by Laura Hale Brockway, ELS, Vice President, Marketing, and
Susie Edwards, Senior Risk Management Representative
Presentation
On September 13, a 14-year-old girl came with her mother to her pediatrician’s office for a well-child visit. The advanced practice registered nurse (APRN) treated the patient.
Physician action
The patient reported that she was performing well in school and that she was involved in several extracurricular activities. A PHQ-9 depression screen was administered, and the results were recorded as normal. The APRN ordered the second dose of the HPV vaccine. (The first dose had been given to the patient nine months earlier with no complications noted.)
At the end of the visit, the medical assistant (MA) administered the vaccine. While in the waiting room checking out with her mother, the patient fainted, fell to the floor, and hit her head.
The APRN took the patient back to the exam room. He noted that the patient felt lightheaded before the fall and was a “little dazed” immediately afterward. The APRN documented a bump on the back of the patient’s head that was painful and that the patient was tearful but answering questions appropriately. He further noted discussing signs and symptoms of concussion with the patient and her mother, and that he would call that afternoon to check on the patient.
The patient and her mother returned the next day, September 14. She was seen by Pediatrician A, who noted the patient had fainted in the waiting room and “was out for 5-10 seconds.” Pediatrician A documented that the patient was “still a little shaken up about what happened and a little out of it but doesn’t really think she has been foggy.” The patient did not have a headache, was not irritable, but did vomit once when she arrived home the day before.
Pediatrician A examined the patient and administered a SCAT 3 to evaluate for concussion. The exam was reassuring, and the patient seemed to be feeling back to her normal self. The patient asked about volleyball tryouts and Pediatrician A noted it was okay to participate if she was feeling well. If she was not feeling well, she was told to sit out and call back to discuss the “back to play protocol.”
On September 19, the patient was seen in the office by Pediatrician B. She noted that the patient reported neck pain for the last five days and had vomited twice after leaving the office on the 14th. (Pediatrician A had noted only one vomiting episode.) Pediatrician B documented that the patient had been “a little off” and had been more sensitive to emotions.
She performed another SCAT and documented that it was “very good in physical and memory testing.” Pediatrician B discussed with the patient and her mother that the patient might have a concussion because she had some head pressure and vomiting and felt more emotional. Pediatrician B also noted the pressure could be from neck muscle spasms. She advised the patient to go to school, but to hold off on physical activity until after she was re-checked in four days.
After the visit, Pediatrician B documented the following:
“I apologized to the mom that she was not informed of the HPV fainting issue. We endeavor to continue to educate our patients on vaccines. She had done fine [with] the first HPV. I reassured mom that we would have office wide discussion regarding HPV side effects. Mom to call me if there are any issues.”
Neither the patient nor her siblings returned to the pediatric practice.
The patient was seen on September 20 by a sports medicine physician. This physician administered a SCAT 5 and diagnosed “concussion with increased symptoms of Vestibular Ocular Reflex Horizontal and Vertical.” He placed the patient on a return to school protocol, but restricted sports until her symptoms resolved.
Four months later, the patient sought treatment with a neurologist. She reported fatigue, memory deficits, and moodiness. Her PHQ-9 and GAD7 scores were abnormal, and the patient and her mother acknowledged that she was having symptoms of depression. The neurologist diagnosed “current moderate episode of major depressive disorder without prior episode and post concussive syndrome.” She encouraged the patient to seek counseling.
The patient received counseling over the next seven months. She was also prescribed escitalopram and rizatriptan by the neurologist.
At her last documented visit with the neurologist — one year after she started counseling and 21 months after she sustained the concussion — the patient was doing well. Her mood was improved, and she no longer had headaches. She had resumed full activity in sports.
Allegations
A lawsuit was filed against the pediatric practice. The plaintiffs alleged that the APRN and MA violated the standard of care by failing to warn the patient and her mother of the risk of fainting after receiving the HPV vaccine and failing to instruct the patient to wait 15 minutes before standing.
It was also alleged that the pediatric practice failed to train/supervise their employees and failed to disclose the risk of the HPV vaccine to the patient. Pediatricians A and B were not named in the lawsuit.
Legal implications
The plaintiff’s pediatric expert claimed that had staff from the pediatric practice told the patient and her mother about the risk of syncope following the HPV vaccine and had the patient been seated for 15 minutes of observation, she would not have fallen and hit her head. This fall caused the patient’s concussion, post-concussion syndrome, anxiety, and post-concussion depression. These actions constituted a deviation from the standard of care.
The defense pediatric expert stated that although the CDC makes recommendations for the administration of vaccines, it — like other organizations —does not define practice standards. A 15-minute wait policy across the board for adolescent vaccinations is not the standard of care.
However, defense experts were critical that there was no mention in the medical record that the patient was notified about the risk of fainting after HPV. Another area of concern for the defense was Pediatrician B’s note about an “office wide discussion regarding HPV side effects.” The plaintiffs would likely use this to prove that all staff members at the pediatric practice should have known about the side effects of the vaccine and had a duty to warn the patient.
Regarding the actions of the defendant APRN, an APRN reviewing the case for the defense stated that the common practice of warning patients about potential vaccine side effects falls to the provider who orders the vaccine and not the medical assistant who administers it. Therefore, this expert would have expected the defendant APRN to have this discussion with the patient and her mother. Additionally, it is not expected that a medical assistant would know about potential vaccine side effects, much less warn the patient about them.
Regarding causation, the defense APRN expert stated that it is hard to predict who will faint after receiving a vaccine. Anxiety, age, and whether the patient has eaten can all contribute to a syncope episode.
Disposition
This case was settled on behalf of the pediatric practice.
Risk management considerations
In 2006, use of the human papillomavirus (HPV) vaccine was recommended by the U.S. Advisory Committee on Immunization Practices (ACIP) to prevent HPV infections and cervical precancer cells that can lead to cancer. The Center for Disease Control and Prevention (CDC) states there has been a drop of 81 to 88 percent in infection with HPV types among teen girls and young adult women since use of the vaccine began. (1)
According to the CDC recommendations for HPV vaccines, “syncope (fainting) can occur after any medical procedure, including vaccination. Adolescents should be seated or lying down during vaccination and remain in that position for 15 minutes after vaccination. This is to prevent any injuries that could occur from a fall during a syncopal event.” The CDC’s vaccination information statement (VIS) also lists fainting as a risk of a vaccine reaction. (1,2)
Physicians or health care providers that administer specific vaccines, including human papillomavirus (HPV), are required by the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26) to provide a current copy of the CDC’s VIS to the patient, parent, or legal representative prior to vaccine administration. Copies should be provided, and practices may also consider keeping laminated copies of the most current VIS statements in exam rooms for patients and parents/legal guardians to easily access and review while waiting to be seen. The law also requires that health care providers administering these vaccines must record in the patient’s medical record:
- the edition date of the VIS distributed; and
- the date the VIS was provided.
In addition, the following must be recorded in the patient’s medical record or a permanent “office log”:
- the name, address, and title of the individual who administers the vaccine;
- the date of administration; and
- the vaccine manufacturer and lot number of the vaccine used. (3)
With most medical practices now using electronic health records (EHRs), a useful function within an EHR is to create templates that include a place for required vaccine documentation, common physician-patient discussion points for vaccines, and instructions given to the patient. Creating a template that includes the discussion of the specific risks of the injection(s), the CDC recommendation to wait 15 minutes while seated after vaccination, and any education and/or handouts given to the patient can assist with documenting physician-patient communications regarding vaccinations. These templates can also serve as a reminder to the provider of important matters to discuss with patients and parents.
You may also consider creating an office vaccine administration policy and procedure that includes discussing the vaccine risks and benefits, obtaining immunization consent from the patient/parent, capturing the patient’s condition post injection (such as whether they tolerated it well, patient complaints, or complications), and what to document.
Instructing patients to wait in the office while seated after the injections may help avoid future related injuries. If patients and/or parents decline, documenting the noncompliance may assist in the defense of an adverse outcome.
Consider conducting an overall “safety assessment” of your practice to identify potential risks of patient injuries or emergencies. Are you and your staff prepared for emergencies? What are risks specific to your practice? (4)
Preparation, planning, and training will make the difference between a panicked response and a stressful but still successful outcome. The following steps can help you effectively plan for such events:
- review emergency situations encountered in the practice during the past year or longer;
- develop a plan for these situations and for other common emergencies;
- ensure the required equipment and medications are on site and up to date; and
- establish emergency response roles and responsibilities among your office staff and conduct training sessions or drills to ensure everyone is comfortable in their role. (4)
Having basic first aid and reasonable processes in place for predictable emergency care will help minimize risks to patients and may improve your defensibility in the event of a liability claim.
Sources
- Centers for Disease Control and Prevention. Human Papillomavirus (HPV). Reasons to get HPV vaccine. Last reviewed November 10, 2021. Available at https://www.cdc.gov/hpv/parents/vaccine/six-reasons.html. Accessed May 29, 2024.
- Centers for Disease Control and Prevention. Vaccines and preventable diseases. HPV vaccination recommendations. Last reviewed November 16, 2021. Available at https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed May 29, 2024.
- Centers for Disease Control and Prevention. Instructions for using VIS. Available at https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html. Accessed June 4, 2024.
LeBlanc C, Murray J, Staple L, Chan B. Review of emergency preparedness in the office setting: How best to prepare based on your practice and patient demographic characteristics. Canada Family Physician. April 2019. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6467671/. Accessed May 29, 2024.
Laura Hale Brockway can be reached at laura-brockway@tmlt.org.
Susie Edwards can be reached at susie-edwards@tmlt.org.
