Davita St. Luke’s Macungie Dialysis

“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: 36372 Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene, for two (2) of two (2) ‘Access of AV Fistula or Graft for Initiation of Dialysis’ observations (Observation #1, Observation #2) and for two (2) of three (3) ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ observations (Observation #1, Observation #3) Findings include: A review was conducted of facility policy/procedure on August 5, 2025 at approximately :30 a.m. Procedure #1-04-01E ‘AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose’ ‘Procedure’ (1) states “Have patient wash access site with appropriate antibacterial soap, if able. If patient is unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent.” (2) Perform hand hygiene. Put on PPE.” ...... (11) “While maintaining aseptic technique, cleanse the site by applying skin antiseptic ....” Observations conducted in the patient treatment area on August 4, 2025 between approximately 9:00 a.m. and 12:00 p.m. revealed the following: Observation #1: During observation #1 of 2 ‘Access of AV Fistula or Graft for Initiation of Dialysis’ on 08/04/25 at approximately 11:15 a.m., of patient #2 at station #9; Employee #4 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site. Observation #2: During observation #2 of 2 ‘Access of AV Fistula or Graft for Initiation of Dialysis’ on 08/04/25 at approximately 11:25 a.m., of patient #8 at station #6; Employee #6 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site. Procedure: 1-03-121 ‘Termination of Dialysis Utilizing B Braun Dialog+ Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Bloodlines’ ‘Procedure’ (7) “... Aseptically disconnect arterial blood line from arterial access connection. ...(14) “Disconnect venous blood line from the venous access. (15) :Discard gloves, perform hand hygiene and put on new gloves.” (16) “Perform post dialysis access care per procedure.” Observation #1: During observation #1 of 3 ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ on 08/04/25 at approximately 9:40 a.m., of patient #9 at station #2; Employee #5 did not perform hand hygiene after disconnecting the bloodlines. Employee #5 removed gloves but did not perform hand hygiene prior to donning new gloves, before removing the needles. Observation #3: During observation #3 of 3 ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ on 08/04/25 at approximately 10:45 a.m., of patient #5 at station #1; Employee #5 did not perform hand hygiene after disconnecting the bloodlines. Employee #5 removed gloves but did not perform hand hygiene prior to donning new gloves, before removing the needles. An interview with the facility Administrator on August 5, 2025 at approximately 2:00 p.m. confirmed the above findings.”

“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: 36372 Based on review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters, for two (2) of two (2) ‘Central Venous Catheter Exit Site Care’ and ‘Initiation of Dialysis with Central Venous Catheter’ observations (Observation #1, Observation #2). Findings: A review was conducted of facility policy/procedure on August 5, 2025 at approximately 9:30 a.m. Procedure #1-04-02B ‘Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure’ ‘Procedure’ (12) “...Perform a 15 second hub scrub every time a CVC is connected or disconnected from the bloodlines, ....” ‘Procedure’ (4) “Remove old dressing and discard.” ....... (12) “Place sterile 2x2 gauze over the catheter exit site leaving connections accessible.” (13) Apply label to the dressing.” (14) “Remove gloves and discard, perform hand hygiene per procedure and re-glove.” Observations conducted in the patient treatment area on August 4, 2025 between approximately 9:00 a.m. and 12:00 p.m. revealed the following: Observation #1: On 08/04/25 at approximately 10:25 a.m. while observing ‘Central Venous Catheter Exit Site Care’ and ‘Initiation of Dialysis with Central Venous Catheter’ observation #1 of (2) for patient #6, station #4; Employee #5 removed the old CVC dressing/removed gloves/hand hygiene/donned clean gloves/cleansed the area around the CVC exit site. Employee #5 left the central venous catheter (CVC) site exposed without a dressing as CVC dialysis was initiated. Employee #5 applied a sterile dressing to the CVC site after cleaning the CVC ports and connecting the sterile syringes. No hand hygiene/donning of new gloves observed before/after connecting the sterile syringes and prior to applying sterile dressing to the CVC access site. Observation #2: On 08/04/25 at approximately 11:40 a.m. while observing ‘Central Venous Catheter Exit Site Care’ and ‘Initiation of Dialysis with Central Venous Catheter’ observation #2 of (2) for patient #7, station #5; Employee #6 removed the old CVC dressing/removed gloves/hand hygiene/donned clean gloves/cleansed the area around the CVC exit site. Employee #6 left the central venous catheter (CVC) site exposed without a dressing as CVC dialysis was initiated. Employee #6 applied a sterile dressing to the CVC site after cleaning the CVC ports and connecting the sterile syringes. No hand hygiene/donning of new gloves observed before connecting the sterile syringes. An interview with the facility Administrator on August 5, 2025 at approximately 2:00 p.m. confirmed the above findings.”