Vaccine Doses Administered Exercise 2008

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

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

5. 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) Proposed Pandemic Priority Doses Administered - Category and Tiers

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. 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. 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. 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. 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. 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. 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. Data Exchange Specifications • Data exchange specifications available on webpage 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. 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. Clinic Level Aggregate ReportingScreen Shot

16. Aggregate Count ConfirmationScreen Shot

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. 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. Patient Level Data CollectionScreen Shot

20. Aggregate Count ConfirmationScreen Shot

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

27. Questions?