Tricity Riverside Dialysis

“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: 44505 Based on observation, interview, and record review, the facility failed to ensure the dialysate (fluid used to remove unwanted waste products from the blood during dialysis [a procedure that removes waste products and excess fluid from blood when the kidneys are no longer functioning properly]) conductivity (test to confirm a desired proportion of components in the dialysate) was tested prior to the initiation of the hemodialysis (a type of dialysis) treatment. This failure had the potential to result in an unsafe provision of care to one out of three sampled patients (Patient 7) receiving hemodialysis. Findings: A review for Patient 7’s Face sheet, indicated, Patient 7 was admitted to the facility on November 21, 2023 with diagnoses which included, end stage renal disease (ESRD - a terminal illness in which a person’s kidneys no longer work properly). Further review of Patient 7’s medical record, indicated Patient 7 has a left forearm Arteriovenous Fistula (AV fistula - used for long-term dialysis, connects a selected artery [a blood vessel that carries blood away from the heart] and a vein [carry blood towards the heart] directly) as her dialysis access, and scheduled to dialyze (to undergo dialysis: a process that uses a special machine for removing harmful waste substance from the blood of people whose kidneys are not working properly) three times a week (Monday, Wednesday, Friday), for 4 hours. On September 9, 2024, at 9:45 AM, an interview was conducted with the Admnistrator (Admin). The Admin stated that there were currently 22 patients in this shift receiving hemodialysis treatment. On September 9, 2024, at 1:15 PM, an observation was conducted with the Licensed Vocational Nurse (LVN). The LVN did not perform a pH check and dialysate conductivity test prior to initiating treatment to Patient 7. On September 9, 2024, at 1:45 PM, an interview was conducted with the LVN. The LVN stated that she forgot to check the pH and conductivity for Patient 7’s machine prior to initiating treatment. LVN stated she should have done so. On September 9, 2023, at 2:45 p.m. an interview was conducted with the Administrator (Admin). The Admin stated the staff were expected to check the pH and conductivity with a (name of conductivity meters and pH instruments) prior to initiating dialysis treatment. A review of the operator’s manual titled, “[Brand and Model A] Hemodialysis Machine Operator’s Manual”, undated, indicated, “Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g., using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment ... Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If conductivity and pH are not within limits, do not initiate dialysis ...””

“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: 44505 Based on interview and record review, the facility failed to ensure that the hemodialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) machine (machine #5) for a patient was maintained in accordance with the manufacturer’s recommendations, for one of three sampled patients (Patient 1). This failure had the potential to result in delayed provision of patient treatment due to malfunctioning equipment. Findings: A review of Patient 1’s Face sheet indicated that Patient 1 was admitted to the facility on July 25, 2023, with diagnoses which included, End Stage Renal Disease (ESRD - a terminal illness in which a person’s kidneys no longer work properly). Further review of Patient 1’s medical record indicated, Patient 1 had a central venous catheter (a tube placed into a large vein [ carried blood towards the heart] dialysis) on the right chest as her dialysis access and was scheduled to dialyze (to undergo dialysis: a process that uses a special machine for removing harmful waste substance from the blood of people whose kidneys are not working properly) two times a week (Monday and Friday) for 3 hours. A review of Patient 1’s treatment record, dated October 2, 2023, indicated: - At 13:28 p.m., Patient 1’s treatment started on hemodialysis machine #5. - At 14:41 p.m., Patient 1’s treatment was terminated early due to machine issues. Further review of Patient 1’s treatment record indicated, Patient 1 was not able to complete her full treatment of 3 hours on October 2, 2023. A review of Patient 1’s Release of Medical Liability for Early Termination,” dated October 2, 2023, indicated, “ ...I’m shortening my treatment time by 1 hour 50 minutes...reason: machine issue...” On September 9, 2024, at 3:35 p.m., a record review and interview were conducted with the Administrator. The Administrator stated, the Preventive Maintenance (maintenance requirement by the manufacturer to ensure equipment safety and reliability) was done by the Biomedical Technician (Biomed - responsible for the maintenance and repair of dialysis machines, water treatment equipment, and other medical equipment in a dialysis facility). The Administrator was unable to provide a Preventive Maintenance Checklist documentation for Machine #5 prior to October 2, 2023. On September 16, 2024, at 2:57 p.m.., Biomed 1 was interviewed. Biomed 1 stated the hemodialysis machines undergo preventive maintenance (to ensure the machine is functioning properly and to prevent unexpected failures), scheduled annually and semiannually. Biomed 1 stated, this maintenance included a checklist recommended by the manufacturer, listing items to be checked, replaced, and calibrated. On September 16, 2024, at 2:57 p.m., Biomed 2 was interviewed. Biomed 2 stated, a checklist was provided by the manufacturer for the scheduled maintenance on the machines. Biomed 2 stated, the checklist should be completed and documented to confirm that the preventive maintenance was completed. A review of the Job description of Bio-Med, undated, indicated, “ ...Function: The Bio-Med technician supervises and coordinates the work of reuse and equipment technicians in the facility. Responsible and accountable for all machine maintenance, repair of equipment in the facility ...repair and recondition all components related to dialysis equipment including blood pumps, air/foam detectors, line clamps, and related equipment. Maintains this equipment at a high level of efficiency at all times ...responsible for service, repair, and maintenance of dialysis equipment in the unit at the highest level of efficiency ...responsible for routine calibration and safety inspection of all dialysis equipment and maintenance of a written log to record the routine procedures ...””

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (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; This Standard is not met as evidenced by: 44505 Based on interview and record review, the facility failed to inform one of three sampled dialysis patients (Patient 1) and/or the emergency contact of the possible symptoms and consequences associated with not completing the prescribed dialysis treatment before being sent home on October 2, 2023. This failure had the potential for adversely affecting the health and well-being of Patient 1. Findings: A review of Patient 1’s Face sheet indicated that Patient 1 was admitted to the facility on July 25, 2023, with diagnoses which included end stage renal disease (a terminal illness in which a person’s kidneys no longer work properly). Patient 1 had a central venous catheter (a tube placed into a large vein used for hemodialysis) in her right chest as dialysis access and was scheduled to dialyze (to undergo dialysis: a process that uses a special machine for removing harmful waste substance from the blood of people whose kidneys are not working properly) twice a week (Monday and Friday) for 3 hours. Patient 1’s daughter was listed as her emergency contact. A review of Patient 1’s Release of Medical Liability for Early Termination,” dated October 2, 2023, indicated, “ ...I’m shortening my treatment time by 1 hour 50 minutes ...reason: machine issue ...I have been advised that if I should have any of these symptoms, I should call 911 or report to the nearest hospital room. I understand that failure to do so could result in heart failure and/or death ...I have given the opportunity to ask and have my questions answered by the staff of this facility. I understand the possible consequences of my choice not to be dialyzed as prescribed by my doctor ...” Further review of Patient 1’s record, indicated there was no documentation showing that Patient 1’s daughter, the emergency contact, was informed on what to do if Patient 1 became symptomatic after termination of treatment. On September 9, 2024, at 3:05 PM, a concurrent interview and review of Patient 1’s Release of Medical Liability for Early Termination form dated 10/2/23, was conducted with the LVN. The LVN stated, Patient 1 had dementia and that the early temination form was not signed. The LVN further stated, there was no documentation showing that the emergency contact, Patient 1’s daughter, was informed of the early termination of treatment or the possible consequences of early termination. On September 9, 2024, at 3:35 PM, a concurrent interview and review Patient 1’s Treatment Flowsheet was conducted with the Administrator. The Administrator stated that there was no documentation indicating that Patient 1’s daughter, the emergency contact, was made aware and educated on what to do if Patient 1 became symptomatic (showing symptoms from not getting dialysis like shortness of breath, fatigue, nauseous, high blood pressure) at home. The Administrator stated, the licensed nurses should have informed Patient 1’s daughter on the possible consequences of early termination and this information should have been documented. A review of the facility’s policy and procedure titled, “Patient Rights and Responsibilities,” dated January 2023, indicated, “ ...as a patient of this dialysis facility, or as a family member or guardian of a patient at this dialysis facility, we want you to know the rights you have under federal and California state law. We are committed to honoring your rights ...patients’ rights ...11. Refuse or discontinue treatment and be told what effect this may have on your health ...””