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Unit A: Program Stewardship and Accountability

Immunization Program Operations Manual (IPOM)

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Enhance stewardship and accountability for all publicly purchased vaccine and VFC and Section 317 funding.

 

Overview

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. Currently, the VFC program supports the purchase of over $3.7 billion in vaccines each year. Because the VFC program is need-based, strong accountability and program stewardship are essential to maintaining a strong VFC program.

In addition, accountability for funding provided through Section 317 is equally important. The utilization of 317 funding for vaccine purchase can affect the integrity of VFC vaccine use. If an awardee plans for more than it can afford with 317 or state/local funds, that could jeopardize the appropriate use of VFC funding. Therefore, awardees need a clear understanding of the costs for serving populations with Section 317 funding as decisions about awardee vaccine financing policies are made. CDC has developed tools to assist in calculating the populations to be served.

This unit outlines a number of elements important to ensuring program stewardship and accountability. To be accountable for vaccine funds, it is important for an awardee to confirm the affordability of its vaccine finance policy and to have clearly examined the populations to be served. Awardees must also develop and keep up-to-date spend plans, based on awardee population estimates and other planning tools. Timely vaccine replenishment, maintaining the integrity and visibility of federal vaccine, proper storage and handling, and return of FET-eligible vaccines all ensure that inventory is appropriately tracked, accounted for, and utilized. Working with VFC-enrolled providers to conduct site visits and ensure compliance with VFC requirements and assuring that 317-funded vaccine is not provided on a routine basis to fully insured individuals are additional ways to demonstrate appropriate program stewardship.

 

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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Required Awardee Objective: A-1

Assure the affordability of the vaccine finance policy and update when budget, target populations, or vaccine recommendations change.

 

Required Activities:

  1. Annually submit Population Estimates Survey (PES) and Cost and Affordability Tool (CAT) based on guidance from CDC.
    • Annually obtain state-level Medicaid and separate CHIP (S-CHIP) [if applicable] enrollment data and submit to CDC according to the prescribed timeline for inclusion into the PES.
    • Review pre-populated data provided by CDC.
    • Provide additional data or alternative data sources for consideration for inclusion in the PES, as needed and appropriate, including population data or other data based on CDC guidance for delegation of authority.
  1. Submit updated PES and/or CAT whenever a change in funding or a change in population served occurs.
  2. Review and analyze vaccine purchases monthly and compare doses ordered to provider level data, making changes to the PES and/or CAT as needed.
  3. Provide updated data for PES as necessary.

Reporting Requirements:

  • Submission of PES data annually.
  • Submission of CAT annually

Required Performance Measures:

  • PES data submitted.
  • CAT submitted.

Allowable funding sources:

317 FA Operations, VFC Operations

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Required Awardee Objective: A-2

Maintain up-to-date vaccine spend plan.

 

Required Activities:

  1. Review spend plan monitoring, replenishment, and missing spend plan reports on a monthly basis.
  2. Review monthly spend plan update message sent by CDC to all awardees via email to provide guidance on required spend plan revisions.
  3. Make necessary spend plan changes based on reports review and the guidance in the monthly spend plan update message.
  4. Correct missing spend plans before CDC’s month end closing process; the awardee’s vaccine advisor will make adjustments to any missing spend plans that are not corrected to attribute the orders to 317 funding.
  5. Participate in periodic conference calls or meetings regarding spend plan with Vaccine Advisor/Project Officer.

Reporting Requirements:

  • Submit an updated spend plan each month as an acknowledgement that the spend plan is up-to-date and reflective of intent, whether changes have been made or not, by the date required by CDC..
  • Correct missing spend plan each month.
  • Participate in periodic conference calls or meetings regarding spend plan with Vaccine Advisor/Project Officer.

Required Performance Measures:

  • Percent of monthly updates submitted by the CDC-requested deadline.
    • Target = 100%
  • Percent of total vaccine budget (dollars) by vaccine by month for which missing spend plans exist.
    • Target = 0%

Allowable funding sources:

317 FA Operations, VFC Operations

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Required Awardee Objective: A-3

Accomplish replenishment of federal vaccine inventory by the end of each federal fiscal year (September 30); this applies only to awardees who distribute vaccines purchased with state and/or local funds.

 

Required Activities:

  1. Review replenishment report at least monthly.
  2. Submit bulk replenishment vaccine orders on a monthly or quarterly basis. (Note: S-CHIP replenishments should be made separately and at least quarterly. See Objective A-5.)

Reporting Requirements:

  • Awardees must enter bulk replenishment orders into VTrckS, including those orders placed on the CDC contracts and those placed via outside purchase mechanisms. Orders placed via outside purchase mechanisms will only be sent to CDC’s centralized distributor for receiving purposes. Actual communication of the order to the vendor will remain the responsibility of the awardee and will take place outside of VTrckS.
  • When entering an awardee purchase order number for a bulk replenishment order in VTrckS, awardees must always use a valid awardee purchase order number rather than a placeholder.

Required Performance Measures:

  • Percent of vaccine doses replenished to federal inventory by the end of the federal fiscal year (September 30).
    • Target = 100%

Allowable funding sources:

317 FA Operations

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Required Awardee Objective: A-4

For those awardees that purchase vaccines on behalf of a separate Child Health Insurance Program (S-CHIP), accomplish replenishment of S-CHIP (where applicable) vaccine inventory quarterly.

 

Required Activities:

  1. Review replenishment report at least monthly.
  2. Submit bulk replenishment vaccine orders on at least a quarterly basis and report S-CHIP vaccine replenishment orders on the VPET sent quarterly.

Reporting Requirements:

  • Awardees must enter bulk replenishment orders into VTrckS, including those orders placed on the CDC contracts and those placed via outside purchase mechanisms. Orders placed via outside purchase mechanisms will only be sent to CDC’s centralized distributor for receiving purposes. Actual communication of the order to the vendor will remain the responsibility of the awardee and will take place outside of VTrckS.
  • Awardees must submit all CDC contract bulk replenishment orders into VTrckS and must submit information about (1) all bulk orders purchased on the CDC contracts and (2) all bulk orders placed via outside purchase mechanisms using the most current version of the "State- and 317 FA-Funded Bulk Order Spreadsheet."
  • When entering an awardee purchase order number for a bulk replenishment order in VTrckS, awardees must always use a valid awardee purchase order number rather than a placeholder.

Required Performance Measures:

  • Percent of vaccine doses replenished to federal inventory by the end of the federal fiscal year (September 30).
    • Target = 100%

Allowable funding sources:

317 FA Operations

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Required Awardee Objective: A-5

Support the integrity and visibility of the federal inventory by complying with NCIRD’s "Policy Regarding Awardee-supported Vaccine Depots" (published September 2009, available in the "Centralized Vaccine Distribution Guide," and shown below).

 

Required Activities:

  1. Ensure all appropriate staff are familiar with this policy and its implication for immunization programs.

Reporting Requirements:

  • Complete questions related to depot activities in the Program Annual Report and Progress Assessments – Vaccines for Children Program Management Survey.

Required Performance Measures:

  • Compliance with the provisions of NCIRD’s "Policy Regarding Awardee-supported Vaccine Depots" (Y/N)
    • Target = Yes

Allowable funding sources:

317 FA Operations

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NCIRD Policy Regarding Awardee-supported Vaccine Depots
Effective September 1, 2009

This document describes and clarifies NCIRD’s existing policy regarding awardee distribution activities and depots, which applies to all but a small number of awardees who have specific distribution requirements based on unique geographic considerations (the Pacific Island awardees and Alaska). Previously, one component of this policy (the use of FA operations funding to support distribution activities following transition to centralized distribution) has been included in discussions with awardees, but not presented as a written policy. A second key component, the requirement that federally-funded vaccine not be shipped to or redistributed from awardee-supported depots, has not been explicitly documented for awardees. The purpose of this document is to ensure that NCIRD’s policy regarding awardee-supported vaccine depots is clear and that all components are explicitly described.

The rationale for NCIRD’s policy regarding awardee-supported vaccine depots reflects a number of key factors, including: an imperative for NCIRD to make optimal use of limited operations funding; the fact that vaccines stored in awardee-supported vaccine depots are not insured against loss; a lack of federal visibility into available inventory and the inability to direct the distribution of federally-funded vaccine that is stored in awardee-supported vaccine depots; the anticipated reduction in the shelf life of operating inventory as portions of the federal vaccine stockpiles are transitioned to NCIRD’s centralized vaccine distributor; and the increased difficulty in managing a central vaccine inventory in the face of large, unanticipated orders for awardee-supported depots that may deplete federal operating inventory and compromise the ability to fill routine provider orders.

  1. All non-direct ship vaccine doses purchased through CDC’s federal vaccine purchase contracts will be distributed via CDC’s centralized distributor.
  2. Section 317 and VFC funding cannot be used to support distribution activities, including purchase of equipment, lease of depot space, fuel costs, or a contract to support distribution services. In addition, awardee staff supported with 100% federal funding cannot participate in redistribution activities. The only exceptions are Alaska and the Pacific Island awardees.
  3. Awardee-supported depots shall not redistribute vaccine purchased with federal funds (i.e., VFC and 317 funds). Where state-funded vaccine has been included in a awardee’s spend plan, the awardee may place orders to have this vaccine shipped to awardee-supported depots for further distribution, so long as the amount of vaccine sent to awardee-supported depots does not exceed the state-funded doses included in the spend plan.
  4. Under centralized distribution, provider orders that include federally-funded vaccine shall only be sent to immunization providers who administer vaccine, not to depots for further distribution.
    1. A provider is defined as an individual or entity that administers the vaccine it receives to patients, either at the site the vaccine is received or at an alternative site where federally-funded vaccine is not routinely stored during non-clinic hours and to which the recipient of the order takes the vaccine and then administers it to patients.
    2. Any provider who stores federally-funded vaccine during non-clinic hours should place orders independently, using a unique PIN number. Such provider sites should have an individual who is responsible for proper vaccine storage and handling on site.
    3. In the case of emergency situations such as outbreaks or following unintentional over-orders or over-shipments of vaccine, redistribution of vaccine doses is permitted and supportable with FA operations funding, but provider orders that contain federally-funded vaccine should not routinely be placed with the intention of further redistribution to other immunization providers.

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Required Awardee Objective: A-6

Participate in the Federal Excise Tax Credit Program by ensuring that all FET-eligible vaccines are submitted for credit within six months of vaccine spoilage or expiry, with all returns entered into VTrckS.

 

Required Activities:

  1. Submit returns for all vaccines distributed via CDC’s centralized distributor back to the centralized distributor for returns processing. The only returns sent directly to the manufacturer are those not originally distributed through CDC’s centralized distributor.
  2. Ensure providers are educated about the returns process for publicly purchased vaccines.
  3. Ensure that provider returns are submitted to CDC’s centralized distributor within six months of expiration of product.
  4. Awardees must ensure that all provider returns are entered into VTrckS before returns are sent back to CDC’s centralized distributor. Awardees must make corrections in provider returns when vaccines physically returned do not match returns entered in VTrckS.

Reporting Requirements:

None.

Required Performance Measures:

  • Percent of returns entered into VTrckS.
    • Target = 100%

Allowable funding sources:

317 FA Operations, VFC Operations

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Required Awardee Objective: A-7

Assure that VFC-enrolled providers comply with VFC program requirements through performance of VFC compliance visits with enrolled providers every other year and other means as defined in the current VFC Operations Guide.

 

Required Activities:

  1. Conduct compliance visits to each enrolled VFC provider at least every other year (once every two years).
  2. Conduct and document provider site education, corrective actions, and appropriate level of follow-up for all provider sites found to be non-compliant with program requirements during the VFC compliance site visit. Follow the Non-compliance with VFC Provider Requirement Protocol outlined in the VFC Operations Guide when defining the level of follow-up necessary to address and resolve issues of non-compliance.
  3. Develop and implement education and training for VFC-enrolled providers to ensure that the VFC Program is implemented according to federal guidance. Topics for education and training must include (but are not limited to) appropriately screening for VFC eligibility to assure VFC vaccine is administered only to VFC-eligible children, proper storage and handling, and implementing appropriate vaccine management to improve vaccine accountability and minimize vaccine loss.
  4. Provide annual training for staff conducting VFC compliance site visits with periodic updates as program requirements change. Compare and use aggregate data collected from VFC compliance site visits and follow-up activities and the annual VFC Program Management Survey to improve the overall implementation of the VFC Program at the awardee and local levels.

Reporting Requirements:

  • Complete questions in the annual VFC Program Management Survey.
    • Number of VFC compliance site visits conducted.
    • Number of provider sites found to be non-compliant for each question on the VFC Site Visit Questionnaire associated with compliance and corrective action.

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

  • Percentage of active providers receiving VFC compliance site visits annually.
  • Percentage of provider sites receiving a VFC compliance site visit that are non-compliant for one or more high-priority questions on the VFC Site Visit Questionnaire.

Allowable funding sources:

317 FA Operations, VFC Operations, VFC/AFIX

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Required Awardee Objective: A-8

Assure proper storage and handling of federally purchased vaccine by program providers as defined in the VFC Operations Guide, Module 6 and the recommendations outlined in the CDC Storage and Handling Toolkit.

 

Required Activities:

  1. Track and report vaccine storage and handling incidents that result in vaccine loss, including reasons for and the number of doses involved in the loss. Use the following definitions for the purpose of tracking and reporting this activity:
    • Incident: At a minimum, any vaccine loss involving 10 or more doses. Awardees that are able to capture incidents involving fewer than 10 doses can include those incidents.
    • Vaccine loss: Vaccine that has expired, spoiled, or has been wasted.
    • Spoiled or expired vaccine: Non-viable vaccine in its original container (vial or syringe) that is able to be returned for excise tax credit. This includes expired vaccine or vaccine that has been spoiled as a result of temperature excursions.
    • Wasted vaccine: Non-viable vaccine that is not able to be returned for excise tax credit. This includes broken vials or syringes, unused vaccine drawn into a syringe, or remaining doses in a multi-dose vial.
    • Vaccine Storage and Handling Incident Categories (reasons for loss):
      • Damage due to power outage
      • Damage due to equipment failure
      • Damage due to human error
      • Expiration before use
      • Broken vials, unused vaccine drawn into a syringe, or remaining doses in a multi-dose vial
  2. Implement vaccine management and accountability policies.
    • Establish and implement policies regarding appropriate and acceptable equipment for vaccine storage and temperature monitoring. Minimum requirements are outlined in Module 6 of the VFC Operations Guide and overall CDC recommendations are outlined in the CDC Storage and Handling Toolkit.
    • Ensure all providers of federally-funded vaccines have written and up-to-date, routine and emergency storage and handling plans.
    • Develop and implement use of formal, written protocols for responding and providing corrective actions to provider sites involved in compromised cold chain or vaccine wastage/expiration/spoilage incidents. The protocol is a written general plan followed by the awardee immunization program for how the awardee manages incidents involving cold chain failure or vaccine loss.
    • Ensure that all provider returns for publicly-purchased, nonviable vaccines are entered into VTrckS and are submitted to CDC’s centralized distributor within six months of expiration/spoilage of product.

Suggested Activities:

  1. Evaluate effectiveness of vaccine management, storage, and handling education/ training provided to awardee immunization staff and to provider staff receiving federally-funded vaccine.
  2. Promote use of online resources to providers

Reporting Requirements:

  • Complete vaccine storage/handling and management questions in the VFC Program Management Survey annually.
    • Vaccine Loss (expired/spoiled/wasted)
      • Total doses distributed by vaccine type.
      • Total number of doses expired/spoiled/wasted by vaccine type due to improper storage and handling.
    • Vaccine Storage and Handling Incidents
      • For each vaccine storage and handling incident category (reason for loss), report (in aggregate) the number of vaccine storage and handling incidents resulting in vaccine loss, and the number of doses expired/spoiled and doses wasted. See sample reporting table below:
        Vaccine Storage and Handling Incident Category Number of Doses Expired/Spoiled Number of Doses Wasted
        Vaccine Return:
           
        Expired vaccine
           
        Failure to store properly upon receipt
           
        Mechanical failure
           
        Natural disaster/power outage
           
        Recall
           
        Refrigerator too cold
           
        Refrigerator too warm
           
        Spoiled
           
        Vaccine spoiled in transit (freeze/warm)
           
        Other
           
        Wastage:
           
        Broken vial/syringe
           
        Lost or unaccounted-for vaccine
           
        Open vial with doses not administered
           
        Vaccine drawn into syringe and not administered
           

Required Performance Measures:

  • Submission of reporting requirements in the VFC Management Survey.

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

  • Percentage of doses ordered by vaccine type that were expired/spoiled/wasted due to improper storage and handling.

Allowable funding sources:

317 FA Operations, VFC Operations, VFC/AFIX, VFC

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Required Awardee Objective: A-9

Implement a plan to assure that Section 317 vaccine is not provided on a routine basis to fully* insured individuals, including children covered by S-CHIP.

 

Required Activities:

  1. Implement policy and plan for routine use of 317-funded vaccine only for individuals who are not fully insured with respect to vaccine. Plan must adhere to guidance set forth in Appendix F, "Use of Vaccine Purchased with 317 Funds."
    • Require providers to screen out fully-insured individuals unless all vaccine support for fully-insured individuals is financed with state funding.

Reporting Requirements:

  • Cost Affordability Tool (CAT) submitted as required.
  • Spend Plan maintained and submitted as required.

Required Performance Measures:

  • 317-funded vaccine use policy developed and implemented.

Allowable funding sources:

317 FA Operations

*For purposes of this requirement, "fully insured" includes anyone with insurance that covers the cost of vaccine, even if the insurance includes a high deductible or co-pay, or if a claim for the cost of the vaccine and its administration would be denied for payment by the insurance carrier because the plan’s deductible had not been met.

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