H1N1 Vaccine Doses Administered Refresher Training All Options

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H1N1 Vaccine Doses AdministeredRefresher
Training (All Options)

• September 9, 2009
  
• Jeanne Tropper, MS, MPH, jwu0_at_cdc.gov
• CRA Development Team
• Division of Integrated Surveillance Systems and
  Services
• National Center for Public Health Informatics

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Agenda

• Learning Objectives
• Background
• Options 1, 2 and 3 Overview and Training
• Action Items
• Upcoming Events and Questions

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Learning Objectives

• The Refresher Training session focuses on
• Understanding procedures for project area setup
  (organizations, users, etc.)
• Reviewing and understanding guidelines for
  reporting aggregate data per option
• Comprehending process and technical
  considerations
• Gaining awareness of steps for submitting and
  confirming aggregate count data
• Identifying and managing potential quality
  control concerns for aggregate reporting

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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
• CDCs CRA system was modified to provide three
  ways for states and partners to report vaccine
  doses administered

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Aggregate Reporting Options via CRA
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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

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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 (1159 pm
  local time for the reporting jurisdiction) on the
  Tuesday following the end of the reporting period

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Definitions

• Event public health programs or emergency
  responses that require the administration of
  countermeasures H1N1 vaccine campaign has been
  defined as an event within CRA
• User Roles CRA has role based user access the
  user can only access system functions appropriate
  to their role two roles
• Public Health Administrator (PHA)
• Data Entry Specialist (DES)
• Data Entry Specialist Lite (DESL)
• Organization Physical location where vaccine or
  countermeasure will be administered

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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)

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Option 1(Data Exchange)
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Guidelines for Reporting Aggregate Data via
Option 1

• 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

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Full Replacement of Aggregate Reports
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Process Technical Considerations (Option 1)

• Local application should have capability to
  collect core data elements and/or aggregate
  report form counts
• Minimum data set should be extracted and put into
  one of three formats following the Data Exchange
  Specification for Novel Influenza - H1N1
  Aggregate Report document
• CDC SDN Digital certificates must be in place for
  access and transfer to CRA
• Quality control concerns for aggregate report
  form counts

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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

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Essential Tasks to PerformOption 1

• Login to CRA
• Upload the data file to CRA
• Note and correct errors and warnings, if any
• Search upload status
• Note to PHINMS users upload process is more
  automated and these steps do not apply if
  interested in implementing PHINMS contact your
  CRA POC

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Option 2(Web-based Aggregate)
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Guidelines for Reporting Aggregate Data via
Option 2

• 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

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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

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Option 2 Training

• Scenario 1 - Project Area Enters and Confirms
  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

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Scenario 1Essential Tasks to Perform

• Enter and confirm aggregate counts at the project
  area/state level - Confirm Aggregate Reports
• Search for aggregate counts and reports
• Replace counts with new data as it becomes
  available - Replace Aggregate Reports

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Scenario 2Essential Tasks to Perform

• Enter aggregate counts into CRA at the
  provider/clinic level - Report Aggregate Counts
• Confirm aggregate data at the project area/state
  level - Confirm Aggregate Reports
• Search for aggregate counts and reports
• Replace counts with new data as it becomes
  available - Replace Aggregate Reports

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Option 3(Web-based Detail)
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Guidelines for Reporting Aggregate Data via
Option 3

• 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

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Process Technical Considerations (Option 3)

• Process Considerations
• Determine who will collect and enter data
• Determine what level of detail vaccination data
  will 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

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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

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Essential Tasks to PerformOption 3

• Enter patient demographic and doses administered
  data collected at the provider level into CRA -
  Add Patient Countermeasures
• View recently added patients
• Confirm aggregate data at the project area level
  - Confirm Aggregate Counts

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Blended Option OverviewOptions 2 and 3

• Scenario
• Data collected at the provider level
• Some providers enter aggregate counts into CRA
• Some providers enter patient level data into CRA
• Public Health Administrator (PHA) logs into CRA
  and confirms aggregate data for the Project Area

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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.gov
• Access CRA Application on SDN Activity Page

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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

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Process Security Considerations

• Evaluate the planned security changes that may be
  applicable to your project area
• Limited features allowable for data entry staff
• Data entry staff must have valid email addresses
  and the Public Health Administrator (PHA) must
  setup the user in CRA
• Begin the process of identifying potential users
  needing access to CRA
• Setup the DESL user and assign the data entry
  staff with appropriate role in the CRA system

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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

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Reminders

• CRA Demonstration Site (http//crademo.cdc.gov)
  should be used for testing data entry and data
  submission
• Contact the PHIN Helpdesk (phintech_at_cdc.gov) for
  login/password information
• 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

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Action Items

• Submit test file to Tony DaSilva (aod7_at_cdc.gov)
  or your designated Project Area point of contact
  to ensure the file can be submitted
• Perform setup tasks as necessary for your Project
  Area (adding organization and users)
• Ensure users have an active SDN digital
  certificate, as required
• Develop quality control mechanisms for aggregate
  report forms
• Review 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

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CRA Team Contact Information

• Jeanne Tropper, NCPHI/DEPR CRA Lead, jwu0_at_cdc.gov
• Warren Williams, NCIRD/ISD Informatics Lead,
  wxw4_at_cdc.gov
• Charles Williams, SRA Contractor, Project Area
  and Public Health Partner Liaison, cpw6_at_cdc.gov
• CRA Help crahelp_at_cdc.gov

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Upcoming Events
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Questions