Davita Edison Dialysis

“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: 52927 Based on one of two treatment station disinfection observations, staff interview, and review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed after removing gloves to prevent cross contamination in accordance with facility policy. Findings include: On 12/10/25 at 10:55 AM, in Station 11, Staff (S)8 was observed wiping the patient recliner with gloved hands. S8 then disposed of the used bleach-soaked cloth, removed his/her gloves, and without the benefit of performing hand hygiene put on a new pair of gloves. S8 proceeded to gather a new bleach-soaked cloth to continue cleaning and disinfecting the patient recliner. During an interview at 10:55 AM, S8 stated he/she should have performed hand hygiene after removing gloves and before putting on a new pair of gloves. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... HAND HYGIENE ... 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves ... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ...” N.J.A.C 8:43A-24.8(d)”

“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 two 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 the chase wall, television, and oxygen concentrator is cleaned and disinfected after patient use. Findings include: 1. On 12/10/25 at 12:09 PM, in Station 1, Staff (S)10 was observed cleaning and disinfecting the hemodialysis station after the patient was discharged. S10 used a bleach-soaked cloth to clean and disinfect the dialysis machine including the prime bucket, blood pressure cuff, dialysis chair, and wall box. S12 did not clean and disinfect the television and countertop (chase wall) area located behind the dialysis machine and chair. During an interview on 12/10/25 at 12:18 PM, S10 stated the countertop and television should be cleaned with a bleach-soaked cloth. S10 confirmed he/she did not clean those areas. A review of S10’s personnel file indicated that S10 successfully completed the “NJ [New Jersey] Specific Infection Control For Dialysis Facilities” which included cleaning and disinfection of equipment and work surfaces on 03/19/25. 52927 2. On 12/10/25 at 10:55 AM, in Station 11, S8 used a bleach-soaked cloth to clean and disinfect all the equipment and surfaces in the station. S8 then placed a bleach-soaked cloth on the oxygen concentrator, used the bleach soaked cloth to clean the cord, right side, and back of the oxygen concentrator. S8 did not clean or disinfect the left side and front of the oxygen concentrator, and did not clean or disinfect the chase wall located behind the dialysis machine and chair. During an interview at 11:30 AM, S8 stated the countertop and wall box are to be cleaned after each patient to prevent cross contamination. S8 also stated he/she was not aware the left side and front of the oxygen concentrator was not cleaned and disinfected. A review of S8’s personnel file indicated that S8 successfully completed the “In-Center Annual Procedural Skills Verification Checklist” which included cleaning and disinfection of equipment and work surfaces on 05/28/25. Facility policy titled, “ Infection Control for Dialysis Facilities,” revised April 2023, stated, “DISINFECTION ... 12. 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 cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front, and sides of dialysis machine; touchscreen; countertops). i. The wall box, Drain and Water supply lines are considered part of the dialysis delivery system ... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses ...” 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: 52927 Based on one of two observations of machine dialysate pH (potential of Hydrogen) testing, staff interview, 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 12/10/25 at 9:57 AM, Staff (S)7 obtained a sample of the machine dialysate in a syringe from the hemodialysis machine in Station 9. S7 placed the fluid into a cup, dipped a RPC K100-0117 CT E-Z Chek 6.8-8.5 pH Test Strip into the fluid and flicked excess fluids off the strip. S8 waited only two seconds before he/she compared the color reaction on the strip to the color chart on the bottle to determine the closet match. During an interview at 10:00 AM, S7 stated, the process is to wait 20-25 seconds to compare the test strip to the bottle. Facility policy titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z CHEK K100-0117 CT 6.8-8.5 pH Test Strips,” revised February 2024, indicated,” Procedure ... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20-25 seconds compare the color reaction on strip to the color chart on bottle to determine the closet match ... “ N.J.A.C. 8:43A-24.4(a)”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44833 Based on observation of two of two clinical areas, staff interview, and a review of manufacturer’s instructions for use (MIFU), it was determined that the facility failed to ensure that: 1) expired supplies are removed from areas of use; and 2) opened multi-use supplies are properly labeled and dated in accordance with facility policy. Findings include: 1. On 12/10/25 at 9:55 AM, during a tour of the Hemodialysis Treatment Floor, the following expired items were observed: Two half full bottles of WaterCheck CP chlorine or peroxide reagent with bleach indicator test strips. One bottle was stored by the dirty sink across from Station 20 and had an opened date of 10/02/25 written on the label with a manufacturer’s expiration date of 07/2025. The second bottle was stored by the dirty sink across from Station 5 and had a handwritten opened date of 09/02/25 with manufacturer’s expiration of 07/2025. One RPC re-circulator (a sterile plastic connector used to connect the two ends of the dialysis treatment lines when not in use) with expiration date 06/30/25 located in a storage drawer across from Station 13. Three BD Safeglide one milliliter (ml) sterile syringes with 26-gauge needle with expiration date of 01/31/25, stored in the medication preparation area across from Station 17. Eight BD Safeglide one ml sterile syringes with 26-gauge needle with an expiration date of 01/31/25, stored in the medication preparation area across from Station 6. One opened box containing 40 individually wrapped, sterile Nipro dull fistula needles with an expiration date of 01/31/22, which were stored in the medication storage area in front of the nurses’ station. At 10:05 AM, during an interview with Staff (S)4, he/she stated that the manufacturer’s expiration dates should be checked before supplies are opened for use and stated that he/she was not sure why the expired chlorine test strips were on the treatment floor. At 11:25 AM, during an interview with S2, he/she confirmed that the above listed supplies were expired and stated that they should have been discarded and not kept in the treatment area. At 11:30 AM, during an interview with S5, he/she confirmed that the one ml syringes were expired and that he/she had planned on using them later that day to administer medication. 51227 2. On 12/10/25 at 10:00 AM, during a tour of the Hemodialysis Treatment Floor, one opened container of “Embrace PRO” test strips was located on top of the table in the designated dirty area across from Station 20. The container did not have a label indicating the date it was opened. During an interview at 10:08 AM, S2, stated that the container should have been labeled when they were opened with the date, time, and initials of the person who opened it. S2 stated the glucometer strips expire four months after opening and confirmed that the container was open and could not confirm when it was opened. 48966 During a tour of the Peritoneal Dialysis (PD) Unit on 12/11/25 at 9:43 AM, in “Prep Room 1” on the top shelf of the cabinet above the countertop, an open box of “Embrace Pro” test strips containing two bottles of test strips was observed. The two bottles of “Embrace Pro” test strips lacked a label with the date of opening. During an interview on 12/11/25 at 10:13 AM, S9, was unsure if both the bottles of the test strips had been opened and used, and proceeded to discard the two bottles of test strips. During an interview on 12/11/25 at 10:14 AM, S14, confirmed the two bottles should have been labeled with the date they were opened. Facility policy titled, “Blood Glucose Testing,” revised April 2025, stated, “... Policy: ... 4. The monitor and strips are stored and used in accordance to monitor manufacturer instructions and approved policies and procedures. ...” A review of the manufacturer’s instructions of Embrace Pro Test Strips, stated, “... Storage and Handling ... Use all the strips within 4 months after the first opening ...” Facility policy titled, “Infection Control for Dialysis Facilities,” with a revised date of April 2023, stated, “... Supplies ...8. Supplies will be stored in a manner that maintains their integrity ... b. Expiration date and package integrity will be verified prior to use ... d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used ...” N.J.A.C. 8:43A-24.4(b)”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 48966 Based on two of two unstable patient care plans reviewed for Patient (P)3, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the Physician completes a comprehensive assessment prior to developing a patient Plan of Care (POC). Findings include: A review of P3’s medical record revealed the patient was deemed unstable in August 2025. Two unstable POC’s, dated 09/18/25 and 10/21/25 lacked documented evidence that a physician’s comprehensive assessment was completed prior to the POC meetings. During an interview on 12/11/25 at 12:10 PM, Staff (S)2 stated the physician reviewed the POC over the phone but confirmed the comprehensive assessment was not completed by the physician for September and October 2025. S2 confirmed the physician attended the POC meeting remotely. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised 2024, stated, “... Assessment: 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectation for care ... 7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: ... At least monthly for unstable patients ...” 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: 44833 Based on staff interview, medical record review, and review of policies and procedures, it was determined that the facility failed to ensure that hemodialysis treatments are provided in accordance with the hemodialysis prescription for blood flow rate (BFR) and dialysate flow rate (DFR) in two of five hemodialysis treatments reviewed for Patient (P)6. Findings include: On 12/11/25, a review of P6’s medical record revealed the following: The “Dialysis Prescription” portion of the “Treatment Details Report” section of the medical record indicated, “... In-Center Hemodialysis treatment, 3 h [hours] 30 m [minutes] and ... Blood Flow Rate 350 mL/min [milliliters per minute], Dialysate Flow Rate 500 mL/min ...” A patient Plan of Care, dated and signed by the interdisciplinary care team and reviewed with the patient on 12/02/25, indicated, “Adequacy ... Maintain adequacy goal ...” A review of the hemodialysis treatment sheets from 11/19/25 through 12/01/25 indicated that the physician prescribed BFR and DFR were not followed on the following treatment dates: On 11/28/25, the machine DFR was documented as “300” for the 3:01 PM, 3:29 PM, 3:59 PM, 4:29 PM, 4:59 PM, 5:29 PM, 6:01 PM, 6:03 PM, 6:05 PM updates, and “310” for the 5:59 PM update with no supporting nursing documentation. On 12/01/25, the machine BFR was documented as “300” for the 6:15 PM, 6:45 PM, 7:15 PM, 7:17 PM, 7:45 PM, and 7:54 PM updates, with no supporting nursing documentation. On 12/12/25 at 9:45 AM, the above findings were confirmed with Staff (S)2, who also stated that nursing staff are responsible to ensure dialysis treatment settings are in accordance with physician orders, and if there is any change made, nursing staff should include documentation to indicate why the change was made. The medical record did not contain documented evidence that the physician was made aware of the changes in DFR and BFR on the above dates. Facility policy, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised October 2024, indicated, “... 1. The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician ... 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs ... 3. Assessment criteria will include, but not be limited to, evaluation of: ... Dialysis prescription, blood pressure, and fluid management needs... 8. The facility’s interdisciplinary team will develop and implement a written individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes ... 9. The plan of care will address, but will not be limited to, the following: Dose of dialysis which addresses care and services to manage the patient’s volume status ...” Facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised April 2024, stated, “... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ...” N.J.A.C. 8:43A-24.13(b)”