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Challenges With Vaccination Data Hinder State and Local Immunization Program Efforts To Combat COVID-19, OEI-05-22-00010

Issuer
Office of Inspector General
Document type
Brief

Summary

A report in brief from the U.S. Department of Health and Human Services Office of Inspector General, OEI-05-22-00010, dated January 2023, on COVID-19 vaccination data received by State and local immunization programs. Based on a December 2021 survey of 56 immunization programs, OIG reports that 44 of the 56 programs received no individual-level vaccination data from VA and 42 of the 56 received none from DoD. It reports that 44 of the 56 programs said they did not receive complete, accurate and timely data from all Federal retail pharmacy providers, and that programs struggled to measure coverage and target outreach. OIG recommends that CDC work with programs and pharmacy partners to mitigate data gaps and provide educational outreach on existing tools. CDC nonconcurred with the first recommendation and concurred with the second.

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U.S. Department of Health and Human Services

Office of Inspector General




Challenges With Vaccination
Data Hinder State and Local
Immunization Program Efforts
To Combat COVID-19




Ann Maxwell
Deputy Inspector General
 for Evaluation and Inspections
January 2023, OEI-05-22-00010
U.S. Department of Health and Human Services
Office of Inspector General
Report in Brief
January 2023, OEI-05-22-00010

Why OIG Did This                    Challenges With Vaccination Data Hinder State
Review
Successful national vaccination
                                    and Local Immunization Program Efforts To
campaigns and routine               Combat COVID-19
vaccination efforts depend on
complete and timely vaccination
                                     Key Takeaway                             What OIG Found
data being available to State and
                                                                           State and local immunization programs reported
local immunization programs.         Many State and local                  experiencing challenges in obtaining data for their
The Centers for Disease Control      immunization programs reported        immunization databases both from Federal agencies
and Prevention (CDC) relies on       having incomplete individual-         that provide vaccinations and from retail pharmacies
State and local immunization
                                     level data for the more than 250      that receive vaccines from CDC (to which we refer as
programs to monitor vaccination
                                     million COVID-19 vaccine doses        retail pharmacy partners). As of December 2021,
coverage and to plan strategies
                                     administered by Federal agencies      nearly all State and local immunization programs
to increase uptake among
                                     and retail pharmacies that receive    reported that they were not receiving individual-level
communities with low coverage.
                                     vaccines directly from CDC.           data on vaccinations from at least one of the three
To fulfill this important role,
                                     These programs rely on                Federal agencies with the largest vaccination
immunization programs need
                                     individual-level data in their        programs: the Department of Veterans Affairs (VA),
complete and accurate
                                     immunization databases to             the Department of Defense (DoD), and/or the Indian
individual-level vaccination data
                                     manage vaccination campaigns.         Health Service (IHS). Most programs reported that
from all providers.
                                                                           they received data from retail pharmacy partners,
Comprehensive data are              but the data were was often incomplete, inaccurate, or delayed. Federal agencies and retail
important for State and local       pharmacy partners are not required to submit vaccination data to immunization programs.
immunization programs;
                                    Immunization programs said that without complete individual-level vaccination data, they
however, two key types of
                                    struggled to accurately measure vaccination coverage and to target outreach to
providers are not required to
                                    unvaccinated and vulnerable populations. Because State and local immunization databases
submit individual-level data to
                                    contain data on all types of vaccinations, if left unresolved, these challenges will likely hinder
immunization programs’
                                    the ongoing COVID-19 vaccination campaign, responses to future public health emergencies,
databases: Federal agencies and
                                    and routine vaccination campaigns (e.g., flu shots).
retail pharmacies that partner
with the Federal government.        State and local immunization programs said that they need help from CDC to obtain
Combined, these two types of        comprehensive vaccination data. Immunization databases are operated by 64 separate
providers have already              States, cities, and territories, with varying policies and technological capabilities. Federal
administered over 250 million       agencies and retail pharmacy partners agreed to submit COVID-19 vaccination data either to
COVID-19 vaccine doses.             State and local immunization databases or directly to CDC. CDC reported that it was
                                    determined that Federal agencies would transmit data directly to CDC only, rather than to
How OIG Did This                    immunization databases, because of policy and technical challenges that could not be
Review                              resolved in the necessary timeframe. Retail pharmacy partners often do not share these
In December 2021, we                challenges, and CDC reported encouraging them to submit data directly to immunization
administered a survey to 56         databases. The Federal government set up systems outside of State and local immunization
State and local immunization        databases to help share data that CDC receives with immunization programs, but the data it
programs that have                  shares are aggregated, and programs reported that these aggregate data were not sufficient
immunization databases. We          to comprehensively monitor their vaccination campaigns. To meet this need in the long
asked immunization programs         term, CDC established and is working to set up the Immunization Gateway (IZ Gateway)—
whether they receive COVID-19       a data-exchange system intended to connect Federal agencies with immunization
vaccination data from Federal       programs—but programs reported that it has been delayed. Given the complexity of
agencies and retail pharmacy        collecting and sharing data across the many different stakeholders that make up the Nation’s
partners; whether they              public health system, CDC has publicly called for updated data authority to better address
experience challenges in            public health concerns. However, there are steps CDC can take in the interim to help address
obtaining complete and accurate     immunization program needs.
data; and how these challenges
impact their vaccination
campaigns, if at all.
What OIG Recommends and How the Agency Responded
We recommend that CDC (1) work with State and local immunization programs, and retail
pharmacy partners, to mitigate reported data gaps and timeliness challenges and (2) provide
educational outreach to ensure that State and local immunization programs are aware of
existing tools to address vaccination campaign needs. CDC nonconcurred with our first
recommendation and concurred with our second recommendation.
KEY FINDINGS
  Challenges with data on vaccines administered by Federal vaccination
  providers hindered State and local immunization programs’ efforts to
  comprehensively monitor COVID-19 vaccination coverage.

         State and local immunization programs reported that they did not receive
         individual-level data on vaccines administered by Federal agencies.
         Federal agencies may submit data either to State and local immunization databases or
         to CDC. However, CDC reported to OIG that it was determined that Federal agencies
         should submit data to CDC for efficiency related to policy and technical challenges in
         establishing connections to immunization databases. CDC shares aggregated Federal
         agency data with State and local immunization programs, but some programs
         reported that these aggregate data were not sufficient for individual-level monitoring.

                         VA has administered over 7.4                   44 of the 56 immunization programs
                         million COVID-19 vaccinations                  reported not receiving any individual­
                                                                        level vaccination data from VA

                         DoD has administered over 7.5                  42 of the 56 immunization programs
                         million COVID-19 vaccinations                  reported not receiving any individual­
                                                                        level vaccination data from DoD


          1l1ti
              • •        IHS has administered over 2.2
                         million COVID-19 vaccinations
                                                                        16 of 25 immunization programs
                                                                        reported challenges obtaining
                                                                        individual-level vaccination data from
                                                                        IHS

         Source: CDC COVID-19 Data Tracker, OIG analysis of survey results, 2022. 1


         State and local immunization programs reported challenges with data on
         individual-level vaccine administration received from pharmacies that
         partner with the Federal government.
         While Federal retail pharmacy providers may submit data either to immunization
         databases or to CDC, CDC reported to OIG that pharmacies were encouraged to
         submit vaccination data to immunization databases because many pharmacies
         already have connections established.

                         Retail pharmacies partnering with              44 of the 56 immunization programs


            eJll         the Federal government have
                         administered over 234.9 million
                         COVI D-19 vaccinations
                                                                        reported not receiving complete,
                                                                        accurate, and timely data from all
                                                                        Federal retail pharmacy providers

         Source: CDC Federal Retail Pharmacy Program, OIG analysis of survey results, 2022. 2
TABLE OF CONTENTS

BACKGROUND................................................................................................................................................ 1
FINDINGS.........................................................................................................................................................8
   Most State and local immunization programs did not receive individual-level data on vaccinations
   administered by at least one Federal agency, and programs reported challenges with the limited data
   received......................................................................................................................................................................................... 8
   Although most immunization programs received individual-level data on vaccines administered by
   retail pharmacy partners, many reported challenges with the data....................................................................11
   With insufficient vaccination data, some immunization programs reported struggling to monitor
   vaccination campaigns, despite Federal efforts ..........................................................................................................12
CONCLUSION AND RECOMMENDATIONS........................................................................................... 17
   Work with State and local immunization programs and retail pharmacy partners to mitigate reported
   data gaps and timeliness challenges...............................................................................................................................18
   Provide educational outreach to ensure that State and local immunization programs are aware of
   existing tools to address vaccination campaign needs............................................................................................18
AGENCY COMMENTS AND OIG RESPONSE ......................................................................................... 19
DETAILED METHODOLOGY...................................................................................................................... 20
APPENDIX ..................................................................................................................................................... 22
   Agency Comments .................................................................................................................................................................22
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 25
   Acknowledgments ..................................................................................................................................................................25
   Contact........................................................................................................................................................................................25
ABOUT THE OFFICE OF INSPECTOR GENERAL.................................................................................... 26
ENDNOTES ....................................................................................................................................................27
BACKGROUND


                    OBJECTIVE
                          Identify the extent to which the immunization databases of States and local
                          immunization programs receive COVID-19 vaccination data from Federal
                          agencies and retail pharmacy partners.




                    State and Local Immunization Databases
                    State and local health departments rely on Immunization Information Systems
                    (IIS)—confidential, population-based, computerized databases that record
                    information on immunization doses and are maintained by State and local
                    immunization programs (hereinafter referred to as immunization databases). 3 These
                    immunization databases can help vaccination providers determine patient needs
                    and assist in surveillance and program operations to guide public health. 4
                    Immunization databases should combine immunization information from
                    participating providers into a single record for each person residing or receiving
                    vaccines in a given jurisdiction. 5 Relying primarily on CDC funding, all 50 States, the
                    District of Columbia, 5 other cities, and 8 territories each operate an immunization
                    database. 6 These databases collectively are the backbone for monitoring
                    vaccinations during a national mass-vaccination campaign, such as the COVID-19
                    vaccination effort. 7, 8

                    According to the Centers for Disease Control and Prevention (CDC), these
                    immunization databases play a critical role in monitoring COVID-19 vaccination
                    administration and coverage estimates. 9 As outlined in the COVID-19 Vaccination
                    Program Interim Playbook for Jurisdiction Operations (the Playbook), CDC instructed
                    State and local immunization programs to use their immunization databases to
                    collect required data on vaccine administration and report those data to CDC. 10
                    Required data include elements such as administration date, dose number, and
                    recipient ethnicity. 11

                    CDC established functional standards and guidance for State and local
                    immunization programs to improve immunization databases so that the databases
                    are capable of achieving the vision of easily accessible real-time, consolidated
                    immunization data. 12 For example, one standard states that databases should
                    support public health response during disease outbreaks. 13 Another standard states
                    that databases should support immunization program activities during a public
                    health emergency according to the jurisdiction’s public health emergency plan. 14
                    CDC conducts an annual survey of immunization programs about their databases,

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                                                                                                 Background | 1
                    using these functional standards to measure progress, identify areas for
                    improvement, set program priorities, and influence policy-level decision making. 15
                    Although jurisdictions rely primarily on CDC grants for IIS maintenance, operation,
                    and enhancement, CDC does not require grantees to satisfy all standards as a
                    condition of funding. 16 Adherence to the functional standards is encouraged, but
                    remains with each IIS program. 17

                    The 64 immunization databases are operated by State and local immunization
                    programs, and vary as to local reporting requirements, data-sharing polices, and
                    system capabilities. For example:

                             •    Some immunization programs operate under State laws or policies that
                                  prohibit sharing personally identifiable information about residents with
                                  the Federal government. 18

                             •    Some immunization databases do not have bidirectional data exchange
                                  capabilities, which limits the ability to share immunization data with
                                  providers and other immunization database users who need it. 19, 20

                             •    Some immunization programs do not require vaccine providers to
                                  report data for individuals over the age of 19. 21

                             •    Some immunization programs do not require all pharmacists to report
                                  vaccinations administered to their immunization database. 22

                    CDC and others have highlighted the need for increased investment and authority
                    related to public health data. CDC called for increased data modernization and
                    authority to address data gaps created by receiving data from a variety of sources in
                    inconsistent ways. 23 Specifically, CDC noted that updated data authority could
                    improve CDC’s legal ability to access secure public health data in a timely and
                    coordinated way. Additionally, in March 2022 former CDC directors called attention
                    to the lack of funding and legal authority needed for CDC to achieve accurate,
                    timely, and comprehensive data. 24

                    Federal Agencies and Retail Pharmacy Partners
                    COVID-19 vaccine providers may receive their vaccine supply directly from CDC,
                    from their respective local health departments, or from a combination thereof. 25
                    Two types of vaccination providers who receive some portion of their vaccine supply
                    directly from CDC are (1) Federal agencies that provide vaccines and (2) retail
                    pharmacies that partner with the Federal government as members of the Federal
                    retail pharmacy partner program. 26, 27

                    Federal agencies and pharmacies that receive vaccines directly from CDC signed
                    agreements which specified the conditions for receiving COVID-19 vaccines. These
                    agreements state that Federal retail pharmacy partners and Federal agency
                    providers should transmit data on vaccine administration either (1) to State and


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                                                                                                 Background | 2
                    local immunization databases or (2) to another system, as designated or agreed to
                    by CDC. CDC told OIG that it was determined that Federal agencies would transmit
                    data directly to CDC only, to allow efficient resolution of policy and technical
                    requirements that could not have been achieved in the necessary timeframe at the
                    individual immunization program level. However, many retail pharmacies were
                    connected to State and local immunization databases prior to the COVID-19
                    vaccination campaign and CDC stated to OIG that it encouraged retail pharmacy
                    partners to directly transmit vaccination data to State and local immunization
                    databases. The signed agreements also outline timeliness expectations for
                    transmitting vaccination data, stating that transmission should occur as soon as
                    practicable, or within 72 hours, depending on the type of vaccination provider and
                    jurisdictions’ immunization database capabilities.

                    The number of these Federal agency and pharmacy partners providing vaccinations
                    varies amongst immunization programs’ jurisdictions, but they are widespread and
                    represent a substantial portion of the data that immunization programs need. For
                    example, while all jurisdictions may not have DoD facilities, VA is present in all
                    States. Combined, these two agencies have administered over 14 million doses to
                    veterans, active military, and other beneficiaries. All State and local immunization
                    programs utilize the Federal retail pharmacy program to help administer
                    vaccinations in their areas. 28 There are 21 pharmacy partners, representing 41,000
                    locations. 29 In addition to including large chain pharmacies (e.g., Walgreens, CVS)
                    the program includes partners with a small number of stores and those which serve
                    rural areas. As of March 2022, pharmacy partners receiving vaccines directly from
                    CDC were responsible for 40 percent of all administered doses of COVID-19
                    vaccines. 30, 31




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                                                                                                 Background | 3
                    Federal agencies and pharmacy partners have administered over 250
                    million COVID-19 vaccinations nationally.

                        the five Federal agencies that provide vaccinations, these three have
                      administered the most doses: the Department of Veterans Affairs (VA), the
                      Department of Defense (DoD), and the Indian Health Service (IHS) .




                        VA has administered
                                                                          •
                                                                         aii&
                                                              DoD has administered
                                                                                                             1ith
                                                                                                       IHS has administered
                             7.4 million                            7.5 million                            2.2 million
                      COVI D-19 vaccinations to             COVID-19 vaccinations to                  COVID-19 vaccinations to
                       veterans, their spouses,              service members and                       American Indians and
                           and caregivers                       eligible civilians                        Alaska Natives


                      There are over 41 ,000 retail pharmacy partners that receive COVID-19 vaccines
                      directly from CDC.

                                                             Retail pharmacy partners have administered over

                                  W1l                                         234.9 million
                                                                          COVI D-19 vaccinations

                    Sources: CDC COVID-19 Data Tracker, CDC Federal Retail Pharmacy Program. 32, 33


                    Immunization Gateway (IZ Gateway)
                    The Immunization Gateway (IZ Gateway) development began prior to the pandemic
                    as a Health and Human Services (HHS) pilot project with the focus of facilitating
                    interstate vaccine administration data exchange. 34, 35 In the Playbook, CDC
                    described the IZ Gateway as a tool for (1) Federal agencies to share immunization
                    data with State and local immunization programs, and (2) sharing among different
                    State and local immunization databases. 36 CDC told OIG that it is not currently
                    planning to use the IZ Gateway to share data between immunization programs and
                    retail pharmacies because most pharmacies can already exchange data with State
                    and local immunization databases. CDC identified connecting immunization
                    databases to the IZ Gateway as an immediate priority in the Playbook.37 However,
                    connecting these systems has been a complex process that encountered setbacks
                    during the campaign. 38, 39

                    Once a jurisdiction or Federal agency provider is connected, the IZ Gateway can
                    provide access to patient-identifiable vaccination records, which is important for
                    immunization programs. For example, once a Federal agency is connected to the IZ
                    Gateway, the agency can report and query any vaccination data with multiple State
                    and local immunization programs. 40 Additionally, multijurisdictional providers and
                    immunization programs can query the IZ Gateway to obtain an individual’s full


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                                                                                                 Background | 4
                    immunization history across States and localities. 41 Immunization programs need
                    identifiable records to link with existing data in their immunization databases and
                    perform functions such as facilitating authorized access to vaccination records by
                    individuals and their providers.

                    Tiberius
                    Tiberius is a platform created specifically for the COVID-19 pandemic that pulls data
                    from various sources to display aggregated, deidentified information related to
                    manufacturing; supply chain; allocation; and delivery and administration of vaccines.
                    Tiberius was developed for Operation Warp Speed (later renamed Countermeasures
                    Acceleration Group (CAG)), the collaboration of the Department of Defense (DoD)
                    and HHS. When CAG was dissolved in December 2021, management of Tiberius
                    was transitioned to CDC. 42 Tiberius provides a zip code view of priority populations
                    and provides tools to assist State and local immunization campaigns in decision
                    making. 43 Tiberius integrates COVID-19 vaccination data from several systems, such
                    as data that Federal agencies and retail pharmacy partners submit to CDC.

                    The Federal government offered technical assistance and other opportunities to
                    State and local immunization programs to help them use Tiberius for their
                    vaccination campaigns. 44 CDC reported to OIG that regular trainings in addition to
                    office hours were offered to State and local immunization programs. If an
                    immunization program reported challenges reconciling data between its
                    immunization database and Tiberius, CDC offered support and, in some cases, a
                    contractor. Additionally, in June 2022, following immunization programs’ feedback
                    asking for increased information about vaccinations provided by retail pharmacy
                    partners, CDC informed jurisdictions that efforts to improve Tiberius and create a
                    more efficient and unified presentation of retail pharmacy partner activity were
                    beginning.

                    However, media outlets reported that State and local immunization programs
                    struggled to leverage Tiberius for their COVID-19 vaccination campaigns. One
                    program noted that the platform was complex and required multiple staff members
                    to undergo training.45 A second program reported that it was unable to use
                    Tiberius to locate and map all critical populations. 46 Unlike the IZ Gateway, Tiberius
                    does not provide access to patient-identifiable records. 47

                    CDC COVID-19 Data Tracker
                    CDC publishes a public online data dashboard, the COVID-19 Data Tracker, which
                    includes aggregate information about vaccinations administered (e.g., vaccination
                    coverage; vaccines administered by race/ethnicity, age, and sex; and vaccinations by
                    county). 48 The information currently is updated weekly. 49 The tracker includes
                    information submitted through State and local immunization databases, the Vaccine
                    Administration Management System (VAMS), and direct data submissions. 50 VAMS
                    is an online tool to manage vaccine administration available to enrolled

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                                                                                                 Background | 5
                    jurisdictions, Federal agencies, and organizations that do not have existing systems
                    to report data on COVID-19 vaccine administration. 51 CDC does not share any
                    personally identifiable information. 52

                    Related Work
                    In conjunction with this work, OIG issued Early Challenges Highlight Areas for
                    Improvement in COVID-19 Vaccination Programs (OEI-04-21-00190), which provides
                    a broader review of challenges faced by State and local immunization programs in
                    the early stages of the COVID-19 vaccination including (1) achieving logistical
                    efficiency, (2) obtaining complete vaccine data from all providers, (3) combating
                    vaccine hesitancy with public health messaging, and (4) overseeing vaccine
                    providers.

                    OIG recommended that CDC (1) update mass vaccination program plans with
                    strategies that address awardee-reported logistical challenges; (2) strengthen
                    reporting of vaccine allocation and administration data; (3) clarify roles and
                    responsibilities within HHS for vaccine public health messaging during a pandemic;
                    and (4) work with State and local immunization programs to enhance current and
                    future capabilities for provider training and oversight.

                    Methodology
                    To understand how many State and local immunization programs were receiving
                    data, in December 2021 we administered an online survey to 56 State and local
                    immunization programs that have immunization databases. These included all 50
                    States and the 6 cities (Chicago, the District of Columbia, Houston, New York City,
                    Philadelphia, and San Antonio) that operate an immunization database. We did not
                    survey the eight territories with an immunization database. We asked immunization
                    programs whether they receive COVID-19 vaccination data from Federal agencies
                    that provide vaccinations and retail pharmacies partnered with CDC, and whether
                    they experience challenges obtaining complete and accurate data. We also asked
                    programs how missing or inaccurate data affects local vaccination campaigns, if at
                    all. We did not ask State and local immunization programs about their
                    immunization database technical capabilities or reporting requirements. We did not
                    survey Federal agencies or retail pharmacy partners.

                    Limitations
                    Our analysis relied only on self-reported data from State and local immunization
                    programs. We did not independently verify information received from
                    immunization programs. We followed up with programs to clarify responses only
                    when their survey results were unclear.




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                                                                                                 Background | 6
        Standards
                    We conducted this study in accordance with the Quality Standards for Inspection
                    and Evaluation issued by the Council of the Inspectors General on Integrity and
                    Efficiency.




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                                                                                                 Background | 7
FINDINGS

        Most State and local immunization programs did not receive
        individual-level data on vaccinations administered by at least
        one Federal agency, and programs reported challenges with the
        limited data received
                    As of December 2021, 52 out of 56 State and local immunization programs reported
                    not receiving any individual-level vaccination data from at least one of the following
                    Federal agencies that provide vaccinations: VA, DoD, and/or IHS. 53 Further,
                    immunization programs reported that when they did receive vaccination data from
                    these Federal agencies, the data were often untimely or incomplete.

                    CDC does not require Federal agencies to submit individual-level vaccination data
                    directly to State and local immunization databases. Federal agencies’ signed
                    agreements with CDC state that vaccination data must be transmitted either to State
                    and local immunization databases or to another system as agreed upon. CDC told
                    OIG that it was determined that Federal agencies would report directly to CDC only,
                    due to policy and technical limitations. State and local immunization databases are
                    designed for individual-level data about vaccine doses and the residents who received
                    them. CDC provides aggregated (i.e., zip-code-level) summaries of COVID-19 vaccine
                    doses administered by the Federal agencies, but this information cannot be
                    integrated directly into State and local immunization databases.54

                    Most immunization programs reported not receiving individual-
                    level data on vaccinations administered by Veterans Affairs or
                    Department of Defense providers
                    Forty-four State and local immunization programs reported not receiving any
                    individual-level data on COVID-19 vaccinations administered by VA, and 42 reported
                    not receiving this data from DoD.




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                                                                                                          Findings | 8
                    Pre-existing data-sharing policies may limit an                 of the 56 immunization
                    agency’s ability to share data on vaccine                    programs reported not
                    administration with a State or local                         receiving any data from VA
                    immunization program. For example, one                       providers
                    immunization program reported that VA
                    maintained that its patients must consent
                    before their data can go to the immunization                  ■■■■                    X   X
                    database. In one State, the governor enacted
                                                                                    X   X   X   X   X     X   X
                    an executive order requiring VA to transmit
                    data to the State’s immunization database. 55
                                                                                    X   X   X   X   X     X   X

                    An additional immunization program reported                     X   X   X   X   X     X   X

                    being told that VA’s current privacy policy                     X   X   X   X   X     X   X
                    does not allow the sharing of health data                       X   X   X   X   X     X   X
                    unless there is a State mandate.                                X   X   X   X   X     X   X

                    Immunization programs reported similar              Source: OIG analysis of survey data, 2022.

                    challenges with DoD, citing DoD confidentiality and privacy concerns. For example,
                    one immunization program reported that DoD clinics are hesitant to share data on
                    vaccine administration without expressed approval from leadership although DoD has
                    released COVID-19 case data to comply with the State’s law. Further, one program
                    specifically stated that there is no requirement for DoD to share data with its local
                    immunization database, and any data obtained is due to local entities building
                    relationships with organizations in their jurisdiction.

                                                                 Of the smaller group of State and local
                      42 of the 56 immunization                  immunization programs that reported receiving
                      programs reported not                      some data from VA or DoD, most reported that
                                                                 their immunization databases do not receive timely
                      receiving any data from DoD
                      providers
                                                                 transmissions on a regular basis. Instead, these
                                                                 programs sometimes reported that VA and DoD
                       ■■■■■■■                                   occasionally submitted files for batch upload or that
                                                                 providers manually entered data directly into the
                        X     X    X     X    X     X    X       immunization database. For example, one
                        X     X    X     X    X     X    X       immunization program reported that VA only
                        X     X    X     X    X     X    X       manually uploads a file upon request of the
                        X     X    X     X    X     X    X       immunization program. Similarly, one program
                        X     X    X     X    X     X    X       reported relying on data being manually entered
                        X                X    X     X    X
                                                                 into the local database by DoD providers.

                                                       VA and DoD data may be of special importance for
                    Source: OIG analysis of survey data, 2022.
                                                       those State and local immunization programs with
                    large veteran and military populations. Veterans comprise more than 10 percent of
                    the adult population in Alaska, Virginia, and Montana.56 Additionally, North Carolina
                    is home to the largest military base in the world and has an estimated 113,000 active
                    duty and reserve personnel. 57, 58 One immunization program that reported having a


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                                                                                                              Findings | 9
                    large veteran population stated that not having data directly from VA created serious
                    quality issues when the immunization program tried to create a complete picture of
                    vaccination coverage.

                    Most immunization programs reported receiving individual-level
                    data on vaccines administered by IHS providers, but many
                    reported challenges
                    In contrast to VA and DoD, most immunization
                                                                                    of the 25 immunization
                    programs reported receiving some vaccination
                                                                                  programs reported not
                    data from IHS, but many programs also reported                receiving any data from IHS
                    that IHS data received were incomplete. Of the 25             providers
                    State and local immunization programs with
                    documented IHS facilities, 2 reported not
                    receiving any data at all, and 14 reported                          ■■■■■
                    challenges, such as with obtaining data from all                    ■■■■■
                    IHS providers. 59, 60 Only nine of these
                    immunization programs reported receiving data
                                                                                        ■■■■■
                    from IHS and did not report challenges in                           ■■
                    obtaining all the data needed.
                                                                                             14 programs
                    Some of the 14 State and local immunization
                    programs that received data but reported
                    challenges attributed these challenges to IHS
                                                                                   A         reported challenges
                                                                                             obtaining data
                                                                             Source: OIG analysis of survey data, 2022.
                    facilities’ differing technological capabilities.
                    Some facilities may have an electronic health record (EHR) that can more easily be
                    connected into an immunization database for automatic submission. One program
                    suggested that this technological difference was dependent on whether a facility is
                    IHS- or Tribally operated, noting that Tribal facilities were not always supported by
                    compatible data-exchange systems and may have faced greater challenges
                    establishing connection with the immunization database. Additionally, immunization
                    programs reported that connecting IHS facilities to their database was challenging
                    because each location must connect to the database individually, requiring testing
                    and troubleshooting unique to each facility.

                    Although not all jurisdictions have IHS facilities, their immunization programs may
                    need data from IHS facilities outside of their area. American Indians and Alaska
                    Natives (AI/ANs) may receive care at any hospital or clinic. 61 For example, one
                    immunization program noted that Tribal lands sometimes span multiple States and
                    therefore the program worked with out-of-State IHS facilities to ensure full coverage.
                    Complete IHS data may be particularly important for certain jurisdictions with high
                    concentrations of AI/AN populations or where a single Tribal land may cover multiple
                    jurisdictions. For example, the Navajo administrative unit alone serves 224,000
                    individuals and has facilities in Arizona, New Mexico, and Utah. 62



Challenges With Vaccination Data Hinder State and Local Immunization Program Efforts To Combat COVID-19
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                                                                                                           Findings | 10
        Although most immunization programs received individual-
        level data on vaccines administered by retail pharmacy partners,
        many reported challenges with the data
                    As of December 2021, 42 State and local immunization programs reported that they
                    received at least some patient-level data directly from all of the pharmacy partners
                    offering vaccinations in their jurisdiction. However, 14 State and local immunization
                    programs reported not receiving any individual-level data from at least one retail
                    pharmacy partner active in their area. One immunization program estimated that its
                    immunization database was missing information on 400,000 doses from retail
                    pharmacy partners at the time of our survey. Moreover, many immunization
                    programs reported quality or timeliness challenges with the data they did receive.
                    Retail pharmacy partners signed agreements with CDC that state that vaccination data
                    must be transmitted either to State and local immunization databases or to another
                    system determined by CDC, and CDC reported to OIG that it encouraged retail
                    pharmacy partners to report to local immunization databases.

                    Many immunization programs reported challenges with
                    vaccination data from pharmacies, such as with timeliness,
                    accuracy, and completeness
                         of the 56 immunization             Thirty immunization programs reported challenges
                      programs reported not                 with vaccination data received from pharmacy
                      receiving any data from at            partners, including receiving untimely, inaccurate,
                      least one retail pharmacy             or duplicate data, or not receiving all vaccination
                      partner                               records from a pharmacy that was otherwise
                                                            submitting data.
                         ■■■■■
                       ■■■■■■■                              Some immunization programs noted that retail
                                                            pharmacy partners sometimes simply failed to
                       ■■■■■■■                              submit data in a timely fashion. One program
                       ■■■■■■■                              reported that some doses were not reported until
                       ■■■■■■■                              months after the actual administration date.

                                                               State and local immunization programs also
                        X    X X      X X      X X
                                                               sometimes reported various concerns about the
                        X X X X X X X                          accuracy and completeness of data received. For
                                30 programs                    example, immunization programs reported that

                      A         ~eceived untimely,
                                inaccurate, or
                                incomplete data
                                                               they discovered patterns of deleted doses, missing
                                                               data elements, and duplicate reporting. One
                                                               immunization program reported that even after
                    Source: OIG analysis of survey data, 2022. working with the pharmacy partners in an effort to
                    resolve these challenges, the program may still be left with inaccurate data.



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                                                                                                          Findings | 11
                    Additionally, some State and local immunization programs reported that retail
                    pharmacy partners sometimes experienced interruptions with their data
                    transmissions. Some immunization programs attributed missing records to delayed
                    or interrupted data transmissions. One immunization program stated that when data
                    transmissions were interrupted, it was unable to recover all data reported during the
                    interruption. Without being able to recover this data, immunization programs are left
                    with records missing. Further, resolving the interruption may require that
                    immunization program staff provide technical assistance to pharmacies, where
                    pharmacy staff often did not know why the transmission was interrupted.

                    Some immunization programs reported that missing or untimely
                    pharmacy vaccination data may be related to third-party data-
                    sharing vendors
                    Retail pharmacies sometimes partner with third-party vendors to manage data-
                    sharing systems for reporting to State and local immunization programs, and
                    immunization programs noted that these vendors might have caused some data
                    challenges. For example, one immunization program reported that a vendor is
                    responsible for data transmissions but the vendor’s system sometimes went down for
                    days at a time. After the connection issue was resolved, the immunization program
                    said that it struggled to obtain the records missing because of the downtime.
                    Another immunization program noted that if a patient scheduled an appointment but
                    then canceled and rescheduled, the vendor might transmit both a record for the
                    canceled appointment and a record for the rescheduled appointment that occurred,
                    resulting in more records for vaccine administration than a patient received. Finally,
                    one program attributed inaccurate dates of administration to a vendor that used the
                    billing date instead of the administration date.

                    Fourteen State and local immunization programs reported that many of the data
                    challenges experienced were associated with one common third-party vendor.
                    Immunization programs reported that this vendor works with some of the country’s
                    largest pharmacy chains. Given that this vendor works with these large chains, this
                    single vendor is likely responsible for transmitting a great deal of retail pharmacy
                    data.


        With insufficient vaccination data, some immunization
        programs reported struggling to monitor vaccination
        campaigns, despite Federal efforts
                    Without complete and reliable individual-level data from all Federal agencies and
                    pharmacy partners, many immunization programs reported facing challenges
                    managing effective vaccination campaigns. While Federal agencies and retail
                    pharmacy partners are not required to submit data directly to immunization
                    databases, State and local immunization programs reported that incomplete data

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                                                                                                          Findings | 12
                    hindered their efforts to estimate vaccination coverage rates, effectively plan strategic
                    targeted interventions, and provide vaccination records to individuals and providers.

                    Difficulty estimating coverage rates

                                                         Some immunization programs reported being unable
                                t®                       to accurately estimate vaccination coverage rates
                                                         without complete and timely vaccination data from
                                                         all providers. Vaccination coverage is the estimated
                     Nearly half of all
                                                         percentage of people in a community who have
                     Americans age 75 or
                                                         received vaccines. 64 Monitoring vaccination
                     older are veterans.63               coverage, through data on vaccine administration,
                     Many of these older veterans
                                                         allows immunization programs to track and measure
                     are eligible for VA health care
                                                         the success of their efforts.
                     services, including
                     vaccinations.                     When data are missing or inaccurate, immunization
                                                       programs cannot confidently determine these
                     Without VA data, one
                                                       estimates. For example, one immunization program
                     immunization program said,
                     it could not accurately           reported that data missing from retail pharmacies
                     estimate vaccination rates        affected its total vaccination count and the
                     for its older populations.        vaccination numbers it reported to the public.
                                                       Another immunization program reported that
                                                       without data from Federal agencies that provide
                    vaccinations, it had difficulty accurately estimating vaccination coverage for counties
                    with large military populations.

                    Although CDC makes Federal agency and pharmacy partner data available at the
                    aggregate level through Tiberius and the public COVID-19 Data Tracker, some
                    immunization programs noted differences in the aggregate data and the programs’
                    databases. Some immunization programs reported that the vaccination coverage
                    estimates in their databases were smaller than CDC’s estimates. One immunization
                    program added that CDC’s publicly reported estimates may also have been larger
                    because a person who received their first dose from a Federal provider and their
                    second from a non-Federal provider could have been counted as two different
                    individuals who received their first doses, not as a single fully vaccinated person. CDC
                    commented that a number of factors may contribute to such discrepancies and some
                    of them are not solely under Federal control, such as incomplete or inaccurate data
                    maintained by State and local immunization programs.




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                                                                                                          Findings | 13
                    Challenges in targeting outreach to unvaccinated and vulnerable populations

                                                            Some immunization programs reported using data


                                  ---
                                   •••
                     Most Americans live
                     within 5 miles of a
                                                            to systematically identify communities with low
                                                            vaccination coverage to plan local pop-up
                                                            vaccination clinics, target vaccination marketing
                                                            campaigns, or conduct other outreach aimed at
                                                            increasing vaccination rates. However, without the
                     pharmacy. CDC partnered with           data needed, some State and local immunization
                     21 retail pharmacies and their         programs reported struggling to plan and enact
                     41,000 retail locations across the     strategic targeted interventions.
                     country because pharmacies can
                     reach people who cannot access      Some immunization programs reported that
                     other providers easily, such as     incomplete data limited their ability to promote
                     rural Americans. 65, 66             health equity because the programs could not
                                                         accurately identify vaccination disparities between
                     Rural Americans are at higher risk  demographic groups. For example, one
                     of death from COVID-19, so
                                                         immunization program reported that without data
                     increasing vaccination rates in
                                                         from VA, DoD, and IHS, it could not accurately
                     remote areas is key. 67 Without
                                                         calculate vaccine rates or provide vaccination
                     complete and accurate data from
                     retail pharmacies, State and local  records for special populations, such as Tribal
                     immunization databases are          members and their families; rural communities;
                     potentially missing vaccination     and veterans experiencing homelessness.
                     records for some Americans          Immunization programs specifically described the
                     disproportionately affected by      importance of IHS data to monitor vaccination
                     COVID-19.                           coverage of American Indians and Alaska Natives
                                                         (AI/ANs), a demographic group at high risk for the
                    negative impacts of COVID-19. AI/ANs have historically experienced a lower life
                    expectancy and disproportionate disease burden compared to other Americans, and
                    AI/ANs are nearly twice as likely to die from COVID-19 as are White Americans. 68, 69

                    Some immunization programs also conducted outreach to individual residents, but
                    incomplete vaccination records made it difficult to efficiently and correctly identify
                    unvaccinated or partially vaccinated residents who would benefit from reminders. For
                    instance, one immunization program said that it sent out reminder letters to all
                    unvaccinated older residents using data in its immunization database, but then it
                    received many calls from individuals who informed the program that they had already
                    been vaccinated by Federal agencies. Similarly, another immunization program noted
                    that incomplete data limit its ability to conduct any outreach about booster needs.

                    Inability to provide up-to-date records to individuals and providers

                    Some immunization programs reported not being able to provide records to
                    residents when requested because these residents had been vaccinated by Federal
                    agency or retail pharmacy providers that did not report to immunization databases.
                    Without complete vaccination data, immunization programs cannot always provide


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                                                                                                          Findings | 14
                    accurate individual vaccination records when requested by residents and health care
                    providers. For example, one immunization program said that it received reports of
                    residents who requested a second or third COVID-19 vaccine dose but faced
                    challenges when vaccination providers could not find evidence of earlier doses in the
                    immunization databases. One purpose of State and local immunization databases is
                    to offer up-to-date vaccination records for individual residents and health care
                    providers, and residents sometimes inquire about obtaining proof of their vaccination
                    status.

                    Lack of comprehensive information on vaccination providers

                    Some immunization programs reported not knowing that lists of all Federal agency
                    providers providing vaccinations in the programs’ jurisdiction were available. Without
                    comprehensive information about all providers operating in their jurisdiction, State
                    and local immunization programs do not know the extent to which the program is
                    missing vaccination data. CDC indicated that it would notify programs of any Federal
                    providers that enroll directly with CDC to receive and dispense vaccinations. 70
                    Additionally, CDC stated that immunization programs can access lists of enrolled
                    providers in Tiberius.

                    The Federal government is making efforts to share vaccination
                    data from Federal providers, but immunization programs
                    reported that these efforts had not yet met program needs
                    CDC and other parts of the Federal government have taken steps to provide
                    immunization programs with data from Federal agencies. However, these efforts did
                    not yet offer all the data that immunization programs needed.

                    The Federal government made aggregate data available, but immunization
                    programs reported that those data did not provide sufficient individual-level
                    details to fully meet immunization programs’ needs

                    The Tiberius data system provides State and local immunization programs with the
                    Federal government’s aggregate, deidentified counts of the total number of vaccines
                    administered by Federal agencies and pharmacy partners. 71 Tiberius also offers
                    aggregate equity and social vulnerability metrics at the zip-code level. However,
                    some programs reported still being unable to confidently estimate vaccination
                    coverage because they could not compare this deidentified data against their own
                    individual-level data records to resolve data discrepancies such as doses that were
                    accidentally recorded twice. Aggregate data also did not provide the type of detail
                    that immunization programs needed to support all vaccination-campaign efforts. For
                    example, one immunization program said that the available aggregate Federal agency
                    data did not allow a sufficiently granular breakdown for use in small-scale health
                    equity promotions. And because aggregate data cannot be used to update records
                    for individual residents, it does not help State and local immunization programs


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                                                                                                          Findings | 15
                    ensure that they provide residents and health care providers with accurate vaccination
                    records.

                    The current Federal immunization data exchange solution will likely solve many
                    issues with Federal agency data, but this solution was delayed and may have
                    outstanding challenges

                    Immunization programs acknowledged that CDC is actively working on setting up the
                    IZ Gateway as a solution to support the exchange of vaccination data between Federal
                    agencies and State and local immunization databases. Some immunization programs
                    anticipated that the IZ Gateway will help them obtain some or all of the data needed
                    from Federal agencies.
                    At the time of our survey in December 2021, the IZ Gateway was not yet operational
                    for the exchange of immunization data between Federal agencies and all State and
                    local immunization databases, but the process has since progressed. Some of these
                    immunization programs reported being in the process of setting up agreements with
                    VA and CDC to share data through the IZ Gateway in the future. In May 2022, CDC
                    reported that 1 immunization program was actively exchanging data with VA, and
                    CDC reported that as of November 2022, 23 immunization programs were doing so.

                    In addition, other immunization programs expressed concerns that they will not be
                    able to connect to the IZ Gateway system when it is ready because of potential
                    technical limitations of their immunization databases. For example, some
                    immunization programs said that the software company contracted to build and
                    maintain their immunization database systems had indicated that it may opt out of
                    participating in the IZ Gateway. Twelve immunization programs reported using this
                    software company for their immunization database systems. If this company opts out
                    of the IZ Gateway, these immunization programs may not be able to exchange
                    immunization data via the IZ Gateway.




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                                                                                                          Findings | 16
CONCLUSION AND RECOMMENDATIONS

                    High-quality, comprehensive data on vaccine administration are essential for State
                    and local immunization programs to protect the health and well-being of the
                    populations they serve. The COVID-19 pandemic highlighted the public health need
                    for this data. Immunization programs need individual-level vaccination data to
                    estimate coverage rates, identify populations in need of vaccines, and protect those at
                    higher risk of negative health outcomes. However, nearly all programs reported
                    challenges in obtaining individual-level data on COVID-19 vaccinations administered
                    by Federal agencies and retail pharmacy partners, with many receiving no individual-
                    level data at all on vaccinations administered by Federal agencies.

                    Vaccine data sharing is complex, as it involves many stakeholders with different
                    policies and technical capabilities. Prior to the pandemic, CDC recognized the need
                    for a long-term solution to facilitate comprehensive sharing of individual-level vaccine
                    data, but that solution was not in place when the public health emergency began.
                    Federal agencies and retail pharmacy partners were not required to submit individual-
                    level COVID-19 vaccination data directly to immunization databases, given existing
                    policy and technical limitations. To help meet the immediate need for immunization
                    program oversight of COVID-19 vaccinations, CDC made available aggregate data,
                    which can be helpful but are not entirely sufficient for vaccination monitoring.

                    CDC is actively working to set up the IZ Gateway as a long-term solution to connect
                    Federal agencies with State and local immunization databases, and to connect
                    different State and local immunization databases with one another. Congress and
                    CDC are also considering changes to immunization databases and the authorities that
                    govern how public health data are collected and shared. 72, 73 These efforts to facilitate
                    data sharing on vaccination administration, for the COVID-19 vaccination campaign as
                    well as for other emerging infectious diseases and routine vaccinations (e.g., flu
                    vaccines), may address challenges described by State and local immunization
                    programs. Recent concerns about the threat of mpox—another infectious disease
                    with available vaccines—underscore the urgency of improving vaccination data
                    sharing. There are additional steps CDC can take to help meet immunization
                    programs’ needs, beyond prioritizing the completion of the IZ Gateway. We
                    recommend that CDC:




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                                                                                   Conclusion and Recommendations | 17
        Work with State and local immunization programs and retail
        pharmacy partners to mitigate reported data gaps and
        timeliness challenges
                    CDC should take action to improve the data immunization programs receive from
                    retail pharmacy partners. CDC should, at minimum, facilitate solutions to sizable gaps
                    in reporting from retail pharmacy partners to State and local immunization programs.
                    For example, CDC could prioritize the 14 immunization programs that reported not
                    receiving any data from at least one retail pharmacy partner present in their
                    jurisdiction. CDC could clarify expectations and facilitate better data reporting for the
                    COVID-19 vaccination campaign and future vaccination efforts. To further improve
                    data quality and transmission timeliness, CDC could also work with the third-party
                    vendors that contract with major national pharmacy chains to identify improvements.

                    OIG’s companion work, Early Challenges Highlight Areas for Improvement in COVID-19
                    Vaccination Programs (OEI-04-21-00190), also recommends that CDC develop
                    strategies to improve vaccine administration data. Specifically, that recommendation
                    states that CDC should define and communicate data quality standards for providers
                    and require that immunization programs develop an approach to provide routine
                    data quality feedback to all providers of IIS reporting. Further, that recommendation
                    states that CDC should continue to work with immunization programs on the
                    collection of complete and accurate race and ethnicity data. This report’s findings
                    also support that recommendation.


        Provide educational outreach to ensure that State and local
        immunization programs are aware of existing tools to address
        vaccination campaign needs
                    CDC should offer updated educational opportunities to ensure that immunization
                    programs understand how existing tools can assist in their COVID-19 vaccination
                    campaigns. These opportunities could include webinars or publication of a
                    frequently-asked-questions document about how to leverage data sources outside of
                    immunization databases, such as Tiberius and the COVID-19 Data Tracker, to address
                    gaps reported to OIG. For instance, CDC could instruct immunization programs on
                    how to access complete lists of Federal agency and retail pharmacy providers through
                    Tiberius.




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                                                                                   Conclusion and Recommendations | 18
AGENCY COMMENTS AND OIG RESPONSE

        CDC nonconcurred with our first recommendation and concurred with our second
        recommendation.

        In nonconcurring with our first recommendation—that CDC should work with State and local
        immunization programs and retail pharmacy partners to mitigate reported data gaps and
        timeliness challenges—CDC indicated that it does not have the legal authority to standardize
        reporting across all jurisdictions. CDC stated that in the absence of a Federal mandate for all
        vaccination events to be reported to IISs, IIS data will continue to be inconsistent. Specifically,
        CDC noted that some jurisdictions lack legal authority to collect and share pharmacy vaccination
        data, and that jurisdictions may not prioritize pharmacy connections to IISs because some
        pharmacies may have lower immunization volume than do other providers.

        While OIG recognizes that limits on legal authority impact CDC’s ability to ensure
        comprehensive vaccination data sharing across all jurisdictions, we continue to believe that CDC
        has opportunities to improve the data immunization programs receive from retail pharmacy
        partners. Indeed, CDC agreed that additional work with pharmacies is needed to ensure robust
        immunization data and stated that it continues to work with partners to address technological
        issues within IISs and pharmacy systems. OIG supports these efforts, and we encourage CDC to
        focus on immunization programs that reported the greatest gaps in data from Federal retail
        pharmacy partners.

        In concurring with our second recommendation—that CDC should provide educational outreach
        to ensure that State and local immunization programs are aware of existing tools to address
        vaccination campaign needs—CDC stated that it provides immunization programs with technical
        assistance; educational outreach; and information on where and how to find data. For example,
        CDC described conducting individual outreach to jurisdictions, holding regular office hours to
        solicit feedback on jurisdictions’ needs, hosting webinars on its data systems, and issuing weekly
        reports on data quality. OIG believes that CDC could take additional steps to help
        immunuization programs leverage data sources outside of immunization databases, such as
        providing instructions on how to access complete lists of Federal agency and retail pharmacy
        providers through Tiberius.

        In technical comments, CDC also stated that concerns raised in our report regarding an
        immunization database software company potentially choosing not to participate in the IZ
        Gateway had been resolved.

        For full text of CDC’s comments, see the Agency Comments appendix at the end of the report.




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                                                                                Agency Comments and OIG Response | 19
DETAILED METHODOLOGY

                    For this data brief, we conducted a survey among State and local immunization
                    programs and analyzed their responses.

        Scope
                    We included 56 State and local immunization programs in our review. This includes
                    all 50 States and the 6 cities (i.e., Chicago, the District of Columbia, Houston, New
                    York City, Philadelphia, and San Antonio) that operate an immunization database. We
                    included all States and cities to ensure that we could provide comprehensive
                    information about immunization data received by State and local programs from
                    Federal agencies and retail pharmacy partners. We did not include the eight U.S.
                    territories with immunization databases in this review.

        Data Sources and Collection
                    In December 2021, OIG sent an online survey to State and local staff who manage
                    immunization programs and immunization databases. All 56 States and localities
                    responded to our survey. In February 2022, OIG followed up via email with seven
                    immunization programs to request more in-depth information regarding unclear
                    responses.

                    Survey questions
                    We used the survey to ask State and local immunization programs about data
                    received from Federal COVID-19 vaccination providers. First, we asked whether
                    programs receive data from (1) Federal agencies that provide vaccinations (VA, DoD,
                    IHS, the Bureau of Prisons (BoP), and the Department of State) and (2) retail
                    pharmacies participating in the Federal retail pharmacy partner program (e.g.,
                    Walgreens, CVS, Walmart), and how programs use this data in immunization
                    campaigns. 74, 75 We asked immunization programs to describe how data are received,
                    either through (1) automated means (e.g., an electronic health exchange, or an HL7
                    system interface) or (2) other methods such as manual entry by providers or program
                    staff, and any challenges with receiving data through either method. Additionally, we
                    asked how State and local immunization campaigns are limited by incomplete data.
                    Finally, we asked State and local immunization programs about how CDC or others
                    could assist with these issues.

                    Data analysis
                    We analyzed surveys and followup emails to understand the data State and local
                    immunization programs are receiving from Federal agencies and retail pharmacy


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                                                                                              Detailed Methodology | 20
                    partners. First, we reviewed survey responses to understand whether State and local
                    immunization programs received any data from Federal agency providers or retail
                    pharmacy partners.

                    After determining whether State and local immunization programs received any data,
                    we reviewed surveys to gain greater insight into how the data were received and any
                    challenges with completeness, accuracy, and timeliness of the data.

                    We analyzed the surveys to identify how immunization programs use this data to
                    administer their vaccination campaigns or any limitations their campaigns experience
                    because of incomplete, inaccurate, or untimely data.




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                                                                                              Detailed Methodology | 21
APPENDIX

        Agency Comments


          ~          U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES                          Public Health Service

      ,::--z~                                                                              Centers for Disease Control
                                                                                             and Prevention (CDC)
                                                                                           Atlanta GA 30329-4027


              DATE:           December 6, 2022

              TO:             Ann Maxwell
    DATE:             December 6, 2022
                          Deputy Inspector General for Evaluation and Inspections

    TO:                Rochelle P. Walensky, MD, MPH
              FROM:Ann Maxwell
                       Director, CDC Centers for Disease Control and Prevention (CDC)
                      Deputy Inspector General for Evaluation and Inspections
              SUBJECT:        INFORM ATTON ONLY - CDC's response to the Office of the Inspector
    FROM:             Rochelle  P. (OTG)
                                   Walensky,
                            General's       draftMD,   MPH
                                                  report, "Challenges With Data From Federal Vaccination
                            Partners Hinder Efforts by
                      Director, CDC Centers for DiseaseState andControl
                                                                 Local Immunization Programs
                                                                         and Prevention      To Combat
                                                                                          (CDC)
                              COVID-1 9, OEI-05-22-00010" (the Report)

    SUBJECT:    INFORMATION ONLY – CDC’s response to the Office of the Inspector
          KEY INFORMATION
                General’s (OIG) draft report, “Challenges With Data From Federal Vaccination
                Partners Hinder
         This memorandum             Efforts
                           is to inform      by State
                                        you that       andresponded
                                                 CDC has    Local Immunization        Programs
                                                                     to the Report by detailing theTo Combat
         agency'sCOVID-19,
                  planned actions  (TAB  A). CDC  appreciates
                               OEI-05-22-00010” (the Report)  the opportunity to review and  comment on
              this report prior to the final release.

    KEY INFORMATION

    This memorandum is to inform you that CDC has responded to the Report by detailing the
    agency’s planned actions (TAB A). CDC appreciates the opportunity to review and comment on
    this report prior to the final release.
             Attachment
              TAB A:          CDC's planned actions regarding recommendations



                                                    _____________________________
                                                    Rochelle P. Walensky, MD, MPH

    Attachment
    TAB A:            CDC’s planned actions regarding recommendations




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                                                                                                             Appendix | 22
     Centers for Disease Control and Prevention (CDC)’s planned actions in response to the
    Office of the Inspector General’s (OIG) draft report, “Challenges With Data From Federal
       Vaccination Partners Hinder Efforts by State and Local Immunization Programs To
                        Combat COVID-19, OEI-05-22-00010” (the Report)

    CDC appreciates OIG’s ongoing work on the Report and strongly supports state and local
    immunization program efforts to increase vaccination rates and reduce vaccine-preventable
    disease through ongoing data collection and monitoring using jurisdiction immunization
    information systems (IIS). As described in the OIG report, complete and timely vaccination data
    is important for immunization programs to successfully identify populations at high risk for
    vaccine-preventable diseases and target interventions and resources efficiently. IIS comprise the
    information systems, programs, people, and process associated with the system and is directly
    related to increasing vaccination rates and reducing vaccine-preventable disease. IIS uses
    confidential, population-based, computerized databases that record immunization doses
    administered by participating providers to persons residing within a given geopolitical area. At
    the point of clinical care, IIS provides consolidated immunization histories for use by a
    vaccination provider in determining appropriate patient vaccinations. IIS provides aggregate data
    on vaccinations for use in surveillance and program operations, and in guiding public health
    action with the goal of improving vaccination rates and reducing vaccine-preventable diseases.
    CDC plans to continue progress in IIS performance, standards, and sustainability; and in
    strengthening connections to and within the public health information technology environment.

    OIG Recommendation (1)
    OIG recommends CDC take action to improve the data immunization programs receive from
    retail pharmacy partners by:
        o Facilitating solutions where there are sizeable gaps in reporting from retail pharmacy
            partners to state and local immunization programs. For example, CDC could prioritize the
            14 immunization programs that reported not receiving any data from at least one retail
            pharmacy partner present in their jurisdiction.
        o Clarifying expectations and facilitating data reporting for the coronavirus disease 2019
            (COVID-19) vaccination campaign and future vaccination efforts.
        o Working with third-party vendors that contract with major national pharmacy chains to
            identify improvements.

    CDC Response: CDC nonconcurs with OIG’s recommendation.
    CDC agrees that additional work with pharmacies is needed to ensure robust reporting of
    immunization data to IIS. CDC continues to work with IIS partners to address technological
    issues within the IIS and/or pharmacy systems. However, the ecosystem in which IIS operate is
    complicated by the web of policies and regulations that govern IIS reporting. IIS policies and
    regulations are enacted at the state and local levels, and CDC does not have the legal authority to
    standardize reporting across the nation. IIS policies govern the reporting entities (i.e. who reports
    to the jurisdiction IIS), what data may be collected, what type of consent is required to collect
    data, and what data may be shared. Currently, some jurisdictions are limited in their ability to
    collect and share data from pharmacies because they do not have the legal authority to do so, per



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                                                                                                          Appendix | 23
    state and local regulations. In other cases, jurisdictions may prioritize pharmacies lower in their
    onboarding queues to focus on high-volume providers of routine immunizations. Ensuring
    sustainable and diverse mechanisms of financial support, a trained workforce, and adequate
    reporting authorities would enhance pharmacy data collection and reporting to the IIS. In the
    absence of a federal mandate for all vaccination events to be reported to the IIS for population
    health monitoring, IIS data will continue to be inconsistent across the nation.

    OIG Recommendation (2)
    OIG recommends CDC offer updated educational opportunities to ensure immunization
    programs understand how existing tools can assist in their COVID-19 vaccination campaigns.
    These could include webinars or the publication of a frequently asked questions document about
    leveraging data sources outside of immunization databases, such as Tiberius and the COVID-19
    Data Tracker, to address gaps reported to OIG. For example, CDC could instruct immunization
    programs to access complete lists of federal agency and retail pharmacy providers through
    Tiberius.

    CDC Response: CDC concurs with OIG’s recommendation.
    CDC agrees that ongoing outreach to ensure awareness of existing tools and data is helpful to
    jurisdictions. CDC provides technical assistance, educational outreach, and information on data
    systems (e.g. where and how to find data). This includes individual outreach to jurisdictions by
    assigned project officers and subject matter experts to provide customized technical assistance,
    regular webinars on data systems (e.g., HHS-CAG webinars on Tiberius, CDC webinars on the
    Immunization Data Lake, Data Clearinghouse, Immunization Gateway, etc.), available reports
    (e.g., provider data, partner administration data), resources and guidance, weekly data quality
    reports to highlight areas of concern and suggested steps for improvement, and regular office
    hours to answer questions and solicit feedback on jurisdiction needs. CDC does not own
    jurisdiction, participating partners, or other federal agency systems and must rely on system
    owners to determine the training needs of their users but does provide communications and
    access to training materials, when feasible.




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                                                                                                          Appendix | 24
ACKNOWLEDGMENTS AND CONTACT

ACKNOWLEDGMENTS AND CONTACT
        Acknowledgments
                    Jonathan Jones, Samantha Handel-Meyer, and Kayla Phelps served as the team
                    leaders for this study. Others in the Office of Evaluation and Inspections who
                    conducted the study include Danielle Noriega and Alexandra Roehll. Office of
                    Evaluation and Inspections headquarters staff who provided support include Kaliane
                    Davidson, Althea Hosein, Christine Moritz, and Sara Swisher.

                    We would also like to acknowledge the contributions of other Office of Inspector
                    General staff, including Lauren Buss, Evan Godfrey, Dwayne Grant, and Rebekah
                    Schwartz.

                    This report was prepared under the direction of Laura Kordish, Regional Inspector
                    General for Evaluation and Inspections in the Chicago regional office; Adam Freeman,
                    Deputy Regional Inspector General; and Hilary Slover, Assistant Regional Inspector
                    General.


        Contact
                    To obtain additional information concerning this report, contact the Office of Public
                    Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found
                    on the OIG website at oig.hhs.gov.

                    Office of Inspector General
                    U.S. Department of Health and Human Services
                    330 Independence Avenue, SW
                    Washington, DC 20201




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                                                                                       Acknowledgments and Contact | 25
ABOUT THE OFFICE OF INSPECTOR GENERAL

                     The mission of the Office of Inspector General (OIG), as mandated by Public Law
                     95-452, as amended, is to protect the integrity of the Department of Health and
                     Human Services (HHS) programs, as well as the health and welfare of beneficiaries
                     served by those programs. This statutory mission is carried out through a nationwide
                     network of audits, investigations, and inspections conducted by the following
                     operating components:

                     The Office of Audit Services (OAS) provides auditing services for HHS,
                     either by conducting audits with its own audit resources or by overseeing audit work
                     done by others. Audits examine the performance of HHS programs and/or its
                     grantees and contractors in carrying out their respective responsibilities and are
                     intended to provide independent assessments of HHS programs and operations.
                     These audits help reduce waste, abuse, and mismanagement and promote economy
                     and efficiency throughout HHS.

                     The Office of Evaluation and Inspections (OEI) conducts national
                     evaluations to provide HHS, Congress, and the public with timely, useful, and reliable
                     information on significant issues. These evaluations focus on preventing fraud, waste,
                     or abuse and promoting economy, efficiency, and effectiveness of departmental
                     programs. To promote impact, OEI reports also present practical recommendations
                     for improving program operations.

                     The Office of Investigations (OI) conducts criminal, civil, and administrative
                     investigations of fraud and misconduct related to HHS programs, operations, and
                     beneficiaries. With investigators working in all 50 States and the District of Columbia,
                     OI utilizes its resources by actively coordinating with the Department of Justice and
                     other Federal, State, and local law enforcement authorities. The investigative efforts
                     of OI often lead to criminal convictions, administrative sanctions, and/or civil
                     monetary penalties.

                     The Office of Counsel to the Inspector General (OCIG) provides
                     general legal services to OIG, rendering advice and opinions on HHS programs and
                     operations and providing all legal support for OIG’s internal operations. OCIG
                     represents OIG in all civil and administrative fraud and abuse cases involving HHS
                     programs, including False Claims Act, program exclusion, and civil monetary penalty
                     cases. In connection with these cases, OCIG also negotiates and monitors corporate
                     integrity agreements. OCIG renders advisory opinions, issues compliance program
                     guidance, publishes fraud alerts, and provides other guidance to the health care
                     industry concerning the anti-kickback statute and other OIG enforcement authorities.



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                                                                                About the Office of Inspector General | 26
ENDNOTES

 1 CDC, Total Doses Administered Reported to the CDC by State/Territory and for Select Federal Entities, as of May 4, 2022.

 Accessed at CDC COVID Data Tracker: Vaccinations in the US on May 4, 2022.
 2 CDC, Total Doses Administered Reported to the CDC by State/Territory and for Select Federal Entities, as of May 4, 2022.

 Accessed at CDC COVID Data Tracker: Vaccinations in the US on May 4, 2022.
 3 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, Section 11:

 COVID-19 Requirements for Immunization Information Systems of Other External Systems, page 38. Accessed at COVID-19
 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on May 14, 2021.
 4 CDC, About Immunization Information Systems.    Accessed at About Immunization Information System (IIS) | CDC on June 9,
 2022.
 5 CDC, Immunization Information Systems Functional Standards (IIS), v4.1. See Essential Infrastructure Functional Standards 1,

 1.1, 1.3, and 1.4. Accessed at IIS Functional Standards v4.1 | CDC on October 1, 2021.
 6 CDC, Immunization Information Systems Annual Report (IISAR) Data Overview.      Accessed at IISAR Annual Report Data
 Overview | CDC on May 11, 2021.
 7 During the 2009 H1N1 pandemic, IISs were leveraged extensively to support mass vaccination efforts. See American

 Immunization Registry Association (AIRA), Mass Vaccination Capabilities Summary, page 5. Accessed at Mass Vaccination
 Capabilities Summary (memberclicks.net) on September 30, 2021.
 8 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, Section 11:

 COVID-19 Requirements for Immunization Information Systems or Other External Systems, page 38. Accessed at COVID-19
 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on May 14, 2021.
 9 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 63,

 Appendix D. Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on
 April 27, 2021.
 10 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 39.

 Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on April 27, 2021.
 11 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, pages 63-

 64. Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on April 27,
 2021.
 12 CDC, Immunization Information System (IIS) Strategic Plan.The 2018-2020 Strategic Plan builds on the prior plan from
 2014-2017. In addition to population-level goals, the plan supports goals for the point of clinical care that support use by
 vaccination providers in determining appropriate patient vaccinations. Accessed at IIS 2018-2020 Strategy Initiative and Plan
 Introduction | CDC on June 9, 2022.
 13 CDC, Immunization Information Systems (IIS) Functional Standards, v4.1.   See Essential Infrastructure Functional Standard 14.
 Accessed at IIS Functional Standards v4.1 | CDC on September 13, 2022.
 14 CDC, Immunization Information Systems (IIS) Functional Standards, v4.1.   See Essential Infrastructure Functional Standard 17.
 Accessed at IIS Functional Standards v4.1 | CDC on September 13, 2022.
 15
   CDC, Immunization Information Systems Annual Report (IISAR) Data Overview. IISAR data from 2012-2019 are currently
 publicly available. Accessed at IISAR Annual Report Data Overview | CDC on June 9, 2022.
 16 Congressional Research Service, Immunization Information Systems: Overview and Current Issues, February 1, 2022.

 Accessed at R47024 (congress.gov) on September 12, 2022.



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                                                                                                                   Endnotes | 27
 17 Congressional Research Service, Immunization Information Systems: Overview and Current Issues, February 1, 2022.

 Accessed at R47024 (congress.gov) on September 12, 2022.
 18 Vermont’s State Plan notes that State law only allows its IIS to provide information to the CDC “in summary, statistical, or

 other form in which particular individuals are not identified.” See Vermont Department of Health, COVID-19 Vaccination
 Plan, page 31, Section 9 B. Accessed at COVID-19 Vaccination Plan (healthvermont.gov) on June 9, 2022. In Minnesota, State
 law prohibits sharing race and ethnicity data. See Kaiser Health News (KHN), Huge Gaps in Vaccine Data Make It Next to
 Impossible to Know Who Got the Shots. Accessed at Huge Gaps in Vaccine Data Make It Next to Impossible to Know Who Got
 the Shots | Kaiser Health News (khn.org) on June 9, 2022.
 19 Trotter, Andrew B., Abbott, Elizabeth, K., et al, Annals of Internal Medicine, Preparing for COVID-19 Vaccination: Call to

 Action for Clinicians on Immunization Information Systems, February 2, 2021. Accessed at Preparing for COVID-19
 Vaccination: A Call to Action for Clinicians on Immunization Information Systems | Annals of Internal Medicine
 (acpjournals.org) on April 27, 2021.
 20 The Office of the National Coordinator for Health Information Technology (ONC) uses its Interoperability Standards

 Advisory (ISA) to identify, assess, and promote interoperability standards and implementation specifications for use by the
 health care industry. See What Is the ISA? on FAQs | Interoperability Standards Advisory (ISA) (healthit.gov). ISA includes a
 standards/implementation specification for transportation and query/response of immunization data between CDC,
 electronic health record (EHR), and IIS. See Transport for Immunization Submission and Query/Response | Interoperability
 Standards Advisory (ISA) (healthit.gov).
 21 AIRA, Landscape Analysis: IIS Adult Vaccination Capture and Data Utilization, page 16.   Accessed at Adult Landscape FINAL
 (immregistries.org) on June 14, 2021.
 22 AIRA, Landscape Analysis: IIS Adult Vaccination Capture and Data Utilization, page 17.   Accessed at Adult Landscape FINAL
 (immregistries.org) on June 14, 2021.
 23 CDC, The Nation Benefits When Public Health Connects.    Accessed at How Data Authority Improves Public Health | CDC on
 December 7, 2022.
 24 The Hill, Former CDC Directors: Coordinating Our Nation’s Health Data Will Save Lives. Accessed at Former CDC directors:

 Coordinating our nation’s health data will save lives | The Hill on September 14, 2022.
 25 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0.  COVID-19
 providers could enroll directly with their jurisdictions’ immunization program, see page 21. Federal agency and retail
 pharmacy providers enrolled directly with CDC, see pages 25 and 74. Accessed at COVID-19 Vaccination Program Interim
 Operational Guidance Jurisdiction Operations (cdc.gov) on April 27, 2021.
 26 The two other Federal agencies that provide vaccinations are the Bureau of Prisons (BoP) and the Department of State.        See
 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 25.
 Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on March 3,
 2022.
 27 For a partial list of pharmacies in the Federal Retail Pharmacy Program, see CDC, COVID-19 Vaccination Program Interim

 Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 74. Accessed at COVID-19 Vaccination Program
 Interim Operational Guidance Jurisdiction Operations (cdc.gov) on March 3, 2022.
 28 CDC, Federal Retail Pharmacy Program, Pharmacies Participating in the Federal Retail Pharmacy Program.       Accessed at
 Pharmacies Participating in COVID-19 Vaccination | CDC on April 6, 2022.
 29 CDC, The Federal Retail Pharmacy Program for COVID-19 Vaccination.       Accessed at COVID-19 Vaccination Federal Retail
 Pharmacy Partnership Program | CDC on March 21, 2022.
 30 Federal retail pharmacy partners have administered a substantial portion of the total doses administered.
                                                                                                        As of March 17,
 2022, 234.9 doses had been administered by these pharmacies. CDC, The Federal Retail Pharmacy Program for COVID-19
 Vaccination. Accessed at COVID-19 Vaccination Federal Retail Pharmacy Partnership Program | CDC on March 21, 2022.




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                                                                                                                    Endnotes | 28
 31 As of April, 7, 2022, 563.4 million total doses had been administered.
                                                                        CDC, COVID-19 Vaccinations in the United States.
 Accessed at CDC COVID Data Tracker: Vaccinations in the US on April 7, 2022.
 32 CDC, Total Doses Administered Reported to the CDC by State/Territory and for Select Federal Entities, as of May 4, 2022.

 Accessed at CDC COVID Data Tracker: Vaccinations in the US on May 4, 2022.
 33 CDC, The Federal Retail Pharmacy Program for COVID-19 Vaccination.       Accessed at COVID-19 Vaccination Federal Retail
 Pharmacy Partnership Program | CDC on May 10, 2022.
 34 Record of IZ Gateway development appears as early as April 2019.See CDC, The Immunization Information System (IIS)
 Landscape. Accessed at The Immunization Information System (IIS) Landscape (healthit.gov) on June 22, 2022.
 35 CDC identifies the COVID-19 pandemic as beginning in December 2019.
                                                                     CDC, CDC Museum COVID-19 Timeline. Accessed
 at CDC Museum COVID-19 Timeline | David J. Sencer CDC Museum | CDC on June 22, 2022.
 36 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 35,

 footnote 7. Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on
 July 23, 2021.
 37 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, page 38.

 Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on July 23, 2021.
 38 In June 2020, an AIRA representative reported that there were still IZ Gateway policy and technical issues that needed to be

 resolved before the Gateway could be leveraged on a national scale. See Coronavirus vaccine: State immunization databases
 hold key to success (usatoday.com) from June 12, 2020. Accessed on July 17, 2021.
 39 As of late 2019, the IZ Gateway was only in a proof-of-concept stage and some programs noted not intending to sign the

 memorandum that allowed for cross-jurisdiction querying of registries. National Governors Association, Supporting an
 Equitable Distribution of COVID-19 Vaccines: Key Themes, Strategies, and Challenges Across State and Territorial COVID-19
 Vaccination Plans, page 19, December 2020. Accessed at Supporting-an-Equitable-Distribution-of-COVID-19-Vaccine.pdf
 (nga.org) on April 6, 2022.
 40 HHS, Immunization (IZ) Gateway Portfolio Overview, see page 2.    Accessed at Immunization (IZ) Gateway Portfolio Overview
 (hhs.gov) on June 15, 2022.
 41 CDC, Immunization Gateway Information Sheet. See Connect: National Provider Organizations to Multiple IISs. Accessed at
 IZ Gateway Information for COVID-19 Vaccination Reporting | CDC on June 15, 2022.
 42 Government Accountability Office (GAO), HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address

 Outstanding Issues, see page 17. Accessed at GAO-22-104453, COVID-19: HHS and DOD Transitioned Vaccine
 Responsibilities to HHS, but Need to Address Outstanding Issues on September 13, 2022.
 43 U.S. Department of Defense, Tiberius Platform Aids COVID-19 Logistics, Delivery.
                                                                                Accessed at Tiberius Platform Aids
 COVID-19 Logistics, Delivery > U.S. Department of Defense > Defense Department News on June 11, 2022.
 44 Politico, States Complain Feds’ Data System Is Holding Up Vaccination Effort.   Accessed at States complain feds' data system
 is holding up vaccination effort - POLITICO on June 11, 2022.
 45 Politico, States Complain Feds’ Data System Is Holding Up Vaccination Effort.   Accessed at States complain feds' data system
 is holding up vaccination effort - POLITICO on June 11, 2022.
 46 USA Today, A National System to Prioritize COVID-19 Vaccines Has Largely Failed As Our States Rely On Their Own Systems.

 Accessed at COVID-19 vaccine: Distribution system fails to live up to promise (usatoday.com) on June 11, 2022.
 47 GovConWire, Palantir Helps HHS Develop ”Tiberius” System to Track COVID-19 Vaccine Production, Distribution.Accessed
 at Palantir Helps HHS Develop 'Tiberius' System to Track COVID-19 Vaccine Production, Distribution - GovCon Wire on June
 17, 2022.
 48 CDC, COVID-19 Data Tracker – Vaccine Distribution & Coverage.     Accessed at CDC COVID Data Tracker on June 23, 2022.




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                                                                                                                   Endnotes | 29
 49 CDC, Frequently Asked Questions about COVID-19 Vaccination Data.
                                                                  See How Often Are COVID-19 Vaccination Data
 Updated? Accessed at Frequently Asked Questions about COVID-19 Vaccination Data | CDC on June 23, 2022.
 50 CDC, Frequently Asked Questions about COVID-19 Vaccination Data.
                                                                  See How Are Vaccine Administration Data Reported
 to CDC? Accessed at Frequently Asked Questions about COVID-19 Vaccination Data | CDC on June 23, 2022.
 51 CDC, Vaccine Administration Management System (VAMS).           Accessed at VAMS COVID-19 Vaccination Reporting | CDC on
 October 19, 2022.
 52 CDC, Data Definitions for COVID-19 Vaccinations in the United States.       Accessed at Data Definitions for COVID-19
 Vaccinations in the United States (cdc.gov) on June 23, 2022.
 53 All Federal agencies are not present in all jurisdictions.   Fifty-two out of 56 jurisdictions are not receiving data from VA,
 DoD, and/or IHS where it is expected or wanted.
 54 CDC stated that availability of DoD vaccine administration data may be more limited due to security concerns.


 55 New York State, Governor Kathy Hochul, Executive Order No. 8:
                                                                Directing the Department of Veterans Affairs to Transmit
 Immunization Records. Accessed at No. 8: Directing the Department of Veterans Affairs to Transmit Immunization Records |
 Governor Kathy Hochul (ny.gov) on March 3, 2022.
 56 Newsweek, Which U.S. States Have the Highest Concentration of Veterans?, November 17, 2018.           Accessed at Which U.S.
 States Have the Highest Concentration of Veterans? (newsweek.com) on March 3, 2022.
 57 The Soldiers Project, Top 5 Largest Military Bases in the World by Population and Area, March 1, 2022.      Accessed at Top 5
 Largest Military Bases in the World by Population & Area (thesoldiersproject.org) on March 3, 2022.
 58 Governing, Military Active-Duty Personnel, Civilians by State.    Accessed at Military Active-Duty Personnel, Civilians by State
 (governing.com) on May 4, 2022.
 59 Not all State and local immunization programs have IHS facilities.      25 States have facilities. IHS, Find Health Care. Accessed
 at Find Health Care | Indian Health Service (IHS) on March 21, 2022.
 60 IHS may not cover all AI/ANs in a jurisdiction. The Playbook instructed jurisdictions to incorporate a variety of AI/AN
 organizations in their planning process (e.g., State-recognized tribes, unrecognized tribes, Urban Indian Health Centers
 (UIHCs)). CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0,
 page 9. Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on
 March 3, 2022.
 61 IHS, Frequently Asked Questions.    Accessed at Frequently Asked Questions | for Patients (ihs.gov) on March 3, 2022.
 62 IHS, Navajo Area.   Accessed at https://www.ihs.gov/Navajo/ on March 3, 2022.
 63 Statista, Percentage of U.S. Population Who Are Veterans in 2019, by Age and Gender.        Accessed at Percentage of U.S.
 population who are veterans by age and gender 2019 | Statista on May 10, 2011.
 64 CDC, What is Vaccination Coverage and Why is it Important?        Accessed at VaxView Vaccination Coverage | CDC on March 3,
 2022.
 65 CDC, The Federal Retail Pharmacy Program for COVID-19 Vaccination.          Accessed at COVID-19 Vaccination Federal Retail
 Pharmacy Partnership Program | CDC on May 10, 2022.
 66 GAO, COVID-19 Federal Efforts to Provide Vaccines to Racial and Ethnic Groups, February 2022.  Accessed at GAO-22-
 105079, Accessible Version, covid-19: Federal Efforts to Provide Vaccines to Racial and Ethnic Groups on May 10, 2022.
 67 Murthy Patel, Bhavini, Sterrett, Natalie, et al., Disparities in COVID-19 Vaccination Coverage Between Urban and Rural

 Counties – United States, December 14, 2020 – April 10, 2021, MMWR Morb Mortal Wkly Rep 2020;71:335340. Accessed at
 MMWR, Disparities in COVID-19 Vaccination Coverage Between Urban and Rural Counties — United States, December 14,
 2020–April 10, 2021 (cdc.gov) on May 9, 2022.
 68 IHS, Disparities, October 2019.   Accessed at Disparities | Fact Sheets (ihs.gov) on March 3, 2022.




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                                                                                                                       Endnotes | 30
 69 Arrazola, Jessica, Masiello, Matthew M., Joshi, Sujata, et al., COVID-19 Mortality Among American Indian and Alaska Native

 Persons — 14 States, January–June 2020, MMWR Morb Mortal Wkly Rep 2020;69:18531856. Accessed at COVID-19 Mortality
 Among American Indian and Alaska Native Persons — 14 States, January–June 2020 | MMWR (cdc.gov) on March 3, 2022.
 70 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0, Role of

 Commercial and Federal Partners, page 25. Accessed at COVID-19 Vaccination Program Interim Operational Guidance
 Jurisdiction Operations (cdc.gov) on February 24, 2022.
 71 Federal COVID-19 data platforms available to immunization programs include HHS’ Tiberius dashboard for vaccine

 distribution and CDC’s public COVID-19 Data Tracker. See CDC, COVID-19 Vaccination Program Interim Playbook for
 Jurisdiction Operations, October 29, 2020, version 2.0, page 49, for description of Tiberius. Accessed at COVID-19 Vaccination
 Program Interim Operational Guidance Jurisdiction Operations (cdc.gov) on March 3, 2022. Also see CDC’s public COVID-19
 data tracker accessed at CDC COVID Data Tracker: Vaccinations in the US and CDC COVID Data Tracker: County View on April
 8, 2022.
 72 The Immunization Infrastructure Modernization Act of 2021 directs HHS to improve data sharing and other aspects of IISs.

 Accessed at H.R.550 - 117th Congress (2021-2022): Immunization Infrastructure Modernization Act of 2021 | Congress.gov |
 Library of Congress on September 15, 2022.
 73 The PREVENT Pandemics Act considers revisions on authories of HHS to support preparedness, including the collection of

 public heath data. Accessed at S.3799 - 117th Congress (2021-2022): PREVENT Pandemics Act | Congress.gov | Library of
 Congress on September 15, 2022.
 74 Some multijurisdictional vaccination providers receive COVID-19 vaccine allocation directly from CDC.  These providers
 include Federal agencies (i.e., BoP, DoD, DoS, VA, and IHS) and select pharmacy partners (e.g., Walgreens, CVS, Walmart, Rite
 Aid Corp). CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, October 29, 2020, version 2.0,
 pages 25 and 74. Accessed at COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations
 (cdc.gov) on February 14, 2022.
 75 We did not ask respondents to differentiate between data received from Federally run and Tribally run IHS facilities.




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                                                                                                                  Endnotes | 31


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