TM 1 Tracking Influenza Vaccine Doses Administered: Pilot Test of CDC’s Countermeasure and Response Administration System PHIN Conference Atlanta, GA August 26, 2008 Jeanne Santoli, MD, MPH 1 and Jeanne Tropper, MS, MPH 2 1 Immunization Services Division National Center for Infectious and Respiratory Diseases Centers for Disease Control and Prevention 2 Division of Emergency Preparedness and Response National Center for Public Health Informatics Centers for Disease Control and Prevention

TM 2 Co-Authors Jeanne Santoli, MD, MPH Jeanne Tropper, MS, MPH Tom Shimabukuro, MD, MBA, MPH Sanjeeb Sapkota, MBBS, MPH Warren Williams, MPH Charles Williams, MPH, MA Ulrica Andujar, MPH Sabrina Walton, MPH

TM 3 Talk Outline Background 2007 Vaccine Doses Administered Pilot Results; Lessons Learned 2008 Vaccine Doses Administered Exercise Question and Answer

TM 4 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

TM 5 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 #

TM 6 HHS Proposed Pandemic Priority Groups

TM 7 Countermeasure Response & Administration (CRA) Overview Genesis was Pre-Event Vaccination System (PVS) for national smallpox vaccination campaign Capability to support mass tracking during an event System has been evolved to support any countermeasure, any event Includes the ability to track both detail (person level) and aggregate counts of countermeasures

TM 8 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 Aggregate Reporting Options HL 7

TM Aggregate Reporting Pilot Test To test the capability to monitor vaccines doses, a pilot using seasonal influenza vaccine as proxy for pandemic was developed Pilot Test Purpose: Project areas on ability to collect and report to CDC; access aggregate reports CDC assessed 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

TM 10 Pilot Minimum Data Set Project Area ID Date of Clinics Age 6 – 23 months 2 – 18 years 19 – 49 years 50 – 64 years 65+ years

TM 11 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”

TM 12 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

TM 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

TM 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

TM 15 Kansas Governor, Kathleen Sebelius, getting influenza vaccination in a Pilot Influenza Clinic, Kansas

TM 16 The Kansas Bee Mascot says: “Be wise, get immunized!”

TM 17 Timeliness Among All Options by Aggregation Method

TM 18 Data Submission Timeline All Options Note: N= 124 clinic dates

TM 19 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

TM 20 Timeliness by System Reporting Technique – Options 1 and 2

TM 21 Need for More Than Systems!

TM 22 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

TM 23 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

TM 24 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

TM 25 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

TM 26 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 influenza season

TM 27 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

TM 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)

TM 29 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

TM 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

TM 31 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.

TM 32 DAX Status Release of CRA v.1.8 development is complete; testing underway Exercise planning underway Vaccine Safety and Doses Administered Conference concluded 08/22/08 Project Areas have submitted POCs Projects Areas are selecting Option choices

TM 33 Acknowledgement Collaborative effort among: National Center for Immunization and Respiratory Diseases (NCIRD) – Immunization Services Division National Center for Public Health Informatics (NCPHI) – Division of Emergency Preparedness and Response; CRA Team Coordinating Office of Terrorism Preparedness and Emergency Response (COTPER) – Division of State and Local Readiness PHEP Grantees and Project Areas – Points of Contact

TM 34 "The findings and conclusions in this report are those of the authors and do not necessarily represent the official positions of the Centers for Disease Control and Prevention."

TM 35 Questions?