Trinitas Sat Linden

“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: 49828 Based one of one observation of the emergency evacuation cart, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the cart contains current annual patient standing orders, and current patient medication orders for use in the event of an emergency. Findings include: On 1/29/25 at 1:25 PM, a review of the contents of the emergency evacuation cart was completed and compared to the contents list titled, “Checklist For Emergency Evacuation Bag.” The contents list indicated the evacuation cart was last checked for contents and expired items on 1/3/25. A review of the contents with the list revealed the following: Of the 44 patients on the current census list at the facility, 18 patients did not have current annual patient standing orders present in the evacuation cart. Of the 44 patients on the current census list at the facility, 13 patients did not have current medication orders present in the evacuation cart. During an interview at 1:45 PM, Staff (S) 12, the Nurse Manager, confirmed that 18 patients did not have current annual standing orders, and 13 patients were missing current medication orders. Facility policy titled, “Maintenance of Emergency Evacuation Cart,” reviewed 2/2023 stated, “... Procedure: The emergency evacuation cart will contain the following items: ... Current Medication List, Annual Patient Standing Orders ...” 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: 48966 Based on one of one observations of initiation of dialysis through an arteriovenous graft (AVG, a type of access used for hemodialysis), 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 the facility policy. Findings include: On 1/29/24 at 11:35 AM, while on the Treatment Floor, an observation of the initiation of dialysis through an arteriovenous graft (AVG) was conducted in Station 15. Staff (S) 8, Patient Care Technician (PCT) cannulated the AVG and checked the placement of the needles with syringes. S8 disposed of the syringes in the sharps container but did not remove his/her gloves and perform hand hygiene and don a new pair of gloves before touching the hemodialysis machine. During an interview at 1:28 PM, S8 confirmed he/she needs to perform hand hygiene after removing gloves. A review of S8’s “Position Specific Competency Validation: Unlicensed Assistive Personnel (UAP)-Hemodialysis Tech” indicated that he/she was educated on Infection Control, which included hand hygiene, on 03/06/23. Facility policy titled, “Renal Dialysis Infection Control,” revised 4/23, stated, “... Procedure: ... 2. Routine Hygiene A. Indications for Hand hygiene: ... Before and after patient contact, after contact with blood, ... After removing gloves ... After handling contaminated items. ...” N.J.A.C 8:43A-24.8(d)”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 51990 Based on an observation of standard infection control precaution of storage waste, staff interviews, and review of facility policies and procedures, it was determined that the facility failed to ensure that clean areas are clearly designated from dirty areas to avoid possible cross contamination in patient station areas. Findings include: On 1/29/25 at 10:52 AM in Station 5, the red biohazard (material of biological origin that can cause possible risk or harm to humans) container touched the clean linen draped over the patient recliner chair. A red sharp container and a tan trash container were also in close proximity to the chair. During an interview at 11:12 AM, Staff (S) 4, a Registered Nurse (RN), stated that the housekeeper cleaned between patient shifts and he/she had pushed the red biohazard container, the sharp container and the tan trash container into the station. S4 stated that the biohazard container should not touch the clean linen draped on the HD (hemodialysis) chair. During an interview on 1/29/25 at 11:20 AM, S10, a Clinical Manager from another facility, stated that housekeeping placed the biohazard, sharp, and trash containers along the wall and they should not be there. Facility policy titled, “Infection Control for Dialysis Facilities,” reviewed 2/23, stated, “... Facility Hygiene ... 26. Clean areas should be clearly designated for preparation, handling, and storage of medication 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 patient stations, staff interview, and review of facility policy, it was determined that the facility failed to ensure that: 1) the hemodialysis machine prime bucket is cleaned and disinfected after patient use; and 2) a clean patient station is not contaminated before the next patient occupies the hemodialysis chair. 1. On 1/29/25 at 10:05 AM, in Station 6, Staff (S) 4, a Registered Nurse (RN), wiped the patient recliner chair, chase wall, and hemodialysis machine with a bleach soaked cloth. S4 did not empty or wipe down the prime bucket that contained a visible clear liquid. S4 proceeded to set up dialysis tubing for the next patient. During an interview at 10:24 AM, S4 stated, “I forgot to empty and wipe the prime bucket. I will do that now.” When asked if he/she should remove the dialysis tubing and set up new tubing since the prime bucket was not emptied or cleaned, S4 responded, “no.” During an interview at 12:27 PM, S6, the Charge Nurse, stated that Station 6 was not considered clean because the prime bucket was not emptied and cleaned. The tubing should be removed and new dialysis tubing set up. Facility policy titled, “Infection Control for Dialysis Facilities,” revised February 2023, 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 a bleach solution of the appropriate strength after completion of procedures, before being used on another patient, after spills of blood, throughout the workday, and after each treatment ...” Facilty policy titled, “Renal Dialysis Infection Control,” revised 4/23, stated, “... 9. Cleaning of Equipment in Between Patient Use ... E. All prime buckets are disinfected at the end of each patient shift using a 10 ml (milliliter) bleach to 1000 ml of water ...” 2. On 1/29/24 at 10:50 AM, during a tour of the Hemodialysis Treatment Floor, Station 6, which was cleaned and disinfected previously, was vacant. S11, Housekeeping Staff, wiped the floor with a bleach-soaked cloth in Station 6. S11 placed his/her gloved hand on the dialysis chairside table, on top of the blood pressure (BP) cuff, as he/she cleaned the floor. S11 did not reclean the chairside table or enquire a new BP cuff for the next patient assigned to Station 6. During an interview at 12:27 PM, S6, the Charge Nurse, confirmed that the table should be recleaned and a new BP cuff should be placed after being touched by a dirty glove. Facility policy titled, “Renal Dialysis Infection Control,” revised April 2023, stated, “ ... Procedure: 1. Standard Precautions ... A. Wear gloves when touching blood, body fluids, secretions, excretions, and contaminated items. Put on clean gloves just before touching mucous membranes and non-intact skin. Change gloves between task and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching non-contaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments ...” 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: 48966 Based on a review of patients tested for Hepatitis B surface Antibody (Anti-HBs) of less than 10 mIU/mL (milli-international units per milliliter), staff interview, and facility document review, it was determined that the facility failed to ensure that six of 44 patients (Patient (P)9, P10, P11, P12, P13, P14) who are susceptible to the Hepatitis B Virus, are tested for the Hepatitis B surface Antigen (HBsAg) monthly. Findings include: A review of the Hepatitis B laboratory results report from January 2024 to January 2025 indicated the following: Patient (P) 9 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 1/25/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in July 2024. P10 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 1/25/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in October 2024. P11 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 7/2/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in October 2024. P12 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 8/16/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in October 2024. P13 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 3/14/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in October 2024. P14 had a negative test result for HBsAg and an anti-HBs test result of less than 10 mlU/mL on 8/14/24, which indicated he/she was susceptible to Hepatits B. The medical record lacked evidence of a HBsAg surveillance test in October 2024. On 1/30/25 at 1:03 PM, the above findings were reviewed with Staff (S) 2, the Nurse Manager. S2 confirmed the missing results for the above mentioned patients. S2 explained the dialysis unit changed to a new electronic health records system in October and he/she could not access the missing labs. Facility policy titled, “Hepatitis Surveillance, Vaccination, and Infection Control Measures,” reviewed February 2023, stated, “... Hepatitis B Testing ... 5. Monthly Hepatitis B Surface Antigen (HBsAG) testing will be completed on patients who are susceptible or immune to Hepatitis B infection, including non-responders to the vaccine ... Scheduled for Routine Testing for Hepatitis B Virus (HBV) ... HBV-susceptible, including non-responders to vaccine * Susceptible is defined as: (HBsAG negative and HBsAb (anti-HBs) negative ...” N.J.A.C. 8:43A-24.4(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-2024” for the RO and water distribution system, and the test results were provided for review for July 2024 through December 2024. The following information was revealed: For the month of October 2024, the RO Unit and RO Re Loop, the Bicarb (bicarbonate) Mix Outlet, Station 1 and Station 15 were scheduled for endotoxin testing according to the “Monthly Microbiology/Endotoxins Schedule-2024.” There were no documented results of the endotoxin tests drawn on 10/2/24. During an interview on 1/31/25 at 11:30 AM, Staff (S) 3, the Director of Renal Services, explained that in September of 2024 another laboratory (lab) began processing the endotoxin test results and that October 2024 was the only month that the endotoxins had not resulted. S3 further explained that they were missed and that he/she called the lab to ensure the endotoxins for these areas would be processed monthly. Facility policy titled, “Analysis of Hemodialysis Water Treatment System,” revised July 2022 stated, “Policy: ... The water utilized in hemodialysis treatments must be tested monthly for the presence of elevated levels of trace elements and endotoxins ... Water samples will be collected from ... all stations, ... the permeate port of the Reverse Osmosis (R/O) system and the bicarbonate exit port of the bicarbonate mixer ... 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 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 concentrate formula produced and the name of the manufacturer of the powdered concentrate on 12 of 12 dates reviewed. Findings include: On 1/29/25, the “Bicarbonate Mixing Tracking Form” for the month of January 2025 was provided by Staff (S) 1, Biomedical Technician, for review. The form did not contain documentation of the bicarbonate concentrate formula produced and the name of the manufacturer of the powdered bicarbonate concentrate on 01/03/25, 01/06/25, 01/08/25, 01/10/25, 01/13/25, 01/15/25, 01/17/25, 01/20/25, 01/22/25, 01/24/25, 01/27/25, and 01/29/25. On 1/30/25 at 10:15 AM, during an interview with S3, Director of Renal Services, S3 confirmed the above findings and stated that the information would be added to the tracking form. Facility policy titled “Procedure for Bicarb [bicarbonate] Mixing using MarCor Single Mix Bicarb Unit,” revised 10/2017, stated “Purpose: All Hemodialysis staff is trained in the proper procedure of Bicarbonate Mixing ... It is the intent of this policy to establish safe guidelines based on Manufacturers’ recommendations for mixing bicarbonate. ... Procedure: ... 10. ... Document on Bicarb Mixing Tracking Form. ...” N.J.A.C 8:43A-24.10(a)5”

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 39228 Based on staff interview and review of facility documents, it was determined the facility failed to ensure that all bicarbonate containers that are disinfected and checked for chlorine residual at the end of each treatment day are recorded on the disinfection log in 12 out of 12 dates reviewed. Findings included: On 1/29/25 at 11:00 AM, The “Bicarbonate Container/Tank Disinfection” logs for January 2025 were reviewed. On 1/29/25 at 12:30 PM, during an interview with Staff (S) 1, the Bio-Medical Technician, S1 explained that the facility provides dialysis treatments three days per week (Monday, Wednesday, and Friday) and that the bicarbonate containers used in the patient treatment stations are disinfected with a bleach/water mixture at the end of each treatment day and then checked for chlorine residual. Upon interview on 1/30/25 at 9:40 AM, S1 confirmed that there are 33 bicarbonate containers and that all 33 containers are disinfected at the end of each treatment day. Review of the logs dated 01/03/25, 01/06/25, 01/08/25, 01/10/25, 01/13/25, 01/15/25, 01/17/25, 01/20/25, 01/22/25, 01/24/25, 01/27/25, and 01/29/25 lacked documented evidence that “Bicarbonate 1” container was disinfected and checked for residual chlorine. Upon interview with S3, Director of Renal Services, on 1/30/25 at 10:00 AM, S3 confirmed that the disinfection and residual check for Bicarbonate 1 container was not documented on the logs and stated that he/she would have the log updated to ensure the log reflects that all containers are disinfected and checked for residual chlorine. Facility policy titled “Renal Dialysis Infection Control,” revised 10/2017, stated, “... Procedure: ... 12. Bicarbonate containers daily disinfection is performed as follows: ... Document on the “bicarbonate container/tank disinfection” form daily cleaning of tanks and containers. ...” NJAC 8:43A-24.10(a)8”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51040 Based on observations, document review, and staff interview, it was determined that the facility failed to ensure that the dialysis facility is maintained to ensure the safety of the patients, the staff and the public. Findings include: During a tour of the facility on 1/30/25 at 9:41 AM with Staff (S) 13, Facilities Director, the following was observed: The laminate countertop along the wall and window near Station 10 was cracked exposing a porous surface that can not be cleaned. The laminate countertop along the wall and window near Stations 11 was broken exposing a porous surface that can not be cleaned. A portable air conditioning unit was vented into the ceiling space which should be vented to the outside of the building per the owner’s manual documents reviewed for the Everstar Portable A/C unit. On page 4 of the manual it states the following, “Window Kit Installation, Your window kit has been designed to fit most standard “vertical”and “horizontal” window applications. However, it may be necessary for you to improvise/modify some aspects of the installation procedures for certain types of windows. Please refer to Fig. 2 & Fig. 2a for minimum and maximum window openings.” A vertical piece of laminate was observed coming off the nurse’s station across from Station 7 leaving a surface approximately 6 inches that cannot be properly cleaned. A glove box holder on the column next to the nurse’s station was coming off the wall across from Station 7. There was a damaged Ground Fault Interrupter Circuit outlet behind Station 5, which could cause harm to anyone who tries to use the outlet. The air-conditioning ceiling inlet near Station 1 had an accumulation of brown colored material on the vent louvers. When touring the Reverse Osmosis Room, beginning at 10:15 AM, the following was observed: There was chipped and missing paint from the concrete floor approximately six square feet in the floor area. One of one fire extinguishers in the Reverse Osmosis Room, which was located near the exit door, was blocked by a dialysis machine and would not be readily accessible in an emergency. The dirty sink near the Soiled Utility Room was missing caulk around the back splash creating a gap exposing a porous surface which can not be properly cleaned. The metal pipe support for the dirty sink, near the Soiled Utility Room was rough, pitted and discolored creating a surface that cannot be properly cleaned. At 10:40 AM, in the Waste Management Room, the following was observed: The entry door, which is a fire rated door, was propped open with a box allowing unauthorized access. There was a missing ceiling tile which would allow smoke generated by a fire to enter the space between the ceiling and the roof and delay the activation of the fire alarm system. The ceiling light fixture cover was hanging from the ceiling which could cause injury by falling onto anyone who was standing under the light. The main breaker panel in the Electrical Room was missing two covers, exposing live electrical wiring which could cause injury if someone places their hand in the box. A Ground Fault Circuit Interrupter outlet in the Staff Break-Room was not functional. Staff S13 pressed the test button located on the electrical outlet at 12:20 PM and the outlet would not reset as designed. During an interview at 12:45 PM, S13 confirmed the above findings. N.J.A.C. 8:43A-17.3(j)(k) N.J.A.C. 8:43A-17.4(a)15”

“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: 49828 Based on one of one medical record reviewed of unstable patients (Medical Record (MR) 5), review of facility policy, and staff interview, it was determined that the facility failed to ensure a comprehensive reassessment is conducted at least monthly for a patient designated as “unstable.” Findings include: A review of Patient (P) ‘s medical record revealed the following: Patient Plan of Care meetings were conducted on 05/31/24, 06/26/24, 07/25/24, 08/26/24, 09/20/24, and 10/28/24 and the patient’s status was determined as “unstable.” There was no documented evidence a comprehensive reassessment was completed by the interdisciplinary team (IDT), inclusive of the Medical Doctor, Registered Nurse, Renal Dietician, and Social Worker, to contribute to the Plan of Care meetings during the months of May, June, July, August, September, and October 2024. During an interview on 01/30/25 at 12:45 PM, Staff (S) 2, the Nurse Manager, confirmed that for the above months there were no comprehensives completed by the IDT. S2 stated the IDT only completed comprehensive assessments for the annual Plan of Care (POC) in April of 2024. Facility policy titled, “Comprehensive Assessment, Plan of Care, and Short-Term Care Plan,” reviewed February 2023, stated, “... Definitions: Comprehensive Assessment consists of an assessment by the Registered Nurse, Social Worker, Dietician, and History and Physical by the Physician. ... Procedure: ... 5. If the patient is deemed unstable then the patient will have a comprehensive assessment and plan of care completed monthly until the patient is deemed stable by the IDT. ...” N.J.A.C 8:43A-24.13(c)”

“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 one of five medical records reviewed (Patient [P] 2), staff interviews, and review of facility documents, it was determined that the facility failed to ensure the hemodialysis (HD) prescription includes specific individualized blood flow rate (BFR) and that the Physician (MD) prescribed needle size (gauge) is followed during the initiation of hemodialysis. Findings include: On 1/30/25, a review of P2’s medical records revealed the following: A Physician order, starting on 1/3/25, stated, “Adjust BFR to maintain an AP [Arterial Pressure] less than (<) negative (-) 250. Notify physician if BFR less than (<) 200 ...” P2’s HD prescription did not indicate clear parameters for determining the specific BFR to deliver during hemodialysis treatment. The prescription did not provide a specific parameter for AP readings. A review of the “Hemodialysis Records” for treatments delivered from 1/8/25 to 1/27/25 indicated the following: The documented BFR delivered per treatment and AP documented was as follows: 1/08/25 - BFR 350; AP -160 1/10/25 - BFR 400: AP -140 1/13/25 - BFR 300; AP -120 1/15/25 - BFR 350; AP -160 1/17/25 - BFR 350; AP -140 1/20/25 - At 11:16 AM, the BFR was 350; AP -170. At 1:30 PM, the BFR was increased to 400; AP -170. The HD treatment ended at 2:16 PM. 1/22/25 - At 11:24 AM, the BFR was 350; AP -120. At 12:00 PM, the BFR was decreased to 330; AP -120. The HD treatment ended at 2:26 PM. 1/24/25 - BFR 350; AP -150 1/27/25 - BFR 350; AP -160 There was no documented evidence as to the reason a specific BFR was delivered or documented evidence that the order was clarified with the physician. On 1/8/25, 1/17/25, 1/20/25, 1/22/25, and 1/27/25, documention indicated that 16 gauge needles were utilized during hemodialysis treatment instead of the ordered 15 gauge needles. On 1/10/25 and 1/13/25 there lacked documented evidence of what size needles were utilized during hemodialysis treatment. During an interview on 1/29/25 at 11:53 AM, Staff (S) 8, a Patient Care Technician (PCT), initiated hemodialysis on Patient (P) 6, stated the BFR is delivered based on the patient’s blood pressure (BP). At 12:00 PM, S6, the Charge Nurse, stated the BFR is delivered based on needle gauge size and AP. During an interview on 1/30/25 at 12:55 PM, Staff (S) 2, a Nurse Manager, stated the BFR delivered was based on the needle gauge used to access the patient for hemodialysis. S2 stated, if 16 gauge needle is used the BFR should be delivered at a rate of 350 and if 15 gauge needle is used the BFR should be delivered at a rate of 400. S10, a Nurse Manager from another facility, present during the interview with S2, confirmed that BFR is established based on needle gauge that S2 described above. S10 added, BFR was a Registered Nurse (RN) discretion. During an interview on 1/30/25 at 1:30 PM, S17, the Alternate Medical Director, stated that the BFR was determined based on the needle size used for accessing the patient, the URR (Urea Reduction Ratio, the measure of how well dialysis removes waste), and any patient comorbidities “like cardiac issues.” A review of the “Patient Plan of Care” in April 2024 and October 2024 indicated, “Dialysis Prescription: ... Needle Gauge: 15... BFR: 350-400 ...” Facility policy titled, “Cannulation of Vascular Access AV Fistula and AV Graft,” reviewed on 2/23 stated, “... Equipment: 2- 16G [gauge] x1 or 15G x 1 cannula needles per physician order ...” Facility policy titled, “Hemodialysis Orders,” reviewed on 2/23 stated, “... A Physician will write standing hemodialysis orders, 1. Standing orders will include dialyzer, treatment time, blood flow rate, ...” N.J.A.C. 8:43A-24.13(b)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 48966 Based on three of three observations of the cannulation (the act of inserting a needle) of a vascular access, staff interview, and review of facility policy, it was determined that the facility failed to ensure that the staff perform skin disinfection in accordance with facility policy and Manufacturer’s Instructions for Use (MIFU) prior to cannulation of the vascular site. Findings include: On 1/29/25 at 11:35 AM in Station 15, Staff (S) 8, a Patient Care Technician, initiated dialysis through a patient’s arteriovenous graft (AVG, a type of vascular access used for hemodialysis). S8 cleansed the right arm AVG with one ChloraPrep in a circular motion for 10 seconds. This was 20 seconds less than required by facility policy. After allowing the access site to dry for one minute, S8 cleansed the first site of the AVG with an alcohol pad in a circular motion for three seconds then immediately cannulated (the action of inserting a metal tube into the body to draw fluid or introduce medication). This is 57 seconds less than required by facility policy. S8 proceeded to cleanse the second site of the AVG with an alcohol pad in a circular motion for eight seconds then immediately cannulated. This is 52 seconds less than required by facility policy. During an interview at 1:28 PM, S8 stated that he/she should cleanse the access with Chlorhexidine for 30-45 seconds and allow it to dry for 30 seconds. S8 stated that he/she should use alcohol on each site for 30 seconds before cannulating. During an interview on 1/31/25 at 9:49 AM, S12, the Nurse Manager at another facilty, stated that the only major antiseptic used to cleansed the access was Chlorhexidine and they should only use alcohol if the patient is allergic to Chlorhexidine. A review of S8’s “Initial And Annual Procedure Review And Skills Assessment” indicated Cannulation of AVF/AVG was signed off on 1/13/25. 51227 On 1/29/25 at 11:35 AM, in Station 5, S4, a Registered Nurse (RN), cleansed the vascular access site with ChloraPrep in a circular motion for five seconds. This was 25 seconds less than required by facility policy. S4 let the site dry for 10 seconds before inserting the fistula needle. This was 20 seconds less than required by facility policy. S4 proceeded to cleanse a second site on the vascular access with ChloraPrep for six seconds in a circular motion. This was 24 seconds less than required by facility policy. S4 let the site dry for 10 seconds before inserting the fistula needle. This was 20 seconds less than required by facility policy. During an interview at 12:12 PM, S4 stated each site should be cleaned for two seconds and allowed to dry for five seconds before inserting the fistula needles. On 1/29/25 at 11:50 AM, in Station 7, S5, a RN, cleansed the vascular site with an alcohol preparation (prep) pad for 10 seconds. This is 50 seconds less than required by facility policy. S5 proceeded to cleanse a second site on the vascular access with an alcohol prep pad for nine seconds. This is 51 seconds less than required by facility policy. During an interview at 12:10 PM, S5 stated each site should be cleaned for 30 seconds when using an alcohol prep pad. During an interview on 1/30/25 at 10:36 AM, S4, the Regional Director, was asked about the 2% Chlorhexidine sponge since the policy speaks to a Chlorhexidine swap stick. S4 said, “the facility staff follow the MIFU for the cleaning and dry time of the access site.” MIFU for the 2% Chlorhexidine stated, “Directions ... use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds ...” Facility policy titled, “Dialysis Access Preparation Prior to Cannulation,” revised July 2020, stated, “ ...2. In the use of 2% Chlorhexidine with alcohol (Preventics 3.154 %): Place one flat side of foam tip to proposed skin site and prep the skin vigorously with a back-and-forth motion with repeated strokes for 15 seconds. Turn the swab stick over to the unused side of the foam tip and repeat the procedure by prepping for a total of 30 seconds. Allow the prepped area to air dry for 30 seconds. Do not blot or wipe dry. Do not reuse swab ... 5. If there is an allergy to 2% Chlorhexidine, use either ... b. In the use of 70% (Alcohol has a short bacteriostatic action time). Apply alcohol pad and wipe in a back & forth rubbing motion for one minute. Must be applied immediately prior to the cannulation of AVF/AVG ...” N.J.A.C. 8:43A-24.8(b)”

“PQ-PCT CERTIFIED CFR(s): 494.140(e)(4) Patient care dialysis technicians must- (4) Be certified under a State certification program or a national commercially available certification program, as follows- (i) For newly employed patient care technicians, within 18 months of being hired as a dialysis patient care technician; or (ii) For patient care technicians employed on October 14, 2008, within 18 months after such date. This Standard is not met as evidenced by: 48966 Based on one of one Patient Care Technician (PCT) Personnel File reviewed (Staff (S) 8), a review of documents and staff interviews, it was determined that the facility failed to ensure that a PCT is certified within 18 months of hire date. Findings include: On 1/31/25 a review P8’s Personnel File revealed on the “Orientation Agreement,” a hire date of 12/12/22. From 12/12/22 to the date of survey, 1/31/25, a total of 25 months had lapsed with no evidence that S8 obtained certification. During an interview on 1/31/25 at 10:50 AM, S2, the Nurse Manager, stated Human Resources monitors certification for the PCTs. S2 has not had any contact with Human Resources regarding P8 taking the exam for certification. During an interview on 1/31/25 at 10:59 AM, S8 stated he/she has had no contact with Human Resources regarding taking the exam for certification. S8 is scheduled for the exam in March 2025. During an interview on 1/31/25 at 11:53 AM, S3, the Director of Renal Services, stated that until this morning, he/she was unaware that Human Resources was no longer responsible to ensure PCTs obtain certification within 18 months of date of hire. The Nurse Manager is responsible to make sure all PCTs are certified within 18 months date of hire.”