Fmc Hamilton Square

“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: 52927 Based on one of two observations of cleaning and disinfection of the dialysis station, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that all equipment in the dialysis station is cleaned and disinfected in accordance with facility policy. Findings include: On 01/07/26 at 9:42 AM, in Station 11, Staff (S)8 was observed cleaning and disinfecting the hemodialysis station after the patient was discharged. S8 used a bleach-soaked cloth to clean and disinfect the top, front, bottom, right side, IV (Intravenous) pole, left side and the tubing of the hemodialysis machine. S8 did not clean and disinfect the prime bucket located on the right side of the machine. S8 used a new bleach-soaked cloth to clean and disinfect the hemodialysis chair. S8 placed the chair in the reclining position, cleaned the left chair table, opened the left chair arm and cleaned the inside of the left arm. S8 also wiped the seat, back, and footrest. S8 closed the glisteningly wet left chair arm immediately. S8 did not allow the surfaces to air dry before closing the left chair arm. S8 continued to open the right chair arm, cleaned the right chair table, inside the right chair arm and closed the glisteningly wet right chair arm immediately. S8 did not allow the surfaces to air dry before closing the right chair arm. S8 did not clean the chase wall behind the patient recliner, the television, or the arm of the television. During an interview at 9:55 AM, the above findings were discussed and confirmed with S8. S8 stated that the chase wall, television, and the arm of the television should have been cleaned and disinfected. S8 added, the chair arms can be closed immediately because there is no dry time. S8 also stated, “the prime bucket did not have water in it, so I did not clean it.” S8 proceeded to use a new bleach-soaked cloth to clean and disinfect the chase wall (a vertical space in a wall that provides an area for water piping), television and the arm of the television. S8 did not clean the prime bucket. Facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/02/25 stated, “... Procedure ... Step 3 ... Action ... Use a cloth wet with 1:100 [one part bleach to 100 parts water] 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, sharps container mounted to the machine, chaise [sic] wall behind chair). Place the chair in Trendelenburg position [head down tilt] and open side panels if chair has swing open sides so all surfaces of the chair are accessible ... Step 4 ... Clean all surfaces. Make the surfaces glisteningly wet and allow to air dry ...” N.J.A.C. 8:43A-24.8(b)”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 52927 Based on review of employee health files, staff interview, and review of facility documents, it was determined that the facility failed to ensure that: 1) three of 107 patients (Patient (P)21, P22, P23) who are susceptible to the Hepatitis B Virus, are tested for the Hepatitis B surface Antigen (HBsAg) monthly; and 2) one of four employees (Staff (S)4) who are susceptible to the Hepatitis B virus with a Hepatitis B surface Antibody (Anti-HBs) of less than 10 mIU/mL (milli-international units per milliliter), have Hepatitis B vaccination status documented in the employee’s health file. Findings include: 1. A review of the Hepatitis B laboratory results report from January 2025 through January 2026 indicated the following: P21 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 07/14/25, 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 2025. P22 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 01/08/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in February, April, and May 2025. P22 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 07/09/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in August, October, and November 2025. P23 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 07/22/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in October and November 2025. On 01/08/26 at 9:43 AM, the above findings were reviewed with S6. S6 confirmed the missing results for the above-mentioned patients. S6 stated, “I am not sure what happened, it seems like the missed HBsAg were overlooked.” Facility policy titled, “Patient Hepatitis B Testing Requirements,” published 02/03/25, stated, “HBV Patient Testing ... Patient Status ... Susceptible ... HBsAg: Negative ... Anti-HBs: less than 10 mlU/mL ... HBsAg ... Monthly Testing ... Note: If anti-HBs declines to less than 10 mlU/mL, test for HBsAg monthly ... “ 2. A review of S4’s health file revealed an anti-HBs test result of less than 10 mlU/mL on 06/26/19, which indicated he/she was susceptible to Hepatitis B. S4’s health file lacked documented evidence of Hepatitis B vaccination status in accordance with facility policy. On 01/09/26 at 10:22 AM, the above finding was reviewed with S2 and S4. S2 stated, “I did not have him/her sign a vaccination declination.” S4 stated, his/her previous clinic initiated the vaccination series and repeated bloodwork in 2023. S4 stated, he/she does not have record of any vaccinations. Facility policy titled, “Employee Requirements for Testing and Vaccination for Hepatitis B,” published 04/05/21, stated, “The Hepatitis B vaccine shall be offered to all employees upon hire or rehire. Prior to vaccine administration, draw the hepatitis B antibody (anti-HBs) to determine susceptibility ... If susceptible, offer vaccine ... The Clinical Manager/RN designee should provide documentation of testing and vaccine administration to the field-based employee’s supervisor to place in the designated section of the field-based employee’s personnel file. The employee’s supervisor is accountable for ensuring timely administration and provision of all vaccine doses ... Documentation ... Hepatitis B vaccination status shall be documented in the employee’s vaccination record including: signed consent or declination forms; dates of all Hepatitis B vaccinations; documentation of having received the vaccination information statement, and any medical records relative to the employee’s ability to receive vaccination (if applicable) ...” N.J.A.C. 8:43A-24.4(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: 48966 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, a review facility documents, it was determined that the facility failed to ensure that provided care and access of a CVC is performed in accordance with facility policy. Findings include: On 01/07/26 at 11:10 AM in Station 6, Staff (S)8 was observed initiating hemodialysis through a right CVC. During CVC exit site care, S8 cleansed the exit site in a circular motion using three separate prepackaged 2% Chlorhexidine swabs for a total of 27 seconds. This was three seconds less than required by facility policy. After cleaning the arterial (red) and venous (blue) limbs with an alcohol prep pad, S8 proceeded to remove the venous end cap and wiped the sides, threads and end of hub with an alcohol prep pad for eight seconds and then attached a 10 cubic centimeter (cc) syringe to the limb. This was two seconds less than required by facility policy. S8 removed the arterial end cap and wiped the sides, threads and end of hub with an alcohol prep pad for seven seconds and then attached a 10 cc syringe to the limb. This was three seconds less than required by facility policy. During an interview on 01/07/26 at 11:33 AM, S8 stated the CVC exit site needs to be cleaned with Chlorhexidine for two to three minutes. S8 further stated to clean the threads and end of the CVC hub with an alcohol wipe for five to ten seconds before attaching the 10 cc syringe. S8’s personnel file was reviewed and indicated the “Annual Clinical Skills Validation” which included CVC exit site care (dressing change) and initiation of dialysis with a CVC was completed successfully on 11/10/25. 52927 On 01/06/26 at 11:27 AM in Station 16, S3 was observed performing CVC exit site care. S3 removed the old dressing from the exit site according to facility policy. S3 used one 2% chlorhexidine gluconate with 70% isopropyl alcohol (Chloraprep) swabstick to clean the exit site in a concentric motion for 14 seconds. S3 then used a second 2% chlorhexidine gluconate with 70% isopropyl alcohol swabstick to clean the exit site in concentric motion for 12 seconds. S3 used two separate swabsticks to clean the exit site for a total of 26 seconds. This was four seconds less than required by facility policy. S3 allowed the exit site to dry for two minutes and then placed a new dressing onto the exit site in accordance to facility policy. During an interview at 11:38 AM, S3 stated, “when using Chloraprep to clean the exit site, I use two swabs for a total of 60 seconds.” Facility policy titled, “Changing the Catheter Dressing Procedure,” published 05/02/25, stated, “... Cleansing the Site: ... 2. Remove swabstick from package by stick end without touching foam applicator. Handle only the stick portion. 2% chlorhexidine gluconate with 70% isopropyl alcohol: Using gentle back forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds ...” Facility policy titled, “FX CorAL Dialyzer: Initiation of Treatment Using a Central Venous Catheter,” Published 05/05/25, stated, “... Preparing the Catheter: Disinfection of the Catheter Connections, ... Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad ... for 10-15 seconds and any time caps are removed ... Step 3 Using a sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) scrub the sides (threads) and the end of the hub thoroughly with friction, making sure to remove any residue ... Step 4 Using the same sterile alcohol pad ... applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. (steps 3 and 4 should take 10-15 seconds.) ...” N.J.A.C. 8:43A-24.4(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: 51990 Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure Reverse Osmosis (RO, a water purification system) microbiological samples (culture testing for colony count and endotoxins) are collected in accordance with facility policy in two of six months of microbial monitoring reviewed. Findings include: A facility document titled, “RO (reverse osmosis, water purification system) Membrane Cleaning/Sanitization Water Holding Tank & (and) Loop Disinfection” was reviewed from June 2025 to December 2025. On 06/05/25, the RO system disinfection was performed. Culture and endotoxin samples were collected on 06/16/25, approximately 11 days after disinfection. On 10/07/25, the RO system disinfection was performed. Culture and endotoxin samples were collected on 10/09/25, approximately two days after disinfection. During an interview on 01/08/26 at 9:25 AM Staff (S)4 stated, the cultures were collected on 06/05/25 before the RO disinfection was performed. However, the samples collected were cancelled by the laboratory. S4 was unable to provide cancellation documentation from the laboratory for cultures collected on 06/05/25. S4 added he/she had no explanation for October. Facility policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” published 02/03/25, stated, “... Scheduled Sampling ... Samples will be collected prior to disinfection and within 96 hours of system disinfection ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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: 51040 Based on observations and staff interview, it was determined that the facility failed to ensure that the surfaces are kept clean to sight and touch. Findings include: During a tour of the facility on 01/07/26, starting at 9:43 AM, with Staff (S)5, the following was observed: At 10:03 AM on the Hemodialysis Treatment Floor at Station 3, the windowsill laminate was loose and coming off the counter. In addition, the laminate to the left of the sink, near Station 3, was broken and temporarily repaired with duct tape. This created an uncleanable surface. At 10:07 AM at Dirty Sink 11, the caulk to cover the gap between the sink and the counter top was missing. At 10:17 AM, in the hallway outside of the Staff Break Room, the wall surface was damaged consisting of approximately 8 inches by 11 inches. These findings were confirmed at the time of discovery by S5. N.J.A.C 8:43A-17.4(a)(15)”

“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: 52927 Based on observation and staff interview, it was determined that the facility failed to ensure that two of two oxygen cylinders located between the emergency code cart and the emergency evacuation cart on the Hemodialysis Treatment Floor are properly secured in accordance with facility policy. Findings include: Reference: National Fire Protection Association 99 2012 Edition Health Care Facilities Code 11.6.2.3 (11) “... Freestanding cylinders shall be properly chained or supported in a proper cylinder stand or cart ...” On 01/06/26 at 11:19 AM, during a tour of the Hemodialysis Treatment Floor, two oxygen cylinders located in between the emergency code cart and the emergency evacuation cart were sitting upright and not properly secured. During an interview at 11:23 AM, Staff (S)2 stated, “Both bottles are empty, they are not to be used and are waiting to be placed in the empty storage area. I put them here to be secure.” Facility policy titled, “Emergency Administration of Oxygen,” published 11/01/21, stated, “Oxygen Cylinders ... Oxygen cylinders must be secured in an area where they will not fall ... Unless in use, secondary (reserve) cylinders/tanks must be secured to racks or rolling stands in a storage area or dedicated area for oxygen ...””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 51990 Based on observations, staff interviews, and a review of manufacturer’s instructions for use (MIFU), it was determined that the facility failed to ensure that: 1) the Diasafe Plus Filter is replaced every 90 days in four out of 23 machines; 2) the Myron L D6 meter (used to check the conductivity and pH [potential of hydrogen] to ensure quality and safety of the dialysate before it is used in dialysis treatment of patients) calibration solutions are not available for use beyond the date of use in three out of five solutions and; 3) the WaterSoft 0-30 Test Strips (used to measure hardness [calcium and magnesium] in water) are not available for use beyond four months after the bottle was opened in one of one bottle. Findings include: 1. On 01/07/25 at 9:35 AM, during the tour of the Hemodialysis Unit, the Diasafe Plus Filters on dialysis machines 1A, 3A, 18A and 23A were dated 09/15/25. During an interview on 01/07/26 at 10:25 AM, Staff (S)4 confirmed above findings and stated the Diasafe filter is changed every three months. A follow-up interview at 10:30 AM with S5 stated that the Diasafe should have been replaced in December 2025 for the above machines. The MIFU for the Diasafe filter was requested from S4 however, the MIFU was not provided. Facility policy titled, “Diasafe Plus Filter Replacement and Integrity Testing,” published 05/02/22. stated, “... Policy- Manufacturer’s Instruction for Use ... The Diasafe Plus filters will be replaced in accordance with the manufacturer’s IFU ... Policy- Diasafe Plus Filter Frequency of Replacement- 2008 Series Machines ... Diasafe Plus Filter will be replaced according to the manufacturer’s recommendation: Every 90 days ...” 2. On 01/07/26 at 10:40 AM, on the clean area counter across from the Nurse’s Station, there were three bottles of Myron L D6 meter calibration solutions available for use. Observation of the bottles revealed the following: A bottle of MesaLabs Conductivity Standard Solution 14.0 mS/cm (milli Siemens per centimeter) labeled, “... Date Opened 12/06/25 ... Discard Date 01/06/26...”. The MIFU on the bottle indicated, “... Discard 30 days after opening ...” which was one day beyond date of use. A bottle of Mesalabs Standard Buffer Solution 7.00 pH (used to measure acidity and basicity of a solution) labeled, “... Date Opened 09/25 ... Discard date 02/26...”. The MIFU on the bottle indicated, “... Discard 90 days after opening ...” which was 30 days beyond date of use. A bottle of CalRite Solution labeled, “... Opened date: 12/20/21 ... Discard Date: N/A [not applicable] ...”. The MIFU on the bottle indicated. “... Discard 90 days after opening ...” which should have been discarded on 03/20/22. During an interview on 01/07/26 at 10:48 AM, S2 confirmed the above findings and stated that the solutions should have been discarded in accordance to the MIFU indicated on the bottles. 3. On 01/07/26 at 12:03 PM, in the RO (Reverse Osmosis, a water purification system) Room with S11 and S12, a clean supply cart contained a bottle of WaterSoft 0-30 Test Strips that contained multiple strips available for use. The bottle was labeled, “... Date Opened [Blank] ... Use by Date within Exp (Expiration) (four [4] months after opening): [Blank]” During an interview on 01/07/26 at 12:20 PM, S12 confirmed the bottle of WaterSoft 0-30 Test Strips was not dated when opened and stated he/she was uncertain of the discard date in accordance with MIFU. Facility policy titled, “Total Hardness Testing with IBT - WaterSoft 0-30 Test Strip Policy and Procedure.” published 07/07/25, stated, “... Policy ... When testing water hardness, follow manufacturer’s instruction for use (IFU) ... The opened bottle strips will expire four months after the date the bottle is opened on or the manufacturer’s expiration date, whichever comes first ...” N.J.A.C. 8:43A-24.11(c)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 52927 Based on observations, staff interviews and a review of facility documents, it was determined that the facility failed to ensure the patient right to privacy for five out of 20 stations. Findings include: On 01/07/25 at 9:55 AM in Station 12, Staff (S)3 discontinued hemodialysis through a right chest wall central venous catheter (CVC, a type of access used for hemodialysis). During the procedure, the curtain was not drawn around the patient, allowing the patients chest to be visible to any staff members or patients that walked by, as well as the patients seated in Station 7 and Station 8. S3 did not verbally ask the patient if he/she preferred the curtain to be closed or not. During an interview on 01/07/26 at 10:12 AM, S3 stated, “The curtains are not usually closed unless there is an isolation issue.” On 01/07/26 at 11:27 AM, in Station 16, S3 initiated hemodialysis through a right chest wall CVC. During the procedure, the curtain was not drawn closed around the patient, allowing patients chest to be visible to any staff members or patients that walked by as well as the patient seated in Station 18. This surveyor did not observe S3 verbally ask the patient if he/she preferred the curtain to be closed or not. During an interview on 01/07/26 at 11:38 AM, S3 stated, “We do not pull curtains in this unit.” 48966 On 01/07/26 at 11:10 AM in Station 6, an initiation of hemodialysis via a right chest CVC was performed by Staff (S)8. In Station 6, the curtains to the right and left of the patient were not drawn around the patient to ensure patient privacy. Both curtains remained secured with a tie against the back wall of the station throughout the entire procedure. S8 did not ask the patient whether he/she wanted the curtains drawn during the procedure. The patient’s exposed right chest was visible to the patients sitting in Stations 1, 2 and 5, in addition to any staff members that walked by the station. During an interview on 01/07/26 at 11:33 AM, S8 stated that he/she does not draw the curtain around patients when providing CVC care and was unaware of a privacy policy. S8 reported asking S2 and was informed that it had previously been a policy but no longer was in effect. S8 further stated that the curtains would be drawn if a patient requested it. During an interview on 01/07/26 at 2:44 PM, S6 and S8 stated they used to close the curtains during CVC care but at some point they no longer close the curtains. If a patient asked for the curtains to be drawn the staff would close them. During an interview on 01/07/26 at 2:45 PM, S7 stated during CVC care the curtains are to be drawn unless a patient requests for the curtains to remain open. 51040 During a tour of the Hemodialysis Treatment Floor on 01/07/25 at 10:05 AM, with Staff (S)5, the privacy curtains to the rear of Stations 4, 5, and 6 were missing. These findings were confirmed at the time of discovery by S5. Facility policy titled, “Patient Rights and Responsibilities,” published 04/04/12, stated, “... Conditions for Coverage: Patients’ Rights ... The patient has the right to- ... 3. Privacy and confidentiality in all aspects of treatment ... Policy: Privacy Rights ... Patients have the right to privacy during activities that may require the exposure off private body parts while in the dialysis facility. Privacy screens or curtains may be used to provide privacy ... “ Facility document titled, “FMCNA Patient Rights,” stated, “... Privacy and confidentiality ... Privacy and confidentiality in all aspects of treatment. This includes ... the right to privacy during activities that may require the exposure of body parts while in the dialysis facility. Privacy screens, curtains, or blankets that do not cover your face or access, may be used to provide privacy ...” N.J.A.C. 8:43A-16.2(a)(10)”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 51990 Based on two of two medical records reviewed (Patient (P)1 and P3), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure a Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) are initiated and a reassessment and revision of the POC are conducted monthly by the IDT [Interdisciplinary Team, includes a Physician, a Registered Nurse (RN), a Social Worker (SW), and a Registered Dietitian (RD)] for an unstable patient. Findings include: A review of P1’s medical record revealed the following: P1 had a peritonitis infection (an inflammation of the peritoneum, the lining of the abdominal wall) on 09/18/25 and a recurrent infection on 11/11/25. P1 had recurrent peritonitis and was not deemed unstable in accordance with facility policy. The medical record lacked documented evidence that an unstable CIA was initiated by the IDT and POC in November 2025 for P1’s recurrent peritonitis infection. Furthermore, there was not a comprehensive reassessment and POC by the IDT in December 2025. During an interview on 01/08/26 at 11:15 AM, Staff (S)13 confirmed that P1 had two peritonitis infection occurrences within three months. S13 stated that the physician does not deem patients unstable with recurrent peritonitis. A review of P3’s medical record revealed a POC meeting, dated 07/21/25, that determined P3’s status was “Unstable” for behavioral issues and concerns. Further review revealed the following: There lacked documented evidence of a completed “Unstable” comprehensive assessment by the Physician, SW, RD for the July 2025 POC. The medical record lacked documented evidence of a completed “Unstable” comprehensive reassessment and POC Meeting by the IDT for August 2025. There was an “Annual” CIA by the IDT for the POC meeting held on 09/24/25. P3’s POC indicated on the “Team Meeting Assessment” portion, “... Reason for meeting: Monthly CIA (Unstable) ... Reason ... Nonadherence ...” P3’s medical record lacked further documented evidence of a completed “Unstable” comprehensive reassessment and POC in October, November and December of 2025. During an interview on 01/09/26 at 9:40 AM, S2 stated P3 is unstable due to ongoing behavioral concerns. He/she confirmed that there were no unstable POC’s completed in the months of October, November, and December of 2025. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” published 07/03/23, stated, “... CIA/POC for Unstable Patients ... Unstable patients must be reassessed by the IDT monthly. Monthly reassessment and any POC updated related to the reason the patient is considered “unstable” must be documented until the issue is resolved ... The following are unstable criteria: ... Marked deterioration in the health status - IDT to identify and document the specific reason, such as: ... g. Chronic or recurrent peritonitis ... Significant change in psychosocial needs ... a. Change in mentation or psychosocial needs ... (Any patient considered at risk for involuntary discharge or transfer must be considered “unstable” under this category) ...” N.J.A.C. 8:43A-24.4(a)”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 48966 Based on two of seven In-Center Hemodialysis medical record reviews (Patient (P)6 and P10), 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 P10’s Plan of Care, dated 07/21/25, stated, “Area of Focus BP [blood pressure] and Fluid Management Open Goal Achieve BP Control as specified by the patient’s physician ... Intervention (s): ... Educate patient/family/caregiver on fluid control In Progress ... “ A review of the “Treatment Sheet For Facility” from 12/19/25 through 01/07/26 in P10’s medical record revealed the following: On 12/19/25, 12/21/25, 12/23/25, 12/30/25, 01/02/26, 01/05/26, and 01/07/26, the pre-treatment (before treatment) “Nursing Evaluation” section stated, “... Edema Ankle Bilateral, 1+ [plus]: 2 mm [millimeters] or less, disappears rapidly. Edema Lower Leg Bilateral [affecting both sides] 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 Registered Nurse (RN). On 01/08/26 at 1:03 PM, the above treatment sheets were reviewed with Staff (S)7. S7 confirmed that the RN needs to evaluate or assess the patient and document edema post treatment if present pre-treatment. During an interview on 01/08/26 at 1:31 PM, S2 stated that if a nurse documents edema pre-treatment then post treatment the edema needs to be reassessed and document the findings. 52927 A review of P6’s Plan of Care, dated 10/07/25, stated, “... Area of Focus BP and fluid management ... Achieve BP Control as specified by the patient’s physician ... Open ... Intervention(s): Educate patient/family/caregiver on signs and symptoms of fluid overload ... In Progress ... Education patient/family/caregiver on blood pressure medications ... In Progress ...” A review of the P6’s, “Treatment Sheet For Facility” from 12/19/25 through 01/07/26 revealed the following: On 12/19/25, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema or swelling] - Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/21/25, the pre-treatment “Nursing Evaluation” section stated, “ ... Fluid Assessment ... Lungs ... decreased breath sounds ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s lung sounds and edema by a RN. On 12/23/25, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/26/25, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/30/25, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 01/02/26, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 01/05/26, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 01/07/26, the pre-treatment “Nursing Evaluation” section stated, “... Fluid Assessment ... Lower Leg [edema] -Severity ... 1+: 2 mm or less; disappears rapidly ... Ankle [edema] - Severity ... 1+: mm or less; disappears rapidly ... Edema Lower Leg- Location ... Bilateral ... Edema Ankle - Location ... Bilateral ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 01/08/26 at 12:39 PM, the above findings were reviewed and confirmed by S6. S6 explained if abnormal lung sounds and edema are present pre-treatment, then it should be reassessed post-treatment. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “... Pre-Treatment ... Step 2 ... During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed: ... Lung sounds (As indicated by patient condition) ... Auscultate lung sounds for Sound: Clear, Decreased breath sounds, Rales (crackles) Rhonchi, wheezing ... Location: Right, Left, Bilateral ... Edema (As indicated by patient condition) Assess the patient for edema: Location: Foot, ankle, lower leg and sacrum, Right, Left, Bilateral, Severity (None, 1+, 2+, 3+ or -4+) ... Post- Treatment ... Lung sounds ... The registered nurse will assess/reassess post treatment as indicated ... Edema ... The registered nurse will assess/reassess post treatment as indicated ...” N.J.A.C. 8:43A-24.4(a)”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 51990 Based on one of one medical record review on a Home Therapy patient (Patient (P)1), staff interview, and review of facility documents, it was determined that the facility failed to ensure that Peritoneal Dialysis (PD, a type of dialysis that uses the lining of the abdomen) solution guidelines/orders are followed as prescribed by the physician in eight out of 60 treatments reviewed. Findings include: A review of P1’s medical record revealed the following: The “Peritoneal Dialysis Weight Change Guidelines At Home” by the physician, dated 01/30/25, stated, “... Check weight daily and use guidelines based off your target weight of 112.2 lbs. [pounds] ... 51 kgs [kilograms] ... If your weight gain is 0 [zero] lbs. [0 kgs] to 4 [four] lbs [1.81 kgs] ... or ... If your weight loss is 0 lbs. [0 kgs] to 4 lbs [1.81 kg] ... Do your current prescription of 5 [five] total exchanges each day with: ... CCPD [Continuous Cycling Peritoneal Dialysis] 1.5% 1 one] Bags ... 2.5% 1 Bags ...” The Peritoneal Dialysis Order by the physician, dated 06/25/25, indicated the EDW (Estimated Dry Weight) was 53.5 kg (117.7 lbs). During an interview on 01/08/26 at 9:15 AM, Staff (S)13 explained the Weight Guidelines ordered by the Physician dated 01/30/25 were to be followed with the new EDW. A review of the “KNX Treatment Summary: PD” for November 2025; and the “KNX Treatment Summary: PD” and “CCPD Daily Flowsheet” for December of 2025 revealed P1’s daily wt’s and the dialysis solutions used. On 11/06/25, the weight was 53.97 kgs (118.34 lbs). A 2.5% solution was used by the patient. The guidelines indicated that 1.5% and 2.5% solution should have been used. On 11/11/25, the weight was 52.7 kgs (115.9 lbs). A 1.5% solution was used by the patient. The guidelines indicated that 1.5% and 2.5% solution should have been used. On 12/03/25 and 12/04/25, the weight was 121.0 lbs. (54.54 kgs). Two 2.5% solutions were used by the patient. The guidelines indicated that 1.5% and 2.5% solution should have been used. On 12/10/25 and 12/11/25, there were no weights documented on the treatment sheets. 2.5% solution was used by the patient on both days. On 12/15/25, the weight was 53.42 kgs (117.5 lbs). A 2.5% solution was used by the patient. The guidelines indicated that 1.5% and 2.5% solution should have been used. On 12/27/25, the weight was 53.06 kgs (116.7 lbs). A 2.5% solution was used by the patient. The guidelines indicated that 1.5% and 2.5% solution should have been used A review of the medical record lacked documented evidence on the rationale for the solution used by P1 and an order from the physician for the change in solution used on the above dates. During an interview on 01/08/26 at 11:45 AM, S13 confirmed the above findings and stated home treatments are reviewed during clinic visits. He/she added that P1 was educated to adjust the solution during PD treatments for presence of edema. S13 was unable to provide documented evidence of education. S13 added, there should have been a physician’s order for the dialysis solutions used by P1. Facility policy titled, “Physician Order Documentation,” published 07/03/23, stated, “... General Policy ... Nurse practice act requires nurses to carry out treatment care, medication administration, lab test, procedure and other treatments based on physician orders ...” Facility policy titled, “Review and Documentation of Home Therapies Patient Health Data,” published 05/01/23, stated, “... Policy ... Treatment data will be reviewed by the home therapies nurse in order to identify trends, determine if patients are following their treatment plan or having problems with their dialysis at home ...” N.J.A.C. 8:43A-24.4(a)”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 51990 Based on a review of facility documents and staff interviews, it was determined that the facility failed to ensure that the water microbiological (colony count and endotoxins) test results are reported and reviewed for one of six months of Quality Assurance Performance Improvement (QAPI) meetings reviewed. Findings include: A review of facility log titled, “Environmental CQI (Continuous Quality Improvement)” revealed that on 11/06/25 the RO (Reverse Osmosis, a purification method) 1, Water Permeate Endotoxin result was 0.149 EU/ml (Endotoxin Units per milliliter) and the Ultrafilters 2, Water Outlet Endotoxin result was 0.139 EU/ml. These were above the facility policy’s action level of 0.125 EU/ml. A review of the facility November 2025 QAPI documents lacked documentation that the water microbiological action level results were reported at the meeting. During an interview on 01/08/26 at 12:45 PM, Staff (S)4 confirmed that the results were not reviewed in QAPI and action plans were not developed. S4 stated, “It was an oversight.” During a phone interview on 01/09/26 at 10:28 AM, S17 stated that he/she reviews water culture results when presented at QAPI. S17 added, he/she was not aware of the elevated results in November 2025. Facility policy titled, “Microbiological Monitoring of Central Water and Bicarbonate Mixing and Delivery System,” published 09/02/25, stated, “... Interpretation of results ... Microbiological reports must be reviewed, interpreted, and if needed, action plan(s) developed within 48 hours of receipt ... Interpret the results according to the table ... Test ... Endotoxin ... Action Level ... 0.125 EU/ml ... For QAPI purposes, the technical staff will review the test results ... Documentation ... Test results and related action plans (if applicable) will be presented at the QAPI meeting ... At a minimum, the Medical Directors must review all test results monthly, during QAPI meetings ...” N.J.A.C. 8:43A-24.18(b)(5)”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 51990 Based on one of one medical record review (Patient (P)1) for peritonitis (inflammation of the peritoneum, the abdominal lining), interviews and review facility documents, it was determined that the facility failed to document analysis of incidents and determine trending of peritonitis incidents in the Quality Assessment and Performance Improvement (QAPI) program. Findings include: A review of P1’s medical record revealed the following: P1 had a peritonitis infection on 09/18/25 and a recurrent peritonitis infection on 11/11/25. P1 had recurrent peritonitis infection within three months. A review of the facility’s QAPI on 01/09/26 revealed that P1’s peritonitis infections were populated in the September 2025 and November 2025 health data. However, there was lack of documented evidence that the peritonitis trends were reviewed and actions plans were developed and implemented to prevent recurrent peritonitis infections during the facility’s QAPI meetings in October and December of 2025. On 01/09/26 at 12:00 PM, Staff (S)12 stated that the treatments were documented in P1’s medical record and that peritonitis infections are discussed at QAPI meetings. Upon request for documentation of the QAPI meeting discussions, S12 failed to provide. A follow-up interview at 12:25 PM with S2 stated that peritonitis trends and action plans should be documented and reviewed at QAPI meetings. N.J.A.C. 8:43A-24.18(c)”