Centro Renal Universitario

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47632 Based on reviwe of policy and procedure and observations made in the treatment area on 02/25/2025, it was determined that the facility failed to ensure that nursing staff verified the pH of the test water appropriately used for dialysis prior to starting treatment on a patient. Findings include: The following was observed while the personnel were preparing hemodialysis machines for the first shift on 02/25/2025 from 8:30 AM through 2:00 PM: 1. On 02/25/2025 at 1:15 PM, registered nurse (RN) (employee #2) observed performed the pH and conductivity test on the hemodialysis machines located at station #25. RN # 2 upon performing the pH on the machine, inserted the strip to reactivate with the pH of the dialysate, but did not wait fifteen (15) seconds to perform the pH reading. 2. On 02/25/2025 at 1:35 PM, registered nurse (RN) employee #7 observed, performed pH and conductivity test on the hemodialysis machines located at station #22. RN #7 upon performing the pH on the machine, inserted the strip to reactivate with the pH of the dialysate, but did not wait fifteen (15) seconds to perform the pH reading. 3.The facility failed to ensure that registered nurses properly perform dialysate pH in accordance with facility policy.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 15884 Based on personnel files reviewed conducted on February 26, 2025, at 9:30 AM with the director of nursing (employee #5), it was determined that the facility failed to maintain an ongoing training program designed to maintain the operator’s knowledge and skills. This deficient practice had the potential to affect 32 out of 32 admitted patients receiving services. 51637 Findings include: a. Through review of the water treatment technician supervisor’s file (employee #4), it was determined that the employee did not have training by the manufacturer (Fresenius) in either year 2023 or year 2024. b. Facility failed to ensure that water treatment technicians are trained annually by the machine manufacturer (Fresenius).”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47632 Based on observations made in the medication room on 02/25/2025, it was determined that the facility failed to ensure that the building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. Findings include: During observations made in the medicine room on 02/11/2025, the following was observed: 1. On 02/25/2025 at 9:07 AM, in the medicine room, the water protection wall of the sink was observed with dark stains. 47384 2. On 02/25/2025 at 8:45AM, peeling paint was observed on columb next to treatment station #26.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 47384 Based on observations made in the tratment area on 02/25/2025, it was determined that the facility failed to ensure that all equipment is maintained and operated in accordance with the manufacturer’s recommendations. Findings include: During inspection of the emergency evacuation bag it was observed: 1. Two (2) Sodium Chloride 0.45% of 1000 milliliters found expired January 2025. 2. Two (2) Sodium Chloride 0.45% of 500 milliliters found expired November 2024 3. Two (2) Sodium Chloride 0.45% of 100 milliliters found expired December 2024 4. Ten (10) Compound dressings found expired June 2024 5. Three (3) syringes found expired December 2024 6. Nine (9) 21 gauge needles found expired December 2024 7. No inspection worksheet was found for this equipmnet. 47632 Based on observations made in the medication room and isolation area on 02/25/2025, it was determined that the facility failed to ensure that all equipment is maintained and operated in accordance with the manufacturer’s recommendations. Findings include: During the observations made in the medicine room on 02/25/2025 at 8:55 AM through 9:20 AM, the following were found: 1. On 02/25/2025 at 9:02 AM, Sodium Chloride 0.45% of 1000 milliliters one (1) of eighteen (18) expired January 2025. During the observations made in the isolation room on the crash cart with the employee #3 on 02/25/2025 at 9:22 AM through 9:50 AM, the following were found: 1. On 02/25/2025 at 9:24 AM, two (2) blood collection tubes with blue cap expired on 10/31/2024 were observed. 2. On 02/25/2025 at 9:28 AM, two (2) blood collection tubes with red cap expired on 05/31/2024 were observed. 3. On 02/25/2025 at 9:31 AM, two (2) blood collection tubes with violet cap expired on 10/31/2024 were observed. 4. On 02/25/2025 at 9:35 AM, one (1) suction catheter #16 FR expired 04/2016 was observed. 5. On 02/25/2025 at 9:38 AM, two (2) clave connectors were observed expired on 02/01/2025. 6. On 02/25/2025 at 9:40 AM, two (2) vyaire humidifiers observed expired 02/01/2025. 7. On 02/25/2025 at 9:45 AM, one (1) XL surgical gown expired on 12/01/2024.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 47632 Based on observations made in the treatment area on 02/25/2025, it was determined that the facility failed to ensure that patients receive treatment in a manner that allows staff to have full view of patients access site for the first shift at patients stations #25, #27, and #29. This deficient effect 3 out of 7 patients observed receiving treatment. Findings include: During the observations made in the treatment area on 02/25/2025 at 8:30 AM through 2:00 PM, the following were found: 1. On 02/25/2025 at 8:25 AM, the patient was located on station # 25, it was observed that the vascular access was covered with sheets. 2. On 02/25/2025 at 8:35 AM, the patient was located on station # 27; it was observed that the vascular access was covered with sheets. 3. On 02/25/2025 at 8:50 AM, the patient was located on station # 29, it was observed that the vascular access was covered with sheets. The facility failed to ensure vascular access sites should be seen by staff members during all dialysis treatment. Allowing patients to cover access provides an opportunity for accidents of needle.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47384 Based on observations made during the survey for fire safety with the facility’s technical supervisor (Employee #4 ) at 11:20 AM, it was determined that the facility failed to have a fire alarm system that is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code and NFPA 80 Standard for Fire Doors and Other Opening Protectives. 19.7.6, 8.3.3.1 (LSC) / 5.2, 5.2.3 (2010 NFPA 80) which could affect 32 out of 32 admitted residents. Findings include: 1) Fire alarm annunciator reported 7 trouble signals that were not restored to normal within 200 seconds. 2) Doors #1, #2 and #4 did not pass internal inspection due to perforations, self-closing mechanisms and paint problems.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 47632 Based on policies, procedure reviewed, and four (4) records reviewed (RR) on 02/25/2025 through 02/26/2025, it was determined that the facility failed to ensure monitor and document the patients’ blood pressure (B/P) and document nurse action when patients present hypotension during dialysis treatment for 1 out of 4 record review (R.R #4). Findings include: 1. R.R #4 is a 70-year-old male admitted to the facility on 02/02/2021 with a diagnostic End Stage Renal Disease. During the record review performed on 02/05/2025 at 2:23 PM, the hemodialysis treatment three a week for four hours, Dializaer 180 Optiflux NRe, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 64.0 kilograms (kg). a. On 02/11/2025 at 1:17 PM, it was revealed that the Blood Pressure (BP) was 188/102mg/Hg. b. On 02/13/2025 at 4:43 PM, it was revealed that the Blood Pressure (BP) was 186/98mg/Hg. c. On 02/22/2025 at 3:34 PM, it was revealed that the Blood Pressure (BP) was 182/95mg/Hg. 2. No evidence was found of nursing interventions or documentation for hypertension.”

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 15884 Based on personnel file review conducted on February 26, 2025, at 9:30 AM with the director of nursing (employee #5), it was determined that the facility failed to ensure that technicians who perform monitoring and testing of the water treatment system are evaluated in order to determine the appropriateness of their executory. This deficient practice had the potential to affect 32 out of patients 32 admitted receiving services. 51637 Findings include: a.Through review of the file of the water treatment technician supervisor (employee #4) it was found facility did not evidence that the employee had a performance evaluation (annual evaluation) of his stated duties during the annual period January through December for the year 2022 either year 2023.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 15884 Based on interview with the Facility Nursing Director (employee #5), and review of policies/procedures, it was determined that the facility failed to adopt and enforce rules and regulations relative to its own governance for the general operation of the facility. This deficient practice had the potential to affect 32 out of patients 32 admitted receiving services. Findings include: 1.During the review of Governing Body activities with the Facility Nursing Director (employee #5), on 02/26/2025 at 9:45 AM the following was identified: a.On year 2023 the facility performs a governing body meeting on January 17, 2023. The governing board only met once that year. b. On year 2024 facility performs a governing body meeting on July 16, 2024. The governing board only met once that year. c. Upon review of the facility’s by laws Reference # 5002 Governing Body of Dialysis Services last update on February 17, 2023, on 02/27/2025 at 10:20 AM. Policy clearly stated on the governing body responsibilities that meetings are going to be performed twice a year. d. Facility Nursing Director (employee #5), stated on interview on 02/26/2025 at 10:45 AM that the governing body must held meetings twice a year accordingly with facility’s by laws Reference # 5002 Governing Body of Dialysis Services. Nursing Director (employee #5) stated that it is the governing body responsibility to enforce rules and regulations relating to its own governance and to the healthcare, safety, protection of patients and to the general operation of the facility.”