FAQs About COVID-19 Vaccinations
Article Source: The Doctors Company, TDC Group
Updated December 14, 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 risks:
- Due to lack of follow-up by the medical practice, a patient could miss their second dose, contract the virus, experience an adverse event, and file 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:
- Use a state-approved 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.
How do I get my office ready for the vaccine?
The CDC provides advice on vaccine storage and handling best practices, a training module for healthcare professionals, and reference material at Healthcare Professionals: Preparing for COVID-19 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. This discussion should include these points:
- Not vaccinating can result in disease or even death.
- Unvaccinated children and adults pose a threat to the population of people who have not been vaccinated or cannot be vaccinated.
- Social implications may include exclusion and quarantine.
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.