Fresenius Medical Care North Star Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 41879 Based on observation, staff interview, and review of policy and procedure, Patient Care Technician (PCT) #1, one of three PCTs observed, failed to ensure a patient performed hand hygiene after glove removal. The finding included: On 05/07/2024 at 11:02 AM, PCT #1 is observed discontinuing a left arm fistula at Station #5. The patient at Station #5 is observed removing the glove to the right hand used to hold pressure to the fistula site. The patient touched his/her belongings, touched the scale to weigh, and touched the automatic door opener with the right hand on the way out of the clinic. No hand hygiene had been performed after patient removed the glove; and no staff encouraged the patient to use hand hygiene before exiting clinic. The finding was verified with PCT #1 on 05/07/2024 at 11:10 AM. Review of the policy, “Hand Hygiene”, reads, “All staff, patients, patient care givers, including physicians and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. Decontamination using alcohol-based hand rub or by washing hands with antimicrobial soap and water should be done; before and after direct contact with patients, entering and leaving the treatment areas, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled, after contact with inanimate objects...”.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 36779 Based on record review and interview, the clinic nursing staff failed to ensure central line catheter site care and dressing changes were performed for two of three patients reviewed for central line catheter care, Patients #1 and #2. The findings included: Observation on 5/7/24 at 12:21 PM revealed Patient #2 dialyzing with a central line to his/her right upper chest. In a concurrent interview, Patient #2 stated the central line had been placed in the hospital in December of 2023 when dialysis started. Review on May 7, 2024 at 1:53 PM of the medical record revealed Patient #2 had been admitted to the Clinic on 1/11/24. Review of the Treatment Sheets revealed no documentation of central line dressing changes on 4/13/24, 4/18/24 and 4/20/24 (three of ten treatments). In an interview on 5/8/24 at 4:50 PM, the Charge Nurse (CN) reviewed Patient #2’s record and confirmed the findings. The CN stated there was no order entered in the electronic medical record (EMR) and therefore the EMR would not prompt the nurses to perform and document the central line catheter care. The CN stated an order should have been entered at the time of admission and there should be documentation of the central line catheter care for every treatment. Review on 5/8/24 at 10:00 AM revealed Patient #1 was admitted to the Clinic on 3/7/24 and had a central line catheter for dialysis access. Review of the Treatment Sheets revealed there as no documented evidence of central line catheter care on 4/16/24, 4/18/24, 4/20/24 and 4/27/24 (four of ten treatments). In an interview on 5/8/24 at 4:05 PM, the CN confirmed the findings and stated there was no physician’s order in the EMR, so the nurses would not be prompted to provide and document central line catheter care. The CN stated a physician’s order should have been entered at the time of admission and there should be documentation of central line catheter care every treatment. Review of the Clinic’s policy titled, “Central Venous Catheter Dressing Change” on 5/8/24 revealed, “...Perform catheter exit-site care and dressing replacement prior to initiation of treatment...Document the dressing change in the...treatment record...””

“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: 41879 Based on observation, staff interview, and review of the CWP (Continuous Water Purifier) 100 RO (Reverse Osmosis) Manufacturer’s Guidelines, the End Stage Renal Dialysis facility staff failed to follow manufactures guidelines to mark the fluid level and date on the disinfectant container to ensure uptake (use) of the Minncare disinfectant. The findings included: On 05/07/2024 at 10:20 AM, the facility’s RO system was observed, and the Minncare container checked for markings to ensure staff were tracking consumption of the disinfection chemical Minncare. The Minncare container contained one black mark with the date 04/24/24 and staff initials. Staff had documented Minncare disinfections on 04/23/24 and 05/01/24; but there was no mark on the container to indicate how much of the chemical had been used on 05/01/24. The finding was verified with Biomedical Technician (BIO) 1 on 05/07/2024 at 12:30 PM. The manufacturer’s guidelines were provided on request. BIO 1 stated, “We do Minncare disinfection once a week. The mark on the jug is for last week and no staff documented Minncare consumption on the Minncare container on 4/30/24 as per our policy.” “Guidelines for disinfection CWP (Continuous Water Purifier) 100 RO system,” reads, “Mark the fluid level and date on the disinfectant container with a permanent marker...”.”

“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: 36779 Based on observation, interview, record review and policy review, the clinic failed to provide ongoing education and monitoring related to a central line catheter device access in place greater than 90 days, for one of three patients observed for central line (Patient #2). The findings included: An observation of Patient #2 receiving dialysis treatment was conducted on 5/7/24 at 12:21 PM. Patient #2 had a central line to his/her right upper chest. In a concurrent interview, Patient #2 stated the central line catheter had “come out twice” and he/she wanted one in his/her “arm” because he/she was afraid the central line catheter would come out again. Patient #2 stated he/she was scheduled to get a catheter in his/her arm when the central line came out the second time, so he/she could not get it that day. Patient #2 stated he/she thought it was a couple of months ago that it happened and he/she asked a staff member last week about getting a catheter in his/her arm but he/she has not heard anything from the Clinic staff. Review of Patient #2’s record on 5/7/24 at 13:53 PM revealed Patient #2 was admitted to the Clinic on 1/11/24 with a diagnosis of End Stage Renal Disease with a central line inserted on 12/15/23 (almost five months ago). Further review of the record revealed there was no documented evidence of ongoing education to Patient #2 and/or his/her family about changing the access site from the central line to peripheral access. In an interview with the Charge Nurse (CN) on 5/8/24 at 3:45 PM, she/he reviewed Patient #2’s record and stated the only documentation she/he could find was a note by a Nurse Practitioner indicating a central line catheter replaced on 2/15/24 (almost three months ago). The CN confirmed the finding and confirmed there was no documented evidence of ongoing education to Patient #2 or his/her family since 2/15/24 regarding changing the access site to peripheral access rather than the central line. Review of the Clinic’s policy titled, “Patient Education” on 5/8/24 revealed, “...Patient education must be documented in the patient’s medical record...Ongoing education will be provided to patients as needed on an individualized basis. Topics not limited to and as applicable should include...Vascular access...””

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 41879 Based on record reviews, staff interviews and policy and procedure reviews, the End Stage Renal Dialysis (ESRD) Center failed to follow physician orders for the Blood Flow Rate (BFR) for three of five In Center Hemodialysis (ICHD) patient records reviewed, Patients 1, 3 and 5. The clinic nursing staff failed to monitor vital signs every 30-45 minutes for Patients 6 and 7; and failed to notify the nurse for a blood pressure outside of parameters for Patient 6, 2 of 7 patients reviewed for physician orders and monitoring. Findings included: A review of Patient 3’s chart on 05/07/2024 at 2:24 PM revealed two of ten treatment sheets documented incorrect Blood Flow Rates (BFR). “Hemo Treatment Orders” dated 04/22/24 read, “Blood Flow Rate :350 and Dialysis Flow Rate: 1.5.” On 04/17/2024, Patient 3’s treatment started at 11:23 AM with a BFR of 300. The BFR was 300 the entire treatment. The treatment ended at 3:34 PM. No reason was documented for the incorrect BFR. On 04/19/2024, Patient 3’s treatment started at 11:20 AM. The BFR was documented as 350. At 12:06 PM the BFR was changed to run at 300. At 12:36 PM the BFR was documented as 250. The treatment ended at 15:34 PM with the BFR at 250. No reason was documented as to why the BFR did not run as prescribed. A review of Patient 5’s chart on 05/08/2022 at 11:57 AM revealed three of ten treatment sheets documented incorrect Blood Flow Rates (BFR). “Hemo Treatment Orders” dated 05/07/2024 read, “Blood Flow Rate : 400 and Dialysis Flow Rate: 1.5 autoflow.” On 04/20/2024, Patient 5’s treatment started at 10:56 AM. The BFR was documented as 350. The BFR ran at 350 until the treatment ended at 13:58 PM. No reason was documented why the BFR was not run as prescribed. On 04/23/2024, Patient 5’s treatment started at 11:07 AM. The BFR was documented as 350. The BFR was decreased to 200 at 12:04 PM and remained at 200 the rest of the treatment which ended at 2:25 PM. No reason was documented why the BFR had not run as prescribed. On 05/04/2024 , Patient 5’s treatment started at 10:41 AM with a BFR of 350. The BFR was decreased to 300 at 12:04 PM, and ran at 300 the remaining treatment which ended at 13:50 PM. No reason was documented why the BFR had not run as prescribed. The findings were verified with the Facility Administrator on 05/08/2024 at 3:00 PM. Review of the policy “Patient Monitoring and Safety Checks During Hemodialysis Treatment,” reads, “Verify dialysate lines are attached and in correct position and DFR, BFR, and UFR is set and functioning per treatment physician order.” Review on 05/07/2024 at 2:25 PM of a treatment sheet for Patient 7 dated 01/24/2024 revealed vital signs had been documented at 12:25 PM and then again at 1:32 PM. The finding was verified with the Facility Administrator during an interview on 05/08/2024 at 3:00 PM. Review of the Policy, “Patient Monitoring and Safety checks During Hemodialysis Treatment,” reads, “Patient Monitoring: Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the FKC Treatment record. Patient monitoring includes: Changes in patient status, Blood pressure, pulse and respirations...”. 36779 Review of Patient #1’s record on 5/8/24 at 11:00 AM revealed Patient #1 was admitted to the Clinic on 3/7/24 with a diagnosis of End Stage Renal Disease. Review of the Treatment Sheets dated 4/18/23 and 4/23/24 revealed Patient #1’s Blood Flow Rate (BFR) was ordered at 400, but administered at 350 for the entire treatments. There was no documentation indicating why it was not administered as ordered and no documentation the PCT (Patient Care Technician) notified the nurse in charge of an inability to achieve the prescribed BFR. In an interview with the Charge Nurse (CN) on 5/8/24 at 4:15 PM, she/he reviewed Patient #1’s record and stated the staff are supposed to document if there is a reason for the BFR to be administered differently than prescribed. The CN confirmed the treatments on 4/16/24 and 4/23/24 were not administered as prescribed and there was no documentation indicating why or notification to the Nurse in charge. Review of the Clinic’s policy titled, “Unable to Achieve Prescribed Blood Flow Rate” on 5/8/24 revealed, “...Achieving prescribed BFR is a critical parameter in achieving adequate treatment...Staff...will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate...” Review of Patient #6’s record on 5/8/24 at 1:45 PM revealed Patient #6 was admitted to the Clinic on 8/22/18 with a diagnosis of End Stage Renal Disease. Review of the Treatment Sheet dated 5/7/24 revealed Patient #6’s blood pressure (BP) was assessed at 7:30 AM and then at 8:30 AM (one hour in between). Review of the Treatment Sheet dated 4/23/24 revealed Patient #6’s BP was 59/44 at 8:32 AM. There was no documented evidence the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the low BP. The next BP was at 9:06 AM (34 minutes later). In an interview with the Charge Nurse (CN) on 5/8/24 at 3:21 PM, she/he reviewed Patient #6’s record and stated on 4/23/24 the BP should have been assessed every 30 minutes. The CN also stated that on 5/7/24 the PCT should have repositioned the BP cuff and retaken the BP immediately and if it was still low the PCT should have notified the RN. The CN confirmed there was no documented evidence the PCT did that. Review of the Clinic’s policy titled, “Determination of Blood Pressure” on 5/8/24 revealed, “...Obtain blood pressure...every 30 minutes or more during hemodialysis treatments as indicated...Verify by reposititioning electronic cuff or use a manual cuff for blood pressures that show...a large drop or elevation in blood pressure is noted...Notify nurse in charge of significant differences in blood pressure readings from patient’s usual range and/or significant changes in blood pressure during treatment...””