California Pacific Medical Center- Van Ness Campus

“DISCHARGE PLANNING-EVALUATION CFR(s): §482.43(a)(2) Standard: Discharge Planning Evaluation (2)A discharge planning evaluation must include an evaluation of a patient’s likely need for appropriate post-hospital services, including, but not limited to hospice care services, post-hospital extended care services, home health services, and non-health care services and community based care providers, and must also include a determination of the availability of the appropriate services as well as of the patient’s access to those services. This Standard is not met as evidenced by: 49264 Based on interview and record review, the facility failed to determine availability of post-hospital services as determined by their initial care coordination assessment (an assessment completed by a case manager around the time of a patient’s admission to assess their living situation prior to admission and their anticipated needs after discharge from the hospital) for two out of 30 sampled patients (Patient 26 and Patient 27) when: 1. Patient 26 requested assistance with increasing In-Home Supportive Services (IHSS, a program that provides in-home assistance to eligible aged, blind, and disabled individuals as an alternative to out-of-home care) hours and a social services consult was ordered but was not completed and when 2. Patient 27’s spouse requested assistance with applying for short-term disability (provides temporary income replacement when a non-work-related illness, injury, or pregnancy prevents you from working for a short period, usually a few weeks to several months) and a social services consult was requested but was not completed. These failures have the potential for a patient’s assessed or voiced needs during hospitalization to not be addressed leading to inadequate post-discharge care and/or preventable hospital readmissions. Findings: 1. A review of the facility’s policy and procedure (P&P) titled, “Policy - Discharge Planning”, last approved 12/14/23, indicated, “The Case Manager and Social Worker is responsible for developing a discharge plan of care through early identification of patient needs and resources, as well as facilitating a coordinated and safe discharge ...The Case Manager or Social Worker evaluates the patient’s needs through chart review, interdisciplinary meetings, healthcare provider assessments, and consultation with patient and/or family, and post-acute services as needed throughout the patient’s hospitalization ...” The P&P indicated staff should “Elicit and incorporate the plan of care goals of the patient/family, physicians, and healthcare team members in the planning process ...” and “Send referrals to appropriate providers for transitional care needs and /or [sic] post-hospital services, financial or insurance services, legal, psychosocial or community support ...Ongoing coordination with post-acute services throughout patient’s hospitalization as needed.” A review of facility’s P&P titled, “Policy - Discharge of Patients”, last approved 08/29/24, indicated, “Nursing, in collaboration with the ... Inter-disciplinary Team, coordinates and facilitates patient care and optimal team communication during the discharge process ... The Inter-disciplinary Team which includes but is not limited to: Nursing ... Social Services ...Case Managers ...In response to the assessed needs [of a patient], appropriate referrals to the Inter-disciplinary Team are made.” A review of a case management note written by Case Manager Nurse (CMRN) 1 for Patient 26 titled, “INITIAL CARE COORDINATION NOTE”, dated 07/07/25, indicated Patient 26 was an 85-year-old patient admitted on 07/06/25 from the hospital’s emergency department for further work up due to difficulty with urination and an increased abdominal size. The note further indicated that Patient 26 “lives alone.” CMRN 1 was not available for interview at the time of survey. During a concurrent interview and record review on 01/12/26 at 10:50 AM with the Manager of Care Coordination (MCC), a case management note for Patient 26 titled, “INITIAL CARE COORDINATION NOTE”, dated 07/07/25, was reviewed. The note indicated, “pt [patient] requesting increase in IHSS hours - placed consult to SW [social work]”. The MCC stated since the patient requested assistance with increasing IHSS hours, a social work consult was placed (ordered). The MCC was asked if there was any documentation in the medical record indicating that the social work consult was ever completed; the MCC stated, “not based on the notes that I can see.” A review of a medical order titled “CONSULT TO SOCIAL SERVICES”, dated 07/07/25, indicated the consult to social services was because “Patient requesting re-assessment/increase in IHSS hours”. The order further indicated it was only released and never completed. During a concurrent interview and record review on 01/12/26 at 11:32 AM with the Director of Care Coordination (DCC), a social worker note, dated 07/08/25, was reviewed. The social worker note indicated a social worker assisted Patient 26 with obtaining an interpreter to discuss advance care planning (ACP, preparing for future decisions about your medical care if you become seriously ill or unable to communicate your wishes) with a doctor. The DCC stated, “I did see a social work consult, but it addressed something else ... the advanced care planning.” The DCC further stated, “there is a social work note but not related to IHSS ...” 2. A review of a case management note written by CMRN 1 for Patient 27 titled, “INITIAL CARE COORDINATION NOTE”, dated 07/08/25, indicated Patient 27 was a 50-year-old patient admitted on 07/07/25 with a medical history of multiple gastrointestinal surgeries that was admitted after a surgery to remove parts of the small and large intestine. CMRN 1 was not available for interview at the time of survey. During a concurrent interview and record review on 01/12/26 at 11:01 AM with the MCC, a case management note for Patient 27 titled, “INITIAL CARE COORDINATION NOTE”, dated 07/08/25, indicated “ pt’s [Patient 27’s] spouse states she is still working and may need to apply for short term disability and may need letter to submit to employer - placed SW [Social Work] consult”. The MCC stated that a Social Work consult was ordered as the patient had an identified need, but the consult was not completed. During a concurrent interview and record review on 01/12/26 at 11:28 AM with the DCC, a medical order, titled “CONSULT TO SOCIAL SERVICES”, dated 07/08/25 was reviewed. The order indicated Patient 27 required the social work consult as they “May need to apply for short term disability - may need letter to submit to employer regarding hospitalization”. The DCC was asked if the social work consult was ever completed or if the patient’s specific social work need was addressed. The DCC stated, “I don’t see it here ... it sounds like something that we missed”.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 39792 Based on observation, interview, and record review, the hospital failed to ensure a lidocaine order (a medication used to treat irregular heartbeats) was administered in accordance with the Physician Orders, facility policies and accepted standards of practice when Patient 100 was administered an accidental bolus (a rapid method of administering a concentrated) dose of Lidocaine. This failure resulted in Patient 100 suffering symptoms of Lidocaine overdose and toxicity including low blood pressure, disorientation, muscle twitching, and seizures (sudden burst of electrical activity in the brain, causing changes in behavior or movements), respiratory failure (when the lungs can’t get enough oxygen into the blood). Patient 100 required medical intervention including the administration of intravenous (IV through a peripheral vein in the arm) norepinephrine [a medication for the management of severe low blood pressure] to regain stable condition in addition to being placed on ECMO (Extracorporeal Membrane Oxygenation, a life-support therapy that provides temporary heart and lung support for patients whose own organs are unable to perform adequately) and died on 7/16/25. Findings: During a concurrent interview and record review on 7/17/25 at 2:50 p.m. with RN 3, Patient 100’s “Medical Record” dated 7/9/25 was reviewed. Patient 100 was admitted to the facility from the same level of care facility at another facility for irregular heartbeats on 7/9/25 at 1:03 a.m. to the Intensive Care Unit (ICU, a specialized unit providing high -level monitoring and treatment for patients). A review of Patient 100’s Physician Orders dated 7/9/25 indicated an order for lidocaine as follow: Lidocaine 2,000 mg (milligram, unit of measure) in D5W IV Drip 250 ml (Intravenous bag containing sugar and water, [milliliters, unit of measure]) Ordered Dose: 2 mg/min (milligram per minute) Admin (administration) Dose: 2,000 mcg/min (microgram/minute) Scheduled start date/time: 7/9/25 1:30 a.m. A review of Patient 100’s Medication Administration Report (MAR) showed that lidocaine was administered to Patient 100 with a rate of 15 ml/hr (milliliter per hour, unit of measure) from 1:34 a.m. to 5:47 a.m. using pump A and again administered from 5:47 a.m. to 5:56 a.m. using pump B. During an interview on 7/17/25 at 11 a.m. with Registered Nurse 1 (RN), RN 1 stated that there was an incident involving Patient 100 receiving an accidental bolus dose (approximately 180 ml) of lidocaine instead of the prescribed dose on 7/9/25. RN 1 stated pump B was placed in standby mode when the Nurse Practitioner (NP) requested to discontinue Patient 100’s lidocaine continuous infusion of 15 ml per hour; however, when the tube was disconnected by RN 1’s colleague, RN 1 observed the medication was dripping out of the tube and the lidocaine bag previously containing about 180 ml of lidocaine was observed to be empty. RN 1 acknowledged that the medication error had occurred, and it contributed to patient 100 suffering from tonic clonic seizures, a type of seizure characterized by a loss of consciousness and involuntary muscle contractions. During an interview on 7/23/25 at 1:00pm, with RN 2, RN 2 stated Patient 100 had an emergency event on 7/9/25 at around 6:00 a.m. and after the event, RN 2 had assisted RN 1 in administering medication to help support Patient 100’s blood pressure. RN 2 stated the Lidocaine tube was being disconnected from entry into Patient 100’s vein and noticed fluid was dripping but the pump was still in standby mode, meaning there should not have been any fluid coming from the tube. RN 2 stated the tube labeled, “Lidocaine” toward Patient 100 was followed up to the IV bag where it was observed to be empty. RN 2 acknowledged, it was identified that Patient 100 had the accidental bolus dose of Lidocaine. During a concurrent record review and interview on 7/17/25 at 2:58 p.m., with RN 3 and Registered Pharmacist 1 (RPh1), Patient 100’s, “Medical Record, Order for Lidococaine” dated 7/9/25, indicated, the lidocaine order was placed at 1:12 a.m. and approximately 67 ml out of the full Lidocaine of 250 ml bag (dispensed from the pharmacy) was administered to Patient 100, leaving approximately 180 ml left in the bag when the administration was stopped at 5:56 a.m. During an observation on 7/16/25 at 2:20 p.m., the empty lidocaine IV bag was still attached to pump B, in the surveyors’ conference room, with the following information on the label: Lidocaine in D5W IV Drip 2000mg/250ml Dose: 2000 mcg/min On the bottom of the label, it was printed: INIT [initial] with one set of RN’s initials During an interview on 7/23/25 at 2:56 pm. with MD 1, MD 1 stated as a consultant for Patient 100 they do not write orders for medications in the medical record. MD 1 stated he spoke with NP and recommened to stop the Lidocaine transfusion since Patient 100 was indicated to be experiencing level of consciousness changes which could be associated with an unwanted symptom of someone who was not tolerating a Lidocaine continuous transfusion. MD 1 stated Patient 100 had tolerated Lidocaine infusions before, but had not experienced these symptoms and it was not uncommon to experience these symptoms if a patient was not tolerating a Lidocaine transfusion. During an interview on 7/23/25 at 3:26 p.m. with ICU Manager, (ICU-M), ICU-M stated that lidocaine IV bag used for lidocaine administration on 7/9/25 was observed to be empty and was unable to explain how Patient 100 had received the accidental bolus dose since the three nurses in the room (Patient 100’s room) observed the pump to be in standby mode. ICU-M stated, the nurse practitioner who made rounds on 7/9/25 had entered the provider held order for Lidocaine on 7/9/25 at 5:57 a.m. The Nurse Practitioner was unavailable to be interviewed by the Department. The Attending Physician was unavailable to be interviewed by the Department. According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization in the United States devoted to the prevention of medication errors), an Acute Care ISMP Medication safety Alert published in 2018, stated, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. The ISMP publication included a list of high alert/ high risk medications to determine which medications require special safeguards to reduce the risk of errors. The list included lidocaine IV. During a review of the facility’s policy and procedure (P&P) titled, “Medication Administration and Safe Practices”, dated 6/20/25, the P&P indicated, “b. The medication must be removed from IV pumps and IV poles once the medication has been discontinued ...RN-#2 (person double checking med) performs an independent verification away from RN #1 by confirming 5 Rights + & appropriateness against the Prescriber order & order & any necessary reference double signature/high risk med section”. During a review of the facility’s P&P titled, “High Alert Medications”, dated 6/20/25, the P&P indicated, lidocaine was not part of the high alert/risk meds. During an interview on 7/17/25 at 5:12 p.m. with the Director of Pharmacy (DOP), the DOP stated, ISMP was a reputable resource, and it did include lidocaine as a high Alert/high risk medication, but both the medication administration and high alert medication policies, did not include lidocaine as a high-risk medication. According to the manufacturer’s product labeling, Lidocaine Hydrochloride and 5% Dextrose Injection serves as a cardiac antiarrhythmic agent(medication used to prevent or correct irregular heart rhythms) intended for intravenous use. There is no specific antidote for overdose of lidocaine. The risk of overdose can be minimized by close monitoring during treatment According to an online publication on low blood pressure by the Mayo Clinic, Mayo Foundation for Medical Education and Research (a nonprofit American academic medical center focused on integrated health care, education, and research), severely low blood pressure can reduce the body’s oxygen levels, which can lead to heart and brain damage, and a sudden fall in blood pressure can be dangerous. A change of just 20 mmHg - a drop from 110 mmHg systolic to 90 mmHg systolic can cause dizziness and fainting, and significant drops in blood pressure can be life-threatening. A review of Patient 100’s clinical record showed that the Patient 100 had a lidocaine blood level of 24 mcg/mL (microgram per milliliter, unit of measure) on 7/9/25. According to another online publication by the Mayo Clinic, for cardiac therapy, optimal therapeutic response is seen when lidocaine serum concentrations are between 1.5 and 5.0 mcg/mL. Toxicity occurs when the serum concentration of lidocaine is greater than 6.0 mcg/mL and is usually associated with symptoms of central nervous system excitation, confusion, dizziness, and blurred or double vision. This can be accompanied by bradycardia (a slow heart rate) and hypotension (low blood pressure) leading to cardiovascular collapse (a life-threatening and critical medical emergency that requires immediate intervention). According to another Acute Care ISMP Medication safety Alert published in 2023, ISMP has advocated for the use of smart infusion pump technology with drug libraries and dose error-reduction systems (DERS) when administering intravenous (IV) infusions. The ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps included: - Close the roller clamp: While the device’s anti-free-flow protection mechanism is intended to eliminate free-flow events, it should not be solely relied upon. If the door latch has been compromised, the anti-free-flow protection may not engage when the door is opened. The antifree-flow protection is a secondary protection mechanism; the roller clamp is the primary method of preventing flow. During times when the practitioner does not intend to administer an infusion to a patient, ensure the roller clamp is closed to prevent an inadvertent bolus dose from being delivered to a patient. Only unclamp the roller clamp when starting or restarting the infusion. -Monitor infusions for unintended flow. Periodically check throughout the infusion that the remaining infusion volume approximately corresponds to the expected delivery time. Check that there is no flow in the drip chamber whenever the pump is off, paused, or not programmed to be infusing. For critical medications, consider more frequent monitoring. During a review of the facility’s P&P titled, “Medication Administration”, dated 6/20/25 the P&P indicated, “All medications require an order from authorized prescriber containing the following elements: 1. Medication/agent 2. Dose 3. Frequency 4. Route of Administration.” During a review of the facility’s P&P titled, “Large Volume Pump (LVP) for Infusions with Interoperability”, dated 9/2024, the P&P indicated, “Demonstrate Discontinuing Fluid Administration ...close all clamps.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 39792 Based on observation, interview, and record review, the facility failed to ensure a high risk/high alert medication (medication that carries a high risk of causing significant patient harm if used incorrectly), lidocaine (a medication used to treat irregular heartbeats was not identified as a high risk/high alert medication. This failure had the potential to cause significant medication errors related to lidocaine overdose and toxicity including low blood pressure, seizures, or death. Finding: During an observation and inspection of a previously used lidocaine IV bag still attached to an infusion pump on 7/16/25 at 2:30 p.m.in the conference room, showed that the IV (intravenous [infusing into a vein])bag was labeled with the following in the center of the label: Lidocaine in D5W IV Drip 2000mg/250ml Dose: 2000 mcg/min On the bottom of the label, it was printed: INIT [initial] with one set of RN’s initials According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization in the United States devoted to the prevention of medication errors), an Acute Care ISMP Medication safety Alert published in 2018, stated, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. The ISMP publication included a list of high alert/ high risk medications to determine which medications require special safeguards to reduce the risk of errors. The list included lidocaine IV. During an interview on 7/17/25 at 5:12 p.m. with the Director of Pharmacy (DOP), the DOP stated, ISMP was a reputable resource and it did include lidocaine as a high Alert/high risk medication, but both the medication administration and high alert medication policies, did not include lidocaine as a high-risk medication. The DOP acknowledged both facility polices needed to be updated to follow the standards of practice. During a review of the facility’s policy and procedure (P&P) titled, “Medication Administration”, dated 6/20/25, the P&P indicated, “ [ double signature/high risk med section] During a review of the facility’s P&P titled, “High Alert Medications”, dated 6/20/25, the P&P indicated, lidocaine was not part of the high alert/risk meds.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 38066 Based on observation and interview, the hospital failed to post the patient rights signage in required areas for patients seen at the Emergency Department (ED). This failure had the potential for individuals to be uninformed of their rights to receive emergency medical care under the Emergency Medical Treatment and Labor Act (EMTALA -the law requiring treatment of all patients requesting care at the ED. Findings: During an observation on 4/28/25 at 10:18 AM, at the ED pediatric waiting room, there was no visible EMTALA sign posted. During an observation and concurrent interview on 4/28/25 at 10:28 AM, with the Emergency Department Manager (EDM), in triage rooms A and B, there were no visible EMTALA sign posted. EDM stated, “We don’t have any inside the rooms. They’re up front, they’re only in the waiting room so the public can see them. I’ve been here for forty years; I’ve never seen them in triage (rooms).” During an observation on 4/28/25 at 10:30 AM, there were patients inside treatment rooms 1, 2, and 4. There was no visible EMTALA sign posted in the rooms. When queried if there were EMTALA signs posted in any of the treatment rooms, EDM stated, “No.” During an interview on 5/1/25 at 9:30 AM, with Registered Nurse (RN)1, RN 1 said, patients brought in by ambulance are triaged in the Emergency Medical Services (EMS -system that responds to emergencies in need of highly skilled pre-hospital clinicians) bay or the outside rooms. RN 1stated, “They would not go to the waiting room prior to triage.” During an interview on 4/30/25 at 9:23 AM, the Accreditation and Licensure Manager (ALM) stated, “We don’t have a policy on the ED postings.””

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 39792 Based on interview and record review the facility to complete a Medical Screen Examination (MSE-screening used to determine whether a patient has an emergent medical or psychiatric condition and treatment for one out of 20 sampled patients (Patient 20) when Pt 20 was brought in by ambulance after attempting suicide by ingesting 60-70 pills and was not supervised until an MSE had been performed and left the facility while unattended prior to being screened by a doctor. This failure had the potential of Pt 20 for delay in psychiatric treatment, ability for second suicide attempt and potential death. Findings: During a record review of Patient 20’s, ED (Emergency Department Notes) and Timeline, dated 3/26/25, with Informatics Coordinator was reviewed. The ED patient care timeline, indicated per RN 2 Pt 20 was brought into the ED by ambulance on 3/26/25 at 3:45 p.m., due to an attempted suicide by taking 60-70 pills of hydroxyzine (medication used to help control anxiety and tension caused by nervous and emotional conditions, overdose symptoms (may include drowsiness, uncontrolled muscle movements or seizures)). RN 2, on 3/26/25 at 3:51 pm. completed, Pt 20’s, Columbus Suicide Severity Rating Scale” (a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple plain-language questions where the assessment would be graded from low, moderate, high and extremely high) Pt 20 scored, “High Risk” on the assessment tool. RN 2 on 3/26/25 at 3:52 p.m. completed the triage for Pt 20 and determined Acuity Level 2 (1-5 level acuity with 1 being immediate treatment required for life saving interventions, 2. Emergent, pt should be seen as soon as possible by a doctor and so on). RN 4 on 3/26/25 at 3:52 pm. called for security to come to the ED. RN 2 on 3/26/25 at 4:03 pm. had indicated Pt 20 had verbalized there was no immediate intent to hurt herself was placed on a bed in the hallway and had observed Pt 20 leave the ED with a “steady gait” and no further documentation regarding communication with Pt 20 was observed in the medical record. RN 4 on 3/26/25 at 4:06 pm was notified that Pt 20 had left the ED without being seen by MD and per the medical record, no further actions were taken by the facility. The medical record did not indicate that security had presented to the ED before Pt 20 had left or that Pt 20 had returned to the ED after the encounter on 3/26/25. During a concurrent interview and record on 4/30/25 at 9:29 a.m. with RN 2, “ED Triage RN Note” dated 3/26/25 at 3:45 pm. was reviewed and RN 2 stated Pt 20 was brought into the ED by ambulance for attempted to commit suicide but did not have an 5150 hold (72- hour emergency psychiatric hold which would allow for involuntary detention as initiated by a qualified mental health professional) by reviewing the nursing notes and from memory. RN 2 reviewed, “ED Note”, dated 3/26/25 at 4:03 pm. which indicated RN 2 had observed Pt 20 leave the ED without being seen or evaluated by a doctor. RN 2 stated Pt 20 was not on a legal 5150 hold and could not be held so there was nothing to be done to make the patient stay in the ED. RN 2 stated if Pt 20 was on a legal 5150 hold then she would have been on a one-to-one watch with security to observe and if she had left then the police would need to have been called but this wasn’t the case here. During a interview on 4/30/25 at 10:39 am. with RN 3, RN 3 stated if a patient had an intentional overdose of a medication and wanted to leave before being evaluated by a doctor, the doctor would be called right away. RN 3 stated, “we would not just let the patient walk out, oh God no!”. RN 3 stated especially with medications in the patient’s system, there could be a delayed effect so the policy would be followed of not letting the patient be alone and requiring a physician to evaluate them before they leave. RN 3 stated the doctor would make the final decision in determining capacity if they (the patient) would be trying to further harm themselves and might place them on a 5150 hold or allow them to leave if the patient had capacity to make that decision. RN 3 stated that they would talk with the patient and to try and get them to stay while trying to get the doctor in the room to evaluate the patient as soon as possible. During a concurrent interview and record review on 4/30/25 at 12:40 pm. with RN 4, RN 4 stated after reviewing, “ED Note”, dated 3/26/25 at 3:52 pm that security was called to watch Pt 20 until the Pt 20 could be evaluated by an ED doctor or psychiatry doctor. RN 2 reviewed the nursing note dated 3/26/5 at 4:03 pm., stated in this situation, security had not come to the unit, the Pt had left before the doctor was able to evaluate and usually there would be an attempt to try and prevent the patient from leaving. RN 4 could not explain why this did not happen in this case. During an interview on 4/30/25 at 1:29 pm. with Lead Security Guard (LSG), LSG stated, the ED nurses would call the security department to come and watch a psychiatric patient who had not been evaluated by a doctor or psychiatrist yet because they do not want the patient to leave or do not want the patient to hurt themselves until they had been evaluated. LSG stated if a psychiatric patient had been placed on a 5150 hold, then the security department would provide 24-hour one-to-one observation until the patient had been discharged or transferred from the ED. LSD stated usually when the call would come in from the ED to request an observation guard, it takes about 5 minutes to get to the unit, unless we are in the middle of doing something else. LSG could not explain when the security guard arrived to the ED since there was no documentation and Pt 20 had left without being evaluated by a doctor (documentation for the security guard starts with observing the patient). During an interview on 5/1/25 at 10:00 with MD3, MD3 stated if a psychiatric patient wants to leave before being evaluated then the nursing staff would “grab one of us quickly to evaluate them to see if it would be safe for them to leave, we can perform a quick assessment”. MD3 stated that sometimes we try and get them to stay with meals, while we are waiting for the results of tests and try and de-escalate and talk to them about why they should stay. MD3 stated the ED can be a busy and chaotic place where things change within seconds and sometimes the nurses can’t find us to evaluate, it just depends. During a concurrent interview and record review on 5/1/25 at 1:08 pm with Emergency Department Manager (EDM), EDM stated the expectations for the nursing staff in the ED would be for patients with a psychiatric complaint of suicidal ideation (contemplation about ending ones’ own life) or attempted suicide or homicidal ideation (thoughts about harming or killing another person) to be to have security at the bedside to provide 1:1 supervision or ensure the nurse remains until security was at the bedside and ensure the patient had been evaluated by the doctor and or psychiatry (doctor) after the medical screening for determination of a 5150 hold screening status. Patients are not allowed to leave until the doctor can evaluate them and if there was an escalation then the doctor would need to get in there to evaluate. The nurse would need to document the attempt to have them stay because they can’t do the medical screening. A review of Pt 20’s ED notes dated 3/26/25 at 4:03 pm. was reviewed and EDM stated she did not know who RN2 was as the name was not familiar and the nurse did not document the attempt to have Pt 20 remain in the ED until the medical screen could take place. EDM stated she could not explain why this did not happen as it was the expectation of the nurses in the ED. During a review of the facility’s policy and procedure titled, “Policy-Care of the Behavioral Health Patient,” dated 10/19/23, indicated “Patient’s who present on a voluntary basis who are a danger to themselves, others, or gravely disabled ...High risk patients will be under constant visual observation, unless the Emergency Department physician or physician from the psychiatry service is in the patient’s room and chooses to close the door ...All high-risk voluntary behavioral health patients in the Emergency Department), will also remain under direct visual observation by Security unless the ED physician or physician from the psychiatry service is in the patient’s room and chooses to close the door for privacy. A qualified clinical designee may be chosen to observe the patient, in lieu of Security, as long as the patient is deemed to non-violent and a Security officer is located in the department. A high-risk voluntary behavioral health patient includes the following: ...Any patient with behaviors, symptoms, or history identified by any evaluating nurse, physician, or clinician suggesting that they are potential danger to self, danger to others, or gravely disabled will identified as high-risk behavioral health patient ...Guidelines for the care of these patients include: 1. Immediately room the patient in a private room ...4. Initiate 1:1 continuous monitoring ...5. Contact Security for assistance ...8. The patient must be under constant visual observation. This may be accomplished by the presence of a security officer, or clinical staff member. This includes the use of the bathroom. The clinical staff will inform the patient of the process and purpose of constant visual observation. 9. The Security officer, or clinical staff designee, assigned to the patient will be given a brief report by the patient’s primary nurse upon the officer’s arrival. The security officer (or designee) will have primary responsibility for keeping the patient in sight and keeping the patient safe ...B. If the patient on a high-risk behavioral health patient elopes: 1. The Charge RN will notify the Police Department immediately and provide a physical description. 2. If there is a reasonable belief the patient may be in the immediate area of the Medical Center, a search may be made by Security ...”. During a review of the facility’s policy and procedure titled, “Policy-Leaving Hospital Against Medical Advice,” dated 4/21/22, indicated, “An adult patient who has capacity *(if patient lacks capacity see policy “Leaving Against Medical Advice-Incapacitated Patient”) has the right to decide whether or not to submit to medical treatment. However, before a patient is discharged prior to the completion of treatment or contrary to medical”.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 49264 Based on interview and record review, the facility failed to provide the stabilizing treatment for an emergency medical condition (EMC) within its capabilities for one of 20 sampled patients (Patient 11) when Patient 11 presented to the emergency department for suicidal ideation (thoughts or plans of ending one’s own life) and was discharged (sent/leave to) home without any physician reassessment after she was observed by nursing staff to be “screaming and ramming her head into the wall repeatedly,” immediately prior to discharge. This failure has the potential for patients with unstabaliazed EMCs to be discharged resulting in deterioration of the patient’s condition. Findings: A review of facility policy and procedure titled “Policy - Medical Emergencies on the Van Ness, Davies, and Mission Bernal Campuses and in Outpatient Clinics and Departments Not Contiguous with the Main Campus (EMTALA)”, dated as effective 04/17/25, indicated, “Patients with Emergency Medical conditions will receive evaluation and treatment within the capability of the facility and the avaialable qualified medical personnel necessary to assure, within reasonable medical probability that the Emergency Medical Condition has been relieved and/or no material deterioration [worsening] to the condition is likely to result from, or occur during, a transfer, transport, or discharge.” A review of a facility provided ambulance report, dated 02/14/25, indicated the San Francisco Fire Department (SFFD) responded to a call for Patient 11. The ambulance report indicated that upon arrival by the Emergency Medical Services (EMS, pre-hospital medical care and transportation often by ambulance), “patient [11] is in handcuffs because she attempted to cut her wrists in front of PD [Police Department]. The patient has as Hx [medical history] of PTSD [Post-traumatic Stress Disorder, a mental health condition due to experiencing an extremely stressful event] and depression with previous suicide attempts ...the patient is placed on a 5150 hold [a 72-hour involuntary psychiatric evaluation and temporary detention for individuals who may be a danger to themselves, to others, or gravely disabled due to a mental health disorder] by SFPD [San Francisco Police Department]. A review of a facility provided document titled “APPLICATION FOR UP TO 72-HOUR ASSESSMENT, EVALUATION, AND CRISIS INTERVENTION OR PLACEMENT FOR EVALUATION AND TREATMENT [5150]”, dated 02/14/25, indicated a police officer detained Patient 11. The document further indicated Patient 11 “stated she was depressed and had PTSD,” and the police officer “witnessed [Patient 11] take out a knife and attempt to cut her wrist”. During a concurrent interview and record review on 05/01/20 at 9:29 AM with Registered Nurse (RN) 1, Patient 11’s ED triage RN Note, dated 02/14/25, was reviewed. The ED triage RN note indicated that Patient 11 “with several recent SI [suicidal ideation] attempts ... 5150 placed for SI, patient attempted to self cut [sic]. No abrasions [damage to skin caused by scraping] or lacerations [break in skin] as bystander intervened. Calm, cooperative.” RN 1 stated most of his assessment came from EMS report and he only recalls what is in his note about how the patient presented to the ED. A review of Emergency Department (ED) Provider Note written by Medical Doctor (MD) 1, dated 02/14/25, indicated that “Psychiatry who evaluated the patient [Patient 11] in the emergency department and feels that the patient does not currently meet 5150 criteria however given her history of cognitive [memory, thinking, and/or reasoning] impairment and significant psychiatric history he [psychiatrist] recommends that the patient be seen by social worker prior to discharge in order to facilitate a safe discharge ... given the patient’s cognitive decline, there is some concern for her return to her facility. Psychiatry is advising that she discuss with the daytime social worker a safe discharge plan.” A review of a psychiatric consult note written by MD 2, dated 02/14/25, indicated MD 2 assessed patient as having a “baseline elevated risk level for suicide.” The psychiatric consult note further indicated, “Despite an elevated baseline risk, she [Patient 11] does not appear above this risk today, and there is insufficient evidence to warrant inpatient psychiatric hospitalization or an LPS [Lanterman-Petris-Short Act, similar terminology to indicate an involuntary psychiatric evaluation and temporary detention like a 5150] ...Primary focus should tailor towards enhancing her ability to navigate psychosocial stressors.” The psychiatric consult note by MD 2 indicated under the plan section, “SW [social work] has been consulted ...Psychiatry Reassessment in the AM [morning], SW to continue to see weekend care options who can help facilitate re-orienting her back home.” During a concurrent phone interview and record review on 05/01/25 at 4:27 PM with Social Worker (SW) 1, a care team social services note for Patient 11, dated 02/14/25, was reviewed. The note indicated, “The case had been discussed with [MD 2] ...Pt [patient] is linked to [behavioral health clinic], but the [sic] are only available during regular business hours. Psychiatry may consider re-assessing the patient in the morning if clinically indicated [appropriate]. Pt will board [stay] in the ED overnight.” SW 1 stated Patient 11 was “not able to participate in conversation ...that’s why we decided to board her in the emergency room.” SW 1 further stated Patient 11’s “therapists in the community were not available ... her assigned APS [Adult Protective Services, agency that responds to reports of abuse, neglect, exploitation, and self-neglect involving older adults and adults with disabilities] social worker was not available...that’s why we decided to observe her.” SW 1 stated Patient 11 was to stay in the ED over the weekend as Patient 11’s community resources were unavailable. A review of a care team social services note for Patient 11 written by SW 2, dated 02/15/25, indicated SW 2 reassessed Patient 11 at 11:41 AM “to meet with patient to assist with discharge planning, as per psych [psychiatry].” The note further indicated, “Throughout >1.5 hour conversation with these SWs, patient [11] repeated her desire to return home to commit suicide at least 10 times. She was unwavering in her SI with plan and intent. This SW’s attempts to safety plan with [Patient 11] were entirely unsuccessful. Patient expressed strong desire to die by suicide either by stabbing herself in the heart or slitting her throat ...she is intent on carrying through with this plan.” The note further indicated, “After consulting with psych resident [MD 4], psych re-evaluated and does not recommend inpatient hospitalization ...he [MD 4] recommended someone meet patient at her housing to remove knives from her possession.” The note also indicated SW 2 called an APS SW who reiterated to SW 2 that “she feels it would be unsafe to discharge patient given her current presentation.” The note also indicated SW 2 called EMS personnel who also “feels it would be unsafe to discharge patient given her current presentation.” Finally, the note indicated SW 2 called the SFPD non-emergency line and was told that “they [SFPD] would need a warrant to remove someone’s knives.” During a phone interview on 04/30/25 12:09 PM with SW 2, SW 2 was asked about her assessment of Patient 11. SW 2 stated, “it was quite a long assessment ...I was working with her for a couple of hours ...she [Patient 11] reiterated that she was feeling suicidal ... she had a plan of how to do it ... she told me about the reasons why she was in that mindset ...” When asked if safety planning [a patient-centered process to create a plan to enhance safety in settings of crisis or potential harm] with Patient 11 was successful, SW stated, “it was unsuccessful ... she [Patient 11] was not able to say how she was going to keep herself safe.” SW 2 further stated that she “consulted with community agencies” to see if anyone could meet with Patient 11 after discharge. SW 2 stated she spoke to an APS SW and an EMS agency, but they were unable to meet with patient immediately after discharge. SW 2 concluded that Patient 11 “was consistent in her inability to safety plan with me [SW 2] ...She did not want to go home and keep herself safe.” During a concurrent interview and record review on 04/30/25 at 3:00 PM with MD 4, Patient 11’s psychiatric progress note written by MD 4, dated 02/15/25, was reviewed. The psychiatric progress note indicated Patient 11 “made statements about using a knife to cut herself, but there were no signs of actual injury on evaluations made by EMS or the ED ...The patient’s capacity to leave the hospital is: Marginal ...Though they [Patient 11] are unlikely to harm themselves and suicide is mitigated [made less severe], they are not actively willing to participate in conversation about safe discharge and active help. They are emotionally motivated and upset, near their psychiatric baseline ...” When asked what MD 4 meant by marginal capacity to leave, MD 4 stated, “part of the discussion I had with safety planning with our social work team is that there is a lot of fear that they [Patient 11] are safe to go home.” MD 4 went on to state that Patient 11 was able to communicate a choice of wanting to go home and per his assessment she continued to be at her baseline elevated risk for suicide as indicated by prior admissions. When asked what type of assessment or behavior would change Patient 11 from baseline that would warrant admission, MD 4 stated Patient 11 currently has “Contingent [dependent on] SI [suicidal ideation] versus non-contingent SI ... her [Patient 11’s] suicidal ideation was largely contingent ... if she was allowed to change apartments ...another factor we were thinking ...if there was a wound or active bleeding ... it would make us more inclined [likely] to keep her [admit patient into the hospital].” A review of a care team social services note for Patient 11 written by SW 1, dated 02/15/25, indicated “SW team worked on this case yesterday and today ... [Patient 11] does not have any support at home to be included into her safety plan ...Pt is unable to remain safely at home at this time. Pt’s outpatient provider ar [sic] only available during regular business hours: On-site CM [case manager] ...APS SW ... [behavioral health clinic] Outpatient Team ...I am unable to secure Pt’s safe DC [discharge] this weekend d/t [due to] to [sic] this particular set of circumstances.” During a concurrent interview and record review on 05/01/25 at 2:27 PM with SW 3, SW 3’s social work note titled “ED Case Management Transition of Care Plan” for Patient 11, dated 02/16/25 was reviewed. The social work note indicated, “SW met with patient at bedside ...Pt unable to engage in safety planning at this time as she remains fixated on sharing her story ... at this time, pt still unable to engage in solution focused discussion (moving to a different apartment, engaging in support from friends, caregiver support) and continues to verbalize desire to go home so she can end her life ...Discussed case with [RN 5] who noted that pt is cleared by psychiatry and attending. SW left for a brief period of time, but was requested by RN to return to bedside as pt was ‘banging her head on the wall.’ Pt emotionally elevated and screaming that she wants to kill herself now and that she no longer wants to go home ...[RN 5] discussed with psychiatry team who maintains no further evaluation is needed ...SFPD noted plan to assist with discharging pt and helping her re-present to [other hospital] for further evaluation.” SW 3 stated she met with Patient 11 and, “essentially spent the whole day with her ... she was initially calm ... she was expressing SI the whole time ...I wasn’t able to engage or have a discussion on safety planning.” SW 3 recalled that RN 5 messaged her to return to bedside as Patient 11 was banging her head against the wall; when SW 3 came to bedside she saw that the patient was back in bed and “she was much more escalated in her emotions.” During a concurrent interview and record review on 05/02/25 at 8:39 AM with MD 5, MD 5’s ED Note for Patient 11 titled, “ED OBSERVATION PROGRESS NOTES - Psychiatric care” dated 02/16/25 at 6:58 AM was reviewed. The note indicated, “The patient’s current clinical status is not changed ...patient seen by social worker who arranged for safe disposition.” MD 5 stated typically for psychiatric patients, once psychiatry has discharged a patient, he would “eye-ball them” [quickly observe] prior to writing his observation note. During a concurrent interview and record review on 05/02/25 at 8:39 AM with MD 5, RN 5’s nursing note, titled “ED Notes Addendum”, dated 02/16/25 at 1:29 PM was reviewed. RN 5’s note indicated “This RN was attempting to discharge pt [Patient 11] at this time. This RN asked pt where she would like to go and would she like to go home. PT starting to have incongruent thought stating she wants us to call police. PT screaming and ramming her head into the wall repeatedly. Nursing staff helped pt back to bed to protect patient from hurting herself. Security and social worker at bedside trying to placate [make less angry] patient.” MD 5 stated he was not notified or aware of Patient 11’s actions at time of discharge. MD 5 further stated “it would have been nice to inform me if something like this happens ... it’s definitely not normal behavior.” During a concurrent interview and record review on 04/30/25 at 3:00 PM with MD 4, RN 5’s nursing note, titled “ED Notes Addendum”, dated 02/16/25 at 1:29 PM was reviewed. RN 5’s note indicated “This RN was attempting to discharge pt [Patient 11] at this time ... PT screaming and ramming her head into the wall repeatedly.” MD 4 stated he was not the psychiatrist that was paged about Patient 11’s actions at time of discharge. When asked if this behavior would warrant an admission, MD 4 stated the behavior “may warrant a reassessment ... [it] could be an admission ... or not an admission ...I think it would be reasonable to come evaluate them [Patient 11] ...at least we can lay eyes on them again ... feel the similar confidence when we signed the [psychiatric] note.” A review of a nursing note, tilted “ED notes”, dated 02/16/25 at 1:35 PM by RN 5 indicated “This RN paging Psych at this time.” A review of a nursing note, tilted “ED notes”, dated 02/16/25 at 1:51 PM by RN 5 indicated “SFPD at bedside at this time.” A review of a nursing note, tilted “ED notes”, dated 02/16/25 at 1:57 PM by RN 5 indicated “Per Psych MD there is no need to further evaluate patient and is fine with PD escorting patient off of the property.” During an interview on 05/01/25 at 1:34 PM with MD 6, MD 6 stated he “got paged by an RN sometime in the afternoon ...asking me if the patient [11] was okay to be discharged ... although they were banging their head ...” MD 6 stated, “based on what I gleaned ... she was at her baseline.” When asked what information he used to make the decision that Patient 11 was at her baseline, MD 5 stated only the conversation with the nurse. When asked what documentation he read prior to the patient’s discharge, MD 6 stated “just [MD 4]’s note”; MD 6 stated he did not read any SW notes. When asked if he physically assessed the patient after being paged, MD 6 stated “no.” When asked if he discussed this discharge with his attending physician [a fully licensed physician that oversees a care team and the work of residents] he stated, “no.””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 28225 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.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 31794 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.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 28225 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.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 28225 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...””

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 28225 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...””

“CONTRACTED SERVICES CFR(s): 482.12(e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. This Standard is not met as evidenced by: 28225 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...””

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 28225 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) ... 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, in the Interventional Endoscopic Service (IES) area, located on the 4th floor of the hospital, inside the Clean Storage Room (CSR) 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 had no thermostat (main control unit for a heating or cooling system). NM 1 explained, 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. NM 1 further stated, the facility used the “Olympus” type of flexible scopes that were inside the Storage Cabinet. The Storage Cabinet’s temperature and humidity had not been monitored since 2019, but it should be monitored to maintain the “integrity” of the scopes. During a review of the facility (Healthcare System’s Name), [Facilities Group Name affiliated with (three) separately certified hospitals], document titled, “Procedure - Cleaning of Surgical Procedural and Sterile Processing Areas, dated 7/25/2022, Indicated, “ Page 2 of 8, 1. Standards of practice for environmental cleaning are outlined in this procedure and determined by Association of periOperative Registered Nurses (AORN (AORN, a national community for operating room nurses who sought to share best practices for patients undergoing surgery ... Page 5 of 8, Sterile Processing Department, Sterile processing areas where decontamination occurs are at the highest risk of all perioperative areas for environmental decontamination ... Sterile Storage/ Preparation and Packaging areas these areas are considered to be clean work areas within the department ... Page 6 of 8, Additional Areas ... additional departmental locations will be inspected daily ... this includes ... storage cabinets ...” According to Association of periOperative Registered Nurses . “Guideline Essentials, Flexible Endoscopes, guideline at a glance. “STORING ... Place flexible endoscopes in a drying cabinet ... Form a multidisciplinary team to collaborate with manufacturer service personnel to determine schedules for preventive maintenance of flexible endoscopes, mechanical processors, and other equipment (eg, the drying cabinet) used for processing flexible endoscopes ...Reviewing and evaluating quality assurance and performance improvement activities may identify failure points that contribute to errors in processing flexi- ble endoscopes and help define actions for improvement and increased competency. Taking corrective action may improve patient safety by enhancing understanding of the principles of and compliance with best practices for processing flexible endoscopes. During an interview on 2/8/24, at 12:50 PM, with the Chief of Facility (COF) and the QAC 1, the COF stated, they “do not monitor” the temperature and humidity in the CSR area as well as the scopes in the storage cabinet. The COF stated, there was a “HEPA (High Efficiency Particulate Air, removes airborne particles) filter” inside the scope cabinet, and the filter was changed every six (6) months. 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 %.” Review of the facility’s P&P titled, “Infection Control Strategies for Handling, Disinfection, and Maintenance of Flexible Scopes, ... Probes and Instruments,” revised date of 3/21/19 indicated, “Storage of Flexible Scopes: 1. Flexible scope ... must be hung and stored vertically ... 2. Scopes should enter the storage area in a manner that clearly illustrates the movement of scopes with the oldest dates ... 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 ensure the standard storage environment of the flexible scopes was in accordance with the manufacturer’s IFU. Review of Olympus Operational Manual Instructions dated 2019 indicated, “Warnings and Caution: Follow the warning given below and cautions given below when handling endoscope. ... After using these endoscopes, reprocess, and store it according to the instructions given ... Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and /or infection...” 4. During an observation on 2/6/24, at 9:30 AM, with the Chief of Nursing (CNE), MSS 1, and SPT 1, in SPD, in the Clean Assembly Area (centralized area where all instruments are sorted and inspected to make sure they are still working properly before they are sterilized), SPT 3 came out from the break room, sat on a chair, and without performing hand hygiene and without donning pair of gloves, started to assemble with his bare hands the clean surgical instruments on the hysterotomy instrument tray. During a concurrent interview on 2/6/24, at 9:30 AM, 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. During an interview on 2/6/24, at 10:32 AM, 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. 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,”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 NHSN and surveillance definitions and comparative database are utilized to evaluate patient outcomes ... 2023 Infection Prevention and Control Program Risk Assessment ... Hand Hygiene ... 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 https://www.cdc.gov > handhygiene, “One of the best ways to prevent the spread of infections is by washing your hands ...” 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...” Review of the Center for Disease Control and Prevention, Hand Hygiene in Healthcare Settings, dated 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.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 31794 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 ... .””

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 28225 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, in the Interventional Endoscopic Service (IES) area, located on the 4th floor of the hospital, inside the Clean Storage Room (CSR) 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 had no thermostat (main control unit for a heating or cooling system). NM 1 explained, 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. NM 1 further stated, the facility used the “Olympus” type of flexible scopes that were inside the Storage Cabinet. The Storage Cabinet’s temperature and humidity had not been monitored since 2019, but it should be monitored to maintain the “integrity” of the scopes. During a review of the facility (Healthcare System’s Name), [Facilities Group Name affiliated with (three) separately certified hospitals], document titled, “Procedure - Cleaning of Surgical Procedural and Sterile Processing Areas, dated 7/25/2022, Indicated, “ Page 2 of 8, 1. Standards of practice for environmental cleaning are outlined in this procedure and determined by Association of periOperative Registered Nurses (AORN (AORN, a national community for operating room nurses who sought to share best practices for patients undergoing surgery ... Page 5 of 8, Sterile Processing Department, Sterile processing areas where decontamination occurs are at the highest risk of all perioperative areas for environmental decontamination ... Sterile Storage/ Preparation and Packaging areas these areas are considered to be clean work areas within the department ... Page 6 of 8, Additional Areas ... additional departmental locations will be inspected daily ... this includes ... storage cabinets ...” According to Association of periOperative Registered Nurses . “Guideline Essentials, Flexible Endoscopes, guideline at a glance. “STORING ... Place flexible endoscopes in a drying cabinet ... Form a multidisciplinary team to collaborate with manufacturer service personnel to determine schedules for preventive maintenance of flexible endoscopes, mechanical processors, and other equipment (eg, the drying cabinet) used for processing flexible endoscopes ...Reviewing and evaluating quality assurance and performance improvement activities may identify failure points that contribute to errors in processing flexi- ble endoscopes and help define actions for improvement and increased competency. Taking corrective action may improve patient safety by enhancing understanding of the principles of and compliance with best practices for processing flexible endoscopes. During an interview on 2/8/24, at 12:50 PM, with the Chief of Facility (COF) and the QAC 1, the COF stated, they “do not monitor” the temperature and humidity in the CSR area as well as the scopes in the storage cabinet. The COF stated, there was a “HEPA (High Efficiency Particulate Air, removes airborne particles) filter” inside the scope cabinet, and the filter was changed every six (6) months. 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 %.” Review of the facility’s P&P titled, “Infection Control Strategies for Handling, Disinfection, and Maintenance of Flexible Scopes, ... Probes and Instruments,” revised date of 3/21/19 indicated, “Storage of Flexible Scopes: 1. Flexible scope ... must be hung and stored vertically ... 2. Scopes should enter the storage area in a manner that clearly illustrates the movement of scopes with the oldest dates ... 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 ensure the standard storage environment of the flexible scopes was in accordance with the manufacturer’s IFU. Review of Olympus Operational Manual Instructions dated 2019 indicated, “Warnings and Caution: Follow the warning given below and cautions given below when handling endoscope. ... After using these endoscopes, reprocess, and store it according to the instructions given ... Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and /or infection...” 4. During an observation on 2/6/24, at 9:30 AM, with the Chief of Nursing (CNE), MSS 1, and SPT 1, in SPD, in the Clean Assembly Area (centralized area where all instruments are sorted and inspected to make sure they are still working properly before they are sterilized), SPT 3 came out from the break room, sat on a chair, and without performing hand hygiene and without donning pair of gloves, started to assemble with his bare hands the clean surgical instruments on the hysterotomy instrument tray. During a concurrent interview on 2/6/24, at 9:30 AM, 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. During an interview on 2/6/24, at 10:32 AM, 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. 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 NHSN and surveillance definitions and comparative database are utilized to evaluate patient outcomes ... 2023 Infection Prevention and Control Program Risk Assessment ... Hand Hygiene ... 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 https://www.cdc.gov > handhygiene, “One of the best ways to prevent the spread of infections is by washing your hands ...” 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...” Review of the Center for Disease Control and Prevention, Hand Hygiene in Healthcare Settings, dated 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.””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 28225 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 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, in the Interventional Endoscopic Service (IES) area, located on the 4th floor of the hospital, inside the Clean Storage Room (CSR) 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 had no thermostat (main control unit for a heating or cooling system). NM 1 explained, 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. NM 1 further stated, the facility used the “Olympus” type of flexible scopes that were inside the Storage Cabinet. The Storage Cabinet’s temperature and humidity had not been monitored since 2019, but it should be monitored to maintain the “integrity” of the scopes. During a review of the facility (Healthcare System’s Name), [Facilities Group Name affiliated with (three) separately certified hospitals], document titled, “Procedure - Cleaning of Surgical Procedural and Sterile Processing Areas, dated 7/25/2022, Indicated, “ Page 2 of 8, 1. Standards of practice for environmental cleaning are outlined in this procedure and determined by Association of periOperative Registered Nurses (AORN (AORN, a national community for operating room nurses who sought to share best practices for patients undergoing surgery ... Page 5 of 8, Sterile Processing Department, Sterile processing areas where decontamination occurs are at the highest risk of all perioperative areas for environmental decontamination ... Sterile Storage/ Preparation and Packaging areas these areas are considered to be clean work areas within the department ... Page 6 of 8, Additional Areas ... additional departmental locations will be inspected daily ... this includes ... storage cabinets ...” According to Association of periOperative Registered Nurses . “Guideline Essentials, Flexible Endoscopes, guideline at a glance. “STORING ... Place flexible endoscopes in a drying cabinet ... Form a multidisciplinary team to collaborate with manufacturer service personnel to determine schedules for preventive maintenance of flexible endoscopes, mechanical processors, and other equipment (eg, the drying cabinet) used for processing flexible endoscopes ...Reviewing and evaluating quality assurance and performance improvement activities may identify failure points that contribute to errors in processing flexi- ble endoscopes and help define actions for improvement and increased competency. Taking corrective action may improve patient safety by enhancing understanding of the principles of and compliance with best practices for processing flexible endoscopes. During an interview on 2/8/24, at 12:50 PM, with the Chief of Facility (COF) and the QAC 1, the COF stated, they “do not monitor” the temperature and humidity in the CSR area as well as the scopes in the storage cabinet. The COF stated, there was a “HEPA (High Efficiency Particulate Air, removes airborne particles) filter” inside the scope cabinet, and the filter was changed every six (6) months. 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 %.” Review of the facility’s P&P titled, “Infection Control Strategies for Handling, Disinfection, and Maintenance of Flexible Scopes, ... Probes and Instruments,” revised date of 3/21/19 indicated, “Storage of Flexible Scopes: 1. Flexible scope ... must be hung and stored vertically ... 2. Scopes should enter the storage area in a manner that clearly illustrates the movement of scopes with the oldest dates ... 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 ensure the standard storage environment of the flexible scopes was in accordance with the manufacturer’s IFU. Review of Olympus Operational Manual Instructions dated 2019 indicated, “Warnings and Caution: Follow the warning given below and cautions given below when handling endoscope. ... After using these endoscopes, reprocess, and store it according to the instructions given ... Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and /or infection...” 4. During an observation on 2/6/24, at 9:30 AM, with the Chief of Nursing (CNE), MSS 1, and SPT 1, in SPD, in the Clean Assembly Area (centralized area where all instruments are sorted and inspected to make sure they are still working properly before they are sterilized), SPT 3 came out from the break room, sat on a chair, and without performing hand hygiene and without donning pair of gloves, started to assemble with his bare hands the clean surgical instruments on the hysterotomy instrument tray. During a concurrent interview on 2/6/24, at 9:30 AM, 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. During an interview on 2/6/24, at 10:32 AM, 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. 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,”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 NHSN and surveillance definitions and comparative database are utilized to evaluate patient outcomes ... 2023 Infection Prevention and Control Program Risk Assessment ... Hand Hygiene ... 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 https://www.cdc.gov > handhygiene, “One of the best ways to prevent the spread of infections is by washing your hands ...” 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...” Review of the Center for Disease Control and Prevention, Hand Hygiene in Healthcare Settings, dated 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.””