H. Fuld Capital Health

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 51990 Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1) all equipment and supplies in the dialysis station are cleanable and are cleaned and disinfected in accordance with facility policy (V0122); 2) dedicated supplies are not removed from the isolation room and the gowns used are removed before leaving the room (V0130) and; 3) staff providing care to HBsAg (Hepatitis surface antigen) positive patients are not providing care to HBV (Hepatitis B Virus) susceptible patients at the same time (V0131). On 12/31/25 at 10:44 AM, an IJ (Immediate Jeopardy) was identified for the facility’s failure to implement infection control practices to prevent the transmission of HBV. At 12:32 PM, the IJ template was presented to the Director of Regulatory Affairs and the Director of Renal Services and a removal plan was requested. An acceptable Removal Plan was received on 12/31/25 at 1:45 PM. The facility implemented and provided staff education. On 12/31/25 at 1:50 PM, the surveyors were able to verify education through facility staff interviews and review of staff education documentation. The IJ was removed on 12/31/25 at 2:11 PM and the Condition Level of non-compliance remains (V0131). Cross reference: 494.30 (a)(1)(ii) - Cleaning and disinfection of contaminated surfaces, medical devices, and equipment 494.30(a)(1)(i) - Isolation of HBV + patients”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 37656 Based on observation, review of facility documents, and interview with staff, it was determined that the facility failed to ensure that: 1) doors allowing access to the Water Treatment Room are secured (V0184); 2) the Reverse Osmosis (RO) Water Storage Tank was monitored for bacteria and endotoxin levels (V0210); 3) 28 out of 32 hemodialysis machines are labeled with the appropriate symbol indicating the correct concentrate proportioning ratio (V0249); and 4) all staff verify the dialysate conductivity (measures how well the solution can carry electricity, indicating the level of dissolved salts or minerals) and pH (potential of hydrogen- measures the acidity or basicity of a solution) readings (V0250). On 12/29/25 at 11:01 AM, an Immediate Jeopardy (IJ) was identified for the facility’s failure to ensure that the doors allowing access to the Water Treatment Room were secured. On 12/29/25 at 2:07 PM, the initial IJ template was presented to the Facility Administrator (FA), a revised IJ template at 3:17 PM, and a Removal Plan was requested. On 12/30/25 at 9:40 AM, an acceptable Removal Plan was received. The facility implemented the following: observation that the door allowing access to the Water Treatment Room was fully closed and locked; interviews with staff revealed staff were educated and all verbalized that the door allowing access to the Water Treatment Room should be secured at all times; review of staff education and sign-in records. The IJ was removed on 12/30/25 at 10:14 AM, after the State Survey Agency verified full implementation of the Removal Plan, and Condition Level non-compliance remains (V0184). Cross Reference: ANSI/AAMI (American National Standards Institute/Association for the Advancement of Medical Instrumentation) RD 52:2004 Requirements as Adopted by Reference 494.40(a) - Environment-Secure & Restricted (V0184) - Water Storage and Distribution (V0210) - Dialysate Proportioning: match machine config w/ratio in use (V0249) - Dialysate Proportioning: monitor pH/conductivity (V0250)”

“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: 37656 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that all surfaces in the dialysis station are cleanable in nine of nine dialysis stations observed (C1, C2, C3, C4, C5, C6, C7, C8, and C9) and that all equipment and surfaces in the dialysis station is cleaned and disinfected in accordance with facility policy in one of two observations of the cleaning and disinfection of the dialysis station. Findings include: On 12/29/25, during tour of the Hemodialysis Treatment Floor, the following was revealed: At 9:50 AM, there were Christmas stockings made of cloth materials hanging on the wall inside of Stations C1 to C9. These cloth stockings have the potential for being contaminated with blood and were not cleanable. At 9:50 AM, there were different colored stockings made of cloth material hanging on the wall inside of Stations C1 to C9. These cloth stockings have the potential for being contaminated with blood and were not cleanable. Upon interview at 9:55 AM, Staff (S)8 stated that the stockings were hung in the stations the week before the Christmas holiday and they will be thrown away when Christmas is over. Upon interview at 10:05 AM, S23 stated that the stockings cannot be cleaned because they were made of cloth. At 10:44 AM, in Station C17, S10 used a bleach-soaked cloth to clean and disinfect the equipment and surfaces within the dialysis station. During disinfection of the hemodialysis machine, S10 did not clean the following: the basket on the left side of the machine that contained a reusable blood pressure cuff the attached IV (intravenous) pole, and the prime bucket located on the right side of the machine. S10 also did not clean the TV (television), the arm of the TV, and the chase wall located behind the patient bed within the station as required by policy. At 10:51 AM, this finding was reviewed and confirmed with S10. S10 stated,”the dialysis techs [technicians] usually clean the stations, but he/she is busy.” Facility policy titled, “Infection Prevention and Isolation Protocols,” revised 08/19, stated, “... C. Disinfection and Decontaminatin [sic] Procedures for Medical Equipment, Devices, and Non Disposable Supplies ... 11. Cleaning of non-disposable treatment related items will be as follows: Item ... Hemodialysis Station Bed including air mattress and side rails/Chair, Pillow, Overbed Table, Call Bell and TV ... Cleaning Procedure ... Wipe with bleach solution and allow to air dry 10 minutes before next use ... Frequency ... After every treatment ... Item ... Hemodialysis Station Blood Pressure Cuff, IV Pump, Syringe Pump and portable IV pole ... Cleaning Procedure ... Wipe with bleach solution and allow to air dry 10 minutes before next use ... Frequency ... After every treatment ... 12. Cleaning of dialysis machines will be as follows: a. External: Equipment ... Hemodialysis Machine ... Cleaning Procedure ... Wipe the back, top, sides and front surfaces (i.e. air detector chamber, blood pump casing and wherever the bloodline circuit was in contact with the machine) with bleach solution and allow to dry 10 minutes before next setup ... Frequency ... After each treatment ...” N.J.A.C. 8:43A-24.8(b) 52927”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 51990 Based on one of one observation of the cleaning and disinfection of a hemodialysis station, staff interviews and a review of facility documents, it was determined that the facility failed to ensure that dedicated equipment and supplies used in an isolation room are not removed from the isolation room. Findings include: On 12/29/25, following the discharge of a Hepatitis B positive patient from Station C28, the Isolation Room, an observation of the cleaning and disinfection of the station was conducted and revealed the following: At 12:45 PM in Station C28, Staff (S)21 cleaned and disinfected Station C28. While still in the station, S21 handed red-colored plastic clamps that were used in the isolation room to S8. S8 then placed the clamps into a plastic container that was not filled with bleach solution located outside the isolation room which had blue clamps that were used for patients in the general treatment area. At 12:54 PM, S21, with the yellow gown on when the the isolation room was cleaned, exited the isolation room with the patient flowsheet in hand, entered the treatment area, proceeded to the nurse’s station, placed the flowsheet on the counter, and then returned to the isolation room. During an interview at 12:50 PM, S8 stated the red clamps used in the isolation room are cleaned with wetted bleach wipes in the room and are then placed in the container located outside of the isolation room in the general treatment area with the blue clamps used. The clamps are then soaked in 1:10 bleach solution (one part bleach to 10 parts water) at the end of the day. S8 also added the staff knows that red clamps are used for the isolation room only. During an interview on 12/29/25 at 12:55 PM, S2 confirmed that S21 should remove the yellow gown when leaving the isolation room. Facility policy titled, “Infection Prevention and Isolation Protocols,” effective 06/24, stated, “... IV. Policy ... C. Disinfection and Decontaminatin [sic] Procedures For Medical Equipment, Devices and Non- Disposable Supplies ... 11. ...Cleaning of non-disposable treatment related items will be as follows: ... Item ... Bleach Soaking Basin ... Cleaning Procedure ... The basin will be filled with a bleach solution ... Frequency ... After each shift of patients ... Cleaning of non-disposable treatment related items (continued) ... Item ... Clamps opened Cleaning Procedure ... Soak a minimum of 10 minutes in bleach solution and rinse with water ... Frequency ... After every treatment ... F. Use of Personal Protective Equipment (PPE) ... 6. Employee Personal Protective Equipment (PPE) will be worn specific to the activity outlined below: ... Post-treatment cleaning of Hemodialysis machine exterior ... For the Hepatitis B Surface Antigen+ & C-diff [Clostridiodes difficile] + [positive] treatment station, PPE [personal protective equipment] must be removed and discarded ... Post-treatment cleaning of Hemodialysis station bed including mattress and side rails/chair, pillow, overbed table, call bell, TV, blood pressure cuff ... For the Hepatitis B Surface Antigen+ & C-diff+ Patient treatment station, the PPE above must be removed ...” N.J.A.C. 8:43A-14.2(b)(4) N.J.A.C. 8:43A-24.4(b)”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 51990 Based on staff interviews and a review of facility documents, it was determined that the facility failed to ensure that all staff providing care to HBsAg (Hepatitis surface antigen) positive patients (Patient[P]14) do not provide care to HBV (Hepatitis B Virus) susceptible [Hepatitis surface antibody (HBsAb) less than (<) 10 mIU/ml (milli-international units per milliliter)] patients (P13) at the same time. Findings include: A review of the facility patient/staffing assignment dated 12/22/25, indicated that Staff (S)13 was assigned to a HBV susceptible patient (P13) in Station C27, which was located in the facility’s buffer area. The buffer area is designated treatment space in a dialysis area used to physically separate patients based on HBV status in order to prevent cross-contamination and transmission of the virus. Stations C21, C22, C23, C24, C25, C26 and C27 are in the buffer area. The HBV susceptible patient (P13) in Station C27 and a HBsAg positive patient (P14) in the Isolation Room (C28) received dialysis on the same shift. A review of the Hepatitis Management report indicated P13’s HBsAb level was 7.2 mIU/ml on 12/02/25 and that P14’s HBsAg was positive on 12/02/25. Furthermore, the Hepatitis Management Report indicated P13’s HBsAb was <10 mIU/ml in the months of May, June, July, August, September, October and November of 2025. A review of P13 and P14’s treatment flowsheets dated 12/22/25, indicated that S13 initiated treatments, performed pre (before) and post (after) assessments and administered intradialytic medications to both P13 and P14 during hemodialysis treatment on the same shift. This can potentially lead to the transmission of HBV. During an interview on 12/31/25 at 10:05 AM, S31 stated the daily patient schedule is completed by S34 who refers to an acuity sheet when assigning patients to their stations. The acuity sheet contained all patients HBsAb status, which determines what patients are assigned to buffer area. S31 confirmed P13’s HBsAb levels and stated, “It was an oversight and the patient should have not been assigned in the buffer area and to the same nurse. Review of the acuity sheet for “Tuesday-Thursday-Saturday,” revision date 12/27/25, provided by S31, indicated P13 was positive for HBsAb and that P14 was positive for HBsAg. Furthermore, P13 did not not have HbsAb laboratory blood drawn after 12/02/25. During an interview on 12/31/25 at 10:50 AM, S1 stated that the Assistant Nurse Managers update all patients HBsAb status on the acuity sheet every month after laboratory blood draws have resulted. S1 added, the above findings were an oversight and stated, “It was a mistake.” Facility policy titled, “Infection Prevention and Isolation Protocols,” effective 06/24, stated, “... IV. Policy: ... E. Guidelines for Preventing and Controlling Infection ... 20. Hemodialysis patient station assignment will be as follows: ... Hepatitis B Surface Antigen + (HbsAg+) ... Staff member caring for HbsAg+ patients will not care for Hepatitis B Virus susceptible patients or HBsAb+ patient whose titer is <10 mIU/ml ...” N.J.A.C. 8:43A-14.2 (b)(9) N.J.A.C. 8:43A-24.4(b)”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 37656 Based on observation, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure the Reverse Osmosis (RO) Water Purification and Storage System Room is locked and secured. Findings include: On 12/29/25 at 11:00 AM in the presence of Staff (S)9, during tour of the Water Room where the water purification and storage system is located, the door to access the Water Room from the Biomed (biomedical) Room was propped open and unsecured. S5 and S6 with another surveyor were in the Water Room at the time of tour. Also, a second door in the Water Room that leads to a back hallway near the exit door was also unlocked and unsecured. Upon interview on 12/29/25 at 11:05 AM, S9 stated, “we never locked the doors from the dialysis unit for staff to do the water testing but the main door leading to the back hallway should have been locked.” Upon interview on 12/29/25 at 12:20 PM, S5 and S6 stated that they entered the Water Room door with another surveyor through unlocked doors coming from the Hemodialysis Treatment Area. S5 and S6 confirmed they were not dialysis staff, and not responsible for monitoring and maintaining the water system in dialysis. S5 and S6 entered the unlocked doors of the water room without the assistance of a dialysis staff member. Upon interview at 12:20 PM, S1 stated that the Water Room should be locked. Facility policy titled, “Product Water Quality, Concentrate, and Dialysate for Hemodialysis,” revised 03/24, stated,”... J. The Water Treatment Room is locked when the unit staff are not present. ...” N.J.A.C. 8:43A-24.10(a)”

“H20 STORAGE-MONITORING CFR(s): 494.40(a) 6.3 Water storage and distribution 6.3.2 Water storage: monitoring Routine monitoring of water storage tanks for bacteria and endotoxin levels is generally accomplished indirectly by monitoring the water at the first outlet to the distribution loop (see 6.3.3). If direct monitoring of a water storage tank is performed as part of a troubleshooting process, bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet. This Standard is not met as evidenced by: 37656 Based on a review of facility documents and staff interview, it was determined that the facility failed to ensure that the Reverse Osmosis (RO) Water Storage Tank is monitored for bacteria and endotoxin levels in two of six months of culture schedules reviewed. Findings include: A review of the “General Culture Checklist” for 2025 indicated that the RO Storage Tank was scheduled for culture and endotoxin testing in January, June and December. A review of the culture and endotoxin results for June to December 2025 did not contain culture and endotoxin results for RO Storage tank testing. Upon interview on 12/30/25 at 1:15 PM, Staff (S)9 stated that the culture and endotoxin of the RO Storage Tank are done every six months. S9 confirmed that he/she could not find results of cultures and endotoxin’s of the Storage tank in June and December of 2025. N.J.A.C 8:43A-24.10(a)(2)”

“DIALYS PROPORT-MATCH MACH CONFIG W/RATIO USED CFR(s): 494.40(a) 5.6 Dialysate proportioning: match machine config w/ratio in use Changing from one proportioning ratio to another requires recalibration for some models of dialysis machines. For those machines, the type of concentrate should be labeled on the machine or clearly indicated by the machine display. It is strongly recommended that facilities configure every machine to use only one type of concentrate. 6.6 Dialysate proportioning Dialysate proportioning should be monitored following the procedures specified by the equipment manufacturer. The user should maintain a record of critical parameters such as conductivity and approximate pH. When the user has specific requirements for monitoring dialysate proportioning, such as when dialysis machine settings are changed to allow the use of concentrates with a different proportioning ratio, the user should develop procedures for routine monitoring of dialysate electrolyte values. This Standard is not met as evidenced by: 37656 Based on observation and staff interview, it was determined that the facility failed to ensure that 28 out of 32 hemodialysis machines are labeled with the appropriate symbol indicating the correct concentrate proportioning ratio. Findings include: On 12/29/25 at 11:00 AM, during tour of the Hemodialysis Treatment Room in the presence of Staff (S)9, all the hemodialysis machines in Stations C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C23, C24, C25, C26, C27, C28, and the four machines that were stored in the Water Room were not labeled with the dialysate proportioning ratio. Upon interview at the time of discovery, S9 stated he/she did not know that all machines should be labeled with the dialysate proportioning ratio. N.J.A.C 8:43A-24.10(a)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 50912 Based on one of one observation of the termination of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview and a review of facility documents, it was determined that the facility failed to ensure the patient’s rights to privacy. Findings include: On 12/29/25 at 10:40 AM, in Station C2, Staff (S)33 terminated hemodialysis on a patient through a right chest wall CVC. During the procedure, the curtain was not completely drawn in front of the patient leaving an approximate three foot opening on the right side. The patient’s right chest wall was visible to staff at the nurse’s station adjacent from Station C2, and to transport personnel and patients being transferred in and out of the treatment floor entrance, which was adjacent from Station C2. During an interview on 12/29/25 at 10:49 AM, S33 confirmed that the curtains should be fully closed around the patient’s station when terminating hemodialysis thru a CVC. S33 explained, then demonstrated that there was not enough length of the ceiling mounted privacy curtain to fully enclose station C2 when fully drawn closed. A review of S33’s personnel file indicated that he/she has completed the “Mandatory Training - Advanced Clinician” that contained education and training on Patients’ Rights and Responsibility on 12/11/25. Facility policy titled, “Patient Rights,” revised 2023, stated, “... Patients shall have the rights to: Treatment that is courteous, considerate, dignified and respectful that supports their dignity. ... Physical privacy to the extent consistent with providing adequate treatment and care activities ...” N.J.A.C. 8:43A-16.2(a)10”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 39228 Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure medical records are stored to protect patient confidentiality. Findings include: On 12/29/25, during a tour of the In-center Hemodialysis Treatment Area, the following was revealed: At 11:40 AM, there were three metal, portable carts located in the nurse’s station area that each contained multiple binders. Upon inspection, the binders had information documented on the outside spine section area, which was facing outward and located directly across from and were visible to patient stations C21, C22, C23, C24 and to any other patients that were to pass by the nurse’s station area. Upon discovery, an interview was conducted at 11:42 AM with Staff (S)4, who confirmed that the binders were medical records for the hemodialysis patient’s and that the patients last name and first initial were documented on the outside spine portion of the binders. Further review at this time indicated that one of the three carts contained 32 medical records that had the patients last name and first initial documented on the outside portion of the binder. The second cart contained 35 medical records that had the patients last name and first initial documented on the outside portion of the binder and the third cart contained 47 medical records, 41 of which had the patients last name and first initial documented on the outside portion of the binder and six of which had the patient’s last name, and full first name documented on the outside portion of the binder. At 11:45 AM, an interview was conducted with S8 who stated the medical records stored on the racks were in-center outpatient hemodialysis patient charts. S8 then stated there is another room for medical record storage in the basement, and that those medical records were stored in the basement until they get picked up by an outside storage company. On 12/31/25 at 10:00 AM, the above findings were confirmed with S2. Review of facility policy titled, “Safeguards to Prevent the Unintended Disclosure of Protected Health Information,” last revised 10/23, stated, “... A. Protected Health Information in Paper Form 1. Medical Records ... i. When not in use, personnel maintain Medical Records in a manner which prevents unauthorized individuals from ... identifying the patient to whom the record pertains. ...” N.J.A.C. 8:43A-16.2(a)10”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 51990 Based on medical record review, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that an elevated blood pressure (BP) greater than(>)180 mm/hg (millimeters of mercury) and/or a decrease in BP are addressed and appropriate interventions are implemented for two of two patients (Patient (P)3 and P10). Findings include: A review of P3’s medical record revealed the following: The “Flowsheet” portion of the “Hemodialysis Treatment Summary” dated 12/28/25 stated, “... Time 11:30 ... ATTR ... Post [after] dialysis ... BP ... 188/165 ... Comments ... [Blank] ... Signature ... Staff RN [registered nurse]...” The medical record lacked documentation of an intervention for P3’s elevated BP of > 180. There was no policy referenced that speaks to the abnormal blood pressure parameters and the intervention that should have been made for the abnormal finding. The “Treatment Medication Due” portion of the “Hemodialysis Worksheet” dated 12/28/25 stated, “... If BP is 180 sys [systolic] or greater, notify provider if there is no standing order for Clonidine. If no response to BP medication with in 1 hr [hour], notify provider ...” Review of the physicians orders indicated that P3 did not have a standing order for Clonidine and there was no documentation by the RN that the physician was notified. A review of P10’s medical record revealed the following: The “Flowsheet” portion of the “Hemodialysis Treatment Summary” dated 12/18/25, stated the following: “... Time 8:25 ... Pre [before] dialysis ... BP... 99/61 ... BFR [blood flow rate] ... 350 ... Comments ... BP low, patient asymptomatic ... Signature ... Staff RN ...” “... Time 8:30 ... Intradialytic ... BP ... [Blank] ... BFR ... 350 ... Comments ... 150 cc [cubic centimeter] saline bolus for BP support ... Signature ... Staff RN ...” “... Time 9:01 ... Intradialytic ... BP ... 88/ 45 ... BFR ... 350 ... Comments ... BP low, patient asymptomatic ... 150 cc bolus saline given ... Signature ... Staff RN ...” “... Time 10:45 ... Intradialytic ... BP ... 88/57 ... BFR ... 350 ... Comments ... BP low, patient asymptomatic ... 150 cc saline bolus given ... Signature ... Staff RN ...” The “Adhoc [for this specific purpose or situation] Order” of the “Hemodialysis Worksheet” dated 12/18/25 stated, “For symptomatic decrease in BP (Lightheadedness, change in mental status, cardiac instability and/or cramping) treat by placing in min [minimal] UF [ultrafiltration], recheck BP, administer 200 ml [milliliter] of saline at BFR 400, then decrease to 200 ...” The medical record indicated P10 was not symptomatic despite the decrease in BP. P10 did not have a physician order for 150 cc saline bolus for BP support. During an interview on 12/30/25 at 2:21 PM, Staff (S)16 confirmed the findings above and stated high a BP should have been rechecked by the RN and addressed for appropriate intervention if the BP remained elevated. S16 also added, for symptomatic low BP, the standing order was to give the patient 200 cc saline bolus. A facility policy on Hypotension and Hypertension was requested from S8 and S16. S8 and S16 stated the staff follows the Treatment Medication and the Adhoc orders on the Hemodialysis Worksheet for decrease and elevated BP interventions. Facility policy titled,”Documentation,” effective 05/24, stated, “ ... I. Purpose: To provide an accurate method of denoting patient activity and medical care during a hemodialysis treatment ... IV. Policy: ... D. The entries will include intervention and outcomes ...””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50912 Based on staff interviews, review of four of four medical records (Patient [P] 3, P4, P5 and P7), and review of facility documents, it was determined that the facility failed to ensure that patients receive the prescribed BFR (Blood Flow Rate, the speed at which blood is pumped through the dialyzer) during hemodialysis treatments. Findings include: A review of P3’s medical record revealed the following: The Plan of Care (POC), dated 7/24/25, stated, “... Dialysis Adequacy of Treatment Hemodialysis (Goal: 1.2 or greater). Patients last Kt/V (Clearance [K] of urea by the volume of distribution [V] over the dialysis [t] time - medical measurement for assessing effectiveness of hemodialysis) 1.46 ... No action taken meets criteria. ... Refer to CVIR (Cardiovascular and Interventional Radiology) for any access issues ...” The “Hemodialysis Orders” section dated 12/17/2025, contained a physician order that stated, “... BFR 350 mL [milliliter]/[per] min [minute], DFR [Dialysis Flow Rate, the speed by which blood and dialysate move through the dialyzer] 600 mL/min ...” A review of the “Hemodialysis Treatment Summary” from 12/17/25 to 12/19/25 indicated that the prescribed BFR order of 350 mL/min was not followed on the following treatment date: On 12/19/25, hemodialysis treatment was initiated at 9:02 AM with the BFR set at 400 ml/min. The BFR remained at 400 mL/min until termination of hemodialysis treatment at 12:02 PM. The medical record lacked documented evidence of a rationale for the BFR not being administered according to the physician’s order on the above date. On 12/31/25 at 2:00 PM, the above finding was reviewed and confirmed with Staff (S)16. Upon interview at 2:03 PM, S16 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. A review of P4’s medical record revealed the following: The POC, dated 9/18/25, stated, “... Dialysis Adequacy of Treatment Hemodialysis (Goal: 1.2 or greater). Patients last Kt/V: 1.31 ... No action taken meets criteria. ...” The “Hemodialysis Orders” section dated 12/01/2025, contained a physician order that stated, “... BFR 400 mL/min, DFR 600 mL/min ...” A review of the “Hemodialysis Treatment Summary” from 12/05/25 to 12/28/25 indicated that the prescribed BFR order of 400 ml/min was not followed on the following treatment dates: On 12/15/25, hemodialysis treatment was initiated at 8:31 AM with the BFR set at 350 mL/min. The BFR remained at 350 mL/min until the termination of the hemodialysis treatment at 11:01 AM. On 12/26/25, hemodialysis treatment was initiated at 7:44 AM with the BFR set at 200 mL/min. The BFR remained at 200 mL/min until 7:51 AM. At 7:52 AM, the BFR was changed to 350 mL/min until 8:18 AM. At 8:18 AM the BFR was changed to 400 mL/min until 8:53 AM. At 8:53 AM, the BFR was changed to 360 mL/min until the termination of the hemodialysis treatment at 10:50 AM. The medical record lacked documented evidence of a rationale for the BFR not being administered according to the physician’s order on the above dates. On 12/31/25 at 10:52 AM, the above findings were reviewed and confirmed with S1. Upon interview at 10:54 AM, S1 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. A review of P5’s medical record revealed the following: The POC, dated 6/24/25, stated, “... Dialysis Adequacy of Treatment Hemodialysis (Goal: 1.2 or greater). Patients last Kt/V: 1.27 ... No action taken meets criteria. ...” The “Hemodialysis Orders” section dated 12/02/2025, contained a physician that stated, “... BFR 350 mL/min, DFR 600 mL/min ...” A review of the “Hemodialysis Treatment Summary” from 12/15/25 to 12/28/25 indicated that the prescribed BFR order of 350 mL/min was not followed on the following treatment dates: On 12/26/25, hemodialysis treatment was initiated at 2:15 PM with the BFR set at 350 mL/min until 2:30 PM. At 2:31 PM, the BFR was lowered to 300 mL/min and remained at 300 mL/min until the termination of the hemodialysis treatment at 4:25 PM. On 12/28/25, hemodialysis treatment was initiated at 1:31 PM with the BFR set at 350 mL/min until 1:41 PM. At 1:42 PM, the BFR was changed to 300 mL/min until the termination of the hemodialysis treatment at 4:19 PM. The medical record lacked documented evidence of a rationale for the BFR not being administered according to the physician’s order on the above dates. On 12/31/25 at 2:00 PM, the above findings were reviewed and confirmed with S16. Upon interview at 2:03 PM, S16 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. A review of P7’s medical record revealed the following: The POC, dated 11/11/25, stated, “... Dialysis Adequacy of Treatment Hemodialysis (Goal: 1.2 or greater). Patients last Kt/V: 1.88 ... No action taken meets criteria. ...” The “Hemodialysis Orders” section dated 12/03/2025, contained a physician order that stated, “... BFR 400 mL/min, DFR 600 mL/min ...” A review of the “Hemodialysis Treatment Summary,” dated 12/16/25 to 12/29/25 indicated that the prescribed BFR order of 400 mL/min was not followed on the following treatment dates: On 12/16/25, hemodialysis treatment was initiated at 3:59 PM with the BFR set at 300 mL/min and it remained at 300 mL/min until the termination of the hemodialysis treatment at 4:53 PM. On 12/18/25, hemodialysis treatment was initiated at 1:25 PM with the BFR set at 400 mL/min until 1:40 PM. At 1:40 PM the BFR was changed to 360 mL/min until 2:48 PM. At 2:49 PM, the BFR was changed to 300 mL/min until the termination of the hemodialysis treatment at 4:35 PM. On 12/20/25, hemodialysis treatment was initiated at 1:11 PM with the BFR set at 200 mL/min until 1:16 PM. At 1:17 PM, the BFR was changed to 350 mL/min and remained at 350 mL/min until the termination of the hemodialysis treatment at 4:19 PM. On 12/23/25, hemodialysis treatment was initiated at 1:28 PM with the BFR set at 200 mL/min until 1:39 PM. At 1:39 PM, the BFR was changed to 350 mL/min and remained at 350 mL/min until the termination of the hemodialysis treatment at 4:42 PM. On 12/27/25, hemodialysis treatment was initiated at 2:08 PM with the BFR set at 400 mL/min until 2:14 PM. At 2:15 PM, the BFR was changed to 350 mL/min until 2:28 PM. The BFR was changed to 300 mL/min at 2:28 PM until 4:38 PM. The BFR was changed to 250 mL/min at 4:38 PM until 4:57 PM. The BFR was changed to 400 mL/min at 4:57 PM until 5:05 PM. At 5:06 PM, the BFR was changed to 350 mL/min until the termination of the hemodialysis treatment at 5:08 PM. On 12/31/25 at 2:00 PM, the above findings were reviewed and confirmed with S16. Upon interview at 2:03 PM, S16 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. Facility policy titled, “Documentation” effective May 2024, stated, “... 1. Purpose: To provide an accurate method of denoting patient activity and medical care during a Hemodialysis treatment ... the entries will include interventions and outcomes ... The Hemodialysis Treatment Summary will include the following ... machine settings ... machine check ... blood and dialysis flow rates ... includes time and date of observation ...” N.J.A.C. 8:43A-24.4(a)”

“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 staff interviews, medical record review and a review of facility documents, it was determined that the Medical Director failed to ensure that: 1) Hepatitis B Virus (HBV) susceptible patients (defined as Hepatitis B surface antibody [HBsAb] levels <10 mIU/mL) are not assigned to the designated buffer area (a designated treatment space in a dialysis area used to physically separate patients based on HBV status in order to prevent cross-contamination and transmission of the virus) adjacent to patients who were Hepatitis B surface antigen (HBsAg) positive and receiving hemodialysis; and 2) patient reassessments are completed every half hour with a signature of care giver and post (after) hemodialysis nursing assessments are completed according to facility policy for one of 10 medical records reviewed (Patient [P]6). Findings include: 1. The facility’s Hepatitis Management Report was reviewed and revealed the following: Patient (P)13’s HBsAb level of <3.0 mIU/mL (milli-international units per milliliter) on 12/02/25 and P15’s HBsAb level of 7.2 mIU/mL. P14’s HBsAg positive on 12/02/25 and P16’s HBsAg positive on 12/01/25. The facility patient and staffing assignment schedules from 12/15/25 through 12/29/25 were reviewed and revealed that buffer area stations C21, C22, C23, C24, C25, C26, and C27 were adjacent to Station C28, the Isolation Room for HBsAg-positive patients. P13, who was HBV susceptible, was assigned to a buffer area station on the following dates: C27 on 12/22/25, C23 on 12/24/25 and C24 on 12/29/25. On the same shifts and dates, P14, who was HBsAg positive, received hemodialysis in the Isolation Room (C28). P15, who was also HBV-susceptible, was assigned to a buffer area station on the following dates: C23 on 12/15/25, C25 on 12/17/25, C22 on 12/19/25, C23 on 12/21/25, C23 on 12/26/25 and C26 on 12/28/25. During the same shifts, P16, who was HBsAg positive, received hemodialysis in the Isolation Room (C28). During an interview on 12/29/25 at 9:35 AM, Staff (S)17 confirmed the buffer area (Stations C21, C22, C23, C24, C25, C26, and C27) were adjacent to Station C28, the Isolation Room for HBsAg-positive patients. During an interview on 12/31/25 at 10:05 AM, S31 confirmed the above findings and stated that HBV susceptible patients should not be assigned to the buffer area adjacent to HBsAg-positive patients. S31 further stated, “It was an oversight.” Facility policy titled, “Infection Prevention and Isolation Protocols,”effective 06/24, stated, “... IV. Policy: ... E. Guideline For Preventing and Controlling Infection ... 20. Hemodialysis patient station assignment will be as follows: ... Hepatitis B Surface Antigen+ (HbsAg+[positive]) ... Isolation Room C28 ... HbsAb+ patients or a space equivalent to the width of one hemodialysis station will be used as a geographic buffer between HbsAg+ and HbsAg- (negative) patients ...” N.J.A.C. 8:43-14.2(b)(9) N.J.A.C. 8:43-24.4(b) 2. A review of P6’s “Hemodialysis Treatment Summary” from 12/17/25 through 12/28/25 revealed the following: On 12/26/25, the “Flowsheet” section indicated that P6’s initiation of hemodialysis began at 1:30 PM and that treatment was terminated at 5:05 PM. From 2:28 PM to 5:05 PM (two hours and 37 minutest), the medical record lacked documented evidence of a patient assessment, to include comments every half hour and the signature of the care giver, in accordance with facility policy. On 12/26/25, the “Post Dialysis Observation” and “RN [Registered Nurse] Assessment Post Treatment” sections lacked documented evidence that a post-dialysis nursing assessment was completed. During an interview on 12/30/25, Staff (S)7 confirmed the above findings. S7 stated, the hemodialysis machines automatically obtain and document the patients blood pressure and heart rate every 15 minutes however, staff members are required to document every 30 minutes in the comment section with their signatures during hemodialysis treatments. S7 also stated, a post-dialysis assessment is to be completed by a nurse. S7 did not know why the post-dialysis assessment was not completed. Facility policy title, “Documentation,” revised June 2019, stated, “V. Procedure: A. Hemodialysis ... 4. The Hemodialysis Treatment Summary or Hemodialysis Treatment Flow Sheet will include the following ... l. Flowsheet includes: time, vitals, blood and dialysate blood flow rates, arterial and venous pressure, ultrafiltration volume, comments every half hour and signature of care giver ... o. Post Treatment Observation includes: time and date of observation, access complications during treatment, blood flow maintained as ordered, hemodialysis treatment length, dialyzer, total heparin given, post hemodialysis access (Refer to Vascular Access Policy RDS:38), post weight, complaints post dialysis, ambulation status, discharged to. p. Post Treatment RN Assessment includes: time and date of assessment, general, respiratory, cardiac, assessment of post weigh, post weight action ordered, skin, edema, GI, muscular/skeletal, behavioral, level of consciousness, pain assessment, laboratory results, antibiotic therapy, blood sugar testing, education discussed with patient, discharge instructions. ... “ N.J.A.C. 8:43A-24.4(a) 52927”