Davita Downtown Durham 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 policy review, observations and staff interviews, the facility staff failed to prevent cross contamination by failing to wet wipe the internal and external surfaces of the prime waste container on the hemodialysis machine in between patient treatments for 1 of 2 observations of cleaning and disinfection of dialysis stations (Sta. #6, HDM #02). Findings included: Review on 10/01/2025 of the current facility policy, “Infection Control for Dialysis Facilities”, (revised April 2023) revealed “... Disinfection ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected... ii. Priming containers are to be emptied prior to disinfection...” Observation on 10/01/2025 at 1040 revealed PCT #2 approached Sta. #6 and proceeded to clean and disinfect the dialysis machine and the station. PCT #2 was observed wiping down the dialysis machine. Observation revealed PCT #3 failed to remove the prime waste container, empty the prime waste container and wet wipe the internal and external surfaces of the container. Observation revealed the PCT reentered the station with clean supplies to set the station for the next patient. Observation revealed PCT #2 failed to disinfect the internal and external surfaces of the prime waste container per facility policy. Interview on 10/01/2025 at 1042 with PCT #2 revealed PCT #2 was working with a preceptor. PCT #2 stated she did not remove and empty the prime waste container. PCT #2 stated she failed to clean and disinfect the prime waste container prior to bringing clean supplies into the station for setting up the hemodialysis machine for another patient. Interview revealed that the prime waste container should have been removed, emptied, disinfected and allowed to dry prior to placing back on the cleaned and disinfected hemodialysis machine. Interview on 10/01/2025 at 1045 with PCT #3, the preceptor who was working with PCT #2 revealed, “I told her to clean the entire machine, that included the prime waste container”. Interview on 10/02/2025 at 1345 with the Charge Nurse revealed if the prime waste container and the hemodialysis machine were not cleaned and disinfected during the cleaning and disinfection of the station, the cleaning and disinfection was not done according to the policy. Interview revealed that the preceptor was responsible for monitoring the new staff while on the treatment floor.”

“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, daily water log, and staff interviews, the facility staff failed to promote the health and safety of dialysis patients by not ensuring that policies were followed in determining the total chlorine color comparison for 2 out of 26 days. Findings included: A review on 10/01/2025 of the facility’s policy “Daily Water System Total Chlorine Monitoring” (revised in October 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) and within every four (4) hours until all activities that require use of dialysis quality water are completed ...” A review on 10/01/2025 of the Routine Total Chlorine Testing Log from 08/01/2025 through 09/30/2025 revealed that on 08/13/2025 the last documented chlorine test was at 0845 and on 0/15/2025 the last documented chlorine test was at 1216. A review on 10/01/2025 of the Daily Water Log from 08/01/2025 through 09/30/2025 revealed that the End of Day Hardness Test was completed at 1542 and 1540 on 08/13/2025 and 08/15/2025 consecutively. Interview on 10/01/2025 at 1305 with the Biomedical Technician revealed that the Technician did not notice that the clinical staff did not complete the Total Chlorine Testing beyond the recorded times on 08/13/2025 and 08/15/2025. Interview on 10/02/2025 at 1345 with the Charge Nurse revealed that the nurse and the technicians were responsible for monitoring the total chlorine in the water every three to four hours while patients were on the machines. The interview confirmed that the staff did not follow the Total Chlorine Testing policy on those days.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 38766 Based on review of facility policy, manufacturer recommendations, Daily Water Treatment Logs, and staff interview, the facility failed to perform or documentation residual chemical testing on the daily water treatment logs by the facility’s staff before patient hemodialysis treatments in 6 of 8 chemical disinfection reviewed. Findings included: Review on 10/01/2025 of the facility’s policy “Water Treatment System Disinfection” (revised in April 2025) revealed “... Policy: ... 13. Facility teammates are to perform independent residual chemical testing before the beginning of the day activities on the first treatment day following a water treatment system or membrane chemical disinfection... 15. Final dialysate at each hemodialysis machine drain should be tested for chemical residual before the initiation of treatment... 16. Please use your facility specific log for documenting results of the residual chemical tests...” Review on 10/01/2025 of the manufacturer recommendation Re: “CWP Operator’s Manual” revealed “... Chemical Disinfection... Frequency: Disinfection must be performed on a regular basis to ensure consistent microbiological quality of the pure water... Once a week should however be regarded as a minimum...” Review on 10/01/2025 of the “Daily Water Treatment Log” for 08/01/2025 through 09/30/2025, revealed a section of the log titled “32. Time Chemical Disinfection Initiated” revealed that the chemical Disinfection was initiated every Monday on the following dates: *08/04/2025 *08/11/2025 *08/18/2025 *08/25/2025 *09/01/2025 *09/08/2025 *09/15/2025, and *09/22/2025 The Daily Water Treatment Log revealed a section of the log title “33. Test For Chemical Residual After Disinfection” revealed no documentation of independent residual chemical testing before the beginning of the day activities on the following dates: *08/06/2025 *08/13/2025 *08/20/2025 *09/03/2025 *09/10/2025, and *09/24/2025 The review revealed that the facility failed to perform or document residual chemical testing as per the policy. Interview on 10/01/2025 at 1305 with the Bio-Medical Technician revealed that the clinic operated on Monday, Wednesday and Friday. Interview revealed that the staff was required to chemically disinfect the water system every Monday night and test for chemical residuals on Wednesday morning using the Minncare test strip. Interview revealed that the Bio-Medical Technician was responsible to audit the waterlog monthly to ensure that the staff had completed lass the required processes. Interview revealed that the Technician failed to realize that the staff was not documenting chemical residual testing on the log. Interview on 10/02/2025 at 0925 with the Facility Administrator revealed that the staff performed the residual testing, “they were just not being documented.” Interview on 10/02/2025 at 1345 with the Charge Nurse revealed that the Patient Care Technician was responsible for completing the water log. The unit nurse was responsible for verifying the parameters on the log to ensure that it was filled out correctly and that the values were within normal limits. The Charge Nurse reported that the form should have been reviewed to ensure that residuals were tested on Wednesday before the opening of the clinic.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38766 Based on review of policy and procedures, medical records, and staff interviews, the facility staff failed to ensure that standing blood pressures, pre- and post-hemodialysis treatments, were taken on ambulatory patients for two out of five in-center patients’ treatment sheets reviewed (Patient #1 and #3). Findings included: Review on 03/01/2021 of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (revised in April 2024) revealed “... Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse... ii. Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient’s electronic record or flow sheet) ...” 1. Medical record review on 10/01/2025 of Patient #1, revealed a 45-years-old female patient admitted for in-center hemodialysis on 05/27/2022. The review revealed that the patient was ambulatory with no assistance needed. Review of the treatment sheets dated 09/15/2025 through 09/26/2025 revealed no pre-treatment standing blood pressure reading on 09/15/2025, 09/19/2025, 09/24/2025, and 09/26/2025. Review of the treatment sheets showed no recorded post-treatment standing blood pressure on 09/24/2025 and 09/26/2025. An interview on 10/02/2025 at 1345 with the Charge Nurse revealed that all ambulatory patients should have a standing blood pressure before and after every treatment. If a patient who can walk refuses to have their standing blood pressure taken, the staff should provide education and document the refusal in the patient’s record. The Charge Nurse added that the problem in implementing the policy “is that we have a lot of new staff rotating in the clinic. The interview confirmed the finding. 2. Medical record review on 10/01/2025 of Patient #3, revealed a 46-years-old female patient admitted for in-center hemodialysis on 08/13/2025. The review revealed that the patient was ambulatory with no assistance needed. Review of the treatment sheets dated 09/15/2025 through 09/26/2025 revealed no pre-treatment standing blood pressure reading on 09/15/2025, 09/17/2025, 09/19/2025, 09/24/2025, and09/26/2025. Review of the treatment sheets showed no recorded post-treatment standing blood pressure on 09/26/2025. An interview on 10/02/2025 at 1345 with the Charge Nurse revealed that all ambulatory patients should have a standing blood pressure before and after every treatment. If a patient who can walk refuses to have their standing blood pressure taken, the staff should provide education and document the refusal in the patient’s record. The Charge Nurse added that the problem in implementing the policy “is that we have a lot of new staff rotating in the clinic. The interview confirmed the finding.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 38766 Based on a review of policy and procedures, medical records, and staff interviews, the facility failed to ensure that a monthly blood sample was submitted to the transplant center for a patient on the active transplant list for 1 of 1 active patient reviewed (Patient #1). The findings included: Review on 10/01/2025 of the current facility policy, “Transplant referral and tracking Process” (revised on October 2024) revealed “Purpose: Named Company has created this policy to serve as a guide for the education, referral, tracking of patient transplant status... Policy: ... 19. For patients who are active on the transplant list, the nurse/designee will obtain the procedure from the transplant center or any required blood draws. Administrative Assistant/designee will request blood draw and shipping materials from the respective transplant center...” A review of the medical record for patient #1 indicated a 45-year-old female was admitted for hemodialysis treatments three times per week on 05/27/2022. The record revealed a letter dated 04/04/2023, from the Named Transplant Center, confirming that the patient was active on the transplant waitlist. However, a letter from the Named Transplant Center dated 09/11/2024 indicated that the Center had not received a serum sample from the clinic for the patient since 05/11/2024, resulting in a 4-month gap. Additionally, on 02/25/2025, the Named Transplant Center sent another letter stating they had not received a serum sample for the patient from the clinic since 11/07/2024, resulting in a three-month gap. The review confirmed that the facility failed to submit the patient’s monthly blood samples to the transplant center as required by the policy. An interview on 10/02/2025 at 1300 with the Facility Administrator (FA) revealed that the clinic did not have a transplant tracking list. This list would allow nurses to easily identify the patients on the transplant waitlist and their corresponding transplant centers. The FA added that “I will create a list going forward.” An interview on 10/02/2025 at 1345 with the Charge Nurse revealed that when a patient was active on a transplant waiting list, the nurse was responsible for preparing the blood draw request, and the patient technician was to collect the sample. The Charge Nurse stated that the clinic did not have a list of patients who were active on the transplant waitlist. The interview revealed that the facility did not adequately monitor the transplant status of the patients.”