1. TM Weekly H1N1 Vaccine Doses Administered Update September 23, 2009 Division of Integrated Surveillance Systems and Services National Center for Public Health Informatics & Immunization Services Division National Center for Immunization and Respiratory Diseases

2. TM Agenda Background Updates DESL User Enrollment Process CRA Training Action Items Upcoming Events and Questions

3. TM Background The National Strategy for Pandemic Influenza: Implementation Plan calls for monitoring of the appropriate use of a scarce pandemic influenza vaccine To accomplish this, states/ Project Areas will track vaccine doses administered, collect and aggregate minimum data elements and transmit weekly to CDC CDC’s CRA system was modified to provide three ways for states and partners to report vaccine doses administered

4. TM Pipe-delimited File State enter data into state’s Immunization Information System or some other equivalent application and is extracted in one of these format. CRA Option 1 Data exchange Aggregate data entered directly into CRA via the web-based aggregate reporting interface CRA Option 2 Direct web entry The file is then securely transferred to CDC via either CRA application or PHIN MS and loaded into CRA for reporting Individual level data is entered directly into CRA via the web based flexible Treatment interface CRA Option 3 Individual level data entry Data is available in CRA for reporting Individual level data are automatically aggregated by CRA system and is available for reporting XML File HL 7 Aggregate Reporting Options via CRA

5. TM H1N1 Vaccine Doses Administered Tracking Pandemic Plan is applied to H1N1 Response CRA will be used to track doses administered (DA) initially; critical component of safety and ensuring targeted groups are reached BRFSS will be running in parallel and will track usage with statistical methods as vaccine coverage increases

6. TM H1N1 Vaccine Doses Administered Updates H1N1 vaccine ordering expected to begin 9/30 First report date starting as soon as dose administration begins: Smaller Volume: some possible Oct 6 Larger Volume: more expected Oct 13 Onwards!

7. TM Security Waiver Provides data entry staff access to limited CRA features to support the H1N1 Response Requires username and password authentication to access the application Supports easier access by not requiring SDN digital certificates Applicable to Option 2 and limited access for Option 3 Guide for Establishing CRA Data Entry Specialist Lite for H1N1 document will be sent to Project Area POCs and made available on the CRA webpage

8. TM DESL User Enrollment Process 1.PHA will access CRA via SDN to add a new user 2.Enter the required fields (first name, last name, phone number) and assign the Data Entry Specialist Lite role 3.Select Assign Resources to User to assign one or more organizations to the new DESL user 4.CDC PHIN Helpdesk contacts PHA to verify new DESL user 5.CDC Security Team sends new DESL user two emails First Email – Contains link to CRA authentication site and username Second Email – Contains password

9. TM Access SDN

10. TM Enter DESL User Email Address

11. TM Add DESL User Information & Assign Role

12. TM Assign Resources to DESL User

13. TM Overview of Setup Tasks CDC has already setup the H1N1 event and the minimum dataset, including vaccine types, aggregate groups and project areas Some basic setup tasks may be required; these include adding Users Organizations Optional fields (Option 3 only)

14. TM CRA Training

15. TM Guidelines for Reporting Aggregate Data Each project area sending data to the CRA system is responsible for submitting counts for each reporting period that aggregates all the doses administered for all clinics in the jurisdiction by age group and dose number Reporting is required for each reporting period, even if no doses were administered Reporting period is based on the MMWR week; defined as Sunday through Saturday Reporting is required by end of day (11:59 pm local time for the reporting jurisdiction) on the Tuesday following the end of the reporting period

16. TM Option 1 - Guidelines for Reporting Aggregate Data Primary code 128 should be used to report aggregated age group and dose number to CDC Based on any formulation of H1N1 vaccine Full Replacement of Aggregate Reports Full replacement of all weekly aggregate counts previously reported, along with new aggregate counts is required for each reporting period Each week, counts for new week plus the counts for all previous weeks must be reported Aggregate counts replaced based on a match to the partner, event, start date, end date, and vaccine type

17. TM Option 1 Training Scenario Data has been collected in the project area via an existing Immunization Information System (IIS) or other application and aggregate counts are manually uploaded to CRA for the reporting period

18. TM Option 2 - Guidelines for Reporting Aggregate Data Option 2 (Web-based Aggregate) Vaccine type Novel Influenza-H1N1-09, all formulations should be used to report aggregate age group and dose number to CDC

19. TM Process & Technical Considerations (Option 2) Process Considerations Determine how data will be entered into CRA Aggregate data submitted at the Project Area only Data submitted at the provider level and confirmed at the Project Area level Determine who will need access to CRA and in what role Technical Considerations Staff entering data online must have access to the internet via web browser Staff confirming data for the Project Area (Public Health Administrator) must have SDN digital certificate

20. TM Option 2 Training Scenario 1 - Project Area Confirms and Submits Counts Data collected at the provider level is sent to the public health authority and aggregated at the Project Area level Public Health Administrator (PHA) logs into CRA and submits confirmed aggregate data for the Project Area Scenario 2 - Providers Enter Counts and Project Area Confirms Total Counts Data is collected and aggregate counts are entered into CRA at the provider level Public Health Administrator (PHA) logs into CRA and confirms aggregate data for the Project Area

21. TM Option 3 - Guidelines for Reporting Aggregate Data Option 3 (Web-based Detail) All vaccine types can be used to track vaccine doses administered Individual vaccine and lot number information can be collected

22. TM Process & Technical Considerations (Option 3) Process Considerations Determine who will collect and enter data Determine the level of detail of vaccination data to be collected Ensure data entry staff (users) and providers (organizations) have been added and assigned to the event Technical Considerations Staff entering data online must have access to the internet via web browser unless they use offline CRA Staff accessing CRA must have SDN digital certificate

23. TM Option 3 Training Scenario Patient level vaccine doses administered data has been collected at the provider level and entered into CRA CRA aggregates patient level data entered by age group and dose number Public Health Administrator (PHA) logs into CRA and confirms aggregate data for the Project Area for the reporting period

24. TM Accessing CRA Preparation Activities Acquire or renew SDN digital certificate as necessary Use CRA event name Novel Influenza (H1N1) 09 for associated setup tasks Logging into CRA Access Secure Data Network (SDN) at https://sdn.cdc.govhttps://sdn.cdc.gov Access CRA Application on SDN Activity Page

25. TM Quality Control Considerations for Provider Supplied Aggregate Reports Scenario Provider sends aggregate report to public health authority Need arises to add aggregate counts from provider forms to IIS individual level data to create an inclusive doses administered report If subsequent patient level reporting is received for a previously submitted aggregate report, Project Areas need to reconcile the aggregate counts with patient level data to avoid double-counting to the CRA system

26. TM Reminders CRA Demonstration Site (http://crademo.cdc.gov) should be used for practicing data entry and data submissionhttp://crademo.cdc.gov Contact the PHIN Helpdesk (phintech@cdc.gov) for login/password informationphintech@cdc.gov CRA Production Site accessed via SDN should be used to perform associated setup tasks Adding organizations (provider locations) and users (staff accessing CRA) Assigning users to organizations Assigning organizations to the event – Novel Influenza (H1N1) 09

27. TM Submit test file to Tony DaSilva (aod7@cdc.gov) or your designated Project Area point of contact to ensure the file can be submitted – (Option 1)aod7@cdc.gov Perform setup tasks as necessary for your Project Area (adding organization and users) – (All Options) Ensure users have an active SDN digital certificate, as required – (All Options) Develop quality control mechanisms for aggregate report forms – (Option 1 & Option 2) Action Items

28. TM Resources Technical Checklist/Preparation Guide (Option 1, 2, & 3) H1N1 Aggregate Data Exchange Specification Sample H1N1 Aggregate Reporting Forms Guide for Establishing CRA Data Entry Specialist Lite for H1N1 Quick Reference Guides Option 2 PHA Users Option 2 DES Users Option 3 PHA Users Option 3 DES Users Synchronization

29. TM CRA Team Contact Information Jeanne Tropper, NCPHI/DEPR CRA Lead, jwu0@cdc.gov jwu0@cdc.gov Warren Williams, NCIRD/ISD Informatics Lead, wxw4@cdc.gov wxw4@cdc.gov Charles Williams, SRA Contractor, Project Area and Public Health Partner Liaison, cpw6@cdc.govcpw6@cdc.gov CRA Help crahelp@cdc.govcrahelp@cdc.gov

30. TM Upcoming Events DateEventTopic September 30Conference Call/Training Session (as needed) Open Conference Call for Project Areas to Touch Base with CDC/CRA October 7Conference Call/Training Session (as needed) Open Conference Call for Project Areas to Touch Base with CDC/CRA October 14Conference Call/Training Session (as needed) Open Conference Call for Project Areas to Touch Base with CDC/CRA

31. TM Questions