Fmc - Paintsville

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 35949 Based on observation, interview, and facility policy review, the facility failed to ensure environmental surfaces in the dialysis treatment stations were disinfected at the end of each dialysis treatment during 2 of 2 observations. This failure had the potential to affect 39 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/2023, indicated, “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day [sic] and it is critical that these items be thoroughly cleaned and disinfected between uses.” The section of the policy titled “Definition” revealed that a “Dialysis Station” was defined as an “Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: - Dialysis machine/cycler and attachments such as IV [intravenous] pole, BP [blood pressure] cuff and hand sanitizer/holder, organizer - Chair/bed - [Brand name of water and dialysate preparation system] - Individual television and remote.” An observation of the hemodialysis treatment area on 05/06/2025 at 11:12 AM, revealed Registered Nurse (RN) #1 failed to disinfect the sanitizer bottle and the bracket attached to the side of the dialysis machine while disinfecting Station 10. An observation of the hemodialysis treatment area on 05/06/2025 at 11:45 AM, revealed Certified Clinical Hemodialysis Technician (CCHT) #3 failed to disinfect the sanitizer bottle and the bracket attached to the side of the dialysis machine while disinfecting Station 2. During concurrent interviews on 05/06/2025 at 11:50 AM, RN #1 and CCHT #3 acknowledged they were trained and expected to disinfect all surfaces in the treatment stations after each dialysis treatment. During an interview on 05/06/2025 at 11:55 AM, the Clinical Manager (CM) confirmed staff were expected to disinfect all surfaces in the dialysis treatment stations after each dialysis treatment, including the sanitizer bottles and the brackets”

“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, facility policy review, and review of a manufacturer’s instructions for use (IFU), the facility failed to maintain arterial drip chamber fluid levels at approximately 90% full and venous drip chamber fluid levels at approximately 70% full during 3 of 3 observations. This failure had the potential to affect 39 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and [Brand name] Dialyzer,” dated 05/05/2025, revealed the section titled, “Final Machine Verification,” included, “Prior to starting the blood pump, verify the following: 1. All connections are secure. 2. Dialysate lines are attached properly to the dialyzer. 3. There is at least 300 ml [milliliters] of saline in the saline bag and the saline line is double clamped. 4. Any unused administration lines are clamped. 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. 6. Arterial and venous monitoring transducers are securely connected, not wet with saline, and the transducer clamps are open. 7. Blood pump segment is threaded through the pump properly. 8. Venous drip chamber is correctly positioned in its housing and venous bloodline is threaded through [sic] venous occluding clamp. 9. No kinks or bends are evident in any of the tubing. 10. No air is noted in the dialyzer or bloodlines.” A facility policy titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) and [Brand name] Dialyzer,” dated 05/05/2025, revealed the section titled, “Final Machine Verification,” included, “Prior to starting the blood pump, verify the following: 1. All connections are secure. 2. Dialysate lines are attached properly to the dialyzer. 3. There is at least 300 ml [milliliters] of saline in the saline bag and the saline line is double-clamped. 4. Any unused administration lines are clamped. 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. 6. Arterial and venous monitoring transducers are securely connected, not wet with saline, and the transducer clamps are open. 7. Blood pump segment is threaded through the pump properly. 8. Venous drip chamber is correctly positioned in its housing and venous bloodline is threaded through (sic) venous occluding clamp. 9. No kinks or bends are evident in any of the tubing. 10. No air is noted in the dialyzer or bloodlines.” An undated “Hemodialysis Blood Tubing Set with Attached Priming Set, Transducer Protectors and Integrated Crit-Line Technology Catalog Number: 03-2722-9C and 03-2742-9C Instructions For Use,” revealed the section titled, “Dialysis Treatment Precautions,” included, “2. 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.” An observation of the hemodialysis treatment area on 05/05/2025 at 10:17 AM, revealed the arterial drip chamber fluid levels were less than (<) 90% full in Station 10 and Station 11, and the venous drip chamber fluid levels were greater than (>) 70% full in Stations 2, 4, 8, 10, 11, and 14. An observation of the hemodialysis treatment area on 05/7/2025 at 8:57 AM, revealed the arterial drip chamber fluid levels were < 90% full in Stations 1, 3, 4, 5, 9, 10, 12, 13, and 16, and the venous drip chamber fluid levels were > 70% full in Stations 1, 2, 3, 4, 5, 7, 9, 10, 12, 13, and 16. An observation of the hemodialysis treatment area on 05/07/2025 at 9:07 AM, revealed the arterial drip chamber fluid levels were < 90% full in Stations 1, 3, 4, 5, 12, 13, and 16, and the venous drip chamber fluid levels were > 70% full in Stations 1, 2, 3, 4, 5, 7, 9, 10, 12, 13, and 16. During an interview on 05/07/2025 at 9:17 AM, the Clinical Manager (CM) reviewed the manufacturer’s IFU and stated the arterial and venous drip chamber fluid levels were not maintained according to the IFU. During an interview on 05/07/2025 at 9:25 AM, Certified Clinical Hemodialysis Technician (CCHT) #3 stated the arterial drip chamber should be “90% or above the line” and the venous drip chamber fluid levels should be “above the line.” CCHT #3 stated the drip chambers were not maintained according to the manufacturer’s IFU. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was trained to maintain the drip chamber fluid levels according to the manufacturer’s IFU.”

“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 dialysis prescriptions for 5 (Patients #1, #2, #3, #4, and #5) of 5 sampled residents who received dialysis treatments at the facility. Findings included: A facility policy titled, “Patient Assessment and Monitoring,” dated 05/01/2023, indicated, “3. Machine Parameters and Extracorporeal Circuit - Check machine settings and measurements: -Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” 1. Patient #1’s “Treatment Sheet for Facility,” dated 04/26/2025, revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). The treatment sheet revealed Patient #1’s BFR was documented as 450 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #1’s “Treatment Sheet for Facility,” dated 04/29/2025, revealed a prescribed BFR of 400 mL/min. The treatment sheet revealed Patient #1’s BFR was documented as 450 mL/min from 1:05 PM until the treatment was terminated at 4:32 PM. The treatment sheet revealed there was no rationale documented as to why the prescribed BFR was not achieved. Patient #1’s “Treatment Sheet for Facility,” dated 05/01/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #1’s BFR was documented as 400 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #1’s “Treatment Sheet for Facility,” dated 05/03/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #1’s BFR was documented between 300 mL/min and 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 05/07/2025 at 1:04 PM, Certified Clinical Hemodialysis Technician (CHHT) #3 stated she was expected to “write down” a reason the prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was expected to “document why” a prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 3:30 PM, the Clinical Manager (CM) confirmed staff were expected and trained to document a reason when the prescribed blood flow rate was not achieved. 2. Patient #2’s “Treatment Sheet for Facility,” dated 04/25/2025, revealed a blood flow rate (BFR) of 450 milliliters per min (mL/min). The treatment sheet revealed Patient #2’s BFR was documented as 400 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 05/07/2025 at 1:04 PM, Certified Clinical Hemodialysis Technician (CHHT) #3 stated she was expected to “write down” a reason the prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was expected to “document why” a prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 3:30 PM, the Clinical Manager (CM) confirmed staff were expected and trained to document a reason when the prescribed blood flow rate was not achieved. 3. Patient #3’s “Treatment Sheet for Facility,” dated 04/19/2025, revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). The treatment sheet revealed Patient #3’s BFR was documented as 315 mL/min from 7:32 AM until the treatment was terminated at 10:05 AM. The treatment sheet revealed there was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 05/07/2025 at 1:04 PM, Certified Clinical Hemodialysis Technician (CHHT) #3 stated she was expected to “write down” a reason the prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was expected to “document why” a prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 3:30 PM, the Clinical Manager (CM) confirmed staff were expected and trained to document a reason when the prescribed blood flow rate was not achieved. 4. Patient #4’s “Treatment Sheet for Facility,” dated 04/16/2025, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). The treatment sheet revealed Patient #4’s BFR was documented as 300 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #4’s “Treatment Sheet for Facility,” dated 04/18/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #4’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #4’s “Treatment Sheet for Facility,” dated 04/21/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #4’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #4’s “Treatment Sheet for Facility,” dated 04/23/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #4’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #4’s “Treatment Sheet for Facility,” dated 04/25/2025, revealed a prescribed BFR of 450 mL/min. The treatment sheet revealed Patient #4’s BFR was documented as 300 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 05/07/2025 at 1:04 PM, Certified Clinical Hemodialysis Technician (CHHT) #3 stated she was expected to “write down” a reason the prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was expected to “document why” a prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 3:30 PM, the Clinical Manager (CM) confirmed staff were expected and trained to document a reason when the prescribed blood flow rate was not achieved. 5. Patient #5’s “Treatment Sheet for Facility,” dated 04/16/2025, revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). The treatment sheet revealed Patient #5’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #5’s “Treatment Sheet for Facility,” dated 04/23/2025, revealed a prescribed BFR of 400 mL/min. The treatment sheet revealed Patient #5’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. Patient #5’s “Treatment Sheet for Facility,” dated 04/28/2025, revealed a prescribed BFR of 400 mL/min. The treatment sheet revealed Patient #5’s BFR was documented as 350 mL/min during the entire treatment, and there was no rationale documented as to why the prescribed BFR was not achieved. During an interview on 05/07/2025 at 1:04 PM, Certified Clinical Hemodialysis Technician (CHHT) #3 stated she was expected to “write down” a reason the prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 1:25 PM, Registered Nurse (RN) #1 stated she was expected to “document why” a prescribed blood flow rate was not achieved. During an interview on 05/07/2025 at 3:30 PM, the Clinical Manager (CM) confirmed staff were expected and trained to document a reason when the prescribed blood flow rate was not achieved.”