Fresenius Medical Care of Rockingham County

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 33306 Based on review of the Emergency Preparedness Plan (E.P.P.) and interview, it was determined the facility failed to include clear delegations of authority or a clear order of succession for commander/person in charge during an emergency situation. Findings include: Review on 9/17/25 of a letter from the E.P.P. to the local emergency center containing annual contact information revealed, “I am confirming that [name omitted] is the Administrator of Fresenius Medical Care of Rockingham County.” This letter was signed on 9/04/25 by Staff A. Review on 9/17/25 of the emergency preparedness training documents and the facility’s current State Licensing Certificate, displayed within the facility, listed Staff C as the Facility Administrator. Review on 9/17/25 of the E.P.P. annual communication letters to the metropolitan planning council, local police department, and three (3) health facility transfer agreements were all signed on 04/01/25 by Staff B as the Facility Administrator. Interview on 09/17/25 at 10:15 a.m with Staff A, Staff B, and Staff C, indicated that they all shared the administrator duties depending on the situations, activities, circumstances, and/or active events. It was unclear who had the final leadership authority during a real world emergency event.”

“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: 38218 Based on observation, interview, and record review, it was determined that the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the dialysis center. Findings include: Observation on 9/16/25 at approximately 8:10 a.m. of the dialysis room revealed two drops of dried brown substance adhered to the floor outside of the nursing station. Interview on 9/16/25 at approximately 8:10 a.m. with Staff A (Administrator) revealed that the two drops of dried brown substance adhered to the floor were blood. Observation on 9/16/25 at approximately 9:35 a.m. of the wall between Station #7 and the Dirty Sink revealed approximately 30 splatters of dried brown substance adhered to the walls over the biohazard sharps container. Interview on 9/16/25 at approximately 9:40 a.m. with Staff C (Certified Clinical Hemodialysis Technician (CCHT)) revealed the splatters of dried brown substance adhered to the walls over the biohazard sharps container were blood. Observation on 9/16/25 at approximately 10:20 a.m. of the wall outside of the soiled utility room above the biohazard sharps container revealed approximately six splatters of dried brown substance adhered to the wall. Interview on 9/16/25 at approximately 10:20 a.m. with Staff D (CCHT) revealed the splatters of dried brown substance adhered to the wall were blood. Observation on 9/16/25 at approximately 12:30 p.m. revealed the same two drops of dried brown substance observed earlier at 8:10 a.m. adhered to the floor outside of the nursing station. 43408 Observation on 9/16/25 at approximately 10:20 a.m. of the Isolation room revealed four splatters of a dried brown substance adhered to the wall behind the biohazard sharps container. Observation on 9/16/25 at approximately 10:20 a.m. of the treatment area revealed the following: At the eye wash station across from Station #2 were 12 splatters of a dried brown substance adhered to the wall behind the biohazard sharps container; between Station #8 and the Dirty Sink were approximately eight splatters of a dried brown substance adhered to the wall behind the biohazard sharps container, across from Station #10 were approximately 16 splatters of a dried brown substance adhered to the wall behind the biohazard sharps container and approximately four splatters of a dried brown substance adhered to the metal platform that holds the biohazard sharps container. Interview on 9/16/25 at approximately 10:30 a.m. with Staff Fé (Registered Nurse) confirmed the above findings in the treatment area. Review on 9/17/25 of the facility policy titled, “Cleaning and Disinfecting the Dialysis Station”, Dated 9/2/25, revealed “... Work Surface Cleaning and Disinfection with Visible Blood...Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible...””

“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, interview, and policy review, it was determined that the dialysis facility failed to change gloves between touching equipment and caring for the patient for 1 of 4 patients with a Central Venous Catheter observed during dialysis treatments. (Patient Identifier is #7.) Findings include: Observation on 9/16/25 at approximately 9:15 a.m. of Staff B (Personal Care Technician) revealed Staff B touched Patient #7 ‘s computer station with gloved hands and then Staff B proceeded to disconnect Patient #7 from dialysis treatment without changing their gloves or performing hand hygiene. Interview on 9/16/25 at approximately 9:20 a.m. with Staff B confirmed the above findings. Review on 9/17/25 of the facility policy titled, “Personal Protective Equipment”, dated 11/6/23 revealed: ... Gloves ... Staff must remove gloves and wash hands after: Patient care, ... Touching any surfaces within the patient station ...”

“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 4 patients with a Central Venous Catheter (CVC) being disconnected from dialysis. (Patient Identifier is #7.) Findings include: Observation on 9/16/25 at approximately 9:15 a.m. revealed that Patient #7 had a field barrier in place under their CVC dialysis access port while receiving dialysis treatment. During discontinuation of treatment, Staff B (Personal Care Technician) did not place a new clean field barrier under the dialysis access port prior to disinfection of catheter and disconnecting the patient. Interview on 9/16/25 at approximately 9:20 a.m. with Staff B confirmed the above findings. Review on 9/16/25 of the facility policy titled, “Termination of Treatment Using a Central Venous Catheter”, dated 1/19/24, revealed: “...Prior to Termination: Preparation... 5. Ensure that a clean under pad is below the catheter limbs...””

“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: 43408 Based on interview, and record review, the dialysis facility failed to ensure all in-center hemodialysis (HD) machines were maintained in accordance with manufacturer’s instructions for 2 of 3 dialysis machines reviewed for preventative maintenance. Findings include: Review on 9/17/25 of the manufacturer’s instructions for the HD machines used at the facility, titled “Fresenius Medical Care 2008T Hemodialysis System Preventative Maintenance Procedures,” revealed the following: “...Scheduled maintenance is performed based on time intervals or number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows: ... 1) Six (6) months, 2) Annually or after 4000 hours of operation...”. Review on 9/17/25 of the facility’s preventative maintenance report titled “FKC Equipment Record” for HD machine #3T0S-124194, with a date range of 7/1/24 through 9/16/25, revealed that annual preventative maintenance was performed on 10/30/24 with documented 9,999 clock hours, and semi-annual preventative maintenance was performed on 4/28/25 with documented 9,999 clock hours. Review on 9/17/25 of the facility’s preventative maintenance report titled “FKC Equipment Record” for HD machine #3T0S-124150, with a date range of 7/1/24 through 9/16/25, revealed that an annual preventative maintenance was performed on 8/20/25 with documented 9,999 clock hours, semi-annual preventative maintenance was performed on 8/28/25 with documented 9,999 clock hours, and an annual preventative maintenance was performed on 8/8/25 with documented 9,999 clock hours. Interview on 9/17/25 at approximately 10:30 a.m. with Staff E (Area Technical Operations Manager) confirmed the above findings and revealed the hours meters had failed on the above HD machines so the center was not able to document the clock hours of the above HD machines.”

“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 3 out of 11 patients reviewed (Patient Identifiers are #3, #4, and #5.) Findings include: Patient #3 Review on 9/18/25 of Patient #3’s hemodialysis prescription, dated 9/6/25, revealed that Patient #3’s hemodialysis prescription was for a BFR (Blood Flow Rate) of 450 milliliters per minute (mL/min). Review on 9/18/25 of Patient #3’s treatment sheet, dated 8/26/25, revealed the BFR was documented at 400 mL/min at 9:03 a.m., 9:31 a.m., 10:02 a.m., and 10:31 a.m. Review on 9/18/25 of Patient #3’s treatment sheet, dated 9/2/25, revealed the following documented BFRs: BFR at 400 mL/min at 9:35 a.m., 10:03 a.m., 10:30 a.m., and 11:05 a.m.; and BFR at 310 mL/min at 11:23 a.m., and 11:34 a.m. Review on 9/18/25 of Patient #3’s treatment sheet, dated 9/4/25, revealed the BFR was documented at 405 mL/min at 8:33 a.m., 9:01 a.m., 9:32 a.m., and 10:01 a.m. Patient #4 Review on 9/18/25 of Patient #4’s hemodialysis prescription, dated 7/26/25, revealed that Patient #4’s hemodialysis prescription was for a BFR of 450 mL/min. Review on 9/18/25 of Patient #4’s treatment sheet, dated 8/23/25, revealed the BFR was documented at 200 mL/min at 11:53 a.m., and 1:17 p.m. Review on 9/18/25 of Patient #4’s treatment sheet, dated 8/30/25, revealed the following documented BFRs: BFR at 350 mL/min at 12:07 p.m., 1:32 p.m., 2:00 p.m., and 2:33 p.m.; and BFR at 400 mL/min at 12:33 p.m., 1:04 p.m., and 3:06 p.m.. Review on 9/18/25 of Patient #4’s treatment sheet, dated 9/4/25, revealed the following documented BFRs: BFR at 400 mL/min at 11:53 a.m., 12:30 p.m., and 2:06 p.m.; and BFR at 410 mL/min at 1:30 p.m. and 2:05 p.m. Review on 9/18/25 of Patient #4’s treatment sheet, dated 9/9/25, revealed the following documented BFRs: BFR at 350 mL/min at 12:17 p.m., 12:30 p.m., and 1:03 p.m.; BFR at 325 mL/min at 1:33 p.m., 2:00 p.m., 2:33 p.m., and 3:01 p.m. Review on 9/18/25 of Patient #4’s treatment sheet, dated 9/13/25, revealed the BFR was documented at 400 mL/min at 12:08 p.m., 12:31 p.m., 1:06 p.m., 1:32 p.m., 2:00 p.m., 2:31 p.m., and 3:24 p.m. Patient #5 Review on 9/18/25 of Patient #5’s hemodialysis prescription, dated 9/3/25, revealed that Patient #5’s hemodialysis prescription was for a BFR of 450 milliliters per minute (mL/min) on Monday, Wednesday and Friday, and hemodialysis prescription, dated 9/6/25, revealed that Patient #3’s hemodialysis prescription was for a BFR of 400 milliliters per minute (mL/min) on Saturday only. Review on 9/18/25 of Patient #5’s treatment sheet, dated 8/25/25, revealed the following documented BFRs: BFR at 265 mL/min. at 6:13 a.m. and 8:33 a.m.; BFR at 285 mL/min. at 6:31 a.m.; BFR at 275 mL/min. at 7:05 a.m. and 7:32 a.m.; BFR at 255 mL/min. at 8:01 a.m. and 9:01 a.m.; BFR at 245 mL/min. at 9:32 a.m., 10:03 a.m., and 11:02 a.m.; BFR at 240 mL/min. at 10:33 a.m.; and BFR at 250 mL/min. at 11:30 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 8/27/25, revealed the following documented BFRs: BFR at 225 mL/min at 6:40 a.m., 9:05 a.m., 9:33 a.m., 10:02 a.m., and 10:32 a.m.; BFR at 200 mL/min at 7:01 a.m. and 11:00 a.m.; BFR at 300 mL/min at 8:05 a.m.; and BFR at 210 mL/min at 8:32 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 8/29/25, revealed the following documented BFRs: BFR at 255 mL/min at 7:14 a.m.; BFR at 235 mL/min at 7:30 a.m.; BFR at 245 mL/min at 8:02 a.m.; BFR at 260 mL/min at 8:31 a.m., 9:31 a.m., and 11:01 a.m.; BFR at 280 mL/min at 9:01 a.m.; BFR at 215 mL/min at 10:01 a.m.; and BFR at 240 mL/min at 10:33 a.m., 11:31 a.m., and 11:45 a.m.. Review on 9/18/25 of Patient #5’s treatment sheet, dated 8/30/25, revealed the following documented BFRs: BFR at 300 mL/min at 6:51 a.m., 8:30 a.m.; BFR at 250 mL/min at 6:59 a.m.; BFR at 200 mL/min at 7:30 a.m.; BFR at 240 mL/min at 8:02 a.m. and 10:00 a.m.; and BFR at 235 mL/min at 8:59 a.m. and 9:29 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/1/25, revealed the following documented BFRs: BFR at 350 mL/min at 6:39 a.m.; BFR at 200 mL/min at 7:02 a.m., 7:31 a.m.., 8:03 a.m., 8:32 a.m., 9:05 a.m., and 9:34 a.m.; BFR at 250 mL/min at 10:03 a.m.; and BFR at 225 mL/min at 10:32 a.m. and 10:56 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/3/25, revealed the following documented BFRs: BFR at 200 mL/min at 6:24 a.m., 7:03 a.m., 7:32 a.m., 8:33 a.m., 9:01 a.m., and 9:40 a.m.; BFR at 175 mL/min at 6:35 a.m.; BFR at 225 mL/min at 8:00 a.m.; BFR at 180 mL/min at 10:03 a.m., and 10:31 a.m.; and BFR at 100 mL/min at 11:02 a.m., and 11:33 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/5/25, revealed the following documented BFRs: BFR at 100 mL/min at 7:07 a.m.; BFR at 130 mL/min at 7:35 a.m.; BFR at 160 mL/min at 8:03 a.m.; BFR at 215 mL/min at 8:32 a.m.; BFR at 300 mL/min at 9:00 a.m.; BFR at 210 mL/min at 9:31 a.m., 9:44 a.m., 9:47 a.m., 10:02 a.m.; BFR at 220 mL/min at 10:38 a.m.; BFR at 230 mL/min at 11:06 a.m.; BFR at 245 mL/min at 11:30 a.m.; and BFR at 250 mL/min at 12:01 p.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/10/25, revealed the following documented BFRs: BFR at 375 mL/min at 8:01 a.m., 8:33 a.m.; BFR at 325 mL/min at 9:01 a.m., 10:00 a.m., 10:30 a.m., and 11:00 a.m.; and BFR at 350 mL/min at 9:33 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/11/25, revealed the following documented BFRs: BFR at 400 mL/min at 6:17 a.m., and 6:30 a.m.; BFR at 380 mL/min at 7:01 a.m.; BFR at 355 mL/min at 7:32 a.m., 7:59 a.m., 8:35 a.m., 8:59 a.m., and 9:31 a.m.; BFR at 350 mL/min at 10:02 a.m.; and BFR at 340 mL/min at 11:25 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/12/25, revealed the following documented BFRs: BFR at 400 mL/min at 6:22 a.m. and 6:32 a.m.; BFR at 350 mL/min at 7:00 a.m., 7:43 a.m., 7:46 a.m., 8:04 a.m., 8:30 a.m., 8:45 a.m., 9:03 a.m., 9:31 a.m., and 10:09 a.m.; and BFR at 325 mL/min at 10:31 a.m., 11:09 a.m., and 11:28 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/13/25, revealed the following documented BFRs: BFR at 375 mL/min at 6:14 a.m.; BFR at 325 mL/min at 6:30 a.m. and 7:36 a.m.; BFR at 300 ml/min at 7:00 a.m., 8:05 a.m., and 8:34 a.m.; and BFR at 385 mL/min at 9:00 a.m. and 9:16 a.m. Review on 9/18/25 of Patient #5’s treatment sheet, dated 9/15/25, revealed the following documented BFRs: BFR at 250 mL/min at 6:11 a.m.; and BFR at 175 mL/min at 6:30 a.m. Review on 9/17/25 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 9/17/25 at approximately 11:30 a.m. with Staff A (Administrator) confirmed the above findings for Patients #3, #4, and #5 and revealed that there was no evidence that a provider was notified of the inability to achieve BFR for Patient #3, #4 and #5.”