HospitalInspections.org

Based on observations, interview, document review, and the investigation of a complaint it was determined the facility failed to provide adequate oversight of the sterilization process.

The findings included:

Facility quality measures related to monitoring of surgical instruments conditions and reporting of instrument issues failed to identify surgical instruments that should have been replaced, repaired and/or removed from service.

Cross reference:
§482.21(a), 482.21(b)(1), 482.21(b)(2)(i) - Quality Assessment and Performance Improvement Program (QAPI) Scope and §482.21(b)(3) - QAPI Data Collection

Based on observation, interview, document review, and the investigation of a complaint, it was determined the facility's Quality Assurance and Performance Improvement Program (QAPI) after implementing actions to improve the sterilization process for surgical instruments, failed to measure the effectiveness of the actions taken, by tracking, trending, and analyzing reported issues. The failure resulted in the survey team observing surgical instruments that were inadequately sterilized and/or in need of replacement and/or repair in five (5) of five (5) surgical trays included in the survey sample.

The findings include:

On February 12, 2024 at 2:05 PM the survey team made observations in the Central Sterile Processing (SPD-Sterile Processing Department) where surgical instruments are decontaminated and sterilized. Present during the tour were hospital Staff #6, Staff #7, Staff #8, Staff #10, Staff #11 and Staff #15. After a tour of the area, the survey team asked to inspect five (5) "ready for use" surgical trays. The surveyors inspected the following surgical trays processed at the facility's SPD:
1. a "cardio-thoracic set" processed 2/6/24- had a small brown colored spot.
2. a "lap set" processed 2/12/24- contained a sticky residue on two instruments and a small moveable white spot on another instrument and two instruments had visible pitting.
3. a "lap soft tissue set" processed 2/10/24- included an instrument with a white residue that easily rubbed off, an instrument with dark brown material that easily rubbed off and three visibly pitted instruments.
4. a "total knee set" processed 2/12/24- had an instrument with residue that could be removed with fingernail and three instruments with pitting and deep scratches at the tip of instruments.
5. "colon closing tray" processed 2/7/24- included an instrument with a brown substance that easily wiped off.

The survey team identified concerns for five (5) of five (5) trays. (see A-0750). Each finding of concern was witnessed and confirmed by a member of the hospital staff accompanying the survey team.

Failure to track surgical instruments and/or surgical trays returned to SPD (Sterile Processing Department)

Review of the facility's QAPI documentation for the past 12 months including infection control (IC) plan and meeting minutes, revealed the facility was aware of issues related to the sterilization of surgical instruments in April 2023. Review of facility document "Sterilization- Biological & UISS" presented by the Infection Control Committee on 4/19/23, revealed, in part: ... "Huddle Point: Quality Checks of Surgical Instruments Before Use:" ... "Background: Throughout the system, (hospital name) staff and (healthcare performance improvement company) surveyors have found surgical instruments that were not properly stored, had compromised packaging, instruments with visible damage, and single use items that have been mistakenly reprocessed. All of the items could potentially cause harm if used on a patient." Noted under "Sterile Instrument Quality Checklist ... Returning Instrument to SPD" ... "3. A Surgical Instrument Documentation Form must be fully completed and accompany all instrument {sic} returned to SPD for reprocessing." The document indicates there is no education in place to guide staff on how to perform quality checks on sterilized surgical instruments and includes recommendations for Surgical Services and Infection prevention to develop education. The document also explains what quality checks should focus on -instruments are stored in appropriate area, barrier wrap has not been compromised, chemical indicator appropriate color, instruments are clean and have no visible damage and single use items have not been reprocessed. QAPI documentation failed to identify any corrective actions that would be taken and how their affectivity would be monitored and revised if needed.

The facility provided mandatory In -service for SPD and OR staff as following: 4/12/23 "Visual Inspection of Instruments, 4/26/23 "(company name): Borescopes", 5/3/23 "(company name): Verify All Clean, Ultrasonic Verify", 7/19/23 "(company name): Protecting your instruments", 7/27/23 "(company name): Inspection and Assembly" and on 10/25/23 "Protecting Your Instruments."

On February 13, 2024 at 1:00 PM, Staff #10 and Staff #15, provided the survey team with a document (chart) showing random audits findings, conducted by SPD and/or IC staff, for year 2023. The document failed to identify how many audits were conducted only that a total of 81 errors (i.e broken/damaged instruments, missing indicator, incorrect/missing/extra instruments in the tray, dirty instruments...) were identified in the year 2023. Staff #10 and Staff #15 indicate no specific staff was assigned to track, trend and/or monitor the identified errors and the data had not been analyzed in detail (i.e. type of instruments returned, type of surgical trays, assembler, etc.)

The survey team was provided evidence of five (5) tray audits conducted in January 2024, by Staff #25 (SPD educator), with the last one performed on 01/15/24. It was indicated to the surveyor the SPD educator would have addressed the findings of audits they conduct with SPD staff. The survey team was not provided with documentation of how processes in SPD are regularly monitored by infection preventionist and/or quality control staff. Staff #10 and Staff #15 indicated the Quality and Education position for SPD had been consolidated in 2023 and that staff education is tailored according to audit findings by Staff #25.

Failure to implement an effective mitigation plan

The survey team's findings during inspection of five random surgical trays (noted above) indicated the facility's actions to mitigate identified issues with the sterilization process were ineffective. The facility's lack of tracking, trending and analyzing for surgical trays returned to SPD due to issues with contamination or condition of instruments, failed to provide the information needed to monitor the plan and make needed changes.

In an interview on February 12, 2024, Staff # 11 indicated the instruments should have been removed from the trays when they were assembled. Staff #11 revealed they (SPD) do not audit of surgical trays "not anymore". The facility "used to have a Quality Coordinator that did that" and they are looking at adding that task to someone's job duties. Staff #11 explained the process for returning surgical instruments to the SPD for issues related to contamination or damage as follows: OR staff would (when finding an issue) complete a form titled "Audit Tracking Tool for Case Carts" or "error sheet". The tracking document is returned to SPD with the tray. There the instrument identified as defective or needing repair is tagged and placed in the repair bin by SPD staff. Staff #11 informed the survey team that they have a company that comes by and checks the instruments and makes repairs.

Staff were unable to provide the survey team with documentation of tracking and trending of returned trays and/or the reporting of issues to QAPI. The hospital uses "SensiTrac" (instrument tracking system) to track location and use of instruments but the system is not being used to track returned instruments/trays.

On February 13, 2024 at 1:00 PM, Staff #10 and Staff #15 met with the survey team to provide more information related to the surveyor's observations in SPD. Staff #15 revealed in the interview "we should have caught it" and discussed immediate actions that had been implemented by the facility since the above noted observation of the survey team. A "Surgical Instrument Action Plan" was created to address survey findings and was shared with the survey team. The actions included an immediate Safety Stand Down held with all staff in sterile processing and operating room to discuss the concerns. The survey team was advised the company contracted to maintain surgical instruments had been contacted and representatives are on site to begin the process of instrument evaluation for all trays.

Based on observation, interviews, document review and the investigation of a complaint, the facility failed to ensure the prevention and potential spread of infectious diseases to patients receiving surgical services by failing to monitor and ensure the proper decontamination and sterilization of surgical instruments.

Findings include:

Observations of sterile surgical trays conducted on February 12, 2024, revealed concerns related to the proper decontamination and sterilization of surgical instruments which have the potential to adversely affect patients undergoing a surgical procedure. Inspections of five surgical instrument trays revealed pitting, scribing and staining of instruments in all five trays and identified additional infection control concerns.

Cross reference 482.42(a)(3), The Infection Prevention and Control Program

Based on observations, interviews, document review and the investigation of a complaint, the facility failed to ensure the prevention and potential spread of infectious diseases by failing to ensure the proper decontamination and sterilization of surgical instruments.

The survey team inspected five (5) surgical trays that were identified as sterile and ready for use. Five (5) of five (5) trays observed contained visibly damaged and/or contaminated instruments.

The findings included:

On February 12, 2024 at 2:05 PM the survey team made observations in the Central Sterile Processing (SPD-Sterile Processing Department) where surgical instruments are decontaminated and sterilized. The surveyors were accompanied by Staff #6, Staff #7, Staff #8, Staff #10, Staff #11 and Staff #15. After a tour of the area, the survey team asked to inspect five (5) post-sterilization trays. The surveyors inspected the surgical trays and observed the following:
1. a "cardio-thoracic set" processed 2/6/24- had a small brown colored spot.
2. a "lap set" processed 2/12/24- contained a sticky residue on two instruments, a small moveable white spot on another instrument and two instruments had visible pitting.
3. a "lap soft tissue set" processed 2/10/24- included an instrument with a white residue that easily rubbed off, an instrument with dark brown material that easily rubbed off and three visibly pitted instruments.
4. a "total knee set" processed 2/12/24- had an instrument with residue that could be removed with fingernail and three instruments with pitting and deep scratches at the tip of instruments.
5. "colon closing tray" processed 2/7/24- included an instrument with a brown substance that easily wiped off.

The survey team identified concerns in five (5) of five (5) trays. Each finding of concern was shown to a member of the facility staff accompanying the survey team.

The facility was aware of issues related to the sterilization of surgical instruments as evidenced by review of facility document "Sterilization- Biological & UISS" presented by the Infection Control Committee on 4/19/23. The document revealed, in part: ... "Huddle Point: Quality Checks of Surgical Instruments Before Use:" ... "Background: Throughout the system, (hospital name) staff and (healthcare performance improvement company) surveyors have found surgical instruments that were not properly stored, had compromised packaging, instruments with visible damage, and single use items that have been mistakenly reprocessed. All of the items could potentially cause harm if used on a patient." Noted under "Sterile Instrument Quality Checklist ... Returning Instrument to SPD" ... "3. A Surgical Instrument Documentation Form must be fully completed and accompany all instrument {sic} returned to SPD for reprocessing." The facility didn't provide documentation of any actions taken, monitoring and assessment or of corrective measures beyond providing staff training.

The facility provided mandatory In -service for SPD and OR staff as following: 4/26/23 "(company name): Borescopes", 5/3/23 "(company name): Verify All Clean, Ultrasonic Verify", 7/19/23 "(company name): Protecting your instruments", 7/27/23 "(company name): Inspection and Assembly" and on 10/25/23 "Protecting Your Instruments."

Facility policy "Infection Prevention Ch 01: Infection Prevention Program" effective 5/21/2021, revealed, in part: " ...O. Policies governing low and intermediate level cleaning and disinfection, high-level disinfection and sterilization will be implemented and monitored."

Facility policy "Infection Prevention: Surveillance, Prevention, and Control of Infection" revealed, in part: " ... II. Prevention and Control of Infection - Evidence Based Practices A. (hospital name) will use evidence based practices to prevent the transmission of infectious disease throughout the organization. B. Evidence based practices are those recommended or mandated by governmental agencies such as the Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), or professional organizations such as the Association for Professionals in Infection Prevention and Control (APIC), the Association of perioperative Registered Nurses (AORN), or Association for the Advancement of Medical Instrumentation (AAMI) Standards."

On February 13, 2024 at 1:00 PM, Staff #10 and Staff #15 met with the survey team to provide additional information. The survey team was provided with a document evidencing results of unknown number of random surgical trays audits conducted in 2023. The document (chart) failed to identify how many audits were conducted only that a total of 81 (eighty-one) errors (i.e broken/damaged instruments, missing indicator, incorrect/missing/extra instruments in the tray, dirty instruments...) were identified in the year 2023. The survey team was provided evidence of five (5) tray audits conducted in January 2024, by Staff #25 (SPD educator), with the last one performed on January 15, 2024. It was indicated to the surveyor the SPD educator would have addressed the findings of audits they conduct with SPD staff. Staff #10 and Staff #15 indicated the Quality and Education position for SPD had been consolidated in 2023 and that staff education is tailored according to audit findings by Staff #25.

In an interview on February 13, 2024 at 11:45 AM, Staff #18 and Staff #19, indicated a team which includes infection preventionists make environment of care rounds in SPD. The team makes observations of general cleanliness of the area, look for integrity of packaging, expiration dates , check individually packaged instruments for integrity and that instruments are not clamped. They do not audit surgical instrument trays. Their goal is to round at least quarterly.

Per Staff #11 a contracted staff #24 performs at least once per week preventive maintenance of instruments that are due and inspects instruments placed in the "repair bin". Based on their condition Staff #24 repairs, removes, replaces or orders new items.

In an interview on February 13, 2024 Staff #15 indicated, "we should have caught it" and explained the immediate actions that had been implemented by the hospital since the discovery by the survey team the previous day. A "Surgical Instrument Action Plan" was created to address survey findings and was shared with the survey team and included an immediate Safety Stand Down held with all staff in sterile processing and operating room to discuss the concerns. The company contracted to maintain surgical instruments had been contacted and representatives were on site to begin the process of instrument evaluation for all trays.

The survey team identified multiple issues related to the condition of surgical instruments indicating a systemic problem.