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Based on observations, staff interviews, review of facility documents and review of nationally recognized guidelines, it was determined that the facility failed to ensure: 1) that humidity levels are monitored and maintained in accordance with facility policy and nationally recognized guidelines; 2) sterile storage carts had a solid bottom shelf, in accordance with the Association for the Advancement of Medical Instrumentation (AAMI) guidelines and facility policy; 3) sterile supplies were removed from external corrugated cardboard boxes before being stored in the sterile storage area, in accordance with facility policy and AAMI guidelines; 4) packages containing surgical instruments are labeled appropriately prior to sterilization, in accordance with AAMI guidelines; 5) sterile peel-pouched packages are not bent or crushed, compromising the sterility of the contents in accordance with facility policy and AAMI guidelines; 6) all surfaces are maintained in a cleanable manner in accordance with centers for Disease Control and Prevention (CDC) guidelines; 7) environmental cleaners and disinfectants are used in accordance with the manufacturer's IFUs and CDC guidelines; 8) routine cleaning of operating room surfaces are performed after procedures in accordance with facility policy and The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice; and 9) expired items are not available for patient use, in accordance with facility policy.

Findings include:

On 8/28/25 at 09:54 AM, Staff (S)3 confirmed that the facility follows Centers for Disease Control and Prevention (CDC) Guidelines, The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, and Association for the Advancement of Medical Instrumentation (AAMI) guidelines.


1. Reference: The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, 2024 Edition, stated, "... Table 5. Design Parameters for Heating, Ventilating, and Air Conditioning ... Area ... Operating Room ... Temperature. 68 -75 [degrees] F [Fahrenheit] ... Relative Humidity 2-60% [percent] ... "

On 08/28/25 at 10:03 AM, during a tour of the Operating Room (OR) Suite accompanied by S2 and S3, it was observed that OR 4 was unoccupied. Upon entrance to OR 4, the thermometer reading was 63 degrees Fahrenheit, 54 % humidity.

Facility policy titled, "Temperature and Humidity (Revised August 2022)" stated, " ... Temperature /Humidity Ranges ... OR: 68-75 degrees Fahrenheit, max 60% humidity ... If any of the areas fall outside the recommended parameters departmental management, Infection control and Facilities are notified ... Facilities will make changes to the Building Automation system until temperature and humidity are in acceptable range. If acceptable ranges are unable to be restored within 4 hours the affected area will be taken out of service ..."

Upon request, S1 provided the temperature and humidity log for the OR suite for the month of August (all readings were documented as obtained at 07:00 AM), which revealed the following:

OR 1: On 08/18/25, the humidity level documented was 73%.
OR 2: the humidity level was out of range on all days in August, with the highest reading of 82.1% humidity recorded on 8/24/25 and the lowest reading of 63.8% humidity recorded on 08/27/25.
OR 3: the humidity level was out of range on all days in August except for 08/11/25 and 08/27/25. The highest humidity level recorded was 77.5% on 08/18/2025 and the lowest reading recorded was 61% on 08/05/2025.
OR 4: Humidity levels were out of range on 08/16/2025 (62%), 08/17/25 (63%), 08/18/25 (74%), 08/20/25 (62.2%), and 08/24/25 (68.8%), with the highest reading of 74% on 08/18/2025. OR 4 was in use on 08/20/2025, when the humidity reading was 62.2%.

Upon interview, S3 stated that he/she was provided with different readings, and all readings provided to him/her were within normal range.

At 3:15 PM an interview was conducted with S12. S12 stated that the HVAC sensor that measures the temperature and humidity in the OR is not working correctly, so the readings are being taken with a Klein tool (infrared thermometer), and stated that the readings initially provided to the surveyor were not correct. No documentation was provided to demonstrate that the readings obtained from the in-room monitoring system should be disregarded, and the temperature and humidity would be obtained using the infrared thermometer. In addition, no documentation of calibration for the infrared thermometer was provided.

At 3:28 PM, S3 provided a different temperature and humidity log that included dates through 08/22/2025. S3 stated that this was the log that was being sent to him/her daily from S15. The document provided by S3 was reviewed and revealed the humidity level in the operating room suite was out of the required range on 8/18/25, with a reading of 61%. The reading was documented as being obtained at 07:00 AM.

This was confirmed with S1, S2, S3, and S12 at 4:00 PM.

2. Reference: AAMI ST79:2017 and 2020 amendments A1, A2, A3, A4 (Consolidated Text): Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities., section 11.1.1 stated, "Storage facilities ... Shelving, carts, and bins used for sterile storage should be maintained organized, clean and dry. The bottom shelf of storage carts or shelving should be solid ..."

On 8/28/2025 at 10:29 AM, a tour of the Sterile Storage area was conducted accompanied by S2 and S3. It was observed that the bottom shelf of a wire cart used for storage was not solid.

Facility policy titled Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, " ... iv. When open wire shelving is used, the bottom shelf and top shelf should be solid ..."

These findings were confirmed with S2 and S3 at the time of discovery.

3. Reference: AAMI ST79:2017 and 2020 amendments A1, A2, A3, A4 (Consolidated Text): Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, section 11.1.1 stated, "Storage facilities ... Sterile items should not be stored on floors, on windowsills, or in areas other than designated shelving, ... Supplies should be removed from external and web-edged shipping containers before transport to any restricted area ... Rationale: External shipping containers and web-edged corrugated cardboard boxes can collect dust, debris, or insects during shipment and bring contaminants into the facility."

On 8/28/2025 at 9:57 AM, during a tour of the Sterile Storage area, in the presence of S2 and S3, a cardboard box that contained protective gowns was observed stored on the floor. At 10:29 AM, during a tour of a second Sterile Storage area corrugated cardboard box that contained arthroscopy pumps was observed stored on the floor.

Facility policy titled, "Storage of Sterile and Clean Supplies SPD" (reviewed 03/2021) was reviewed and stated, " ... J. Outside shipping cartons are prohibited in clean/sterile storage locations ..."

These findings were confirmed with S2 and S3 at the time of discovery.

4. Reference: ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Section 13.3.2 Package labeling and expiration dating, stated, "Each item or package intended for use as a sterile product should be labeled with a lot control identifier prior to sterilization. The lot control identifier should identify ... c) the person who assembled the package; ..."

On 8/28/25 at 10:38 AM, during a tour of the sterile storage area with S2 and S3, the following items were observed to be available for patient use, and the initials identifying the person that sterilized the items was not documented:
Hip retractor sterilized on 10/1/24
Gelpi retractor sterilized on 8/7/25
Hip retractor sterilized on 12/20/24

This was confirmed with S3 at 10:40 AM.

5. 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, "... Sterile items should be ... 4) Stored so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised."

On 08/28/25 at 10:39 AM, in the Sterile Storage area, in the presence of S2 and S3 more than five sterilized peel-pouched packages containing surgical instruments were crushed and bent in a plastic storage bin.

Facility policy titled Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, " ...G. Sterile packs should not be subjected to sharp objects, moisture, dropping, compression, or any other activity that could affect the sterility of the device ..."

This finding was confirmed with S3 at the time of discovery.

6. CDC (Centers for Disease Control and Prevention) Guideline for Prevention of Surgical Site Infection, 1999 page 261 stated, "(2) Environmental Surfaces ... (e.g., tables, floors, walls, ceilings, lights) ... it is important to perform routine cleaning of these surfaces to reestablish a clean environment after each operation."

On 8/28/25 at 10:16 AM, while in operating room (OR)4 with S2 and S3, white tape, as well as tape residue, was observed on the the C-arm (an x-ray system that provides real-time x-ray images during surgical procedures). The tape and tape residue makes the surface an uncleanable surface.

The metal base of the operative table was observed with paint chipping and visible cracks. When touched, paint chips easily detached from the base, resulting in loose fragments on the floor beneath the table. The cracked and chipped areas create a porous and uncleanable surface, which does not allow for effective cleaning and disinfection.

A black, upholstered chair with multiple cracks and tears was observed in OR 4.

At 10:34 AM, while in OR 1, a black upholstered chair with multiple cracks and tears was observed. The surface cracks make the chairs uncleanable.

These findings were confirmed with S2 and S3 at the time of discovery.

7. Reference: Centers for disease Control and Prevention, "Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, Last update June 2024). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html" stated, "5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities ...5c. Follow manufacturer's instructions for proper use of disinfection (or detergent) products ..."

On 08/28/25 at 10:16 AM, upon entrance to Operating Room (OR) 4, which was not in use, a canister of Sani-Cloth AF3 disposable wipes was observed with the lid open.
The Sani-Cloth Germicidal Disposable Wipe AF3, Instructions for Use (IFU) was reviewed and, stated, " ...When not in use, keep lid closed to prevent moisture loss."

The findings were discussed with S3 at 10:18 AM, who confirmed the lid on the canister of Sani-Cloth AF3 disposable wipes should be closed when not in use.

8. Reference: AORN Guidelines for PeriOperative Practice, 2024 Edition, stated, " ... Environmental Cleaning ... 4. OR and Procedure Rooms ... 4.2 Operating and procedure rooms must be cleaned and disinfected after each patient procedure 4.2.1 ... 4.2.2 Remove trash and used linen from the room ... 4.2.3 Clean and disinfect all items used during patient care, including anesthesia carts, including the top and drawer handles; anesthesia machines, including dials, knobs, and valves ... The anesthesia work area, consisting of the anesthesia machine, anesthesia cart ... contains irregular, complex surfaces that encounter frequent hand contact. Failing to clean these surfaces properly can lead to cross transmission of potential pathogens ..."

Facility policy titled, "Environmental Sanitation and Terminal Cleaning OR" (last reviewed March 2025) stated, " ... Rooms will be properly cleaned between cases ... After Surgery-Environmental Services. 15. Anesthesia ventilator machine and work surface and locked cart are to be wiped down ... 45. All waste and soiled linen bags are closed and removed from the OR area ..."

On 08/28/25 at 10:13 AM, during a tour of OR4 with S2 and S3, the trash receptacle without a lid was observed to contain discarded items including, but not limited to, a contaminated swab stick, and soiled gloves. A stainless steel two-level cart was observed in the room with seven packages of sterile gloves, a package of gauze sponges, and a package of povidine-iodine solution scattered on the top shelf. The lower shelf had two bags of intravenous solution and a wrapped sterile pack.

A blue bin that was designated for the collection of reusable medical devices for third-party reprocessing was observed to be overflowing. The container contained excess items piled above the rim, including cords and tubing, which were not contained within the bin.

When asked if the room was ready for the next case, S3 confirmed the room turnover was complete and ready for the next scheduled procedure.

During an observation of a post-procedure room turnover on 08/28/25 at 10:34 AM, in OR 1, S7 was cleaning the work surface of the anesthesia machine; however, a paper towel and supplies that were on the surface were not moved, and the cleaning was performed around the items.

At 10:40 AM, the finding was confirmed with S3.

9. On 08/28/25 at 10:41 AM, in the Sterile Storage area, in the presence of S2 and S3, three manufacturer-prepared trocars with an expiration date of 06/27/25 were identified on the shelves and available for patient use.

Facility policy titled, Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, " ... F. All manufacturer-prepared sterile packages are considered sterile unless an expiration date has been reached ..."

This finding was confirmed with S3 at the time of discovery.