Dialyze Direct Carmel, in

“CFC-PATIENTS- RIGHTS CFR(s): 494.70 This Condition is not met as evidenced by: 45607 Based on record review and interviews, the Interdisciplinary Team of the ESRD failed to ensure they were responsible for and documented their efforts in the discharge planning/ transfer of their patient’s dialysis treatments to other ESRD entities, failed to ensure patient treatments were not delayed, failed to inform the Medical Director of the den closure, and failed to notify the physician when two patients were transferred to the hospital due to lack of dialys treatments. An Immediate Jeopardy was called on 8-28-2024 at 2:22 PM when it was determined that Dialyze Direct did not notify nor assist patients finding a new dialysis facility for treatment when they decided to close the den at the skilled nursing facility. Dialyze Direct left the placement of treatment on the skilled nursing facility. Patients went 4 or more days without treatment and 2 were hospitalized with critical labs. The cumulative effect of these systemic problems resulted in the End Stage Renal Dialysis supplier’s inability to ensure the provision of quality of care in a safe environment for the Condition for Coverage 42 CFR 494.70: Patients ’ Rights.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to maintain emergency supplies according to manufacturer instructions for 2 of 5 emergency evacuation kits observed. (Location of Dens: 1 and 5) Findings Include: 1. On 09-05-2024 at 10:09 AM, dated 03-31-2017, Dialyze Direct, LLC. policy titled “Emergency Preparedness” was provided by the Regional Director, Admin 1. The policy indicated but was not limited to, “... Staff should have supplies available to provide patient care during an evacuation ...The evacuation kit contents will be reviewed on a monthly basis for missing or expired. Supplies that are missing or have expired must be replaced immediately ...” 47343 2. A review of Den #1’s Emergency Preparedness kit on 09-04-2024 at 8:15 AM evidenced a bottle of hand sanitizer with an expiration date of 05-2024. During an interview with Registered Nurse (RN) 3 on 09-04-2024 at 8:24 AM, they indicated they updated and reviewed the Emergency Preparedness kit and binder every month, at the beginning of the month. They indicated they must have missed the expired hand sanitizer in the kit. 44774 3. On 09-04-2024 at 11:00 AM, when reviewing the contents of the emergency tote at Den # 5, failed to contain bags of saline, multiple gloves were loose in the tote, and the tote failed to contained a stethoscope. On 09-04-2024 at 3:15 PM, when Registered Nurse (RN) 4, with Den # 5, was queried as to what ought to be in the Emergency Tote, indicated there should be enough saline in the tote to cover at least one shift and indicated would be adding more saline syringes than needed, and did not feel the current quantity was adequate.”

“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: 47343 Based on observation and interview, the agency failed to ensure supplies were properly stored for 1 of 5 dialysis dens surveyed at a skilled nursing facility. (Den at Entity #1) Findings Include: 1. A policy titled “Infection Prevention and Control Policy and Practices” with a revised date of 06-01-2023 indicated but was not limited to, “ ... Clean areas shall be clearly designated for the preparation, handling and storage of ... unused supplies and equipment. Clean areas shall be clearly separated from contaminated areas where used supplies and equipment are handled. ...” 2. During the flash tour of the den at Entity #1 on 09-04-2024 at 6:05 AM, dialyzers, tubing, and normal saline bags were evidenced on the top of the dialysis machines at Station 1 and Station 2. 3. During another den observation at the Entity #1 on 09-04-2024 at 11:05 AM, a dialyzer, tubing, Normal Saline bag, and a bag of lab tubes were observed on the top of the dialysis machines at Station 3 and Station 4. 4. During an interview with PCT 3 on 09-04-2024 at 8:06 AM, they indicated nothing was supposed to be on top of the dialysis machines.”

“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: 47022 Based on observation, record review, and interview, the dialysis staff failed to disinfect dialysis chairs post dialysis treatment in 2 of 3 post treatment observations in 1 of 5 dialysis dens observed (Den at Entity #22) in a skilled nursing facility. (Patient Care Technician [PCT] 62, 63, Registerd Nurse [RN] 68). Findings include: 1. A policy dated 12/01/2014, titled, “Infection Prevention and Control Policies and Practices,” indicated the dialysis facility would provide a sanitary environment to minimize the transmission of infectious agents between the dialysis facility and the adjacent public areas. The policy indicated all surface areas and equipment shall be cleaned and disinfected with a facility approved disinfectant. 2. During an observation on 09/04/2024 beginning at 11:30 AM, Patient 27 at station #1 was transported post dialysis treatment by the dialysis RN 68 in the same dialysis treatment chair to the skilled nursing facility nursing desk. There was no evidence the RN 68 decontaminated the chair or the chair was utilized by another patient. During an observation on 09/04/2024 beginning at 2:45 PM, Patient 27’s dialysis treatment chair had not been returned to the dialysis treatment room for sanitizing. 3. During an observation on 09/04/2024 beginning at 8:15 AM, Patient 30 at station #5 was transported to the dialysis treatment room and PCT 63 indicated the Patient used his/her own chair during dialysis. Post treatment PCT 63 failed to ensure the dialysis chair was decontaminated post treatment. During an observation on 09/04/2024 beginning at 2:45 PM, Patient 30’s dialysis treatment chair had not been returned to the dialysis treatment room for sanitizing. 4. During an interview on 09/04/2024 beginning at 2:45 PM, PCT 62 indicated dialysis chairs were decontaminated after being returned to the dialysis treatment room from the skilled nursing facility for Patients that required hoyer lifts (mechanical lift to assist in transferring patients).”

“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: 47022 Based on observation, record review and interview, the dialysis staff failed to evidence the central venous catheter (CVC) (catheter into large vein) were disinfected per policy for 2 of 3 (Patient: #39 and 29) patients with CVC care observed in 1 of 5 dialysis dens observed (Den at Entity #22) in a skilled nursing facility. Findings include: 1. A policy dated 07/01/2019, titled, “Central Venous Catheter Care Policy, Procedure,” indicated the dialysis hubs (catheter access) were to be disinfected using an appropriate antiseptic. The policy indicated the dialysis lines were to be removed, the hubs were to be disinfected with an antiseptic pad for each hub and the hubs were to be cleansed by scrubbing the sides and end of the hub at least several centimeters towards the body. The policy indicated when using alcohol swabs for the anti-microbial agent the application time was 60 seconds. 2. During an observation on 09/04/2024, beginning at 8:00 AM, Patient 39’s dialysis CVC, at station #8, was accessed by PCT 63. During the observation PCT 63 scrubbed the CVC’s red hub for 6 seconds and scrubbed the blue hub for 13 seconds with an alcohol swab and did not swab the hub lines prior to labs being drawn from the CVC hub. The PCT failed to scrub the hubs for 60 seconds when using an alcohol swab. 3. During an observation on 09/04/2024, beginning at 11:00 AM, Patient 29’s dialysis CVC, at station #6, was disconnected by PCT 63. During the observation PCT 63 scrubbed the CVC’s blue hub for 3 seconds and the red hub for 5 seconds with an alcohol swab and did not swab the hub lines prior to the syringe insertion. The PCT failed to scrub the hub for 60 seconds when using an alcohol swab. 4. During an interview on 09/04/2024, beginning at 11:10 AM, PCT 63 indicated CVC hubs and lines should be disinfected with an alcohol swab for at least 30 seconds at the initiation and termination of dialysis.”

“PR-INFORMED-D/C & TRANS P&P INC IVD CFR(s): 494.70(b)(1) The patient has the right to- (1) Be informed of the facility’s policies for transfer, routine or involuntary discharge, and discontinuation of services to patients; This Standard is not met as evidenced by: 44232 Based on record review and interviews, the Interdisciplinary Team of the ESRD failed to ensure they were responsible for and documented their efforts in the discharge planning/ transfer of their patient’s dialysis treatments to other ESRD entities, failed to ensure patient treatments were not delayed, failed to inform the Medical Director of the den closure, in 6 of 6 patients (Patients #1-6) in 1 of 1 dialysis dens (at Entity #25) that have closed within the last 6 months, and failed to notify the physician of 2 of 2 patients (Patients: #1 and 5) transferred to the hospital due to lack of dialys treatments. Findings include: 1. A review of a Dialyze Direct, Limited Liability Company (LLC), revision dated 03-31-2017, titled “Patient Rights and Responsibilities Policy” indicated but not limited to, “ ... ensure all facility staff and contract staff shall observe these patients’ rights ... Become informed of his/her rights as a patient in advance of, or when discontinuing, the provision of care ... “ 2. On 08-26-2024 at 10:41 AM, Dialyze Direct Administrator provided a current list of their den locations. The list failed to include the den at Entity #25, (A skilled nursing facility-[SNF]). During this time, when asked about the den, the Administrator stated, “They just closed it last month or two.” At 10:55 AM, the Administrator indicated the den at Entity #25’s location was terminated and confirmed the last day for the den staff to treat patients was August 9, 2024. The Administrator indicated they provide paperwork and support but it was the SNF facility’s social worker’s job to find the patients a place for dialysis. 3. A review of a document titled, “Long-Term Care Facility Renal Dialysis Affiliation Agreement,” was provided by the Administrator on 08-26-2024 at 11:29 AM. The agreement was signed on 03-11-2020 by the Chief Operating Officer of Dialyze Direct and Person 45, the General Counsel for Entity #25. This agreement failed to evidence the nursing facility’s responsibility to find new placement for the shared patients. During an interview on 08-26-2024 at 12:20 PM, when asked to be shown where the outlines of responsibility for transfer and discharge of the dialysis patients could be located in the agreement, the Administrator reviewed the agreement and stated, “That contract is vague.” 4. A review of an email dated June 10, 2024, from the Dialyze Direct General Counsel & Chief Compliance Officer to Person 27, the Administrator of Entity #25, indicated July 10, 2024, would be the final day for Dialyze Direct to provide services at the skilled nursing facility (SNF). The email failed to include any discharge planning for the ESRD patients who reside in the facility and their plan of where the ESRD patients will be discharged to for their continuation of hemodialysis treatments. 5. A review of an email dated July 2, 2024, from Dialyze Direct General Counsel & Chief Compliance Officer to Person #46, the Chief Operating Officer for the den at Entity #25, indicated Dialyze Direct’s knowledge of ESRD patients not having a discharge facility for the SNF patients to continue to receive treatment, therefore Dialyze Direct extended their final day to August 9. The email failed include any discharge planning for the ESRD patients who reside in the facility and their plan of where the ESRD patients will be discharged to for their continuation of hemodialysis treatments. 6. A review of the clinical record for Patient 5, revealed the final dialysis treatment in the den at Entity #25 was completed on 08-07-2024. A review of the discharge summary from Entity #33, a hospital, indicated Patient #5 was admitted on 08-14-2024 with a diagnosis of Hyperkalemia, ESRD on Hemodialysis, and Dependence on Renal Dialysis. The summary indicated Patient 5’s last dialysis treatment at the den at Entity #25 was on 08-07-2024 (7 days before hospitalization) but refused treatment on 08-08-2024 to attend a facility function. The summary indicated Patient 5’s Potassium was a critical high at 6.5 (normal range 3.5-5.0), and Creatinine was at 2.1 (normal range 0.7-1.3). Patient 5 was discharged on 08-21-2024 to Entity #22, where another Dialysis Direct den is located. The record failed to evidence that the physician was notified of the patient’s impending discharge and hospitalization and failed to evidence any discharge planning with the patient/patient representative nor with the Entity #25. During an interview on 08-27-2024 at 2:59 PM, the nephrologist for Dialyze Direct, Physician 1, indicated they were not aware of Patient 5’s hospitalization due to critical laboratory values due to the last dialysis treatment date of 08-07-2024. During an interview on 08-28-2024 at 9:55 AM, Patient 5 confirmed they had been in Entity #33, a hospital, after the den closed at Entity #25. Patient 5 indicated that 1 week before the dialysis den closed, they were told they were no longer going to be able to receive dialysis in the den at Entity #25. Patient 5 further confirmed they had been trying to transfer closer to Chicago, where their only family is. Patient 5 stated, “Friday, 08-09-2024, I was packed and ready to go to the den at Entity #22. They kept telling me it was paperwork. The next thing I know, I am in an ambulance on my way to the hospital. It was a mess. I shouldn’t have to go through that. It should have been better arranged.” 7. A review of the clinical record for Patient 1, revealed the final dialysis treatment was completed in the den at Entity #25 on 08-09-2024. A review of the discharge documents from Entity #33, a hospital, indicated Patient 1 was admitted on 08-14-2024 for a diagnosis of fluid overload needing dialysis, Acute on Chronic Hypoxic Respiratory Failure, Hyperkalemia, ESRD on hemodialysis, and anemia. The document indicated the patient’s last dialysis treatment at the den at Entity #25 was on 08-09-2024, five days prior to hospital admission. The document indicated the patient’s potassium was a critical high at 6.5 (normal range 3.5-5.0), Creatinine was a critical high at 10.4 (normal range 0.7-1.3), and a critical low hemoglobin of 6.4 (normal range 11.4-15.4), which the patient received 1 unit of blood. The document revealed that the patient is morbidly obese, and the patient reported that both facilities have known for 2 months of the pending closure of the den and nothing was done about it, however since that was not accomplished, the plan was to send her to the emergency room. The document also indicated that the patient reported that she has been trying to get a spot for treatment but keeps getting declined. Patient 1 was discharged on 08-23-24 to Entity #42, a new SNF, and the dialysis treatments to be conducted at Entity #44, and an outpatient dialysis facility. The record failed to evidence that the physician was notified of the patient’s impending discharge and hospitalization and failed to evidence any discharge planning with the patient/patient representative nor with the Entity #25. 8. A review of the clinical record for Patient 6, revealed the final dialysis treatment in the den at Entity #25 was on 8-07-2024. The record indicated Patient 6 begun their initial treatment at Entity #35, an outpatient hemodialysis facility on 08-14-2024, which was 7 days after their last treatment. The clinical record failed to evidence any discharge planning with the patient/patient representative nor with the Entity #25. During an interview on 08-29-2024 at 11:13 AM, Patient 6 confirmed they had received dialysis treatments at Entity #25’s dialysis den. Patient 6 further indicated since closure, they were transported three times a week to Entity #35, an in-center outpatient dialysis treatment center. Patient #6 indicated they had their SNF physician set up dialysis treatments with Entity #35 “since no one else was doing anything”. 9. A review of the clinical record for Patient 2 revealed the final dialysis treatment in the den at Entity #25 was on 8-09-2024. The record indicated Patient 2 began their treatment at Entity #44, an outpatient hemodialysis facility on 08-13-2024, which was 4 days after their last treatment. The clinical record failed to evidence documentation of any discharge planning with Entity #25 and failed to evidence that the patient/patient representative was notified in advance of the transfer to Entity #44. 10. A review of the clinical record for Patient 3 revealed the final dialysis treatment in the den at Entity #25 was on 8-09-2024. The record indicated Patient 3 began their treatment at Entity #35, an outpatient hemodialysis facility on 08-13-2024, which was 4 days after their last treatment. The clinical record failed to evidence documentation of any discharge planning with Entity #25 and failed to evidence that the patient/patient representative was notified in advance of the transfer to Entity #35. 11. A review of the clinical record for Patient 4 revealed the patient’s final dialysis treatment in the den at Entity #25 was on 8-09-2024. The record indicated Patient 4 began their treatment at Entity #39, an outpatient hemodialysis facility on 08-14-2024, which was 4 days after their last treatment. The clinical record failed to evidence documentation of any discharge planning with Entity #25 and failed to evidence that the patient/patient representative was notified in advance of the transfer to Entity #39. 12. During an interview on 08-26-2024 at 10:56 AM, the Administrator indicated the dialysis facility will provide all the paperwork and support to help with patient transfer but it was ultimately the SNF’s responsibility to place the patient. 13. During an interview on 08-26-2024 at 1:56 PM, Dialyze Direct social worker indicated they were asked to assist with the discharge as needed and coordinated with one of their employees (DD) to make sure the patient records were given to the skilled nursing facility so the SNF could get the patients placed. 14. During an interview on 08-26-2024 at 2:46 PM, the Medical Director indicated when a patient is discharged or transferred, the attending nephrologist must discharge the patient and coordinate care with the patient’s new attending nephrologist. The Medical Director further indicated he was aware of the possibility of the dialysis den closure at Entity #25 but was not aware it had closed. 15. During an interview on 08-27-24 at 10:15 AM, the former Area Manager indicated she told Administration at Entity #25 that it was their responsibility to place patients for dialysis treatment and Dialyze Direct would offer support. 16. During an interview with the RN 5 on 08/27/2024 at 10:48 AM, when asked if they told the patients about the closure, she indicated she had not due to not having the answers for them and didn’t want to cause them any worry. 17. During an interview on 08-27-2024 at 1:52 PM, the Patient Services Specialist, Person 41, at the Renal Network, indicated that the ESRD network had no reports in the Dialyze Direct notification system of the den closure at Entity #25. 18. During an interview on 08-28-2024 at 10:24 AM, the Administrator confirmed they did not discuss the closure and ongoing dialysis care needs with any of the patients who received dialysis treatment in the den at Entity #25.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44716 Based on record review and interview, the agency failed to ensure a complete comprehensive assessment including co-morbidities was completed on 1 of 2 (Patient #10) records reviewed in 1 of 5 dens. (Den #6) Findings include: A review of a policy dated 03/31/2017 titled, ‘COMPREHENSIVE INTERDISCIPLINARY ASSESSMENT POLICY REFERENCE: #DD-CS-1300’ revealed “ ... The comprehensive assessment must include, but is not limited to, the following: 1. Evaluation of current health status and medical condition, including co-morbid conditions ...” On 09/04/2024 the clinical record review of Patient 10 was completed, which failed to evidence co-morbidities in the initial assessment completed by Registered Nurse (RN)1 on 08/12/2024. On 09/04/2024 at 11:10 RN 1 after looking at Patient 10’s medical record indicated there were no co-morbidities listed and there should be. RN 1 further stated, “We need to know why patients are receiving dialysis”.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44774 Based on observation, record review, and interview, the facility failed to ensure policy and procedures were followed in relation to notifying the physician of the drops of systolic/diastolic blood pressures and that staff appropriately managed hypotensive patients by investigating the cause with the skilled nursing facility in 2 of 12 (Patients #31 and #35) dialysis patients at 1 of 5 dens surveyed in a skilled nursing facility. (Den at Entity #5) Findings include: 1. Review of an agency policy dated 08-10-2022, titled ‘CLINICAL PARAMETERS FOR NOTIFICATION OF THE REGISTERED NURSE AND/OR NEPHROLOGIST OR APRN POLICY, PROCEDURE REFERENCE: #DD-CS-1123’ stated, “ ... The licensed registered nurse determines the need to intervene and assess the patient immediately ... Blood pressure: Systolic BP < 90 mm Hg or > 180 mm Hg and/or decrease of the systolic blood pressure of at least 20 mmHg and/or in the diastolic blood pressure of at least 10 mmHg between the supine reading and the upright reading ... Mental status: Changes in behavior from pre-dialysis assessment ... The licensed nurse notifies the physician as needed of changes in the patient’s condition ...” 2. Review of the 09-04-2024 treatment run for Patient 31 evidenced the following: 0821, Initiation of treatment B/P of 152/89 0900, B/P 122/76, 0930, B/P 130/79 1000, B/P 138/90 1030, B/P 125/84 1102, B/P 122/76 1124, B/P 69/52, with the note, “ ... treatment completed, patient cramping, RN aware, stable vitals ...” There was no indication the physician was made aware of the drop in B/P at 0900 or the final hypotensive B/P of 69/52 with the noted cramping for Patient 31. 3. Review of the 09-04-2024 treatment run for Patient 35 evidenced the following: 0837, initiation of treatment, B/P 116/70 0900, B/P 118/79 0930, B/P 129/76 1000, B/P 166/86 1036, B/P 176/92 1100, B/P 142/81 1135, B/P 124/68 There was no indication the physician was made aware of the elevations in the systolic B/P. On 09-04-2024 at 11:24 AM, Patient 35 was observed in station #1, Patient Care Technician (PCT) 5 and RN 4 found the patient to be non-responsive to questions with a blood pressure reading of 69/52. Additional intravenous saline was administered and the patient quickly recovered, squeezing the nurse’s hand on command and answering the nurse’s questions. Review of the 09-05-2024 treatment run for Patient 35 evidenced the following: 0818 initiation of treatment B/P 121/75 0830, B/P 154/114 0900, B/P 151/110, noted, “ patient became wheezy/dry cough, started on O2 at 2 liters.” 0906, “Patient requests to come off.” 0911, B/P 160/106, noted, “treatment completed with stable vitals.” There was no indication the physician was made aware of the elevations in systolic/diastolic B/P or their respiratory status. 4. On 09-04-2024 at 10:30 AM, Registered Nurse (RN) 4 indicated had concerns earlier related to Patients 31, 32, and 35 coming from the SNF floor to dialysis with low blood pressures. Indicated suspected the SNF staff had not held antihypertensive medications (medications which lower blood pressure or ‘B/P’) before patients were brought to the den for their treatment, an ongoing issue with the SNF. 5. On 09-05-2024 at 1:45 PM, RN 4 was queried as to what actions had been taken on 09-04-2024, and whether they had contacted the SNF staff to inquire if medications been administered that could affect Patient 31, 32, and 35’s blood pressures before they arrived for treatment on 09-04-2024. RN 4 indicated they had not contacted SNF staff to inquire further. When queried as to whether Physician 2, the patients’ nephrologist, had been contacted about yesterday’s concerns related to the aforementioned hypotensive patients, RN 4 indicated had not called yesterday, but would be speaking to the physician about this concern later today. 6. On 09-05-2024 at 4:28 PM, Physician 2 returned phone call, indicated had not been contacted by the dialysis den nurse at Den # 5 regarding concerns related to patients coming in for treatment with lower blood pressures. Indicated had been aware there were ‘communication gaps’ between SNF and dialysis nursing staff, and had requested Dialyze Direct Leadership sort out communication problems a week and a half ago.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 44774 Based on record review and interview the interdisciplinary team failed to develop plans of care for 2 of 7 (Patients #13 and #14) clinical records reviewed in 1 of 5 dialysis dens surveyed in a skilled nursing facility. (Den #5) Findings include: Review of an agency policy dated 01-13-2024, titled ‘INTERDISCIPLINARY TEAM IN THE LONG TERM CARE SETTING POLICY REFERENCE: #DD-CS-1187’ stated, “ ... The Interdisciplinary Team at Dialyze Direct Dialysis Services will work collaboratively with the Interdisciplinary Team of the Long Term Care (LTC) discuss patient status and the evolving plan of care ...” 1. Review of the clinical record for Patient 13, indicated received dialysis treatments from Den # 5, with an admission date of 06-26-2024, failed to evidence a plan of care. 2. Review of the clinical record for Patient 14, indicated received dialysis treatments from Den # 5, with an admission date of 07-23-2024, failed to evidence a plan of care. 3. On 09-04-2024 at 10:05 AM, Registered Nurse (RN) 4 indicated there were no plans of care for Den #5 patients, only comprehensive assessments.”

“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: 45607 Based on record review and interview, the dialysis facility failed to ensure the physician was notified of increased post treatment weights for 1 of 6 (Patient #1) patients receiving treatments in the dialysis den at Entity #25, and based on observation, record review and interview, the dialysis facility failed to obtain post treatment weights on hoyer lift (mechanical lifts to assist in transferring patients) patients that had weights completed by the skilled nursing facility prior to each dialysis treatment in 4 of 4 (Patient #27, 29, 30, 33) hoyer lifts patients records reviewed of patients that reside in a skilled nursing facility and receive treatments in the dialysis den at Entity #22. Findings include: 1. A review of policy “Clinical Parameters for Notification of the Registered Nurse and/or Nephrologist or APRN Policy/Procedure,” revised 08-10-2022, indicated but not limited to “Post treatment findings reportable to the licensed nurse may include the following ... Fluid removal: Less than 50% of the prescribed treatment goal removed ... The licensed nurse notifies the physician as needed of changes in the patient ’ s condition. 2. A policy dated 12/01/2014, titled, “Care and Assessment of Patient Post-Hemodialysis Policy, Procedure,” indicated the dialysis Registered Nurse would be responsible for completing the post-hemodialysis nursing assessment that would include assessment of vital signs and weight. The policy indicated the post treatment weight could be estimated by subtracting the net fluid volume removed from pre-treatment weight when a patient was unable to be weighed post treatment. 3. A review of Patient 1’s clinical record included treatment run sheets from 07-16-24 through 08-09-2024. Patient #1’s dialysis prescription indicated their estimated dry weight (EDW) was 202.0 kilograms (kg). On 07-22-24 Patient 1’s post treatment weight was 208.0 kg, 6.0 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 07-23-24 Patient 1’s post treatment weight was 206.9 kg, 4.9 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 07-24-24 Patient 1’s post treatment weight was 205.6 kg, 3.6 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 07-29-24 Patient 1’s post treatment weight was 208.5 kg, 6.5 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 07-30-24 Patient 1’s post treatment weight was 206.6 kg, 4.6 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 08-05-24 Patient 1’s post treatment weight was 207.6 kg, 5.6 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 08-06-24 Patient 1’s post treatment weight was 208.3 kg, 6.3 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. On 08-07-24 Patient 1’s post treatment weight was 205.8 kg, 3.8 kg over the prescribed EDW. The clinical record failed to evidence the physician was notified of the patient’s post treatment weight. 4. During an interview on 08-29-24 at 11:36 AM, with the float Registered Nurse who provided treatment in the den at Entity #25, indicated the attending physician would have been notified of Patient 1’s and Patient #3’s post treatment weights outside of parameters when the physician was rounding at the facility. 47022 5. A Dialysis Hand Off Communication Report dated 09/04/2024 for Patient 27 indicated the skilled nursing facility weight pre-dialysis treatment was 97.5 kilograms. During an observation on 09/04/2024, beginning at 11:30 AM, the Patient was brought to the skilled nursing facility ’ s nursing station in the dialysis chair and the dialysis Registered Nurse returned to the dialysis room. A Treatment Sheet dated 09/04/2024 indicated the post weight was obtained by estimated calculation of subtracting the Patient ’ s pre-weight from the net fluid removal. The Treatment Sheet indicated the estimated dry weight (weight without extra fluid) was 98.0 kilograms and the estimated post weight was 96.5 kilograms 6. A Dialysis Hand Off Communication Report dated 09/04/2024 for Patient 29 indicated the skilled nursing facility weight pre-dialysis treatment was 100.6 kilograms. A Treatment Sheet dated 09/04/2024 indicated the post weight was obtained by estimated calculation of subtracting the Patient’s pre-weight from the net fluid removal. The Treatment Sheet indicated the estimated dry weight was 105 kilograms and the estimated post weight was 100.4 kilograms. 7. A Dialysis Hand Off Communication Report dated 09/04/2024 for Patient 30 indicated the skilled nursing facility weight pre-dialysis treatment was 99.5 kilograms. A Treatment Sheet dated 09/04/2024 indicated the post weight was obtained by estimated calculation of subtracting the Patient’s pre-weight from the net fluid removal. The Treatment Sheet indicated the estimated dry weight was 95.0 kilograms and the estimated post weight was 96.5 kilograms. 8. A Dialysis Hand Off Communication Report dated 09/04/2024 for Patient 33 indicated the skilled nursing facility weight pre-dialysis treatment was 110 kilograms. A Treatment Sheet dated 09/04/2024 indicated the post weight was obtained by estimated calculation of subtracting the Patient’s pre-weight from the net fluid removal. The Treatment Sheet indicated the estimated dry weight was 105 kilograms and the estimated post weight was 107.3 kilograms. 9. During an interview on 09/04/2024, beginning at 11:15 AM, Registered Nurse 68 indicated hoyer lifts Patients 27, 29, 30 and 33 are weighed before the dialysis treatment by the skilled nursing facility but not after the end of the dialysis treatment. Registered Nurse 68 indicated the skilled nursing facility may weigh the patients after dialysis treatment, but the dialysis facility does not obtain post weights from the skilled nursing facility and the post weights are calculated based on fluid removal.”

“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: 44774 Based on observation, record review and interview, dialysis facility staff failed to ensure the arteriovenous fistula (AVF) (entry into the blood vessel for hemodialysis [process to cleanse the blood of a patient whose kidneys do not work normally]) was properly sanitized prior to cannulation (needle insertion) in 1 of 2 (Patient: #36) cannulations observed at Entity #5, and 1 of 2 (Patient #30) cannualations observed at Entity #22, out of 5 dialysis dens observed in a skilled nursing facility. Findings include: 1. Review of an agency policy dated 12-01-2024, titled ‘CANNULATION OF AN ARTERIOVENOUS FISTULA REFERENCE: #DD-CS-0258’ stated, “ ... Trained dialysis staff is responsible to prepare the access area and to use proper technique in cannulating the AV fistula ... 3. Once area is prepared, do not palpate access unless a repeat prep is done ...” 2. On 09-04-2024 at 9:45 AM, while working with Patient 36, at Den #5, PCT 5 was observed preparing to cannulate the upper site of patient’s AVF (Arteriovenous Fistula), had sanitized the site, then palpated the site with their gloved finger, failing to re-sanitize the site before inserting the needle. 3. On 09-04-2024 at 2:05 PM when queried as to the event, PCT 5 indicated, ‘yes’ had done so, and indicated should have changed gloves and re-sanitized the site. 47022 4. During an observation at Den #22 on 09/04/2024, beginning at 8:15 AM, Patient 30, left upper arm AVF was accessed by PCT 63 by disinfected the left upper arm with an alcohol swab after auscultation with a stethoscope. PCT 63 palpated the AVF access site after the alcohol prep and cannulated with the blue line. 5. During an interview on 09/04/2024, beginning at 10:30 AM, PCT 62 indicated the AVF access site should not be palpated after the site was disinfected and if the site was palpated again the area must be recleaned.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 44232 Based on record review and interview, the interdisciplinary team (IDT) failed to ensure the individual plan of care addressed the patient’s needs and expected outcomes for a safe transfer to another entity for treatment and identified the ongoing dialysis needs in 6 of 6 (Patients: #1- 6) patient records reviewed in 1 of 1 recently closed dens (Den at Entity #25) in the last six months. Findings Include: 1. A review of a Dialyze Direct, LLC, revision dated 01-31-2024, titled “Interdisciplinary Team (IDT) In The Long Term Care Setting Policy,” indicated but not limited to, “ ... The Interdisciplinary Team at Dialyze Direct Dialysis Services Facility is responsible for providing each patient with an individualized and comprehensive assessment of their needs ... “ 2. Review of Patient 1’s clinical record included a POC dated 09-08-2023. The plan of care failed to be revised, addressing Patient 1’s need for ongoing dialysis treatment plans before the den at Entity #25 closed, plans for safe transfer to Entity #42 a SNF with outpatient hemodialysis treatments at Entity #44, and expected outcomes addressing those needs. 3. Review of the clinical record for Patient 5, contained a care plan reviewed on 05-17-2024, signed by all IDT members. The plan of care failed to evidence Patient 5’s need for ongoing dialysis treatment and safe transfer from the den at Entity #25 to the den at Entity #22 and the expected outcomes addressing those needs. During an interview on 08-28-2024 at 9:55 AM, Patient 5 confirmed the IDT did not review the den closure and their ongoing care needs for dialysis treatment with them. During an interview on 08-27-2024 at 2:59 PM, Physician 1 confirmed IDT’s responsibility was to review and update the care plan with any changes in the patient’s needs. 4. A review of the clinical record for Patient 4, contained a care plan reviewed on 06-19-2024, signed off by all IDT members. The plan of care failed address Patient 4’s need for ongoing dialysis treatment plans before the den at Entity #25, closed, plans for safe transfer to Entity #39, an outpatient hemodialysis facility, and the expected outcomes addressing those needs. 5. A review of the clinical record for Patient 6 contained a care plan reviewed on 05-13-2024, signed by all IDT members. The plan of care failed to be revised, addressing Patient 6’s need for ongoing dialysis treatment plans before the den at Entity #25 closed, plans for a safe transfer to Entity #35, an outpatient hemodialysis facility, and the expected outcomes addressing those needs. 45607 6. Review of Patient 2’s clinical record included a POC dated 06-07-2024. The plan of care failed to be revised, addressing Patient 2’s need for ongoing dialysis treatment plans before the den at Entity #25 closed, plans for safe transfer to Entity #44, an outpatient hemodialysis facility, and the expected outcomes addressing those needs. 7. Review of Patient 3’s clinical record included a POC dated 12-08-2023. The plan of care failed to be revised, addressing Patient 3’s need for ongoing dialysis treatment plans before the den at Entity #25 closed, plans for safe transfer to Entity #35, an outpatient hemodialysis facility, and expected the outcomes addressing those needs. 8. During an interview on 08-28-2024 at 10:24 AM, the Administrator confirmed they did not discuss the closure of the den at Entity #25 and the den patients’ ongoing dialysis care needs with any of the patients at Den #25.”

“H-COORDINATION OF CARE BY MEMBER OF IDT CFR(s): 494.100(c)(1)(ii) Services include, but are not limited to, the following: (ii) Coordination of the home patient’s care by a member of the dialysis facility’s interdisciplinary team. This Standard is not met as evidenced by: 44232 Based on record review and interview, the dialysis facility failed to ensure coordination of care was maintained to ensure the health and safety of care delivery in 6 of 6 (Patients ##1-6) discharged records reviewed in 1 of 1 (at Entity #25) den closed within the last 6 months between Dialyze Direct and the Skilled Nursing facility as well as between Dialyze Direct and the new dialysis entities; and failed to ensure coordination of patient care occurred between Dialyze Direct and Skilled Nursing Facility (SNF) staff and physician when issues related to patterns of hypotension among patients receiving dialysis were identified in 3 of 12 (Patients 31, 32, and 35) active records reviewed in 1 of 5 (at Entity #5) dialysis dens surveyed in a skilled nursing facility. Findings Include: 1. A review of a Dialyze Direct, Limited Liability Company (LLC), revision dated 03-31-2017, titled “Admissions” indicated but not limited to, “ ... In the event the facility ceases to operate, the facility Governing Body must notify CMS, the state survey agency and applicable ESRD network. The interdisciplinary team must assist patients to obtain dialysis in other facilities ... “ 2. A review of a facility document dated 03-11-2020 by the Chief Operating Officer of Dialyze Direct, Corp 3, a “Long-Term Care Facility Renal Dialysis Affiliation Agreement document titled, “Long-Term Care Facility Renal Dialysis Affiliation Agreement,” was provided by the Administrator on 08-26-2024 at 11:29 AM. The agreement was signed on 03-11-2020 by the Chief Operating Officer of Dialyze Direct, Corporate 3, and Person 45, the General Counsel of Den # 25. The agreement indicated but was not limited to,” ... Provision of Renal Dialysis Services at an Outpatient Dialysis Facility ... it may be necessary for a Dialysis Resident to receive a Renal Dialysis treatment on the premises of an outpatient dialysis facility. The Dialysis Facility will coordinate such care with the LTC Facility ... “ 3. A review of a Dialyze Direct, LLC, revision dated 03-31-2017, titled “Admission and Discharge to the Chronic Hemodialysis Outpatient Unit Policy,” indicated but not limited to, “ ... Transfer: Every effort must be made to transfer patient to another outpatient facility. Documentation must show such efforts were extensive and all venues were pursued ... “ 4. A review of the inactive clinical record for Patient 4 contained a discharge summary dated 08-10-2024, signed by the Quality Education Director. The summary indicated Patient 4’s reason for discharge was due to the den closure at Entity #25, and that the patient moved to a new skilled nursing facility. Patient 4’s last dialysis treatment in the den at Entity #25 was on 08-09-2024. A review of the record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity, and failed to evidence that the Dialyze Direct staff coordinated care with Entity #39, the outpatient hemodialysis facility, where Patient 4 started receiving dialysis treatment on or before 08-14-2024. During an interview on 08-28-2024 at 3:54 PM, Person 38, the Admissions Coordinator, for Entity #39, the outpatient dialysis center, indicated the only communication note was from Entity #25’s facility staff. 5. A review of Dialyze Direct’s discharge summary dated 08-10-2024, signed by the Quality Education Director at Dialyze Direct, indicated Patient 5 transferred to Entity #22, a skilled nursing facility due to the den closure at Entity #25, however, the patient remained a resident at Entity #25 until 8-14-2024, which at that time, the patient was transferred to the hospital. The discharge summary dated 08-10-2024 failed to be updated to accurately reflect the client’s condition when discharged to the hospital on 8-14-2024 and the record failed to evidence that the Dialyze Direct’s physician for the den at Entity #25 was notified when the patient’s was transferred to the hospital. A review of the discharge summary from Entity #33, a hospital, indicated Patient 5 had been admitted on 08-14-2024 with critical lab values and required dialysis treatments. The document further indicated Patient 5 had been transferred to Entity #22, a skilled nursing facility that provided dialysis through their den on 08-21-2024. A review of the record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity, and failed to evidence that the Dialyze Direct staff coordinated care with Entity #22 dialysis den staff, where Patient 5 started receiving dialysis treatment on or before 08-21-2024. During an interview on 08-27-2024 at 2:59 PM, the nephrologist for Dialyze Direct, Physician 1, indicated they were not aware of Patient 5’s hospitalization due to critical laboratory values due to the last dialysis treatment date of 08-07-2024. Physician 1 indicated Dialyze Direct’s philosophy is continuity of care before they are discharged from care to ensure safe transfer. During an interview on 08-28-2024 at 9:55 AM, Patient 5 confirmed they had been admitted to Entity #33 on 08-14-2024 due to not receiving their dialysis treatments and became sick. Patient 5 indicated they had not received dialysis treatment since Thursday, 08-07-2024. The patient indicated they were transferred to another skilled nursing facility, where they received dialysis treatments now. Patient 5 stated, “It was a mess. I shouldn’t have to go through that. It should have been better arranged.” 6. A review of the inactive clinical record for Patient 6, contained a discharge summary dated 08-10-2024, signed by the Quality Education Director. The discharge summary indicated Patient 6’s reason for discharge was due to the den closure at Entity #25. Patient 6’s last dialysis treatment date at the den at Entity #25 was 08-07-2024. The patient started treatment at Entity #35, an outpatient dialysis treatment center on 08-14-2024. A review of the record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity, and failed to evidence that the Dialyze Direct staff coordinated care with Entity #35, the outpatient hemodialysis facility, where Patient 6 started receiving dialysis treatment on or before 08-14-2024. During an interview on 08-28-2024 at 3:54 PM, Person 37, the Admissions Coordinator, for Entity #35 outpatient dialysis treatment center, indicated the only communication noted was from Entity #25. During an interview on 08-29-2024 at 11:13 AM, Patient 6 confirmed they had received dialysis treatments at Entity #25’s dialysis den. Patient 6 further indicated since they closed it, they were transported three times a week to Entity #35, an outpatient dialysis treatment center. Patient 6 indicated they had their skilled nursing facility physician set up dialysis treatments with Entity #35 “since no one else was doing anything”. 7. During an interview on 08-28-2024 at 12:32 PM, the General Council and Chief Compliance Officer confirmed it is the obligation of Dialyze Direct’s employees, that when a den closes, and the patients are admitted to another facility, they are to coordinate care and it is their responsibility to follow up. 45607 8. A review of Dialyze Direct’s discharge summary dated 08-12-2024, that was signed by the Quality Education Director, indicated Patient 1 transferred to another unspecified SNF due to the den closure at Entity #25, however, the patient remained a resident at Entity #25 until 8-14-2024, which at that time, the patient was transferred to the hospital. The discharge summary failed to be updated to accurately reflected the client’s condition when transferred to the hospital on 8-14-2024. The clinical record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity. A review of documents from Entity #33, a hospital, indicated Patient 1 was admitted on 08-14-2024 for a diagnosis of fluid overload needing dialysis, Acute on Chronic Hypoxic Respiratory Failure, Hyperkalemia, and ESRD on hemodialysis. Patient 1 was discharged from the hospital on 08-23-24 to Entity #42, a skilled nursing facility, and dialysis treatments to be provided at Entity #44, an outpatient dialysis treatment center. The clinical record failed to evidence coordination between Dialyze Direct and Entity #44 on or before 08-23-2024. 9. A review of the clinical record for Patient 2 contained a discharge summary dated 08-10-2024, signed by the Quality Education Director. The summary indicated Patient 2’s reason for discharge was due to the den closure at Entity #25 and that the patient moved to a new facility. Patient 2’s last dialysis treatment in the den at Entity #25 was on 08-09-2024. The record indicated Patient 2 began their treatment at Entity #44, an outpatient hemodialysis facility on 08-13-2024. The clinical record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity and failed to evidence coordination of care between the Dialyze Direct and Entity #44, the receiving outpatient dialysis treatment center on or before 08-13-2024. 11. A review of the clinical record for Patient 3 contained a discharge summary dated 08-10-2024, signed by the Quality Education Director. The summary indicated Patient 3’s reason for discharge was due to the den closure at Entity #25. Patient 3’s last dialysis treatment in the den at Entity #25 was on 08-09-2024. The record indicated Patient 3 began their treatment at Entity #35, an outpatient hemodialysis facility on 08-13-2024. The clinical record failed to evidence coordination between Dialyze Direct and Entity #25 in regards to discharge planning and transfer to another dialysis entity and failed to evidence coordination of care between the Dialyze Direct and Entity #35, the receiving outpatient dialysis treatment center on or before 08-13-2024. 12. During an interview on 08-26-2024 at 10:56 AM, the Administrator indicated the dialysis facility will provide all the paperwork and support to help with patient transfer but it was ultimately the SNF’s responsibility to place the patient. 13. During an interview on 08-27-24 at 10:15 AM, the former Area Manager indicated she told Administration at Entity #25 that it was their responsibility to place patients for dialysis treatment and Dialyze Direct would offer support. 14. During an interview on 08-26-2024 at 2:46 PM, the Medical Director indicated when a patient is discharged or transferred, the attending nephrologist must discharge the patient and coordinate care with the patient’s new attending nephrologist when a patient is transferred and it is the responsibility of the Dialyze Direct social worker (SW) to work in conjunction with the SNF SW to find a place for the patient to receive dialysis . The Medical Director further indicated he was aware of the possibility of the dialysis facility closure in Entity #25 but was not aware it had already closed. 15. During an interview on 08-28-2024 at 3:16 PM, when queried regarding the discharge summaries and coordination of care documented with the dialysis facilities the patients were transferred to on all 6 patients discharged from the den at Entity #25, the Quality Educator Director confirmed they had completed the discharge summaries on the 6 patients. The Quality Educator Director further confirmed there were no coordination care notes between the den at Entity #25 and the receiving dialysis facilities for the 6 patients. 44774 16. On 09-04-2024 at 10:30 AM, Registered Nurse (RN) 4 indicated had concerns earlier related to Patients 31, 32, and 35 coming from the SNF floor to dialysis with low blood pressures. (See: V 504) RN 4 indicated she suspected the SNF staff had not held antihypertensive medications (medications which lower blood pressure or ‘B/P’) before patients were brought to the den for their treatment, that this was an ongoing issue with the SNF. 17. A review of the treatment runs for patient’s 31, 32 and 35 from 09-02-2024 through 09-05-2024 evidenced episodes of hypotensive and hypertensive blood pressure results along with a change in respiratory status for Patient #35. There was no evidence that coordination of care occurred between the SNF and Entity #5 or that the physician was notified of these changes. 18. On 09-05-2024 at 1:45 PM, RN 4 was queried as to what actions had been taken on 09-04-2024, and whether they had contacted the SNF staff to inquire if medications been administered that could affect patient #31, #32, and #35’s blood pressures before they arrived for treatment on 09-04-2024. RN 4 indicated they had not contacted SNF staff to inquire further. When queried as to whether Physician 2, the patients’ nephrologist, had been contacted about yesterday’s concerns related to the aforementioned hypotensive patients, RN 4 indicated she had not called yesterday, but would be speaking to the physician about this concern later today. 19. On 09-05-2024 at 4:28 PM, Physician 2 returned phone call, indicated had not been contacted by the dialysis den nurse at Entity 5 regarding concerns related to patients coming in for treatment with lower blood pressures. Physician 2 indicated they had been aware there were ‘communication gaps’ between SNF and dialysis nursing staff, and had requested Dialyze Direct Leadership to sort out the communication problems a week and a half ago.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 45607 Based on record review and interview, the Medical Director failed to ensure they participated in the development of a policy to address patient discharge/transfer procedure for the closure of a dialysis unit (den) in a skilled nursing facility (SNF) for 1 of 1 Medical Director. Findings include: 1. Review of the “Admission and Discharge to the Chronic Hemodialysis Outpatient Unit Policy,” revised 03-31-2017, failed to include a discharge/transfer process due to a den closure in a SNF. 2. During an interview on 09-05-2024 at 1:20 PM when queried about how he participates in the development, review, and approval of the facility ’ s policies and procedures, the Medical Director indicated Dialyze Direct policies were set up by a central office and were then approved by the governing body. 3. During an interview on 09-05-2024 at 3:51 PM, the Administrator relayed there was no policy regarding dialysis den closures prior to the start of the survey.”

“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: 44232 Based on record review and interview, the Medical Director failed to ensure the policies and procedures were followed, ensuring patient rights and safety in 13 Dialyze Direct Dens located in 13 skilled nursing facilities in Indiana, resulting in 2 Patient hospitalizations. (Patients: #1, and 5) Findings Include: 1. A policy titled “Emergency Preparedness,” revised date 03-31-2017, indicated but was not limited to, “... Staff should have supplies available to provide patient care during an evacuation ...The evacuation kit contents will be reviewed on a monthly basis for missing or expired. Supplies that are missing or have expired must be replaced immediately ...” (See E028) 2. A policy titled “Infection Prevention and Control Policy and Practices,” with a revised date of 06-01-2023, indicated but was not limited to, “ ... Clean areas shall be clearly designated for the preparation, handling, and storage of ... unused supplies and equipment. Clean areas shall be clearly separated from contaminated areas where used supplies and equipment are handled. ...” (See V117 and V122) 3. A policy dated 07/01/2019, titled, “Central Venous Catheter Care Policy, Procedure,” indicated the dialysis hubs (catheter access) were to be disinfected using an appropriate antiseptic. The policy indicated the dialysis lines were to be removed, the hubs were to be disinfected with an antiseptic pad for each hub and the hubs were to be cleaned by scrubbing the sides and end of the hub at least several centimeters towards the body. The policy indicated when using alcohol swabs for the anti-microbial agent the application time was 60 seconds. (See V147) 4. A policy titled “Patient Rights and Responsibilities Policy,” revised date 03-31-2017, indicated but not limited to, “ ... ensure all facility staff and contract staff shall observe these patients’ rights ... Become informed of his/her rights as a patient in advance of, or when discontinuing, the provision of care ... “ (See V450) 5. A policy titled “Comprehensive Interdisciplinary Assessment Policy,” dated 03-31-2017 revealed “ ... The comprehensive assessment must include, but is not limited to, the following: 1. Evaluation of current health status and medical condition, including co-morbid conditions ...” (See V502) 6. A policy tiled. A review of an agency policy dated 08-10-2022, titled “Clinical Parameters For Notification Of The Registered Nurse And/or Nephrologist Or PRN Policy, Procedure,” dated 08-10-2022, stated, “ ... The licensed registered nurse determines the need to intervene and assess the patient immediately ... Blood pressure: Systolic BP < 90 mm Hg or > 180 mm Hg ... Mental status: Changes in behavior from pre-dialysis assessment ... The licensed nurse notifies the physician as needed of changes in the patient’s condition ... “ (See V504) 7. A policy dated 12-01-2014, titled “Cannulation of a Peripheral AV Graft, Policy, Procedure,” indicated that once the AVF area was prepped, the access area should not be palpated unless a repeat prep was completed. (See V550) 8. A review of a policy dated 01-31-2024, titled “Interdisciplinary Team (IDT) In The Long Term Care Setting Policy,” indicated but not limited to, “ ... The Interdisciplinary Team at Dialyze Direct Dialysis Services Facility is responsible for providing each patient with an individualized and comprehensive assessment of their needs ... “ (See V542 and V559) 9. A review of a policy revision dated 03-31-2017, titled “Admissions,” indicated but was not limited to “ ... In the event the facility ceases to operate, the facility Governing Body must notify CMS, the state survey agency and applicable ESRD network. The interdisciplinary team must assist patients to obtain dialysis in other facilities ... “ (See V590) 10. A policy titled “Admission and Discharge to the Chronic Hemodialysis Outpatient Unit Policy,” revised date 03-31-2017, indicated but not limited to, “ ... Transfer: Every effort must be made to transfer patient to another outpatient facility. Documentation must show such efforts were extensive and all venues were pursued ... “ (See V590) 11. A policy dated 12/01/2014, titled, “Care and Assessment of Patient Post-Hemodialysis Policy, Procedure,” indicated the dialysis Registered Nurse would be responsible for completing the post-hemodialysis nursing assessment that would include assessment of vital signs and weight. The policy indicated the post treatment weight could be estimated by subtracting the net fluid volume removed from pre-treatment weight when a patient was unable to be weighed post treatment. (See V543) 45607 12. During an interview on 9/5/24 at 1:20 PM, the Medical Director indicated he was ultimately responsible for everything that happens in the dialysis unit.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 44774 Based on record review and interview the Governing Body failed to notify the State Agency (SA) of the closure of a dialysis den, in 2 of 2 recently closed dens (Dens at Entity #25 & #66) in the last 7 months, and failed to notify the SA of an additional 3 beds/chairs and additional space for 1 of 5 dialysis dens observed , (Den at Entity #5). Findings include: 1. Review of IDOH records failed to evidence notification had been made, nor had approval been sought, by Dialyze Direct to service additional dialysis patients in a newly added room, with three (3) additional dialysis stations/chairs. 2. On 09-04-2024 during an observation of a den at Entity #5, Registered Nurse (RN) 4 unlocked the door of another room adjacent to the currently active den. This room contained 3 additional dialysis stations/chairs. RN 4 indicated this room had been in use 6 months prior. 3. During an interview on 09-05-2024 at 3:44 PM, the Administrator indicated the SA was not notified of the room addition at Den #5 because State agency notification was not their policy. 45607 4. On 08-22-2024, IDOH was notified of a den closure at Entity #25 and the lack of placement and hospitalizations of a few residents who was receiving dialysis treatment at the den. A review of IDOH records failed to evidence notification had been made by Dialyze Direct to the SA regarding closure of the dialysis den in at Entity #25. 5. On 09-03-2024, IDOH surveyors were informed by the Administrator that a dialysis den at Entity #66, a skilled nursing facility, had also closed. This was confirmed by a letter that was provided, indicating the den was closing at Entity #66 on 02-06-2024. A review of IDOH records failed to evidence notification had been made by Dialyze Direct to the SA regarding closure of the dialysis den at Entity #66. 6. During an interview on 09-03-2024 at 1:47 PM, the Administrator relayed she probably did not notify the SA because it wasn’t a policy. 7. During an interview on 09-05-2024 at 3:51 PM, the Administrator relayed there was no policy regarding dialysis den closures prior to the start of the survey.”

“GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS CFR(s): 494.180(i) The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network’s current statement of work. Each facility must participate in ESRD network activities and pursue network goals. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to notify The Renal Network, they were closing 2 dialysis dens at 2 of 2 skilled nursing facilities (Dens at Entity # 25 and #66) within the last 7 months. Findings include: 1.Review of a letter dated 06-10-2024 from General Counsel and Chief Compliance Officer, Corp 3, to Person 27, the former Administrator of Den # 25 (a skilled nursing facility),email indicated July 10, 2024, will be the final day for Dialyze Direct to provide services at the SNF] but failed include any discharge planning for the ESRD patients who reside in the facility and their plan of where the ESRD patients will be discharged to for their continuation of hemodialysis treatments. 2. A review of an email dated June 10, 2024, from the Dialyze Direct General Counsel & Chief Compliance Officer to Person 27, the Administrator of Entity #25, indicated July 10, 2024, would be the final day for Dialyze Direct to provide services at the skilled nursing facility (SNF) but failed include any discharge planning for the ESRD patients who reside in the facility and their plan of where the ESRD patients will be discharged for their continuation of hemodialysis treatments. 3. Review of a letter received Dialyze Direct dated 02-06-2024 indicated the den at Entity #66 would be ending dialysis services in their facility 30 days from the date of the letter. 4. During an interview on 09-05-2024 at 3:47 PM, the Administrator relayed the facility did not report the dialysis den closures of Dens #25 and #66 to the Renal Network because it wasn’t a policy. 5. During an interview on 09-05-2024 at 3:51 PM, the Administrator relayed there was no policy regarding dialysis den closures prior to the start of the survey. 6. During an interview on 08-27-2024 at 1:52 PM, the Patient Services Specialist, Person 41, at the Renal Network, indicated that the ESRD network had no reports in the Dialyze Direct notification system of the den closures.”