Chapman Global Medical Center

“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: 29558 Based on observation, interview, and record review, the hospital failed to ensure the GB was responsible for the conduct of the hospital as evidenced by: 1. The GB failed to ensure the contracted dialysis service was provided in a safe and effective manner. Cross reference to A084. 2. The GB failed to oversee the contracted dialysis service when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Dialysis 1). Cross reference to A083. 3. The hospital failed to ensure the GB had oversight of the institutional plan and budget allocation for dialysis contract services for 2025. Cross reference to A077. The cumulative effect of these systemic failures resulted in the hospital’s inability to provide quality healthcare in a safe environment for the patients.”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d)(7) The plan must be prepared- o Under the direction of the governing body; and o By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure the GB had oversight of the institutional plan and budget allocation for dialysis contract services for 2025. This failure resulted in the lack of assurance for the availability and continued provision of safe and quality dialysis services for the patients. Findings: Review of the hospital’s Bylaws of the Governing Body adopted 4/18/24, showed: Article IV Governing Board Operation; Section 9: Facility Plans and Budgets. The Governing Board, together with the hospital CEO, shall develop short-term and long-term fiscal management plans including, but not limited to, annual capital and operating budgets, and a long-range master plan, to the end that the hospital may effectively serve the community. Such plans shall be submitted to the Board of Directors or its designee for review and approval. Planning for care, treatment and services addresses the following: the needs and expectations of patients and as appropriate, families and referral sources, staff needs, scope of care, treatment and services needed by patients at all of the hospital’s location, resources (financial and human) for providing care and support services, recruitment, retention, development, and continuing education needs of all staff and data for measuring the performance of processes and outcomes of care. During an interview on 10/29/25 at 1455 hours, with the CNO/CEO, the CNO/CEO stated the dialysis service was a contracted service. The corporation informed her there would be a new dialysis company, Dialysis 1. The CNO/CEO stated that bills for contracted services, such as dialysis, were sent to the corporation which was responsible for paying the contractors. The CNO/CEO stated she did not handle contractor payments and stated that the corporation was mainly responsible for the hospital’s budget. During a telephone interview on 10/30/25 at 0912 hours, with the Chief Quality and Patient Safety Officer (PSO), with the CNO/CEO present, the Chief Quality and Patient Safety Officer (PSO) stated the reason for the termination of Dialysis 2 was the corporation not paying the contractor. A concurrent interview and review of the hospital’s budget and actual performance hospital’s budget and actual performance was conducted on 11/3/25 at 1515 hours, with the CNO/CEO. The CNO/CEO stated that for the purchased services like dialysis, the hospital did not have issues with the budget; however, overall, the corporation had control of the hospital’s budget.”

“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: 37663 Based on interview and record review, the hospital failed to ensure GB oversight of the contracted dialysis service when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Dialysis 1). This failure had the potential to result in the increased risk of health outcomes for the patients receiving dialysis services in the hospital. Findings: Review of the hospital’s Bylaws of the Governing Board adopted 4/18/24, showed: * The purpose of the Governing Board is to recommend and implement hospital’s policies, promote patient safety and performance improvement, facilitate quality patient care, and provide for organizational management and planning of the hospital. *Article I: The functions and duties of the Governing Board (hereinafter referred to collectively as the “Governing Board” or individual members as “member”) shall be as directed from time to time by the Board of Directors of the Corporation, consistent with the standards of the Joint Commission on Accreditation of Healthcare Organizations (JC) and applicable laws and regulations. Such functions shall include, but not limited to: - Approving the hospital’s written scope of services, providing organization management and planning. - Providing resources needed to maintain safe, quality care, treatment, and services. * Article IV: The Governing Board shall have responsibility for the business and affairs of the hospital to the extent delegated by the Board of Directors. The Governing Board shall delegate responsibility and authority for the day-to-day management of the hospital to the hospital CEO. The Governing Board shall participate in and support an institution process periodically review, evaluate, and revise key hospital policies and procedures to address integrated patient care. During a review of the hospital’s P&P titled “Organizational-Wide Quality Assessment and Performance Improvement Program,” reviewed in March 2024, the hospital’s P&P showed the following: - Governing Board: The Governing Board shall be responsible for ensuring the provision of optimal quality care, safety, and organizational-wide performance. The Board is ultimately accountable for the safety and quality of patient care provided in every department and service of the hospital and has legal responsibility and operational authority for the hospital and performance. - Quality Assurance Improvement Committee is the hospital- based multidisciplinary body that serves to coordinate organizational quality improvement activities. Membership includes but is not limited to representatives from both clinical and non-clinical areas including the Medical Staff, Senior Leadership (CEO, CNO, CQO, CFO), Quality Coordinator, Risk Management/Patient Safety Officer, and other clinical and non-clinical staff as appropriate on an ad hoc basis. Council meetings are scheduled at least quarterly. Activities include but are not limited to: ... Review new service proposals ensuring appropriate quality measures are established. Review of the Dialysis Services Agreement showed this Dialysis Service Agreement effective as of 10/25/25, was entered into by and between the hospital and Dialysis 1. The Dialysis Services Agreement was signed by Dialysis 1’s CEO and the corporate CFO of the hospital. During a telephone interview on 10/29/25 at 1412 hours, with the Dialysis 1 Nurse Manager, the Dialysis 1 Nurse Manager stated they provided dialysis service to the hospital; however, their company did not have their own dialysis staff nurses yet. Dialysis 1 pulled nurses from Dialysis 3. These two companies were owned by the same owner. The Dialysis 1 Nurse Manager stated the onboarding process, including completion of staff competency, had not been done and the personnel files for nurses were not available. The Dialysis 1 Nurse Manager stated their company was notified to provide dialysis service 48 hours prior to the start date. She and the company’s owner decided to use Dialysis 3 nurses due to the short notice. Dialysis 1 operated under a business license and has no CCN or licensed. During an interview with the CNO/CEO on 10/29/25 at 1423 hours, the CNO/CEO who identified as the Interim Chairman of the Governing Board since February 2025, stated the corporate informed the CNO/CEO on 10/22/25 that they were changing to another dialysis company. The CNO/CEO stated the CNO/CEO sent a memo on 10/24/25 to the Medical Executive Committee stating the hospital was changing to a new dialysis company effective 10/26/25. The CNO/CEO stated the CEO was responsible for reviewing contracts and would know if the contractor was ready to provide services. The CNO/CEO stated the CNO/CEO reviewed local contracts specific to the hospital but did not review the contract for Dialysis 1. On 10/30/25 at 1000 hours, a concurrent interview and review of the Standard Operating Procedure for contract process approval and the service contract with Dialysis 1 was conducted with the CNO/CEO. The CNO/CEO stated whoever approved or signed the contract was the one who reviewed the contract agreement; and for the Dialysis 1 contract, the corporate CFO signed the contract. The CNO/CEO verified the dialysis contract signed by the corporate CFO was undated. On 10/31/25 at 0620 hours and 11/3/25 at 1115 hours via email correspondence, the hospital verified that the acute inpatient dialysis was referring to both emergent and maintenance dialysis for inpatient. The hospital was notified that the contracted dialysis vendor, Dialysis 1 was not licensed to provide dialysis services.”

“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: 37663 Based on observation, interview, and record review, the hospital failed to ensure the contracted dialysis service was provided in a safe and effective manner as evidenced by: 1. The contracted dialysis nurse did not provide dialysis treatment for one of one sampled patient (Patient 1) as per the physician’s order and as per the contracted dialysis vendor (Dialysis 1)’s P&P. 2. There was no documented evidence to show the hospital evaluated the contracted dialysis vendor (Dialysis 2). 3. The hospital failed to ensure preventative maintenance was completed on contracted equipment as per the hospital’s P&P. These failures placed patients at risk of serious harm, including inadequate treatment, delayed medical response, and potential life-threatening complications during dialysis. Findings: Review of the hospital’s Bylaws of the Governing Board adopted 4/18/24, showed Article IV: Section 7: Patient Care. The Governing Board shall participate in and support an institutional process to periodically review, evaluate, and revise key hospital policies and procedures to address integrated patient care. During a review of the hospital’s P&P titled Policy and Procedure Manual Review Approval dated October 2023, the P&P showed * Based on the standard of nursing practice and standards of patient care, the policies and procedures are defined to describe the scope and conduct of patient care provided by the nursing staff. These standards, P&P are defined in writing and developed by the CNO, RN, and other designated nursing members in collaboration with other clinical and administrative groups when appropriate. * Procedure: Initiation, revision and approval of a policy or procedure. All policies that impact Medical Management need to be reviewed at the appropriate medical committee meeting. 1. Review of Dialysis 1’s P&P titled Termination of Dialysis Treatment Using the Tablo System dated 5/1/23, showed the following: * Verify all medications have been administered and documented. * After the treatment is ended, rinse back the patient’s blood. Before rinse back, ensure at least 300 - 500 ml of normal saline (IV salt solution) is in the bag prior to rinse back. If not, replace saline bags. To prevent air from entering the blood circuit, make sure the saline line is primed. * Once treatment is completed .... begin blood return. When the blood return is completed, the screen will prompt the user to take blood pressure readings and deliver saline bolus as needed before disconnecting the patient lines. * If a patient exhibits signs and symptoms of hypotension, place the patient on a modified Trendelenburg and administer normal saline per standing or physician order. Document intervention and patient’s response in the EMR. During a review of Patient 1’s medical record on 10/30/25 at 1500 hours, with the Program Coordinator and Data Analyst, Patient 1’s medical record showed Patient 1 was admitted to the hospital on 10/21/25, to the ICU with diagnoses of hyperkalemia, end-stage renal disease (ESRD) on hemodialysis. The patient’s weight on admission was 59 kg. During a review of Patient 1’s dialysis order dated 10/27/25 and electronically signed by the physician on 10/28/25 at 1644 hours, the order showed the following: * Dialysis duration of 3 hours. * UF goal of 2.5 liters. * BFR: 400 ml/min * Blood flow intolerance: if unable to maintain flow due to vascular access patency, patient intolerance (such as chest pain or access discomfort), or elevated venous pressure, “adjust blood flow between mL/min to mL/min.” The blood flow range was 400 ml/min. * UFR intolerance: if unable to maintain the UFR due to patient intolerance (such as hypotension, chest pain, muscle cramping, nausea, or vomiting), “adjust UFR to achieve liters to liters.” The UFR range was 2 to 2.5 liters. During a review of the Hemodialysis Treatment Flowsheet dated 10/28/25, the Hemodialysis Treatment Flowsheet showed the following: - The name of Dialysis 3 was crossed out. The hand-written name of Dialysis 1 was written under the Hemodialysis Treatment Flowsheet. - The Time On section showed “0150” hours. The patient’s pre-weight was 59 kg. The patient’s BP was 135/68 mmHg. - The UF goal was 2500 ml. - The prime section showed 200 ml. - The Patient Education section showed the boxes of “No Education Provided” and “Altered Mental Status” were checked. - At 0155 hours, the dialysis treatment was initiated. The patient’s BP was 155/80 mmHg. The BFR was 200 ml/min. 300 ml fluid was removed. - At 0210 hours, the patient’s BP was 132/83 mmHg. The BFR was 400 ml/min. 102 ml fluid was removed. The patient’s vital signs were stable, and the patient had no distress. - At 0225 hours, the patient’s BP was 132/69 mmHg. The BFR was 400 ml/min. 142 ml fluid was removed. The patient was alert and had no issues. - At 0240 hours, the patient’s BP was 136/66 mmHg. The BFR was 400 ml/min. 387 ml fluid was removed. The patient was alert and tolerated well. - At 0255 hours, the patient’s BP was 123/68 mmHg. The BFR decreased to 300 ml/min. 580 ml (total) fluid was removed. The patient complained of nausea and demanded to decrease the UF goal. - At 0310 hours, the patient’s BP was 125/61 mmHg. The BFR was 300 ml/min. 643 ml (total) fluid was removed. The UF goal was decreased and the BFR was lowered. - At 0325 hours, the patient’s BP was 113/53 mmHg. The BFR was 300 ml/min. 800 ml (total) fluid was removed. The patient’s BP was trending down. The patient was upset and wanted UF lowered. - At 0340 hours, the patient’s BP was 105/55 mmHg. The BFR was 300 ml/min. 940 ml (total) fluid was removed. The patient was complaining (RN’s writing was not legible). - At 0355 hours, the patient’s BP was 113/64 mmHg. The BFR was 300 ml/min. 1009 ml (total) fluid was removed. The patient’s vital signs were stable. The patient was repositioned, UF... (RN writing not legible). - At 0410 hours, the patient’s BP was 97/59 mmHg. The BFR was 300 ml/min. 1200 ml (total) fluid was removed. The patient’s BP was trending down. The UF goal was lowered. - At 0425 hours, the patient’s BP was 90/51 mmHg. The BFR was 300 ml/min. 1260 ml (total) fluid was removed. the patient’s BP kept dropping. The UF goal was lowered. - At 0440 hours, the patient’s BP was 99/57 mmHg. The BFR was 300 ml/min. 1254 ml (total) fluid was removed. The UF remained off. The patient was alert, had no distress. - At 0455 hours, the patient’s BP was 92/54 mmHg. The BFR was 300 ml/min. 1300 ml (total) fluid was removed. the treatment completed and blood was returned. - The Time Off section showed “0455” hours. The patient’s BP was 118/63 mmHg. The Post-Weight section was left blank. - The Comments section showed Patient 1 kept complaining and moving arm during the dialysis treatment. The BP was trending down, and 1.3 liters of net fluid was removed. - The “NS:” section was left blank. During an interview with the Program Coordinator and Data Analyst on 10/30/25 at 1500 hours, the Program Coordinator and Data Analyst was asked for the RN bedside progress note to show the physician was notified of the event during dialysis treatment on 10/28/25 and order for the BP parameters. The Program Coordinator and Data Analyst stated there was no documentation to show the physician was called, the UF goal of 2 to 2.5 liters was not reached, and there was no order for BP parameters during dialysis treatment. On 11/3/25 at 1550 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the CNO/CEO. The following was shared with the CNO/CEO: * There was no documented evidence to show Patient 1’s was weighed after the dialysis treatment. * There was no documented evidence to show the physician was notified of the UFR goal was not met. * There was no documented evidence to show the dialysis nurse clarified with the physician about the BP parameter when the patient’s SBP was decreased to approximately 90 mmHg. * There was no documented evidence to show whether the NS was used to prime the saline line or administered to the patient. The CNO/CEO stated the CNO/CEO could not speak for the dialysis nurse who provided the dialysis treatment to the patient. The findings were verified with the CNO/CEO. 2. During an interview on 10/29/25 at 1423 hours, with the CNO/CEO, the CNO/CEO stated she reviewed the contracts for the purpose of performance improvement and for Dialysis 2 contracted service, the hospital did not encounter any issue with their service. However, during a review of the QAPI meeting minutes from September and December 2024, and April 2025, there was no documentation of dialysis contract evaluated for their performance. During an interview on 10/30/25 at 1000 hours, with the CNO/CEO, the CNO/CEO was asked for the hospital’s P&P for Contract Services. The CNO/CEO stated the hospital did not have P&P for Contract Services. During a review of the GB meeting minutes dated February 2025 (annual meeting), the documentation showing Hospital Agreements listing were approved. The findings were shared with the CNO/CEO and Director of Quality. 45560 3. During a review of “Dialysis Services Agreement,” the Dialysis Service Agreement showed this Dialysis Service Agreement effective as of 10/25/25, was entered into by and between the hospital and Dialysis 1. Article II Agency Responsibilities section showed Dialytic Services Equipment section showing during the term of this Agreement, the agency (Dialysis 1) shall provide and operate all of equipment for the performance of Dialytic Services in accordance with the following terms and conditions: - Maintenance. Agency shall, at its sole cost and expense, check, monitor, repair and maintain the equipment in accordance with applicable laws, the manufacturer’s specifications, and hospital standards. Preventive maintenance shall be documented and labeled in accordance with hospital policies. During a review of the hospital’s P&P titled, “Preventive Maintenance Verification System,” dated December 2023, the P&P showed biomedical engineering is to use a color-coded sticker system to identify equipment’s preventative maintenance due date, performance verification indication. and functional status. During a concurrent interview and observation on 10/29/25 at 1500 hours, with the Director of Quality in the dialysis equipment storage room located in the ICU, a Tablo Dialysis machine observed with no preventative maintenance sticker. The Director of Quality acknowledged no preventative maintenance sticker was found on the Tablo Dialysis machine. During an interview on 11/3/25 at 1600 hours with the CNO/CEO, the CNO/CEO was notified of the absence of a preventive maintenance sticker on the Tablo Dialysis machine and acknowledged the above findings.”