Fresenius Medical Care Angier Dialysis

“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: 26622 Based on facility policy review, observation and interview, the patient care staff failed to prevent cross-contamination by failing to clean and disinfect the hemodialysis machine and patient chair per the facility policy for 2 of 3 observations of staff cleaning the dialysis station (Patient Care Technician [PCT] #1, Stations #11 and #9) Findings include: Review on 12/30/2025 of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station” published 09/02/2025 revealed, “... ...Background [space] ...The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. ...Definition [space] Dialysis Station [ space] ...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycle and attachments such as IV pole, BP cuff and hand sanitizer holder, sharps container mounted to the machine. [space] Chair/bed ...Cleaning of the Dialysis Machine [space] Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. ... Procedure [space] Step ...3. Use a cloth wet with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine...). Place the chair in Trendelenburg position and open side panels if chair has swing open sides so all surfaces of the chair are accessible. ... Step 4 [space] Clean all surfaces. Make the surfaces glisteningly wet and allow to air dry...” 1. Observation on 12/30/2025 at 1000 of the staff cleaning and disinfecting the dialysis station revealed PCT #1 entered station #11, donned clean gloves, obtained 1:100 wet wipe and proceeded to wipe down/disinfect the hemodialysis machine and patient chair. The observation revealed that PCT #1 disinfected the front and top of the dialysis machine. PCT #1 failed to wet wipe the side surfaces of the dialysis machine. The observation revealed PCT #1 wet wipe the lower seat cushion, back cushion, chairside table and outside of chair swing panels under the chairside table. The observation revealed that PCT #1 failed to open the chair side panels and clean the outside of the chair seat cushion and the inside of the chair side panel. Observation revealed that PCT #1 failed to place the chair in a Trendelenburg position and disinfect between the back seat cushion and the bottom seat cushion. Observation failed to reveal a glistening wet appearance after disinfection. The observation revealed the PCT failed to follow the facility policy. Interview on 12/30/2025 at 1400 with the Area Team Leader revealed the staff were expected to disinfect all sides of the dialysis machine to include the prime waste container, dialysate hoses, Hansen connectors, keyboard and control panel. The interview revealed that the staff should have opened the chair sides and cleaned the side of the seat cushion and inside of the chair door panels. The interview revealed the machine and the chair should have a glistening wet appearance after disinfection. 2. Observation on 12/30/2025 at 1045 of the staff cleaning and disinfecting the dialysis station revealed PCT #1 entered station #9, donned clean gloves, obtained 1:100 wet wipe and proceeded to wipe down/disinfect the hemodialysis machine and patient chair. The observation revealed that PCT #1 disinfected the front and top of the dialysis machine. PCT #1 failed to wet wipe the side surfaces of the dialysis machine. The observation revealed PCT #1 wet wipe the lower seat cushion, back cushion, chairside table and outside of chair swing panels under the chairside table. The observation revealed that PCT #1 failed to open the chair side panels and clean the outside of the chair seat cushion and the inside of the chair side panel. Observation revealed that PCT #1 failed to place the chair in a Trendelenburg position and disinfect between the back seat cushion and the bottom seat cushion. Observation failed to reveal a glistening wet appearance after disinfection. The observation revealed the PCT failed to follow the facility policy. Interview on 12/30/2025 at 1400 with the Area Team Leader revealed the staff were expected to disinfect all sides of the dialysis machine to include the prime waste container, dialysate hoses, Hansen connectors, keyboard and control panel. The interview revealed that the staff should have opened the chair sides and cleaned the side of the seat cushion and inside of the chair door panels. The interview revealed the machine and the chair should have a glistening wet appearance after disinfection.”

“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: 26622 Based on policy review, observation and interview, the patient care staff failed to prevent cross contamination by failing to disinfect the CVC (Central Venous Catheter) exit site with 2 % Chlorhexidine Gluconate/70 % Isopropyl alcohol for 30 seconds per facility policy, and failing to place exit site dressing prior to initiating treatment and prior to CVC cap and hub connector disinfection for 1 of 2 observed CVC exit sites disinfected with Chlorhexidine (PCT #1, Station #11), and by failing to disinfect the CVC hubs per facility policy in 1 of 2 observation during a hemodialysis treatment initiation using a CVC (PCT #1, Station #11). Findings include: Review on 12/30/2025 of the facility policy titled “Changing the Catheter Dressing Procedure,” published 05/02/2025 revealed “Policy *Complete catheter exit-site care and dressing replacement before initiation of treatment. ... Timing of Exit Site Dressing Change Catheter exit site disinfection and dressing change is to be completed prior to cap and hub connector disinfection. ... Cleaning the Site ... Step 2 ...2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the are of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. Review on 12/30/2025 of the facility policy titled “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” published 05/05/2025 revealed “... Preparing the Catheter Dressing Change ... the catheter exited site care and dressing replacement must be completed prior to accessing the bloodstream. ... Preparing the Catheter: Disinfection of the Catheter Connections... *Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad...for 10-25 seconds and any time caps are removed, or blood lines are disconnected... to reduce risk of contamination. ...” Observation on 12/30/2025 at 1030 on the treatment floor revealed PCT #1 entered Station #11 to initiate a hemodialysis treatment with a Central Venous Catheter. PCT #1 donned clean gloves, removed the old catheter dressing and disinfected the catheter exit site with a Chlorhexidine swabstick for less than 30 seconds. Observation revealed that the patient’s clothing fell down over the disinfected exit site. The observation revealed that the PCT failed to re-disinfect the CVC exit site prior to applying new dressing and initiating hemodialysis treatment. PCT #1 proceeded to remove the catheter hub caps and scrubbed the hubs for 5 seconds. The observation revealed that PCT #1 failed to apply the exit site dressing prior to disinfecting the catheter hubs and prior to initiation of treatment. Observation revealed the facility policy was not followed. Interview on 12/30/2025 at 1400 with the Area Team Leader revealed that the staff were expected to disinfect the catheter exit site for 30 seconds with Chlorhexidine swabstick, allow the exit site to dry for 30 seconds and apply a new dressing. Interview revealed that if the site was contaminated after disinfection process, the staff were expected to re-disinfect the catheter exit site prior to applying a new dressing. The staff were expected to disinfect the CVC hubs with alcohol for 10-15 seconds prior to initiating the hemodialysis treatment. The interview revealed that the facility staff failed to follow the facility policy for discontinuing a Central Venous Catheter.”

“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: 26622 Based on policy and procedure review, observations, and staff interviews, the facility failed to ensure staff performed skin antisepsis per policy before cannulation of 2 of 2 Arterio-venous fistula/graft (AVF/AVG) cannulation procedures observed (Station #3, PCT #2; Station #10, PCT #1). Findings include: Review on 12/30/2025 of the facility policy “Access Assessment and Cannulation,” Published: 05/05/2025, revealed “... Assessment of Vascular Access Step 1 Prior to treatment, ask patient to wash access area with soap and water... If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water. Note: If unable to wash with soap and water, staff may use hand sanitizer with 60-70% alcohol to clean access arm...in place of soap and water. ... Skin Disinfection Step 1 Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulation. ...” 1. Observation on 12/30/2025 at 1050 in the patient treatment area, revealed PCT #2 entered Station #3 and prepared to access the patient’s AVF/AVG. Observation revealed PCT #2 failed to wash the skin over access sites with soap and water and failed to verbally confirm with patient that access sites were washed with soap and water. Observation revealed PCT #2 donned clean gloves and applied antiseptic (70% isopropyl alcohol pad) to each access site over the skin in a concentric circle for less than 10 seconds. The observation revealed the PCT failed to clean each access site for 30 seconds per facility policy. Interview on 12/30/2025 at 1400 with the Area Team Leader revealed that the staff were expected to ask the patients if the access arm was washed with soap and water upon entrance to clinic. The staff were expected to wash the access arm with soap and water if the patient had not washed upon entrance to the clinic treatment area. The interview revealed that the staff were expected to disinfect each access site for 30 seconds when using alcohol pads. Interview revealed the PCT did not follow the facility policy. 2. Observation on 12/30/2025 at 1355 in the patient treatment area, revealed PCT #1 entered Station #10 and prepared to access the patient’s AVF/AVG. Observation revealed PCT #1 donned clean gloves and applied antiseptic (70% isopropyl alcohol pad) to each access site for less than 30 seconds. Observation revealed PCT #1 failed to clean each access site for 30 seconds per facility policy. Interview on 12/30/2025 at 1400 with the Area Team Leader revealed the staff were expected to disinfect each access site for 30 seconds when using alcohol pads. Interview revealed the PCT did not follow the facility policy.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 26622 Based on policy review, medical record review and interview, the facility failed to ensure a PPD (Tuberculosis) skin test was completed for 2 of 6 in-center hemodialysis patients records reviewed (Patient #1 and #6). Findings include: Review of the facility policy titled “Patient Tuberculosis Testing,” published 05/02/2025 revealed “... Background [space] Patients with End Stage Renal Disease (ESRD) should have at least one test for Mycobacterium tuberculosis infection to screen for tuberculosis. New Admission Screening ...On admission, review the medical records of each patient to determine if they have received TB testing within the last year. ... Patients who have no documented TB test within the last year will be tested using the TST (Mantoux Tuberculin Skin Test). Physician order is required. ... Documentation [space] Document results of TB test, treatment (if needed), and any required follow-up care in the Tuberculosis Testing Assessment in the electronic medical record. ...” 1. Review of the open medical record for Patient #1 revealed a 58-year-old female admitted to the facility on 11/21/2025 for in-center hemodialysis treatments. The medical record revealed a verbal electronic physician order documented by a nurse on 11/17/2025 at 1301 for Tubersol 0.1 milliliter (TB skin test - PPD) intrdermal once. Review of the medication administration records failed to reveal nurse documentation of the Tubersol administration. Interview on 12/31/2025 at 1500 with the clinical manager revealed the nursing staff were expected to follow the physician’s order. The interview revealed the clinical manager was not able to find documentation in the medical record of the TB skin test administration. 2. Review of the open medical record for Patient #6 revealed an 87-year-old female admitted to the facility on 09/15/2025 for in-center hemodialysis treatments. The medical record failed to reveal physician order for Tubersol 0.1 milliliter (TB skin test - PPD). Review of the medication administration records failed to reveal nurse documentation of Tubersol being administered. Interview on 12/31/2025 at 1500 with the clinical manager revealed the nursing staff or the physician were expected to write a physician’s order for the TB skin test (Tubersol - PPD) on admission. The interview revealed the clinical manager was not able to find documentation of a physician’s order or nursing administration in the medical record for a TB skin test.”