Davita Elizabeth City Dialysis

“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: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to prevent cross-contamination by failing to deliver medications separately to each patient during the preparation and administration of 1 of 2 observed medication preparations (Station #6, Station #10, and Station #4, Staff #2). Findings included: A review on 06/04/2025 of the facility policy, “Infection Control for Dialysis Facilities,” revised on 04/2025, revealed “PURPOSE: To minimize the spread of infection or bloodborne pathogen in the dialysis facility environment... SUPPLIES... 10. ... medications ... taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients...” An observation on 06/04/2025 from 1030 through 1200 (90 minutes) revealed that Staff #2 left the nursing station carrying multiple labeled syringes of Heparin (medication used as a blood thinner) from patient station to patient station. Observation revealed the staff was delivering the syringes to multiple hemodialysis stations already occupied by patients. The observation revealed syringes labeled with the patient’s name, and the medication was left on the chairside table at Station #6, #10, and then #4. An interview on 06/04/2025 with RN #3 revealed that the patient’s medication syringes should be carried to each patient one at a time. The interview showed that medication syringes for different patients must not be brought into another patient’s treatment area. The interview revealed the staff failed to follow the facility policy.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 38766 Based on the facility’s policies and procedures, routine total chlorine testing logs, and staff interviews, the facility staff failed to promote the health and safety of dialysis patients by not ensuring the policies were followed in determining the total chlorine color comparison for 19 out of 52 days. Findings included: A review on 06/04/2025 of the facility’s policy “Daily Water System Total Chlorine Monitoring “revised in 10/2024 revealed, “...Policy:...3. Total Chlorine testing is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment (s) ... All samples are to be drawn only after the water system has been operating for at least 15 minutes. Document results on Routine Total Chlorine Testing Log... 5. For direct feed systems, the RO (Reverse Osmosis) must have been operating for at least 15 minutes. For indirect feed systems (holding tanks), observations and readings will be obtained while the RO is operating continuously for a minimum of 15 minutes and continues to operate while testing is being completed....” A review on 06/04/2025 of the facility’s policy “E-Z Check Sensitive Total Chlorine Testing” revised 10/2021 revealed “... Vigorously move test strip back and forth in the test water for 10 seconds... 4. Wait a full 30 seconds...” A review on 06/04/2025 of the Routine Total Chlorine Testing Log from 03/01/2025 through 04/30/2025 revealed that the RO was on at 0400 daily. The review indicated that on the following dates: 03/5/2025, 03/12/2025, 03/13/2025, 03/19/2025, 03/20/2025, 03/26/2025, 03/27/2025, 04/02/2025, 04/03/2025, 04/09/2025, 04/10/2025, 04/14/2025, 04/16/2025, 04/17/2025, 04/23/2025, 04/24/2025, 04/25/2025, 04/28/2025, and 04/30/2025, the sample was collected, read, and documented in less than 15 minutes from the time the RO was on. An interview on 06/04/2025 at 1205 with the Biomedical Technician revealed that the RO was automatically set to turn on at 0400. The Technician reported that the RO should be running for 15 minutes and the sample port on for a full one (1) minute before collecting the sample for testing. The interview revealed that the Technician performed a monthly audit and did not notice it. The interview revealed that the Technician was more concerned about the staff checking the chlorine level every four hours and failed to recognize the timing of the first check in the morning.”

“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: 38766 Based on policy review, record review, and staff interviews, the facility staff failed to promote patient safety by not ensuring the patient removed sunglasses to assess patient status during dialysis treatment for one (1) of one (1) patient observed the patient wearing sunglasses during treatment. Findings included: A review on 06/04/2025 of the facility’s policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” revised in 04/2024 revealed, “...Intradialytic Data Collection/Assessment... c. The vascular access site, bloodline connections, and the patient’s face should be visible throughout the dialysis treatment...” Observation on 06/04/2025 from 1030 to 1200 (90 minutes) revealed Patient #10 dialyzing in Station #7 wearing dark sunglasses. The observation noted that the patient kept the sunglasses on, and the staff did not ask for them to be removed during the 90-minute observation period. The observation revealed that the facility staff failed to ensure the patient did not wear sunglasses during treatment. An interview on 06/04/2025 at 1150 with Patient #10 during the observation revealed that the staff never asked the patient to lift her glasses during vital signs and safety checks. The patient stated that if the staff had asked her to lift her glasses during treatment, she would have complied. An interview on 06/05/2025 at 1205 with PCT #3 revealed that the staff was responsible for continuously monitoring patients and ensuring that access sites and faces were uncovered. The PCT added that the staff should be able to visualize the patient’s eye during safety checks. The interview confirmed the findings.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 38766 Based on a review of policies and procedures, observations, and staff interviews, the facility staff failed to follow the facility policy in cannulating an AVF/G (Arterial Venous Fistula/Graft) in one of three observations (PCT #1). Findings included: A review on 06/03/2025 of the facility policy “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” revised 04/2020 revealed, “...15. Apply a new tourniquet for cannulating AF fistula or graft. Apply to the extremity above the fistula or graft firmly enough to impede but not occlude venous flow. Remove the tourniquet post cannulation. A tourniquet should be used to distend the fistula even when the vessel does not appear to require it...” An observation on 06/03/2025 at 1152 revealed PCT #1 entered station #10 to initiate dialysis with an AVF/G for Patient #8. The observation revealed PCT #1 cleaned the access sites, palpated the sites to evaluate the access, performed hand hygiene, donned new gloves, and proceeded directly to cannulation. The observation revealed PCT #1 failed to apply a tourniquet above the access sites before palpating and cannulating the access. An interview on 06/03/2025 at 1225 with PCT #1 revealed that the policy was to apply a tourniquet above the access sites before cannulating the patient. The PCT added that “there was no reason for not using a tourniquet.” An interview on 06/04/2025 at 1130 with RN #3 revealed it was the expectation that the PCTs would apply a tourniquet for all cannulation of a fistula. The interview revealed staff training was done according to the policy.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to comply with policies and procedures by not ensuring the patient’s medication syringe was not left unattended in one of two medication preparation observations (PCT #4). Findings included: A review on 06/04/2024 of the facility’s policy, “Medication Policy” revised 10/2023, revealed “...Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: ...11. ..., Non-refrigerated medications are to be stored in the cabinet (s) and locked ..., or if not under supervision by the licensed teammate or per state regulations...” Observations on 6/03/2025 from 1110 to 1300 (110 minutes) of the treatment area revealed that staff attended to the patients during treatments. An observation around 1135 revealed a syringe labeled with a patient’s name, and the medication was left unsecured on the chairside table at Station #9. The observation indicated that at 1210, PCT #4 entered station #9, initiated the patient’s treatment, and administered the syringe for pre-treatment medication. An interview on 06/03/2025 at 1250 with PCT #4 revealed that the heparin syringe should not be left unattended in the patient’s station. The PCT reported that she pulled the heparin syringe from the medication drawer and placed it on the chairside table with the supplies before the patient arrived for treatment. The PCT stated, “That was my fault, and I am sorry.” The interview confirmed the findings.”