Davita West Orange Dialysis

“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: 44833 Based on two of six staff members observed for infection control, staff interview, and review of facility documents, it was determined that the facility failed to ensure proper hand hygiene is performed to prevent cross contamination. Findings include: On 12/03/25 at 10:35 AM, Staff (S)5 and S6 were observed performing a discontinuation of patient’s dialysis treatment utilizing a Central Venous Catheter (CVC, a type of access used for hemodialysis) in Station 3. S6 entered Station 3 and put on a clean set of disposable gloves and obtained the patient’s blood pressure and heart rate using a digital machine which was positioned on the patient’s chair side table. Once complete, S6 exited Station 3, removed his/her gloves, and disposed of them. Without first performing hand hygiene, S6 put on new clean gloves as he/she entered patient occupied Station 18. At 10:49 AM, S5 entered Station 3 and performed hand hygiene using alcohol-based hand rub (ABHR) before he/she put on clean gloves. S5 assessed the patient using a stethoscope, documented on the computer stationed next to the treatment station, and appropriately performed a glove change with hand hygiene. S5 then touched the hemodialysis machine and, without first changing gloves or performing hand hygiene, returned to the patient and used an iodine prep pad to wipe the exit site of the CVC and applied a sterile gauze dressing with a clear sterile dressing cover. He/she then removed his/her gloves, and without first performing hand hygiene, put on new gloves, and continued with the remainder of the termination of the patient’s treatment and care. During an interview at 11:30 AM, S5 stated hand hygiene should be performed in between every glove change, and gloves should be changed when going from touching the treatment equipment to going to direct contact with the patient. During an interview at 11:45 AM, S6 stated that hand hygiene should be performed when gloves are being changed, and that it is very important for infection control. On 12/5/25 at 12:25 PM, the surveyor interviewed S1, who stated that staff should never touch a machine and then have contact with a patient without changing gloves and performing hand hygiene. S1 further stated that hand hygiene should be used in between each glove change to prevent the spread of infection. 51227 On 12/03/25 at 10:35 AM in Station 11, S4 was observed initiating hemodialysis through a left arm arteriovenous fistula (AVF, a type of access used for hemodialysis). S4 typed on the computer and checked the patients blood pressure. S4 then removed his/her gloves, went to the nurse’s station, and obtained supplies. Without the benefit of performing hand hygiene first, S4 put on a new pair of gloves and cleaned the dialysis access site with alcohol prep pads for the appropriate amount of time. Next, S4 removed his/her gloves and without the benefit of performing hand hygiene first, put on a new pair of gloves before he/she proceeded to insert two needles into the dialysis access site. During an interview at 11:00 AM, S4 stated, “I should have performed hand hygiene after I removed my gloves, each time.” On 12/03/25 at 12:10 PM, S4 entered patient occupied Station 15 and touched the computer. S4 then removed his/her gloves and, without the benefit of performing hand hygiene first, put on a new pair of gloves and entered Station 16. S4 was adjusting the blood pressure cuff of the patient in Station 16 when the hemodialysis machine started to alarm in Station 11. S4 proceeded to remove his/her gloves and put on new gloves without the benefit of hand hygiene first. S4 entered Station 11 and touched the hemodialysis machine to silence the alarm. During an interview at 11:45 AM, S6 stated hand hygiene is very important, and the use of hand sanitizer or hand washing should be performed when gloves are being changed. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, indicated, “... Hand Hygiene 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, ... d. after patient and dialysis delivery system contact, ... f. between patients even if contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. a. Gloves should be changed when: ... ii. When going from a ‘dirty’ area or task to a ‘clean’ area or task ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system ...” 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: 51227 Based on two of two observations of the cleaning and disinfection of a dialysis station, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that the chase wall and water box is cleaned and disinfected after patient use. Findings include: On 12/03/25 at 10:10 AM, in Station 6, Staff (S)5, used a bleach-soaked cloth to clean and disinfect the hemodialysis machine, patient recliner chair, television, and blood pressure cuff. S5 did not clean and disinfect the back chase wall of the station and the water box to prevent cross contamination. During an interview at 10:15 AM, S5 stated that he/she should have cleaned the back chase wall and water box. 48966 On 12/03/25 at 10:25 AM, in Station 7, S12 was observed cleaning and disinfecting the hemodialysis station after the patient was discharged. S12 used a bleach-soaked cloth to clean and disinfect the dialysis machine including the prime bucket, blood pressure cuff, dialysis chair, and television. S12 did not clean and disinfect the chase wall or the water box located behind the dialysis machine and chair. During an interview on 12/03/25 at 10:31 AM, S12 stated the countertop and wall box needs to be cleaned with a bleach-soaked cloth but he/she did not do so. A review of S12’s personnel file indicated that S12 successfully completed the “In-Center Annual Procedural Skills Verification Checklist” on 01/07/25. The annual checklist did not include cleaning and disinfection of the dialysis station. During an interview on 12/06/25 at 12:11 PM, S11 confirmed after reviewing the “In-Center Annual Procedural Skills Verification Checklist,” the cleaning and disinfection of the dialysis station was not included. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... DISINFECTION ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by health care personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops) ... b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient ...” N.J.A.C. 8:43A-24.8(b)”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 52927 Based on one of one observation of the initiation of hemodialysis using a central venous catheter (CVC, a type of access used for hemodialysis) and review of facility policy and procedure, it was determined that the facility failed to ensure that CVC initiation is performed aseptically. Findings include: On 12/03/25 at 10:18 AM, in Station 18, Staff (S)5 initiated dialysis through a right chest wall CVC. S5 placed a new dressing to the exit site according to facility policy. With gloved hands, S8 removed a pen from his/her shirt pocket located under the protective gown and labeled the CVC dressing. S8 then dropped his/her pen onto the blue pad, located on the side table of the dialysis chair, that contained clean supplies. S8 removed his/her gloves, performed hand hygiene and put on new, clean gloves. Next S8 placed a new blue pad on top of the contaminated supplies and replaced the CVC care items. S8 then removed his/her gloves, performed hand hygiene, and obtained a new pair of clean gloves from the contaminated blue pad that remained under the new pad. S8 then removed the arterial cap and continued to initiate dialysis in accordance with facility policy During an interview on 12/03/25 at 11:30 AM, S5 stated he/she should not have used the gloves the pen touched as they were no longer considered clean. Facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised April 2025, stated, “... Notes: Use Dialysis Precautions and aseptic technique throughout procedure ...” N.J.A.C. 8:43A-24.4(b)”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 48966 Based on one of one observation of total chlorine testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure accurate testing of the water treatment system for chlorine/chloramine removal. Findings include: A review of the RPC E-Z Chek Sensitive Total Chlorine Test Strip instructions for use stated, “... Test Procedure ... 2) Remove one test strip from the foil packet and swish it in the sample for the amount of time indicated according to the following temperature ranges: Water sample temperature from 42 degrees F [Fahrenheit] to 61 degrees F (6 degrees C [Celsius]) to 16 degrees C), swish time 60 seconds. ... 4) Wait 20 seconds for the test strip to develop. ... 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample. ...” On 12/03/25 at 11:15 AM, Staff (S)4 performed a test for total chlorine levels in the Water Treatment Room. S4 obtained a sample of water and, after filling and dumping the cup with water three times, S4 dipped a RPC E-Z Chek Sensitive Total Chlorine Test Strip into the water sample and swished the strip in a back and forth motion for one minute and 20 seconds. S4 then removed the strip from the water and compared the test strip color to the color chart to determine the level of chlorine after two seconds. S4 exceeded the required one minute dip time in the water sample and did not wait 20 seconds after removing the test strip to compare the strip to the color chart. This was not in accordance with manufacturer’s instructions for use. During an interview immediately after the observation, S4 stated to dip the test strip in the water sample for one minute and the wait 20 seconds before comparing the strip to the color chart. A review of S4’s personnel file revealed that he/she was last evaluated on the chlorine testing procedure and determined to have a “satisfactory performance of skill by teammate” on 10/06/25. Facility policy titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip,” revised October 2023, stated, “... 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds ... 5. After the 20 second wait period, immediately compare the strip color to the K100-0118 color chart to determine the Total Chlorine level in the sample ...” N.J.A.C. 8:43A-24.10(a)(3)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that: 1) a defect-free environment is maintained at all times; and 2) patient owned equipment is approved for use within the facility prior to use on the treatment floor. Findings include: 1. During a tour conducted at 11:30 AM on 12/03/25 with Staff (S)2, it was discovered that the return air vent registers located throughout the patient treatment area and support space were visibly dusty and grimy. S2 stated that the return air vent registers would be cleaned as soon as possible by building maintenance. N.J.A.C. 8:43A-17.3(j) 39223 2. On 12/03/25 at 10:33 AM in Station 3, Patient (P)2 was observed receiving his/her hemodialysis treatment. P2 was observed to have a red light that was plugged into the outlet located behind the hemodialysis machine. He/She picked up the red light, flipped a switch located on the cord to turn the light on, and then placed the light directly onto his/her chest, underneath his/her shirt. The cover over the wires had started to separate at the connection between the cord and the on/off switch, exposing the wiring underneath. During an interview at 11:28 AM, after the patient had completed hemodialysis treatment, S5, who had provided care to P2, stated that he/she was not sure if the patient’s personal red light lamp was approved for use on the hemodialysis treatment floor. At 11:32 AM, S11 confirmed that the patient’s personal red light lamp was not approved for use on the hemodialysis treatment floor and immediately went to the patient’s chairside to discuss with the P2. Facility policy titled, “Patient Owned (Non-DaVita Furnished) Medical Equipment,” revised October 2025, stated, “... 1. All patient owned (non-DaVita furnished equipment) medical devices required for patient use during treatment or while in the dialysis facility, such as but not limited to Ventricular Assist Devices (VAD), wearable external defibrillator, Ventilator, Continuous Positive Airway Pressure (CPAP) or BiPap machine, require an order from a physician and approval for use of the device through the facility Governing Body. ... 3. If the medical device requires electricity to operate, the device must first be cleared by Biomed to assure no electromagnetic interference with dialysis delivery systems. There must also be a visual device inspection performed by the Biomed. This visual inspection would include an initial check that electrical cords are not frayed, there are no burn marks on the plug or cord and that plug is intact. No extension cords will be used and a dedicated electrical outlet is not needed. The Biomed will also verify that the facility environment in which this device will be used is consistent with manufacturer’s recommendations. ...””

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 52927 Based on one of five medical records reviewed (Patient (P)5), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that the Physician completes a comprehensive assessment prior to developing a patient Plan of Care (POC). Findings include: A review of P5’s medical record revealed a POC, dated 11/24/25 which lacked document evidence that a physician’s comprehensive assessment was completed prior to the POC meeting. During an interview on 12/04/25 at 1:19 PM, Staff (S)1 and S11 confirmed there was no evidence that a comprehensive assessment was completed by a physician in November of 2025. During an interview on 12/05/25 at 12:01 PM, S13 stated comprehensive assessments are to be completed by physicians prior to the POC meeting. S13 continued to state, P5 was seen monthly in his/her office, however those visits were documented in a separate Electronic Medical Record (EMR) system from the facility’s EMR system. S13 confirmed he/she did not document the visits in the facility’s EMR system. Facility policy title, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised 2024, stated, “... Assessment: 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectation for care ... In the states of ... New Jersey ... Semi- Annual (stable patients) ... Complete patient plan of care and patient plan of care meeting within 15 days of the completion of the reassessment ...” N.J.A.C. 8.43A-24.13(c)”

“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: 48966 Based on two of two observations of the initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 12/03/25 at 10:35 AM, in Station 4, Staff (S)7, initiated dialysis through a patient’s right upper arm AVF. S7 cleansed the first (arterial) site with one 70% isopropyl alcohol pad in a circular motion for 60 seconds, let it dry for one minute, and then cannulated (act of inserting a needle) the arterial needle. S7 proceeded to clean the second (venous) site with one 70% isopropyl alcohol pad in a circular motion for 60 seconds, let it dry for one minute, and then cannulated the venous needle. S7 did not cleanse each site with four alcohol pads in accordance with facility policy. During an interview on 12/03/25 at 10:59 AM, S7 stated that when using alcohol only to clean the access site, to do so with one alcohol pad per site for one minute and let it dry for one minute. During an interview on 12/03/25 at 12:08 PM, S11 stated that for each site, four alcohol pads should be used for a total of 60 seconds. S11 emphasized to use four alcohol pads for the arterial site and four alcohol pads for the venous site. A review of S7’s training and education records indicated that an “In-Center Annual Procedural Skills Validation Checklist” that included training in AVF/AVG cannulation was successfully completed on 03/31/25. 51227 On 12/03/25 at 10:35 AM, S4, was observed entering Station 11 to initiate hemodialysis through an AVF. S4 cleansed the first site of the AVF with an alcohol preparation (prep) pad in a circular motion for 10 seconds. S4 did not acquire three new alcohol prep pads as required by facility policy. S4 cleaned the site for 50 seconds less than required by facility policy. S4 proceeded to clean the second site with one alcohol prep pad for 10 seconds. S4 did not acquire three new alcohol prep pads. S4 cleaned the site for 20 seconds less than required by facility policy. During an interview at 11:00 AM, S4 was asked about the procedure on performing skin disinfection of the site for an AVF. S4 stated, he/she should clean the site for 60 seconds using an alcohol prep pad for each site. Facility policy titled, “AV Fistula Or Graft Cannulation With Nipro or Medisystems Safety Needles (SFN) And Administration Of Heparin Loading Dose,” revised April 2025, stated, “... Notes: ... Use Isopropyl Alcohol 70% as the single antiseptic ONLY when the patient has documented allergies to other skin antiseptics ... Skin Antiseptic Isopropyl Alcohol 70% Effective Volume At least 4 prep pads per site Effective Contact time 60 seconds ... Procedure ... 12. For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation ...” N.J.A.C. 8:43A-24.8(b)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 52927 Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that monthly notes are completed by the physician for four of the six months reviewed for Patient (P)5. Findings include: A review of P5’s medical record lacked documented evidence of a physician’s monthly progress note for July, August, October, and November of 2025. On 12/04/25 at 1:19 PM, upon request for the missing physician monthly progress notes listed above, S1 and S2 confirmed there was no documented evidence of a physician monthly progress note for July, August, October and November of 2025 in P5’s medical record. During an interview on 12/05/25 at 12:01 PM, S13 stated that progress notes are done monthly by the physicians. S13 continued to state, P5 was seen monthly in his/her office, however those visits were documented in a separate Electronic Medical Record (EMR) system. S13 confirmed he/she did not document the visits in the facility’s EMR system. Facility policy titled, “Progress Note Policy,” revised October 2025, stated, “... Physician: The attending Nephrologist is required to record progress notes at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times ...” N.J.A.C. 8:43A-24.13(d)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51227 Based on observations, staff interviews, and review of facility documents, it was determined that the Medical Director failed to ensure that: 1) facility policy for three of three observations of heparin (a blood thinner) administration is implemented; and 2) expiration dates of medications and supplies are monitored and discarded and open medications are labeled according to facility policy. Findings include: 1. On 12/03/25 at 10:35 AM, in Station 11, Staff (S)4 initiated hemodialysis through an Arteriovenous Fistula (AVF, a type of vascular access used for hemodialysis). The following was observed: S4 obtained vascular access of the patient’s left forearm dialysis access site and asked S6 to administer heparin. S4 then proceeded to attach the dialysis lines to the patient and initiated hemodialysis treatment before S6 was able to prepare and administer the heparin. At 10:45 AM, S6 stated this was not the process for administering heparin and that it should have been given before the treatment was started according to their policy. During an interview at 11:00 AM, S4 stated that after the administration of heparin he/she is supposed to wait three to five minutes before initiating the hemodialysis treatment. S4 stated, “It was my mistake, I should not have started the treatment before heparin was given.” 52927 On 12/03/25 at 12:17 AM, in Station 8, S3 was observed initiating hemodialysis treatment through a right chest wall central venous catheter (CVC, a type of access used for hemodialysis). S8 attached a heparin filled syringe to the venous port and slowly injected the heparin with a back-and-forth motion. After waiting one minute, S8 proceeded to attach the dialysis lines to the CVC and initiated treatment. This was two minutes less than the required wait time according to facility policy. During an interview at 12:30 PM, S3 stated the wait time after heparin is administered is three to five minutes. 48966 On 12/03/25 at 10:35 AM, in Station 4, S7 was observed initiating hemodialysis treatment through a right upper arm AVF. S6 attached a heparin filled syringe to the venous needle and slowly injected the heparin with a back-and-forth motion. After waiting two minutes, S7 proceeded to attach the dialysis lines to the fistula needles and initiated treatment. This was one minute less than the required wait time in accordance with facility policy. During an interview on 12/03/25 at 11:07 AM, S7 was unsure of the required wait time before initiating treatment and proceeded to check. At 12:02 PM, S7 stated after the heparin bolus is given you need to wait three to five minutes before initiating treatment. Facility policy titled, “AV Fistula Or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose,” revised April 2025, stated, “... 28. Attach heparin loading dose to venous fistula needle, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into fistula or graft. Re-clamp ... 29. Do not initiate dialysis for a minimum of three (3) to five (5) minutes after administering heparin loading dose. ...” Facility policy titled, “Central Venous Catheter (CVC) Clearguard HD Antimicrobial End Procedure,” revised April 2025, stated, “... 23. Procedure ... Attach heparin loading dose to venous limb, as applicable ... 23. Rationale ... DO NOT initiate dialysis for a minimum of 3-5 minutes after heparin administration to allow heparin to circulate systemically. 24 ... Procedure ... After a minimum of 3-5 minutes, remove syringe from each access port one at a time, then attach each blood line tips or catheter limbs ...” N.J.A.C. 8:43A-9.3(a) N.J.A.C. 8:43A-9.4(b) 2. On 12/03/25 at 12:19 PM, a tour of the Peritoneal Dialysis Treatment area was conducted and the following was observed: In Home Training Room 1, the upper cabinet above the drawers labeled “tape, 4x4 gauze pads, 2x2 gauze pads, Band-Aids” contained a white plastic container on the first shelf. The white container contained six rolls of cloth tape, two rolls of paper tape and 14 cotton tip applicators. At the bottom of the container was an opened Gentamicin Sulfate Cream 1% tube that lacked an opening date and the initials of the person who opened it. In Home Training Room 3, the upper cabinet above the drawers labeled “KT/V supplies” contained four packages of Baxter Ultra Set CAPD [continuous ambulatory peritoneal dialysis] Disposable Disconnect Y-Set on the first shelf. The four packages had an expiration date of October 2025. The third drawer from the top contained a clear container where nine packets of CareAll Triple Antibiotic Ointment were observed. All nine packets had an expiration date of March 2025. During an interview on 12/03/25 at 12:48 PM, S10 stated the Gentamicin Sulfate Cream should have not been in the cabinet and was unsure why it was there. S10 explained each patient receives their own supply of Gentamicin cream at home. S10 stated the disposable CAPD bags are used for training purposes before being discarded. S10 added the Triple Antibiotic packets found in the drawer are not used and was unsure of why the packets were there. S10 added that Home Training Room 3 is only used for monthly clinic visits. Facility policy titled, “Medication Policy,” Revision date: November 2023, stated, “... Policy ... 17 ... l. Insulin and other medication with preservatives are dated and initialed once opened ... n. Disposal of expired medications, including over the counter ... are removed from the treatment and inventory areas and disposed of per state/local regulations ...” Facility policy titled, “Infection Control For Dialysis Facilities.” Revision Date: April 2023, stated, “... Supplies 8. ... Expiration date and package integrity will be verified prior to use ...” N.J.A.C. 8:43A-9.3(a) N.J.A.C. 8:43A-9.5(f)”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 37656 Based on a review of the treatment flow sheets of Patient #1 (P1), staff interview, and review of facility documents, it was determined, the facility failed to: 1. ensure that changes in blood pressure (BP) readings during hemodialysis treatment are reassessed by a Registered Nurse (RN) (in one of seven treatments), 2. follow the prescribed dialysis treatment time (in two of seven treatments). Findings include: 1. A review of the Patient Summary Report revealed: In-Center Active Medications: ... “Clonidine 0.1 Milligram Oral Every 4 hours as needed ... order start date: 6/14/2023” A review of P1’s treatment flow sheet dated, 11/6/2023, revealed the following: 6:31 AM - blood pressure (BP) 157/70 7:01 AM - BP 188/74, a systolic blood pressure increase of 31 above the prior BP reading The Patient Care Technician (PCT) stated in his/her notes that the RN was made aware 7:31 AM - BP 191/85, the PCT documented that the RN was made aware 8:01 AM - BP 181/87, PCT stated the RN was made aware 9:01 AM - BP 188/90 Treatment was terminated by the PCT The above flow sheet lacked documented evidence that the RN reassessed the elevated BP at 7:01 AM, 7:31 AM, 8:01 AM, and 9:01 AM after PCT made him/her aware. The Post Treatment assessment note was signed by the RN at 12:39 PM, three hours and 38 minutes after the patient’s treatment was terminated. Medical Record #1 lacked documentation that the RN performed an assessment of P1 prior to P1 being discharged, and lacked documentation that Clonidine was given to P1. In an interview on 12/5/23 at 12:20 PM, S2, Clinical Coordinator, stated that the RN should have assessed the patient when they were made aware of the elevated BP and should have given the patient Clonidine per physician’s order. Per S2, the RN should have reported this to the physician prior to the discharge of the patient and should have given Clonidine to P1 per facility policy and physician orders. A review of the facility policy and procedure titled, Pre -Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revision date: October 2023, states, “... INTRADIALYTIC DATA COLLECTION/ASSESSMENT ... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use her/his clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary. ... POST TREATMENT DATA COLLECTION/ASSESSMENT ... 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. ... ABNORMAL FINDINGS ... the following are considered abnormal findings and should be reported to the licensed nurse and documented on the patient’s medical record ... Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ... Blood Pressure: Pre dialysis: ... Systolic greater than 180 mm/Hg (millimeter/Mercury) or less than 90 mm/Hg ... Diastolic greater than or equal to 100 mm/Hg ...Blood Pressure -Intradialytic...difference of 20 mm/hg increase or decrease from patient’s last intradialytic treatment BP reading... Blood Pressure Post Treatment: ... Sitting BP for patients that cannot stand: ... Sitting BP greater than 140 mm/Hg or less than 90 mm/Hg ... Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ...” 2. A review of P1’s treatment flow sheets revealed the following: Dialysis Prescription: “Treatment time: 3h [hour] 30m [minutes] (210 min) ...” On 10/25/23, P1’s treatment was initiated at 5:54 AM by a Registered Nurse (RN), and ended at 8:33 AM, two hours and 41 minutes later. This was 49 minutes less than the ordered time. On the “Close Treatment Reason” portion of the flow sheet, it stated, “Set up Issue (delayed getting pt (patient) on, machine set incorrectly).” The flow sheet contained documentation that a RN verified the patient’s prescription at 7:35 AM on 10/25/23 that stated, “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” The flow sheet lacked documentation by the PCT that the RN was made aware of the shortened treatment due to the machine being set incorrectly. Medical Record #1 lacked documentation that a RN had assessed P1 prior to P1 being discharged. The Post Treatment Assessment was completed by the RN at 18:45 (6:45 PM), 10 hours and 12 minutes after the treatment was terminated. On 11/17/2023, P1’s treatment was initiated at 5:28 AM by Staff (S) 4, a Patient Care Technician (PCT), and ended at 8:26 AM, two hours and 58 minutes later. This was 32 minutes less than the ordered time. On the “Close Treatment Reason” portion of the flow sheet, it stated, “Set up Issue (delayed getting pt (patient) on, machine set incorrectly).” The flow sheet contained a documentation that a RN verified the patient’s prescription at 6:14 AM on 11/17/23 that stated, “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” Medical Record #1 lacked documentation by the PCT that the RN was made aware of P1’s shortened treatment. The Medical Record lacked documentation that the RN had assessed P1 prior to discharge. The Post Treatment Assessment was completed by the RN at 8:50 AM. A review of RN monthly progress notes, dated 11/22/23, indicated that on 11/20/23, ... “Patient (P1) called from his/her home and spoke with MSW (Master Social Worker) reporting he/she does not feel safe at dialysis due to a PCT that put him/her on the machine on 11/17/23 ... . PCT in question had set up the machine for 180 minutes instead of 210 minutes. ...” During an interview on 12/5/23 at 3:15 PM, S1, the Facility Administrator, stated that S4 apologized to P1 for putting the wrong treatment time on, which caused a shortened treatment time. S1 stated that S4 and the other teammates were re-educated about checking the patient’s prescription prior to setting up the machine, and were given a copy of the policy and procedure for the Pre-Intra-Post Treatment Data collection, Monitoring and Assessment. There was no staff sign in sheet available for review. A review of the facility policy titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised October 2023, states, “... 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) ... a. The assessment includes the following components: ... ii. Verification that machine safety checks have been completed and documented ... iii Verification of prescription including machine parameters ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ... . The prescription components are confirmed by a license nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ... b. treatment time ... POST TREATMENT DATA COLLECTION/ASSESSMENT ... 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. ...””