Fmc Port City

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure patients and staff had a mask covering the nose during two of four observations of Central Venous Catheter (CVC- A long, flexible tube inserted in the neck, chest, or groin, that leads to the vena cava, a large vein that empties into the heart that can be used for hemodialysis )initiation and disconnection. The failure to have a mask covering the nose and mouth during initiation or discontinuation of dialysis via the CVC had the potential for exposure of the CVC to infectious material and this could impact nine patients with CVC’s. Findings include: Observation on 06/09/25 at 1:25 PM revealed Registered Nurse (RN) 2 was at Station 15 with Patient (P) 8 discontinuing the dialysis treatment via CVC. RN2’s mask and the patient’s mask did not cover the nose as required. During an interview on 06/09/25 at 1:30 PM RN2 confirmed the patients mask, and his/her mask was not covering the nose as required to prevent contamination of the CVC. Observation on 06/11/25 at 8:55 AM revealed RN1 was at Station 15 discontinuing the treatment via the CVC for P8. The staff’s mask was not covering the nose as required. During an interview on 06/11/25 at 9:00 AM RN1 confirmed his/her mask was not covering the nose as required. RN1 stated the mask should be covering the mouth and nose during discontinuation via the CVC to prevent contamination of the CVC. During an interview on 06/11/25 at 2:30 PM the Clinical Manager confirmed that the staff and patients’ mask must be covering the nose and mouth during initiation and discontinuation of dialysis via the CVC to prevent contamination of the CVC. Review of the facility’s policy titled, “Initiation and Termination Using a Central Venous Catheter (CVC)” revised 11/04/24 indicated, “ ...A mask must be worn that covers the nose and mouth by staff, patients and care partner for all procedure that require accessing the catheter.””

“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: 28297 Based on interview, facility document review and review of “2008T Machine Preventive Maintenance Procedures” document, the facility failed to ensure eight of 23 machines had annual or semi-annual maintenance completed in a timely manner. The failure to complete preventative maintenance in a timely manner had the potential for machine malfunction and this could affect 52 in-center patients. Findings include: Review of the “FKC Equipment Record” for 23 dialysis machines revealed the following: 1. Machine serial number 6TOS-158755 had annual preventative maintenance 07/30/24 and no other maintenance was completed until 04/30/25 when it had annual preventative maintenance. The semi-annual maintenance should have been completed in January 2025 per “Machine Preventative Maintenance Procedure.” 2. Machine serial number 6TOS-158794 had annual preventative maintenance 07/30/24 and no other maintenance was completed until 04/30/25 when it had annual preventative maintenance. The semi-annual maintenance should have been completed in January 2025 per “Machine Preventative Maintenance Procedure.” 3. Machine serial number 6TOS-158812 had annual preventative maintenance 08/27/24 and no other maintenance was completed until 04/30/25 when it had annual preventative maintenance. The semi-annual maintenance should have been completed in February 2025 per “Machine Preventative Maintenance Procedure.” 4. Machine serial number 6TOS-158822 had annual preventative maintenance 08/27/24 and no other maintenance was completed until 04/30/25 when it had annual preventative maintenance. The semi-annual maintenance should have been completed in February 2025 per “Machine Preventative Maintenance Procedure.” 5. Machine serial number 6TOS-158870 had annual preventative maintenance 09/10/24 and no other maintenance was completed until 05/29/25 when it had annual preventative maintenance. The semi-annual maintenance should have been completed in March 2025 per “Machine Preventative Maintenance Procedure.” 6. Machine serial number 6TOS-158977 had semi-annual preventative maintenance 09/10/24 and no other maintenance was completed until 05/29/25 when it had annual preventative maintenance, two months late. 7. Machine serial number 6TOS-159022 had semi-annual preventative maintenance 10/31/24 and no other maintenance was completed until 05/29/25 when it had annual preventative maintenance, one month late. 8. Machine serial number 6TOS-159026 had semi-annual preventative maintenance 10/31/24 and no other maintenance was completed until 05/29/25 when it had annual preventative maintenance, one month late. During an interview on 06/09/25 at 1:45 PM the Area Technical Operations Manager (ATOM) stated “We were trying to go through the schedule and get all the annual done in the first six months and failed to put the semi-annual in the schedule for the end of the year. He/she confirmed eight machines were found to be late on either semi or annual maintenance.” Review of the “Fresenius 2008T Preventative Maintenance Procedures,” undated indicated, “ ...Preventative Maintenance for the 2008T Hemodialysis System is simple and straightforward. Scheduled maintenance is performed based on timed intervals or number of hours a machine operates, whichever comes first. The time and hour interval are as follows: ...Machines with extended life Pump Components receive maintenance every six (6) months, annually or after 4000 hours of operation ...””