TM 1 Vaccine Doses Administered: Overview of Data Collection and Reporting Pandemic Influenza Vaccine: Doses Administered And Safety Training Conference.

TM1

Vaccine Doses Administered: Overview of Data Collection and

Reporting Pandemic Influenza Vaccine:

Doses Administered And Safety Training ConferenceAtlanta, GA

Joint Presentation August 21, 2008 by:Immunization Services Division

National Center for Immunization and Respiratory Diseases

andDivision of Emergency Preparedness and Response

National Center for Public Health Informatics

TM2

Talk Outline

• Background• 2007 Vaccine Doses

Administered Pilot Results; Lessons Learned

• 2008 Vaccine Doses Administered Exercise

• CRA New Features• Interactive Session

TM3

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

TM4

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 #

TM5

HHS Proposed Pandemic Priority Groups

http://www.pandemicflu.gov/vaccine/allocationguidance.pdf

TM6

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

TM7

Overall Proposed Doses Administered Category and

Tiers for Data ReportingHomeland and Nations

SecurityTier 1 (HNSt1) Tier 2 (HNSt2) Tier 3 (HNSt3)

Health Care and Community Support ServicesTier 1 (HCCSSt1)Tier 2 (HCCSSt2)Tier 3 (HCCSSt3)

Critical Infrastructure Tier 1 (CIt1) Tier 2 (CIt2) Tier 3 (CIt3)

General PopulationTier 1 (GPt1) Tier 2 (GPt2) Tier 3 (GPt3) Tier 4 (GPt4) Tier 5 (GPt5)

TM8

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

TM9

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

TM10

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

TM11

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

TM12

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”

TM13

Phase I: Pre-Pilot Planning

Apr-Oct 2007

CDC

Tasks

2007 Pilot ActivitiesPhase 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

PA

Tasks

Apply lessons learned – CRA development, future pilot

TM14

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

TM15

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

TM16

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

TM17

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

TM18

Timeliness Among All Options by Aggregation Method

11 11

5

21

6

23

3

0

5

10

15

20

25

30

Data Exchange Web Form Aggregation Individual Pt Data

Num

ber o

f Pro

ject

Are

as Yes (Within 48 hrs)

No( >48 hrs)

Did not report

TM19

Data Submission Timeline All Options

55

24

95

15 16

0

10

20

30

40

50

60

24 hrs 48 hrs 72 hrs 96 hrs >120 hrs Data notreported

Timeline of Data Submission (Hrs)

Nu

mb

er

of

Cli

nic

Da

tes

Note: N= 124 clinic dates

TM20

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

TM21

Timeliness by System Reporting Technique –

Options 1 and 2

21

0

24

10

65 40

63

0

5

10

15

20

25

30

Nu

mb

er

of

Clin

ic D

ate

s

Yes-48 hours

No-48 hours

TM22

Need for More Than Systems!

26 27

4

16

0

5

10

15

20

25

30

35

40

System Manual

Data Aggregation Method

Num

ber

of C

linic

Dat

es

Yes-48 hours

No-48 hours

TM23

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

TM24

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

TM25

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

TM26

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

TM27

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

TM28

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

TM29

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)

TM30

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

TM31

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

TM32

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)

TM33

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

TM34

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

TM35

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

TM36

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

TM37

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

TM38

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

TM39

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?

TM40

1. What are the best practices on screening for

priority groupings?Sample form

Comments on tools such as forms to the bucket classifications

TM41

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?

TM42

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?

TM43

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?

TM44

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?

TM45

Thank you!

Lunch Time