Davita Mebane Dialysis

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 38766 Based on a review of policy and procedures, observations, and staff interviews, the facility staff failed to disinfect infectious surfaces to minimize the spread of infection in 1 (one) of 19 hemodialysis stations observed on the treatment floor. Findings included: A review on 07/01/2021 of the facility policy titled “Infection Control for Dialysis Facilities” revised 04/2023 revealed “Purpose: To minimize the spread of infections or blood-borne pathogens in the dialysis facility environment... Disinfection... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. A ...i. The wall box, Drain, and Water supply lines are considered part of the dialysis delivery system...” Observation on 03/18/2025 between 1155 and 1255 on the treatment floor revealed a clear bin under the water box behind the hemodialysis machine in station #14. The observation indicated that the bin was roughly half full of a clear liquid. An interview on 03/18/2025 at 1220 with PCT #1 during the observation revealed that PCT #1 did know the bin was behind the hemodialysis machine. The interview revealed that a patient was at the station early in the morning, and the bin was not emptied or cleaned between patients. The interview revealed that it was a slow drip but could not tell where the leak was coming from. An interview on 03/18/2025 at 1235 The Biomedical Technician revealed that if a bin was placed under the water box, this indicated a leak at the station. The interview revealed that the staff were to notify Biomed of any leak on the treatment floor. The interview revealed that if Biomed had been notified of the leak, Biomed would have repaired the leak and emptied and disinfected the bin with 1:100 (one part bleach to 100 part water) bleach solution. A follow-up interview on 03/20/2025 at 0930 revealed the cleaning person had placed the bin under the water box behind the station. The interview revealed that the cleaning person saw the water leaking under the box and placed the bin under the water box to collect the water. The interview revealed that the bin was placed under the box on Friday or Saturday of last week. The interview confirmed the findings.”

“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: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to maintain oxygen (O2) cylinders per facility policy for five (5) of nine (9) O2 cylinders observed. Findings included: A review on 03/18/2025 of the “Safety Data Sheet” prepared on 09/06/2024 revealed “...Section 7: Handling and Storage ...Storage... Oxygen... Store and handle in accordance with all current regulations and standards. Grounding and bonding required...” An observation on 03/18/2025 between 1155 and 1255 during a tour of the treatment floor revealed that 9 oxygen cylinders were stored towards the back door near the lab area. Five of the nine cylinders were on the floor unsecured. An interview on 03/18/2025 at 1600 with the Manager of Clinical Services revealed that the oxygen cylinders were not supposed to be left unsecured on the floor. The interview revealed that the FA had ordered the holders, and the clinic was waiting for delivery. The interview confirmed that the policy was not followed.”

“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: 38766 Based on a review of the facility’s policy, Fire drill exercise documentation, and interview, the facility staff failed to ensure fire drill exercises were performed per policy. Findings included: A review on 03/20/2025 of the facility’s policy “Facility Emergency Management Plan (ICHD, Home) revised 10/2024 revealed “...Fire Safety Preparedness 1. FA, or designee, is responsible to: ...b. Conduct and review quarterly fire safety and evacuation training and drills for compliance, identify additional training and education needs...” A review on 03/20/2025 of the facility’s fire drill documentation from January 2024 to the present revealed that a fire drill was conducted on 12/10/2024. The review revealed no documentation of fire drills from January 1, 2024, to December 9, 2024 (the first three quarters of the calendar year). The review revealed that the facility failed to perform fire drill exercises as per policy. An interview with the FA on 03/20/2025 at 1620 revealed that the fire drill on December 10, 2024, was the only documentation found. The interview revealed that fire drills should be conducted every quarter. The interview revealed that the FA was on leave, and the facility failed to follow the policy in her absence.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 38766 Based on a review of policy and procedures, medical records review, and staff interviews, the facility staff failed to perform and/or document patient monitoring every 30-45-minute during dialysis treatments for three (3) of eight (8) in-patient records reviewed (Patient #2, #3, and #6). Findings included: A review on 03/19/2025 of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, revealed “... Intradialytic Data Collection/Assessment ...9. ...a. Vital signs and treatment monitoring ...iii. Non-nocturnal treatments are completed at least every thirty (30) minutes...” 1. An open medical record review on 03/19/2025 for Patient #2 revealed a 60-year-old male was admitted to the facility for ICHD treatments on 12/14/2022. A review of the treatment sheet dated 03/12/2025 revealed the treatment started at 0702 and ended at 1054 (229 minutes). The treatment flowsheet revealed no documented vital signs from 0901 through 1001 (60 minutes). A review of the treatment flowsheet on 03/17/2025 revealed the treatment started at 0736 and ended at 1118 (218 minutes). The treatment flowsheet revealed no documented vital signs from 1001 through 1118 (77 minutes). The review revealed the facility staff failed to monitor the patient every 30 minutes during the hemodialysis treatment per the facility policy. An interview on 03/20/2025 at 1330 with CCHT #2 revealed that the staff should take the patient’s vital signs and safety checks every 30 minutes. The CCHT confirmed that the policy required these checks to be conducted and documented every 30 minutes. 2. An open medical record review on 03/19/2025 for Patient #3 revealed a 46-year-old female was admitted to the facility for ICHD treatments on 12/12/2024. A review of the treatment sheet dated 03/4/2025 revealed the treatment started at 0720 and ended at 1104 (224 minutes). The treatment flowsheet revealed no documented vital signs from 0720 through 0816 (56 minutes). A review of the treatment flowsheet on 03/13/2025 revealed the treatment started at 0712 and ended at 1115 (243 minutes). The treatment flowsheet revealed no documented vital signs from 1000 through 1115 (75 minutes). The review revealed the facility staff failed to monitor the patient every 30 minutes during the hemodialysis treatment per the facility policy. An interview on 03/20/2025 at 1330 with CCHT #2 revealed that the staff should take the patient’s vital signs and safety checks every 30 minutes. The CCHT confirmed that the policy required these checks to be conducted and documented every 30 minutes. 3. An open medical record review on 03/19/2025 for Patient #6 revealed a 54-year-old female was admitted to the facility for ICHD treatments on 09/09/2024. A review of the treatment sheet dated 03/4/2025 revealed the treatment started at 0540 and ended at 0846 (186 minutes). The treatment flowsheet revealed no documented vital signs from 0603 through 0702 (59 minutes). An interview on 03/20/2025 at 1330 with CCHT #2 revealed that the staff should take the patient’s vital signs and safety checks every 30 minutes. The CCHT confirmed that the policy required these checks to be conducted and documented every 30 minutes.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 38766 Based on policy review, medical record review, and staff interviews, the facility staff failed to follow the adequacy plan of care by failing to dialyze 2 of 10 (Patient #8 and #7) in-center hemodialysis patients at the prescribed BFR/DFR and/or treatment duration. Findings included: A review on 03/18/2025 of the facility policy titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” revised April 2024 revealed “INTRADIALYTIC DATA COLLECTION/ASSESSMENT ... 9. ... b. At a minimum, obtain and document the following: ...iii. Blood and dialysate flows, arterial and venous pressures ... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate), the reason will be documented and the licensed nurse informed...” 1. An open medical record review on 03/18/2025 for Patient #8 revealed a 45-year-old female admitted to the facility for ICHD treatments on 05/21/2020. A review of the Physician orders revealed Patient #8’s Blood Flow Rate (BFR) was ordered at 400 and Dialysate Flow Rate (DFR) at 800. A review of the treatment flowsheet on 03/04/2025 revealed the treatment started at 0632 and ended at 1243 (315 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 358/800, with no documentation for the decrease in the BFR. A review of the treatment flowsheet on 03/07/2025 revealed the treatment started at 0651 and ended at 1204 (313 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 298/782, with no documentation for the decrease in the BFR/DFR. A review of the treatment flowsheet on 03/10/2025 revealed the treatment started at 0641 and ended at 1222 (341 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 303/800, with no documentation for the decrease in the BFR. A review of the treatment flowsheet on 03/12/2025 revealed the treatment started at 0648 and ended at 1207 (315 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 361/800, with no documentation for the decrease in the BFR. A review of the treatment flowsheet on 03/14/2025 revealed the treatment started at 0641 and ended at 1137 (296 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 319/800, with no documentation for the decrease in the BFR. An interview on 03/20/2025 at 1330 with the FA revealed that the facility’s PCTs should notify the nursing staff any time they decrease the patient’s BFR/DFR, or the patients are unable to achieve their ordered BFR/DFR. The interview further revealed that the nursing staff should have assessed and documented the reason for the decrease or the patient’s inability to obtain the prescribed BFR/DFR. The interview confirmed the medical record findings that patient #8 was not treated at the prescribed BFR/DFR. 2. An open medical record review on 03/18/2025 for Patient #7 revealed a 45-year-old female admitted to the facility for ICHD treatments on 10/28/2024. A review of the Physician orders revealed Patient #7’s Blood Flow Rate (BFR) was ordered at 400 and Dialysate Flow Rate (DFR) at 500. A review of the treatment flowsheet on 03/03/2025 revealed the treatment started at 1311 and ended at 1621 (190 minutes). A review of the Flowsheet revealed Patient #7’s BFR/DFR averages were 371/467, with no documentation for the decrease in the BFR/DFR. A review of the treatment flowsheet on 02/10/2025 revealed the treatment started at 1331 and ended at 1622 (171 minutes). A review of the Flowsheet revealed Patient #8’s BFR/DFR averages were 300/500, with no documentation for the decrease in the BFR. An interview on 03/20/2025 at 1330 with the FA revealed that the facility’s PCTs should notify the nursing staff any time they decrease the patient’s BFR/DFR, or the patients are unable to achieve their ordered BFR/DFR. The interview further revealed that the nursing staff should have assessed and documented the reason for the decrease or the patient’s inability to obtain the prescribed BFR/DFR. The interview confirmed the medical record findings that patient #8 was not treated at the prescribed BFR/DFR.”