Davita Downtown San Antonio Dialysis

“CFC-COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 This Condition is not met as evidenced by: 34839 Based on an onsite visit and an interview it was determined that the facility is not in compliance with applicable State regulatory licensing requirements. Based on record review and interview, it was determined the facility failed to report to the department (Texas Department of Health and Human Services Commission) the death of 7 dialysis patients (Patient’s #18, #19#20 # 14 # 15 #16 and #17) reviewed for 2023 that had not been reported within the 10 working days. in accordance with State law and the facility’s policy. The facility also failed to test the conductivity with an independent meter prior to initiation of treatment. Refer to tag V101, for specific evidence.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34839 39425 Based on observation, interview, and record review, the facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patient health and safety. This practice promotes risk of cross contamination and/or infection to all patients, staff and the public, as evidenced by: 1.) the facility failed to perform monthly HBsAg (Hepatitis B Antigen) testing on 2 susceptible patient (Patients #6 and #9) and no evidence of labs for 4 patients (Patient’s #3, #4, #8 and #10). Refer to V tag: V124 for specific evidence. 2.) the facility failed to ensure that monthly infection control audits were completed, monitored for accuracy and that there was documentation that infection control issues were reported to the facility’s medical director and the quality improvement committee for corrective action(s). Specifically, there was no data reported in the QAPI for January through November of 2023 to show a trend of improvement or decline in trends. QAPI failed to identify, review or discuss other areas of deficient practices related to infection control identified by the surveyors within the facility. Refer to V tag: V144 for specific evidence. 3.) The facility failed to properly maintain the physical environment of the clinic for the safety of patients and staff. Specifically, A.) the facility failed to provide a surface that can be disinfected for the 6 stations inside the Home Hemodialysis facility. The splash zones in each station had chips of dry wall exposed with bugs and debris on 6 of the 6 stations. B.) the facility failed to provide proper ventilation and air conditioning (HVAC) systems. Refer to V tag: V401 for specific evidence. 4.) the facility failed to provide sufficient space to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. Refer to V tag: V404 for specific evidence. These deficient practices placed all 13 patients at the facility at risk of infection and/or cross contamination.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 39425 45179 Based on observation, review of documentation and interview, it was determined that the physical environment was not maintained to ensure the safety of staff and patients. Specifically, 1.) the facility failed to provide a surface that can be disinfected for the 6 stations inside the Home Hemodialysis facility. The splash zones in each station had chips of dry wall exposed with bugs and debris on 6 of the 6 stations. 2.) the facility failed to provide proper ventilation and air conditioning (HVAC) systems. Refer to V tag: V401 for specific evidence. 3.) the facility failed to provide sufficient space to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. Refer to V tag: V404 for specific evidence. These deficient practices placed all 13 patients at the facility at risk of infection and/or cross contamination.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 39425 Based on record review and interview, the facility failed to develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program and to analyze, track, trend, and develop appropriate action and follow up as required to improve health outcomes, the prevention of infections, the reduction of medical errors and adverse events. Specifically, the facility’s Quality Assessment and Performance Improvement Committee (QAPI) failed to: A. Ensure the facility had a dedicated Infection Control reporting program in which staff identified, tracked and trended infections in the facility; and B. Ensure a thorough review of the patient mortalities to allow for identification, prevention and reduction of mortality and morbidities by developing an action plan to prevent and/or decrease mortality events; and C. Ensure a review of facility staffing to include; orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff; and D. Ensure facility staff to measure, analyze and track fluid management for the 13 current patients (Patient’s #1-#13) that were being weighed by the Skilled Nursing Facility (SNF) staff and not verified by the Home Hemodialysis (HHD) staff. As a result, patients were not meeting fluid management goals. These deficient practices placed all current 13 home hemodialysis patients receiving treatment by the facility staff at an increased risk of significant health infections, and errors leading up to and including the possibility of death by failing to reduce and prevent medical errors and adverse events. The cumulative effects of this deficient practice resulted in the facility’s inability to comply with the condition of Participation: QAPI Refer to tags V110, V124, V144, V626, V628 V684, V685 for specific evidence.”

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 39425 Based on employee file review, review of staffing assignments, review of policy and proedures and staff interviews, the facility failed to: 1.) have a qualified Nurse manager with at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. Registered Nurse Staff #4 did not have the required training completed to work independently as a Nurse manager. Refer to tag V684 for specific evidence. 2.) have a Registered Nurse that has at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality (HHD) for which the nurse will provide self-care training. Specifically the facility failed to have a trained Home Hemodialysis (HHD) Registered Nurse (RN) dialyze 13 patients (Patient’s #1-#13) on 1/23/24 and 1/24/24. Refer to tag V685 for specific evidence.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 39425 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: A.) Ensure a sanitary environment in the Home Hemodialysis facility to minimize the sources and transmission of infectious agents between the unit and adjacent public areas by failing to: 1.) Ensure the Home Hemodialysis facility had a dedicated Infection Control reporting program in which staff identified, tracked, and trended infections in the facility, and Refer to tags V144 and V401 for specific evidence. B.) Ensure the dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Refer to tags: V401 and V404 for specific evidence. C.) Ensure that the facility developed, implemented, maintained, and evaluated an effective data-driven quality assessment and performance improvement program; and to analyze, track, trend, and develop appropriate action and follow up as required to improve health outcomes, the prevention of infections, the reduction of medical errors and adverse events. The facility’s QAPI failed to: 1.) Ensure the facility had a dedicated Infection Control reporting program in which staff identified, tracked and trended infections in the facility; and 2.) Ensure a thorough review of the patient mortalities to allow for identification, prevention and reduction of mortality and morbidities by developing an action plan to prevent and/or decrease mortality events; and 3.) Ensure a review of facility staffing to include; orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff; and Refer to tags V110, V124, V144, V626, and V628 for specific evidence. D) Ensure the designated Home Hemodialysis supervising Registered Nurse and Charge Nurse were qualified. Refer to tags V684 and V685 for specific evidence. E)Ensure 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. Refer to tag V0751 for specific evidence. These deficient practices placed all 13 Home Hemodialysis patients receiving treatment in the facility at an increased risk of significant health infections, and medical errors leading up to and including the possibility of death by failing to reduce and prevent medical errors and adverse events.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 39425 Based on observation, record review, and interview, the facility’s Governing Body failed to carry out responsibilities, monitoring, and oversight to ensure facility policies and procedures were followed for the safety of the patients; and that the Conditions of Participation (COP) were met for: 1.) CFR 494.20 Compliance with Federal/State/Local Laws Refer to COP V100 2.) CFR 494.30 Infection Control Refer to COP V110 3.) CFR 494.60 Physical Environment Refer to COP V400 4.) CFR 494.110 Quality Assessment & Performance Improvement Refer to COP V625 5.) CFR 494.140 Personnel Qualifications Refer to COP V680 6.) CFR 494.150 Responsibilities of the Medical Director Refer to COP V710 These deficient practices placed all current 13 home hemodialysis patients receiving treatment by the facility staff at an increased risk of significant health infections, and errors leading up to and including the possibility of death by failing to reduce and prevent medical errors and adverse events.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 39425 Based on record review and interview, it was determined the facility failed to report to the department (Texas Department of Health and Human Services Commission) the death of 7 dialysis patients (Patient’s #18, #19#20 # 14 # 15 #16 and #17) reviewed for 2023 that had not been reported within the 10 working days. in accordance with State law and the facility’s policy. In addition, the facility failed to test the conductivity with an independent meter prior to initiation of treatment. Findings included: A.) Review of the facility’s Discharged Patient list for 1/1/23 to 12/31/23 revealed the following: Patient #18 last treatment 6/9/23, expired on 6/11/23. Patient #19 last treatment 3/17/23, Patient #19 expired on 3/20/23. Patient #20 last treatment 3/29/23, Patient #20 expired on 4/8/23. Patient #14 last treatment 11/3/23, discontinued dialysis. Documentation provided by the HDD SNF indicated Patient #14 expired. Patient #15 last treatment 10/6/23, extended absence more than 30 days. Documentation provided by the HDD SNF indicated Patient #15 expired. Patient #16 last treatment 12/4/23, transferred to another provider. Documentation provided by the HDD SNF indicated Patient #16 expired. Patient #17 last treatment 9/20/23, discontinued dialysis and sent to hospital. Documentation provided by the HDD SNF indicated Patient #17 expired. Review of Patient’s #14, #15, #16, #17, #18, #19, and #20 medical records revealed there was not a discharge summary completed that included the following, as applicable; the disposition of the patient and include the diagnosis or cause of death, date of death, location of death, and reason for discharge. Further review revealed there was not a Mortality Review Form completed for Patient’s #14, #15, #16, #17, #18, #19 and #20. Surveyor requested all Texas Department of Health Reports (TDH) submitted for the last year, none were provided. Interview on 2/1/24 at 17:46 PM in the facility conference room with S#5 surveyor reiterated the request for all TDH reports, S#5 stated “ she can’t produce them”. B.) Review of the 13 patient treatment sheets dated 1/23/24 and 1/24/24 The facility failed to do independent conductivity testing on all 13 machines. Policy and Procedure: 8-01-01 Title: General Statement on Clinical Policies Policy reads in part, #2 Facility and facility teammates will operate and furnish services in compliance with applicable Federal, State, local laws and regulations pertaining to licensure and any other relevant health and safety requirements including individual ESRD Network requirements. Texas Administration Code Rule, section 117.32(c)(3), Regulation 0069 of the Texas Department of State Health Services ASPEN Regulation Set reads in part: Water Treatment, Dialysate Concentrates, and Reuse. (c) Dialysate. (3) Prior to each patient treatment, staff shall verify the dialysate conductivity and pH of each machine with an independent device.”

“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 medical record review and interview the facility failed to perform 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. Specifically, the facility failed to perform monthly HBsAg (Hepatitis B Antigen) testing on 2 susceptible patient (Patients #6 and #9) and no evidence of labs for 4 patients (Patient’s #3, #4, #8 and #10). This placed all 13 patients on census at the facility at risk of infection. 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. Findings include: Review of the facility Vaccination and Surveillance Report revealed the following: 6 of the 13 current patient’s (Patient # 3 Patient #4 Patient #6 Patient #8 Patient #9 Patient # 10 ) active patients did not have a monthly Hepatitis antigen drawn for patients with an antibody less than 10, or no labs provided. 2 of the 13 active patients (Patient# 6 and Patient#9) did not have a monthly Hepatitis B antigen drawn for January 2024. 4 of the 13 patients ( Patient#3 Patient#4 Patient#8 and Patient#10 ) did not have any labs on the monthly Hepatitis surveillance report. Review of the facility policy and procedure TITLE: HEPATITIS B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE. Policy:1-05-02 revised October 2023. POLICY#4 All patients will be routinely tested (as required by the schedule for routine surveillance testing for Hepatitis B Virus ( refer to Routine Surveillance Testing Table). Review of the Routine Surveillance Testing Table states in part: Antigen negative Antibody <10 patient is susceptible and Surveillance Testing is Monthly. Interview with Staff #4 on 2/1/24 at 1730 at the nurses station confirmed the above findings and further stated, “We are aware there are missing lab draws.””

“IC-STAFF REPORT IC ISSUES CFR(s): 494.30(b)(3) [The facility must-] (3) Require all clinical staff to report infection control issues to the dialysis facility ’ s medical director (see § 494.150 of this part) and the quality improvement committee. This Standard is not met as evidenced by: 39425 Based on the facility’s records reviewed, facility contracts reviewed and interview, it was determined that the facility failed to ensure that monthly infection control audits were completed, monitored for accuracy and that there was documentation that infection control issues were reported to the facility’s medical director and the quality improvement committee for corrective action(s). There should be a documented reporting mechanism for infection control issues. The nurse manager, administrator and medical director should each be able to describe the infection control program and reporting mechanisms. Infection control and patient safety issues should be continuously reported and discussed in Quality Assurance and Performance Improvement (QAPI) committee meetings, and the response taken to address these issues should be documented. Specifically, there was no data reported in the QAPI for January through November of 2023 to show a trend of improvement or decline in trends. QAPI failed to identify, review or discuss other areas of deficient practices related to infection control identified by the surveyors within the facility. Failure to identify infection control issues puts all 13 patients at risk of infection and up to and including death. Findings included: Review of the contract agreement with Chome Hemodialysis Coordination Agreement, docusigned on 11/17/2022 indicated, in part: J) Company, in collaboration with Owner as needed, will develop and implement policies and protocols for the delivery of Renal Dialysis Services and Services that are equivalent to the standards of care provided to dialysis patients receiving treatments in a dialysis facility. These protocols will include requirements set forth at 42 CFR 494.30 and 494.80 through 494.100, including procedures for infection control... Review of the facility Infection Manager Monthly checklist reads in part, Overseeing Environmental services ( semi annual ) Can be delegated and completed over several days Auditor needs to have working knowledge of Facility’s infection control policies, procedures, guidelines and practices. Ensure all teammates are audited at least once a quarter. Discuss audit results with your team and Facility Administrator Assist with plan development and implementation. Report on audit in the Infection control section in FHR. Review of the Facility Health Report ( FHR, also known as QAPI ) from January through November of 2023 revealed: 1. FHR approved on 9/27/23 stated: Issue statement: “ Infection control audit not completed for July 2023”, when in fact the graft in the FHR revealed no audits were completed for May and August. Baseline Process and Results: “ clinic Team Mates (TM’s) will complete Infection Control (IC) audits with completion 100% rate for the next 3 months” Review of the graft in the FHR for October 2023 ( 2 months later ), Comment: “Audits completed. Goal met [Improvement Plan] IP closed.” There was no tracking or trending available as the audits only had a yes no answer typed with no data driven documentation completed. Surveyor requested 6 months of the facilities infection control audits to see the tracking and trending. S#5 stated “She [Staff # 1]can’t produce them.” Surveyor asked S#2 who the infection control manager was; without response. Surveyors asked the Facility Administrator if there was a sign in sheet for QAPI for the HHD program. On 2/1/24 at 1301 the Facility Administrator stated “There is no sign in sheet.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 34839 Based on observation, interview, and review of the Facility’s Home Hemodialysis (HHD) contract with the Skilled Nursing Facility (SNF), the facility staff failed to ensure the HHD in the SNF was designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Specifically, 1.) the facility failed to provide a surface that can be disinfected for the 6 stations inside the Home Hemodialysis facility. The splash zones in each station had chips of dry wall exposed with bugs and debris on 6 of the 6 stations. 2.) the facility failed to provide proper ventilation and air conditioning (HVAC) systems. Findings included: Review of the contract agreement, Chome Hemodialysis Coordination Agreement docusigned on 11/17/2022 indicated, in part: J) Company, in collaboration with Owner as needed, will develop and implement policies and protocols for the delivery of Renal Dialysis Services and Services that are equivalent to the standards of care provided to dialysis patients receiving treatments in a dialysis facility. These protocols will include requirements set forth at 42 CFR 494.30 and 494.80 through 494.100, including procedures for infection control... Observations conducted in the facility on 1/31/24 from 1515 to 1535 revealed the following: The wall behind stations 1, 2, 3, 4. 5. and 6 (splash zone) was not made of a surface that could be cleaned and disinfected. Also, the ledge behind each station (splash zone) was found to have bugs and debris behind 4 of 6 stations. Ledge found with cracked peeling paint. Open boxes of gloves were stored in the splash zone for all 6 stations. Approximately 6 inches of unpainted wall with multiple holes. There was a portable air conditioning unit with a hose hanging outside a window in the Home Hemodialysis facility. There was a rusty like substance and dirt found on the air vents in the ceiling. Multiple water stains in the ceiling and a large crack in the ceiling. In 2 areas in the Home Hemodialysis facility there was a black substance coming out of the cracks where the flooring was glued together. Interview with Staff #5 on 1/31/24 at 1340 revealed “I know that they had to change out little things, like some receptacles and we had to make sure that the water boxes were there. We had to make sure the water pressure was good because those machines obviously take more than your standard little box. All of those things should have taken place and that should have been shared along the way somehow. Whether that would have been a monthly call with the local office leader just to say we’re progressing. Again I’m not going to speak improperly to what (Regional Operations Manager) did. I’m telling you that there should have been involvement from day one on the trajectory of this launch.””

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 34839 Based on observation and interview, the facility failed to provide sufficient space to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. Findings included: Observation of the Home Hemodialysis (HHD) program at the Skilled Nursing Facility (SNF) treatment area on 1/31/24 from 1515 to 1535 revealed the following: Portable air conditioning unit and DeWalt patient emergency supplies box blocking emergency exit door. Three dialysis machines to the right hand side in the den and four dialysis machines to the left hand side. There was not sufficient amount of space between the rows of patient chairs for a stretcher in case of an emergency. There was approximately only four feet of space from dialysis machine to dialysis machine in the treatment area. In the event of blood splatter, patients could be subject to cross contamination. In an interview conducted on 1/31/24 at 1535 with the Biomedical staff member #12, confirmed the above findings.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 21863 Based on record review and interview, the facility failed to develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program and to track, trend, and develop appropriate action and follow up as required to improve health outcomes and the prevention and reduction of medical errors and; in accordance with the facility’s policies. Specifically, the facility’s Quality Assessment and Performance Improvement Committee (QAPI) failed to: 1.) Ensure a thorough review of the patient mortalities monthly for seven patient deaths identified from 1/1/23 to 12/31/23; to allow for identification, prevention and reduction of mortality and morbidities by developing an action plan to prevent and/or decrease mortality events. Specifically, the facility had 7 patient deaths for calendar year, 1/1/23 to 12/31/23 that were not assessed and thoroughly reviewed in the QAPI meetings. (Patients #14, 15, 16, 17, 18, 19 and 20). Findings included: 1.) Review of the QAPI meeting minutes for 1/1/23 to 12/31/23 revealed there was no evidence the committee analyzed, trended or assessed patient deaths/mortalities. Review of the facility’s Discharged Patient list for 1/1/23 to 12/31/23 revealed the following: Patient #18 last treatment 6/9/23, expired on 6/11/23. Patient #19 last treatment 3/17/23, Patient #19 expired on 3/20/23. Patient #20 last treatment 3/29/23, Patient #20 expired on 4/8/23. Patient #14 last treatment 11/3/23, discontinued dialysis. Documentation provided by the HDD SNF indicated Patient #14 expired. Patient #15 last treatment 10/6/23, extended absence more than 30 days. Documentation provided by the HDD SNF indicated Patient #15 expired. Patient #16 last treatment 12/4/23, transferred to another provider. Documentation provided by the HDD SNF indicated Patient #16 expired. Patient #17 last treatment 9/20/23, discontinued dialysis and sent to hospital. Documentation provided by the HDD SNF indicated Patient #17 expired. Review of Patient’s #14, #15, #16, #17, #18, #19, and #20 medical records revealed there was not a discharge summary completed that included the following, as applicable; the disposition of the patient and include the diagnosis or cause of death, date of death, location of death, and reason for discharge. Further review revealed there was not a Mortality Review Form completed for Patient ’ s #14, #15, #16, #17, #18, #19 and #20. Review of the facility ’ s SNF HHD Continuous Quality Improvement Program, policy 14-01-09, originated October 2020 revealed the following, in part; 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: · Patient Safety, including o Review of sentinel events o Review of trends of adverse patient occurrences including falls and blood loss o Review of product, equipment, or medication notices or recalls · Infection Control, including o Incidence of infections o Vaccination rates for Hepatitis B, Influenza, and Pneumococcal · Adequacy of Dialysis (Kt/V) · Nutritional Status (Albumin) · Mineral Metabolism and Renal Bone Disease · Anemia Management · Vascular Access · Growth and Capacity · Mortality - review of deaths · Hospitalizations and Emergency Ambulance Transfers · Patient Satisfaction and Grievances · Other indicators as reflected in the Facility Health Meeting (FHM) application Review of the facility’s policy titled, Discharge Summary Policy 3-02-01B, last revised October 2022 indicated the following, in part; 4. In the event of a patient death, complete the ESRD Death Notification, CMS-2746, within two (2) weeks of the date of death. Per CMS, if the patient was a dialysis patient, the dialysis facility last responsible for the patient ’ s maintenance dialysis (or home dialysis) must complete this form. In an interview on 2/1/24 at 4:10 PM with Facility Staff #5 confirmed there was not a discharge summary completed for Patient ’ s #14, #15, #16, #17, #18, #19, and #20. Further interview at 5:45 PM with Facility Staff # 5 confirmed there were not any Mortality Reviews completed for Patient ’ s #14, 15, 16, 17, 18, 19 and 20 and further confirmed that deceased Patient ’ s #14, 15, 16, 17, 18, 19 and 20 were not reviewed in the QAPI meetings from 1/1/23 through 12/31/23.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 39425 Based on record review and interview, the dialysis facility failed to measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. Specifically, the dialysis facility staff failed to measure, analyze and track fluid management for the 13 current patients (Patient’s #1-#13) that were being weighed by the Skilled Nursing Facility (SNF) staff and not verified by the Home Hemodialysis (HHD) staff. As a result, patients were not meeting fluid management goals. Findings included: Review of the Home Hemodialysis (HHD) Skilled Nursing Facility (SNF) program’s Quality Assessment and Performance Improvement (QAPI) meeting minutes for October 2023 and November 2023 documented; 1. Frequent Post Weight Above Target Weight (TW) at 62.5 % with goal of 18% Issue Statement: November: Facility did not reach goal for TW current 62.5%. Baseline Process and Results: November: Patients are monitored post treatments weights to find weights out of range. Doctor (Dr) is notified of any out of range that needs to be adjusted. Process Improvement Goals: Post facility weights will be decreasing in the following months leading to be within range. Percentage is trending up. Process Deep Dive: Patient (Pt) target weights are adjusted accordingly to be able to monitor post weights and accuracy. Working with SNF staff to remind them of weighing patients correctly. Issue Statement: October: Facility did not reach goal for TW current 60%. Baseline Process and Results: October: Patients are monitored post treatments weights to find weights out of range. Dr is notified of any out of range that needs to be adjusted. Process Improvement Goals: Post facility weights will be decreasing in the following months leading to be within range. Percentage is trending up. Process Deep Dive: Pt target weights are adjusted accordingly to be able to monitor post weights and accuracy. Working with SNF staff to remind them of weighing patients correctly. Interview with Regional Operations Manager on 1/31/24 at 1430 in the HHD SNF dialysis den stated, “The nursing home staff weigh the patients and bring them to the den.” Surveyor asked if the staff verify the weights. Regional Operations Manager stated “No, but we have retrained the nursing home staff.” Surveyors asked the Facility Administrator if members of the QAPI program signed in for QAPI. On 2/1/24 at 1301 the Facility Administrator stated “There is no sign in sheet.””

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 39425 Based on staff file review, review of facility contracts, facility policy and procedures and interviews, the facility failed to have a qualified Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. Specifically, Registered Nurse Staff #4 did not have the required training completed to work independently as a Nurse manager. Findings: Review of the Skilled Nursing Facility and Home Hemodialysis Facility Contract revealed: Chome Hemodialysis Coordination Agreement docusigned on 11/17/2022 indicates, in part: B) Company will provide a Registered Nurse (“Company RN”) to perform each HHD Patient’s HHD treatments and a patient care dialysis technician (a “PCT”), as needed, to assist each Company RN. Each Company RN and PCT (collectively, “Company Staff”) will meet applicable state and federal qualifications. The Company RN’s competency will be approved by the dialysis Center medical director and governing body. Policy: 8-02-05 Training Programs for New Patient Care Provider Teammates Revision Date April 2022 Policy reads in part: 5. Orientation and training for new experienced teammates in the dialysis modality for which they have been hired is identical to the training of new non-experienced teammates with the following exceptions: -New experienced HHD and/or new experienced PD teammates will attend the theory class(es) specific to the modality they are working in. -The Facility Administrator/designee will verify that all critical components of the modality specific training are completed prior to the new teammate receiving independent patient care assignment. -The form is to be signed by the clinical new teammate RN trainer, the Medical Director, and the Facility Administrator. Review of the facility Onboarding and Training records and the HHD Training requirement grid that states an overseeing RN “Texas 720 Hours”, Staff #4 did not meet the training requirements to be the supervising nurse, nor the facility charge nurse as required by Federal and State requirements as well as the facility Job description that was signed on 10/16/2023. Orientation Scavenger Hunt completed 11/2023. Skills check Verification completed 11/27/23. Verification of competency completed on 12/21/23. No evidence provided for verification of the required 6-month training in home hemodialysis modality, nor previous work history to verify 12 months in hemodialysis. Interview with Regional Operations Manager Staff #1 on 1/30/24 at 1503 regarding having a nurse manager that meets the qualifications of a nurse manager stated “I don’t have one. I haven’t had one since she (Staff #3) left.” On 1/30/24 at 1510 Staff #1 stated “I don’t have the governing body as her (Staff #4) as an overseeing Registered Nurse.” Surveyors asked during conference call on 1/30/24 with former Regional Operation Director Staff #13 and current Regional Operations Director Staff #14 if they were aware they had a nurse manager that did not meet qualification, Staff #13 at 1541 stated “I did not.” Staff #14 stated at 1542 “I was not aware.” Surveyors went on to state the federal regulation regarding the qualification of a nurse manager and if Regional Operations Director Staff #14 was aware of the regulation, Staff #14 stated on 1/30/24 at 1550 “Not these particular regs (Regulations) you’re mentioning to me.” Interview with Medical Director on 1/30/24 revealed at 1053 stated “It’s under my CCN, but I don’t, I guess, I was not aware of that because I don’t attest for that clinic (SNF).” The Medical Director further stated, “The doctor (Medical Director at the SNF) was supposed to be the medical director for that clinic. So, the way I was told, was that she is overseeing it. We did have our meetings that they were calling in on those, but I was not signing off on any records. I mean that’s the truth. The doctor (Medical Director at the SNF) rounded so yeah; I wasn’t really involved. That’s the truth.” Surveyors asked if the Medical Director knew what was in the contract for the Medical Director. The Medical Director on 1/30/24 stated at 1054 “Uh, I don’t think so. I don’t know. I don’t know what is in my contract; but, but, I, all the clinics that, well, I guess there’s a big debacle then because I was not aware that I’m responsible for overseeing.””

“PQ-SELF/HOME TRG RN-12 MO RN+3 MO MODALITY CFR(s): 494.140(b)(2) (2) Self-care and home dialysis training nurse. The nurse responsible for self-care and/or home care training must- (i) Be a registered nurse; and (ii) Have at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality for which the nurse will provide self-care training. This Standard is not met as evidenced by: 39425 Based on staff file, medical file review, facility policy and procedures and interview, the Home Hemodialysis (HHD) facility failed to have a Registered Nurse that has at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality (HHD) for which the nurse will provide self-care training. Specifically the facility failed to have a trained Home Hemodialysis (HHD) Registered Nurse (RN) dialyze 13 patients (Patient’s #1-#13) on 1/23/24 and 1/24/24. Findings included: Medical file review revealed: Patient’s #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, and #13 Patient Treatment Details Reports from 1/23/24 and 1/24/24 were completed and signed by Staff #2 Policy: Training Requirement Grid for 40/80/160 Hours Teammate Registered Nurse or Patient Care Technician Internal Facility Teammate Transfer with 6 months of hemodialysis in the last year with (In Center Hemodialysis, or Home Hemodialysis or In Center Hemodialysis/Home Hemodialysis modality plus Acute experience or Acute Only) 80 hours *80 Hours Teammate can take an independent assignment, but still required to finish 160 hours total 160 hours -All new to HHD SNF documents required as usual -Verify that all applicable certifications and health records are collected in accordance with Facility policies, facility/program requirements, and any state or federal regulations prior to the teammate providing care. Policy: 8-02-05 Training Programs for New Patient Care Provider Teammates Revision Date April 2022 Policy reads in part: 5. Orientation and training for new experienced teammates in the dialysis modality for which they have been hired is identical to the training of new non-experienced teammates with the following exceptions: -New experienced HHD and/or new experienced PD teammates will attend the theory class(es) specific to the modality they are working in. -The Facility Administrator/designee will verify that all critical components of the modality specific training are completed prior to the new teammate receiving independent patient care assignment. -The form is to be signed by the clinical new teammate RN trainer the Medical Director, and the Facility Administrator. Review of Staff #2 staff file revealed: Experienced Hemodialysis Teammate Expedited Skills Checklist (Origination Date: 1/6/22) completed for Staff #2 indicated Home Hemodialysis facility Orientation: Signed 1/23/24 Items listed below performed as applicable by State Board of Nursing or state regulations: Infection Control: Signed 1/26/24 Hemodialysis Devices-Dialysis Delivery System Specific: Signed 1/26/24 Patient Assessment (Nurse): Signed 1/26/24 Vascular Access: Signed 1/26/24 Dialysis Treatment: Signed 1/26/24 Interview with Staff #2 on 1/30/24 at 1218 stated “(Regional Operations Manager Staff #1) stated that I don’t need any additional education. Staff #2 said, I hadn’t done HHD before. I didn’t know it was an HHD program. I have been doing dialysis 7 years. I worked January 23rd and 24th” at the HHD Skilled Nursing Facility (SNF). Additionally, on 1/30/24 at 1222 Staff #2 stated after surveyor questioned what do you do for a (*Chlorine breakthrough)? “Check it again and check the second port.” Surveyor continued questioning with what would you do if the chlorine level was still out of range. “I’d stop treatment. Contact the Medical Doctor. I don’t know if there is a second port.” *Dialysis machines contain carbon filters which capture Chlorine/Chloromines present in water. Testing is required at least every four hours to determine if the Chlorine/Chloromines are below minimum standards. Chlorine breakthrough means the Chlorine/Chloromine level is above minimum standards. Chlorine/Chloromine levels above minimum standards reaching patients blood causes the destruction of red blood cells. Destruction of patient red blood cells could lead up to and including death of the patient. Interview with the Medical Director on 1/30/24 at 1057 regarding the Facility Administrator Registered Nurse going into the SNF and performing HHD in an environment that they have never been trained to perform “It’s definitely my fault that I didn’t that know. It was the arrangement, and I have to say it was kind of chaotic. The only thing I always said is; I’m not signing up on it, I’m not attesting to doing any of those things because I’m not doing them ever, so I never did that.” Interview with the Facility Administrator on 1/30/24 at 1038 revealed: Surveyors asked if the Nurse Administrator was aware of the unqualified staff member that went to the SNF and performed HHD on the patients there, Nurse Administrator “I am now with the situation that she wasn’t trained, that was explained to me.” Surveyors asked who explained that to her “Umm Staff #1 when I talked to her.” Surveyors asked if she was aware on the 23rd when the nurse was sent to the facility to perform HHD in the SNF, “No, I wasn’t made aware until after everything happened.” Interview with the Regional Operations Director Staff #14 on 1/30/24 at 1557 Surveyor asked did you give the approval for them to run that facility for two days with unqualified personnel on Tuesday and Wednesday (1/23/24 and 1/24/24)? “Yes” Surveyor went on to ask were you aware that an unqualified nurse was dialyzing patients in your program? “Yes, I wanted her signed off on as much as we could.””

“MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY CFR(s): 494.150 The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. This Standard is not met as evidenced by: 39425 Based on patient record review, staff file review and interview the facility failed to have the medical director accountable to the governing body for the quality of medical care provided to patients. Specifically, the Medical Director for the Home Hemodialysis (HHS) program in the Skilled Nursing Facility (SNF) failed to be accountable for the medical care of all current 13 patients (Patient’s 31-#13) receiving HHD in the SNF. Findings included: HHD SNF Patient’s records reviewed (Patient’s #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12 and #13) and staff file review revealed no oversight provided by facility Medical Director. Interview with Medical Director on 1/30/24 revealed at 1053 stated “It’s under my CCN, but I don’t, I guess, I was not aware of that because I don’t attest for that clinic (HHD SNF).” The Medical Director further stated, “The doctor (Medical Director at the HHD SNF) was supposed to be the medical director for that clinic. So, the way I was told, was that she is overseeing it. We did have our meetings that they were calling in on those, but I was not signing off on any records. I mean that’s the truth. The doctor (Medical Director at the HHD SNF) rounded so yeah; I wasn’t really involved. That’s the truth.” Surveyors asked if the Medical Director knew what was in the contract for the Medical Director. The Medical Director on 1/30/24 stated at 1054 “Uh, I don’t think so. I don’t know. I don’t know what is in my contract; but, I, all the clinics that, well, I guess there’s a big debacle then because I was not aware that I’m responsible for overseeing.””

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 39425 Based on record review and interview the facility’s Medical Director failed to ensure the facility’s Home Hemodialysis (HHD) program in the Skilled Nursing Faciltiy (SNF) was incorporated into the facility Quality Assessment and Performance Improvement (QAPI) program. Specifically, the Medical Director failed to: -Ensure the HHD SNF facility physical plant was safe for patients -Ensure infection control audits were performed -Ensure staff monitored patient Hepatitis B status for all patients. -Ensure Patient’s deaths and mortality reviews were conducted, tracked, and trended -Ensure qualified staff were providing care for the patients Refer to tags V124, V144, V401, V404, V626, V684, and V685”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 39425 Based on staff file review, Skilled Nursing Facility and facility contract, and interview, the facility’s Medical Director failed to ensure the Home Hemodialysis (HHD) Skilled Nursing Facility (SNF) staff had the necessary staff education, training, and performance to work at the SNF independently. Specifically, the facility’s Medical Director did not attest nor sign off to two staff members completed training; the Skilled Nursing Facility Registered Nurse Manager and the facility Registered Nurse Charge Nurse for days 1/23/24 and 1/24/24. Findings: Refer to evidence in citations, V684 and V685”

“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: 39425 Based on record review, staff file review, and interview the facility’s Medical Director failed to ensure 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. Findings: Refer to evidence in tags V101, V124, V626, V684, and V685”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 21863 Based on review of records and interview, the facility failed to ensure patient discharge summaries were completed within 30 days of discharge in accordance with the facility’s policy for 20 of 20 patients reviewed that were discharged in 2023 from the facility (Patient ’ s #14, #15, #16, #17, #18, #19, #20, #21, #23, #24, #25, #26, #27, #30, #31, #32, #33, #34, #35 and #36). Specifically, Patient ’ s #14, #15, #16, #17, #18, #19, #20, #21, #23, #24, #25, #26, #27, #30, #31, #32, #33, #34, #35 and #36 did not have a discharge summary completed in their record that included the following, as applicable and in accordance with the facility policy; the disposition of the patient and include the diagnosis or cause of death, date of discharge or death, location of death, transplant or relocation information when appropriate, and reason for discharge if not for transplantation or death; including voluntarily or involuntarily terminated dialysis. Findings included: Review of the facility’s Discharged Patient list for 1/1/23 to 12/31/23 revealed the following: Patient #14 last treatment 11/3/23, discontinued dialysis. Documentation provided by the HDD SNF indicated Patient #14 expired. Patient #15 last treatment 10/6/23, extended absence more than 30 days. Documentation provided by the HDD SNF indicated Patient #15 expired. Patient #16 last treatment 12/4/23, transferred to another provider. Documentation provided by the HDD SNF indicated Patient #16 expired. Patient #17 last treatment 9/20/23, discontinued dialysis and sent to hospital. Documentation provided by the HDD SNF indicated Patient #17 expired. Patient #18 last treatment 6/9/23, expired on 6/11/23. Patient #19 last treatment 3/17/23, Patient #19 expired on 3/20/23. Patient #20 last treatment 3/29/23, Patient #20 expired on 4/8/23. Patient #21 last treatment 12/1/23, extended absence more than 30 days. Patient #23 last treatment 5/12/23, transferred to another provider. Patient #24 last treatment 5/8/23, discontinued dialysis. Patient #25 last treatment 5/5/23, discontinued dialysis. Patient #26 last treatment 10/20/23, discontinued dialysis. Patient #27 last treatment 3/20/23, transferred to another provider. Patient #30 last treatment 4/14/23, regained renal function. Patient #31 last treatment 10/6/23, transferred to another provider. Patient #32 last treatment 11/15/23, transferred to another provider. Patient #33 last treatment 8/21/23, extended absence more than 30 days. Patient #34 last treatment 11/10/23, transferred to another provider. Patient #35 last treatment 9/25/23, transferred to another provider. Patient #36 last treatment 6/16/23, discharge reason, “lost to follow-up” Review of Patient’s #14, #15, #16, #17, #18, #19, #20, #21, #23, #24, #25, #26, #27, #30, #31, #32, #33, #34, #35 and #36 medical records revealed there was not a discharge summary completed that included the following, as applicable; the disposition of the patient and include the diagnosis or cause of death, date of discharge or death, location of death, transplant or relocation information when appropriate, and reason for discharge if not for transplantation or death; including voluntarily or involuntarily terminated dialysis. Review of the facility’s policy titled, Discharge Summary Policy 3-02-01B, last revised October 2022 indicated the following: PURPOSE: To verify that a Discharge Summary is completed for all patients that expire, transfer, or transplant including voluntarily or involuntarily terminated dialysis care from DaVita and the requirements for documentation of the discharge. POLICY: 1. A Discharge Summary will be completed in a maximum of 30 days from a patient ’ s discharge date or sooner according to state regulations. 2. All discharge summaries will be signed and dated by the attending nephrologist and nurse. 3. The Discharge Summary form is located in REGGIE. 4. In the event of a patient death, complete the ESRD Death Notification, CMS-2746, within two (2) weeks of the date of death. Per CMS, if the patient was a dialysis patient, the dialysis facility last responsible for the patient ’ s maintenance dialysis (or home dialysis) must complete this form. If the patient was a transplant patient, the transplant center is responsible for completing this form. In an interview on 2/1/24 at 4:10 PM with Facility Staff #5 confirmed there was not a discharge summary completed for Patient ’ s #14, #15, #16, #17, #18, #19, #20, #21, #23, #24, #25, #26, #27, #30, #31, #32, #33, #34, #35 and #36 after discharge. In addition, Staff #5 confirmed with Staff #1 that discharge summaries were not completed for Patient ’ s #14, #15, #16, #17, #18, #19, #20, #21, #23, #24, #25, #26, #27, #30, #31, #32, #33, #34, #35 and #36 Staff #5 and further stated that if the discharge summaries were done, they would have been right on top of the Patient ’ s closed record. 34839”

“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: 39425 Based on interview, facility policies and procedures, Home Hemodialysis (HHD) Skilled Nursing Facility (SNF) contract and HHD SNF Leadership Team form; the facility’s governing body failed to adopt and enforce 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. Specifically, the governing body failed to: a) Oversee the HHD SNF operations b) Update and appoint staff members at HHD SNF c) Enforce facility’s policies and procedures d) Abide by the HHD SNF facility contract e) Ensure qualified staff members who provided HHD care f) Quality Assurance and Performance Improvement (QAPI) cover scope of modalities provided Findings included: The HHD SNF (also known as DSD) Leadership Team form reads in part: Facility DSD dialysis programs provide on-site staff-assisted HHD to residents using conventional dialysis machines in skilled nursing facilities as an extension of HHD services, operating under the oversight and governance of a facility certified by CMS to provide HHD services. Each DSD team ultimately report to the facility medical director and are under the same QAPI and governing body oversight. The purpose of this meeting is to document the DSD leadership team’s request for the governing body of the Facility’s CCN to review the following items. The DSD leadership team has discussed the below and are recommending the governing body’s approval for implementation in the DSD program. a) DSD Facility provided no documentation of facility Medical Director oversight. Interview with the Medical Director on 1/30/24 at 1057 “As I said, I will never attest to anything regarding that clinic.” b) Initial Governing Body Meeting Date:12/12/2022 Governing Body Members: Medical Director: Listed Medical Director is not the Medical Director of the facility. Facility Administrator is not listed. c.) See V101, V124, V144, V401, V404, V626, V684, V685, V711, V712, V713, V715, V729, and V751 for specific evidence. d) Chome Hemodialysis Coordination Agreement reads in part: Company will maintain direct responsibility for the safety and quality of the renal dialysis services provided to the HHD patients admitted to the center, consistent with ESRD (Code of Federal Regulations) CFR requirements, the ESRD prospective payment system rules, as well as the terms of this agreement. Company is responsible for the safe delivery of dialysis to the HHD patient, including review of qualifications, training, competency verification, and monitoring of company staff. Company is responsible for the quality and safety of the dialysis treatments and the management of the HHD patients’ ESRD treatment-related conditions. See V101, V124, V144, V401, V404, V626, V684, V685, V711, V712, V713, V715, V729, V751 e.) See V684 and V685 f.) See V110, V124, V144, V626, V628 V684, V685 for specific evidence.”