The unprecedented COVID-19 global pandemic has challenged healthcare professionals to balance the health and safety of the public while meeting the care needs of patients. Looming concerns regarding the associated medical professional liability risks have provided additional strain during this time. COVID-19 vaccinations provide a glimmer of hope for the future, yet also present their own set of unique challenges. The intent of this resource is to assist with your COVID-19 vaccine administration efforts and to provide associated risk management recommendations.
Vaccine Administration Considerations
The CDC offers basic Vaccine Administration Guidance applicable to all vaccines. It is important to ensure that your existing policies and procedures for vaccine administration are up to date, and that they contain these basic elements. The CDC also offers COVID-Specific Vaccine Guidance that outlines basic considerations necessary to have a successful vaccination program including healthcare provider training, vaccine provider identification, tracking, storage and handling, recipient education, and safe vaccination setting.
Multiple vaccine candidates are in various stages of approval. Since each of these vaccines is unique, recommendations for administration, storage and handling, reporting, and patient education will vary. Be sure to review and understand the vaccine specific information for any and all of the COVID-19 vaccines you plan to administer.
Prioritization of vaccine administration is crucial to protect the supply chain. The CDC’s Advisory Committee on Immunization Practices (ACIP) is largely responsible for these recommendations and has initiated a phased approach. It is important to understand the fluidity of this situation as the FDA continues to authorize or approve additional COVID-19 Vaccines. You can stay abreast of these recommendations through the CDC.
Post-Administration Monitoring and Follow-up
Providing patient education on known vaccination side effects and established risks is a common step in the vaccine administration process. The expedited COVID-19 vaccine development process makes this somewhat more complicated. You should be prepared to answer more challenging questions from patients related to the unknown. Consider taking an informed consent process approach, in which both the known risks and intended benefits of the vaccine are outlined, and honestly address what is known regarding long-term risks or delayed adverse reactions. You may wish to provide additional education on the v-safe after vaccination health checker, which is intended to assist efforts in monitoring vaccine safety. Since a second vaccine dose may be required and multiple vaccines may ultimately be available at that time, it is imperative that patients understand the importance of knowing which vaccine they were given. You may wish to provide them with more than one copy of their vaccine information or provide detailed instructions and encouragement to use the safe smartphone-based tool which stores their vaccine information and will remind them when and if a second dose is required. A specific follow-up process should be in place to ensure patients receive a second dose when necessary. Be sure to document the patient education process in detail, just as you would document any informed consent discussion. In the event the patient refuses to return for their second vaccine dose, be sure they are educated on and understand the risks. Document this just as you would document any informed refusal discussion.
Legal Immunity and Coverage Issues
The Public Readiness and Emergency Preparedness (PREP) Act is intended to provide some immunity from liability for claims resulting from the administration or use of countermeasures to diseases. The noted exception is a cause of action for death or serious physical injury caused by willful misconduct. The COVID-19 PREP Act declaration liability protections are in effect with respect to the Recommended Activities under the Act and there have been Amendments. While this may prove helpful in certain scenarios, it is important to establish a COVID-19 Vaccination Program based on CDC and ACIP recommendations centered on patient safety with well-documented informed consent and refusal processes.
- CDC: COVID-19 Vaccination Communication Toolkit
Educational materials about COVID-19 For patients and staff
- FDA: COVID-19 Vaccination Information
Updates on vaccine authorization and other vaccine news
- Healthgrades: State-by-State COVID Vaccine Guide
Links to state health department web pages outlining vaccine allocation, distribution, and administration
- HHS: HIPAA, COVID-19, and the Workplace
An overview of how the HIPAA Privacy Rule impacts vaccine status inquiry of patients, visitors, and staff.
- NORCAL Group: Informed Consent and Refusal Resource
Informed consent risk management strategies and recommendations that can be used to facilitate the vaccination process
- NORCAL Group: COVID-19 Immunization Coverage Updates
Answers to policyholder and partner frequently asked questions about coverage and other issues related to the COVID-19 Pandemic
- NORCAL Group: Non-COVID-19 Vaccination Compliance During the Pandemic
Risk management recommendations for general vaccinations, including resources for planning vaccinations clinics at satellite, temporary, or off-site locations