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“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: 51227 Based on one of two observations for the cleaning and disinfection of a dialysis station, staff interview, and review of facility documents, it was determined that the facility failed to ensure that visible blood is cleaned and disinfected according to facility policy to prevent cross contamination. Findings include: On 2/19/25 at 9:30 AM, in Station 18, Staff (S) 9, a Patient Care Technician (PCT), removed a fistula needle from a patient’s left arm arteriovenous fistula (AVF, a type of access used for hemodialysis). While holding pressure to the AVF with gauze, S9 placed a plastic pressure clamp on the removal site. The patient’s access immediately bled down the inside of the hemodialysis treatment chair. After stabilizing, the patient was discharged at 9:40 AM. At 9:45 AM, in Station 18, S9 used a 1:100 bleach-soaked cloth (one part bleach to 100 parts water) to clean a baseball sized blood spill from the inside of the left arm of the hemodialysis treatment chair. After wiping away the visible blood, S9 did not perform a second cleaning. There was no visible blood left on the hemodialysis chair. This was not in accordance with facility policy which required staff to acquire a new cloth and perform a second cleaning of the surface. At 10:15 AM, S9 confirmed blood was present on the hemodialysis treatment chair and stated the spill was less than 10ml (milliliters). S9 then confirmed he/she did not perform a second cleaning of the surface and stated he/she was unsure if policy required that a second cleaning be performed after wiping the visible blood with a 1:100 bleach soaked cloth. Facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 9/5/13, stated, “... Work surface cleaning and disinfection with visible blood <10ml and other potentially infectious material using bleach solutions: Use 1:100 bleach solution to clean surfaces with visible blood. After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface. ...” 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: 48966 Based on two of two observations for the care of 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 that: 1) the CVC threads and end of the hubs are cleaned during the termination of hemodialysis and; 2) the CVC limbs are cleaned during the initiation of hemodialysis according to facility policy to prevent catheter related infections. Findings include: 1. On 2/19/25 at 9:51 AM in Station 16, Staff (S) 15, a Registered Nurse (RN), discontinued hemodialysis treatment with a CVC on a patient. S15 disconnected the red bloodline from the CVC, scrubbed the end of the hub and the threads with an alcohol preparation (prep) pad for eight seconds. This was two seconds less than the 10 second minimum required by facility policy. S15 then proceeded to disconnect the blue bloodline from the CVC, scrubbed the end of the hub and threads with a alcohol prep pad for seven seconds. This was three seconds than less required by facility policy. During an interview at 9:56 AM, S15 stated the catheter ends and threads need to be scrubbed for 30 seconds. On 2/21/25, S15’s “Coaching Report” was reviewed and indicated that a skills validation checklist including discontinuation of dialysis with a CVC was completed 4/17/24. Facility policy titled, “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer,” published 11/04/2024, stated, “... Termination: Disinfection of Catheter and Disconnecting the Patient ... Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other appropriate antiseptic product such as chlorhexidine or povidone ... for 10-15 seconds anytime caps are removed, or bloodlines are disconnected (i.e. End of treatment or treatment interruption) ... 6. Using a sterile alcohol pad, (or other appropriate antiseptic product such as chlorhexidine or povidone ... scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood) ... (This step should take 10-15 seconds) ...” N.J.A.C. 8:43A-24.8(b) 51227 2. On 2/19/25 at 9:50 AM, in Station 4, S6, a Registered Nurse (RN), initiated hemodialysis through a CVC. After cleansing of the exit site, S6 scrubbed the end of the hubs with a alcohol preparation (prep) pad for 15 seconds. S6 did not move from the hub toward the body of the catheter (limbs) with the alcohol prep pad in accordance with facility policy. During an interview at 10:25 AM, S6 stated he/she only has to clean the hub for 15 seconds, and does not have to clean the limbs of the catheter. During an interview on 2/20/25 at 10:21 AM, S2, the Clinic Manager stated that the body mentioned in the CVC policy refers to cleaning of the limbs. S2 also stated that the RN’s should clean the limbs as well as the hubs during the treatment initiation through a CVC. Facility policy titled, “Initiation of Treatment Using A Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” published 5/6/24, stated, “... Preparing the catheter: Disinfection of the catheter connections, heparin removal, flushing the catheter and heparin administration ... 4. Using the same sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) applying gentle friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. (Steps 3 and 4 should take 10-15 seconds.) ...” N.J.A.C. 8:43A-24.8(b)”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48966 Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that: 1) the acid mixing equipment is properly maintained and; 2) the dialysis facility is maintained to ensure the safety of the patients, the staff and the public. Findings include: 1. On 2/19/25 at 11:31 AM, during a tour of the Water and Acid Mixing Room in the presence of Staff (S) 7, the Bio-Medical (Bio Med) Technician, the following was observed: The acid mixing unit contained white precipitate on both the top and bottom of the unit along with white precipitate encrusted around the filter housing. White precipitate was observed on the wall behind the acid mixer. During an interview at 12:01 PM, S7 confirmed the white precipitate was present on the top and bottom of the acid mixing unit and on the filter housing. S7 stated the staff who make the acid were responsible to make sure the acid mixer was cleaned. During an interview on 2/20/25, S4, the Area Technical Manager, confirmed that the staff were responsible to clean the acid mixer. S4 provided the “End of Day Mixers, Storage Tanks and Wall boxes Cleanup with Wall box Valve Check” checklist guideline staff use, which included the “exterior surface of the Acid Mixer to be wiped down.” S4 stated the staff were required to sign off upon completion. N.J.A.C. 8:43A -17.4(a)15 51040 2. During a tour of the facility on 2/20/25 at 9:46 AM, with S7, the Bio Med Technician, the following was observed: The fresh air vent screen/register within the Reverse Osmosis Room was covered with a grayish brown material and appeared grimy. The computer cable box outlet cover in the Social Workers Office was cracked, unsecured, and presented a sharp edge that could cause an injury. The cubicle curtain in Station 4 was horizontally too short to properly allow the patient privacy from others. The hinge on the door to the pipe chase wall in Station 6 was unsecured at the upper left hand hinge enabling the unsecured cabinet door to become a hazard if it were opened. The exit door from the treatment floor to the parking lot did not positive latch when opened and returned to the closed position. This allows pest and vermin to enter the building and allows unauthorized access to the treatment floor. During an interview at 12:45 PM, S7 confirmed the above findings. N.J.A.C. 8:43A-16.2(a)10 N.J.A.C. 8:43A-17.3(j) N.J.A.C. 8:43A-17.3(l) N.J.A.C. 8:43A-17.4(a)13 N.J.A.C. 8:43A-17.4(a)15”

“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: 48966 Based on observations, staff interviews and review of manufacturer’s instructions for use (MIFU) for Minncare HD Residual Test Strips, it was determined that the facility failed to ensure that expired Minncare HD Residual Test Strips are not available for use on the hemodialysis treatment floor for one of one bottle. Findings include: On 2/19/25 at 10:20 AM during a tour of the hemodialysis treatment floor, an open bottle of Minncare HD Residual Test Strips was observed at Dirty Sink 8, located across from Station 17. The Minncare HD Residual Test Strips bottle had a printed expiration date of 9/22/24. During an interview at 10:58 AM, Staff (S) 9 and S10, Patient Care Technicians (PCTs), confirmed the Minncare HD Residual Test Strips bottle was beyond the expiration date. S9 and S10 stated that the morning after monthly water disinfection of the water treatment system and pipes was completed, the strips would be used to check for residual Minncare (a disinfectant) at each machine by the assigned opening staff member. S9 and S10 did not know when the strips were last used. During an interview at 11:05 AM, S2, a PCT, confirmed that the opening staff used Minncare test strips monthly after the disinfection of the water system and pipes. During an interview at 11:25 AM, S12, a PCT, stated he/she was the opening staff on 2/19/25. S12 confirmed that the Minncare HD Residual Test Strips bottle that were available on the treatment floor were beyond the expiration date. S12 explained that once a month S7, the Biomedical Technician, performed a water disinfection with Minncare and the next morning all machines would be tested for residual Minncare with the Minncare HD Residual test strips. S12 was not sure when the strips were last used and confirmed no other Minncare HD Residual Test Strips bottle was available for use on the hemodialysis treatment floor. S12 explained S7 leaves a note and a new Minncare HD Residual Test Strip bottle every month following the disinfection of the water system. During an interview at 1:18 PM, S7, confirmed the opening staff should check for residual Minncare at each machine the morning following the monthly water disinfection. S7 stated he/she leaves a note at the time clock, nurses station, and in the water room to inform the opening staff that water disinfection has been completed and to instruct the staff member to check for residual Minncare using the described test strips. Review of the MIFU for the Minncare HD Residual Test Strips stated, “... Test Strips may be used up to and including the last day of the month indicated by the expiration printed on the container ...” N.J.A.C. 8:43A-24.11(c)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 51227 Based on two of two observations, staff interview, and review of facility policy, it was determined that the facility failed to ensure each patient’s right to privacy. Findings include On 2/19/25 at 9:50 AM, in Station 4, Staff (S) 6, the Charge Nurse, initiated hemodialysis through a patient’s right chest Central Venous Catheter (CVC, a type of dialysis access). The patient was wearing a T-shirt which was fully opened down the middle during the procedure exposing his/her chest. The curtains were fully extended on both the left and right sides, however, the curtain was not fully extended in the front of the station, leaving a two-foot opening. The patient’s exposed chest was visible to patients and staff walking past Station 4. Staff members were observed walking past Station 4 during the procedure. During an interview at 10:25 AM, S6 stated, “these are new curtains, I don’t know why it doesn’t cover the whole station, but it should.” At 10:50 AM, in Station 18, S6 initiated hemodialysis through a left thigh graft located on patient’s left leg. The patients left thigh was exposed during the procedure. The curtains were drawn to left of the patient, and in front of the patient. However, the privacy curtain to the right of the patient was absent. In the adjacent Station 19, directly to the right, S11, a Patient Care Technician (PCT) was observed setting up the hemodialysis machine. S11 was able to see the patient during the procedure while setting up Station 19. The open curtain also caused the patient to be exposed during the procedure to the patients who were present in Stations 2, 3, and 4. During an interview at 11:00 AM, S11 stated, “the curtain between Station 18 and 19 fell last night and I believe someone put a work order in but I’m not sure.” Facility policy titled, “FMCNA Patient Rights,” published 6/28/18, stated, “... Privacy and confidentiality ... the right to privacy during activities that may require the exposure of body parts while in the dialysis facility. Privacy screens, curtains, or blankets that do not cover your access, may be used to provide privacy ...” N.J.A.C. 8:43A-16.2(a)10”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 49828 Based on medical record review, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that: 1) post hemodialysis nursing assessments are completed according to facility policy for two of seven medical records reviewed (Patient (P) 6, and P7) and; 2) the patient plan of care (POC) for managing the patient’s volume status for one of seven medical records reviewed (P7), is implemented. Findings include: 1. A review of P6’s plan of care, dated 12/23/24, stated, “Area of Focus: Hospitalization within last 90 days ... Intervention (s): ... Monitor parameters that may lead to hospitalization (albumin, fluid overload, vascular access, anemia, and medications ... In Progress ... Area of Focus: BP [blood pressure] and Fluid Management ... Achieve BP Control as specified by the patient’s physician ...” A review of the “Treatment Sheet For Facility” from 1/30/25 through 2/18/25 in P6’s medical record revealed the following: On 2/4/25, the pre-treatment (before treatment) “Nursing Evaluation” section stated, “... Ankle [Edema] - Severity, 1+ [one plus]:2mm [millimeter, indent] disappears rapidly ... Notes: ... BLLE chrnic [Bilateral Lower Extremity Edema, chronic] ...” The post treatment (after treatment) “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a Registered Nurse (RN). On 2/6/25, 2/13/25, and 2/18/25, the pre-treatment “Nursing Evaluation” section stated, “... Ankle - Severity, 1+:2mm disappears rapidly, Lower Leg [edema] - Severity, 1+:2mm disappears rapidly, ... Notes: ... BLLE chronic ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. 51227 A review of P7’s medical record revealed the following: A Plan of Care, dated 10/28/24, stated “Area of Focus BP and Fluid Management ... Monitor fluid gains and discuss high weight gains with patient ...” A review of P7’s hemodialysis “Treatment Sheets For Facility” from 1/23/25 through 2/11/25, revealed the following: During hemodialysis treatments on 1/25/25 and 2/6/25, the pre-treatment “Nursing Evaluation” section stated, “... Bilateral lower leg/ankle edema, 1+:2 mm or less, disappears rapidly ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. During hemodialysis treatments on 1/28/25 and 2/4/25, the pre-treatment “Nursing Evaluation” section stated, “... Bilateral lower leg/ankle edema, 2+:2-4 mm indent, disappears in 10-15 seconds ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 2/20/25 at 1:20 PM, the above Treatment Sheets for P6, and P7 were reviewed with Staff (S) 2, the Clinic Manager. S2 stated that the RN is required to document a re-assessment post treatment if present pre-treatment. Additionally, S3 confirmed the above treatment sheets for P6 and P7 were missing re-assessments of edema. Facility policy titled, “Patient Assessment and Monitoring,” published 5/01/23, stated, “... Pre-Treatment ... 2. During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed: ... Edema (As indicated by patient condition) Assess the patient for edema: [bullet] Location: foot, ankle, lower leg and sacrum. [bullet] Right, Left or Bilateral [bullet] Severity (None, 1+, 2+,3+ or 4+) 3 Document findings and interventions in the medical record. ... Post-Treatment ... 1 [Step] ... Edema The registered nurse will assess/re-assess post treatment as indicated. 2 [Step] Document findings in the patient’s record. ...” N.J.A.C. 8:43A-24.4(a) 2. A review of Medical Record (MR) 7 revealed a physician’s order for hemodialysis treatment three times per week and included a dry weight (DW) of 114.5 kilograms (kg). A Comprehensive Interdisciplinary Assessment, which included the Plan of Care, dated 10/28/24, stated, “... Area of Focus Body Weight EDW [estimated dry weight] 114.5 kg ... Goal: Patient will maintain/achieve desired body weight. Less than 5% unintended loss of dry weight in 1 month. Less than 7% unintended dry body weight loss in 3 months ...” A review of P7’s hemodialysis “Treatment Sheets For Facility” from 1/23/25 through 2/11/25, revealed the following: On 1/23/25, P7’s pre-treatment weight was 122.4 kg, and the post-treatment weight was 118.4 kg. The post-treatment weight was 3.9 kg greater than the EDW. On 1/25/25, P7’s pre-treatment weight was 120.9 kg, and the post-treatment weight was 117.1 kg. The post-treatment weight was 2.6 kg greater than the EDW. On 1/28/25, P7’s pre-treatment weight was 122.6 kg, and the post-treatment weight was 119.1 kg. The post-treatment weight was 4.6 kg greater than the EDW. On 1/29/25, P7’s pre-treatment weight was 121.2 kg, and the post-treatment weight was 118.3 kg. The post-treatment weight was 3.8 kg greater than the EDW. On 1/30/25, P7’s pre-treatment weight was 121.9 kg, and the post-treatment weight was 117.9 kg. The post-treatment weight was 3.4 kg greater than the EDW. On 2/1/25, P7’s pre-treatment weight was 121.1 kg, and the post-treatment weight was 118.0 kg. The post-treatment weight was 3.5 kg greater than the EDW. On 2/4/25, P7’s pre-treatment weight was 124.2 kg, and the post-treatment weight was 119.7 kg. The post-treatment weight was 5.2 kg greater than the EDW. On 2/6/25, P7’s pre-treatment weight was 122.6 kg, and the post-treatment weight was 118.7 kg. The post-treatment weight was 4.2 kg greater than the EDW. On 2/8/25, P7’s pre-treatment weight was 122.7 kg, and the post-treatment weight was 119.5 kg. The post-treatment weight was 5.0 kg greater than the EDW. On 2/11/25, P7’s pre-treatment weight was 124.2 kg, and the post-treatment weight was 121.1 kg. The post-treatment weight was 6.6 kg greater than the EDW. Additionally, the hemodialysis “Treatment Sheets For Facility” for P7 from 1/23/25 through 2/11/25, lacked documented evidence that the Medical Doctor (MD) or Advanced Practice Nurse (APN) were notified that P7 was not meeting his/her ordered EDW. During an interview on 2/20/24 at 1:15 PM, S2, the Clinic Manager, confirmed P7 was above the EDW for nine out of the nine treatment dates. S2 stated that P7 had come in for extra treatments and experienced cramping, which indicated the patient was unable to have more fluid removed to meet the ordered EDW. S2 stated he/she would expect the RN to notify the MD or APN to adjust the EDW. Additionally, S2 confirmed the MR lacked documented evidence the MD or APN was informed and stated he/she would follow up on the finding. Facility policy titled, “Volume Management in ESRD Patients on Hemodialysis,” published 9/7/21, stated, “... Fluid Interventions ... Overestimation of EDW leads to chronic fluid overload, and underestimation of EDW increases the risk of dialytic hypotension. Therefore, the clinical care team must be diligent in the determination of EDW and routinely assess and adjust this metric ...” Facility policy titled, “Nursing Supervision and Delegation,” published 11/6/23, stated, “... Guidelines for PCT/LPN/LVN/RN [patient care technician/licensed practical nurse/licensed vocational nurse/registered nurse]: When to Refer a Patient to the Team Leader/Charge Nurse for Further Assessment ... Fluid Status Any weight gains greater than 4kg pre-treatment. Any swelling in the facial area, and lower extremity edema. Any post treatment weight with a variance from the estimated dry weight of 1.0 kg. Any weight loss or no change in weight from a patient’s last treatment post weight ...” N.J.A.C. 8:43A-24.13(b)”

“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: 51227 Based on two of three observations of medication administration, staff interview, and review of facility policy, it was determined that the facility failed to ensure that the policy for the administration of heparin is implemented. Findings include: On 2/19/25 at 10:05 AM, in Station 3, Staff (S) 9, a Patient Care Technician (PCT) initiated hemodialysis through an Arteriovenous Graft (AVG, a type of vascular access used for hemodialysis). The following was observed: S6, a Registered Nurse (RN), attached a pre-filled heparin syringe to the venous access line and slowly injected the heparin with a back-and-forth motion. S9 then initiated the dialysis treatment after 10 seconds following the administration of heparin. This was two minutes and 50 seconds less than required by facility policy. During an interview at 10:15 AM, S9 stated that after the RN administers heparin, the staff is supposed to wait three to five minutes before initiating the hemodialysis treatment. On 2/19/25 at 10:30 AM, in Station 1, S10, a PCT, initiated hemodialysis through an Arteriovenous Fistula (AVF, a type of vascular access used for hemodialysis). The following was observed: S6, a RN attached a pre-filled heparin syringe to the venous access line and slowly injected the heparin with a back-and-forth motion. S10 then initiated the dialysis treatment after two minutes following the administration of heparin. This was one minute less than required by facility policy. During an interview at 10:45 AM, S10 stated that after the RN administers the heparin, staff is suppose to wait three to five minutes before initiating the hemodialysis treatment. Facility policy titled, “Heparin Bolus Administration,” published 11/1/21 stated, “... Administering Heparin ... 5. Allow heparin to circulate within the bloodstream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit ...” N.J.A.C. 8:43A-9.3(a)”