Davita Ashburn 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: 42929 Based on seven (7) infection control observations, interviews, and facility document review, it was determined the facility staff (EMP) failed to perform hand hygiene after glove removal and between each patient or station. Findings: Review of the facility’s policy titled “Infection Control for Dialysis Facilities” last revised April 2023 states in part: “... Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ...b. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... f. Between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chair side keyboard/mouse ...” Observation on June 9, 2025, at 11:56 AM, EMP9 set up dialysis machine at station #16, removed gloves, did not perform hand hygiene, then retrieved new gloves and stethoscope, then donned gloves. Observation on June 9, 2025, at 11:58 AM, EMP9 removed clamp from the patient’s arm at station #4, then removed gloves and did not perform hand hygiene. EMP9 went to the nurses station, retrieved goggles and placed on face, then donned new gloves. Observation on June 9, 2025, at 12:14 PM, EMP9 removed blood collection tubes from the centrifuge, then placed more tubes in the centrifuge and closed the lid. EMP9 then removed gloves, did not perform hand hygiene, retrieved goggles, went to station #4, donned new gloves, then proceeded to tape the patient’s fistula. Observation on June 9, 2025, at 12:43 PM, EMP9 removed gloves after cleaning station #17, did not perform hand hygiene, then donned new gloves at station #4 and began to set up the dialysis machine at station #4 for the next patient. Observation on June 9, 2025, at 12:55 PM, EMP9 removed blood collection tubes from the centrifuge, then placed more tubes in the centrifuge and closed the lid. EMP9 removed gloves, did not perform hand hygiene, then touched a stool and moved a chair, then left the treatment floor. EMP9 did not perform hand hygiene prior to leaving the treatment floor. Observation on June 9, 2025, at 1:17 PM, EMP9 assisted a patient at station #8, then removed gloves, did not perform hand hygiene, then donned new gloves and proceeded to touch the machine at station #11. Observation on June 9, 2025, at 1:22 PM, EMP9 removed used bloodlines from station #8, removed gloves, did not perform hand hygiene, then removed goggles from face, then proceeded to work at the computer between stations #8 and #9. Interview on June 9, 2025, at 2:34 PM, EMP6 indicated that hand hygiene should be performed anytime gloves are removed, including after handling blood collection tubes.”

“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: 42929 Based on four (4) infection control observations, review of facility documents and interviews, it was determined that the facility staff (EMP) failed to clean and disinfect contaminated surfaces as per infection control standards and the facility’s policy. Findings: Review of the facility’s policy titled “Infection Control for Dialysis Facilities” last revised April 2023 states in part: “... Disinfection ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., controls; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system.... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If an item cannot be cleaned and disinfected it will be dedicated for use on a single patient.... 16.... Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled....” Observation on June 9, 2025, at 11:50 AM, EMP9 did not wipe the outside arms of the chair under the tray tables and did not put the tray tables down to wipe in the crease between the table and chair at station #16. Observation on June 9, 2025, at 12:17 PM, EMP8 did not wipe the outside arms of the chair under the tray tables and did not put the tray tables down to wipe in the crease between the table and chair at station #6. EMP8 did not leave the arms of the chair open to dry after wiping. EMP8 did not wipe the IV (intravenous) pole, television screen and arm, wall box, counter behind the chair, or the sharps container at that station. Observation on June 9, 2025, at 12:19 PM, EMP9 did not wipe the outside left arm of the chair under the tray table and did not put the tray tables down to wipe in the crease between the table and chair at station #4. EMP9 did not wipe the IV (intravenous) pole, television screen and arm, wall box, counter behind the chair, or the sharps container at that station. Observation on June 9, 2025, at 12:29 PM, EMP9 removed the acid jug from the base of the machine at station #17 after the patient vacated the chair after treatment. EMP9 placed the jug on the cart next to the new acid jugs. EMP9 did not wipe the acid jug removed from the station prior to placing it with other clean jugs. Interview on June 9, 2025, at 2:34 PM, EMP6 indicated that the used acid jug should be cleaned when removing from a vacated station and prior to placing on the cart with the clean, unused acid jugs.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and facility document review, it was determined that the facility staff (EMP) failed to perform initiation of treatment with the central venous catheter (CVC) and catheter care as per the facility’s policy for one (1) of two (2) CVC care and treatment initiation observations. Findings: Review of facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” last revised April 2025 states in part: “... Notes: ... Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the bloodlines, including line reversal, or if the patient is disconnected during treatment for any reason.... 3. Verify patient’s clothing is secured away from the exit site/work area... Rationale: ... Securing the patient’s clothing away from the work area minimizes the risk of cross-contamination.... 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap.... 13. Apply label to the dressing indicating: Date dressing change was performed. Initials of TM performing procedure.... 16.... Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried.... 24.... After a minimum of 3-5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate blood line tips or catheter limbs....” Observation on June 9, 2025, at 1:20 PM, EMP8 failed to secure the patient’s shirt away from the CVC exit site while cleaning the site causing the shirt to shift back to the exit site multiple times during cleaning. EMP8 did not clean each CVC limb/cap with a new large alcohol prep pad after cleaning the exit site. After removing the cap from the CVC hub, EMP8 scrubbed each CVC hub with an alcohol pad for less than five (5) seconds. EMP8 held the blood line tips in hand with the blood line tips touching EMP8’s glove prior to attaching each blood line to the catheter hub. Interview on June 9, 2025, at 2:34 PM, EMP6 indicated that CVC lumen/limb should be wiped from top to bottom after cleaning the exit site and the CVC hubs should be scrubbed for thirty (30) seconds.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 42929 Based on interview with staff (EMP), document review, and review of facility policies, it was determined that the facility failed to document hot water disinfection time and temperature as per the facility policy, and failed to have a policy addressing the facility’s process for collecting culture and endotoxin samples. Findings: Review of the facility’s policy titled “Water Endotoxin Testing Policy” last revised April 2025 states in part: “... 4. Routine endotoxin samples are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Monthly is defined as within a calendar month....” Review of the facility’s policy titled “Water Culture Policy” last revised April 2025 states in part: “... 4. Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Monthly is defined as within a calendar month....” Review of the facility’s policy titled “Biomed Equipment Management” last revised April 2025 states in part: “... 30. Hot water disinfection systems will use manufacturers’ instructions for disinfection using hot water. Hot water disinfections systems will be monitored for temperature and time of the exposure to hot water as specified by the manufacturer. The hot water disinfection will be [greater than or equal to] 80 degrees Celsius to control bacteria proliferation in the distribution systems. The temperature of the water will be recorded at the point furthest from the hot water device....” Review of the CWP Operations Manual page 21 states in part: “... Circulation of hot water in the distribution loop should be circulated on a regular basis, preferably every day, to minimize bacterial growth in the distribution loop....” Page 104 states in part: “3.6 Chemical Disinfection ... 3.6.1 Frequency. The required chemical disinfection frequency to fulfill the desired microbiological requirements for the product water depends on several factors, such as the following. The quality of the inlet water. Local regulations regarding the microbiological quality of dialysis water, culturing techniques etc. Local preferences, such as the use of chemicals. No general rules can be given that cover all situations. The chemical disinfection schedule should be based upon microbiological testing performed by the clinic. A maximum period between chemical disinfection should be established to ensure acceptable product water bacteriological quality according to the clinic standards. As a guideline, MCP recommends a minimum weekly chemical disinfection to ensure consistent product water microbiological quality. Review of the CWP RO Unit Chemical Disinfection log revealed a section labeled “CWP Hot Water Recirculation” and then below that a row labeled “Start of Hot Water Circulation”, that is documented as “Automatically Every Night at 11:00 PM”. The next row is labeled “Low Disinfection Temperature Alarm”. There was no row to document the temperature and time of the exposure to hot water as specified by the manufacturer and no other documentation of temperature and time provided. Documentation revealed the water distribution loop had chemical disinfection on February 4, 2025, and February 5, 2025, and the culture and endotoxin samples were drawn on February 7, 2025, two days after the system was chemically disinfected and not within the 72 hours prior to disinfection as per the facility’s policy. Documentation revealed the water distribution loop had chemical disinfection on March 8, 2025, and the culture and endotoxin samples were drawn on March 4, 2025, greater than the 72 hours prior to disinfection as per the facility’s policy. Documentation revealed the water distribution loop had chemical disinfection on May 8, 2025, at 4:00 AM and the culture and endotoxin samples were obtained on March 8, 2025. There was no time documented for when the samples were obtained and if they were obtained before or after the system had chemical disinfection. Interview on June 9, 2025, at 11:52 AM, EMP5 indicated that the facility’s central water plant (CWP) is heat disinfected daily, and EMP5 was told that it doesn’t matter when the cultures and endotoxin samples are drawn in relation to when the machine is chemical disinfected monthly. EMP5 indicated that EMP5 does not need to draw the culture and endotoxin samples within the 72 hours prior to the chemical disinfection as per the facility’s policy, because the system is heat disinfected daily. Interview on June 10, 2025, at 12:30 PM, EMP16 provided the surveyor with the CWP operation manual’s instructions related to circulation of hot water in the distribution loop and weekly chemical disinfection. EMP16 indicated that the cultures and endotoxin samples can be drawn at any time since the CWP is heat disinfected daily. Interview on June 10, 2025, at 12:35 PM, EMP1, EMP11, and EMP12 agreed that the company should have a policy that reflects the process that the cultures and endotoxin samples can be drawn at any time, and not just within the 72 hours prior to the chemical disinfection as stated in the facility’s policy.”