Innovative Renal Care Newark

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 44819 Based on observations and review of policies, the facility failed to ensure staff had clear access to clean and dirty sinks during patient treatments, placing 14 of 14 patients receiving dialysis during the 7/2/2025 first patient run at risk of exposure to infection. Findings include: The Facility policy “Infection Control,” dated 1/2021 and last revised 11/29/2022, revealed, “...Each Center will maintain and clearly label separate ‘clean’ and ‘dirty’ work areas...” During an observation of the patient treatment area on 7/1/2025, between 9:43 and 10:00 AM, the two sinks located at each end of the work counter closest to the patient treatment entrance could not be identified as either a handwashing (clean) sink or a “dirty” sink. This was due to disposable towels placed in front of the identifying signs. EMP6 confirmed this finding on 7/1/2025 at 9:50 AM.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 47821 Based on a review of facility policies, protocols, and documents, as well as a review of medical records (MR) and staff (EMP) interviews, the facility failed to provide the necessary care and services needed to achieve the desired / appropriate hemoglobin level goal for 1 out of 8 patients (PT2) sampled. Findings include: The Facility protocol “Anemia Management Protocol-IV [intravenous] / SC [subcutaneous] Mircera”, revised 3/24/2023, revealed, “...Anemia Management Goals...Hemoglobin (Hgb)...10.0 g/dl [grams per deciliter]-11.0 g/dl...Monitor hemoglobin every two weeks, unless dose is on hold...If Hemoglobin < [less than] 9 g/dl, notify MD for further orders...Mircera should not be given more frequently than every 2 weeks...” PT2: A. Review of facility document “Anemia Management Report” dated 7/1/2025 revealed the following Hgb lab values for PT2: - 3/19/2025 Hgb 7.6 - 3/28/2025 Hgb 8.6 - 4/16/2025 Hgb 10.6 - 5/7/2025 Hgb 12.2 (21 days after last lab value) Review of MR2 revealed no evidence that the physician was notified of the 3/19/2025 Hgb of 7.6 or the 3/28/2025 Hgb of 8.6. During an interview on 7/2/2025 between 2:15 and 2:25 PM, EMP2 confirmed the 5/7/2025 Hgb level was not monitored according to the Anemia Management Protocol and that there is no evidence of physician notification of Hgb levels below 9 on 3/19/2025 and 3/28/2025. B. Review of PT2’s Mircera documentation revealed: a) “Dialysis Order Report” revealed an order dated 3/17/2025 for Mircera 150 mcg (micrograms) IVP (intravenous push) to be administered during the 2nd treatment every 2 weeks. b) “HD (Hemodialysis) Treatment Flowsheet” revealed: - 4/16/2025 revealed that Mircera was administered at 1:00 PM - 4/23/2025 revealed that Mircera was administered at 1:48 PM (7 days since last dose) During an interview on 7/2/2025 between 2:25 and 2:25 PM, EMP2 confirmed the patient received Mircera more frequently than every 2 weeks.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 44819 Based on a review of facility policies, documents, and staff (EMP) interviews, the facility failed to analyze and develop action plans for 4 out of 6 months when their anemia management indicators did not meet their goal. Findings include: The Facility’s “Anemia Management Protocol - IV [intravenous]/SC [subcutaneous] Mircera,” revised 3/24/2023, stated, “...Anemia management goals...Hemoglobin (Hgb) 10.0 g/dl [grams per deciliter] - 11.0 g/dl...” The Facility’s policy, “Quality Assurance & Performance Improvement (QAPI),” dated 5/13/2024 and last revised 1/13/2025, revealed, “...QAPI outcomes will be continually monitored, and the IDT [interdisciplinary team] will meet monthly to discuss trends and develop action plans as necessary to improve outcomes...” The facility’s Anemia Management monitoring in the Facility’s QAPI electronic application identified the Facility’s anemia management goal of 60% of patients having Hgb levels between 10.0 and 11.0 g/dl. A review of the Facility’s QAPI Anemia Management monitoring between 1/2024 and 4/2025 revealed: - 3/2024 incenter hemodialysis Hgb 10-11 of 51.7%. - 6/2024 incenter hemodialysis Hgb 10-11 of 56.6%. - 11/2024 incenter hemodialysis Hgb 10-11 of 55.1%. - 1/2025 incenter hemodialysis Hgb 10-11 of 58.0%. There is no evidence that the IDT reviewed the results for possible root causes or developed actions needed to improve the outcomes. During the review of the QAPI Anemia Management monitoring on 7/2/2025 between 9:50 and 10:50 AM, EMP2 confirmed the findings.”