HospitalInspections.org

Based on observation, interview and record review, the facility failed to ensure Condition of Participation: Governing Body §482.12 was met for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 3 when:

1. Governing Body did not maintain oversight of rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) provided by (Contractor Name). This failure resulted in the potential exposure of patients at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system) for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) of 30 sampled patients. (Refer A-083)

2. Governing Body did not ensure rectal probe provided by (Contractor Name was cleaned and disinfected according to the manufacturer's instructions for use (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored properly) and facility policy. This failure resulted in the potential exposure for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) of 30 sampled patients at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system). (Refer A-084)

3. Governing Body did not ensure contractor responsibilities and services to be provided with rented rectal probes were specified on the Contract agreement. This failure resulted in the potential exposure for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12) of 30 sampled patients.at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system). (Refer A-085)

The cumulative effects of these systemic failures resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs §482.42 was met when the facility facility did not:

1. Follow the manufacturer's instructions for use (MIFU, provides detailed instructions on how equipment should be used, maintained, and stored properly) of low-level disinfectant (a process that kills bacteria and some viruses on items that only come in contact with intact skin) during manual cleaning (removal of visible soil, example, organic and inorganic material, from reusable medical devices) for the Transvaginal Probe (TVP, wand-like instrument connected to a computer that is inserted into the vagina to produce images of the organs in the pelvic region). This failure had the potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another). (Refer to A749)

2. Follow the MIFU to use rigid containers or the probe holder on the ultrasound unit during transport of TVP to and from Ultrasound Room 2. The deficient practice had potential result for damage to the probes. (Refer to A749)

3. Do required Annual Preventive Maintenance (PM, also called Time-based maintenance is done at scheduled time intervals to minimize equipment degradation and reduce loss of performance) for the Trophon2 machine (a closed, automated high-level disinfection [HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores] device). The failure had potential result for Trophon2 machine not cleaning and disinfecting effectively. (Refer to A749)

The cumulative effects of these failures resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on observation, interview and record review, Governing Body for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 3 failed to maintain oversight of rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) provided by (Contractor Name). This failure resulted in the potential exposure to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system) for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and Patient 12) of 30 sampled patients.

Findings:

During a group interview on 2/5/24, at 10:07 AM, at (Hospital) H 1 with the Director of Accreditation and Licensing (DAL), Manager of Accreditation and Licensing (MAL), Director of Quality, Patient Safety, and Infection Control (DQI), Chief Nursing Executive (CNE), and Infection Control Manager (ICM), the DQI stated, in November 2023 the facility received an email notification from (Healthcare System's Name) there may be potential patients at risk regarding infection control issues with the use of the ultrasound rectal probes. The DQI stated, the email contained instruction to reach out to the local managers (of hospitals operating under (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] to evaluate the process. The DQI stated, the facility's use of the ultrasound rectal probe dated back ten years and it was a rented equipment. The DQI further stated, that before the hospital was notified of the rectal probe disinfection issue, the staff performed low level disinfection (LLD, a process that kills bacteria and some viruses on items that only come in contact with intact skin) prior to using the probe and the re-processing (cleaning, disinfection, and sterilization of reusable medical equipment/devices) of the ultrasound rectal probe did not include high-level disinfection. The DQI further stated, the facility suspended the use of the rectal probe, identified the patients at risk, sent notification letters to patients at risk, and notified local and state agencies. The use of the rectal probe was re-launched sometime in December 2023.

During a review of facility's document titled, "(Contractor's Name) Rectal Probe Review Timeline", received 2/5/24 indicated, "11/13/2023, 9:55 AA, Systems (Healthcare System) e-mail inform and action needed - HLD rectal probes, sites need to take immediate action to stop the use of inadequate disinfected devices on patients and implement an effective HDL process. 1. Identify all your usable devices that contact mucous membranes or sterile body sites., 2. Stop use of all devices identified in item one with inadequate HDL., 3. Investigate the current process and ensure appropriate HDL sterilization processes in place for MIFU., 4. Perform and document a risk assessment., 5. Resume use of these devices only when an appropriate disinfection* process is in place ... Please note : We are in the process validated facts and may have additional guidance as we learn more information we have reached out the company and are awaiting their response ... 11/14-15/2023 ... IC (Infection Control) fact finding and investigation + (plus) suspend use of probes ... 11/30/2023, Initiate Training, Education and Communication to Staff + local audits ... 12/11 and 15/2023, Relaunch of (Contractor's Name) (rectal) Probe at H 1, H 2, H 3 (12/15) ... 1/8/2024, [Facilities Group Name affiliated with (three) separately certified hospitals] Notify CDPH ... 2/5/24, To date ... 179 [ Facilities Group Name affiliated with (three) separately certified hospitals] patients were notified ... "

Review of the facility letter sent to the State Agency [SA, California Department of Public Health (CDPH, ensures compliance with state licensing laws and federal certification regulations)], dated 1/8/24 indicated, "Notice of rectal probe disinfection process issue... we have newly learned that the disinfection process performed on this equipment did not meet the required high level disinfection ("HDL") process for reusable rectal probes ... Immediate actions taken: We suspended the use of all reusable rectal probes ... 2. We ensured that an appropriate level of disinfection or sterilization is in place ... Next steps: 1. Patients identified as having a potential exposure are being notified ... 2. We are offering these patients free Hepatitis C (liver infection caused by the hepatitis C virus), Hepatitis B (inflammation of the liver by the hepatitis B virus) and HIV (HIV- a virus that attacks the immune system) tests."

During an interview on 2/6/24, at 7:09 AM, at H 1, with Director of Surgical Services (DSS) 1 stated, before the hospital was notified (via (Healthcare System's Name) email dated 11/13/2023) of the rectal probe disinfection issue, the (Contractor Name), (Vendor Representative (VR) brought the rectal probe (from contractor facility) into the hospital operating room (OR, sterile location where surgical procedures were performed) before each procedure.

During an observation on 2/6/24, at 7:34 AM, at H 1, with DSS 2, VR was in the OR suite during a Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure.

During an observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the OR suite, VR stated, rectal probe model 8848 was used during the procedure (2/6/24). VR stated, whenever a rectal probe was needed for a procedure, he or another VR brought the rectal probe from the contractor facility to the hospital [(one of (three) separately certified hospitals) where it was scheduled to be used. VR stated, before the hospital was notified of the rectal probe disinfection issue, after the procedure he (VR) wiped the rectal probe thoroughly with the disinfectant wipe, put it inside the rectal probe container, and brought it back with him to the contractor facility. VR stated, he's brought the rectal probe from the contractor facility to the hospital for the procedures since "a few years". VR said he learned (was trained) how to disinfect the rectal probe "on the job". VR stated, he had no documentation (from contractor) to verify competency (ability to do something successfully, effectively, or efficiently) with disinfection/decontamination of the rectal probe. VR further stated, after the rectal probe was brought back to the contractor facility, he did not know if further decontamination of the rectal probe was done at the contractor facility or before the rectal probe was reused for another procedure.

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During an interview on 2/6/24, at 2:04 PM, at H 1 with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

During an interview on 2/6/24, at 2:39 the PM, at H 1, with the OR Scrub Technician (ST 1), and Quality Assurance Coordinator (QAC 1), ST 1 stated she had been employed in the facility for six and a half years and had assisted in procedures using the ultrasound rectal probe. ST 1 stated, the "old process" was, in the OR, after the procedure was completed, the surgeon would hand the rectal probe to the (VR) and the VR wiped the probe with a cloth. When done, the VR left the facility with the rectal probe.

During a review of facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024, document indicated columned lists information with [ Facilities Group Name affiliated with (three) separately certified hospitals], Patient (s) Name, Medical Record Number, Date of Birth, Date of Procedure, Procedure, Address, Medical Doctor's Name(s), Page 8 indicated Total: 179 (total number of patients affected with rectal probe disinfection issue) ..."

During an interview on 2/7/24 at 4 PM, at H 1, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The 8 (eight) pages document was the list of patients affected with rectal probe disinfection issue for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H)1, H 2, and H 3. Also, individuals(s) with authority and responsibilities for the conduct of the hospital and patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

During a video call interview on 2/9/24 at 10:14 AM, at H 1 surveyors reviewed facility contract agreement packet titled, "Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, with Senior Director (Strategic Sourcing) (SDSS) for [(Name) Healthcare System] and Strategic Sourcing Manager for Contracting (SSMC), DAL was scribe. SDSS confirmed she signed contract agreement between "customer" [(Name) Healthcare System] and "contractor" [(Contractor Name) contractor who provided rectal probes)]. SDSS verified initial contract date was April 18, 2016, and expiring on 4/30/24. SSMC stated contract had auto renewal option. SDSS stated, for [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals] who use the same services, we [(Name) Healthcare System] employees responsible for contract agreement(s)] try to consolidate vendors [contractor(s)]. This one (contract agreement) started before I started with [(Name) Healthcare System]. SDSS confirmed contract applied to all [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals]. Surveyors reviewed with SDSS and SSMC contract agreement, "Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work" (Contractor) responsibilities and services to be provided for rented rectal probes (models not indicated), to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified. SDSS stated, I think this contract has a gap. There should be additional amendment. SSMC stated, I'm not seeing amendments, looking for updates in the contracts, changes in the services ... Sixth amendment: current executed version, did not have vendor responsibilities, (in exhibit E, that should have been included in the current contract). SDSS stated, Basic HLD (high level disinfection) for scopes (general policy) - that policy requires that we perform HLD for items from vendors, checked by biomed. IC (Infection Control) department should be involved but this device (rented rectal probe) was not on the list of things that need HLD. It is the hospital's responsibility to apply the IFU (instructions for use). It's the directors in each department that is responsible for following the MIFU (manufacturer's instructions for use).

During an interview on 2/9/24 at 2:06 PM, at H 1, with Chief Operating Officer (COO) and DAL as scribe, COO stated, he was one of a group of individuals who had oversight (authority and responsibilities (governing body) for the conduct of the hospital and patient care for [(Name) Healthcare System] [Facilities Group Name affiliated with (three) separately certified acute care hospitals] He confirmed each hospital had its own provider (Medicare) number. COO stated the rectal probe disinfection issue was not usual by definition - confirmed it was an unusual occurrence. The COO stated that before reporting (to CDPH), "we wanted to investigate to make sure what was happening. We had to determine whether patients were affected, which hospitals were using (the rectal probe), had to determine facts." COO stated, with routine negotiation (of contracts) Board of Directors [(Name) Area Operating Board] were not involved in what was included in the contract. [(Name)Healthcare] "System" was responsible for contracts (agreement) with (Contractor) (effective 4/18/16, renewed 4/18/2021); but, he (COO) would have input. The COO stated, "The (Contractor) (vendor representative) is not responsible for the HLD, it's the hospital's job. Our policy indicates, in general, we're supposed to do it (HLD). The HLD is our responsibility, we're supposed to sterilize prior to use, to prevent transmission of infections. There was belief that we were doing what we were supposed to do in cleaning it (rectal probe), and equipment used for patients. HLD - that is our responsibility and we failed to do that." The COO stated the directors of surgical services [DSS) - (Representatives for Quality Assurance are responsible for ensuring MIFU is followed. COO stated, regarding rectal probe disinfection issue not included in Quality Assurance Performance Improvement (QAPI) minutes for November to December 2023, January 2024 - "we have not gotten there yet, but it does not mean we did not discuss it."

During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. at H2, in the operating room (OR), ST 2 stated the surgical procedure had just finished and he was beginning the "pre-cleaning" process for the rectal ultrasound probe used in the procedure. During the pre-cleaning process, ST 2 was observed wiping the probe with disinfecting wipes beginning at the tip of the probe moving toward the top of the probe and ending at the cord which connects to the ultrasound monitor (in a dirty to clean direction). After wiping the probe, ST 2 placed the probe into a bin and stated, "Now it needs to dry for three minutes." ST 2 left the probe in the bin for three minutes while performing other tasks. ST 2 then stated, it had been three minutes and he covered the bin with a red bag. The bin containing the probe was then sent in the elevator to the Sterile Processing Department (SPD an area within the hospital in which medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m., at H2, in the SPD, SPT 4 stated, he had just received the probe from the OR and was beginning the High-Level Disinfection process (a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of spores). SPT 4 stated a leak test (a process required to protect patients from infection that could result from leaks in the device and also protects the device from damage) was required for the probe to ensure there were no small holes in the probe. SPT 1 placed the leak tester on the end of the probe cord and pumped the pressure to a reading of 150 mm (millimeter of mercury- a measurement used to record pressure). Immediately after obtaining a pressure reading of 150 mm, SPT 1 stated, "It's holding strong, so it passed the leak test." SPT 4 did not monitor the pressure reading during the leak test for a specific amount of time.

During an interview on 2/14/24 at 10:10 a.m. at H2, with the Infection Prevention Manager (IPM), IPM stated the facility was part of a [hospital system] who had multiple hospitals in the state; in addition, the facility was part of a small group of three hospitals which shared a governing body and had a shared Infection Prevention Department. IPM stated she had oversight of three hospitals and there was a dedicated Infection Preventionist (IP) at each hospital. IPM further stated the three hospitals shared another IP who had oversight of surgical services for all three hospitals. IPM stated, in November 2023, she received a call from the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system regarding the facility's use of rectal ultrasound probes. IPM stated, she was unaware if the facility used the rectal ultrasound probes, and she sent out an email to the Surgical Services Department at the facility to inquire about the use of the probes.

IPM stated the hospital used the Spaulding Classification System (a nationally recognized infection control standard which is used to define the minimum level of disinfection required for a medical device) to determine how medical devices should be cleaned. IPM stated rectal ultrasound probes required High-level Disinfection (HLD- a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) because the probe came in contact with mucous membranes (soft lining of body cavities and canals that lead to the outside of the body). IPM stated, she received an email response from the Surgical Services Manager who confirmed the rectal ultrasound probes were used in the operating room (OR) and reported the cleaning and disinfecting procedure did not include HLD. IPM stated she was unaware of the facility's process for cleaning and disinfecting the probes until that date. IPM stated, at that time, the facility was instructed to stop the use of the probes as the cleaning and disinfection process was inadequate.

During an interview on 2/14/24 at 1:10 p.m., at H2, with the Surgical Services Manager (MSS 3), MSS 3 stated the facility performed surgical procedures using a rectal ultrasound probe. MSS 3 stated the facility contracted with a vendor who brought the rectal ultrasound probe to the Operating Room (OR) to be used for a procedure and OR staff cleaned the probe with a disinfecting wipe, covered the probe with a plastic sheath, and used it during the procedure. MSS stated, after the procedure, OR staff removed the plastic sheath, cleaned the probe with a disinfecting wipe, and gave the probe back to the vendor. MSS 3 confirmed the facility used the Spaulding Classification System to determine how medical devices should be cleaned. MSS 3 confirmed, according to Spaulding Classification, rectal ultrasound probes come in contact with mucus membranes (soft lining of body cavities and canals that lead to the outside of the body) and required High-Level Disinfection at a minimum. MSS 3 stated she had worked at the facility for approximately four years and stated, "This is the way it was always done so I didn't question it." MSS 3 stated the facility was instructed to stop the use of the probes until further notice.

During an interview on 2/14/24 at 2:42 p.m., at H2, with the Infection Prevention Registered Nurse (IP 1), IP 1 stated the IFU for the disinfecting wipes indicated a "wet time" of three minutes which meant the device should be maintained wet with the disinfecting product for three minutes and then dried with a cloth. IP 1 stated staff were expected to follow manufacturer's IFU for all medical devices, for cleaning and disinfecting products. IP 1 further stated, it was his understanding that the rectal ultrasound probe manufacturer IFU allowed for low- level disinfection (a process that kills bacteria and some viruses on items that only come in contact with intact skin). IP 1 confirmed rectal ultrasound probes come in contact with mucus membranes and should be, at minimum, HLD according to the facility's policy.

During an interview on 2/15/24 at 12 p.m. at H2, with the Director of Quality, Patient Safety, and Infection Control (DQI), the DQI stated in November 2023, she received a call from CPIC inquiring about the process the facility used to clean and disinfect rectal ultrasound probes. DQI stated the facility reported their process and were instructed to suspend using the probes because they were not HLD.

During an interview on 2/15/24 at 9:30 a.m., at H2, with the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system, CPIC stated she worked for [hospital system name] which owned multiple hospitals in the state and the facility was a system hospital. CPIC stated, in November 2023, she received a concern from a staff member at a different hospital related to cleaning and disinfecting rectal ultrasound probes, so she reached out to all system hospitals to determine what their current process was. CPIC stated it was determined the facility was renting the rectal ultrasound probes from [vendor]. CPIC further stated, it was determined the facility was not cleaning and disinfecting the rectal ultrasound probes adequately. CPIC stated rectal ultrasound probes were considered semi-critical devices (any device that comes in contact with a mucus membrane) and required HLD, at a minimum. CPIC confirmed the facility was not performing HLD on these devices. CPIC stated the facility was instructed to stop using the rectal ultrasound probes until an investigation was conducted.

During an interview on 2/27/24 at 1:48 PM, the IP 1 stated, " We don't see (train or check competency) vendors directly".

During a concurrent interview and record review on 2/27/24 at 3 PM, with the Director of Accreditation and Licensing (DAL), the "List of [hospital] Patient Notification" was reviewed. DAL stated the facility identified a list of patients who had procedures using the rectal ultrasound probe and may have been affected by the failure to HLD the probes. DAL stated, the list included a total of twelve patients. The DAL further stated, facility sent notification letters to patients 1 to 8 on the list, and notification letters to Patients 9 to 12 were sent out "today" (2/27/24).

During a review of facility document, e-mail communication, dated February 27, 2024, at 2:30 PM, From: DAL, To: CPIC, Carbon Copy to: COO, indicated, "Subject: {Facilities Group Name affiliated with (three) separately certified hospitals], Hospital 3, Rectal Probe List ... We are in the middle of our ... survey regarding director probes. It came to our attention this morning that we had four patients who had rectal probe 8808e who were not on the initial list and were not sent notification letters. I am attaching updated list for (Hospital 3) only ..."

Review of the facility,(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Policy and Procedures (P&P) titled, "Vendors and Sales Representatives, Special Instruments/Equipment /Supplies Guidelines in the Surgical Services Department", revised 6/16/22 indicated, "Purpose to outline responsibilities and provide guidelines for vendor activities involving the Surgical Services department ... Scheduling and Approvals ... [Facilities Group Name affiliated with (three) separately certified hospitals] Surgical Services arranging ... 1 ... b. vendors are notified in a timely manner to allow for instrument and supplies to be prepared for the case ... 3 .... e. Manager/Supervisor/Service Leader or designee will arrange for staff education with the vendor prior to using new or unfamiliar instruments or equipment... f. Equipment or instruments may not be used during a procedure without appropriate education and or support for staff ... Sterile Processing Departments, 1 ... vendors must check in at SPD prior to entry. 2. The instrument/implant company (contractor) is responsible for delivery and pickup of instruments and implants ... 5. Pre-Procedure sets will arrive at least 24-48 hours ... a. Instruments/implant sets must be inspected, cleaned, and decontaminated, and sterilized by [Facilities Group Name affiliated with (three) separately certified hospitals] staff prior to use ... Post Procedure, 1. SPD staff will process sets through the washer/decontaminator or hand wash, if needed. Inspect for cleanliness and organize the instruments and sets. SPD staff will then place them in a specified card/area for vendor pickup ... The Operating Room ... 8 The Circulating RN ... Confirm, prior to the start of the procedure that the loaner instruments have been processed at [Facilities Group Name affiliated with (three) separately certified hospitals] ..."

During a review of the facility (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], document titled, "Infection Prevention and Control Plan," dated 3/16/23, indicated, "Geographical Location, [Facilities Group Name affiliated with (three) separately certified hospitals], is a group of (Name ) area acute care facilities with 585 beds ... [Facilities Group Name affiliated with (three) separately certified hospitals], provides tertiary (high level of specialized care) care services for ... California ... Authority and Responsibilities, The Governing Body and the [hospital] Infection Prevention and Control Committee members have the overall authority and responsibility for the Infection Prevention and Control Program..."

Based on observation, interview and record review, Governing Body for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 3 failed to ensure rectal probe provided by (Contractor Name) was cleaned and disinfected according to the manufacturer's instructions for use (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored properly) and facility policy. This failure resulted in the potential exposure for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and Patient 12) of 30 sampled patients at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system).

Findings:

During a group interview on 2/5/24, at 10:07 AM, at (Hospital) H 1 with the Director of Accreditation and Licensing (DAL), Manager of Accreditation and Licensing (MAL), Director of Quality, Patient Safety, and Infection Control (DQI), Chief Nursing Executive (CNE), and Infection Control Manager (ICM), the DQI stated, in November 2023 the facility received an email notification from (Healthcare System's Name) there may be potential patients at risk regarding infection control issues with the use of the ultrasound rectal probes. The DQI stated, the email contained instruction to reach out to the local managers (of hospitals operating under (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] to evaluate the process. The DQI stated, the facility's use of the ultrasound rectal probe dated back ten years and it was a rented equipment. The DQI further stated, that before the hospital was notified of the rectal probe disinfection issue, the staff performed low level disinfection (LLD, a process that kills bacteria and some viruses on items that only come in contact with intact skin) prior to using the probe and the re-processing (cleaning, disinfection, and sterilization of reusable medical equipment/devices) of the ultrasound rectal probe did not include high-level disinfection. The DQI further stated, the facility suspended the use of the rectal probe, identified the patients at risk, sent notification letters to patients at risk, and notified local and state agencies. The use of the rectal probe was re-launched sometime in December 2023.

During a review of facility's document titled, "(Contractor's Name) Rectal Probe Review Timeline", received 2/5/24 indicated, "11/13/2023, 9:55 AA, Systems (Healthcare System) e-mail inform and action needed - HLD rectal probes, sites need to take immediate action to stop the use of inadequate disinfected devices on patients and implement an effective HDL process. 1. Identify all your usable devices that contact mucous membranes or sterile body sites., 2. Stop use of all devices identified in item one with inadequate HDL., 3. Investigate the current process and ensure appropriate HDL sterilization processes in place for MIFU., 4. Perform and document a risk assessment., 5. Resume use of these devices only when an appropriate disinfection* process is in place ... Please note : We are in the process validated facts and may have additional guidance as we learn more information we have reached out the company and are awaiting their response ... 11/14-15/2023 ... IC (Infection Control) fact finding and investigation + (plus) suspend use of probes ... 11/30/2023, Initiate Training, Education and Communication to Staff + local audits ... 12/11 and 15/2023, Relaunch of (Contractor's Name) (rectal) Probe at H 1, H 2, H 3 (12/15) ... 1/8/2024, [Facilities Group Name affiliated with (three) separately certified hospitals] Notify CDPH ... 2/5/24, To date ... 179 [ Facilities Group Name affiliated with (three) separately certified hospitals] patients were notified ... "

Review of the facility letter sent to the State Agency [SA, California Department of Public Health (CDPH, ensures compliance with state licensing laws and federal certification regulations)], dated 1/8/24 indicated, "Notice of rectal probe disinfection process issue... we have newly learned that the disinfection process performed on this equipment did not meet the required high level disinfection ("HDL") process for reusable rectal probes ... Immediate actions taken: We suspended the use of all reusable rectal probes ... 2. We ensured that an appropriate level of disinfection or sterilization is in place ... Next steps: 1. Patients identified as having a potential exposure are being notified ... 2. We are offering these patients free Hepatitis C (liver infection caused by the hepatitis C virus), Hepatitis B (inflammation of the liver by the hepatitis B virus) and HIV (HIV- a virus that attacks the immune system) tests."

During an interview on 2/6/24, at 7:09 AM, at H 1, with Director of Surgical Services (DSS) 1 stated, before the hospital was notified (via (Healthcare System's Name) email dated 11/13/2023) of the rectal probe disinfection issue, the (Contractor Name), (Vendor Representative (VR) brought the rectal probe (from contractor facility) into the hospital operating room (OR, sterile location where surgical procedures were performed) before each procedure.

During an observation on 2/6/24, at 7:34 AM, at H 1, with DSS 2, VR was in the OR suite during a Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure.

During an observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the OR suite, VR stated, rectal probe model 8848 was used during the procedure (2/6/24). VR stated, whenever a rectal probe was needed for a procedure, he or another VR brought the rectal probe from the contractor facility to the hospital [(one of (three) separately certified hospitals) where it was scheduled to be used. VR stated, before the hospital was notified of the rectal probe disinfection issue, after the procedure he (VR) wiped the rectal probe thoroughly with the disinfectant wipe, put it inside the rectal probe container, and brought it back with him to the contractor facility. VR stated, he's brought the rectal probe from the contractor facility to the hospital for the procedures since "a few years". VR said he learned (was trained) how to disinfect the rectal probe "on the job". VR stated, he had no documentation (from contractor) to verify competency (ability to do something successfully, effectively, or efficiently) with disinfection/decontamination of the rectal probe. VR further stated, after the rectal probe was brought back to the contractor facility, he did not know if further decontamination of the rectal probe was done at the contractor facility or before the rectal probe was reused for another procedure.

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During an interview on 2/6/24, at 2:04 PM, at H 1 with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

During an interview on 2/6/24, at 2:39 the PM, at H 1, with the OR Scrub Technician (ST 1), and Quality Assurance Coordinator (QAC 1), ST 1 stated she had been employed in the facility for six and a half years and had assisted in procedures using the ultrasound rectal probe. ST 1 stated, the "old process" was, in the OR, after the procedure was completed, the surgeon would hand the rectal probe to the (VR) and the VR wiped the probe with a cloth. When done, the VR left the facility with the rectal probe.

Review of the facility,(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Policy and Procedures (P&P) titled, "Vendors and Sales Representatives, Special Instruments/Equipment /Supplies Guidelines in the Surgical Services Department", revised 6/16/22 indicated, "Purpose to outline responsibilities and provide guidelines for vendor activities involving the Surgical Services department ... Scheduling and Approvals ... [Facilities Group Name affiliated with (three) separately certified hospitals] Surgical Services arranging ... 1 ... b. vendors are notified in a timely manner to allow for instrument and supplies to be prepared for the case ... 3 .... e. Manager/Supervisor/Service Leader or designee will arrange for staff education with the vendor prior to using new or unfamiliar instruments or equipment... f. Equipment or instruments may not be used during a procedure without appropriate education and or support for staff ... Sterile Processing Departments, 1 ... vendors must check in at SPD prior to entry. 2. The instrument/implant company (contractor) is responsible for delivery and pickup of instruments and implants ... 5. Pre-Procedure sets will arrive at least 24-48 hours ... a. Instruments/implant sets must be inspected, cleaned, and decontaminated, and sterilized by [Facilities Group Name affiliated with (three) separately certified hospitals] staff prior to use ... Post Procedure, 1. SPD staff will process sets through the washer/decontaminator or hand wash, if needed. Inspect for cleanliness and organize the instruments and sets. SPD staff will then place them in a specified card/area for vendor pickup ... The Operating Room ... 8 The Circulating RN ... Confirm, prior to the start of the procedure that the loaner instruments have been processed at [Facilities Group Name affiliated with (three) separately certified hospitals] ..."

During a review of ( Manufacturer's Name), titled, "Product Data Sheet, 8848 Endo Cavity Biplane Transducer", dated July 2019, indicated, "The 8848 (Model) Endo Cavity Biplane Transducer [used to visualize (see) structures from inside body] design for use with the flex focus 1202 ultrasound system ... ideal for precise volume studies and guiding process and guiding prostate therapy ideal also for imaging the anterior and posterior compartments of the pelvic floor ... biplane imaging gives greater confidence in guiding therapy for a better orientation during needle placement expanded, sector allows complete visualization of the prostate ... perform quick reliable puncture and biopsy procedures with reusable needle guide ... unique fully immersible (capable of totally submerged in water without damage) transducer for easy sterilization ( a process that destroys or eliminates all forms of microbial life by physical or chemical methods) ... Reprocessing (a multistep process that includes cleaning, inspection, assembly, functional testing, disinfection, packaging, labeling, sterilization, and storage) ...Complete details and procedures can be found in Care and Cleaning ... Follow manufacturer's instructions for use (MIFU) ..."

During a review of the (MIFU) for the rectal ultrasound probe, titled "[Manufacturer] Care and Cleaning", dated 2022, indicated, "Page 29, Levels of Reprocessing The level of reprocessing depends on the type of equipment and its use. The CDC (the nation's leading science-based, data-driven, service organization that protects the public's health) ... classify medical devices according to their use. For each classification, they specify the level of disinfection/sterilization processing that is required before use ... Device Classification: Semi-Critical; Use: Device contacts mucus membranes (for example, endocavity (anus (the external body orifice (opening) at the end of the digestive tract (bowel-intestine), the opposite end from the mouth); rectum (is at the end of your colon (large intestine) and on the other side of your anal canal); vagina( the elastic, muscular reproductive organ of the female genital tract); Required Processing: Immediate cleaning and high-level disinfection or sterilization ..."

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During a review of facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024, document indicated columned lists information with [ Facilities Group Name affiliated with (three) separately certified hospitals], Patient (s) Name, Medical Record Number, Date of Birth, Date of Procedure, Procedure, Address, Medical Doctor's Name(s), Page 8 indicated Total: 179 (total number of patients affected with rectal probe disinfection issue) ..."

During an interview on 2/7/24 at 4 PM, at H 1, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The 8 (eight) pages document was the list of patients affected with rectal probe disinfection issue for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H)1, H 2, and H 3. Also, individuals(s) with authority and responsibilities for the conduct of the hospital and patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

During a review of facility contract agreement, titled, ""Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, indicated, "Page 1 of 20, [(Name) Healthcare System], Sixth Amendment; This Sixth Amendment (the "Amendment") is effected as of April 18, 2021 (the "Effective Date") by and between (Healthcare System's Name) ... (" Customer") and (Contractor Name), a (STATE) limited liability corporation ... WHEREAS customer and contracted entered into an agreement dated April 18, 2016 under which Contractor agreed to provide Laser Rental Services (rectal probe) (the "Agreement") ... 1. Renewal Term. The parties agree to extend the expiration date of the Agreement to April 30, 2023. Upon the expiration of the Renewal Term, this agreement shall automatically renew for successive (1) one year terms until terminated in accordance with IV, TERM AND TERMINATION of the Agreement. DocuSigned by [(Name) Healthcare System] Director Strategic Sourcing and [Contractor Name) Managing Director ... Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work, (Contractor) responsibilities and services to be provided with rented rectal probes to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified/ or documented on contract agreement documents reviewed.

During a video call interview on 2/9/24 at 10:14 AM, at H 1 surveyors reviewed facility contract agreement packet titled, "Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, with Senior Director (Strategic Sourcing) (SDSS) for [(Name) Healthcare System] and Strategic Sourcing Manager for Contracting (SSMC), DAL was scribe. SDSS confirmed she signed contract agreement between "customer" [(Name) Healthcare System] and "contractor" [(Contractor Name) contractor who provided rectal probes)]. SDSS verified initial contract date was April 18, 2016, and expiring on 4/30/24. SSMC stated contract had auto renewal option. SDSS stated, for [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals] who use the same services, we [(Name) Healthcare System] employees responsible for contract agreement(s)] try to consolidate vendors [contractor(s)]. This one (contract agreement) started before I started with [(Name) Healthcare System]. SDSS confirmed contract applied to all [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals]. Surveyors reviewed with SDSS and SSMC contract agreement, "Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work" (Contractor) responsibilities and services to be provided for rented rectal probes (models not indicated), to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified. SDSS stated, I think this contract has a gap. There should be additional amendment. SSMC stated, I'm not seeing amendments, looking for updates in the contracts, changes in the services ... Sixth amendment: current executed version, did not have vendor responsibilities, (in exhibit E, that should have been included in the current contract). SDSS stated, Basic HLD (high level disinfection) for scopes (general policy) - that policy requires that we perform HLD for items from vendors, checked by biomed. IC (Infection Control) department should be involved but this device (rented rectal probe) was not on the list of things that need HLD. It is the hospital's responsibility to apply the IFU (instructions for use). It's the directors in each department that is responsible for following the MIFU (manufacturer's instructions for use).

During an interview on 2/9/24 at 2:06 PM, at H 1 with Chief Operating Officer (COO) and DAL as scribe, COO stated, he was one of a group of individuals, [Board of Directors [Name) Area Operating board] who had oversight of [(Name) Healthcare System] [Facilities Group Name affiliated with (three) separately certified acute care hospitals]. He confirmed each hospital had its own provider (Medicare) number. COO stated the rectal probe disinfection issue was not usual by definition - confirmed it was an unusual occurrence. The COO stated that before reporting (to CDPH), "we wanted to investigate to make sure what was happening. We had to determine whether patients were affected, which hospitals were using (the rectal probe), had to determine facts." COO stated, with routine negotiation (of contracts) Board of Directors [(Name) Area Operating Board] were not involved in what was included in the contract. [(Name)Healthcare] "System" was responsible for contracts (agreement) with (Contractor) (effective 4/18/16, renewed 4/18/2021); but, he (COO) would have input. The COO stated, "The (Contractor) (vendor representative) is not responsible for the HLD, it's the hospital's job. Our policy indicates, in general, we're supposed to do it (HLD). The HLD is our responsibility, we're supposed to sterilize prior to use, to prevent transmission of infections. There was belief that we were doing what we were supposed to do in cleaning it (rectal probe), and equipment used for patients. HLD - that is our responsibility and we failed to do that." The COO stated the directors of surgical services [DSS) - (Representatives for Quality Assurance are responsible for ensuring MIFU is followed. COO stated, regarding rectal probe disinfection issue not included in Quality Assurance Performance Improvement (QAPI) minutes for November to December 2023, January 2024 - "we have not gotten there yet, but it does not mean we did not discuss it."

During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. at H2, in the operating room (OR), ST 2 stated the surgical procedure had just finished and he was beginning the "pre-cleaning" process for the rectal ultrasound probe used in the procedure. During the pre-cleaning process, ST 2 was observed wiping the probe with disinfecting wipes beginning at the tip of the probe moving toward the top of the probe and ending at the cord which connects to the ultrasound monitor (in a dirty to clean direction). After wiping the probe, ST 2 placed the probe into a bin and stated, "Now it needs to dry for three minutes." ST 2 left the probe in the bin for three minutes while performing other tasks. ST 2 then stated, it had been three minutes and he covered the bin with a red bag. The bin containing the probe was then sent in the elevator to the Sterile Processing Department (SPD an area within the hospital in which medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m., at H2, in the SPD, SPT 4 stated, he had just received the probe from the OR and was beginning the High-Level Disinfection process (a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of spores). SPT 4 stated a leak test (a process required to protect patients from infection that could result from leaks in the device and also protects the device from damage) was required for the probe to ensure there were no small holes in the probe. SPT 1 placed the leak tester on the end of the probe cord and pumped the pressure to a reading of 150 mm (millimeter of mercury- a measurement used to record pressure). Immediately after obtaining a pressure reading of 150 mm, SPT 1 stated, "It's holding strong, so it passed the leak test." SPT 4 did not monitor the pressure reading during the leak test for a specific amount of time.

During an interview on 2/14/24 at 10:10 a.m. at H2, with the Infection Prevention Manager (IPM), IPM stated the facility was part of a [hospital system] who had multiple hospitals in the state; in addition, the facility was part of a small group of three hospitals which shared a governing body and had a shared Infection Prevention Department. IPM stated she had oversight of three hospitals and there was a dedicated Infection Preventionist (IP) at each hospital. IPM further stated the three hospitals shared another IP who had oversight of surgical services for all three hospitals. IPM stated, in November 2023, she received a call from the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system regarding the facility's use of rectal ultrasound probes. IPM stated, she was unaware if the facility used the rectal ultrasound probes, and she sent out an email to the Surgical Services Department at the facility to inquire about the use of the probes.

IPM stated the hospital used the Spaulding Classification System (a nationally recognized infection control standard which is used to define the minimum level of disinfection required for a medical device) to determine how medical devices should be cleaned. IPM stated rectal ultrasound probes required High-level Disinfection (HLD- a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) because the probe came in contact with mucous membranes (soft lining of body cavities and canals that lead to the outside of the body). IPM stated, she received an email response from the Surgical Services Manager who confirmed the rectal ultrasound probes were used in the operating room (OR) and reported the cleaning and disinfecting procedure did not include HLD. IPM stated she was unaware of the facility's process for cleaning and disinfecting the probes until that date. IPM stated, at that time, the facility was instructed to stop the use of the probes as the cleaning and disinfection process was inadequate.

During an interview on 2/14/24 at 1:10 p.m., at H2, with the Surgical Services Manager (MSS 3), MSS 3 stated the facility performed surgical procedures using a rectal ultrasound probe. MSS 3 stated the facility contracted with a vendor who brought the rectal ultrasound probe to the Operating Room (OR) to be used for a procedure and OR staff cleaned the probe with a disinfecting wipe, covered the probe with a plastic sheath, and used it during the procedure. MSS stated, after the procedure, OR staff removed the plastic sheath, cleaned the probe with a disinfecting wipe, and gave the probe back to the vendor. MSS 3 confirmed the facility used the Spaulding Classification System to determine how medical devices should be cleaned. MSS 3 confirmed, according to Spaulding Classification, rectal ultrasound probes come in contact with mucus membranes (soft lining of body cavities and canals that lead to the outside of the body) and required High-Level Disinfection at a minimum. MSS 3 stated she had worked at the facility for approximately four years and stated, "This is the way it was always done so I didn't question it." MSS 3 stated the facility was instructed to stop the use of the probes until further notice.

During an interview on 2/14/24 at 2:42 p.m., at H2, with the Infection Prevention Registered Nurse (IP 1), IP 1 stated the IFU for the disinfecting wipes indicated a "wet time" of three minutes which meant the device should be maintained wet with the disinfecting product for three minutes and then dried with a cloth. IP 1 stated staff were expected to follow manufacturer's IFU for all medical devices, for cleaning and disinfecting products. IP 1 further stated, it was his understanding that the rectal ultrasound probe manufacturer IFU allowed for low- level disinfection (a process that kills bacteria and some viruses on items that only come in contact with intact skin). IP 1 confirmed rectal ultrasound probes come in contact with mucus membranes and should be, at minimum, HLD according to the facility's policy.

During an interview on 2/15/24 at 12 p.m. at H2, with the Director of Quality, Patient Safety, and Infection Control (DQI), the DQI stated in November 2023, she received a call from CPIC inquiring about the process the facility used to clean and disinfect rectal ultrasound probes. DQI stated the facility reported their process and were instructed to suspend using the probes because they were not HLD.

During an interview on 2/15/24 at 9:30 a.m., at H2, with the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system, CPIC stated she worked for [hospital system name] which owned multiple hospitals in the state and the facility was a system hospital. CPIC stated, in November 2023, she received a concern from a staff member at a different hospital related to cleaning and disinfecting rectal ultrasound probes, so she reached out to all system hospitals to determine what their current process was. CPIC stated it was determined the facility was renting the rectal ultrasound probes from [vendor]. CPIC further stated, it was determined the facility was not cleaning and disinfecting the rectal ultrasound probes adequately. CPIC stated rectal ultrasound probes were considered semi-critical devices (any device that comes in contact with a mucus membrane) and required HLD, at a minimum. CPIC confirmed the facility was not performing HLD on these devices. CPIC stated the facility was instructed to stop using the rectal ultrasound probes until an investigation was conducted.

During an interview on 2/27/24 at 1:48 PM, the IP 1 stated, " We don't see (train or check competency) vendors directly".

During a concurrent interview and record review on 2/27/24 at 3 PM, with the Director of Accreditation and Licensing (DAL), the "List of [hospital] Patient Notification" was reviewed. DAL stated the facility identified a list of patients who had procedures using the rectal ultrasound probe and may have been affected by the failure to HLD the probes. DAL stated, the list included a total of twelve patients. The DAL further stated, facility sent notification letters to Patients 1 to 8 on the list, and notif

Based on observation, interview and record review, Governing Body for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 3 failed to ensure contractor responsibilities and services to be provided with rented rectal probes were specified on the Contract agreement. This failure resulted in the potential exposure for twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and Patient 12) of 30 sampled patients.at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system).

Findings:

During a group interview on 2/5/24, at 10:07 AM, at (Hospital) H 1 with the Director of Accreditation and Licensing (DAL), Manager of Accreditation and Licensing (MAL), Director of Quality, Patient Safety, and Infection Control (DQI), Chief Nursing Executive (CNE), and Infection Control Manager (ICM), the DQI stated, in November 2023 the facility received an email notification from (Healthcare System's Name) there may be potential patients at risk regarding infection control issues with the use of the ultrasound rectal probes. The DQI stated, the email contained instruction to reach out to the local managers (of hospitals operating under (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] to evaluate the process. The DQI stated, the facility's use of the ultrasound rectal probe dated back ten years and it was a rented equipment. The DQI further stated, that before the hospital was notified of the rectal probe disinfection issue, the staff performed low level disinfection (LLD, a process that kills bacteria and some viruses on items that only come in contact with intact skin) prior to using the probe and the re-processing (cleaning, disinfection, and sterilization of reusable medical equipment/devices) of the ultrasound rectal probe did not include high-level disinfection. The DQI further stated, the facility suspended the use of the rectal probe, identified the patients at risk, sent notification letters to patients at risk, and notified local and state agencies. The use of the rectal probe was re-launched sometime in December 2023.

During a review of facility's document titled, "(Contractor's Name) Rectal Probe Review Timeline", received 2/5/24 indicated, "11/13/2023, 9:55 AA, Systems (Healthcare System) e-mail inform and action needed - HLD rectal probes, sites need to take immediate action to stop the use of inadequate disinfected devices on patients and implement an effective HDL process. 1. Identify all your usable devices that contact mucous membranes or sterile body sites., 2. Stop use of all devices identified in item one with inadequate HDL., 3. Investigate the current process and ensure appropriate HDL sterilization processes in place for MIFU., 4. Perform and document a risk assessment., 5. Resume use of these devices only when an appropriate disinfection* process is in place ... Please note : We are in the process validated facts and may have additional guidance as we learn more information we have reached out the company and are awaiting their response ... 11/14-15/2023 ... IC (Infection Control) fact finding and investigation + (plus) suspend use of probes ... 11/30/2023, Initiate Training, Education and Communication to Staff + local audits ... 12/11 and 15/2023, Relaunch of (Contractor's Name) (rectal) Probe at H 1, H 2, H 3 (12/15) ... 1/8/2024, [Facilities Group Name affiliated with (three) separately certified hospitals] Notify CDPH ... 2/5/24, To date ... 179 [ Facilities Group Name affiliated with (three) separately certified hospitals] patients were notified ... "

Review of the facility letter sent to the State Agency [SA, California Department of Public Health (CDPH, ensures compliance with state licensing laws and federal certification regulations)], dated 1/8/24 indicated, "Notice of rectal probe disinfection process issue... we have newly learned that the disinfection process performed on this equipment did not meet the required high level disinfection ("HDL") process for reusable rectal probes ... Immediate actions taken: We suspended the use of all reusable rectal probes ... 2. We ensured that an appropriate level of disinfection or sterilization is in place ... Next steps: 1. Patients identified as having a potential exposure are being notified ... 2. We are offering these patients free Hepatitis C (liver infection caused by the hepatitis C virus), Hepatitis B (inflammation of the liver by the hepatitis B virus) and HIV (HIV- a virus that attacks the immune system) tests."

During an interview on 2/6/24, at 7:09 AM, at H 1, with Director of Surgical Services (DSS) 1 stated, before the hospital was notified (via (Healthcare System's Name) email dated 11/13/2023) of the rectal probe disinfection issue, the (Contractor Name), (Vendor Representative (VR) brought the rectal probe (from contractor facility) into the hospital operating room (OR, sterile location where surgical procedures were performed) before each procedure.

During an observation on 2/6/24, at 7:34 AM, at H 1, with DSS 2, VR was in the OR suite during a Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure.

During an observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the OR suite, VR stated, rectal probe model 8848 was used during the procedure (2/6/24). VR stated, whenever a rectal probe was needed for a procedure, he or another VR brought the rectal probe from the contractor facility to the hospital [(one of (three) separately certified hospitals) where it was scheduled to be used. VR stated, before the hospital was notified of the rectal probe disinfection issue, after the procedure he (VR) wiped the rectal probe thoroughly with the disinfectant wipe, put it inside the rectal probe container, and brought it back with him to the contractor facility. VR stated, he's brought the rectal probe from the contractor facility to the hospital for the procedures since "a few years". VR said he learned (was trained) how to disinfect the rectal probe "on the job". VR stated, he had no documentation (from contractor) to verify competency (ability to do something successfully, effectively, or efficiently) with disinfection/decontamination of the rectal probe. VR further stated, after the rectal probe was brought back to the contractor facility, he did not know if further decontamination of the rectal probe was done at the contractor facility or before the rectal probe was reused for another procedure.

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During an interview on 2/6/24, at 2:04 PM, at H 1 with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

During an interview on 2/6/24, at 2:39 the PM, at H 1, with the OR Scrub Technician (ST 1), and Quality Assurance Coordinator (QAC 1), ST 1 stated she had been employed in the facility for six and a half years and had assisted in procedures using the ultrasound rectal probe. ST 1 stated, the "old process" was, in the OR, after the procedure was completed, the surgeon would hand the rectal probe to the (VR) and the VR wiped the probe with a cloth. When done, the VR left the facility with the rectal probe.

During an interview on 2/6/24 at 1:30 PM, at H 1, with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC), and DAL as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores) ?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why HLD was not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During a review of facility contract agreement, titled, ""Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, indicated, "Page 1 of 20, [(Name) Healthcare System], Sixth Amendment; This Sixth Amendment (the "Amendment") is effected as of April 18, 2021 (the "Effective Date") by and between (Healthcare System's Name) ... (" Customer") and (Contractor Name), a (STATE) limited liability corporation ... WHEREAS customer and contracted entered into an agreement dated April 18, 2016 under which Contractor agreed to provide Laser Rental Services (rectal probe) (the "Agreement") ... 1. Renewal Term. The parties agree to extend the expiration date of the Agreement to April 30, 2023. Upon the expiration of the Renewal Term, this agreement shall automatically renew for successive (1) one year terms until terminated in accordance with IV, TERM AND TERMINATION of the Agreement. DocuSigned by [(Name) Healthcare System] Director Strategic Sourcing and [Contractor Name) Managing Director ... Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work, (Contractor) responsibilities and services to be provided with rented rectal probes to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified/ or documented on contract agreement documents reviewed.

During a video call interview on 2/9/24 at 10:14 AM, at H 1, surveyors reviewed facility contract agreement packet titled, "Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, with Senior Director (Strategic Sourcing) (SDSS) for [(Name) Healthcare System] and Strategic Sourcing Manager for Contracting (SSMC), DAL was scribe. SDSS confirmed she signed contract agreement between "customer" [(Name) Healthcare System] and "contractor" [(Contractor Name) contractor who provided rectal probes)]. SDSS verified initial contract date was April 18, 2016, and expiring on 4/30/24. SSMC stated contract had auto renewal option. SDSS stated, for [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals] who use the same services, we [(Name) Healthcare System] employees responsible for contract agreement(s)] try to consolidate vendors [contractor(s)]. This one (contract agreement) started before I started with [(Name) Healthcare System]. SDSS confirmed contract applied to all [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals]. Surveyors reviewed with SDSS and SSMC contract agreement, "Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work" (Contractor) responsibilities, services to be provided, rented rectal probes (models not indicated), to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified. SDSS stated, I think this contract has a gap. There should be additional amendment. SSMC stated, I'm not seeing amendments, looking for updates in the contracts, changes in the services ... Sixth amendment: current executed version, did not have vendor responsibilities, (in exhibit E, that should have been included in the current contract). SDSS stated, Basic HLD (high level disinfection) for scopes (general policy) - that policy requires that we perform HLD for items from vendors, checked by biomed. IC (Infection Control) department should be involved but this device (rented rectal probe) was not on the list of things that need HLD. It is the hospital's responsibility to apply the IFU (instructions for use). It's the directors in each department that is responsible for following the MIFU (manufacturer's instructions for use).

During an interview on 2/9/24 at 2:06 PM, at H 1, with Chief Operating Officer (COO) and DAL as scribe, COO stated, he was one of a group of individuals, [Board of Directors [Name) Area Operating board] who had oversight of [(Name) Healthcare System] [Facilities Group Name affiliated with (three) separately certified acute care hospitals]. He confirmed each hospital had its own provider (Medicare) number. COO stated the rectal probe disinfection issue was not usual by definition - confirmed it was an unusual occurrence. The COO stated that before reporting (to CDPH), "we wanted to investigate to make sure what was happening. We had to determine whether patients were affected, which hospitals were using (the rectal probe), had to determine facts." COO stated, with routine negotiation (of contracts) Board of Directors [(Name) Area Operating Board] were not involved in what was included in the contract. [(Name)Healthcare] "System" was responsible for contracts (agreement) with (Contractor) (effective 4/18/16, renewed 4/18/2021); but, he (COO) would have input. The COO stated, "The (Contractor) (vendor representative) is not responsible for the HLD, it's the hospital's job. Our policy indicates, in general, we're supposed to do it (HLD). The HLD is our responsibility, we're supposed to sterilize prior to use, to prevent transmission of infections. There was belief that we were doing what we were supposed to do in cleaning it (rectal probe), and equipment used for patients. HLD - that is our responsibility and we failed to do that." The COO stated the directors of surgical services [DSS) - (Representatives for Quality Assurance are responsible for ensuring MIFU is followed. COO stated, regarding rectal probe disinfection issue not included in Quality Assurance Performance Improvement (QAPI) minutes for November to December 2023, January 2024 - "we have not gotten there yet, but it does not mean we did not discuss it."

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During a review of facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024, document indicated columned lists information with [ Facilities Group Name affiliated with (three) separately certified hospitals], Patient (s) Name, Medical Record Number, Date of Birth, Date of Procedure, Procedure, Address, Medical Doctor's Name(s), Page 8 indicated Total: 179 (total number of patients affected with rectal probe disinfection issue) ..."

During an interview on 2/7/24 at 4 PM, at H 1, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The 8 (eight) pages document was the list of patients affected with rectal probe disinfection issue for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H)1, H 2, and H 3. Also, individuals(s) with authority and responsibilities for the conduct of the hospital and patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

During a review of facility contract agreement, titled, ""Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, indicated, "Page 1 of 20, [(Name) Healthcare System], Sixth Amendment; This Sixth Amendment (the "Amendment") is effected as of April 18, 2021 (the "Effective Date") by and between (Healthcare System's Name) ... (" Customer") and (Contractor Name), a (STATE) limited liability corporation ... WHEREAS customer and contracted entered into an agreement dated April 18, 2016 under which Contractor agreed to provide Laser Rental Services (rectal probe) (the "Agreement") ... 1. Renewal Term. The parties agree to extend the expiration date of the Agreement to April 30, 2023. Upon the expiration of the Renewal Term, this agreement shall automatically renew for successive (1) one year terms until terminated in accordance with IV, TERM AND TERMINATION of the Agreement. DocuSigned by [(Name) Healthcare System] Director Strategic Sourcing and [Contractor Name) Managing Director ... Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work, (Contractor) responsibilities and services to be provided with rented rectal probes to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified/ or documented on contract agreement documents reviewed.

During a video call interview on 2/9/24 at 10:14 AM, at H 1 surveyors reviewed facility contract agreement packet titled, "Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, with Senior Director (Strategic Sourcing) (SDSS) for [(Name) Healthcare System] and Strategic Sourcing Manager for Contracting (SSMC), DAL was scribe. SDSS confirmed she signed contract agreement between "customer" [(Name) Healthcare System] and "contractor" [(Contractor Name) contractor who provided rectal probes)]. SDSS verified initial contract date was April 18, 2016, and expiring on 4/30/24. SSMC stated contract had auto renewal option. SDSS stated, for [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals] who use the same services, we [(Name) Healthcare System] employees responsible for contract agreement(s)] try to consolidate vendors [contractor(s)]. This one (contract agreement) started before I started with [(Name) Healthcare System]. SDSS confirmed contract applied to all [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals]. Surveyors reviewed with SDSS and SSMC contract agreement, "Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work" (Contractor) responsibilities and services to be provided for rented rectal probes (models not indicated), to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified. SDSS stated, I think this contract has a gap. There should be additional amendment. SSMC stated, I'm not seeing amendments, looking for updates in the contracts, changes in the services ... Sixth amendment: current executed version, did not have vendor responsibilities, (in exhibit E, that should have been included in the current contract). SDSS stated, Basic HLD (high level disinfection) for scopes (general policy) - that policy requires that we perform HLD for items from vendors, checked by biomed. IC (Infection Control) department should be involved but this device (rented rectal probe) was not on the list of things that need HLD. It is the hospital's responsibility to apply the IFU (instructions for use). It's the directors in each department that is responsible for following the MIFU (manufacturer's instructions for use).

During an interview on 2/9/24 at 2:06 PM, at H 1 with Chief Operating Officer (COO) and DAL as scribe, COO stated, he was one of a group of individuals, [Board of Directors [Name) Area Operating board] who had oversight of [(Name) Healthcare System] [Facilities Group Name affiliated with (three) separately certified acute care hospitals]. He confirmed each hospital had its own provider (Medicare) number. COO stated the rectal probe disinfection issue was not usual by definition - confirmed it was an unusual occurrence. The COO stated that before reporting (to CDPH), "we wanted to investigate to make sure what was happening. We had to determine whether patients were affected, which hospitals were using (the rectal probe), had to determine facts." COO stated, with routine negotiation (of contracts) Board of Directors [(Name) Area Operating Board] were not involved in what was included in the contract. [(Name)Healthcare] "System" was responsible for contracts (agreement) with (Contractor) (effective 4/18/16, renewed 4/18/2021); but, he (COO) would have input. The COO stated, "The (Contractor) (vendor representative) is not responsible for the HLD, it's the hospital's job. Our policy indicates, in general, we're supposed to do it (HLD). The HLD is our responsibility, we're supposed to sterilize prior to use, to prevent transmission of infections. There was belief that we were doing what we were supposed to do in cleaning it (rectal probe), and equipment used for patients. HLD - that is our responsibility and we failed to do that." The COO stated the directors of surgical services [DSS) - (Representatives for Quality Assurance are responsible for ensuring MIFU is followed. COO stated, regarding rectal probe disinfection issue not included in Quality Assurance Performance Improvement (QAPI) minutes for November to December 2023, January 2024 - "we have not gotten there yet, but it does not mean we did not discuss it."

During an interview on 2/14/24 at 10:10 a.m. at H2, with the Infection Prevention Manager (IPM), IPM stated the facility was part of a [hospital system] who had multiple hospitals in the state; in addition, the facility was part of a small group of three hospitals which shared a governing body and had a shared Infection Prevention Department. IPM stated she had oversight of three hospitals and there was a dedicated Infection Preventionist (IP) at each hospital. IPM further stated the three hospitals shared another IP who had oversight of surgical services for all three hospitals. IPM stated, in November 2023, she received a call from the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system regarding the facility's use of rectal ultrasound probes. IPM stated, she was unaware if the facility used the rectal ultrasound probes, and she sent out an email to the Surgical Services Department at the facility to inquire about the use of the probes.

IPM stated the hospital used the Spaulding Classification System (a nationally recognized infection control standard which is used to define the minimum level of disinfection required for a medical device) to determine how medical devices should be cleaned. IPM stated rectal ultrasound probes required High-level Disinfection (HLD- a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) because the probe came in contact with mucous membranes (soft lining of body cavities and canals that lead to the outside of the body). IPM stated, she received an email response from the Surgical Services Manager who confirmed the rectal ultrasound probes were used in the operating room (OR) and reported the cleaning and disinfecting procedure did not include HLD. IPM stated she was unaware of the facility's process for cleaning and disinfecting the probes until that date. IPM stated, at that time, the facility was instructed to stop the use of the probes as the cleaning and disinfection process was inadequate.

During an interview on 2/14/24 at 2:42 p.m., at H2, with the Infection Prevention Registered Nurse (IP 1), IP 1 stated the IFU for the disinfecting wipes indicated a "wet time" of three minutes which meant the device should be maintained wet with the disinfecting product for three minutes and then dried with a cloth. IP 1 stated staff were expected to follow manufacturer's IFU for all medical devices, for cleaning and disinfecting products. IP 1 further stated, it was his understanding that the rectal ultrasound probe manufacturer IFU allowed for low- level disinfection (a process that kills bacteria and some viruses on items that only come in contact with intact skin). IP 1 confirmed rectal ultrasound probes come in contact with mucus membranes and should be, at minimum, HLD according to the facility's policy.

During an interview on 2/15/24 at 9:30 a.m., at H2, with the Clinical Process Improvement Consultant (CPIC) for the facility's hospital system, CPIC stated she worked for [hospital system name] which owned multiple hospitals in the state and the facility was a system hospital. CPIC stated, in November 2023, she received a concern from a staff member at a different hospital related to cleaning and disinfecting rectal ultrasound probes, so she reached out to all system hospitals to determine what their current process was. CPIC stated it was determined the facility was renting the rectal ultrasound probes from [vendor]. CPIC further stated, it was determined the facility was not cleaning and disinfecting the rectal ultrasound probes adequately. CPIC stated rectal ultrasound probes were considered semi-critical devices (any device that comes in contact with a mucus membrane) and required HLD, at a minimum. CPIC confirmed the facility was not performing HLD on these devices. CPIC stated the facility was instructed to stop using the rectal ultrasound probes until an investigation was conducted.

During an interview on 2/15/24 at 12 p.m. at H2, with the Director of Quality, Patient Safety, and Infection Control (DQI), the DQI stated in November 2023, she received a call from CPIC inquiring about the process the facility used to clean and disinfect rectal ultrasound probes. DQI stated the facility reported their process and were instructed to suspend using the probes because they were not HLD.

During a concurrent interview and record review on 2/27/24 at 3 PM, with the Director of Accreditation and Licensing (DAL), the "List of [hospital] Patient Notification" was review

Based on observation, interview and record review, the facility failed to ensure leaders for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 3 maintained oversight of Department Services
operational policies and procedures for Infection Control, Sterile Processing Department (SPD an area within the hospital in which medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care), Biomedical (Biomed ensures medical devices and equipment are in good repair, functions effectively and are efficient.) Department, Outpatient Radiology Department (imaging technology (used to help in the diagnosis a medical condition), and Contract Services when:

1. The facility failed to follow the manufacturer's instructions for use (MIFU, provides detailed instructions on how equipment should be used, maintained, and stored properly) of low-level disinfectant (a process that kills bacteria and some viruses on items that only come in contact with intact skin) during manual cleaning (removal of visible soil, example, organic and inorganic material, from reusable medical devices) for the Transvaginal Probe (TVP, wand-like instrument connected to a computer that is inserted into the vagina to produce images of the organs in the pelvic region). This failure had the potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another) for one (Patient 15) of 30 sampled patients.

2. The facility failed to follow the MIFU to use rigid containers or the probe holder on the ultrasound unit during transport of TVP to and from Ultrasound Room 2. The deficient practice had potential result for damage to the probes.

3. The facility failed to do required Annual Preventive Maintenance (PM, also called Time-based maintenance is done at scheduled time intervals to minimize equipment degradation and reduce loss of performance) for the Trophon2 machine (a closed, automated high-level disinfection [HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores] device). The failure had potential result for Trophon 2 machine not cleaning and disinfecting effectively.

4. The facility failed to clean and disinfect rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) according to the MIFU and facility policy. As a result of this failure, twelve (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and Patient 12) of 30 sampled patients were potentially exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) or human immunodeficiency virus (HIV- a virus that attacks the immune system).

Findings:

1. During an observation on 2/27/24 at 1:28 PM, in the Outpatient Radiology Department area in the hospital, in the Decontamination Room (Decon Area - area where reusable equipment, instruments and supplies are cleaned and decontaminated by means of manual or mechanical cleaning processes and chemical disinfection), with the Imaging Supervisor (IS) and Quality Assurance Coordinator (QAC) 2, Ultrasound Sonographer (US) 1 was performing the pre-cleaning process of the TVP used for Patient 15. After donning gloves, US 1 held the TVP in one hand and with the other hand pulled out one sheet of disinfectant wipe from a canister, labeled, "Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes (Clorox wipes). Thereafter, US 1 wiped the TVP with the Clorox wipe starting from the bottom part that connects to the ultrasound monitor with a single stroke, moving toward the cord and up to the tip of the probe, then disposed the Clorox wipe in the trash bin. The Clorox wipes canister indicated "1 (one) minute contact time (refers to how long a disinfectant needs to stay wet on a surface to be effective). US 1 did not monitor the amount of time the TVP stayed wet after wiping it with the Clorox wipe.

During a concurrent interview on 2/27/24 at 1:28 PM, US 1 stated the wipes were used to pre-clean (manual cleaning) the TVP. "Rest the probe on the counter (countertop) over a paper towel for one minute to let the probe dry."

During an interview on 2/28/24 at 2:04 PM. with IP 1, in the presence of QAC 4, IP 1 stated the dwell time (also known as contact time) for the disinfectant wipes to be effective "have to be on surface for minimum of one minute before drying. My expectation is, when they (staff) wipe (TVP) is to wipe and keep it wet for one minute. When they wipe, we ask them to do "unidirectional (moving or operating in a single direction)." IP 1 also stated if the TVP starts to dry before the one-minute contact time is completed, staff is expected to use another (disinfectant) wipe to wipe again until one minute wetness is reached. IP 1 added, "Every disinfectant requires a certain time to dissolve, to clear the wall of microbes. We always pick the longest time, to be effective, it (contact time) has to be at least one minute... to capture bacteria and viruses that require one minute of neutralization of the cell wall or cell membrane."

Review of the document, titled, "Clorox Healthcare Hydrogen Peroxide Disinfectant Wipes," provided by the facility on 2/28/24, indicated, "1 (one) minute contact time ... DIRECTIONS FOR USE: ...This product may be used to preclean or decontaminate ... semi-critical (any device that comes in contact with a mucus membrane) medical devices prior to sterilization or high-level disinfection (HLD - a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores ) ... Disinfection:... TO CLEAN, DISINFECT AND DEODORIZE HARD, NONPOROUS SURFACES: Wipe surface until completely wet. Allow this product to remain wet for contact time listed on label. Let air dry. For heavily soiled areas, a precleaning is required ..."

Review of the TVP's MIFU, titled "(Manufacturer) Ultrasound Probes and Accessories Processing," dated 2023, indicated " Probe Processing - To prevent transmission of disease, adequate cleaning and disinfection are necessary before first use, between patient use, and every time the probe is stored or transported in a nonclean container like shipping case. All probes must be thoroughly cleaned prior to disinfection. The required level of disinfection is based on the type of tissue the probe will contact during use. These recommendations suit the Spaulding classification (a strategy for sterilization or disinfection of inanimate (nonliving) objects and surfaces based on degree of risk involved in their use) for intended use, and federal guidelines ... for proper processing of reusable medical instruments ... Table 2-1 of Care Methods by type of tissue ... Type of tissue ... Mucosal or Non-intact skin ... Cleaning followed by High-Level Disinfection ... Probe Manual Cleaning - Thorough cleaning is a mandatory first step to allow adequate subsequent disinfection or sterilization. Choose the most convenient method, either the wipe or enzymatic soak ... Cleaning with Wipes ...1. Hold the probe by the handle near the cable strain relief. DO NOT suspend or hold the probe by the cable as this may damage the probe. 2. Dispense a cleaning wipe from the wipe canister. 3. Gently wipe the probe with a cleaning wipe from the cable strain relief to the acoustic lens (i.e. from cleanest to dirtiest area). Gently wipe the probe's acoustic lens. NOTE - Pay special attention to acoustic lens, edges, and crevices, removing all gel, product, and body fluids. 4. Turn the probe and continue wiping until the entire surface of the probe has been wiped. As the wipe becomes visibly soiled, discard the wipe into clinical trash and dispense fresh wipes as needed. As needed for additional focused cleaning to crevices, wrap a clean wipe around a soft nylon bristle brush or other suitable instrument to access crevices, such as biopsy notches. 5. Visually inspect the probe for any remaining soil and, if necessary, repeat steps 3 and 4 until the probe is visibly clean ..."


2. During a concurrent observation and interview on 2/27/24 at 1:26 PM, inside the Ultrasound Room 2 (UR 2), located in the Outpatient Radiology Department, a TVP placed and sealed inside a red biohazard plastic bag (used to dispose of biohazardous waste material that is potentially infectious or could be a threat to people's health) was placed on the probe holder of the ultrasound machine. The TVP was connected to the ultrasound machine. US 1 stated the TVP was used for Patient 15 and was ready for disinfection. US 1 disconnected the TVP from the ultrasound machine, pulled out the TVP from the probe holder, and exited UR 2 while holding the TVP. After exiting UR 2, US 1 walked towards the adjacent Decon Area and entered the room. US 1 performed the disinfection process for the TVP. After the disinfection process was completed, US 1 wrapped the TVP inside a green plastic bag, sealed it with a sticker indicating the TVP has passed the disinfection process, and transported the TVP back to UR 2.

Review of the TVP's MIFU, titled "(Manufacturer) Ultrasound Probes and Accessories Processing," dated 2023, indicated "Probe Transportation-Transport and store the ultrasound probes covered as needed and secured. When transporting a clean or dirty ultrasound probe, ensure the probe is protected from cross contamination and possible damage. This can include the use of covers per the appropriate disinfection/contamination level, and the use of rigid containers or the probe holder on the ultrasound unit to secure. NOTE: Do not use cloth or plastic bags to transport probes. This could result in damage to the probes ..."

During an interview with IP 1 on 2/29/24 at 11:35 AM, in the presence of QAC 4, IP 1 confirmed ultrasound probe transport should protect probes from damage during transport.

3. During a concurrent observation and interview on 2/26/24, at 11:48 AM, with the Chief Technician (CT 1), a Trophon2 machine in the Decon Area, located on the 2nd floor, in the Outpatient Radiology Department was observed. The Trophon2 machine was sitting on top of the counter table near the sink with an orange color sticker which read: "PM (Preventative Maintenance) due Jan (January) 2024". Next to it was a green color sticker with a bar code and a number "5329730," and a handwritten sticker was posted on the Trophon2 machine which read: "WO (Work Order) # (number) CWKD0503213, 1/5/24, for PM due for 2 (two) machines, 1 of 2 out 1/29/24." The CT 1 stated, the Trophon2 machine was a "loaner" from the vendor, the PM was due on "1/5/24", and a work order was made waiting for the other Trophon from the vendor.

During a review of facility document titled, "Work Order for Ultrasound Trophon PM", undated, handed by the facility staff, the Work Order for Ultrasound Trophon PM indicated, "Work order CWKD0503213 has been submitted with the following details. Number: CWKD0503213, Work Order Type: Field Service Request ... Department: Ultrasound. Reason for Service: ... Issue: PM due."

During an interview on 2/26/24, at 2:55 PM, with the Ultrasound Sonographer (US 1), US 1 stated, the facility received the Trophon2 machine "last year" and acknowledged the PM for the Trophon2 machine was due on 1/5/24. The US 1 stated, the Trophon2 machine was a "loaner", the other Trophon machine was with the vendor, it would take a few months before they could take it back, and the facility was waiting to exchange it with the Trophon2 that has a PM due on 1/5/24.

During a review of facility document titled, "Trophon2 High Level Disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) Log A, Department: Ultrasound, Location xxx (name of the facility", the Trophon2 High Level Disinfection Log A, indicated the date the cartridge replacement was loaded, the lot batch number, and the expiration date. For the month of January 2024, random check of the log showed the Trophon2 machine was used for HLD of the Transvaginal probe (TVP, wand-like instrument connected to a computer that is inserted into the vagina to produce images of the organs in the pelvic region) used by the patients on the following dates: on 1/16/24 for three patients, on 1/17/24 for three patients, on 1/19/24 for eight patients, on 1/24/24 for five patients, on 1/25/24 for five patients, and on 1/30/24 for four patients. For the month of February 2024, a random checked of the log showed the Trophon2 machine was used for HLD of the TVP used by the patients on the following dates: on 2/1/24 for five patients, on 2/2/24 for seven patients, on 2/6/24 for four patients, on 2/15/24 for seven patients, on 2/21/24 for five patients, on 2/23/24 for six patients, and on 2/26/24 for two patients.

During a follow up interview on 2/26/24, at 3:01 PM, with the CT 1, CT 1 stated, the PM for Trophon2 machine was important to make sure the machine was "working properly."

During a review of facility e-mail, dated 2/27/24, at 11:08 AM, handed by the facility staff, indicated "Subject: CWDK0503213, ... Department: Ultrasound. ... Opened: 2024-01-05 09:02:56 ... Control number: 5329730 ... Modality: Sterilizer, ... Work order: CWDK05503213, ... Short description: 2.26 xxx (name of the facility staff) called back to get the status of this request, as no one has reached out them and the Original call was made on 1/5/24, Escalating to high priority. ... ."

During an interview on 2/27/24, at 12:46 PM, with the Imaging Supervisor (IS 1), and with the Quality Assurance Coordinator (QAC 2), IS 1 stated, the Trophon2 was received by the facility a "year ago", it was picked up "today" and given to the vendor. The Trophon2 machine was a "loaner", it was a "smart technology", the moment it's turned on it would run a test, "does an internal test" and another test for the chemical indicator. The IS stated, the PM was more for "formality" having a routine that all equipment were accounted for. When asked, how safe to use the Trophon2 machine if it had passed the due date for PM, the IS 1, stated, she did not have an "appropriate answer", did not know what the PM of the Trophon2 machine consists of.

In an interview on 2/28/24, at 12:40 PM, with the with the Director of Diagnostic Imaging Services (DDIS), DDIS stated, the PM for the Trophon2 machine was the responsibility of the Bio-med Department, an alternate PM on the Trophon2 was conducted and the Trophon had shipped out. The DDIS stated, the PM ideally would have been done and the PM work should be done so the equipment "does not break down." The Trophon2 has a warm-up cycle, making sure the machine was ready and it was working. In the end the testing was either pass or fail and if it failed, the facility would not proceed with the re-processing (process carried out on a used device in order to allow its safe reuse).

During an interview on 2/28/24, at 2:05 PM, with the Infection Preventionist (IP 1) and QAC 3, IP 1 stated, the PM was mainly to check if the equipment was disinfecting effectively. If the PM was not up to date, he considered that it did not guarantee to meet the standard one hundred percent (100% infection control). The "indicator" (on the trophon2) gives a certain level of condition that the process was working and even if the indicator says it passed, it could not guarantee to meet the standard one hundred percent (100%, for infection control). The implication of this was potential "exposure to unknown pathogens" and could not guarantee (the standard 100%) from the due date and onwards, "due date is due date". The IP stated, to prevent adverse event, stop the use immediately, let the team know when events like that happened, staff need to let "us know", inform the Bio-med (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient), and coach the team who used the Trophon2.

Review of the facility's P & P titled, "Infection Control Strategies -Manual High-Level Disinfection - for Endocavity probes (devices used for internal scanning for rectal or vaginal patient exams, as defined in the facility policy). Using Trophon EPR HLD System ... Policy: ... C. Staff who perform HLD ... with the Trophon2 ... will follow the manufacturer's instructions for use..."

Review of the Trophon2 User Manual dated 9/2019 indicated, "Part E-Maintenance and Routine Care, Section E1: Preventative Maintenance Service, Your Trophon2 requires annual preventive maintenance ... Part G-Service Requirement and Warranty Provision. ... To ensure the safety and efficacy of your HLD operations, Trophon2 requires a preventive service every 12 months..."

4. During a group interview on 2/5/24, at 10:07 AM, at H 1 with the Director of Accreditation and Licensing (DAL), Manager of Accreditation and Licensing (MAL), Director of Quality, Patient Safety, and Infection Control (DQI), Chief Nursing Executive (CNE), and Infection Control Manager (ICM), the DQI stated, in November 2023 the facility received an email notification from (Healthcare System's Name) there may be potential patients at risk regarding infection control issues with the use of the ultrasound rectal probes. The DQI stated, the email contained instruction to reach out to the local managers (of hospitals operating under (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] to evaluate the process. The DQI stated, the facility's use of the ultrasound rectal probe dated back ten years and it was a rented equipment. The DQI further stated, that before the hospital was notified of the rectal probe disinfection issue, the staff performed low level disinfection (LLD, a process that kills bacteria and some viruses on items that only come in contact with intact skin) prior to using the probe and the re-processing (cleaning, disinfection, and sterilization of reusable medical equipment/devices) of the ultrasound rectal probe did not include high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores). The DQI further stated, the facility suspended the use of the rectal probe, identified the patients at risk, sent notification letters to patients at risk, and notified local and state agencies. The use of the rectal probe was re-launched sometime in December 2023.

During a review of facility's document titled, "(Contractor's Name) Rectal Probe Review Timeline", received 2/5/24 indicated, "11/13/2023, 9:55 AA, Systems (Healthcare System) e-mail inform and action needed - HLD rectal probes, sites need to take immediate action to stop the use of inadequate disinfected devices on patients and implement an effective HDL process. 1. Identify all your usable devices that contact mucous membranes or sterile body sites., 2. Stop use of all devices identified in item one with inadequate HDL., 3. Investigate the current process and ensure appropriate HDL sterilization processes in place for MIFU., 4. Perform and document a risk assessment., 5. Resume use of these devices only when an appropriate disinfection* process is in place ... Please note : We are in the process validated facts and may have additional guidance as we learn more information we have reached out the company and are awaiting their response ... 11/14-15/2023 ... IC (Infection Control) fact finding and investigation + (plus) suspend use of probes ... 11/30/2023, Initiate Training, Education and Communication to Staff + local audits ... 12/11 and 15/2023, Relaunch of (Contractor's Name) (rectal) Probe at H 1, H 2, H 3 (12/15) ... 1/8/2024, [Facilities Group Name affiliated with (three) separately certified hospitals] Notify CDPH ... 2/5/24, To date ... 179 [ Facilities Group Name affiliated with (three) separately certified hospitals] patients were notified) ... "


Review of the facility letter sent to the State Agency [SA, California Department of Public Health (CDPH, ensures compliance with state licensing laws and federal certification regulations)], dated 1/8/24 indicated, "Notice of rectal probe disinfection process issue... we have newly learned that the disinfection process performed on this equipment did not meet the required high level disinfection ("HDL") process for reusable rectal probes ... Immediate actions taken: We suspended the use of all reusable rectal probes ... 2. We ensured that an appropriate level of disinfection or sterilization is in place ... Next steps: 1. Patients identified as having a potential exposure are being notified ... . 2.We are offering these patients free Hepatitis C (liver infection caused by the hepatitis C virus), Hepatitis B (inflammation of the liver by the hepatitis B virus) and HIV (HIV- a virus that attacks the immune system) tests."

During an interview on 2/6/24, at 7:09 AM, at H 1 with Director of Surgical Services (DSS) 1 stated, before the hospital was notified (via (Healthcare System's Name) email dated 11/13/2023) of the rectal probe disinfection issue, the (Contractor Name), (Vendor Representative (VR) brought the rectal probe (from contractor facility) into the hospital operating room (OR, sterile location where surgical procedures were performed) before each procedure.

During an observation on 2/6/24, at 7:34 AM, at H 1 with DSS 2, VR was in the OR suite during a Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure.

During an interview on 2/6/24 at 8:49 AM, at H 1 with VR, in the OR suite, VR stated, rectal probe model 8848 was used during the procedure (2/6/24). VR stated, whenever a rectal probe was needed for a procedure, he or another VR brought the rectal probe from the contractor facility to the hospital [(one of (three) separately certified hospitals) where it was scheduled to be used. VR stated, before the hospital was notified of the rectal probe disinfection issue, after the procedure he (VR) wiped the rectal probe thoroughly with the disinfectant wipe, put it inside the rectal probe container, and brought it back with him to the contractor facility. VR stated, he's brought the rectal probe from the contractor facility to the hospital for the procedures since "a few years". VR said he learned (was trained) how to disinfect the rectal probe "on the job". VR stated, he had no documentation (from contractor) to verify competency (ability to do something successfully, effectively, or efficiently) with disinfection/decontamination of the rectal probe. VR further stated, after the rectal probe was brought back to the contractor facility, he did not know if further decontamination of the rectal probe was done at the contractor facility or before the rectal probe was reused for another procedure.

During an interview on 2/6/24 at 1:30 PM at H 1 with (Medical Director Pharmacy and Infection Control for [Name Healthcare System] (MDIC) and Director of Accreditation and Licensing (DAL) as scribe (wrote (for facility) questions asked and answers given during interview), the MDIC stated, he had oversight for (Healthcare System's Name). He stated, the contractor would come in (on scheduled procedures dates) with (rectal) probe attached to the machine and told (facility) equipment was ready to go. MDIC stated, the rectal probe disinfection issue was discovered when (date not mentioned) a hospital that was part of the Healthcare System wanted to own/buy the equipment. A representative (name not mentioned) from (Contractor Name) came in and asked "why are you not doing high-level disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores)?" (Contractor Name) was not doing leak testing. MDIC stated, (Contractor Name) did not have a policy on disinfection. A new representative inquired why was HLD not being done. (Healthcare System Name) received (date not given) the report from a (Healthcare System Name) staff (identifier not mentioned). The MDIC further stated, "As soon as we learned, we stopped using (rectal probe). We set up the process- analyzed, identified the system gap related to the (Contractor Name) and set up a process, collected data, who was using the probes, the type of probes used. We developed a standard work for the specific probes ..." The MDIC stated, 450 patients from the whole Healthcare System were affected. The problem was presented to Biomed (biomedical department ensures medical devices and equipment are in good repair, functions effectively and are efficient.) as a whole package- machine (rectal probe connected into ultrasound system); went to Biomed as a piece of equipment, looked at it as a single package. They (Biomed) thought it (rectal probe) was no different than an external equipment, slipped under the radar because of the way the company presented it. MDIC stated, expectation was if it goes in the orifices, it needs HLD. We missed it - the need for HLD (information on duration not done not mentioned) for the rectal probes.

During a review of facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024, document indicated columned lists information with [ Facilities Group Name affiliated with (three) separately certified hospitals], Patient (s) Name, Medical Record Number, Date of Birth, Date of Procedure, Procedure, Address, Medical Doctor's Name(s), Page 8 indicated Total: 179 (total number of patients affected with rectal probe disinfection issue) ..."

During an interview on 2/7/24 at 4 PM, at H 1 with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. Also, Governing Body (person(s) with authority and responsibilities) were the same for [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3.; and all facility policies and procedures for H 1, H 2, and H 3. were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

During a review of facility contract agreement, titled, ""Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, indicated, "Page 1 of 20, [(Name) Healthcare System], Sixth Amendment; This Sixth Amendment (the "Amendment") is effected as of April 18, 2021 (the "Effective Date") by and between (Healthcare System's Name) ... (" Customer") and (Contractor Name), a (STATE) limited liability corporation ... WHEREAS customer and contracted entered into an agreement dated April 18, 2016 under which Contractor agreed to provide Laser Rental Services (rectal probe) (the "Agreement") ... 1. Renewal Term. The parties agree to extend the expiration date of the Agreement to April 30, 2023. Upon the expiration of the Renewal Term, this agreement shall automatically renew for successive (1) one year terms until terminated in accordance with IV, TERM AND TERMINATION of the Agreement. DocuSigned by [(Name) Healthcare System] Director Strategic Sourcing and [Contractor Name) Managing Director ... Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work, (Contractor) responsibilities and services to be provided with rented rectal probes to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified/ or documented on contract agreement documents reviewed.

During a video call interview on 2/9/24 at 10:14 AM, at H 1 surveyors reviewed facility contract agreement packet titled, "Contract #SC14548, [(Name) Healthcare System], Sixth Amendment", Renewed 4/30/2023, with Senior Director (Strategic Sourcing) (SDSS) for [(Name) Healthcare System] and Strategic Sourcing Manager for Contracting (SSMC), DAL was scribe. SDSS confirmed she signed contract agreement between "customer" [(Name) Healthcare System] and "contractor" [(Contractor Name) contractor who provided rectal probes)]. SDSS verified initial contract date was April 18, 2016, and expiring on 4/30/24. SSMC stated contract had auto renewal option. SDSS stated, for [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals] who use the same services, we [(Name) Healthcare System] employees responsible for contract agreement(s)] try to consolidate vendors [contractor(s)]. This one (contract agreement) started before I started with [(Name) Healthcare System]. SDSS confirmed contract applied to all [(Name) Healthcare System], [Facilities Group Name in (Name) Area affiliated with (three) separately certified acute care hospitals]. Surveyors reviewed with SDSS and SSMC contract agreement, "Page 1 of 20 ... AGREEMENT, I. SERVICES COVERED, 1. Services/ Products/Scope of Work" (Contractor) responsibilities and services to be provided for rented rectal probes (models not indicated), to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area] were not indicated/specified. SDSS stated, I think this contract has a gap. There should be additional amendment. SSMC stated, I'm not seeing amendments, looking for updates in the contracts, changes in the services ... Sixth amendment: current executed version, did not have vendor responsibilities, (in exhibit E, that should have been included in the current contract). SDSS stated, Basic HLD (high level disinfection) for scopes (general policy) - that policy requires that we perform HLD for items from vendors, checked by biomed. IC (Infection Control) department should be involved but this device (rented rectal probe) was not on the list of things that need HLD. It is the hospital's responsibility to apply the IFU (instructions for use). It's the directors in each department that is responsible for following the MIFU (manufacturer's instructions for use).

During an interview on 2/9/24 at 2:06 PM, at H 1 with Chief Operating Officer (COO) and DAL as scribe, COO stated, he was one of a group of individuals, [Board of Directors [Name) Area Operating board] who had oversight of [(Name) Healthcare System] [Facilities Group Name affiliated with (three) separately certified acute care hospitals]. He confirmed each hospital had its own provider (Medicare) number. COO stated the rectal probe disinfection issue was not usual by definition - confirmed it was an unusual occurrence. The COO stated that before reporting (to CDPH), "we wanted to investigate to make sure what was happening. We had to determine whether patients were affected, which hospitals were using (the rectal probe), had to determine facts." COO stated, with routine negotiation (of contracts) Board of Directors [(Name) Area Operating Board] were not involved in what was included in the contract. [(Name)Healthcare] "System" was responsible for contracts (agreement) with (Contractor) (effective 4/18/16, renewed 4/18/2021); but, he (COO) would have input. The COO stated, "The (Contractor) (vendor representative) is not responsible for the HLD, it's the hospital's job. Our policy indicates, in general, we're supposed to do it (HLD). The HLD is our responsibility, we're supposed to sterilize prior to use, to prevent transmission of infections. There was belief that we were doing what we were supposed to do in cleaning it (rectal probe), and equipment used for patients. HLD - that is our responsibility and we failed to do that." The COO stated the directors of surgical services [DSS) - (Representatives for Quality Assurance are responsible for ensuring MIFU is followed. COO stated, regarding rectal probe disinfection issue not included in Quality Assurance Performance Improvement (QAPI) minutes for November to December 2023, January 2024 - "we have not gotten there yet, but it does not mean we did not discuss it."

During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. at H2, in the operating room (OR), ST 2 stated the surgical procedure had just finished and he was beginning the "pre-cleaning" process for the rectal ultrasound probe used in the pr

Findings:

1.) During a concurrent observation and interview on February 26, 2024, at 12:10 p.m., with the Director of the Sterile Processing Department (DSPD,) in the Sterile Processing Department (SPD) Clean Room, the endoscope storage cabinet was observed with eight endoscopes hanging on hooks, each with a large white label attached, stored inside the closed cabinet. The DSPD stated each endoscope storage label indicated the endoscope serial number, the date of disinfection and date of expiration (date the endoscope should be reprocessed). The DSPD further stated the "hang time," the facility followed was 21 days, based on recommendations by AAMI (Association for the Advancement of Medical Instrumentation) and ASGE (American Society for Gastrointestinal Endoscopy).

During an interview on February 26, 2024, at 2 p.m., with facility Infection Preventionist (IP), he stated facility policy and procedure followed current guidelines and recommendations by AAMI, and ASGE, as well as standards and recommended practices by AORN (Association of Perioperative Registered Nurses), for surgical instrument processing and storage. The IP also stated the facility was required to follow manufacturer's instructions for use and disinfection of surgical instruments.

A review of facility policy and procedures (P & P,) titled, "Infection Control Strategies for Handling and Maintenance for Handling Disinfection and Maintenance of Flexible Scopes Rigid Endoscopes Probes Instruments," dated 6/22/2023, indicated: "...Storage of Flexible Scopes, 1. Flexible scope with channels must be hung and stored vertically without coiling, touching each other, or touching bottom/sides of storage unit., 2. Scopes should enter into the storage area in a manner that clearly illustrates the movement of scopes with the oldest dates forward, to ensure appropriate rotation. After a thorough review of current literature regarding device 'hang time,' any additional reprocessing will be event related, rather than time based." The facility P & P indicated the following: "References: 1. Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST91: 2015."

A review of facility P & P reference article, "ANSI/AAMI ST91: 2015," the following was indicated, "Due to the lack of consensus and evidence on storage time, it is recommended that the healthcare facility conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed to use on the next patient."

During an interview and concurrent record review on February 28, 2024, at 2:15 p.m., with the facility RN, Manager of GI and Interventional Services/ Endoscopic Procedures (RNMG 1) he stated the facility followed recommendations by the AORN, AAMI, and ASGE for endoscope and probe disinfection and storage. RNMG 1 further stated the facility conducted a Risk Assessment for endoscope storage and presented facility document titled, "Proactive Risk Assessment: Endoscope Shelf-Life June 2015." The RNMG 1 stated the facility Risk Assessment had not determined a specified "hang time," definition for facility endoscopes. Review of facility Risk Assessment dated June 2015 indicated, "...AORN recommendation [for endoscope storage] is 5 days...At [facility name], we date all scopes after high level disinfection, scopes are stored in special cabinets...A small minority of scopes are not used regularly and may be stored for > [greater than] one month." The RNMG 1 confirmed the facility did not have a specific"hang time," documented in facility policy and procedures.

During a concurrent observation and interview on February 29, 2024, at 10:04 a.m., with the DSPD in the facility SPD Clean Room, the endoscope storage cabinet contained eight endoscopes with labels which indicated dates of expiration were not consistent with a 21- day "hang time" for endoscope storage and expiration. The DSPD confirmed the following dates were observed on the processing labels for eight endoscopes hanging in the SPD Clean Room endoscope storage cabinet:

Scope 1: Process Date: 2/28/2024, Expiration Date: 3/17/2024 (18 days)
Scope 2: Process Date: 2/27/2024, Expiration Date: 3/17/2024 (19 days)
Scope 3: Process Date: 2/28/2024, Expiration Date: 3/17/2024 (18 days)
Scope 4: Process Date: 2/28/2024, Expiration Date: 3/17/2024 (18 days)
Scope 5: Process Date: 2/28/2024, Expiration Date: 3/17/2024 (18 days)
Scope 6: Process Date: 2/24/2024, Expiration Date: 3/14/2024 (19 days)
Scope 7: Process Date: 2/12/2024, Expiration Date: 3/03/2024 (20 days)
Scope 8: Process Date: 2/28/2024, Expiration Date: 3/17/2024 (18 days)

All dates indicated endoscopes were stored well over the current recommended storage time (7 days) for endoscopes, as recommended by AORN.

2.) During an interview and concurrent record review on February 29, 2024, at 11:21 a.m. with facility IP, he confirmed the facility's P &P titled, "Infection Control Strategies for Handling and Maintenance for Handling Disinfection and Maintenance of Flexible Scopes Rigid Endoscopes Probes Instruments," dated 6/22/2023, indicated, "...'hang time,' any additional reprocessing will be event related, rather than time based," and did not specify a definite "hang time," for storage of endoscopes. The IP stated the facility conducted a Risk Assessment regarding for endoscope storage and reprocessing was conducted by the facility in June 2015, however no further Risk Assessment for endoscope storage had been done since that time, and there was no other facility document that specified a consistent "hang time" for endoscope storage. The IP provided documentation of an article titled, "Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update, dated 4 January 2017, (article reviewed and approved by the Governing Board of ASGE, copyright 2017 by ASGE). Upon concurrent review of the article with the IP, the article indicated, "...in the interest of utmost caution, the Society of Gastroenterology Nurses and Associates currently espouses a maximal storage interval without processing of 7 days...and AORN recommends that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient." The IP confirmed the facility followed the recommendations of ASGE, however the facility did not have a current Risk Assessment for endoscope shelf life/hang time, and the facility did not currently follow endoscope storage time consistent with AORN recommendations.



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3. During an observation on 2/27/24 at 1:28 PM, in the Decontamination Room ( Decon Area - area where reusable equipment, instruments and supplies are cleaned and decontaminated by means of manual or mechanical cleaning processes and chemical disinfection), located in the Outpatient Radiology Department (area in the hospital where imaging technology is used to help in the diagnosis a medical condition) with the Imaging Supervisor (IS) and Quality Assurance Coordinator (QAC) 2, Ultrasound Sonographer (US) 1 was performing the pre-cleaning process of the TVP for use for Patient 15. After donning gloves, US 1 held the TVP in one hand and with the other hand, pulled out one sheet of disinfectant wipe from a canister, labeled, "Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes (Clorox wipes). Thereafter, US 1 wiped the TVP with the Clorox wipe starting from the bottom part that connects to the ultrasound monitor, moving toward the cord and up to the tip of the probe with a single stroke, then disposed the Clorox wipe in the trash bin. US 1 did not monitor the amount of time the TVP stayed wet while wiping it with the Clorox wipe.

During a concurrent interview on 2/27/24 at 1:28 PM, US 1 stated the wipes are used to pre-clean (manual cleaning) the TVP. The Clorox wipes canister indicated "1 (one) minute contact time (refers to how long a disinfectant needs to stay wet on a surface to be effective). Rest the probe on the counter (countertop) over a paper towel for one minute to let the probe dry."

During an interview on 2/28/24 at 2:04 PM. with IP 1, in the presence of QAC 4, IP 1 stated the dwelling time (also known as contact time) for the disinfectant wipes to be effective "have to be on surface for minimum of one minute before drying. My expectation is when they (staff) wipe it (TVP) is to wipe and keep it wet for one minute. When they wipe, we ask them to do unidirectional (moving or operating in a single direction)." IP 1 also stated if the TVP starts to dry before the one-minute contact time is completed, staff is expected to use another (disinfectant) wipe to wipe again until one minute wetness is reached. IP 1 added, "Every disinfectant requires a certain time to dissolve, to clear the wall of microbes. We always pick the longest time, to be effective, it (contact time) has to be at least one minute ... to capture bacteria and viruses that require one minute of neutralization of the cell wall or cell membrane."

Review of the document, titled, "Clorox Healthcare Hydrogen Peroxide Disinfectant Wipes," provided by the facility on 2/28/24, indicated, "1 (one) minute contact time ... DIRECTIONS FOR USE: ...This product may be used to preclean or decontaminate ... semi-critical (any device that comes in contact with a mucus membrane) medical devices prior to sterilization or high-level disinfection (HLD - a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores ) ... Disinfection:... TO CLEAN, DISINFECT AND DEODORIZE HARD, NONPOROUS SURFACES: Wipe surface until completely wet. Allow this product to remain wet for contact time listed on label. Let air dry. For heavily soiled areas, a precleaning is required ..."

Review of the TVP's MIFU, titled "(Manufacturer) Ultrasound Probes and Accessories Processing," dated 2023, indicated " Probe Processing - To prevent transmission of disease, adequate cleaning and disinfection are necessary before first use, between patient use, and every time the probe is stored or transported in a nonclean container like shipping case. All probes must be thoroughly cleaned prior to disinfection. The required level of disinfection is based on the type of tissue the probe will contact during use. These recommendations suit the Spaulding classification (a strategy for sterilization or disinfection of inanimate objects and surfaces based on degree of risk involved in their use) for intended use, and federal guidelines ... for proper processing of reusable medical instruments ... Table 2-1 of Care Methods by type of tissue ... Type of tissue ... Mucosal or Non-intact skin ... Cleaning followed by High-Level Disinfection (a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) ... Probe Manual Cleaning - Thorough cleaning is a mandatory first step to allow adequate subsequent disinfection or sterilization. Choose the most convenient method, either the wipe or enzymatic soak ... Cleaning with Wipes ...1. Hold the probe by the handle near the cable strain relief. DO NOT suspend or hold the probe by the cable as this may damage the probe. 2. Dispense a cleaning wipe from the wipe canister. 3. Gently wipe the probe with a cleaning wipe from the cable strain relief to the acoustic lens (i.e. from cleanest to dirtiest area). Gently wipe the probe's acoustic lens. NOTE - Pay special attention to acoustic lens, edges, and crevices, removing all gel, product, and body fluids. 4. Turn the probe and continue wiping until the entire surface of the probe has been wiped. As the wipe becomes visibly soiled, discard the wipe into clinical trash and dispense fresh wipes as needed. As needed for additional focused cleaning to crevices, wrap a clean wipe around a soft nylon bristle brush or other suitable instrument to access crevices, such as biopsy notches. 5. Visually inspect the probe for any remaining soil and, if necessary, repeat steps 3 and 4 until the probe is visibly clean ..."

Review of the facility's policy and procedure (P&P) titled, "Infection Control Strategies for Handling Disinfection and Maintenance of Flexible Scopes, Rigid Endoscopes, Probes, Instruments," dated 6/22/23, indicated, "Purpose: To provide standardized guidelines regarding the handling, maintenance, disinfection and/or storage of ...endocavity probes (probes inserted into the human body), and instruments/equipment that require high level disinfection or sterilization ... Pre-cleaning processes are utilized by qualified staff, as directed in Standard Work (a document with step-by-step instructions) to facilitate gross removal of blood and tissue. These initial steps in the HLD/sterilization process aid in reducing the bioburden (the number of contaminated organisms found in a given amount of material before undergoing a sterilizing procedure) on equipment. By preventing dried or baked materials on an instrument or device, terminal disinfection or sterilization is more effective and instrument integrity is preserved ... Endocavity probes are heat sensitive, reusable semi-critical devices that require HLD..."

4. During a concurrent observation and interview on 2/27/24, at 1:26 PM, with the Ultrasound Sonographer (US) 1 and with the IS and QAC 2, the TVP located inside the room with a signage "Ultrasound Room 2" in the Outpatient Radiology Department on the 2nd floor, was observed. The TVP was resting on the probe holder and was covered by a red biohazard plastic bag (used to dispose of biohazardous waste material that is potentially infectious or could be a threat to people's health). US 1 stated, the TVP was just used for Patient 15 and it was ready for low level disinfection (LLD - a process that kills bacteria and some viruses on items that only come in contact with intact skin). US 1 took the TVP with her hand and without placing the TVP on a puncture-resistant container, transported the TVP to the Decon area to perform LLD. US 1 stated the staff use red bags to transport TVP to the Decon Area for LLD.

Record review of the facility's undated "Standard Work: High-Level Disinfection using the Trophon 2," indicated "Task Description ...Transportation of Probes Task Description ...4. If transporting probe to another room, place probe into approved transport container that has a BIOHAZARD sign and carry to designated area for processing ..."

During an interview with IP 1 on 2/29/24, at 11:35 AM, in the presence of QAC 4, IP 1 confirmed ultrasound TVP transport should protect probes from damage during transport.

Review of the TVP's MIFU, titled "(Manufacturer) Ultrasound Probes and Accessories Processing," dated 2023, indicated "Probe Transportation-Transport and store the ultrasound probes covered as needed and secured. When transporting a clean or dirty ultrasound probe, ensure the probe is protected from cross contamination and possible damage. This can include the use of covers per the appropriate disinfection/contamination level, and the use of rigid containers or the probe holder on the ultrasound unit to secure. NOTE: Do not use cloth or plastic bags to transport probes. This could result in damage to the probes ..."


31794

5. During a concurrent observation and interview on 2/26/24, at 11:48 AM, with the Chief Technician (CT 1), a Trophon2 machine in the Decon Area, located on the 2nd floor, in the Outpatient Radiology Department was observed. The Trophon2 machine was sitting on top of the counter table near the sink with an orange color sticker which read: "PM (Preventative Maintenance) due Jan (January) 2024". Next to it was a green color sticker with a bar code and a number "5329730," and a handwritten sticker was posted on the Trophon2 machine which read: "WO (Work Order) # (number) CWKD0503213, 1/5/24, for PM due for 2 (two) machines, 1 of 2 out 1/29/24." The CT 1 stated, the Trophon2 machine was a "loaner" from the vendor, the PM was due on "1/5/24", and a work order was made waiting for the other Trophon from the vendor.

During a review of facility document titled, "Work Order for Ultrasound Trophon PM", undated, handed by the facility staff, the Work Order for Ultrasound Trophon PM indicated, "Work order CWKD0503213 has been submitted with the following details. Number: CWKD0503213, Work Order Type: Field Service Request ... Department: Ultrasound. Reason for Service: ... Issue: PM due."

During an interview on 2/26/24, at 2:55 PM, with the Ultrasound Sonographer (US 1), US 1 stated, the facility received the Trophon2 machine "last year" and acknowledged the PM for the Trophon2 machine was due on 1/5/24. The US 1 stated, the Trophon2 machine was a "loaner", the other Trophon machine was with the vendor, it would take a few months before they could take it back, and the facility was waiting to exchange it with the Trophon2 that has a PM due on 1/5/24.

During a review of facility document titled, "Trophon2 High Level Disinfection (HLD, a cleaning process which achieves elimination of all microorganisms in or on a medical device, except for small numbers of bacterial spores) Log A, Department: Ultrasound, Location xxx (name of the facility", the Trophon2 High Level Disinfection Log A, indicated the date the cartridge replacement was loaded, the lot batch number, and the expiration date. For the month of January 2024, random check of the log showed the Trophon2 machine was used for HLD of the Transvaginal probe (TVP, wand-like instrument connected to a computer that is inserted into the vagina to produce images of the organs in the pelvic region) used by the patients on the following dates: on 1/16/24 for three patients, on 1/17/24 for three patients, on 1/19/24 for eight patients, on 1/24/24 for five patients, on 1/25/24 for five patients, and on 1/30/24 for four patients. For the month of February 2024, a random checked of the log showed the Trophon2 machine was used for HLD of the TVP used by the patients on the following dates: on 2/1/24 for five patients, on 2/2/24 for seven patients, on 2/6/24 for four patients, on 2/15/24 for seven patients, on 2/21/24 for five patients, on 2/23/24 for six patients, and on 2/26/24 for two patients.

During a follow up interview on 2/26/24, at 3:01 PM, with the CT 1, CT 1 stated, the PM for Trophon2 machine was important to make sure the machine was "working properly."

During a review of facility e-mail, dated 2/27/24, at 11:08 AM, handed by the facility staff, indicated "Subject: CWDK0503213, ... Department: Ultrasound. ... Opened: 2024-01-05 09:02:56 ... Control number: 5329730 ... Modality: Sterilizer, ... Work order: CWDK05503213, ... Short description: 2.26 xxx (name of the facility staff) called back to get the status of this request, as no one has reached out them and the Original call was made on 1/5/24, Escalating to high priority. ... ."

During an interview on 2/27/24, at 12:46 PM, with the Imaging Supervisor (IS 1), and with the Quality Assurance Coordinator (QAC 2), IS 1 stated, the Trophon2 was received by the facility a "year ago", it was picked up "today" and given to the vendor. The Trophon2 machine was a "loaner", it was a "smart technology", the moment it's turned on it would run a test, "does an internal test" and another test for the chemical indicator. The IS stated, the PM was more for "formality" having a routine that all equipment were accounted for. When asked, how safe to use the Trophon2 machine if it had passed the due date for PM, the IS 1, stated, she did not have an "appropriate answer", did not know what the PM of the Trophon2 machine consists of.

In an interview on 2/28/24, at 12:40 PM, with the with the Director of Diagnostic Imaging Services (DDIS), DDIS stated, the PM for the Trophon2 machine was the responsibility of the Bio-med Department, an alternate PM on the Trophon2 was conducted and the Trophon had shipped out. The DDIS stated, the PM ideally would have been done and the PM work should be done so the equipment "does not break down." The Trophon2 has a warm-up cycle, making sure the machine was ready and it was working. In the end the testing was either pass or fail and if it failed, the facility would not proceed with the re-processing (process carried out on a used device in order to allow its safe reuse).











28225

Based on observation, interview and record review, the facility failed to:

1. Document endoscope (instrument introduced into the body to view its internal parts) "hang time" (storage in between uses) in facility policy. The failure had the potential to extend storage of endoscopes past the optimal recommended storage time, and could subject the instruments to possible contamination and increased risk of infection for endoscopy patients.


2. Conduct an annual Risk Assessment to determine safe "hang time" for endoscopes. The failure had the potential to extend storage of endoscopes past the optimal recommended storage time, and could subject the instruments to possible contamination and increased risk of infection for endoscopy patients. The failure had the potential to extend storage of endoscopes past the optimal recommended storage time, and could subject the instruments to possible contamination and increased risk of infection for endoscopy patients.

3. Follow the manufacturer's instructions for use (MIFU, provides detailed instructions on how equipment should be used, maintained, and stored properly) of low-level disinfectant (a process that kills bacteria and some viruses on items that only come in contact with intact skin) during manual cleaning (removal of visible soil, example, organic and inorganic material, from reusable medical devices) for the Transvaginal Probe (TVP, wand-like instrument connected to a computer that is inserted into the vagina to produce images of the organs in the pelvic region). This failure had the potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another).

4. Follow the MIFU to use rigid containers or the probe holder on the ultrasound unit during transport of TVP to and from Ultrasound Room 2. The deficient practice had potential result for damage to the probes.

5. Do required Annual Preventive Maintenance (PM, also called Time-based maintenance is done at scheduled time intervals to minimize equipment degradation and reduce loss of performance) for the Trophon 2 machine (a closed, automated high-level disinfection [HLD, a cleaning process which achieves elimination of all microorganisms in or on medical device, except for small number of bacterial spores] device). The failure had potential result for Trophon 2 machine not cleaning and disinfecting effectively.