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1001 SAINT JOSEPH LANE

LONDON, KY 40741

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and policy review, it was determined the facility failed to assure staff followed their policy titled "Safety/Oxygen Enriched" related to the use of extreme caution with flammable items and failed to ensure staff was knowledgeable of skin preparations which contained flammable ingredients. Interview with surgical staff (Operating Room Manager and Operating Room Assistant Manager) revealed staff was not knowledgeable that the ChloraPrep routinely used for surgical skin preparations in anesthetizing locations contained 70 percent alcohol and was a risk for surgical fires.

The findings include:

Review of the facility's policy titled "Safety/Oxygen Enriched" (dated 05/12/10) revealed the facility had a system in place for staff to use extreme caution with items that contained flammable ingredients (e.g., alcohol, benzoin, petroleum jelly, and aerosols). Even though an in-service had been conducted related to Surgical Preparation with ChloraPrep on 05/25/10, staff was unaware ChloraPrep contained alcohol and was a risk for surgical fires.

Review of the ingredients of the ChloraPrep used for patient preoperative skin preparation revealed a warning label placed inside each disposable kit. The warning label stated, "Keep away from fire or flame to reduce risk of fire." Further review of the label revealed ChloraPrep contained 2 percent Chlorhexidine Gluconate and 70 percent v/v Isopropyl Alcohol (a flammable ingredient).

Interview with the Operating Room (OR) Manager on 07/21/11, at 2:00 PM, revealed the OR did not use alcohol based skin preparations. The OR Manager stated the facility changed from Iodine skin preparation approximately one year ago to ChloraPrep. According to the OR Manager, ChloraPrep did not contain alcohol.

An interview was conducted on 07/21/11, at 2:05 PM, with the OR Assistant Manager, who stated the facility did not use alcohol based skin preparation during surgical procedures. The Assistant OR Manger confirmed Chlora Prep was routinely used for skin preparation prior to surgical procedures. According to the Assistant Manager the Chlora Prep did not contain alcohol.

Observation of a surgical procedure (needle directed left breast biopsy) conducted on 07/22/11, at 11:55 AM, revealed the Circulator Nurse performed the ChloraPrep skin preparation prior to the surgical procedure. Further observation revealed the Circulator Nurse placed a sterile towel under the patient's left breast to absorb drips during the application of the ChloraPrep. The soiled towel was removed and another sterile towel was placed under the patient's left arm/breast prior to draping the patient. During the procedure, the Circulator Nurse stated the sterile towel was routinely placed under the drape to absorb drips. According to the safety points (for the product ChloraPrep), towels should be removed before draping.