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Based on observation and interview, the hospital was not found to be in compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41). The hospital failed to comply with the Life Safety Code requirements. Findings included:

LIFE SAFETY CODE
The hospital was found not in compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) as evidenced by deficiencies issued as a result of a Life Safety Code Inspection. The hospital was found not in compliance with 42 CFR, Subpart 482.41(b), Life Safety from Fire, and the 2000 edition of National Fire Protection Association (NFPA)101, Life Safety Code (LSC), Chapter 19 existing Health Care Occupancies.

During the facility tour on 1/24/11, from 1:30 p.m. to 4:30 p.m. observations were made of non-compliance with LSC:

See the following K tags: K-0011, 0017, 0020, 0029, 0030, 0033, 0038, 0052, 0056, 0057, 0072, and 0076.

These deficient practices was verified by the Senior Manager of Maintenance Operations at the time of the inspection.

Based on observation, interview, training record review, and policy review, the hospital failed to ensure infection control policies were developed, and practices implemented, to promote sanitary conditions for 2 of 2 patient's observed during surgery (P2, P3), and failed to ensure sanitary conditions were maintained in the kitchen. Findings include:

During observation of 2 of 2 surgical procedures in the Surgical Suite the hospital did not ensure appropriate infection control practices related to surgical attire were followed.

P2 was observed while undergoing a right total knee replacement on 1/25/11, at 8:05 a.m. Although the RN-A had a surgical hat on, some hair was uncovered and visible on the back of her head. A Certified Registered Nurse Anesthetist (CRNA-A) had a surgical hat on, however, hair was visible on her forehead and on the back of her head.

P3 was observed while undergoing a laparoscopic cholecystectomy on 1/25/11, at 9:55 a.m. Both Registered Nurses in the operating room (RN-B and RN-C) wore surgical hats, however hair was visible hanging out of the back of their hats. RN-B wore a watch and a ring on her left hand, which were visible and had been worn while completing a surgical skin prep.

The hospital policy, "Operating Room Attire/Hygiene," last reviewed 2/10, indicated all head and facial hair was to be completely covered when in semi-restricted and restricted areas. The policy also indicated all personnel entering semi-restricted areas of the surgical suite should have all jewelry and watches confined within the scrub attire or removed.

The Operating Room Director was interviewed on 1/27/11, at 10:30 a.m. She stated all hair should be covered while staff are in the operating room suite and jewelry should not be worn while completing surgical skin prep.


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A tour of the kitchen was conducted on 1/25/11, at 8:40 a.m. with the dietary manager. The following was noted:

There were two of two "Heat on Demand" low-raters that had surfaces which were un-cleanable and in ill-repair. Each cart held trays that had the capability of holding heat for hot foods and each cart had a black rubber seal around the edge. The first cart had black tape around the edges of the black rubber. The black rubber had split and the tape was holding the rubber together on the cart. The tape was not adhering to the edge in some places. The cart did have trays in it ready for food service. The dietary manager indicated the surface would not be cleanable with the tape on the cart.

The second cart had a black rubber seal around the edge of the cart. The black rubber was split at the corners. The cart did have trays in it ready for food service. The cracked rubber rendered the low-rater uncleanable. The dietary manger indicated she would send a slip to maintenance for repair.

The flour, rice, and sugar bins all had scoops left in them. The dietary manager stated a month ago, all of the staff had been in-serviced about not leaving the scoops in the bins. She also indicated this was not acceptable practice.

The in-services records were reviewed. On 12/20/10, an in-service was held for the dietary staff to protect the food from becoming contaminated from utensils left in the bins. The education consisted of not storing a scoop in the flour, sugar and rice bins as it was,"against the health department regulations." The scoops were to be stored in an accessible area near the food bins.

The work standard (policy) for the storage of scoops dated 12/20/10, directed the staff to store all scoops in a separate bin separate from the rice, flour and sugar bins.

Based on observation, interview, and record review, the hospital was found not to be in compliance with the Conditions of Participation of Surgical Services (CFR 482.51) due to failure to develop and implement policies/procedures related to the use of alcohol based skin preparations in anesthetizing locations to prevent the risk of surgical fires for 3 of 3 (P2, P3, P50) patients. Findings include:

Refer to findings at A-0951 regarding lack of policies/procedures related to the safe use of alcohol skin prep solution.

The hospital did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) issued a Survey and Certification Memo on 1/12/07, addressing risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations in not considered safe, unless appropriate fire risk reduction measure are taken, preferably as part of a systemic approach by the hospital to preventing surgery related fires.

P2 was observed on 1/25/11, at 9:05 a.m. as the surgical site was prepped with Dura-Prep (an alcohol based skin preparation) prior to a right total knee replacement. The RN-A did not document the time the skin preparation was applied nor the time the RN-A had verified the skin prep was dry.

P3 was observed on 1/25/11, at 10:26 a.m. as the surgical site was prepped with Dura Prep (an alcohol based skin preparation) prior to undergoing a laparoscopic cholecystectomy. The RN-B did not document the time the skin preparation was applied nor the time the RN-B had verified the skin prep was dry. RN-B began to prep the entire abdominal area, including the lower abdomen, at 10:26 a.m. and completed the skin prep at 10:29 a.m. Some of the prep solution had dripped down the sides of the patient's abdomen. At 10:30 a.m. a physician's assistant (PA) and a certified surgical technologist (CST) applied a surgical drape over the patient's lower abdomen, which had just been prepped with the alcohol-based solution. RN-B had not visualized the area which had been prepped, to determine the prep solution was dry, prior to the area being draped.




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P50 was observed during a surgical procedure at 8:10 a.m. on 1/27/11. The patient's groin areas were observed to have been cleansed with DuraPrep prior to puncture for a femoral catheter placement to conduct an angiogram. The area was observed to have been allowed to dry for greater than three minutes prior to the insertion of the catheter. A time-out procedure was utilized. However, an interview at 8:10 a.m. on 1/27/11, with tech-E stated there was no specific procedure in place to document that the DuraPrep was dry.

On 1/26/11, at 10:45 a.m. an interview was conducted with the Senior Director of Surgical Services and the Operating Room Director regarding the policy/procedure for use of alcohol based skin preparations. They verified the hospital was using alcohol based skin preps in surgical cases, based on the surgeons' preference on the type of skin prep to be used. They stated the hospital had not developed a policy related to the use of alcohol based skin preparation solutions within areas where anesthesia was administered. They stated the staff do not document in the patient record verifying the appropriate procedures were followed to ensure the proper use of the alcohol based skin preparation prior to the surgical procedure.


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Based on observation, interview, record review and policy review, the hospital failed to ensure proper procedures were followed for 3 of 3 patients (P2, P3 and P50) related to the use of alcohol based skin preparation agents in anesthetizing locations to prevent the risk of surgical fires. Findings include:

The hospital did not develop nor implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) issued a Survey and Certification Memo on 1/12/07, which addressed risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measure are taken, preferably as part of a systemic approach by the hospital to prevent surgery related fires.

P2 was observed on 1/25/11, at 9:05 a.m. as the surgical site was prepped with Dura-Prep (an alcohol based skin preparation) prior to a right total knee replacement. The RN-A documented the type of skin prep solution which had been used in the electronic medical record. However, the RN-A did not document the time the skin preparation was applied nor the time the RN-A had verified the skin prep was dry. RN-A was interviewed at 9:25 a.m. and stated she was not aware of any policy/procedure related to the use of alcohol based skin preparation agents. She stated the time the skin prep was applied and the time it was determined to have dried was not documented. She stated staff were directed to wait three minutes before applying surgical drapes, as recommended by the manufacturer of the product.

P3 was observed on 1/25/11, at 10:26 a.m. as the surgical site was prepped with Dura Prep (an alcohol based skin preparation) prior to undergoing a laparoscopic cholecystectomy. RN-B began to prep the entire abdominal area, including the lower abdomen, at 10:26 a.m. and completed the skin prep at 10:29 a.m. Some of the prep solution had dripped down the sides of the patient's abdomen, as there was no material to absorb the excess prep solution. At 10:30 a.m. a physician's assistant (PA) and a certified surgical technologist (CST) applied a surgical drape over the patient's lower abdomen, which had just been prepped with the alcohol-based solution. RN-B had not visualized the area which had been prepped, to determine the prep solution was dry, prior to the area being draped. RN-B was interviewed at 10:35 a.m. and stated staff did not document the time the alcohol based prep solution was applied nor the time it was dry. A review of the patient's electronic medical record indicated the type of prep solution had been documented, however, there was no documentation of the time the prep solution had been applied nor the time the solution had been determined to have dried. She stated she was not aware of any policy/procedure related to the use of alcohol based skin preparation solutions. She stated she routinely waited three minutes before applying surgical drapes to the area which had been prepped per the manufacturer's recommendations. She verified she had not visualized the surgical site to ensure the prep solution had dried, prior to the placement of the first surgical drape.


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P50 was observed during a surgical procedure at 8:10 a.m. on 1/27/11. The patient's groin areas were observed to have been cleansed with DuraPrep prior to puncture for a femoral catheter placement to conduct an angiogram. The area was observed to have been allowed to dry for greater than three minutes prior to the insertion of the catheter. A time-out procedure was utilized. However, an interview at 8:10 a.m. on 1/27/11, with tech-E stated there was no specific procedure in place to document that the DuraPrep was dry.


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On 1/25/11, at 12:50 p.m. RN-D and RN-E were interviewed regarding the use of alcohol based preparations in the outpatient surgical department. Both RN's D and E stated the outpatient surgical services followed the policies of the surgical services of the hospital. The procedure indicated any areas of the body that received an alcohol based preparation were allowed to dry for three minutes prior to draping the patient. Both RN's further added there was no place on the forms in the medical record to document the procedures taken related to use of alcohol based skin preparation.

The ambulatory surgery manager was interviewed at 9:00 a.m. on 1/26/11. She stated that all staff were aware of the need to wait at least 3 minutes to ensure that areas cleansed with alcohol based preparations were dry prior to start of surgical procedures. She also stated the outpatient surgical department utilized the hospital's overall surgical policies related to the use of these products. The ambulatory surgery manager verified she had been unaware of the requirement to document that the alcohol based preparation was dry.

At the time of the survey conducted by the State Agency on January 24-27, 2011, the Surgical Services Conditions of Participation (CoP) was reviewed and there was discussion regarding the use of alcohol based skin preparations in anesthetizing locations. The hospital did not have a policy/procedure at that time that specifically addressed the use of the alcohol based skin preparations and the appropriate fire risk reduction measures to be taken to prevent surgical fires per recommendations of the S&C Memo 07-11. At that time, there was discussion regarding the need to document the implementation of the procedures in the patient record in order to be in compliance with the federal regulations.

The Senior Director of Surgical Services and the Operating Room Director were interviewed on 1/26/11, at 10:45 a.m. The hospital policy, "Infection Control-Work Practices, Care Practices, Equipment and Supplies, Sanitation, and Quality Management," last reviewed 12/2010, was reviewed. Although the policy addressed various surgical skin preparations, it did not address the use of alcohol based skin preparations. The Senior Director and the Operating Room Director stated the hospital did not have a policy related to the use of alcohol based skin preparations in anesthetizing areas. They stated the time the prep solution was applied and the time the area was determined to be dry was not documented. They also verified this was not addressed as part of the pre-operative "time out" which was used to verify other essential information to minimize the risk of medical errors
during the procedure.