Fmc - Nak Berea, LLC

“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, manufacturers’ directions for use (DFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s DFU by not maintaining the arterial drip chamber fluid levels at 85% to 95% full and the venous drip chamber fluid levels at 65% to 75% full during 3 of 3 observations. Failure to follow the manufacturers’ DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 29 patients who received dialysis treatments at the facility. Findings included: A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 06/28/2024, indicated, “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, “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 DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks [sic] will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 03/10/2025 at 11:40 AM revealed the arterial drip chamber fluid levels were less than (<) 85% full and greater than (>) 75% full in Stations 1, 4, 5, 7, and 10. Observation of the hemodialysis treatment area on 03/12/2025 at 9:50 AM revealed the arterial drip chamber fluid levels were < 85% full and the venous drip chamber fluid levels were > 75% full in Stations 1, 2, 5, 6, 7, 9, 11, and 13. Observation of the hemodialysis treatment area on 03/12/2025 at 2:55 PM revealed the arterial drip chamber fluid levels were < 85% full in Stations 1, 7, 9, and 12, and the venous drip chamber fluid levels were > 75% full in Stations 1, 7, 9, 11, and 12. During an interview on 03/12/2025 at 2:55 PM, Registered Nurse #1 and Patient Care Technician #3 stated they were not familiar with the bloodline manufacturer’s DFU, and both confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 03/13/2025 at 9:44 AM, the Facility Administrator reviewed the manufacturer’s DFU and confirmed the staff were expected to follow the bloodline manufacturer’s DFU. The Facility Administrator acknowledged she was “unaware” of the information in the bloodline manufacturer’s DFU regarding the chamber levels. During an interview on 03/13/2025 at 11:19 AM, the Medical Director confirmed the staff should follow the bloodline manufacturer’s DFU.”

“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 5 (Patients #1, #2, #3, #4, and #5) of 5 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 29 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 02/21/2025 revealed a prescribed blood flow rate (BFR) of 350 milliliters per minute (mL/min). Patient #1’s BFR was documented as 250 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 02/28/2025 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 400 mL/min from 11:04 AM until 12:56 PM and 300 mL/min from 12:56 PM until the treatment was terminated at 1:20 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 03/07/2025 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 300 mL/min from 10:32 AM until the treatment was terminated at 1:48 PM. There was no rationale documented why the prescribed BFR was not achieved. 2. Patient #2’s treatment sheet dated 02/24/2025 revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient #2’s BFR was documented as 400 mL/min from 11:08 AM until the treatment was terminated at 2:12 PM. There was no rationale documented why the prescribed BFR was not achieved. 3. Patient #3’s treatment sheet dated 03/07/2025 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 the achieved BFR. Patient #3’s BFR was documented as 250 mL/min and the DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #3’s treatment sheet dated 03/10/2025 revealed a prescribed BFR of 400 mL/min. Patient #3’s BFR was documented as 250 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 4. Patient #4’s treatment sheet dated 02/26/2025 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 achieved BFR. Patient #4’s BFR was documented as 400 mL/min and the DFR was documented as 500 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient #4’s treatment sheet dated 02/28/2025 revealed a prescribed BFR of 400 mL/min and a prescribed DFR of 1.5 x the achieved BFR. Patient #4’s BFR was documented as 400 mL/min and the DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. 5. Patient #5’s treatment sheet dated 02/21/2025 revealed a prescribed dialysate flow rate (DFR) of 800 milliliters per minute (mL/min). Patient #5’s DFR was documented as 700 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient #5’s treatment sheet dated 03/07/2025 revealed a prescribed blood flow rate (BFR) of 450 mL/min and a prescribed DFR of 800 mL/min. Patient #5’s BFR was documented as 400 mL/min and the DFR was documented as 600 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. During an interview on 03/12/2025 at 2:17 PM, the Facility Administrator confirmed staff were trained and expected to document a reason why the prescribed BFRs and/or DFRs were not achieved. During an interview on 03/12/2025 at 3:55 PM, Registered Nurse #1 stated she was trained and expected to document why the prescribed BFRs and/or DFRs were not achieved. During an interview on 03/12/2025 at 4:25 PM, Patient Care Technician #3 confirmed staff were trained and expected to document why the prescribed BFRs and/or DFRs were not achieved. During an interview on 03/13/2025 at 11:19 AM, the Medical Director confirmed the staff were expected to document any concerns related to following the prescribed BFRs and DFRs.”

“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’ machine parameters according to the expectations in their policy for 3 (Patients #1, #2, and #3) of 5 sampled patients. Failure to monitor patients’ machine parameters according to the facility’s policy during dialysis treatments provided an opportunity for changes to the patients’ arterial and venous pressures to be unrecognized and unaddressed and negatively impact the care provided to the 29 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 02/24/2025, revealed machine parameters were not documented for 85 minutes, from 11:07 AM until 12:32 PM. Patient #1’s treatment sheet, dated 03/03/2025, revealed machine parameters were not documented for 155 minutes, from 10:32 AM until the treatment was terminated at 1:07 PM. 2. Patient #2’s treatment sheet, dated 03/03/2025, revealed machine parameters were not documented for 61 minutes, from 12:03 PM until 1:04 PM. Patient #2’s treatment sheet, dated 03/05/2025, revealed machine parameters were not documented for 60 minutes, from 12:01 PM until 1:01 PM. Patient #2’s treatment sheet, dated 03/10/2025, revealed vital signs were not documented for 65 minutes, from 12:00 PM until 1:05 PM. 3. Patient #3’s treatment sheet, dated 03/07/2025, revealed machine parameters were not documented for 61 minutes, from 8:02 AM until 9:03 AM, and for 57 minutes, from 9:35 AM until 10:32 AM. During an interview on 03/12/2025 at 2:17 PM, the Facility Administrator confirmed staff were expected to follow the facility’s policy and document the machine parameters every 30 minutes and not to exceed every 45 minutes. During an interview on 03/12/2025 at 3:55 PM, Registered Nurse #1 confirmed staff were trained and expected to document the machine parameters “every 30 minutes.” During an interview on 03/12/2025 at 4:25 PM, Patient Care Technician #3 stated the machine parameters were expected to be documented “every 30 minutes.” During an interview on 03/13/2025 at 11:19 AM, the Medical Director stated staff were expected to document the machine parameters per the facility’s policy.”