HospitalInspections.org

Based on record review, policy review, document review, staff and patient interviews, the Hospital's surgical services staff failed to follow policy, procedure and acceptable standards of practice to maintain safety practices, and to provide supervision over the sterile processing department.

The cumulative effects of this deficient practice resulted in an Immediate Jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death).

Findings Include:

1.The hospital failed to ensure it followed the policy and procedure for reprocessing of sterile instruments in the Sterile Processing Department (SPD). [Refer to A-0951, 482.51(b)]

Surveyors notified Hospital Administration on 01/29/25 at 4:47 PM, that an immediate jeopardy (IJ) existed related to §482.51 Condition of Participation: Surgical Services related to reprocessing of sterile instruments in the SPD.

2. The hospital failed to ensure it was following policy and procedures related to endoscopic and colonoscope cleaning and processing. [Refer to A-0951, 482.51(b)]

On 02/05/25 at 11:05 AM Surveyors notified Hospital Administration, that the immediate jeopardy (IJ) §482.51 Condition of Participation: Surgical Services was amended to include endoscopic and colonoscope cleaning and processing.

Surveyors exited the hospital on 02/06/25 at 5:58 PM. Hospital administration was notified that their written plan of removal (POR) had not been accepted prior to the survey exit and that the immediate jeopardy remains in place.


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Based on document review, record review, staff and patient interview, the Hospital failed to ensure staff followed policies and procedures to achieve and maintain high standards of medical practice and patient care. This deficient practice places patients at risk for harm and injury during surgical procedures.

Findings Include:

Review of policy titled "Sterile Processing Procedures" dated 10/02/2023, showed, " ...PURPOSE To provide procedures for sterilizing items to be used in the surgical environment. One of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning, inspection and decontamination, followed by a sterilization process ...Sterilization provides the highest level of assurance that surgical items are free of viable microbes ...New employees and all persons utilizing the sterilizing equipment will complete an annual competency on the principles of sterilization and safety. 11. Sterilization records will be maintained according to hospital/regulatory guidelines ...All objects to be sterilized must first be thoroughly cleaned to remove all bio-burden and other residue. Point of care cleaning will start at point of use ...Instruments are to be inspected to ensure that they are clean, dry and functioning properly. Soiled objects shall be returned for decontamination. Objects that do not function properly shall be removed and replaced with properly functioning items ...Delivery to Facility ...Vendors are expected to check-in all trays in the designated SPD [Sterile Processing Department] receiving location in accordance with the facility's established receiving process as well as ensure appropriate tray content for processing in preparation for the surgical procedure ...Vendors are expected to inventory their respective equipment, items, and/or sets following the decontamination process ...Sterile items should be stored at least eight (8) to ten (10) inches above the floor on a closed surface (wire racks require plastic bottom liners), at least eighteen (18) inches below sprinkler heads, and at least two (2) inches from the outside walls ...the cause of failure is immediately identified and confined to one load or one item in the load, the cause of the failure will be corrected, and the load will be reprocessed. If the cause of the failure is not immediately identified, the load will be quarantined and all loads back to the last negative BI will be recalled. Items in these loads will be retrieved, if possible, and reprocessed. The sterilizer in question will be taken out of service for further investigation of root causes. Follow the AAMI ST79 [Association for the Advancement of Medical Instrumentation] Current edition for the recall procedure. 4. If all items are not recalled, the Director of Perioperative Services or designee will notify the CMO/CNO[Chief Medical Officer/Chief Nursing Officer], and Infection Preventionist. Physician and patient notification to occur. 5. An occurrence report will be completed, and Patient Safety/Risk Management notified immediately ..."

Review of policy titled "High Level Disinfection - HLD" dated 01/25/2023, showed, " ...This policy applies to all staff and departments within the [The Hospital Region], performing high level disinfection (HLD) ... Personal protective equipment (PPE) consistent with manufacturer's instructions will be used during the HLD process. PPE may include utility gloves, exam gloves, fluid resistant gowns, and eye protection. Precleaning will be performed on all equipment and scopes before undergoing HLD ...All scopes will be reprocessed at least every 7 days ...Equipment will be stored in a manner consistent with IFU [In for use] to maintain the integrity of the HLD process ..."

Review of a document by the Association of periOperative Registered Nurses (AORN) titled, "Key Takeaways: 20 Critical Updates to Prevent Patient Infections & Outbreaks Related to Endoscope Use," dated 04/12/23, showed, " ...Moderate-quality evidence supports a maximum storage time of 7 days ..."

Review of document titled "Sterile Processing Tech" job description, undated, showed, " ...CRCST or CSPDT [Certified Registered Central Service Technician/Certified Sterile Processing and Distribution Technician] certification required within 18 months of hire or transfer ..."

Review of a document titled, "Infection Prevention Program Manager" dated 01/30/24 showed, " ...Responsible for the collaborative approach and implementation of an entity specific facility-wide infection prevention and control program. Reports to the entity Director of Quality and Patient Safety Officer ... Provides strict and continuous oversight on equipment and environmental cleaning, as well as low and high level disinfection and sterilization processes throughout the operating group. Assures that there are preventive, surveillance, and control procedures relating to sterilization, disinfection, and cleaning practices in all departments throughout the operating group ..."

1.Endoscopic/Colonoscope Processing

Review of a document titled, "[State Agency]1.21.2025 - Occurrence Reports 7.1.2024-1.6.2025", showed, " ...07/15/24 ...Not a Safety Event ...[Staff O2] called me that morning as she had an entire day to do (clean and disinfect) scopes and the tech did not know how to do scopes. She asked the trainer to do them and they could not do them either ...If a patient is scheduled for surgery it expected that ALL parties are trained to do their function ..."

During an interview 01/22/25 at 5:01 PM, Staff E, stated that the high-level disinfection of endoscopes and colonoscopes is a different process than the decontamination and sterilization of surgical instruments. Staff went on to state that the hospital found no gap in scope reprocessing. Therefore, the endoscopy and the colonoscopy procedures continued unchanged.

Review of a document titled, "Weekly Endoscope Cabinet Cleaning Log" dated 2024, showed the last cleaning to be completed on 12/13/24. The endoscope drying cabinet had not been cleaned for about 5 weeks.

Review of a document titled, "Weekly Endoscope Cabinet Cleaning Log" showed the cabinet had last been cleaned on 01/31/25.

During an interview on 01/23/25 at 10:16 AM, Staff E stated that the cabinet should have been cleaned weekly.

During an interview 02/04/25 at 9:54 AM, Staff E stated that all endoscopes that were present in the cabinet on 01/23/25 should have been reprocessed before use due to the cabinet not being cleaned from 12/13/24 through 01/23/25.

During observation on 02/04/25 at 9:54 AM of Supply Room for disinfected endoscopes showed an endoscope that was to be reprocessed on 01/28/25 still in the cabinet.

During an interview 02/04/25 at 9:54 AM, Staff E, stated that scopes are only good for 7 days after they have been processed and then the scope must be reprocessed.

During an interview on 02/04/25 at 10:50 AM, Staff M2, stated that, processed dates on scopes are not checked before use on a patient prior to endoscopy or colonoscopy.

During an observation on 02/04/25 at 9:56 AM of the endoscopic cleaning room showed three unidentified staff present not wearing gowns, face shields, gloves, or shoe covers. The staff failed to wear the proper PPE per policy when cleaning endoscopes


2. Sterile Processing Department

Upon entrance to the hospital on 01/21/25, document review titled, "[State Agency] 1.21.2025 - Occurrence Reports 7.1.2024-1.6.2025" showed the hospital had identified 73 incidents involving the Sterile Processing Department (SPD).

The hospital brought in an auditing organization from 12/09/24 - 12/11/24 to conduct an audit of the sterile processing department.

During an interview on 01/27/25 at 1:28 PM, Staff C, stated that management had a very high level meeting with the auditor. Staff C went on to state there was a primary debriefing held on 12/13/24 and then another meeting was held on 12/16/24. The facility staff stated that they did not receive a written report from the auditor, and they denied taking any meeting minutes or notes from these meetings. Hospital Management determined as long as all instruments were reprocessed, the operating room would be able to reopen on 12/17/24.

When staff arrived on 12/17/24 at 6:00 AM, cassettes (containers which hold and organize instruments for various procedure sets) were found that staff had not reprocessed.

At that time, the hospital administration decided to go on diversion for all outpatient surgery and began reprocessing all instruments.

During an interview on 01/22/24 at 2:49 PM Staff H, stated that the hospital would only do a surgery if it meant saving a life or limb or if the surgeon obtains special approval.

The Hospital brought in the Director of the Sterile Processing Department (SPD) on 12/19/24 from the hospital system and retrained staff on decontamination of surgical instruments.

During an interview on 01/27/25 at 1:29 PM Staff C stated that as of 01/14/25 all instruments had been reprocessed.

Review of a document titled, "[The Hospital] Incident Log 1.21.2025 - 1.27.2025" showed, " ...CFA (Certified First Assist) and an RN were setting up for the surgeon's first case. The instrument set's acetabular reamer (hip joint instrument) was opened, and when the nurse and first assist checked the casket, an unidentified foreign object (UFO) was found. This instrument tray was last sterilized on 01/24/25. The nurse called the sterile processing department (SPD) to have the set turned over immediately. The patient's surgery was delayed 4 hours while the instruments were reprocessed ..."

During an interview on 01/24/25 at 10:45 AM, Staff E, stated, " ...We have had some trays contaminated since the OR [operating room] reopened. One tray had an unidentified foreign object (UFO) at bottom of tray and light adapter was left on the knee scope..."

During an interview on 01/28/25 at 9:25 AM, Staff O, stated that, since restarting surgeries in January 2025, there has been a hair in the tray, an unknown blue substance and on 01/27/25 an orthopedic tray had a UFO needing to be reprocessed.

During an interview on 01/28/25 at 11:20 AM, Staff P, stated that, on 01/27/25 the OR had a hip tray that had to be reprocessed and delayed the case over 4 hours.


Review of a document titled, "[State Agency] 1.21.2025 - Occurrence [sic] Reports 7.1.2024-1.6.2025" showed, " ...11/12/2024 5:07 PM ...TKA [Total knee arthroplasty] delayed due to contaminated [sic] instruments. Specials tray contaminated due to improper placement of filter. Knee Misc (miscellaneous) tray cement was noted on impacted [surgical instrument]. Items were contained and removed from sterile field ..."

Review of a document titled, "[State Agency] 1.21.2025 - Occurrence Reports 7.1.2024-1.6.2025" showed, " ...11/13/2024 09:28 AM ...We plan to meet with the staff on Friday, 11/15/24, to discuss these issues and the importance of making sure items are free of bioburden before sterilization. This will be everyone's verbal warning and corrective action will start going forward ..."

Review of a document titled, "[State Agency] 1.21.2025 - Occurrence Reports 7.1.2024-1.6.2025" showed, " ...11/18/2024 9:05 AM ...The OR team was opening this case for set up, upon opening the Stryker Mako Power Tray, the scrub noticed that the drill had a piece of bone on the handpiece, the tray was not placed on the sterile field, it was removed and taken back to decontamination for reprocessing. A second occurrence [sic] happened, the case cart for this case was not pulled and all the instruments had to be allocated for this 0730 [7:30 AM] start time, the case had a delayed [sic] for this reason. This was also noted in the chart. Third occurrence [sic] happened, a fly was noted to be in the OR after procedure had started. The fly landed on [surgeon] while scrubbed in, the anesthesia provider was able to kill the fly, but this case was deemed contaminated ..."

During an interview on 01/23/25 at 3:30 PM, Staff L2 stated that the audit company had identified a lot of gaps in the sterilization process at that time and there was also a lawyer involved staff were told that anything they were saying, doing, writing, texting or emailing needed to be under attorney-client privilege. Staff were told they needed to speak as little as possible around this matter, but we needed to shut down the OR.

During an interview on 01/23/25 at 6:10 PM, Staff C, Director of Quality and Patient Safety Manager, stated that we had some occurrence reports with bioburden in instrument trays. The hospital had an outside audit company review the SPD department. It was found every single instrument was needing to be reprocessed. Staff C went on to state, " ...patients were not notified, because its low to no risk ..."

During an interview on 01/28/25 at 9:25 AM, Staff O, stated that, we have had multiple issues with bioburden and debris on trays and have personally killed 16 flies in one day in the operating suites. Concerns over the contaminated trays are to be taken to the manager and stated, "we fear retaliation and are told to stay in our lane."

During an interview on 01/28/25 at 11:20 AM, Staff P, stated that, there has been issues with dirty instruments longer than 6 months. Flies come into the OR suites since the trash and loading dock is next to OR. We try to make sure that the fly doesn't land on the sterile field.

During an interview on 01/29/25 at 9:20 AM, Staff B2, Infection Prevention Manager, stated that I am not an expert in SPD, we had incident reports and kept it on the radar, so we had outside auditor come to hospital in December 2024 and the auditor let us know that there were concerns related to sterile processing.

During an interview on 02/04/25 at 1:51 PM, Staff F2, stated that, there have been bone fragments on instruments for years, but recently has become more frequent. The auditor wanted to shut down the OR on Monday [December 16th 2025] but the hospital went ahead and finished all the cases. Staff F2 went onto state that trays that were opened during a surgical case even if one instrument used the whole tray should be reprocessed and SPD failed to do so.

During an interview on 02/06/25 at 8:37 AM, Staff N2, Chief Nursing Officer (CNO), stated that my top job is to recruit nurses. We celebrate the reported occurrences and not sure if there was any process improvement after the incident reports for bioburden and bone fragments were found on instruments. If the instruments are not cleaned, then there would be risk of infection, and the hospital needs to improve on surgical site infections. There are a lot of flies due to cattle and do not know what interventions they are doing to zap the flies.

During personnel file review on 02/05/25 at 5:15 PM documentation failed to show that Staff P had obtained certification within 18 months of hire date. Staff P, Sterile Processing Tech, had hire date of 01/23/23 and received Certified Registered Central Service Technician (CRCST) certification on 01/15/25.

Review of a document titled, "Infection Preventionist Residency" dated 04/16/24 showed, " ...Estimated time for completion: 6-9 months (save your exercises). When you have completed this "IP Residency" you need to pass the "IP Core Competency Training" (annually) located within Pathways ..." Further review failed to show Staff B2 had completed HLD - pre clean/HLD/storage and Endoscopy exercises as of 02/05/25 at time of review.