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FAQs About COVID-19 Vaccinations

Updated September 13, 2021: As healthcare providers engage in the process of distributing 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.

There are limitations on discharging a patient. For example, a patient cannot be terminated if they are in a critical phase of treatment. Also, a practice cannot discharge a patient for improper grounds that would violate a state or federal law, such as the Civil Rights Act or the Americans with Disabilities Act (ADA). COVID-19 vaccination is a highly charged and very much politicized issue. Once all the vaccines have full Food and Drug Administration (FDA) regulatory approval and not just emergency use authorization, the federal government will no doubt establish clear guidelines. But for now, terminating a clinical relationship with an unvaccinated patient is a gray area, and healthcare providers should be cautious and consider a more measured approach. A terminated patient relationship carries many potential adverse risks, such as a report to the medical board, negative blogging and social media posts, and complaints to third-party payers, including the Centers for Medicare and Medicaid Services (CMS) and the Office for Civil Rights (OCR).

For the protection of patients and medical office staff, some clinicians have considered setting limits on how they will treat unvaccinated patients. For instance, some in-office clinicians have wondered if it is possible to limit their treatment of unvaccinated patients to telemedicine consultations.

Adopting a blanket policy of refusing to see all unvaccinated patients, or refusing to see any unvaccinated patients in person, would probably be unwise. A blanket refusal resulting in termination of the doctor-patient relationship could be regarded as abandonment, resulting in a malpractice suit, a medical board complaint, an investigation by the Office for Civil Rights (OCR) for violation of the Americans with Disabilities Act (ADA), and probably adverse blogging, negative posts on social media, and other potential reputational harms.

Clinically, not all circumstances are suitable for virtual evaluation, such as complaints presented by certain dermatology and pulmonary patients, and many presentations mandate an onsite visit. Also, some patients have legitimate medical exemptions from vaccine eligibility, e.g., immunocompromised patients.

In addition, some patients may express legally recognized religious objections. The U.S. Supreme Court’s recent decisions express a more protective stance toward religious liberties.

When a patient reports that a disability prevents them from receiving a COVID-19 vaccine, healthcare providers may understandably feel cautious about asking patients for details. However, it is appropriate for a medical assistant (MA) to ask the patient during the intake conversation if there have been changes in the patient’s medical history or status since the last visit. As part of coordination of care, specialty offices can contact primary care physicians to properly inquire about any disabilities mentioned by patients.

The Pfizer-BioNTech vaccine has received full approval from the Food and Drug Administration (FDA), improving upon the existing emergency use authorization (EUA). The Johnson and Johnson single-dose Janssen vaccine and the Moderna vaccine are both awaiting final nonemergent regulatory approval. Once those full approvals emerge, presumably the Centers for Disease Control and Prevention (CDC) and other federal agencies will issue new and/or revised rules, regulations, and guidelines. Meanwhile, medical offices should consider their local community’s current rate of COVID-19 transmission as they make decisions regarding safe and reasonable measures for their practice settings as conditions unfold.

As clinicians await full FDA approval of all available vaccines, they are advised to stay up to date on evolving guidelines from the CDC, as well as recommendations from their specialty’s medical professional societies. Each state’s executive orders should be kept top of mind, as should any hospital bylaws. Healthcare providers can protect themselves, their medical office staff, and their patients with pre-vaccine infection-control measures such as masking and the use of other personal protective equipment (PPE), as well as social distancing for in-office patients, accompanied by use of telemedicine wherever warranted by the physician’s best clinical judgment.

Numerous states have granted healthcare providers and facilities limited temporary protections from liability for treatment provided in relation to the public health emergency. Also, the U.S. Department of Health and Human Services (HHS) 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. According to a regulatory change from the HHS effective March 11, 2021, an expanded group of health professionals including midwives, paramedics, and dentists can now administer COVID-19 vaccines without being held liable for harms. HHS also expanded the liability shield to include physician assistants, eye doctors, and veterinarians who are licensed or who have been licensed in any state within the past five years. 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 is not 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 to assist with documentation of the physician-patient discussion.

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. For more communication tips, see Communicating with COVID-19 Vaccine-Hesitant Patients: Top Tips.

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—do not 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.

The Institute for Safe Medication Practices (ISMP) has identified the following potential concerns to consider when administering COVID-19 vaccines:

  • Dilution errors when reconstituting the Pfizer-BioNTech vaccine. Ensure the correct diluent and the correct volume.
  • Administration of monoclonal antibodies instead of the Moderna vaccine. Carefully review vial labels prior to drawing up vaccine doses to reduce the risk of wrong product administration.
  • Administration to wrong age group. Follow the age-specific guidelines in the Emergency Use Authorization (EUA) documents provided with the vaccine.
  • Vaccine waste. Consider syringe type, storage requirements, cancelled appointments, etc.
  • Second dose scheduling errors. Implement a system to ensure patients receive their second dose on time and the dose is from the same vaccine type.
  • Review the complete report, “Learning from Errors with the New COVID-19 Vaccines.”

Should an error in vaccine administration occur, conduct a disclosure discussion with the patient 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.

Reporting vaccine errors and serious adverse events is mandatory under the EUAs. Submit vaccine error reports to the Vaccine Adverse Event Reporting System (VAERS).

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 tracking system to ensure patients receive the second vaccination. Document all follow-up communications with patients in the medical record. To help patients comply with the second dose of the vaccine, suggest the CDC smartphone app called V-safe After Vaccination Health Checker.

Educate patients on the potential side effects of the vaccine, which include fever, pain at the injection site, muscle aches, fatigue, headaches, and chills.

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 have adopted more specific documents, to be found at the jurisdiction’s department of health websites, often noted in the plan summaries.

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.

The following can reduce your risk:

  • Document the refusal and why the patient does not 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.

The CDC provides advice on vaccine storage and handling best practices, a training module for healthcare professionals, and reference material in the COVID-19 Vaccine Training Module for Healthcare Professionals.

For CDC information specifically addressing the Pfizer-BioNTech COVID-19 vaccine, the Moderna vaccine, and the Janssen (Johnson and Johnson) vaccine, visit U.S. COVID-19 Vaccine Product Information (administration, storage, handling, safety and reporting) and Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.

See the FDA’s Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) which gives information on vaccine administration, safety, storage, informed consent, and reporting adverse events:

Pfizer - Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

Moderna - Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

Janssen (Johnson & Johnson) - Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

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 do not 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.

Ensure that your clinic is prepared for anaphylactic reactions prior to administering the vaccine (e.g., stock epinephrine in 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.

Certain adverse events are required to be reported to the Vaccine Adverse Event Reporting System (VAERS).

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.

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.”

In 2005, Congress passed into law the , 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.”

The law and its broad application were relatively obscure until the advent of the COVID-19 pandemic when, on March 17, 2020, U.S. 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.

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.

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 occurs first.

In addition to PREP Act protections, on January 19, 2021, the Office for Civil Rights announced that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA rules on covered healthcare providers or their business associates in connection with the good faith use of online or web-based scheduling applications for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency. The enforcement discretion is retroactive effect to December 11, 2020. Read the full enforcement discretion document here.


The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

09/21

A Message From Our Chairman

Richard E. Anderson
MD, FACP

Committed to Assisting Our Members

The extraordinary development of COVID-19 vaccines has raised hopes for significant progress in overcoming this pandemic.

READ MORE

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