Davita Burlington North 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: 52927 Based on observation, staff interview and a review of facility documents, it was determined that the facility failed to ensure that plastic hemostat clamps are disinfected in accordance with facility policy. Findings include: On 01/14/26 at 9:43 AM, during a tour of the Hemodialysis Treatment Area, a clear plastic container labeled “1:100 bleach [one part bleach to 100 parts water]” located at the designated “dirty” sink area across from Station 8 was observed. The container had two blue, plastic hemostats that were submerged and soaking in the bleach solution. One of two clamps was observed in a closed position which was not in accordance with facility policy. During an interview at 9:50 AM, Staff (S)7 confirmed the clamps should be soaking in the open position. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... Disinfection ... 14. Non- disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses ... b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution ...” N.J.A.C. 8:43A-24.8(b)”

“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: 52927 Based on three of three observations of hemodialysis using a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview, and review of facility documents, it was determined that the facility failed to ensure staff clean and disinfect during CVC care in accordance with facility policy. Findings include: On 01/14/26 at 10:34 AM, in Station 3, Staff (S)4 initiated dialysis through a right chest wall CVC. S4 removed the arterial cap, then used an alcohol preparation (prep) pad for 20 seconds to scrub the sides, threads and end of the hub and then attached a 10 milliliter (mL) syringe. Next, S4 removed the venous cap, used a new alcohol prep pad for eight seconds to scrub the sides, threads and end of the hub and then attached a 10 mL syringe. This was seven seconds less than required by facility policy. Then, S4 wiped the arterial catheter hub with a new alcohol prep pad for four seconds before connecting to the arterial blood line. This was 11 seconds less than required by the facility policy. S4 proceeded to use a new alcohol prep pad for two seconds to scrub the sides, threads and end of the venous hub prior to connecting the venous catheter limb to the venous blood line. This was 13 seconds less than required by facility policy. During an interview at 10:40 AM, S4 stated, “cleaning of the hubs is for 30 seconds.” A review of S4’s personnel file revealed that on 05/19/25, he/she completed the “Annual Skills Checklist” which includes, “properly performs scrubbing of the hub of CVC limbs,” satisfactorily. 53665 On 01/15/26 at 09:45 AM, in Station 3, S6 discontinued the patient’s right chest wall CVC from the hemodialysis machine. Upon completion of treatment, S6 performed hand hygiene, put on clean gloves and placed a clean drape under the catheter lines. S6 discarded his/her gloves, performed hand hygiene, and put on new gloves. S6 clamped the arterial (red) blood line and disconnected the blood line from the arterial catheter limb. S6 scrubbed the catheter hub with a new alcohol preparation (prep) pad for six seconds, this was nine seconds less than required by facility policy. S6 then attached a pre-filled normal saline solution syringe and injected the contents into the catheter. S6 discarded his/her gloves, performed hand hygiene, and put on new gloves. S6 clamped the venous (blue) blood line and disconnected the blood line from the venous catheter limb. S6 then scrubbed the catheter hub with a new alcohol prep pad for eight seconds. This was seven seconds less than required by facility policy. S6 attached a pre-filled normal saline solution syringe and flushed the catheter. S6 discarded his/her gloves, performed hand hygiene, and put gloves on. S6 disconnected the syringe from the arterial limb, scrubbed the hub with a new alcohol prep pad for 10 seconds, and placed the end cap on the catheter. S6 scrubbed the hub of the catheter for five seconds less than the required amount of time in accordance with facility policy. S6 then disconnected the syringe from the venous limb, scrubbed the hub of the catheter for 11 seconds, and placed the end cap on the catheter. S6 scrubbed the hub of the catheter for four seconds less than the required amount of time in accordance with facility policy. During an interview on 01/15/26 at 10:10 AM, S6 stated that catheter hubs should be scrubbed for 15 seconds with an alcohol prep pad after disconnecting the catheter from the blood lines and prior to putting on the end caps. A review of facility personnel files showed S6 completed annual skills competencies that included “CVC Care,” which stated, “... Satisfactory performance of skill ...” in June 2025. Facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised April 2025, stated, “... NOTES: ... Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines. For disconnection process, hub scrub will be completed immediately prior to cap placement. Device Disinfectant and Skin Antiseptic ... 70% Alcohol pad, Effective for, CVC Hubs, Effective Contact Time, 15 second scrub ... Procedure ... 16. Verify both catheter clamps are closed. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of the hub thoroughly with friction making sure to remove any residue, for example blood ...” N.J.A.C. 8:43A-24.4(b)”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 48966 Based on one of one observations of machine dialysate pH (potential of Hydrogen) testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure that pH testing is completed in accordance with facility policy and are able to determine if pH testing of dialysate results are within acceptable limits. Findings include: On 01/14/26 at 9:57 AM, Staff (S)3 obtained a sample of the machine dialysate in a cup from the hemodialysis machine in Station 2. S3 dipped a RPC K100-0117 CT E-Z Chek 6.8-8.5 pH Test Strip into the fluid and shook the excess fluid off the strip. S3 waited five seconds before he/she compared test results to the color scale on the bottle. The pH test strip result was 7.5. During an interview on 01/14/26 at 9:58 AM, S3 stated after dipping the pH test strip in the sample for one second to read the pH test strip immediately and compare it to the color scale on the bottle. When asked what is the acceptable pH range, S3 stated 6.2-7.9. This was not in accordance with facility policy. Facility policy titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z CHEK K100-0117 CT 6.8-8.5 pH Test Strips,” revised February 2024, stated, “... Procedure ... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20-25 seconds compare the color reaction on strip to the color chart on bottle to determine the closet match ... 6. pH test results should be between 6.9-7.6 ...” N.J.A.C. 8:43A-24.10(a)(7)”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 53665 Based on observation, staff interview, medical record review, and review of facility documents, it was determined that the facility failed to ensure implementation of hemodialysis prescription orders for dialysate temperature for one of two observations of hemodialysis treatment (Patient (P)2), and six of seven medical records reviewed (P5, P6, P7, P8, P10, and P11). Findings include: Following observation of the initiation of hemodialysis on P2 on 01/14/26 at 9:50 AM, in Station 5, Staff (S)4 was asked to show P2’s prescription and machine setup to surveyors. He/she showed the prescription on the computer and confirmed that P2 was prescribed a dialysate temperature of 35.5 degrees Celsius (C) by their physician. S4 then showed the machine set up which revealed the patient’s dialysate temperature was set to 37 degrees C. S4 stated that the staff was required to manually input the temperature according to the prescription and confirmed that he/she had not changed the machine dialysate temperature at the time of observation and interview. S4 stated, “I have an hour to verify the prescription is correct.” S4 confirmed that the patient had already begun treatment at the time of the observation and that the “temperature should be set to what was prescribed by the physician.” A review of P5’s medical record revealed the following: “Patient Summary Report,” stated, “... Active Treatment Order(s) ... Dialysate Temperature 35.5 degrees C ...” A review of the hemodialysis treatment sheets from 12/23/25 to 01/12/26 indicated that the prescribed dialysate temperature of 35.5 degrees C was not administered in accordance with the physician order above of the following treatment dates: On 12/23/25, the machine temperature was documented as 37 degrees C. On 12/29/25, the machine temperature was documented as 37 degrees C. On 01/02/26, the machine temperature was documented as 36 degrees C. On 01/05/26, the machine temperature was documented as 36 degrees C. The medical record did not contain documented evidence that the physician was aware of the changes in temperature on the above dates. A review of P10’s medical record revealed the following: A review of P10’s Plan of Care (POC), dated 12/31/26, stated, “... Adequacy ... Maintain adequacy goal ...” The Patient Summary Report stated, “... Active Treatment Order ... Dialysate Temperature 37.0 degrees C ...” A review of the hemodialysis treatment sheets from 12/23/25 to 01/12/26 indicated that the prescribed dialysate temperature of 37 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 12/23/25, the machine temperature was documented as 36 degrees C. On 01/02/26, the machine temperature was documented as 37.4 degrees C. On 01/09/26, the machine temperature was documented as 36.1 degrees C. On 01/10/26, the machine temperature was documented as 36.2 degrees C. On 01/12/26, the machine temperature was documented as 36.2 degrees C. The medical record did not contain any documented evidence that the physician was aware of the changes in temperature on the above dates. During an interview on 1/15/26 at 11:30 AM, S1 stated that the verification process should be completed at the time the machine was set up to ensure the prescription was being followed prior to the patient starting treatment. S1 continued, there was no documented evidence that the dialysate temperatures were being changed to match the prescription during the treatments listed above. 48966 A review of P7’s medical record revealed the following: The “Active Treatment Orders” portion of the “Patient Summary Report” section of the medical record stated the hemodialysis prescription: “... In-Center Hemodialysis Treatment - [facility name] ... Dialysate Temperature - 37 [degrees] C ... Start Date - 12/18/2025 ...” A review of hemodialysis treatment sheets from 12/22/25 to 01/13/26 indicated that the prescribed temperature of 37 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 12/24/25, the machine temperature was documented as 36.5 degrees C. On 12/27/25, the machine temperature was documented as 36.0 degrees C. On 01/08/26, the machine temperature was documented as 36.5 degrees C. On 01/10/26, the machine temperature was documented as 36.1 degrees C. On 01/13/26, the machine temperature was documented as 36.5 degrees C. The medical record did not contain documented evidence that the physician was aware of the change in temperatures on the above dates. A review of P11’s medical record revealed the following: The “Active Treatment Orders” portion of the “Patient Summary Report” section of the medical record stated the hemodialysis prescription: “... In-Center Hemodialysis Treatment - [facility name] ... Dialysate Temperature - 37 [degrees] C ... Start Date - 12/18/2025 ...” A review of hemodialysis treatment sheets from 12/22/25 to 01/13/26 indicated that the prescribed temperature of 37 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 12/22/25, the machine temperature was documented as 36.0 degrees C. On 12/27/25, the machine temperature was documented as 36.7 degrees C. On 12/30/25, the machine temperature was documented as 36.2 degrees C. On 01/10/26, the machine temperature was documented as 36.8 degrees C. The medical record did not contain documented evidence that the physician was aware of the change in temperatures on the above dates. During an interview on 01/15/26 at 11:06 AM, S1 confirmed that the physician’s prescription included the machine temperature. S1 explained that the temperature documented on the “Machine Setup” area on the hemodialysis flowsheet reflected the machine’s temperature at the time of setup and may have not reached the prescribed temperature. S1 was unable to show documentation of the programmed machine dialysate temperature at the time the prescription was verified by the Registered Nurse (RN). 52927 A review of P6’s medical record revealed the following: The Plan of Care, dated 12/09/26, stated, “... Adequacy ... Maintain adequacy goal ...” The “Dialysis Prescription” portion of the “Treatment Details Report” section of the medical record stated that, “... Dialysate Temperature ... 36.5 [degrees Celsius] ...” A review of the hemodialysis “Treatment Details Report “ from 12/23/25 through 01/12/16 indicated that the prescribed temperature of 36.5 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 12/26/25, the machine temperature was documented as 37 degrees C. On 12/29/25, the machine temperature was documented as 36.7 degrees C. On 12/31/25, the machine temperature was documented as 36.0 degrees C. On 01/02/26, the machine temperature was documented as 37.0 degrees C. On 01/05/26, the machine temperature was documented as 37.0 degrees C. On 01/09/26, the machine temperature was documented as 36.0 degrees C. On 01/12/26, the machine temperature was documented as 36.0 degrees C. The medical record lacked documented evidence that the physician was aware of the changes in temperature on the above dates. A review of P8’s medical record revealed: A review of P8’s Plan of Care, dated 01/06/26, stated, “... Adequacy ... Maintain adequacy goal ...” The “Dialysis Prescription” portion of the “Treatment Details Report” section of the medical record stated that, “... Dialysate Temperature ... 37.0 [degrees Celsius] ...” A review of the hemodialysis “Treatment Details Report” from 12/22/25 through 01/13/26 indicated that the prescribed temperature of 37.0 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 12/27/25, the machine temperature documented as 36.8 degrees C. On 12/30/25, the machine temperature documented as 36.7 degrees C. On 01/09/26, the machine temperature was documented as 36.0 degrees C. On 01/10/26, the machine temperature was documented as 36.7 degrees C. The medical record lacked documented evidence that the physician was aware of the changes in temperature on the above dates. During an interview at 10:45 AM, S8 stated that the “37 degrees Celsius is the default temperature, and the staff members have to manually change the temperature to match the prescription.” Facility policy titled, “Pre-Intra-Post [before-during-after] Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024, stated, “Policy: ... 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) ... a. The assessment includes the following components: ... iii. Verification of prescription including machine parameters ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ... The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. Prescription components include but are not necessarily limited to: a. Dialyzer make and model, b. Treatment time, c. Target weight, d. UFR [ultrafiltration rate] and Max UFR, e. UF Profiling, f. Blood flow rate, g. Dialysate flow rate, h. All accesses evaluated, i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb[bicarbonate]) and j. Heparinization (intradialytic infusion setting) ...” Facility policy titled, “Testing pH [potential of hydrogen] and conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate,” revised October 2024, stated, “... Temperature: Verify dialysate temperature is set to the prescribing physician’s order and within range set by the dialysis delivery systems manufacturer’s specifications and the dialysate is within acceptable range. Document results in the electronic treatment record or dialysis delivery system log, as applicable.” N.J.A.C. 8:43A-8.4(a)”

“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: 48966 Based on one of one observation of the initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 01/14/26 at 10:00 AM, in Station 2, Staff (S)3, initiated dialysis through a patient’s left upper arm AVG. S3 cleansed the first (arterial) site with one 70% isopropyl alcohol pad in a circular motion followed by one Povidone Iodine prep pad for two seconds, let it dry for one minute, and then cannulated (act of inserting a needle) the arterial needle. This was 28 seconds less than the 30 seconds required by facility policy and one minute less for the drying time required by facility policy. S3 proceeded to clean the second (venous) site with one 70% isopropyl alcohol pad in a circular motion followed by one Povidone Iodine prep pad for four seconds, let it dry for one minute, and then cannulated the venous needle. This was 26 seconds less than the 30 seconds required by facility policy and one minute less for the drying time required by facility policy. During an interview on 01/14/26 at 10:10 AM, S3 was unsure of how long to wipe when using Povidone Iodine and stated the dry time is three to five minutes. A review of S3’s training and education records indicated that an “In-Center Annual Procedural Skills Validation Checklist” that included training in AVF/AVG cannulation was successfully completed on 05/30/25. Facility policy titled, “AV Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose,” revised April 2025, stated, “... Skin Antiseptic Povidone Iodine ... Effective Contact Time 30 seconds Air Drying Time 2 minutes ... Procedure 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry. (For contact and dry time refer to table above). ...” N.J.A.C. 8:43A-24.8(b)”