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. The intent of this resource is to assist with your COVID-19 vaccine administration efforts and to provide associated risk management considerations.
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 interim clinical considerations, provider requirements and support, guidance for talking with vaccine recipients, and COVID-19 tracking and reporting systems. Be sure to review and understand the vaccine-specific product information for any and all of the COVID-19 vaccines you plan to administer.
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. While initially the expedited COVID-19 vaccine development process made this somewhat more complicated, the safety of COVID-19 vaccines is better understood now that hundreds of millions of doses have been administered. 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. 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 over time. A specific follow-up process should be in place to ensure patients receive additional doses 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 a recommended additional 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: Vaccine Recipient Education
Resources for healthcare providers and staff
- FDA: COVID-19 Vaccination Information
Updates on vaccine authorization, eligibility and other vaccine news
- Healthgrades: State-by-State COVID Vaccine Guide
State specific vaccine resources include vaccine locations
- U.S. Department of Health and Human Services (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