Davita Millburn Dialysis

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 39228 Based on one of one observation of medication preparation, review of manufacturer’s instructions for use (MIFU), staff interviews, and a review of facility policy, it was determined that the facility failed to ensure that: 1) clean areas utilized for medication preparation are separate from hand washing sink areas to avoid possible cross contamination for one of one medication preparation observation; and 2) one of two Embrace PRO blood glucose meters are stored in a clean and dry area, in accordance with the MIFU. Findings include: 1. On 09/18/24 at 10:20 AM, while on the Treatment Floor, Sink 18, labeled “Clean Sink,” located next to the Nurse’s Station, was observed to be directly adjacent to a countertop that had a refrigerator, a cabinet underneath it, and a cabinet above it. At 11:04 AM, Staff (S) 5, the Charge Nurse, removed ten of the 10 ml (milliliter) syringes and one Heparin vial from the cabinets, and placed them onto the countertop. S5 stated that the countertop area was used for medication preparation and that he/she was going to prepare the Heparin into the ten syringes for intravenous medication administration. At 11:10 AM, while S5 prepared the Heparin syringes on the countertop, S6, a Licensed Practical Nurse, washed his/her hands with soap and water in Sink 18. S6 then dried his/her hands with a paper towel at Sink 18. This created a potential for cross contamination due to splashing while S6 washed and his/her hands at Sink 18. At 11:25 AM, an interview was conducted with S9, the Supervising Manager of Clinical Services. S9 confirmed the above finding and stated that he/she would install “Plexiglass” between the sink and the medication preparation area to protect it from potential cross contamination. Facility policy titled, “Medication Policy,” revised October 2023, stated, “... Policy: ... 21. An aseptic environment ... is used when preparing medications. ...” N.J.A.C. 8:43A-9.3(a) 50912 2. On 09/18/24 at 10:15 AM, during a tour of the Treatment Room, an Embrace PRO (Professional Choice) blood glucose meter was located on top of a narrow shelf adjacent to “Dirty” Sink 13. The surfaces of “Dirty” Sink 13 and the narrow shelf where the glucose meter was lying had multiple areas of clear liquids present. During an interview at 11:05 AM, the findings were reviewed with S2, a Registered Nurse. He/She could not determine if the blood glucose meter had been cleaned after it was last used. S2 stated that after each use, the glucometer should be cleaned with a 1:100 bleach solution, allowed to dry, and returned to the glucometer case located inside a drawer labeled “Glucometer.” When questioned, S2 was not sure if the policy was to keep the glucometer in a clean or dirty area. He/She stated, “The glucometer machine needs to be cleaned after each patient use and not kept on a shelf that has splashes of water.” S2 then proceeded to clean the glucometer with a 1:100 bleach cleaning solution, waited for it to dry, placed it inside the glucometer case and put it back in the drawer labeled “Glucometer.” A review of the MIFU for the Embrace PRO blood glucose monitor stated, “... Safekeeping ... Make sure to keep the Embrace PRO Meter in a sanitary environment ... Keep the test port away from dirt, blood, or water ...” N.J.A.C. 8:43A-24.8(d)”

“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: 50912 Based on observation of one of two Embrace PRO (Professional Choice) Blood Glucose Test Strips, review of facility policy and procedures, manufacturer’s instructions for use (MIFU), and staff interview, it was determined the facility failed to ensure that the Embrace PRO test strips (strips used in blood glucose meters for testing blood sugar) are maintained in accordance with the MIFU. Findings include: On 09/18/24 at 10:20 AM, during tour of the Dialysis Treatment Floor, an opened container of “Embrace PRO” test strips was located inside the bottom drawer of a cabinet left of “Dirty” Sink 13. The container did not have a label indicating the date it was opened. During an interview at 11:15 AM, Staff (S) 2, Registered Nurse stated that he/she did not know who opened the container of test strips or when it was opened. S2 stated the glucometer strips expire four months after opening. S2 then discarded the opened bottle of glucometer strips since he/she was not able to determine when it was opened. S2 then opened a new container of glucometer strips and labeled it with his/her initials, the date and the time. Facility policy titled, “Blood Glucose Testing,” revised December 2019, stated, “ ...Policy... 4. The monitor and strips are stored and used in accordance to monitor manufacturer instructions and approved policies and procedures. ...” A review of the MIFU for the Embrace PRO test strips, stated, “... Storage and Handling ... Use all the strips within 4 months after the first opening ...” N.J.A.C. 8:43A-24.11(c)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 48966 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy for one of one observation of the initiation of hemodialysis through an arteriovenous graft/fistula (AVG/AVF). Findings include: On 09/18/24 at 10:02 AM, Staff (S) 6, a Licensed Practical Nurse (LPN), initiated dialysis through a patient’s AVF in Station 17. After cleansing each site of the AVF with alcohol pads in a circular motion, S6 applied betadine for 20 seconds in a circular motion to each site and allowed the betadine to dry for one minute and 30 seconds prior to cannulation (the action of inserting a metal tube into the body to draw fluid or introduce medication). The application of betadine was 10 seconds less than required by facility policy. The betadine dry time was 30 seconds less than required by facility policy. During an interview at 10:18 AM on 09/18/24, S6 stated, “I think I should clean the sites with betadine for 60 seconds and allow to dry for two minutes.” A review of S6’s personnel record indicated the Nurse Skills Checklist for cleansing cannulation sites were demonstrated on 04/16/24 and satisfactory performance by a new teammate signed off on 05/01/24. Facility policy titled, “AV Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration of Heparin Loading Dose,” revised October 2022, stated, “... Procedure 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry. (For contact and dry time refer to the table above) ... Povidone Iodine ... Effective Contact Time 30 seconds, Air Drying Time 2 minutes ...” N.J.A.C. 8:43A-24.8(b)”