Davita Metuchen

“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 observation, 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 in order to avoid possible cross contamination for one of two workstation areas. Findings include: On 04/29/25 at 10:15 AM, a blue scissor clamp, folded disposable pad, BiCart (bicarbonate concentrate), hemodialysis tubing, and one liter of normal saline solution were observed sitting on the countertop adjacent to the clean sink across from Station 4. At 10:23 AM Staff (S) 6 (Registered Nurse [RN]) was observed washing his/her hands in Clean Sink 5, located across from Station 4. At 10:59 AM, S8 (Patient Care Technician [PCT]) was observed washing his/her hands at Clean Sink 5, located across from Station 4. During both observations, on the countertop next to the clean sink, the above listed clean supplies remained. This created a potential cross contamination risk from water splashing onto the supplies during the hand washing procedure. During an interview on 04/29/25 at 11:14 AM, S8 confirmed the supplies on the countertop next to the clean sink 5 were used for the next shift of patients. S8 stated that he/she should store the clean supplies used for patients at the other counter top located across from Station 1 and 2, away from the clean sink. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “ ... FACILITY HYGIENE ... 19. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas ... b. 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-24.8(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 one of one observation of the care of 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 hemodialysis through a CVC is performed in accordance with facility policy and procedure to prevent catheter related infections. Findings include: On 05/01/25 at 12:12 PM in Station 1, Staff (S)6 (Registered Nurse [RN]) initiated hemodialysis through a right chest CVC. S6 placed a blue under pad and a sterile 4x4 gauze pad under the catheter limbs. S6 removed the blue (venous) cap off one end of the CVC and used a sterile alcohol prep pad to scrub the threads and the end of the hub of the catheter for 15 seconds. S6 proceeded to remove the red (arterial) cap off the other end of the CVC, used a sterile alcohol prep pad and scrubbed the threads and the end of the hub the catheter for 15 seconds. S6 attached a 10 ml (milliliter) syringe to each limb and aspirated five milliliters of blood from each catheter limb. S6 removed the 10 ml syringe from the venous limb and discarded the syringe in the red sharps container. S6 then left Station 1 to retrieve supplies, without placing a new cap on the venous limb. This left the venous limb hub open and in contact with the 4x4 gauze pad underneath the CVC. During an interview on 05/01/25 at 12:46 PM, S6, stated he/she left Station 1 to retrieve alcohol wipes. S6 confirmed the end of the venous limb hub was left open and that he/she should have left the 10cc syringe on the end or placed a new syringe on the end of the venous limb before leaving to retrieve supplies. S6’s personnel file was reviewed and indicated that the “In-Center Annual Procedural Skills Verification Checklist” for CVC care was satisfactory, performed on 01/07/25. Facility policy titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End caps Procedure,” revision date: October 2024, stated, “ ... Procedure ... 16. ... Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of the hub thoroughly with friction making sure to remove any residue, for example blood. ... Rationale Verify open lumen is not placed on a non-sterile surface and minimize the time it is open ... 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 the arterial limb and attach a saline filled syringe. Repeat step for venous limb ... “ N.J.A.C. 8:43A-24.8(b)”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 48966 Based on one of two observations for machine pH (potential of Hydrogen) testing, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that pH testing is completed in accordance with facility policy. . Findings include: On 04/29/25 at 10:35 AM in Station 2, Staff (S)7 (Patient Care Technician [PCT]) in training, was observed testing the pH of the hemodialysis machine. S7 used a 10 milliliter (ml) syringe to obtain a sample from the dialysis lines where normal saline solution was recirculating. S7 obtained a sample of the normal saline solution in a cup, dipped the pH strip for one second, and read the strip within five seconds. S7 compared the pH test strip to the table on the bottle. S7 did not test from the dialysate sample port, as required by facility policy. During an interview on 04/29/25 at 10:43 AM, when asked which sample port should be used to test the dialysate pH of the machine, S7 stated, “I was told to get a sample from any easy access port, so I get it from the dialysis lines.” S7 then pointed to the sample port on the dialysis lines. During an interview on 04/29/25 at 11:34 AM, S4 (Biomedical Technician) confirmed that in order to test the pH of the dialysate used in the machine, the sample needs to be obtained from the dialysate sample port. During an interview on 04/30/25 at 09:23 AM, S2 (Facility Administrator) explained S7 is on week six of PCT training and should have a preceptor with him/her when checking the pH. S7 anticipated PCT training is to be completed at weeks nine to ten. A review S7’s orientation training, Module 1, “Principles of Dialysis & Hemodialysis Devices,” indicated that he/she properly demonstrated the manual pH test, and, “meets expectations.” Facility policy titled, “Testing pH For Acetate Based Dialysate Using PRC E-Z Chek K100-0117 6.8-8.5 Test Strips,” stated, “ ... Procedure ... 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second Or Using a new syringe obtain dialysate sample from the sample port, then allow fluid to flow over the pad for one (1) second ...” N.J.A.C. 8:43A-24.4(a)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 33556 Based on observation and staff interview, it was determined the facility failed to provide a defect free environment while maintaining all surfaces cleanable and in good repair. Finding include: During a tour conducted on 04/30/25 at 11:15 AM with Staff (S)4 (Biomedical Technician), open and/or defective seams were discovered on the monolithic flooring installed throughout the patient Treatment Area. Open or gaping seams prevent the floor surface from being cleaned effectively while acting as a catch point for debris and other unsanitary material. At the exit conference on 04/30/25, S3 (Facility Administrator) stated that a work order had been placed for the floor repair last year but when requested could not provide further vendor or corporate evidence that the work was going to be completed. N.J.A.C. 8:43A-17.4(a)(15)”

“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: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that all systems and equipment are maintained in good working order. Finding include: During a tour conducted on 04/30/25 at 11:15 AM, with Staff (S)4 (Biomedical Technician), missing or misadjusted fire sprinkler escutcheons were identified within the Entrance Vestibule, exterior Electrical Room, and the Conference Room. Missing or misadjusted fire sprinkler escutcheons could affect the activation or performance of a fire sprinkler system. The missing or misadjusted sprinkler escutcheons were acknowledged by S4 upon discovery.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 39223 Based on medical record review, staff interviews, and review of facility policy, it was determined that the facility failed to ensure that patients are encouraged to participate in planning their care for four of seven patient medical records reviewed (Patient (P)2, P4, P5, and P7). Failure to encourage participation could deny patients the right to be informed about care, to make changes or to refuse any aspect of care. Findings include: P2’s Plan of Care (PoC) meeting, dated 03/17/25, revealed a patient invitation to attend the PoC meeting. A box checked off on the letter indicated that the patient did not intend to attend the meeting. The date of the invitation was 03/17/25, the same day the meeting was held. This was not a day the patient was present in the facility for treatment and the patient did not attend the PoC meeting per Staff (S)3 (Facility Administrator). There was no documented evidence that the patient was encouraged to participate in his/her PoC. P4’s PoC meeting, dated 03/03/25, revealed a patient invitation to attend the PoC meeting. A box checked off on the letter indicated that the patient did not intend to attend the meeting. The date of the invitation was 03/04/25, one day after the meeting had occurred. There was no documented evidence that the patient was encouraged to participate in his/her PoC. P5’s PoC meeting, dated 01/21/25, revealed a patient invitation to attend the PoC meeting. A box checked off on the letter indicated that the patient did not intend to attend the meeting. The date of the invitation was 01/21/25, the same day the meeting was held. This was not a day the patient was present in the facility for treatment and the patient did not attend the PoC meeting per S3. There was no documented evidence that the patient was encouraged to participate in his/her PoC. P7’s PoC meeting, dated 12/18/24, revealed a patient invitation to attend the meeting. A box in the letter indicated that the patient did not intend to attend the meeting. The date of the invitation was 12/18/25, the same day as the meeting was held. There was no documented evidence that the patient was encouraged to participate in his/her PoC. 49828 During an interview on 04/30/25 at 02:07 PM, Staff (S)10, the Nephrologist for P7, stated that sometimes the patient is invited to attend the meeting. S10 stated that the Charge Nurse or the Facility Administrator will invite the patients to attend the PoC meeting. During an interview on 04/30/25 at 02:30 PM, S3 (Facility Administrator) stated that the patients are verbally invited by the nurses to attend PoC meetings prior to the day of the meeting and again on the day of the meeting. According to S3, the invitation for the PoC meeting was printed on the day of the PoC meeting. S3 confirmed that P2 and P5 were not present in the facility the days the invitations were printed, and meetings were held. S3 stated that P4’s original invitation letter may have not been in the PoC documentation and another was printed by staff following the PoC meeting day. S3 confirmed that there was no documented evidence P2, P4, P5, and P7 were invited to participate in the PoC meetings prior to the meeting dates described above. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised October 2024 stated, “... ASSESSMENT: The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative ... PLAN OF CARE: ... 14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative ...” N.J.A.C. 8:43A-24.13(c)”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 49828 Based on seven of nine hemodialysis treatment sheets reviewed for Patient (P)2, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that the physician’s hemodialysis prescription orders for dialysate temperature is provided as ordered during hemodialysis treatment. Findings include: A review of P2’s medical record revealed the following: The “Active Treatment Orders” portion of the “Patient Summary Report” section of the medical record stated the hemodialysis prescription: “ ... In-Center Hemodialysis Treatment - [facility name] ... Dialysate Temperature - 36 [degrees] C [Celsius] ... Start Date - 03/11/2025 ... “ A review of hemodialysis treatment sheets from 03/20/25 to 04/26/25 indicated that the prescribed temperature (temp) of 36 degrees Celsius (C) was not administered in accordance with the physician order above on the following treatment dates: On 03/20/25, 03/22/25, 03/27/25, 03/29/25, 04/19/25, 04/24/25, and 04/26/25, the machine temperature was documented as 37 C. During an interview on 05/01/25 at 10:07 AM, Staff (S)11 (Charge Nurse) stated the staff member should adjust the temperature of the dialysate to match the patient’s ordered prescription. S11 confirmed that on 03/20, 03/22, 03/27, 03/29, 04/19, 04/24, and 04/26, there was no documented evidence that staff followed P2’s prescribed dialysate temperature order. The medical record did not contain documented evidence that the physician was aware of the change in temperatures on the above dates. N.J.A.C. 8:43A-24.6(d)(4)”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 49828 Based on three of seven medical records reviewed (Medical Record (MR)2, MR5, and MR7), staff interview, and review of facility documents, it was determined that the facility failed to ensure that the medical records accurately document provider assessments. Findings include: A review of MR2 indicated that a comprehensive assessment was completed as follows: A Comprehensive Encounter was created by Staff (S)16 (Advanced Practice Nurse [APN]), on 10/05/24. The documentation was edited, finalized and electronically signed on 10/06/24 by S10 (Nephrologist). A Comprehensive Encounter was created by S16, on 11/12/24. The documentation was edited, finalized, and electronically signed on 12/06/24 by S10. A Comprehensive Encounter was created by S16, on 12/03/24. The documentation was edited, finalized, and electronically signed on 12/06/24 by S10. A Comprehensive Encounter was created by S16, on 01/28/25. The documentation was edited, finalized, and electronically signed on 02/13/25 by S10. An ICHD (In-Center Hemodialysis) Comprehensive Encounter was created by S16, on 03/20/25. The documentation was edited, finalized, and electronically signed on 03/22/25 by S10. A review of MR5 for monthly physician notes revealed the following: A Comprehensive Encounter was created by S16, on 10/04/24. The documentation was edited, finalized and electronically signed on 10/06/24 by S10. A Comprehensive Encounter was created by S16, on 11/13/24. The documentation was edited, finalized, and electronically signed on 12/06/24 by S10. A Comprehensive Encounter was created by S16, on 12/06/24. The documentation was edited, finalized, and electronically signed on 12/08/24 by S10. A Comprehensive Encounter was created by S16, on 01/20/25. The documentation was edited, finalized, and electronically signed on 02/02/25 by S10. A Comprehensive Encounter was created by S16, on 02/12/25. The documentation was edited, finalized, and electronically signed by S10 on 03/22/25, 38 days after the note was created. 39223 A review of MR7 indicated that a comprehensive assessment was completed as follows: A Comprehensive Encounter was created by S16, on 10/05/24. The documentation was edited, finalized and electronically signed on 10/06/24 by S10. A Comprehensive Encounter was created by S16, on 11/12/24. The documentation was edited, finalized, and electronically signed on 12/03/24 by S10. A Comprehensive Encounter was created by S16, on 12/03/24. The documentation was edited, finalized, and electronically signed on 12/06/24 by S10. A Comprehensive Encounter was created by S16, on 01/23/25. The documentation was edited, finalized, and electronically signed on 02/02/25 by S10. A Comprehensive Encounter was created by S16, on 02/11/25. The documentation was edited, finalized, and electronically signed by S10 on 03/22/25, 39 days after the note was created. On 03/06/25 the ICHD Comprehensive Note was created by the S16. The note was edited, finalized, and electronically signed by S10 on 04/29/25, 54 days after the note was created. It was unable to be determined which parts of the documentation on the comprehensive assessments listed above were completed by S16 and which were completed by S10. During an interview on 04/30/25 at 02:07 PM, S10 stated that the Nurse Practitioner will see the patients at different times than he/she does, and the Nurse Practitioner will pre-populate the Comprehensive Assessment. S10 further explained that later, he/she will go into the note when he/she has had a chance to review the patient’s labs, the note, and has seen the patient. During an interview on 05/01/25 at 11:24 AM, S15 (Medical Director) stated that the Physicians have to document, or they can addend the Nurse Practitioner or Physician Assistant’s note. The Medical Staff Bylaws, dated May 20, 2021, stated, “... 2.2.2 Rounding and Documentation Requirements (a) ... (i) In-center and/or nocturnal patients: must be evaluated and examined by a nephrologist no less than once per month in-person in the facility while the patient is on dialysis ...” N.J.A.C. 8:43A-7.4(a) N.J.A.C. 8:43A-13.4(b) N.J.A.C. 8:43A-13.4(c)”