Innovative Renal Care East Orange

“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 one of one observation, staff interviews and a review of facility documents, it was determined that the facility failed to ensure that the PD (Peritoneal Dialysis, a treatment for kidney failure that uses the lining of the abdomen (peritoneum) as a filter to remove waste products and excess fluid from the blood) emergency evacuation box is secured and contains a comprehensive checklist of all supplies, a staff and patient emergency contact list, and patients PD orders in the event of an emergency. Findings include: On 04/30/25 at 9:10 AM, Staff (S)1 (Clinical Manager [CM]) stated the PD emergency evacuation box was in the Exam Room across from the PD Training Room. At 9:15 AM, review of the PD emergency evacuation box and emergency binder revealed the following: The emergency box was not locked and this was confirmed with S1. The checklist titled “Home Program Emergency Evacuation Box Checklist” was completed in April 2025. The box contained the following supplies that were not listed on the checklist: seven blood collection sets and five nasal cannulas (a medical tubing the delivers oxygen). The checklist indicated the following supplies were present: clamps, cannulation needles, a sharps container, and a pocket mask. However, the box did not have the supplies. The box did not contain pens and pencils, povidone-iodine swabs, scissors, treatment forms/blank flow sheets and a weather radio/ac[sic] with back-up battery in accordance with facility policy. The emergency binder contained the staff “Disaster Contact Listing” last updated on 09/23/22 and a copy of the patient’s rounding reports that were last printed on 07/04/24. During an interview on 04/30/25 at 9:40 AM, S1 confirmed that the checklist did not list all the supplies in the PD emergency evacuation box and that supplies were missing. The CM indicated that the staff and patient emergency contact information were not current. At 10:14 AM, during an interview, S10 (Home Training Coordinator) stated the emergency box was broken therefore could not be locked. He/she confirmed that the evacuation box was checked monthly and stated that the patients face sheet and PD orders were not current. Facility policy titled, “Emergency Evacuation Box,” stated, “ ... To ensure that: ... supplies needed for patient care in an emergency evacuation are readily available to provide care to the patients; and ... Guidelines: ... 4. Each emergency evacuation box shall have: ... A copy of the patient rounding report... A copy of all center associates’ [sic] home or mobile phone numbers... 5. The Center Manager or designee will ensure that rounding reports for the patients are updated and replaced monthly... 7. A designated associate will review the contents of the box and replace missing or expired supplies at least monthly... 10. Theses supplies will include at a minimum... Pen and Pencils ... Povidone- iodine swabs ... Scissors ... Treatment forms/ blank flowsheet ... Weather radio/ac[sic] with battery back-up ...” 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: 51227 Based on one of one observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed during the initiation of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis) to prevent cross contamination in accordance with facility policy. Findings include: On 04/28/25 at 10:40 AM in Station 2, Staff (S)4 (Registered Nurse) initiated hemodialysis through a CVC. S4 removed the old dressing of the CVC and then removed his/her gloves. Without the benefit of performing hand hygiene, S4 donned (put on) a new pair of gloves and cleansed the exit site. S4 removed his/her gloves, did not perform hand hygiene, donned a new pair of gloves, and then applied a new dressing onto the exit site. S4 then connected a pre-filled saline syringe into each CVC line and administered the saline. S4 then removed his/her gloves and without the benefit of performing hand hygiene, donned a new pair of gloves and then connected the patient to the hemodialysis machine. During an interview at 10:50 AM, S4 stated, “I realized that there was no hand sanitizer at the station for me to perform hand hygiene after taking off my gloves.” Facility policy titled, “G40 Infection Control,” revised November 2022, stated, “... General Infection Control Measures ... 8. Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items ...” 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: 51990 Based on one of one observation of the dirty sink area, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that clean supplies are not stored in designated dirty areas to avoid possible cross contamination. Findings include: On 04/29/25 at 12:55 PM, during a tour of the PD (Peritoneal Dialysis, a treatment for kidney failure that uses the lining of the abdomen (peritoneum) as a filter to remove waste products and excess fluid from the blood) Training Room the following was revealed: A sink labeled “Dirty Sink” had a PD cycler/machine on the countertop next to the sink. Inside the cabinet above the dirty sink, the following clean/unused supplies were found; 13 PD Drainage bags, 10 CAPD (Continuous Ambulatory Peritoneal Dialysis) Y-set tubing, one Extraneal Solution, and one Dianeal Solution. Above the cabinets in the dirty sink area were two unopened boxes of supplies. Under the dirty sink, an opened gallon of Purebright Bleach Solution was stored. During an interview on 04/30/25 at 10:15 AM, Staff (S)10 (Home Training Coordinator) confirmed that the PD cycler/machine that was on the countertop in the dirty area was cleaned after a patient use. He/she stated that the clean/unused supplies were stored in the cabinets above the dirty sink area due to lack of storage space in the Training Room. S10 also stated that the bleach solution should not be stored underneath the sink. Facility policy titled, “Infection Control,” revised 11/29/22, stated, “... General Infection Control Measures ... 16. Each center will maintain and clearly label separate “clean” and “dirty” work areas. Clean items, such as medication and gloves are kept in the designated “clean” areas. Contaminated items, such as lab samples are to be stored in the designated “dirty” areas. “Dirty” areas are those areas where contamination with blood or other biohazardous substances would be expected to be encountered (e.g., treatment area, etc.). Depending on the center layout and configuration, clean and dirty areas will be designated in a manner that decreases the risk of cross contamination. ...” N.J.A.C. 8:43A-24.8(b)”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 37656 Based on one of one observation of a wetted external transducer protector (provides a protective barrier between dialysis bloodlines and the dialysis machine), it was determined that the facility failed to ensure that the staff inspect the protector if fluid is visible on the side of the transducer protector that faces the machine. Findings include: On 04/28/25 at 10:15 AM, the external transducer protector on the dialysis machine in Station 13 was wet with red fluid while a patient was dialyzing. At 10:25 AM, Staff (S)5 (Patient Care Technician) was at the station and discontinued dialysis and removed one fistula needle. While the patient was holding his/her access, S5 removed the bloodlines from the machine. After removing the bloodlines, S5 was preparing to throw the blood lines into a red garbage container, without first inspecting the transducer protector’s side facing the machine. S5 was interrupted by this surveyor and was asked what he/she was supposed to do prior to throwing away the blood lines with a wet transducer protector. S5 could not answer and did not know what to do. This surveyor pointed to the transducer, which was visibly not wet on the side facing the machine. The personnel file for S5 was reviewed on 04/30/25 and indicated that S5 did not have specific education for a wetted external transducer protector. This was confirmed by S1 (Clinic Manager) on 04/30/25 at 12:00 PM. Facility policy titled, “IC31 Changing Wet Transducer Protectors,” effective date 06/12/2024, stated, “... 4. Remove the wet transducer protector from the machine and check the back of the transducer protector for any signs of blood. ...” N.J.A.C. 8:43A-24.8(c)”

“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 one observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that sharps containers are replaced in accordance with facility policy. Findings include: On 04/29/25 at 12:55 PM, during a tour of the PD )Peritoneal Dialysis, a treatment for kidney failure that uses the lining of the abdomen (peritoneum) as a filter to remove waste products and excess fluid from the blood) Training Room, a sharps container mounted on a wall, was filled with needles above the three quarters (3/4) marked line on the container. During an interview on 04/30/25 at 10:14 AM, Staff (S)10 (Home Training Coordinator) confirmed that the sharps container was full and stated that engineering controls should have been notified to change the sharps container. Facility policy titled, “Bloodborne Exposure Control Plan,” revised 12/22/23, stated, “... B. Engineering Controls ... [facility name] will use engineering controls to eliminate or minimize employee exposure. Example of engineering controls include sharp disposal ... 8. Sharps containers must be replaced when they are 3/4 full. The containers are considered full at this level. ...” N.J.A.C. 8:43A-17.5(b) 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 observation, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that four out of 13 blood pressure (BP) cuffs are maintained to allow for adequate cleaning and disinfection. Findings include: On 04/28/25 at 10:03 AM, during a tour of the Hemodialysis Treatment Room, the BP cuffs at Stations 7, 10, 11, and 12, were covered with white lint on the Velcro portion of the cuff, which rendered the BP cuffs uncleanable. On 04/28/25 at 10:25 AM, the above findings were discussed with Staff (S)2 (Interim Charge Nurse), who stated that he/she will change the BP cuffs covered with lint immediately. Facility policy titled, “G45 Cleaning and Disinfection of Equipment, Supplies and Treatment Area,” last revision date 06/20/24, stated, “... Policy ...7. All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks and crevices come in contact with the bleach solution, which is discarded after use. ...” N.J.A.C 8:43A-24.8(b)”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 50912 Based on review of medical records, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that patients who are susceptible to the Hepatitis B Virus (HBV) are tested monthly for the Hepatitis B surface Antigen (HBsAg) in eight of 70 patients reviewed (Patients (P) 17, 18, 19, 20, 21, 22, 23, and 24). Findings include: Reference: The Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), dated 04/27/01, states, “Prevention and Management of HBV Infection ... Preventing HBV (Hepatitis B Virus) transmission among chronic hemodialysis patients requires a) infection control precautions recommended for all hemodialysis patients b) routine serologic testing for markers of HBV infection and prompt review of results ... Immunogenicity defined as greater or equal to 10 milliliter (ml) - International Units (IU) in 90 percent to 95 percent of adults with normal immune status. The need for routine follow-up testing and vaccination, or isolation is based on patients serologic status ... HBV susceptible patients ... test susceptible patients monthly for HBsAg, including those who have not yet received Hepatitis B vaccine, b) are in the process of being vaccinated or c) have not adequately responded to vaccination. According to the table, Schedule for Routine testing for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Infections: HBV - susceptible including non-responders to vaccine - Monthly testing for HBsAg ...” A review of the Hepatitis B Audit report from March 2024 through March 2025 indicated the following: P17 had an anti-HBs (Hepatitis B surface antibody) test result of less than 10 mIU/ML (milli-international units per milliliter) on 05/30/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in June, August, September and October 2024. P18 had an anti-HBs test result of less than 10 mIU/ML on 07/01/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, September, October, November, and December 2024. P19 had an anti-HBs test result of less than 10 mIU/ML on 07/01/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, September, and October 2024. P20 had an anti-HBs test result of less than 10 mIU/ML on 07/19/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, September, and October 2024. P21 had an anti-HBs test result of less than 10 mIU/ML on 07/02/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, September, and October 2024. P22 had an anti-HBs test result of less than 10 mIU/ML on 04/10/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in May, June, August, September, and October 2024. P23 had an anti-HBs test result of less than 10 mIU/ML on 07/29/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, September, and October 2024. P24 had an anti-HBs test result of less than 10 mIU/ML on 02/27/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in March and April 2025. A review of the above findings was completed with Staff (S)1(Clinic Manager), who confirmed that the above lab (laboratory) testing was missed. Facility policy titled, “G43 Hepatitis B: Control and Management,” last revision date 12/22/23 stated, “... 4. All patients will be retested for Hepatitis B surface antigen (HBsAg) and the Hepatitis B surface antibody (Anti-HBs) to verify the patients baseline status upon entry into the center ... 9. On an ongoing basis, patients are considered to be susceptible to Hepatitis B if their HBsAg values are determined to be negative or non-reactive, and Anti-HBs values are determined to be negative or indeterminate ... 10. Patients are considered to be protected if their: Anti HBs values are determined to be positive or protected ... 16. Patients are monitored and vaccinated based on their current status as defined by the table below ... Screening Test HBsAg ...Vaccine Non-Responder or Susceptible: Monthly ...’’ N.J.A.C 8:43A-24.4(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 two of two observations in the Medication Preparation Area, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that: 1) expired medications are not available for use; and 2) medications are administered within one hour of preparation. Findings include: 1. On 04/28/25 at 10:45 AM, during a tour of the Medication Preparation Area located within the Nurses Station, a Medication Refrigerator contained an opened one half full multidose vial of Tuberculin Purified Protein Derivative (Mantoux). The vial was labeled opened on 03/24/25. The vial was 8 days past it’s beyond use date. At 10:55 AM this finding was confirmed with Staff (S)2 (Interim Charge Nurse). At 11:40 AM, S2 explained that Mantoux multidose vials are discarded 30 days from the date the vials are opened. Facility policy titled, “G40 Infection Control,” last revision date 11/29/22, stated, “... General Infection Control Measures ... 19. Unless manufacturer guidelines or package inserts specify a shorter time period, multidose medication can be used up to 28 days after opening ... After that time, the medication vial and any remaining medication must be discarded ...” 2. On 04/28/25 at 11:35 AM, in a locked top drawer located in the Medication Preparation Area, there were four 5 cc (cubic centimeter) syringes that contained two cc’s of Intravenous (IV) Heparin. The syringes were dated 04/28/25 and timed 9:00 AM which was one hour and thirty five minutes beyond their use. At 11:38 AM, this finding was confirmed with S3 (Registered Nurse). At 11:40 AM, S2 stated that Heparin filled syringes can only be used within one hour of its preparation and must be discarded after. Facility policy titled, “G48 Medications; Handling, Administration, Storage and Disposal.” Last Revision Date 03/07/25, stated, “... HANDLING and ADMINISTRATION ... 19. Re-constituted medications must be administered within 1 (one) hour of preparation per pharmacy regulation. ...” 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: 51227 Based on two of two observations of the initiation and termination of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview, a review of facility documents, and a review of MIFU (Manufacturers Instructions For Use), it was determined that the facility failed to ensure that initiation and termination of hemodialysis using a CVC is performed in accordance with facility policy and the MIFU. Findings include: On 04/28/25 at 10:40 AM, in Station 2, Staff (S)4 (Registered Nurse), initiated hemodialysis through a CVC. S4 cleansed the CVC exit site using a 2% (percent) Chlorhexidine Gluconate prepackaged swab for 15 seconds This was 15 seconds less than required by facility policy. S4 then removed the arterial cap and used one alcohol preparation (prep) pad to clean the hub and limb for seven seconds. S4 acquired a new alcohol prep pad and proceeded to remove the venous cap from the venous limb and scrubbed the hub and limb for seven seconds. S4 did not clean and disinfect the arterial and venous cap prior to removal before cleaning the hubs according to facility policy. During an interview at 10:50 AM, S4 stated, he/she should clean the exit site for 60 seconds. When asked about the process of cleaning the caps S4 stated, he/she doesn’t have to clean them, just the hubs. On 04/29/25 at 2:20 PM in Station 2, S4 discontinued hemodialysis treatment through a CVC on Patient (P)13. S4 disconnected the arterial bloodline from the CVC, scrubbed the hub and the thread using a 2% Chlorhexidine Gluconate prepackaged swab for 17 seconds. This was 13 seconds less than the 30 seconds minimum required by facility policy. S4 then proceeded to disconnect the venous bloodline from the CVC, and scrubbed the hub and thread for 13 seconds. This was 17 seconds less than required by facility policy. During an interview at 2:28 PM, S4 stated the catheter threads and hubs need to be scrubbed for 60 seconds per facility policy. A review of S4’s training and education records indicated that a CVC Skills Verification Checklist including discontinuation of dialysis with a CVC was completed on 10/17/24. Facility policy titled, “ICO5F CVC: Initiation & Discontinuation of Treatment,” effective date 06/20/2024, stated, “... Initiation Of Treatment ... Actions: ... 2. ... Disinfect according to manufacturer’s instructions with one of the following products: 2 % Chlorhexidine with alcohol ... 3. Prior to cap removal, disinfect the arterial cap and limb. Using the same antiseptic pad apply antiseptic with friction to the catheter, moving from the hub at least several centimeters towards the body. Hold the limb until the antiseptic is dry. 4. Repeat step #3 for the venous limb, using a new disinfect pad. 5. Ensuring the limb clamp is closed, remove the arterial cap, and disinfect the hub with a new antiseptic pad ... Discontinuation Of Treatment ... 15. Disinfect according to manufacturer’s instructions with one of the following products: 2 % Chlorhexidine with alcohol ... 22. Disinfect the arterial hub with a new antiseptic pad. Scrub the side (threads) and the end of the hub thoroughly with friction, making sure to remove any residue, ...” A review of the MIFU for ChloraPrep Single Swabstick, stated, “... Directions ... dry surgical site use repeated back-and-forth strokes for 30 seconds ...” N.J.A.C. 8:43A-24.8(b) 50912”

“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: 39228 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that that chlorine is tested every four hours on one of three treatment days reviewed. Findings include: On 04/29/25 at 10:22 AM, the facility document titled, “TOTAL CHLORINE LOG: 60 SECOND” dated, 4/19/25, was reviewed with Staff (S)1 (Clinical Manager), and revealed that a Post Carbon Tank #1 chlorine test was documented as completed at 5:00 AM, 8:30 AM and 12:00 PM. There was no documentation of a Post Carbon Tank #1 chlorine check for the remainder of the day. The patient treatment schedule dated 04/19/25 indicated that three patients (Patient (P)14, P15, and P16) were dialyzed on the third patient shift. Review of the hemodialysis treatment flowsheets indicated that on 04/19/25, P14’s treatment ended at 4:39 PM, four hours and 39 minutes after the last documented chlorine check; P15’s treatment ended at 4:50 PM, four hours and 50 minutes after the last documented chlorine check; and P16’s treatment ended at 5:10 PM, five hours and ten minutes after the last documented chlorine check. On 04/29/25 at 10:29 AM, S1 stated that chlorine testing is conducted at the beginning of each treatment day and then every four hours until treatments are completed. S1 stated that the PCT (Patient Care Technician) failed to document the testing that was done on 04/19/25 at 4:00 PM. Review of facility policy titled, “IC23A Total Chlorine Testing,” last revision date: 04/10/23, stated, “... Policy: 1. Chlorine/chloramine levels must be tested at the beginning of each treatment day prior to initiating treatment and again prior to the beginning of each patient shift or every four hours; whichever comes first. ...” N.J.A.C 8:43A-24.10(a)(3)”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 39228 Based on three of three observations of acid concentrate jugs utilized on the hemodialysis treatment floor and staff interviews, it was determined that the facility failed to ensure that all jugs that contain dialysate concentrate are labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. Findings include: On 04/28/25 at 9:50 AM, during a tour of the Treatment Floor, Station 8, Station 10, and Station 13 each had a jug placed in front of the dialysis machines in the station that contained a clear solution. All three jugs were unlabeled. During an interview on 04/28/25 at 9:57 AM, Staff (S)7 (Patient Care Technician), stated that the jugs in Stations 8, 10, and 13 each contained 3.0 K (potassium)/2.50 Ca (calcium) dialysate concentrate. S7 explained that the 3.0 K/2.50 Ca dialysate concentrate solution in the jugs is taken from the acid storage tank located in the Water Treatment Room by a staff member and brought onto the treatment floor. On 04/28/25 at 10:50 AM, during a tour of the Water Treatment Area, S6 (Facility Technical Manager) stated that the facility has two acid storage tanks and that one of the tanks contains a 2.0 K/2.50 Ca acid concentrate solution and the other storage tank contains the 3.0 K/2.50 Ca acid concentrate solution. S6 explained that the 2.0 K/2.50 Ca and the 3.0 K/2.50 Ca acid concentrate solutions are delivered to the facility in 55 gallon drums and then transferred to the storage tanks. The concentrates are then delivered directly to the hemodialysis stations via a central delivery system. S6 further explained that over the past week there was an issue with the delivery system for the 3.0 K/2.50 Ca acid concentrate, therefore, the staff had to utilize jugs to retrieve the acid directly from the storage tank and then transfer the jugs to the patient stations. S6 stated that he/she had ordered parts and are still waiting for them to get delivered so that he/she could fix the issue. S6 confirmed that the jugs should have been labeled with the specific acid concentration. On 4/29/25, a request was made for a policy related to the labeling of the acid concentrate jugs. At 10:14 AM, S1 (Clinic Manager) provided the policy titled “IC06 Dialysate Concentrates: Mixing/Use in Individual Containers,” however, the policy did not specify the labeling requirements of the acid jugs when the acid is retrieved from one of the storage tanks.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 51227 Based on one of two observations of machine dialysate pH (potential of Hydrogen) testing and conductivity, staff interview, and review of facility documents, it was determined that the facility failed to ensure that pH testing and conductivity is completed in accordance with facility policy. Findings include: On 04/28/25 at 10:30 AM, in Station 2, Staff (S)4 (Registered Nurse) was observed setting up the hemodialysis lines on the dialysis machine. While the dialysis machine went through its internal testing, S4 brought the patient to Station 2 and assessed him/her. Once the machine completed its internal testing, S4 did not test the dialysate pH and conductivity prior to the start of the patients treatment. During an interview at 10:50 AM, S4 confirmed that he/she should have checked the dialysate pH and conductivity before initiating dialysis and stated, “I am per diem [as needed], and I didn’t know I had to check the conductivity at this facility.” Facility policy titled, “Checking Conductivity & pH of dialysate,” revised 06/20/24, stated, “... Policy: ... 3. It is mandatory that independent testing of conductivity of dialysate is performed prior to the start of each patient treatment and whenever there is a change in the dialysate during treatment ... 8. The pH of dialysate should be between 6.9 - 7.6. If readings from independent testing are not within the specified limits, do not initiate treatment. Notify the technical manager and pull the machine from service ...” N.J.A.C. 8:43A-24.4(a)”

“MICROB MONITOR-MO H20 SAMPLES/METHOD CFR(s): 494.40(a) 7.2 Microbial monitoring methods: monthly water samples/method 7.2.1 General Culture water ...weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Monitoring can be accomplished by direct plate counts, in conjunction with the measurement of bacterial endotoxin. 7.2.2 Sample collection Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened and the water should be allowed to run for at least 60 seconds before a sample is collected in a sterile, endotoxin-free container. A minimum of 50 mL of water, or the volume specified by the laboratory performing the test, should be collected. Sample taps should not be disinfected. This Standard is not met as evidenced by: 39228 Based on staff interview and a review of facility documents, it was determined that the facility failed to ensure that bacteria and endotoxin levels are monitored at the Bicarb (bicarbonate) Loop Return at least monthly in two of six months reviewed. Findings include: On 04/28/25 at 10:17 AM, during a tour of the Water Treatment Area, Staff (S)6 (Facility Technical Manager) stated that monthly bacteria and endotoxin samples are obtained from the RO (reverse osmosis), the loop return, the pre-ultrafilter, the post ultrafilter, the bicarb loop return, and the bicarb feed. A review of facility document titled; “Water Culture Samples Schedule Water Room & Stations” indicated that water samples from the “Bicarb Loop Return” were to be collected monthly. A review of the monthly water culture and endotoxin results for “Bicarb Dist System Return” lacked evidence of results for the months of November and December 2024. On 04/29/25 at 11:16 AM, the monthly water culture and endotoxin reports for the “Bicarb Dist System Return” were reviewed with S6 who confirmed that cultures and endotoxins at the Bicarb Loop Return should be collected monthly and he/she stated that in November and December 2024 they were missed. Facility policy titled, “Technical Operations Manual Department Microbiological Testing: Water,” current revision date: 02/05/24, stated, “Policy: Bacteria and Endotoxin Testing Frequency Testing will be completed: Every calendar month ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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: 39228 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that microbiological samples are collected according to facility policy in two of six months of microbial monitoring reviewed. Findings include: A review of the Reverse Osmosis (RO) Cleaning Log, the Reverse Osmosis and Distribution Loop Disinfect Log and the Culture and Endotoxin laboratory results for November 2024 through April 2025 revealed the following: On 12/13/24, culture and endotoxin samples were collected. Six days later, on 12/19/24, the RO Distribution Loop was disinfected with bleach. On 01/16/25, the RO machine was disinfected with low/high pH (potential of Hydrogen) and Minncare and the RO Distribution Loop was disinfected with Minncare. Five days later, on 01/21/25, culture and endotoxin samples were collected. Facility policy required that within 72 hours of culture and endotoxin sample collection, the RO must be disinfected. The culture and endotoxin samples were not collected within 72 hours before disinfection on the above dates which was not in accordance with facility policy. During an interview on 04/29/25 at 11:16 AM, the above findings were reviewed with Staff (S)6 (Facility Technical Manager) who confirmed that the bacteria and endotoxin samples were not collected within 72 hours prior to disinfection according to facility policy. Facility policy titled, “Technical Operations Manual Microbiological Testing: Water,” current revision date 02/05/24, stated, “Policy: Bacteria and Endotoxin Testing Frequency Testing will be completed: ... Prior to disinfection of the RO machine and distribution system. Definition: Prior to Disinfection Prior to disinfection means: “a sample taken within 72-hours preceding the next disinfection”. ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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 discontinuation of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview and a review of facility documents, it was determined that the facility failed to ensure patient’s rights to privacy. Findings include: On 04/28/25 at 2:20 PM in Station 2, Staff (S)4 (Registered Nurse) discontinued hemodialysis on Patient (P)13 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. P13’s chest was visible from the patient in Station 4, which was located across from the left side of Station 2. During an interview on 04/28/25 at 2:28 PM, S4 confirmed that the curtains should be fully closed around the patient’s station when discontinuing hemodialysis. S4 stated that he/she will make sure that the curtains are fully closed next time. A review of S4’s personal file indicated that “Patient Rights Training and Education - New Jersey” was completed on 07/08/21. Facility policy titled, “G10 Patient Rights and Responsibilities,” revised 11/20/22, stated, “... 3. Be treated with consideration and respect and in full recognition of the patient’s individual and personal needs, including the right for privacy in treatment, interviews and examinations to the extent possible and in accordance with HIPAA [Health Insurance Portability and Accountability Act] guidelines. ...” N.J.A.C 8:43A-16.2(a)10”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 51990 Based on two of two medical records reviewed (Patient (P)1 and P6), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that patients are screened for tuberculosis (TB, infectious bacterial disease that mainly affects the lungs) in accordance with facility policy. Finding includes: A review of P1 and P6’s medical records revealed the following: P1 was admitted on 04/03/25. There was no documented evidence of a baseline TST (tuberculin skin test) upon admission. During an interview on 04/29/25 at 11:15 AM, Staff (S)1 (Clinical Manager) stated P1 was readmitted to the facility and should have had a TST done to re-screen for TB. P6, had a negative TST result on 05/04/23. There was no documented evidence that a TB Risk Assessment Questionnaire (TB-RAQ) was completed in 2024. On 04/30/25 at 10:14 AM, P6’s TB-RAQ was requested from S10 (Home Training Coordinator). He/she was unable to provide the TB-RAQ. Facility Policy titled, “Infection Control,” revised 11/29/22, stated, “... Organisms Spread by Airborne Transmission ... 52. Routine Surveillance to identify patients exposed to tuberculosis will be carried out per the IRC policy for Tuberculosis Screening. ... “ Facility policy titled, “Tuberculosis Screening,” revised 06/20/24, stated, ... Policy: ... 2. All patients will be tested upon admission for baseline tuberculin skin test results (TST) and re- screened if TB exposure is detected. ... 3. Ongoing TB screening for all patients is completed by administering a TB Risk Assessment Questionnaire annually at a minimum ... “ N.J.A.C. 8:43A-24.8(b)(d)”

“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: 51227 Based on observations of the initiation of hemodialysis through an arteriovenous fistula (AVF, a type of vascular access used for hemodialysis), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 04/28/25 at 10:20 AM, Staff (S)7 (Patient Care Technician [PCT]), was observed entering Station 9 to initiate hemodialysis through an AVF. S7 cleansed the first site of the AVF with normal saline and a gauze pad in a circular motion for 17 seconds. S7 did not cleanse the site with a disinfectant in accordance with facility policy. S7 proceeded to clean the second site with normal saline and a gauze pad for 19 seconds, S7 did not cleanse the site with a disinfectant in accordance with facility policy. During an interview at 10:25 AM, S7 was asked about the use of normal saline for performing skin disinfection of the site for an AVF. S7 stated, “This patient is allergic to alcohol and their skin gets irritated with iodine so we can only use normal saline.” During an interview at 11:30 AM, S2 (Charge Nurse) stated if a patient has an allergy or sensitivity to the disinfectants, soap and water should be used to clean the site not normal saline. At 11:35 AM, a policy regarding skin sensitivity to disinfectant alternatives was requested to S2, but none was provided. Facility policy titled, “ ICO4F AVF/AVG Cannulation, Treatment Initiation & Termination Closed Procedure - New Jersey,” Effective date 06/20/2024, stated, “Actions ... 10. Each needle insertion site is then disinfected according to manufacturer’s instructions with one of the following products: 2 % Chlorhexidine with alcohol, 70 % Alcohol, 10 % Povidone-iodine ...” N.J.A.C. 8:43A-24.8(b) 50912”

“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: 51990 Based on two of three medical records reviewed (Patient [P]1 and P12), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that patient information in the medical record is complete and accurate. Findings include: On 04/29/25 at 10:00 AM, Staff (S)1 (Clinical Manager [CM]) stated P1 was admitted to the hospital from 01/16/25 to 04/02/25. P1 was discharged from the facility on 02/25/25 due to a prolong hospitalization, greater than 30 days, and admitted back in the facility on 04/03/25 and had hemodialysis (HD) treatments on 04/03/25 and 04/05/25. P1 was readmitted to the hospital on 04/06/25 and remained hospitalized at the time of survey. A review of the “Nursing Initial Assessment” dated 04/16/25, in P1’s medical record revealed the following: The RN assessment portion contained a note that stated, “Assessment is for 04/03/25. Late entry d/t [due to] patient going to the hospital following hd tx [hemodialysis treatment] ...” Per interview above with S1, the patient was hospitalized 04/06/25. The assessment also stated that P1’s HBsAg (Hepatitis B surface antigen) was negative on 04/03/25. The medical record did not contain evidence of HBsAg testing and results upon re-admission. The RN assessment for extremity edema indicated, “none.” A review of the Physician’s “Dialysis Visit Note,” dated 04/03/25, indicated P1’s edema was severe in all extremities. During an interview on 04/29/25 at 11:55 AM, S1 stated P1’s HBsAg result was “Nonreactive” on 03/15/25 at the hospital before admission in the facility. The CM confirmed the above information. A review of P1’s “Social Worker (SW) Quarterly Note” dated 04/18/25 stated the following: “The patient is currently hospitalized.” “Depression Screening Completed: Yes ... Screening for clinical depression is documented as negative, and a follow up plan is not required ... “ “Identified Issues: No problems identified ...” During an interview on 04/29/25 at 12:20 PM, the surveyor confirmed with S9 (Social Worker) that P1’s assessment was done on 04/18/25 when patient was hospitalized. S9 stated, “I got confused. Patient was due for a quarterly note, and I should have done an initial assessment.” The assessment and documentation were dated when patient was hospitalized and was not present in the facility. Facility Manual titled, “Social Worker Manual,” updated 04/11/25, stated, “... Social Worker Progress Notes ... Initial Progress Notes ... The Social Worker must meet with all new patient within two (2) weeks of the admission to complete the initial admission note. ...” N.J.A.C. 8:43A-13.3(a)(7)(9) 37656 A review of P12’s medical record, a Home Peritoneal Dialysis (PD, a treatment for kidney failure that uses the lining of the abdomen (peritoneum) as a filter to remove waste products and excess fluid from the blood) patient, revealed the following: P12 was admitted on 03/18/25. P12 was started on a home training program on 03/18/25 that included all the education necessary to perform safe PD at home per facility policy. The medical record also contained a document titled, “PD Training Final Exam as a Post Learning Assessment” that was provided by S10 (Home PD Registered Nurse [RN]) and completed by a patient. The “PD Training Final Exams as a Post Learning Assessment” stated: “Completing a Safe Exchange, keeping Clean, Lesson 2: Doing Dialysis at Home - Keeping Clean, Lesson 3: Taking Care of Your Catheter and Exit Site to Prevent PD Infections, Lesson 4: Steps for a Safe Treatment, Lesson 5: Managing Fluids and Diet, Lesson 7: Ordering Supplies and Equipment, and Lesson 6: Understanding Your Medications.” The patient education exam did not contain the name of the patient, the date it was completed, and did not indicate if the answers were acceptable. Therefore, it could not be determined if this education was for P12. In an interview on 04/30/25 at 10:28 AM, S10 stated that the above document was completed by P12 but he/she forgot to place a label with P12’s name on it. Facility policy titled, “HT01 Home Dialysis Training Program,” revision date 01/13/25, stated, “... Training Schedule: ... Documentation of home training will include treatments, trainings, skills, checklists, and exams as appropriate. ...” N.J.A.C. 8:43A- 24.20(a)(3)”