The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

Based on observation, staff interview, review of policies and procedures, and review of the instrument inspection and sterilization logs, the facility failed to thoroughly address areas of infection prevention related to keeping sterilized ENT surgical instruments free from biofilm. The facility further failed to use single use brushes for single use and failed to maintain complete records of sterilization processes. The findings were:

According to AORN 2012 Perioperative Standards and Recommended Practices, "Care of Instruments, Recommendation IV, section IV.a., "...Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved."

During an interview on 7/29/14 at 12:05 PM the quality director stated biofilm (a thin coating containing biologically active organisms which coats the surface of surgical instruments and medical devices) was found on 5/6/14 on an ENT instrument that had completed the sterilization process. He stated it was determined no patient harm resulted from the incident and all of the sterilized and packaged ENT surgical sets were inspected and re-sterilized. He further stated after the initial inspection of all sets was completed on 5/7/14 and 5/8/14, a process for random inspections was implemented. Review of the action plan that was developed as a result of the incident showed it was revised on 7/15/14. This review also showed the incident was reported to the state infectious disease specialist, a new enzymatic dispenser was installed for cleaning, additional sterile processing staff was hired, staff training was provided, and a post-sterilization inspection process was implemented.

The following concerns were identified regarding the facility's response to this identified problem:

1. Review of the report of investigation of the incident, action plan and instrument inspection log revealed no evidence of identified goals or system for evaluating the effectiveness of the measures that were implemented.

2. According to Policy # 5, titled, "Recall of Contaminated Sterilized Goods", dated July 2014, "Those items in the involved sterilized load will be searched for and removed from the shelf and re-done." Review of the load and instrument inspection logs revealed the items that were sterilized with the soiled instrument were not removed from the shelf and re-done in accordance with this policy. During an interview on 7/30/14 at 2 PM the quality director confirmed this was not done. He further stated a root cause analysis was not done.

3. According to AORN 2012 Perioperative Standards and Recommended Practices, "Care of Instruments, Recommendation V", "Cleaning and decontamination should occur as soon as possible after instruments and equipment are used". During an interview on 7/31/14 at 2:30 PM, surgeon #1 stated sometimes used instruments were not washed and sterilized for one or more days, making it more difficult to remove dried substances. He further stated the post incident investigation did not address the issue of used instruments being left unclean for prolonged periods of time.

The following concerns were identified regarding the post sterilization inspection process that was implemented on 5/7/14:

1. Interview with sterile supply technician #1 on 7/29/14 at 11:50 AM revealed the newly implemented process entailed using a magnifying glass to inspect 3 randomly selected packaged instrument sets that had completed the sterilization process. He stated the results were documented in the instrument inspection log. He further stated it was unclear the time frame for the random checks. Review of the revised July 2014 policy showed the 3 random checks were to be done, but did not identify the interval (i.e. weekly, monthly or yearly) or the specific surgical instruments that were to be inspected using this process.

2. Review of the surgery log showed 41 ENT surgeries were performed from 5/11/14 to 7/29/14. Review of the instrument inspection log showed from 5/11/14 to 7/29/14, 20 sterilized packaged ENT sets were randomly selected for inspection with a magnifying glass. Rust was identified on one of the instruments on 5/14/14 (this was 5% of the sets inspected). Further review of the instrument inspection log showed only 4 sets were inspected on 6/11/14 and at no other time during that month.

The following concerns were identified regarding current practices:

1. Observation of sterile supply technician #2 during manual cleaning of used ENT instruments on 7/29/14 at 10:30 AM revealed he selected a used brush from a brush holder container that held four unpackaged used brushes. At that time he stated, these were the brushes that he used. When he completed the task he returned the brush to the holder. Interview the quality director on 8/6/14 at 8:48 AM revealed the brushes were single-use and should be discarded after use.

2. Review of the sterilization records showed on 5 days from 5/25/14 to 7/25/14 documentation was lacking in one or more of the following areas: the date/time of the process, chemical and/or biological indicator information, and lot number. Interview with sterile supply technician #1 on 7/29/14 at 11:50 AM confirmed the lack of documentation and stated the missing information made it difficult to know what actually happened during the sterilization process.