Patient injury during colposcopy
Presentation and physician action
A 21-year-old woman came to her ob-gyn for a colposcopy due to an abnormal PAP smear and a finding of severe cervical dysplasia. The ob-gyn’s medical assistant set up the procedure room for the colposcopy. She removed a bottle of acetic acid from the cabinet and poured some into a cup for the ob-gyn to use during the procedure.
The ob-gyn, assisted by her nurse, began the procedure. The ob-gyn soaked some cotton balls in the acetic acid and placed the cotton balls in the vaginal vault. A speculum was already inserted and the patient complained that the speculum was pinching and causing pain. The speculum was removed, but the patient continued to complain of pain. The cotton balls were removed, but the patient was still in pain. The acetic acid bottle was examined and found to be 100% concentration instead of the normal 3% solution.
The ob-gyn noticed that the patient’s vaginal area was turning white, so she immediately began copious irrigation. She used approximately 10 to 12 gallons of ice water. She had the patient void, and then moved her to another exam room table. The ob-gyn consulted a dermatologist and an emergency medicine physician, who both told her to continue irrigating. Subsequently, the ob-gyn’s office manager and nurse drove the patient to the emergency department (ED). Before the patient left for the ED, the ob-gyn used moist gauze and applied 2% xylocaine gel to the vulva area.
The ED physician diagnosed second-degree burns and blisters to the patient’s genitalia. She was kept on 23-hour observation and then discharged with prescriptions for hydrocodone, xylocaine gel, and silvadene cream. She was instructed to follow up with the ob-gyn.
Four days after she left the hospital, the patient returned to the ob-gyn. The ob-gyn noted that the vagina and buttock area appeared to be healing well and appropriately. The ob-gyn prescribed hydrocodone, a broad-spectrum antibiotic, and a numbing spray to apply to the buttock area. The patient was seen again three weeks later. She complained of slight pain in the buttock area while sitting. She was asked to follow up in one month, but did not return.
The patient sought a second opinion from another ob-gyn due to buttock scarring and pain during sexual intercourse. The patient was concerned about damage to her reproductive organs from the chemical burns.
The ob-gyn referred her to a plastic surgeon for the scarring and informed her that he had no way to evaluate her concerns short of surgery. The patient was not exhibiting any symptoms related to problems with her reproductive organs at the time of the examination, and the ob-gyn felt a surgical consultation was not indicated.
The patient has not sought treatment from a plastic surgeon for scarring, but still undergoes treatment for dysplasia. She stopped taking pain medications two weeks after the incident.
Allegations
A lawsuit was filed against the ob-gyn alleging that she was negligent in failing to check the acetic acid concentration before using it during the colposcopy, resulting in second-degree burns to the patient’s cervix, vagina, vulva, and buttocks.
Legal implications
During the investigation of this claim, the ob-gyn’s practice reviewed invoices from their medical supplier. Six weeks before the incident, an order was placed for acid acetic 3% 500ML. However, 100% acetic acid was shipped, and a medical technician who received the shipment did not review the shipment invoice or read the label on the bottle before putting it in the procedure room for use. The practice did not have a policy or procedure in place for checking medical supplies that were shipped to the office.
The plaintiff’s expert was critical of the ob-gyn’s office policies and procedures and her treatment of the patient. This physician stated that the ob-gyn and her staff were negligent in using the 100% acetic acid and for failing to have a plan in place to check invoices and labels of medical supplies.
Regarding the treatment of the patient, the plaintiff’s expert felt the ob-gyn did not respond appropriately to the situation when the acetic acid began burning the patient. The expert felt the ob-gyn should have flushed the chemical burn with 4 x 4 sponges while tilting the pelvis up to keep acid away from the patient’s buttocks. Further, the ob-gyn should have called an ambulance while the patient’s pelvis was tilted upward and should not have allowed her to go to the bathroom.
The plaintiff’s expert also testified that the patient suffered severe chemical burns and scarring and will likely have some potential loss of fertility based upon her testimony that she has pain during sexual intercourse.
The defense expert was supportive of the ob-gyn’s actions and stated that she acted appropriately in responding to the patient’s burn. This ob-gyn stated that using 4 x 4 sponges to flush the patient’s vagina would have resulted in the patient having a more serious burn without any water lavage. It was this physician’s opinion that the patient suffered a superficial burn to the vagina and it is unlikely that a first- or second- degree burn could cause infertility. Any problems with fertility that the patient could experience in the future would be unrelated to this incident.
Disposition
This case was settled on behalf of the ob-gyn.
Risk management considerations
Though it could be argued that this situation developed due to the negligent supplying of 100% acetic acid by the medical supply company, the defense faced obstacles due to the ob-gyn’s lack of a policy or procedure to check medical supply shipments. The ob-gyn testified that no one read the label on the bottle when it arrived in the office, when it was stocked, or when it was used.
A physician’s practice should develop policies and procedures to follow in the delivery of patient care. This includes any products used during a procedure. Assignment of duties to staff must be clear and followed consistently.
In this case, checking the acetic acid at delivery or when stocked was a staff responsibility, but was not documented in writing. Physicians may assume vicarious liability for the actions of their employees. The third opportunity to discover the strength of the acetic acid was missed when the medical assistant set up the procedure room for the colposcopy. Clearly outlining staff responsibilities in written policies and protocols reduces the chance of unwanted outcomes, and may increase physician defensibility.
CME credit
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