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) 2, 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 for 33 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-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 33 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 to (Healthcare System's Name), ([Facilities Group Name] affiliated with (three) separately certified acute care hospitals in (Name) area], Hospital 2, were specified on the contract agreement. This failure resulted in the potential exposure to approximately 33 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 the systemic failures resulted in the facility's inability to provide quality healthcare in a safe environment.

The facility failed to ensure the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs §482.42 was met when:

1. Rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) were not cleaned and disinfected according to the manufacturer's instructions for use (IFU) and facility policy. (Refer to A-0749 Finding 1)

2. Staff failed to follow the facility's Standard Work (a document with step-by-step instructions) and manufacturer's instructions for use (IFU) when cleaning and disinfecting a rectal ultrasound probe (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure), after a procedure. (Refer to A-0749 Finding 2)

3. One rusty cylinder tank of "compressed air (air that is pressurised to greater than atmospheric pressure)" was observed in the Operating Room. (Refer to A-0750)

4. Facility leadership failed to oversee the process of cleaning and disinfecting rectal ultrasound probes and failed to identify the process for cleaning and disinfection of rectal ultrasound probes did not adhere to nationally recognized guidelines. (Refer to A-0772)

5. The facility's Infection Control Plan was not specific to the population served and the services provided at the hospital. (Refer to A-0786)

The cumulative effects of these failures resulted in the facility's inability to meet the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs.

Based on observation, interview and record review, the facility failed to ensure Condition of Participation: Surgical Services §482.51 was met when:

1. Rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) were cleaned and disinfected according to the manufacturer's instructions for use (IFU) and facility policy. As a result of this failure, thirty-three 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). (Refer A=0951 Finding #1)

2. Staff did not follow the facility's Standard Work (a document with step-by-step instructions) and manufacturer's instructions for use (IFU) when cleaning and disinfecting a rectal ultrasound probe (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure), after a procedure. This failure resulted in the potential that the probe was not adequately disinfected. (Refer A=0951 Finding #2)

3. One rusty cylinder tank of compressed air (air that is pressurized to greater than atmospheric pressure) was in Operating Room 5. This deficient practice had the potential for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen. (Refer A=0951 Finding #3)

4. Sterile surgical instruments (tools used to perform surgery) were stored to prevent contamination when rigid instrument cases were stored on top of soft wrapped instrument packs. This failure resulted in the potential for contaminated surgical instruments. (Refer A=0951 Finding #4)

5. Total of six (6) expired plastic containers of sterile water humidifier with expiration date of "2/8/23" were stored in the bottom of the three-tiered rack inside the Clean Room of the Post Anesthesia Care Unit (PACU, is a critical care unit and specialty that focuses on the recovery and treatment of patients immediately following surgical procedures and anesthesia). This failure resulted in the potential cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen. (Refer A=0951 Finding #5)

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

Based an observation, interview and record review, the Governing Body for (Healthcare System's Name), for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 2 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 for 33 patients 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 (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 observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the Operating Room (OR, sterile location where surgical procedures were performed) 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.

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 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 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. 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. 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. 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. 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. 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. 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 a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

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, the Governing Body for (Healthcare System's Name), for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 2 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 33 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 (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 observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the Operating Room (OR, sterile location where surgical procedures were performed) 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 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) ..."

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 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 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. 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. 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 a review of the manufacturer's IFU for the disinfecting wipes the facility used on the rectal ultrasound probe, the IFU indicated, "This product is not to be used as a terminal sterilant/HLD on any surface or instrument that is introduced directly into the human body ... or contacts intact mucus membranes ... this product may be used to preclean medical devices prior to HLD."

During an interview on 2/14/24 at 10:10 a.m. 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. 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 (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. 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. with the Infection Prevention Registered Nurse (IP 1), 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. 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 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), 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 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 a 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, the P&P indicated, "The Spaulding Classification is used to define the minimum level of disinfection or sterilization required ... This classification system is based on the type of instrument used as well as the type of tissue exposed ... Semi-critical items= HLD required: devices contact mucous membranes or non-intact skin ... Endo cavity probes [a probe inserted into the human body] are heat sensitive, reusable Semi-critical devices that require HLD."

During a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

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, the Governing Body for (Healthcare System's Name), for [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 2 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 33 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 (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 observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the Operating Room (OR, sterile location where surgical procedures were performed) 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. 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. 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).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m. in 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), 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. 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. 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."

During an interview on 2/14/24 at 2:42 p.m. 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. 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 a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

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, the facility failed to ensure Hospital 2 leaders 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), Operating Room (OR, sterile location where surgical procedures were performed), and Contract Services for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 2 when:

1. Rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) were cleaned and disinfected according to the manufacturer's instructions for use (IFU) and facility policy. As a result of this failure, thirty-three 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).

2. Staff did not follow the facility's Standard Work (a document with step-by-step instructions) and manufacturer's instructions for use (IFU) when cleaning and disinfecting a rectal ultrasound probe (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure), after a procedure. This failure resulted in the potential that the probe was not adequately disinfected.

3. One rusty cylinder tank of compressed air (air that is pressurized to greater than atmospheric pressure) was in Operating Room 5. This deficient practice had the potential for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.

4. Sterile surgical instruments (tools used to perform surgery) were stored to prevent contamination when rigid instrument cases were stored on top of soft wrapped instrument packs. This failure resulted in the potential for contaminated surgical instruments.

5. Total of six (6) expired plastic containers of sterile water humidifier with expiration date of "2/8/23" were stored in the bottom of the three-tiered rack inside the Clean Room of the Post Anesthesia Care Unit (PACU, is a critical care unit and specialty that focuses on the recovery and treatment of patients immediately following surgical procedures and anesthesia). This failure resulted in the potential cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.

The deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.

Findings:

1. 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 (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 observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the Operating Room (OR, sterile location where surgical procedures were performed) 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.

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 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 an interview on 2/14/24 at 10:10 a.m. 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. with the Infection Prevention Registered Nurse (IP 1), 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. 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 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), 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. 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 review of the facility's "Infection Prevention and Control Plan," dated 3/16/23, the "Infection Prevention and Control Plan" indicated, a Risk Assessment was completed, and the facility identified one category of risk as "Infections Due to Disinfection or Sterilization Failures." The facility did not identify patients undergoing procedures using the rectal ultrasound probe as a population at risk and did not identify HLD of the probes as an indicator.

During a 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, the P&P indicated, "The Spaulding Classification is used to define the minimum level of disinfection or sterilization required ... This classification system is based on the type of instrument used as well as the type of tissue exposed ... Semi-critical items= HLD required: devices contact mucous membranes or non-intact skin ... Endo cavity probes [a probe inserted into the human body] are heat sensitive, reusable Semi-critical devices that require HLD."

During a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

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, "Page 4 ... This document is a comprehensive evaluation, risk assessment. and prevention and control plan ... this process is completed annually. The risk assessment is completed at least annually and whenever significant changes occur ...The purpose of Infection Prevention and Control Department is to minimize the morbidity, mortality, and economic burden associated with healthcare associated infections (HAIs) through prevention and control endeavors in both patient and staff populations ... the most current CDC (Centers for Disease Control and Prevention, the nation's leading science-based, data-driven, service organization that protects the public's health.) NHSN (National Healthcare Safety Network-healthcare associated tracking system) and surveillance definitions and comparative database are utilized to evaluate patient outcomes ... Infection Prevention and Control is a facility wide patient safety component involving all departments. The Infection Preventionist, along with the Infection Prevention and Control Committee. Determines the specific focus of surveillance, education, and consultation effort on an ongoing basis ... 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 ... Facilities Group Name affiliated with (three) separately certified hospitals], provides tertiary (high level of specialized care) care services for ... California ... Page 7 ... 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..."

2. During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. 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).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m. 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 1:10 p.m. with the Surgical Services Manager (MSS 3), MSS 3 confirmed ST 1 should have wiped the rectal ultrasound probe with disinfecting wipes from the cord to the tip of the probe (clean to dirty direction). MSS 3 stated equipment should be wiped from clean to dirty to prevent cross contamination (spreading germs from dirty areas to clean areas). MSS 3 was unable to verbalize the IFU for the disinfecting wipes and stated, "We let it dry for three minutes to make sure it's dried." MSS was unaware the probe should have been dried with a cloth according to the Standard Work.

During an interview on 2/14/24 at 2:42 p.m. 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.

During a concurrent interview and record review on 2/15/24 at 1:33 p.m. with the Sterile Processing Department Manager (SPDM), the manufacturer IFU for the rectal ultrasound probe was reviewed. SPDM confirmed, SPT 4 did not follow the IFU for leak testing the probe and should have waited 45 seconds to ensure the leak test was completed.

During a review of the facility's procedure for cleaning and disinfecting rectal ultrasound probes titled, "Standard Work- [manufacturer] Probes 'model 888oe and 88848' High Level Disinfection (HLD)," dated 1/31/24, the Standard Work indicated, "Pre-cleaning occurs at the point of use ... clean probe using a manufacturer approved disinfectant wipe ... thoroughly dry the probe with a soft cloth." The Standard Work further indicated a leak test was required for rectal ultrasound probes with each cleaning process, "Perform leak test per manufacturers recommendation."

During a review of the manufacturer's instructions for use (IFU) for the disinfecting wipes used on the rectal ultrasound probe, the IFU indicated, "Ultrasound Transducers and Probes ... use germicidal cloth to thoroughly wet the surface. Allow surface to remain wet three minutes ..."

During a review of the manufacturer's IFU for the rec

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

1. Rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) were cleaned and disinfected according to the manufacturer's instructions for use (IFU) and facility policy. As a result of this failure, thirty-three 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).

2. Staff followed the facility's Standard Work (a document with step-by-step instructions) and manufacturer's instructions for use (IFU) when cleaning and disinfecting a rectal ultrasound probe (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure), after a procedure. This failure resulted in the potential that the probe was not adequately disinfected.

Findings:

1. During an interview on 2/15/24 at 9:30 a.m. 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 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), 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 2/14/24 at 1:10 p.m. 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 (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. 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."

During an interview on 2/14/24 at 2:42 p.m. with the Infection Prevention Registered Nurse (IP 1), 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 a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

During a review of the manufacturer's IFU for the rectal ultrasound probe, titled "[Manufacturer] Care and Cleaning", dated 2022, the IFU indicated, "The CDC classifies medical devices according to their use. For each classification, they specify the level of disinfection/sterilization processing that is required before use ... Classification: Semi-Critical- device that contacts mucus membranes. Required Processing: Immediate cleaning and high-level disinfection or sterilization."

During a review of the manufacturer's IFU for the disinfecting wipes the facility used on the rectal ultrasound probe, the IFU indicated, "This product is not to be used as a terminal sterilant/HLD on any surface or instrument that is introduced directly into the human body ... or contacts intact mucus membranes ... this product may be used to preclean medical devices prior to HLD."

During a 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, the P&P indicated, "The Spaulding Classification is used to define the minimum level of disinfection or sterilization required ... This classification system is based on the type of instrument used as well as the type of tissue exposed ... Semi-critical items= HLD required: devices contact mucous membranes or non-intact skin ... Endo cavity probes [a probe inserted into the human body] are heat sensitive, reusable Semi-critical devices that require HLD."

2. During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. 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).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m. 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 1:10 p.m. with the Surgical Services Manager (MSS 3), MSS 3 confirmed ST 1 should have wiped the rectal ultrasound probe with disinfecting wipes from the cord to the tip of the probe (clean to dirty direction). MSS 3 stated equipment should be wiped from clean to dirty to prevent cross contamination (spreading germs from dirty areas to clean areas). MSS 3 was unable to verbalize the IFU for the disinfecting wipes and stated, "We let it dry for three minutes to make sure it's dried." MSS was unaware the probe should have been dried with a cloth according to the Standard Work.

During an interview on 2/14/24 at 2:42 p.m. 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.

During a concurrent interview and record review on 2/15/24 at 1:33 p.m. with the Sterile Processing Department Manager (SPDM), the manufacturer IFU for the rectal ultrasound probe was reviewed. SPDM confirmed, SPT 4 did not follow the IFU for leak testing the probe and should have waited 45 seconds to ensure the leak test was completed.

During a review of the facility's procedure for cleaning and disinfecting rectal ultrasound probes titled, "Standard Work- [manufacturer] Probes 'model 888oe and 88848' High Level Disinfection (HLD)," dated 1/31/24, the Standard Work indicated, "Pre-cleaning occurs at the point of use ... clean probe using a manufacturer approved disinfectant wipe ... thoroughly dry the probe with a soft cloth." The Standard Work further indicated a leak test was required for rectal ultrasound probes with each cleaning process, "Perform leak test per manufacturers recommendation."

During a review of the manufacturer's instructions for use (IFU) for the disinfecting wipes used on the rectal ultrasound probe, the IFU indicated, "Ultrasound Transducers and Probes ... use germicidal cloth to thoroughly wet the surface. Allow surface to remain wet three minutes ..."

During a review of the manufacturer's IFU for the rectal ultrasound probe, titled, "[manufacturer] Care and Cleaning," issued 2022, the IFU indicated, "Leak Testing Procedure ... pump to increase the pressure to 150 mm ... once 150 is reached, observe the pressure for 45 seconds ... if the pressure is stable, place in the water tank ..."

Based on observation, interview, and record review the facility failed to ensure sanitary and clean environment when one rusty cylinder tank of compressed air (air that is pressurised to greater than atmospheric pressure) was observed in the Operating Room. This deficient practice had the potential for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.


Findings:


During an observation of the Operating Room (OR, a sterile location where surgical procedures are performed), located on Level- A, North Tower building and interview on 2/13/24, at 11:48 AM, with the Manager Surgical Services (MSS 3) and with the Quality Assurance Coordinator (QAC 3), Room 5 (five) of the OR was observed. There were three-cylinder tanks attached to the anesthesia cart machine. The first was an "oxygen tank (metal cylinders that store oxygen under pressure)", the middle was a "compressed air (air that is pressurised to greater than atmospheric pressure)" tank, and the third was "nitrous oxide" (colorless, odorless anesthetic adjuvant) tank. The compressed air tank, which was the middle tank, had a light to dark brown discoloration around the tank. The MSS 3 wiped the tank with a dry paper towel and a light to dark discoloration around the tank came off which left a mark on the dry the paper towel. MSS 3 stated, it was "not dirt", it was "rust" and it (compressed air tank) was not supposed to be in the OR.

During an interview on 2/14/24, at 3:01 PM, with the Infection Preventionist (IP 1), the photo of the compressed air tank with light to dark brown discoloration around the tank observed in the OR was shown to him. The IP 1 stated, it should not be in the OR and staff should do hand hygiene (means cleaning the hands by using either handwashing [washing hands with soap and water], antiseptic hand wash, antiseptic hand rub [i.e. alcohol-based hand sanitizer including foam or gel]).

Review of the facility's Policy and Procedure titled, "Purchasing, Storing and Usage of Medical Gas Cylinders", with the last revised date of 4/21/22 indicated, "xxx (name of the facility) shall provide a safe, systemic methods of ... storing, ... using medical compressed gas cylinders. ... PRECAUTIONS/COMPLICATIONS: ... B. Aged poorly maintained rusted or modified cylinders should not be used ... ."

Based on interview and record review, the facility failed to oversee the process of cleaning and disinfecting rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) and failed to identify the facility's process for cleaning and disinfection of rectal ultrasound probes did not adhere to nationally recognized guidelines. As a result of this failure, thirty-three 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:


During an interview on 2/14/24 at 10:10 a.m. 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. with the Surgical Services Manager (MSS 3), MSS 3 stated she was contacted by the Infection Prevention Department regarding the use of rectal ultrasound probes in the Surgical Services Department and responded that the facility performed surgical procedures using the rectal ultrasound probe in the OR. MSS 3 stated the facility contracted with a vendor who brought the rectal ultrasound probe to the 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 3 stated, after the procedure, OR staff removed the plastic sheath, cleaned the probe with a disinfecting wipe, and gave the probe to back to the vendor. MSS 3 confirmed, according to Spaulding Classification, rectal ultrasound probes come in contact with mucus membranes 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. with the Infection Prevention Registered Nurse (IP 1), IP 1 stated he oversaw infection control practices in the ORs and Sterile Processing Departments for three hospitals. He stated his responsibilities included surveillance of instrument processing including HLD procedures. IP 1 stated, "It is my understanding the hospital followed the manufacturer instructions for use (IFU) [for the rectal ultrasound probe]." IP 1 confirmed rectal ultrasound probes come in contact with mucus membranes and should be, at minimum, HLD according to the facility's policy and nationally recognized standards of practice.

During an interview on 2/15/24 at 12 p.m. 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 review of the facility's "Infection Prevention and Control Plan," dated 3/16/23, the "Infection Prevention and Control Plan" indicated, a Risk Assessment was completed, and the facility identified one category of risk as "Infections Due to Disinfection or Sterilization Failures." The facility did not identify patients undergoing procedures using the rectal ultrasound probe as a population at risk and did not identify HLD of the probes as an indicator.

During a 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, the P&P indicated, "The Spaulding Classification is used to define the minimum level of disinfection or sterilization required ... This classification system is based on the type of instrument used as well as the type of tissue exposed ... Semi-critical items= HLD required: devices contact mucous membranes or non-intact skin ... Endo cavity probes [a probe inserted into the human body] are heat sensitive, reusable Semi-critical devices that require HLD."

*The facility's P&P referenced the Centers for Disease Control's (CDC- national public health agency that develops scientific based guidelines to prevent infectious disease) definitions of Semi-critical items and High-Level Disinfection. (www.cdc.gov/hicpac/pdf/guidelines/disinfection_Nov_2008.pdf).

During a review of the manufacturer's IFU for the rectal ultrasound probe, titled, "[manufacturer] Care and Cleaning," issued 2022, the IFU indicated, "The CDC classifies medical devices according to their use. For each classification, they specify the level of disinfection/sterilization processing that is required before use ... Classification: Semi-Critical- device that contacts mucus membranes. Required Processing: Immediate cleaning and high-level disinfection or sterilization."

During a review of the facility's job description titled, "Infection Preventionist, Acute," the job description indicated the Infection Preventionist responsibilities included, "Coordinates hospital-wide infection control program including performance improvement to identify and prevent healthcare associated infections ...Makes rounds for the purpose of case finding, environmental sanitation monitoring, and supervision of infection control practices to support compliance with recommended practices ..."

During a review of the facility's "Infection Prevention and Control Plan," dated 3/16/23, the "Infection Prevention and Control Plan" indicated, "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, the facility failed to ensure surgical services 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), Operating Room (OR sterile location where surgical procedures were performed), and Contract Services when:


1. Rectal ultrasound probes (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure) were cleaned and disinfected according to the manufacturer's instructions for use (IFU) and facility policy. As a result of this failure, thirty-three 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).

2. Staff did not follow the facility's Standard Work (a document with step-by-step instructions) and manufacturer's instructions for use (IFU) when cleaning and disinfecting a rectal ultrasound probe (probe inserted into the rectum which uses sound waves to produce images during a surgical procedure), after a procedure. This failure resulted in the potential that the probe was not adequately disinfected.

3. One rusty cylinder tank of compressed air (air that is pressurized to greater than atmospheric pressure) was in Operating Room 5. This deficient practice had the potential for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.

4. Sterile surgical instruments (tools used to perform surgery) were stored to prevent contamination when rigid instrument cases were stored on top of soft wrapped instrument packs. This failure resulted in the potential for contaminated surgical instruments.

5. Total of six (6) expired plastic containers of sterile water humidifier with expiration date of "2/8/23" were stored in the bottom of the three-tiered rack inside the Clean Room of the Post Anesthesia Care Unit (PACU, is a critical care unit and specialty that focuses on the recovery and treatment of patients immediately following surgical procedures and anesthesia). This failure resulted in the potential cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.

The deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.


Findings:

4. During a concurrent observation and interview on 2/13/24 at 11:50 a.m., with the Sterile Processing Department Manager (SPDM), the sterile instrument storage area was observed. On the bottom rack of a three-tiered rack labeled "plastics", there were two rigid instrument cases observed stored directly on top of a sterile soft wrapped instrument pack. SPDM stated rigid instrument cases should not be stacked on top of soft wrapped instrument packs because the rigid cases could puncture the soft packs and contaminate the instruments. SPDM stated the soft pack needed to be re-sterilized (made completely free of contamination from bacteria, virus, or spores).

During a review of the facility's policy and procedure (P&P), dated 6/29/21, the P&P indicated, "Sterile items will be stored under the following conditions ... wrapped packages above (not below) rigid container systems when they are stored on the same shelf ... positioned so that items are not crushed or punctured this jeopardizing their sterility."


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5. During a concurrent observation and interview on 2/13/24, at 12:20 PM, with the Manager Surgical Services (MSS 3), the Clean Utility Room of the Post Anesthesia Care Unit (PACU), located on Level-A, North Tower, was observed. Inside the Clean Utility Room of the PACU, the bottom rack of a three tier shelf-cart had six (6) plastic containers of sterile water inhalation with the expiration date of "2023-02-08". The MSS 3 stated, they were sterile water used as humidifier (to add moisture to the dry oxygen from an oxygen source). The MSS 3 acknowledged, they were expired, "we don't use" expired items, it was "missed", and expired items had the potential for "adverse reaction," like infection.

Review of the facility's P&P titled, "Stock Rotation and Outdates", with the effective date of 1/19/23 indicated, "Objective: To ensure utilization of single use disposable medical supplies before expiration dates ... Procedure - Outdating: 1. Materials Management staff will review all items in regular stock ... and remove those expiring within 30 days, replacing those items with newer stock. ... Expiration outdating of supplies ... will be the responsibility of the individual units ... "



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Findings:

1. 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 (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 observation and interview on 2/6/24 at 8:49 AM, at H 1, with VR, in the Operating Room (OR, sterile location where surgical procedures were performed) 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.

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 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 an interview on 2/14/24 at 10:10 a.m. 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. with the Infection Prevention Registered Nurse (IP 1), 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. 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 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), 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. 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 review of the facility's "Infection Prevention and Control Plan," dated 3/16/23, the "Infection Prevention and Control Plan" indicated, a Risk Assessment was completed, and the facility identified one category of risk as "Infections Due to Disinfection or Sterilization Failures." The facility did not identify patients undergoing procedures using the rectal ultrasound probe as a population at risk and did not identify HLD of the probes as an indicator.

During a 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, the P&P indicated, "The Spaulding Classification is used to define the minimum level of disinfection or sterilization required ... This classification system is based on the type of instrument used as well as the type of tissue exposed ... Semi-critical items= HLD required: devices contact mucous membranes or non-intact skin ... Endo cavity probes [a probe inserted into the human body] are heat sensitive, reusable Semi-critical devices that require HLD."

During a concurrent interview and record review on 2/15/24 at 3:45 p.m. 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 facility sent notification letters to all patients on the list. The list included a total of thirty-three patients.

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, "Page 4 ... This document is a comprehensive evaluation, risk assessment. and prevention and control plan ... this process is completed annually. The risk assessment is completed at least annually and whenever significant changes occur ...The purpose of Infection Prevention and Control Department is to minimize the morbidity, mortality, and economic burden associated with healthcare associated infections (HAIs) through prevention and control endeavors in both patient and staff populations ... the most current CDC (Centers for Disease Control and Prevention, the nation's leading science-based, data-driven, service organization that protects the public's health.) NHSN (National Healthcare Safety Network-healthcare associated tracking system) and surveillance definitions and comparative database are utilized to evaluate patient outcomes ... Infection Prevention and Control is a facility wide patient safety component involving all departments. The Infection Preventionist, along with the Infection Prevention and Control Committee. Determines the specific focus of surveillance, education, and consultation effort on an ongoing basis ... 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 ... Facilities Group Name affiliated with (three) separately certified hospitals], provides tertiary (high level of specialized care) care services for ... California ... Page 7 ... 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..."

2. During a concurrent observation and interview with the Scrub Technician (ST 2) on 2/14/24 at 8:16 a.m. 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).

During a concurrent observation and interview with the Sterile Processing Technician (SPT 4) on 2/14/24 at 8:26 a.m. 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 1:10 p.m. with t

Based on interview and record review, the facility failed to ensure the facility's Infection Control Plan was specific to the population served and the services provided at the hospital. This failure resulted in the potential for facility specific infection control risks to go unaddressed.


Findings:


During an interview on 2/13/24 at 10:08 am, with the Director of Accreditation and Licensing (DAL), DAL stated, stated the facility had 153 beds.

During a review of the list of the facility's services provided by DAL on 2/14/24, the facility's services included: General Medical Surgical Services, Critical Care Services, Emergency Services, Surgery, Radiology (imaging such as x-rays), Nuclear Medicine (specialized area of medicine that uses very small amounts of high-speed energy waves to examine organ function), and Interventional Neuroradiology (advanced medical specialty using three dimensional imaging to insert catheters through the groin area which are threaded into the brain).

During a review of the facility's "Infection Prevention and Control Plan," dated 3/16/23, the "Infection Prevention and Control Plan" indicated, "[group of separately certified hospitals] is a group of bay area acute care facilities with 585 beds ... [group of separately certified hospitals] provides tertiary (high level of specialized care) care services for Northern California."

The Infection Control Plan further indicated: Programs and Services: included Cardiac and Transplant Services, Women and Children's Services, Pediatric Hematology/Oncology (cancer services).

Most Common Admitting Diagnoses: included single live born infant delivery and post-term pregnancy. Most Common Surgical Procedures: included delivery of products of conception (placenta- afterbirth).

Evaluation of the 2022 Infection Control Plan: included data analysis of indicators from 2022 including Surgical Site Infections (SSIs), Hand Hygiene, use of Immediate Use Steam Sterilization (IUSS-process of sterilizing surgical instruments rapidly for emergencies), and Surgical Instrument processing audits.

During a review of the facility's "Infection Control and Epidemiology Committee Meeting" minutes from September 2023 to January 2024, the minutes indicated, the committee included staff members from each of the separately certified hospitals. Data for Surgical Site Infections and IUSS was reported to the committee, however the data was not specific to each hospital.

During a concurrent interview and record review on 2/14/24 at 10:10 a.m. with the Infection Prevention Manager (IPM), the facility's "Infection Prevention and Control Plan" dated 3/16/23 was reviewed. 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 separately certified hospitals which shared a governing body and had a shared Infection Prevention Department. IPM stated the hospital's Infection Control Plan was developed for [hospital system] and all hospitals within [system name] used the same Infection Control Plan. IMP stated the Summary of 2022 Goals and Outcomes portion was not specific to the facility but was a combined summary of the three separately certified hospitals together. IPM stated the SSI, Hand Hygiene, IUSS data reviewed in the plan was a combination of all three separately certified hospitals and did not reflect the outcomes of the facility specifically. IPM confirmed facility specific outcomes were not included in the Infection Control Plan. IPM further stated the risk assessment portion of the Infection Control Plan was not specific to the facility but was based on risks identified from the three separately certified hospitals together. IPM stated, the Infection Control and Epidemiology Committee Meeting reviewed data from all three separately certified hospitals combined and data was not specific to the facility. IPM stated, the facility did not offer Women and Children's Services, Transplant Services, or Pediatric Hematology/Oncology services and confirmed the Infection Control Plan was not specific to the facility's population served or services provided.