November 2, 2020 — This is a developing story. Please check back for updates.
TMLT staff received questions from physicians concerned about the COVID-19 vaccine, and how its development and deployment could affect liability risks.
Because the vaccine is not yet available, the specific liability risks are largely unknown. However, the TMLT risk management department urges physicians to stay up-to-date on COVID-19 vaccination plans.
The CDC has published 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans and the Coronavirus Vaccine (COVID-19) web page. These resources provide updates on vaccine development, safety issues, and clinical vaccine trials.
In addition, state health departments are sharing information regarding vaccine development, provider registration, and required protocols. The Texas DSHS provides updated information here.
Once a vaccine (or vaccines) is available, practices should follow the CDC and FDA guidelines regarding vaccine storage, safety protocols, and vaccine administration. This includes:
- patient screening and selection;
- informed consent process;
- providing current vaccine information statements (VIS) to patients/guardians;
- vaccine administration documentation; and
- patient monitoring post-vaccine.
Health care providers should follow regulatory guidelines when the vaccine becomes available, and regularly review guidelines to ensure any changes are noted.
Because this will be a new vaccine, new or updated guidance may be given frequently by the manufacturer, the CDC, or the FDA. State health department guidelines and recommendations may also change.
If changes to the guidelines do occur, practices should adjust processes to align with guidelines available at the time of vaccine administration. The VIS may also change or be updated, so practices should check regularly to ensure that the appropriate, updated version is being shared with patients.
Risk management recommendations
Maintain documentation of initial guidelines and copies of VIS, and copies of any changes to vaccine guidelines or updated VIS versions as you use them. This will demonstrate that at the time each vaccine was given the most current/appropriate guidelines were followed.
Although adverse reactions following vaccine administration are rare, they can occur. As you will see in the information below, the CDC draws attention to the possibility of syncope occurring following the administration of vaccines and advises providers administering them to consider a 15-minute monitoring period. It is prudent risk management to implement this protocol. Once the protocol for a vaccine observation period has been established, inform patients about it before their visit so they can plan accordingly.
A written emergency protocol that addresses staff training, available emergency medications and equipment, and the process for handling an urgent or emergent situation (such as a reaction to a vaccine) should be in place. A physician, physician assistant, or advance practice registered nurse should be available to assist in the event of an urgent or emergent situation.
These vaccination guidelines are offered for currently available vaccines. They should already be in place for all administered vaccinations.
CDC: Screen for contraindications and precautions
“Always screen patients for contraindications and precautions before a vaccine is administered, even if the same vaccine was administered previously. A patient’s health status or the recommendations for contraindications and precautions may have changed since the last dose was given. Screening helps prevent adverse reactions such as anaphylaxis. At each visit, use a standardized screening tool to assess patients consistently and correctly.”
CDC: Preventing and managing an adverse reaction
“Parents, guardians, legal representatives, and adolescent and adult patients should be informed about the benefits of and risks from vaccines in language that is culturally sensitive and at an appropriate educational level. Opportunity for questions should be provided before each vaccination. Discussion of the benefits of and risks from vaccination is sound medical practice and is required by law.”
“Although allergic reactions are a common concern for vaccine providers, these reactions are uncommon and anaphylaxis following vaccines is rare, occurring at a rate of approximately one per million doses for many vaccines.1 Epinephrine and equipment for managing an airway should be available for immediate use.2 The best practice to prevent allergic reactions is to identify individuals at increased risk by obtaining a history of allergy to previous vaccinations and vaccine components that might indicate an underlying hypersensitivity.”
“Vaccine providers should be familiar with identifying immediate-type allergic reactions, including anaphylaxis, and be competent in treating these events at the time of vaccine administration. Providers should also have a plan in place to contact emergency medical services immediately in the event of a severe acute vaccine reaction.”
“Among all age groups, 80% of reported syncope episodes occur within 15 minutes of vaccine administration (additional information). Providers should take appropriate measures to prevent injuries if a patient becomes weak or dizzy or loses consciousness. Adolescents and adults should be seated or lying down during vaccination. Vaccine providers, particularly when vaccinating adolescents, should consider observing patients (with patients seated or lying down) for 15 minutes after vaccination to decrease the risk for injury should they faint.3 If syncope develops, patients should be observed until the symptoms resolve.”
CDC: Contraindications and precautions
“National standards for pediatric vaccination practices have been established and include descriptions of valid contraindications and precautions to vaccination (2). Persons who administer vaccines should screen patients for contraindications and precautions to the vaccine before each dose of vaccine is administered (Table 4-1). Screening is facilitated by consistent use of screening questionnaires, which are available from certain state vaccination programs and other sources (e.g., the Immunization Action Coalition ).
“Contraindications (conditions in a recipient that increases the risk for a serious adverse reaction) to vaccination are conditions under which vaccines should not be administered.”
“In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.”
CDC: VIS information
“Providing patients/parents copies of vaccine information statements (VIS) is not a new requirement. It should be part of your process for all administered vaccinations. Patients are not required to sign the VIS; however, patient consent must be documented in the medical record. Current VIS are available from the CDC.”
As more becomes known about the coronavirus and vaccine risks and benefits, new recommendations will be shared by the FDA, CDC, and state health departments. Providers are urged to closely follow these resources to ensure compliance with guidelines.
- Texas DSHS COVID-19 Provider Vaccine Information
- 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans
- Coronavirus vaccine information (COVID-19)
- TMA COVID-19 Resources
Learn more about our COVID-19 Resources here.
Have a coverage question? Please direct it to your Underwriter. You may also contact our underwriting department by phone at 800-580-8658 or 512-425-5800 or by email at firstname.lastname@example.org.
- Bohlke K, Davis RL, Marcy SM, et al. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics. 2003;112(4):815-820. DOI: 10.1542/peds.112.4.815
- Kroger A, Atkinson W, Pickering L. General immunization practices. In: Plotkin S, Orenstein W, Offit P, eds. Vaccines. 6th ed. China: Elsevier Saunders; 2013:88-111.
- CDC. Syncope after vaccination—United States, January 2005-July 2007. MMWR Morb Mortal Wkly Rep. 2008;57(17):457-460.