State health officials have begun distributing COVID-19 vaccines across the state, based on guiding principles that prioritize essential health care workers and vulnerable populations.
There are numerous requirements and steps physicians and health care facilities must adhere to in order to administer vaccines.
Below are 10 things to know about administering the vaccines that have received an EUA from the FDA so far.
- State Registries: In order to administer a vaccine, you must be enrolled in Texas' immunization registry, ImmTrac2. Enrollment in ImmTrac2 is part of the registration process at EnrollTexasIZ.dshs.texas.gov.
- Ordering and Inventory: You will be required to submit requests, accept your allocation, and report inventory for the COVID-19 vaccine via the Texas Vaccine Allocation & Ordering System (VAOS). Be sure to check your email spam folder and accept your allocation within 48 hours. Resources:
- Records and Reporting: You will need to report patient information for each vaccine administered to ImmTrac2 within 24 hours of administration. COVID-19 vaccination records must be preserved for at least three years following vaccination, and will need to be made available to any federal, state, local, or territorial public health department to the extent authorized by law. You also need to submit a daily report of the doses administered into the Texas Department of Emergency Management (TDEM) Therapeutics and Vaccine Reporting Portal and report any unused or wasted doses specifically into VAOS.
- Payment: You cannot sell or seek payment for COVID-19 vaccine and any accompanying supplies provided free by the federal government. Administration fees may be applied; however, you must administer the vaccine regardless of whether the recipient can pay the fees. If you are enrolled in Medicare or plan to enroll to administer the vaccine, you need to keep up to date on coding, billing, and payment requirements from CMS.
- Temperature Monitoring: You must have a digital data logger to closely monitor and record the refrigerator and freezer temperatures that store the COVID-19 vaccine. These records must be preserved for at least three years. Find more information on the requirements of digital data loggers on the DSHS website.
- Ancillary Supplies: COVID-19 vaccine shipments will come with all ancillary supplies, including needles, syringes, alcohol prep pads, surgical masks, face shields, diluent (if applicable), and COVID-19 vaccination record cards for patients. For the Pfizer/BioNTech vaccine, you may receive these supplies in a separate shipment.
- Time Limitations: The vaccines come in multi-dose vials and need to be completely used within a limited period of time after the vial is removed from the refrigerator or freezer. The Pfizer/BioNTech vaccine requires reconstitution with saline. More details on administration, dilution (if applicable), and time limitations are available in these Pfizer/BioNTech, Moderna, and Janssen/Johnson&Johnson fact sheets.
- Patient Education: Before you give the shot, you have to provide to the patient an approved Emergency Use Authorization (EUA) fact sheet or vaccine information statement (VIS). Here are the current EUA fact sheets for recipients of the Pfizer/BioNtech, Moderna, and Janssen/Johnson&Johnson vaccines. After the first dose, you must give your patient a COVID-19 vaccination record card, which is included in your vaccine shipment. For Pfizer/BioNtech and Moderna, the card is to ensure the first dose and second dose are from the same vaccine manufacturer. If the patient’s card is lost, you can look up which first dose the patient received in ImmTrac2. You cannot give a patient doses from different vaccine manufacturers.
- Safety: You must administer a COVID-19 vaccine in accordance with all requirements and recommendations of CDC and CDC’s Advisory Committee on Immunization Practices (ACIP). Here are the ACIP’s recommendations for the Pfizer/BioNTech,Moderna, and Janssen/Johnson&Johnson vaccines, as well as CDC’s Interim Considerations for Use of mRNA COVID-19 Vaccines.
- Adverse Events: You must input any moderate and severe adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). Note that you should report adverse events only to VAERS, which is co-managed by the CDC and the U.S. Food and Drug Administration (FDA). You also must promote to recipients V-Safe, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins. Resources: safe Provider Information Poster (PDF) safe Information Sheet (PDF)
CDC also has published Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites.
Find more tools, resources, and information on TMA’s COVID-19 Resource Center, which is continually updated.
Last Updated On
March 05, 2021
Originally Published On
December 23, 2020