Tier 2 (CIt2) Tier 3 (CIt3) General Population Tier 1 (GPt1) Tier 2 (GPt2) Tier 3 (GPt3) Tier 4 (GPt4) Tier 5 (GPt5)

6. TM 6 PI Vaccine Doses Administered Minimum Data Set for Reporting to CDC Project Area ID Reporting Period Start and End Dates Vaccine Type (CVX code) HHS Pandemic Priority Groups Homeland and Nations Security Health Care and Community Support Services Critical Infrastructure General Population Dose # Count of Doses Administered per Priority Group and Dose #

7. TM 7 Options for Aggregate Reporting to CDC Option 1: For states and project areas collecting data via an existing immunization information system (IIS) or other application, technical specifications were developed for three different data exchange formats: flat file (pipe- delimited), XML file, HL7 Option 2: For states and project areas collecting data manually, an aggregate reporting screen was added to CDC’s CRA application to allow direct data entry via a web browser Option 3: For states and project areas using CDC’s CRA application to collect patient level information, selected data elements will be automatically aggregated

8. TM 8 2008 Doses Administered Exercise Report data weekly for four consecutive weeks from eight or more clinics during the timeframe of Oct. 1 – Dec. 31, 2008; fully successful criteria: Weekly reporting: aggregate reporting data is sent by Tuesday for the previous reporting week (Sunday through Saturday; MMWR week); for any four consecutive weeks Increased volume: data is from a minimum of eight clinics over the course of the four weeks Priority group tracking: each general population priority group is tracked

9. TM 9 Pilot Minimum Data Set Project Area ID Date of Clinics Priority Groups – General Population General population, Tier 1 (GPt1) contains "Pregnant women“ “Infants and toddlers 6 - 35 months old" General population, Tier 2 (GPt2) contains “Household contacts of infants < 6 months" “Children 3 - 18 years with high risk conditions" General population, Tier 3 (GPt3) contains “Children 3 - 18 years without high risk conditions" General population, Tier 4 (GPt4) contains “Persons 19 - 64 with high risk conditions" “Persons > 65 years old" General population, Tier 5 (GPt5) contains “Healthy adults 19 - 64 years with high risk conditions“ Note: other 9 “Tier Groups” must be accommodated, however, not planning to collect data on these for the 2008 exercise

10. TM 10 Screening Form CDC has developed a sample screening form intended as a generic guide Example of one strategy/algorithm to determine the correct priority group Project Areas can choose whether to use Project Areas are encouraged to develop and share best practices for screening The CDC form and forms Project Areas are willing to share will be posted on the CRA web page

11. TM 11 Option 1: Data Exchange Summary Healthcare provider collects and maintains patient- level information locally and submits selected data to the IIS or other application The state submits aggregate data to CDC’s CRA system on a weekly basis via Immunization Information System or other application using one of three data exchange formats: Flat file (pipe-delimited) OR Extensible Markup Language (XML) file OR Health Level Seven (HL7) Version 2.5

12. TM 12 Option 1: Considerations Process Considerations Determine to what level data will be reported for DAX Determine who will collect the data Aggregate data exchange must be consolidated at the project area prior to submission to CDC Technical Considerations Local application should have capability to collect core data elements Core data elements should be extracted and put into one of three formats following the Data Exchange Specification for Pandemic Influenza Aggregate Report Transport mechanism should be determined and consistent with CDC PHIN standards CDC SDN Digital certificates must be in place for access and transfer to CRA

13. TM 13 Data Exchange Specifications Data exchange specifications available on webpage http://www.cdc.gov/phin/activities/applications- services/cra/2008Exercise.html http://www.cdc.gov/phin/activities/applications- services/cra/2008Exercise.html Reorganized and reformatted New Pandemic Influenza Priority Groups Event-specific Valid Value/Data Validation Worksheets Explanation of “full replacement of aggregate reports” Improved sample messages

14. TM 14 Option 2: Web Entry Aggregate Scenario 1 Point of Contact at Partner Jurisdiction Data entry of aggregate counts for jurisdiction Confirm aggregate counts to report to CDC Scenario 2 Data Entry Specialist at Clinic / POD Data entry of clinic-level aggregate counts Point of Contact at Partner Jurisdiction Confirm aggregate counts for the jurisdiction to report to CDC Generate Counts by Clinic Report

15. TM 15 Clinic Level Aggregate Reporting Screen Shot

16. TM 16 Aggregate Count Confirmation Screen Shot

17. TM 17 Option 2: Considerations Process Considerations Determine to what level data will be reported for DAX Project Area Clinic level Determine who will enter information on-line Technical Considerations Staff entering data on-line must have access to the internet via web browser Staff accessing CRA must have a digital certificate Staff and clinics (organizations) must be pre-loaded into CRA system

18. TM 18 Option 3 Web Entry Detail Scenario 3 Data Entry Specialist at Clinic / POD Data entry of person-level vaccine doses administrated for the clinic Point of Contact at Partner Jurisdiction Confirm aggregate counts for the jurisdiction to report to CDC Generate Counts by Clinic Report

19. TM 19 Patient Level Data Collection Screen Shot

20. TM 20 Aggregate Count Confirmation Screen Shot

21. TM 21 Option 3: Considerations Process Considerations Determine who will collect and enter data and at what level of detail Project Areas have the option to collect detailed individual level information using the new event set up feature; additional elements are for Project Area use only Technical Considerations Staff entering data on-line must have access to the internet via web browser Staff accessing CRA must have a digital certificate Staff and clinics (organizations) must be pre-loaded into CRA system

22. TM 22 PHEP Biosurveillance Credit PHEP biosurveillance credit At least one of the eight clinics must be in a CRI/MSA location At least one of the eight clinics must be in a non-CRI/MSA location For Project Areas residing fully within a CRI/MSA location (i.e. LA, DC, Chicago, NYC) all eight clinics by default will be CRI-MSA with no non-CRI-MSA clinics reported For Project Areas of the Pacific Islands and Territories, Puerto Rico, and the Virgin Islands, which do not have designated CRI-MSA locations, all eight clinics will be non-CRI-MSA with no CRI-MSA reported.

23. TM 23 Expected Benefits and Lessons Learned Expand capabilities to screen for priority groups, report on a regular basis under increased volume conditions more comparable to a pandemic Identify and address technical gaps, equipment needs, operational barriers, staff training needs Gain a better understanding of resources and personnel needs at all levels: clinic, project area, registry and CRA operations

24. TM 24 DAX Status CRA V.1.8 development is complete On schedule for release to production 09/15/2008; testing underway Project Areas have submitted POCs Projects Areas have selected Option choices 23 – Option 1 35 – Option 2 4 – Option 3

25. TM 25 Next Steps Confirm the four week period Project Area will participate in exercise – September 19 Option 2 – Add clinics that will be submitting aggregate counts to the CRA Application – September 26 Option 3 – Add clinics where patient-level information will be collected to the CRA Application – September 26 Complete form identifying eight clinics - work with CRA point of contact

26. TM 26 Technical Assistance CRA webpage Quick reference/Checklist CRA Exchange (Sitescape) Contact email CRAHelp@cdc.govlp@cdc.gov PHIN Email – PHINTech@cdc.govPHINTech@cdc.gov To obtain a digital certificate To obtain access to the CRA demonstration site

27. TM 27 Questions?