Fmc Hudson Home Therapies

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 39228 Based on medical record review, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that: 1) the interdisciplinary team completes a comprehensive assessment prior to developing a patient Plan of Care for one of two home hemodialysis patients reviewed (Patient [P]2); 2) a hemodialysis prescription to meet the individualized needs of a patient following a renal transplant is documented in the medical record for one of two medical records reviewed (P2); and 3) a revision of the plan of care is conducted for a patient (P2) who meets the criteria for being unstable, due to delayed graft function that requires prolonged dialysis. Cross Reference: 494.80 PA (Patient Assessment)-IDT (Interdisciplinary Team) members/responsibilities 494.80(a)(2) PA-Appropriateness of dialysis Rx (prescription) 494.80(d)(2) PA-Frequency reassess-unstable q (every) mo (month)”

“Multiple Occupancies CFR(s): NFPA 101 Multiple Occupancies - Sections of Ambulatory Health Care Facilities Multiple occupancies shall be in accordance with 6.1.14. Sections of ambulatory health care facilities shall be permitted to be classified as other occupancies, provided they meet both of the following: * The occupancy is not intended to serve ambulatory health care occupants for treatment or customary access. * They are separated from the ambulatory health care occupancy by a 1 hour fire resistance rating. Ambulatory health care facilities shall be separated from other tenants and occupancies and shall meet all of the following: * Walls have not less than 1 hour fire resistance rating and extend from floor slab to roof slab. * Doors are constructed of not less than 1-3/4 inches thick, solid-bonded wood core or equivalent and is equipped with positive latches. * Doors are self-closing and are kept in the closed position, except when in use. * Windows in the barriers are of fixed fire window assemblies per 8.3. Per regulation, ASCs are classified as Ambulatory Health Care Occupancies, regardless of the number of patients served. 20.1.3.2, 21.1.3.3, 20.3.7.1, 21.3.7.1,42 CFR 416.44 This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure Ambulatory Healthcare Occupancies are separated by Mercantile, Mall Occupancies by not less than a 2-hour fire resistance rating. Findings include: On 05/07/25 at 10:45 AM, during a tour with Staff (S)1 (Biomedical Technician), the glass door separating the Patient Waiting Room, and the Covered Mall lacked fire rating markings from the Manufacture. In addition, the glass door failed to self-latch. This finding was confirmed at the time of discovery by S1.”

“Doors with Self-Closing Devices CFR(s): NFPA 101 Doors with Self-Closing Devices Doors required to be self-closing are permitted to be held open by a release device complying with 7.2.1.8.2 that automatically closes all such doors throughout the smoke compartment, entire facility, and all stair enclosure doors upon activation of: * Required manual fire alarm system, and * Local smoke detectors designed to detect smoke passing through the opening or a required smoke detection system; and * Automatic sprinkler system, if installed; and * Loss of power 20.2.2.4, 20.2.2.5, 21.2.2.4, 21.2.2.5 This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the fire enclosure is properly maintained to prevent to spread of fire and or smoke. Findings include: On 05/07/25 at 11:05 AM, during a tour with Staff (S)1 (Biomedical Technician), it was observed that the automatic-closing device for the door was missing on the entry door to the old doctor’s office, now being used as a storage room. This finding was confirmed at the time of discovery by S1.”

“Exit Signage CFR(s): NFPA 101 Exit Signage Exit and directional signs are displayed in accordance with 7.10 with continuous illumination also served by the emergency lighting system. 20.2.10, 21.2.10, 7.10 This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that there are a required amount of exit signs. Findings include: On 05/07/25 at 11:08 AM, during a tour with Staff (S)1 (Biomedical Technician), it was observed that there is a need for an additional exit sign in the hallway between Room 2 and the office area, and an additional sign is needed to direct personnel to the rear exit stairwell. This finding was confirmed at the time of discovery by S1.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas must meet one of the following: *Contain 1 hour rated enclosure when non-sprinklered *Sprinkler protected with smoke resistive separation *Severe Hazard locations contain sprinkler protection and 1 hour separation with 3/4 hour rated self-closing doors 20.3.2, 21.3.2, 38.3.2, 38.3.2.2, 39.3.2.1, 39.3.2.2, 8.7 This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the fire rating enclosure is properly maintained to resist the passage of fire or smoke. Findings include: On 05/07/25 at 10:57 AM, during a tour with Staff (S)1 (Biomedical Technician), it was observed that the Electrical Room door was missing its 90-minute fire rating tag. S1 could not determine the fire rating for the Electrical Room door. This finding was confirmed at the time of discovery by S1.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the sprinkler head in the medical waste storage room is properly maintained. Findings include: On 05/07/25 at 11:05 AM, during a tour with Staff (S)1 (Biomedical Technician), the sprinkler head in the Medical Waste Storage Room was spackled and painted over, which would inhibit its activation in the event of a fire. This finding was confirmed at the time of discovery by S1.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 21.7.1.4 through 21.7.1.7 This Standard is not met as evidenced by: 51040 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that fire drills are conducted on a quarterly basis with staff. Findings include: On 05/07/25 at 1:00 PM, during a review of the fire drill documents it was found that the facility has not conducted any fire drills with the staff in the past two years. This finding was confirmed in an interview with Staff (S)1 (Biomedical Technician) on 05/07/25 at 1:10 PM who stated, “the facility only conducts fire drills with patients each month and not with the staff.””

“Electrical Systems - Other CFR(s): NFPA 101 Electrical Systems - Other List in the REMARKS section, any NFPA 99 Chapter 6 Electrical Systems requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 6 (NFPA 99) This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the electrical system is properly maintained. Findings include: On 05/07/25 at 10:55 AM, during a tour with Staff (S)1 (Biomedical Technician), it was observed in the Electrical Room that a 4 inch x 4 inch electrical box did not have a cover on it. This finding was confirmed at the time of discovery by S1.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50912 Based on one of one observation of the clean/dirty work area, staff interview, and review of facility policy, it was determined that the facility failed to clearly designate clean areas from dirty areas to avoid possible cross contamination. Findings include: On 05/07/25, during a tour of the Home Therapy Suite Area, the following was revealed: At 10:32 AM, inside the Supply Storage area, there was a designated clean/handwashing sink. Sitting on the edge of the sink and on the countertop area directly next to the sink were the following supplies: two yellow hemostat clamps, an empty small clear opaque plastic container, three stay safe organizer clamps, a pair of scissors, a half full jug of bleach solution with a pitcher on top, a clear lidless opaque plastic container that had three yellow hemostat clamps inside, a large jug half full with pre-diluted bleach 1:100 (one part bleach with 100 parts water) concentration and a small bottle with nozzle full with prediluted bleach 1:10 (one part bleach with 10 parts water) solution. This created a potential cross contamination risk from water splashing onto the supplies during hand washing procedure by staff. At 11:08 AM, these findings were confirmed with Staff (S)2 (Home Therapies Clinic Manager), who stated that the above mentioned items were clean supplies. Facility policy titled, “Dialysis Precautions,” published 01/04/12, stated, “... Clean versus Dirty Areas ... Clean Area: An area designated for unused equipment, supplies and medications. ... Dirty Area: An area where this [sic] a is a potential contamination with blood or body fluids ... Clean areas should be clearly designated for preparation and handling of ... unused supplies and equipment ... Clean areas should be clearly separated from dirty areas where used supplies. Equipment or blood samples are handled and stored. ...” 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: 51990 Based on medical record review of Hepatitis B (a viral infection that causes inflammation of the liver and can lead to serious liver damage) laboratory (lab) results, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the monthly HBsAg (Hepatitis B surface antigen) testing is completed for 8 of 20 susceptible patients (P2, P3 P4, P7, P10, P11, P13, P14, and P17) in accordance with facility policy and Centers for Disease Control and Prevention (CDC) recommendations. Findings include: Reference: The 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) ... Infections: HBV - susceptible including non-responders to vaccine - Monthly testing for HBsAg ...” A review of a facility document titled “Lab Results/ Medication Administration Summary” from May 2024 to May 2025 lacked evidence of monthly HBsAg testing for the following patients: P2 did not have HBsAg testing in May 2024. P3 did not have HBsAg testing in April, May, June, July, August. September, October, and November of 2024; and January and April of 2025. P7 did not have HBsAg testing in January, February, April, and May of 2025. P10, P11, P13, and P14 did not have HBsAg testing in April 2025. P17 did not have HBsAg testing in April and May of 2025. On 05/09/25 at 9:30 AM, a review of the above findings were completed with Staff (S)2 (Home Therapies Clinical Manager) who stated that the above labs were probably missed. Facility policy titled, “Patient Hepatitis B Testing Requirements,” published 02/02/25, stated, “... HBV Patient Testing ... Hepatitis B Laboratory testing is required for all patients based upon immunity status. ... Patient Status ... Susceptible ... HBsAg: Negative ... Anti-HBs: less than 10 mlU/ml ... Anti-HBc “total”: Positive ... HBsAg ... Monthly Testing ...””

“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: 50912 Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure supplies are monitored and discarded in accordance with the manufacturer’s expiration dates. Findings include: On 05/07/25 at 11:30 AM, a tour of the Home Therapy Suite area was conducted and the following was observed: In the Supply Storage area, inside the cabinet on the left side of the clean sink, there were two “Next Stage Dialysis Test Kits” (a dialysate fluid collection kit used for home hemodialysis machines) that had a manufacturer’s label affixed to the outside with the expiration date of 03/11/25. This was 57 days past its beyond use date. At 12:01 PM, these findings were confirmed with Staff (S)2 (Home Therapies Clinic Manager) who stated the package kit was expired and it should have been discarded. When asked who is responsible for checking expirations dates of supplies, he/she stated that all facility staff members check for expiration dates. Facility policy tilted, “Expiration Dates of Sterile Supplies,” published 07/04/2012, stated, “... Purpose: The policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date. ... Policy ... Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date. ...” N.J.A.C. 8:43A-24.11(c)”

“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: 39228 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the interdisciplinary team (IDT) completes a comprehensive assessment prior to developing a patient Plan of Care (POC) for one of two home hemodialysis (HHD) patients reviewed (Patients [P]2). Findings include: A review of P2’s medical record revealed that the patient had a kidney transplant on 09/24/24. A POC meeting occurred on 10/30/24. There was no documented comprehensive assessment by the Registered Nurse (RN) and no documented comprehensive assessment by the physician for the POC dated 10/30/24. During an interview on 05/09/25 at 09:55 AM, Staff (S)2 (Home Therapy Clinic Manager) confirmed that the comprehensive assessments by the RN and the physician for the POC dated 10/30/24 were not completed. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan Of Care,” published 07/03/23, stated, “ ... General Policy for Patient Assessment and Plan of Care The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, ... a registered nurse, the patient’s attending physician ... The Comprehensive Assessment ... must be completed electronically in the patient’s medical record. ... Role of the Interdisciplinary team: CIA The physician is responsible for ensuring the completion of the medical portion of the CIA and reviewing the completed interdisciplinary CIA and Plan of Care. ... Each member of the IDT is responsible for completing their part of the comprehensive interdisciplinary assessment. ...” N.J.A.C. 8.43A-24.13(c)”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 39228 Based on medical record review of one of two home hemodialysis (HHD) patients (Patient [P]2), staff interview, and review of facility documents, it was determined that the facility failed to ensure a hemodialysis prescription to meet the individualized needs of a patient following a renal transplant is documented in the medical record Findings include: A review of P2’s medical record with Staff (S)2 (Home Therapy Clinical Manager) revealed a physician’s order, dated 09/18/24 that stated, “Home HD [Hemodialysis] using NxStage with PureFlow 3X [times] Week, Mon [Monday] Wed [Wednesday] Fri [Friday], Estimated Treatment Time: 3 hrs [hours] 45 min [minutes], ...EDW [estimated dry weight] 91.5 kg, [kilograms] ...” On 09/24/24, P2 had a kidney transplant. There were no documented physician orders for HHD treatments following P2’s transplant until 04/07/25. Further review of the medical record revealed the following: The patient had HHD treatments post (after) transplant under the care of the facility on the following dates: 10/03/24, 10/15/24, 10/17/24, and 10/27/24. The patient also had a treatment at the facility on 10/25/24. P2 continued to have HHD treatments on 11/15/24, 11/22/24, 11/23/24, 12/03/24, 12/7/24, 12/28/24, 12/29/24, 01/01/25, 02/03/25, 02/13/25, and 02/18/25. The HHD treatments were not completed three times per week in accordance with the above physician’s order. During an interview on 05/08/25 at 10:52 AM, S2 stated that S10 (Nephrologist) was P2’s attending physician and was also the facility Medical Director until March of 2025. S2 explained that the patient received HHD treatments prn (as needed) after the transplant because the kidney was not working fully. S2 confirmed that the medical record evidence lacked a physician’s order for the prn treatments for the above dates. Upon further interview on 05/08/25 at 12:48 PM, S2 stated that because P2 received dialysis post-transplant as needed, his/her HHD orders were based on the patient’s needs at each treatment. S2 stated that the facility nursing staff communicated via telephone with S10, who was in communication with the transplant center, regarding each treatment and received telephone HHD orders verbally from S10 at the time of each treatment. S2 explained that the nursing progress notes should contain the documentation regarding the physician’s verbal orders however, review of the nursing progress notes provided by S2 dated 10/18/24, 10/25/24, 10/30/24, 11/18/24, 11/27/24, and 02/07/25 did not contain documentation that a telephone order for treatment was received from S10. Facility policy titled, “Physician Order Documentation,” stated, “... Background All ... treatments a patient receives require an electronic order signed by the physician ... It is the nurses’ responsibility to ensure that all treatments ... have an accurately documented physician order. ... General Policy Nurse practice acts require nurses to carry out treatment care, based on physician orders. These orders can be entered electronically, given by telephone, ... Telephone Orders Telephone orders must be: ... Recorded in the medical record. Signed by the physician ...” N.J.A.C. 8:43A-8.4(a) N.J.A.C. 8:43A-24.4(a)”

“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: 39228 Based on medical record review of one of two home hemodialysis (HHD) patients (Patient [P]2), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that a revision of the plan of care is conducted for P2 who met the criteria for being unstable, due to delayed graft function that requires prolonged dialysis. Findings include: A review of P2’s medical record with Staff (S)2 (Home Therapy Clinical Manager) revealed that on 09/24/24, P2 had a kidney transplant. Further review of the medical record revealed the following: The patient required HHD treatments beyond seven days after transplant on the following dates: 10/03/24, 10/15/24, 10/17/24, and 10/27/24. The patient also had a treatment at the facility on 10/25/24. A plan of care (POC) meeting was held on 10/30/24 and the patient was classified as “stable” by the Interdisciplinary Team (IDT). This was not in accordance with the facility policy and procedure, which required the patient to be classified as unstable and have a comprehensive interdisciplinary assessment (CIA) and plan of care (POC) completed by the IDT every 30 days. P2 continued to have HHD treatments under the care of the facility on 11/15/24, 11/22/24, 11/23/24, 12/03/24, 12/07/24, 12/28/24, 12/29/24, 01/01/25, 02/03/25, 02/13/25, and 02/18/25. The patient had no home hemodialysis treatments with the facility in March of 2025 and resumed home hemodialysis treatments with the facility in April of 2025. The next POC meeting for P2 did not occur until 04/28/25. During an interview on 05/08/25 at 10:52 AM, S2 stated that S10 (Nephrologist) was P2’s attending physician and was also the facility Medical Director until March of 2025. S2 explained that P2 received HHD treatments after the transplant because the kidney was not fully working. On 05/08/25 at 11:47 AM, a telephone interview was conducted with S10 who stated that P2 had delayed graft function and required dialysis following his/her kidney transplant. S10 stated that the transplant center was taking care of and seeing the patient. S10 stated that P2 never came to see him/her so he/she was technically not taking care of the patient and that P2’s care was directed by the transplant team. S10 stated that he/she had communication with the transplant team regarding P2’s care. S10 stated that he/she did speak to P2 over the phone. S10 further explained that he/she did not discharge the patient post (after)-transplant to keep P2 in the census and to “keep his/her orders.” S10 stated that he/she expected P2 to recover but that P2 never completely recovered so dialysis never stopped. S10 stated that P2 had HHD treatments as needed following the transplant. S10 also confirmed that the transplant nephrologist did not have privileges at the facility. Upon further interview on 05/08/25 at 12:48 PM, the POC dated 10/30/24 and the facility policy titled “Managing the Patient Post Transplant with Delayed Graft Function Requiring Prolonged Dialysis (DGF-PD)” was reviewed with S2. S2 confirmed that P2 was not made unstable on 10/30/24 per the facility policy. Facility policy titled, “Managing the Patient Post Transplant with Delayed Graft Function Requiring Prolonged Dialysis (DGF-PD),” published 05/06/24, stated, “... Background Delayed graft function (DGF) is a common complication occurring most often after deceased donor kidney transplant. To support the most successful outcome, patients with delayed graft function require individualized, multi-disciplinary management by the attending nephrologist, transplant center, nursing staff, dietician, and social worker that includes frequent communication amongst the interdisciplinary team (IDT) and other direct patient care staff. These patients require dialysis and a plan of care that is patient specific, continuously monitored, and re-evaluated for recovery or rejection. ... Definitions Delayed graft function (DGF): The requirement for dialysis within 7 days after implantation of a renal allograft. Delayed Graft Function Requiring Prolonged Dialysis (DGF-PD): The requirement for dialysis beyond 7 days after implantation of a renal allograft. ... Supportive Care Supportive Care to optimize recovery of kidney function is the goal when treating a patient with DGF-PD. The expectation of staff with respect to the care of the patient with DGF-PD includes the following: ... Care Planning The IDT will address the care planning needs of the patient. Each patient with the diagnosis of DGF-PD will be considered unstable and will have a Comprehensive Interdisciplinary Assessment (CIA) and plan of care (POC) completed by the Interdisciplinary Team (IDT) every 30 days. ...” N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.13(c)”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 39228 Based on medical record review of one of two home hemodialysis (HHD) patients (Patients [P]2), staff interview, and review of facility documents, it was determined that the facility failed to ensure that all patient Plan of Care (POC) meetings are attended and signed by all members of the interdisciplinary team (IDT) in accordance with the facility policy and procedure. Findings include: A review of P2’s medical record revealed that a POC meeting occurred on 10/30/24. There was no documented evidence that a comprehensive assessment was completed by the physician. The “Team Approval Signatures” section of the POC indicated that the physician had attended the meeting remotely and had a documented approved date by the physician of 01/24/25, 85 days after the Plan of Care meeting. During an interview on 05/09/25 at 9:55 AM, Staff (S)2 (Home Therapy Clinic Manager) confirmed the above findings. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan Of Care,” published 07/03/23, stated, “ ... General Policy for Patient Assessment and Plan of Care The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, ... the patient’s attending physician ... The Comprehensive Assessment and Plan of Care (adult patient) must be completed electronically in the patient’s medical record. The Plan of Care should be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP member within 30 days of the interdisciplinary team meeting. ... Role of the Interdisciplinary team: CIA The physician is responsible for ensuring the completion of the medical portion of the CIA and reviewing the completed interdisciplinary CIA and Plan of Care. ...” N.J.A.C. 8.43A-24.13(c)”

“H-PT/CAREGIVER DEMO COMPREHEND TRAINING CFR(s): 494.100(b)(1) The dialysis facility must - (1) Document in the medical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training; This Standard is not met as evidenced by: 51990 Based one of two medical records reviewed (Patient [P]5), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the home hemodialysis (HHD, a form of home dialysis) patient and/or care partner have received adequate training and demonstrated competency of HHD training. Findings include: P5 was admitted on 03/03/25 at the facility for HHD training with a care partner. Review of the medical record revealed the following: The Treatment Medication - Outpatient Dialysis Anticoagulation orders starting on 03/14/25 stated, “ ... Heparin Pork 1000Units/ml [milliliter] CatherterLock [sic] SelfAdmin [sic] Home Arterial Red Post [after] 1800 units Post Dialysis Every Treatment ... Heparin Pork 1000Units/ml CatherterLock [sic] SelfAdmin [sic] Home Venous Blue Post 1800 units Post Dialysis Every Treatment ... “ and a physician order starting 03/31/25, stated, “ ... Heparin Sodium (Porcine) 1000Units/ml Systemic Admin [sic] Method: Bolus 4000 units IVP [Intravenous Push] Every Treatment ... “ A review of the “NxStage Home Treatment Sheets” indicated the following: The home treatment sheets dated 03/14/25, 03/17/25, 03/19/25, 03/21/25, 03/24/25, 03/26/25, 03/31/25, 04/02/25, 04/07/25, 04/09/25, 04/10/25, 04/11/25, 04/23/25, 04/25/25, 04/28/25, 04/30/25, 05/02/25, 05/05/25, and 05/07/25, lacked documented evidence that the patient and/or care partner administered Heparin in P5’s arterial and venous catheter after every dialysis treatment. The home treatment sheets dated 03/31/25, 04/02/25, 04/04/24, 04/07/25, 04/09/25, 04/10/25, 04/11/25, 04/23/25, 04/25/25, 04/28/25, 04/30/25, 05/02/25, 05/05/25, and 05/07/25, lacked documented evidence that the patient and/or care partner administered Heparin IVP every dialysis treatment. There was a physician’s order dated 03/07/25 that stated, “Venofer 100mg [milligram] every treatment time 10 treatments, MonTuesThuFri [sic].” Staff (S)2 (Home Therapies Clinical Manager) stated on 05/08/25 at 10:35 AM that P5’s care partner administered the Venofer during HHD training’s on 03/14/25, 03/17/25, 03/19/25, 03/21/25, 03/24/25, 03/26/25, and 3/28/25. However, there was no documented evidence that the care partner administered Venofer on the HHD flowsheet. The care partner’s “Venofer Home Training Skills Performance Checklist” was completed 03/14/25. During an interview on 05/08/25 at 11:45 AM, S2 stated the care partner forgot to document that he/she administered the Heparin and Venofer to P5. S2 stated that he/she had reinforced medication administration documentation multiple times. A review of the medical record lacked evidence of education to the patient and/or care partner reinforcing medication administration documentation.”

“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: 51990 Based on one of two medical records reviewed (Patient [P]4), staff interview, and a review of facility documents, it was determined that the Medical Director failed to ensure complete CCPD (Continuous Cycling Peritoneal Dialysis, a type of peritoneal dialysis that uses a machine to automate the process of filling and emptying the abdomen with dialysis fluid) orders for CCPD training are entered into a patients medical record on admission. Findings include: A review of P4’s medical record revealed the following: The patient was admitted on 04/29/25 for CCPD training. The Physician’s order, starting on 04/29/25 stated, “... Peritoneal Dialysis ... CCPD Training with exchange Dextrose 1.5; 2.5; and 4.5%, 5X [times] Week for 15 times ...” A review of the “CCPD Daily Flowsheet” for treatments delivered on 04/29/25, 04/30/25 and 05/05/25 indicated that the Dextrose solution administered was 2.5%. The CCPD prescription did not include information to determine which Dextrose concentration was to be administered during CCPD training. There was no documented evidence that the order was clarified with the physician which left it to the Registered Nurse’s discretion to decide which solution was to be used during the training. During an interview on 05/08/25 at 10:15 AM, the surveyor clarified P4’s CCPD prescription with Staff (S)2 (Home Therapies Clinical Manager) and S2 stated, “The physician gives us the PD orders on the phone, and it is in my nurse’s notes.” A review of the medical record lacked documented evidence of a telephone order from the physician for the Dextrose solution to be used. Facility policy titled, “Patient Admission,” published 05/05/25, stated, “ ... Medical Record Requirements... At a minimum, the required document to admit a patient include: ... Dialysis orders ... “ Facility policy titled, “ Home Dialysis Support Service, “ published 05/02/22, stated, “ ... IDT Support Services... In addition to patient and care partner, home patient has access to the following members of the IDT who provides patient support services: ... Medical Director ... Oversees the Home Therapies Program ... Physician/ Physician Extender ... Directs the medical care and treatment of the patient on home dialysis ...” N.J.A.C. 8:43A-7.3(a)3 N.J.A.C. 8:43A-8.4(a)”