Danville Dialysis Services, LLC

“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: 50688 A. Based on document review, observation, and interview, it was determined that: for 2 of 2 Registered Nurses (E #3, E#4) observed cleaning and disinfecting dialysis stations, the Facility failed to follow infection control precautions by not cleaning/disinfecting equipment, as required. Findings Include: 1. On 12/11/2024 from 12:15 PM to 2:00 PM, an observational tour was conducted in the dialysis treatment area. The following was observed: - At approximately 1:30 PM, the Registered Nurse (E # 3) did not fully wipe to disinfect all surfaces of blue clamps hanging on the IV pole of the dialysis machine at Station #18. - At approximately 1:15 PM, the Registered Nurse (E # 4) did not fully wipe to disinfect all surfaces of blue clamps hanging on the IV pole of the dialysis machine at Station #20. 2. On 12/12/2024 the Facility’s policy title “Special Procedures #14 ...Preparing a Patient Station” (Revised November 2022), was reviewed and noted, “After each patient treatment a 1:100 (1 ml bleach: 99 ml of water) bleach solution, having a 5 minute contact time, will be used on all hemodialysis machines, PD cyclers, recliners, BP cuffs, call lights, TV’s, and trash cans used for patient care ...Wipe down the hemodialysis machine from top to bottom to include sides and back of machine and IV pole.” 3. On 12/12/2024 at approximately 10:05 AM, an interview was conducted with the Administrator (E #2), and Clinical Care Coordinator (E#1). E #1 and E#2 verbally confirmed that the blue clamps hanging on each dialysis machine IV pole remain with the dialysis machine. E#1 stated when a blue clamp is used it is placed “on top of the dialysis machine until the station is cleaned” following patient treatment. E#1 and E#2 verbally agreed there is no policy, procedure, or training to ensure this process is completed. B. Based on observation, document review, and interview the Facility failed to ensure 10 of 10 bleach-filled spray bottles, used for disinfecting dialysis chairs/machines, were properly labeled. Findings include: 1. An observational tour of the dialysis treatment area was conducted on 12/12/2024 at approximately 12:15 PM - 2:00 PM., the following was noted: -10 spray bottles were labeled as containing 1:100 bleach (1 ml bleach: 99 ml of water), but lacked labeling to reflect the date and time of preparation and initials of the person preparing the solution. 2. On 12/12/2024 at approximately 9:30 AM, the policy titled “Special Procedures #18 ...Bleach Water Preparation” (published 12/2024) was reviewed. The policy states, “Bleach water will be prepared every 24 hours by housekeeping staff.” 3. On 12/11/2024 at approximately 1:00 PM, during the observational tour, an interview was conducted with the Clinical Care Coordinator (E #1). E #1 noted the bleach solution is prepared every evening. 4. On 12/12/2024 at approximately 10:10 AM, an interview was conducted with the Administrator (E#2) and Clinical Care Coordinator (E#1). During discussion regarding preparation of bleach solution and ensuring preparation is completed every 24 hours, as required by policy, E#1 noted the bleach solution is prepared every evening “by housekeeping”. E#2 verbally agreed there is no labeling on each spray bottle to denote when and by whom each spray bottle of bleach is prepared, and stated “I’m going on trust” with regard to ensuring bleach is prepared every 24 hours.”

“INVENTORY CONTROL CFR(s): 494.50(b)(1) 9.2 Inventory control Reprocessing supplies should be used on a first-in, first-out basis, and outdated supplies should be identified and discarded. This Standard is not met as evidenced by: 50645 Based on observation, and interview, it was determined the Facility failed to ensure all inventory of patient care supplies were discarded when they expired. Findings include: 1. A tour of the treatment and storage areas was completed on 12/11/24 between 12:30 PM and 2:00 PM. During the tour, the following supplies were found outdated and were available for patient use. a. Bak Snap 3 milliliter luer lock syringe 21 Gauge x 1 inch, seven syringes were expired. The manufacturer’s expiration date was 11-25-2021. 2. On 12/11/24 at approximately 1:30 PM, an interview was conducted with the Clinical Care Coordinator (E #1). E #1 verbally agreed the supplies were expired and the expired supplies were removed from the treatment area. E #1 stated, “We don’t have a formal policy regarding expired supplies but if something is expired per the manufacturer’s expiration date, it should be discarded.””

“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: 50645 Based on document review and staff interview, it was determined for 1 of 7 (Pt #6) patient records reviewed for DFR (Dialysate Flow Rate), the ESRD (End Stage Renal Disease) Facility failed to ensure the patient’s DFR was achieved and maintained in accordance with the dialysis prescription. Findings include: 1. On 12/12/2024 at approximately 11:15 AM, Pt #6’s record was reviewed. Pt #6 was admitted to the facility on 09/20/24 with a diagnosis of ESRD. Pt #6’s clinical record contained a physician order dated 12/02/24 that noted the Dialysate Flow Rate (DFR) 800. Pt #6’s treatment sheet dated 12/02/2024, (1 of 13 treatments) indicated Pt #6 was dialyzed at a DFR of 350 the whole treatment time. The record lacked documentation as to why the prescribed Dialysate flow rate was not run. 2. On 12/12/2024 at 11:00 AM, an interview with the Clinical Care Coordinator (E #1) was conducted. E #1 reviewed the treatment record of Pt #6 and verbally agreed the DFR was not achieved and there was no documentation in the records indicating why.”