Updated January 7, 2020: As healthcare providers prepare to distribute COVID-19 vaccines, many face questions regarding best practices for vaccine administration, as well as documentation. Answers to the frequently asked questions below will help your practice protect patients and staff while mitigating liability risks.
- What possible malpractice risks do I face in providing the COVID-19 vaccine?
- Numerous states have granted healthcare providers and facilities limited temporary protections from liability for treatment provided in relation to the public health emergency, and the U.S. Department of Health and Human Services expanded the scope of the PREP Act immunity to potentially cover more healthcare providers who administer the vaccine or where not administering a vaccine is a covered countermeasure for certain individuals. However, patients can still make claims. Based on previous vaccination-related claims, the following are some potential risk scenarios:
- Due to lack of follow-up by the medical practice, a patient misses their second dose, contracts the virus, experiences an adverse event, and files suit.
- A patient who isn’t adequately monitored after being given the vaccine faints and is injured in the fall or experiences an allergic reaction.
- No informed consent is obtained, and the patient experiences a severe complication, interfering with their ability to work. The patient states they would never have had the injection had they known of the potential complications.
- Informed refusal is not obtained, and the patient then claims they were unaware of the risks of not taking the vaccine. The Doctors Company provides a Refusal to Consent to Treatment, Medication, or Testing form.
- How can I reduce the chance of a malpractice suit when administering the COVID-19 vaccination?
- Consider taking the following steps to enhance patient safety and avoid medical malpractice risks:
- Screen patients for contraindications and precautions prior to administering the vaccine to prevent adverse events following vaccinations.
- Educate patients regarding vaccination schedules.
- Designate a staff member to monitor for revisions and/or new recommendations from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
- Provide written educational materials to patients in their preferred language (e.g., vaccine information sheets). Conduct and document a thorough informed consent discussion using language the patient can understand. Include information on the potential consequences of contracting the disease as a result of non-vaccination.
- Use a vaccination informed consent form, and document the consent discussion in the medical record.
- Educate staff and conduct skills verification on accepted procedures, new standards, and risk prevention methods. Document these efforts in administrative training files.
- Store and handle vaccinations in accordance with manufacturers’ guidelines. Monitor these practices with staff—don’t just assume they are being followed correctly.
- Follow basic medication administration safety protocols for vaccine administration. Be aware of the most common vaccine-related errors by reviewing “Confusion Abounds! 2-Year Summary of the ISMP National Vaccine Errors Reporting Program” Part I and Part II.
- Should an error in vaccine administration occur, conduct a disclosure discussion with the patient/parent utilizing The Doctors Company's Disclosure Resources. Conduct a root cause analysis with your staff to determine why an error occurred and to prevent reoccurrence in the future by adjusting office procedures and providing staff training, as needed.
- Be responsive to patients who express concerns about reactions to their vaccines. Document these discussions in the medical record.
- Ensure all vaccines are entered into the specific state vaccine monitoring program.
- Have a follow-up and tracking system to ensure patients receive the second vaccination. Document all follow-up communications with patients in the medical record.
- Educate patients on the potential side effects of the vaccine, which include fever, pain at the injection site, muscle aches, fatigue, headaches, and chills.
- Where can I get information on how the vaccine will be distributed in my state?
- The CDC provides links to each state’s vaccination program executive summary. These serve as interim playbooks for states, territories, tribal governments, and local public health programs to operationalize the COVID-19 vaccination plan. Each state and territory has adopted more specific documents, to be found at the jurisdiction’s department of health websites, often noted in the plan summaries.
- Once the vaccine is being administered, how long do I have to continue to supply personal protective equipment (PPE) to my staff?
- Physicians should continue to require appropriate PPE for all staff until the national vaccination rate meets CDC guidelines (expectation is the third quarter of 2021). Follow CDC guidelines for recommended use of PPE in the clinical setting.
- What do I do when a patient does not return, or refuses to return, for their second dose of the vaccine?
- The following can reduce your risk:
- Document the refusal and why the patient doesn’t want to return.
- Follow up with a certified letter and telephone call to remind the patient of the need to return.
- Place a copy of the letter and its receipt along with documentation of the telephone call in the patient’s record.
- Remind the patient that the efficacy of the vaccine is significantly reduced if not followed with the second vaccination.
- What should I do about patients who refuse to be vaccinated or refuse to return for a second required dose?
- It is a physician’s obligation to talk with all patients (or their guardians) about what could happen if they decline vaccination. Consider the following when having a discussion with the patient:
A successful and safe vaccination campaign will be an important step in lowering public health risks associated with this pandemic.Tell patients that vaccines don’t save lives—vaccination does.
Inform patients that even if they are vaccinated, they need to continue the safe practices recommended by the CDC. Currently, the Pfizer vaccine has been shown in clinical trials to be 95 percent effective, but vaccinated people can still get the virus (not from the vaccine, but acquired in the community), perhaps with fewer symptoms—so they may not realize when they are infected. Thus, they may spread the virus to others. Until we have achieved “herd” immunity, all individuals, regardless of vaccination status, will still need to continue the practices of appropriate masking, social distancing, and handwashing. If there is contact with a known positive individual, the vaccinated individual should follow the current CDC guidelines for testing and quarantine.
- What should I do if a patient experiences an adverse event following administration of a COVID-19 vaccine?
- Ensure that your clinic is prepared for anaphylactic reactions prior to administering the vaccine (e.g., stock epinephrine prefilled syringes, H1 antihistamines such as diphenhydramine, blood pressure cuffs, stethoscopes, a wristwatch or other timing device, and oxygen; ensure 911 accessibility). Supplies might also include (though the following are not required) pulse oximeters, oxygen, bronchodilators (such as albuterol), H2 antihistamines (such as famotidine, cimetidine), IV fluids, intubation kits, and adult pocket-sized masks with one-way valve for CPR). The CDC provides guidance at Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites.
Keep in mind that Phase 3 trials are not complete in all cases, and the population studied was limited in the interim analysis. Therefore, before an adverse event occurs, read more from the FDA’s fact sheet for administering vaccines. On page 8, you will find instructions for submitting a report to the Vaccine Adverse Event Reporting System (VAERS) by text or phone.
- Will my medical malpractice insurance cover me in case of an adverse event related to administering a COVID-19 vaccine?
- Most likely. We must approach each claim based on its facts, and coverage cannot be guaranteed in every case—for instance, we cannot defend a member who has broken the law. That said, members acting in good faith and within the best community standards of care should not have additional anxiety on this point. We stand behind our members as they practice good medicine during this unprecedented public health crisis.
- Where can I find additional resources on the COVID-19 vaccine?
- The American College of Physicians has put together an extensive guide and resources for you. It provides “expanded planning and implementation resources to include guidance on mitigation of post-vaccination symptom effects on staffing; resources to build vaccination confidence; reimbursement links; a second dose tracker link; FAQ links; guidance for recommending vaccines to patients, and fact sheets for patients.”
- What liability protections do I have when administering the vaccine?
- In 2005, Congress passed into law the Public Readiness and Emergency Preparedness Act, commonly referred to as the PREP Act. The PREP Act provides limited legal liability in order to facilitate the development and implementation of medical countermeasures during a federally declared public health emergency and has been recently amended to provide immunity to providers who administer the COVID-19 vaccine, in addition to other clarifying directives.
The PREP Act provides “liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.”
On December 3, 2020, Secretary Azar declared that liability protections will be afforded to those Covered Persons who “manufacturer, test, develop, distribute, administer, or use” the COVID-19 vaccine. The liability protections were triggered when the vaccine itself was defined as an approved Covered Countermeasure. In addition, the scope of the PREP Act was clarified to acknowledge that there are situations when not administering a Covered Countermeasure is appropriate and can fall within the Act’s liability protections.
For purposes of administering the COVID-19 vaccine, the amended declaration includes in its definition of Covered Persons as persons who are authorized under law to “prescribe, administer, deliver, distribute or dispense” the vaccine and includes pharmacists who meet specific training requirements. (4)
The liability protections for COVID-19 vaccine countermeasures began on December 3, 2020, through the final day of the federally declared emergency or October 1, 2024, whichever date is first.
The law and its broad application were relatively obscure until the advent of the COVID-19 pandemic when, on March 17, 2020, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar issued a declaration under the Act to provide limited immunity for countermeasures necessary to combat the virus.
Since then, four amendments to the declaration have been issued to clarify what countermeasures and covered persons are under the Act’s limited liability umbrella ranging from the use of telehealth to respirators.