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 a review of facility documentation, staff interviews and a tour of the operating suites, the facility failed to ensure a sanitary environment was provided as two OR suites were linked by a sterilization room that had no doors. Both ORs and the sterilization room were used regularly. In addition, immediate use steam sterilization was used without regard for current professional standards or facility policy and without biological indicator testing.

Findings were:

In an interview with Staff #1, the facility CEO, on the afternoon of 2/3/15 in the administration conference room, regarding a recent survey from an accrediting service, she stated, "We had a visit from [an accreditation service] last week. The woman [referring to surveyor] decided our OR set up suddenly wasn't OK..." The CEO stated that the hospital performs approximately 83 surgeries per month. "It's generally 15 a week that are actual surgeries. Those tend to be ortho cases or c-sections, and general surgery cases ... "

In the same interview, Staff #2, the facility CFO, stated, "Let me tell you what we've done to address this since they [the accreditation service] were here. We have one OR open that we're using for emergency situations. While one OR is closed off, we're working on fixing up the other one. We've put up two plastic barriers now. The inner one - the one that's on the sub-sterile room side [referring to the "flash" sterilization area] - has a zipper. That was the first barrier we set up while [the accreditation service] was here, and that was the one she had an issue with. So now we've set up a second plastic barrier that's solid on the OR side - on the outside of the zippered barrier...We did one c-section this week in OR 2 - actually I think it was this morning - because it had already been arranged..."

A tour of the OR 1 and OR 2 suites with Staff #1-4 at approximately 2:30 p.m. on 2/3/15 revealed they were connected by a sterilization room which contained an autoclave. The sterilization room had no doors and essentially was an open hallway between the two ORs. The sub-sterile sterilization room had been used to sterilize contaminated instruments and equipment from the ORs. The physical design of these areas presented a risk for cross contamination.

A tour of OR suite 2, the room in which a c-section had been performed that morning, with Staff #3, the Director of Nursing, and Staff #4, the OR Director, revealed a solid plastic barrier taped over the door of the sub-sterile "flash" sterilization area with duct tape. The part of the plastic not taped to the wall had been glued which left an approximate 4" to 6" flap of loose plastic beyond the glue. The duct tape, already coming up at the edges and on the floor, left sticky residue on the floor and walls which made cleaning impossible. In addition, it was not clear the back of the plastic overlap was included in the cleaning. When these issues were pointed out to Staff #3 and #4, they agreed that both items posed problems.

The issue was discussed with Staff #2 following the OR tour on the afternoon of 2/3/15. He stated he understood the problem and immediately got hospital construction workers to remove the solid plastic barrier covering the sub-sterile area of OR 2. The solid plastic sheet was then glued to the inside of the door frame of the sub-sterile area with the zippered plastic sheet placed on top of that. This presented a solid plastic surface inside the doorframe of OR 2, but with no tape and no plastic overlap

OR 2 was again toured with Staff #3 and #4 at approximately 4:10 p.m. on the afternoon of 2/3/15. It was found to be as described above. With this modification, the problem posed by the airflow from the open sub-sterile area into either OR seemed to be temporarily addressed and no longer appeared to be an immediate jeopardy to the safety of patients undergoing procedures in the suites.

The above findings were confirmed in an interview with the facility CEO and other administrative staff on the afternoon of 2/3/15 in the facility conference room.

Cross refer standard deficiency 482.42(a)(1) Infection Control Program.
Based on a review of facility documentation, staff interviews and a tour of the operating suites, the facility failed to ensure an adequate system to control infections and communicable diseases in patients by failing to follow its own policy regarding the sterilization of surgical instruments.

Findings were:

In an interview with Staff #4, OR Director, on the afternoon of 2/3/15 in the facility conference room, she was asked about the use of the term "flash" sterilization area to describe the sub-sterile area between the two OR suites containing the autoclave. She was also asked when the sterilizer was actually used. She stated, "We don't really "flash" anything. I keep trying to get the staff to get away from using that term. That autoclave is just used when a tool is dropped or maybe for eye day. Our doctor who does eyes brings in his own equipment. And if a rep brings in a specific tool and we're borrowing it and it's needed for a second surgery - then it might be done...Our rep for that autoclave told us it's not a gravity sterilizer, or something like that, so it's not true flashing. It's a full-steam cycle, it's just the drying time that might be a problem." When asked about the issue of not being able to obtain results of a biological indicator test prior to allowing the instruments to be used, she stated, "No, that's not an issue."

A review of an undated letter from Getinge, the company that supplied the hospital with the sterilizer, included the following, in part, "Upon receiving call from staff on concerns brought to their attention I was asked to verify cycle type being used by OR staff for sterilization. I arrived on December 22, 2011 and verified that Customer was using a full steam cycle consisting of a 4 minute exposure and the necessary dry time needed to get instruments dry enough for follow-up cases.

The unit that is currently installed is a Model 433HC Pre-Vacuum sterilizer capable of running full prevac loads and also has capability of flashing instruments using a gravity/flash setting.

Returned to Facility on January 3rd, 2012 to again verify that customer was still using the Pre-Vacuum cycle as designed and have properly in-serviced staff that a Flash/Gravity Cycle is to only be used when an emergent situation arises or Manufacture specifications say to do so..."

A review of the Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, revealed the following: "Flash sterilization is a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal. To address some of these concerns, many healthcare facilities have done the following: ...used biological indicators that provide results in 1 hour for flash-sterilized items...Flash sterilization is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use. It also is used when there is insufficient time to sterilize an item by the preferred package method. Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time...Because of the potential for serious infections, flash sterilization is not recommended for implantable devices..."

The facility's Steam Sterilization Record Keeping Envelope contained Getinge BIOSIGN SSI Test Pack stickers with the date of use. The following is an excerpt from the Getting Biosign SSI Test Pack website:

Biosign? SSI Test Pack with instant read and 24 hour Biological result ...Product Specification ...
A test pack specifically designed for biological testing and monitoring of 132?C pre-vacuum steam sterilization cycles ...The product gives the user instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters ...
The BIOSIGN? SSI TEST PACK with instant read contains a BIOSIGN? Steam-24 Biological Indicator (BI) and an INSTANT READ Integrator Record Card ...The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters (i.e., temperature - surveyor addition) when the color changes from PURPLE (FAIL) to GREEN (PASS) ...
3 Easy Steps: ...
3. Activate ...the BI and incubate for biological results in 24 hours...
Note: Biosign SSI Test Packs are not recommended for monitoring flash sterilization cycles."

In a review of the Steam Sterilization Record Keeping Envelopes for the autoclave in the sub-sterile area of the OR suites, the envelope of 1/7/15 included a sticker for the Gentinge BIOSIGN SSI TEST PACK which had turned green. The envelope had two boxes toward the upper right of the front side which stated:
"Constant Read CI (chemical indicator): PASS (Green) FAIL (Purple)
BI (biological indicator) Results: + Growth (Yellow) and - No Growth (Red/Purple)"

The word "PASS" was circled in the CI box. Nothing was circled in the BI Results box. In a telephone interview with Staff #4, the OR Director, at 3:25 p.m. on 2/5/15, she confirmed that there were no biological indicator results available for 1/7/15. On that date, the autoclave had been used to sterilize instruments for two patients.

On 1/21/15, a date the OR Director identified as an "eye day," meaning all procedures that day were eye-related and performed by the only physician who performs procedures on eyes at the facility, the documentation on the Steam Sterilization Record Keeping Envelope read as follows:
Load 1: "Bowie Dick Test "
In the upper right area of the envelope was the box which read:
"BI Results: +Growth (Yellow) and -No Growth (Red/Purple)"

The area "-No Growth (Red/Purple)" had been circled indicating a negative result for the biological indicator results of the test. The Bowie Dick Test is not a test involving biological indicators. Thus, the documented result was inaccurate. In the same telephone interview noted above, when the OR Director was asked why the biological indicator results were marked as positive next to a Bowie Dick test, she stated, "I don't know why that's there." When asked if there was a biological indicator test result for 1/21/15 for the autoclave, the OR Director stated, "No, there's no biological results for that day." On that date, the autoclave had been used to sterilize instruments for 14 patients.

In January 2015, the autoclave in the sub-sterile area of the OR suites was used to sterilize instruments a total of 29 times up to and including 1/27/15. No biological indicator results for the autoclave under discussion were available for surveyor review for the month of January 2015.

Facility policy entitled Immediate Use Steam Sterilization, no effective date, included the following, in part:
"On a daily basis, the Orderly/SNA shall perform a biological indicator test (ATTEST) in a flash cycle and record the results appropriately. Any potential sterilizer failure shall be reported to the Surgical Services Manager immediately..."

The above findings were confirmed in an interview with the facility CEO and other administrative staff on the afternoon of 2/3/15 in the facility conference room.