Davita Paris Dialysis

“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: 46886 Based on observations, policy reviews, and employee interviews, facility staff failed to perform hand hygiene per facility protocol for one (1) of two (2) AV fistula disconnect observations. (OBS 2) Findings include: A 2/27/25 review of Infection Control for Dialysis Facilities procedure revealed: “ Hand Hygiene ...1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene ...after contamination with blood or other infectious material ...7. Disposable gloves will be worn when caring for the patient or touching the patient ’ s equipment at the dialysis station ...Gloves should be changed when ...soiled with blood, dialysate or other body fluids ...when going from a “ dirty “ area or task to a “ clean “ area or task...When moving from a contaminated body site to a clean body site of the same patient ... On 2/26/25 at approximately 12:00 pm at hemodialysis station #15, EMP5 was observed performing an arterio-venous fistula disconnect. EMP5 removed two fistula needles then held pressure at the fistula site. When EMP5 finished holding pressure at the site and changed the bandage, they failed to remove the contaminated gloves and perform hand hygiene prior to contacting the patient ’ s belongings and wheelchair. The staff member failed to follow policy and perform hand hygiene/glove changes upon completing a “ dirty “ task -AV fistula disconnect- and beginning a “ clean “ task--handling patient belongings for discharge. The finding was reviewed with EMP1, Facility Administrator, and EMP2, Manager of Clinical Services during an exit interview on 2/26/25 at approximately 2:00 pm.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 46886 Based on observations (OBS), policy review, and interviews with staff, the facility staff failed to perform central line (CVC) disinfection per CDC guidelines and facility policy for one (1) of two (2) CVC disconnect observations. (OBS1) Findings include: A 2/27/25 review of CDC website guidelines for infection prevention in dialysis centers revealed: “ Catheter hub disinfection ...Scrub catheter hubs with an appropriate antiseptic after cap is removed and before accessing. Perform every time catheter is accessed or disconnected... “ Centers for Disease Control. (March 29, 2024.). CDC Dialysis Safety: Best Practices for Bloodstream Infection Prevention in Dialysis Setting. U.S. Centers for Disease Control and Prevention. <https://www.cdc.gov/dialysis-safety/hcp/clinical-safety/index.html> A 2/27/25 review of facility Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure policy 1-04-02B revealed: “ Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason ... “ A 2/26/25 observation (OBS1) at dialysis station #10 at approximately 10:15 am revealed: EMP3 failed to scrub the CVC/blood line connection with a disinfection wipe prior to site disconnection and catheter flush post dialysis treatment. The finding was reviewed with EMP1, Facility Administrator, and EMP2, Manager of Clinical Services, during an interview at approximately 2:00 pm on 2/26/25.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 46886 Based on observations (OBS) and interviews with staff, the facility failed to label a dialysate mixing system for positive content identification for one (1) of one (1) water room OBS. Findings include: During the 2/24/25 facility flash tour at approximately 9:30 am with EMP4 the dialysate mixing tank located near the facility water room was found filled with an unidentified fluid. Two separate labels were found hanging on the mixing tank, neither label contained a date, time, or the initials of a team member. EMP4 was unable to positively identify the contents of the mixing tank or how long the contents had remained in the tank. EMP1, facility administrator, and EMP4 were unable to verify if a staff member was in the process of mixing acid or if the contents of the tank were for cleansing the vessel after completion of acid mixing. The finding was reviewed during an exit interview on 2/24/25 at approximately 2:30 pm with EMP1, Facility Administrator, and EMP2, Manager of Clinical Services.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 46886 Based on procedure reviews, observations, and employee interviews (EMP), the facility failed to create a clearly defined policy which instructed staff on how and when to label fluid types present within a dialysate mixing system for two (2) of two (2) procedures reviewed. (Procedure # 1 and #2) Findings include: During the 2/24/25 unannounced facility flash tour at approximately 9:30 am with EMP4, water technician, the dialysate mixing tank located near the facility water room was found filled with an unidentified fluid. Two separate labels were found hanging on the mixing tank, neither label contained a date, time, or the initials of a team member. EMP4 was unable to positively identify the contents of the mixing tank or how long the contents had remained in the tank. EMP1, facility administrator, and EMP4 were unable to verify if a staff member was in the process of mixing acid or if the contents of the tank were for cleansing the mixing tank after the completion of a dialysate batch. During an exit interview on 2/27/25 at approximately 2:00 pm, EMP2 stated that the policies did not specify the labeling of RO water during the rinse step of the acid mixing process. EMP2 further clarified that Procedure 1-20-17A did not contain instructions on when to label the contents of the mixing system. A 2/27/25 review of Procedure #1: 1-20-17A Preparation of Citric Complete Concentrate with Rockwell Dri-Sate Mixer determined that the policy failed to provide staff with clear guidance on when to label the mixer contents. A 2/27/25 review of Procedure #2: Form 1-20-17B Citric Complete Batch Production Record revealed, “ [Step]9. Label mixer with Date & Time, Catalog Number and Formula ... “ Further review of Procedure 1-20-17B determined that the procedure failed to provide staff with clear guidance on labeling the mixer contents during [Step]16..rinse performed. The findings were reviewed with EMP1 Facility Administrator and EMP2 Manager of Clinical Services during an exit interview on 2/27/25 at approximately 2:00 pm.”