Fresenius Medical Care El Paso Gateway

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 43999 Based on facility documentation, observation and staff interviews, the facility failed to comply with applicable State laws and regulations pertaining to licensure and any other relevant health and safety requirements, when the facility did not report hospital transfers or patient deaths to the department within ten working days. Findings: Review of the facility patient admission/discharge report for January 2025 to August 6, 2025, revealed four patient deaths with no documentation found for the required report to the department within 10 working days. Patient #16 had a progress not dated 6/20/25 of a hospital transfer for further evaluation of respiratory distress and agitation during treatment. Clinic Manager (CM) , Staff #1 interviewed 9/22/25 confirmed the facility did not report hospital transfers or deaths to the state department as required. There is no way to know when a patient is transferred to the hospital unless the staff provide the information to the manager. The facility hospitalizations are reviewed in the monthly Quality meetings but do not reflect when a patient is transferred from the facility to hospital emergency room for further evaluation . The CM stated she was unaware this was a requirement.”

“PR-RECEIVE UNDERSTANDABLE INFORMATION CFR(s): 494.70(a)(2) The patient has the right to- (2) Receive all information in a way that he or she can understand; This Standard is not met as evidenced by: 43999 Based on record review and interview, the facility failed to ensure that patient #1 received information regarding a verbal complaint in a way the patient could understand. Findings: Facility policy titled “Patient’s Rights and Responsibilities” state in part “The patient has a right to: 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD; 2. Receive all information in a way that he or she can understand; 3. Privacy and confidentiality in all aspects of treatment; 4. Privacy and confidentiality in personal medical records; 5. Be informed about and participate if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; In review of the facility grievance/compliant log from January 2025 to present, there was no documentation of patient #1 verbal compliant . Review of the patient’s medical record documentation did not provide patient communication related to the verbal complaints voiced to the facility staff that started in July 2025 to present day. There was no formal documentation of the complaint that detailed actions taken with evaluation for resolution. In interviews 9/23/25 with patient #1 & #13, it was shared the facility staff listen but do not do provide any information that actions are taken to address the patients’ concerns. In an interview 9/23/25 with staff #1, it was shared the patients complaints are investigated and then discussed with the patient as to the actions taken and the patient’s satisfaction to the resolution. If there is no resolution , additional review is initiated and updated to the patient. Documentation of the complaint and resolution for the patient complaints was not provided during the survey. In an interview during record review on 9/23/25 with the CM (staff #1), the above findings were confirmed.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 43999 Based on observation, record review and interview, the facility staff nurse failed to follow policy to address patients care during the hemodialysis treatment per the facility’s policy for hypertension in 1 (Patient #2) of 1 sampled patients. Findings: Facility Policy titled “Patient Assessment and Monitoring published 05/01/2023, in parts stated: Purpose -The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment.. Data Collection -Direct patient care staff may collect data such as weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT/LPN note any changes or abnormal findings in the patient ’ s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. ·The RN will notify the patient ’ s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. Patient # 1 A review of Patient # 1’s treatment sheet dated 08/15/25 revealed the following documentation: PRE-DIALYSIS VITALS AND EVALUATION signed by PCT AW(kg) 69.7 TWR(kg)1.2 GAIN(kg) 1.7 BPSIT 165/90 BPSTAND 164/100 PULSE 76R RESP 18 TEMP98.1 CONFIRM PATIENT IDENTITY AND DIALYSIS ORDERS: Yes DATE/TIME: 08/15/2025 09:38 NEW COMPLAINT OR NEW OBSERVATIONS SINCE LAST TREATMENT (INCLUDING FALL OR INJURY): No new findings OTHER COMMENTS: 09:46 AM By RN: bp slightly elevated per pt took bp meds prior to treatment stress bp med compliance fluid wt gains within range. PRE-DIALYSIS VITALS AND EVALUATION NURSING APPROVAL TO START TREATMENT: signed by PCT DATE/TIME: 08/15/2025 09:47 There was no documented assessment of the patient’s (pt) above parameter blood pressure by the registered nurse prior to the start of the hemodialysis treatment. 09:34 AM: Treatment started: Blood Pressure: (BP) 166/91 UF On;Treatment Initiated Without Problem; Access Visible; Green AMP Light; Denies Complaints; Patient Alert ; Started signed by PCT 10:05 AM: BP:180/101 Access Visible;Green AMP Light; Denies Complaints; Patient Alert ; bp elevated lowered legs pt denies symptoms, signed by RN 10:24 AM: BP: 1698/95 UF On; Access Visible; RN Notified; Green AMP Light; Denies Complaints; Patient Alert ; HBP, signed by PCT 10:54 AM: BP:184/87 UF On; Access Visible; RN Notified; Green AMP Light; Denies Complaints; Patient Alert ; HBP; Oxygen Litres/Min:, 2.0 signed by PCT 11:07 Ended signed by PCT COMMENTS: at 11: 00 bp remained elevate at 160/89 HR 69 took prn clonidine to medicate pt d/t elevated bp upon arrival to PT noted PT to be unresponsive assessed for HR, no HR present cpr initiated EMS called AED applied 2 shocks delivered via AED EMS arrived and took DISCHARGED TO: Hospital DATE/TIME: 08/15/2025 11:30 AM An interview was conducted with Staff # 1 on 09/23/25 that confirmed the facility nursing staff failed to follow policy regarding the out-of-parameter vital signs.”