Hope Kidney Clinic Lakeview

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 34839 Based on observation, record review, and staff interviews, the facility’s A. biomedical staff failed to follow Policy and Procedure Device Evaluation Following Patient Event Published 4/5/21 Policy reads in part: “Trained staff will collect dialysate specimens and send to Spectra Laboratories for both colony count and LAL analysis as soon as practical following a patient event, and in accordance with “Microbiological Monitoring of Dialysate” policy. Evaluate the dialysis machine functional testing as follows: If ... If the machine passes the functional test/self-test portion of the “Device Evaluation Following Patient Event” form, and it is believed that the device was not, in any way, involved in causing or contributing to the event. Then The machine may be returned to service immediately upon authorization by the Medical Director, Clinical Manager/Program Manager/Regional Technical Operations Manager and/or Area Technical Operations Manager. No further authorization from Corporate Clinical Services is required.. Record review revealed 5 out of 7 dialysis machine did not have dialysate cultures drawn and 2 out of 2 machines were not removed from the treatment area post an adverse event for a device evaluation. 4 out of 7 machines did not have authorization signatures in order to be returned to service. (Cross Refer to Tag V275 )”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 34839 Based on observation, interview, and record review, the facility’s registered nurse failed to ensure facility’s direct care staff: follow facility’s current policy and procedure on Patient Monitoring and Safety Checks During Hemodialysis Treatment; policy # 23502; published 9/05/2023; version 5 directs staff as follows: Note “Patients must be under continual observation. Patients will not be left unattended during treatment.” Safety checks access: “Monitor and document Safety Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the -- Treatment Record. Safety checks includes: . Confirm each patient’s face and access are uncovered. . Confirm all patient connections are ALWAYS secure and uncovered due to serious risk of exsanguinations that could go undetected if the access is covered. .Confirm blood lines are secured to the patient ( not chair, bed rail, pillows or bed sheet etc.). .If applicable, confirm HemaClip device is attached to the external CVC venous lumen and blood line connector prior to initiation of blood pump and at each safety check throughout treatment.” Documentation “ Document monitoring and safety checks in --- treatment record and/ or in the Contracted Entity electronic medical record per contractual agreement” Findings include: Observation on 2/6/25 from 11:23 AM through 11:40 AM. revealed patients at station numbers 1, 5, 8, 10 and 14 had their access covered with blankets. Surveyor had to inform S#1 to redirect staff to uncover the patients accesses. Cross refer V407”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 34839 Based on observation, record review and interview, the facility’s Medical Director failed to ensure the delivery of quality patient care and clinical outcomes relative to infection control, physical environment, patient assessment, Quality Assurance and Performance Improvement, personnel qualifications and governance by ensuring the implementation of the facility’s policies and procedures. Specifically, the Medical Director failed to: The medical director failed to ensure through a robust and effective governing body and QAPI program that staff members followed their own policies and procedures in regard to infection control, following manufacturer guidelines, competent performance of staff in daily operations of the dialysis facility, staff maintain up to date licensing, and water monitoring activities. The medical director failed to ensure the QAPI program performed the required audits for the infection control and physical plant and accurate flow sheet audits. Refer to tag V0715 for specific evidence”

“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: 34839 Based on record review, interview and facility policies and procedures the facility failed to routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. [ HBV-Susceptible Patients. Susceptible patients should begin receipt of hepatitis B vaccine immediately upon admission. Test susceptible patients monthly for HBsAg, including those who a) have not yet received hepatitis B vaccine, b) are in the process of being vaccinated, or c) have not adequately responded to vaccination. Note that, while the patient’s anti-HBs is <10 mIU/mL, he/she is considered susceptible to hepatitis B, and should be tested for HBsAg monthly]. Promptly review results, and ensure that patients are managed appropriately based on their testing results.. This deficient practice has potential to cause harm to all patients and staff who have negative anti-HBs. Facility policy titled” Patient Hepatitis B Testing Requirements” Published 02/03/2025 version # 3 states inpart on page #4 Susceptible (Patients) Anti-HBs Less than 10mlU/ml HBsAG Negative Monthly testing for HBsAg Findings included: Review of the Hepatitis B summary report and the Lab Result/ Medication Administration Summary revealed the following patients with <10 Antibodies were missing monthly antigens. P#5 missing 02/2024 and 03/2024 monthly antigen P#6 missing 02/2024 and 03/2024 monthly antigen P#7 missing 01/2025 monthly antigen P#8 missing 01/2025 and 02/2025 antigen P#9 missing 09/2024 monthly antigen Review of the January 27, 2025 Governing Body and the December QAPI dated 1/22/25 did NOT identify missing labs. Interview with S#3 2/6/25 at 3:12 PM stated “I see a lot of room for improvement in this clinic.” Surveyors stated “you can’t see if you’re drawing monthly”; S#3 responded “Correct.” Finding confirmed with Clinical Manager, Director or Operations and Clinical Coordinator on 12/9/25”

“ADVERSE EVENTS-ACTIONS EXPECTED CFR(s): 494.40(d) A dialysis facility must maintain active surveillance of patient reactions during and following dialysis. When clinically indicated (for example, after adverse patient reactions) the facility must- (1) Obtain blood and dialysate cultures and endotoxin levels; (2) Evaluate the water purification system; and (3) Take corrective action. This Standard is not met as evidenced by: 34839 Based on record review and interviews, the facility failed to follow policy and procedure” Device Evaluation following Patient Event” for 6 out of 7 patient events. Policy and Procedure Device Evaluation Following Patient Event Published 4/5/21. Policy reads in part: “Trained staff will collect dialysate specimens and send to Spectra Laboratories for both colony count and LAL analysis as soon as practical following a patient event, and in accordance with “Microbiological Monitoring of Dialysate” policy. Evaluate the dialysis machine functional testing as follows: If ... If the machine passes the functional test/self-test portion of the “Device Evaluation Following Patient Event” form, and it is believed that the device was not, in any way, involved in causing or contributing to the event. Then The machine may be returned to service immediately upon authorization by the Medical Director, Clinical Manager/Program Manager/Regional Technical Operations Manager and/or Area Technical Operations Manager. No further authorization from Corporate Clinical Services is required. Findings include: a. Review of the Incident reports and The device Evaluation Following Patient Event Forms, on 2/6/25 revealed: P#1 had cardio pulmonary resuscitation CPR on the following dates 10/28/24 the facility failed to remove the machine for device evaluation and draw required labs. 11/8/24 the facility failed to draw required labs 11/26/24 the facility failed to draw required labs P#2 had CPR performed on 1/17/24 the facility failed to draw required labs nor was the machine authorized to return to service. P#3 had CPR performed on 1/8/24 and the facility failed to draw required labs, nor was the machine authorized to return to service. P#4 5/27/24 the facility failed to remove the machine for device evaluation and draw the required labs. ATOM Area Technical Operations Manager on 2/6/25 at 12:14 PM regarding if he knew that dialysate lab wasn’t being drawn after adverse events stated, “I just found out.” Surveyors pointed out that the biomedical technician (Biomed) wasn’t drawing dialysate cultures stated, “That is a problem.” Interview with S#6 at 12:19PM, surveyor asked have you read the policy regarding sequestering machines? S#6 stated “Its been a while.” Director of Operations on 2/6/25 at 12:21 PM stated “I can’t believe they didn’t draw cultures. Nobody is signing anything.” Regarding not sequestering the machines after adverse events, Director of Operations on 2/6/25 at 1255 stated, “I found that out last week when I got a call regarding the reports. I talked to S#6 and told him, so you’re telling me it wasn’t pulled.” Surveyors questioned that this was not identified until surveyors reached out, Director of Operations stated “Yes.” Regarding machines not sequestered after adverse events S#6 stated at 12:10 PM “If it wasn’t reported to me, I wouldn’t have done it.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 34839 Based on observation and record review, the facility’s direct care staff failed to ensure patients’ vascular accesses and faces are not covered while receiving hemodialysis treatment and that patients are consistently monitored while receiving hemodialysis treatment. Covering patients’ vascular accesses and not being monitored continually, predisposes patients to bleeding out from the vascular access site, resulting in actual harm and death, which directly affects all patients receiving hemodialysis treatment in the facility. 5 of the 12 patients dialyzing had accesses covered. Findings: Review of the facility’s current policy and procedure on Patient Monitoring and Safety Checks During Hemodialysis Treatment; policy # 23502; published 9/05/2023; version 5 directs staff as follows: Note “Patients must be under continual observation. Patients will not be left unattended during treatment.” Safety checks access: “Monitor and document Safety Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the -- Treatment Record. Safety checks includes: . Confirm each patient’s face and access are uncovered. . Confirm all patient connections are ALWAYS secure and uncovered due to serious risk of exsanguinations that could go undetected if the access is covered. .Confirm blood lines are secured to the patient ( not chair, bed rail, pillows or bed sheet etc.). .If applicable, confirm HemaClip device is attached to the external CVC venous lumen and blood line connector prior to initiation of blood pump and at each safety check throughout treatment.” Documentation “ Document monitoring and safety checks in --- treatment record and/ or in the Contracted Entity electronic medical record per contractual agreement” Treatment area observations were performed on 2/6/25 from 11:23 AM until 11:40 AM Findings: Station #1 Machine #1 patient dialyzing with access covered. Station #5 Machine #10 patient dialyzing with access covered. Station #8 Machine #2 patient dialyzing with access covered. Station #14 Machine #4 patient dialyzing with access covered. Station #10 Machine #28 patient dialyzing with access covered. 5 out of 12 patients dialyzing with accesses covered. Surveyor immediately directed S#1 to redirect staff to uncover the patients accesses.”

“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: 34839 Based on facility medical records and interview the medical director failed to be responsible for the implementation of the policies and procedures by all staff. This includes holding medical staff accountable for complying with facility policies and procedures, e.g., updating plans of care, being knowledgeable of the QAPI targets and working to achieve those targets in their patients, ensuring physical plant, infection control, personnel audits and flowsheet audits were completed and reported to the governing body and QAPI. The findings include: The medical director failed to ensure through a robust and effective governing body and QAPI program that staff members followed their own policies and procedures in regard to infection control, following manufacturer guidelines, competent performance of staff in daily operations of the dialysis facility, staff maintain up to date licensing, and water monitoring activities. The medical director failed to ensure the QAPI program performed the required audits for the infection control and accurate flow sheet audits. Findings included: #1. The facility’s clinical coordinators Registered Nursing license expired October 31/2024. Review of the facility QAPI for November and December did not identify the lapse in license. October QAPI under tab EMPLOYEE TRACKING, reported 1 RN licence due this month. Continue to monitor monthly for approaching expiration of courses and licenses. November QAPI under tab EMPLOYEE TRACKING, reported 1 RN licence due this month. Continue to monitor monthly for approaching expiration of courses and licenses. Interview with Director of Operations and S#7 at 11:38 AM S#2 “We’re getting a new manager. she’s on leave, her license was expired.” Surveyors questioned how long was she working with an expired license. Director of Operations continued, “She was expired for 2 months. She said she didn’t realize it was expired. The manager was termed. It was on his tracker, October, but he didn’t do anything about it. We identified that the previous Clinical Manager just copied and pasted month to month if QAPI” S#7 stated on 2/6/2025 at 11:40 AM “I’m the clinical coordinator. I’m in charge of regulatory compliance.” Surveyor asked, you are in charge of regulatory for this facility and you let your licence expire. S#7 stated “Yes”. # 2, Water Skills Validation Validate all facility specific skills employee has successfully completed training All skills dated for 12/6/2024 RN signed 2/5/2025 Technical Validator Signature 2/5/2025 Clinical Manager Signature 2/5/2025 Medical Director Signature-No signature present Interview on 2/6/2025 with the Director of Operations at 1:14 PM stated “He (Biomedical Technician) threw away the original. So, we printed out a corrections made.” #3 During observations in the treatment area at 11:23 AM at station #9 machine #15 surveyor observed low diastolic BP. Surveyor asked the Patient care Technician ( PCT)to review the consecutive blood pressures and documentation. Machine blood pressure readings under blood pressure history: 10:06 BP 153/54 10:26 BP 176/56 10:46 BP 151/27 10:48 BP 160/37 10:50 BP 163/50 10:52 BP 143/31 10:54 BP 127/43 11:06 BP 159/42 11:26 BP 171/43 11:28 BP 127/59 Surveyor requested to see the PCT and RN documentation. S#8 showed the surveyor the documentation part of the treatment on the chairside computer at 11:28 AM and the only vital sign posted was at 10:05 AM for the initiation of treatment with a BP 153/54. Interview with S#9 on 2/6/2025, surveyor asked why only one vital sign was documented since 10:00 AM. At 11:28 AM S#9 stated “Yeah, we’ve been running around, putting patient on. This is not my clinic, I’m just here helping.” Review of the final paper treatment sheet revealed the staff did not address the patient’s low diastolic BP nor did the final paper flowsheet match recorded vital signs on chairside computer. 10:05 BP 153/54 10:30 BP 163/50 11:00 BP 159/42 11:30 BP 127/59 Review of the facility approved reportable parameters states in part : PCT to RN reporting during dialysis “ B/P systolic >180, systolic <90, change in systolic > 20 points. It also states “ STOP REPORT TO THE RN AND DOCUMENT Reported to RN and What was reported. During interviews with the Director of Operations and the facility medical director, Surveyor asked the Director of Operations why the low diastolic blood pressures and the > than 20 points for systolic were not recorded or addressed on the treatment sheet, and how did the staff back time the vitals. On 2/6/2025 the Director of Operations looked at picture on surveyors phone showing chairside computer screen stated at 4:24 PM “Yes, there is nothing there. They put them in manually on the flowsheet.” Surveyor continued to ask the Director of Operations, do you find this alarming that the BP was not addressed, or documented timely and accurately? Director of Operations stated, “Yes.” Surveyor asked Director of Operations who does the required treatment sheet audits. Director of Operations stated “We have not been able to produce the treatment sheet audits along with physical plant audits, infection control audits and personnel file audits because the clinical manager was terminated.” Surveyor asked the medical director if she reviewed any of the facility audits. The medical director on 2/6/205 at 4:24PM stated, “Not with my own eyes.””

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 34839 Based on employee file review and staff interviews, the facility failed to maintain current documentation on 8 out of 8 staff files reviewed, to demonstrate personnel met the basic requirements of their assigned roles. 1. demonstrated annual skills and competency training. 2. received specific dialysis machine training. 3. demonstrated in center Hemodialysis Training. Refer to tag V681 for specific evidence. Based on employee file review and staff interviews, the facility failed to maintain current documentation to demonstrate personnel met the basic requirements of their assigned roles. Specifically, the facility failed to provide evidence that facility float pool staff members: 1. demonstrated annual skills and competency training for 3 out of 3 facility float pool staff members. 2. received specific dialysis machine training for 3 out of 3 facility float pool staff members. 3. demonstrated in center Hemodialysis Training for 1 out of 3 facility float pool staff members. Refer to tag V681 for specific evidence. Based on employee file review and staff interviews, the facility failed to maintain current documentation to demonstrate personnel met the basic requirements of their assigned roles. Specifically, the facility failed to provide evidence that facility float pool staff members: 1. demonstrated annual skills and competency training for 3 out of 3 facility float pool staff members. 2. received specific dialysis machine training for 3 out of 3 facility float pool staff members. 3. demonstrated in center Hemodialysis Training for 1 out of 3 facility float pool staff members. Refer to tag V681 for specific evidence.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34839 Based on interview and record review, the facility failed to ensure 8 of 8 direct care staff skills and or competencies were assessed prior to providing care and services to hemodialysis patients. The facility also has a transitional care unit utilizing 3 in center Nxstage machines, the facility failed to ensure proper training was completed for direct care staff, and licensed nurses were initiating and discontinuing treatment on a patient with a central venous catheter. No evidence of annual training on ancillary equipment utilized in the facility. These findings have the likelihood to cause harm to all 136 patients treated in the facility by failure to ensure the ongoing review of staff competencies and orientation to facility as needed for facility specific tasks. Findings: Review of S# 1 Staff training record revealed: No Water competency and skills training for 2023 Water training web based completed 1/23/2024, skills verification was not completed until 6/13/2024 and not signed by the medical director. Nxstage machine training expired 8/22/2020 No ancillary equipment training provided. Review of S#2 Staff training record revealed: No training of the Nxstage machine. No ancillary equipment training Review of S#3 training record revealed: No annual Skill verification for 2023 and 2024 Nxstage machine training expired 5/5/24 No ancillary equipment training Review of S#4 training record revealed: No date of completion on “ being prepared worksheet” Emergency preparedness was due 1/30/24 Annual clinical exam web based completed 1/9/24 Annual skills verification due 3/30/24 not completed until 6/11/24 no signature from preceptor. Annual water training expired 1/9/24 No Nxstage machine training. Review of S#5 training record revealed: Nxstage machine training expired 4/28/24 No annual water skills validation for 2023 S#6 training record review revealed: No Nxstage machine training S#7 training record revealed: No Nxstage machine training Annual skills verification had no preceptor signature nor type of machine trained on. S#8 training record revealed: Skills validation completed 4/24/24 no clinical manager signature nor signature from RN manager or RN evaluator designee and date. Review of treatment sheets for Patient #1 with a central venous catheter, dates 5/18/24, 5/21/24, 5/27/24 and 5/31/24 revealed a Patient Care Technician initiated and discontinued treatments. Interview with S#1 at on 6/19/24 at 11:33AM in the facility conference room stated “I ’ m going through the charts and I’m updating as I go and I am behind.” S#1 went on to also state, “ I know I’m behind on the preceptor training, they need to have yearly training and the preceptor training’s are out of date.” Surveyor asked S#3 on 6/19/24 at 2:45PM if Patient Care Technicians were able to initiate and terminate treatments on patients with central venous catheters and S#3 responded “No, they can’t put on catheters.” Review of the facility Governing Body dated March 26, 2024 reads in part under staff chart audit “ Missing documentation on charts will be completed by end of April 2024, Staff will be scheduled to complete Learning Management System (LMS).” Review of the facility Governing Body dated April 23,2025 reads in part “Review of chart progress reviewed with Director of Operations (DO) on a weekly basis, planned to be completed by the end of May 2024. Staff will be scheduled for LMS courses.” Review of the facility Governing Body dated May 22 2024 reads in part “Review of the charts progress reviewed with the DO planned to be completed by the end of June 2024. Self identified missing documents on staff charts. Documents have been obtained and will be added to their charts. Staff will be scheduled for LMS courses.””