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Unit C: Assuring Access to Vaccines

Immunization Program Operations Manual (IPOM)

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Assure access to vaccines.

 

Overview

Assuring access to vaccines involves a variety of elements including the Vaccines for Children Program (including working with American Indian/Alaska Native (AI/AN) populations) and the Perinatal Hepatitis B Prevention Program.

The Vaccines for Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. VFC was created by the Omnibus Budget Reconciliation Act of 1993 as a new entitlement program to be a required part of each state's Medicaid plan. The program was officially implemented in October 1994 as part of the President's Childhood Immunization Initiative. Funding for the VFC program is approved by the Office of Management and Budget and allocated through the Centers for Medicare & Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC). CDC buys vaccines at a discount from the manufacturers and makes them available to awardees (i.e., state health departments and certain local and territorial public health agencies), allowing private physicians' offices and public health clinics registered as VFC providers to order these vaccines. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the Advisory Committee on Immunization Practices through passage of VFC resolutions.

In addition to ensuring that AI/AN populations have access to VFC-funded vaccines, it is also important to ensure that AI/AN tribes are engaged in the program planning process for activities affecting their communities. AI/AN tribes have a unique political and legal status that distinguishes them from traditionally defined minority and other population groups. As sovereign nations, AI/AN tribes maintain a government-to-government relationship with the federal government. As a federal agency, CDC has special obligations to AI/AN tribes and is committed to fulfilling its critical role in assuring that AI/AN communities are safer and healthier. CDC policy calls for enhanced AI/AN access to CDC programs, including programs funded by CDC through grants and cooperative agreements. As recipients of the Immunization and Vaccines for Children Program cooperative agreement awards from CDC, immunization programs are thus required to engage AI/AN tribes in the planning and implementation of immunization program activities that affect AI/AN populations.

The perinatal hepatitis B prevention program was initiated to reduce the number of infants born to women chronically infected with hepatitis B. Infants who become infected with hepatitis B virus have a 90% risk for developing chronic Hepatitis B infection and a 25% lifetime risk for dying prematurely from cirrhosis or hepatocellular carcinoma. A key strategy to eliminate mother-to-child transmission of hepatitis B virus (HBV) is to prevent infants born to HBsAg-positive women from becoming infected. ACIP recommends post-exposure prophylaxis with Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine within 12 hours of birth to all infants born to hepatitis B surface antigen (HBsAg)-positive women followed by completion of the hepatitis B vaccine series. This approach has been shown to be 85%-95% effective in preventing HBV infection.

Two important public health documents have objectives focusing on decreasing or eliminating hepatitis B infection in infants and young children. The Healthy People 2020 objective states, "Reduce chronic hepatitis B virus infections in infants and young children (perinatal infections)from a baseline of 799 perinatal infections in 2007 to a goal of 400."

The Department of Health and Human Services (HHS) released an action plan in May 2011, entitled "Combating the Silent Epidemic of Viral Hepatitis[84 pages]". HHS states the action plan will be the road map for the achievement of hepatitis-related Healthy People 2020 objectives. One goal outlined in the action plan is to "Eliminate mother-to-child transmission of hepatitis B." Coordination is needed to ensure that infants born to HBsAg-positive women receive the immunization services to protect them against hepatitis B infection. The perinatal hepatitis B prevention program has an important role in assisting with the achievement of these goals and objectives.

The perinatal hepatitis B prevention program began in 1990 as part of the Vaccine and Immunization Amendments (P.L. 101-502) because Congress recognized the need to foster efforts to prevent perinatal HBV transmission and made resources available to develop and implement programs. The CDC has annually awarded funds to support perinatal hepatitis B prevention programs among the 64 immunization funding recipients. These programs have made great strides in the prevention of hepatitis B transmission from mothers to infants, but gaps remain in the identification of HBsAg-positive pregnant women and in the management of their infants.

For 2010, the National Immunization Survey (NIS) reported approximately 92% coverage level for the three-dose hepatitis B vaccine series for children 19-35 months of age. Despite high hepatitis B vaccine series coverage levels for children 19-35 months of age, challenges remain. For 2010, the NIS reported that the coverage level for the birth dose of hepatitis B vaccine by day one of age was 56.1 percent, and the coverage level improved only to 64.1 percent by day three of age. The low coverage level of the birth dose of hepatitis B vaccine makes it even more critical to identify infants born to HBsAg-positive women, obtain post-exposure prophylaxis, complete the three-dose hepatitis B vaccine series, and obtain post-vaccination serologic test results to determine if the exposed infant is protected against hepatitis B infection. For children born to HBsAg-positive women in 2008, less than half of the expected infants born to HBsAg-positive women were identified by the perinatal hepatitis B prevention program, and only 56% of the identified infants were reported to have post-vaccination serologic testing.

To improve outcomes and eliminate mother-to-child transmission of hepatitis B, programs need to evaluate current activities and make changes based on the evaluation results. Several sources of data should be used to evaluate the progress of perinatal hepatitis B prevention programs, such as CDC’s expected births to HBsAg-positive women, NIS coverage data, and awardee-specific perinatal hepatitis B program data. The identification of areas for improvement in perinatal hepatitis B prevention programs will help to achieve the important hepatitis B goals outlined in Healthy People 2020 and HHS’s Viral Hepatitis Action Plan.

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References

 

Awardees must identify activities that will describe HOW the following required objectives will be accomplished. Suggested activities are provided for each objective, but awardees are strongly encouraged to think strategically about the specific activities that will best help them achieve this goal.

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List of States with Federally and State-Recognized Tribes or Urban Indian Health Programs

  • Alabama
  • Alaska
  • Arizona
  • California
  • Colorado
  • Connecticut
  • Delaware (state-recognized only)
  • Florida
  • Idaho
  • Illinois (Urban Indian program only)
  • Iowa
  • Kansas
  • Louisiana
  • Maine
  • Maryland (state-recognized only)
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Montana
  • Nebraska
  • Nevada
  • New Jersey (state-recognized only)
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Oklahoma
  • Oregon
  • Rhode Island
  • South Carolina
  • South Dakota
  • Texas
  • Utah
  • Vermont (state-recognized only)
  • Virginia (state-recognized only)
  • Washington
  • Wisconsin
  • Wyoming

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Required Awardee Objective: C-1

Document the process used by the awardee to meaningfully engage American Indian tribal governments, tribal organizations representing those governments, tribal epidemiology centers, or Alaska Native Villages and Corporations located within its boundaries in immunization activities.

 

Suggested Activities:

  1. Convene meetings with tribal stakeholders.
  2. Develop written agreements (e.g., MOUs/MOAs) for collaboration with tribes or tribal immunization programs.
  3. Engage tribes in immunization activities related to program components.
  4. Where feasible, share resources (funds, staff, technical assistance, etc.) with tribes to support immunization activities in tribal communities.

Suggested Reporting Elements:

  • Provide documentation summarizing efforts to engage with tribes on immunization-related issues.

Suggested Performance Measures (target to be defined by awardee):

  • Point-of-contact with each tribe in awardee’s jurisdiction identified.
  • At least one meeting convened with tribal stakeholders, annually.

Allowable Funding Sources:

317 FA Operations, VFC Operations

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Required Awardee Objective: C-2

Enroll and sustain a network of VFC and other providers to administer federally funded vaccines to program-eligible populations according to CDC/ACIP and NVAC standards.

 

Required Activities:

  1. Maintain and implement written policies and protocols to recruit and enroll providers.
  2. Identify and recruit new providers, including non-traditional providers, providers serving adolescents, and providers newly licensed or newly established in areas serving VFC-eligible children1.
  3. Collaborate with medical societies, state licensing boards, state Medicaid agency, and/or other organizations to identify providers to recruit and enroll.
  4. Ensure VFC providers complete and submit provider enrollment and profile forms annually.

Reporting Requirements:

  • Complete annual VFC Program Management Survey:
    • Number of total VFC provider sites enrolled2 and active3.
    • Number of new VFC provider sites enrolled and active.

Required Performance Measures (target to be defined by awardee):

  • Submission of reporting requirements in the VFC Program Management Survey.
  • Percentage of VFC-enrolled provider sites that are active.
  • Percentage of VFC-enrolled provider sites that are newly enrolled in the reportable calendar year.
  • Annual net change in the number of enrolled and active VFC provider sites between the current and past reporting periods.

Allowable funding sources:

317 FA Operations, VFC Operations, VFC/AFIX

Footnotes


  1. Enrolling new providers is an ongoing process; awardees should enroll/maintain a sufficient number of providers to meet the needs of their VFC-eligible population.
  2. Enrolled providers are providers who have a current, signed VFC provider agreement.
  3. Active providers are enrolled providers who have received VFC vaccine within the current report year

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Required Awardee Objective: C-3

Assure compliance with all VFC statutory requirements described in the VFC Operations Guide.

 

Required Activities:

  1. Develop and implement procedures to have all VFC providers complete and submit provider enrollment and provider profile forms annually.
  2. Submit request to receive the CDC required VFC enrollment form at least 4-6 weeks prior to awardee annual re-enrollment. Awardees may not impose additional requirements for enrollment. Follow guidance outlined in Module 3 of the VFC Operations Guide located in the VFC Documents library.
  3. Maintain and implement written accountability policies as outlined in the VFC Operations Guide.
  4. Enter and maintain current VFC policies within the VFC Policy and Procedures Template located within the Program Annual Report and Progress Assessments (PAPA).
  5. Complete and submit the VFC Program Management Survey annually.

Reporting Requirements:

  • Submit for review changes to VFC program policies and procedures annually.
  • Report additional information pertaining to immunization program policies, activities, and accountability measures via the VFC Program Management Survey.

Required Performance Measures:

  • Submission of the VFC Program Management Survey.
  • Maintain complete VFC policies and procedures that reflect current guidance outlined in the VFC Operations Guide.

Allowable funding sources:

317 FA Operations, VFC Operations, VFC/AFIX

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Required Awardee Objective: C-4

Assure compliance with HHS Deputization Guidance.

 

Required Activities (if applicable):

  1. Identify a network of VFC providers to deputize in order to vaccinate children who are underinsured with respect to vaccine in geographic areas that lack sufficient access to FQHCs and RHCs.
  2. Submit to CDC a justification for review and approval that describes the need to use deputization to reach underinsured children and specify the number and type (local health department [LHD] or non-public provider) of VFC providers proposed for deputization by FQHCs/RHCs within awardee’s jurisdiction.
  3. Using the CDC-provided deputization MOU template, execute a memorandum of understanding (MOU) to confer deputization by the signatory FQHCs/RHCs to the identified VFC providers and outline requirements to be met by the deputized sites.

Reporting Requirements:

  • Pre-deputization implementation (if applicable)
    • Total number of VFC-enrolled LHDs in the awardee’s jurisdiction.
    • Number of VFC-enrolled LHDs proposed for deputization.
    • Number of clinic sites (if different than number of LHDs) proposed for deputization.
    • Justification for the need for deputization.
  • Post-deputization implementation (if applicable)
    • Total number of VFC-enrolled LHDs in the awardee’s jurisdiction.
    • Total number of clinics deputized and the aggregate utilization.
      Measures to capture utilization (choose one option):
      • Total number of visits of children who are underinsured with respect to vaccine and receive VFC vaccines in deputized clinics, by age category (ages 0-6, 7-18).
      • Total number of doses of vaccine administered in deputized clinics to children who are underinsured with respect to vaccine, by age category (ages 0-6, 7-18).
      • Number of individual children who have received VFC vaccine in deputized clinics because they were underinsured with respect to vaccine at one or more clinic visits, by age category (ages 0-6, 7-18).

Required Performance Measures (if applicable):

  • Submission and approval of justification for deputization and the deputization MOU.
  • Submission of all required reporting requirements for deputization via the VFC Management Survey, annually.
  • Annual net change in the number of individual children who have received VFC vaccine in deputized clinics because they were underinsured with respect to vaccine at one or more clinic visits.

Suggested Performance Measures (if applicable):

  • Annual net change in the total number of visits of children who are underinsured with respect to vaccine and receive VFC vaccines in deputized clinics
  • Annual net change in the total number of doses of vaccine administered in deputized clinics to children who are underinsured with respect to vaccine.

Allowable Funding Sources:

317 FA Operations, VFC Operations, VFC/AFIX

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Required Awardee Objective: C-5

Work with partners, as appropriate, to assure coordination of the following activities in order to prevent perinatal hepatitis B transmission.

 

a. Identification of HBsAg-positive pregnant women.

Suggested Activities:

  1. Identify and work with local and state chapters of national organizations and other organizations that focus on prenatal, postpartum, and pediatric care to develop and disseminate education on screening all women during every pregnancy for HBsAg. Educational content should include:
    • When to test
    • What serologic markers to order in test
    • How to interpret results
    • What steps to implement when a pregnant woman’s HBsAg results are positive

    Potential organizations to approach/explore for collaboration may include professional associations, academic institutions, health insurers, laboratories, and/or family planning clinics.

  2. Identify and work with social service agencies/institutions that provide services to high-risk populations to provide educational materials on how to prevent perinatal hepatitis B transmission for distribution to appropriate clients. Agencies should include WIC, religious organizations, refugee/immigration assistance programs, and other community-based organizations.
  3. Develop and distribute simple instructions for all providers that may interact with pregnant women on how to notify the awardee's perinatal hepatitis B prevention program of identified HBsAg-positive pregnant women.
  4. Develop mechanisms to identify women who are HBsAg-positive and pregnant. Mechanisms could include manual review of lab results and follow-up or development and pilot testing of other methods to identify HBsAg-positive pregnant women through billing systems or other automated methods.

Reporting Requirements:

  • Annual Assessment of Progress toward Goals to Prevent Perinatal HBV Transmission

Suggested Performance Measures (target to be defined by awardee):

  • Change in number and/or percent of identified births to HBsAg-positive women by awardee compared to expected births to HBsAg-positive women by awardee.

Allowable funding sources:

317 FA Operations

 

b. Newborn prophylaxis with hepatitis B vaccine and HBIG.

Suggested Activities:

  1. Collaborate with birthing hospitals to establish mechanisms to confirm women’s HBsAg status at time of delivery and, if a woman presents for delivery without documentation or HBsAg status is unknown, establish policies or mechanisms to immediately test for HBsAg status.
  2. If mother is HBsAg-positive, establish policies or mechanisms to administer hepatitis B vaccine and HBIG to infant within 12 hours of birth. If HBsAg status is unknown at birth, administer hepatitis B vaccine to infant within 12 hours of birth. Collaborate with birthing hospitals to establish policies or mechanisms to administer HBIG to infant as soon as HBsAg-positive status is confirmed, but no later than one week after birth.
  3. Develop mechanisms for birthing hospitals to routinely provide documentation of date and time of HBIG and hepatitis B vaccine administration to exposed newborn to the infant’s identified health care provider and the perinatal hepatitis B prevention program.
  4. Develop policies and mechanisms to have birthing hospitals routinely provide documentation of date/time and type of post-exposure prophylaxis administered to infants born to women with unknown HBsAg status to the newborn’s pediatrician and the perinatal hepatitis B prevention program and to provide results of HBsAg screening to program when results become available.
  5. Collaborate with birthing hospitals to develop policies or procedures for administering the first dose of hepatitis B vaccine to all infants born to HBsAg-negative women before hospital discharge or, for infants weighing less than 2,000 grams, at one month of age or hospital discharge, whichever comes first.

Reporting Requirements:

  • Annual Assessment of Progress toward Goals to Prevent Perinatal HBV Transmission

Suggested Performance Measures (target to be defined by awardee):

  • Change in number and/or percent of identified infants born to HBsAg-positive mothers that received HBIG and a dose of hepatitis B vaccine within 1 calendar day of birth.

Allowable funding sources:

317 FA Operations

 

c. Timely completion of doses two and three.

Suggested Activities:

  1. Develop mechanisms and implement reminder/recall of infants enrolled in the perinatal hepatitis B prevention program so that they receive all required vaccine doses of the hepatitis B vaccine series on schedule.
  2. Develop and implement protocols to actively follow up with families that do not receive the full hepatitis B vaccine series according to the most current ACIP-recommended childhood immunization schedule.
  3. Develop and implement mechanisms to ensure that the perinatal hepatitis B prevention program receives documentation of administration date (mm/dd/yyyy) for all hepatitis B vaccine doses administered to identified infants born to HBsAg-positive women.

Reporting Requirements:

  • Annual Assessment of Progress toward Goals to Prevent Perinatal HBV Transmission

Suggested Performance Measures (target to be defined by awardee):

  • Change in number and/or percent of identified infants born to HBsAg-positive mothers that received HBIG and a dose of hepatitis B vaccine within 1 calendar day of birth and completed a 3-dose hepatitis B vaccine series by 12 months of age.

Allowable funding sources:

317 FA Operations

 

d. Post-vaccination serology.

Suggested Activities:

  1. Identify contributing factors that prevent infants from obtaining post-vaccination serologic testing (PVST) within the ACIP-recommended testing and time frame.
  2. Develop and implement action plan to reduce or eliminate identified factors within the program’s control that prevent infants from obtaining timely PVST.
  3. Identify, contact, and collaborate with other entities that may be able to reduce or eliminate identified factors outside program control that prevent infants from obtaining timely and appropriate PVST.
  4. Develop and implement mechanisms to remind/recall infants enrolled in the perinatal hepatitis B prevention program to receive PVST when due.
  5. Develop and implement protocols to actively follow up with families of infants that do not obtain PVST according to the ACIP recommendations.
  6. Develop and implement protocols to close infants to PHBPP services with PVST results that report the infants are protected against hepatitis B infection.
  7. Develop and implement protocols to actively follow up with families of infants with PVST results that indicate infants remain susceptible to hepatitis B infection to revaccinate infant with 2nd hepatitis B vaccine series and receive PVST after the completion of the 2nd hepatitis B vaccine series.
  8. Develop and implement mechanisms to obtain and document date of infant’s PVST and results from appropriate sources (i.e., family, lab, health care provider, etc.).

Reporting Requirements:

  • Annual Assessment of Progress toward Goals to Prevent Perinatal HBV Transmission

Suggested Performance Measures (target to be defined by awardee):

  • Change in number and/or percent of infants in birth cohort that complete PVST by end of reporting period.

Allowable funding sources:

317 FA Operations

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