Davita Lumberton 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: 49828 Based on one of one observation of a staff member’s hand hygiene, staff interview, and review of facility policy, it was determined that the facility failed to ensure that hand hygiene is performed to prevent cross contamination in accordance with facility policy. Findings include: On 04/09/25 at 11:20 AM, Staff (S) 5, a Patient Care Technician (PCT), was observed in the patient occupied Station 19 typing with gloved hands on the mobile computer workstation’s keyboard. S5 then exited the station and entered the patient occupied Station 16 while wearing the same gloves and interacted with the patient, and typed on the mobile computer workstation, located within the station. S5 did not remove his/her gloves or perform hand hygiene when he/she exited Station 19 and prior to entering Station 16. During an interview at 11:23 AM, S5 stated he/she should have changed his/her gloves and perform hand hygiene with sanitizer prior to entering another occupied patient station. Facility policy titled, “Infection Control for Dialysis Facilities,” Revised April of 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 ... d. after patient and dialysis delivery system contact. ... f. between patients even if contact is casual ... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. ... 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station ... a. Gloves should be changed when: ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system. ...” 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: 39223 Based on observations, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1) all surfaces and equipment in the patient station are cleaned and disinfected between use for two of two observations of the cleaning and disinfection of the station and; 2) Peritoneal Dialysis (PD) training rooms are cleaned and disinfected between use for one of five observations Findings include: 1. On 04/09/25 at 9:50 AM, in Station 14, Staff (S) 6, a Patient Care Technician, was observed cleaning and disinfecting the station. S6 used bleach soaked cloths to wipe all surfaces of the hemodialysis treatment machine, tubing from the hemodialysis treatment machine to the water box, prime bucket, blood pressure cuff and tubing. S6 then wiped all surfaces of the patient recliner chair, side tables, the television and supporting arm, and chase wall. S6 did not wipe the outer surfaces of the oxygen concentrator located inside the patient station. During an interview at 10:06 AM, S6 stated that he/she did not wipe the oxygen concentrator with bleach soaked cloths because the last patient did not use the oxygen concentrator during his/her treatment. 51227 On 04/09/25 at 9:35 AM, S18, a Registered Nurse (RN), used bleach-soaked cloths to clean and disinfect Station 19. S18 wiped the hemodialysis machine, recliner, and chase wall. S18 did not clean an IV (intravenous) pole that was in Station 19. During an interview at 2:10 PM, S18 stated, he/she did not clean the IV pole because it wasn’t used by the patient but that he/she should have cleaned the pole. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “ ... Disinfection 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment/training area ... b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces ... “ N.J.A.C. 8:43A-24.8(b) 49828 2. On 04/09/25 at 1:24 PM, during a tour of the Home Training Rooms for Peritoneal Dialysis (PD), in Training Room 5, a dirty water box was observed in the back right corner of the room. The water box was white with a large amount of yellow fluid in the base, where there were two visible dead insects seen in the fluid. During an interview at the time of discovery, S11, a Facility Administrator at another clinic and previous home program Clinical Coordinator at the facility, confirmed the findings listed above and stated that the water box should be cleaned by staff in between patients. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... Disinfection ... 13. At the end of each treatment, the dialysis station/training room will be cleaned and disinfected. ... i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. ... Teammates will monitor and address wall box residue/build up and patency issues. ...” N.J.A.C. 8:43A-24.8(b)”

“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 observation and staff interview, it was determined that the facility failed to ensure that the physical plant is maintained for the safety of the patients, the staff, and the public. Findings include: On 04/09/25 at 10:30 AM, a tour of the facility was conducted with Staff (S) 3, the Biomedical Technician, and the following was observed: At 10:50 AM, next to Station 1, the Ground Fault Circuit Interrupter (GFCI) outlet and outlet cover were stained with a white crusty material, which could cause it not to function properly. At 10:53 AM, the wall paint and wall covering were peeling due to an old ceiling water leak, next to Station 2. The surface cannot be cleaned and maintained properly. At 11:05 AM, the “#2” domestic water heater in the Reverse Osmosis Room was damaged at the bottom from the mixing of chemicals near the unit. At 11:12 AM, the wall located behind the door leading from the Treatment Floor to the Storage Room had three holes, approximately 1/4” in size. According to S3, the holes were caused from a previously mounted ladder hanger. The above findings were confirmed at the times of discovery by S3. N.J.A.C. 8:43A-17.3(j)”

“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: 51227 Based on observation, review of facility policy and procedures, review of the manufacturer’s instructions for use (MIFU), and staff interview, it was determined that the facility failed to ensure that two of two Embrace PRO Blood Glucose Test Strip Bottles are maintained in accordance with the MIFU. Findings include: On 04/09/25 at 9:30 AM, during a tour of the Hemodialysis Treatment Floor, two bottles of “Embrace PRO” Blood Glucose test strips, stored inside a box located on the table adjacent to the water room door, were observed to be opened. The boxes contained a label dated, “07/03/25.” The opened bottles, which are sealed until opened, did not have dates of opening or expiration dates. During an interview at 9:45 AM, Staff (S) 2, the Clinical Coordinator (CC), stated that the containers should be labeled, not just the box. He/she also stated that staff will only open one container at a time and not both containers. S2 stated the glucometer strips expire four months after opening. He/she stated that both containers were open and could not confirm when each was opened to ensure they were not used past their expiry date. 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 MIFU for the Embrace PRO test strips, stated, “ ... Storage and Handling ... Use all the strips within 4 months after the first opening ... “ N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.11(c)”

“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: 51227 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 a review of facility documents, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to cannulation (the act of inserting dialysis needles into an access to allow blood to be circulated between the patient and the dialysis machine) in accordance with facility policy. Findings include: On 04/09/25 at 10:40 AM, Staff (S) 6, a Patient Care Technician (PCT), was observed entering Station 3 to initiate hemodialysis through an AVF. S6 cleansed the first site of the AVF with iodine in a circular motion for 10 seconds. This was 20 seconds less than required by facility policy. S6 proceeded to clean the second site with iodine for 15 seconds. This was 15 seconds less than required per facility policy. After cleaning the AVF, S6 applied a tourniquet which touched the top (venous) of the access site. S6 moved the tourniquet off the top of the access site and inserted the fistula needle without the benefit of cleaning the site again. During an interview at 10:52 AM, S6 stated, he/she should clean the site with iodine for 30 seconds. When asked if he/she should have cleaned the access site again, after the tourniquet had touched the site, S6 stated, “Yes, I should have.” 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 ... Procedure: ... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. ... “ N.J.A.C. 8:43A-24.8(b)”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 39223 Based on one of two observations of the removal of fistula needles post (after) treatment, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that vascular accesses are monitored to prevent access failure when using venipuncture clamps after termination of hemodialysis. Findings include: On 04/09/25 at 9:47 AM in Station 15, Staff (S) 5, a Patient Care Technician (PCT), removed the arterial needle from Patient (P) 5’s left upper arm fistula and placed gauze over the needle site. At 9:49 AM, S5 applied a white vascular site clamp on the access site. S5 returned to check for bleeding at 10:02 AM. P5 continued to bleed through the pressure dressing. S5 returned the white vascular site clamp onto P5 at 10:03 AM. At 10:23 AM S6, a PCT, removed the clamp from P5’s access. Staff did not return to check for bleeding or assess the vascular access site for a thrill or a bruit above and below the clamp until 20 minutes later, at 10:23 AM. This was not in accordance with facility policy which required a reassessment of the site every 10 minutes. During an interview at 10:23 AM, S6 stated that the site should be checked every 10 to 15 minutes depending on if the patient was prone to bleeding. After 30 minutes, if bleeding continued it should be reported to the Registered Nurse. A review of P5’s medical record contained a Plan of Care, dated 01/27/25, that stated, “... Access Support maintenance and functioning of permanent dialysis access ...” Facility policy titled, “Utilizing Vascular Access Clamp Procedure,” revised April 2023, stated, “ ... 8. Clamp may remain in place for 5 [five] - 10 minutes before checking to see if bleeding has stopped. 9. Bruit and thrill must be re-checked a minimum of every 10 minutes while using access clamps and documentation performed in the patient’s treatment record. ... 12. Clamp may remain in place for an additional 5 [five] - 10 minutes before checking to see if bleeding has stopped. Access clamp should not be left on longer than 20 minutes. ... “ N.J.A.C. 8:43A-24.6(f)(1)(iii)”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 39223 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the patient’s home care treatments are in accordance with the physician’s orders for one of one medical record reviewed for low albumin (Patient (P) 7). Findings include: A review of P7’s medical record revealed physician orders, dated 08/27/24, which indicated peritoneal dialysis (PD) treatments should occur nightly with four exchanges containing a PD solution strength of 1.5% Dextrose. A review of the last Plan of Care Meeting, dated 09/20/24, stated, “... Fluid/BP [blood pressure], Maintain post weight compared to target weight. Blood pressure within range ... Psychosocial ... Patient displays effective coping skills and verbalizes understanding and ability to follow treatment regimen for preferred modality. ...” A review of the patient’s “Amia Prescribed Verses Actual Report” for treatments completed 02/01/25 through 04/08/25 revealed that for all of the treatments completed, a 2.5% Dextrose PD Solution was utilized. This was not in accordance with the physician prescribed order of 1.5% Dextrose PD Solution. The patient’s home treatment records were reviewed with Staff (S) 8, a PD Registered Nurse (RN). During an interview at 11:30 AM, S8 stated that the patient should use 1.5% Dextrose PD solution. A review of ordered and delivered PD Solutions from 01/01/25 through 04/09/25 revealed the following: On 04/01/25, 15 boxes (30 bags) of 1.5% Dextrose PD Solution and 15 boxes (30 bags) of 2.5% Dextrose PD Solution were ordered, and the order was then delivered on 04/08/25. On 02/01/25, six boxes (12 bags) of 2.5% Dextrose PD Solution were ordered, and the order was then delivered on 02/11/25. There was no documented evidence an order for 1.5% Dextrose PD Solution was received. On 02/26/25, 11 (22 bags) of 1.5% Dextrose PD Solution and 27 boxes (54 bags) of 2.5% Dextrose PD Solution were ordered, and the order was then delivered on 03/11/25. There was no documented evidence that the patient’s prescription (physician orders) for peritoneal dialysis was changed following the physician order placed on 08/27/24, which indicated the patient should be dialyzing with PD Solution strength of 1.5 % Dextrose. During an interview on 04/10/25 at 11:50 AM, S8 stated that he/she would expect the patient to go through two bags of 1.5% Dextrose PD Solution every night. After reviewing the above PD supply orders, S8 stated that he/she was not sure why the patient would order that many boxes of 2.5% Dextrose PD Solution. After review of the Prescribed versus Actual Report and the ordered supplies, S8 was not able to determine what strength of PD Solution the patient was utilizing during home treatments.”

“H-HOME PT PLAN OF CARE DEV/UPDATED CFR(s): 494.100(b)(1)(iii) Services include, but are not limited to, the following: (iii) Development and periodic review of the patient’s individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs and meets the measurable and expected outcomes as specified in §494.90 of this part. This Standard is not met as evidenced by: 39223 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the patient’s Plan of Care is updated and adjusted in accordance with facility policy for one of one medical record reviewed for low albumin levels (Patient (P) 7). Findings include: A review of P7’s medical record revealed physician orders, dated 08/27/24, indicating peritoneal dialysis (PD) treatments occurring nightly with four exchanges containing a PD solution strength of 1.5% Dextrose. A review of the last three months of albumin lab (laboratory) results revealed a trend of low albumin results: 12/05/24 - 3.1 grams per deciliter (g/dL) 02/18/25 - 2.9 g/dL 03/03/25 - 2.8 g/dL A review of the last Plan of Care Meeting, dated 09/20/24, stated, “... Albumin level trends to move towards and remain within recommended and appropriate clinical ranges. Time frame 2 [two] months Long-Term Intervention(s) Provide ongoing albumin-related coaching ...” An invitation to the next plan of care, scheduled for 03/14/25, was present, but there was no documented evidence that the Plan of Care Meeting occurred. A PD Comprehensive Note, completed by the physician, dated 02/18/25, stated, “... Has been missing [his/her] last few visits due to lower ext [extremity] wounds/now s/p [status post] bilat [bilateral] tmas [transmetatarsal amputations]. Not on abx. [antibiotics]. Has not had recent labs ... Nutrition Comments: need updated labs ... work on protein to heal ...” A Patient Note completed by the Social Worker (SW), dated 02/18/25, stated, “... SW spoke with pt [patient] during clinic appointment regarding the IDT’s [Interdisciplinary Team] concern for pts compliance. Pt was offered to attend care conference with the Medical Director, CC [Clinic Coordinator], FA [Facility Administrator], and SW but [he/she] declined. ... was encouraged to call the clinic if concerns arise instead of missing appointments. ...” A Registered Dietician (RD) Comprehensive Assessment, dated 02/18/25, stated, “... Albumin Comment 3.1 - below goal in December - awaiting current labs. Does not want supplements provided under ONS [Oral Nutrition Supplement] protocol. Patient is buying from kate farms supplements - tried to take 1 [one] shake daily. Encouraged HBV protein foods. Patient has multiple amputations - encouraged protein for healing. ...” A RD Monthly Progress Note, dated 03/25/25, stated, “... Pt did not attend scheduled PD clinic visits (after rescheduling appt [appointment] time from earlier in 03/2025), This writer unable to review nutrition-related lab outcomes with pt r/t [related to] absence. Will continue to be available for ongoing education and support as pt accepts. ...” During an interview on 04/10/25 at 11:10 AM, Staff (S) 1, the Facility Administrator, S8, a PD Registered Nurse (RN), and S11, the former Clinic Coordinator, it was revealed that a Plan of Care Meeting was not held on 03/17/25 when the patient missed his/her scheduled appointment. S1 stated that a “Core Team Meeting” was held about P7, but was unable to provide documented evidence of the meeting and any outcomes or interventions related to the patient’s plan of care. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised October 2024, stated, “... 22. Implementation of assessments and plans of care are detailed in table below: ... In the states of ... New Jersey ... semi-annual (stable patients) ... Complete patient plan of care and patient plan of care meeting within 15 days of the completion of the reassessment. ...” N.J.A.C 8:43A-24.13(c)”