Fresenius Medical Care of Anson County

“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 staff interview and infection control audit checklist, the facility staff failed to clean and disinfect the Hansen connectors for 3 of 3 HDM and station disinfections (Station #16, HDM #2; Station #14, HDM #17 and Station #12, HDM #8). The findings include: Review on September 11, 2025 of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station” published September 5, 2025 revealed, “Purpose ... Responsibility ...Background ...Definition ...General Cleaning ...Cleaning of the Dialysis Machine [space] Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment. ...” 1. Observation on September 10, 2025 at 11:15 AM revealed, certified technician #1 obtained 1:100 bleach cloths to clean and disinfect Station #16, HDM #2. The observation revealed, all non-disposable equipment was cleaned and disinfected except for the Hansen connectors. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed, infection control audits are performed and did not reveal any concerns with cleaning and disinfecting of the Hansen connectors. Review on September 11, 2025 of the facility’s infection control audit checklist revealed, no audits were performed on October 2024, November 2024 and January 2025 and from September 2024 through August 2025, the facility staff had a 90% to 100% for cleaning and disinfection of the dialysis station. 2. Observation on September 10, 2025 at 11:45 AM revealed, certified technician #2 obtained 1:100 bleach cloths to clean and disinfect Station #14, HDM #17. The observation revealed, all non-disposable equipment was cleaned and disinfected except for the Hansen connectors. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed, infection control audits are performed and did not reveal any concerns with cleaning and disinfecting of the Hansen connectors. Review on September 11, 2025 of the facility’s infection control audit checklist revealed, no audits were performed on October 2024, November 2024 and January 2025 and from September 2024 through August 2025, the facility staff had a 90% to 100% for cleaning and disinfection of the dialysis station. 3. Observation on September 11, 2025 at 10:50 AM revealed, certified technician #1 obtained 1:100 bleach cloths to clean and disinfect Station #12, HDM #8. The observation revealed, all non-disposable equipment was cleaned and disposed except for the Hansen connectors. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed, infection control audits are performed and did not reveal any concerns with cleaning and disinfecting of the Hansen connectors. Review on September 11, 2025 of the facility’s infection control audit checklist revealed, no audits were performed on October 2024, November 2024 and January 2025 and from September 2024 through August 2025, the facility staff had a 90% to 100% for cleaning and disinfection of the dialysis station.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 32003 Based on policy review, observations, medical record reviews and staff interview, the facility staff failed to ensure the dialysate flow rate was administered as prescribed for 2 of 3 patients (#1 and #8) and failed to ensure the blood flow rate was administered as prescribed for 2 of 3 of patients (#2 and #8). The findings include: Review on September 11, 2025 of the facility’s policy, “Patient Assessment and Monitoring” published May 1, 2023 revealed, “Purpose ...Responsibility ...Definitions ...Delegation ...Data Collection ...Pre-Treatment ...During Treatment ...Step 1 ...Step 3 [space] Machine Parameters and Extracorporeal Circuit [space] Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. ...” 1. Observation on September 10, 2025 at 11:35 AM revealed, dialysis treatment for Patient #1 was in progress with a dialysate flow rate of 500 milliliters per minute Open medical record review on September 11, 2025 revealed Patient #1 was admitted to the in-center facility in 2020. The physician ordered a dialysate flow rate of 800 milliliters per minutes. Treatment sheet review from August 25, 2025 through September 5, 2025 (6-consective treatments) revealed, on September 1, 2025 - the dialysate flow rate was not at the prescribed rate for treatment duration 242-minutes. Review revealed staff did not document a reason for not administering the prescribed dialysate flow rate. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed the dialysate flow rate was not as prescribed for Patient #1 on September 1, 2025. 2. Observation on September 10, 2025 at 11:21 AM revealed, dialysis treatment for Patient #2 was in progress with a blood flow rate of 500. Open medical record review on September 11, 2025 revealed Patient #2 was admitted to the in-center facility in 2024. The physician ordered a blood flow rate of 500. Treatment sheet review from August 25, 2025 through September 5, 2025 (6-consective treatments) revealed, on August 25, 2025 - the blood rate was not at the prescribed rate for treatment duration of 209-minutes and on September 3, 2025 - the blood flow rate was not at the prescribed rate for treatment duration of 262-minutes. Review revealed staff did not document a reason for not administering the prescribed blood flow rate. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed the blood flow rate was not as prescribed for Patient #2 on September 1, 2025. 3. Observation on September 10, 2025 at 12:25 PM revealed, dialysis treatment for Patient #8 was in progress with a blood flow rate of 400 and a dialysate flow rate of 700. Open medical record review on September 11, 2025 revealed Patient #8 was admitted to the in-center facility in 2018. The physician ordered a blood flow rate of 400. Treatment sheet review from August 25, 2025 through September 5, 2025 (6-consective treatments) revealed, on August 25, 2025 - the blood rate was not at the prescribed rate for treatment duration of 218-minutes. On September 1, 2025 - the dialysate flow rate was not at the prescribed rate for the treatment duration of 144-minutes. On September 3, 2025 - the blood flow rate was not at the prescribed rate for the treatment duration of 229-minutes. Review revealed staff did not document a reason for not administering the prescribed blood flow rate. Interview on September 11, 2025 at about 3:10 PM with the Clinical Manager revealed the blood and dialysate flow rates were not as prescribed for Patient #8 on September 1, 2025.”