Davita Matawan Dialysis

“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: 39223 Based on three of four observations of clean sink areas, staff interview, and review of facility documents, it was determined that the facility failed to ensure that clean supplies are not stored in designated clean areas next to sinks where splashing and possible cross contamination may occur. Findings include: On 05/27/25 at 11:05 AM, during a tour of the In-Center Treatment Floor, the following was revealed: Three oxygen concentrators were observed to be stored adjacent to the clean sink, designated for handwashing, located across from Station 13. At 11:12 AM, Staff (S)6 (Patient Care Technician) approached the clean sink located across from Station 13 and proceeded to wash his/her hands with soap and water. This created the potential for cross contamination due to splashing during the handwashing process. At 11:14 AM, one wheelchair was observed next to the clean sink, designated for handwashing, located across from Station 10. At 11:15 AM, two oxygen concentrators were observed next to the clean sink, designated for handwashing, located across from Station 4. During an interview at 11:20 AM, S6 stated that the oxygen concentrators were cleaned and disinfected before being stored in the area next to the clean sinks across from Station 4 and Station 13. S6 confirmed that the areas next to the clean sinks were considered designated clean areas. Review of facility policy, titled “Infection Control for Dialysis,” revised April 2023, stated, “ ... FACILITY HYGIENE ... 19. ... a. Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place. ... “ N.J.A.C. 8:43A-24.4(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: 48966 Based on three of three observations of the cleaning and disinfection of a dialysis station, staff interviews, and review of facility documents, it was determined that the facility failed to ensure all surfaces and equipment in the patient station are cleaned and disinfected before preparing the hemodialysis machine for a new patient. Findings include: On 05/27/25 at 10:04 AM, in Station 5, the hemodialysis machine was set up with new dialysis lines for the next patient. Staff (S)4 (Patient Care Technician [PCT]), was observed using a bleach soaked cloth to wipe the dialysis chair, side tables, television, and chase wall but did not wipe the wall box. S4 did not wait until the dialysis station was clean and disinfected before setting up for the next patient to prevent cross contamination. During an interview at 10:06 AM, S4, stated that the dialysis station should be completely clean and disinfected before setting up the hemodialysis machine for a new patient. S4 discarded the dialysis lines on the machine. S4 was not sure if the wall box needed to be cleaned between patients. S4 stated, “the wall boxes are cleaned by the cleaning staff each night.” On 05/27/25 at 10:32 AM, in Station 17, S6 (PCT), was observed cleaning and disinfecting the station. S6 used bleach soaked cloths to wipe all surfaces of the hemodialysis machine but did not empty and wipe the prime bucket. S6 then wiped all surfaces of the patient recliner chair, side tables, and the television but did not wipe the chase wall and wall box. S6 proceeded to bring clean supplies to the dialysis machine for the next patient. During an interview at 10:44 AM, S6 confirmed that the prime bucket was not emptied or wiped and that the chase wall and wall box was not wiped with a bleach soaked cloth. S6 stated that he/she should have not brought the clean supplies to the hemodialysis machine because the prime bucked was not emptied or cleaned. 51227 On 05/27/25 at 10:35 AM, Staff (S)11 (Charge Nurse) used bleach-soaked cloths to clean and disinfect Station 10. S11 wiped the hemodialysis machine and patient recliner chair. S11 did not clean the chase wall or wall box in Station 10. During an interview at 10:40 AM, S11 stated, he/she should have cleaned the chase wall and water box after patient use. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “ ... Disinfection ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuff) and frequently contacted by healthcare personnel e.g., control panel; top, front, and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system ... ii. Priming containers are to be emptied prior to disinfection ... b. ... Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient ... “ N.J.A.C. 8:43A-24.8(b)”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 48966 Based on observation of one of one initiation of hemodialysis using a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interview and review of facility documents, it was determined that the facility failed to ensure that the initiation of dialysis using a CVC is performed aseptically in accordance with facility policy and procedure. Findings include: On 05/27/25 at 11:40 AM, in Station 14, Staff (S)5 (Registered Nurse [RN]), was observed initiating the hemodialysis treatment to Patient (P)12 through a right chest Central Venous Catheter (CVC). S5 placed multiple clean gloves, two 10 ml (milliliter) syringes, two 10 ml pre-filled saline syringes, and eight to 10 alcohol pads on the clean, disposable pad on the recliner table. After changing the CVC dressing, S5 removed the arterial (red) cap from the CVC and wiped the sides, threads and end of hub for 30 seconds with an alcohol prep pad. S5 connected an empty 10 ml syringe and aspirated approximately five mls of blood into the syringe. S5 removed the syringe from the arterial limb, and placed it onto the clean, disposable pad, next to the pile of clean gloves, potentially contaminating the clean supplies. S5 then flushed with the normal saline syringe before he/she proceeded to remove the venous (blue) cap from the CVC. S5 wiped the sides, threads and end of hub for 30 seconds with an alcohol prep pad and connected an empty 10 ml syringe. S5 aspirated approximately five mls of blood, removed the syringe from the venous limb, and placed it onto the clean, disposable pad, next to the pile of clean gloves, potentially contaminating the clean supplies. S5 then flushed with the normal saline syringe. This was not in accordance with facility policy and procedure. During an interview at 12:31 PM, S5 stated that he/she should not place the blood filled syringes onto the disposable pad next to the clean supplies. S5 stated he/she should dispose of the blood filled syringes in a sharps container. S5’s personnel file was reviewed and indicated the “In-Center Annual Procedural Skills Verification Checklist” which included CVC Care was signed and completed on 8/14/24. Facility policy titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” Revised April 2025, stated, “ ... Procedure ... 2. ... Set up clean field with all appropriate supplies on a clean, moisture proof barrier. ... Rationale ... 2. ... Verifying that you have all appropriate supplies prior to initiation procedure minimizes opportunities for cross contamination ... 17. Attach sterile 10 ml syringes to the arterial and venous limbs. 18. Open the catheter clamps. Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. ... 21. Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb ... “ N.J.A.C. 8:43A-24.8(b)”

“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 medical record review, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the physician ordered blood flow rate (BFR) is met or the reason it could not be met, is documented for three of the nine treatment sheets reviewed for Medical Record (MR)6. Findings include: A review of MR6 revealed a plan of care meeting, dated 05/08/25, that stated, “ ... Area of Focus BP [Blood Pressure] and Fluid Management ... Goal Achieve BP Control as specified by the patient’s physician ... “ Further review of MR6 revealed the following: A physician’s order for hemodialysis treatments three days per week, with a blood flow rate of 400 was started on 03/09/25. The “Treatment Details Report,” dated 03/15/25, documented a BFR of 350 from 6:33 AM, when hemodialysis treatment started, until 10:04 AM, three hours and 30 minutes later, when treatment ended. The “Treatment Details Report,” dated 04/03/25, documented a BFR of 350 from 6:28 AM, when hemodialysis treatment started, until 10:05 AM, three hours and 30 minutes later, when treatment ended. A physician’s order for hemodialysis treatments three days per week with a BFR of 400 was started on 04/09/25. The “Treatment Details Report,” dated 05/13/25, documented a BFR of 350 from 10:11 AM, when hemodialysis treatment started, until 12:21 PM, two hours and 10 minutes later, when treatment ended. This was not in accordance with physician orders. There was no documented evidence of the reason why the ordered BFR was not met, or that the physician was notified of the change. During an interview on 05/29/25 at 9:45 AM, Staff (S)11 (Charge Nurse) stated the reason for BFR changes should be documented by the Registered Nurse and confirmed the treatment sheets lacked documented evidence of the change in BFR. Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, stated, “ ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. Prescription components include but are not necessarily limited to: ... f. Blood flow rate ... “ N.J.A.C. 8:43A-8.4(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: 48966 Based on one of two observations of the initiation of hemodialysis through an arteriovenous fistula (AVF, a type of vascular access used for hemodialysis), staff interview, and 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 the facility policy. Findings include: On 05/27/25, at 11:10 AM, in Station 10, Staff (S)4 (Patient Care Technician [PCT]) was observed removing the plastic wrap from the left arm fistula (AVF) and wiping off the topical numbing cream with a 2x2 gauze. S4 did not clean the AVF with a cleansing agent. S4 proceeded to cleansed the arterial (first) site of the AVF with an alcohol pad in a circular motion then wiped with one Betadine pad for two seconds and let the site dry for one minute before cannulating (the act of inserting a needle). This was 28 seconds less than the 30 seconds required by facility policy and one minute less for the drying time required by facility policy. S4 proceeded to cleanse the venous (second) site of the AVF with an alcohol pad in a circular motion then wiped with one Betadine pad for six seconds and let the site dry for one minute before cannulating. This was 24 seconds less than the 30 seconds required by facility policy and one minute less for the drying time required by facility policy. During an interview at 11:21 AM, S4 stated the AVF needed to be cleaned with soap and water or another type cleansing agent. S4 also stated that when using Betadine you need to clean for 20 seconds and let it dry for five seconds before cannulating the AVF. S4’s personnel file was reviewed and indicated the “In-Center Annual Procedural Skills Verification Checklist” which included AVF/AVG Cannulation was signed and completed on 8/14/24. Facility policy titled, “AV Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose,” revised April 2025, stated, “ ... Skin Antiseptic Povidone Iodine ... Effective Contact Time 30 seconds Air Drying Time 2 minutes ... Procedure 1. Have patient wash access site with appropriate soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. ... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry. (For contact and dry time refer to table above). ... “ N.J.A.C. 8:43A-24.8(b)”

“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: 48966 Based on one of one observation of the medication preparation area, staff interviews, and review of Manufacturer’s Instructions for Use (MIFU), it was determined that the facility failed to ensure that bottles of LiquaCel (concentrated liquid protein supplement) are not available for use beyond the expiration date and are dated when opened. Findings include: On 05/27/25 at 11:25 AM, during an observation of the medication preparation area, three bottles of LiquaCel were found in the third drawer from the left of the cabinet. One apple flavored bottle had an open date of 05/23/25 and an expiration date of “10/24.” A half-empty bottle of grape flavored LiquaCel did not have a recorded date of when it was opened. During an interview at 11:32 AM, Staff (S)4 (Registered Nurse) confirmed that one LiquaCel bottle was not dated and the other LiquaCel bottle was expired. S4 stated that the LiquaCel bottles must be dated when first opened and should be used within three months of opening. S4 stated, “We just received some of these supplements” and then he/she discarded the two bottles. During an interview on 05/28/25 at 9:21 AM, S10 (Manager of Clinical Services) stated that LiquaCel is good for three months once opened or until the expiration date on the bottle. Review of the LiquaCel MIFU stated, “ ... Storage: may or may not be refrigerated. Do not use if safety seal is broken. Be sure to date when first opened. Use within three months of opening ... “”