Davita Garden State Dialysis

“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: 39228 Based on a review of six of ten Hepatitis B susceptible patient’s laboratory results (Patient (P) 3, P4, P6, P7, P8, and P9), review of facility policy, and staff interview, it was determined that the facility failed to ensure that Hepatitis B antigen testing is performed monthly for all susceptible patients. Findings include: A review of the Hepatitis B laboratory results for all hemodialysis patients revealed the following: P3 was documented as Hepatitis B susceptible with an antibody level of 8 mIU/mL (milli-international units per milliliter) on 7/5/23. P3 had a negative Hepatitis B antigen test on 8/16/23 and was not retested until 10/20/23. P3 did not have a Hepatitis B antigen test for the month of September 2023. P4 was documented as Hepatitis B susceptible with an antibody level less than 4 mIU/mL on 1/11/23. P4 had a negative Hepatitis B antigen test on 1/11/23 and was not retested until 6/23/23. P4 did not have a Hepatitis B antigen test for the months of February, March, April, and May 2023. P6 was documented as Hepatitis B susceptible with an antibody level less than 4 mIU/mL on 1/11/23. P6 had a negative Hepatitis B antigen test on 1/20/23 and was not retested until 7/5/23. P6 did not have a Hepatitis B antigen test for the months of February, March, April, May, and June 2023. P7 was documented as Hepatitis B susceptible with an antibody level less than 4 mIU/mL on 1/13/23. P7 had a negative Hepatitis B antigen test on 1/13/23 and was not retested until 7/7/23. P7 did not have a Hepatitis B antigen test for the months of February, March, April, May, and June 2023. P8 was documented as Hepatitis B susceptible with an antibody level less than 4 mIU/mL on 1/20/23. P8 had a negative Hepatitis B antigen test on 1/20/23 and was not retested until 7/12/23. P8 did not have a Hepatitis B antigen test for the months of February, March, April, May, and June 2023. P9 was documented as Hepatitis B susceptible with an antibody level of 9 mIU/mL on 1/11/23. P9 had a negative Hepatitis B antigen test on 1/11/23 and was not retested until 8/16/23. P9 did not have a Hepatitis B antigen test for the months of February, March, April, May, June, and July 2023. Staff (S)1, the facility Clinic Manager, provided the facility policy titled, “Hepatitis B: Control and Management,” last revised 7/21/22, that stated, “... Policy: ... Hepatitis B Testing ... 16. Patients are monitored ... based on their current status as defined by the table below. Screening Test HBsAg ... Susceptible Monthly ...” During an interview on 11/3/23 at 10:50 AM, S1 confirmed that P3, P4, P6, P7, P8, and P9 did not receive monthly Hepatitis B antigen testing in accordance with the facility policy. N.J.A.C. 8:43A -24.8 (d)”

“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: 39223 Based on medical record review and staff interview, it was determined that the facility failed to ensure that two of five patients (Patient (P) 1 and P3) received their hemodialysis treatment in accordance with the physician prescribed dialysis order. Findings include: A review of P3’s medical record revealed the following: The Hemodialysis (HD) Treatment Flowsheet dated 10/16/23 indicated a physician ordered Blood Flow Rate (BFR) of 350. The HD treatment was initiated at 10:14 AM. At 10:58 AM, Staff (S) 6, a Registered Nurse, documented a note that stated, “pt [patient] ‘feeling sick and bad.’ RN returned blood ... 11:04 ... tx [treatment] paused. patient nausea ... 11:16 ... treatment resumed, RN resuming tx at BFR 250 for 15 mins [minutes] UF [Ultrafiltration] goal reduced to 400. ...” A BFR of 250 was documented at 11:30 AM and 12:00 PM. 44 minutes after resuming treatment with a BFR of 250, at 12:30 PM, the BFR was documented as the prescribed rate of 350. The HD Treatment Flowsheet dated 10/23/23 indicated a physician ordered BFR of 350. The HD treatment was initiated at 10:17 AM by the Patient Care Technician (PCT). At 10:19 AM, documentation indicated that the BFR was 400 with a note by the PCT that stated, “... Blood flow rate at prescribed rate ...” The BFR remained at 400 until 13:00 [1:00 PM], two hours and 41 minutes later, when it was changed to 350. There was no documented evidence of a physician order for a BFR of 400. There was no documented evidence to indicate why the BFR was higher than the prescribed BFR of 350. The HD Treatment Flowsheet dated 10/25/23 indicated a physician ordered BFR of 350. The HD treatment was initiated at 10:25 AM with the ordered BFR of 350. At 12:55 PM, the BFR was documented as 250 and S6 documented a note that stated, “... Patient nausea, UF reduced to 400. BFR 300 ...” The documented BFR at 13:03 [1:03 PM] was 300. 33 minutes later, the HD treatment was terminated at 13:28 [1:28 PM]. There was no documented evidence that the BFR was returned to 350 prior to the end of HD treatment. A review of P1’s medical record revealed the following: The HD Treatment Flowsheet dated 10/11/23 indicated a physician ordered BFR of 400. At 10:43 AM, the HD treatment was initiated. At 13:31 [1:31 PM], a note documented by the RN stated, “HR still high. c/o [complained of] nausea. UF [ultrafiltration] off. BFR lowered to 350. NSS given ...” The BFR remained at 250 until treatment ended 41 minutes later, at 14:12 [2:12 PM]. During an interview on 11/3/23 at 10:45 AM, S6 stated that the BFR can be decreased in response to a heart rate (HR) over 120 or if someone was nauseous. S6 stated that he would document it and let the MD (Medical Doctor) know of the decrease in the BFR. During an interview with S1, the Facility Clinic Manager, on 11/2/23 at 2:05 PM, the above flow sheets were reviewed. S1 stated that the RN should verify the prescription before the hemodialysis treatment was started. S1 stated that lowering the BFR was not an intervention protocol in response to an elevated heart rate or nausea. Review of facility policy titled, “IC08 Monitoring & Documentation Of Patient Care During Treatment,” last revised 11/29/22, stated, “... POLICY: ... 4. The following must be documented before “starting” the patient’s treatment in the electronic documentation system: ... Treatment RX - indicating caregiver review and verification of all patient treatment data and machine set-up information. Orders ...” N.J.A.C. 8:43A-24.13 (b)”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 39223 Based on review of one of five medical records (Patient (P) 1), review of the facility transplant center communication, patient interview, and staff interview, it was determined that the interdisciplinary team failed to ensure the patient plan of care reflected a current plan for transplantation referral. Findings include: On 11/1/23 at 1:12 PM, an interview was conducted through a language interpretation service with P1. P1’s primary language was Spanish and was unable to converse in English. During the interview, P1 stated that he/she had applied to [Transplant Facility #1] to be placed on the transplantation list. P1 then stated that he/she was not sure of the outcome from that evaluation and that he/she would reapply if it was needed. A review of P1’s medical record revealed a Plan of Care meeting was held on 9/29/23 that stated, “... Pt [patient] is interested in transplant but unfortunately was determined to not be a candidate at [Transplant Facility #1]. ...” During an interview on 11/1/23 at 1:45 PM, Staff (S) 7, a Social Worker, stated that he and one other staff member were responsible for the transplantation process for this facility. S7 clarified that P1 was denied placement on the transplant list due to a need for further information. S7 provided a copy of a letter sent to P1, written in Spanish, from Transplant Facility #1 that stated P1 needed to complete further testing in order to finish the evaluation for kidney transplantation, and if further testing was not completed, then Transplant Facility #1 would assume that P1 was no longer interested in being placed on the transplant list. The letter was received by the facility on 7/6/20. When S7 was asked for documentation related to follow-up with the above letter, a letter dated 8/12/20 from Transplant Facility #1 was provided. S7 clarified that the patient was denied due to lack of follow-up testing as opposed to not being a medical candidate for transplantation. The letter addressed to P1, written in English, stated, “... confirming that we are closing your initial evaluation from December 31, 2019, due to incompletion of evaluation testing and no response to my 30 day letter or messages left requesting call back. When you are ready and still interested in Kidney Transplant, please call us to schedule an appointment ... .” When asked to provide documentation that P1 was educated on the closure of his/her evaluation due to lack of follow up testing, S7 was unable to provide. When asked for documentation of any further activity by the facility related to the patient’s transplant status, S7 provided a Transplant Report, dated 12/28/22, that stated, “... Patient referred to kidney transplant but the application for evaluation was closed due to unable to complete evaluation testing. ... .” There was no documented evidence of follow-up by the facility to see if P1 was still interested in transplantation. A request for the policy on the transplantation process at the facility was made on 11/2/23 to Staff #1, the Facility Administrator, who was unable to provide. N.J.A.C. 8:43A -24.13 (b)”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 37656 Based on medical record review of one of one peritoneal dialysis (PD) patient (Patient (P)5), staff interview, and facility policy review, it was determined that the facility failed to ensure that a home visit was conducted when a diagnosis of peritonitis was identified with a patient performing home peritoneal dialysis, in accordance with facility policy. Findings include: A review of P5’s medical record revealed the following: The monthly nurse’s note indicated that P5 had MRSA (Methicillin Resistant Staphylococcus Aureus) [bacterial infection] peritonitis on 8/31/23. P5 was placed on antibiotics. The medical record lacked evidence that a home visit was conducted. Upon interview on 11/2/23 at 12:10 PM, Staff (S) 2, PD Registered Nurse, stated that she spoke to the patient about a home visit in September 2023, but couldn’t schedule it because P5 worked during the daytime. S2 could not provide documented evidence of her conversation with the patient. S2 stated they will try to schedule a home visit again. Facility policy titled, “Home Therapy Home Visit, Effective Date: 11/2021,” stated, “Purpose: To determine if home environment is safe for completing dialysis treatments ... POLICY: Home visits will be completed by the Home RN Coordinator and IDT (interdisciplinary team), as available at the initiation of home dialysis initially. ... Subsequent visits will occur on annual basis and when a problem is identified with either patient health or equipment that could be related to treatment at home. ...” N.J.A.C. 8:43A-24.20 (a)(2)”

“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 observation of the medication preparation area and medication storage areas, staff interview and review of facility policy and procedure, it was determined the facility failed to ensure that multi-dose vials are labeled properly when opened, in accordance with facility policy. Findings Include: On 11/1/23 at 11:31 AM, the top left cabinet above the medication refrigerator contained two opened multi-dose Heparin 1:100 units/milliliter vials. One of the open vials of Heparin was not labeled. The other opened vial was labeled with an open date of 11/1/23, an expiration date of 12/1/23 (30 days), and initials. At 11:35 AM, an interview was conducted with Staff (S) 2, a Registered Nurse, who explained that the opened multi-dose unlabeled Heparin vial should have been labeled with the opened date and initialed. S2 explained further that the opened, labeled Heparin vial should have been dated for 28 days not 30 days. S2 discarded the vials. Review of facility policy titled,”G48 Medications: Handling,Administration, Storage & Disposal,” revised 6/2023, stated, “... Handling & Administration ... 9. Multi-dose medication vials can be used up to 28 days after initial entry, as long as the vial is handled aseptically and stored per manufacturer instructions ... 10. Multi-dose medication vials shall be labeled with the date the vial is first entered and the initials of the person who first entered the vial. ...” N.J.A.C. 8:43A-9.3(b)”