Long Term Care Facilities Enrolling in CDC COVID-19 Vaccination Program 90 Day Initiative Using the Sub-Provider Agreement
The Centers for Disease Control and Prevention (CDC) greatly appreciates your organization’s participation in the CDC COVID-19 Vaccination Program. A major goal of this program is to improve vaccine uptake in long term care facilities (LTCF). LTCFs should reach out to their enrolled pharmacy provider or local health department to facilitate vaccination in their facilities. LTCFs that are not partnered with an enrolled pharmacy or local health department to conduct on-site vaccination clinics, and are unable to do so through the existing CDC COVID-19 Vaccination Program, may choose to participate in the program through a sub-provider agreement. This sub-provider Agreement is only for use by long term care facilities (LTCF) not already enrolled as full providers in the CDC COVID-19 Vaccination Program that wish to access single dose vial COVID-19 vaccine through enrolled pharmacy providers for direct administration by the LTCF to their residents and staff. These LTCFs should reach out to a select enrolled pharmacy provider to discuss intentions to participate in the COVID-19 Vaccination Program as a sub-provider prior to submitting a sub-provider Agreement. This Agreement is interim and valid through March 15, 2023, unless extended by CDC.
NOTE: Pfizer-BioNTech COVID-19 Vaccine for people 12 years of age and older in single-dose vials is the ONLY vaccine product/presentation available in this program.
To qualify for this program, the LTCF:
- Must partner with a designated pharmacy enrolled as a COVID-19 Vaccine Provider
- Cannot be a regular fully enrolled COVID-19 Vaccine Provider
General Planning
- Review requirements outlined in the COVID-19 Vaccine Sub-Provider Agreement.
- Be aware of any state-specific requirements, e.g., training or data reporting requirements.
- Assign a staff member(s) to lead the program.
- Identify a pharmacy provider.
- Your pharmacy provider must be currently enrolled as a COVID-19 Vaccine Provider.
- If your facility does not have a pharmacy provider, contact:
- A local, currently enrolled pharmacy to see if they would be willing to participate or
- The immunization program at your state/local health department for potential partners.
- Identify the point of contact for your pharmacy provider.
- Complete and submit the online sub-provider agreement, and download a copy for your records.
- Share the following information with your pharmacy provider:
- Contact information for the LTCF responsible official, and other LTCF leads.
- 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.
- Any long term care facility that receives COVID-19 vaccine from a COVID-19 Vaccine Provider Pharmacy must be enrolled in CDC’s COVID-19 Vaccination Program 90 Day Initiative using the Sub-Provider Agreement for Long Term Care Facilities.
- All staff who receive, handle, manage, prepare, or administer vaccine must be fully trained on storage, handling, preparation, and administration requirements for COVID-19 vaccine as applicable to the individual’s role.
Storage and Handling
- Review the storage and handling guidance for Pfizer-BioNTech COVID-19 vaccine (gray cap, single-dose vial) for persons 12 years of age and older.
- Determine where the vaccine will be stored. There are 2 options:
- Option 1: At the partnering pharmacy until transported to the LTCF for immediate administration.
Create a process with your pharmacy partner for obtaining:Initial supply of vaccine and CDC COVID-19 vaccination record cards.Follow the manufacturer’s and CDC’s guidance on transporting the vaccine.
Additional doses of vaccine and record cards as needed.
Identify staff who will:Contact your pharmacy partner and order COVID-19 vaccine.
Accept the vaccine delivery from the pharmacy, check for the correct number of doses, and monitor applicable beyond-use times.Pfizer-Bio-NTech COVID-19 vaccine (gray-capped single-dose vials) can be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours. If not administered within 12 hours, the vaccine must be discarded. - Option 2. At the Long Term Care Facility.
Follow the manufacturer’s and CDC’s guidance on storing the vaccine.
Create a process with your pharmacy partner for obtaining:
Initial supply of vaccine and CDC COVID-19 vaccination record cards.Assess for storage equipment needs.
Additional doses of vaccine and record cards as needed.Pfizer-BioNTech COVID-19 vaccine (gray-capped single-dose vials) may be stored between 2°C and 8°CIdentify staff who will:
(36°F and 46°F) for up to 10 weeks. If not administered within 10 weeks, the vaccine must be discarded.Read and record storage unit temperatures each workday.
Monitor inventory weekly.
Order more vaccine, as needed.
- Option 1: At the partnering pharmacy until transported to the LTCF for immediate administration.
- Establish a process for training appropriate staff on vaccine storage and handling practices.
- Determine a process to identify, manage, and report vaccines exposed to out-of-range temperatures.
- Determine 3-year record retention protocols for vaccine storage documentation including expired or wasted vaccine.
- Vaccine storage unit must be able to maintain the appropriate temperatures.
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 the appropriate temperatures and monitor beyond-use times/dates if applicable.
- Vaccine must be transported following the manufacturer’s and CDC’s guidance
- Document and report expired or wasted vaccine.
- All temperature excursions must be documented, and appropriate actions taken.
Vaccine Administration
- Review Pfizer-BioNTech COVID-19 Vaccine clinical materials including modules, videos, and job aids.
- Pfizer-BioNTech COVID-19 Vaccine • Preparation and Administration Summary (cdc.gov)
- Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC
- COVID-19 Vaccine Interim COVID-19 Immunization Schedule for 6 Months of Age and Older (cdc.gov)
- COVID-19 Vaccine Training Modules (cdc.gov)
- COVID-19 Vaccine Administration Module (cdc.gov)
- Establish a process for training appropriate staff on vaccine administration practices.
- Establish standing orders, if applicable.
- Assess for needed injection supplies.
- Establish a process to remind staff administering vaccine when a resident’s dose is due.
- Develop emergency protocols and assess for any needed emergency supplies.
- Determine a process to provide the appropriate FDA Recipient Vaccine Information Fact Sheet to vaccine recipients or designated guardian.
- Use the prevaccination checklist and guidance to screen for contraindications and precautions.
- Identify a designated area to prepare the vaccine.
- Establish a process to monitor beyond-use times (12 hours) for vaccine stored between 8°C to 25°C (46°F to 77°F).
- Document the vaccine in the recipient’s medical record and CDC COVID-19 vaccination record card.
- Determine how vaccine adverse events and vaccine administration errors will be reported to the Vaccine Adverse Event Reporting System.
- Vaccine must be prepared and administered following the manufacturer’s and CDC’s guidance.
- COVID-19 vaccine must be administered regardless of an individual’s ability to pay and regardless of their insurance coverage status, and do not seek any reimbursement from the recipient or recipient’s family. May seek appropriate reimbursement from a program or insurer that covers COVID-19 vaccine administration fees for the vaccine recipient.
- Distribute the current, corresponding Recipient/Caregiver FDA Vaccine Information Fact Sheet(s) (hard copy or electronically) prior to each COVID-19 vaccine dose administered.
- Document administered doses on a CDC COVID-19 vaccination record card and in the recipient’s medical record within 24 hours of administration.
- Vaccine administration errors must be reported to the Vaccine Adverse Event Reporting System (VAERS).