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Based on observations, review of hospital policies, quality performance plan, medical records, personnel files, manufacturer's instructions for use and staff and provider interviews, the hospital failed to have an effective organizational leadership to ensure oversight of clinical contracts and infection control practices for care in a safe environment.

The findings included:

1. Based on observation, review of the Infection Control Plan, policies, manufacturer's instructions, contract review, physician and staff interviews, the hospital governing body failed to provide oversight for high-level disinfection procedures using contracted equipment, failed to ensure the manufacturer's instructions were followed, and failed to provide Infection Prevention and Control surveillance in all clinical care areas to reduce the risk of infections.

~ Cross refer to §485.627(a) Governing Body or Responsible Individual: C0962

2. The hospital staff failed to ensure prevention and control of infections by failing to follow manufacturer's IFUs and policy guidelines for high-level disinfection of semi-critical devices for 2 of 3 outpatient procedures (Patient #1 and #11).

~ Cross refer to §485.640 Infection Prevention Control Standard: C 1208

3. Hospital leadership failed to ensure systems were in place and operational to mitigate the risk of infections by failing to oversee contracted services for medical device reprocessing of semi-critical equipment; and failed to audit adherence to infection control policies in the operating room (OR), pain clinic and the cancer infusion center.

~ Cross refer to §485.640 Infection Prevention and Antibiotic Stewardship Program Standard: C1225

4. The hospital's Infection Prevention and Control Professional (IPCP #4) failed to ensure oversight of annual competency validation for staff performing High Level Disinfection (HLD) specifically related to reprocessing of semi-critical items for 4 of 4 hospital staff performing HLD (DPS#3, ST#7, Radiology Staff #5, RN #6); and failed to ensure contracted agency staff was educated on the hospital's policy requiring HLD of intracavity probes (semi-critical items) for 1 of 1 contracted agency staff (MRFT#1) in the Operating Room.

~ Cross refer to §485.640 Infection Prevention and Antibiotic Stewardship Program Standard: C 1239

Based on observation, review of the Infection Control Plan, policies, manufacturer's instructions, contract review, physician and staff interviews, the hospital governing body failed to provide oversight for high-level disinfection procedures using contracted equipment, failed to ensure the manufacturer's instructions were followed, and failed to provide Infection Prevention and Control surveillance in all clinical care areas to reduce the risk of infections.

The findings included:

Observation on 07/25/2024 at 0727 in the hospital's Operating Room (OR), revealed in preparation for an Ultrasound-Guided Transperineal Prostate Biopsy for Patient #1, the contracted MR (Magnetic Resonance) Fusion Technologist (MRFT#1) removed an unpackaged ultrasound (US) transducer (used to send sound waves through the rectal wall and into the prostate and tissue around the rectum) from the bottom drawer of a metal, rolling cart brought in by the contracted representative. Observation revealed three (3) additional, unpackaged ultrasound transducers in the bottom drawer. Observation revealed at 0735, MRFT#1 disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited seven (7) minutes before entering OR suite #1 and attaching the US transducer to the Artemis 3D Semi-Robotic Prostate Fusion Biopsy System mechanical arm at 0742. Observation revealed MRFT #1 placed a "CIVCO, Sterile NeoGuard Transducer Cover" (endocavity probe cover used as a viral barrier for transrectal US procedures) over the US transducer probe. At 0830, following the procedure for Patient #1, MRFT #1 removed and disposed of the "CIVCO, Sterile NeoGuard Transducer Cover," disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" and placed the probe on a clean table to dry. Following Environmental Services (EVS) turnover of OR suite #1, MRFT #1 obtained a second US transducer probe from the bottom drawer of the metal rolling cart at 0835, disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited five (5) minutes (0840) before entering OR suite #1 and attaching the US transducer to the Artemis 3D Semi-Robotic Prostate Fusion Biopsy System mechanical arm in preparation for Patient # 11's procedure. Observation revealed the US transducer probe was processed and disinfected as Non-critical equipment for Patient #1 and Patient #11.

Review on 07/23/2024 of the hospital Infection Control Plan, dated 04/20/2023 revealed, "I. PURPOSE The mission of [Hospital] Infection Prevention and Control Program is to promote a healthy and safe environment for patients, ... by reducing the risk or acquisition and transmission of health care associated infections....C. Limit the transmission of infections associated with the use of medical equipment, devices, and supplies... III. PROCEDURE All departments and services are included .... C. Develop and implement a preventive program designed to minimize infection risks to patients... D. Leadership is instrumental in the program by providing support for and monitoring of compliance with set policies and procedures.... Surveillance of healthcare associated infection includes assessing and monitoring.... device-associated procedures, surgical procedures..."

Review on 07/24/2024 of the hospital's policy titled, "Reprocessing of Medical Devices with High Level Disinfection, dated 01/04/2024" revealed, "A. ... 2. Semi-critical items are objects which come in contact with mucous membranes or with skin that is not intact such as.... rectal probes... High level disinfection is the minimum level of processing required. HLD is the process that eliminates all microorganisms with the exception of some bacterial spores. 3. Non-critical items are objects that come in contact with intact skin but not mucous membranes such as bedrails, bedpans, and IV [intravenous] poles. Disinfection with an EPA [Environmental Protection Agency] registered disinfectant is the requirement for reusable items... E. Choosing Appropriate Method of Disinfection 1. Any reusable item that comes in contact with mucous membranes including those in the lungs or gastrointestinal tract or that comes in contact with non-intact skin must receive minimum of HLD. Probe covers do not eliminate the need for HLD since these covers are not always 100% impervious [do not allow fluid to pass through]. 2. Each area performing HLD is responsible for complying with manufacturer instructions for device cleaning/disinfection and use of HLD agents and enzymatic cleaners. 3. Manufacturer's instructions should be readily available in the practice setting.... 5. Prior to purchase of new equipment/patient care items, evaluate reprocessing requirements to determine feasibility for your practice setting. 6. Consult with Infection Prevention department when implementing a new HLD process...L. Education/Competency/Quality Control 1. Staff performing high level disinfection must complete an initial and annual competency validation. a. Competencies should be specific to each type of scope/probe an individual will be performing HLD on. 2. Competency validation must be kept in the department..."

Review on 07/25/2024 of the manufacturer's IFU (instructions for use) provided by MRFT#1, via electronic communication on 07/25/2024 at 1000 revealed, "HITACHI C41V Probe INSTRUCTION MANUAL... Q1E-EP1363-6 2017.... 4. Cleaning, Disinfection and Sterilization The probe and accessory must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. WARNINGS - The probe is delivered unsterile. Prior to the first use, reprocess the probe. - Temperature should not exceed 60 [degrees] C during reprocessing... Transportation before using The probe should be packed in a sterile pouch or container to transport from Central Sterile Supply Department (CSSD) to an operating room.... Levels of reprocessing requirements: Depending on the application of the product and with regard to risk evaluation, the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical, semi-critical or critical. Supporting information concerning this topic is listed in the table below. The user is responsible for correct classification of the medical device... Classification...semicritical...Definition Application part contacts mucosa (intracavitary application) ...Processing Cleaning Disinfection (Disinfectant with virucidal effect) ...According to the intended uses, C41V probe is classified as semicritical ... 4.3 Manual Cleaning and disinfection Prepare following items before manual cleaning and disinfection: a) Detergent: Cidezyme (Johnson & Johnson, #2258) or another cleaning agent with approved material compatibility for this medical device. b) Disinfectant: Cidex OPA (Johnson & Johnson, # 20391) or another disinfectant with approved material compatibility for this medical device. ..." Review revealed the Probe was not cleaned by contract staff or hospital staff following the hospital's policy and IFU prior to patient care use.

Review on 07/25/2024 of the manufacturer IFU revealed, "Super Sani-Cloth Germicidal Disposable Wipe.... Kills HIV-1 (AIDS Virus), Hepatitis B Virus (HBV) on the precleaned environmental surfaces/objects and precleaned external surfaces of ultrasound transducers and probes previously soiled with blood/bodily fluids in two (2) minutes at room temperature ... This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that .... contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection ..." Review revealed that the Sani-Cloth Germicidal Disposable Wipe was not equivalent to high-level disinfection, and therefore unsafe to clean the Probe used for patient care.

Interview 07/25/2024 at 0736 with MRFT#1 revealed the US Guided Transperineal biopsy procedure was considered a "clean procedure" versus a sterile procedure. Interview revealed, "The scope is used as a guide only. The [biopsy] needle is inserted directly into the perineum after being prepped with Chlorhexidine [used as a mild antiseptic]. Interview revealed MRFT #1 used Super Sani-Cloth Germicidal Disposable Wipes to clean the probe prior to taking it into the OR suite and again immediately following removal of the CIVCO, Sterile NeoGuard Transducer Cover, "I usually use two (2) [C41V probes] to allow for drying time." The interview revealed contracted staff did not adhere to the hospital's policy and the Probe's manufacturer instruction for use.

Interview on 07/25/2024 at 0925 with MD #1, the surgeon who performed the procedure for Patient #1, revealed in review of the manufacturer "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" guidelines, MD #1 classified the C41V probe as a "Semi-critical" device and verified that HLD was indicated.

Interview with MRFT#1 on 07/25/2024 at 0925 revealed she received on the job training and was taught to clean the C41V probe with Super Sani-Cloth Germicidal Disposable Wipes. Interview confirmed that the hospital staff and the contracted MRFT failed to identify the classification of the C41V probe as a Semi-critical item resulting in improper reprocessing of the probe.

Interview on 07/25/2024 at 1035 with the Director of Peri-operative Services (DPS#3) revealed that per the IFU from Hitachi, the probe used for Ultrasound-Guided Transperineal Biopsies was classified as Semi-critical equipment and HLD was recommended. Interview revealed, "In my mind, we're using the probe in a non-critical capacity due to the nature of the procedure and how it is performed. The probe itself is used as a guide and in contact with intact skin." Interview revealed, "We are not currently following [cleaning and disinfection] recommendations for Semi-critical items. Going forward, we plan to follow recommendations for semi-critical items for HLD." Interview revealed, "Lesson learned, I'll make sure vendors are familiar with or aware of IFU. I just took her [MRFT#1's] word for it [that intermediate or low-level disinfection was acceptable]."

Interview on 07/26/2024 at 1600 with the Administrative Director of Quality and Ambulatory Services revealed "...Review of local contracts is not part of our QAPI meeting or dashboard. That is handled at an executive level ..." The interview revealed hospital Quality Assessment Performance Improvement was not involved with hospital contract assessment or improvement measures to include Infection Prevention and Control (IPC) surveillance of Clinical Care Contracts.

Interview on 07/29/2024 at 1154 with the Infection Prevention and Control Professional (IPCP#4) revealed that she was not involved in the selection process for determining which vendor would be the best selection for the desired services. "That usually falls under the Director of that department." Interview revealed, "I don't remember that specific contract [current contract for US Guided Transperineal Prostate Biopsies]. I thought we were still doing High Level Disinfection [HDL]. I was not aware the vendor had changed." Interview revealed Environment of Care (EOC) rounds were conducted twice a year in the hospital's Pain Clinic and Cancer Infusion Center and that there was no Infection Control data monitoring procedures or infection rates for the two (2) outpatient clinics. "We typically don't have a lot of infections." Interview revealed, "Oversight of cleaning and disinfection falls to the Department Head" and that there had been no observations of the cleaning and disinfection process in the OR or of procedures performed in the Pain Clinic and Cancer Infusion Center by the IPCP to date. Interview confirmed administrative staff failed to ensure auditing of adherence to Infection Prevention and Control policies and procedures and failed to evaluate new equipment/devices, for reprocessing requirements.

In summary, the hospital failed to provide oversight for high-level disinfection procedures using contracted equipment, failed to ensure the manufacturer's instructions were followed, and to failed to provide Infection Prevention and Control surveillance in all clinical care areas to reduce the risk of infections.

Based on observation, review of hospital policy and procedure, contracts, manufacturer's guidelines and instructions for use (IFU), job descriptions, personnnel file review, medical records, Infection Prevention and Control (IPC) data, and staff and physician interviews, hospital leadership failed to maintain an effective, on-going infection control program.

The findings included:

1. The hospital staff failed to ensure prevention and control of infections by failing to follow manufacturer's IFUs and policy guidelines for high level disinfection of semi-critical devices for 2 of 3 outpatient procedures (Pt #1, Pt #11).

~ Cross refer to §485.640 Infection Prevention and Antibiotic Stewardship Program Standard: C 1208

2. Hospital leadership failed to ensure systems were in place and operational to mitigate the risk of infections by failing to oversee contracted services for medical device reprocessing of semi-critical equipment; and failed to audit adherence to infection control policies in the operating room (OR), pain clinic and the cancer infusion center.

~ Cross refer to §485.640 Infection Prevention and Antibiotic Stewardship Program Standard: C1225

3. The hospital's Infection Prevention and Control Professional (IPCP #4) failed to ensure oversight of annual competency validation for staff performing High Level Disinfection (HLD) specifically related to reprocessing of semi-critical items for 4 of 4 hospital staff performing HLD (DPS#3, ST#7, Radiology Staff #5, RN #6); and failed to ensure contracted agency staff was educated on the hospital's policy requiring HLD of intracavity probes (semi-critical items) for 1 of 1 contracted agency staff (MRFT#1) in the Operating Room.

~ Cross refer to §485.640 Infection Prevention and Antibiotic Stewardship Program Standard: C 1239

Based on observation, review of policies and procedures, "Super-Sani-Cloth Germicidal Disposable Wipe" instructions for use (IFU), Equipment Lease and Support Agreement, manufacturer cleaning, disinfection, and sterilization guidelines, manufacturer "Smart Connect Transducers and Approved Disinfectants & Sterilization List for U.S.A.", manufacturer probe instruction IFU, medical records and staff interviews, the hospital staff failed to ensure prevention and control of infections by failing to follow manufacturer's IFUs and policy guidelines for high-level disinfection of semi-critical devices for 2 of 3 outpatient procedures (Patient #1 and #11).

The findings included:

Observation on 07/25/2024 at 0727 in the hospital's Operating Room (OR), revealed in preparation for an Ultrasound-Guided Transperineal Prostate Biopsy for Patient #1, the contracted MR (Magnetic Resonance) Fusion Technologist (MRFT#1) removed an unpackaged ultrasound (US) transducer (used to send sound waves through the rectal wall and into the prostate and tissue around the rectum) from the bottom drawer of a metal, rolling cart brought in by the contracted representative. Observation revealed three (3) additional, unpackaged ultrasound transducers in the bottom drawer. Observation revealed at 0735, MRFT#1 disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited seven (7) minutes before entering OR suite #1 and attaching the US transducer to the Artemis 3D Semi-Robotic Prostate Fusion Biopsy System mechanical arm at 0742. Observation revealed MRFT #1 placed a "CIVCO, Sterile NeoGuard Transducer Cover" (endocavity probe cover used as a viral barrier for transrectal US procedures) over the US transducer probe. At 0830, following the procedure for Patient #1, MRFT #1 removed and disposed of the "CIVCO, Sterile NeoGuard Transducer Cover," disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" and placed the probe on a clean table to dry. Following Environmental Services (EVS) turnover of OR suite #1, MRFT #1 obtained a second US transducer probe from the bottom drawer of the metal rolling cart at 0835, disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited five (5) minutes (0840) before entering OR suite #1 and attaching the US transducer to the Artemis 3D Semi-Robotic Prostate Fusion Biopsy System mechanical arm in preparation for Patient # 11's procedure. Observation revealed the US transducer probe was processed and disinfected as Non-critical equipment for Patient #1 and Patient #11.

Review on 07/24/2024 of the hospital's policy titled, "Reprocessing of Medical Devices with High Level Disinfection", dated 01/04/2024 revealed, "A. Equipment Cleaning Categories...2. Semi-critical items are objects which come in contact with mucous membranes or with skin that is not intact such as.... rectal probes... High level disinfection (HLD) is the minimum level of processing required... 3. Non-critical items are objects that come in contact with intact skin but not mucous membranes such as bedrails, bedpans, and IV [intravenous] poles. Disinfection with an EPA [Environmental Protection Agency] registered disinfectant is the requirement for reusable items... E. Choosing Appropriate Method of Disinfection 1. Any reusable item that comes in contact with mucous membranes including those in the lungs or gastrointestinal tract or that comes in contact with non-intact skin must receive minimum of HLD. Probe covers do not eliminate the need for HLD since these covers are not always 100% impervious [do not allow fluid to pass through]. 2. Each area performing HLD is responsible for complying with manufacturer instructions for device cleaning/ disinfection and use of HLD agents and enzymatic cleaners. 3. Manufacturer's instructions should be readily available in the practice setting.... 6. Consult with Infection Prevention department when implementing a new HLD process..."

Review on 07/25/2024 of the "Super Sani-Cloth Germicidal Disposable Wipe" IFU (Instructions for Use) revealed, "Kills HIV-1 (AIDS Virus), Hepatitis B Virus (HBV) on the precleaned environmental surfaces/objects and precleaned external surfaces of ultrasound transducers and probes previously soiled with blood/bodily fluids in two (2) minutes at room temperature... This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that .... (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection ..."

Review on 07/25/2024 of the "MR FUSION EQUIPMENT LEASE AND SUPPORT AGREEMENT", signed 11/17/2023 revealed, "... 2.6 Equipment Handling. In addition to following Facility's requirements applicable to utilization of the Equipment on Facility's patients, Facility will follow, and will direct the Physician to follow, all policies, procedures, guidelines and instructions provided to Facility by [Contracted Agency].... with regard to the utilization and handling of Equipment ("Contract Agency Instructions"), including without limitation, all [Contracted Agency] Instructions applicable to Facility's reprocessing of the Equipment."

Review on 07/25/2024 of the "HITACHI 20, MAY 2020 2ND Ed Hitachi Healthcare Business Unit" manufacturer guidelines provided by MRFT#1 titled, "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" revealed "Table 1 Levels of Disinfection Requirements... Classification... Semi-critical Definition... Device contact mucous membranes (Intracavity applications) ... Levels of disinfection... High..."

Review on 07/25/2024 of the "Hitachi Aloka Smart Connect Transducers and Approved Disinfectants & Sterilization List for U.S.A. (Ver19 1612)" IFU provided by MRFT#1 revealed cleaning and disinfections guidelines for Non-critical items, Semi-critical items, and Critical items. Review of the Semi-critical guidelines revealed the C41V probe was compatible with solutions used for HLD (i.e., Cidex, Cidex OPA Cidex Plus, etc.).

Review on 07/25/2024 of the "HITACHI C41V Probe INSTRUCTION MANUAL...Q1E-EP1363-6 2017 manufacturer IFU provided by MRFT#1, via electronic communication on 07/25/2024 at 1000 revealed, "... 4. Cleaning, Disinfection and Sterilization The probe and accessory must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. WARNINGS - The probe is delivered unsterile. Prior to the first use, reprocess the probe. - Temperature should not exceed 60 [degrees] C [celsius] during reprocessing... Transportation before using The probe should be packed in a sterile pouch or container to transport from Central Sterile Supply Department (CSSD) to an operating room.... Levels of reprocessing requirements: Depending on the application of the product and with regard to risk evaluation, the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical, semi-critical or critical... The user is responsible for correct classification of the medical device... Classification...semicritical...Definition: Application part contacts mucosa (intracavitary application) ...Processing Cleaning Disinfection (Disinfectant with virucidal effect) ...According to the intended uses, C41V probe is classified as semicritical...4.1 Point of use (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: 1) Remove the protective cover. 2) Clean the probe of all patient's blood or fluid with running tap water until the surface of the probe looks visually clean. 3) Wipe the whole surface of the probe with gauze pad and remove superficial visible impurities and leavings of ultrasound jelly 4.3 Manual Cleaning and Disinfection Prepare following items before manual cleaning and disinfection: a) Detergent: Cidezyme or another cleaning agent with approved material compatibility for this medical device. b) Disinfectant: Cidex OPA or another disinfectant with approved material compatibility for this medical device c) Two tanks, one for cleaning and one for disinfection...Manual Cleaning: Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution, and contact time). 1) The temperature of the detergent solution should be between 15-30 degrees C, concentration is 1.6%...2) Immerse the immersible part of the probe without connector into the diluted solution... Wipe the immersible part of the probe under the surface of the detergent solution with a soft cloth to remove all visible soil. Be sure that all grooves of the probe are implemented during the cleaning process. 3) The immersible part of the probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer. 4) Wipe the un-immersible parts of the probe with a soft cloth dipped with the detergent solution. 5) Rinse the probe with running tap water for 1 minute... 6). Visually check the outer surface of the probe for cleanness. Manual disinfection: 1) Prepare the disinfectant solution in a tank with cold water (please follow the instructions of the disinfectant manufacturer regarding application, concentration, microbiological efficiency, service life and contact time). 2) Confirm the concentration of the disinfectant before immersing the probe. Although Cidex OPA does not need to be diluted, it is recommended to use test strips to verify the concentration. The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration (MEC)... 3) Immerse the immersible part of the probe into the disinfectant... Set a clock to insure [sic] the recommended contact time which is 5 minutes. 4) Rinse the immersible part of the probe with deionized water for 1 minute...

1. Medical record review on 07/26/2024 for Patient #1 revealed a 62-year-old male presented to the hospital's outpatient department for a scheduled US Guided Transperineal prostate biopsy procedure on 07/25/2024. Review of the Operative Note by MD #1, dated 07/25/2024 at 0832, revealed once Patient #1 was placed on the OR table, MAC (Monitored Anesthesia Care) was induced, perineum prepped and draped in a sterile fashion, and timeout performed identifying the patient procedure and location. 20 cc of lidocaine was used to provide local anesthetic to the perineum. and the transrectal ultrasound probe was placed in the rectum. Once the mapping was confirmed, a 12-core biopsy was performed transperineal using ultrasound guidance obtaining cores. The ultrasound probe was then removed and the patient was transferred to the PACU (Post-Anesthesia Care Unit) in stable condition for continued monitoring.

Interview on 07/24/2024 at 1040 with the hospital Director of Perioperative Services (DPS#3) revealed, "Radiology does all HLD for ultrasound probes .... There is no reprocessing [HLD] at this time." Subsequent interview at 1219 with DPS#3 revealed the hospital transitioned from performing Ultrasound (US) Guided Transrectal biopsies to US Guided Transperineal biopsies in February 2024. Interview revealed the probe used for the procedure (C41V) was "wiped down between patients and a sterile cover applied [CIVCO, Sterile NeoGuard Transducer Cover] for the next patient... purple-top wipes [Super Sani-Cloth Germicidal Disposable Wipe], with a 2-3-minute drying period was used to clean/disinfect the C41V] probe." Interview revealed, "The hospital determines the level of disinfection and it [C41V probe] was considered a Non-critical item per the vendor.

Interview 07/25/2024 at 0736 with MRFT#1 revealed the US Guided Transperineal biopsy procedure was considered a "clean procedure" versus a sterile procedure. Interview revealed, "The scope is used as a guide only. The [biopsy] needle is inserted directly into the perineum after being prepped with Chlorhexidine [used as a mild antiseptic]. Interview revealed MRFT #1 used Super Sani-Cloth Germicidal Disposable Wipes to clean the probe prior to taking it into the OR suite and again immediately following removal of the CIVCO, Sterile NeoGuard Transducer Cover, "I usually use two (2) [C41V probes] to allow for drying time."

Interview on 07/25/2024 at 0925 with the surgeon who performed the procedure for Patient #1 (MD #1), DPS#3 and MRFT#1 revealed that in review of the manufacturer's "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" guidelines, MD #1 classified the C41V probe as a "Semi-critical" device and verified that HLD was indicated, stating "Per the definition, it is a Semi-critical item." During the interview, MRFT #1 shared that she received on the job training and was "taught to clean the C41V probe with Super Sani-Cloth Germicidal Disposable Wipes, with the virucidal." Interview confirmed that the hospital staff and MRFT#1 failed to appropriately identify the classification of the C41V probe as a Semi-critical item resulting in improper reprocessing of the medical device.

Interview on 07/25/2024 at 1035 with DPS#3 revealed if it was determined that the C41V probe used for Ultrasound-Guided Transperineal Biopsies was classified as Semi-critical equipment, "HLD is recommended, per review of the IFU from Hitachi." Interview revealed, "In my mind, we're using the probe in a Non-critical capacity due to the nature of the procedure and how it is performed. The probe itself is used as a guide and in contact with intact skin." Interview revealed, "We are not currently following [cleaning and disinfection] recommendations for Semi-critical items. Going forward, we plan to follow recommendations for Semi-critical items for HLD. Lesson learned, I'll make sure vendors are familiar with or aware of IFU. I just took her [MRFT#1] word for it [that intermediate or low-level disinfection was acceptable]."

2. Medical record review on 07/26/2024 for Patient #11 revealed a 64-year-old male presented to the hospital's outpatient department for a scheduled US Guided Transperineal prostate biopsy procedure on 07/25/2024. Review of the operative note by MD #1, dated 07/25/2024 at 0911, revealed once Patient #11 was placed on the OR table in OR suite #1, MAC (Monitored Anesthesia Care) was induced, perineum prepped and draped in a sterile fashion, and timeout performed identifying the patient procedure and location. 20 cc of lidocaine was used to provide local anesthetic to the perineum. and the transrectal ultrasound probe was placed in the rectum. Once the mapping was confirmed, a 12-core biopsy was then performed Transperineal using ultrasound guidance obtaining cores. The ultrasound probe was then removed and the patient was transferred to the PACU (Post-Anesthesia Care Unit) in stable condition for continued monitoring.

Interview on 07/25/2024 at 0925, following completion of Patient #11's procedure, with the surgeon who performed the procedure for Patient #1 (MD #1), DPS#3 and MRFT#1 revealed that in review of the manufacturer "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" guidelines, MD #1 classified the C41V probe as a "Semi-critical" device and verified that HLD was indicated stating, "Per the definition, it is a Semi-critical item." During the interview, the MRFT shared that she received on the job training and was taught to clean the C41V probe with Super Sani-Cloth Germicidal Disposable Wipes, with the virucidal." Interview confirmed that the hospital staff and the contracted MRFT failed to appropriately identify the classification of the C41V probe as a Semi-critical item resulting in improper reprocessing of the medical device.

Interview on 07/25/2024 at 1035 with DPS#3 revealed if it was determined that the C41V probe used for Ultrasound-Guided Transperineal Biopsies was classified as Semi-critical equipment, "HLD is recommended, per review of the IFU from Hitachi." Interview revealed, "In my mind, we're using the probe in a Non-critical capacity due to the nature of the procedure and how it is performed. The probe itself is used as a guide and in contact with intact skin." Interview revealed, "We are not currently following [cleaning and disinfection] recommendations for Semi-critical items. Going forward, we plan to follow recommendations for Semi-critical items for HLD. Lesson learned, I'll make sure vendors are familiar with or aware of IFU. I just took her [MRFT#1] word for it [that intermediate or low-level disinfection was acceptable]."

Based on reviews of the Infection Control Plan, job description, hospital policies and procedures, manufacturer guidelines, observation, review of Infection Prevention and Control (IPC) data and staff and physician interviews, hospital leadership failed to ensure systems were in place and operational to mitigate the risk of infections by failing to oversee contracted services for medical device reprocessing of semi-critical equipment; and failed to audit adherence to infection control policies in the operating room (OR), pain clinic and the cancer infusion center.

The findings included:

Review on 07/23/2024 of the hospital's Infection Control Plan, dated 04/20/2023 revealed, "I. PURPOSE The mission of [Hospital] Infection Prevention and Control Program is to promote a healthy and safe environment for patients, healthcare providers and visitors by reducing the risk or acquisition and transmission of health care associated infections. II. POLICY The four basic categories of goals of [Hospital] Infection Prevention and Control program are.... B. Limit the transmission of infections associated with procedures C. Limit the transmission of infections associated with the use of medical equipment, devices, and supplies. III. PROCEDURE All departments and services are included in the Infection Prevention and Control Program....Surveillance is defined as the ongoing, systematic collection, analysis, interpretation, and dissemination of data.... Prevention focuses on risks of infection and ways to decrease those risks... D. Leadership is instrumental in the program by providing support for and monitoring of compliance with set policies and procedures.... Surveillance of healthcare associated infection includes assessing and monitoring.... device-associated procedures, surgical procedures, and services or procedures appropriate to the facility... "

Review on 07/26/2024 of the "Infection Preventionist/Employee Health Nurse Job Description" revealed the job description was signed 11/23/2022. Review revealed, "...She/He is responsible for the identification, investigation, reporting, prevention and control of healthcare associated infections (HAIs) among patients and personnel...She/He is responsible for assisting with in-service programs related to infection prevention and control.... [Hospital] Criteria Based Performance Standards, Hospital Policies...and various other laws/regulations require that we assess the ongoing competency of our staff to assure that the staff maintains competency to perform their duties proficiently.... Essential Functions ... surveillance activity... Monitors proper use of germicides, cleaning products, antiseptic and disinfectants in use throughout the facility. Monitors methods of asepsis, sterilization and disinfection employed throughout the facility..."

Review on 07/24/2024 of the hospital's policy titled, "Reprocessing of Medical Devices with High Level Disinfection, dated 01/04/2024" revealed, "A. Equipment Cleaning Categories...2. Semi-critical items are objects which come in contact with mucous membranes or with skin that is not intact such as.... rectal probes... High level disinfection (HLD) is the minimum level of processing required.... 3. Non-critical items are objects that come in contact with intact skin but not mucous membranes such as bed rails, bed pans, and IV [intravenous] poles. Disinfection with an EPA [Environmental Protection Agency] registered disinfectant is the requirement for reusable items... E. Choosing Appropriate Method of Disinfection 1. Any reusable item that comes in contact with mucous membranes including those in the lungs or gastrointestinal tract or that comes in contact with non-intact skin must receive minimum of HLD. Probe covers do not eliminate the need for HLD since these covers are not always 100% impervious [do not allow fluid to pass through]. 2. Each area performing HLD is responsible for complying with manufacturer instructions for device cleaning/disinfection and use of HLD agents and enzymatic cleaners. 3. Manufacturer's instructions should be readily available in the practice setting.... 6. Consult with Infection Prevention department when implementing a new HLD process."

Review on 07/25/2024 of the "HITACHI 20, MAY 2020 2ND Ed Hitachi Healthcare Business Unit" manufacturer guidelines provided by MRFT #1 titled, "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" revealed "Table 1 Levels of Disinfection Requirements... Classification... Semi-critical Definition... Device contact mucous membranes (Intracavity applications) ... Levels of disinfection ... High..."

Review on 07/25/2024 of the "Hitachi Aloka Smart Connect Transducers and Approved Disinfectants & Sterilization List for U.S.A. (Ver19 1612)" IFU provided by MRFT#1 revealed cleaning and disinfections guidelines for Non-critical items, Semi-critical items, and Critical items. Review of the semi-critical guidelines revealed the C41V probe was compatible with solutions used for HLD (i.e., Cidex, Cidex OPA Cidex Plus, etc.).

Review on 07/25/2024 of the manufacturer IFU provided by MRFT#1, via electronic communication on 07/25/2024 at 1000, of "HITACHI C41V Probe INSTRUCTION MANUAL... Q1E-EP1363-6 2017" revealed, "... 4. Cleaning, Disinfection and Sterilization The probe and accessory must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. WARNINGS - The probe is delivered unsterile. Prior to the first use, reprocess the probe. - Temperature should not exceed 60 [degrees] C [celsius] during reprocessing... Levels of reprocessing requirements: Depending on the application of the product and with regard to risk evaluation, the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical, semi-critical or critical. . The user is responsible for correct classification of the medical device... Classification...semicritical...Definition Application part contacts mucosa (intracavitary application) ...Processing Cleaning Disinfection (Disinfectant with virucidal effect) ...According to the intended uses, C41V probe is classified as semicritical..."

Observation on 07/25/2024 at 0727 in the Operating Room (OR), revealed a case scheduled for Patient #1. Observation revealed the contracted MR (Magnetic Resonance) Fusion Technologist (MRFT#1) removed an unpackaged ultrasound (US) transducer (used to send sound waves through the rectal wall and into the prostate and tissue around the rectum) from the bottom drawer of a metal, rolling cart brought in by the contracted representative. Observation revealed at 0735, MRFT#1 disinfected the US transducer with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited seven (7) minutes before entering OR suite #1 and attaching the US transducer to the Semi-Robotic Prostate Fusion Biopsy System mechanical arm at 0742. Observation revealed MRFT #1 placed a probe cover (used as a viral barrier for transrectal US procedures) over the US transducer probe. At 0830, following Patient #1's procedure for Patient #1, MRFT #1 removed and disposed of the probe cover, disinfected the probe with a "Super Sani-Cloth Germicidal Disposable Wipe" and placed the probe on a clean table to dry. A second case [Patient #11] followed after Patient #1's procedure was completed. MRFT #1 obtained a second US transducer probe from the bottom drawer of the metal rolling cart at 0835, disinfected the probe with a "Super Sani-Cloth Germicidal Disposable Wipe" outside OR suite #1 and waited five (5) minutes (until 0840) before entering OR suite #1 and attaching the US transducer to the Semi-Robotic Prostate Fusion Biopsy System mechanical arm in preparation for Patient # 11's procedure. Observation revealed the US transducer probe was processed and disinfected as Non-critical equipment for Patient #1 and Patient #11.

Interview on 07/25/2024 at 0925, with MD #1 (surgeon who performed the procedure), DPS#3 and MRFT#1 revealed that in review of the manufacturer's "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" guidelines, MD #1 classified the C41V probe as a "Semi-critical" device and verified that HLD was indicated. MD #1 stated, "Per the definition, it is a Semi-critical item." During the interview, MRFT#1 shared that she received on the job training and was taught to clean the C41V probe with Super Sani-Cloth Germicidal Disposable Wipes. Interview confirmed the hospital staff and MRFT#1 failed to appropriately identify the classification of the C41V probe as a Semi-critical item resulting in improper reprocessing of the medical device.

Review on 07/24/2024 of the hospital's IPC data revealed no data was available for the cleaning and disinfection process for the C41V probe used for Ultrasound Guided Transrectal or Transperineal Prostate Biopsies in the Operating Room (OR).

Interview on 07/29/2024 at 1154 with the hospital Infection Prevention and Control Professional (IPCP#4) revealed that she was not involved in the selection process for determining which vendor would be the best selection for the desired services. "That usually falls under the Director of that department." Interview revealed, "I don't remember that specific contract [current contract for US Guided Transperineal Prostate Biopsies]. I thought we were still doing High Level Disinfection [HDL]. I was not aware the vendor had changed." Interview revealed Environment of Care (EOC) rounds were conducted twice a year in the hospital's Pain Clinic and Cancer Infusion Center and that there was no Infection Control data monitoring procedures or infection rates for the two (2) outpatient clinics. "We typically don't have a lot of infections." Interview revealed, "Oversight of cleaning and disinfection falls to the Department Head" and that there had been no observations of the cleaning and disinfection process in the OR or of procedures performed in the Pain Clinic and Cancer Infusion Center by the IPCP to date. Interview confirmed administrative staff failed to ensure auditing of adherence to Infection Prevention and Control policies and procedures in the Operating Room (OR), Pain Clinic, or Cancer and Infusion Center.

Based on hospital policy reviews, contract review, personnel file reviews, and staff interview, the hospital's Infection Prevention and Control Professional (IPCP #4) failed to ensure oversight of annual competency validation for staff performing High-level disinfection (HLD), specifically related to reprocessing of semi-critical items for 4 of 4 hospital staff performing HLD (DPS #3, ST #7, Radiology Staff #5, and RN #6) per policy; and failed to ensure contracted agency staff was educated on the hospital's policy requiring HLD of intracavity probes (semi-critical items) for 1 of 1 contracted agency staff (MRFT #1) in the Operating Room (OR).

The findings included:

1. Review on 07/24/2024 of the hospital's policy titled, "Reprocessing of Medical Devices with High Level Disinfection, dated 01/04/2024" revealed, " ...L. Education/Competency/Quality Control 1. Staff performing high level disinfection must complete an initial and annual competency validation. a. Competencies should be specific to each type of scope/probe an individual will be performing HLD on. 2. Competency validation must be kept in the department..."

a. Review of the Director of Perioperative Services (DPS) #3's personnel file on 07/26/2024 revealed the hospital's "Competency Verification Tool Practice: High-Level Disinfection" for DPS #3, with a completion date of 02/15/2021.

b. Review of Surgical Technician #7 (ST#7's) personnel file on 07/26/2024 revealed the hospital's "Competency Verification Tool Practice: High-Level Disinfection" for ST #7, with a completion date of 02/19/2021.

c. Review of Registered Diagnostic Medical Sonographer (Radiology Staff #5)'s personnel file on 07/26/2024 revealed the hospital's "Competency Verification Tool Practice: High-Level Disinfection" for Radiology Staff #5, with a completion date of 01/27/2021.

d. Review of Registered Nurse (RN #6's) personnel file on 07/29/2024 revealed the hospital's "Competency Verification Tool Practice: High-Level Disinfection" for RN #6, with a completion date of 02/15/2021.

Interview on 07/29/2024 at 1350 with the DPS #3 revealed annual competency validation for staff performing HLD had not been maintained and the competency validation checklists from 2021 were the most current competency validations available for review. Interview confirmed hospital leadership failed to ensure oversight of annual competency validation for staff performing High-level disinfection (HLD), specifically related to reprocessing of intracavity probes classified as semi-critical items.

2. Review 07/24/2024 of the hospital's policy titled, "Reprocessing of Medical Devices with High Level Disinfection, Reviewed 01/04/2024" revealed, "A. Equipment Cleaning Categories...2. Semi-critical items are objects which come in contact with mucous membranes or with skin that is not intact such as.... rectal probes... High level disinfection (HLD) is the minimum level of processing required. HLD is the process that eliminates all microorganisms with the exception of some bacterial spores. 3. Non-critical items are objects that come in contact with intact skin but not mucous membranes such as bedrails, bedpans, and IV [intravenous] poles. Disinfection with an EPA [Environmental Protection Agency] registered disinfectant is the requirement for reusable items... E. Choosing Appropriate Method of Disinfection 1. Any reusable item that comes in contact with mucous membranes including those in the lungs or gastrointestinal tract or that comes in contact with non-intact skin must receive minimum of HLD. Probe covers do not eliminate the need for HLD since these covers are not always 100% impervious [do not allow fluid to pass through]. 2. Each area performing HLD is responsible for complying with manufacturer instructions for device cleaning/disinfection and use of HLD agents and enzymatic cleaners. 3. Manufacturer's instructions should be readily available in the practice setting..."

Review 07/25/2024 of the contract titled, "[Contracted Agency] MR FUSION EQUIPMENT LEASE AND SUPPORT AGREEMENT", signed 11/17/2023 revealed, "1. EQUIPMENT AND SUPPORT. 1.1 The Equipment. [Contracted Agency] will provide transportation of Equipment to and from Facility's site. During the intervals in which the Equipment is located at Facility's site, the Equipment is and shall remain the property of [Contracted Agency]; provided that during such intervals, the Facility shall maintain use, possession, and control over the Equipment... [Contracted Agency] will also prepare quality assurance and quality improvement reports (the "Reports") concerning use of the Equipment and Facility directs and authorizes [Contracted Agency] to share the Reports with each Physician....whose patients are treated with the Equipment as part of treatment support. 1.2 Personnel. [Contracted Agency] will provide technical personnel ("Personnel") to assist in the installation of the Equipment. The personnel will provide support to and act at the direction of those physicians in charge of the MR Fusion biopsy procedure who have been appointed to the medical staff of the Facility and granted urology privileges by the Facility... The Personnel provided by [Contracted Agency] shall meet all applicable qualifications imposed by Facility and by applicable laws, regulations, and rules ("Applicable Laws") and by credentialing or other appropriate parties."

Review on 07/25/2024 of the "Super Sani-Cloth Germicidal Disposable Wipe" IFU revealed, "Kills HIV-1 (AIDS Virus), Hepatitis B Virus (HBV) on the precleaned environmental surfaces/objects and precleaned external surfaces of ultrasound transducers and probes previously soiled with blood/bodily fluids in two (2) minutes at room temperature ... This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection ..."

Review on 07/29/2024 of the "Performance Evaluation" for MRFT #1 revealed a Date of Hire of 02/27/2023, no date for "Evaluation Completed on", and "Performance Evaluation Period: 2023." Review of the evaluation revealed, "This letter [dated July 29, 2024] is to confirm that the above individual's performance was evaluated for the stated period of time by an [Contracted Agency] Clinical Supervisor and has met all the necessary requirements for their position. His/her evaluation was satisfactory and is good standing with the company.... Possess knowledge and practice O.R. [Operating Room] protocol and practices sterile technique: [indicated with a check mark] Displays appropriate skills for MR Fusion imaging and localization competencies: [indicated with a check mark] Displays appropriate judgment within scope of training [indicated with a check mark] ... The annual performance evaluation also included an assessment and review of .... Infection Control, Patient Safety, Equipment Competencies, National Patient Safety Goals...." Review of "[Contracted Agency] Certificate of Completion" for MRFT #1 revealed the contracted employee satisfactorily completed annual competencies to include "Aseptic Principles/Techniques & Infection Control Training" 12/29/2023. Review of "trophon2 [automated HLD system] Protection by design TRAINING 2024" certificate revealed MRFT #1 successfully completed the trophon2 product training approved by Nanosonics Limited 05/23/2024 with an expiration date of 05/23/2025. Review failed to reveal evidence of education by the hospital Infection Control Professional on the hospital's "Reprocessing Medical Devices with High Level Disinfection" policy requiring HLD as the minimum level of processing required for intracavity probes (semi-critical items).

Interview on 07/25/2024 at 0925 with the surgeon who performed the procedure for Patient #1 (MD #1), DPS#3 and MRFT#1 revealed that in review of the manufacturer's "Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories" guidelines, MD #1 classified the C41V probe as a "Semi-critical" device and verified that HLD was indicated, stating "per the definition, it is a semi-critical item." During the interview, MRFT#1 shared that she received on the job training and was "taught to clean the C41V probe with Super Sani-Cloth Germicidal Disposable Wipes, with the virucidal." Interview confirmed that the hospital staff and the contracted MRFT failed to appropriately identify the classification of the C41V probe as a Semi-critical item resulting in improper processing of the item and that the contracted agency staff was not aware of the hospital's reprocessing policy requirements.

Interview on 07/29/2024 at 1154 with the hospital Infection Prevention and Control professional (IPCP) revealed that she was not involved in the selection process for determining which vendor would be the best selection for the desired services. "That usually falls under the Director of that department." Interview revealed, "I don't remember that specific contract [current contract for US Guided Transperineal Prostate Biopsies]. I thought we were still doing High Level Disinfection [HDL]. I was not aware the vendor had changed."

Interviews on 07/29/2024 at 1350 with the hospital's Director of Nursing (DON), DPS#3, and Director of Quality and Risk (DQR) revealed the hospital utilized a "universal platform housing vendor competencies to validate vendor competencies." Interview revealed hospital administrative staff believed the appropriate level of cleaning and disinfection of the C41V probe had occurred based on confirmation of "Required Credentials, Required Policies, and Required Info [Information] Reviews" report from the universal platform data on MRFT#1. Designated members of leadership receive notification when the vendor checks into the hospital with a displayed summary of validated competencies included. Interview revealed that manufacturer instructions for use for the C41V probe had not been reviewed prior to 07/25/2024 and that the DON, DPS#3, nor the DQR were aware that MRFT#1 had received "on the job training" for processing the C41V probe as a Non-critical item. During the interview, DPS#3 shared that she trusted that the appropriate training had taken place for processing the C41V probe and that appropriate disinfection processes were in place. Interview confirmed that the hospital leadership failed to ensure the contracted agency staff (MRFT#1) was educated on the hospital's policy requiring HLD of intracavity probes (Semi-critical item).

NC00201173, NC00196911