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Based on document review, interview and observation, it was determined that the governing body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The governing body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:

Cross reference: CFR 482.42 Infection Control

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Based on observation and staff interview it was determined that the facility failed to clean and maintain walls, floors and equipment to ensure a clean, safe and sanitary environment for patient care services in surgical suites and sterile storage rooms.

Findings include:

1. On 1/9/13, base bumper guards at the entrance to the substerile room located between OR #4 and #5 were noted detached from the wall perimeters.

2. The storage room located in the 'Cysto' room was observed with heavy dust accumulation on the floor perimeters and on the storage rack.

3. On 1/9/13 at 12:45 PM, the OR Post Anesthesia Care Unit (PACU) was without hot running water. Three handwash sinks stationed in the unit and one handwash sink located in the bathroom were all without hot running water.

Based on observation, staff interview, review of facility policies and procedures and a review of equipment manufacturer's recommendations it was determined that the facility failed to ensure that all equipment is maintained to an acceptable level of safety and quality.

Findings include:

Reference #1: AAMI ST 79 section 5.3 on 'Disposition of sterile items' states, "Disposable items that have been opened or that have damaged packaging should be discarded; such items should not be reprocessed unless the manufacturer provides written reprocessing instructions and all FDA requirements for the reprocessing of single-use items are met."

1. A review of weekly surveillance records for sterile storage room, 'ENT Supply Room' and interview with Staff # 17 conducted on 1/9/13, revealed that the ENT storage room is checked for cleanliness, proper storage and proper labeling weekly.

a. On 1/9/13 at 1030 AM, one reprocessed peel package of an endobronchial suction catheter was observed being stored in the 'Flexible Bronchoscopy Cart' located in the ENT storage room. This specific catheter later identified as single-use 'Covidien Mallinckrodt Endobronchial Suction Catheter' was noted with a sterilization sticker label which revealed that the catheter was reprocessed in Sterrad on Feb 25, 2004. Staff # 18 was not able to provide an explanation why this single-use item was reprocessed.

b. Manufacturer's written reprocessing instructions were not available upon request for this specific single-use item.

c. This item was not identified in the weekly survellance rounds.

Reference #2: AAMI ST 79 section 7.2.2 on 'Manufacturer's instructions' state, "The written recommendations of the device manufacturer should always be followed."

1. On 1/9/13 at 11:15 AM, numerous reprocessed 'Laryngeal Mask Company Limited' Laryngeal masks were observed stored in locked OR anesthesia cart identified as 'difficult intubation.' The manufacturer of 'Laryngeal Mask Company Limited' recommends "the masks are to be used a maximum of 40 times before being discarded. Continued use beyond the maximum times is not recommended as degradation of the components may result in impaired performance or abrupt failure of the device." Proper reprocessing documentation was not available for 1 out of 3 laryngeal masks.

2. Manufacturer, 'The Laryngeal Mask Company Ltd' instructions state, "The following procedures are essential to ensure sterilization without damage to the LMA-Fastrach: 1. Immediately prior to steam autoclaving, remove all air from the LMA-Fastrach cuff. Carefully insert a syringe into the valve port and fully deflate the cuff, so that the cuff remains tightly deflated. CAUTION: If a deflated mask immediately and spontaneously reinflates, even slightly, do not autoclave or re-use the mask."

a. On 1/9/13, 2 peel packaged LMA-Fastrach cuffs observed in the OR 'difficult intubation' anesthesia cart were noted fully inflated. Staff #18 was not familiar with the deflation procedure required by the manufacturer of the LMA-Fastrach prior to steam autoclaving.

3. Manufacturer instructions of 'Riley FLASHPAK' state, "DAILY: The container should be washed with a surgical instrument detergent, rinsed with tap water and dried with a soft absorbent towel. If desired, the container may also be processed through either a washer/sterilizer or a washer/decontaminator as necessary. "On 1/9/13, at 11:45 AM, a total of 3 'Riley FLASHPAK' containers were observed stored in the substerile room located between OR # 4 and #5. All three containers appeared to be in used and in unclean condition with accumulation of old steam buildup in the interior surfaces. Staff #18 stated that the Flashpaks are being sent down to the sterile processing department weekly to be cleaned. Staff #18 stated that he/she does not keep track how many Flashpaks are sent down from the OR to be washed every week, was unaware of total number of Flashpaks available for use in the OR. Specific policies and procedures on proper use, handling and maintenance of FLASHPAK containers have not been developed by this facility.

Reference #3: AAMI ST 79 section 8.9.2 on 'Storage facilities' state, "Sterile items should be stored in a manner that reduces the potential for contamination. In general, the temperature in storage areas should be approximately 24°C (75°F). There should be at least 4 air exchanges per hour and relative humidity should be controlled so that it does not exceed 70% (AIA 2006)."

1. Based on a tour of the new OR sterile storage room and interview with Staff # 41 on 1/9/13, it was determined that the temperature and the relative humidity is not being monitored by staff in the new OR sterile storage room.

Reference #4: The CDC Guideline for Prevention of Surgical Site Infection, 1999, (d) Sterilization of surgical Instruments, (2) indicates; perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional sets, or to save time.

1. Based on a review of Flash sterilization records for January 2012 through September 2012, it was determined that flash sterilization of orthopedic surgical instrument trays (Total knee trays, Hip trays) occurred 17 to 33 times each month due to sets having been used previously and the lack of available additional instrument sets for use. Staff # 1 and # 4 indicated that the facility/physicians have been reluctant to alter scheduling practices to accommodate the routine and desired sterilization processing parameters required until capital budget purchasing of additional instruments has been completed.

Based on observation, staff interview, and review of documentation on January 9, 2013, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program has not adequately implemented the Association for the Advancement of Medical Instrumentation(AAMI) standards that were selected by the facility.

The Condition of Participation for Infection Control is not met.

Findings include:

1. The facility failed to provide and maintain sanitary environment to avoid sources and transmission of infections and communicable diseases. (Cross refer to A0701)

2. The facility failed to implement nationally recognized infection control guidelines. (Cross refer to A0724)