Fmc Azalea City

“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: 35949 Based on observation, interview, manufacturer’s instructions for use (IFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s IFU by not maintaining the arterial drip chamber fluid levels at approximately 90% full and the venous drip chamber fluid levels at approximately 70% full during 4 of 4 observations. Failure to follow the manufacturer’s IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 77 patients who received dialysis treatments at the facility. Findings included: A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 05/05/2025, indicated, “8. Fill the Pre-pump arterial chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 85% - 95% full and tighten cap. Close the clamp on the level adjust line.” Further review indicated, “12. Fill venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full. Tighten cap and close clamp on the level adjust line when chamber is filled.” The manufacturer’s IFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors,” indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible separation or leaks. b. Do not allow the access or bloodline connections to be covered with a blanket or clothing during treatment. c. Maintain fluid level in arterial chamber at approximately 90% full and venous chamber at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air leaks will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 06/30/2025 at 10:10 AM revealed the arterial drip chamber fluid levels were approximately less than (<) 90% full in Stations 3, 4, 10, 11, 12, 21, 23, and 25, and approximately greater than (>) 70% full in Stations 3, 4, 10, 11, 16, 17, 19, 21, 23, and 25. Observation of the hemodialysis treatment area on 07/02/2025 at 8:40 AM revealed the arterial drip chamber fluid levels were approximately < 90% full in Stations 4, 5, 10, 13, 16, 18, 21, and 23, and approximately > 70% full in Stations 4, 5, 10, 13, 15, 16, 18, 19, 20, 21, 23, 24, and 25. Observation of the hemodialysis treatment area on 07/02/2025 at 12:12 PM revealed the arterial drip chamber fluid levels were approximately < 90% full in Stations 5, 10, 16, 17, and 24, and approximately > 70% full in Stations 3, 5, 10, 13, 14, 15, 17, 18, 20, 22, 23, and 24. Observation of the hemodialysis treatment area on 07/03/2025 at 8:35 AM with the Facility Administrator revealed the arterial drip chamber fluid levels were approximately < 90% full in Stations 1, 2, 10, 12, 13, 16, 21, and 22, and approximately > 70% full in Stations 1, 2, 10, 12, 13, 16, 18, 21, 22, and 24. During an interview on 07/03/2025 at 10:05 AM in the treatment area with the Facility Administrator after review of the manufacturer’s IFU, the Facility Administrator confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 07/03/2025 at 2:52 PM, Certified Clinical Hemodialysis Technician #5 stated the drip chambers should be “more than 3/4 full in both [chambers].” During an interview on 07/03/2025 at 3:13 PM, Registered Nurse #1 stated the drip chamber fluid levels should be “70 to 90% [full]” in the arterial drip chamber and “60 to 707% [full]” in the venous drip chamber.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 3 (Patients #1, #3, and #7) of 7 sampled patients. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 77 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Physician Order Documentation,” published 07/03/2023, indicated, “Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders.” 1. Patient #1’s treatment sheet dated 06/10/2025 revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient #1’s BFR was documented as 300 mL/min from 1:04 PM until the treatment was terminated at 3:20 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 06/14/2025 revealed a prescribed dialysate flow rate (DFR) of 800 mL/min. Patient #1’s DFR was documented as 500 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. 2. Patient #3’s treatment sheet dated 06/13/2025 revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min) and a prescribed dialysate flow rate (DFR) of 1.5 times (x) the BFR. Patient #3’s BFR was documented as 420 mL/min, and the DFR was documented at 700 mL/min from 1:08 PM until 2:55 PM. From 2:55 PM until the treatment was terminated at 3:34 PM, the patient’s BFR was documented at 350 mL/min, and the DFR was documented between 0 mL/min and 800 mL/min. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #3’s treatment sheet dated 06/16/2025 revealed a prescribed BFR of 400 mL/min. Patient #3’s BFR was documented as 350 mL/min from 1:41 PM until the treatment was terminated at 3:07 PM. There was no rationale documented why the prescribed BFR was not achieved. 3. Patient #7’s treatment sheet dated 06/13/2025 revealed a prescribed dialysate flow rate (DFR) of 800 milliliters per minute (mL/min). Patient #7’s DFR was documented as 500mL/min from 12:31 PM until 1:31 PM and again from 2:33 PM until the treatment was terminated at 2:45 PM. There was no rationale documented why the prescribed DFR was not achieved. Patient #7’s treatment sheet dated 06/20/2025 revealed a prescribed DFR of 800 mL/min. Patient #7’s DFR was documented as 500 mL/min from 12:35 PM until the treatment was terminated at 3:43 PM. There was no rationale documented why the prescribed DFR was not achieved. Patient #7’s treatment sheet dated 06/23/2025 revealed a prescribed DFR of 800 mL/min. Patient #7’s DFR was documented as 600 mL/min from 1:30 PM until 2:04 PM and 500 ml/min from 2:04 PM until 2:33 PM. There was no rationale documented why the prescribed DFR was not achieved. Patient #7’s treatment sheet dated 06/25/2025 revealed a prescribed DFR of 800 mL/min. Patient #7’s DFR was documented as 500 mL/min from 12:35 PM until 3:03 PM. There was no rationale documented why the prescribed DFR was not achieved. During an interview on 07/01/2025 at 1:45 PM, the Facility Administrator confirmed staff should “chart why” the prescribed BFRs and/or DFRs were not achieved. During an interview on 07/03/2025 at 2:52 PM, Certified Clinical Hemodialysis Technician #5 stated staff “are supposed to document when” deviated from the prescription. During an interview on 07/03/2025 at 3:13 PM, Registered Nurse #1 stated she was trained and expected to “chart why” the prescribed BFRs and/or DFRs were not achieved.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35949 Based on interview, record review, and facility policy review, the facility failed to monitor patients’ vital signs and machine parameters according to the expectations in their policy for 4 (Patients #1, #3, #4, and #6) of 7 sampled patients. Failure to monitor patients’ vital signs and/or machine parameters according to the facility’s policy during dialysis treatments provided an opportunity for changes to the patients’ vital signs, blood flow rate, dialysate flow rate, and/or arterial and venous pressures to be unrecognized and unaddressed and negatively impact the care provided to the 77 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, indicated, “During Treatment - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. - Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations.” 1. Patient #1’s treatment sheet dated 06/10/2025 revealed vital signs were not documented for 55 minutes from 12:05 PM until 1:00 PM, and machine parameters were not documented for 59 minutes, from 12:05 PM until 1:04 PM. 2. Patient #3’s treatment sheet dated 06/16/2025 revealed vital signs and machine parameters were not documented for 67 minutes, from 11:00 AM until 12:07 PM. Patient #3’s treatment sheet dated 06/20/2025 revealed vital signs and machine parameters were not documented for 91 minutes, from 10:30 AM until 12:01 PM. 3. Patient #4’s treatment sheet dated 06/23/2025 revealed machine parameters were not documented for 87 minutes, from 2:05 PM until 3:32 PM. Patient #4’s treatment sheet dated 06/25/2025 revealed machine parameters were not documented for 56 minutes, from 1:37 PM until 2:33 PM. 4. Patient #6’s treatment sheet dated 06/11/2025 revealed machine parameters were not documented for 93 minutes, from 11:35 AM until 1:08 PM. During an interview on 07/01/2025 at 1:45 PM, the Facility Administrator confirmed staff were trained and expected to document vital signs and machine parameters not to “exceed 45 minutes.” During an interview on 07/03/2025 at 2:52 PM, Certified Clinical Hemodialysis Technician #5 stated vital signs and machine parameters were expected to be documented “every 30 minutes.” During an interview on 07/03/2025 at 3:13 PM, Registered Nurse #1 confirmed staff were trained and expected to document vital signs and machine parameters “every 30 minutes.””