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PANDEMIC: COVID-19 RESOURCES & UPDATES

COVID-19 Vaccination: Risk Management Recommendations

Posted/Updated on 5/17/21 11:00 AM

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. Additionally, the CDC has compiled each state’s interim playbook outlining their phased operational vaccination response plan.

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 VAERS reporting process and the v-safe after vaccination health checker, which are both 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 V-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.

Additional Resources

Topics: COVID-19, Vaccine, Vaccination

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The information provided on this site offers risk management recommendations and resource links. Guidance and recommendations contained in this website are not intended to determine the standard of care, but are provided as risk management advice only. The ultimate judgment regarding the propriety of any method of care must be made by the healthcare professional. The information does not constitute a legal opinion, nor is it a substitute for legal advice. Legal inquiries about this topic should be directed to an attorney. NORCAL Group makes no representation regarding compliance with state or federal law by offering these resources. These documents and links are provided for your convenience and reference only, and the provision of these materials does not mean NORCAL Group is affiliated or associated with these organizations.