Fmc Irvington

“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 one of one emergency cart and two of two emergency evacuation boxes are properly maintained and contain a comprehensive list of contents, documents including the staff emergency contact list and patient’s treatment information, and that expired items are not available for use. Findings include: On 06/04/25, in the In-Center Treatment Area, the emergency evacuation boxes, and the emergency cart were reviewed and revealed the following: At 12:30 PM, Staff (S)10 (Biomedical Technician) provided a checklist titled, “Emergency Box Contents Log In-Center - Monthly,” dated 05/05/25. The checklist indicated that a portable radio and a sharps container were included in the emergency evacuation boxes; however, the boxes did not contain the items. The checklist also indicated that the lock number of one of the boxes was 6956738 but the locks on the boxes were numbered 6956757 and 6957681, which did not match what was documented for one of the boxes. Upon further review, the evacuation boxes contained the following items: three tourniquets, 11 clamps, three airways, fifteen, 18g (gauge) needles, 36 syringe caps, and three tongue blades which were not included on the checklist. The emergency boxes also lacked a staff emergency contact list and patients’ dialysis treatment information. At 12:55 PM, S3 (Clinical Manager) and S10 confirmed that the radio and the sharps container were not in the box, that the checklist did not include the above supplies and that the staff emergency contact list and the patient’s dialysis information were not included in the emergency boxes. At 1:20 PM, the emergency cart checklist titled, “Emergency Code Cart and Medication Checklist (Monthly),” dated 05/05/25, was reviewed. It listed a suction canister with no expiration date; however, the cart had a suction canister that expired in 02/2017. The checklist indicated a 10F (French) catheter, an airway, and a sharps container. The cart did not contain a 10F catheter, an airway, or a sharps container. The cart also contained supplies not listed on the checklist which included 17-3cc (cubic centimeter) syringes, 15-10cc syringes, 3-60cc syringes, 34-18g needles, 6-22g needles, three Central Venous Catheter caps, five Intravenous (IV) Blood Collection Sets, one BP (blood pressure) cuff, one stethoscope, eight plastic hemostat clamps, and three humidifier canisters. Upon further review, the cart also contained the following expired items: 6-0.9% Normal Saline Solution bags (expired 06/2023), two boxes of 2x2 gauze pads (expired 05/2022 and 07/2023), three Recirculating Adapters/Priming Connectors (expired 10/2020), three IV administration sets (two expired 12/2020 and one expired 02/2022), and three nasal cannulas (expired 06/2023). At 1:45 PM, S4 (Registered Nurse) confirmed that the cart was checked monthly and stated he/she was not aware that the suction canister had an expiration date. S3 also confirmed the missing items, the supplies not included on the checklist, and the presence of the above expired supplies. A Pharmacist’s Quarterly Review dated 05/19/25, stated that all emergency kits, medications, and evacuation kits were “in good date.” 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 be 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 ... An itemized log must be kept indicating the contents and expiration dates of contents ...” N.J.A.C. 8:43A-15.1(a)”

“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 one of one observation of a clean/dirty workspace/area, staff interview, and a 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 06/04/25 during a tour of the Hemodialysis Treatment Floor, the following was revealed: At 10:02 AM, a portable, three-tiered metal shelf, located by the half wall across from Station 4, contained the following clean supplies on all three shelves: 21-1-liter NSS (Normal Saline Solution) bags, 18 BiBag bags (dry bicarbonate concentrate used in hemodialysis treatment), and 16 hemodialysis tubing sets in plastic packaging. A large gray trash container was observed to directly touch the metal shelf. Staff were observed disposing used gloves, gowns, wet paper towels, and used supplies into the gray trash container, creating the potential for cross contamination of the clean supplies. Upon discovery, Staff (S)7 (Patient Care Technician), stated the portable metal clean supply shelf should not touch the trash can and stated, “The trash cans are usually kept at the ends of the half wall away from the metal shelves where clean supplies are stored. I don’t know how it got there.” 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-24.8(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: 51990 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the plastic hemostat clamps were disinfected in accordance with facility policy. Findings include: On 06/04/25 at 12:30 PM, during a tour of the Treatment Area, a clear plastic container, located on the “dirty sink” countertop area, had 39 plastic hemostat clamps inside that were soaking in an unlabeled liquid. Thirteen of the clamps were observed in a closed position, and five were not fully submerged in the solution. During an interview at 12:45 PM, Staff (S)4 confirmed the clamps in the container were being soaked in a diluted bleach solution. S4 confirmed that the container was not labeled with the bleach-to-water dilution ratio, date, or initials of the staff member that prepared it. S4 was unable to identify the bleach-to-water dilution ratio that was mixed in the container. S4 also acknowledged that the clamps should be in an open position and fully submerged while soaking in the disinfectant. Facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/5/23, stated, “... Bleach Solution ... Bleach solution will be mixed in the appropriate dilution in accordance with the type of cleaning and disinfection required ... Cleaning Clamps ... Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution per the Mixing Bleach policy... Make sure the items are completely submerged, unclamped, and in open position when placed in the solution ...” Facility policy titled, “Mixing Bleach,” published 02/03/25, stated, “ ... Background ... Understanding dilution ratios: ... Diluting a bleach solution to: 1:100 = 1 part bleach to 99 parts water... 1:10 = 1 part bleach to 9 parts water ... Procedure ... Follow the steps below for mixing bleach: ... Step ... 2. Pour the measure amount of water needed into a labeled opaque container. Measuring ensures proper concentration ... 4. Label opaque container with “Bleach Solution”, strength of solution, date and time prepared and preparer’s initials ...” N.J.A.C. 8:43A-24.8(b)”

“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: 37656 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 all staff adhere to the manufacturer’s recommendations for the water hardness test strips. Findings include: On 06/04/25 at 10:30 AM, an open bottle of Water Soft 0-30+ ppm (parts per million) Water Hardness test strips was observed in the clean supply area in front of the Nurses’ Station. The bottle did not specify the date it was opened. The Water Soft 0-30+ ppm Water Hardness test strips MIFU stated, “Use by date within expiration (4 (four) months after opening).” In an interview on 06/04/25 at 10:40 AM, Staff (S)4 (Registered Nurse), stated that the test strips were used at the start of the day on 06/04/25. S4 confirmed that the bottle had no date of opening and discarded the bottle.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 50912 Based on two of two observations of patient monitoring during hemodialysis (Patients [P]8 and P13), staff interview and a review of facility documents, it was determined that the facility failed to ensure all patients’ access and bloodline connections remain in view of staff throughout the dialysis treatment to ensure patient safety. Findings include: On 06/04/25 at 10:07 AM, in Station 13, during an observation of P8’s hemodialysis through a right femoral Central Venous Catheter (CVC, a type of access used for hemodialysis), the following was revealed: P8 had a white blanket on top of his/her right femoral area which covered him/her from the waist down to his/her knees. The blanket did not allow for the CVC access to be visible to staff. At 10:28 AM, Staff (S)5 (Registered Nurse), entered Station 13, typed on the dialysis machine’s keyboard, did not uncover the access, then exited the station. At 11:08 AM, P8’s access continued to remain covered with the blanket. P8’s access was not visible to staff from 10:07 AM to 11:08 AM, a length of 61 minutes. During an interview on 06/04/25 at 11:08 AM, S5 confirmed this finding and stated that a patient’s access should be checked every 20 minutes and should remain uncovered while on hemodialysis. 37656 On 06/04/25 at 10:10 AM, during a tour of the Treatment Area, in Station 15, P13’s dialysis access and a portion of the dialysis bloodlines were covered by a white blanket and the patient was asleep. At 10:42 AM, S4 (Registered Nurse), was in the station typing on the machine’s keyboard. S4 did not uncover the access and the bloodlines and exited the station without checking the patient’s access. Upon interview on 06/04/25 at 10:45 AM, S4 stated that they are supposed to assess the patient’s vital signs and check the vascular access and bloodlines to make sure they are visible to staff every 20 minutes and document in the treatment flow sheet. Facility policy titled, “Patient Assessments and Monitoring,” published 05/01/2023, stated, “... During Treatment ... Follow the steps below for monitoring patient and machine parameters during treatment: ... Access ... Ensure access remains uncovered throughout the treatment ...” N.J.A.C. 8:43A-24.4(a)”

“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 one observation 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 06/04/25 at 9:41 AM in Station 13, Staff (S)5 (Registered Nurse) initiated hemodialysis on Patient (P)8 through a right femoral CVC. During the procedure, the curtain was not fully drawn in front of the patient leaving an approximate two feet opening. P8’s groin was visible to the patient in Station 11, which was located directly across from Station 13. During an interview on 06/04/25 at 9:48 AM, S5 confirmed that the curtains should be fully closed around the patient’s station when initiating hemodialysis and stated that he/she will make sure that the curtains are fully closed next time. A review of S5’s personnel file indicated that “Compliance, Privacy and Security,” a web-based learning activity, was completed on 10/21/23. 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-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50912 Based on medical record review, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that abnormal blood pressures (BP) occurring during three of nine hemodialysis treatments for Patient (P)7 are assessed by the Registered Nurse (RN) in accordance with facility policy and procedure. Findings include: A review of P7’s Plan of Care, dated 05/19/25, stated, “... BP and Fluid Management ... Goal: Achieve BP control as specified by the patient’s physician ... Met Goal ... Continue to monitor patient ... In Progress ...” A review of P7’s Treatment Sheet for Facility revealed the following: On 05/19/25 the following was documented by a Patient Care Technician (PCT): 17:01 [5:01 PM] BP 165/101; “... Denies complaint ...” 17:26 [5:26 PM]: BP 156/102 17:45 [5:45 PM]: BP 151/102 18:09 [6:09 PM]: BP 157/111; “... Treatment discontinued without problem. Problem: Diastolic high, no c/o (complaint). Ended. ...” There was no documented evidence that the PCT alerted the RN of P7’s elevated diastolic blood pressures throughout the duration of hemodialysis treatment. Additionally, the medical record lacked documented evidence that the RN acknowledged the abnormal blood pressure and assessed P7 for symptoms of hypertension in accordance with facility policy. On 05/21/25 the following was documented by a PCT: 17:20 [5:20 PM]: BP 168/110; “... Denies complaints ...” 17:40 [5:40 PM]: BP 174/111 17:59 [5:59 PM]: BP 161/113 18:20 [6:20 PM]: BP 177/105 “... Treatment discontinued without problem. Problem: BP HIGH, NO C/O (complaint of). ...” There was no documented evidence that the PCT alerted the RN of P7’s elevated diastolic blood pressures throughout the duration of hemodialysis treatment. Additionally, the medical record lacked documented evidence that the RN acknowledged the abnormal blood pressure and assessed P7 for symptoms of hypertension in accordance with facility policy. On 05/23/25 the following was documented by a PCT: 16:01 [4:01 PM]: BP 171/100; “... Denies complaints ...” 16:23 [4:23 PM]: BP 180/105 16:41 [4:41 PM]: BP 184/109 17:02 [5:02 PM]: BP 184/112 17:21 [5:21 PM]: BP 173/110 17:41 [5:41 PM]: BP 188/116 18:01 [6:01 PM]: BP 132/107 “... Denies complaints ...” There was no documented evidence that the PCT alerted the RN of P7’s elevated diastolic blood pressures throughout the duration of hemodialysis treatment. Additionally, the medical record lacked documented evidence that the RN acknowledged the abnormal blood pressure and assessed P7 for symptoms of hypertension in accordance with facility policy. On 06/05/25 at 12:07 PM, above findings were reviewed and confirmed with Staff (S)3 (Clinic Manager). S3 stated that the PCT should have notified the RN immediately of the elevated blood pressures. S3 stated that the RN is expected to assess the patient and notify the nephrologist for further orders, Facility policy titled, “Patient Assessment and Monitoring,” Published 05/01/2023 stated, “Purpose ... to provide guidance to (name of facility) direct patient care staff on assessment and monitoring patients before, during and after treatment ... The direct patient care staff may obtain the following data ... Blood Pressure ... Record blood pressure. Verify. Systolic blood pressure greater than 180 mm/Hg (millimeters of Mercury) and/or diastolic blood pressure greater than 100 mm/Hg. ... the Registered Nurse will review the data collected above and assess the following parameters as needed ... determine if any clinical interventions are necessary ... 3. Document findings and interventions in the medical record. Contact the physician as needed for additional orders based on assessment findings and clinical judgement ... During Treatment Step 1 ... Blood Pressure: Record blood pressure ... Report to the nurse ... Systolic blood pressures greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg ...” N.J.A.C. 8:43A-24.4(a)”

“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: 37656 Based on medical record review, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that: 1) the plan of care for a patient’s target weight is achieved through dialysis treatment in one of five medical records reviewed (Patient [P]1) and; 2) staff assess and evaluate all patients for edema (fluid build-up in the body tissues) post (after) hemodialysis treatment in accordance with facility policy in five of five medical records reviewed (P1,P2, P3, P5, and P6). Findings include: 1. P1’s Hemodialysis Orders dated, 04/12/25 stated, “Treatment time: 04:00 (4 hours) ... EDW (estimated dry weight) 65.5 kg (kilogram) ...” A review of P1’s plan of care, dated 05/12/25, 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 signs and symptoms of fluid overload ... In Progress ... Monitor fluid gains and discuss high weight gains with patient ... In Progress ...” A review of P1’s “Treatment Sheets For Facility” revealed the following: On 05/15/25, Pre-weight (before dialysis) -73.00 kg, 7.50 kg above the EDW, Post weight (after dialysis): 71.10 kg, 5.6 kgs above the EDW. On 05/17/25, Pre-weight -71.60 kg, 6.10 kg above the EDW, Post weight: 69.80 kg, 4.3 kgs above the EDW. On 05/20/25, Pre-weight -71.20 kg, 5.70 kg above the EDW, Post weight: 70.20 kg, 4.7 kgs above the EDW. On 05/22/25, Pre-weight -71.00 kg, 5.50 kg above the EDW, Post weight: 70.80 kg, 5.3 kgs above the EDW On 05/24/25, Pre-weight -72.70 kg, 7.20 kg above the EDW, Post weight: 71.20 kg, 5.7 kgs above the EDW On 05/27/25, Pre-weight -73.60 kg, 8.10 kg above the EDW, Post weight: 71.60 kg, 6.1 kgs above the EDW On 05/29/25, Pre-weight -72.60 kg, 7.10 kg above the EDW, Post weight: 71.20 kg, 5.7 kgs above the EDW On 05/31/25, Pre-weight -72.90 kg, 7.40 kg above the EDW, Post weight: 71.50 kg, 6.0 kgs above the EDW On 06/03/25, Pre-weight -72.50 kg, 7.0 kg above the EDW, Post weight: 71.70 kg, 6.2 kgs above the EDW The above treatment flow sheets indicate P1 was not dialyzed in accordance with the provider’s EDW order of 65.5 kg. The treatment flow sheets also did not contain documentation from the RN that the EDW had been addressed and discussed with the physician. In an interview on 06/06/25 at 9:30 AM, Staff (S)3 (Clinic Manager) stated that the EDW should have been discussed with the physician. 2. A review of P1’s “Treatment Sheets For Facility” revealed the following; On 05/15/25, 05/17/25, 05/20/25, 05/27/25, and 05/29/25, the pre-treatment Nursing Evaluation, stated, “Fluid Assessment ... Lower leg, 1+(one plus): 2 mm (two millimeters) or less, disappears rapidly ... Ankle - Severity 1+: 2 mm or less, disappears rapidly ...Edema Lower Leg -Location ... Bilateral ... Edema Ankle -Location ... Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the ankle and lower leg edema. On 05/22/25 and 06/03/25 the pre-treatment Nursing Evaluation, stated, “Fluid Assessment ... Ankle - Severity 1+ : 2 mm or less, disappears rapidly ... Edema Ankle -Location ... Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the ankle edema. On 05/31/25, the pre-treatment Nursing Evaluation, stated, “Fluid Assessment ... Lower leg, 1+: 2 mm or less, disappears rapidly ... Edema Lower Leg -Location ... Bilateral” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lower leg edema. In an interview on 06/05/25 at 2:40 PM, the above flow sheets were reviewed with Staff (S) 3 (Clinic Manager). S3 confirmed the above findings and stated that if there were abnormal findings in the pre-assessment of the patients, the staff should document a re-assessment of the abnormal findings post-treatment. A review of P2’s plan of care, dated 04/28/25, 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 ... Monitor fluid gains ... In Progress ...” A review of P2’s “Treatment Sheets For Facility” from 05/14/25 through 06/03/25 revealed the following: On 05/24/25 and 06/03/25, the pre-treatment Nursing Evaluation, stated, “Fluid Assessment ... Edema ... Ankle Bilateral ... Lower leg Bilateral ... 1+: 2 mm or less, disappears rapidly.” The post-treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the bilateral ankle and leg edema. On 06/05/25 at 1:38 PM, the above findings were reviewed with S3. S3 confirmed that the post hemodialysis re-assessment of edema was not documented on the above mentioned hemodialysis flowsheets and stated that staff nurses should reassess and document post-treatment edema if abnormal findings were found pre-treatment. A review of P3’s plan of care, dated 04/14/25, stated, “Area of Focus BP 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 ... Monitor fluid gains ... In Progress ...” A review of P3’s “Treatment Sheets For Facility” from 05/14/25 through 06/03/25 revealed the following: On 05/20/2025, 05/22/2025, 05/29/2025, 05/31/2025, and 06/03/2025, the pre-treatment Nursing Evaluation, stated, “Fluid Assessment... Ankle - Severity 1+: 2 mm or less, disappears rapidly ...Edema Lower Leg -Location ... Bilateral ... Edema Ankle -Location ... Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lower leg and ankle edema. A review of P5’s plan of care, dated 04/14/25, stated, “Area of Focus BP 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 ... Monitor fluid gains ... In Progress ...” A review of P5’s “Treatment Sheets For Facility” from 05/14/25 through 06/03/25 revealed the following; On 05/15/25, 05/17/25, 05/20/25, 05/22/25, 05/24/25, 05/27/25, 05/29/25, 05/31/25, and 06/03/25, the pre-treatment Nursing Evaluation, stated, “Fluid Assessment... Ankle - Severity 1+: 2 mm or less, disappears rapidly ...Edema Lower Leg -Location ... Bilateral ... Edema Ankle -Location ... Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lower leg and ankle edema. On 06/05/25 at 12:15 PM, S3 reviewed the above findings and confirmed that no post-treatment edema assessment was documented for P3 and P5. A review of P6’s plan of care, dated 03/17/25, stated, “Area of Focus BP 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 ... Monitor fluid gains ... In Progress ...” A review of the “Treatment Sheets For Facility” from 05/14/25 through 06/03/25 in P6’s medical record revealed the following: On 05/21/25 at 12:27 PM, the pre-treatment “Nursing Evaluation” indicated “Sacrum (Supine Patients), 1+: 2 mm or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:58 PM lacked documented evidence of a re-assessment of the sacral edema. On 05/23/25 at 12:44 PM, the pre-treatment “Nursing Evaluation” indicated “Sacrum (Supine Patients), 1+: 2 mm or less, disappears rapidly.” The post-treatment “Nursing Evaluation” at 3:44 PM lacked documented evidence of a re-assessment of the sacral edema. On 06/05/25 at 1:38 PM, the above findings were reviewed and confirmed with S3 and stated that the staff nurses should reassess and document post-treatment edema if abnormal findings were found pre-treatment. Facility policy 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 ... Severity ... Post Assessment ... Follow the steps below for obtaining post-treatment assessing data: ... 1. The direct patient care staff may obtain the following: ... Edema ... The Registered Nurse will assess/ re-asses post treatment as indicated ... 2. Document findings in the patient’s record ...” N.J.A.C. 8:43A-24.4(a) 50912 51990”

“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 staff interview, a review of three of three medical records (Patient [P]2, P6, and P7) and a review of facility documents, it was determined that the facility failed to ensure patients receive the prescribed BFR (Blood Flow Rate, the speed at which blood is pumped through the dialyzer during hemodialysis) as ordered by the physician. Findings include: A review of P2’s medical record revealed the following: The plan of care, dated 05/19/25, stated, “Area of Focus Dialysis Adequacy (IHD) Access Open ... Intervention (s): Educate patient/family/caregiver on adequacy principles ... In Progress ... Continue to monitor patient In Progress ...” The “Orders Summary Report,” dated 05/14/25, the physician order stated, “... 180 NRe Optiflux, BFR 400, DFR (Dialysis Flow Rate) Manual 800 ml/min (milliliter per minute) ...” The hemodialysis treatment sheets, “Treatment Sheet for Facility,” from 05/17/25 to 06/03/25 indicated that the prescribed BFR of 400 was not followed on the following treatment dates: On 05/20/25, a BFR of 350 mL/min was set from the initiation of the treatment at 4:00 PM until the end of the treatment at 8:01 PM. On 05/27/25, a BFR of 400 mL/min was set from the initiation of the treatment at 3:37 PM and was changed to 300 mL/min at 4:01 PM and remained at 300 mL/min until the end of the treatment at 7:40 PM. On 05/29/25, a BFR of 350 mL/min was set from the initiation of the treatment at 12:39 PM until the end of the treatment at 3:24 PM. On 05/31/25, a BFR of 350 mL/min was set from the initiation of the treatment at 12:43 PM until the end of the treatment at 4:02 PM. On 06/03/25, a BFR of 350 mL/min was set from the initiation of the treatment at 12:17 PM and was changed to 325 mL/min at 1:04 PM and remained at 325 mL/min until the end of the treatment at 4:42 PM. On 06/05/25 at 1:38 PM, these findings were reviewed and confirmed with Staff (S)3 (Clinical Manager). A review of P6’s medical record revealed the following: The plan of care, dated 03/17/25, stated, “Area of Focus Dialysis Adequacy (IHD) Access Open ... Intervention (s): Continue to monitor patient In Progress ...” The “Orders Summary Report,” dated 05/02/25, the physician order stated, “...250 NRe Optiflux, BFR 450, DFR Manual 800 ml/min ...” The hemodialysis treatment sheets, “Treatment Sheet for Facility,” from 05/14/25 to 06/03/25 indicated that the prescribed BFR of 450 was not followed on the following treatment dates: On 05/14/25, a BFR of 450 mL/min was set from the initiation of the treatment at 12:26 PM and it was changed to 350 mL/min at 1:22 PM and remained at 350 mL/min until the end of the treatment at 3:44 PM. On 05/23/25, a BFR of 450 mL/min was set from the initiation of the treatment at 12:49 PM and was changed to 400 mL/min at 1:00 PM and remained at 400 mL/min until the end of the treatment at 4:00 PM. On 05/26/25, a BFR of 450 mL/min was set from the initiation of the treatment at 12:52 PM and was changed to 350 mL/min at 1:01 PM and remained at 350 mL/min until 3:47 PM. On 06/05/25 at 2:03 PM, these findings were reviewed and confirmed with S3. A review of P7’s medical record revealed the following: The plan of care, dated 05/19/25, stated, “Area of Focus Dialysis Adequacy (IHD) Access Open ... Intervention (s): Continue to monitor patient In Progress ...” The “Orders Summary Report,” dated 05/14/25, the physician order stated, “... 160 NRe Optiflux, BFR 400, DFR Manual 800 ml/min ...” The hemodialysis treatment sheets, “Treatment Sheet for Facility,” from 05/14/25 to 06/02/25 indicated that the prescribed BFR of 400 was not followed on the following treatment dates: On 05/14/25, a BFR of 350 mL/min was set from the initiation of the treatment at 2:42 PM until the end of the treatment at 6:00 PM. On 05/16/25, a BFR of 350 mL/min was set from the initiation of the treatment at 2:47 PM, until the end of the treatment at 6:30 PM. On 05/21/25, a BFR of 400 mL/min was set from the initiation of the treatment at 2:33 PM, then changed to 350 ml/min at 3:02 PM and remained at 350 ml/min until the end of the treatment at 6:20 PM. On 05/26/25, a BFR of 350 mL/min was set from the initiation of the treatment at 2:24 PM, until the end of the treatment at 6:02 PM. On 05/28/25, a BFR of 350 mL/min was set from the initiation of the treatment at 2:48 PM, until the end of the treatment at 6:21 PM. On 05/30/25, a BFR of 350 mL/min was set from the initiation of the treatment at 2:38 PM, until the end of the treatment at 6:03 PM. On 06/02/25, a BFR of 300 mL/min was set from the initiation of the treatment at 2:29 PM, until the end of the treatment at 6:21 PM. On 06/05/25 at 12:07 PM, these findings were reviewed and confirmed with S3. The medical records for P2, P6, and P7 lacked documented evidence that the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the change in BFR, and the reason for the change. All three medical records also lacked evidence that the RN notified the physician that the BFR was set lower than the prescribed rate. During an interview on 06/05/25 at 2:03 PM, S3 confirmed that the dialysis prescriptions for P2, P6, and P7 were not administered according to the physician order on the above dates and that the documentation on the treatment records lacked notification of the RN by the PCT that the BFR had been adjusted, or notification of the physician to obtain an order by the RN to change the BFR. S3 provided the physicians orders for hemodialysis for the above dates which did not include any orders for the changes in the BFRs indicated above. Facility policy titled, “Patient Assessment and Monitoring” published 05/01/23, stated, “... Data Collection ... Direct patient care staff may collect data ... If the PCT... note any changes in the patient’s condition or vascular access ... the registered nurse must assess the patient. ... The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. ... During Treatment ... Document machine parameters ... every 30 or more often as needed ... Follow the steps below for monitoring ... machine parameters during treatment ... Machine Parameters and Extracorporeal Circuit ... Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ... Document any findings and interventions in the medical record ...” N.J.A.C. 8:43A-24.4(a)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 51990 Based on three of three observations of the initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G, a type of vascular access used for hemodialysis) for Patient [P]9, P11 and P12, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that staff clean and disinfect the patient’s vascular access site prior to initiating hemodialysis treatment in accordance with the facility policy. Findings include: On 06/04/25 at 10:35 AM, at Station 10, Staff (S)9 (PCT, Patient Care Technician) initiated HD on P11 through a right arm AVF. S9 cleaned the arterial access site with a sterile alcohol pad for 15 seconds and then immediately cannulated the site with a fistula needle. The venous site was then cleaned with a new alcohol pad for 20 seconds, followed by immediate cannulation with a fistula needle. During an interview on 06/04/25 at 10:55 AM, Staff S9 confirmed that each needle site should have been cleaned with an alcohol pad for 30 seconds. On 06/04/25 at 10:40 AM, in Station 1, S6 (PCT) initiated HD through P9’s left forearm AVF. S6 cleansed the first site of the AVF with an alcohol pad in a circular motion for 18 seconds and immediately cannulated the site with a fistula needle. S6 cleansed the second site of the AVF with an alcohol pad in a circular motion for 16 seconds, then proceeded to cannulate the site with a fistula needle. Upon interview on 06/04/25 at 10:49 AM, S6 stated he/she should clean each site with an alcohol pad for 30 seconds and then allow them to dry. When questioned regarding the observation noted above, S6 stated, “I thought I had cleaned the sites long enough.” A review of S6’s training records revealed that he/she had completed AVG Education and Training in November 2023. S6’s file did not contain AVG education and training in 2024. At 11:00 AM in Station 4, S7 (PCT) initiated HD on P12 using a right arm AVG. S7 cleaned the arterial site with a clean alcohol pad for 7 seconds then immediately cannulated the arterial needle. The venous site was then cleaned for 11 seconds, followed by immediate venous needle cannulation. During an interview on 06/04/25 at 11:15 AM, when asked by the surveyor about disinfecting access sites, S7 stated, “I know I didn’t clean the sites for 30 seconds.” Facility policy titled, “Access Assessment and Cannulation,” published 05/05/25, stated, “ ...Skin Disinfection ... Step ... 1. Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds ... “ N.J.A.C. 8:43A-24.8(b) 50912”

“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 medical record review, staff interview, and a review of facility documents, it was determined that the Medical Director failed to ensure that: 1) a Registered Nurse (RN) completes a pre-treatment assessment for all new patients before initiating their first hemodialysis (HD) treatment in three of three medical records reviewed (Patient [P]1, P3 and P5); and, 2) Heparin is administered, prior to the initiation of HD, in accordance with facility policy in one of the two observations (P11). Findings include: 1. A review of P1’s medical record indicated that his/her first day of hemodialysis was 01/03/25. A review of P3’s medical record indicated that his/her first dialysis treatment was on 03/17/2025. A review of P5’s medical record indicated that his/her first dialysis treatment was on 03/20/2025. All three medical records lacked documented evidence that a Registered Nurse (RN) completed a pre-treatment assessment prior to the initiation of each patient’s first dialysis treatment in the facility. During an interview on 06/06/25 at 9:13 AM, Staff (S)3 (Clinic Manager) confirmed that the pre-treatment assessments for P1, P3, and P5 were not completed. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” published 07/03/23, stated, “ ... Prior to Initiation of the First Treatment for Patients New to Dialysis ... A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs ...” N.J.A.C. 8:43A-24.14(a)(4) 2. On 06/04/25 at 10:35 AM, in Station 10, S9 (Patient Care Technician) initiated HD on P11 through a right arm AVF (arteriovenous fistula). After the cannulation of the venous needle, at 10:47 AM, S5 (RN) administered Heparin through P11’s venous needle. At 10:49 AM, S9 initiated HD on P11. This was two minutes after the Heparin was administered. During an interview on 06/04/25 at 10:55 AM, Staff S9 acknowledged that he/she should have waited 3 minutes before starting dialysis. Facility policy titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” published 05/05/25, stated. “... Prior to Initiation: Heparin Administration ... If ordered by the physician, follow the steps below to systemically heparinize the patient: ... Step ... 4. Wait at least 3-5 minutes prior to initiation of dialysis to allow time for the protein-binding to occur, prevent loss of heparin through the dialyzer, and provide full anticoagulation as soon as treatment starts ...” N.J.A.C. 8:43A-9.3(a) 51990”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 37656 Based on three of three medical records reviewed (Patients [P]1, P3 and P5), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that all medical records are complete and accurate. Findings include: A review P1’s Initial Plan of Care (POC) dated 02/17/25 and the 90 day POC dated 05/12/25, revealed that the “Team Meeting Assessment” section stated: “Current Stability Status: N/A.” A review of P3 and P5’s Initial POC’s, both dated 04/14/25, revealed that the “Team Meeting Assessment” section stated: “Current Stability Status: N/A.” During an interview on 06/05/25 at 2:00 PM, S3 (Clinic Manager), stated that P1, P3, and P5 were all stable patients, and that the “N/A” entry is a system issue and is automatically generated. As a result, this does not reflect the patient’s stability status. A review of P3’s “History and Physical,” dated 03/01/25, revealed that the history and physical was written by an Internal Medicine Physician at a hospital prior to the patient’s admission on 03/17/25. The medical record lacked documented evidence that the attending Nephrologist at the dialysis facility completed a history and physical prior to P3’s first treatment at the facility. During an interview on 06/05/25 at 12:15 PM, S3 confirmed that there was no history and physical in the medical record from the attending physician at the dialysis facility. A review of P3 and P5’s RN (Registered Nurse) Comprehensive Initial Assessments (CIA) indicated the following: P3’s CIA, dated 04/09/25, noted that the Tuberculosis Skin Test (TST) status was “unknown;” however, the TST Administration Record showed a negative reaction on 03/19/25. P5’s CIA, dated 04/08/25, indicated that the TST status was “unknown,” while the record documented a negative reaction on 03/22/25. During an interview on 06/06/25 at 9:15 AM, S3 confirmed these findings. Facility policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care,” published, 07/03/23, stated, “ ... General Policy for Patient Assessment and Plan of Care ... Patient stability must be reviewed monthly. The Interdisciplinary team will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy ... Documents provided by the Patient’s Attending Physician prior to Admission ... The patient’s attending physician prior to admission to the facility will: Provide documentation including a current history and physical or hospital or clinic discharge summary prior to the patient’s first visit at the dialysis facility ...” Facility policy titled, “Documenting Progress Notes, Transfers, Transplants, Discharges and Order Review,” published 11/04/24, stated, “... Background ... The facility must maintain a complete and accurate medical record that is unique for each patient. Information in the medical record should clearly portray that patient, the care provided by facility staff and the outcomes of that care ... Progress Notes ... Progress/clinical notes may be written by each discipline including medical, nursing, nutrition services, social work and patient care technician as necessary. Progress/clinical notes documentation should provide a picture of the patient’s care, including response to treatment, Progress notes shall be written as necessary or according to state requirement to document the condition of care of the patient ...” N.J.A.C. 43A-13.3(a)(6) N.J.A.C. 8:43A-24:13(b) N.J.A.C. 8:43A-24.14 (a)(4) 51990”