Reduce Patient Safety Risks With Vaccinations

Generally, vaccine administration is regarded as a simple office procedure, often performed without the direct supervision of a physician or licensed practitioner. Although vaccinations are a routine procedure, it is important to remain mindful of patient safety considerations, risk mitigation, and how to respond when a patient or parent refuses vaccination. Whether you are seeing children or adults for travel abroad or general disease prevention, take time to assess the vaccine administration protocols in your practice.

Consider the following scenarios and risk mitigation strategies.

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 infants, patients with cancer, or those taking certain medications.
• Social implications may involve exclusion and quarantine. If a disease outbreak occurs in a community, unvaccinated children may be excluded from school or organized 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.
• Attempt to determine the source of the concerns and fears and provide evidence-based facts.
• 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.

Many healthcare practitioners refuse to treat patients who are vaccine resistant due to potential disease exposure to staff, other patients in the office, and the community at large. The Doctors Company article “Practitioner Refusal to Treat Vaccine-Hesitant Patients in the Office Setting” provides insight into the ethical and legal considerations and guidance on managing potential new and existing patients when this issue occurs.

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: An 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 the office’s recommended immunization protocols, and even though the child returned for three additional well visits, the child never received Prevnar 13. The child later developed pneumococcal meningitis, which resulted in hemiparesis, seizures, and vision and hearing impairment. This disease could have been prevented if the practitioner had updated the immunization protocols and the child had received the updated vaccine.
• Dental injury resulting from a fall: A teenager received a Gardasil vaccine. Even though the parent was monitoring the patient in the exam room, the patient fainted and fell off the exam table, resulting in a tooth avulsion, tooth luxation, fractured wrist, and laceration to the patient’s hand.
• Injection site reaction: An adult patient complained of redness and swelling at the injection site for a flu vaccine, a reaction that interfered with the patient’s job performance over the course of several months and resulted in several weeks of physical therapy. No informed consent for the vaccine had been obtained. The patient asserted that, had the potential complications been known, the patient would not have had the injection.
• Vaccination overdose: An adult patient with a history of ankylosing spondylitis requested a pneumovax vaccination. No informed consent was obtained. The patient was asked about receiving a previous pneumovax, which the patient denied. Although the practitioner never verified the patient’s vaccination status, the patient had received the same 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 the patient’s immunization history.

Risk Mitigation Strategies

The following strategies may help to avoid potential vaccination issues:

• Tracking. Ensure that immunization tracking is up to date and well documented in the patient record so that patients remain on schedule. Obtain copies of vaccination records from previous practitioners or state registries. Create easy-to-read office forms in common languages for documenting administration.
• Screening. Screen patients for contraindications and precautions prior to administering any vaccine to prevent adverse events following vaccinations. Reference CDC Guidelines and Vaccination Administration Protocols.
• Schedules. Designate a reliable licensed staff member to monitor for revisions/new recommendations in FDA/CDC vaccination schedules. Ensure that office procedures, vaccination forms, and medication inventories reflect new vaccination schedules.
• Informed consent. Provide factual information to patients. Conduct and document a thorough informed consent discussion, including the risks, benefits, and alternatives of the vaccination. Provide Vaccine Information Statements prior to vaccine administration. Include information on the consequence of diseases contracted as a result of nonvaccination. Obtain patient or parent signatures on an informed consent form that includes potential side effects and complications.
• Parental disagreement. 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.
• Hesitancy. 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 (AAP) to assist with addressing vaccine-hesitant parents.
• Refusal. Document the discussion in the progress notes when the immunization is refused. Consider using the AAP’s Refusal of Recommended Immunizations or The Doctors Company’s sample informed refusal form.
• Exemptions. 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.
• Monitoring. Instruct patients to remain seated and not to leave the office immediately after injection. Monitor patients closely post-administration for anaphylaxis, vasovagal response, and reaction at the injection site. Document the patient record with any reactions, suspected side effects, and complications.
• Staff education. Educate staff and conduct skills verification on accepted procedures, new standards, and risk-prevention methods. Document these efforts in administrative training files.
• Storage. Store and handle vaccinations in accordance with CDC guidelines. Monitor these practices with staff; do not just assume they are being followed correctly.
• Reactions. Be responsive to patients who express concerns about reactions from their vaccines. Document these discussions in the patient record and notify the licensed practitioner.
• Errors. Follow basic medication administration safety protocols for vaccine administration. Be aware of the most common vaccine-related errors by reviewing “Don't Be Guilty of These Preventable Errors in Vaccine Administration!” on Immunize.org. Review CDC protocols for Preventing Vaccine Administration Errors.
• Disclosure. Should an error in vaccine administration occur, conduct a disclosure discussion with the patient/parent using 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 revising office procedures and providing staff training as needed.
• Reporting. Report Adverse Events to the Vaccine Adverse Event Reporting System. 

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

• Provide evidence-based information regarding vaccination for informed decision making.
• Encourage parents of young children to follow recommended vaccination schedules from birth through six years for 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 and RSV.

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.