Fmc Princeton

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 51990 Based on observations, staff interviews and a review of facility documents, it was determined that the facility failed to ensure that the emergency cart and emergency evacuation box contain a comprehensive checklist of all supplies and equipment, and that the evacuation box contains current patient and staff emergency contact information. Findings include: On 05/14/25 at 11:20 AM, in the In-center Treatment Area, the emergency cart and the emergency evacuation box were reviewed and revealed the following: A review of a checklist titled, “Emergency Code Cart and Medication Checklist (Monthly),” dated 04/04/25, indicated the emergency cart had a suction machine and a canister; four Adrenalin vials; and two Solumedrol vials with an expiration date of 07/01/25. The cart did not have a suction machine and a canister and contained only two Adrenalin vials instead of four. The expiration date on the two Solumedrol vials was written as ‘06/01/26’ instead of 07/01/25. The cart also contained a bottle of Nitroglycerin tablets, which were not on the checklist. During an interview on 05/14/25 at 11:35 AM, Staff (S)2 (Biomedical Technician) stated the suction machine was taken off the emergency cart to get cleaned and the canisters were ordered. S6 (Director of Operations) confirmed that the checklist did not list the correct number of Adrenalin vials, the accurate expiration date of the Solumedrol, and the list did not include the bottle of Nitroglycerin tablets. At 11:40 AM, S2 provided the checklist titled, “Emergency Box Contents Log Incenter- Monthly” dated 04/04/25, indicated the following: Two bottles of Heparin 1:1000 unit/ml (milliliter) vials had an expiration date of 10/01/26 and that the box contained safety locks. Upon inspection, the Heparin bottles in the cart had an expiration date of 08/01/26 and the cart did not contain the safety lock. The emergency box did not contain the staff emergency contact information. The patient’s emergency contact information was last printed on 03/05/25. During an interview at 11:55 AM, S7 (Clinical Manager from another facility) confirmed the Heparin vials expiration date and the missing safety locks in the evacuation box. He/she stated that the staff emergency contact information and current patient information should be printed monthly and be in the emergency box. Facility policy titled, “Emergency Medications, Equipment and Supplies,” published 02/03/25 stated, “... Policy... The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available: ... Suction machine, disposable catheter and canisters ... Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates, cleanliness, and proper functioning of all equipment ... An itemized log must e kept indicating the contents and expiration dates and contents ... Emergency Evacuation Box ... An emergency evacuation box must: ... Contain all patients and staff emergency contact information. Be checked monthly or after use for contents, expiration dates and cleanliness ...” N.J.A.C. 8:43A-15.1(a)”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 51040 Based on document review and staff interview, it was determined that the facility failed to ensure that the facility emergency contact list as part of the communication plan is maintained. Findings include: On 05/15/25 at 10:45 AM, during document review of the Emergency Operation Plan, the latest contact list was dated 7/20/20. This was confirmed during interview with Staff (S)2 (Biomedical Technician) at the time of the finding.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 51990 Based on observations, staff interviews and a review of facility documents, it was determined that the facility failed to ensure that clean supplies are separated from contaminated areas in order to avoid possible cross contamination in two of two clean areas observed and that clean clamps are not stored in potentially contaminated areas in one of one dirty area observed. Findings include: During observation on 05/14/25 at 9:52 AM, in Station 6, Staff (S)4 (Registered Nurse [RN]) terminated hemodialysis on Patient (P)7 through a Central Venous Catheter (CVC, a type of access used for hemodialysis). There was a blue pad located on top of the treatment chair side table that had clean supplies used to terminate hemodialysis (HD) treatment. This included gloves, alcohol prep pads, two pre-filled saline syringes, two heparin filled syringes, and a pack of two CVC caps. S4 performed hand hygiene and retrieved a pair of the gloves from the side table and donned (put on) them. He/she scrubbed the hub of the venous (blue) line with a alcohol prep pad and then placed the used alcohol prep pad on top of clean gloves which were directly next to the clean supplies. He/she disconnected the venous line, flushed the CVC with the saline syringe, injected the heparin, then capped the CVC. The used saline and heparin syringes were discarded onto the clean blue pad that touched the clean CVC supplies that were on the side table. S4 proceeded to disconnect the arterial (red) line and used the remainder of the clean supplies to terminate HD. Placing used items on the blue pad touching the clean supplies had a potential to contaminate the clean supplies. During an interview on 05/14/25 at 10:15 AM, S4 stated that he/she should have discarded the used supplies on a separate pad and not on the pad that had the clean supplies. On 5/14/25 at 11:05 AM, in the Medication Preparation Area, a designated clean space, there was a trash can filled with used paper towels, syringe and alcohol wrappers and alcohol prep pads that were under the sink. During an interview 05/14/24 at 11:40 AM, S2 (Director of Operations) stated that the trash can should not be under the sink. 37656 On 05/14/25 at 10:40 AM, during tour of the Treatment Room, there were 11 blue plastic hemostat clamps (used by staff to secure lines during hemodialysis) and three white vascular access clamps (used by staff on the patients with AVF/G (Arteriovenous Fistula/Graft - patients’ access), to apply pressure to the venipuncture site after fistula/graft needle removal), on a blue chuck at the dirty counter next to the centrifuge (a machine used for blood sample preparation prior to sending it to the laboratory). Drying clean clamps next to the centrifuge had a potential for contamination of blood due to splatter. Upon interview at 10:45 AM, S5 (Registered Nurse) stated that the clamps were being dried there and this area is where they usually dry the clamps after soaking them in a bleach solution. Facility policy titled, “Dialysis Precautions,” published 01/04/12, stated, “... Clean versus Dirty Areas ... Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handles or stored ... Dirty Area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. ...” N.J.A.C. 8:43A-24.4(b) N.J.A.C. 8:43A-24.8(b)”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 51990 Based on the review of Hepatitis B (a viral infection that causes inflammation of the liver and can lead to serious liver damage) laboratory (lab) results, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that Hepatitis B Core Antibody (HBcAb) and Hepatitis B Surface Antibody (HBsAb) testing is completed upon patient’s admission and that monthly HBsAg (Hepatitis B surface antigen) testing is completed for 7 of 69 patients (P3, P6, P10, P12, P13, P15, and P20) in accordance with facility policy and Centers for Disease Control and Prevention (CDC) recommendations. Findings include: Reference: The CDC Morbidity and Mortality Weekly Report (MMWR), dated 04/27/01, states, “Prevention and Management of HBV Infection ... Preventing HBV (Hepatitis B Virus) transmission among chronic hemodialysis patients requires a) infection control precautions recommended for all hemodialysis patients b) routine serologic testing for markers of HBV infection and prompt review of results ... Immunogenicity defined as greater or equal to 10 milliliter (ml) - International Units (IU) in 90 percent to 95 percent of adults with normal immune status. The need for routine follow-up testing and vaccination, or isolation is based on patients’ serologic status ... HBV susceptible patients ... test susceptible patients monthly for HBsAg, including those who have not yet received Hepatitis B vaccine, b) are in the process of being vaccinated or c) have not adequately responded to vaccination. According to the table, Schedule for Routine testing for Hepatitis B Virus (HBV) ... Infections: HBV - susceptible including non-responders to vaccine - Monthly testing for HBsAg ...” A review of a facility document titled “Lab Results/ Medication Administration Summary” from May 2024 to May 2025 revealed the following: The following patients did not have evidence of testing of HBcAb on admission: P3, P10, and P13. The following patients did not have HBsAb testing on admission: P10, P12, P13. The following susceptible patients (patients with Hepatitis B Surface Antibody (HBsAb) less than 10mlU/ml), did not have monthly testing: P6 did not have HbsAg testing in April 2025 P15 did not have HBsAg testing in April 2025 P20 did not have HbsAg testing in July 2024 On 05/16/25 at 10:25 AM, a review of the above findings was completed with Staff (S)7 (Clinical Manager at another facility), who stated that the above labs had no results and were probably missed. Facility policy titled, “Patient Hepatitis B Testing Requirements,” published 02/03/25, stated, “... New Permanent Admission Hepatitis B Testing ... HBV status should be known prior to admission for all new patients. ... If Hepatitis B surface antibody Anti-HBs) and Hepatitis B core antibody “total” (anti- HBc “total”) are not available prior to admission, obtain a physician order to immediately draw blood specimens and submit for testing. Anti-HBs and anti-HBc “total” results must be available within 7 days of admission... HBV Patient Testing ... Hepatitis B Laboratory testing is required for all patients based upon immunity status. ... Patient Status ... Susceptible ... HBsAg: Negative ... Anti-HBs: less than 10 mlU/ml ... Anti-HBc “total”: Positive ... HBsAg ... Monthly Testing ...” N.J.A.C. 8:43A-24.4(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: 37656 Based on one of one observation of the initiation of hemodialysis through 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 catheter exit site care is performed in accordance with facility procedure (Patient (P)2). Findings include: On 05/14/25 at 11:22 AM, Staff (S)5 (Registered Nurse), initiated dialysis on P2 in Station 14. S5 cleaned the catheter site for 10 seconds with a 2% Chlorhexidine swab and allowed it to dry for 45 seconds. This was not in accordance with facility procedure. Upon interview at 11:40 AM, S5 stated the exit site should be swabbed for 15 seconds. On 05/16/25, a review of S5’s personnel file indicated that he/she received education on initiation of treatment using a CVC and was signed off by the preceptor on 03/20/24. The personnel record lacked evidence of education for 2025. Facility procedure titled, “Changing the Catheter Dressing Procedure,” published 05/02/25, stated, “... Cleaning the Site ... 1 Perform hand hygiene and don [put on] clean gloves. 2 ... 2% Chlorhexidine ... : Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area 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. ...” 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: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the building is free from defects to ensure safety of the patients, the staff, and the public. Findings include: On 05/15/25 at 11:47 AM, during a tour with Staff (S)2 (Biomedical Technician), there were three ceiling tiles missing inside the Janitor’s Closet, which has a potential for escape of smoke in the event of fire. This finding was confirmed at the time of observation by S2.”

“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: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that: 1) the restroom sprinkler head escutcheon plate is in place; 2) the emergency generator has a remote emergency shut off switch; and 3) oxygen cylinders in the back hallway are properly secured and labeled. Findings include: 1. On 05/15/25 at 10:15 AM, during a tour with Staff (S)2 (Biomedical Technician), it was observed in the restroom off the waiting area that a sprinkler head escutcheon plate was missing. National Fire Protection Association (NFPA) Standard for Installation of Sprinkler Systems 30, 2022 Edition,7.2.6.2*, stated, “Escutcheons used with recessed, flush-type, or concealed sprinklers shall be part of a listed sprinkler assembly.” 2. On 05/15/25 at 10:35 AM, during a tour with S2, it was observed that the emergency generator did not have a remote shut down switch as required. NFPA Electrical Code 70 2020 Edition, stated, “Generators with greater than 15 kW [kilowatt] rating shall be provided with an additional requirement to shut down the prime mover. This additional shutdown means shall be located outside the equipment room or generator enclosure and shall also meet the requirements of 445.18(B)(1) and (B)(2).” 3. On 05/15/25 at 12:45 PM, during a tour with S2, in the back hallway outcove there were four unsecured, unlabeled type E oxygen cylinders that were standing upright next to the red cabinet. Cylinders must be labeled full or empty when stored. This was confirmed by S2 at the time of discovery. NFPA Healthcare Facilities Code 99 2012 Edition, 11.6.2.3(11), stated, “Freestanding cylinders shall be properly chained or supported in a proper cylinder stand or cart.””

“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: 51990 Based on one of one observation of the termination of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview and a review of facility documents, it was determined that the facility failed to ensure patient’s rights to privacy. Findings include: On 05/14/25 at 09:52 AM in Station 6, Staff (S)4 (Registered Nurse) terminated hemodialysis on Patient (P)7 through a right chest wall CVC. During the procedure, the curtains were not fully closed in front of the station leaving an approximate two feet opening. P7’s chest was visible from the nurse’s station and to patients that passed/walked in front of the station. During an interview 05/14/25 at 10:13 AM, S4 confirmed that the curtains should be fully closed around the patient’s station when terminating hemodialysis. Facility policy titled, “Patient Rights and Responsibilities,” published 04/04/12, stated, “... Policy: Privacy Rights ... Patients have the right to privacy during activities that may require the exposure of private body parts while in the dialysis facility. Privacy screens or curtains may be used to provide privacy ...” N.J.A.C. 8:43A-16.2(a)10”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 37656 Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that the interdisciplinary team (IDT) completes a comprehensive interdisciplinary assessment (CIA) prior to developing a patient plan of care (POC) for two of two hemodialysis patients reviewed (Patients [P]3 and P4). Findings include: A review of P3’s medical record revealed the following: P3’s POC indicated that he/she was deemed unstable due frequent hospitalizations in February, March, and April 2025. The medical record lacked evidence of a comprehensive assessment from the RN (Registered Nurse) in February 2025 and from the SW (Social Worker) in March 2025. Upon interview on 05/16/25 at 10:50 AM, Staff (S)1 (Clinic Manager) confirmed that there was no comprehensive assessments in the above months from the RN and SW. 51990 A review of P4’s medical record revealed the following: The POC dated 11/01/24 lacked evidence of a completed CIA by the Physician (MD), the SW, and the Registered Dietitian (RD). On 05/15/25 at 10:45 AM, S7 (Clinical Manager from another facility) confirmed that the MD, SW and RD did not complete a CIA for the patient’s POC in November 2024. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan Of Care,” published 07/03/23, stated, “... General Policy for Patient Assessment and Plan of Care ... The patient’s Plan of Care will be guided and developed based on the findings identified in the Comprehensive Interdisciplinary Assessment ... The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, ... a registered nurse, the patient’s attending physician ... The Comprehensive Assessment ... must be completed electronically in the patient’s medical record. ... Role of the Interdisciplinary team: CIA The physician is responsible for ensuring the completion of the medical portion of the CIA and reviewing the completed interdisciplinary CIA and Plan of Care. ... Each member of the IDT is responsible for completing their part of the comprehensive interdisciplinary assessment. ...” N.J.A.C. 8:43A-24.13(b)”

“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: 50912 Based on two of seven medical records reviewed (Patient [P]2 and P5), staff interview, and review of facility documents, it was determined that the facility failed to ensure that post (after)hemodialysis nursing assessments are completed according to facility policy. Findings include: A review of P2’s plan of care, dated 04/25/25, stated, “Area of Focus BP [blood pressure] and Fluid Management Open Goal Achieve BP Control as specified by the patient’s physician ... Intervention (s): ... Educate patient/family/caregiver on fluid control ... In progress ... Continue to monitor patient ... Open ... Monitor fluid gains ...” A review of the “Treatment Sheets for Facility” from 04/25/25 through 05/14/25 in P2’s medical record revealed the following: On 05/07/25 at 11:23 AM, the pre-treatment (before treatment) “Nursing Evaluation” indicated “bilateral [affecting both sides] ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:10 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/09/25 at 11:25 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, one plus: two mm or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 2:52 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/12/25 at 11:07 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, one plus: two mm or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 4:25 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. A review of P5’s plan of care, dated 03/25/25, stated, “Area of Focus BP and Fluid Management Goal Achieve BP Control: Open ... Achieve BP Control as specified by the patient’s physician ... Open ... Educate patient/family/caregiver on fluid control ... Change patients’ dry weight algorithm ... In progress ...” A review of the “Treatment Sheets for Facility” from 04/25/25 through 05/14/25 in P5’s medical record revealed the following: On 05/02/25 at 11:21 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:49 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/05/25 at 11:40 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:03 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/07/25 at 11:01 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 2:40 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/09/25 at 11:30 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:12 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 05/12/25 at 11:21 AM, the pre-treatment “Nursing Evaluation” indicated “bilateral ankle edema, bilateral lower leg, plus one: two mm (millimeters) or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 2:59 PM lacked documented evidence of a re-assessment of the bilateral ankle edema. During an interview on 05/15/25 at 11:28 PM, Staff (S)1 (Clinical Manager) reviewed the above findings and confirmed that the post hemodialysis re-assessment of edema was not documented on the above-mentioned hemodialysis flowsheets. S1 stated that staff nurses should reassess and document post-treatment edema if abnormal findings were found pre-treatment. Facility policy and procedure titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “... Purpose ... provide guidance to [facility name] direct patient care staff on assessment and monitoring patients before, during and after treatment ... Edema (As indicated by patient condition): Assess the patient for edema ... Location: foot, ankle, lower leg ... Right, Left or Bilateral ... Severity ... Post Treatment ... Follow the steps below for obtaining post-treatment assessment data ... Edema ... The registered nurse will assess/re-assess post treatment as indicated ...” N.J.A.C. 8:43A-24.4(a)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 50912 Based on one of seven medical records reviewed (Patient [P]2) and staff interview, it was determined that the facility failed to ensure that patients are seen and evaluated monthly by the attending physician/nephrologist and progress notes are entered in the medical record monthly. Findings include: A review of P2’s medical record lacked documented evidence of monthly physician’s progress notes for December 2024, February 2025 and March 2025. On 05/15/25 at 11:45 AM, the above findings were reviewed with Staff (S)1 (Clinical Manager). S1 confirmed that no physician progress notes were entered in the patient’s electronic medical record for the above-mentioned months for P2. S1 stated that P2’s physician either sees his/her patients in the office for monthly visits or sees his/her patients in the facility. N.J.A.C 8:43A-24.13(d)”

“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: 37656 Based on observation, staff interviews, medical records review, and review of facility documents, it was determined the facility Medical Director failed to ensure that: 1) patients are assessed for pain pre (before) and post (after) treatment in two of four hemodialysis medical records reviewed (Patient [P]1 and P9); 2) the medical record contains documentation that the patient was educated on the effects of a shortened treatment for three of five shortened treatments reviewed for P1; and 3) sample medications are not available for patient use in one of one medication storage area in accordance with facility policy. Findings include: 1. The Treatment Flowsheets dated 04/24/25, 04/28/25, 04/29/25, and 05/13/25 for P9 lacked evidence of a pain assessment before and after dialysis treatments. On 05/16/25 at 10:20 AM, Staff (S)1 (Clinic Manager) confirmed the above findings. The Treatment Flowsheets dated 04/26/25, 04/29/25, and 05/13/25 for P1 lacked evidence of a pain assessment before and after dialysis treatments. On 05/1/525 at 12:37 PM, S1 confirmed the above findings. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, stated, “... Pre-Treatment ... Step 1 ... State of well-being/Reported by the patient/General observation Evaluate: Statement of well-being or pain or discomfort and location ... post-treatment ... State of well-being/Reported by the patient/General observation Ask the patient if he or she has anything more to report or any additional observations prior to discharge ...” Facility policy titled, “Pain Assessment and Management,” published: 07/03/2023, stated, “... Policy All patients will be assessed for pain using a 0-10 scale for adults or a 0-10 Wong-Baker faces pain tool for children, elderly or cognitive impaired, and documented in the patient’s electronic medical record ... “ N.J.A.C. 8:43A-16.2(a)14 39228 2. A review of the Treatment Flowsheets for P1 revealed the following: On 04/26/25, the “Treatment Status” section of the flowsheet stated, “... Late Arrival with Inability to Extend Treatment ...” The “Hemodialysis Orders” section of the treatment flowsheet stated, “... Scheduled Hours: 03:30 [three hours, 30 minutes]...” P1’s initiation of hemodialysis began at 11:23 AM and treatment was terminated at 2:10 PM, 43 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that the patient was educated on the effects of a shortened treatment. On 05/06/25, the “Treatment Status” section of the flowsheet stated, “... Unexpected, Patient Request ... Against Medical Advice ...” The “Hemodialysis Orders” section of the treatment flowsheet stated, “... Scheduled Hours: 03:30 ...” P1’s initiation of hemodialysis began at 10:53 AM and treatment was terminated at 1:04 PM, one hour and 19 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that the patient was educated on the effects of a shortened treatment. On 05/13/25, the “Treatment Status” section of the flowsheet stated, “... Late Arrival with Inability to Extend Treatment ...” The “Hemodialysis Orders” section of the treatment flowsheet stated, “... Scheduled Hours: 03:30 ...” P1’s initiation of hemodialysis began at 11:20 AM and treatment was terminated at 1:26 PM, one hour and 24 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that the patient was educated on the effects of a shortened treatment. On 05/16/25 at 9:00 AM, S1 stated that the Registered Nurse should be documenting that the education of the effects of a shortened treatment was provided to the patient on the flowsheet and confirmed that the education was missing on the above treatment dates. Facility policy titled, “Early Termination or Arriving Late for Treatment,” published 11/07/22, stated, “... Early Termination ... If a patient requests to leave treatment early: ... The RN ... must document ... and reinforce the consequences of not receiving the entire prescribed treatment. ... Arriving Late ... Counsel and educate the patient on effects of shortened treatment. ... Documentation ... All discussion with the patient ... must be documented in the patient’s medical record. ...” N.J.A.C. 8:43A-24.4(a) 51990 3. On 05/14/25 at 11:05 AM, in the Medication Preparation Area, there was an unopened bottle of Velphoro (a medication used to control phosphorus blood level) tablets with a note that stated, “Samples from Dr. (Doctor) [physician’s name] office” located in a locked supply cabinet that was available for patient use. During an interview on 05/14/25 at 11:00 AM, Staff (S)4 (Registered Nurse) explained that Velphora is ordered by the physician. However, when the patient could not afford the medication, then the sample of Velphora tablets were supplied to the patient. S4 confirmed the Velphora was from the physician’s office. During an interview on 05/15/25 at 9:15 AM, S15 (Charge Nurse) stated, “we do not give sample medication to patients.” S6 (Director of Operations) stated, “I didn’t know we kept samples here.” Facility policy titled, “Medication Preparation and Administration,” published 2/6/23, stated, “... Controlled Substances and Sample Medications ... No sample medication will be kept in out distributed from the outpatient dialysis unit ...” N.J.A.C. 8:43A-9.3(b)(9)”