Fmc North Newark

“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: 1) the emergency cart contains a comprehensive checklist of all supplies; 2) expired items are not available for use; and 3) evacuation boxes contain all necessary supplies and a staff emergency contact list in the event of an emergency in three of four evacuation boxes. Findings include: On 04/09/25 at 11:28 AM, Staff (S)1 (Facility Administrator) stated that the facility has one emergency code cart and four emergency evacuation boxes. S1 confirmed that two in-center hemodialysis (ICHD) evacuation boxes are located on the Treatment Floor and that two PD (peritoneal dialysis)/HHD (home hemodialysis) boxes are in the Home Training area. 1. At 11:30 AM, the emergency cart was reviewed. S2 (Biomedical Technician) provided a checklist titled, “Emergency Code Cart and Medication Checklist (Monthly),” dated 04/04/25. The cart contained the following supplies that were not listed on the checklist: two blue clamps, one pair of scissors, 18 band aids, four 21g (gauge) blood collection set needles, three 18g needles, four 19g needles, five 21g needles, two 3ml (milliliters) syringes with 22g needles attached, five 10ml syringes, one biohazard bag, one Blood Pressure (BP) cuff, two NSS (normal saline) 1000ml bags, two IV (intravenous) sets, two 4 X 4 gauze, two 2 x 2 gauze, 20 blue under pads and one bag of safety control locks. The checklist indicated there were two vials of Dextrose 50% IV, however, the cart did not contain Dextrose 50% IV. During an interview on 04/09/25 at 12:10 PM, S3 (Interim Charge Nurse) confirmed that the checklist did not list all the supplies in the emergency code cart. On 04/09/25 at 11:41 AM, the blue binder on top of the two ICHD emergency evacuation boxes did not include an updated list of contents. At 11:43 AM, S1 was asked for the updated log and he/she explained that the log is now maintained electronically. At 11:59 AM, S2 provided a copy of the April 2025 electronic “Emergency Box Contents Log Incenter.” The contents of the two ICHD emergency evacuation boxes were compared to the electronic “Emergency Box Contents Log Incenter” and revealed the following: Two bottles of 1:1000 unit/ml of Heparin were not present and only 14 saline bags were found instead of the 20 listed on the log. During an interview at 12:18 PM, S3 confirmed the missing items in the evacuation boxes. S3 stated the facility ran out of Heparin in March and it may have been taken from the boxes. 2. The emergency cart contained two vials of expired Sodium Bicarbonate Injection 50mlEq (milliequivalent)/50ml with an expiration date of 03/01/25. During an interview on 04/09/25 at 12:10 PM, S3 stated that the emergency code cart should be checked monthly for expired medication and supplies. 3. At 1:30 PM, during the tour in the Home Training area, the two PD/HHD emergency evacuation boxes were reviewed. The boxes did not contain any staff emergency contact information. During an interview on 04/09/25 at 1:40 PM, S10 (Home Therapy Registered Nurse) confirmed that the emergency boxes did not contain staff emergency contact information. This was not in accordance with facility policy. Facility policy titled, “Emergency Medications, Equipment and Supplies,” published 02/03/25 stated, “... Definitions ... Emergency Evacuation Box: An emergency evacuation box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location ... Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates, ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ... Emergency Evacuation Box ... Contain all patient and staff emergency contact information ... Be checked monthly or after use for contents, expiration dates ... Complete the monthly check in the approved documentation system ...” N.J.A.C. 8:43A-15.1(a) 48966”

“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: 51990 Based on two of two observations of hand hygiene during the discontinuation of dialysis via an AVF (arteriovenous fistula, an access used for hemodialysis) and during the initiation of dialysis through a CVC (central venous catheter, an access used for hemodialysis), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed to prevent cross contamination in accordance with facility policy. Findings include: On 04/09/25 at 10:12 AM, in Station 4, Staff (S)5 (Registered Nurse) removed the venous fistula needle from Patient (P)9’s left arm AVF. With a gloved right hand, P9 applied pressure to the venous site with a clean 4 x 4 gauze. S5 subsequently removed the arterial fistula needle and P9 applied pressure to the arterial site with a clean 4 x 4 gauze with the same gloved right hand. At 10:25 AM, P9’s AVF needle sites reached hemostasis (the process of stopping the bleeding). With the glove still on his/her right hand, P9 then left the patient station and walked to the scale with S5 to be weighed. P9 then discarded the glove and left the treatment area. P9 did not perform hand hygiene prior to to leaving the patient station and exiting the treatment area. During an interview on 04/09/25 at 10:35 AM, S3 (Interim Charge Nurse) stated patients should wash their hands after applying pressure to stop bleeding of vascular access sites and before leaving the treatment area. 37656 On 04/09/25 at 10:50 AM, S7 (RN) initiated dialysis through a CVC at Station 19. S7, with gloved hands, pulled the curtain around the station then with the same gloves on, S7 touched the clean supplies on the dialysis chair side table. S7 then removed his/her gloves, did not perform hand hygiene, exited the station and went to the medication preparation area and prepared Heparin. S7, did not perform hand hygiene, then re-entered Station 19, donned (put on) a clean pair of gloves and he/she proceeded to perform CVC care and initiate dialysis through the CVC. S7 then exited the station with the same gloved hands while carrying blood tubes, entered the Dirty Utility Room and placed the two blood tubes into the room. S7, with the same gloved hands, then exited the Dirty Utility Room and retrieved clean yellow clamps from a clean storage container located on the Treatment Floor. S7 then re-entered Station 19 and secured the patient’s dialysis lines. S7 did not perform hand hygiene according to facility policy. During an interview on 04/09/25 at 11:10 AM, S7 stated that he/she was nervous and should have performed hand hygiene per policy. On 04/11/25, a review of S7’s personnel file indicated that he/she had infection control training and initiation of dialysis through a CVC on 09/11/24. Facility policy titled, “Hand Hygiene,” published 11/6/23, stated, “... Responsibility All staff, patients, ... must follow the same requirements for hand hygiene. ... Policy ... The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used: ... Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... When ... Before and after direct contact with patients ... Entering and leaving the treatment area ... Immediately after removing gloves ... After contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space ...” N.J.A.C 8:43A-24.8(d)”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 51990 Based on one of two observation of the disposal of arteriovenous fistula (AVF) needles, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the proper disposal of sharps is followed in accordance with facility protocol. Findings include: On 04/09/25 at 10:12 AM, in Station 4, Staff (S)5 (Registered Nurse) removed the AVF needle from Patient (P) 9’s left arm AVF venous site, activated the safety guard and discarded the AVF needle into a red biohazard container. S5 then proceeded to remove the arteriovenous fistula needle from P9’s arterial site, activated the safety guard and discarded the AVF needle into a red biohazard container. During an interview on 04/09/25 at 10:20 AM, with S3 and S5 (Interim Charge Nurse) regarding the disposal of AVF needles into a biohazard container, S5 stated, “I was nervous” and further stated that needles should be disposed in the sharp containers and not in the red biohazard containers. S3 confirmed that AVF needles are only discarded in sharp containers. Facility Plan titled, “Medical Waste Management Plan,” reviewed 11/20/23, stated, “... Medical Waste Containers and Proper Disposal ... All medical and potentially infectious (Biohazard) waste must be disposed in either sharps containers, red bags or other designated containers in accordance with local, state and federal regulations ... Sharps: ... Must be disposed of in a container that is rigid, puncture resistance, leak proof ... “ Facility Protocol titled, “Medical Waste Protocol,” effective date 01/01/24, stated, “... Sharps Container: ... Needle ... Syringes ... Lancets ...’’ N.J.A.C. 8:43A-17.5(a)(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: 1) all surfaces of the plastic hemostat clamps are disinfected after use; and 2) all equipment and areas in the dialysis station are cleaned and disinfected in one of two observations of the cleaning of the dialysis stations according to facility policy. Findings include: 1. On 04/09/25 at 10:42 AM, during a tour of the Treatment Floor, a clear opaque container with a lid that had a 1:100 bleach solution (one part bleach to 100 parts water) in it was observed on the dirty sink located across from Station 11. The container had 16 plastic blue hemostat clamps that were not fully submerged and soaking in the bleach solution. Six of the 16 clamps were in the closed position. The soaking of the clamps in the closed position and the clamps not fully submerged could potentially prevent the bleach solution from contacting and disinfecting all surfaces of the hemostat clamps. On 04/09/25 at 10:45 AM, these findings were confirmed with Staff (S)5 (Registered Nurse) and S22 (Licensed Practical Nurse). Upon interview at 10:49 AM, S5 stated that dirty clamps should be fully submerged and in an open position while soaking in the bleach. 37656 2. On 04/09/25 at 11:20 AM, S23 (Patient Care Technician) was observed during the cleaning and disinfection of Station 12. S23 cleaned the blood pressure (BP) tubing and placed it in the unclean BP cuff holder mounted to the dialysis machine prior to cleaning the dialysis machine. S23 did not clean the chase wall in the station. On 04/09/25 at 11:39 AM, S23 when asked if he/she was done cleaning, S23 stated “yes.” S23 then recleaned the BP cuff tubing, the BP cuff holder, and cleaned the chase wall. Facility policy titled, “Cleaning and Disinfection of the Dialysis Station,” published 09/05/23, stated, “... 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 ... Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: ... 3. Use a cloth wetted with 1:100 bleach solution or EPA [Environmental Protection Agency]-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P [blood pressure] cuff, hand sanitizer dispenser and holder, chaise wall behind chair ...” 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: 51990 Based on one of two observations of medication storage in the Peritoneal Dialysis (PD)/ Home Hemodialysis (HHD) Training Area, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that expired medications are not available for use. Findings include: On 04/09/25, during a tour of the PD/HHD Training Rooms, the following was revealed: At 12:55 PM, in Home Hemo Training Room 1, there was an open tube of Gentamycin Cream, an antibiotic ointment, that was labeled, “Opened: 03/03/25.” This was 38 days past its maximum time for use. During an interview on 04/09/25 at 1:10 PM, Staff (S)11 (Home Therapy Registered Nurse) explained that the Gentamycin Cream is discarded according to the manufacturer’s expiration date. This was not accordance with facility policy. Facility policy titled, “Medication Preparation and Administration,” published 02/06/23, stated, “... Monitoring Expired Medications Expiration dates for all stored medication are to be monitored on a monthly basis... The following table includes expiration date of bulk type items or outpatient dialysis floor stock. Medication Product Category ... Floorstock topical medication such as ointments, ophthalmic etc. ... Expiration Date/ Maximum Time Period for Use ... 28 days after opening ... “ 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: 51990 Based on two of two observations of the initiation of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that the catheter exit site care is performed in accordance with facility procedure for (Patient (P)10 and P12). Findings include: On 04/09/25 at 10:48 AM in Station 5, Staff (S)3 (Interim Charge Nurse) initiated hemodialysis on P10 through a right chest CVC. S3 cleaned the catheter exit site with an alcohol pad for 18 seconds. S3 subsequently cleaned the exit site with a second alcohol pad for 24 seconds then immediately applied the dressing. S3 did not allow the site to dry in accordance with facility procedure. During an interview on 04/09/25 at 11:08 AM, S3 stated the CVC exit site should be cleaned for 30 to 40 seconds. A review of S3’s “Skills Validation Checklist” indicated that the “CVC Validation Checklist” was evaluated on 12/11/24. 37656 On 04/09/25 at 10:50 AM, in Station 19, S7 (Registered Nurse), initiated hemodialysis on P12 through a CVC. During catheter exit site care, S7 swabbed the site with 2% Chlorhexidine for 15 seconds. This was not in accordance with facility procedure. During an interview on 04/09/25 at 11:10 AM, S7 stated that he/she did not time it and will do it next time. On 04/11/25, a review of S7’s personnel file indicated that he/she had infection control training and initiation of dialysis through CVC on 09/11/24. Facility procedure titled, “Changing the Catheter Dressing Procedure,” published 2/5/2024, stated, “... Cleaning the Site ... 1 Perform hand hygiene and don [put on] clean gloves. 2 ... 2% Chlorhexidine ... : Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. ... If using alcohol pad: Using gentle friction, disinfect the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry. ...” N.J.A.C. 8:43A-24.8(b)”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 48966 Based on staff interviews and review of facility documents, it was determined that the facility failed to ensure disinfection of the RO (reverse osmosis) unit is performed according to facility policy in three out of six months reviewed. Findings include: A review of the “AquaBplus RO Disinfect” logs and the Culture and Endotoxin laboratory results for October 2024 through March 2025 revealed the following: On 10/10/24, culture and endotoxin samples were collected. On 10/15/24, the RO unit was disinfected with Minncare (Peracetic Acid). On 01/14/25, culture and endotoxin samples were collected. On 01/19/25, the RO unit was disinfected with Minncare. On 03/11/25, culture and endotoxin samples were collected. On 03/16/25, the RO unit was disinfected with Minncare. Facility policy required that within 96 hours of culture and endotoxin sample collection, the RO must be disinfected. The disinfection of the RO was completed greater than 96 hours on the above dates after the culture and endotoxin samples were collected which was not in accordance with facility policy. During an interview on 04/10/25 at 10:53 AM, Staff (S)2 (Biomedical Technician) confirmed that the disinfection of the RO unit was performed greater than 96 hours from the sample collections in October 2024, January 2025, and March 2025. S2 stated that he/she believed that the 96 hours did not start until the lab (laboratory) processed and posted the results of the culture and endotoxin samples which on average may take three days. During an interview on 04/10/25 at 11:05 AM, S9 (Area Technical Operations Manager), confirmed that the disinfection of the RO unit was performed greater than 96 hours from the sample collections in October 2024, January 2025, and March 2025. S9 stated that after the samples are obtained the facility has 96 hours (four days) to disinfect the RO unit. S9 stated that it was an incorrect practice to wait for the results of the samples to be obtained before disinfection of the RO unit takes place. Facility policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” Published: 02/03/2025, stated, “... Scheduled Sampling Samples will be collected prior to disinfection and with 96 hours of system disinfection ...””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that: 1) the facility sprinkler system is properly maintained; and 2) all penetrations through the smoke partitions are properly sealed to prevent smoke or fire from traveling from one compartment to another. Findings include: 1. On 04/10/25 at 10:40 AM, during a tour with Staff (S)2 (Biomedical Technician) it was observed at the end of the hallway at the parking garage door, the escutcheon plate was missing on the ceiling sprinkler head. The plate must be in place so the sprinkler head activates properly. This was confirmed by S2 at the time of discovery. National Fire Protection Association 25 Installation of Sprinkler Systems 2023 Edition, “5.2.1.1.6 Escutcheons for pendent sprinklers that are not recessed, flush, or concealed shall not be required to be replaced if found missing during the inspection.” 2. At 12:58 PM, during a tour of the Electrical Room with S2, there were multiple electrical conduit pipes going through the smoke partition, an area approximately 4 feet x 18 inches with no fire stop material. This was confirmed by S2 at the time of discovery. National Fire Protection Association NFPA 101 Life Safety Code 2012 Edition 714.4.1.2 Through Penetration Firestop states that firestop systems are required in walls and shall be tested to ASTM E814 or ANSI/UL1479 for F Rating.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 51990 Based on two of two observations of the initiation of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interviews and a review of facility documents, it was determined that the facility failed to ensure patient’s rights to privacy. Findings include: On 04/09/25 at 10:48 AM in Station 10, Staff (S)3 (Interim Charge Nurse) initiated hemodialysis on Patient (P)10 through a right chest wall CVC. During the procedure, the curtain was not fully drawn on the left side of the patient leaving an approximate two feet opening. P10 was visible to the patient in Station 9. The curtains were not fully closed in front of the station leaving an approximate two feet opening. P10’s chest was visible from the patient in Station 2, which was located across from Station 10. During an interview 04/09/25 at 11:08 AM, S3 confirmed that the curtains should be fully closed around the patient’s station when initiating hemodialysis. A review of S3’s personal file indicated that “Patient Rights- New Jersey” education was completed on 03/15/25. 37656 On 04/09/25 at 10:50 AM in Station 19, S7 (Registered Nurse) initiated hemodialysis on P12 through a right chest wall CVC. During the procedure, the curtain was not fully drawn on the right side of the patient leaving an approximately three feet opening visible to anyone entering the entrance door to the treatment room. P12’s chest was visible during the procedure which violates patient’s privacy. During an interview on 04/09/25 at 11:10 AM, S7 stated that he/she will make sure the curtain is fully closed covering the patient during initiation of dialysis. On 04/11/25, a review of S7’s personnel file indicated that he/she had Patient Rights training on 07/25/24. Facility policy titled, “Patient Rights and Responsibilities,” published 4/4/2012, 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”

“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: 48966 Based on four of seven medical records reviewed (Patient [P] 1, P2, P3 and P4), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that post (after) hemodialysis nursing assessments are completed according to facility policy. Findings include: A review of P1’s Plan of Care, dated 10/25/24, stated, “Area of Focus BP [blood pressure] and Fluid Management Goal Achieve BP Control as specified by the patient’s physician Open ... Intervention (s): ... Educate patient/family/caregiver on fluid control In Progress, Educate patient/family/caregiver on signs and symptoms of fluid overload In Progress, Educate patient/family/caregiver on sodium control In Progress ...” A review of the “Treatment Sheets For Facility” from 03/19/25 through 04/07/25 in P1’s medical record revealed the following: On 03/19/25, the pre-treatment (before treatment) “Nursing Evaluation” section stated, “... Edema Ankle-Location -Bilateral, Ankle -Severity 1+ (plus): 2 mm [millimeters] or less, disappears rapidly. Edema Lower Leg -Location Bilateral, Lower Leg-Severity 1+: 2 mm [millimeters] or less, disappears rapidly. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a Registered Nurse (RN). On 04/02/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle-Location -Bilateral [affecting both sides], Ankle -Severity 1+: 2 mm [millimeters] or less, disappears rapidly. Edema Lower Leg -Location Bilateral, Lower Leg-Severity 1+: 2 mm [millimeters] or less, disappears rapidly. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 04/04/25, the pre-treatment (before treatment) “Nursing Evaluation” section stated, “... Edema Ankle-Location -Bilateral, Ankle -Severity 1+: 2 mm [millimeters] or less, disappears rapidly. Edema Lower Leg -Location Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. 50912 A review of P2’s Plan of Care, dated 12/23/24, 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 ... Continue to monitor patient In Progress Monitor fluid gains: Completed ...” A review of the “Treatment Sheet for Facility” from 03/14/25 through 04/07/25 in P2’s medical record revealed the following: On 03/26/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle bilateral, 2+[plus]: 2-4 mm [millimeters] indent, disappears in 10-15 seconds. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 03/28/25, 03/31/25, 04/04/25 and 04/07/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle left, left lower leg, 1+: 2-4 mm indent, disappears rapidly ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. A review of P3’s Plan of Care, dated 02/10/25, 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 and discuss high weight gain with patient: In Progress ...” A review of the “Treatment Sheet for Facility” from 03/19/25 through 04/07/25 in P3’s medical record revealed the following: On 03/21/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle bilateral 2+: 2-4 mm indent, disappears 10-15 seconds. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 03/19/25, 03/24/25, 03/26/25, 03/28/25 and 04/07/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle bilateral, 1+: 2 mm or less, disappears rapidly ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. A review of P4’s Plan of Care, dated 01/15/25, 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 ... Educate patient/family/caregiver on signs and symptoms of fluid overload: In Progress ...” A review of the “Treatment Sheet for Facility” from 03/21/25 through 04/07/25 in P4’s medical record revealed the following: On 03/21/25, 03/24/25 and 04/04/24 the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle bilateral 2+: 2-4 mm indent, disappears 10-15 seconds. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 03/26/25, 03/28/25 and 04/07/25, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle bilateral, 1+: 2 mm or less, disappears rapidly ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. During an interview on 04/10/25 at 1:09 PM, Staff (S)14 (acting Charge Nurse) explained if there is no edema pre-treatment, then edema does not need to be assessed post-treatment. However, if edema is present pre-treatment, it should be reassessed post-treatment. Facility policy tilted, “Patient Assessment and Monitoring,” published 05/01/2023, stated, “... Pre-Treatment 2 ... During nursing rounds, the Registered Nurse will review the data collected and assess the following parameters as needed: ... Edema (As indicated by patient condition) Assess the patient for edema: Location: foot, ankle, lower leg and sacrum Right, Left or Bilateral Severity (None, 1+, 2+, 3+ or - 4+) ... Post-Treatment 1 ... Lung sounds Edema Heart Sounds. The registered nurse will assess/re-assess post treatment as indicated. ...” N.J.A.C. 8:43A-24.4(a)”

“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: 37656 Based on staff interview, review of one of two medical records (Patient [P] 5) and a review of facility documents, it was determined that the facility failed to ensure that patients receive the prescribed DFR (Dialysate Flow Rate, the rate at which the dialysate passes through the dialyzer during hemodialysis). Findings include: P5’s Hemodialysis orders start date, 02/17/25, stated, “... DFR Manual 600 mL/min (milliliter per minute) ...” A review of P5’s Treatment Sheets on the following dates revealed the following: On 03/24/25, 04/03/25, 04/05/25, 04/07/25, and 04/08/25, P5 was dialyzed with a DFR of 800 mL/min. The treatment sheets did not contain any documentation of why the DFR was at 800. The treatment sheet lacked evidence that the Patient Care Technician (PCT) notified the RN (Registered Nurse) of the change in the DFR. The pre (before) and post (after) treatment assessment by the RN did not contain documentation of why P5 was dialyzed at 800 mL/min. During an interview on 4/11/25 at 9:45 AM, Staff (S)3 (Interim Charge Nurse) stated that the DFR change should be ordered by the physician and the RN should be informed by the PCT for a change in dialysis prescription. S3 confirmed that P5 had no current order to change the DFR to 800. Facility policy titled, “Nursing Supervision and Delegation” published 11/06/23, stated, “... Reporting of Patient Care Findings to the Team Nurse in Charge ... The staff member who collects information pre, post and during treatment will document their findings. Any observed changes or abnormal findings ... must be reported to the registered nurse who will assess the patient. ... Daily Treatment Record Review Prior to discharge, the RN must review the treatment record ... The record must be reviewed for: ... correct dialysate prescription was delivered. ...” 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 patients 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) N.J.A.C. 8:43A-24.13(b)”

“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 two of three observations of the initiation of hemodialysis (HD) through an arteriovenous fistula/graft (AVF/G, a type of vascular access used for hemodialysis), staff interview, and a review of facility policy and procedure, it was determined that the facility failed to ensure that the patient’s vascular access is maintained through proper skin disinfection of the access site prior to initiating the dialysis treatment. Findings include: On 04/09/25 at 9:58 AM in Station 8, Staff (S)6 (Patient Care Technician) initiated HD on Patient (P)8 through a left arm AVG. S6 cleaned the arterial site with a clean alcohol pad for 15 seconds and immediately cannulated the arterial needle (involves inserting the arterial needle). S6 subsequently cleaned the venous site with a clean alcohol pad for 12 seconds and immediately cannulated the venous needle. During an interview on 04/09/25 at 10:43 AM, S6 stated each needle site should have been cleaned for 15 seconds. This was not in accordance with facility policy. 50912 On 04/09/25 at 10:30 AM, S4 (Patient Care Technician) initiated dialysis through P11’s AVF on his/her left forearm at Station 16. S4 cleansed the first site of the AVF with an alcohol pad in a circular motion for eight seconds and immediately cannulated the site with a hemodialysis fistula needle. S4 cleansed the second site of the AVF with an alcohol pad in a circular motion for five seconds, then proceeded to cannulate the site with the hemodialysis fistula needle. Upon interview on 04/09/25 at 10:46 AM, S4 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, S4 stated, “I thought I had cleaned the sites long enough.” A review of S4’s training records revealed that he/she had completed AVG Education and Training on 04/24/24 and a computer based AVF/AV Graft Monitoring and Surveillance Education Training on 12/19/24. Facility policy titled, “Access Assessment and Cannulation,” published 05/06/24, 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 two inches in a concentric circle for 30 seconds and allow to dry before cannulating ...” N.J.A.C. 8:43A-24.8(b)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 48966 Based on staff interviews, review of facility documents, and medical record review, it was determined the facility Medical Director failed to ensure that: 1) patients are assessed for pain pre (before) and post (after) treatment in one of five hemodialysis medical record reviewed (Patient [P] 1); and 2) opened, needle punctured, multidose medication vials are discarded and not available for patient use after being taken into a patient room in accordance with facility policy and procedure and CDC (Centers for Disease Control and Prevention) guidelines in two of two observations of medication storage in the Peritoneal Dialysis (PD)/ Home Hemodialysis (HHD) area. Findings include: 1. A review of P1’s “Nursing Evaluation,” on the “Treatment Sheet For Facility” dated 03/21/25 through 04/07/25, revealed the following: The pre and post treatment pain assessment was not documented on the following treatment dates: 03/28/25, 03/26/25, 03/31/25 and 04/07/25. The post treatment pain assessment was not documented on 03/24/25. During an interview on 03/10/25 at 1:09 PM, Staff (S)14 (Acting Charge Nurse) confirmed pain should be assessed by the Registered Nurse pre and post-treatment for patients. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, stated, “... Pre-Treatment ... Step 1 ... State of well-being/Reported by the patient/General observation Evaluate: Statement of well-being or pain or discomfort and location ... post-treatment ... State of well-being/Reported by the patient/General observation Ask the patient if he or she has anything more to report or any additional observations prior to discharge ...” Facility policy titled, “Pain Assessment and Management,” published: 07/03/2023, stated, “... Policy All patients will be assessed for pain using a 0-10 scale for adults or a 0-10 Wong-Baker faces pain tool for children, elderly or cognitive impaired, and documented in the patient’s electronic medical record ... “ N.J.A.C. 8:43A-16.2(a)14 51990 2. Reference: CDC, “Preventing Unsafe Injection Practices,” dated 03/26/24, Preventing Unsafe Injection Practices | Injection Safety | CDC; stated, “... Assign medications packaged as multi-dose vials to a single patient whenever possible. Multi-dose vials that are used for more than one patient should be kept and accessed in a clean medication preparation area away from immediate patient treatment areas. If a multi-dose vial enters an immediate patient treatment area, dedicate it for single patient use only. Examples of immediate patient treatment areas include ... patient rooms or bays ...” On 04/09/25 at 12:45 PM, during a tour of the CAPD (Continuous Ambulatory Peritoneal Dialysis)/ Home Training Room 3, a Training Room used for PD patients, an open, needle punctured, multi-dose vial of Heparin Sodium Injection 30,000 units (u)/30 ml (milliliter) was in an unlocked supply cabinet and was available for use. The vial was labeled, “Opened: 04/07/25.” At 12:55 PM, in Home Hemo Training Room 1, a Training Room used for Home Hemodialysis patients, an open, needle punctured, multi-dose vial of Heparin Sodium Injection 30,000u/30 ml was in an unlocked supply cabinet and was available for use. The vial was labeled, “Opened: 04/04/25.” The opened multi-dose vials of Heparin in Room 1 and Room 3 were not labeled with a patient’s name. During an interview on 04/09/25 at 1:10 PM, S11 (Home Therapy Registered Nurse) stated that the Heparin vials should be stored in the locked cabinet in the training rooms. S11 explained that Heparin is prepared aseptically in the training room on the clean counter space with proper disinfection. S11 indicated that in Training Room 3, the Heparin was used on a new patient that started PD (Peritoneal Dialysis) training in the facility on 04/07/25. The open Heparin vial observed in Training Room 1 was used on a HHD (Home Hemodialysis) patient who received dialysis treatment for respite care (a temporary assistance provided to caregivers), in the facility since 04/04/25. Facility policy titled, “Medication Preparation and Administration,” published 02/06/23, stated, “... IV (intravenous) Solutions ... Once an IV solution is taken into a patient station or room it cannot be used for any other patient ... Securement ... All medications will be kept in a locked cabinet except when in use ...” N.J.A.C. 8:43A-9.3(a)”