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) 1 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 to approximately 141 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 to approximately 141patients 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 1, were specified on the contract agreement. . This failure resulted in the potential exposure to approximately 141patients at risk to be exposed to infectious diseases such as hepatitis (inflammation of the liver caused by infection) and/or human immunodeficiency virus (HIV- a virus that attacks the immune system). (Refer A-085)

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

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs §482.42 was met when:

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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for 141 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). (Refer to A-0749, Finding 1; Refer to A-0772, Finding 1)

2. One staff (Sterile Processing Technician, SPT 2) did not change gloves after manual washing of the rectal probe, before getting Endozime sponge from clean supplies cart. The deficient practices had potential result for increased patients' risks for healthcare associated infections. (HAI, infections people get while they are receiving health care for another condition). (Refer to A-0749 Finding 2; Refer to A-0772 Finding 2)

3. The "standard storage environment" for the Flexible scopes in the storage cabinet was not maintained /monitored as per manufacturer's instructions for us (MFIU).
This deficient practice resulted in the potential damage to the "integrity" of the device and for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen. (Refer to A-0749 Finding 3; Refer to A-0772 Finding 3)

4. One staff (SPT 3) did not perform hand hygiene (clean the hands by using either handwashing [washing hands with soap and water], or use antiseptic hand rub [i.e. alcohol-based hand sanitizer including foam or gel]) before assembling the clean surgical instruments used for a hysterotomy (surgical removal of uterine content).
This failure had potential for cross contamination of microorganisms. (Refer to A-0749 Finding 4; Refer to A-0772 Finding 4)

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

Based on observation, interview and record review, the facility failed to ensure Condition of Participation: Surgical Services §482.51 was met for Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for 141 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). (Refer to A-0951, Finding 1)

2. Sterile Processing Technician (SPT) 2 did not change gloves after manual washing of the rectal probe, before getting Endozime (enzymatic detergent to pre-clean/clean and remove soils from the exterior of endoscopes, medical devices, accessories, and surgical instruments) sponge from clean supplies cart. The deficient practice had potential result for increased patients' risks for healthcare associated infections (HAI, infections people get while they are receiving health care for another condition) (Refer to A-0951, Finding 2)

3. The flexible scopes (movable tube with light and tiny camera on one end) Storage Cabinet Cabinet's temperature and humidity was not maintained/monitored in accordance with the manufacturer's instructions. This deficient practice resulted in the potential damage to the "integrity" of the device.) (Refer to A-0951, Finding 3)
.
4. SPT 3 did not perform proper 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]), before assembling the clean surgical instruments in a hysterotomy tray (tray which contain surgical instruments for removal of uterine content). This failure had potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another). (Refer to A-0951, Finding 4)

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

Based on observation, interview and record review, the governing body for (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 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) when rectal probe was not 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. For (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1, this failure resulted in the potential exposure to approximately 141 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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

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

During an interview on 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 failed to ensure rectal probe provided by (Contractor Name) patients was safe to use when rectal probes were not 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. For (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 this failure resulted in the potential exposure to 141 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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

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

During a review of ( 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 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 failed to ensure Contractor responsibilities and services to be provided with rented rectal probes for use were specified on the contract agreement. For (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 this this failure resulted in the potential exposure to approximately 141 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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

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

During an interview on 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 patient care (governing body) were the same for [(Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] H 1, H 2, and H 3; and all facility policies and procedures for H 1, H 2, and H 3 were (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals] policies and procedures.

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 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) 1 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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for 141 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).

2. Sterile Processing Technician (SPT) 2 did not change gloves after manual washing of the rectal probe, before getting Endozime (enzymatic detergent to pre-clean/clean and remove soils from the exterior of endoscopes, medical devices, accessories, and surgical instruments) sponge from clean supplies cart. The deficient practice had potential result for increased patients' risks for healthcare associated infections (HAI, infections people get while they are receiving health care for another condition)

3. The flexible scopes (movable tube with light and tiny camera on one end) Storage Cabinet Cabinet's temperature and humidity was not maintained/monitored in accordance with the manufacturer's instructions. This deficient practice resulted in the potential damage to the "integrity" of the device.
.
4. SPT 3 did not perform proper 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]), before assembling the clean surgical instruments in a hysterotomy tray (tray which contain surgical instruments for removal of uterine content). This failure had potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another).

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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

Review of the facility, (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], titled, "Policy- Circulating Nurse's Responsibilities", dated 7/21/22, indicated, "The circulating nurse is a licensed Registered Nurse who has special education in perioperative (the period of time extending from when the patient goes into the hospital, clinic, or doctor's office for surgery until the time the patient is discharged home) nursing. He/she plans, coordinates, delivers, and evaluates nursing care to the patient during surgical and invasive procedures. The circulating nurse will circulate in only one operating room at a time ... Plan ... 2. Reviews the surgeon's preference card/list and ensures that all necessary supplies, instruments and equipment are appropriate, available and ready for use ..."

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

During a review of ( 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 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 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 an interview on 2/8/24, at 1:35 PM, with the Infection Preventionist (IP) and with the QAC 1, IP stated, the rectal probe issue was discussed in the Infection Control Committee, they looked at the re- processing of the probe, the rectal probe was considered a semi-critical item (devices contact with mucous membranes or non-intact skin) and needed HLD.

Review of the facility's Infection Control and Epidemiology Committee Meeting dated 12/21/23 indicated, "TOPIC: ... III. Service Line Reports: Discussion /Conclusion/Recommendations: ... Surgery/SPD: ... rectal probe (2 types) new process- grey enzymatic wipes at POU (Point of Use) leak test from vendor, send to SPD, Trophon (high level disinfection system) for last case. ..."

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 6 ... Programs and Services ... General Patient Care Services, Diagnostic Imaging/Interventional Radiology; Surgical Service, Surgery: Endoscopy (a medical procedure where a doctor puts tube-like instrument into the body to look inside), Same Day Surgery ... 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..."2023 Infection Prevention and Control Program Risk Assessment ... Infections due to Disinfection or Sterilization Failures, Populations at Risk, Ultrasound patients, Trophon used for ultrasound, disinfection, Method of Disinfection for USN (ultrasound- rectal) probes, monitor compliance with use ... 2023 Specific Surveillance Plan with Goals, Infections due to Disinfection or Sterilization Failures , Indicator: Safe Equipment, Goal: Scope Cleaning, 100 % (percent); Case Finding: Results of Departmental monitoring of high level infection, Population: Scopes used in patient procedures; Actions to Reduce Risk: follow manufacturers recommendations for high level disinfection; Methods of analysis: SPD % of scopes meeting all data points, Data Entry: sterile processing database ..."

2. During an observation on 2/5/24, at 12:07 PM, with DSS 1 and 2, MSS 1 and 2, SPT 1 and 2, and QAC 1, in the SPD of manual washing of the rectal probe 8848, SPT 2 put on a pair of gloves, took the rectal probe from the container, immersed it in water in the sink and rinsed it. After rinsing the rectal probe, SPT 2 went to the nearby three tier cart of clean supplies and without changing his gloves, took one Endozime sponge and continued the manual cleaning using the sponge and then rinsed it.

During concurrent interviews on 2/5/24, at 12:07 PM, MSS 1 stated, SPT 2 should have changed gloves when taking supplies from the clean cart for infection control. DSS 1 stated, the ultrasound rectal probe was used in the Operating Room for ten years. Before the hospital was notified of the rectal probe disinfection issue, the rectal probe did not pass through the SPD for HLD before it was used for procedures. DSS 1 stated, in the OR, the OR staff would use a "wipe cloth" to wipe the rectal probe, placed it inside a plastic sheath, then handed it to the Vendor Representative.

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,"Populations at Risk, All patients, staff medical staff and volunteers, Compliance to CDC hand hygiene program, Poor hand hygiene increases the risk of HAIs ..."

According to, Centers for Disease Control and Prevention (.gov), https://www.cdc.gov > Glove_removal_job_aid, Removing Gloves Safely, "All employees using disposable gloves must observe the following precautions: Wash hands before putting on gloves, Never wash or reuse disposable gloves, Remove gloves after they become contaminated ..."

Review of the facility's Policy and Procedures (P&P) titled, "Procedure-Instruments, Powered Equipment, and Rigid Endoscopes: Reducing Bio-burden, Care and Cleaning", revised 6/30/21, indicated, "GENERAL GUIDELINE: 1. Prior to use ...loaned and/or transported instruments, powered equipment and devices ... will be cleaned /decontaminated, ... undergo HLD (High Level Disinfection) or sterilization per manufacturer's IFU. ... 6. Any instrument opened on to the sterile field in an operating or procedure room will be cleaned and decontaminated before patient use ... PROCEDURES: ... 2. Preparing items for decontamination: a. The type of decontamination required for a particular item/device depends on ... manufacturer's IFU. B. All instruments opened on to the sterile field require decontamination (process of removing soil and pathogenic microorganisms from objects) ..."

Record review of (Manufacturer Name of the of the Rectal Probe) User Guide, with issue Date of 6/2022, indicated, "Chapter 4. Reprocessing Information and Methods: ... Automated Reprocessing Methods Proper cleaning is essential ... Appendix: Reprocessing Information and Tables. ... Validated Reprocessing Methods for the Flex Transducer series. ... Sterilization: ... Sterrad NX (a compact unit which sterilizes medical devices) ... Transducer

Based on observation, interview, and record review the facility failed to ensure the hospital infection prevention and control program was implemented 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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for 141 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).

2. One staff (Sterile Processing Technician, SPT 2) did not change gloves after manual washing of the rectal probe, before getting Endozime sponge from clean supplies cart. The deficient practices had potential result for increased patients' risks for healthcare associated infections (HAI, infections people get while they are receiving health care for another condition).

3. The "standard storage environment" for the flexible scopes (movable tube with light and tiny camera on one end) in the Storage Cabinet was not maintained/monitored in accordance with the manufacturer's instructions for use (MIFU). This deficient practice resulted in the potential damage to the "integrity" of the device and for cross contamination (transfer of harmful bacteria from one person, object or place to another) to happen.

4. One staff (SPT 3) did not perform proper 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]), before assembling the clean surgical instruments in a hysterotomy tray (tray which contain surgical instruments for removal of uterine content). This failure had potential for cross contamination of microorganisms.


Findings:

1. During a group interview on 2/5/24, at 10:07 AM, 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 "Sutter System" that 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 xxx [Healthcare System's Name]) 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.

Record review of the facility letter sent to the State Agency (SA, is the California Department of Public Health, CDPH), dated 1/8/24 indicated, "Notice of rectal probe disinfection process issue. ... 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."

Record review of the untitled facility provided document, dated 2/5/24, indicated the list of patients who had the procedures done using the rectal probe from 11/2/22 to 11/9/23. The number of patients who were potentially exposed to infectious diseases for Hospital 1 (one) was approximately 141.

During an interview on 2/5/24, at 12:07 PM, with the Director of Surgical Services (DSS 1 and 2), Manager Surgical Services (MSS 1 and 2), the Sterile Processing Technicians (SPT 1 and 2), and the Quality Assurance Coordinator, (QAC 1), DSS 1 stated, the ultrasound rectal probe was used in the Operating Room (OR, sterile location where surgical procedures were performed) for ten years, the OR staff would use a "wipe cloth" to wipe the rectal probe, placed it inside a plastic sheath, then handed it to the Vendor Representative. The DSS 1 stated, prior to the breach incident, the ultrasound rectal probe did not pass through the Sterile Processing Department (SPD, area within the hospital in which medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care) for HLD before use on surgical procedures.

Review of the facility's Policy and Procedures (P&P) titled, "Procedure-Instruments, Powered Equipment, and Rigid Endoscopes: Reducing Bio-burden (the number of bacteria living on a surface that has not been sterilized), Care and Cleaning", revised 6/30/21, indicated, "GENERAL GUIDELINE: 1. Prior to use ...loaned and/or transported instruments, powered equipment and devices ... will be cleaned /decontaminated, ... undergo HLD (High Level Disinfection) or sterilization per manufacturer's IFU. ... 6. Any instrument opened on to the sterile field in an operating or procedure room will be cleaned and decontaminated before patient use ...

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

Review of the facility's P&P titled, "Vendors and Sales Representatives, Special Instruments/Equipment /Supplies Guidelines in the Surgical Services Department", revised 6/16/22 indicated, "Scheduling and Approvals: ... Sterile Processing Departments: ... 5. Pre-procedure sets will arrive at least 24-48 hours ... a. Instruments/implant sets must be inspected, cleaned, and decontaminated, and sterilized by Hospital 1 (one) staff prior to use. ... ."

During an interview on 2/7/24, at 3:15 PM, with the Sterile Processing Technician (SPT 1) and with the QAC 1, SPT 1 stated, has been employed in the facility since 1996. The SPT 1 stated, before the hospital was notified of the rectal probe disinfection issue, the SPD staff did not receive the rectal probe, did not know it existed, and had no contact with the probe until about a "month ago" when the ultrasound rectal probe was sent for HLD in the SPD. The SPT 1 stated, currently the hospital used two types of ultrasound rectal probes: Type/Model "8848" and "8808e" and depending on the type/model of the rectal probes, it would be sent for HLD using the appropriate sterilizer machine as per manufacturer ' s recommendation.

Record review of Manufacturer 1 (one) User Guide, with issue Date of 6/22, indicated, "Chapter 4. Reprocessing Information and Methods: ... Automated Reprocessing Methods Proper cleaning is essential ... Appendix: Reprocessing Information and Tables. ... Validated Reprocessing Methods for the Flex Transducer series. ... Sterilization: ... Sterrad NX (a compact unit which sterilizes medical devices) ...Transducers ... Endocavity (a transducer which comes into contact with the anal cavity, the vagina, or the oral cavity): 8848 ... ."

During an interview on 2/8/24, at 1:35 PM, with the Infection Preventionist (IP) and with the QAC 1, IP stated, the rectal probe issue was discussed in the Infection Control Committee, they looked at the re- processing of the probe, the rectal probe was considered a semi-critical item (devices contact with mucous membranes or non-intact skin) and needed HLD.

Review of the facility's Infection Control and Epidemiology Committee Meeting dated 12/21/23 indicated, "TOPIC: ... III. Service Line Reports: Discussion /Conclusion/Recommendations: ... Surgery/SPD: ... rectal probe (2 types) new process- grey enzymatic wipes at POU (Point of Use) leak test from vendor, send to SPD, Trophon (high level disinfection system) for last case. ..."

2. During a concurrent observation and interviews on 2/5/24, at 12:07 PM, with the DSS 1 and 2, the MSS 1, the SPT 1 and 2, and the QAC 1, the manual washing of the rectal probe, type/ model 8848, was observed in the Decontamination Area (area where reusable equipment, instruments, and supplies are cleaned and decontaminated by means of manual or mechanical cleaning processes and chemical disinfection). The SPT 1 stated, the rectal probe was used on a patient "last week", it would be used on a patient "tomorrow", and manual cleaning would be done today. The SPT 2 put on a pair of gloves, took the rectal probe from the container, immersed it in water in the sink and rinsed it. After rinsing the rectal probe, the SPT 2 went to the nearby three tier cart of clean supplies and without changing his gloves, took one Endozime (enzymatic detergent to pre-clean/clean and remove soils from the exterior of endoscopes, medical devices, accessories, and surgical instruments) sponge and continued the manual cleaning using the sponge and then rinsed it. When asked if he needed to change gloves going from dirty to clean area, the SPT 2 looked at the surveyor and did not speak.

In an interview on 2/5/24, at 12:25 PM, with the MSS 1, MSS 1 stated, the SPT 2 should change the pair gloves when taking supplies from the clean cart, for infection control.

Review of the Center for Disease Control and Prevention, Hand Hygiene in Healthcare Settings, with the last reviewed date of 11/21/23 indicated, "Glove is not a substitute for cleaning your hands. ... It is important to change your gloves: IF ... Moving from contaminated body site to clean body site. Gloves look dirty or have blood or bodily fluids on them after completing the task."

3. During a concurrent observation of the Interventional Endoscopic Service (IES) area, located on the 4th floor of the hospital and interview on 2/8/24, at 11:45 AM, with the Nurse Manager (NM 1) and the QAC 1, the Clean Storage Room (CSR) of the EIS was observed. In the CSR, there were one Blanket Warmer machine, one Refrigerator Freezer machine, several medical supplies on the metal shelf tray, and several flexible scopes hanging inside the Storage Cabinet. The NM 1 verified, the CSR has "ambient air (an environment's actual air temperature) and the CSR has no thermostat (main control unit for a heating or cooling system). The NM 1 explained, it was his assumption the temperature and humidity were monitored but after his discussion with the Chief of Facility (CoF) only the Blanket Warmer and the Medication Freezer were monitored. The NM 1 further stated, the facility used the "Olympus" type of flexible scopes, and the temperature and humidity of the flexible scopes Storage Cabinet were not monitored since 2019, it should be monitored to maintain the "integrity" of the scopes.

Review of the Olympus Operational Manual Instructions, dated 2019 indicated, "Chapter 2.2: Specifications: Environment: ... standard storage environment (e.g. within the hospital) Ambient temperature: 5-40 ° (degrees) C (Celsius), (41-104 ° (degrees) F (Fahrenheit), Relative Humidity: 10-19 %."

In an interview on 2/8/24, at 12:50 PM, with the Chief of Facility (CoF) and the QAC 1, CoF stated, they "do not monitor" the temperature and humidity of the CSR in the IES area as well as the the Storage Cabinet where the flexible scopes were stored. The CoF stated, there was a "HEPA filter (High Efficiency Particulate Air, removes airborne particles)" in the scope cabinet and the filter was changed every six (6) months.

Review of the facility's P&P titled, "Infection Control Strategies for Handling, Disinfection, and Maintenance of Flexible Scopes, ... Probes and instruments," with the last revised date of 3/21/19 indicated, "Storage of Flexible Scopes: 1. Flexible scope ... must be hung and stored vertically ... After thorough drying, maybe stored in a manner described by the manufacturer's instructions for use." The facility policy did not identify the specific temperature and humidity range to maintain the standard storge environment where the flexible scopes were stored in accordance with the manufacturer's IFU.

Review of the Olympus Operational Manual Instructions, dated 2019 indicated, "Warnings and Caution: Follow the warning given below and cautions given below when handling this endoscopes. ... After using these endoscopes, reprocess, and store it according to the instructions given in the endoscope's companion "REPROCESSING MANUAL ... Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and /or infection. ... ."

4. In a concurrent observation and interview on 2/6/24 at 9:30 AM, with the Chief of Nursing (CNE), MSS 1, and SPT 1, the Assembly Area (centralized area where all instruments are sorted and inspected to make sure they are still working properly before they are sterilized) of the SPD was observed. The SPT 3 came out from the break room, sat on the chair, and without performing hand hygiene and without donning pair of gloves, started to assemble the clean surgical instruments of the hysterotomy instrument tray with his bare hands. The SPT 3 stated, he had worked in SPD for five years and while holding the instrument with his bare hands he explained what task he was performing. When asked if he performed hand hygiene before assembling the clean instruments, SPDT 3 stated, "no, I did not" and he continued the task.

In an interview on 2/6/24, at 10:32 AM, with the CNE stated, hand hygiene should be done before and after performing task and before the next task, it would be a good practice to perform hand hygiene.

Review of the facility's P&P titled, "Infection Control Strategies - Hand Hygiene" with the last revised date of 1/18/19 indicated, "Purpose: the purpose of hand hygiene is to remove dirt, organic material and transient microorganisms from the hands in order to decrease the risk of cross contamination from patient, patient care equipment, and environment. Policy: ... All staff must cleanse hands with alcohol-based hand sanitizer or soap and water at the following times: At the beginning of work ... ."

Based on observation, interview and record review, the facility failed to ensure hospital leaders maintained implementation of nationally recognized hospital-wide infection surveillance, prevention, and control policies and procedures for Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for approximately 141 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).

2. Sterile Processing Technician (SPT) 2 did not change gloves after manual washing of the rectal probe, before getting Endozime (enzymatic detergent to pre-clean/clean and remove soils from the exterior of endoscopes, medical devices, accessories, and surgical instruments) sponge from clean supplies cart. The deficient practice had potential result for increased patients' risks for healthcare associated infections (HAI, infections people get while they are receiving health care for another condition)

3. The flexible scopes (movable tube with light and tiny camera on one end) Storage Cabinet Cabinet's temperature and humidity was not maintained/monitored in accordance with the manufacturer's instructions. This deficient practice resulted in the potential damage to the "integrity" of the device.
.
4. SPT 3 did not perform proper 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]), before assembling the clean surgical instruments in a hysterotomy tray (tray which contain surgical instruments for removal of uterine content). This failure had potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another).

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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

Review of the facility, (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], titled, "Policy- Circulating Nurse's Responsibilities", dated 7/21/22, indicated, "The circulating nurse is a licensed Registered Nurse who has special education in perioperative (the period of time extending from when the patient goes into the hospital, clinic, or doctor's office for surgery until the time the patient is discharged home) nursing. He/she plans, coordinates, delivers, and evaluates nursing care to the patient during surgical and invasive procedures. The circulating nurse will circulate in only one operating room at a time ... Plan ... 2. Reviews the surgeon's preference card/list and ensures that all necessary supplies, instruments and equipment are appropriate, available and ready for use ..."

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

During a review of ( 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 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 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 an interview on 2/8/24, at 1:35 PM, with the Infection Preventionist (IP) and with the QAC 1, IP stated, the rectal probe issue was discussed in the Infection Control Committee, they looked at the re- processing of the probe, the rectal probe was considered a semi-critical item (devices contact with mucous membranes or non-intact skin) and needed HLD.

Review of the facility's Infection Control and Epidemiology Committee Meeting dated 12/21/23 indicated, "TOPIC: ... III. Service Line Reports: Discussion /Conclusion/Recommendations: ... Surgery/SPD: ... rectal probe (2 types) new process- grey enzymatic wipes at POU (Point of Use) leak test from vendor, send to SPD, Trophon (high level disinfection system) for last case. ..."

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 6 ... Programs and Services ... General Patient Care Services, Diagnostic Imaging/Interventional Radiology; Surgical Service, Surgery: Endoscopy (a medical procedure where a doctor puts tube-like instrument into the body to look inside), Same Day Surgery ... 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..."2023 Infection Prevention and Control Program Risk Assessment ... Infections due to Disinfection or Sterilization Failures, Populations at Risk, Ultrasound patients, Trophon used for ultrasound, disinfection, Method of Disinfection for USN (ultrasound- rectal) probes, monitor compliance with use ... 2023 Specific Surveillance Plan with Goals, Infections due to Disinfection or Sterilization Failures , Indicator: Safe Equipment, Goal: Scope Cleaning, 100 % (percent); Case Finding: Results of Departmental monitoring of high level infection, Population: Scopes used in patient procedures; Actions to Reduce Risk: follow manufacturers recommendations for high level disinfection; Methods of analysis: SPD % of scopes meeting all data points, Data Entry: sterile processing database ..."

2. During an observation on 2/5/24, at 12:07 PM, with DSS 1 and 2, MSS 1 and 2, SPT 1 and 2, and QAC 1, in the SPD of manual washing of the rectal probe 8848, SPT 2 put on a pair of gloves, took the rectal probe from the container, immersed it in water in the sink and rinsed it. After rinsing the rectal probe, SPT 2 went to the nearby three tier cart of clean supplies and without changing his gloves, took one Endozime sponge and continued the manual cleaning using the sponge and then rinsed it.

During concurrent interviews on 2/5/24, at 12:07 PM, MSS 1 stated, SPT 2 should have changed gloves when taking supplies from the clean cart for infection control. DSS 1 stated, the ultrasound rectal probe was used in the Operating Room for ten years. Before the hospital was notified of the rectal probe disinfection issue, the rectal probe did not pass through the SPD for HLD before it was used for procedures. DSS 1 stated, in the OR, the OR staff would use a "wipe cloth" to wipe the rectal probe, placed it inside a plastic sheath, then handed it to the Vendor Representative.

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,"Populations at Risk, All patients, staff medical staff and volunteers, Compliance to CDC hand hygiene program, Poor hand hygiene increases the risk of HAIs ..."

According to, Centers for Disease Control and Prevention (.gov), https://www.cdc.gov > Glove_removal_job_aid, Removing Gloves Safely, "All employees using disposable gloves must observe the following precautions: Wash hands before putting on gloves, Never wash or reuse disposable gloves, Remove gloves after they become contaminated ..."

Review of the facility's Policy and Procedures (P&P) titled, "Procedure-Instruments, Powered Equipment, and Rigid Endoscopes: Reducing Bio-burden, Care and Cleaning", revised 6/30/21, indicated, "GENERAL GUIDELINE: 1. Prior to use ...loaned and/or transported instruments, powered equipment and devices ... will be cleaned /decontaminated, ... undergo HLD (High Level Disinfection) or sterilization per manufacturer's IFU. ... 6. Any instrument opened on to the sterile field in an operating or procedure room will be cleaned and decontaminated before patient use ... PROCEDURES: ... 2. Preparing items for decontamination: a. The type of decontamination required for a particular item/device depends on ... manufacturer's IFU. B. All instruments opened on to the sterile field require decontamination (process of removing soil and pathogenic microorganisms from objects) ..."

Record review of (Manufacturer Name of the of the Rectal Probe) User Guide, with issue Date of 6/2022, indicated, "Chapter 4. Reprocessing Information and Methods: ... Automated Reprocessing Methods Proper cleaning is essential ... Appendix: Reprocessing Information and Tables. ... Validated Reprocessing Methods for the Flex Transducer series. ... Sterilization: ... Sterrad NX (a compact unit which sterilizes medical devices) ... Transducers ... Endocavity (a transducer which comes into contact with the anal cavity, the vagina, or the oral cavity): 8848 ..."

3. During a concurrent observation and interview on 2/8/24, at 11:45 AM, with the Nurse Manager (NM 1) and QAC 1,

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/Vendor Representative (VR) for Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], Hospital (H) 1 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 (MIFU, provide detailed instructions on how equipment should be used, maintained, and stored). This failure resulted in the potential exposure for 141 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).

2. Sterile Processing Technician (SPT) 2 did not change gloves after manual washing of the rectal probe, before getting Endozime (enzymatic detergent to pre-clean/clean and remove soils from the exterior of endoscopes, medical devices, accessories, and surgical instruments) sponge from clean supplies cart. The deficient practice had potential result for increased patients' risks for healthcare associated infections (HAI, infections people get while they are receiving health care for another condition)

3. The flexible scopes (movable tube with light and tiny camera on one end) Storage Cabinet Cabinet's temperature and humidity was not maintained/monitored in accordance with the manufacturer's instructions. This deficient practice resulted in the potential damage to the "integrity" of the device.
.
4. SPT 3 did not perform proper 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]), before assembling the clean surgical instruments in a hysterotomy tray (tray which contain surgical instruments for removal of uterine content). This failure had potential for cross contamination (transfer of harmful bacteria from one person, object, or place to another).

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, 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 ... "

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) ...

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

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

During an observation on 2/6/24, at 7:34 AM, with DSS 2, Patient 16 was transferred from the preoperative (before procedure) area to the OR suite for Transperineal (area between the anus (end of large intestine) and scrotum (reproductive structure under the penis) Ultrasound (imaging sends out (emits) high-frequency sound waves, directed at the tissue being examined, and recording the reflected sound or echoes to create an image) guided implantation of HDR (high dose rate) catheters into the prostate) procedure. (Contractor Name), VR was in the Operating Room (OR sterile location where surgical procedures were performed) suite during Patient 16's procedure.

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

During a review of facility document, "Medical Doctor Procedure Note", dated 2/6/24, for Patient 16, indicated, "Procedure: Transperineal Ultrasound guided implantation of HDR... Description of Procedure ... Using ultrasound guidance, bradytherapy (the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue) catheters were advanced into the prostate (a gland below your bladder and in front of your rectum. It adds fluid to your semen). A total of 24 catheters were advanced ..."

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

During an interview on 2/6/24, at 2:04 PM with Circulating OR Registered Nurse (RN) RN 1, and Quality Assurance Coordinator (QAC) 1, RN 1 stated, he had worked for Hospital 1 Campus OR for 5 years, on the evening shift. RN 1 stated, if cases (procedures) were scheduled early, on the evening before the procedure, SPD brings to the OR area a cart with instruments needed for the case and doctor requested; then he sets up the equipment in an available OR (suite) for the early morning case. RN1 stated the machine (ultrasound system) and rectal probe were not included with equipment he set up in the OR room for Patient 16's case scheduled for 2/6/2024. RN1 stated, "as I recall", the rectal probe is connected to the machine and brought in by the (Contractor Name VR) on the morning of procedure (before the hospital was notified of the rectal probe disinfection issue).

Review of the facility, (Healthcare System's Name), [Facilities Group Name affiliated with (three) separately certified hospitals], titled, "Policy- Circulating Nurse's Responsibilities", dated 7/21/22, indicated, "The circulating nurse is a licensed Registered Nurse who has special education in perioperative (the period of time extending from when the patient goes into the hospital, clinic, or doctor's office for surgery until the time the patient is discharged home) nursing. He/she plans, coordinates, delivers, and evaluates nursing care to the patient during surgical and invasive procedures. The circulating nurse will circulate in only one operating room at a time ... Plan ... 2. Reviews the surgeon's preference card/list and ensures that all necessary supplies, instruments and equipment are appropriate, available and ready for use ..."

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

During a review of ( 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 2/7/24 at 4 PM, with DAL, DAL stated it was she who notified SA regarding the rectal probe disinfection issue. The facility's document with 8 (eight) pages, not titled, printed 2/50 (sic)/2024 was the list of patients affected with rectal probe disinfection issue for (Healthcare System's Name), [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 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 an interview on 2/8/24, at 1:35 PM, with the Infection Preventionist (IP) and with the QAC 1, IP stated, the rectal probe issue was discussed in the Infection Control Committee, they looked at the re- processing of the probe, the rectal probe was considered a semi-critical item (devices contact with mucous membranes or non-intact skin) and needed HLD.

Review of the facility's Infection Control and Epidemiology Committee Meeting dated 12/21/23 indicated, "TOPIC: ... III. Service Line Reports: Discussion /Conclusion/Recommendations: ... Surgery/SPD: ... rectal probe (2 types) new process- grey enzymatic wipes at POU (Point of Use) leak test from vendor, send to SPD, Trophon (high level disinfection system) for last case. ..."

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

During a video call interview on 2/9/24 at 10:14 AM, 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 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 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 6 ... Programs and Services ... General Patient Care Services, Diagnostic Imaging/Interventional Radiology; Surgical Service, Surgery: Endoscopy (a medical procedure where a doctor puts tube-like instrument into the body to look inside), Same Day Surgery ... 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..."2023 Infection Prevention and Control Program Risk Assessment ... Infections due to Disinfection or Sterilization Failures, Populations at Risk, Ultrasound patients, Trophon used for ultrasound, disinfection, Method of Disinfection for USN (ultrasound- rectal) probes, monitor compliance with use ... 2023 Specific Surveillance Plan with Goals, Infections due to Disinfection or Sterilization Failures , Indicator: Safe Equipment, Goal: Scope Cleaning, 100 % (percent); Case Finding: Results of Departmental monitoring of high level infection, Population: Scopes used in patient procedures; Actions to Reduce Risk: follow manufacturers recommendations for high level disinfection; Methods of analysis: SPD % of scopes meeting all data points, Data Entry: sterile processing database ..."

2. During an observation on 2/5/24, at 12:07 PM, with DSS 1 and 2, MSS 1 and 2, SPT 1 and 2, and QAC 1, in the SPD of manual washing of the rectal probe 8848, SPT 2 put on a pair of gloves, took the rectal probe from the container, immersed it in water in the sink and rinsed it. After rinsing the rectal probe, SPT 2 went to the nearby three tier cart of clean supplies and without changing his gloves, took one Endozime sponge and continued the manual cleaning using the sponge and then rinsed it.

During concurrent interviews on 2/5/24, at 12:07 PM, MSS 1 stated, SPT 2 should have changed gloves when taking supplies from the clean cart for infection control. DSS 1 stated, the ultrasound rectal probe was used in the Operating Room for ten years. Before the hospital was notified of the rectal probe disinfection issue, the rectal probe did not pass through the SPD for HLD before it was used for procedures. DSS 1 stated, in the OR, the OR staff would use a "wipe cloth" to wipe the rectal probe, placed it inside a plastic sheath, then handed it to the Vendor Representative.

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,"Populations at Risk, All patients, staff medical staff and volunteers, Compliance to CDC hand hygiene program, Poor hand hygiene increases the risk of HAIs ..."

According to, Centers for Disease Control and Prevention (.gov), https://www.cdc.gov > Glove_removal_job_aid, Removing Gloves Safely, "All employees using disposable gloves must observe the following precautions: Wash hands before putting on gloves, Never wash or reuse disposable gloves, Remove gloves after they become contaminated ..."

Review of the facility's Policy and Procedures (P&P) titled, "Procedure-Instruments, Powered Equipment, and Rigid Endoscopes: Reducing Bio-burden, Care and Cleaning", revised 6/30/21, indicated, "GENERAL GUIDELINE: 1. Prior to use ...loaned and/or transported instruments, powered equipment and devices ... will be cleaned /decontaminated, ... undergo HLD (High Level Disinfection) or sterilization per manufacturer's IFU. ... 6. Any instrument opened on to the sterile field in an operating or procedure room will be cleaned and decontaminated before patient use ... PROCEDURES: ... 2. Preparing items for decontamination: a. The type of decontamination required for a particular item/device depends on ... manufacturer's IFU. B. All instruments opened on to the sterile field require decontamination (process of removing soil and pathogenic microorganisms from objects) ..."

Record review of (Manufacturer Name of the of the Rectal Probe) User Guide, with issue Date of 6/2022, indicated, "Chapter 4. Reprocessing Information and Methods: ... Automated Reprocessing Methods Proper cleaning is essential ... Appendix: Reprocessing Information and Tables. ... Validated Reprocessing Methods for the Flex Transducer series. ... Sterilization: ... Sterrad NX (a compact unit which sterilizes medica