032646-Fmc-Glendale Town Center

“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: 44268 Based on document review, observation, and interview, it was determined that the facility failed to ensure: Staff performed hand hygiene when moving from one patient station to another, wear gloves on both hands when touching the patient machine, and before and after direct contact with a patient. Findings include: The policy titled “Hand Hygiene” revealed: “...Before and after direct contact with patients ...Immediately after removing gloves ...After contact with inanimate objects near the patient ....” Observation on 01/27/2025 revealed Employee #23 preparing to silence an alarm at station #22 with one glove fully on their right hand, however no glove on their left hand. Observation on 01/27/2025 revealed Employee #23 preparing to silence an alarm at station #21 with one glove fully on their right hand, however no glove on their left hand. Observation on 01/27/2025 at 11:44 am revealed Employee #23 giving a pen to the patient in station #8 with bare hands, then Employee #23 walked over to the glove station and donned a pair of gloves without performing hand hygiene and reset an alarm at station #6. Observation on 01/27/2025 at 12:11 am revealed Employee #23 donned a glove only covering the fingers on their right hand to address an alarm at chair #21. Employee #1 confirmed on 01/28/2025 that Employee #23 did not perform hand hygiene after touching the patients’ machines or touching the patient as required per facility policies and procedures.”

“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: 44268 Based on document review and interview, it was determined that the facility failed to demonstrate compliance with machine and ancillary equipment preventative maintenance which has the potential risk of damaged and/or non-calibrated equipment being used to provide treatments to dialysis patients. Findings include: A policy titled “Priming an Optiflux Single Use E-Beam Dialyzer”, revealed “...Preform the Pressure Holding Test on all 2008 machines ...If using a FRESENIUS dialysis machine, it is mandatory that the AUTOMATIC TESTING be performed at this time ...Included in this test is the PRESSURE HOLDING TEST, which verifies the integrity of the volumetric balancing system specific to the Fresenius dialysis machine ...If the AUTOMATIC TESTING FAILS, repeat the test ...If the cause of the failure cannot be corrected, or if it fails subsequent tests, the machine SHOULD NOT BE USED ....” Observation on 01/27/2025 revealed a machine that failed the automatic test. Employee #16 then performed the test a second time which failed again. Employee #16 then performed the test a third time. The machine passed the test, and then employee #16 proceeded to use the machine. Employee #1 confirmed in an interview on 01/27/2025 that Employee #16 did not follow policies and procedures to take the machine off the floor and not use it for patient care.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44268 Based on a review of facility policy, medical records, and staff interviews, it was determined that the facility failed to ensure that staff followed the attending physician’s prescribed hemodialysis (HD) order for blood flow rate (BFR) setting for each individual patient. Failure to follow physician orders and not reporting abnormalities poses the potential risk of inadequate dialysis, decreased clearances, and hospitalizations. Findings include: The facility policy titled “Patient Assessment and Monitoring” requires: “...Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow....” Patient #1 A treatment sheet dated 07/30/2024 revealed that a blood flow rate was prescribed at 400ml/min. At 09:28 the blood flow was set to 450ml/min, at 10:25 it was set to 300ml/min, at 11:00 it was set to 350ml/min, then set to 300ml/min at 13:21, with no documentation alerting the RN. Patient #2 A treatment sheet dated 01/17/2025 revealed that a blood flow rate of 500ml/min was prescribed. At 06:50, the blood flow rate was set to 450ml/min, with no documentation alerting the RN. A treatment sheet dated 01/20/2025 revealed that a blood flow rate of 500ml/min was prescribed. At 07:45, the blood flow rate was set to 450ml/min, with no documentation alerting the RN. A treatment sheet dated 01/22/2025 revealed that a blood flow rate of 500ml/min was prescribed. At 08:24, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 01/24/2025 revealed that a blood flow rate of 500ml/min was prescribed. At 06:56, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 01/17/2025 revealed that a blood flow rate of 500ml/min was prescribed. At 09:26, the blood flow rate was set to 450ml/min, with no documentation alerting the RN. Patient #3 A treatment sheet dated 06/21/2024 revealed that a blood flow rate of 400ml/min was prescribed. At 17:51, the blood flow was set to 450ml/min, but no documentation alerted the RN. Patient #4 A treatment sheet dated 01/15/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 08:52, the blood flow was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 01/17/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 08:49, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. Patient #5 A treatment sheet dated 06/27/2024 revealed that a blood flow rate of 300ml/min was prescribed. At 16:26, the blood flow rate was set to 400ml/min, at 17:30 the BFR was set to 300ml/min, with no documentation alerting the RN. A treatment sheet dated 08/15/2024 revealed that a blood flow rate of 400ml/min was prescribed. At 17:55, the blood flow rate was set to 450ml/min, with no documentation alerting the RN. Employee #1 confirmed during an interview on 01/28/2025, that this practice does not follow facility policy and procedures or physician orders.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44268 Based on a review of facility policy, medical records and staff interviews, it was determined that the facility failed to require clinical staff to notify the nurse and provide a documented intervention for (4) out of (5) patients reviewed when the patient’s blood pressure (BP) and/or heart rate (HR) were out of range per the facility policy, which poses the potential risk of cardiovascular compromise and hospitalization. Findings include: The facility policy titled “Patient Assessment and Monitoring....” published on May 1, 2023, revealed:” ...Report to the nurse: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic...Heart rates that have dropped below 60 or risen above 100 ...Report to the nurse any significant findings....” A facility document titled “2024 AZ Hemodialysis Standing Orders” revealed, “...Intra HD for a significant drop in systolic BP >40mm/Hg ...Notify nurse....” Facility documents titled, “...Treatment Sheets....” revealed: Patient # 1 06/27/2024 revealed: 11:41 HR 103 12:15 HR 101 07/30/2024 revealed: 11:25 HR 102 13:00 HR 104 08/01/2024 revealed: 09:30 HR 103 10:20 HR 111 12:21 HR 109 13:34 HR 144 08/06/2024 revealed: 09:26 HR 107 11:00 HR 120 12:41 HR 102 13:01 HR 105 08/08/2024 revealed: 10:41 HR 117 08/13/2024 revealed: Pre-treatment HR 54 10:00 HR 54 10:23 HR 53 10:46 HR 57 13:02 BP 186/78 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range and/or a change in vital signs. Patient #2 01/15/2025 revealed: 09:21 BP 83/54 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Patient #4 01/15/2025 revealed: 08:52 HR 59 09:04 HR 52 09:23 HR 103 01/17/2025 revealed: Pre-treatment Standing BP 198/76 Pre-treatment Sitting BP 186/83 08:02 BP 203/73 01/20/2025 revealed: Pre-treatment Standing BP 202/81 Pre-treatment Sitting BP 207/98 07:37 BP 182/80 07:42 BP 194/68 08:03 HR 105 09:02 HR 102 09:21 HR 104 10:38 HR 114 01/24/2025 revealed: 07:48 BP 217/93 08:22 BP 214/67 08:42 BP 196/69 10:02 HR 55 10:44 HR 49 10:48 HR 56 01/27/2025 revealed: Pre-treatment Standing BP 201/88 Pre-treatment Sitting BP 224/96 09:03 HR 114 09:22 HR 110 09:44 HR 103 10:43 HR 101 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Patient #5 07/23/2024 revealed: Pre-treatment HR 59 17:29 HR 56 17:47 HR 57 18:02 HR 58 Employee #1 confirmed during an interview on 01/28/2025 that no documentation of RN notification and/or intervention for out-of-range vitals was available as required per facility policy.”