Davita Dialysis Care of Kannapolis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 32003 Based on policy review, observations, staff interview and personnel worksheet review, the facility staff failed to ensure patients performed hand hygiene for 3 of 3 AVF/G discontinuation observations for patients #1, #8 and #19. The findings include: Review on April 3, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE: ...NOTES: ...POLICY: ...HAND HYGEINE [space] 1. ...2. Patients and caregivers will be encouraged to [space] a. ...b. Perform hand hygiene after treatment before leaving treatment area. ...” 1. Observation on April 1, 2025 at 11:25 AM revealed, Patient #1 was located at dialysis station #9 as Technician #1 removed dialysis needles and the patient held manual pressure with a gloved hand. Observation revealed, hemostasis was achieved, the patient removed the glove and exited the in-center treatment area without performing hand hygiene. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included hand hygiene. Review on April 3, 2025 of the personnel worksheet revealed, Technician #1 was knowledgeable of infection control practices as the last education was completed November 2024. 2. Observation on April 1, 2025 at 2:00 PM revealed, Patient #8 was located at dialysis station #7 as Technician #1 removed the dialysis needles and the patient held manual pressure with a gloved hand. Observation revealed, hemostasis was achieved, the patient removed the glove and exited the in-center treatment area without performing hand hygiene. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included hand hygiene. Review on April 3, 2025 of the personnel worksheet revealed, Technician #1 was knowledgeable of infection control practices as the last education was completed November 2024. 3. Observation on April 2, 2025 at 12:27 PM revealed, Patient #19 was located at dialysis station #24 as Technician #2 removed the dialysis needles and the patient held manual pressure with a gloved hand. Observation revealed, hemostasis was achieved, the patient removed the glove and exited the in-center treatment area without performing hand hygiene. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included hand hygiene. Review on April 3, 2025 of the personnel worksheet revealed, Technician #2 was knowledgeable of infection control practices as the last education was completed November 2024.”

“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: 32003 Based on observation, staff interview and personnel worksheet review, the facility staff failed to remove PPE when going from the in-center treatment area to the supply-water room area for 1 of 1 total chlorine testing observation. The findings include: Review on April 3, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE: ...NOTES: ...POLICY: ...HAND HYGEINE ...PPE (i.e., gown, gloves, eye protection, face shield) [space] 5. ...PPE is to be: a. Removed prior to leaving the treatment area. ...” Observation on April 2, 2025 at 12:40 PM revealed, Technician #5 entered the supply/water room area(clean) from the in-center treatment area (dirty) without removing the gown to visualize the total chlorine results from the [continuous chlorine monitoring system]. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses. Review on April 3, 2025 of the personnel worksheet revealed, Technician #5 was knowledgeable of infection control practices as the last education was completed November 2024 and the last water/dialysate education was completed February 2025.”

“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: 32003 Based on policy review, observations, and staff interview, the facility staff failed to clean and disinfect non-disposable equipment between patient use for 3 of 3 observations at stations #9 and #1. The findings include: Review on April 3, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE: ...NOTES: ...POLICY: ...HAND HYGEINE ...PPE ...SUPPLIES ...DISINFECTION [space] 12. ...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. ...14. Non-disposable items are to be disinfected after each patient use ...” 1. Observation on April 1, 2025 at 11:44 AM revealed, Technician #3 cleaned and disinfected dialysis machine #23 and the chair located at station #9. Observation revealed, the technician failed to clean and disinfect the laminate and yellow placard that hung from the IV pole attached to the dialysis machine. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included cleaning and disinfecting of the dialysis machine and station. Review on April 3, 2025 of the personnel worksheet revealed, Technician #3 was knowledgeable of infection control practices as the last education was completed November 2024. 2. Observation on April 1, 2025 at 1:40 PM revealed, Technician #4 cleaned and disinfected dialysis machine #16 and the chair located at station #1. Observation revealed, the technician failed to clean and disinfect the oxygen concentrator that was located at the chairside and the yellow placard that hung from the IV pole attached to the dialysis machine. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included cleaning and disinfecting of the dialysis machine and station. Review on April 3, 2025 of the personnel worksheet revealed, Technician #4 was recently hired at the facility and infection control education was documented as not applicable. 3. Observation on April 2, 2025 at 3:48 PM revealed, Technician #5 cleaned and disinfected dialysis machine #16 and the chair located at station #1. Observation revealed, the technician failed to clean and disinfect the oxygen concentrator that remained at the chair side after use by Patient #12. Interview on April 3, 2025 at 9:30 AM with the Clinical Coordinator revealed, monthly infection control audits were performed in which, the trends were shared with the nurses as well as, staff were provided with monthly education that included cleaning and disinfecting of the dialysis machine and station. Review on April 3, 2025 of the personnel worksheet revealed, Technician #5 was knowledgeable of infection control practices as the last education was completed November 2024.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 32003 Based on policy review, dialysis machine disinfection log and staff interview, the facility staff failed to ensure all dialysis machines underwent weekly integrated heat disinfection for 2 of 2 months (February and March 2025). The findings include: Review on April 3, 2025 of the facility’s policy, “[brand] DIALYSIS DELIVERY SYSTEM CLEANING AND DISINFECTION POLICY” revised April 2019 revealed, “PURPOSE: To promote patient safety by cleaning and disinfection of [brand] dialysis delivery systems. ...” Review on April 2, 2025 of the facility’s dialysis delivery system disinfection log revealed, the dialysis machines were supposed to undergo weekly integrated heat disinfection on Wednesdays which would be identified as performed if the dialysis machine was “off” at the start of the next treatment day. Review revealed: on February 5, 2025, the facility had 31-dialysis machines in use and dialysis machine #16 was “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On February 12, 2025, the facility had 31-dialysis machines in use and dialysis machines #16, #18, and #19 were “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On February 19, 2025, the facility had 31-dialysis machines in use and documentation revealed not any of the machines underwent integrated heat disinfection. On February 26, 2026, the facility had 31-dialysis machines in use and dialysis machines #16 and #24 were “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On March 5, 2025, the facility had 31-dialysis machines in use and dialysis machine #16 was “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On March 12, 2025, the facility had 31-dialysis machines in use and dialysis machine #16 was “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On March 19, 2025, the facility had 31-dialsysis machines in use and dialysis machine #16 was “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. On March 26, 2025, the facility had 30-dialysis machines in use and dialysis machines #12 and #16 were “on” at the start of the next treatment day which indicated that integrated heat disinfection was not performed. Interview on April 2, 2025 at about 4:15/4:30 PM with the Facility Administrator revealed although not indicated on the dialysis delivery system disinfection log, the facility staff should notify the biomedical technician if a dialysis machine does not undergo weekly integrated heat disinfection.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 32003 Based on policy reviews, observation, batch production log review, and staff interviews, the facility failed to document the date of the 5-micron filter for 1 of 1 acid mixing system for 2 of 2 months reviewed (February and March 2025). The findings include: Review on April 3, 2025 of the facility’s policy, “CITRIC COMPLETE TM DRY ACID CONCENTRATE MIXING” revised November 2024 revealed, “PURPOSE: [space] To provide guidance to verify that the Citric Complete Dry Acid Concentrate will produce liquid acid concentrate from commercially packaged dry powder in a safe and fully documented process that is consistent with instructions given by the manufacturer. ...” Review failed to reveal how often the 5-micron filter should be replaced. Review on April 3, 2025 of the facility’s policy, “PREPARATION OF CITRIC COMPLETETM CONCENTRATE WITH ROCKWELL® DRI-SATE (DS) MIXER” revised November 2024 revealed, “Materials required: ...5-micron filter ...” Review failed to but the policy failed to reveal how often the filter should be replaced. Observation on April 1, 2025 at 11:59 AM of the water treatment area revealed, the label on the 5-micron filter was last dated in March 2025. Review on April 2, 2025 of the facility’s acid batch mixing log revealed, the date of the filter and/or replacement should be documented either monthly or after transfer of 1500 gallons. In February 2025, the facility staff mixed 14-batches of 100-gallons of dry acid concentrate and in March 2025, the facility staff mixed 11-batches of 100-gallons of dry acid concentrate for a total of 2,500-gallons in a 2-month period. Review revealed the facility staff failed to document the date of the filter or filter replacement date on the log for each batch that was mixed. Interview on April 2, 2025 at 12:50 PM with the Biomedical Technician revealed, the 5-micron filter should be labeled with a date and the filter should be changed every 15-batches. Interview on April 2, 2025 at about 4:15/4:30 PM with the Facility Administrator revealed that although the acid policies does not indicate when the 5-micron filter should be changed, the date of the filter should be documented on the acid batch mixing log.”

“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: 32003 Based on policy review, medical record reviews, and staff interviews, the facility staff failed to provide patients with an advanced notice of their POC meeting for 5 of 5 ICHD patients (Patients #1, #7, #10, #11, #13, and #17). The findings include: Review on April 3, 2025 of the facility’s policy, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” revised October 2024 revealed, PURPOSE: ...ASSESSMENT: ...PLAN OF CARE: [space] 8. The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care ...9. The plan of care will address, but not be limited to, the following: ...in-center hemodialysis ...Home hemodialysis ...peritoneal dialysis ...” Review failed to reveal how and when the facility staff would notify patients of their POC meeting. 1. Open medical record review on April 3, 2025 revealed, Patient #1 was admitted to the ICHD program in December 2024. The last POC was performed in January 2025 but failed to reveal how and when the patient was notified of their POC meeting. Interview on April 3, 2025 at 1:35 PM revealed that patients were verbally told about their POC meetings about 1-week before time. During the interview, documentation was requested but was not provided before survey completion. 2. Open medical record review on April 3, 2025 revealed, Patient #7 was admitted to the ICHD program in January 2014. The last POC was performed in June 2024 but failed to reveal how and when the patient was notified of their POC meeting. Interview on April 3, 2025 at 1:35 PM revealed that patients were verbally told about their POC meetings about 1-week before time. During the interview, documentation was requested but was not provided before survey completion. 3. Open medical record review on April 3, 2025 revealed, Patient #10 was admitted to the ICHD program in January 2022. The last POC was performed in June 2024 but failed to reveal how and when the patient was notified of their POC meeting. Interview on April 3, 2025 at 1:35 PM revealed that patients were verbally told about their POC meetings about 1-week before time. During the interview, documentation was requested but was not provided before survey completion. 4. Open medical record review on April 3, 2025 revealed, Patient #11 was admitted to the ICHD program in October 2022. The last POC was performed in April 2024 but failed to reveal how and when the patient was notified of their POC meeting. Interview on April 3, 2025 at 1:35 PM revealed that patients were verbally told about their POC meetings about 1-week before time. During the interview, documentation was requested but was not provided before survey completion. 5. Open medical record review on April 3, 2025 revealed, Patient # 17 was admitted to the ICHD program in November 2022. The last POC was performed in January 2025 but failed to reveal how and when the patient was notified of their POC meeting. Interview on April 3, 2025 at 1:35 PM revealed that patients were verbally told about their POC meetings about 1-week before time. During the interview, documentation was requested but was not provided before survey completion.”