Fmc - Centre Point

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30177 Based on observations, interview, manufacturer’s directions for use (DFU) and policy review, the facility failed to follow the bloodline manufacturer’s DFU for one of one observation day during hemodialysis treatments by failing to ensure the arterial drip chamber fluid levels were at 90% full. Failure to follow the manufacturer’s DFU had the potential to negatively impact the safety of the 148 patients receiving in-center hemodialysis treatments at this facility. Findings include: During an observation on 11/20/24 at 9:55 AM with the Charge Nurse 8, the arterial drip chamber fluid levels were less than 90% full in 14 of 41 Stations (5, 8, 41, 40, 39, 38, 9, 25, 16, 35, 17, 18, 7 and 8) in use. During an interview on 11/20/24 at 10:05 AM, the Charge Nurse confirmed the arterial drip chamber fluid levels were less than 90% in Stations 5, 8, 41, 40, 39, 38, 9, 25, 16, 35, 17, 18, 7 and 8 in use. Review of the manufacturer’s DFU indicated, “Maintain fluid level in arterial chamber at approximately 90% full. “ Review of the facility’s policy titled, “Machine Start Up and Priming a single Use Dialyzer Utilizing Fresenius 2008 Series dialysis Delivery Systems and Nipro or Combiset Blood Lines for First Shift of the Day, When the arterial drip chamber is approximately 90% full or at the manufacturer’s fill line indicator ...””

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 30177 Based on observation and interview, the facility failed to display the current State agency and end stage renal disease (ESRD) network mailing addresses and telephone complaint numbers. Failure to display the information had the potential for patients’ grievances to go unreported and/or unresolved, which had the potential to negatively impact all 148 patients receiving treatments at this facility. Findings include: During observations on 11/20/24 at 11:15 AM, the facility displayed a copy of the patient’s rights. However, it did not include the current mailing addresses and telephone complaint numbers for the State Survey Agency and ESRD Network. The document failed to include information on how to contact the ESRD Network or the State Survey Agency. In a joint interview with the Clinic Manager and the Director of Operations on 11/23/24 at 1:15 PM, the Clinic Manager confirmed the current mailing addresses and telephone complaint numbers for the State Survey Agency and ESRD Network were not displayed in the facility.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 30177 Based on observation and interview, Registered Nurse (RN) 1 failed to administer Venofer (Intravenous iron used treatment anemia) per manufacturer’s instruction for use (IFU) slowly over two to five minutes. Administering Venofer too rapidly can cause adverse reactions such as low blood pressure, shortness of breath, headache, vomiting, nausea, dizziness, joint aches, paresthesia (tingling sensation), muscle pain, edema, and cardiovascular collapse, which had the potential to negatively impact all 148 patients receiving treatments at this facility. Findings include: During observations of medication administration on 11/20/24, RN1 administered intravenous (IV) Venofer over 40 seconds to Patient (P) 11 at 11:54 AM, over 32 seconds to P12 at 12:02 PM, and over one minute to P2 at 12:12 PM. A review of the facility’s policy titled “Special Considerations: Venofer,” published on 07/01/24 revealed that “Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg diluted in a maximum of 100 milliliter (mL) of 0.9 % normal saline (NaCl) over a period of at least 5 minutes ...” A review of the IFU for Venofer revealed, “Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes ... In an interview with RN1 on 11/20/24 at 12:15 PM, he/she confirmed that they failed to administer Venofer over 2 - 5 minutes for P11, P12, and P2.”