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Based on medical record review, document review and staff interview, the facility failed to implement and maintain an effective, on-going, data driven Quality Assessment and Performance Improvement (QAPI) program. Specifically, data collected from the facility's VOICE (Incident/Occurrence Electronic Reporting System) Reports on contamination of surgical equipment/trays, were not utilized to identify issues, analyze causes, identify rooms for improvement, and implement corrective actions and re-evaluated to determine effectiveness and prevent recurrence. This was noted in six (6) of six medical records reviewed. (Patient # 1, # 2, # 3, # 4, # 5, and # 6)

These failures may have placed patients at risk for infection.

Findings:

Review of the facility's Incident Log dated July 2022 to November 18, 2022, identified four (4) patients with incidents category of "Contamination."

Per interview with Staff L, Interim Chief Quality Officer, Deputy Chief Medical Officer on 11/14/2022 at 4:00 PM, Staff was asked for a QA/PI review of the July 13, 2022, contamination event. Staff was also asked for the QA/PI reviews of subsequent cases of similar contamination issues on October 7, 19, and 20, 2022.
Staff L stated the July 13, 2022, case was not discussed at a QA/PI level. Staff L stated it was only one case and there was no pattern.
Staff L stated there was no QA/PI review of the subsequent cases. They would be discussed on the next QA/PI meeting sometime at the end of November 2022.

The facility's, Performance Improvement/Patient Safety Committee reports of July 23, 2022, September 27, 2022, and October 25, 2022, were reviewed. There was no documented evidence that the "Contamination events" were mentioned and addressed.


See Tag A 283.

Based medical record review, document review and staff interview, the facility failed to identify opportunities for improvement and implement corrective actions that would lead to improvement. Specifically, data collected from Incident/Occurrence reports on contamination of surgical equipment/tray, were (a) not analyzed and tracked, (b) preventative measures were not fully implemented, (c) monitoring was not fully implemented and measures re-evaluated for effectiveness to prevent recurrence.
This was noted six (6) of six (6)medical records reviewed. (Patient #1, #2, #3, #4, #5, and #6)

These failures may have placed patients at risk for infection.

Findings include:

Review of the facility's Incident Log dated July 2022 to November 18, 2022, identified four (4) patients with incidents category of "Contamination."
Two (2) additional patients with contamination issues were reported to the surveyors on 11/14/2022, by the facility's Regulatory staff.

A facility's VOICE Event Report (Incident Report) for Patient #1, event date 7/13/2022 at 10:30 AM, documented:
"Specific Event Type: Contamination. Report revealed, during a surgical repair of a broken left thighbone, one of the instruments (Smith and Nephew Intertan Gold Tray Lag Screw Driver) was grossly soiled in the tray. The cannulated driver came in the instrument tray with a 3.2 K-wire still inside the cannula from a previous surgery. There was no other instrument tray available. So, the surgeon had no choice but to remove the grossly soiled previously used K-wire and flushed the cannula repeatedly with betadine solution before inserting a new K-wire in order to proceed with the procedure. Central Sterile Processing (CSP) staff were notified and came to the OR to assess. The count sheet and soiled K-wire were taken by CSP staff back to CSP for educational purposes. RN supervisor notified...

Provider Attestation: physician documented a new K-wire was used soaked in betadine to clean the cannulated drill by passing it through the cannulated drill multiple times. The drill had been autoclaved before the procedure.
The patient was doing well post-operatively day #2 (POD #2) without fever or wound drainage..."

Additional Voice Event Report documentation: " Per IPAC (Infection Prevention and Control) IPAC: IPAC is monitoring/surveillance on the patient for 90 days. As of August 17, 2022 no infection to date identified. All surgical instruments should be Decontaminated, Prepped and Packaged, and Sterilized as per policy. No surgical instruments should be cleaned with betadine solution.
Severity Level D. No Harm reached the patient. Patient monitoring required."

There was no documented evidence of a comprehensive review and analysis by a multidisciplinary team was conducted at the time of the event.

There was no documented evidence, Central Sterile staff and Surgical/Medical staff were re-educated on the complete process of the facility's policy and procedure on decontamination, cleaning, and sterilization process.

There was no documented evidence of a systemic review and identification of similar equipment/instruments with disposable parts. Central Supply and Nursing staff were not educated to prevent recurrence.

There was no documented evidence a systemic corrective plan of action was put in place to prevent recurrence.

Subsequent events of contaminated equipment/tray were identified from VOICE Reports of 10/7/2022, 10/19/2022, and 10/20/2022.


The facility's VOICE Event Report for Patient #2, event date 10/07/2022 at 2:27 PM documented: "Procedure event, Other specific Event Type: debris on depth gauze, removal from field right away, new one was used, glove changed. Brief Factual Description: The Stryker Loaner Tray "T2 Alpha Basic" measuring guide was found with dry debris. The scrub nurse removed immediately from the field and all surgical team changed their gloves. The occurrence was reported to the Central Sterile supervisor. The Voice was reported by the Circulating Nurse...

-Provider Attestation: Patient had distal femur fracture underwent retrograde nail. While using the depth gauze to measure the length of the nail, noticed the debris on it. The depth gauze was removed from the field and new depth gauze from other set was used. Glove change was done... Antibiotic paste was used."

On 10/12/2022 at 12:34 PM, Voice Event Report entry from Risk Management staff: "the dirty depth gauze never touched the guide wire or entered the patient's body.
This was the second event by a Central Sterile Processing Department (CSPD) employee, despite remediation related to HLD (High Level Disinfection) training in decontamination and assembly.

On 11/10/2022 at 10:43 AM, Voice Event Report documented details from Risk Management (course of action) which included:

- " First Course of Action: 10/7/2022, after further investigation it was found that policy and practice for inspection of trays were not followed. The technician responsible for assembly of tray was suspended without pay.

- Second Course of Action: 10/7/2022, the technician responsible for cleaning and decontaminating the tray is pending investigation and investigation by Labor Relations.

-Third Course of Action: 10/7/2022 Immediate training and education was provided to all CSPD staff by CSPD management team. Detailed description of education was provided, and signatures of all staff were collected to ensure everyone received the appropriate training.

There was no documented evidence, Central Sterile staff and Surgical/Medical staff were re-educated on the complete process of the facility's policy and procedure on decontamination, cleaning, and sterilization process.

-Fourth Course of Action: 10/24/2022. Weekly tray audits were modified to include technician associates as part of the criteria for quality assurance. This will help CSPD management team to better monitor staff needing additional training and coaching to minimize errors with instrument processing. No end date indicated.

There was no documented evidence of the audits.

-Fifth Course of Action: 9/27/2022, Boroscope was purchased to see inner cannulas and lumen using a scope monitoring system. The Boroscope will be placed in decontamination to perform quality inspections."

There was no documented evidence of training.

On 10/11/2022 at 9:30 AM, Voice report from Risk Management: "Severity Level, D - No Harm. Resolution/Outcome Notes included: Reviewed occurrence and the patient's medical record. Departmental referral to Director of Nursing (DON) Peri-op and Central Sterile. File reported to: N/A."


The facility's VOICE Event Report for Patient #3, event date 10/19/2022 at 2:00 PM documented:
"Specific Event Type: Instrument Issue. Severity Level was C - No Harm reached the patient. Brief description revealed: When the instrument tray was opened, there were disposable navigation balls attached to the instrument. The tray was discarded and not used according to the nurses in the room. Incident was reported to the charge RN."

-Manager, Staff and Leadership Notes documented: GE Navigation tray was not pre-clean appropriately after use in the OR. Pre-clean consist of removing and disposing of all consumables post-surgery in the room. After point of use pre-cleaning then trays are transported to CSPD decontamination.
The Central Sterile Technician was not responsible for the point of use pre-cleaning and therefore did not know to remove the disposable balls.
Tray was immediately sent for re-processing following the manufacturer's Instructions For Use (IFUs). The GE Navigation Device was returned on time and did not delay the procedure.

-CSPD management has placed a safety feature when assembling the tray. A message will automatically pop up on the screen whenever staff scan the GE Navigation tray and will read, "Ensure all disposable ball tips were removed."

On 10/21/2022 at 10:35 AM, VOICE report by Risk Management (RM) staff: " Resolution/Outcome Notes: Tray was opened and then discarded. It did not reach the patient. No evidence of injury to patient. Instrument was not used on patient. No formal RM review required. File reported to: N/A."

The facility did not ensure a root cause analysis of the subsequent event, action plan put in place and evaluated for effectiveness to prevent occurrence.

Similar findings of contaminated equipment/tray were subsequently identified with the facility's VOICE Report dated 10/20/2022.

During interview on 11/14/2022 at 4:00 PM, Staff L, Interim Chief Quality Officer, Deputy Chief Medical Officer, Staff were asked for a QAPI review of the July 13, 2022, contamination event. Staff was also asked for the QAPI reviews of the subsequent cases of similar contamination issues on October 7, 19, and 20, 2022.
Staff L stated the July 13, 2022, case was not discussed at a QAPI level. Staff L stated it was only one case and there was no pattern. Staff L stated there was no QAPI review of subsequent cases; however, the cases would be discussed on the next QAPI meeting, sometime at the end of November 2022.

The facility's, Performance Improvement/Patient Safety Committee Reports of July 23, 2022, September 27, 2022, and October 25, 2022, were reviewed. There was no documented evidence that the "Contamination events" were mentioned and addressed.

Based on medical record review, document review and staff interview, the facility failed to ensure compliance with Decontamination, Cleaning, and Sterilization of surgical equipment, in accordance with nationally recognized infection prevention and control guidelines. Specifically,

1. The facility's policies and procedure on Decontamination, Cleaning, and Sterilization, and Manufacturer's instructions for use, Decontamination, Cleaning, and Sterilization of equipment were not followed.

2. Contamination problems identified on surgical equipment/tray were not addressed in collaboration with the hospital-wide Quality Assessment and Performance Improvement (QAPI) program in a timely manner to prevent recurrences, ensure patient safety, and quality of care.

These breaks in infection control practices place patients at risk for infection.

Findings:

Review of the facility's Incident Log dated July 2022 to November 18, 2022, identified four (4) patients with incidents category of "Contamination."

A facility's VOICE Event Report (Incident Report) for Patient #1, event date 7/13/2022 at 10:30 AM, documented:
"Specific Event Type: Contamination. Report revealed, " During an ORIF to left femur, one of the instruments (Smith and Nephew Intertan Gold Tray Lag Screwdriver) was grossly soiled in the tray. The cannulated driver came in the instrument tray with a 3.2 K-wire still inside the cannula from a previous surgery. There was no other instrument tray available. So, the surgeon had no choice but to remove the grossly soiled previously used K-wire and flushed the cannula repeatedly with betadine solution before inserting a new K-wire in order to proceed with the procedure. CSP staff were notified and came to the OR to assess. The count sheet and soiled K-wire were taken by CSP staff back to CSP for educational purposes. RN supervisor notified."


Subsequent VOICE Reports documented incidents of contaminated equipment/tray on 10/7/2022 and 10/19/2022.


See Tag 0750.

Based on medical record review, document review, and staff interview, in six (6) of six (6) medical records reviewed, the facility did not ensure contaminated equipment/tray were not utilized in a surgical procedure, and did not implement a comprehensive corrective action to prevent recurrence. (Patient #1, #2, #3, #4, #5, #6)

These breaches in infection control practices may have placed patients at risk for infection.


Findings include:

(a) Smith and Nephew Orthopedic Device, Manufacturer's Instruction for Care, Maintenance, Cleaning and Sterilization 2022 documented:
"Loaners sets should undergo all steps of decontamination, cleaning, disinfection, inspection and terminal sterilization described in this instruction document...

"Warnings Cleaning and Sterilization. Single-use devices must not be reused. Use of a device is defined as contact of the device with blood or bodily fluids from a patient. Reuse may increase risk of breakage, failure, patient infection, patient injury and revision surgery."

"Steam sterilization is the only method that has been validated for processing by Smith and Nephew."


(b)The facility's policy and procedure titled, "Decontamination - SPD (Sterile Processing Department)" last reviewed on 4/5/2022, noted, CSS (Central Sterile Supply) personnel are to perform the proper cleaning, disinfecting of patient devices through the decontamination area, following infection control procedures which included, but not limited to: ..."

(c) The facility's "The Functional Job Description of Central Sterile Technician" was reviewed and documented:
Purpose of Position: Central Sterile Technicians are tasked with the reprocessing of reusable medical devices following IFU while abiding by guidelines and best practices."


Review of the facility's Incident Log dated July 2022 to November 18, 2022, identified four (4) patients with incidents category of "Contamination."
Two (2) additional patients with contamination issues were reported to the surveyors on 11/14/2022, by the facility's Regulatory staff.
(Patient #1, #2, #3, #4, #5, and #6)

Review of Patient #1 Medical Record (MR) identified on 7/13/2022, at 7:45 AM, the RN Circulator Note, patient in the Operating Room for Open Reduction Internal Fixation (ORIF) of Left Hip-Stryker Trigen Nail. Pre-procedure Timeout included timeout questions were documented.

At 9:00 AM, Timeout for Sign-in, with timeout questions documented
At 10:33 AM, Timeout for Pre-incision documented.
At 12:20 PM, Case Tracking Event: Procedure finished.

At 12:29 PM, Physician's Note; Timeout for Sign-Out was conducted which included questions as: Are counts correct? Yes; Have all new equipment problems been addressed? No; Have all recovery issues been reviewed? Yes. Comments documented Lag Screw Drill from Intertan Gold Tray had KWIRE still inserted from previous use. CSP managers notified.

At 12:36 PM, Case Tracking Event: Anesthesia finished.


A facility's VOICE Event Report (Incident Report) for Patient #1, event date 7/13/2022 at 10:30 AM, documented:
"Specific Event Type: Contamination. Report revealed, " During an ORIF to left femur, one of the instruments (Smith and Nephew Intertan Gold Tray Lag Screwdriver) was grossly soiled in the tray. The cannulated driver came in the instrument tray with a 3.2 K-wire still inside the cannula from a previous surgery. There was no other instrument tray available. So, the surgeon had no choice but to remove the grossly soiled previously used K-wire and flushed the cannula repeatedly with betadine solution before inserting a new K-wire in order to proceed with the procedure. CSP staff were notified and came to the OR to assess. The count sheet and soiled K-wire were taken by CSP staff back to CSP for educational purposes. RN supervisor notified."

Provider Attestation: physician documented A new K-wire was used soaked in betadine to clean the cannulated drill by passing it through the cannulated drill multiple times. The drill had been autoclaved before the procedure.
The patient was doing well post-operatively day #2 (POD #2) without fever or wound drainage."

Additional Voice Event Report documentation: " Per IPAC (Infection Prevention and Control) IPAC: IPAC is monitoring/surveillance on the patient for 90 days. As of August 17, 2022, no infection to date identified. All surgical instruments should be Decontaminated, Prepped and Packaged, and Sterilized as per policy. No surgical instruments should be cleaned with betadine solution.
Severity Level D. No Harm reached the patient. Patient monitoring required."


During interview of Staff I, Attending Orthopedic Surgeon on 11/18/2022 at 10:00 AM, and Staff S, Director of Regulatory, the following information were obtained:
-Staff I was asked of any recollection of Patient #1? Staff I recollected a 91-year-old patient with medical history of Hypertension, Thyroid Disease, and Bowel Cancer.
-Staff I explained patient had a left femoral fracture which required fixation. The tray was not from the hospital, a company comes and brings the tray. The patient was already anesthetized, surgery had started, and the nail was in. The nurse noted a guidewire in the cannulated drill from a previous surgery.
-Staff I explained an old Kwire was removed, cannula was flushed with Betadine, and a new Kwire was put in the cannulated drill.
-Staff I stated based on his professional judgement, there was the need to pursue the surgery for patient safety. Patient was a 91-year-old with comorbidities.
-Staff I stated the implant company was asked if they had another tray and they did not have another tray of similar kind. The nail was already in with the matching Kwire. This particular implant was the implant of choice for the patient's fracture.
-Staff I was asked if he was familiar of the Manufacturer's instruction for use which included only Steam Sterilization. Staff I responded "not aware." Staff I stated they had a Mortality and Morbidity meeting during grand round where the case was presented and discussed. Staff I stated, " it was felt that it was the best call of action at that time."
-Staff I was asked if flash sterilization was mentioned as an option, and Staff I stated, "no." Staff I stated he monitored the patient for wound status. Wound was clean, and no signs of infection post operatively. The patient had subsequent visits related to Ortho surgery.


Per interview with Staff O, Administrative Director of Central Supply on 11/15/2022 at 10:45 AM, the following information were obtained:
-Staff O was asked of her familiarity with events of contaminated equipment/trays in the OR. Staff O reported they had a July 13, 2022 event, and in October 2022 had near misses, did not reach patients.
-Staff O was asked of her recollection of the July 13, 2022, event. Staff O stated the surgeon noted a K-wire in the drill. Central Supply was called. An alternative instrument was offered to the surgeon. The surgeon decided not to change the instrument and proceeded with the case. The surgeon removed the Kwire and flushed the instrument with Betadine. A new Kwire was placed after cleaning. Staff O stated this was not an acceptable practice. Old Kwire should not have been used in the drill. Flushing with Betadine is not an acceptable practice as well.
-Staff O indicated that if the instrument was capable of Immediate-Use Steam Sterilization (IUSS), IUSS could have been requested, and it would have been done. IUSS (formerly known as Flash Sterilization) takes 15 to 30 minutes. . Staff O stated, the request for Flash Sterilization was not made for this case as no one notified her.
-Staff O explained, it is the expectations from the staff, if a stain is identified on the equipment/tray, staff was to remove and replace the whole tray. If a debris is identified, staff was to remove and replace the whole tray.
-Staff O stated a debriefing was conducted on 7/14/2022 with all Central Supply and Nursing staff. Medical staff was not present. Staff O explained there was heightened awareness after the July event. Corrective action for Nursing included training on the whole cycle of Decontamination, Cleaning, and Sterilization and Escalation.

There was no documentation that Central Sterile and Surgical/Medical staff were re-educated and re-in serviced on the complete process of the facility's policy and procedure on decontamination, cleaning, and sterilization process.

There was no documentation that a systemic review and identification of similar equipment/instruments with disposable parts were identified and Central Supply staff, and Nursing staff were educated to prevent recurrence.

Subsequent recurrence of contaminated equipment/tray were identified on 10/07/22.


Review of Patient #2 MR identified on 10/7/2022, General Surgery information at 10:15 AM, patient had a surgical procedure to fix a broken thighbone. The surgical procedure ended at 3:36 PM.

The facility's VOICE Event Report for Patient #2, event date 10/07/2022 at 2:27 PM documented:
"Procedure event, Other specific Event Type: debris on depth gauze, removal from field right away, new one was used, glove changed. Brief Factual Description: The Stryker Loaner Tray "T2 Alpha Basic" measuring guide was found with dry debris. The scrub nurse removed immediately from the field and all surgical team changed their gloves. The occurrence was reported to the Central Sterile supervisor. The VOICE was reported by the Circulating Nurse...

Provider Attestation: Patient had distal femur fracture underwent retrograde nail. While using the depth gauze to measure the length of the nail, noticed the debris on it. The depth gauze was removed from the field and new depth gauze from other set was use and glove changed before proceeded further. Antibiotic paste was used."

On 10/12/2022 at 12:34 PM, Voice Event Report entry from Risk Management staff: "the dirty depth gauze never touched the guide wire or entered the patient's body. This was the second event by a CSPD employee (Central Supply Processing Department), despite remediation related to HLD (High Level Disinfection) training in decontamination and assembly.

Subsequent recurrence of contaminated equipment/tray were identified on 10/19/2022 and 10/20/2022.

There was no documented evidence that a comprehensive corrective action was implemented to included training to prevent recurrence.


Review of Patient #3 MR identified on 10/19/2022, patient underwent a surgical procedure for Bilateral Craniotomy procedure for Intra-Cranial Pressure (ICP) control.

The facility's VOICE Event Report for Patient #3, event date 10/19/2022 at 2:00 PM documented:
"Specific Event Type: Instrument Issue. Severity Level was C - No Harm reached the patient. Brief description revealed: When the instrument tray was opened, there were disposable navigation balls attached to the instrument. The tray was discarded and not used according to the nurses in the room. Incident was reported to the charge RN."

-Manager, Staff and Leadership Notes documented: GE Navigation tray was not pre-clean appropriately after use in the OR. Pre-clean consist of removing and disposing of all consumables post-surgery in the room. After point of use pre-cleaning then trays are transported to CSPD decontamination.
The Central Sterile Technician was not responsible for the point of use pre-cleaning and therefore did not know to remove the disposable balls.
Tray was immediately sent for re-processing following the manufacturer's IFUs. The GE Navigation Device was returned on time and did not delay the procedure.

-CSPD management has placed a safety feature when assembling the tray. A message will automatically pop up on the screen whenever staff scan the GE Navigation tray and will read, "Ensure all disposable ball tips were removed."

Similar findings of contaminated equipment/tray were identified for Patients #4, #5, and #6.

During interviews with Staff P, Assistant Director of Central Supply and Staff Q, Director of Central Supply, on 11/15/2022 at 12:50 PM, the following information were obtained:
-The facility has written policies and procedures on Decontamination, Cleaning and Sterilization.
Staff P was asked what was the expectation of the Central Supply Technicians in regards to Decontamination, Cleaning, and Sterilization? Staff P stated staff are expected to follow the policies and procedures on Decontamination, Cleaning and Sterilization. Staff are expected to follow their job descriptions and responsibilities. Staff P added the employees involved were disciplined.