Fresenius Medical Care of Riverside

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 37536 Based on observation, interview, and record review, the facility failed to ensure accurate medication administration procedure when one medication tablet was left unattended at a patient’s chairside table (Patient 5). This failure had the potential for medication to be diverted, taken inappropriately or not taken as prescribed, placing Patient 5 at risk for harm. Findings: On May 14, 2025, at 10:50 a.m., a concurrent observation and interview were conducted with Patient 5 during dialysis. One medication tablet (pill) was observed in a medicine cup sitting on the chairside table. Patient 5 stated, it was his Sensipar (medication that reduces the amount of calcium and phosphorus in the blood) and stated he will take it after treatment. On May 14, 2025, at 10:55 a.m., a concurrent observation and interview were conducted with Registered Nurse (RN) 1 at Patient 5’s chair. RN 1 stated Patient 5’s medication should not have been left unattended at the chairside table. RN 1 stated Sensipar is to be administered after dialysis treatment and should not be left with the patient. On May 14, 2025, at 11:30 a.m., an interview was conducted with the Charge Nurse (CN). The CN stated, medication should not be left on a patient’s chairside table to be taken later. The CN stated, the nurse should administer the medication, observe the patient taking it and then document that it was given. Patient 5’s record was reviewed. Patient 5 was admitted to the facility on August 20, 2019, with diagnoses which included end stage renal disease (final permanent stage of chronic kidney disease in which the kidneys have lost nearly all their ability to function effectively). A record review of the facility’s “P&P” titled “Medication Preparation and Administration” published on February 6, 2023, the “P&P” indicated, “Pre-drawing Medications ... These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration ...””

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 37536 Based on observation, interview and record review, the facility failed to close the door to the isolation room (a separate room used to dialyze hepatitis B virus positives) during dialysis (a medical procedure using special machines to filter waste and excess water from the blood) treatment for one of 24 sampled patients. This failure increased the risk of cross-transmission and exposure through blood spills, splattering or spurting. Findings: On May 14, 2025, at 1:56 p.m., an observation of the Isolation room was conducted. The Patient Care Technician (PCT1) was observed initiating a patient’s hemodialysis treatment. The isolation door was left open during the cannulation and initiation of the patient’s dialysis treatment. On May 14, 2025, at 2:15 p.m., an interview was conducted with PCT 1. PCT 1 stated, Patient 1 was Hepatitis B positive. PCT 1 stated he left the isolation door open during the initiation of dialysis treatment. PCT 1 stated he was unsure whether the isolation door should remain closed or open during the initiation of dialysis treatment. On May 14, 2025, at 2:31p.m., an interview was conducted with the Charge Nurse (CN). The CN stated the isolation door should be kept closed during treatment initiation because of the risk of cross-contamination from blood spatter. A review of the facility’s policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)”, dated November 6, 2023, indicated, “ ...Patients that are HBsAg positive must dialyze in the separate room ...The separate room is required to have a door to contain any spurting of blood, body fluids, and other contaminates to prevent cross contamination ...The door must be closed during times when blood spurting or spattering is possible ...””

“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: 37536 Based on interview and record review, the facility failed to properly inform and educate four out of four sampled dialysis patients (Patient 1, 2, 3, 4) regarding changes to their dialysis appointment times. This failure had the potential to adversely affect the health and psychological well-being of the patients. Findings: On May 14, 2025, interviews were conducted with the following patients regarding their new scheduled appointment times: -At 10: 45 a.m., Patient 2 stated, he was unhappy with the new schedule and that no one had informed him that his appointment would be moved to a later time. -At 10:48 a.m., Patient 3 stated, she felt like she had no choice in the matter. Patient 3 further stated she told them about her dilemma with the new schedule, but they have not done anything. -At 11 a.m., Patient 4 stated, she was not told anything about why her appointment times and chair assignment were being changed. -At 11:05 a.m., Patient 1 stated that he was not happy with his new appointment schedule and did not understand why his time was changed from 9 a.m. to a later time. Patient 1 further stated that the facility does not care about his needs. Further review of Patient 1, 2, 3, and 4’s records indicated there was no documentation that the rationale for the schedule change or the expected benefits had been communicated with the patients. On May 14, 2025, at 11:45 a.m., the Patient Care Technician (PCT) was interviewed. The PCT stated, she received a letter from the front desk to hand out to patients. The PCT stated the first letter only informed patients that schedule changes were coming but did not provide new appointment times and served only as a “heads up.” The PCT further stated that two weeks later another letter was given with the new scheduled times. On May 15, 2025, at 2:50 PM, the Registered Nurse (RN) was interviewed. The RN stated that they just gave the letter to the patients, no education was provided. The RN further stated, the first letter had no effective date. The RN stated the management had not informed the floor staff of the schedule changes, which created confusion. The RN stated the scheduling system did not reflect the complete picture, and as a result, some patients were unhappy because they had to rearrange their personal schedules again. On May 15, 2025, at 3:30 p.m., a concurrent interview and record review were conducted with the Administrator. The Administrator stated the facility did not follow its process for communicating upcoming schedule changes to patients. The Administrator further stated that the rationale for the changes was not explained, and there was no documentation that an in-service had been provided for either patients or staff. A review of the facility’s “Schedule Change Talking Points- Patients”, dated March 15, 2023, indicated, “ ...A. Communicate upcoming changes to the patients ...we suggest that the patient be told in person, either individually or in a group, along with a patient letter addressed to each patient. The key items to discuss with the patients include the rationale behind changing the appointment schedule, the expected benefits ...and the centers expectations...B. Illustrate the rationale behind the changes to schedule ...when discussing the pending changes to the appointment schedule with your patients, utilize screenshots of the visual schedule and graphs. We suggest creating a one-page document that you can share with the patients comparing the current schedule and the revised schedule to illustrate the benefits the change will provide ...C. Discuss the expected benefits for the patients ...Discuss the center’s expectations of patients ...E. Notify patients of their new appointment time ...F. Reinforce messages to patients prior to, and during Go Live week ...G. Expected patient reactions ...” A review of the facility’s policy and procedure titled, “Patient Rights and Responsibilities,” dated April 4, 2012, indicated, “ ...all facility staff are responsible for ensuring the patient’s rights are respected and protected by the facility ...the patient has the right to 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 ...receive all information in a way that her or she can understand ...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47202 Based on observation, interview and record review, the facility failed to ensure one of two patient bathrooms were safe, functional, and in good working condition, when the toilet was observed with movement when pushed and leaned on. This failure had the potential to cause physical injuries to patients receiving care and treatment in the facility. Findings: On January 23, 2024, at 8:16 am, an unannounced visit was conducted to the facility regarding a physical environment concern. On January 23, 2024, at 10:20 a.m., during a concurrent observation and interview with the Biomedical Technician (BT) of the patient bathroom inside the treatment room, the toilet was observed with movement when pushed and leaned on. During a concurrent interview with the BT, he stated, the toilet moved and was “wobbly”. The BT stated, “it’s not supposed to be like that.” The BT further stated, if used by a patient there is potential for the patient to tip on the side and fall. On January 23, 2024, at 11:10 a.m., during an interview with the Facility Administrator (FA), she stated, she was made aware that the patient toilet in the treatment room being wobbly and had movement on January 22, 2023 . The FA further stated, the patient bathrooms should be clean, functional, and in good working condition. The FA stated, the bathroom toilet should be safe for patient use. The FA stated, the toilet should not be moving and wobbly. The FA further stated, the toilet was not safe and a patient could fall if used. A review of the facility policy and procedure titled, “Biomedical Support Services,” dated July 6, 2021, indicated, “...This policy applies to all equipment...essential to the safe operation of the facility...Includes...Plumbing Equipment/Systems...Repairs ...Any equipment or device that is not fully functioning...must be repaired or replaced...””