Do all eligible providers need to complete the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training Modules in order to be eligible to administer the vaccine? Does the PREP Act Declaration’s requirement that all providers take the CDC COVID-19 Vaccine Training Modules apply to providers administering COVID-19 vaccines in a jurisdiction where they are licensed? Does it only apply to providers practicing in jurisdictions where they do not have licensure or practice authority under an interstate compact such as the Nurse Licensure Compact?
The requirement for the CDC training is specific to professions added to the list of qualified persons under the seventh amendment. It is aimed at groups who may not administer intramuscular (IM) injections or vaccines as a routine part of their practice, who have retired, or are students. Thus, physicians who routinely prescribe, dispense, and administer vaccines under their license would not need to stop vaccinating and take the CDC training, nor would non-traditional providers who are already authorized by their state and who received state training. However, if a state, tribe, or territory chooses to use providers listed in the seventh amendment using the PREP Act declaration as the authority for these providers, the CDC training is required.
Some states require vaccinators to take a state-specific training course in order to be eligible to administer COVID-19 vaccines. Are these types of state requirements that are in addition to the PREP Act Declaration/amendments requirements considered to “effectively prohibit” a potential vaccinator from administering COVID-19 vaccines? If so, does HHS plan to clarify the PREP Act’s authority with states that have these requirements?
The seventh PREP Act amendment indicates that states, tribes, and territories may add training requirements.
Regarding the CDC COVID-19 Vaccine Training Modules, is there additional guidance available as to the meaning or implementation of “documentation” and “observation period” as the terms are utilized in the Declaration? What would be the minimal observation period and documentation requirement?
HHS defers to the states, tribes, and territories to determine the best method for documenting compliance with requirements stated in the declaration.
Why must all personnel administering the COVID-19 vaccine be skilled and qualified to perform CPR?
In case of an adverse event, HHS wants to ensure that staff who are CPR trained are available. Because of the variety of venues, from mass vaccination clinics to small operations, vaccinators need to have the requisite skills to deal with any adverse events immediately. The intent is to avoid any possible delay in care due to a centralized, but physically distant CPR trained individual or group, time required to call for assistance, or in the unlikely event of simultaneous medical emergencies or adverse events.
There are many types of Cardio-Pulmonary Resuscitation (CPR) courses (CPR, CPR + basic first aid, CPR + AED, etc.). What type of CPR training satisfies the requirements?
This requirement is satisfied by, among other things, a certification in basic CPR by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education, or the Accreditation Council for Continuing Medical Education. The PREP Act declaration only requires basic CPR and not the other associated trainings. It also does not specify in-person or virtual, so this determination is at the discretion of the professional and the organization or agency the individual will be working under in their vaccinator role. Since there is no uniform CPR training required of all states, the decision is left up to the jurisdiction where the individual will be performing their duties. If the individual meets the requirement within the PREP Act and that of the requirement of the state where they are performing the vaccinator duties, they are covered.
Does HHS have a list of suggested CPR training providers?
HHS does not maintain a list of CPR training providers.
Do I have to attend an in-person CPR training to meet the requirements of the PREP Act?
The PREP Act declaration does not specify whether the CPR training must be in-person or virtual, so this determination is at the discretion of the professional and the organization or agency the individual will be working under in their vaccinator role.
For clarification, the Accreditation Council for Pharmacy Education (ACPE) accreditation standards for pharmacy programs indicate that all graduates must be properly trained for vaccine administration but doesn't technically approve those certification programs. Programs that are used by the schools, including the CDC recognized American Pharmacists Association (APhA) Pharmacy-Based Immunization Delivery certificate training program which many schools do use, satisfies the provisions of the amendment – correct?
The declaration allows schools to determine the appropriate level of training for students.
Can one health care professional provide supervision to another type of health care professional (i.e., can an RN supervise a pharmacy intern in a vaccination clinic)?
The declaration does not address supervisory requirements of one specific licensed profession over another. Newly covered healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering IM injections, and for whom administering IM injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student. Supervision for covered students should be provided by a currently practicing healthcare professional experienced in administering IM injections.
Where is the documentation to be housed or presented as meeting requirements to participate?
HHS defers to states, tribes, and territories regarding maintenance of documentation.
Regarding supervisory requirements, if the supervisor can vaccinate as part of their license, is that the same criterion as being “experienced” in IM injections?
Yes, if an individual is licensed to provide IM injections within the current scope of practice, this qualifies as “experienced.”
What type of just in time training is required for people who don’t do IM injections? Why are pharmacists called out specifically for training? Why not leave that to the states?
Newly covered healthcare professionals and students must have documentation of completion of the CDC COVID–19 Vaccine Training Modules and, if applicable, such additional training as may be required by the state, territory, locality, or tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines. The declaration allows schools to determine the appropriate level of training for students. Newly covered healthcare professionals and students must also have documentation of an observation period by a currently practicing healthcare professional experienced in administering IM injections, and for whom administering IM injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student. Pharmacist training requirements were established in the third PREP Act amendment that authorized pharmacists to prescribe, dispense, and administer both COVID-19 vaccines and Childhood vaccines. Training requirements for pharmacists are specific to the practice of pharmacy to support that broader authorization. (See
Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act; Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing).