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The Conditions of Participation for Surgical services was not met.

The Hospital failed to ensure a patient was free from injury during a surgical procedure when an instrument was not used for the intended purpose resulting in a full thickness burn of the right thigh and required a subsequent surgery.

Cross reference:
0951 Operating Room Policies 482.51[b]

Based on clinical record reviews, observations, review of facility documentation and interviews for one of 15 sampled patients (Patient #1) who was reviewed for safety during a surgical procedure the Hospital failed to ensure a patient was free from injury during a surgical procedure when an instrument was not used for the intended purpose resulting in a full thickness burn of the right thigh and required a subsequent surgery.
The finding includes:

Patient #1 was admitted to the hospital with diagnoses to include dysplasia of the cervix.
The Gynecology history and physical identified patient #1 had cervical intra-epithelial neoplasia with plan for cold knife cone cervical biopsy.

Review of the operative note dated 4/11/23 identified a pre-operative diagnosis of cervical intraepithelial neoplasia 3 and the completed procedure identified as biopsy of cervix cold cone. The procedure note identified the cervix was cauterized until hemostasis was achieved and then at that point it was noted that the drape overlying the patient's right leg was burnt underlying the plastic Bovie canister that had been clamped to the drape using a triple tooth tenaculum. The note identified that upon removal of the drape the patient's right thigh was noted to be burnt in two places (5 X 1 CM). The note identified it appeared the Bovie cord was punctured and conducted electricity to the tenaculum.

The surgical history and physical (H&P) dated 4/11/23 identified patient #1 sustained full thickness burn to right thigh from an electrocautery wire during an elective surgery cervix biopsy. The H&P identified a plan for the patient to return to the operating room for excisional debridement of wound and admitted after surgery for intravenous antibiotic therapy.

A second operative note dated 4/11/23 identified patient #1 had a pre -operative diagnosis of full thickness burn wound to right medial thigh and noted the procedure completed as debridement, excision of skin and subcutaneous tissues of the right medial thigh full thickness burn wound. The note identified the burn was excised in a full thickness manner creating one wound of 7 CMS to 2 mm deep.

The wound consult note dated 4/11/23 at 4:03 PM identified patient #1 was seen after sharp debridement of third-degree thermal burn to the right medial thigh. The wound note indicated the wound was adequately debrided and without infection or necrosis. The wound consult note further identified recommendations to consult with plastic surgery to address options for skin grafting.

Review of an Email communication dated 4/11/23 sent to operating room staff identified that effective immediately (4/11/23) Alice clamps were the only approved instruments to be used in securing surgical drapes. The email further indicated that Edna clamps (non-penetrating towel clips) would be added to the surgical sets and would be the standard going forward. Additionally, the email directed that Bovie cords must be inspected prior to use.

In an interview with Director #2 (perioperative services) on 4/13/23 at 10:40 AM the Director identified that following the incident patient #1 was seen by MD #2 (medical director - trauma surgeon) to evaluate the 3rd degree burn. Director #1 identified the incident was disclosed to the family and indicated that an investigation of the incident revealed that the tenaculum clap was utilized for securing drapes and wires from the cautery machine which was not the indented use for the clamp. Director #2 identified that the plan of correction was put in place on the day of the incident to include education of staff on the use of non-perforating clamps (Alice clamps) when securing drapes, how to safely secure drapes, inspection of the Bovie cord before use, completion of fire safety procedures, as well as review of fire safety policy.

An interview with RN #1 (Scrub nurse) on 4/13/23 at 10:20 AM identified during preparation of patient #1 for the surgical procedure on 4/11/22 she used a snap clamp to secure the drapes and Bovie (cautery pencil) as was the practice. RN #1 stated during the procedure MD #1 (surgeon) requested the snap camp that was used to secure the cautery pencil and RN #1 replaced the snap/Kelly clamp with a tenaculum clamp that was given to her by the surgeon. RN #1 indicated that during the use of the cautery pencil MD #2 observed a break in the integrity of the drapes around the tenaculum clamp and unto the patient's thigh. RN #1 identified that the circulating and charge RN were notified.

An interview with MD #1(Surgeon) on 4/17/23 at 10:15 AM identified that during the surgical procedure he requested a second Kelly clamp that was being used to secure the drapes and provided a tenaculum clamp to be used in place of the Kelly clamp. MD #1 identified that during the use of the Bovie a defect was noticed in the drape and upon investigation a burn to the patient's thigh was noticed. MD #1 identified that the line to the Bovie pencil was examined and found to have a defect in the line. MD #1 stated that after the burn was identified the procedure was completed, the patient was transferred to post anesthesia care unit and MD #2(chief of surgery) was notified and wound care was consulted. MD #1 identified that a wound debridement (subsequent surgery) was completed and identified patient #1 would need a future skin graft.

An interview with MD #3 (Surgical Resident) on 5/9/23 at 9:30 AM identified as he was using the cauterizing equipment (Bovie) he noticed smoke in his periphery and stopped the procedure. MD #3 stated he was unsure of the origin of the smoke. MD #3 stated he noticed a hole in the drape in the shape of the tenaculum and on investigation identified a wound to patient #1's leg. MD #3 indicated he assessed the cord to the Bovie pencil and identified a perforation which he thought may have caused conduction of electricity to the tenaculum.

The tenaculum is a sharp point hook forceps surgical equipment used for holding and manipulating parts such as the cervix during a surgical procedure. The hospital failed to ensure the safety of the patient during a surgical procedure when a tenaculum forceps was not used for the intended purpose causing to puncture of the electrocautery cord with conduction of electricity through the tenaculum resulting in 3rd degree burns the patient's thigh.

Review of the manufacturer's warnings for the tenaculum forceps identified the device shall be used in accordance with the instructions for use. The warnings further identified that improper use of the device may cause serious injury.