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2701 S BRISTOL ST

SANTA ANA, CA 92704

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on interview and record review, the hospital failed to ensure the medical staff was accountable to the GB for the quality of care and services provided to patients in regard to implementation of ongoing professional practice evaluation (OPPE) for the medical staff. This failure increased the risk for substandard outcomes for patients receiving care from the medical staff.

Findings:

Review of the hospital's Medical Staff Bylaws and General Rules and Regulations dated April 2025, indicated;

* Article 2, Section 1.B. showed the Medical Staff is accountable to the Governing Board for the quality and appropriateness of the professional performance and ethical conduct of its members, and to strive for achievable quality patient care, efficiently delivered and maintained consistently with available resources.

* Article 5, Section 3 showed Medical Staff members are subject to ingoing evaluation based on peer review criteria. The information collected will be evaluated and used as part of the reappointment process. Data will be collected no less than every six months and no more than every nine months.

Review of the hospital's P&P titled Professional Practice - Ongoing (OPPE) and Focused (FPPE) dated September 2023 showed annually, an OPPE Report Card for each practitioner scheduled for review will be prepared with data that has been collected, collated, and transcribed onto the Report Card by the Quality Management Department. The reports will be given to the Department Chair who will review the information and identify any unsatisfactory triggers or trends which would require a focused review. A summary of his/her assessment will be reported to the Credentials Committee, Medical Executive Committee, and the Governing Board, including any recommendations for focus review. Each practitioner's OPPE report will be maintained in the Medical Staff Office and will be incorporated with the practitioner's reappointment information.

During a concurrent interview and record review on 10/29/25 at 1130 hours, with the Director of Medical Staff and the Medical Staff Coordinator, the hospital's credential files were reviewed. The Director of Medical Staff stated the OPPE was last conducted in 2023. The Director of Medical Staff stated the OPPEs were not currently being conducted.

On 10/31/25 at 1236 hours, the above concern was shared and acknowledged by the CNO, the Director of Quality and the Director of CCU. The CNO shared there were 213 practitioners currently undergoing the initial credentialing and reappointment process.

CONTRACTED SERVICES

Tag No.: A0084

Based on interview and record review, the hospital failed to ensure the Governing Body maintained oversight of contracted dialysis service as evidenced by:

1. The Governing Body failed to verify that the contracted dialysis vendor (Vendor B) was licensed to provide dialysis services.

2. The Governing Body failed to ensure a registered nurse (RN 1) working under the contracted dialysis vendor (Vendor B) completed the required competency validation prior to providing patient care.

These deficient practices resulted in the hospital's lack of oversight of contracted dialysis services and created a risk that dialysis care and documentation were inconsistent with the hospital's quality and safety standards.

Findings:

On 10/29/25 at 1020 hours, an interview was conducted with the CNO. The CNO stated the hospital's dialysis contract with Vendor A ended on 10/25/25 and a new contract was executed with Vendor B on the same date. The CNO stated Vendor B would provide acute dialysis services to hospital patients.

Review of the Dialysis Services Agreement showed this Dialysis Services Agreement effective as of 10/25/25 between the hospital and Vendor B. Further review of the Dialysis Services Agreement showed all agency personnel who provide dialytic services under this agreement must be approved by the hospital before such personnel provide services at the hospital. The agency shall review each nurse's competency prior to permitting such nurse to perform dialytic services at the hospital. The agency shall require, maintain, provide, and have promptly available for hospital's review the following documents for each agency nurse providing services: the licensure, evidence of current certification BLS, health status, certification of liability insurance, and documented training on OSHA standards for blood borne pathogens.

1. On 10/29/25 at 1437 hours, an interview was conducted with the Clinical Nurse Manager for Vendor B. The Clinical Nurse Manager for Vendor B stated Vendor B did not need a certification license as it was providing acute care services. The Clinical Nurse Manager for Vendor B stated this was communicated with the hospital.

On 10/31/25 at 1030 hours, the CNO stated she was unaware that Vendor B was not certified by the CMS and stated all communications between Vendor B and the hospital were conducted at the corporate level. The CNO acknowledged the hospital failed to verify Vendor B's licensure status before initiating dialysis services at the hospital.

2. On 10/29/25 at 1052 hours, review of Patient 1's medical record showed Patient 1 was admitted to the hospital on 10/26/25 and transferred to another hospital on 10/28/25.

Review of the Hemodialysis Treatment Flowsheet showed Patient 1 received hemodialysis on 10/26/25 at 2100 hours and on 10/28/25 at 1230 hours. However, documentation for both treatments was completed by RN 1 using the hemodialysis treatment flowsheet for Vendor C, not Vendor B.

On 10/31/25 at 1111 hours, an interview was conducted with RN 1 and the Clinical Nurse Manager for Vendor B. RN 1 stated RN 1 worked for both Vendor B and Vendor C and used Vendor C's flowsheet because it was the only one available. The Clinical Nurse Manager for Vendor B confirmed RN 1 was assigned under Vendor B's contract when he performed the dialysis treatments for Patient 1.

Review of RN 1's competency file showed the last completed competency verification for hemodialysis initiation and pre-dialysis functions was dated 9/6/24, under Vendor C, not Vendor B.

On 10/31/25 at 1133 hours, the CNO, Director of Quality, and Director of CCU reviewed and acknowledged the findings.