Davita Charlotte East 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: 32003 Based on policy review, observations, and staff interview, the facility staff failed to clean and disinfect non-disposable equipment between patient use for 2 of 3 observations (stations #6 and #10). The findings include: Review on April 24, 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. ...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., control panel; 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. ...” 1. Observation on April 22, 2025 at 12:25 PM revealed, technician #1 cleaned and disinfected dialysis machine #33 and the chair located at station #6. Observation revealed, the technician failed to clean and disinfect the blue bag and the laminate that hung from the IV pole attached to the dialysis machine, the chase wall and the acid box. Interview on April 3, 2025 at 2:35 PM with the Facility Administrator revealed all items in contact with the dialysis machine and station should be cleaned and disinfected between patient use. Review on April 3, 2025 of the personnel worksheet revealed, technician #3 was hired at the facility and was knowledgeable of infection control practices for dialysis facilities as the last education was completed January 2025. 2. Observation on April 22, 2025 at 1:12 PM revealed, technician #2 cleaned and disinfected dialysis machine #7 and the chair located at station #10. Observation revealed, the technician failed to clean and disinfect the blue bag and the laminate that hung from the IV pole attached to the dialysis machine, the chase wall and the acid box. Interview on April 3, 2025 at 2:35 PM with the Facility Administrator revealed all items in contact with the dialysis machine and station should be cleaned and disinfected between patient use. Review on April 3, 2025 of the personnel worksheet revealed, technician #2 was hired at the facility and was knowledgeable of infection control practices for dialysis facilities as the last education was completed April 2024.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 32003 Based on policy review, acid log review and staff interview, the facility staff failed to document the acceptable ranges for specific gravity for 2 of 2 months reviewed (March and April 2025) and failed to document the time that the mixed acid batch was transferred to the holding tank for 2 of 2 months reviewed (March and April 2025). The findings include: Review on April 9, 2025 of the facility’s policy, “PREPARATION OF CITRIC COMPLETE TM CONCENTRATE WITH ROCKWELL® DAMX ACID CONCENTRATE MIXER” originated November 2024 revealed, “Material required ...Procedure [space] 1. ...13. Licensed nurse must verify that the complete contents of Citric Complete packages are added to the batch. ...Both teammate preparing the concentrate and the licensed nurse must sign the Citric Complete Batch Production Record where indicated. Once the temperature and specific gravity values are confirmed, and entered on the Batch Production Record, the solution is ready for use. ...” Review failed to reveal that the date and time when the batch was transferred to the storage tank were required by policy. Review on April 22, 2025 of the “Citric Complete TM Batch Productive Record” revealed the acceptable ranges for specific gravity was not documented March 31, 2025, April 11, 2025, and April 21, 2025. On March 4, 2025 and April 11, 2025, the date and time the acid batch was transferred to the storage tank was not documented. Interview on April 22, 2025 at about 1:30 PM with the Biomedical technician revealed that there were some data missing from the citric acid batch production log.”

“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: 32003 Based on teammate policy review, observations, personnel worksheet review, and staff interview, the facility staff failed to ensure staff secured and wore long hair up for 2 of 2 observations (Technicians #1 and #3). The findings included: Review on April 24, 2025 of the facility’s policy, “[organization] TEAMMATE POLICIES” effective February 1, 2022 revealed, “1. New Hire ...2. Employment ...3. Benefits ...4. Pay Practices ...5. Work Environment ... Hair must be clean and long hair must be worn up or otherwise secured to prevent hair from falling onto any clean or sterile field or from becoming accidentally entangled in equipment. ...” 1. Observation on April 22, 2025 at 12:25 PM revealed, technician #1 long hair was pulled back into a pony-tail that was not worn up as the technician provided treatment discontinuation care to Patient #3. Review on April 24, 2025 of the personnel worksheet revealed that technician #1 was hired at the facility and completed facility-based competencies in April 2025. Interview on April 24, 2025 at 2:35 PM with the Facility Administrator revealed, staff with long hair should secure and wear their hair up when providing direct patient care. 2. Observation on April 23, 2025 at about 12:00 PM revealed, technician #3 long hair was not secured and was not worn up as the technician provided treatment initiation care to Patient #11. Review on April 24, 2025 of the personnel worksheet revealed that technician #3 was not listed and completion of facility-based competencies was undetermined. Interview on April 24, 2025 at 2:35 PM with the Facility Administrator revealed, staff with long hair should secure and wear their hair up when providing direct patient care.”