Fmc - Dialysis Services of Audubon

“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, schematic review, and facility procedure and policy review, the facility failed to follow the bloodline manufacturer’s DFU 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 3 of 3 observations; and failed to maintain the integrity of the water purification system during 1 of 1 observations. Failure to follow the manufacturers’ DFU and maintain the integrity of the water purification system had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 62 patients who received dialysis treatments at the facility. The findings included: 1. Review of 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 Smartech Hemodialysis Blood Tubing Set with Attached Priming Set, Transducer Protectors and Integrated Crit-Line Technology,” 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 03/03/2025 at 11:15 AM revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 7, 9, 10, 12, 14, 16, 22, and 25, greater than (>) 95% full in Station 18, and the venous drip chamber fluid levels were > 75% full in Stations 10, 12, 14, and 25. Observation of the hemodialysis treatment area on 03/04/2025 at 9:55 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 2, 3, 4, 5, 12, 13, 14, 16, and 21, and the venous drip chamber fluid levels were > 75% full in Stations 2, 4, 5, 12, 13, 14, 16, and 21. Observation of the hemodialysis treatment area on 03/05/2025 at 10:07 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 1, 2, 6, 13, 14, 15, 16, 23, and 26, and the venous drip chamber fluid levels were > 75% full in Stations 1, 2, 3, 5, 6, 14, 16, 18, 23, and 26. During an interview on 03/05/2025 at 10:25 AM, the Clinical Manager reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 03/05/2025 at 10:28 AM, Certified Clinical Hemodialysis Technician #7 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 03/05/2025 at 3:31 PM, Registered Nurse (RN) #5 confirmed staff were expected to follow the bloodline manufacturer’s DFU. During an interview on 03/06/2025 at 8:19 AM, the Medical Director confirmed the staff were expected to “follow the [manufacturer’s] DFU for the bloodlines” chamber levels. 2. Review of facility policy titled, “Equipment Installation - Operation - Maintenance - Repair - And [sic] Disposal,” published 07/06/2021, indicated, “This policy applies to all equipment that: Removes, infuses, touches, measures, controls, or has the potential to affect the outcome of patient treatments or dialysis fluid. Is deemed essential in performing dialysis in a safe manner; and/or Is essential to the safe operation of the facility. This includes but is not limited to: Medical Equipment, Electrical Systems, Plumbing Equipment/Systems, Meters or Measurement Devices, Television Mounting Hardware, Concentrate Production and Delivery Equipment, Water Purification Equipment, HVAC [heating, ventilation, and air conditioning] Systems, Life Safety Equipment/Systems, Dialysis Chairs, Physical Plant (ceilings, floors, etc.).” Further review indicated, “Unless otherwise directed by company policy and procedures, all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions for use (IFU),” and “Any equipment or device that is not fully functioning in accordance with IFU or company policy, must be repaired or replaced as soon as reasonably possible.” An undated schematic adhered to the wall near the backflow preventer indicated, “Backflow devices should not demonstrate continual leaks or drips from the discharge port. The sudden flow of water from the discharge port, followed by a sudden stop of fluid, would indicate the device is operating properly.” Observation of the water purification system on 03/03/2025 at 10:59 AM revealed the discharge port of the backflow preventer valve leaked and was dripping water. During an interview on 03/03/2025 at 10:59 AM while observing the backflow preventer discharge port, the Clinical Manager confirmed the water purification system should not leak. During an interview on 03/03/2025 at 11:05 AM while observing the backflow preventer discharge port, the BioMedical Technician confirmed the integrity of the water purification system was not currently maintained. During an interview on 03/06/2025 at 8:19 AM, the Medical Director stated the integrity of the water purification system should be maintained.”

“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 6 of 7 sampled patients (Patients #1, #2, #3, #5, #6, and #7). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 62 patients who received dialysis treatments at the facility. The 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 02/24/2025 revealed a prescribed dialysate flow rate (DFR) of 600 milliliters per minute (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. Patient #1’s treatment sheet dated 03/03/2025 revealed a prescribed DFR of 600 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 #2’s treatment sheet dated 02/14/2025 revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient #2’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 #2’s treatment sheet dated 02/20/2025 revealed a prescribed BFR of 450 mL/min. Patient #2’s BFR was documented between 225 mL/min and 300 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 3. Patient #3’s treatment sheet dated 02/19/2025 revealed a prescribed blood flow rate (BFR) of 350 milliliters per minute (mL/min). Patient #3’s BFR was documented as 300 mL/min from 7:32 AM until 8:34 AM. There was no rationale documented why the prescribed BFR was not achieved. Patient #3’s treatment sheet dated 03/03/2025 revealed a prescribed BFR of 350 mL/min. Patient #3’s BFR was documented as 300 mL/min from 8:36 AM until the treatment was terminated at 11:10 AM. There was no rationale documented why the prescribed BFR was not achieved. 4. Patient #5’s treatment sheet dated 02/11/2025 revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient #5’s BFR was documented as 400 mL/min from 11:12 AM until 1:03 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient #5’s treatment sheet dated 02/13/2025 revealed a prescribed BFR of 450 mL/min. Patient #5’s BFR was documented between 300 mL/min and 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #5’s treatment sheet dated 02/15/2025 revealed a prescribed BFR of 450 mL/min. Patient #5’s BFR was documented between 350 mL/min and 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 5. Patient #6’s treatment sheet dated 02/14/2025 revealed a prescribed blood flow rate (BFR) of 550 milliliters per minute (mL/min). Patient #6’s BFR was documented as 450 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #6’s treatment sheet dated 03/01/2025 revealed a prescribed BFR of 550 mL/min. Patient #6’s BFR was documented between 400 mL/min and 450 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 6. Patient #7’s treatment sheet dated 02/28/2025 revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). Patient #7’s BFR was documented as 350 mL/min from 1:03 PM until the treatment was terminated at 3:17 PM. There was no rationale documented why the prescribed BFR was not achieved. During an interview on 03/05/2025 at 8:10 AM, the Clinical Manager confirmed the identified deficiencies on the patients’ treatment sheets and stated staff were trained and expected to document a reason when the BFR and/or DFRs were not as prescribed. During an interview on 03/05/2025 at 3:00 PM, Certified Clinical Hemodialysis Technician #7 stated staff were expected to “document a reason” when the prescribed BFR and/or DFR is not achieved. During an interview on 03/05/2025 at 3:31 PM, Registered Nurse #5 stated it is “correct” to document a reason why the prescribed BFR and/or DFR is not achieved. During an interview on 03/06/2025 at 8:19 AM, the Medical Director stated staff were expected to “document why” when the patients’ prescription was not followed.”

“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 the expectations in their policy for 5 of 7 sampled patients (Patients #1, #2, #3, #5, and #7). Failure to monitor patients’ vitals and/or 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 62 patients who received dialysis treatments at the facility. The 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 02/26/2025, revealed machine parameters were not documented for 87 minutes, from 9:33 AM until 11:00 AM, and vital signs were not documented for 62 minutes, from 10:30 AM until 11:32 AM. 2. Patient #2’s treatment sheet, dated 02/24/2025, revealed machine parameters were not documented for 81 minutes, from 9:34 AM until 10:55 AM. 3. Patient #3’s treatment sheet, dated 02/12/2025, revealed machine parameters were not documented for 61 minutes, from 8:07 AM until 9:08 AM. Patient #3’s treatment sheet, dated 02/17/2025, revealed vital signs were not documented for 51 minutes, from 8:13 AM until 9:04 AM. 4. Patient #5’s treatment sheet, dated 02/20/2025, revealed machine parameters were not documented for 67 minutes, from 11:30 AM until 12:37 PM, and for 54 minutes, from 12:37 PM until 1:34 PM. Patient #5’s treatment sheet, dated 02/27/2025, revealed machine parameters were not documented for 67 minutes, from 11:38 AM until 12:31 PM, and for 71 minutes, from 2:03 PM until the treatment was terminated at 3:14 PM. 5. Patient #7’s treatment sheet, dated 02/13/2025, revealed machine parameters were not documented for 67 minutes, from 12:56 PM until 2:03 PM. Patient #7’s treatment sheet, dated 02/17/2025, revealed machine parameters were not documented for 122 minutes, from 1:02 PM until the treatment was terminated at 3:04 PM. During an interview on 03/04/2025 at 4:35 PM, the Clinical Manager confirmed staff were expected to document vitals and machine parameters “not greater than every 45 minutes.” During an interview on 03/05/2025 at 3:00 PM, Certified Clinical Hemodialysis Technician #7 stated she was expected to document vital signs and machine parameters “every 30 minutes.” During an interview on 03/05/2025 at 3:31 PM, Registered Nurse #5 stated staff were expected to be “checking vitals [signs] every half hour” and also documenting the machine parameters. During an interview on 03/06/2025 at 8:19 AM, the Medical Director stated staff were expected to “follow [facility’s] policy and procedure” by documenting both vital signs and machine parameters “every 30 minutes.””