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Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases as evidenced by: failure to identify the extent of water infiltration following a leak in the sterile storage room, in order to determine possible water contamination of sterile instrument trays and provide appropriate environmental cleaning and decontamination (A0750).

Cross Reference:
482.42(a)(3)- Infection Prevention, Control, and Surveillance.

Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to identify the extent of water infiltration, following a leak in the sterile storage room ceiling, in order to determine possible water contamination of sterile instrument trays and provide appropriate environmental cleaning and decontamination.

Findings include:

Reference: ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 11.1.1, stated, "...Storage facilities...Sterile storage area should be kept clean and dry. ...Shelving, carts, and bins used for sterile storage should be maintained organized, clean, and dry. ...Rationale: ...Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces. ..."

Facility Procedure titled, "Storage of Sterile Supplies," Effective Date 12/31/24, stated, "...3. Procedure: ...4. Sterile packs shall not be subjected to sharp objects, moisture, ...or any other activity which could affect the sterility of the device. ..."

On 2/20/25 at 10:30 AM, a tour was conducted of the sterile processing room with Staff (S)3, S4, and S5. At 10:43 AM, an interview was conducted with S12, who stated that a leak had occurred from the ceiling of the sterile storage room during the early morning hours on Sunday, 2/16/25. An interview with S6, revealed that when he/she arrived to work on Sunday, 2/16/25 at 7:00 AM, the water was leaking "really hard," a "large bin" had been placed to capture the water, and he/she was told that the leak began around 11:00 PM. S6 stated that the leak occurred over the prepared case carts for Monday's operating room (OR) cases, and that all the contents and carts had been removed to be decontaminated during the night and resterilized during the day. S6 stated that he/she did not pull any additional trays contaminated by water, because "they were already pulled. Night shift did that part." S6 stated that when arriving to work, the racks of sterile trays on wheels had been pushed to the back of the room away from the water but were not covered. S6 stated, "I covered all the racks to make sure water didn't splash on the trays." S6 confirmed that there was no cover placed over the racks before he/she arrived at 7:00 AM. S6 stated around the leak "there were huge plastic bags coming from the ceiling, coming from high to the bottom" but he/she was not aware of the time the plastic was placed. When asked if there were any other leaks that occurred in the sterile storage room, S6 and S12 both stated, "there was only one leak."

At 10:50 AM, in the sterile storage room, with S3, S4, and S5, S4 stated, "yes, there was a water leak. We placed a protective barrier around to cover it. The dry water spots stopped about here ..." S4 indicated that water stopped prior to reaching a shelf which was bolted to the floor and contained sterile processed instruments, observed with sterilization dates prior to the water leak. "We protected the area and had an infection control person in on the weekend. It began after midnight, and by the morning a protective barrier was placed. All single use items were discarded. Our EVS [environmental services] cleaned up the area. A company is coming this evening to do additional cleaning." S3 stated "Our EVS already cleaned the area, but the outside company is repeating some processes to ensure we didn't miss anything." S8 was identified as the Infection Control person who responded on site Sunday morning, 2/16/25. When asked if any other leaks had occurred in the sterile storage area in the last week, S4 stated "no."

At 11:22 AM, an interview occurred with S8, in the presence of S3, S4, S5, and S7. S8 stated that the water started on the C4 unit above the Sterile Storage room. He/she stated that a toilet had been "tied into stormwater" and that rain had backed the toilet up, causing the leak. S8 stated that where the water came down to the sterile storage area "we built up a containment barrier around the leaking and continued with cleaning." S8 stated that he/she arrived to the sterile storage room on Sunday morning, 2/16/25, "around 11 AM. [Named S6] was still covering the shelves along with the charge nurse from the OR." On the stationary rack, observed within proximity of where the leak was noted to have been, five shelves with sterile instrument trays were observed. S3, S4, S5, and S8 confirmed the rack, which did not have wheels, was not moved away from the leak. At 12:07 PM, S3 stated that he/she "would not dispute that 70% [of the trays on the rack] were there that day [while the leak was occurring]." Instrument packs on the shelves were observed with sterilization dates occurring prior to 2/16/25, including but not limited to an "NBI Gyn Clamps Labey" tray with a date of 12/30/24 and an NBI Gyn Biopsy Punch" tray with a date of 10/3/2024.

When asked which area was cleaned, S4 indicated the area directly under where the leak had been, where the case carts were presently set up. When asked if anything around that area was cleaned, S4 stated "No." S4 indicated that a dumpster had been placed to contain the water. At 11:39 AM, down the center of the sterile storage room, discolored stain spots were observed on the lower shelf. A request was made to speak with Environmental Services (EVS) staff.

At 11:41 AM, in a supply room next to the sterile storage room, an interview occurred with S9 and S10 in the presence of S3 and S8. S9 stated that as a result of the water leakage that occurred on the morning of 2/16/25, "the area was draped off and remediated. We cleaned from this door all the way down to the barrier using 2 hospital grade germ aids. We pre-cleaned on Sunday at 3:00 PM, then did another cleaning that night." S9 stated that the 3:00 PM pre-cleaning was done "to the affected area," which S9 confirmed was the area underneath where the water leaked. On Sunday morning, "the plastic went up down to the floor. Debris and ceiling tiles were on the floor. We picked them up and out of the way. We removed the bulk of the debris. The carts were covered." S10 stated that he/she "moved the dumpster to clean underneath." After the 3:00 PM pre-cleaning, S9 and S10 confirmed that other than the normal nightly cleaning, no additional cleaning had been done to the sterile storage area. When asked if the shelves were wiped down within proximity to the water, S9 stated that EVS is not responsible for cleaning the shelves. At 11:56 AM, when asked who cleans the shelves in the sterile storage area, S3 stated, "EVS does" and S9 stated, "I don't do your shelves, sir." When asked if the stationary rack of shelves within proximity to the water leakage was cleaned, S3 stated, "We don't consider that area contaminated." S4 stated that the depth of the dumpster placed would have prevented splashing onto that rack. When asked when the dumpster was placed, he/she stated, "sometime Sunday." No one was able to identify the time the dumpster was placed. When asked what was being done to prevent the splashing from the time the water leak began [around midnight] until the time the dumpster was placed, S8 stated, "we used towels, blankets." Upon interview, at 12:56 PM, S3 and S5 confirmed that they do not have any documentation of who cleans the shelves in the sterile processing area, or of the last time they were cleaned.

At 12:19 PM, a second interview was conducted in the sterile storage area with S6. S6 stated that "around 9 AM, I covered the carts with plastic. There were towels and blankets on the floor." S6 confirmed that plastic barriers were not placed around the racks until he/she was able to do it around 9 AM. A staff member [S13] entered the sterile storage room, and S6 stated that S13 had been working on Sunday, the day of the leak. S13 stated he/she came into work around 7:30 AM and had been told the leak started around 11 PM. S13 stated, "At 7:30 when I came in, the dumpster was here. There were towels, blankets all over. The water was halfway down the room." At 12:30 PM, an ICRA (Infection Control Risk Assessment) for the Sterile Storage area was requested. S4 indicated that one had been completed for the C4 unit, but not for the Sterile Storage area.


At 3:00 PM, review of the invoice for the contracted cleaning company revealed that the area to be cleaned tonight is "Post Flood Clean Up: Technicians to clean all ceilings, walls, floors, and equipment found in the flood area." The facility failed to provide documentation or evidence that the flood area was restricted to the area underneath the leak only, and that water did not contaminate or splash the surrounding instrument trays or shelving.

At 5:27 PM, during exit conference, S5 stated that the cleaning invoice had been adjusted to include the entire sterile storage room. A request was made to provide documentation via email. Documentation was received on 2/20/25 at 5:56 PM, and now stated the following: "Sterile Storage Room Service: Clean all vertical and horizontal surfaces of the racks. Clean insides of all bins on shelf."

On 2/21/25 at 10:22 AM, during a telephone interview, the following was revealed by S19:

There were two incidents in the past week where the ceiling had leaked in the sterile storage area. The first occurred on Thursday, 2/13/25 around midnight, with water leaking from the ceiling above where the prepared case carts are placed. S19 stated that water was not pouring directly on the trays, but with the impact of water gushing, there could be splatters of water that dry but still contaminate. S19 stated, "The water smelled. Staff had to put on plastic bags to cover themselves." S19 stated that "if any kind of water goes in sterile storage, the trays are to be reprocessed," but that sterile processing staff were instructed to hold off on reprocessing anything that was not wet until the water was evaluated. S19 stated that Plant and Engineering notified sterile processing staff that the water was sewage water, that leadership was notified, and sterile processing staff were instructed only to reprocess the case carts which were directly under the leak. S19 stated the water leak stopped in the early morning.

S19 further stated that another leak occurred on the night of Saturday, 2/15/25, in the same area of the sterile storage area. He/she stated that in the morning of 2/16/25, "the flood was still bad. Water was splashing all over the place." S19 stated he/she was told that the water was "category 3 [contaminated] water, coming from a toilet." S19 stated that staff were again notified by leadership that until they were able to tell if the water was clean or dirty, they did not need to reprocess the instruments, and that a hygienist was coming to check the water. On Monday, 2/17/25, during a huddle with leadership and infection control, sterile processing staff were notified that the trays within proximity to the leak did not need to be reprocessed.

On 2/24/25 at 10:20 AM, an interview occurred with S17. The following was revealed: There were two water leaks in the ceiling of the sterile storage area; one on Thursday night, 2/13/25, and one on Saturday night, 2/15/25. The leak on Thursday also originated from the unit on the 4th floor. S17 stated that on 2/14/25, upon opening the ceiling in the Sterile Storage Room on the 3rd floor, they learned that the plumbing from the 4th floor toilet was incorrectly tied into a 4-inch storm drain. S17 indicated that they were able to unclog the drain, and the water receded, so they believed that the clog was repaired. However, on Saturday into Sunday, water entered through the storm drain and caused another leak, making the facility aware that further repair was needed. When asked if the plumbing had been corrected, S17 stated "yes" however, he/she was unable to provide a work order and indicated that he/she would have to reach out to the vendor. S17 indicated that the facility does not keep internal work orders when leaks are repaired. The vendor work order, indicating the plumbing repair, was not received by survey exit on 2/24/25. When asked if the facility performed any type of water testing, S17, stated "no, the water was cold and visually clear."

At 11:12 AM, a telephone interview occurred with S21 [facility's contracted construction staff member]. S21 stated that when his/her employee was here on Sunday morning (2/16/25) around 7:30 or 8 AM, "water was overflowing [from the toilet on C4] coming from the toilet seal...wouldn't stop, we were HEPA vacuuming it until the plumbers got here." S21 stated that when he/she arrived to the sterile storage area around 10 AM, "I went down and [named employee] already set up containment. Somebody from the hospital already put a garbage disposal [there]. There was some water on the floor. S21 stated, "the water coming from the toilet was pretty clean. But whenever you see a seal broken [from a toilet] or overflow you treat it like a category 3." When asked if anyone from the facility was notified that the water was category 3, S21 stated, "Everyone saw water coming from the toilet. I didn't think I had to tell anyone. [Named S8] was there. [Named S8] saw the water overflowing."

At 1:14 PM, during an interview with S4 he/she stated when staff are unsure if water was in contact with an instrument, "when in doubt, we should reprocess." S4 stated the decision to reprocess instruments is made by "Central Sterile [named S3 and named S5] or Infection Control would make the decision." S4 confirmed that following the flood beginning on Saturday 2/15/25 around 11 PM, the day and afternoon staff were interviewed regarding the extent of the water infiltration, and the night staff was not interviewed. When asked if there was an ICRA (Infection Control Risk Assessment) for the sterile storage room, S4 stated he/she completed the ICRA for the sterile storage room on Thursday, 2/20/25, after it was requested by the surveyors, and confirmed that "once the repair started, we should have had the ICRA." The ICRA was provided to the surveyors on 2/24/25.

At approximately 4:00 PM, S1 stated that following surveyor tour on 2/20/25, the SPD staff had begun reprocessing the instruments on the stationary rack within proximity to the leak, out of an abundance of caution. On 2/24/25 at 4:26 PM, a tour was conducted of the sterile storage room. The stationary rack with 5 shelves, located in proximity to the leak, now contained sterile processed trays all dated beginning 2/20/25. A request was made to view the sterilization records from the reprocessed items. The sterilization records provided documented that on 2/20/25, the sterilization trays began decontamination between 3:34 PM and 4:27 PM, following surveyor tour of the sterile storage area. The facility failed to identify the potential for water contamination of the stationary rack until 2/20/25, four days after water exposure.

The facility failed to identify the exposure of the instrumentation surrounding the water leak from the time it began, approximately 2/15/25 at 11:00 PM, until the time the leak was contained, on 2/16/25 between 7:45 AM and 9 AM.