Fresenius Medical Care of Lebanon

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 38218 Based on observation and policy review, it was determined that the dialysis facility failed to change gloves between touching equipment and caring for the patient and between patients for 3 of 7 patients observed during dialysis treatments (Patient Identifiers are #2, #17, and #9) Findings include: Patient #2 Observation on 10/21/24 at approximately 8:15 a.m. of Staff B (Personal Care Technician) revealed Staff B touched Patient #2’s computer station with gloved hands and then Staff B proceeded to disconnect Patient #2 from dialysis treatment without changing their gloves or performing hand hygiene. Interview on 10/21/24 at approximately 8:20 a.m. with Staff B confirmed the above findings. Patient #17 and Patient #9 Observation on 10/21/24 at approximately 9:30 a.m. of Patient #17 receiving dialysis treatment at Station 1 revealed Staff D (Patient Care Technician) had touched the machine with gloved hands and then touched Patient #17 with the same gloves on. Staff D did not change gloves and went over to Station 4 where Patient #9 was receiving dialysis treatment. Staff D used their same gloved hands to silence Patient #9’s machine. Interview on 10/21/24 at approximately 9:35 a.m. with Staff D confirmed the above findings. Review on 10/22/24 of the facility policy titled, “Personal Protective Equipment”, published 2/14/18, revealed: “ ...Disposable gloves must be used:...when touching any part of the dialysis machine or equipment at the dialysis station...Change gloves and practice hand hygiene between each patient and/or station to prevent cross-contamination...””

“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: 38218 Based on observation, interview, and policy review, it was determined the dialysis facility failed to ensure the cleaning and disinfection of contamininated surfaces, medical devices, and equipment in 1 of machines observed for cleaning and disinfection. Findings include: Observation on 10/21/24 at approximately 9:30 a.m. of Staff D (Personal Care Technician) revealed him/her cleaning the dialysis Station #1. Staff D did not clean the stethoscope and the pole attached to the dialysis station prior to setting up the machine for the next patient. Interview on 10/21/24 at approximately 9:40 a.m. with Staff D confirmed the above findings. Review on 10/22/24 of the facility policy titled, “Cleaning and Disinfection of the Dialysis Station”, Dated 11/2/20 revealed: “...General Cleaning, The dialysis station could become contaminated with blood and other body fluids during treatment. After use, all non-disposable equipment and supplies must be disinfected with 1:100 bleach or manufacturer’s recommendations or discarded.””

“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: 38218 Based on observation, interview, and policy review, it was determined that the dialysis facility failed to follow appropriate infection control recommendations to prevent potential catheter-related infections for 1 out of 2 patients with a Central Venous Catheter (CVC) being disconnected from dialysis (Patient Identifier #14). Findings include: Observation on 10/21/24 at approximately 10:20 a.m. revealed that Patient #14 had a field barrier in place with a dried red/brown substance under their CVC dialysis access port while receiving dialysis treatment. During discontinuation of treatment, Staff E (Certified Clinical Hemodialysis Technician) did not place a new clean field barrier under the dialysis access port prior to reinfusing the extracorporeal circuit. Interview on 10/21/24 at approximately 10:30 a.m. with Staff E confirmed the above findings. Review on 7/29/24 of the facility policy titled, “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer”, Dated 2/7/22 revealed: “...Prior to Termination: Preparation... 5. Ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing...””

“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: 43408 Based on interview and record review it was determined that the dialysis facility failed to follow the hemodialysis prescriptions for 9 out of 16 prescriptions reviewed (Patient Identifiers are #1, #2, #3, #4, #5, #7, #8, #9, and #10.) Findings include: Patient #1 Review on 10/22/24 of Patient #1’s hemodialysis prescription dated 10/2/24 revealed that Patient #1’s hemodialysis prescription was for a DFR of 800 mL/min and BFR of 450 mL/min. Review on 10/22/24 of Patient #1’s treatment sheet dated 10/7/24 revealed the Dialysate Flow Rate (DFR) was documented at 400 milliliters per minute (mL/min) and the Blood Flow Rate (BFR) was documented at 200 mL/min at 4:43 p.m., 5:10 p.m., 5:38 p.m., 5:39 p.m., and 6:03 p.m.. Patient #2 Review on 10/22/24 of Patient #2’s hemodialysis prescription dated 10/4/24 revealed that Patient #2’s hemodialysis prescription was for a DFR of 500 mL/min. Further review of Patient #2’s prescriptions revealed a special attention entry, with a start date of 9/25/24, to use a 1 potassium (K) bath for the first hour of dialysis each treatment. Review on 10/22/24 of Patient #2’s treatment sheet 10/7/24 through 10/18/24 revealed the following: On 10/7/24, the DFR was documented at 800 mL/min at 8:24 a.m., 8:34 a.m., 9:19 a.m., 9:51 a.m., 10:01 a.m., 11:08 a.m., 11:19 a.m., 11:36 a.m., 12:06 p.m., and 12:08 p.m., and there was no documentation that a 1 K bath was administered for one hour; On 10/11/24, there was no documentation that a 1 K bath was administered for one hour; On 10/18/24, the DFR was documented at 800 mL/min at 8:28 a.m., 9:01 a.m., 9:34 a.m., 10:04 a.m., 10:39 a.m., 11:02 a.m., 11:36 a.m., and 12:06 p.m, and there was no documentation that a 1 K bath was administered for one hour. Patient #3 Review on 10/22/24 of Patient #3’s hemodialysis prescription dated 10/16/24 revealed that Patient #3’s hemodialysis prescription was for BFR of 500 mL/min. Review on 10/22/24 of Patient #3’s treatment sheet 10/7/24 through 10/18/24 revealed the following: On 10/11/24 the BFR was documented at 400 mL/min at 3:56 p.m., and 450 mL/min at 5:03 p.m., 5:33 p.m., 6:07 p.m., 7:02 p.m., and 7:33 p.m.; On 10/18/24 the BFR was documented at 400 mL/min at 4:33 p.m., 4:39 p.m., and 5:32 p.m. Patient #4 Review on 10/22/24 of Patient #4’s prescriptions revealed a special attention entry, with a start date of 3/15/24, “...run the pt [patient] on 1 K dialysate x 1 h [hour] every treatment. Switch to 2 K for the rest of the treatment...” Review on 10/22/24 of Patient #4’s dialysis treatment records from 10/9/24 through 10/18/24 revealed no documentation that a 1 K bath was delivered for the first hour of dialysis treatment on the following days 10/7/24, 10/11/24, 10/14/24 and 10/18/24. Patient #5 Review on 10/22/24 of Patient #5’s hemodialysis prescription revealed a special attention entry, with a start date of 7/9/24, “...Continue 1 K bath until further notice per MD [Medical Doctor]...” Review on 10/22/24 of Patient #5’s treatment sheet 10/8/24 through 10/19/24 revealed there was no documentation of a 1 K bath administered for one hour on the following days: 10/10/24, 10/12/24, 10/15/24, 10/17/24 and 10/19/24. Patient #7 Review on 10/22/24 of Patient #7’s hemodialysis prescription dated 10/8/24 revealed that Patient #7’s hemodialysis prescription was for a DFR of 800 mL/min. Review on 10/22/24 of Patient #7’s treatment sheet dated 10/8/24 revealed the DFR was documented at 700 mL/min at 1:33 p.m., 2:02 p.m., 2:31 p.m., 3:50 p.m., 4:00 p.m., 4:36 p.m., and the DFR was documented at 600 mL/min at 3:06 p.m.. Patient #8 Review on 10/22/24 of Patient #8’s hemodialysis prescription dated 10/12/24 revealed that Patient #8’s hemodialysis prescription was for BFR of 450 mL/min. Review on 10/22/24 of Patient #8’s treatment sheet 10/8/24 through 10/19/24 revealed the following: On 10/15/24 the BFR was documented at 400 mL/min at 12:49 p.m., 1:07 p.m., 1:33 p.m., 2:02 p.m., 2:38 p.m., 3:05 p.m., and 3:32 p.m.; On 10/17/24 the BFR was documented at 400 mL/min at 1:03 p.m., 1:34 p.m., 2:05 p.m., 3:03 p.m., 3:28 p.m., and 3:47 p.m.. Patient #9 Review on 10/22/24 of Patient #9’s hemodialysis prescription dated 10/21/24 revealed that Patient #9’s hemodialysis prescription was for DFR of 500 mL/min. Review on 10/22/24 of Patient #9’s treatment sheet 10/9/24 through 10/21/24 revealed the following On 10/21/24 the DFR was documented at 800 mL/min at 7:25 a.m., 7:32 a.m., 8:04 a.m., 8:34 a.m., and 9:19 a.m.. Patient #10 Review on 10/22/24 of Patient #10’s hemodialysis prescription dated 10/15/24 revealed that Patient #10’s hemodialysis prescription was for BFR of 450 mL/min. Review on 10/22/24 of Patient #10’s treatment sheet 10/10/24 through 10/19/24 revealed the following: On 10/15/24 the BFR was documented at 375 mL/min at 7:35 a.m., 8:06 a.m., 8:31 a.m., 8:32 a.m., 9:05 a.m., 10:01 a.m.,10:03 a.m., 10:37 a.m., 11:04 a.m., and 11:16 a.m.; On 10/17/24 the BFR was documented at 375 mL/min at 7:30 a.m., 8:06 a.m., 8:31 a.m., 9:01 a.m., 9:32 a.m., 9:33 a.m., 10:02 a.m., 10:34 a.m., and 11:03 a.m.; On 10/19/24 the BFR was documented at 200 mL/min at 7:16 a.m.. The BFR was documented at 400 mL/min at 7:30 a.m.. The BFR was documented at 375 mL/min at 8:01 a.m., 8:32 a.m., 9:01 a.m., 9:35 a.m., 10:07 a.m., 10:31 a.m., 11:05 a.m., and 11:14 a.m.. Review on 10/22/24 of facility’s policy titled, “Pre-Treatment Safety Checks Procedure”, published 2/6/23, revealed: “...The clinician initiating treatment must verify the prescribed set up matches: patient’s identity, prescription: dialyzer, dialysate composition, dialysate flow rate, time, goal set, needle size, temperature...” Review on 10/22/24 of the facility policy titled, “Unable to Achieve Prescribed Blood Flow Rate”, dated 11/1/21, revealed: “...Notification: Notify physician/extender if unable to achieve prescribed blood flow rate. Documentation: Document in patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physicians orders...” Interview on 10/22/24 at approximately 11:00 a.m. with Staff A (Charge Nurse) confirmed the above treatments were not following the dialysis prescription for Patients #1, #2, #3, #4, #5, #7, #8, #9, and #10 and revealed that there was no evidence that a provider was notified of the inability to achieve BFR for Patient #1, #3, #5, #8 and #10.”