Fmc - Ashland

“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 directions for use (DFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the arterial drip chamber fluid levels at 90 percent (%) full and the venous drip chamber fluid levels at 70% full during 4 of 4 observations. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 44 patients who received in-center dialysis treatments at the facility. The findings include: Review of the facility’s 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.” Further review indicated, “Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full.” The manufacturer’s DFU titled “CombiSet Smartech Hemodialysis Blood Tubing Set with Attached Priming Set, Transducer Protectors and Integrated Crit-Line Technology Catalog Number 03-2722-9C and 03-2742-9C,” 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 chambers 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.” Observations of the hemodialysis treatment area on 12/09/2024 at 10:22 AM and 10:42 AM revealed the arterial drip chamber fluid levels were less than (<) 90% full in Stations 3, 4, 6, 10, 14, 15, and 16, and the venous drip chamber fluid levels were greater than (>) 70% full in Stations 3, 4, 6, 9, 10, 14, 15, and 16. Observations of the hemodialysis treatment area on 12/11/2024 at 12:30 PM with the In-Center Hemodialysis Clinical Manager (IHD CM), revealed the arterial drip chamber fluid levels were < 90% full, and the venous drip chamber fluid levels were > 70% full in Stations 6, 7, 8, 9, 11, 12, 13, and 14. During an interview on 12/11/2024 at 12:35 PM, the IHD CM reviewed the manufacturer’s DFU and confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 12/11/2024 at 2:25 PM, Registered Nurse 4 stated he was trained and expected to maintain the drip chambers at “75% full.” During an interview on 12/11/2024 at 3:17 PM, Patient Care Technician 14 stated she was trained and expected to fill the chambers to “3/4” full. During an interview on 12/11/2024 at 4:50 PM, the Medical Director confirmed the staff members were expected to follow the 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 2 of 3 sampled in-center patients, Patient (P) 1 and P3. Failure to follow the medical provider’s dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 68 patients who received dialysis treatments or home treatment oversight at the facility. The findings include: Review of the facility’s 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. Review of P1’s treatment sheet dated 11/20/2024, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). P1’s BFR was documented as 400 mL/min from 8:04 AM until the treatment was terminated at 10:03 AM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P1’s treatment sheet dated 11/22/2024, revealed a prescribed BFR of 450 mL/min. P1’s BFR was documented between 350 mL/min and 400 mL/min during the entire treatment. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P1’s treatment sheet dated 11/24/2024, revealed a prescribed BFR of 450 mL/min. P1’s BFR was documented as 350 mL/min from 6:30 AM until the treatment was terminated at 10:07 AM. There was no rationale documented why the prescribed BFR was not achieved. Review of P1’s treatment sheet dated 11/29/2024, revealed a prescribed BFR of 450 mL/min. P1’s BFR was documented between 350 mL/min and 400 mL/min from 1:00 PM until 2:34 PM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P1’s treatment sheet dated 12/04/2024, revealed a prescribed BFR of 450 mL/min. P1’s BFR was documented between 300 mL/min and 350 mL/min during the entire treatment. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P1’s treatment sheet dated 12/09/2024, revealed a prescribed BFR of 450 mL/min. P1’s BFR was documented between 350 mL/min and 400 mL/min from 7:00 AM until the treatment was terminated at 10:06 AM. There was no rationale documented as to why the prescribed BFR was not achieved. 2. Review of P3’s treatment sheet dated 11/23/2024, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). P3’s BFR was documented as 400 mL/min from 2:32 PM until 3:04 PM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 11/27/2024, revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 400 mL/min from 12:00 PM until the treatment was terminated at 3:26 PM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 11/30/2024, revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 400 mL/min from 12:30 PM until the treatment was terminated at 1:13 PM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 12/03/2024, revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 400 mL/min from 3:00 PM until the treatment was terminated at 4:15 PM. There was no rationale documented as to why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 12/05/2024, revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented between 250 mL/min and 400 mL/min during the entire treatment. There was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 12/10/2024 at 1:15 PM, the In-Center Hemodialysis Clinical Manager confirmed staff was trained and expected to document reasons when the prescribed BFR was not achieved. During an interview on 12/11/2024 at 2:25 PM, Registered Nurse 4 stated he was trained and expected to “document why” the prescribed BFR was not achieved. During an interview on 12/11/2024 at 3:17 PM, Patient Care Technician 14 stated she was expected to “chart” why the prescribed BFR was not achieved. During an interview on 12/11/2024 at 4:50 PM, the Medical Director confirmed staff was expected to document reasons for changes or adjustments to the prescribed BFR.”

“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/or machine parameters according to their policy for 2 of 3 sampled in-center patients, Patient (P) 1 and P3. Failure to monitor patients’ vitals and machine parameters according to the facility’s policy provided an opportunity for changes to the patients’ condition during dialysis treatments to be unrecognized and unaddressed and negatively impact the care provided to the 44 in-center patients who received dialysis treatments at the facility. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, indicated that blood pressure and pulse rate should be checked, during hemodialysis treatment, every 30 minutes or more as needed, but not to exceed 45 minutes. Per the policy, staff was to document machine parameters and safety checks every 30 minutes or more often as needed, but not to exceed 45 minutes. 1. Review of P1’s treatment sheet, dated 11/22/2024, revealed monitoring was not documented for 53 minutes, from 6:07 AM until 7:00 AM. Review of P1’s treatment sheet, dated 11/29/2024, revealed monitoring was not documented for 1 hour and 49 minutes, from 2:34 PM until the treatment was terminated at 4:23 PM. 2. Review of P3’s treatment sheet, dated 12/03/2024, revealed monitoring was not documented for 60 minutes, from 2:00 PM until 3:00 PM. Review of P3’s treatment sheet, dated 12/05/2024, revealed monitoring was not documented for 69 minutes, from 2:49 PM until 3:58 PM. During an interview on 12/10/2024 at 1:15 PM, the In-Center Hemodialysis Clinical Manager stated staff was trained and expected to monitor patients every 30 minutes per the facility’s policy. During an interview on 12/11/2024 at 2:25 PM, Registered Nurse 4 stated staff was trained and expected to monitor patients “at least every 30 minutes.” During an interview on 12/11/2024 at 3:17 PM, Patient Care Technician 14 stated staff was expected to monitor the patients “every 30 minutes.” During an interview on 12/11/2024 at 4:50 PM, the Medical Director stated staff was expected to monitor patients every 30 minutes according to the facility’s policy.”