Trinitas Hospital

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 50912 Based on one of one observation of the emergency evacuation box, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the emergency box contains staff emergency contact information. Findings include: On 12/17/25 at 11:37 AM, the in-center hemodialysis emergency evacuation box was reviewed, and contained a checklist titled, “Emergency Box Contents.” The checklist was last reviewed on 12/2025. The emergency evacuation box did not contain any current physician and staff emergency contact information. During an interview at 11:42 AM, Staff (S)8 stated that the current physician and staff emergency contact information contact list should be updated monthly, and be contained inside the emergency evacuation box. Facility policy titled, “Maintenance Emergency Evacuation Cart,” revised July 2024 stated, “... Procedure: The emergency evacuation cart will contain the following items: ...Current MD (Medical Doctor) List and Contact Information, Current Staff List and Contact Information ...” N.J.A.C. 8:43A-15.1(a)”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 51990 Based on one of one observation of hand hygiene during the cleaning and disinfection of the dialysis station, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed to prevent cross contamination, in accordance with facility policy. Findings include: On 12/17/25 at 11:30 AM in Station 4, Staff (S)7 was observed cleaning the dialysis machine. With gloves on hands, S7 exited the patient station and proceeded to enter Station 6. He/she then stripped the used linens on the bed that was occupied by a patient, exited the station, touched the receptacle and discarded the linen. With the same gloves still on hands, S7 walked to the clean counter, wetted clean wipes in a container that contained 1:100 bleach solution (one part bleach to 100 parts water). S7 then entered Station 5 and proceeded to clean the dialysis machine. S7 did not perform hand hygiene and change gloves. During an interview on 12/17/25 at 11:45 AM, S7 was questioned about hand hygiene and glove changes and stated, “I washed my hands earlier” and confirmed he/she did not perform glove changes. A review of S7’s personnel file revealed the “Initial and Annual Procedure Review and Skills Assessment” was completed on 01/09/25 and contained topics of Infection Control for Dialysis Facilities and Hand Washing and Use of Alcohol Based Hand Rubs. Facility policy titled, “Infection Control for Dialysis Facilities,” reviewed 02/23, stated, “... Staff Hygiene ... 1. Hand hygiene is to be performed upon entering the facility, prior to gloving, after removal of gloves ... after patient and machine contact ... before touching clean areas ... and before leaving the patient care area ...” N.J.A.C. 8:43A-24.8(b)”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 50912 Based on one of one observation and staff interview, it was determined that the facility failed to ensure that the pHoenix XL 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) is disinfected after use in the patient’s dialysis station, before being stored in a clean area. Findings include: On 12/17/25 at 10:18 AM, Staff (S)11 was observed taking the pHoenix XL meter from the clean sink to Station 7 to perform pH and Conductivity testing. S11 then returned the pHoenix XL meter to the clean sink for storage. At 10:22 AM, S11 was observed taking the pHoenix XL meter a second time to Station 7 to do a repeat pH and conductivity test. S11 then returned the pHoenix XL meter to the clean sink for storage. During both instances, S11 did not clean and disinfect the meter prior to placing it back on the clean sink for storage. On 12/17/25, upon interview at 10:28AM, S11 stated that the pHoenix XL meter was always stored at the clean sink, and since it was only touching the clean machine, it did not need to be cleaned and disinfected. Upon interview at 11:01 AM, S16 confirmed that anytime the pHoenix XL meter is taken to and from dialysis station, it should be cleaned and disinfected. Facility policy titled, “Infection Control for Dialysis facilities,” revised 2/2017, stated, “... Purpose: To provide a safe, clean environment for all patients and staff of the dialysis facility and to prevent the spread of infectious or bloodborne pathogens. ... Facility Hygiene ... 24. Wipe down all non-disposable items and equipment ... with an appropriate disinfectant after each treatment. ...” N.J.A.C. 8:43A-24.8(b)”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 51227 Based on one of two observations of cleaning and disinfection of the prime bucket, staff interview, and review of facility documents, it was determined that the facility failed to ensure that infection control policies and procedures are followed. Findings include: On 12/17/25 at 10:35 AM, Staff (S)11 entered Station 7, brought the prime bucket to the dirty sink and discarded contents into the sink. S11 proceeded to bring the prime bucket to clean sink number “2,” grabbed a cloth soaked with bleach, and cleaned the prime bucket in the clean sink. During an interview at 10:50 AM, S11 stated he/she dumps the prime bucket contents in the dirty sink but cleans it at the clean sink where the cloths and bleach are located. S11 stated it was “ok” to clean the prime bucket at the clean sink. During an interview at 10:55 AM, S6 stated the prime bucket should be emptied and cleaned at the dirty sink not the clean sink. Facility policy titled, “Infection Control for Dialysis Facilities,” reviewed 2/23, stated, “ ... Facility Hygiene ... 26. Clean areas should be clearly designated for the preparation, handling, storage of medications, and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. ...” N.J.A.C. 8:43A-24.8(b)”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 51227 Based on one of two observations of the cleaning and disinfection of a dialysis station, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all rails on the hospital bed used by a patient during dialysis are cleaned and disinfected after patient use. Findings include: On 12/17/25 at 10:25 AM, in Station 7, Staff (S)10 took off the used linen from the bed and began to clean the bed with a bleach-soaked cloth. S10 cleaned the bed and the two side rails on both sides. S10 did not clean and disinfect the foot rail and the head rail of the bed to prevent cross contamination. During an interview at 11:10 AM, S10 stated that all the rails including the foot and head rails should be cleaned and disinfected. During an interview on 12/18/25 at 1:40 PM, S16 stated all sides of the bed rails should be cleaned including the foot and head rails. Facility policy titled, “Infection Control for Dialysis Facilities,” reviewed 2/23, stated, “ ... Facility Hygiene ...30. Equipment including the dialysis delivery system, the interior and exterior of the prime container, dialysis chair and side tables, blood pressure cuff, and work surfaces will be wiped clean with clean with a bleach solution of the appropriate strength ...” N.J.A.C. 8:43A-24.8(b)”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. 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 to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 39228 Based on staff interview and a review of facility documents, it was determined that the facility failed to ensure that endotoxin testing of the Reverse Osmosis (RO) machine and water distribution system are completed monthly for one of six months reviewed. Findings include: The “Monthly Microbiology/Endotoxins Schedule-2025” for the RO and water distribution system, and the test results were provided for review for January 2025 through June 2025. The following information was revealed: For the month of February 2025, the RO Reloop Valve and the Bicarb (bicarbonate) Sample Valve were scheduled for endotoxin testing according to the “Monthly Microbiology/Endotoxins Schedule-2025.” There were no documented endotoxin results drawn on 02/06/25 for the RO Reloop Valve and the Bicarb Sample Valve. During an interview on 12/18/25 at 11:05 AM, Staff (S)14 stated, “I don’t have documentation of these results for February. I contacted the lab [laboratory] and I will let you know if they were completed.” A follow-up interview was conducted with S14 on 12/18/25 at 12:50 PM, who stated that the lab requisition was filled out incorrectly and the endotoxin levels were not tested for the Bicarb Sample Valve and the RO Reloop Valve on 02/06/25. Facility policy titled, “Analysis of Hemodialysis Water Treatment System,” reviewed February 2023 stated, “Policy: ... The water utilized in hemodialysis treatments must be tested monthly for the presence of elevated levels of trace elements and endotoxins as required by the American Association of Medical Instrumentation (AAMI) RD-52 ... The Biomedical Engineering Department Staff is responsible for collecting water samples and forwarding it to an AAMI-approved laboratory for chemical analysis and endotoxin testing. ... Test result records are maintained in the water report book ...” N.J.A.C. 8:43A-24.10(a)(1) N.J.A.C. 8:43A-24.10(a)(2)”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 39228 Based on staff interview, review of manufacturer’s instructions for use (MIFU), and a review of facility documents, it was determined that the facility failed to ensure that the Bicarbonate Mixing Tracking Form, used to document the mixing of bicarbonate in the facility, contained the time the bicarbonate was mixed and the correct number of bags mixed of the powdered concentrate on one of seven dates reviewed. Findings include: On 12/18/25, the “45X RenalPure Powder Bicarbonate Mixing Tracking Form” for the month of December 2025 was provided by Staff (S)14 for review and revealed the following: On 12/12/25, the form lacked documentation of the time the powdered bicarbonate concentrate was mixed. The form also stated that on 12/12/25, there were 50 gallons of powdered bicarbonate mixed, however, the “# (number) of bags” section on the form stated “3” bags were mixed. Review of the “Renal Pure Powder Bicarbonate” MIFU on 12/18/25 at 12:58 PM, with S14, stated, “... This package will produce 25 gallons ... of concentrated bicarbonate solution ...” During an interview on 12/18/25 at 1:00 PM, S14 confirmed the above findings and stated that the staff should have documented that time of mixing and that two bags of bicarbonate powdered concentrate were mixed instead of three. Facility policy titled “Central Distribution of Bicarbonate Mixing (3 North),” reviewed 02/2017, stated “Policy: All hemodialysis staff is trained on the mixing of bicarbonate through a central distribution system. The nurse manager in conjunction with the biomedical technician is to ensure compliance with this procedure. Purpose: It is the intent of this policy to establish safe guidelines based on the manufacturers recommendations for mixing of bicarbonate. ...” N.J.A.C 8:43A-24.10(a)5”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 51990 Based on one of seven medical records reviewed (Patient (P)3), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that a Comprehensive Interdisciplinary Assessment (CIA) is completed by the IDT [Interdisciplinary Team, includes a Physician, a Registered Nurse (RN), a Social Worker (SW), and a Registered Dietitian (RD)] on a new patient within 30 days. Findings include: A review of P3’s medical record revealed the following: P3 was admitted to the facility on 01/21/25 for in-center hemodialysis treatments. The initial Plan of Care (POC) meeting was held on 02/22/25. The CIA by the RD was completed on 03/18/25. This was 24 days after the initial POC meeting was held and 56 days after the initiation of dialysis of P3. During an interview on 12/18/25 at 11:10 AM, Staff (S)5 confirmed the above findings and stated, “I don’t know why the CIA was completed late.” Facility policy titled, “Comprehensive Assessment, Plan of Care, and Short Term Care Plan,” reviewed 02/23, stated, “... Procedure: ... 1. The interdisciplinary team will complete a comprehensive assessment and plan of care on all new patients to the dialysis facility within 30 days or 13 outpatient hemodialysis treatments beginning with the first outpatient dialysis treatment ...” N.J.A.C. 8:43A-24.13(b)”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 51990 Based on one of seven medical records reviewed (Patient (P)3), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that a Comprehensive Interdisciplinary Reassessment (CIA) is completed by the IDT [Interdisciplinary Team, includes a Physician, a Registered Nurse (RN), a Social Worker (SW), and a Registered Dietitian (RD)] on patients 90 days after the completion of the initial assessment. Findings include: A review of P3’s medical record revealed the following: P3 was admitted to the facility on 01/21/25 for in-center hemodialysis treatments. The 90 day Plan of Care (POC) was completed on 05/24/25. The CIA by the RN was completed on 05/23/25. The medical record lacked documented evidence of a comprehensive reassessments completed by the Physician, SW and RD for May 2025. During an interview on 12/18/25 at 11:15 AM, Staff (S)6 confirmed the above findings for the missing documents. Facility policy titled, “Comprehensive Assessment, Plan of Care, and Short Term Care Plan,” reviewed 02/23, stated, “Definitions: ... Comprehensive assessment consists of an assessment by the Registered Nurse, Social Worker, Dietitian and a History and Physical by the Physician. ... Procedure: ... 2. A follow up comprehensive assessment and plan of care will be completed 90 days after the initial assessment to provide information to adjust the patient’s plan of care ...” N.J.A.C. 8:43A-24.13(b)”

“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 one of seven medical records reviewed (Patient [P]7), staff interview, and a review of facility documents, it was determined that the facility failed to ensure a comprehensive reassessment and a revision of the Plan of Care (POC) are conducted at least 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 P7’s medical record revealed the following: P7’s hospitalization admission log indicated that he/she was hospitalized during the following dates: from 06/10/25 to 06/13/25; from 06/14/25 to 06/17/25; from 06/29/25 to 07/03/25; from 08/11/25 to 08/18/25; from 08/29/25 to 09/27/25; and from 11/24/25 to 12/02/25. P7 had frequent hospitalizations and was not deemed unstable in accordance with facility policy. The medical record lacked documented evidence of a unstable Comprehensive Interdisciplinary Reassessment (CIA) by the IDT and POC for July, August, September, October and November of 2025. During an interview on 12/19/25 at 11:15 AM, Staff (S)2 stated P7 is chronically unstable and confirmed the above findings of the missing documentation. Facility policy titled, “Comprehensive Assessment, Plan of Care, and Short Term Care Plan,” reviewed 02/2023, stated, “... Definitions: ... Comprehensive assessment consists of an assessment by the Registered Nurse, Social Worker, Dietitian and a History and Physical by the Physician. The IDT holds a Plan of Care meeting which the patient is invited to ... Unstable is defined as: ... i. Extended or frequent hospitalizations ...Procedure: ... 5. If the patient is deemed unstable then the patient will have a comprehensive assessment and plan of care completed monthly until patient is deemed stable by IDT ...” 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: 51227 Based on one of seven medical records reviewed (Patient [P]1), staff interview, and review of facility documents, it was determined that the facility failed to ensure that abnormal blood pressure (BP) occurring during hemodialysis treatments are reported to the Nephrologist (a physician who specializes in treating patients with kidney disease) in accordance with facility policy and procedure. Findings include: On 12/18/25, a review of P1’s medical record revealed the following: The “Default Flowsheet Data,” dated 11/29/25, revealed the following BP measurements: 0609: BP 170/107 0615: BP 190/114 0630: BP 200/95 0730: BP 176/99 0800: BP 179/96 0830: BP 161/93 0900: BP 175/98 0946: BP 164/81 There was no documentation that the Registered Nurse (RN) acknowledged P1’s elevated diastolic BP or made the Nephrologist aware. The “Default Flowsheet Data” dated 12/04/25, revealed the following BP measurements: 0620: Pre (before) assessment BP documented by a RN 204/107 1004: Post (after) assessment BP documented by a RN 180/90 There was no other documentation of BP’s throughout the dialysis treatment except for the pre and post assessments. There was no documentation that the RN acknowledged P1’s elevated BP during pre-treatment or made the Nephrologist aware. The above documentation was confirmed with Staff (S)6 on 12/18/25 at 12:01 PM with a review on Epic (electronic health record). When asked about the missing blood pressures, S6 stated the RN or PCT (patient care technician) taking care of this patient at the time must have not saved the information. S6 also stated that the facility is still getting used to the transition to Epic. The “Default Flowsheet Data” dated 12/09/25, revealed the following BP measurements: 0630: BP 179/103 0700: BP 173/93 0730: BP 203/104 0800: BP 190/112 0830: BP 169/108 0900: BP 169/104 0930: BP 166/103 There was no documentation that the RN acknowledged P1’s elevated diastolic BP or made the Nephrologist aware. The “Default Flowsheet Data” dated 12/11/25, revealed the following BP measurements: 0600: BP 195/109 0615: BP 191/118 0630: BP 167/97 0700: BP 160/101 0730: BP 177/110 0800: BP 169/109 0830: BP 167/104 0900: BP 182/115 0930: BP 173/105 0945: BP 172/105 1008: BP 172/105 1010: BP 178/79 There was no documentation that the RN acknowledged P1’s elevated diastolic BP or made the Nephrologist aware. P1 is a new admission with a start date of 10/11/25 and a plan of care dated for 11/18/25 with no mention of P1’s elevated BP. During an interview on 12/18/25 at 12:45 PM, S6 reviewed the above treatment sheets with this surveyor and confirmed the findings of elevated diastolic BP’s. S6 stated the RN should document signs and symptoms when a patient has elevated BP and make the Nephrologist aware of the findings. S6 also stated, “the RN should check to see if the vital signs crossed over into Epic during the date of 12/04/25.” Facility policy titled, “Management of Blood Pressure,” reviewed 2/23, stated, “ ... Procedure: Pre dialysis procedure the nurse will: ... 4. Treat cardiovascular problems ... In the event the patient experiences hypertension, the nurse will: 1. Assess and evaluate the patient for symptoms. 2. Call Nephrologist for further orders.” Facility policy titled, “Assessment of Hemodialysis Patient,” reviewed 02/23, stated, “... Monitoring of the patient during the hemodialysis treatment should include but not limited to: a) The monitoring of the patient’s blood pressure, pulse and respirations at least every 30 minutes for the stable, chronic patient and a minimum of every 15 minutes for the acute or unstable patient. The nephrologist should be notified immediately if the registered nurse notes any changes in systolic blood pressure ... from the baseline during the hemodialysis treatment. ...” N.J.A.C. 8:43A-24.4(a)”

“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: 51990 Based on two of seven medical records reviewed, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that the prescribed BFR (blood flow rate, the speed at which blood is pumped through the dialyzer during hemodialysis) is documented in one of two medical records (Patient (P)3) and the prescribed DFR (dialysate flow rate, the speed at which the dialysate solution moves through the dialyzer) is documented as ordered in one of two medical records (P7). Findings include: A review of P3’s medical record revealed the following: The Plan of Care (POC) dated 09/27/25, stated, “... Dialysis Prescription: ... Flow Rate: ... DFR: 800 ... BFR: 350 ...” The “Therapy Plan Information” dated 10/04/25, stated “... Dialysis Treatment Orders ... ESRD (End Stage Renal Disease) Hemodialysis outpatient ... Every visit ...Dialysis Flow rate (ml/min, milliliter per minute): 800 ml/min ... BFR (ml/min): 350 ml/min ...” A review of P3’s “Default Flowsheet Data” dated, 11/22/25, indicated that P3’s hemodialysis (HD) treatment was initiated at 11:30 AM with a BFR set at 350 ml/min. However, the BFR was not documented from 12:00 PM to 2:06 PM. This was two hours and six minutes that the BFR was not documented on the flowsheet. A review of P7’s medical record revealed the following: The POC dated 09/30/25, stated, “... Dialysis Prescription: ... Flow Rate: ... DFR: 800 ... BFR: 350 ...” The “Therapy Plan Information” dated 10/15/25, stated “... Dialysis Treatment Orders ... ESRD Hemodialysis outpatient ... Every visit ...Dialysis Flow rate (ml/min): 800 ml/min ... BFR (ml/min): 350 ml/min ...” A review of P7’s “Default Flowsheet Data” indicated a DFR of 500 ml/min at 7:30 PM. This was not the prescribed DFR. Furthermore, the DFR was not documented for the first two hours and 35 minutes and the remainder of the treatment that ended at 8:39 PM. This was an additional hour and nine minutes. The medical record lacked documented evidence of a rationale of the DFR not delivered according to the physician’s order on the above date. On 12/18/25 at 1:05 PM the above findings were reviewed and confirmed with Staff (S)16. During an interview on 12/19/25 at 1:12 PM, S2 stated that the facility transitioned to Epic (electronic health record) in October 2025 and the staff is still learning the system. 50912 A review of P6’s medical record revealed the following: The POC, dated 09/17/25, stated, “... To bring Hgb [Hemoglobin] level to 11 ... To bring albumin to normal level ... To educate patient on the importance of keeping MD [Medical Doctor] appointment. ...” The “Dialysis Prescription” section dated 10/02/2025, stated a physician order for “... Dialyzer: Theranova Dialyzer 400, BFR 350 mL/min, DFR 800 mL/min ...” A review of the “Default Flowsheet Data” from 11/03/25 to 12/18/25 indicated that the prescribed BFR order of 350 mL/min and DFR order of 800 ml/min was not followed and/or documented on the following treatment dates: On 11/06/25, hemodialysis treatment was initiated at 6:47 AM with the DFR set at 800 mL/min until 7:00 AM. At 7:00 AM, there was no documented DFR rate until termination of hemodialysis treatment at 10:00 AM. On 11/10/25, hemodialysis treatment was initiated at 6:15 AM with the BFR set at 200 ml/min until 6:30 AM. At 6:30 AM, there was no documented BFR rate until termination of hemodialysis treatment at 9:47 AM. On 11/24/25, hemodialysis treatment was initiated at 6:42 AM with the DFR set at 800 mL/min until 7:00 AM. At 7:00 AM, DFR was decreased to 500 mL/min until termination of hemodialysis treatment at 10:19 AM. On 12/11/25, hemodialysis treatment was initiated at 6:28 AM with the BFR set at 200 ml/min until 6:28 AM. At 6:28 AM, there was no documented BFR rate until termination of hemodialysis treatment at 10:22 AM. The medical records lacked documented evidence of a rationale for the DFR not being administered according to the physician’s order and why the DFR and BFR are not documented on the above dates. On 12/18/25 at 1:13 PM, the above findings were reviewed and confirmed with Staff (S)6. Upon interview at 1:16 PM, S6 stated that staff members should write a comment about why they cannot achieve the prescribed DFR and that both the DFR and BFR administered during hemodialysis should be documented on the treatment flowsheets. Facility policy titled, “Assessment of Hemodialysis Patient,” reviewed 02/23, stated, “... Policy ... Monitoring of the patient during the hemodialysis treatment should include but not be limited to ... m) Monitoring of dialysis machine parameters which include ... blood flow rate and dialysate flow rate ...” N.J.A.C. 8:43A-24.4(a)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 50912 Based on two of two observations of the initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff clean and disinfect the patient’s vascular access site prior to initiating hemodialysis treatment in accordance with facility policy. Findings include: On 12/17/25 at 10:30 AM, at Station 9, Staff (S)11 initiated hemodialysis treatment on a patient through a left arm AVF. S11 cleaned the arterial access site with a sterile alcohol pad for nine seconds and then immediately cannulated the site with a fistula needle (the process of inserting dialysis needles into the patient’s access to allow blood flow to and from a dialysis machine). The venous site was then cleaned with a new sterile alcohol pad for nine seconds, followed by immediate cannulation with a fistula needle. This was not in accordance with facility policy. Upon interview at 10:38 AM, S11 stated that he/she thought that he/she cleaned the AVG/F sites long enough. A review of S11’s training records revealed that he/she had completed the Annual Mandatory education on 6/06/25 that contained training and education on AVG/AVF initiation, termination and access site care. 51227 On 12/17/25 at 11:55 AM, S9 was observed entering Station 11 to initiate hemodialysis through an AVF. S9 cleansed both sites of the AVF with a chlorhexidine swab in a circular motion for 20 seconds. This is 10 seconds less than required by facility policy. During an interview at 12:10 PM, S9 was asked about the procedure on performing skin disinfection of the site for an AVF. S9 stated that he/she cleans the site for 30 seconds when using a chlorhexidine swab. Facility policy titled, “Dialysis Access Preparation Prior to Cannulation,” revised 7/20, stated, “Procedure: ... 4. In the use of One Maxi Swabstick with 3.15% Chlorhexidine Gluconate and 70% isopropyl Alcohol. Peel apart the pouch to expose swab stick. Remove swab stick from the package, do not touch the foam tip. Apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back and forth repeated strokes for 15 seconds with each side of the applicator for a total of 30 seconds. ... Purpose: Establish the proper preparation of the arm access prior to cannulation. ... b. In the use of 70% [percent] alcohol has a short bacteriostatic action. Apply alcohol pad and wipe it in a back and forth rubbing motion for one minute. ...” N.J.A.C. 8:43A-24.8(b)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 51227 Based on one of one medical record review for Peritoneal Dialysis (Patient [P]4), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that a physician examines the patient and documents monthly progress notes for five of six months reviewed. Findings include: A review of P4’s medical record lacked documented evidence of a physician’s monthly progress note for July, August, September, October, and November of 2025. P4’s medical record contained a typed-up paper with the above dates on them with no signature or assessments from the Medical Director. During an interview on 12/18/25 at 10:47 AM, the above missing monthly physician notes were reviewed with Staff (S)5. S5 confirmed that when a physician writes a monthly progress note it should be signed and dated and not typed up on a paper. N.J.A.C. 8:43A- 24.13(d)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51227 Based on observations, staff interviews and a review of facility documents, it was determined that that the Medical Director failed to ensure that: 1) in four out of 14 dialysis stations, the facility implements fall prevention policies and procedures; 2) oral nutritional supplement (ONS) is dispensed to patients by a Registered Nurse (RN) or a Registered Dietitian (RD) in accordance with facility policy in one of one observation of ONS administration (Patient (P)12; and 3) the staff performs a pre[before]-treatment assessment prior to initiating hemodialysis and a post [after]-treatment assessment after termination of hemodialysis per facility policy in one of two medical records reviewed (P5). Findings include: 1. On 12/17/25 at 10:15 AM, during a tour of the facility, occupied patient beds in Stations 1, 5, 6, and 7 beds were not in the lowest position while the patient was in bed. At 10:30 AM Staff (S)7, attended to the patient in Station 6 but did not lower the bed when leaving the station. During an interview at 10:40 AM, S6 stated, the beds should be in the lowest position while patients are in them. We put them up when initiating treatment but should be lowered when leaving the stations. Facility policy titled, “Fall Prevention for Adults Procedure,” effective date 10/7/2025, stated, “ ... 3. Procedure: ... Required Action Steps ...Plan of Care Low Risk: ... Bed in low position, brakes on ...” N.J.A.C. 8:43A-24.4(a) 51990 2. On 12/17/25 at 10:36 AM in Station 6, a Patient Care Technician (PCT), retrieved a bottle of Ensure (an oral nutritional supplement) from the cabinet and handed the Ensure to P12 who was lying in the bed. During an interview on 12/17/25 at 10:50 AM, S7, stated. “Ensure is a drink. It is not a medication.” A follow up interview at 11:15 AM with S8 confirmed that Ensure is administered by a RN. During an interview on 12/19/25 at 10:45 AM, S16 confirmed the above findings. A follow- up interview at 11:00 AM, S17 stated RD’s evaluate and makes the decision for ONS based on patient’s albumin (a form of protein) level less than 3.5 g/dl (grams per deciliter). S17 confirmed RNs and RD’s give patients the oral supplements. A review of S7’s personnel file revealed the Job Description stated, “... Summary ... you will provide direct patient care under the supervision of an RN ...” S7’s “Initial and Annual Procedure Review and Skills Assessment,” the Medication portion indicated “NA (not applicable)” on 01/09/25. Facility policy titled, “Hemodialysis Outpatient Oral Nutritional Supplement Program,” reviewed 02/24, stated, “... Policy ... RD/RN dispense the supplement ...” N.J.A.C. 8:43A-24.6(f)(4)(iv) 37656 3. A review of P5’s medical record revealed the following: A review of the “Default Flowsheet Data” documents in the Epic system (electronic health record), with the assistance of S6 indicated: On 11/21/25, P5’s treatment was started at 11:14 AM and ended at 2:42 PM. The medical record lacked evidence of a complete physical assessment of the patient prior to initiation of hemodialysis and at the termination of the hemodialysis treatment. On 11/24/25, P5’s treatment was started at 11:17 AM and ended at 3:05 PM. The medical record lacked evidence of a complete physical assessment of the patient prior to initiation of hemodialysis and at the termination of the hemodialysis treatment. On 11/26/25, P5’s treatment was started at 11:49 AM and ended at 3:14 PM. The medical record lacked evidence of a complete physical assessment of the patient prior to initiation of hemodialysis and at the termination of the hemodialysis treatment. On 12/08/25, P5’s treatment was started at 11:32 AM and ended at 3:20 PM. The medical record lacked evidence of a complete physical assessment of the patient prior to initiation of hemodialysis and at the termination of hemodialysis treatment. On 12/10/25, P5’s treatment was started at 11:17 AM and ended at 3:11 PM. The medical record lacked evidence of a complete physical assessment of the patient prior to initiation of hemodialysis and at the termination of the hemodialysis treatment. Upon interview on 12/19/25 at 1:39 PM, S6 stated and confirmed the assessments were not entered in the Epic system and were not sure if they were done. S6 also confirmed that the above treatments were performed by different staff members. A review of S19’s (one of the staff members) personnel file indicated that he/she had an annual procedure review and skills assessment that includes patient assessment, pre, intra (during), post dialysis assessment on 01/13/25. Facility policy titled, “Assessment of Hemodialysis Patient,” reviewed 2/23, stated, “A complete physical assessment of the patient, by a registered nurse must be performed prior to initiation of the hemodialysis treatment to ensure the patient is hemodynamically stable to undergo the treatment. Continuous monitoring of vital signs must be performed throughout the hemodialysis treatment at least every 30 minutes and at the termination of the treatment. ...” N.J.A.C. 8:43A-24.4(a)”