1. TM 1 Vaccine Doses Administered: Overview of Data Collection and Reporting Pandemic Influenza Vaccine: Doses Administered And Safety Training Conference Atlanta, GA Joint Presentation August 21, 2008 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 Talk Outline Background 2007 Vaccine Doses Administered Pilot Results; Lessons Learned 2008 Vaccine Doses Administered Exercise CRA New Features Interactive Session

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 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 #

5. TM 5 HHS Proposed Pandemic Priority Groups http://www.pandemicflu.gov/vaccine/allocationguidance.pdf

6. TM 6 Current Thinking on Data Collection and Aggregation Strategies The proposed HHS prioritization format lists: 4 Categories, 14 Tier Groups and numerous Target Groups Data collection and aggregation will be: by Category, by each Tier Group (1, 2, 3 …) within each Category, and by each Tier Group across all Categories Data collection and aggregation will not be done at the individual Target Groups Examples next slide

7. TM 7 Overall Proposed Doses Administered Category and Tiers for Data Reporting Homeland and Nations 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)

8. TM 8 Countermeasure and Response Administration (CRA) Genesis in Pre-Event Vaccination System (PVS) for national smallpox vaccination campaign Supports mass tracking during an event Evolved to support any countermeasure, any event (medical interventions such as vaccines, pharmaceuticals; non-medical such as patient isolation and quarantine, scarce medical equipment and social distancing measures) Tracks both detail (person level) and aggregate counts of countermeasures

9. TM 9 Aggregate Reporting of Pandemic Vaccine Doses Administered Data Exchange (Option 1): Project Area has own system (IIS or other CRA); may send using: pipe delimited, XML file, HL7 Web Entry Aggregate (Option 2): Project Area collects/aggregates data manually or electronically; enters via aggregate reporting screen Web Entry Detail (Option 3): Project Area collects individual data via CRA; minimum data set is automatically aggregated

10. TM 10 2007 Seasonal Influenza Pilot Test To test the capability to monitor vaccines doses, a pilot using seasonal influenza vaccine as proxy for pandemic was developed Priority areas to be assessed: Project areas on ability to collect and report to CDC; access aggregate reports CDC on technical capability of CRA to accept and aggregate data Exercise was designed to be minimally invasive to normal operations Time frame: November 1 – December 31, 2007 Frequency: Repeatable; at minimum - twice

11. TM 11 2007 Pilot Minimum Data Set Project Area ID Vaccination Dates Age Groups 6 – 23 months 2 – 18 years 19 – 49 years 50 – 64 years 65+ years

12. TM 12 Parameters for Participation in 2007 Pilot Identify Point of Contact (POC) Select option choice Identify minimum of two clinic dates Send data for both clinics within 48 hours – “fully successful”

13. TM 13 Phase I: Pre-Pilot Planning Apr-Oct 2007 CDCTasksCDCTasks 2007 Pilot Activities Phase II: Pilot Test Nov-Dec 2007 Phase III: Post-Pilot Jan-Mar 2008  Webinars - Orientation & introduction  Webinars - Option specific; open Q&A;  Selection of POC  Conference Calls - Individual project areas; follow up for Q&A  PHIN conference presentation  Identify & submit option choices  CRA Development - Version 1.6 release  Pilot Test - Receive & process clinical data from 62 project areas  Finalize & submit clinic dates  Review option-specific checklist  Develop/administer feedback questionnaire  Respond to feedback questionnaire  Develop After Action Report  Conference Call - After Action Review feedback of pilot  Obtain digital certificates  Conduct results briefings  Participate in After Action Review conference call  Submit influenza vaccine doses administered data to CDC  Pilot Test – Project Area support & trouble shooting PATasksPATasks  Apply lessons learned – CRA development, future pilot

14. TM 14 2007 Option Choices by Project Area Web Entry aggregate Web Entry Detail Data Exchange LA county DC NY City Chicago Marshall Islands Guam Mariana Islands Virgin Islands Puerto Rico Palau FS Micronesia American Samoa

15. TM 15 2007 Summary Results Pre-Planning 100% (62/62) identified a POC 100% (62/62) selected an Option 85% (53/62) submitted both clinic dates Pilot 89% (55/62) submitted some data 11% (7/62) did not submit any data 64% (35/55) fully successful Post-Pilot 55 Respondents completed on-line feedback questionnaire 61% (38/62) participated in After Action Review call

16. TM 16 Kansas Governor, Kathleen Sebelius, getting influenza vaccination in a Pilot Influenza Clinic, Kansas

17. TM 17 The Kansas Bee Mascot says: “Be wise, get immunized!”

18. TM 18 Timeliness Among All Options by Aggregation Method

19. TM 19 Data Submission Timeline All Options Note: N= 124 clinic dates

20. TM 20 Aggregation Method Among Web Entry Aggregate Users (Option 2) IIS or other system : 23.5% 8/34 Spreadsheet : 41.2% 14/34 Paper based (reported) : 17.6% 6/34 Paper based (did not report) : 17.6% 6/34

21. TM 21 Timeliness by System Reporting Technique – Options 1 and 2

22. TM 22 Need for More Than Systems!

23. TM 23 Option Choice Switching 5 Project Areas (PA) switched from original option choice to other choice when data reporting began Option 3 to Option 1: 1 PA Option 2 to Option 1: 2 PA Option 3 to Option 2: 1 PA Option 1 to Option 2: 1 PA

24. TM 24 Feedback Questionnaire Project Areas requested to complete anonymous, on-line feedback questionnaire Nine questions highlighting: Efficiency of communication from CDC Benefits of pilot test Issues/barriers encountered Feedback to improve future exercises

25. TM 25 Question: How beneficial was this pilot test to you in preparing for a pandemic influenza event in the future? 14 respondents : Very Beneficial 38 respondents : Somewhat Beneficial 3 respondents : Not Beneficial

26. TM 26 Question: What issues, if any, did you encounter while transmitting data to CDC? 18 respondents : digital certificate 12 respondents : file format 12 respondents : SDN (timing out); technical issues 9 respondents : Coordination with their local health departments

27. TM 27 After Action Review Call Feedback Confirmed findings from Feedback Questionnaire SDN timing out affected efficiency Digital certificate process was a concern Supplemented findings from Feedback Questionnaire CRA was easy to use CDC/CRA support was good (technical and project) Need consistent communication by CDC Distribution lists Requesting all information at once Leading implementer information Support for expanded pilot for 2008 - 2009 influenza season

28. TM 28 Strategies for Addressing Challenges Digital certificates: two parallel approaches System design to allow lower level of security; expected late FY2009 Internal decision memorandum of understanding Timing-out user sessions: immediate issue corrected; reviewing configuration to avoid in future Communications: Training conference Communication consistency Small group calls

29. TM 29 2007 Pilot Total Doses Administered 56,667 doses administered across all project areas Doses administered by age group: 6 – 23 Months:6.4% (3,618) 2 – 19 Years: 23.0% (12,999) 20 – 49 Years:22.6% (12,836) 50 – 64 Years :24.4% (13,847) 65 Years +: 19.6% (11,119) Not identified 4.0% (2,248)

30. TM 30 Conclusions Excellent willingness to participate across project areas Vast majority (89%) of Project Areas able to collect, transmit, retrieve data Nearly 2/3 of Project Areas submitted data within 48 hour time period Challenges do exist, technical issues are being addressed CRA able to accept, aggregate data submitted doses Issues/barriers identified will assist in improving Pandemic Influenza preparedness Project Areas supportive of broader/deeper testing during 2008 influenza season

31. TM 31 2008 - 2009 Seasonal Influenza Exercise Objectives Timeframe: October 1 - December 31, 2008 Increase volume: to test system and operational capacities, Project Areas send data from a minimum of eight clinics during the four weeks Track prioritization: to test tracking priority groups, Project Areas use proposed prioritization framework Weekly reporting: to test weekly reporting capability, Project Areas send data for a minimum of four consecutive weeks Tied to 2009 CDC PHEP continuation guidance biosurveillance requirement

32. TM 32 Priority Groups for 2008 Exercise Focus on General Population Category and its Tier Groups 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 old“ Build Other 9 “Tier Groups” (Not planning to collect data on these for the 2008 exercise)

33. TM 33 Exercise Next Steps Exercise timeframe is 10/01 – 12/31/2008 CRA version 1.8 to be released 09/15/2008 Training scheduled for 09/17/2008 and monthly thereafter to support Project Area timeframes Expect to follow procedures similar to 2007 pilot compile and report results: Activities requirements Webinars/teleconference calls Exercise poll After action call Presentations After Action Report

34. TM 34 CRA New Feature: Upload Confirmation What is it? Allows Project Area to verify and confirm counts entered by local health departments Why is it needed? Support growing technical and operations capacity of Project Areas Support Project Areas ability to choose multiple options to report DA Ensure counts are verified by each Project Area When is it available? Incorporated with in CRA Version 1.8 schedule for release 09/15/2008 Component of DAX 2008 influenza season exercise

35. TM 35 Confirmation Procedures Option 1: Data Exchange Same as 2007 exercise Personnel at local health departments enter vaccine administrations using the Project Area’s IIS or other electronic system The Project Area POC uploads or messages Project Area-level aggregate file Aggregate counts are automatically confirmed when aggregate file is accepted into the CRA system

36. TM 36 Confirmation Procedures Option 2: Web Entry Aggregate New process using CRA confirmation screen Data Entry Specialist (DES) at the local health department enters clinic-level aggregate counts of vaccine doses administered Clinic-level doses administered are aggregated and displayed on confirmation screen Project Area POC confirms aggregate counts and reports counts to the CDC A report listing the aggregate counts for each clinic/POD can be generated

37. TM 37 Confirmation Procedures Option 3: Web Entry Detail Similar to Option 2 DES at local health department or clinic enters person-level vaccine doses administered Clinic-level doses administered are aggregated and displayed on screen Project Area POC confirms aggregate counts and reports counts to the CDC A listing of the aggregate counts for each clinic can be generated

38. TM 38 Confirmation Procedures Mixed Options Project Areas may now use multiple options to report doses administered data Clinic-level and person-level doses administered entered by the local health departments are aggregated and displayed on the screen Project Area POC confirms and reports the aggregate counts for the Project Area to the CDC A report listing of the aggregate counts for each clinic can be generated Extensive coordination of the entire PA is needed

39. TM 39 Interactive Dialog Feedback topics 1.What are the best thoughts and practices on screening for priority groupings? 2.How do Doses Administered (DA) data collection efforts help with overall preparedness efforts? 3.Does the testing and work help promote automation efforts? 4.Does pilot help/hurt collection of routine seasonal data? 5.Future role for increase private vaccination administration efforts?

40. TM 40 1. What are the best practices on screening for priority groupings? Sample form Comments on tools such as forms to the bucket classifications

41. TM 41 2. How do Doses Administered (DA) data collection efforts help with overall preparedness efforts? Feedback on communication and collaboration bridge between immunization and preparedness? Resources sharing? Opportunities for future projects?

42. TM 42 3. Does the testing and work help promote automation efforts? Increasing use of techniques to capture data? Use of PHIN MS transport standards? Opportunities for IIS improvement? What are the barriers to increase automation? Does more automation equal better?

43. TM 43 4. Do exercises (2007 pilot) improve collection of routine seasonal data? Do clinics pay better attention to details during exercises, impact other data collection efforts? Any noticeable trends (good or not so good) in reporting of seasonal influenza data from last year’s exercise?

44. TM 44 5. Future role for increase in private vaccination administration efforts? What would be the impact and challenges of targeting industry clinics or occupational groups to collect DA data? What are the system roll out and trainability issues?

45. TM 45 Thank you! Lunch Time