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Based on observations, document review, and interview the facility did not provide services well organized and in accordance with acceptable standards of practice. Specifically, the facility failed to ensure that there is a quality approved process for perioperative between case and terminal room cleaning of the Operating Room (OR), an anesthesia machine was not cleaned, lead aprons (worn to block the radiation generated in making X-ray images) were not cleaned, and unqualified staff are training staff to complete perioperative between cases and terminal cleaning of the ORs.

This CONDITION is not met as evidenced by:

Cross Reference:
482.51(b) Operating Room Policies

Based on observation, staff interview, and facility documents, the facility failed to ensure the condition of the physical plant, and the overall hospital environment is maintained in such a manner that the safety and well-being of patients are assured. Specifically, a broken scrub sink (used for scrubbing hands) in between Operating Room (OR) one and OR two.

Findings include:

Observation on 01/14/25 at 02:13 PM in between OR one and OR two revealed one out of two faucets on the scrub trough was labeled with a faded orange "out of order" tag with a red biohazard bag tied around the base of the faucet.

Review on 01/17/25 of the facility document titled "Work Order #: 255061," dated 05/23/24, indicated the scrub sinks between OR one and OR two's water pressure is too strong and sprays, the water pressure trickles and is running brown water. The completion of the work order is dated 11/7/24.

Interview on 01/17/25 at 08:55 AM with Staff (P), Facilities Supervisor, revealed the scrub sink located between OR one and OR two needed a mixing valve and a faucet replaced. "I was not notified that there was an issue with the faucet until the New York State Department of Health pointed it out. I can only speculate that the repair was not completed as it wasn't a high priority." "The reporting of problems is a consistent problem in order for repairs to be completed." Facilities staff work Monday thru Friday from 09:00 AM until 05:00 PM, which causes a challenge to getting repairs completed in the operating room. A repair would be done during the working hours to cater the schedule. Repairs would not be completed off shift unless it was an emergency. For emergencies, there is an on-call shift for off hours, nights, and weekends.

Interview on 01/17/25 at 03:00 PM with Staff (A), Administrator, verified these findings.

Based on observation, document review, and interview, the hospital did not escalate physical plant concerns, which posed risk to patient safety, to the attention of appropriate staff. Specifically,
1. A broken anesthesia machine located in Operating Room (OR) one was still in use by staff for an unintended use.
2. A functioning flash autoclave (a machine used in an emergency that uses pressurized steam to sterilize items by killing bacterial, viruses, fungi, and spores) located in Operating Room #119 (between operating room one and operating room two) did not have a current inspection and was no longer in use but could have been accidently used by staff.

Findings #1:

Observation on 01/14/25 at 01:13 PM in OR two revealed an anesthesia machine, with no sign indicating retired or out of service and a biomedical sticker dated April 2025.

Review on 01/17/25 of the facility "Work Order #307188" indicated the Draeger Medical anesthesia machine in OR two had a work order requested on 08/28/23.

Review on 01/17/25 of the facility document titled "Service Report Dispatch Number U00821334", dated 08/29/23, revealed the unit failing a leak test (a leak is identified somewhere within the anesthesia machine's breathing system). Contacted tech support indicated an option would be to replace the breathing system. The service order is left open while waiting to hear on the repair/replacement decision from the facility. On 08/28 the facility verifies that they are not going to repair this unit and have instead submitted capital for a replacement unit.

Interview on 01/15/25 at 09:35 AM with Staff (N), Anesthesiologist, revealed the anesthesia machine located in OR two cannot be used, so procedures requiring anesthesia are completed in OR one. If Staff (N) had noticed any equipment needed repair, they would discuss it with the OR nurses in the room or with Staff (D), Manager of Surgical Services.

Interview on 01/16/25 at 11:12 PM with Staff (Q), Lead Biomedical Technician revealed the anesthesia machine located in OR two was pulled out of service. There is a module in the machine that needs to be updated but was a very costly update. The vaporizer equipment was removed from the anesthesia machine so that a patient would not be able to be put under anesthesia. The anesthesia machine was left in the OR to be used for the cardiac monitor. There is a backup cardiac monitor that would be available to use in the OR in place of utilizing the out of service anesthesia machine. The previous OR Manager and Staff (A), Administrator were aware that the anesthesia machine was pulled out of service.

Interview on 01/17/25 at 09:15 AM with Staff (Y), System Director for Clinical Engineers revealed the malfunctioning anesthesia machine and OR two is listed in their system as" retired" which indicates it should be removed from the premises. Staff (Y) was unaware that this item was retired until the survey staff was on site. An out of service piece of equipment would be listed as retired and not included in the preventative maintenance schedule.

Interview on 01/17/25 at 03:11 PM with Staff (A), Administrator, revealed they were unaware that the anesthesia machine was removed from service and made inactive on 08/28/23 and should not have been in use.

Findings #2:
Observation and interview on 01/14/25 at 01:04 PM in OR Room# 119 with Staff (D), Manager of Surgical Services, revealed a functioning flash autoclave with a biomedical maintenance sticker dated June 2022. There was no sign on the machine indicating that the machine was no longer in service. Staff (D) stated the autoclave was no longer in use and there is normally a sticker on the machine alerting staff that the machine is not to be used. Staff (D) was uncertain as to the last time the autoclave was used, but it had not been used in the eight months that they were employed. When asked why the machine was still in the room, Staff (D) stated, "I don't know." Observation on 01/14/25 at 02:00 PM revealed Staff (D) placing an "out of service" tag on the flash autoclave.

Review on 01/17/25 of the policy titled "Equipment Repair", last revised October 2021, revealed the facility utilizes a computer maintenance management system (CMMS) (computerized information system used to facilitate the scheduling, monitoring, and documentation of equipment inspection, testing, and maintenance). In response to a facilities work order the assigned technician inspects damaged or malfunctioning equipment to determine what repairs or adjustments, if any, are needed. If the assigned technician determines that the work cannot be done in-house, they obtain approval from the System Director to have the work performed by an external vendor. When work has been completed by the assigned individual, or the external vendor, the assigned individual documents the repairs made and the date the work was completed on the corrective maintenance order for entry in the CMMS. If the repair work is not done at or near the time of the equipment scheduled preventive maintenance, the preventive maintenance schedule is updated accordingly. If the repairs cannot be completed within one workday, the assigned individual notifies the user department. If the repair work is performed by an external vendor, the assigned individual inspects or tests the equipment upon return to make sure the repairs have been made properly and that the equipment meets appropriate electrical safety standards before returning it to the user department. If the assigned individual or external vendor determines that the equipment cannot be repaired, the technician returns the equipment to the user department with instructions to dispose of it in accordance with the Medical Center's policy and procedure for equipment transfer or disposal.

Review on 01/17/25 of the document titled "Request #279993", dated 1/15/2025 at 10:04 AM, revealed confirmation from Facilities Engineering of an online request from Staff (D), Manager of Surgical Services for the removal of a broken autoclave sterilizer from OR Room #119.

Interview on 01/17/25 at 03:00 PM with Staff (A), Administrator verified these findings.

Based on observations, document review, and interview, for two of two Operating Rooms (OR), the facility did not ensure that cleaning of the OR was consistent with generally accepted standards of practice. Specifically,
1. The facility failed to ensure that there is a quality approved process for a perioperative between case and terminal room cleaning of the OR.
2. An anesthesia machine located in OR one was not cleaned between operating room use and was not terminally cleaned.
3. The facility failed to clean lead aprons (worn to block the radiation generated in making X-ray images) stored in the OR following use.
4. Untrained staff are training other staff to complete perioperative between case cleaning and terminal cleaning.

Findings Include:

Observation on 01/14/25 at 01:50 PM of Staff (H), Environmental Services, Operating Room, completing a terminal clean in OR one revealed the following: Staff (H) wore hospital supplied scrubs, eye protection, gloves, name tag hanging off lanyard around their neck, and a procedure mask. The cleaning process began with moving the equipment from the outside of the room and pushing it to the middle of the room. The walls were then wiped with a daily disinfectant with a blue reusable mop head. When wiping the walls around the suction canister attached to the wall next to the anesthesia machine, the suctioning tubing was touched with the mop multiple times. The suction tubing was not discarded. After the walls were wiped, the same mop head was used to wipe the ceiling. The floor was then mopped with a disposable mop pad on approximately one quarter of the room. The Pyxis (automated medications dispensing machine) was then wiped down with a Sani-Wipe (commercial cleaning agent used by the facility) and pushed back against the wall over where the floor was mopped. Four Sani-Wipe were then used to wipe a tabletop around the items that laid across the table. The Sani-Wipe container was empty, and Staff (H) exited OR one with their gloves on (did not wash their hands) to obtain another canister from the hallway. Staff (H) did not wash hands or change gloves before reentering OR one. Staff (H) moved two lead aprons from the surgical table and hung them on the wall over the top of other lead aprons without wiping them clean. Sani-Wipe were then used to wipe down two lead thyroid collars (attaches to the lead aprons). Using the same Sani-Wipe, the surgical table and tourniquet cuff (used to stop life threatening external bleeding) were wiped. New Sani-Wipe were obtained to wipe the bottom shelf of the surgical table and the bed arms. The removable pads on the bed arms were not removed and underneath the removeable padding was not wiped. A new Sani-Wipe were used to wipe down the IV pole, medical gas canisters, the bed mattress, the underside of the mattress, and the bed frame and wheels. The same Sani-Wipe was used on the two overhead lights that were pulled down. The dirty portion of the light was pulled onto the cleaned mattress, without the bed mattress being recleaned. Garbage was pulled from the cans and placed near the door. A new garbage liner was placed in the can. The remainder of the floor was then mopped with a disposable mop pad. After the floor was mopped, the step stool was wiped on all sides with a Sani-Wipe. Additionally, an aesthesia machine located in the OR was not cleaned by Staff (H).

Observation on 01/15/25 at 09:24 AM of the between procedure turnover clean in OR two revealed the following: Staff (J), Registered Nurse, used one Sani-Wipe to wipe down all horizontal surfaces of the room, including pillows, the monitor, anesthesia keyboard, anesthesia machine, Pyxis, and the top surface of the supply cart. A new wipe was used to wipe down the Olympus procedure cart (a mobile trolley or workstation that can be used for endoscopy and other medical procedures), cords, and tubing. The garbage was bagged and emptied by Staff (J) without gloves and their procedure mask was pulled down, not covering their nose or mouth. While the garbage was being bagged for removal, Staff (O), Surgical Technician brought a clean scope into the room and was opening the scope to prepare for the next patient. The floors, ceiling, and walls were not observed to be spot cleaned.

Review on 01/17/25 of policy "Sanitation, Operating Room," last approved June 2024, indicated room turnover between OR procedures will be performed by OR staff during the day shift. Collaboration between surgical aides and housekeeping will be done after 03:30 PM. Terminal cleaning of the OR will be done by the night shift Environmental Services personnel. OR Environmental Services responsibilities include two staff members on weekdays and one staff member on weekends to provide daily cleaning of all areas of the operating room.

Review on 01/14/25 of the facility checklist document "Perioperative Between Case/Terminal Cleaning" (used for staff training and competency), last revised 10/31/24, lacked specific directions or steps the staff needed to follow to complete perioperative between case cleanings and terminal cleanings in the OR.

Review on 01/14/25 of the facility document "Perioperative Between Case/ Terminal Cleaning", dated 10/31/24, revealed the facility checklist document was performed on Staff (H), Environmental Services, Operating Room with Staff (D), Manager of Surgical Services as the trainer.

Review on 01/17/25 of the personnel file of Staff (D), Manager of Surgical Services revealed no documentation of training for OR terminal cleaning and turnover cleaning.

Interview on 01/15/25 at 07:10 PM with Staff (H), Operating Room Housekeeper, revealed they have been the dedicated operating room housekeeper since the middle of October 2024. They were educated on cleaning in the operating room verbally by Staff (I), System Director of Environmental Services, and in person by a former operating room housekeeper. The trainer they were working with did not train them effectively, they researched as much procedural information as they could find in the policies and when the policies did not reflect the information, they looked at other information online and through environmental services. Staff (H) stated they found a pamphlet from the environmental services storage cabinet that explained terminal cleaning and they referenced this pamphlet often, although uncertain if it was part of the facility policy to do so. Staff (H) stated there was no additional training after the original in-person trainer was done and there was no training received from the Staff (D), Manager of Surgical Services. Staff (D) did sign their competency that they were competent to do a turnover and a terminal clean, however the process was rushed, and did not show their competency accurately.

Interview on 01/14/25 at 10:00 AM with Staff (D), Manager of Surgical Services, revealed they supervise the staff performing terminal cleaning and turnover cleaning; however, they were not trained themselves. Staff (D) was unable to verbalize the process for the performance of these duties or the products used in cleaning.

Interview on 01/15/25 at 12:50 PM with Staff (M), System Radiology Supervisor revealed that lead aprons should not be stored in the OR suite. Lead aprons should not be stored on top of one another, they should be hung on a lead hanger. Lead aprons should be wiped when soiled with a Clorox hydrogen peroxide cleaner. Lead aprons are soiled after wear from the wearers sweat and possible splash from the procedure.

Interview on 01/15/25 at 01:13 PM with Staff (K), Radiology Supervisor revealed lead aprons should not be hung or stored in the operating room suites. Lead should be cleaned per manufacturer's instructions, but warm soapy water or hydrogen peroxide wipes would be indicated for all brands. Sani-Wipes break down the lead. It is not appropriate to hang not sanitized lead on top of another lead apron. Staff (K) stated the facility does not have a policy that indicated appropriate storage and cleaning products for the lead aprons.

Interview on 01/15/25 at 01:52 PM with Staff (I), System Director of Environmental Services, revealed Staff (D), Manager of Surgical Services, trained Staff (H), Environmental Services, Operating Room. There is a step-by-step procedure on how to terminally clean the operating room at the end of the day. Staff were trained in cleaning the operating room by the operating room staff. Staff (I) stated it is their understanding that the operating room housekeeper would have completed the mandatory five days of dedicated training for the operating room and there is a competency sheet to sign off after each procedure is completed and visualized. Staff (I) stated it is their understanding that, Manager of Surgical Services completed the housekeeper's competency, and Staff (D), Manager of Surgical Services was directly trained in the operating room to complete turnover and terminal cleanings.

Interview on 01/15/25 at 06:07 PM with Staff (L), Vice President of Support Services, revealed there is a system wide terminal cleaning and turnover facility checklist document that the facility has access to, but they are unaware if it is being used.

Interview on 01/17/25 at 03:00 PM with Staff (C), Director of Patient Safety and Quality and Staff (A), Administrator verified these findings.