Alaris Health at Essex

“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: 50912 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that one of one emergency evacuation box contains all necessary supplies and current patient treatment information, and that expired items are not available for use. Findings include: On 12/02/25, in the Medication Preparation Area, an emergency evacuation box was reviewed and revealed the following: At 11:10 AM, a checklist titled, “Emergency Evacuation Checklist,” in the Evacuation Binder was signed off for completeness of contents by the Director of Nursing (DON) dated 12/01/25. The checklist indicated that 18, one-liter Normal Saline (NSS) bags and 18, 15g (gauge) hemodialysis fistula needles were included in the emergency evacuation box, however, the box did not contain the items. The checklist also indicated that the Emergency Evacuation Box Binder contained the updated monthly Patient Dialysis Orders for December, however, when the binder was checked, the “Patient Summary” that contained all patients’ most recent dialysis treatment information, had a printing date of 06/06/25 for all 51 patients. Upon further review, the Emergency Evacuation Box also contained the following expired items: five Catheter Kits (package containing hemodialysis supplies), four expired on 08/25/25 and one expired 09/25/25. At 11:20 AM, Staff (S)4 confirmed that the NSS bags and hemodialysis fistula needles were not contained in the emergency box, the Patient Summary printed containing treatment information for the patients was from six months ago in June 2025 and that there were five expired Catheter Kits in the emergency box. S4 stated that he/she is responsible for checking the emergency box monthly and should have disposed of the expired items, printed the latest patient treatment information for the month of December and replaced the missing items. Facility policy titled, “Emergency Preparedness,” revision date 03/31/2017 stated, “... Policy ... the content of the evacuation kit will include, at minimum, enough supplies to provide care to a full shift of patients ... Each kit should contain (a) Copy of each patient’s treatment orders and medication list. On a monthly basis patient orders and medications list should be updated. ... The Evacuation kit will be reviewed on a monthly basis for missing items or expired. Supplies that are missing or expired must be replaced immediately. ...” N.J.A.C. 8:43A-15.1(a)”

“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: 50912 Based on one of two observations of Central Venous Catheter (CVC, a type of access used for hemodialysis) exit site cleaning, staff interview, and review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed during exit site cleaning of a CVC to prevent cross contamination in accordance with facility policy. Findings include: On 12/02/25 at 9:50 AM in Station 1, Staff (S)8 was observed cleaning the CVC exit site of a patient. S8 removed the old, existing dressing of the CVC and then removed his/her gloves. S8 donned (put on) a new pair of gloves, without the benefit of performing hand hygiene, and cleaned the CVC exit site in a back-and-forth motion for 48 seconds with a 2% Chlorhexidine swab. S8 then removed his/her gloves and without the benefit of performing hand hygiene first, donned a new pair of gloves before he/she applied a new dressing onto the exit site. S8 proceeded to remove his/her gloves and without the benefit of performing hand hygiene first, donned a new pair of gloves before he/she removed the old gauze around the CVC limbs. During an interview on 12/02/25 at 10:13 AM, S8 confirmed he/she did not hand sanitize between glove changes. S8 stated, “I should hand sanitize between glove changes.” A review of S8’s education and training file revealed that he/she was signed off and had completed the “Clinical and Staff Orientation Checklist” dated 09/18/2025 that contained topics regarding Hand Hygiene, Alcohol Based Handrub and Central Venous Catheter Care. Facility policy titled, “Hand Hygiene Handwashing Policy, Procedure,” revision date 10/06/2020, stated, “... Purpose: To provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs and infection. ... Policy: ... Before applying clean gloves ... After coming in contact with patient’s intact skin ... after working on a contaminated body site and then moving to a clean body site of the same patient. ...” N.J.A.C. 8:43A-24.8(b)”

“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: 50912 Based on two of two observations of clean/dirty workspaces/areas, staff interviews, and review of facility policy, it was determined that the facility failed to clearly designate clean areas from dirty areas to avoid possible cross contamination. Findings include: On 12/02/25 during a tour of the Hemodialysis Treatment Floor, the following was revealed: At 10:10 AM, a blue paper pad was observed on top of the chase wall shelf inside Station 3, which was occupied by a patient on hemodialysis. On top of the blue paper pad were five blue hemostat clamps, three yellow hemostat clamps and a green access clamp. The hemostat clamps that were left to dry on the blue paper pad were inside the patient occupied station which can create a potential for cross contamination. Upon discovery, S3 stated that the hemostat clamps were clean and are placed on the blue pads to dry. In addition, a dirty sink was observed one foot to the left side of the chase wall shelf where the hemostat clamps were left to dry. This can create a potential for cross contamination due to splashing when fluids are emptied by staff into the dirty sink. During an interview on 12/03/25 at 12:58 PM, S1 stated that the hemostat clamps should be left to dry in a clean area. Facility policy titled, “Infection Prevention and Control- Staff Education,” revision date 03/31/2017 stated, “... Policy: Staff shall receive Infection Prevention and Control training and education ... Proper methods to clean and disinfect equipment and environmental surfaces to minimize transmission of microorganisms. ...” N.J.A.C. 8:43A-24.8(b)”

“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: 50912 Based on observations, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that all surfaces of access and plastic hemostat clamps are disinfected after use and that seven out of 18 blood pressure (BP) cuffs are maintained to allow for adequate cleaning and disinfection. Findings include: On 12/02/25 at 9:58 AM, during a tour of the Treatment Floor, a clear opaque plastic container with a lid labeled “Dirty Clamps,” that contained a 1:100 bleach solution (one part bleach to 100 parts water) in it, was observed on a shelf on top of the dirty sink located adjacent from Station 3. Inside the container was one white access clamp and two plastic blue hemostat clamps that were not fully submerged and soaking in the bleach solution. The container also had four blue hemostat clamps that were fully submerged but in the closed position while soaking in the bleach solution. The soaking of the hemostat clamps in the closed position and the clamps being not fully submerged could potentially prevent the bleach solution from contacting and disinfecting all surfaces of the hemostat clamps. On 12/02/25 at 10:06 AM, these findings were confirmed with Staff (S)3. Upon interview at 10:09 AM, S3 stated that dirty clamps should be fully submerged and in an open position while soaking in the bleach solution. On 12/02/25 at 10:15 AM, during a tour of the Hemodialysis Treatment Floor, the BP cuffs in Stations 6, 8, 11, 13, 14, 15 and 16 were heavily covered with white lint on the Velcro portion of the cuff, which rendered the BP cuffs uncleanable. On 12/02/25 at 10:32 AM, this finding was confirmed with S4. Facility policy titled, “Cleaning and Disinfection of Medical Devices and Equipment Policy,” revision date 09/29/2020, stated, “... Policy ... Hemostat clamps are to be disinfected using facility-approved disinfectant (Bleach 1:100 or if contaminated with blood use Bleach 1:10). Clamps are to be disinfected in an open position ...” Facility policy titled, “Cleaning and Disinfection of Medical Devices and Equipment Policy,” revision date 09/29/2020, stated, “... Policy ... staff shall clean and disinfect surfaces, medical devices and equipment ... using facility-approved EPA disinfectant or a 1:100 bleach solution. ...” N.J.A.C 8:43A-24.8(b)”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 50912 Based on one of one observation in the Medication Preparation Area, staff interview, and a review of Manufacturers Instruction for Use (MIFU), it was determined that the facility failed to ensure that expired medications are not available for use. Findings include: On 12/02/25 at 10:50 AM, during a tour of the Medication Preparation Area, a Medication Refrigerator contained an opened, half full, multidose vial of Tuberculin Purified Protein Derivative (Mantoux) Tubersol. The vial was labeled opened on 10/06/25. A review of the Tuberculin Purified Protein Derivative (Mantoux) Tubersol MIFU stated, “... A vial of Tubersol which has been entered and in use for 30 days should be discarded. Do not use after expiration date. ...” The vial was 27 days past it’s beyond use date. At 10:55 AM this finding was confirmed with Staff (S)4 who stated that Mantoux multidose vials are discarded 30 days from the date the vials are opened. N.J.A.C. 8:43A-9.3(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: 50912 Based on one of two observations of Central Venous Catheter (CVC, a type of access used for hemodialysis) exit site care, staff interview, and review of facility policy, it was determined that the facility failed to implement infection control practices for cleansing the CVC access site prior to initiation of hemodialysis. Findings include: On 12/02/25 at 11:02 AM, in Station 8, Staff (S)4, initiated CVC exit site care on a patient’s right chest wall. S4 cleansed the CVC exit site in a back-and-forth scrubbing motion with a 2% Chlorhexidine Gluconate pre-packaged swab for 15 seconds. This was 15 seconds less than required by facility policy. During an interview at 11:08 AM, S4 stated the CVC exit site should be cleansed for 30 seconds and then further stated that he/she thought they had cleaned it long enough. Facility policy titled, “Central Venous Catheter Care Policy Procedure” revision date 08/16/2021, stated, “... Note: Chlorhexidine is the preferred anti-microbial agent for use when cleansing the central venous site ... Application Time Method: 30-60 seconds; back and forth scrubbing motion from exit site ...” N.J.A.C. 8:43A-24.8(b)”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 51990 Based on staff interview and a review of facility documents, it was determined that the facility failed to ensure that total chlorine testing is conducted every four hours in accordance with facility policy. Findings include: A review of the document titled “TCL-1 Total Chlorine Log for Central Water Systems” for October 2025 stated that on 10/04/25, a chlorine test was performed by staff at 9:15 AM. There was no further documented chlorine testing done on this date. A review of the “Dialysis Patient Schedule” dated 10/04/25, indicated the last patient to complete hemodialysis treatment was at 2:08 PM. This was four hours and 53 minutes after the last chlorine test was performed. The “TCL-1 Total Chlorine Log for Central Water Systems” for October 2025 also stated that on 10/31/25, the second chlorine test of the day was performed by staff at 5:30 AM, followed by a third test performed at 9:45 AM. This was four hours and 15 minutes after last chlorine test was performed. During an interview on 12/02/25 at 12:30 PM, Staff (S)9 confirmed the above findings. Facility policy titled, “Daily Water System Total Chlorine Monitoring,” effective 04/18/17, stated, “... Policy ... 2. Total Chlorine Testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require use of dialysis quality water are completed ...” N.J.A.C. 8:43A-24.10(a)(3)”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 51990 Based on observation, staff interviews, review of two of two personnel files (Staff [S]4 and S6), and a review of facility documents, it was determined that the facility failed to ensure that all staff members responsible for chlorine and chloramine testing in the facility are trained to the necessary steps to take in the event of a chlorine breakthrough in accordance with facility policy and procedure. Findings include: On 12/02/25 at 12:03 PM in the RO (Reverse Osmosis, a water purification system) Room, Staff (S)6 performed chlorine testing. S6 then read the chlorine test results 0.02ppm (parts per million) and S4 verified the results. During an interview at 12:15 PM, S4 and S6 stated the acceptable level for chlorine testing is less than 0.1ppm. The surveyor then asked S4 and S6 what the staff members responsibilites would be in the event that the chlorine testing result exceeded the recommended levels. S4 was unable to provide the information. S6 stated that the RO system is placed on bypass and the Nurse Manager and Medical Director are notified for further instructions. This was not in accordance with facility policy. On 12/03/25 at 9:27 AM, an interview was conducted with S9, who stated that he/she conducts the staff’s annual water training. S9 indicated that the Chlorine Breakthrough Plan staff responsibilites are part of this training. A review of S4 and S6’s personnel files revealed the following: S4’s last documented Water Training was completed on 03/13/23. S6’s date of hire was 11/01/18. There was no documented evidence of Water Training provided for S6 upon hire and thereafter. Facility policy titled, “Daily Water System Total Chlorine Monitoring,” effective date 04/18/17, stated, “... Policy: ... I. Only trained teammates may perform daily water system chlorine testing ... 1. To verify that Chlorine and Chloramine levels are within the limits specified by AAMI (Association of Advance medical Instruments) ... the sum of free Chlorine and Chloramine, to verify that total levels are less than 0.1 ppm (parts per million), ... II. ... a. If results of Total chlorine testing from the primary carbon tank is greater tan 0.1 ppm, the test should be immediately repeated on a freshly drawn sample to verify the result are not a “false positive” ... c. If the results of the repeat Total Chlorine is greater than 0.1 ppm, proceed immediately with the steps below ... 10. Draw a sample for Total Chlorine testing from sample port located downstream of the second (secondary) carbon tank ... 13. If the results from the secondary carbon filter or set tanks indicate a lever greater than 0.1 ppm, the charge nurse must be immediately notified ans dialysis treatments must be discontinued by placing dialysis delivery system in bypass ... 14. ... The Medical Director, Facility Administrator/designee and Biomed teammate will be notified immediately from either the primary and secondary carbon filters ...” N.J.A.C. 8:43A-24.10(a)(7)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 33556 Based on observation and staff interview, it was determined that the facility failed to ensure a defect free environment is maintained at all times. Findings include: On 12/04/25 at 11:00 AM, during a facility tour conducted with Staff (S)9, the following were noted: Visibly dusty and grimy return air vent registers were identified on the Treatment Floor adjacent to Station 12 and Station 13, and in the Dirty Utility Room. Uncleanable defective gaping seams and integral floor base detachments from the wall were discovered on the monolithic floor surface throughout the Treatment Area. Water-stained ceiling tiles were found within Station 15, in the Wheelchair Storage Room, and the EVS (environmental services) closet. S9 confirmed the above findings upon discovery. N.J.A.C. 8:43A-17.3(j) 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: 51990 Based on one of one observation, staff interview, and a review of manufacturer’s instructions for use (MIFU), it was determined that the facility failed to ensure that the Water Check RC (Residual Chlorine) testing strips (used to check for residual bleach for dialysis machines after bleach disinfection) are not available for use within three months after opening the bottle. Findings include: On 12/02/25 at 9:35 AM, during the tour of the Hemodialysis Unit, on the nurse’s station counter, a bottle of Water Check RC testing strips that contained multiple strips was available for use. The bottle was labeled, “Date Opened: 06/03/25 ... Use by Date within Exp (Expiration) (three [3] months after opening): 09/01/25,” Upon interview at the time of discovery, Staff (S)3 stated the strips were last used on 11/26/25. During a follow-up interview on 12/02/25 at 9:52 AM, S1 stated the strips should have been discarded in September. Review of the Water Check RC testing strips MIFU stated, “... Storage: ... Use the strip within three months after opening ...” 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: 50912 Based on one of two observations of the initiation 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 the patient’s rights to privacy. Findings include: On 12/02/25 at 9:48 AM in Station 1, Staff (S)8 initiated hemodialysis on a patient through a right chest wall CVC. During the procedure, the curtain was not completely drawn in front of the patient leaving an approximate six feet opening. The patient’s right chest wall was visible to staff at the nurse’s station directly across from Station 1, and to transport personnel and patients being transferred in and out of the treatment floor entrance, which was adjacent from Station 1. During an interview on 12/02/25 at 9:56 AM, S8 confirmed that the curtains should be fully closed around the patient’s station when initiating hemodialysis thru a CVC. A review of S8’s personnel file indicated that he/she has completed the “Patients’ Rights and Responsibility,” training and education on 12/04/25. Facility policy titled, “Patient Rights and Responsibilities,” undated, stated, “... 10. To be treated with courtesy, cooperation, respect, and recognition of the patient’s dignity, individuality, and right to privacy, including, but not limited to, auditory and visual privacy. ...” Facility policy titled, “Central Venous Catheter Care Policy, Procedure,” revision date 08/16/2021 stated, “... Procedure 1. Provide patient privacy ...” N.J.A.C. 8:43A-16.2(a)10”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 51990 Based on one of five medical records reviewed (Patient [P]2), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure a comprehensive reassessment and a revision of the plan of care is conducted at least monthly by the IDT (Interdisciplinary Team, includes a Physician, a Registered Nurse (RN), a Social Worker (SW), and a Registered Dietitian (RD) for an unstable patient. Findings include: A review of the facility’s hospitalization log indicated that P2 was hospitalized during the following dates; from 08/04/25 to 08/12/25 and from 08/12/25 to 08/28/25. A review of P2’s medical record revealed the following: P2 was made “Unstable” on 08/29/25 for frequent hospitalizations. A review of the Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC), dated 08/29/25 lacked documention by the Physician and the RN. There was a completed CIA and POC by the IDT on 09/18/25 which indicated that P2 remained unstable, however, the medical record lacked documented evidence that a CIA and a POC was completed by the IDT in October 2025. During an interview on 12/03/25 at 12:45 PM, S1 stated P2 is chronically unstable and confirmed the above findings of the missing documentation. Facility policy titled, “Comprehensive Interdisciplinary Assessment Policy,” revised on 3/31/17, stated, “... Performed by: ... Interdisciplinary Team (Attending Physician, or physician extender (where permitted by State law), Registered Nurse (RN) ... Special Considerations: ... 2. “Unstable patients” include but not limited to patients with the following: ... Extended or frequent hospitalization ...” N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.13(c)”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50912 Based on one of two medical records reviewed [Patient (P)4], staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the prescribed BFR (blood flow rate, the speed at which blood is pumped through the dialyzer during hemodialysis) ordered by the physician is administered for four of eight hemodialysis treatments reviewed. Findings include: A review of P4’s medical record revealed the following: The Plan of Care, dated 10/28/25, stated, “... Adequacy, Maintain adequacy goal. Continue with current dialysis prescriptions. ...” The “Hemodialysis Treatment Orders” section dated 11/10/2025, stated a physician order for “... 4 hours; Bath 2.5 K [potassium], 2 Ca [calcium], 36.0 HCO3 [bicarbonate]; BFR 350/DFR [Dialysis Flow Rate] 700 ...” A review of the “Treatment Details Report” from 11/11/25 to 11/29/25, indicated that the prescribed BFR order of 350 mL/min (milliliters per minute) was not followed on the following treatment dates: On 11/11/25, hemodialysis treatment was initiated at 9:07 AM with the BFR set at 600 mL/min. The BFR was changed to 400 mL/min at 9:12 AM and remained at 400 mL/min until termination of hemodialysis treatment at 1:00 PM. On 11/22/25, hemodialysis treatment was initiated at 9:33 AM with the BFR set at 400 mL/min. At 12:03 PM, the BFR was changed to 350 mL/min and remained at 350mL/min until termination of treatment at 1:03 PM. On 11/26/25, hemodialysis treatment was initiated at 9:41 AM with the BFR set at 400 mL/min. The BFR remained at 400 mL/min until the termination of treatment at 1:31 PM. On 11/29/25, hemodialysis treatment was initiated at 9:15 AM with the BFR set at 600 mL/min. At 9:19 AM the BFR was changed to 150 mL/min and remained at 150 mL/min until 9:33 AM. At 9:33 AM, the BFR was changed to 250 mL/min and remained at 250 mL/min until 12:33 PM. At 12:33 PM the BFR was changed to 200 mL/min and remained at 200 mL/min until termination of treatment at 1:19 PM. The medical record lacked documented evidence of a rationale for the BFR not being administered according to the physician’s order on the above dates. On 12/03/25 at 1:09 PM, above findings were reviewed and confirmed with Staff (S)2. Upon interview at 1:12 PM, S2 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. Facility policy titled, “Intradialytic Assessment and Monitoring Procedure” revision date 03/31/2017, stated, “... Policy ... (facility name) shall routinely monitor the patient’s response to hemodialysis treatment and the accuracy of the machine functions. ... Staff RN shall be responsible for evaluating the patient’s response to the dialysis treatment, performing patient assessment ... The following machine parameters shall be checked ... Dialysis flow, Blood flow ... checks of machine monitor setting ...” N.J.A.C. 8:43A-24.4(a)”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 37656 Based on a review of facility documents and staff interview, it was determined that the facility failed to aggregate, trend, and analyze both isolated and repeated events in their review regarding adverse occurrences in QAPI (Quality Assessment and Performance Improvement) in five out of six months of QAPI meeting minutes reviewed. Findings include: The facility’s QAPI meeting minutes for May to November 2025 were reviewed and revealed the following: On 05/21/25, a QAPI meeting for the April 2025 data was held. The Adverse Events section stated: “3 Medical emergencies noted on April 2025 and patients were admitted to [facility name].” On 06/26/25, a QAPI meeting for the May 2025 data was held. The Adverse Events section stated: “One patient was sent to ER [emergency room] for immediate evaluation and medical treatments.” On 08/23/25, a QAPI meeting for the July 2025 data was held. The Adverse Events section stated: “One patient was sent to ER for immediate evaluation and medical treatments.” On 09/24/25, a QAPI meeting for the August 2025 data was held. The Adverse Events section stated: “Three (3) patients were sent to ER for immediate evaluation and medical treatments.” On 10/22/25, a QAPI meeting for the September 2025 data was held. The Adverse Events section stated: “Two (2) patients were sent to ER for immediate evaluation and medical treatments.” The QAPI meeting minutes in the above referenced months did not contain evidence that the facility tracked, trended, and analyzed the above data that indicated both isolated and repeated events of medical emergencies. In an interview at 1:58 PM on 12/04/25, Staff (S)1 stated that the events are recorded in the treatment flow sheet by the staff member assigned to the patient on the date the events happened. S1 stated that he/she gathers the data every month and reports it to QAPI but could not provide documented evidence of the tracking, trending and analysis of the adverse occurrences. Facility policy titled, “Quality Assurance Performance Improvement,” revised 02/15/17, stated, “Purpose: ... To review and document quality improvement activities on a formal setting with input with interdisciplinary team and continually improve patient outcomes. ... COMPONENTS: Quality Indicators based on internal and external expectations. ... Trending tool ... Meeting minutes that document discussion, analyses, action and result. ... Action Plans focused on addressing the specific causes of problems or issues ... PROCEDURE: ... Review of data driven focus areas: morbidity and mortality, medical injuries, infection prevention and control. ...” N.J.A.C 8:43A 18.2(f) N.J.A.C 8:43A 24.18(b)5”

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 39223 Based on observation, staff interview, and review of facility documentation, it was determined that the facility failed to provide Cardiopulmonary Resuscitation (CPR) in accordance with Basic Life Support (BLS) guidelines (Cross Refer Tag E-0028). This failure resulted in an Immediate Jeopardy (IJ), posing serious risk of harm to the patients. The above findings resulted in an Immediate Jeopardy (IJ) on November 1, 2024 at 4:42 PM. The IJ template was provided to Staff (S) 1, Director of Nursing, on 11/1/24 at 4:55 PM and a removal plan was requested. An IJ Removal plan was provided by the facility on 11/4/24 at 12:55 PM, and was accepted. Full implementation of the accepted RP was verified by staff interview, review of facility documentation (staff education, policy, and Governing Body meeting minutes). It was determined that the IJ removal plan was successfully implemented and the IJ was removed on 11/4/24 at 1:15 PM. Cross Reference: CfC 494.62 (b)(9)”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 39223 Based on observation, medical record review, staff interview, and review of facility documents, it was determined that the facility failed to develop and implement an individualized Patient Plan of Care by failing to: 1) develop a plan of care to address the patient’s oxygen needs (Tag V-0542); 2) implement the Patient Plan of Care to ensure the patient meets his/her ordered Estimated Dry Weight (Tag V-0543); and 3) ensure that all members of the Interdisciplinary Team (IDT) contribute to the development and implementation of the Patient Plan of Care. Cross reference: 494.90(a) POC-IDT Develops Plan of Care 494.90(a)(1) POC-Manage Volume Status 494.90(b)(1) POC-Completed/Signed by IDT and Patient”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 39223 Based on medical record review, interviews, and review of facility documentation, it was determined that the Medical Director failed to ensure the delivery of quality patient care by failing to: 1) ensure that all staff receive an annual evaluation of their competencies and that staff providing care are educated on the assessment and care of patients with oxygenation needs. (Tag V-713); and 2) develop and implement a policy for care of the tracheostomy and/or ventilated patient during hemodialysis treatment (Tag V-714) Cross reference: 494.150(b) - Medical Director Responsibility-Staff education, training and performance 494.150(c)(1) - Medical Director Responsibility-development, review and approval of patient care policies and procedures”

“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: 49828 Based on observation of one of one emergency equipment box, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the emergency evacuation cart did not contain expired items. Findings include: On 8/7/24 at 2:00 PM, the contents of the emergency evacuation box were reviewed and compared to the inventory checklist titled, “Emergency Evacuation Kit Checklist.” The hemodialysis unit included 18 patient stations, which indicated a full shift was 18 patients. Upon inspection of the items in the emergency evacuation box, it was revealed that 18 of the 18 “Nipro Priming Sets” (used for the administration of intravenous fluids) had expired on 05/04/24. A 2:10 PM, the findings were reviewed with Staff (S)8, the Charge Nurse, who disposed of the expired supplies noted above. A review of the facility policy titled, “Emergency Evacuation Kit Policy” stated, “Policy: ... The content of the evacuation kit will include, at minimum, enough supplies to provide care for a full shift of patients ... The evacuation kit contents will be reviewed on a monthly basis for missing or expired [sic]. Supplies that are missing or expired must be replaced immediately ...””

“Means of Egress - General CFR(s): NFPA 101 Means of Egress - General Aisles, passageways, corridors, exit discharges, exit locations, and accesses are in accordance with Chapter 7, and the means of egress is continuously maintained free of all obstructions to full use in case of emergency, unless modified by 18/19.2.2 through 18/19.2.11. 18.2.1, 19.2.1, 7.1.10.1 This Standard is not met as evidenced by: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that all means of exiting the building are maintained clear and usable at all times. Findings include: During a tour conducted on 8/7/24 at 11:30 AM with Staff (S)1, the Bio-Med Technician, the following was observed: A large amount of corrugated box material was stacked within the service hallway located on the treatment floor, possibly affecting the hallway’s use as an exit during an emergency. The door from the service hallway leading to the building exit was partially blocked by a nursing facility supply delivery preventing the door from opening fully when operated. S1 stated the corrugated material was just on its way for recycling and also that this was not the first time the exit door was blocked by a nursing home delivery.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that the automatic fire sprinkler system is maintained in good repair. Findings include: During a tour conducted on 8/7/24 at 11:30 AM with Staff (S)1, the Bio-Med Technician, the sprinkler head installed within the supply/storage room was found without its cover possibly affecting its performance and/or activation. S1 confirmed the above finding upon discovery and said the sprinkler head would be repaired as soon as possible.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 39228 Based on one of one observation of the cleaning and disinfection of an isolation room on the treatment floor, staff interview and review of facility documents, it was determined the facility failed to ensure staff properly wear personal protective equipment (PPE) when cleaning and disinfecting the room following the discharge of an isolation patient. Finding include: On 8/7/24 at 10:20 AM, Patient (P) 6, exited Station 18. Upon interview at 10:21 AM, Staff (S) 8, the Charge Nurse, stated that Station 18 is an isolation room and that P6 had just completed treatment and was on contact isolation precautions for Candida auris (an organism that can cause infection in immunocompromised people). At 10:22 AM, prior to entering Station 18, S7, a Patient Care Technician, applied a yellow-colored gown overtop of the white gown that he/she was already wearing. The yellow gown was left un-tied in the back and was hanging low in the front and back. This exposed the upper portion of his/her white gown from the elbow and the waist up to the shoulders. S7 then entered Station 18, and proceeded to clean and disinfect patient care equipment, the dialysis machine, and the chaise wall with the untied gown hanging down. Upon completion of the cleaning, S7 removed the yellow gown and exited the room. S7 did not remove the white gown and proceeded back on to the treatment floor to care for patients. At 10:30 AM, during an interview, S8 explained that staff are required to wear a yellow-colored gown to protect their clothing when they clean and disinfect a contact isolation room. S8 stated that S7 was not wearing the gown properly and that it should have been tied and not hanging down exposing the white gown. S8 stated that staff wear white gowns over their clothing while on the treatment floor when caring for patients and that staff may wear the yellow gown over top of the white gown when entering an isolation room, but it should be tied and not hanging down. A review of the facility policy titled, “Personal Protective Equipment PPE Policy,” last revised 3/31/17, stated, “ ... Policy: Staff shall wear ... (PPE) appropriate to the anticipated potential exposure. Staff shall wear PPE during: ... Cleaning and disinfecting of patient care supplies and equipment ...” Facility policy titled, “Transmission Based (Contact, Droplet, Isolation) Precautions Policy, Procedure,” last revised 1/31/20, stated, “... Contact Precautions: Contact Precautions shall be used with patients with known or suspected infections or evidence of syndromes that represent an increased risk for contact transmission. ... Personal Protective Equipment ... Gowns shall be worn whenever it is anticipated that clothing will have direct contact with ... potentially contaminated environmental surfaces or equipment ...” N.J.A.C. 8:43A-24.8(b)”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 39228 Based on two of two observations of clean supply carts, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that clean supplies remain separate from contaminated equipment in order to avoid potential cross contamination. Findings include: On 8/7/24 at 9:58 AM, during a tour of the treatment floor, a plastic cart located across from Station 7 that contained three drawers was directly next to a red colored container that was labeled “Biohazard.” At the time of discovery, the three drawers in the cart were opened and inspected, and found to have clean patient care supplies in them. At 10:00 AM, an interview was conducted with Staff (S) 7, a Patient Care Technician, who stated that the three drawers contained clean patient supplies and that the cart is always stored there for easy access to supplies. At 10:12 AM, a metal cart, located across from Station 16, contained four open shelves with clean patient supplies inside. The cart was located directly next to a container that had an open area on the top portion of it and appeared to have used patient care supplies in it. Upon interview at the time of discovery, S8, the Charge Nurse, confirmed that the metal cart had clean patient care supplies in it and that the container located directly next it was a sharps container for used needles. S8 then proceeded to move the metal cart with the clean supplies away from the sharps container and stated, “We always store them here but there usually not so close to each other.” Review of facility policy and procedure titled, “Infection Prevention and Control Practices,” last revised: 6/1/23, stated, “... Clean areas shall be designated for ... unused supplies and equipment. Clean areas shall be clearly separated from contaminated areas where used supplies and equipment are handled. ...” 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: 49828 Based on observation, staff interview, and review of facility policy, it was determined that the facility failed to ensure staff follow proper procedure for Central Venous Catheter (CVC) care during two of two observations. Findings include: On 8/7/24 at 10:17 AM, Staff (S) 6, a Registered Nurse, initiated hemodialysis through a CVC on the patient in Station 11. The following was observed: Upon the removal of the patient’s end caps, S6 wiped the end caps and limbs with an alcohol swab in accordance with facility policy. S6 then released both CVC limbs, which allowed the ends to make contact with the pad placed on the patient’s chest. S6 then picked up each CVC limb and attached a sterile 10 milliliter (ml) syringe to each and aspirated three to five ml of blood into each syringe. S6 then disconnected each syringe from the CVC limbs. Upon removal, the end of each CVC limb made contact with the pad beneath. S6 then connected a pre-filled saline syringe to each CVC limb and injected the contents before connected the patient to the hemodialysis machine. During an interview at the time of discovery, S6 confirmed that he/she did not clean the catheter limbs after they touched the pad. S6 stated that he/she was not able to aseptically connect the patient to the hemodialysis machine because he/she could not hold the CVC limbs and remove the cap of the sterile saline syringe at the same time. At 10:50 AM in Station 15, S12, a Registered Nurse, initiated hemodialysis through a CVC on the patient in Station 15. The following was observed: S12 removed the end cap on the red CVC limb before he/she cleaned the patient’s CVC limb with one alcohol swab for five seconds. S12 repeated the same process on the limb for five seconds. S12 then connected the patients’ bloodlines to the hemodialysis machine without the benefit of aspirating blood or attaching a sterile saline flush to assess for patency first. During an interview at the time of discovery, S12 stated he/she was unsure how long he/she cleaned the patient’s end caps and limbs for because he/she “was not counting.” S12 stated he/she believes the policy stated to scrub for 20 seconds. A review of the facility policy titled, “Initiation/Termination of Hemodialysis Using Dual Lumen Catheter,” stated, “ ... Procedure: Initiation of Treatment ... Open alcohol pad and clean end caps then move up catheter limb (Approx. [approximately] 4 inches), Take second alcohol remove end cap and clean threads vigorously for 15 seconds Attach 10 ml syringe Aspirate 3-5 ml of blood and discard, Attach syringe with normal saline to flush catheter limb to assess for patency, repeat above steps with other limb. Attach blood lines, unclamp limbs, and initiate treatment ...”. N.J.A.C. 8:43A-24.8(b)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 33556 Based on observation of the hemodialysis treatment room and support areas, and staff interview, it was determined that the facility failed to ensure that a defect free environment is maintained at all times. Findings include: On 8/7/24 at 11:30 AM, a tour of the hemodialysis patient treatment area and support spaces was conducted in the presence of Staff (S) 1, the Biomedical Technician. The following areas were damaged, uncleanable, and in need of repair: The seams on the monolithic floor surface were found parted and gaping throughout the patient treatment area. The flooring was especially damaged in the patient scale area. The integral floor base had become unglued and separated from the wall creating a gap in the following areas: outside the patient isolation treatment room, the patient scale area, Station 18, and the service hallway off the treatment floor. The water-chase structure located within Station 8 was moisture damaged with laminate separation from the wood-like base material. Water or liquid-stained ceiling tiles were found in the following areas: the Supply/Storage Room, the EVS (Environmental Services) closet, the Clean Utility/Storage Room, the Soiled Utility Room, Biomedical Technician office, and Station 7. There was no privacy curtain installed at Station 10 and as such was not available for use if needed. The clean sink adjacent to the Patient Toilet Room was chemically surface damaged and the backsplash was not flush to the surface of the cabinet leaving an inaccessible separation. S1 confirmed the above upon discovery and stated the above issues would be addressed as soon as possible. 49828 On 8/7/24 at 9:56 AM, a tour of the dialysis treatment area was conducted, and the following was observed: A “Clean” sink adjacent to the “Patient Restroom” had a reddish-brown substance on all the cabinet hardware. The dialysis chairs in the following stations had a reddish-brown substance on the top base of the wheels in the following stations: Station numbers 1, 2, 3, 6, 9, 11, 12, 13, 14, 15, and 17. A black stool on wheels located in Station 7 had numerous tears on the surface of the leather, exposing an uncleanable layer of fabric below it. The patient chair in Station 9 had a tear in the fabric on the right arm of the chair, exposing the inside foam which was an uncleanable surface. N.J.A.C. 8:43A-17.3(a) N.J.A.C. 8:43A-17.3(i) N.J.A.C. 8:43A-17.4(a)(13) N.J.A.C. 8:43A-17.4(a)(15)”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 39223 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that: 1) dialysate orders include Sodium levels for two of five patients and document the dose of Sodium delivered for three of five patient (Patient (P) 1, P3, and P5); and 2) the ordered dialysate is administered as prescribed by the physician in three of nine treatments reviewed for P2. Findings include: 1. Medical Record (MR) 1 was reviewed and revealed an order for hemodialysis treatments three times per week with a dialysate composition of 3 Potassium (K+), 2.5 Calcium (Ca ++) and Bicarbonate 35. The area of the dialysate order that specified the Sodium level was blank. A review of hemodialysis treatment sheets lacked documented evidence of what level of sodium was delivered to the patient. MR 3 was reviewed and revealed an order for hemodialysis treatments three times per week with a dialysate composition of 2K+, 2.5 Ca ++, Bicarbonate 35. The area of the dialysate order that specified the Sodium level was blank. A review of the hemodialysis treatment sheets dated 07/19/24 through 08/07/24 lacked documented evidence of the level of sodium delivered to the patient. On 8/8/24 at 3:05 PM, the above findings were reviewed with Staff (S) 17, the Director of Nursing, who stated that there should be a level of sodium ordered for each patient’s dialysate order, and the nurse should clarify the sodium level before administering hemodialysis treatment. S17 confirmed that the physician orders and the hemodialysis treatment flowsheets lacked documentation of what level sodium was ordered and delivered to the patients reviewed above. 49828 MR5 was reviewed and revealed an order for hemodialysis treatments three times per week. The “Dialysis Orders” portion of the “Out-Patient Center Hemodialysis Physician Standing Order” section of the medical record stated the hemodialysis prescription: “ ...Sodium: 138 ...”. A review of the hemodialysis treatment sheets dated 7/19/24 through 8/7/24 lacked documented evidence of the level of sodium delivered to the patient. N.J.A.C. 8:43A-9.4(a) 39228 2. A review of P2’s medical record revealed the following: On 7/24/24, the “Prescription” section of the treatment sheet stated, “... Prescription Duration: 3:00 hrs [hours] ... Bath [Ordered Dialysate composition]: 2K [potassium] 2.5Ca ...” The “Pre Treatment” section of the treatment sheet stated, “... Treatment Dialysis Prescription *Outpatient Hemodialysis ... K: 2, Ca: 2.5 ... (12/11/2023 - current) [initials of the Patient Care Technician (PCT)] ... Open Hemodialysis Prescriptions ... Prescription Type: Outpatient Hemodialysis Start Date: 05/20/24 ... Bath: 3K 2.5Ca ... Rx [prescription] Frequency: 3x [times] per week ...” On 7/26/24, the “Prescription” section of the treatment sheet stated, “... Prescription Duration: 3:00 hrs ... Bath: 2K 2.5Ca ...” The “Pre Treatment” section of the treatment sheet stated, “... Treatment Dialysis Prescription *Outpatient Hemodialysis ... K: 2, Ca: 2.5 ... (12/11/2023 - current) [initials of the Patient Care Technician] ... Open Hemodialysis Prescriptions ... Prescription Type: Outpatient Hemodialysis Start Date: 05/20/24 ... Bath: 3K 2.5Ca ... Rx Frequency: 3x per week ...” On 7/29/24, the “Prescription” section of the treatment sheet stated, “... Prescription Duration: 3:00 hrs ... Bath: 2K 2.5Ca ...” The “Pre Treatment” section of the treatment sheet stated, “... Treatment Dialysis Prescription *Outpatient Hemodialysis ... K: 2, Ca: 2.5 ... (12/11/2023 - current) [initials of the Patient Care Technician] ... Open Hemodialysis Prescriptions ... Prescription Type: Outpatient Hemodialysis Start Date: 05/20/24 ... Bath: 3K 2.5Ca ... Rx Frequency: 3x per week ...” On 8/8/24 at 2:13 PM, the above referenced treatment sheets were reviewed with Staff (S) 17, the Director of Nursing. S17 confirmed that 2K Baths were administered on the above treatment dates instead of the ordered 3K Bath. S17 explained that the PCT who initiated the treatments on the above dates electronically selected the order that gets entered into the “Pre Treatment” section of the treatment sheet and that the prescription will then get carried over into the “Prescription” section of the treatment sheet. S17 further explained that the PCT did not select the current physician order dated 05/20/24 and instead followed the order that was placed on 12/11/23. N.J.A.C. 8:43A-9.4(b)”

“PA-MSW-PSYCHOSOCIAL NEEDS CFR(s): 494.80(a)(7) The patient’s comprehensive assessment must include, but is not limited to, the following: (7) Evaluation of psychosocial needs by a social worker. This Standard is not met as evidenced by: 39228 Based on staff interview, medical record review, and a review of facility documents, it was determined that the facility failed to ensure that the Social Worker (SW) collaborated with the interdisciplinary (IDT) team members to assess the patient’s psychosocial needs for one of three assessments reviewed for Patient (P) 2. Findings include: A review of P2’s medical record revealed the following: P2 was admitted to the facility on 10/18/23. The Initial Comprehensive Interdisciplinary Assessment meeting was held on 11/22/23. The Social Workers (SW’s) Psychosocial Assessment portion of the comprehensive interdisciplinary assessment was blank. The Care Teams “Signatures” section lacked documentation that the SW reviewed the assessment and did not contain a signature from the SW. On 8/9/24 at 11:15 AM, an interview was conducted with Staff (S) 5, the Social Worker. S5 was questioned regarding the blank areas of the above plan of care and the lack of a signature from the SW for P2. S5 stated, “I was out on medical leave from October 2023 until January 2024 and if the meetings were done during that time frame, then I did not complete them.” S5 then stated that no one was covering for him/her while he/she was out on leave. A review of the facility policy titled, “Comprehensive Interdisciplinary Assessment Policy,” last revised 3/31/17, stated, “... Performed by: Interdisciplinary Team (Attending physician or physician extender (where permitted by State law), registered nurse (RN) , registered dietician (RD), and Social Worker (SW), patient and/or care partner ... Policy: ... The comprehensive assessment and plan of care must be developed by an interdisciplinary team (IDT) consisting of at least the attending physician/physician extender treating the patient for ESRD, a registered nurse, a social worker, a registered dietitian and patient or patient designee, if patient chooses. ... Comprehensive assessment Frequency: An initial comprehensive assessment shall be conducted on all new patients ... within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session ...” N.J.A.C. 8:43A-24.13(b)”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 39223 Based on observation, medical record review, staff interview, and review of facility documents, it was determined that the facility failed to develop a plan of care to address the patient’s oxygen needs for two of two patients (Patient (P) 1, and P3). Findings include: On 8/7/24 at 10:50 AM, during a tour of the hemodialysis unit, Patient (P) 3 received hemodialysis in Station 10. P3 was receiving oxygen at 4 L (liters) per minute through a tracheostomy collar that was placed directly in front of P3’s open tracheostomy. During an interview on 8/7/24 at 10:42 AM, Staff (S) 8, the Charge Nurse, stated that the staff receive report from the nursing home about the patient and a face-to-face hand-off with the patient’s Registered Nurse (RN) occurs before treatment is initiated. During this hand-off report, the oxygen levels are set and communicated by the nursing home RN to the dialysis RN. A review of Medical Record (MR) 3 indicated that the patient had a past medical history of a tracheostomy that required oxygen through a ventilator. Further review revealed the following: The Comprehensive Interdisciplinary Assessment dated for 02/28/24, which included the Plan of Care for P3, stated, “... If patient has declined participation, please indicate reason ... medically unable ... patient is with trach [tracheostomy] attached to ventilator ... Review of Systems ... Mouth, Neck, Throat ... trach intact and secure ... Respiratory ... Oxygen use ... ventilator dependent ...” There was no documented level of oxygen that was administered to the P3. The hemodialysis treatment flow sheets dated 7/19/24 through 8/7/24 lacked documented evidence that the patient was on a ventilator, had a tracheostomy, and/or was receiving oxygen. There lacked documented evidence that the facility’s nephrologist ordered oxygen to be given through the patient’s tracheostomy during P3’s hemodialysis treatments. There lacked documented evidence that the facility’s nephrologist ordered a ventilator or a trach collar to be utilized for the patient’s respiratory support during hemodialysis treatments. A review of MR 1 was conducted and indicated that the patient had a past medical history of a tracheostomy that required oxygen delivered through a ventilator. Further review revealed the following: The Comprehensive Interdisciplinary Assessment dated for 07/17/24, that includes the Initial Plan of Care for P1, stated, “... Patient has chosen to participate in assessment ... Other ... on trach attached to ventilator ... Other Co-Morbidities ... chronic hypoxic respiratory problem ... Review of Systems ... Mouth, Neck, Throat ... trach in place and secured ... Respiratory ... Oxygen use ... trach on ventilator support ...” There lacked documented evidence of a physician order for oxygen through the patient’s tracheostomy during patient’s hemodialysis treatments. The hemodialysis treatment flow sheets dated 7/19/24 through 8/7/24 revealed the following: On 7/22/24, the following Note was documented at 3:26 PM by the Registered Nurse (RN), “... Suctioning done, for further observation ...” There was no documented evidence that the patient was on a ventilator, had a tracheostomy, and/or was receiving oxygen on this hemodialysis treatment flow sheet or on any of the other treatments reviewed. There lacked documented evidence that the facility’s nephrologist ordered oxygen to be given through the patient’s tracheostomy during P1’s hemodialysis treatments. There lacked documented evidence that the facility’s nephrologist ordered a ventilator to be utilized for the patient’s respiratory support during hemodialysis treatments. On 8/8/24 at 3:05 PM, S17, the Director of Nursing, stated that there was no documentation in the hemodialysis treatment sheets, which included the RN physical assessments, of a tracheostomy, pulse oxygen levels, ventilator use, and delivered dose of oxygen. Upon request for a staff education plan related to care of the tracheostomy patient during hemodialysis and request for a facility policy on the care of the tracheostomy patient, S17 was unable to provide.”

“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: 39223 Based on observation, medical record review, staff interview and review of facility documents, it was determined that the facility failed to implement the patient plan of care (POC) for managing the patient’s volume status for two of five medical records reviewed (Patient (P) 1 and P5). Findings include: A review of Medical Record (MR) 1 indicated a physician’s order for hemodialysis treatment three times per week and included a dry weight (DW) of 45.0 kilograms (kg). A Comprehensive Interdisciplinary Assessment, which included the Plan of Care, dated 07/17/24, stated, “... Treatment Rx [Prescription] ... Dry Weight (Kg): 45.00 ... Treatment Information ... achieving the edw [estimated dry weight] goal and BP [blood pressure] protocol ... Avg [Average] Weight Gain 0.5 ... Adequacy Treatment Plan: Continue the current dialysis prescriptions. ...”The “RTC Hemodialysis Treatment Information” documentation for the hemodialysis treatments completed 7/19/24 through 8/2/24 were reviewed and revealed the following: On 7/22/24, P1’s post treatment weight was 45.5 kg. On 7/24/24, P1’s pre-treatment weight was 51.1 kg. This was 5.6 kg more than the last treatment’s post-weight. 6.1 kg would need to be removed to attain the ordered DW. After removal of 0.5 kg, the post-treatment weight was 50.6 kg. This was less than 50% of the amount needed to meet the DW. On 7/26/24, P1’s pre-treatment weight was 52.6 kg. This was 7.1 kg more than the last treatment’s post-weight. 7.6 kg of fluid needed to be removed to attain the ordered DW. After removal of 0.5 kg, the post-treatment weight was 52.1 kg. This was less than 50% of the amount needed to meet the DW. On 7/29/24, P1’s pre-treatment weight was 51.9 kg. 6.9 kg of fluid needed to be removed to meet the ordered DW. After removal of 2.5 kg, the post-treatment weight was 49.4 kg. This was less than 50% of the amount needed to meet the DW. On 7/31/24, P1’s pre-treatment weight was 54.3 kg. This was 4.9 kg more than the last treatment’s post-weight. 9.3 kg of fluid needed to be removed to attain the ordered DW. After removal of 1.1 kg, the post-treatment weight was 53.2 kg. This was less than 50% of the amount needed to meet the DW. On 8/2/24, P1’s pre-treatment weight was 53.6 kg. 8.6 kg of fluid needed to be removed to attain the ordered DW. After removal of 1.9 kg, the post-treatment weight was 51.7 kg. This was less than 50% of the amount needed to meet the DW. The above findings were reviewed with Staff (S) 17, the Director of Nursing on 8/8/24 at 3:05 PM. S17 stated that the Charge RN should notify the Nephrologist when a patient’s weight is significantly above the dry weight. S17 confirmed that there was no documented evidence that the Nephrologist was notified when the patient gained more than 2.5 kg between treatments or that the patient was consistently not meeting the prescribed dry weight. 49828 Patient (P) 5’s medical record (MR) documented a physician’s order for hemodialysis treatment that included an estimated dry weight (EDW) of 98 kilograms (kg). On 07/17/24, a POC meeting for P5 had been conducted and a note from Staff (S) 17, Director of Nursing, stated, “Adjust EDW.” The Care Teams “Signatures” section of the PoC lacked documentation that the Nephrologist reviewed the assessment and did not contain a signature from the Nephrologist. “Hemodialysis Treatment Information” were reviewed for 7/19/24 through 8/7/24 and revealed the following: On 7/19/24, P5’s pre-treatment weight was 88.7 kg. and the post-treatment weight was 86.5 kg. The post-treatment weight was 11.5 kg less than the EDW. On 7/22/24, P5’s pre-treatment weight was 84.5 kg, and the post-treatment weight was 82.9 kg. The post-treatment weight was 15.1 kg less than the EDW. On 7/24/24, P5’s pre-treatment weight was 82.9 kg, and the post-treatment weight was 82.5 kg. The post-treatment weight was 15.5 kg less than the EDW. On 7/26/24, P5’s pre-treatment weight was 84.5 kg, and the post-treatment weight was 83 kg. The post-treatment weight was 15 kg less than the EDW. On 7/29/24, P5’s pre-treatment weight was 83.5 kg, and the post-treatment weight was 84.2 kg. The post-treatment weight was 13.8 kg less than the EDW. On 7/31/24, P5’s pre-treatment weight was 92.8 kg, and the post-treatment weight was 91.3 kg. The post-treatment weight was 6.7 kg less than the EDW. On 8/2/24, P5’s pre-treatment weight was 81.6 kg, and the post-treatment weight was 80.4 kg. The post-treatment weight was 17.6 kg less than the EDW. On 8/5/24, P5’s pre-treatment weight was 83.3 kg, and the post-treatment weight was 82.1 kg. The post-treatment weight was 15.9 kg less than the EDW. On 8/7/24, P5’s pre-treatment weight was 81.9 kg, and the post-treatment weight was 80.9 kg. The post-treatment weight was 17.1 kg less than the EDW. On 7/17/24, a POC meeting for P5 had been conducted and a note from Staff (S) 17, Director of Nursing, stated, “Adjust EDW.” The Care Teams “Signatures” section of the POC lacked documentation that the Nephrologist reviewed the assessment and did not contain a signature from the Nephrologist. During an interview on 8/9/24 at 10:00 AM, S2, Medical Director and P5’s Primary Nephrologist, stated that S8, Charge Nurse, calls to communicate patients’ weights. S2 stated there is no set standard for weight communication and he/she will monitor the patient’s weight to see if weight loss from hospitalizations can be corrected prior to changing the EDW. S2 confirmed that the communications with S8 were not documented into the patient’s medical record and stated, “we need to do better with our notes.” A review of the facility policy titled, “Comprehensive Interdisciplinary Assessment Policy,” stated, “ ...Component of The Comprehensive Assessment: The comprehensive assessment must include, but is not limited to, the following: ...3. Evaluation of blood pressure and fluid management ...”. A review of facility policy titled, “Clinical Parameters for Notification of the Registered Nurse and/or Nephrologist or APRN [Advanced Practice Registered Nurse] Policy and Procedure,” revised 8/10/22, stated, “... 4. Patient data reportable to the licensed registered nurse prior to initiation of treatment may include the following: Weight: [symbol for greater than or equal to] 2.5 kg weight gain from previous treatment ... 5. Post treatment findings reportable to the licensed nurse may include the following: Fluid removal: Less than 50% of the prescribed treatment goal removed ... 6. The licensed nurse notified the physician as needed of the changes in the patient’s condition. ...” N.J.A.C. 8:43A-24.13(b)”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 39223 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all patient Plan of Care (POC) meetings are attended and signed by all members of the interdisciplinary team (IDT) for four of five medical records reviewed (Patient (P) 1, P2, P3, and P5) Findings include: A review of P1’s medical record revealed that a POC meeting was held on 7/17/24. There lacked documented evidence of a physician’s comprehensive assessment and a signature documenting attendance at the meeting by the physician. A review of P3’s medical record revealed that a POC meeting was held on 2/28/24. There lacked documented evidence of a physician’s comprehensive assessment and a signature documenting attendance at the meeting by the physician. A review of P5 medical record revealed a POC meeting was held on 7/17/24. There lacked documented evidence of a physician’s signature documenting attendance at the meeting by the physician. The above findings were reviewed with Staff (S) 17, the Director of Nursing. During an interview on 8/8/24 at 12:40 PM, S17 stated that the Registered Nurse (RN), Social Worker (SW), and Renal Dietician (RD) attend POC meetings, but the attending physician is not always there at the meeting. 39228 A review of P2’s medical record revealed that P2 was admitted to the facility on 10/18/23. The Initial Comprehensive Interdisciplinary Assessment meeting was held on 11/22/23. The SW Psychosocial Assessment portion of the comprehensive interdisciplinary assessment was blank. The Care Teams “Signatures” section lacked documentation that the SW reviewed the assessment and did not contain a signature from the SW. On 8/9/24 at 11:15 AM, an interview was conducted with S5, the SW. S5 was questioned regarding the blank areas of the above plan of care and the lack of a signature from the SW for P2. S5 stated, “I was out on medical leave from October 2023 until January 2024 and if the meetings were done during that time frame, then I did not complete them.” S5 then stated that no one was covering for him/her while they were out on leave. A review of the facility policy titled, “Comprehensive Interdisciplinary Assessment Policy,” last revised 3/31/17, stated, “... Performed by: Interdisciplinary Team (Attending physician or physician extender (where permitted by State law), registered nurse (RN) , registered dietician (RD), and Social Worker (SW), patient and/or care partner ... Policy: ... The comprehensive assessment and plan of care must be developed by an interdisciplinary team (IDT) consisting of at least the attending physician/physician extender treating the patient for ESRD, a registered nurse, a social worker, a registered dietitian and patient or patient designee, if patient chooses. ... Comprehensive assessment Frequency: An initial comprehensive assessment shall be conducted on all new patients ... within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session ...” N.J.A.C. 8:43A-24.13(b) N.J.A.C. 8:43A-24.13(c)”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 39223 Based on three of three personnel files reviewed (Staff (S) 6, S7, and S9), medical record review, staff interviews, and review of facility policy, it was determined that the Medical Director failed to implement the facility’s staff education plan by ensuring that: 1) All staff receive an annual evaluation of their competencies; and 2) Staff providing care are educated on the assessment and care of patients with oxygenation needs. Findings include: 1) Review of personnel files for S6, a Registered Nurse, S7, a Certified Hemodialysis Technician, and S9, a Certified Hemodialysis Technician, did not include annual clinical skills competency documentation. During an interview on 8/12/24 at 12:52 PM, S17, the Director of Nursing, confirmed that the annual competencies were not completed and stated that the facility was developing a form for documenting staff annual competencies. 2) On 8/7/24 at 10:50 AM, during a tour of the hemodialysis unit, Patient (P) 3 received hemodialysis in Station 10. P3 was receiving oxygen at 4 L (liters) per minute through a tracheostomy collar that was placed directly in front of P3’s open tracheostomy. During an interview on 8/7/24 at 10:42 AM, S8, the Charge Nurse, stated that the staff received education of tracheostomy patients from him/her as part of their training. Review of Medical Record (MR) 1 and MR3 revealed that both patients were noted in their Plans of Care to have tracheostomies and ventilators. Both medical records indicated that the patients required unspecified levels of oxygen in their Plans of Care. MR 1 documented an episode of suctioning. (Cross refer V 542). During an interview on 8/8/24 starting at 3:02 PM, S17 stated that the nurses are informally trained by the Respiratory Therapist and Charge Nurse on how to care for tracheostomy and ventilator patients during hemodialysis. Upon request for documented evidence of staff education and competencies on the care of the tracheostomy and/or ventilated patient during hemodialysis, S17 was unable to provide. Facility policy titled, “Initial Orientation and Annual Clinical Staff Training and Competency Policy,” approved 12/01/21, stated, “... 2. Dialyze Direct provides for the continuing educational needs of its staff based on assessment of staff performance, as well as regulatory requirements. ... 6. Verification of clinical competencies are required for all patient care personnel initially and annually, to consist of knowledge assessments and observations of task performance. ...” N.J.A.C. 8:43A-24.12(a) N.J.A.C. 8:43A-24.12(b)”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 39223 Based on observation, medical record review, and staff interview, it was determined that the Medical Director failed to develop and implement a policy for care of the tracheostomy and/or ventilated patient during hemodialysis treatment. Findings include: On 8/7/24 at 10:50 AM, during a tour of the hemodialysis unit, Patient (P) 3 received hemodialysis treatment in Station 10. P3 received oxygen at 4 L (liters) per minute through a tracheostomy collar that was placed directly in front of P3’s open tracheostomy. Review of Medical Record (MR) 1 and MR3 revealed that both patients were noted in their Plans of Care to have tracheostomies and ventilators. Both medical records indicated that the patients required unspecified levels of oxygen in their Plans of Care. MR 1 documented an episode of suctioning. (Cross refer V 542). During an interview starting at 3:05 PM on 8/8/24, Staff (S) 17, the Director of Nursing, stated that there was no documentation in the hemodialysis treatment sheets, which included the RN physical assessments, of a tracheostomy, pulse oxygen levels, ventilator use, and delivered dose of oxygen for P1 and P3. Upon request for a facility policy on the care of the tracheostomy patient, S17 was unable to provide. During an interview starting at 9:50 AM on 8/9/24, S2, the Medical Director, stated that a Respiratory Therapist will come over from the connected Nursing Home when a nurse calls because a ventilated or tracheostomy patient need assistance. S2 stated that the Dialysis Registered Nurse can assess and suction ventilated/tracheostomy patients. S2 also stated that the Charge Nurse will train the Dialysis RNs during orientation on this patient population. S2 stated that S17 would have documentation of the training. N.J.A.C. 8:43A-6.3(a)(3)”