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CDC Announces Changes to COVID-19 Vaccine Administration

In an effort to improve COVID-19 vaccine acceptance, CDC announced a 90-day Initiative utilizing sub-provider agreements for LTC providers to administer single-dose COVID-19 vaccines. In the CDC document Long Term Care Facilities Enrolling in CDC COVID-19 Vaccination Program 90-Day Initiative Using the Sub-Provider Agreement, Note that LeadingAge advocated for these efforts in their All-Hands-On-Deck Proposal that was jointly submitted with AHCA/NCAL to the CDC. LeadingAge Iowa outlined the requirements in the initiative document as well as the sub-provider agreement for members to quickly view. In addition, LeadingAge stated that the LTC pharmacy drop down list only contains 21 pharmacies.  HHS is aware of this and is working to correct the error. If members are unable to locate their pharmacy partner on the drop down list, please email Kellie or Shannon and this information will be passed onto LeadingAge.

Qualifications:

  • Long-term care providers who are already enrolled as vaccine providers should not complete the sub-provider agreement.
  • Long-term care providers must partner with one pharmacy enrolled as a COVID-19 Vaccine Provider to complete the sub-provider agreement. In the event that a LTC provider isn’t currently partnered with a COVID-19 Vaccine Provider, the provider could contact a currently enrolled pharmacy to inquire about willingness to participate in the initiative or contact state/local public health departments as a potential partner.

Notes:

  • The Pfizer-BioNTech COVID-19 vaccine is the only vaccine product/presentation available in a single-dose vial for this program.

Planning:

  • Review requirements outlined in the COVID-19 Vaccine Sub-Provider Agreement.
  • Be aware of state-specific requirements (such as training or data reporting requirements).
  • Assign a staff member(s) to lead the program.
  • Complete the online sub-provider agreement.
  • Determine staff roles and training needs.
  • Create plans to educate all staff of the importance of COVID-19 vaccination for residents and staff.
  • Encourage consistent messages emphasizing the importance of vaccination from all staff to residents, family members, and other visitors.

Sub-Provider Agreement Requirements:

  • The provider will order COVID-19 vaccines from the designated partner pharmacy for direct administration by designated staff to the residents or staff.
  • The provider will store, prepare and administer the COVID-19 vaccine in accordance with applicable requirements and recommendations of CDC and the ACIP.
  • Within 24 hours of administering a dose of COVID-19 vaccine, the provider will record the Vaccine Administration Data in the medical record and if required under state immunization information system (In Iowa, this would be IRIS).
  • Preserve vaccine recipient’s record for at least 3 years following vaccination (or longer if required by the state, local or territorial law). Records must be made available to any federal, state, local, or territorial public health department to the extent authorized by law.
  • Providers must not sell or seek reimbursement for COVID-19 vaccine, syringes, needles, or other constituent products and ancillary supplies that the federal government provides without cost.
  • The vaccine must be administered to the individual regardless of the individual’s ability to pay administration fees or coverage status. Organizations may seek appropriate reimbursement from a program or insurer that covers COVID-19 vaccine administration fees for the vaccine recipient.
  • Providers must conform with standard policies for obtaining consent including providing an FDA EUA Fact Sheet, FDA Vaccine Information Fact Sheet, or CDC Vaccine Information Statement as applicable, to each vaccine recipient, the adult caregiver, or other legal representative.
  • Providers must provide a completed CDC COVID-19 vaccination record card to every recipient, the adult caregiver, or other legal representative, or otherwise maintain the card in the resident’s records.
  • The Vaccine Provider (pharmacy partner) is authorized to provide the long-term care provider only single dose vials of COVID-19 vaccines. The long-term care provider must store and handle such doses under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with CDC requirements contained in the CDC Initiative document.
    • Option 1 – the partner pharmacy will store the vaccine until transported to the LTCF for immediate administration. The vaccine dose(s) must be stored between 46-77 degrees Fahrenheit for up to 12 hours. If the vaccine dose is not administered within 12 hours, the doses must be discarded.
    • Option 2 – the LTCF can store the vaccine. The vaccine must be stored between 36-46 degrees Fahrenheit for up to 10 weeks.  If not administered within 10 weeks, the vaccine must be discarded. If Option 2 is elected, the LTCF will identify staff who will read and record storage unit temperatures each workday, monitor inventory weekly, and order more vaccine as needed.
    • Notes on storage: The provider must complete and submit the sub-provider agreement at https://protect-ows.hhs.gov/secure-upload/forms/hiffl4creafa4uk4qpvorelbns prior to administering any COVID-19 vaccine.
      • A “dormitory-style” unit CANNOT be used, even for temporary storage. These units have a single exterior door and an evaporator plate/cooling coil, usually located in an icemaker/freezer compartment and are a significant risk for out-of-range storage temperatures.
      • Food or drink cannot be stored in the vaccine storage unit.
      • A digital data logger (DDL) must be used to monitor the storage unit temperature.
      • Storage unit temperatures must be read and recorded at least once each workday.
      • Store the vaccine at appropriate temperatures and monitor beyond-use times/dates if applicable.
      • Vaccine must be transported following the manufacturers and CDC’s guidance.
      • Document and report expired or wasted vaccine.
      • All temperature excursions must be documented, and appropriate actions taken.
    • The provider must report moderate and severe adverse events following vaccination to the VAERS website as required by CDC. Reporting requirements can be found at https://vaers.hhs.gov/reportevent.html.
    • The provider consents to site visits by jurisdictions and CDC for quality assurance purposes, and consents to release Vaccine Administration Data to CDC upon request.
    • Unless extended by CDC, the agreement will terminate on March 15, 2023.

LeadingAge Iowa also reached out to Iowa HHS regarding this initiative for clarification.  Providers who submit a sub-agreement to CDC are not required to complete additional Iowa Vaccine Provider Agreements to be in compliance. Iowa HHS indicated that the partner pharmacy that is enrolled as a vaccine provider would be required to report to IRIS, however, this may want to be discussed when planning with the partner pharmacy to ensure that reporting is completed. If providers have questions related to COVID-19 vaccines, they can reach out to Iowa HHS at 1-800-831-6293 extension 1 or [email protected].  In addition, Iowa HHS has COVID-19 vaccine information on their website at https://idph.iowa.gov/emerging-health-issues/novel-coronavirus/vaccine.