Ameri-Tech Kidney Center-Bedford LLC

“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: 28297 Based on observation, interviews, and policy review the facility failed to ensure one of two Registered Nurses (RN) 1 performed hand hygiene as required. RN1 failed to perform hand hygiene after glove changes during two of four observations of Central Venous Catheter (CVC) (A flexible catheter that is placed in a central vein used for hemodialysis) care. The failure to perform hand hygiene after glove changes had the potential for cross contamination and this could affect 18 patients in the facility with CVC’s. Findings include: 1. Observation on 01/13/25 at 2:45 PM, RN1 was completing discontinuation of dialysis via CVC for Patient (P) 5 at Station #5. After RN1 reinfused the blood via the extracorporeal circuit, then he/she removed gloves and donned new gloves without washing or sanitizing hands. 2. Observation on 01/13/25 at 4:35 PM, RN1 was at Station #4 initiating the dialysis treatment via CVC for P6. RN1 removed the old dressing from the CVC site, then proceeded to do CVC lumen care including withdrawing blood, flushing with normal saline, and administering Heparin. RN1 then removed his/her gloves and applied new gloves without washing or sanitizing hands. He/she then proceeded to clean the CVC site and applied a new dressing. When the task was completed and treatment initiated, RN1 disposed of all dirty supplies, removed gloves but failed to complete hand hygiene. During an interview on 01/15/25 at 9:15 AM, RN1 acknowledged he/she may not have sanitized hands after glove changes that surveyor observed as he/she though they only needed to hand hygiene after glove changes if the gloves were “stained.” During an interview on 01/15/25 at 1:00 PM, the Facility Administrator confirmed the facility policy and best practice is that staff were to hand hygiene after every glove change to prevent cross contamination. Review of the facility policy “Hand Hygiene,” revised 10/28/22 indicated the following: “ ...Perform hand hygiene: ...immediately after glove removal, before putting on gloves ...””

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 28297 Based on interviews, record reviews, facility document review and policy review the facility failed to appropriately manage the patient’s anemia for one of seven patients (P) 6. The failure to manage anemia had the potential for patients’ hemoglobin (A protein inside the red blood cells that carries oxygen from the lungs to tissues and organs in the body and carries carbon dioxide back to the lungs) to not be at therapeutic range and this could affect 53 in-center patients. Findings include: Review of the Dialysis Facility Report for Fiscal Year 2025 indicated in 2023, 40% of eligible hemodialysis patient-months had a hemoglobin value below 10 g/dL, compared to 21% in your State, 21% in your Network, and 23% nationally. Review of the Quality Assessment and Performance Improvement (QAPI) dashboard provided by the facility revealed the following: September 2024 hemoglobin less than 10.0 grams/deciliter (G/dl) was 39.53%. October 2024 hemoglobin less than 10 g/dl was 26.19%. November 2024 hemoglobin less than 10 g/dl was 25.58%. The facility QAPI dashboard did not have a specific goal for hemoglobin less than 10 g/dl listed. Review of the face sheet provided by the facility for P6 revealed the facility admitted the patient on 01/26/24 with diagnosis including end stage renal disease (ESRD). Review of P6 labs and medication management provided by the facility indicate the following: 1. On October 14, 2024- P6 hemoglobin was 8.0 g/dl and received Micera 150 micrograms every 2 weeks. October 21, 2024-hemoglobin was 7.5 g/dl; October 28, 2024-hemoglobin was 7.9 g/dl with patient 6 still receiving Micera 150 mcg [micrograms] every 2 weeks. 2. On November 4, 2024, P6’s hemoglobin went up to 9.3 g/dl, and November 11, 2024, hemoglobin went up to 10.0 g/dl. P6 Micera dose was decreased to 100 mcg every 4 weeks, and he/she received a dose on 11/11/24. 3. On December 2, 2024, the patient hemoglobin dropped to 9.8 g/dl and on December 9, 2024, the patient hemoglobin dropped to 8.7 g/dl. The patient Micera dose was changed on 11/15/24 to 75 mcg every four weeks and the dose was not given until 12/09/24. During an interview on 01/15/25 at 9:15 AM RN 1 stated he/she was the anemia manager for the clinic. RN1 stated the maximum facility dose for Micera was 150 mcg every 2 weeks and if the physician wanted more, they had to do a specific individual order. RN1 confirmed P6 should have been on Micera every 2 weeks and not every 4 weeks, and the dose should not have decreased from 100 mcg to 75 mcg based on the patients’ labs. During an interview on 01/15/25 at 1:00 PM the Facility Administrator stated there did appear to be an error in the anemia management for P6. He/she stated they need to have a better process for anemia management. Review of the facility “ESA/Anemia protocol (Micera)” last revised 03/23/24 indicated, “ ...In ESA-naive patients, start Mircera® at dose of 0.6 mcg/kg [kilogram] IVP [intravenous push]/subcutaneous, injected every 2 weeks .... Dose increases should not be made more frequently than monthly in most cases (MD may override protocol to make adjustment every 2 weeks in select cases). Decreases may be made every 2 weeks. Avoid overly frequent adjustments. See the accompanying Mircera® Dosing Algorithm for dosage ...Rate of decline > 0.5 g/dL over 2 weeks, and Hgb: o > 11.0 g/dL - HOLD o 10.6 - 11.0 g/dL - PER HOLD RESTART o 10.1 - 10.5 g/dL - INCREASE dose by 25% o ? 10.0 g/dL - INCREASE dose by 50% ...” Review of the facility policy “Anemia Management” provided by the facility revised 01/21 indicated, “Purpose: To assist the patient in achieving optimal erythropoiesis. To ensure the patient obtains the maximum benefit from the administration of erythropoietin stimulating agents (ESAs) and iron. ... Each IRC care center will designate at least one nurse to act as the center’s Anemia Manager. Each center will ensure that all nurses are knowledgeable about the center’s anemia protocol to ensure that active, timely and ongoing anemia management continues in the absence of the center’s designated Anemia Manager. Hemoglobin results from the lab are reviewed promptly upon receipt from the lab. Results will be placed in the patient’s record via a lab interface or manually by the associate receiving the result ...””