Reduce Patient Safety Risks With Vaccinations, Including COVID-19

With the CDC’s recommendations for continued COVID-19 vaccination and boosters, healthcare providers are asking about the risks involved in administering vaccines (especially to children) and how to respond when a patient or parent refuses vaccination.

Generally, vaccine administration is regarded as a simple office procedure, often performed without the direct supervision of a physician or licensed professional. Although vaccinations are a routine procedure, it is important to remain vigilant about patient safety considerations. Whether you are seeing children or adults for COVID-19 vaccinations, travel abroad, or general disease prevention, take time to assess the vaccine administration protocol in your practice.

As with any medical intervention, discuss the risks, benefits, and alternatives of the vaccination with the patient, document the medical record, and ensure that safety protocols are followed.

What to Do When a Patient or Parent Declines Vaccines

Consider the following points when talking with patients (or their guardians) about the potential consequences of declining vaccination.

• Not vaccinating can result in disease or even death.
• Unvaccinated children and adults pose a threat to those unable to receive vaccinations due to age or weakened immune systems, such as patients with cancer or taking certain medications.
• Social implications may include exclusion and quarantine. If a disease outbreak occurs in a community, parents may be asked to remove their unvaccinated child from organized events and activities due to the threat of transmission.
• Females of childbearing age who are unvaccinated and who become pregnant are vulnerable to diseases such as rubella, which can cause congenital rubella syndrome with congenital fetal anomalies.

Remind parents to alert medical and dental personnel of their child’s immunization status each time the child seeks healthcare in case distinctive care is required.

Could This Happen in Your Office?

The Doctors Company performed a closed claims analysis of vaccine-related events in the medical office setting. Could one of these case examples occur in your office?

• Missed vaccination: A 4.5-month-old male infant received the pneumococcal conjugate vaccine (PCV) Prevnar 7, which provided protection against seven serotypes of pneumococcus. The following year, the FDA approved the use of Prevnar 13, which provided protection against an additional six serotypes of the disease. The American Academy of Pediatrics recommended that those vaccinated with Prevnar 7 also receive Prevnar 13. The physician did not update recommended immunization protocols in her office, and even though the child returned for three additional well visits, the child never received Prevnar 13. At age 39 months, the child developed serotype 6A pneumococcal meningitis, which resulted in left hemiparesis, seizures, and vision and hearing impairment. This disease could have been prevented if the child had received Prevnar 13.
• Dental injury: A 13-year-old female received a Gardasil vaccine. Even though her mother was monitoring her in the exam room, the patient fainted and fell off the exam table, resulting in a tooth avulsion, a tooth luxation, a fractured wrist, and a laceration to her hand.
• Injection site reaction: A 35-year-old female complained of redness and swelling at the injection site for a flu vaccine, interfering with her ability to perform her job over the course of several months and resulting in several weeks of physical therapy. No informed consent for the vaccine had been obtained. She stated she would never have had the injection had she known of the potential complications.
• Vaccination overdose: A 41-year-old female with a history of ankylosing spondylitis requested a pneumovax vaccination. No informed consent was obtained. The patient was queried regarding whether she had previously received pneumovax, which the patient denied. Actual vaccination status was never verified by the physician; however, the patient had received the vaccine two years earlier. The patient developed inflammatory response syndrome, including the amputation of a toe, which was alleged to have resulted from administering the vaccine without checking her immunization history and because the vaccine was not indicated for patients younger than 65 years old.

Risk Mitigation Strategies

To help avoid potential issues, consider the following strategies:

• Ensure that immunization tracking is up to date and well documented in the medical record so that patients remain on schedule. Obtain copies of vaccination records from previous providers or state registries. Create easy-to-read office forms in common languages for documenting administration.
• Screen patients for contraindications and precautions to administering any vaccine to prevent adverse events following vaccinations. Reference the CDC guidelines for various vaccines and specific CDC guidance for COVID-19 vaccine administration.
• Educate patients and parents regarding vaccination schedules.
• Designate a reliable licensed staff member to monitor for revisions/new recommendations of FDA/CDC vaccination schedules. Ensure that new vaccination schedules are incorporated with office procedures and included on office vaccination forms.
• Provide factual information to patients. Conduct and document a thorough informed consent discussion; use Vaccine Information Statements prior to vaccine administration. Include information on the consequence of diseases contracted as a result of nonvaccination. Since parental immunization attitudes vary, be knowledgeable and prepared to address concerns utilizing appropriate communication methods. Use this resource from the American Academy of Pediatrics to assist with addressing vaccine-hesitant parents.
• Obtain patient or parent signatures on an informed consent form that includes potential side effects and complications. In the case of parents who have disagreed with each other previously on vaccination, consider requesting both signatures on a vaccination consent. In cases of pediatric patients of divorce in which sole physical custody is involved, the custodial parent or guardian should provide documentation showing legal authorization to sign a consent. Document the discussion in the progress notes when the immunization is refused. Consider using the Refusal to Vaccinate form from the American Academy of Pediatrics or The Doctors Company’s sample informed refusal form.
• Check the U.S. Equal Employment Opportunity Commission and state vaccination laws regarding exemptions, and educate patients accordingly. Be aware that in some circumstances, Title VII of the Civil Rights Act and the Americans with Disabilities Act require an employer to provide reasonable accommodations for certain employees who do not get vaccinated.
• Monitor patients closely post-administration for anaphylaxis, vasovagal response, and reaction at the injection site. Document the medical record with any reactions, suspected side effects, and complications.
• 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 CDC 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 the articles “Recommendations for Practitioners to Prevent Vaccine Errors Part 2: Analysis of ISMP Vaccine Errors Reporting Program (ISMP VERP)” and “Don’t Be Guilty of These Preventable Errors in Vaccine Administration.”
• Should an error in vaccine administration occur, review CDC protocols for COVID-19 Vaccine: Administration Errors and Deviations. 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 prevent reoccurrence in the future by adjusting office procedures and providing staff training as needed.
• Be responsive to patients who express concerns about reactions from their vaccines. Document these discussions in the medical record.
• Report Adverse Events to the Vaccine Adverse Event Reporting System. 

The CDC provides resources to assist healthcare providers in raising awareness of the benefits of immunizations. Use CDC materials to:

• Provide evidence-based information regarding COVID-19 vaccination for informed decision making.
• Encourage parents of young children to follow recommended vaccination schedules from birth through six years for other routine vaccinations.
• Help parents make sure older children have received vaccinations by the time they return to school.
• Remind college students to get required vaccinations before moving into dormitories.
• Educate adults, including healthcare workers, about vaccines and boosters they may need.
• Inform pregnant women about getting vaccinated to protect newborns from disease such as whooping cough.

For guidance and assistance in addressing any patient safety or risk management concerns, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.