Fmc - Gary Dialysis

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure 38% of qualified in center hemodialysis [HD] (a process to filter the blood of a patients whose kidneys do not work normally) patients susceptible to Hepatitis B (liver infection) were offered the Hepatitis B vaccine (Patient #4, Patient #18, Patient # 23, Patient #24, Patient #27, Patient #28, Patient #29, Patient #30, Patient #31, Patient #33, Patient #35); and failed to ensure 43% of patients who completed a Hepatitis B vaccine series before 11/16/2025 were retested to ensure immunity 2 months after completion of the series (Patient #32, Patient #34, Patient #37). Findings include: 1. A policy, dated 02/07/2022, titled, “Patient Vaccination for Hepatitis B,” indicated the Hepatitis B vaccine should be offered to all susceptible patients, patients would sign a vaccination consent or declination form, test patients who have received a Hepatitis B vaccine for Hepatitis B surface antibody 2 months after the final dose of the vaccine, protection against Hepatitis B was not maintained when antibody titers fall below 10 mIU/milliliter, and patients who do not respond to the primary vaccine series should be revaccinated with one additional vaccine series. 2. A Hepatitis B Summary Report, for Patient #4, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Report failed to evidence Patient was offered a Hepatitis B vaccination. 3. A Hepatitis B Summary Report, for Patient #18, dated 08/18/2025, indicated a Hepatitis B surface antibody of <10. The Report failed to evidence Patient was offered a Hepatitis B vaccination. 4. A Hepatitis B Summary Report, for Patient #23, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10 (susceptible to Hepatitis B). The Report indicated Patient refused a Hepatitis B vaccination on 04/10/2025, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 5. A Hepatitis B Summary Report, for Patient #24, dated 08/14/2025, indicated a Hepatitis B surface antibody of <10. The Report failed to evidence Patient was offered a Hepatitis B vaccination. 6. A Hepatitis B Summary Report, for Patient #27, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Report indicated Patient refused a Hepatitis B vaccination on 04/17/2025, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 7. A Hepatitis B Summary Report, for Patient #28, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. The Report indicated Patient refused a Hepatitis B vaccination on 04/26/2025, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 8. A Hepatitis B Summary Report, for Patient #29, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. The Report indicated Patient refused a Hepatitis B vaccination on 08/16/2021, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 9. A Hepatitis B Summary Report, for Patient #30, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Report indicated Patient refused a Hepatitis B vaccination on 04/08/2025, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 10. A Hepatitis B Summary Report, for Patient #31, dated 10/17/2024, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 04/08/2025, and the clinical record failed to evidence a signed declination of the Hepatitis B vaccine. 11. A Hepatitis B Summary Report, for Patient #33, dated 02/17/2025, indicated a Hepatitis B surface antibody of <10. The Report failed to evidence Patient was offered a Hepatitis B vaccination. 12. A Hepatitis B Summary Report, for Patient #35, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. Patient was admitted on 07/15/2025, a Hepatitis B surface antibody, dated 04/04/2025, was <4. The Report failed to evidence Patient was offered a Hepatitis B vaccination. 13. A Hepatitis B Summary Report indicated Patient #32 completed the Hepatitis B vaccination series on 09/16/2025, indicated the most recent Hepatitis B Surface Antibody was 02/18/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 14. A Hepatitis B Summary Report indicated Patient #34 completed the Hepatitis B vaccination series on 08/18/2025, indicated the most recent Hepatitis B Surface Antibody was 02/17/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 15. A Hepatitis B Summary Report indicated Patient #37 completed the Hepatitis B vaccination series on 09/15/2025, indicated the most recent Hepatitis B Surface Antibody was 02/17/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 16. During an interview on 12/02/2025, beginning at 12:10 PM, Clinical Manager 1 indicated patients that refused a Hepatitis B vaccination should of had a signed declination document in their clinical record, Hepatitis B antibodies should have been rechecked 2 months after the Hepatitis B vaccine series was completed, and patients with a Hepatitis B antibody test less than 10 should have been offered a series or a booster vaccine. Clinical Manager 1 indicated Patient #35 should have been offered a Hepatitis B vaccination upon admission. Clinical Manager 1 indicated no staff was assigned to monitor the status of Hepatitis B labs and vaccinations and she had recently taking over monitoring of patient Hepatitis B status.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure staff surveillance audits for central venous catheter [CVC] (dialysis access) care were completed in 1 of 1 facility with an active in-center hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) CVC rate of 55% from 12/2024 to 12/2025. Findings include: A Request for 12 months, from November 2024 to November 2025, of Staff Audits evidenced PCT audits were not completed for observed CVC care or infection control. A Personnel List, received on 11/25/2025, indicated there were 5 full time PCTs, 1 part time PCT and 2 float PCTs on staff at the dialysis facility. A Cleaning and Disinfection of Dialysis Station Audit for December 2024 to November of 2025 failed to indicate audits were performed in March, May, June, September, October, and November 2025. An Audit Performance Facility Form, unknown author, dated 11/18/2025, indicated multiple audits had been missing in different months. The Form indicated there was not a process in place of who was responsible for audits and the goal was for audits to be done on a monthly, quarterly, and annual basis by specific staff. The Form indicated the new manager, Clinical Manager 1 was educated on the audit process on 11/18/2025. During an interview, on 12/02/2025, beginning at 12:00 PM, Clinical Manager 2 indicated Staff Audits should have been completed to include 1 observation per month for 1 staff member to observe an initiation of a CVC, discontinuation of a CVC, and CVC exit site care; she relayed the audits were not completed. During an interview, on 12/03/2025, Clinical Manager 1 indicated her date of hire for the Clinical Manger of the dialysis facility was in July 2025 with a preceptor, a Facility Administrator from a sister facility, and started her role as the Clinical Manager on 11/01/2025.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure staff performing dialysate mixing completed periodic audits of the staff’s compliance with procedures in 2 of 2 PCTs personnel records reviewed that performed dialysate mixing (PCT 4, PCT 5) and had the ability to affect 85 in-center hemodialysis (a process to filter the blood of a patient whose kidneys do not work normally) patients. Findings include: 1. Granuflo Mixing Logs, dated 11/03/2025 and 11/19/2025, indicated PCT 4 mixed the Granuflo, measured the temperature and specific gravity using a Hydrometer (instrument to measure density of liquids). 2. A Water Skills Validation Facility Form for PCT 4, dated 10/08/2024, indicated “not applicable” to the PCT tasks of bicarb system mix, rinse, disinfection, dry acid solution, and hydrometer use. 3. The Personnel Record review for PCT 4, with date of hire 07/22/2024, failed to evidence documentation of bicarb system mixing education. 4. Granuflo Mixing Logs, dated 11/15/2025, indicated PCT 5 mixed the Granuflo, measured the temperature and specific gravity using a hydrometer. 5. A Water Skills Validation Facility Form, for PCT 5, failed to evidence competency for bicarb system mix, rinse, disinfection, dry acid solution, and hydrometer use was completed prior to 12/01/2025. 6. A Personnel Record review, for PCT 5, date of hire 01/08/2024, failed to evidence documentation of bicarb system mixing education. 7. During an interview, on 12/03/2025, beginning at 10:00 AM, Clinical Manager 1 indicated PCT 4 and PCT 5 did perform dialysate mixing and the facility did not have documentation of skills validation for mixing dialysate completed, prior to 12/01/2025, and mixing skills validation should have been completed and documented.”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure a transient (temporary) patient that was provided Hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) in the facility for greater than 60 days had laboratory work up that included comprehensive metabolic testing, dialysis adequacy, complete blood count and iron studies in 1 of 1 patients records reviewed that was a transient patient (Patient #1). Findings include: A policy, dated 07/03/2023, titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” indicated the comprehensive interdisciplinary assessment would included but not limited to evaluation of appropriateness of dialysis prescription to include at least a monthly Kt/V (adequacy) for an HD patient; prescribed lab testing, evaluation of anemia (low blood count), renal bone disease (phosphorus, calcium blood test), and nutrition evaluation (albumin blood test). The policy indicated a comprehensive interdisciplinary assessment was not required for a transient patient dialyzing less than 30 days. A review of Patient #1’s blood test results on 12/01/2025, admission date of 09/20/2025, failed to evidence albumin, calcium, phosphorus, or iron labs were completed since admission, and failed to evidence a Kt/V was completed before 11/15/2025. An Orders Summary Report indicated Patient’s medication included Mircera (intravenous medication used for treatment of anemia), start date of 09/20/2025, and Venofer (intravenous medication used to treat iron deficiency), with a start date of 09/23/2025. During an interview on 12/02/2025, beginning at 12:05 PM, Clinical Manager 2 indicated Patient was transient and should of had a complete blood count including platelets, ferritin level, TSAT, Iron, Phosphorus, Calcium, basic metabolic panel blood tests after being at the dialysis facility for greater than 30 days and did not have the labs completed.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure a transient temporary) patient that received hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) for greater than 60 days had received a plan of care from the referring dialysis facility or completed a plan of care in 1 of 1 transient patient records reviewed (Patient #1). Findings include: A policy, dated 07/03/2023, titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” indicated if a patient was transferring dialysis facilities and the transferring facility had not provided a current plan of care the receiving facility would complete a plan of care within 30 days of admission. The policy indicated transient patients dialyzing less than 30 days do not require completion of a plan of care. A record review, on 12/02/2025, for Patient #1, admission date of 09/20/2025, failed to evidence a plan of care. During an interview, on 12/02/2025, beginning at 12:05 PM, Clinical Manager 2 indicated Patient #1 was to be a transient patient and the dialysis facility did not have a plan of care and requested the referring dialysis facility’s plan of care on 12/02/2025. Clinical Manager 2 indicated a plan of care should have been completed at the dialysis facility or the referring dialysis facility’s plan of care should have been in the patient’s clinical record after the patient remained at the dialysis facility for greater than 30 days and the plan of care was not available until 12/02/2025.”

“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: 47022 Based on record review and interview, the dialysis facility failed to manage patient’s volume status measured by target weight as directed in the plan of care in 1 of 1 in-center hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) clinical records reviewed that resided in a skilled nursing facility (Patient #4). Findings include: 1. A policy, dated 05/01/2023, titled, “Patient Assessment and Monitoring,” indicated pre-weight would be compared to the estimated dry weight and post-weight would be evaluated to ensure the weight was consistent with the goal set on the HD machine. 2. A policy, dated 07/03/2023, titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” indicated the plan of care would be guided and developed based on the findings identified in the comprehensive interdisciplinary assessment and the patient’s stability would be reviewed monthly. 3. A Plan of Care, dated 02/24/2025, for Patient #4 indicated interventions would include changing the patient’s dry weight by algorithm or physician order and monitoring weight between treatments for gains between 0 and 1.5 kilograms (kgs). 4. An Orders Summary Report, dated 11/04/2025, indicated Patient’s estimated dry weight [EDW] (body weight without extra fluid) of 52.8 kgs. 5. Treatment Flowsheets evidenced the following: A. 11/06/2025 HD pre-weight of 57.30 kgs, and post-weight of 55.60, and RN evaluation indicating Patient left over EDW and not teachable B. 11/08/2025, EDW 52.8 kgs, HD pre-weight 57.80 kgs, post-weight 56.8 kgs, and ultrafiltration [UF] (fluid removal) turned off during HD due to low blood pressure of 99/62, 99/68 with goal reduced to 1.2 kgs of fluid removal C. 11/11/2025, EDW 52.8 kgs, HD pre-weight 54.8 kgs, post-weight 53.3 kgs, and RN evaluation indicated Patient confused, left over EDW, continue plan of care. D. 11/13/2025, EDW 52.8 kgs, HD pre-weight 56.2 kgs, post-weight 55.10 kgs, UF turned off during HD due to low blood pressure 101/51, and RN evaluation indicated Patient not teachable E. 11/15/2025, EDW 52.8 kgs, HD pre-weight 56.7 kgs, post-weight 55.70 kgs, UF turned off during HD, and RN note indicated adjust target weight removal to max hourly Ultrafiltration Rate [UFR], not to exceed UFR of 13/ml/kg/hr F. 11/18/2025, EDW 52.8 kgs, HD pre-weight 58.9 kgs, post-weight 58.3 kgs, low blood pressure of 95/68 and 95/69 during treatment, a Kt/V (dialysis adequacy goal >1.2) of 1.13, and a RN note that indicated Patient’s blood pressure dropped during treatment, unable to remove target fluid removal, EDW not achieved, discharged via wheelchair G. 11/20/2025, EDW 52.8 kgs, HD pre-weight 55.9 kgs, post-weight 55.4 kgs, low blood pressures of 89/51 and 94/53 with UF turned off and saline fluid twice, and a RN post treatment note that indicated patient left over EDW, low blood pressure, fluids given, UF decreased during treatment, Kt/v of 1.17 H. 11/22/2025, HD pre-weight 60.20 kgs, post-weight 59.20, UF turned off due to low blood pressure, and an RN note indicating increased treatment by 15 minutes I. 11/25/2025, EDW 52.8 kgs, HD pre-weight 58.7, post-weight 57.09 kgs, Kt/v of 0.71, RN note indicated post treatment EDW achieved, 4 of 6 prior treatments required increased time for adequate fluid removal 6. A Nutrition Progress Report, dated 10/30/2025, indicated Patient resided at a skilled nursing facility faxed fluid report recommendations to skilled nursing facility’s nurse. 7. During an interview, on 12/03/2025, beginning at 10:00 AM, Clinical Manager 1 indicated patients’ weights needs to be reviewed for fluctuations and Patient #4’s EDW should have been adjusted.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure staff assessed patients’ hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) access to prevent access failure in 2 of 2 observed initiations of HD with an arteriovenous fistula [AVF] or arteriovenous graft [AVG] (HD access) (Patient #8, Patient #16). Findings include: 1. A policy, dated 05/05/2025, titled, “Access Assessment and Cannulation,” indicated evaluation of the access would be performed routinely prior to cannulation at each dialysis session. The policy indicated an AVF/AVG access site should be auscultated (listened to) with a stethoscope to assess for a bruit (high pitch/whistle). 2. During an observation, on 12/01/2025, beginning at 10:00 AM, PCT 2, at Station #12 was initiating HD for Patient #8. During the observation, PCT 2 failed to auscultate the AVF/AVG site prior to cannulation (inserted needles). 3. During an observation, on 11/25/2025, beginning at 10:50 AM, PCT 3, at Station #1 was initiating HD for Patient #16. During the observation, PCT 3 failed to auscultate the AVF/AVG site prior to cannulation. During an interview, on 11/25/2025, beginning at 11:15 AM, PCT 3 indicated she did not auscultate Patient #16’s AVF/AVG prior to cannulation due to she had felt for Patient’s bruit (thrill) and since the bruit was good she did not need to auscultate the AVF/AVG. 4. During an interview, on 12/01/2025, beginning at 2:20 PM, Clinical Manager 1 indicated PCTs should auscultate an AVF/AVG site prior to cannulation.”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility’s Quality Assessment and Performance Improvement [QAPI] Program failed to include efforts to reduce the use of central venous catheters [CVC] (dialysis access) in order to reduce the incident of infections related to catheter use in 1 of 1 dialysis facility with a 51% CVC catheter rate >90 days on 12/02/2025, and a 55% catheter rate over previous 12 months of in-center hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) patients. Findings include: 1. A policy, dated 11/04/2024, titled, “Quality Assessment and Performance Improvement Program,” indicated the program would identify opportunities and resolve identified problems through the use of continuous quality improvement methodology to achieve measurable improvement. The policy indicated the clinical manager would be responsible for developing, implementing, maintaining, and evaluating an effective data-driven QAPI program. The policy indicated the clinical manager would measure, analyze and track quality indicators. 2. The current in center HD patient census on 11/25/2025 was 85. 3. The Dialysis Facility Report for 2022 to 2023 indicated a CVC rate of 44% at the dialysis facility compared to 20% for the state. 4. A Trend Form dated October 2025, for patients with CVC greater than 90 days evidenced a Performance Target of 9.40% of patients’ months with a CVC and the current Performance was at 47.7%. The Trend Form evidenced the following CVC rate >90 days: A. November 2024 52.2% of patients with a CVC B. December 2024 48.9% of patients with a CVC C. January 2025 48.9% of patients with a CVC D. February 2025 53.3% of patients with a CVC E. March 2025 54.3% of patients with a CVC F. April 2025 45.1% of patients with a CVC G. May 2025 46% of patients with a CVC H. June 2025 48.2% of patients with a CVC I. July 2025 46% of patients with a CVC J. August 2025 52.2% of patients with a CVC K. September 2025 54% of patients with a CVC L. October 2025 53.7% of patients with a CVC 5. QAPI Meeting Notes reviewed evidenced the following: A. April 2025 staff would provide quarterly education for patients refusing permanent access placement. B. May 2025 facility had a minimal increase of catheters greater than 90 days since April 2025, staff updating information in dashboard C. July 2025 8 patients are listed as refusal for permanent access due to medical necessity, 27 patients with CVCs and few patients had fistulogram referrals sent D. August 2025 facility had a new access manager, and nurses are getting orders for fistulogram referrals E. October 2025 no CVC information was documented 6. A Vascular Access Communication Log failed to include referrals for vein mapping, surgeon referrals or patient education for 2025. A. The Access Log indicated Patient #38 was scheduled for vein mapping 01/15/2024. A NHSN (National Health and Safety Network) Event Information Form, dated 11/25/2025, indicated Patient #38 continued to have a CVC. B. The Access Log indicated Patient #39 was scheduled for vein mapping 02/16/2024. A NHSN Event Information Form, dated 11/25/2025, indicated Patient #38 continued to have a CVC. 7. During an interview, on 12/02/2025, beginning at 12:00 PM, Clinical Manager [CM] 2 indicated Patient #36 had a central venous catheter [CVC] (access for dialysis) infection on 10/01/2025, and Patient #40 had a CVC infection on 07/26/2025. During the same interview, CM 1 indicated there was no documentation that Patient #36 and Patient #40 were offered or educated on permanent access. 8. During an interview, on 12/01/2025, beginning at 2:20 PM, CM 1 indicated the CVC vascular access manager was in place, however she went on leave. CM 1 indicated the facility would be implementing patient education and initiate scheduling of vein mapping to increase the permanent vascular access numbers. CM 2 indicated she had no current documentation of implementing an action plan for their CVC rate. 9. During an interview, on 12/02/2025, beginning at 10:00 AM, the Medical Director indicated she was aware of the high CVC rate at the facility. The Medical Director indicated the facility had to find a new vascular surgeon since the surgical center that had previously completed permanent vascular access closed. The Medical Director indicated there are several issues to completing permanent vascular access for patients including transportation to appointments, and insurance coverage.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility’s Quality Assessment and Performance Improvement [QAPI] Program failed to include infection surveillance information that included the site of infection and full identification of infecting organism in 6 of 6 patient infection documentation reviewed (Patient #4, Patient #36, Patient #40, Patient #41, Patient #42, Patient #43). Findings include: 1. A policy, dated 11/04/2024, titled, “Quality Assessment and Performance Improvement Program,” indicated the QAPI committee would monitor data and information in order to prioritize areas for improvement, determine root causes, develop, implement, evaluate and revise action plans that resulted in sustainable improvement in patients care. The policy indicated the QAPI elements to be reviewed would include but not limited to infection surveillance. 2. During an interview on 12/02/2025, beginning at 12:00 PM, Clinical Manager [CM] 2 indicated the infection log given that was documented on the NHSN (National Healthcare Safety Network) Event Information Form would have to be looked up and investigated to see what was the diagnosis and source of infection, and the Event Information Forms did not contain the diagnosis, source, symptoms, or location of infections. 3. A NHSN Event Information Form for Patient #4, dated 05/03/2025, indicated patient was on intravenous [IV] antimicrobial (an agent that kills microorganisms or stops their growth) medication, administered from 05/03/2025 to 05/10/2025. The Form failed to indicate the diagnosis, the site of the infection, the event that was report and under section of problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient #4’s infection was related to escherichia coli [e.coli] (infection causing bacteria) related to an abdominal fistula (abnormal opening in the digestive tract) due to an abscess (collection of pus due to an infection). A NHSN Event Information Form, dated 07/31/2025, indicated patient had positive blood cultures (infection in blood), and failed to indicate source of positive blood cultures, diagnosis, location of infection, and under section problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient’s blood cultures indicated e.coli infection remained from the previous May 2025 infection. 4. A NHSN Event Information Form, dated 10/01/2025, for Patient #36, indicated IV antimicrobial start date of 10/01/2025 until 10/22/2025, indicated no blood sample was collected for culture, and failed to evidence source, location, diagnosis of infection, infecting organism, and under section problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient had a central venous catheter [CVC] (access for dialysis) infection and the CVC was exchanged. 5. A NHSN Event Information Form, dated 07/26/2025, for Patient #40, indicated IV antimicrobial start date of 07/26/2025 through 08/14/2025, did not indicate if a blood sample was collected for culture, and failed to evidence source, location, diagnosis of infection, infecting organism, and under section problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient had a CVC infection. 6. A NHSN Event Information Form, dated 07/09/2025, for Patient #41, indicated IV antimicrobial was started on 07/09/2025 for 1 dose, indicated no blood sample was collected for culture, and under section problems to be reported indicated none. The Form failed to evidence a source, location, diagnosis of infection, or infecting organism. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient complained of chills and nausea. CM 2 indicated blood cultures were draw and 1 dose of IV antimicrobial was given and then discontinued due to symptoms resolved and the blood cultures were negative. 7. A NHSN Event Information Form, dated 07/29/2025, for Patient #42, indicated IV antimicrobial was given 07/29/2025 through 08/23/2025, and failed to evidence a source, location, diagnosis of infection or infecting organism, and under section problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient received IV antimicrobials for osteomyelitis (bone infection) of the right great toe. 8. A NHSN Event Information Form, dated 07/31/2025, for Patient #43, indicated IV antimicrobial start date of 07/31/2025 through 08/21/2025, and failed to evidence source, location, diagnosis of infection, infecting organism, and under section problems to be reported indicated none. During an interview on 12/02/2025, beginning at 12:00 PM, CM 2 indicated Patient received IV antimicrobials for ostemyelitis of the right eye orbital bone.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility’s Quality Assessment and Performance Improvement [QAPI] program failed to ensure continuous monitoring of Hepatitis B (Liver infection) immunizations for incenter hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work properly) patients to take action that resulted in performance improvements, and failed to ensure performance improvements were tracked and sustained in 1 of 1 dialysis facility. Findings include: 1. A policy, dated 11/04/2024, titled, “Quality Assessment and Performance Improvement Program,” indicated action plans would be determined based on the severity of the identified problems and those that had the potential to affect patient health and safety. The policy indicated an action plan would include implementing the action plan with a specific goal, identifying staff members responsible for the action plan, monitoring progress and effectiveness of the action plan, review and document monthly until a resolution was achieved, reassess the plan if unsuccessful and sustain the plan of successful. 2. A Hepatitis B Summary Report, dated 11/25/2025, indicated 61% of active in center HD patients had the Hepatitis B vaccine. 3. A Hepatitis B Summary Report, for Patient #4, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary Report failed to evidence Patient was offered a Hepatitis B vaccination. 4. A Hepatitis B Summary Report, for Patient #18, dated 08/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary Report failed to evidence Patient was offered a Hepatitis B vaccination. 5. A Hepatitis B Summary Report, for Patient #23, dated 11/18/2025 indicated a Hepatitis B surface antibody of <10 (susceptible to Hepatitis B). The Summary indicated Patient refused a Hepatitis B vaccination on 04/10/2025, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 6. A Hepatitis B Summary Report, for Patient #24, dated 08/14/2025, indicated a Hepatitis B surface antibody of <10, and the clinical record failed to evidence a Hepatitis B vaccine was offered. 7. A Hepatitis B Summary Report, for Patient #27, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 04/17/2025, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 8. A Hepatitis B Summary Report, for Patient #28, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 04/26/2025, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 9. A Hepatitis B Summary Report, for Patient #29, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 08/16/2021, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 10. A Hepatitis B Summary Report, for Patient #30, dated 02/18/2025, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 04/08/2025, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 11. A Hepatitis B Summary Report, for Patient #31, dated 10/17/2024, indicated a Hepatitis B surface antibody of <10. The Summary indicated Patient refused a Hepatitis B vaccination on 04/08/2025, and the clinical record failed to evidence a declination of the Hepatitis B vaccine. 12. A Hepatitis B Summary Report, for Patient #33, dated 02/17/2025, indicated a Hepatitis B surface antibody of <10. The Summary Report failed to evidence a Hepatitis B vaccination was offered. 13. A Hepatitis B Summary Report, for Patient #35, dated 11/18/2025, indicated a Hepatitis B surface antibody of <10. Patient was admitted on 07/15/2025, a Hepatitis B surface antibody, dated 04/04/2025, was <4. The Summary Report failed to evidence a Hepatitis B vaccination was offered. 14. A Hepatitis B Summary Report indicated Patient #32 completed the Hepatitis B vaccination series on 09/16/2025, indicated the most recent Hepatitis B Surface Antibody was 02/18/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 15. A Hepatitis B Summary Report indicated Patient #34 completed the Hepatitis B vaccination series on 08/18/2025, indicated the most recent Hepatitis B Surface Antibody was 02/17/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 16. A Hepatitis B Summary Report indicated Patient #37 completed the Hepatitis B vaccination series on 09/15/2025, indicated the most recent Hepatitis B Surface Antibody was 02/17/2025, and failed to evidence a Hepatitis B Surface Antibody was rechecked 2 months after the series was completed. 17. QAPI Meeting Notes, dated May 2025 to October 2025, indicated Hepatitis B Reports were reviewed, all new patients would be tested for Hepatitis B antibodies upon admission and started on the vaccination series and all patients would be tested annually in February, and in August 2025 the Hepatitis B vaccination rate was 69.2%. The QAPI Meetings Notes failed to evidence the person responsible for monitoring Hepatitis B vaccinations and labs, monitoring of improvement or decline in percentage of patients vaccinated or performance improvements activities were sustained. 17. During an interview on 12/02/2025, beginning at 12:10 PM, Clinical Manager 1 indicated patients that refused a Hepatitis B vaccination should of had a signed declination document completed, Hepatitis B antibodies should have been rechecked 2 months after the Hepatitis B series was completed, and patients with a Hepatitis B antibody test less than 10 should have been offered a series or a booster vaccine. Clinical Manager 1 indicated no staff was assigned to monitor the status of Hepatitis B labs and vaccinations and she had recently taking over monitoring of patient Hepatitis B status.”

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure staff that perform water treatment system monitoring had completed a training program prior to independently performing water treatment system tasks in 2 of 2 personnel records reviewed of PCTs that performed water unit open and closing (PCT 4, PCT 5) and had the ability to affect 85 in center hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) patients. Findings include: 1. A Water Skills Facility Validation Form, dated 10/08/2024, for PCT 4, indicated not applicable for unit open and closing. 2. Water Pre-Treatment Open Logs for September and October 2025 indicated PCT 4 performed water pre-treatment opening on 09/03/2025, 09/16/2025, 09/27/2025, 10/08/2025, and 10/16/2025. 3. A review of the Personnel Record for PCT 4, failed to evidence successful completion of training to open and close the dialysis unit, until 12/01/2025, after the survey began. 4. A review of the Personnel Record for PCT 5, failed to evidence successful completion of training to open and close the dialysis until 12/01/2025, after the survey began. 5. A Water Pre-Treatment Open Log for September 2025 indicated PCT 5 performed water pre-treatment opening on 09/12/2025, 09/20/2025, and 09/27/2025. 6. During an interview, on 12/03/2025 beginning at 10:00 AM, Clinical Manager 1 indicated the dialysis facility had no further documentation for PCT 4 and PCT 5 water room skills evaluation prior to 12/01/2025, and should have been completed before they were assigned to complete these tasks.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure documentation of staff orientation to the facility were completed in 3 of 3 PCT’s personnel records reviewed (PCT 3, PCT 4, PCT 5). Findings include: 1. Personnel Record Review for PCT 3, transferred to dialysis facility 11/08/2025, failed to evidence a facility orientation was completed. 2. Personnel Record Review for PCT 4, date of hire of 07/22/2024, failed to evidence a facility orientation was completed. 3. Personnel Record Review for PCT 5, date of hire of 01/08/2024, failed to evidence a facility orientation was completed. 4. During an interview, on 12/03/2025, beginning at 10:00 AM, Clinical Manager 1 indicated PCT 3, PCT 4, and PCT 5’s personnel records did not have documentation of their orientation.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to evidence they implemented their internal grievance process (See V765) and failed to evidence documentation of their intervention(s), reassessment(s) to resolve Patients’ behaviors and ongoing problems, the documentation of Patient’s behaviors that seriously impaired the facility’s ability to operate, and documentation of their attempts to avert the IVD, prior to implementing (See V767). The cumulative effect of the systemic problems has resulted in the dialysis facility inability to they followed their policies regarding Grievances and Involuntary Discharges resulting in the Condition for Coverage at 494.180 Governance.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis clinic failed to evidence they implemented and followed their internal grievance process, failed to review the grievance within a reasonable timeframe, and failed to inform the patient of the steps taken to resolve the grievance in 2 of 2 complaints documented in October of 2024 related to Quality of Care /Treatment and Patient Rights (Patient #3 and Patient #4) and in 1 of 2 discharged clinical records reviewed Patient #2). Findings include: 1. The policy dated 01/02/2014 and titled, “Patient Grievance,” indicated a meeting with the patient would occur within 5 days to discuss the grievance, to resolve it as quickly as possible and provide updates to the patient. The actions taken are to be documented in the Patient Grievance Status Report. The policy indicated a grievance was any complaint or concern raised by a patient. 2. A policy dated 06/28/2018, titled, “Patient Rights and Responsibility List,” indicated the patient would be treated with dignity, consideration, respect and include sensitivity to the psychological needs and ability to cope with ESRD, the right to be informed about treatment options available to the patient, the patient can make a complaint and receive a response without fear or concern that services would be affected. The patient had the right to speak up to help protect their health and safety. The patient had the right to tell the staff if something didn’t feel or look safe, and the patient would behave appropriately and not act in a way that made other people in the clinic uncomfortable or afraid for their safety such as threatening, cursing, or yelling. 3. The clinics’ complaint log evidenced a complaint from Patient #3, dated 10/10/2024. Patient #3’s voiced concern that he/she was not able to tolerate their dialysis treatment, and they disliked the clinic and wanted to transfer. The complaint failed to evidence documented communication with Patient #3 or documentation of a resolution. 4. During an interview on 11/25/2024, beginning at 3:24 PM, Patient #3 indicated they had filed a complaint with the dietician regarding the amount of fluid being taken off during hemodialysis (a process to filter the blood of a person whose kidneys do not work normally) and felt sick during their treatment. Patient #3 indicated there was no follow up regarding their complaint. A. During an interview on 11/27/2024 beginning at 11:30 AM, the registered dietician [RD] indicated she did document Patient #3’s concerns and did notify the social worker, CM, and the administrator through a TEAM’S message; no further information was provided regarding this grievance by survey exit. B. During an interview on 11/25/2024, beginning at 9:40 AM, the SW indicated they had yet to document or follow up with Patient #3 regarding their grievance reported to and filed by the RD. C. During an interview on 11/25/2024, beginning at 11:30 AM, Administrator 4 indicated she had not touched base with Patient #3 since the grievance was written. 5. The complaint log evidenced a complaint from Patient #4, dated 10/15/2024, which indicated Patient reported being treated rudely by an unnamed RN and a PCT. Patient reported he/she felt disrespected and did not want to return to the clinic. The grievance failed to evidence documentation of follow up / communication with Patient #4 and of a resolution. A. During an interview on 11/25/2024, beginning at 9:40 AM, the SW indicated she was involved with Patient #4’s complaint of disrespectful behavior of the dialysis staff and Patient did not want to return to the clinic. The SW indicated Administrator 4 was to discuss Patient 4’s concerns with the staff involved. B. During an interview on 11/25/2024, beginning at 3:20 PM, Patient #4 indicated he/she threw up while on the treatment floor and felt bad, feelings were hurt when the staff said “eww.” Patient #4 indicated a complaint was made to SW and indicated he/she had not yet received a follow up from the facility. 6. During an interview on 11/26/2024, beginning at 11:37 AM, the facility Administrator indicated she had begun as the Administrator position on 10/14/2024; she indicated she and Administrator 4 were to address complaints during the transition. The Administrator indicated she had not addressed the complaints voiced by Patient #3 nor Patient #4. 7. During an interview on 11/25/2024, beginning at 11:30 AM, Administrator 4 indicated a complaint should be addressed within 24 hours and further indicated follow-up with complainant and any grievance should be addressed, and the resolution should be documented. Administrator 4 indicated she was not involved with Patient #4’s complaint and had not touched base with Patient #3 since the grievance was written. 8. During a follow up interview on 11/26/2024, beginning at 10:50 AM, Administrator 4 indicated the current Administrator took over the role on 10/14/2024 and she had left the Administrator position as of 09/28/2024. She indicated Corporate Staff 1 covered as the facility Administrator from 09/28/2024 to 10/14/2024. Administrator 4 indicated Corporate Staff 1 and herself were to cover complaints when the clinic was without a designated clinical manager in October 2024. 9. During an interview on 11/25/2024, beginning at 11:05 AM, the CM indicated she began in her position on 10/14/2024, though did not enter the facility until 10/21/2024. The CM indicated she was not involved with the complaints by Patient #3 or Patient #4. 10. During an interview on 11/22/2024, beginning at 7:35 PM, Patient #2 indicated PCT 4 and PCT 10 wrote on their personal protective gowns, phrases included “tell the truth,” “TikTok,” and “elderly abuse” on 10/23/2024; Patient relayed they felt the writing was retaliation towards him/her. A, A review of the grievance documented within the clinics Complaint Log, through 11/22/2024 failed to evidence documentation of Patient #2’s complaint related to PCTs’ writing on their personal protective gown(s). B. During an interview on 11/25/2024, beginning at 11:05 AM, the CM indicated the SW informed her of Patient #2’s complaint of staff who wrote on their gowns on 10/23/2024. The CM relayed she went to the floor and PCT 2 and PCT 10 had written on their gowns; the CM relayed the words written were related to domestic violence and TikTok. The CM relayed Patient #2 indicated they believed the words on the PCT’s gowns were directed towards him/her. C. During a follow up interview on 11/26/2024, beginning at 12:01 PM, the CM indicated the SW notified her that Patient #2 was weepy and upset over the words written on the personal protective gown worn by PCT 10. The CM indicated she did not write a grievance related to Patient #2’s complaint and there was no documented follow up regarding Patient #2’s grievance. The CM indicated there was an in-service that was held regarding professionalism on 10/31/2024. D. During an interview on 11/26/2024, beginning at 11:00 AM, the SW indicated she was notified of Patient #2’s concern about the PCTs writing on their personal protective gowns; the SW indicated she did not write a grievance about Patient #2’s concern, and she did not document a follow up regarding the grievance.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 47022 Based on record review and interview, the facility failed to evidence documentation of their intervention(s), reassessment(s) to resolve Patients’ behaviors and ongoing problems, the documentation of Patient’s behaviors that seriously impaired the facility’s ability to operate, and documentation of their attempts to avert the IVD, prior to implementing, for 1 of 1 clinical record reviewed of an IVD (Patient #2). Findings include: 1. The policy dated 04/04/2012 and titled, “Disruptive Patient Behavior and Use of Behavioral Agreement [BA],” indicated the POC should be revised or adjusted to demonstrate interventions or resources, agreed upon by the patient, and IDT to resolve barriers or other issues contributing to disruptive behavior. The patient’s disruptive behavior, all interventions to defuse the patient’s behavior, and the outcome of those efforts should be documented; the policy indicated the BA should be individualized to the behaviors the patient exhibited that are considered disruptive or dangerous to the safety of the patient, other patients, and / or the staff. The policy indicated the BA should define the responsibilities of the IDT in working with the patient to achieve success. The policy indicated the SW’s role was to work with the patient, counsel or teach more effective coping and communication skills, to have regular contact with the patient to support, review the progress, contacts should be documented in a progress note, and updates provided to the IDT. The SW would collaborate with the CM to determine the need for staff meeting(s) or an in-service to ensure staff, who care for the patient, understand the BA and their role in supporting a positive outcome. 2. The policy titled, “Immediate and Non-Immediate Involuntary Patient Discharge” dated 11/04/2024, defined an IVD when patients were discharged, from the facility, against their will. The policy indicated the IVD would be based on escalating behavior, when there was no physician, the clinic was unable to meet the patient’s medical needs or lack of payment. The policy indicated the Medical Director would ensure no patient was involuntary discharged from the facility unless the patient’s behavior was deemed disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate was seriously impaired. The policy indicated the IDT was required to document their assessments, the ongoing behavior concerns, their efforts to resolve the problem(s), and the IDTs’ efforts to resolve conflict and psychological issues, contributing to the behavior(s) in the patient’s medical record. 3. A copy of Patient #2’s Discharge Letter, dated 09/23/2024 indicated Patient would be discharged after their 10/23/2024’s hemodialysis (process to filter the blood of a person whose kidneys do not work properly) treatment. The letter relayed the determination to discharge was based on behaviors that were disruptive and abusive to the extent it impaired the delivery of care and the ability to operate effectively was seriously impaired. The letter indicated the facility held multiple POC meetings to address Patient’s concerns, indicated assistance would be provided for transfer to another dialysis facility. If a transfer to another dialysis provider was not found, Patient was to seek medical attention at Entity 6, a hospital for further HD. The letter included a list of dialysis facilities to contact. During an interview on 12/03/2024 at 12 PM, corporate person 2 indicated the verbiage used in the IVD notice was incorrect; the POC meetings were not held with the Patient. 4. Patients’ clinical record evidence that the most recent KDQOL (quality of life survey for dialysis patients) was assessed in February of 2024. The mental health component indicated Patients’ current score was 37.5, the previous annual assessment score was 60.5, with an average range of 40.8 to 61.5. The assessment indicated all scores were below average. Additional comments indicated incidents at the clinic have caused her stress, Patient is listed as unstable, and under a BA, Patient declines attendance or review of POC, to resurvey in one year. 5. A review of Patient #2’s clinical record failed to evidence the IDT updated Patients’ POC with the specific behaviors identified as abusive, disruptive, and / or impeding other patients’ care, interventions to resolve the issues, reassessments and measurable goals to determine resolution of the disruptive behavior(s). A. The POC dated 07/31/2024 indicated for the goal for Patient’s emotional/mental health was to improve their KDQOL scores, disruptive behaviors would be minimized, the SW and IDT would continue to monitor unspecified behaviors, the need of a behavior plan and indicated there were no bothersome symptoms during the review period. The POC included as an area of focus for modality, was education related to home dialysis and indicated the intervention was to educate Patient on their treatment options. The plan indicated there were no issues in adherence to treatment, they were monitoring unspecific behaviors. B. A Comprehensive RN Assessment dated 08/14/2024 indicated failed to evidence documentation regarding Patients’ behaviors. The assessment indicated Patient adhered to their prescribed treatment, the treatment prescription was adequate, and goals were met. C. A Psychosocial Progress note for Patient #2 dated 08/16/2024 indicated Patient #2 reported no changes since previous month, patient’s mood appeared stable, and the patient did not complain about the staff just stated that things were the same. D. The record included an 08/16/2024 POC Meeting invitation, for meeting date 08/23/2024, which was declined by Patient. E. A Psychosocial Progress note dated 08/28/2024, indicated Patient #2 was disrespectful to the RN, the nurse practitioner spoke to Patient to address Patient’s concerns, and the social worker encouraged the RN to call the human resource/compliance line. F. The POC dated 08/30/2024 indicated the goal was for Patients KDQOL score to improve to an undefined goal, indicated unspecified disruptive behaviors would be minimized, and the IDT would continue to monitor the need of a behavior plan for unspecified behaviors. The POC included as intervention(s) to help Patient identify the most bothersome symptom(s) and the SW was to monitor the undefined symptoms and or behavior(s), and as an intervention to provide crisis intervention as needed. The POC noted there were no needs at the time the POC was reviewed. The POC indicated there were no issues with adherence and Patient was compliant with treatment. The POC indicated Patient was aware of modality treatment options and would continue to educate and monitor. The POC was signed by RN 2, dated 09/23/2024, and indicated Patient chose not to sign the POC. G. The record included an undated POC Meeting invitation, for meeting date of 09/23/2024; documentation indicated Patient declined to attend. H. An ESRD Comprehensive SW Assessment, dated 09/20/2024, indicated there was no other required support needed or desired. I. A Psychosocial Progress note dated 09/23/2024 indicated a patient informed the staff that Patient #2 informed him/her that one of the Patient Care Technicians (PCT) murdered a patient and another PCT tried to assault the patient. The SW note indicated that Patient understood the statements were a violation of Patient’s behavioral agreement. The Psychosocial note failed to indicate the clinical manager, and the social worker met with the Patient as described in the behavior agreement to discuss concerns. J. The POC dated 09/23/2024 indicated behavior monitoring was in progress and Patient’s behavior had not changed; undefined what behavior(s) were unchanged within the POC. The POC included under the area of focus of emotional/mental health, indicated Patient’s goal included for their KDQOL score to improve, indicated disruptive behaviors would be minimized, and SW to monitor. An area of focus was treatment adherence, with the goal of improving adherence, identifying barriers leading to missed or shortened treatments, and indicated the facility was “in progress” of providing education. Under the area of focus for dialysis adequacy issues, indicated Patient adhered to their treatment. K. The Comprehensive RN Assessment dated 09/23/2024 indicated under any mental or neurological concerns: not applicable and failed to evidence behavior concerning documentation. The assessment indicated Patient adhered to prescribed treatment, the treatment prescription was adequate, and goals were met. L. The POC dated 10/23/2024 indicated Patient was compliant with treatment, and Patient’s mental status and behaviors had not changed, and indicated Patient was to be involuntarily discharged on 10/23/2024. M. Plans of care dated 07/31/2024, 08/30/2024 09/23/2024 and 10/23/2024 failed to evidence documentation of why Patient was not a candidate for home dialysis nor progress towards an evaluation. N. The clinical record included Patients’ KDQOL Scores Report, dated 02/28/2024; the record failed to evidence further KDQOL Scores Report were documented. O. A Rounding Note dated 08/30/2024 failed to evidence documentation of identified Patient behaviors. The Note indicated Patient insisted on having 4 liters ultrafiltration (amount of fluid taken off during dialysis) despite having low blood pressure and an adjustment in dry weight. The note indicated the medical director discussed with Patient their concern of hypovolemia (low fluid in the body) and increased ultrafiltration. The Rounding Nurse Practitioner notes dated 08/26/2024, 09/11/2024, and 09/20/2024 failed to evidence notation regarding negative behaviors exhibited by Patient #2 or reported. P. A Comprehensive Physician Assessment dated 09/23/2024, authored by the Medical Director, indicated Patient was “threatening to staff,” was “noncompliant with orders” and exhibited disruptive behavior; the clinical record failed to evidence the specific behaviors that threatened staff, was disruptive, and or documentation of interventions, successful and unsuccessful, related to the disruptive behavior which the provider was requesting to cease. 6. During an interview on 11/25/2024, beginning at 1:15 PM, the Medical Director indicated a behavior contract was given to Patient #2 due to disruptive behavior beginning in February 2024. They indicated Patient #2 had placed flyers in hospitals with Patient’s Tik Tok site, that named and described the dialysis clinic and the medical director as poor providers of care. The Medical Director indicated Patient #2 did tell other patients, in their clinic lobby, that he/she was not treated right, was abused, and had inadequate care. The Medical Director indicated Patient #2’s IVD was based on Patient’s treatment of the staff, indicated Patient’s verbal abusive behaviors towards the physician and staff. When asked about Patient’s non-compliance with orders, the Medical Director indicated Patient would want to take off more fluid during dialysis than was recommended and prescribed. 7. The BA dated 02/12/2024 indicated Patient to be considerate of other patients and staff, respect the personal rights of other patients and staff, follow the rules of the facility, Patient would not use swear words, threat, foul language to degrade, hurt or be disrespectful to staff or other patients, would act appropriately which included not acting in a way that would make other people in the clinic uncomfortable or afraid for their safety such as kicking, hitting, threatening cursing and yelling, Patient would bring to the attention of the team any concerns, issues, or complaints in order to discuss. If Patient used vulgar, degrading, or inappropriate language towards a staff member or another patient, Patient would be verbally reminded of the terms of the BA and if the behavior continued, Patient’s treatment would be ended and would be asked to leave. If Patient declined to leave the facility, the police would be called. Prior to the next treatment, Patient would have a meeting with the clinical manager and the SW. If Patient was physically violent towards a patient or staff member, the police would be called, and Patient would be immediately discharged from the clinic; Patient declined to sign the BA. 8. During an interview on 11/22/2024 beginning at 7:35 PM, Patient #2 indicated they received a discharge notice letter on 9/23/2024, from the SW; the letter notified him/her of their IVD with a 30-day notice and discharge date. Patient indicated they did not know they would be discharged, indicated they were informed he/she had exhibited abusive and disruptive behavior that impaired the facility’s ability to function. Patient indicated they said nothing and would sit in their corner chair. Patient indicated they did not seek further information of a home dialysis program. 9. During an interview on 11/25/2024, beginning at 9:40 AM, the SW indicated Patient #2 was inappropriate, relayed they felt harassed by the staff, and felt threatened and would bring up an incident from February 2024 with Administrator 4, a time when Patient and the facility called the police. The SW indicated some of the clinic staff received an injunction letter from an Attorney General, in September of 2024, related to a formal complaint filed, and that was why the facility decided to do an IVD. 10. During an interview 11/25/2024, beginning at 9:40 AM, SW indicated she monitored Patient’s behavior by reports from staff; if the staff notified the SW of Patient #2’s behavior she would make a note of it in her head to see if Patient’s behaviors’ continued. The social worker indicated they did not complete KDQOL on unstable patients, indicated KDQOL were completed annually, and indicated Patient’s #2’s last KDQOL was from February 2024. The SW indicated she did not adjust Patients goals monthly; the SW indicated she should have adjusted Patients’ goals and have made them more specific to Patient. The SW indicated she did not attempt a temporary transfer to another in network dialysis facility because Patient #2 did not want to go to a facility where Administrator 4 worked. 11. During an interview on 11/25/2024, beginning at 11:30 AM, Administrator 4 indicated she was the facility’s Administrator until 09/28/2024, indicated during the last week of September the IDT met regarding Patient #2 violation of the behavior contract when Patient #2 told other patients about how a PCT murdered a patient and another PCT abused him/her. Administrator 4 indicated interventions provided by the facility for Patient #2 was that Patient was advised behavior was not appropriate by telling patients about abuse and murder at the facility. 12. During a follow up interview on 11/26/2024, beginning at 10:50 AM, Administrator 4 indicated the alternate Administrator had approved the involuntary discharge. Administrator 4 indicated she was not aware of Patient #2 being offered a temporary transfer to another in-network dialysis facility because Patient did not want to be at any facility the Administrator 4 was at so that they excluded Patient from other in-network facilities. 13. During an interview on 11/26/2024, beginning at 12:23 PM, SW 2 indicated she did present the involuntary discharge letter to Patient #2; she indicated she read the letter to Patient related to Patient’s disruptive behavior and that Patient shared with other patients in the lobby. SW 2 relayed Patient relayed to other patients a PCT killed a patient and another PCT assaulted Patient #2. SW 2 indicated there was no staff in-service training between 02/21/2024 and 10/31/2024 training documented. SW 2 indicated the facility’s social worker should have documented regular interactions with Patient and assessment team during the POC meetings. SW 2 indicated the facility’s SW should have had meetings with Patient #2 regularly to assess barriers and offer counseling resources and this is not documented within Patients’ clinical record. SW 2 indicated Patient #2 was listed as unstable and the POC should have been addressed monthly, adjusted to reevaluate with a timeline, should have utilized documentation to document interventions and patient interactions. When asked, SW2 could not clearly identify the measurable goals within the POC. SW2 indicated the facility’s SW should have looked at documentation to see if behavior interventions should have been adjusted if Patient #2 was not meeting behavior goals and the social worker should have made notes as to why the goals were adjusted. 14. During a follow up interview on 12/02/2024, beginning at 9:10 AM, Administrator 4 indicated Patient #2 was disrupting other patients’ care due to Patient #2 required a lot of time and other patients would start dialysis late however, she did not have documentation of other patients’ dialysis treatments being affected. Administrator 4 indicated she could not provide documentation of the interventions implemented to resolve Patient #2’s behavior due to the social worker would have verbal communication with Patient and the social worker should have addressed. 15. During an interview on 12/02/2024, beginning at 10:05 AM, RN 2 indicated Patient #2 did not have escalating behaviors, she would adjust the POC if needed and indicated no other patients’ care was delayed or impaired due to providing care to Patient #2. 16. During a follow up interview on 12/02/2024 beginning at 3:00 PM, the SW indicated Patient #2 was offered home hemodialysis and home peritoneal dialysis options, however Patient did not want to burden Family Member 1. SW failed to evidence documentation of the home program options. The SW indicated Patient was offered counseling but was refused. Documentation of the counseling and home program options offered was not provided by survey exit. 17. When evidence of staff training was requested, Staff in service training dated 02/20/2024 and 10/31/2024 was provided; no further documentation of staff in-service /meeting(s) /huddles were provided by survey exit.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47022 Based on observation and interview, the dialysis failed to ensure the staff provided central venous catheter (CVC) (catheter placed into a large vein) care per provider policy in 3 of 6 observations of CVC dialysis initiation care and 2 of 3 dialysis discontinuation of CVC care on 08/20/2024 and 08/21/2024. (Patient #1, 12, 20, 21, and 23). Findings include: 1. The Policy dated 05/06/2024 and titled, “Initiation of Treatment Using a Central Venous Catheter ... “ indicated prior to initiation of a CVC a mask should be on the Patient, the hub of the CVC must be scrubbed with 70% alcohol pad for 10-15 seconds and any time caps are removed, or blood lines are disconnected to reduce the risk of contamination. 2. A Policy dated 02/05/2024 and titled, “Changing the Catheter Dressing Procedure,” indicated apply chloraprep on the skin in a back-and-forth motion to allow the solution to penetrate the cell layers of the epidermis (top layer of skin) and to ensure the entire area of the catheter insertion site was cleansed with chloraprep (antiseptic) prior to the dressing (covering) was applied. 3. During observations on 8/20/24: A. Beginning at 9:50 AM at Station #17, Registered Nurse (RN) 1 was observed initiating dialysis of Patient #20 by wiping the CVC, the red and blue hubs (access line) for less than 2 seconds each with an alcohol swab, then RN 1 inserted syringes into each the hub. After pulling blood back into the syringes, RN 1 cleansed the red hub for less than 2 seconds with an alcohol swab and inserted a vacutainer (tube to draw labs), then RN 1 removed the vacutainer and syringe and cleansed the red and blue hub for less than 2 seconds with an alcohol swab and then Patient’s dialysis was initiated. B. Beginning at 10:20 AM, at Station #15 Patient Care Technician (PCT) 4 was observed discontinuing dialysis of Patient #21’s CVC by wiping the each hub, the blue and the red hub for less than 5 seconds each, using an alcohol swab and then PCT 4 capped the hubs. C. Beginning at 10:50 AM, during an observation at station #16, Patient #23 was not wearing a mask , PCT 4 was observed discontinuing the CVC; PCT 4 wiped the red hub for 5 seconds with an alcohol swab and the blue hub was wiped for 6 seconds with an alcohol swab and then syringes were inserted into each hub, the red and blue, at 10:57 AM. Then PCT 4 gave Patient a mask to place over their mouth and nose. D. Beginning at 11:40 AM, during an observation of Patient #1 at Station #15, PCT 4 was observed wiping Patients’ CVC exit site with a chloraprep (antiseptic) swab; PCT 4 wiped from the left side to the top and to the right side in a back and forth motion, and then turned over the swabbed and touched the CVC’s insertion site, however PCT 4 did not clean around the insertion site. PCT 4 applied a dressing (insertion site cover) then wiped each of the 2 hubs with an alcohol sawp, wiped the red hub for 8 seconds and wiped the blue hub for 6 seconds, then syringes were inserted into the red and blue hub. 4. During an interview on 08/20/2024, beginning at 10:25 AM, RN 1 indicated the hubs of a CVC should be scrubbed with an alcohol swab for 1-2 minutes. 5. During an interview on 08/20/2024, beginning at 11:45 AM, RN 3 indicated the CVC hubs should be scrubbed with an alcohol swab for 30 seconds. 6. During an observations on 8/21/24, beginning at 10:25 AM, at Station #19 PCT 1 was observed providing care to Patient #12, observed to wipe Patients’ CVC with a chloraprep swab, using a circular motion from the insertion site outward and then returned to the insertion site to swab again and then a dressing was applied. 7. During an interview on 08/21/2024, beginning at 11:00 AM, PCT 3 indicated a CVC site should be cleansed with chloraprep from the insertion side to the outside and do not touch the insertion site again with the chloraprep swab after inside to outside cleansing was completed, and indicated the hubs of the CVC should be cleansed with an alcohol swab for 15 seconds.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to evidence a Patient’s current individualized dialysis prescription was evaluated to meet the needs of a Patient, failed to evidence the Patient was assessed or the physician was notified in 1 of 1 Patients records reviewed with a documented fall (Patient #2). Findings include: 1. A policy dated 02/06/2023, titled, “Patient Safety Event Reporting and Documentation,” indicated documentation of patient events should include patient assessment and documentation should include the physician was notified. 2. A Clinical Note Report dated 07/11/2024 indicated Patient #2 fell outside of the dialysis building when trying to get into the transportation van, Patient denied hitting his/her head and denied need to go to the Emergency Room and wanted to go home because his/her hand hurt. The Clinical Note failed to document if an assessment was attempted on Patient to include vital signs. 3. A Treatment Sheet dated 07/11/2024 for Patient #2 indicated Patient received a bolus of 7000 units of Heparin (blood thinner) during hemodialysis (process to clean the blood of a patient whose kidneys do not work normally). 4. During an interview on 08/20/2024, beginning at 6:15 PM, Patient #2 indicated he/she fell outside after dialysis and thought he/she had passed out because only remembered people were surrounding him/her and he/she did not understand what was going on. Patient #2 indicated he/she could not remember if he/she asked to go to the hospital and the driver of the transportation van and the Patient’s family member had to assist Patient to get into his/her home. 5. During an interview on beginning at 10:15 AM, registered nurse (RN) 2 indicated Patient #2 fell when trying to get into transportation van while carrying bags, RN 2 indicated Patient refused an ambulance and the staff did not check Patient’s vital signs, Patient denied hitting their head, and physician should have been notified and would have documented if the physician was notified. RN 2 indicated the Patient was not brought into the building for an evaluation. RN 2 indicated Patient did not have any visible injuries. 6. During an interview on 08/21/2024, beginning at 1:50 PM, the Administrator indicated after a Patient fall, the physician should be notified and there was not documentation that a physician was notified. The Administrator indicated Patient should have vitals signs assessed after the fall and if Patient refused assessment the physician should have been notified.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to identify a Patient fall in the QAPI (quality assessment and performance improvement) program to limit the number of patients who are adversely affected by such occurrences in 1 of 1 Patient’s records reviewed with a documented fall. (Patient #2). Findings include: 1. A policy dated 02/06/2023, titled, “Patient Safety Event Reporting and Documentation,” indicated the policy was to provide guidelines for all clinical staff on identifying, reporting and documentation patient related safety events to provide a standardized process for the management of patient safety events. The policy indicated when a safety event occurred, staff are required to report, document and review the event. The policy indicated events that occurred outside the facility may be considered a serious safety event when related to the dialysis treatment or the care provided. The policy indicated the patient safety event should be reviewed during the QAPI program to perform an analysis of the events to identify trends to include preventability and determine an opportunity for improvement. The policy indicated an unplanned descent to the floor or ground would indicate a fall and would be included in a patient safety event. 2. A Grievance Report dated 07/18/2024 indicated Patient #2 fell getting into a transportation van after dialysis treatment on 07/11/2024. 3. During an interview on 08/21/2024, beginning at 10:15 AM, Registered Nurse 2 indicated Patient #2 fell attempting to get into the transportation van and indicated they did not complete an incident report. 4. During an interview on 08/21/2024, beginning at 1:50 PM, the Administrator indicated an adverse event report was not completed for Patient #2 after the reported fall, and should have been completed.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 47022 Based on observation and interview, the dialysis clinic failed to ensure patient care was provided per policy during 1 of 1 on site observation of care. Findings include: 1. A policy dated 11/06/2023, titled, “Hand Hygiene,” indicated alcohol based hand rub or hand washing with antimicrobial soap and water should be used before and after direct contact with patients, immediately after removing gloves, after contact with inanimate objects near the patient. 2. During an observation on 05/15/2024: A. Beginning at 10 AM, Patient Care Technician (PCT) 3 was at dialysis station 4 with Patient #9; PCT 3 was observed wearing gloves on both hands and touching the computer screen and keyboard as they checked and entered Patient information. PCT then moved to station 3 with Patient #2 present and while wearing the same gloves, touched the computer screen and keyboard in station 3, then without changing gloves or hand sanitizing, returned to station 4 with Patient #9 and then removed gloves and sanitized hands. B. Beginning at 10:10 AM, PCT 3 was observed with a glove on their right hand and touched the computer screen for station #3, PCT 3 then removed the right hand glove and walked Patient to the scale and pressed the scale button to weigh Patient; PCT failed to sanitize hands after they removed their gloves and before providing direct patient care. C. During an interview on 05/16/2024, beginning at 9:40 AM, PCT 4 indicated gloves are to be removed between patients and hands sanitized. D. During an interview on 05/15/2024, beginning at 12:30 PM, PCT 2 indicated he/she has had infection control training and should change gloves and sanitized hands between patients. E. During an interview on 05/15/2024, beginning at 12:45 PM, PCT 3 indicated they have had infection control training and inservices. PCT 3 indicated gloves should be changed between patients and hands sanitized and hand sanitizing should occur after gloves removed and after each patient interaction.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 47022 Based on observation and interview, the facility failed to ensure the treatment area was free from possible contaminates in 1 of 1 observation of the incenter hemodialysis treatment floor. Findings include: During an observation on 05/15/2024, beginning at 9:15 AM, a nature sweet, sweet and salty granola bar was noted at the south workstation on the treatment floor next to the dialyzers and saline bags. During an observation on 05/15/2025, at 10:55 AM, the granola bar remained on the south workstation. During an interview on 05/15/2024, beginning at 10:55 AM, Patient Care Technician (PCT) 5 indicated the granola bar at the workstation should not be at the workstation and it did not belong to a patient. During an interview on 05/15/2024, beginning at 11:40 AM, Registered Nurse 1 indicated there should be no food at the workstations on the dialysis floor.”

“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, interview, and record review, the dialyis clinic failed to ensure dialysis equipmement was decontaminated between each patient use. Findings include: A policy dated 09/05/2023, titled, “Cleaning and Disinfecting the Dialysis Station,” indicated the dialysis station included the chair, reusable equipment to include IV pole and blood pressure cuff should be disinfected with bleach solution after completion of a dialysis (removal of toxins from people whose kidneys no longer worker normally) procedure. During an observation on 05/15/2024, beginning at 10:25 AM, Patient Care Technician (PCT) 2 was observed as they cleaned dialysis station #23. Noted the stations’ blood pressure cuff was lying on the floor. PCT 2 picked the cuff from the floor and hung the blood pressure cuff back on to the IV pole without decontamination. During an interview on 05/15/2024, beginning at 12:45 PM, PCT 3 indicated during station cleaning, the blood pressure cuff should be cleaned with bleach solution and hung on the IV pole, if a blood pressure cuff were to touch the floor it should be recleaned.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 42909 Based on record review and interview, the Interdisciplinary Team (IDT) failed to ensure the initial interdisciplinary comprehensive assessment was completed for 1 of 2 newly admitted patients who received dialysis treatments for greater than 30 days, and received at least 13 hemodialysis sessions (Patient #34). The findings include: 1. Patient #34’s clinical record included a hospital document dated 02/16/24, which evidenced Patient had a heart transplant in 2020, was deemed dialysis dependent during this hospitalization (2/01/24 - 2/13/24), and a central venous catheter (CVC) (a tube inserted into a large vein, usually under the right collarbone, for administration of dialysis treatments) was placed on 02/06/24. 2. As of 4/17/24, the clinical record failed to evidence all members of the IDT completed a discipline-specific initial comprehensive assessment to assure all required elements of the comprehensive assessment were addressed. The record evidenced: A. An admission and first treatment visit note dated of 02/15/24. B. Treatment notes dated 02/16/24, 2/19/24, 2/21/24, and 2/26/24. C. A hospitalization occurred from 02/26/24 - 3/01/24. A hospital document evidenced the patient was hospitalized on 02/26/24, after complaints of shortness of breath and chest pain during their dialysis treatment. D. Treatment records dated 3/04/24, 3/06/24 and 3/08/24. E. Hospitalization occurred from 3/11/24 to 4/02/24. F. Treatment record notes dated 4/03/24, 4/05/24, 4/08/24, 4/10/24, and 4/12/24, (4/12/24 being the 13th dialysis treatment session), and 4/15/24. G. Nurse Practitioner (NP) 1’s provider visit note, dated 4/03/24, indicated Patient was status post hospitalization (3/11/24 - 4/02/24) and now required a dobutamine drip (an intervenous [IV] drug given to treat severe heart failure) and was unstable. 3. During an interview on 4/17/24 at 9:11 AM, the Administrator indicated Patient #34 didn’t have a POC yet because of the lengthy hospital stay, the IDT meeting to finalize the initial POC was scheduled for 4/29/24, and all components of the inderdisciplinary assessments would be done, reviewed, and used to create the POC at that time. During an interview on 4/17/24 at 11:40 AM, the Clinical Manager indicated the Medical Director rounded monthly at the facility; the patient was in the hospital the last time the Medical Director rounded, therefore Patient was not seen. The Medical Director was next scheduled to be in the clinic on 4/29/24 and the comprhensive assessment and care plan was scheduled to be completed at that time.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 42909 Based on record review and interview, the Interdisciplinary Team (IDT) failed to ensure a comprehesive reassessment was completed for 1 of 2 newly admitted patients who received outpatient hemodialysis sessions for greater than 30 days, and was classified as “unstable” (Patient #34). The findings include: Patient #34’s clinical record included a hospital document dated 2/16/24, which evidenced the patient had a heart transplant in 2020, had frequent re-hospitalizations due to complex co-morbidities, was deemed dialysis dependent during this hospitalization (2/01/24 - 2/13/24), a central venous catheter (CVC) (a tube inserted into a large vein, usually under the right collarbone, for administration of dialysis treatments) was placed on 2/06/24, and dialysis treatments would begin immediately. Patient #34’s clinical record included but not limited to an admission and first treatment visit note dated of 2/15/24, a visit note dated 2/26/24, hospitalization 2/26/24 - 3/01/24, a visit note dated 3/08/24, and hospitalization 3/11/24 - 4/02/24. A hospital document evidenced the patient was hospitalized on 2/26/24, after complaints of shortness of breath and chest pain during dialysis treatment. An undated document received on 4/16/24, titled “Unstable Patients”, indicated Patient #34 was listed as unstable in March (2024), and was not listed as unstable in February (2024). Nurse Practitioner (NP) 1’s provider note dated 4/03/24 indicated the patient was status post hospitalization (3/11/24 - 4/02/24), now required a dobutamine drip (an intravenous [IV] drug), given to treat severe heart failure, and was unstable. As of 4/17/24, the clinical record failed to evidence a completed initial comprehensive assessment or reassessment. During an interview on 4/17/24 at 9:11 AM, the Administrator indicated Patient #34 didn’t have a POC yet because of the lengthy hospital stay, the IDT meeting to finalize the initial POC was scheduled for 4/29/24, and all components of the inderdisciplinary assessments would be done, reviewed, and used to create the POC at that time. During an interview on 4/17/24 at 11:40 AM, the Clinical Manager indicated the Medical Director rounded monthly at the facility, the patient was in the hospital the last time the Medical Director rounded, so the patient was not seen, and the Medical Director would be here next on 4/29/24.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure they maintained a sanitary environment specific to the mixing and storage of bleach solutions (See V111), failed to ensure staff completed hand hygiene according to hand hygiene policies and procedures (See V113), failed to ensure staff completed disinfection of dialysis stations according to facility policies and procedures (See V122), failed to ensure staff followed best practice and disinfected the connection hub of the central venous catheter prior to administering intravenous medication (See V143), and failed to ensure staff performed central venous catheter (CVC) site care according to facility policies and procedures (See V147). The cumulative effect of these systemic issues resulted in the facility being unable to provide adequate infection control measures. Therefore, Fresenius Medical Care Gary was found out of compliance with Conditions of Coverage 494.30 Infection control.”

“CFC-PATIENTS- RIGHTS CFR(s): 494.70 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to protect the patients’ right to be free from verbal abuse from facility staff (See V452), failed to ensure the patient’s right to privacy during verbal interactions between staff was maintained (See V454), failed to ensure the patient’s clinical documents remained confidential and private on the in-center hemodialysis (ICHD) treatment floor (See V455), failed to protect the patients’ rights and ensure the patient received his/her dialysis prescription as ordered (See V463), failed to investigate and document resolution of patient grievances according to facility policy (See V465), failed to ensure all patients remained free from retaliation for filing a complaint with the State Agency (SA) and/or with the facility (See V467), and failed to ensure policies and procedures were followed when they involuntarily discharged a patient (See V469). The Administrator and Clinic Manager were notified on 02/19/24 at 3:22 PM of an Immediate Jeopardy at 42 CFR 494.70 Patients’ Rights. The Immediate Jeopardy was identified, beginning on 02/09/2024. The immediacy was not abated prior to survey exit on 02/22/24. The scope and severity of these systemic problems resulted in the ESRD facility failing to protect and promote Patients’ Rights, which resulted in Fresenius Medical Care Gary was found to be out of compliance with 42 CFR 494.70 Patients’ Rights. 42524”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 42617 Based on record review and interview, the interdisciplinary team (IDT) failed to ensure the patient’s plan of care was individualized, included measurable interventions, outcomes, or goals, evidenced interventions the patient and/or IDT was conducting to address disruptive behaviors, and the IDT met at least annually to review and update the plan of care (See V541); failed to ensure the physician was notified when an ICHD patient was below their Estimated Dry Weight (EDW) prior to treatment or when the ICHD patient’s post-treatment weight was greater than/less than 1 kilogram of the ordered EDW, failed to ensure staff followed facility policies specific to the treatment of orthostatic hypotension, and failed to ensure patients were assessed and/or monitored per policy (See V543); failed to ensure the ICHD patient’s dialysis prescription was followed during treatment specific to the blood flow rate (See V544); the clinic failed to ensure they provided the necessary care for patients to achieve appropriate albumin levels (See V545); the clinic failed to ensure they provided the necessary care for patients to achieve appropriate hemoglobin levels (See V547), and failed to ensure the plan of care was reviewed and signed by the patient, and if the patient declined to sign, this would be indicated on the plan of care (See V556). The cumulative effects of these systemic issues resulted in the dialysis facility failing to implement and maintain the patient’s plan of care. Fresenius Medical Care Gary was found out of compliance with 42 CFR 494.90 Patient plan of care.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis clinic failed to maintain a sanitary environment specific to the mixing and storage of bleach solutions used for disinfection of the dialysis stations and clamps, which had the potential to affect all in-center hemodialysis (ICHD) patients in 4 of 5 observations of the incenter dialysis treatment floor. Findings include: 1. The review of facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated bleach solution should be stored in a covered container “to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” 2. The review of facility policy titled “Mixing Bleach,” dated 8/25/20, indicated when preparing the 1:10 concentration bleach solution, staff should mix 1 millilter (mL) bleach for every 9 mL of water. When preparing the 1:100 concentration bleach solution, staff should mix 1 mL bleach for every 99 mL of water. The policy indicated the container with the bleach solution should be labeled with the solution’s concentration and covered with a lid. 3. During an observation on the in-center hemodialysis treatment floor on 2/14/24 beginning at 8:20 AM, one container of bleach solution was observed open. 4. During an observation on the ICHD treatment floor on 2/19/24, the following was observed: a. At 8:32 AM, one container of bleach solution with clamps sitting in the solution was observed open. b. At 8:45 AM, one container of bleach solution was observed open and sitting at a clean handwashing sink. c. At 8:57 AM, one container of bleach solution was observed open. d. At 10:55 AM, one container of bleach solution was observed open and sitting at a clean handwashing sink. Patient Care Technican (PCT) 3 was observed washing his/her hands at the sink. At 10:57 AM, PCT 1 wash observed dipping a clean gauze pad into the bleach solution and left the container open as he/she left the handwashing station. The technician used the bleach-soaked gauze pad to clean an ICHD dialysis station. e. At 11:16 AM, one container of bleach solution was observed open and sitting at a clean handwashing sink. PCT 7 was observed washing his/her hands at the sink. 5. During an observation on the ICHD treatment floor on 2/20/24 at 9:02 AM, one container of bleach solution was observed open and sitting at a clean handwashing sink. PCT 5 was observed washing his/her hands at the sink with the open beach container. 6. During an interview with PCT 1 on 2/21/24 beginning at 8:14 AM, the technician reported he/she made 2 of the 4 bleach solutions being used on the ICHD treatment floor. PCT 1 reported one container was 1 part bleach to 10 parts water (1:10 concentration) and the other was 1:100 concentration. The technician stated when preparing the 1:10 bleach solution, he/she would measure out 50 milliliters (mL) bleach, and when preparing the 1:100 bleach solution, he/she would measure out 10 milliliters (mL) bleach. During an observation on the ICHD treatment floor on 2/21/24 at 8:21 AM, a sign on the treatment floor was observed with instructions on how to prepare bleach solutions. For 1:10 bleach solution, staff were to mix 10 mL bleach to 990 mL water. For 1:100 bleach solution, staff were to mix 10 mL bleach and 900 mL water. During a follow-up interview with PCT 1 on 2/21/24 beginning at 8:22 AM, the technician reported when preparing the 1:10 concentration bleach solution, he/she would mix 50 mLs bleach with 1000 mLs water. For the 1:100 concentration bleach solution, PCT 1 would mix 10 mLs bleach with 1000 mLs water. The technician showed the surveyor the male urinal container staff used to measure out water and pointed to the 1000 mL marker, indicating this was the line PCT 1 filled the water to when mixing both 1:10 and 1:00 bleach solutions. During an observation on the ICHD treatment floor on 2/21/24 beginning at 10:21 AM, PCT 1 soaked 4x4 cloth pads in the container which the PCT had previously indicated was 1:100 concentration bleach solution made with 10 mLs bleach and 1000 mLs water. The technician used the soaked gauze pads to clean Station #19. During an observation on the ICHD treatment floor on 2/21/24 beginning at 10:37 AM, PCT 4 soaked 4x4 gauze pads in the container which PCT 1 had previously indicated was 1:100 concentration bleach solution made with 10 mLs bleach and 1000 mLs water. The technician used the soaked cloth pads to clean Station #2. 7. During an interview with PCT 5 on 2/21/24 beginning at 10:48 AM, the technician reported he/she made 2 of the 4 bleach solutions being used on the ICHD treatment floor. PCT 5 stated the container sitting at a clean handwashing sink was 1:10 concentration and the container at a dirty sink was 1:100 concentration. The container indicated as 1:100 concentration was observed to be labeled “1:100 concentration” and had clamps soaking in it. PCT 5 reported he/she prepared the 1:100 concentration bleach solution using 10 mLs bleach and 1000 mLs water. The technician stated the container he/she used to measure the water was not on the treatment floor at that time. PCT 5 and surveyor observed the container sitting at the clean handwashing sink failed to evidence a label with the concentration of the solution. PCT 5 stated this solution would need to be remade as the container failed to evidence a label. During a follow-up interview with PCT 5 on 2/21/24 beginning at 12:50 PM, the technician reported the container sitting at the clean handwashing sink was 1:100 concentration bleach solution and the container at the dirty sink with clamps soaking in it was 1:10 concentration. PCT 5 stated both bleach solutions would need to be remade as the containers failed to evidence they were clearly marked with the solution’s concentration. The technician showed the surveyor the male urinal container used to measure out water when preparing the bleach solution. PCT 5 reported when making 1:100 concentration bleach solution, he/she mixed 10 mL bleach with 990 mLs water. When asked to point to the marking on the male urinal container that was 990 mLs water, PCT 5 pointed to the marking for 975 mLs. The male urinal container used to measure water failed to evidence a marking for 990 mLs. 8. During an interview with Clinic Manager 2 on 2/21/24 beginning at 1:20 PM, the clinic manager reported when staff were preparing 1:10 concentration bleach solution, they should mix 10 mLs bleach with 900 mLs water. When preparing 1:100 concentration bleach solution, staff should mix 10 mLs bleach with 990 mL water. Clinic Manager 2 reported staff used a male urinal container to measure water for the bleach solution. When asked to point to the marking on the male urinal container that was 990 mL, the clinic manager pointed to the marking for 975 mLs. 9. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, Clinic Manager 2 reported the bleach containers should be stored with the lid on. 42524 10. During an interview on 2/20/24 at 10:00 AM, Registered Nurse (RN) 4 indicated the bleach containers should remain closed. 11. During an observation of the ICHD treatment area on 2/22/2023 at 9:57 AM, one container of bleach solution was observed sitting open on the counter across from the nurse’s station.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff completed hand hygiene according to hand hygiene policies and procedures during 3 of 4 days of in-center hemodialysis (ICHD) treatment floor observations (Patient Care Technicians (PCT) 2, 5, 7, 8, 9). Findings include: 1. The review of facility policy #47664 titled “Hand Hygiene,” dated 11/06/23, indicated hand hygiene should be performed before and after direct contact with patients, when entering and leaving the treatment area, and immediately after removing gloves. The policy also indicated when performing hand hygiene by washing hands with soap and water, the procedure should last “40 - 60 seconds.” 2. During an observation on the ICHD treatment floor on 2/19/24, the following was observed: a. At 9:17 AM, Patient Care Technician (PCT) 7 was observed leaving Station #7. The technician removed his/her gloves, walked to a supply station, donned new gloves, and re-entered Station #7. PCT 7 failed to perform hand hygiene in between glove change. b. At 9:42 AM, PCT 2 was observed removing his/her gloves, adjusting his/her mask, donning new gloves, and entering Station #7. PCT 2 failed to perform hand hygiene in between glove change. c. At 9:43 AM, PCT 7 was observed assisting Patient #9 holding pressure to his/her arteriovenous (AV) fistula site, which had bled through the gauze. PCT 7 cleaned the excess blood from the patient’s skin, discarded the bloodied gauze and barrier, removed his/her gloves, and washed his/her hands for less than 5 seconds. PCT 7 then entered Station #20 and donned gloves. During an interview with PCT 7 on 2/20/24 beginning at 9:59 AM, the technician reported hand hygiene should be performed prior to donning new gloves. d. At 10:34 AM, PCT 2 was observed drawing up Heparin (a blood thinner medication) from a multi-dose vial at the medication preparation area. The technician took the medication vial to Station #8, changed his/her gloves, and injected the medication into Patient #10’s Central Venous Catheter (CVC). The technician failed to perform hand hygiene in between glove changes. During an interview with PCT 2 on 2/20/24 beginning at 9:40 AM, the technician reported hand hygiene should be performed “every time” he/she takes off gloves. e. At 10:36 AM, PCT 7 was observed washing his/her hands for less than 5 seconds. f. At 11:16 AM, PCT 7 was observed washing his/her hands for 12 seconds. g. At 11:31 AM, PCT 9 entered Station #3 with ungloved hands. The technician placed tape on the patient’s drape, donned 1 glove, obtained additional supplies from the supply station in the middle of the treatment floor, and donned a second glove. PCT 9 opened supply packaging, left the station to throw away trash, and adjusted his/her face shield as re-entering Station #3. PCT 9 then began initiating Patient #30’s dialysis using an AV fistula. 3. During an observation on the ICHD treatment floor on 2/20/24, the following was observed: a. At 8:50 AM, PCT 7 was observed to wash his/her hands for 5 seconds. b. At 9:03 AM, PCT 5 was observed to wash his/her hands for 20 seconds. 5. During an observation on the ICHD treatment floor on 2/21/24 at 9:49 AM, PCT 8 was observed in Station #16 with Patient #32. The technician was observed and changed his/her gloves, though failed to perform hand hygiene in between glove changes. 6. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, the administrative staff reported staff should perform hand hygiene in-between glove changes, after removing gloves, and after handing items that soiled or have visible blood. 42524 7. During an observation of the ICHD treatment floor on 2/20/24, the following was observed: a. At 9:20 AM, PCT 2 was observed writing on the daily schedule. PCT 2 then donned gloves and began to set up the dialysis machine at Station #2; PCT 2 failed to peform hand hygiene prior to donning gloves. b. At 9:25 AM, PCT 5 was observed he/she washed their hands with soap and water, they completed the entire hand-washing procedure, including drying their hands, in 8 seconds. c. At 9:33 AM, PCT 5 was observed washing his/her hands with soap and water after removing needles for the Patient at Station #18. PCT 3 completed the entire hand-washing procedure, including drying his/her hands, in 7 seconds. d. At 9:50 AM, PCT 5 was observed washing his/her hands with soap and water. PCT 3 completed the entire hand-washing procedure, including drying his/her hands, in 6 seconds. 8. During an interview on 2/20/24 at 9:53 AM, PCT 5 indicated handwashing was to be done in between patients and when hands are soiled. The technican indicated hands should be scrubbed for a minimum of 20 seconds with soap and water.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff completed disinfection of dialysis stations according to facility policies and procedures and best practice in 5 of 6 observation of staff disinfecting a dialysis station (Patient Care Technicians (PCT) 1, 2, 9). Findings include: 1. The review of the facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated when disinfecting a dialysis station, staff should open the side panels of a treatment chair to disinfect all chair surfaces. “Special attention” should be paid to cleaning the control panel on the dialysis machine “and other surfaces that are frequently touched and potentially contaminated with patients’ blood / bodily fluids.” The policy indicated all the surfaces of the machine, including “the air detector chamber, blood pump casing, IV pole, and wherever the extracorporeal circuit was in contact with the machine” should be disinfected. The policy also indicated staff should allow all surfaces to air dry. 2. During an observation on 2/19/24 beginning at 8:52 AM, PCT 9 was observed cleaning Station #4 after the patient left the treatment floor. PCT 9 failed to open and clean the chair’s side panels. While the station was visibly wet with bleach, PCT 9 placed new supplies on the chair’s side table. 3. During an observation on the ICHD treatment floor, PCT 9 was observed cleaning Station #3 after the patient left the treatment floor. PCT 9 failed to open and clean the chair’s side panels. During an interview with PCT 9 on 2/19/24 beginning at 3:59 PM, the technician reported when cleaning a dialysis station after use, the treatment chair’s side panels should be opened and wiped down with a bleach pad. PCT 9 reported the station should be allowed to dry for 30 - 60 seconds prior to placing new equipment in the station. 5. During an observation on the ICHD treatment floor on 2/21/24 beginning at 10:21 AM, PCT 1 was observed cleaning Station #19 after the patient left the treatment floor. While wiping down the dialysis machine, the technician failed to clean the top of the IV pole where the saline bag had hung. After wiping down the machine and prior to cleaning the treatment chair, PCT 1 took a new saline bag to the station, hung it on the IV pole, and connected blood line tubing. PCT 1 then began cleaning the station’s chair. The technician wiped the chair’s side panels then immediately closed them, failing to allow the side panels to dry. 6. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, the administrative staff indicated when disinfecting a dialysis station, staff should wipe down the entire station, including opening the chair and wiping down all sides. The administrative staff indicated the dialysis machine should be wiped down from top to bottom, including the IV pole, BP cuff and tubing, and back of the machine. Clinic Manager 2 stated staff should leave the chair side panels open to allow the bleach solution to dry. 42524 7. During an observation on 2/20/24 at 9:15 PM, PCT 2 was observed cleaning Station #2. PCT 2 failed to clean the IV pole, failed to clean inside the blood pump door, and failed to clean the shelf behind the station. PCT 2 failed to remove the standard blood pressure cuff that remained in the basket and failed to clean the side of the dialysis machine. PCT 2 cleaned a large blood pressure cuff and then placed it on the dirty shelf. 8. During an interview on 2/20/24 at 9:20 AM, PCT 2 indicated when cleaning the station, the entire machine needs to be wiped down, including opening all doors, wiping the sides and back of the machine, the dialysate lines, and machine shelf. The technician indicated the blood pressure cuff should be cleaned and the chair should have the sides opened anad be fully reclined.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42617 Based on observation and interview, the dialysis facility failed to ensure staff followed best practice when disinfecting the connection hub a central venous catheter (CVC) prior to administering intravenous medication for 1 of 1 observations of staff discontinuing in-center hemodialysis (ICHD) using a CVC (Patient Care Technician (PCT) 9) and 1 of 4 observations of staff initiating ICHD using a CVC (PCT 3). Findings include: 1. During an observation at Station #4 on 2/19/24 beginning at 8:37 AM, Patient Care Technician (PCT) 9 was observed disconnecting Patient #12 from his/her dialysis using a Central Venous Catheter (CVC, a long catheter placed into a large vein). After disconnecting the dialysis blood line from the first CVC hub, PCT 9 scrubbed the hub for 5 seconds with a 70% alcohol pad then connected a saline syringe. PCT 9 repeated the procedure with the second CVC hub, scrubbing the hub for 3 seconds with a 70% alcohol pad. During an interview with PCT 9 on 2/19/24 beginning at 3:59 PM, the technician reported the CVC hub should be scrubbed for 30-60 seconds prior to connecting any syringes or dialysis tubing. 2. During an observation at Station #9 on 2/19/24 beginning at 10:18 AM, PCT 3 was observed initiating Patient #6’s dialysis using a CVC. After connecting a saline syringe to the first CVC hub, the technician scrubbed the second hub with a 70% alcohol pad for 4 seconds then connected a saline syringe. During an interview with PCT 3 on 2/19/24 beginning at 4:04 PM, the technician reported the CVC hub should be scrubbed for 15 seconds prior to connecting any syringes or dialysis tubing. 3. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, Clinic Manager 2 reported staff should scrub the hub of a CVC with an alcohol pad for 10-15 seconds prior to connecting a syringe or dialysis tubing.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff followed central venous catheter (CVC) site care according to facility policies and procedures for 3 of 3 observations of staff performing CVC exit site care (Patient Care Technician (PCT) 1, 2, and 3). Findings include: 1. The facility procedure #45664 titled “Changing the Catheter Dressing Procedure,” dated 2/05/24, indicated when changing the dressing on a central venous catheter (a long catheter placed in a large vein for dialysis), staff should disinfect the area around the catheter’s insertion site, allow the disinfect to dry, and then place a new sterile dressing to the site. 2. During an observation at Station #9 on 2/19/24 beginning at 10:18 AM, PCT 3 was observed performing site care to Patient #6’s CVC. PCT 3 cleaned the site with a disinfectant swab beginning at the base of the catheter and going towards the insertion point. After cleaning the catheter site, Patient #6’s shirt touched the cleaned area prior to PCT 3 applying a new dressing. During an interview with PCT 3 on 2/19/24 beginning at 4:04 PM, the technician reported when performing site care to a CVC, the technician would begin cleaning at the base of the catheter, move the swab up towards insertion point, and take it down the other side of the catheter. PCT 3 reported the patient’s clothing should be clamped or taped so it does not touch the cleaned site prior to applying a new dressing. 3. During an observation at Station #8 on 2/19/24 beginning at 10:27 AM, PCT 2 was observed performing site care to Patient #10’s CVC. PCT 2 cleaned the site with a disinfectant swab beginning at the base of the catheter and going towards the insertion point. 4. During an observation at Station #16 on 2/19/24 beginning at 10:39 AM, PCT 1 was observed performing site care to Patient #28’s CVC. PCT 1 cleaned the site with a disinfectant swab moving from the outer edges of the catheter to the insertion point. The technician failed to clean the site for 30 seconds. 5. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, the administrative staff indicated the CVC site should be cleaned beginning at the insertion point and going outward.”

“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: 42617 Based on observation and interview, the dialysis facility failed to ensure all medication not immediately given was labeled with the intended patient’s name for 2 of 2 medication syringes observed being stored for later use and failed to ensure the in-center hemodialysis (ICHD) treatment floor remained free of potential trip hazards for 1 of 4 days of ICHD treatment floor observations, which had the potential to affect all ICHD patients. Findings include: 1. During an observation on the in-center hemodialysis treatment floor on 2/20/24 at 8:59 AM, two unlabeled 3 milliliter (ml) syringes filled with a clear solution were observed on the counter of a supply station. During an interview with PCT 7 on 2/20/24 at 9:54 AM, the technician reported he/she had previously drawn up Heparin into the 2 unlabeled syringes for 2 patients and had stored them at the supply station until needed. PCT 7 stated he/she “knew” which patient was to be given which Heparin syringe. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:40 PM, the administrative staff reported medication prepared for a later administration should be labeled and kept in a locked compartment. 2. During an observation on the ICHD treatment floor on 2/21/24 at 8:24 AM, three supply boxes and 1 tub filled with saline bags were observed in the middle of the treatment floor by Stations #7 and #8. Two of the supply boxes were unopened and sitting on a cart. The tub filled with saline bags and 1 empty supply box were sitting on the treatment floor. Facility staff and patients were observed having to walk around the boxes and tub.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to protect the patients’ right to be free from verbal abuse from facility staff for 2 of 2 reported and/or observed incidents of verbal abuse towards in-center hemodialysis (ICHD) patients by facility staff (Patients #3 and 21) and 1 of 1 discharged clinical record reviewed (Patient # 8) who transferred to another clinic within the 14 days prior to complaint survey. Findings include: 1. The policy titled “Patient Rights and Responsibilities,” dated 4/04/12, indicated the facility “must protect and provide for the exercise” of the patient’s rights. The policy indicated the patient’s rights included but was not limited to “respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs ....” 2. During an interview with Patient #3 on 2/14/24 beginning at 9:09 AM, Patient reported that on 02/09/24, Patient Care Technician (PCT) 1 scratched and slapped him/her while setting up Patient’s dialysis treatment. Patient reported he/she had previously filed a complaint with the facility against PCT 1, so the technician was only supposed to “push the buttons” on Patient’s dialysis machine and was not to provide direct patient care, however on 2/09/24, the facility was short-staffed and PCT 1 had to set up Patient’s dialysis treatment. Administrator came to Patient’s chairside shortly after to discuss the alleged incident. Patient #3 reported during his/her conversation with Administrator, Patient asked how Administrator would like if their family member was being assaulted? Patient #3 reported Administrator became angry at Patient’s comment regarding his/her family member and began yelling at Patient. Patient reported he/she was “in fear of my life” and had become anxious when seeing Administator on the treatment floor on 02/09/24. The review of an audio recording of Patient #3 and Administrator’s interaction on 02/09/24 evidenced during the interaction, Patient #3 stated PCT 1 wanted to “beat the garbage out of me ... we could have had a fight. I’ve had people assault me before.” Administrator responded, “And you beat them up.” Patient denied saying he/she had beat anyone up and patient hoped “somebody beat [the Administrator’s family member] up like [PCT 1]’s doing.” Administrator stated his/her family member had died and Patient #3 responded stating “And maybe that’s why.” Administrator was heard yelling “So my [family member] is dead and [Patient #3] thinks [the family member]’s dead because [the family member] got beat up. You have lost your mind.” Additional staff members could be heard coming to the chairside and telling Administrator to walk away. During an interview with Employee E on 02/14/24 beginning at 12:31 PM, the employee reported he/she was on the treatment floor during Patient #3 and Administrator’s interaction on 02/09/24. The employee reported the Administrator “got loud” when speaking with Patient #3. During an interview with Administrator on 02/19/24 at 3:27 PM, the employee reported an audio recording on the treatment floor violated the policies and procedures Patients agree to abide by when they are admitted to the facility. The administrator indicated he/she did not yell at Patient #3, rather he/she was talking loudly because Administrator wanted everyone to hear what he/she was saying as Patient #3 “has done this many times.” 3. During an observation on the ICHD treatment floor on 2/22/24 beginning at 12:45 PM, PCT 10 was observed interacting with Patient #21 while Patient was receiving ICHD. Patient raised his/her legs and the technician told Patient to put their legs down. When Patient asked why, PCT 10 stated “because you not that sexy.” Patient attempted to get out of the treatment chair several times saying he/she wanted something to eat. PCT 10 told Patient not to get out of their chair and then said “[Patient #21] if I have to ...” Patient interrupted the technician, asking what the employee was going to do? PCT responded stating “you know.” At 12:59 PM, PCT 10 told Patient #21 “you have acted like a small child and I don’t like it ... you have proven you don’t know how to act.” The technician informed Patient that his/her extended care facility may not allow Patient #21 to return “because of how you acted today.” PCT 10 told Patient #21 he/she would be glad when Patient left for the day. Patient #10 told the technician he/she was being starved “to death;” the technician was observed laughing. During an observation on the ICHD treatment floor on 2/22/24 beginning at 2:45 PM, PCT 10 was observed discontinuing Patient #21’s ICHD treatment. Patient #21 asked the technician if he/she was going home. PCT 10 responded he/she didn’t know if Patient was going home “because [Patient #21] have acted just so terribly today ... like a child ... I don’t appreciate it ... You might never get [to the extended care facility].” PCT 10 and Patient #21’s conversation could be heard on the other side of the ICHD treatment floor. RNs 4 and 5 and PCTs 4, 5, and 8 were present on the treatment floor during the observation but did not intervene. During an interview with RN 5 on 02/22/24 beginning at 2:35 PM, the nurse reported Patient #21 was more “aggravated” than his/her baseline. The nurse reported the facility typically had snacks available for Patient #21 “to keep the peace,” however this was not available on 02/22/24. RN 5 reviewed Patient #21’s medical record and indicated Patient had a history of anxiety and panic disorder. A review of Patient #21’s medical record indicated Patient was currently taking Aricept and Memantine (medications used to treat dementia) as well as Clonazepam for anxiety. 4. An agency document titled “Admission/Discharge” report, received on 2/16/24, evidenced patient #8 was transferred to another facility on 02/05/24. 5. The clinical record for Patient #8 evidenced a discharge summary dated 02/05/24; the record failed to evidence why Patient #8 was discharged from the facility. During a phone interview on 02/16/24 at 10:42 AM, Patient #8 indicated there was always loud music and yelling. The staff were very blasé and acted like it was not a medical facility. Patient #8 indicated the staff didn’t care about Patients, it was ghetto. Staff would hang their lab coats around their neck and then they would brush against you with the sleeves of their street clothes. Patient #8 indicated how were they to know if the staff had a dog licking all over their sleeve or where the sleeve had previously touched. Patient #8 indicated the nurses were as bad as the PCTs. Patient #8 indicated staff would go person to person with the same gloves, put a glove on one finger to use the machine, or hold their access site. Patient #8 indicated they could not take it, indicated when they would complain about the music and the unsanitary practices, staff indicated Patient #8 complained too much. Patient #8 stated “My rights were violated there,” indicated if they said something to staff about what they didn’t like, the staff would get snotty. Patient #8 indicated he/she had the right to say how they felt, but staff did not listen. Patient #8 indicated when he/she said something about loud music, they would say what you don’t like music. Patient #8 indicated Staff would play on their phone more than a 17-year-old and not pay attention to Patients. Patient #8 indicated on one visit, they had to yell over the music to notify staff, that their access site had started to bleed, as no one was paying attention. Patient #8 indicated they were told all they did was complain. Patient #8 stated, “I didn’t feel I should have to go through that,” Patient #8 indicated they showed up for their last dialysis treatment and staff told Patient #8 they were not to be there. Patient #8 indicated he/she were scheduled, the PCT left and returned and then said, “Fine, they said you can be here.” During an interview on 02/16/2024 at 2:40 PM, Clinic Manager 2 indicated from his/her understanding Patient #8 transferred to another unit because there were Patients around Patient #8 who would play music during treatment, and Patient #8 was upset because it was too loud. The Clinic Manager indicated staff would sometimes play music during the holidays and on Friday afternoons, but it was at an acceptable level, or the Clinic Manager would have staff turn it down. Clinic Manager 2 indicated Patient #8 did not express this to him/her, but it was the Clinic Manager’s understanding of why Patient #8 left.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 42524 Based on observation, record review, and interview, the dialysis facility failed to ensure the patient’s right to privacy during verbal interactions between staff was maintained for 1 of 1 patient observed with low blood pressure on the treatment floor (Patient #22). Findings include: The review of facility policy titled “Patient Rights and Responsibilities,” dated 4/04/12, indicated the patient had the right to “privacy and confidentiality in all aspects of treatment.” During an observation on 2/20/24 at 9:03 AM, Patient Care Technician (PCT) 2 was at Station #1 with Patient #22. PCT 2 called across the room to Registered Nurse (RN) 4 and indicated Patient #22 blood pressure was 98/56. PCT 2 failed to keep the confidentiality of Patient #22’s treatment. During an interview on 2/20/2023 at 10:00 AM, PCT 2 indicated he/she should have gone to the nurse and not called out the blood pressure from across the room.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure the patient’s clinical documents remained confidential and private on the in-center hemodialysis (ICHD) treatment floor for 3 of 4 days of ICHD observations, which had the potential to affect all ICHD facility patients. Findings include: 1. During an observation of the in-center treatment floor on 2/14/24 beginning at 2:55 PM, an ICHD treatment schedule for 2/14/24 with patients’ full names was observed in the trash. During an interview with Administrator on 2/14/24 beginning at 3:05 PM, Administrator reported documents with protected health information (PHI), including treatment schedules, should be placed int the facility’s shredder bin. 2. During an observation of the ICHD treatment floor on 2/19/24 at 11:44 AM, Registered Nurse (RN) 4 was observed reviewing Patient #3’s medical record on a computer at the nurse’s station. RN 4 left the nurse’s station to speak with the patient in Station #3. The nurse failed to lock the computer prior to leaving the nurse’s station, leaving Patient #3’s medical record open on the computer screen. 42524 3. During an observation on 2/20/24 at 9:00 AM, a clipboard was observed on the ledge of the nursing station. The clipboard contained an early termination form for Patient #23. This form included Patient #23 name, the date 2/20/2024, and the time 8:40 AM. The agency failed to keep Patient #22 medical record information confidential. During an interview on 2/20/24 at 9:05 AM, RN 5 indicated the form should not have been left on the counter. The form and clipboard should have been put away or at least kept face down on the desk until someone could take care of it.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to protect the patients’ rights specific to ensuring the patient received his/her dialysis prescription as ordered for 1 of 1 records reviewed of a patient whose in-center hemodialysis (ICHD) treatment was shortened without the patient’s consent (Patient #3). Findings include: During an interview with Patient #3 on 2/14/24 beginning at 9:09 AM, Patient reported that on 02/09/24, Patient Care Technician (PCT) 1 scratched and slapped him/her while setting up Patient’s dialysis treatment. Patient reported he/she had previously filed a complaint with the facility against PCT 1, so the technician was only supposed to “push the buttons” on the patient’s dialysis machine and not provide direct patient care, however on 2/09/24, the facility was short-staffed and PCT 1 had to set up the patient’s dialysis treatment. Administrator came to Patient’s chairside shortly after to discuss the alleged incident. Patient #3 reported during his/her conversation with Administrator, the employee denied the alleged incident between Patient #3 and PCT 1 occurred and Patient asked how Administrator would like if their family member was being assaulted? Patient #3 reported Administrator became angry at Patient’s comment regarding his/her family member and began to yell at Patient. While leaving the treatment floor, Administrator yelled “take [him/her] off [the dialysis treatment.].” Patient #3 reported after his/her interaction with Administrator, the facility staff ended his/her treatment 2 hours prior to the ordered end time. The review of an audio recording of Patient #3 and Administrator’s interaction on 02/09/24 evidenced during the interaction, Patient #3 stated PCT 1 wanted to “beat the garbage out of me ... we could have had a fight. I’ve had people assault me before.” Administrator responded, “And you beat them up.” Patient denied saying he/she had beat anyone up and patient hoped “somebody beat [the Administrator’s family member] up like [PCT 1]’s doing.” Administrator stated his/her family member was dead and Patient #3 responded stating “And maybe that’s why.” Administrator was heard yelling “So my [family member] is dead and [Patient #3] thinks [the family member]’s dead because [the family member] got beat up. You have lost your mind.” Additional staff members could be heard coming to the chairside and telling Administrator to walk away. Administrator could then be heard yelling in the distance “take [Patient #3] off [his/her dialysis treatment].” During an interview with Employee H on 02/14/24 beginning at 11:24 AM, the employee reported on 02/9/24, a police officer and ambulance came to the facility after the alleged assault by PCT 1 against Patient #3. Employee H reported Patient was “stable,” so the police officer sent the ambulance away prior to the EMT assessing Patient #3. The employee also reported Patient #3 received his/her full treatment on 02/09/24. The review of Patient #3’s medical record evidenced Patient’s treatment on 02/09/24 ended at 8:55 AM, which was 1 hour 37 minutes prior to the ordered end of treatment. Employee H documented Patient’s dialysis prescription, including Estimated Dry Weight (EDW, physician-ordered goal weight patients are to be at the end of dialysis treatment) was not achieved “due to [Patient #3’s] inappropriate behavior.” Patient #3’s post-dialysis blood pressure was 165/103, heart rate was 113, and weight was 95.2 kilograms (kg). The record indicated Patient’s EDW was 91.0 kg, a difference of 4.2 kg. During an interview with Medical Director on 2/14/24 beginning at 1:25 PM, the physician reported he/she was not aware Patient #3’s treatment ended early on 02/09/24. During an interview with Administrator on 02/14/24 beginning at 3:54 PM, Administrator reported on 02/09/24, as he/she was leaving the treatment floor after speaking with Patient #3, Administrator advised facility staff to end Patient #3’s treatment early due to Patient saying he/she “should have” hit PCT 1. During an interview with Employee G on 02/15/24 beginning at 1:00 PM, the employee reported on 02/09/24, Patient #3 stated he/she felt like they were going to have a stroke, so Employee G spoke with Employee H and was advised to end Patient’s treatment early. Administrator then came to Patient #3’s chairside to discuss the earlier alleged incident with PCT 1, so Employee H waited until the conversation was over to begin disconnecting Patient #3 from their treatment. The review of Patient #3’s medical record failed to evidence Patient reported signs or symptoms of a stroke (headache, confusion, slurred speech, etc) at any point during his/her treatment on 2/09/24. During a follow-up interview with Patient #3 on 02/16/24 beginning at 10:55 AM, Patient reported on 02/09/24, after the alleged assault by PCT 1, Patient #3 asked to speak with a nurse because he/she felt anxious and his/her blood pressure was elevated. Patient #3 stated he/she told staff he/she was concerned he/she might have a stroke, but staff told her to take deep breaths and to try to stay on treatment. Patient #3 reported he/she had calmed down and was feeling ok until his/her interaction with Administrator, after which he/she was “shaky.” Patient #3 reported he/she did not voice any concerns and/or symptoms of a stroke after their interaction with Administrator. The review of the facility’s adverse event log between 2/14/23 - 2/14/24 evidenced 2 adverse events involving Patient #3 dated 02/09/24. The log included: a. An adverse event for “hemolysis” documented by PCT 1 at 9:19 AM. The event report indicated after performing Patient #3’s CVC care, the technician secured Patient #3’s CVC lines to Patient’s left shoulder. Patient began to pull the lines and “direct where [he/she] would like to place the tape.” PCT 1 documented he/she asked Patient to loosen the arterial line “to prevent the machine from alarming due to noticing restriction.” Patient #3 “became argumentative,” telling the technician “that is not the reason for the machine alarming,” and asking the technician to “just do what [he/she] was asked to do.” PCT 1 documented he/she placed tape where Patient requested and Patient “yelled out ... I know you just didn’t hit me! Back away from me!’ The event report indicated the technician [sic] “confessed that [he/she] did not hit [Patient #3],” left Patient’s station, and informed the facility’s management. PCT 1 documented Patient #3 “called the police to make a report.” Review of Patient #3’s clinical record evidenced Patient’s dialysis treatment began on 2/09/24 at 7:04 AM. Review of the police report filed regarding the police investigation of PCT 1’s alleged assault against Patient indicated the assault was initially reported to the police at 7:09 AM. The police officer’s last radio log was at 8:16 AM to report the investigation was complete. Patient #3’s treatment floor sheet indicated the patient’s treatment ended at 8:57 AM, which was after Patient and Administrator spoke. b. An adverse event for “Dialysis Weight/[Ultrafiltration] Goal Variance” documented by Administrator at 3:11 PM. The event report indicated Patient #3 “had a behavioral occurrence while at treatment ... [Patient] had an outburst, called the police alleging that [he/she] was assaulted by a PCT. [Patient #3] threatened stating that [he/she] ‘should’ve fight [sic] [the technician] back.’ [Patient #3’s] treatment was immediately ended.””

“PR-INFORMED OF INTERNAL GRIEVANCE PROCESS CFR(s): 494.70(a)(14) The patient has the right to- (14) Be informed of the facility’s internal grievance process; This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to investigate and document resolution of patient grievances according to facility policy for 2 of 4 patients who reported they filed grievances with the facility (Patient #3 and 8). Findings include: 1. The review of facility policy titled “Patient Grievance,” dated 1/02/14, indicated all patients had the right to file a grievance at any time and could be filed written or verbally. The policy indicated the social worker’s responsibility for grievances included “assisting in assessing and resolving patient grievances as appropriate” and the clinic manager and/or administrator was to meet with the complainant “within 5 days to discuss the grievance, resolve it as quickly as possible, and provide periodic updates to the patient.” 2. The review of facility’s grievance log indicated on 8/09/23, Patient #3 filed a verbal grievance with MSW 1. The log indicated Patient wanted to file a grievance against Registered Nurse (RN) 1 because the nurse administered fluid when Patient’s blood pressure dropped and the Patient thought he/she was becoming “ill” because of the additional fluid. The log indicated Patient #3 “also had complaints about [his/her] dry weight” and reported when he/she requested to speak with Medical Director, the facility nurses refused to contact the physician. The grievance log indicated MSW 1 documented a “late entry” that he/she spoke with Patient #3 and Patient reported “nothing is changed.” MSW 1 documented Patient “did not want to elaborate.” The grievance log failed to evidence a documented resolution to the patient’s grievance, however the grievance was marked as “resolved” on 9/15/23. The review of Patient #3’s medical record evidenced a Progress Note documented by MSW 1 on 8/9/23. The note indicated MSW 1 spoke with Patient at his/her chairside and Patient reported he/she wanted to file the above grievance. MSW 1 documented he/she educated Patient on “chain of command” for grievance procedures and discussed the situation with Administrator. The record indicated the next social work note was dated 10/23/23, within which MSW 1 documented Clinic Manager 2 reported Patient #3 was not listening to staff “regarding [his/her] treatment” and was not adhering to treatment orders. During an interview with MSW 1 on 2/15/24 beginning at 11:27 AM, the social worker stated he/she reported Patient #3’s complaint to Administrator. MSW 1 could not recall when he/she followed up with Patient regarding his/her complaint and stated the patient declined to elaborate on how his/her treatments were going, so the social worker marked the grievance as resolved. The social worker reported the facility attempted to hold a meeting with Patient #3 in either October or December 2023 in part due to the patient’s non-adherence to his/her ordered treatment, but Patient did not come to the meeting. Patient #3’s record indicated the patient was given notification of an involuntary discharge on 2/12/24 with an effective date of 3/12/24. The listed reasons for discharge included the facility could no longer meet the patient’s needs. 3. A review of the facility’s grievance log for 2/14/23 - 2/14/24 indicated on 12/13/23, Patient #8 filed a verbal grievance with MSW 1. The log indicated Patient was “very agitated,” reported he/she “can’t get any rest due to the noise in the clinic ... the PCT’s ‘talk to much’ [sic] ... music was playing and [Patient #8’ did not understand why [he/she] has to listen to music ....” The log indicated Patient’s family member had suggested noise-cancelling headphones, but Patient could not afford them. MSW 1 spoke with Patient #8 to follow-up regarding the grievance and Patient stated he/she was “okay ... things appear the same.” The log indicated Patient transferred to another dialysis facility and the complaint was marked as “resolved” on 1/24/24. During an interview with MSW 1 on 2/15/24 beginning at 3:47 PM, the social worker reported Patient #8 transferred to another dialysis facility because the patient was dissatisfied with the facility and had said it was “too loud” on the treatment floor. MSW 1 reported he/she received the above grievance from Patient on 12/13/23. The social worker reported in response to the complaint, the social worker provided Patient with the facility’s grievance policy and chain of command and informed Clinic Manager 2 of Patient’s concerns. MSW 1 reported when he/she followed up with Patient #8 regarding the grievance, Patient reported no improvement. The social worker reported the grievance was marked as “resolved” because Patient transferred to another facility and the corporate owner of the facility had a “Continuity of Care” division which would follow-up with Patient regarding his/her transfer. 42524 4. The review of an agency document titled “Admission/Discharge” report received on 2/16/24, evidenced patient #8 was transferred to another facility on 02/05/24. The review of Patient #8’s clinical record evidenced a discharge summary dated 02/05/24; the record failed to evidence why Patient #8 was discharged from the facility. During a phone interview on 02/16/24 at 10:42 AM, Patient #8 indicated there was always loud music and yelling on the in-center hemodialysis treatment floor. The staff were very blasé and acted like it was not a medical facility. Patient #8 indicated the staff didn’t care about Patients, it was ghetto. Staff would hang their lab coats around their neck and then they would brush against you with the sleeves of their street clothes. Patient #8 indicated how were they to know if the staff had a dog licking all over their sleeve or where the sleeve had previously touched. Patient #8 indicated the nurses were as bad as the PCTs. Patient #8 indicated staff would go person to person with the same gloves, put a glove on one finger to use the machine, or hold their access site. Patient #8 indicated they could not take it, indicated when they would complain about the music and the unsanitary practices, staff indicated Patient #8 complained too much. Patient #8 stated “My rights were violated there,” indicated if they said something to staff about what they didn’t like, the staff would get snotty. Patient #8 indicated he/she had the right to say how they felt, but staff did not listen. Patient #8 indicated when he/she said something about loud music, they would say what you don’t like music. Patient #8 indicated Staff would play on their phone more than a 17-year-old and not pay attention to Patients. Patient #8 indicated on one visit, they had to yell over the music to notify staff, that their access site had started to bleed, as no one was paying attention. Patient #8 indicated they were told all they did was complain. Patient #8 stated, “I didn’t feel I should have to go through that,” Patient #8 indicated they showed up for their last dialysis treatment and staff told Patient #8 they were not to be there. Patient #8 indicated he/she were scheduled, the PCT left and returned and then said, “Fine, they said you can be here.” During an interview on 02/16/2024 at 2:40 PM, Clinic Manager 2 indicated from his/her understanding Patient #8 transferred to another unit because there were Patients around Patient #8 who would play music during treatment, and Patient #8 was upset because it was too loud. The Clinic Manager indicated staff would sometimes play music during the holidays and on Friday afternoons, but it was at an acceptable level, or the Clinic Manager would have staff turn it down. Clinic Manager 2 indicated Patient #8 did not express this to him/her, but it was the Clinic Manager’s understanding of why Patient #8 left.”

“PR-INFORMED-MAY FILE INT/EXT GRIEVANCE ANON CFR(s): 494.70(a)(16), (17) The patient has the right to- (16) Be informed of his or her right to file internal grievances or external grievances or both without reprisal or denial of services; and (17) Be informed that he or she may file internal or external grievances, personally, anonymously or through a representative of the patient’s choosing. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to ensure all patients remained free from retaliation for filing complaints with the State Agency (SA) and/or with the facility for 1 of 1 active patient which the staff indicated they reported a complaint to the SA and/or facility (Patient #3). Findings include: 1. The review of facility policy titled “Patient Grievance,” dated 1/02/14, indicated all patients had the right to file a grievance at any time and could be filed written or verbally. The policy also indicated any grievance “that involves a situation or practice that may place patients or staff members in immediate danger must be resolved immediately.” 2. During an interview with Patient #3 on 2/14/24 beginning at 9:09 AM, Patient reported that on 02/09/24, Patient Care Technician (PCT) 1 scratched and slapped him/her while setting up Patient’s dialysis treatment. Patient reported he/she had previously filed a complaint with the facility against PCT 1, so the technician was only supposed to “push the buttons” on the patient’s dialysis machine and not provide direct patient care, however on 2/09/24, the facility was short-staffed and PCT 1 had to set up the patient’s dialysis treatment. Administrator came to Patient’s chairside shortly after to discuss the alleged incident. Patient #3 reported during his/her conversation with Administrator, the employee told Patient he/she was aware Patient had filed complaints before with the SA. Patient #3 reported Administrator denied the alleged incident between the Patient #3 and PCT 1 occurred. The review of the facility’s adverse event log evidenced an event documented on 3/22/23 by PCT 1. The event report indicated Patient #3 “became loud and argumentative” with the technician and refused to allow the technician to continue working with Patient. During an interview with PCT 1 on 2/14/24 beginning at 12:00 PM, the technician reported he/she had “issues” with Patient #3 prior to the 2/09/24 alleged incident. PCT 1 reported in 2023, Patient became upset when the technician would not put the patient’s shoes on. PCT 1 reported Patient #3 filed a complaint regarding the 2023 incident and since then, the technician would limit his/her work with Patient #3 to only managing the patient’s dialysis machine. Patient #3’s medical record included a Progress Note documented on 3/22/23 by MSW 1. The note indicated PCT 1 reported during treatment, Patient #3 “became verbally abusive because [Patient] disagreed” about his/her dialysis prescription orders. Patient reported he/she did not want PCT 1 to continue to work with him/her. The review of an audio recording of Patient #3 and Administrator’s interaction on 02/09/24 evidenced during the interaction, Administrator stated he/she was aware Patient had made complaints to the SA. When Patient denied he/she had filed complaints with the SA, Administrator stated “yes you have ... I know everything.” Administrator stated the alleged assault by PCT 1 did not occur, as if it had, the technician would be “in a police car.” During an interview with Registered Nurse (RN) 1 on 02/14/24 beginning at 11:24 AM, the employee reported there was “always drama” with Patient #3 and the patient was “always complaining about this and that.” RN 1 stated “everybody knows” Patient #3 had called the SA and complained about the facility in the past. RN 1 documented Patient #3 had “called out” the employee to other staff before. The review of facility’s adverse event log evidenced an event documented on 5/31/23 by RN 1. The event report indicated Patient #3 was “loud and argumentative and yelling with techs.” Patient reportedly “continued ranting in waiting room” about RN 1. The review of facility’s grievance log indicated on 8/09/23, Patient #3 filed a verbal grievance with Medical Social Worker (MSW) 1. The log indicated Patient wanted to file a grievance against RN 1 because the nurse administered fluid when Patient’s blood pressure dropped and the Patient thought he/she was becoming “ill” because of the additional fluid. During an interview with Employee C on 02/14/24 beginning at 12:40 PM, the employee reported the last time the SA conducted a survey of the facility was due to Patient #3 filing a complaint. 3. The review of the facility’s grievance log for 2/14/23 - 2/14/24 indicated on 12/13/23, Patient #8 filed a verbal grievance with MSW 1. The log indicated Patient was “very agitated,” reported he/she “can’t get any rest due to the noise in the clinic ... the PCT’s ‘talk to much’ [sic] ... music was playing and [Patient #8’ did not understand why [he/she] has to listen to music ....” The log indicated Patient’s family member had suggested noise-cancelling headphones, but Patient could not afford them. The log indicated MSW 1 spoke with Patient #8 to follow-up regarding the grievance and Patient stated he/she was “okay ... things appear the same.” The log indicated Patient transferred to another dialysis facility. 42524”

“PR-RECEIVE WRITTEN NOTICE 30 DAYS PRE IVD CFR(s): 494.70(b)(2) The patient has the right to- (2) Receive written notice 30 days in advance of an involuntary discharge, after the facility follows the involuntary discharge procedures described in §494.180(f)(4). In the case of immediate threats to the health and safety of others, an abbreviated discharge procedure may be allowed. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to ensure all policies and procedures specific to involuntarily discharging a patient were followed for 1 of 1 patient in which the facility had initiated an involuntary discharge in February 2024 (Patient #3). Findings include: 1. The policy titled “Routine and Involuntary Patient Discharge,” dated 9/04/19, indicated the Medical Director was to ensure no patient was involuntarily discharged unless “the facility can no longer meet the patient’s documented medical needs ... the patient’s behavior is deemed disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired.” The policy indicated a patient at risk for involuntary discharge must be reassessed by the interdisciplinary team (IDT) and the IDT should document in the patient’s medical record “the reassessments, ongoing problem(s), and effort(s) made to resolve the problem(s).” For involuntary discharges due to disruptive or abusive behavior, the facility should consult the “Disruptive Patient Behavior and Use of Behavioral Agreement” policy “at the first sign of disruptive or abusive behavior that does not rise to the level of a severe and immediate threat to the health and safety of others.” The policy indicated prior to an involuntary discharge, “there must be evidence in the patient’s medical record of the IDT’s efforts to help the patient resolve any conflict or psychological issues contributing to the behavior.” For involuntary discharges due to the facility’s inability to meet the patient’s needs, the facility should consider “all reasonable alternatives for continuing to provide care to the patient in the facility.” The facility should conduct a meeting between the IDT and the patient and/or patient’s representative “to discuss the patient’s current status and barriers to providing a safe treatment environment for the patient” and discuss other treatment modalities and other locations that provide dialysis, such as a nursing home. The patient’s medical record should include “documentation of all efforts to manage the patient’s care and outcomes as well as all discussions with the patient and his/her representative.” 2. The policy titled “Disruptive Patient Behavior and Use of Behavioral Agreement,” dated 4/04/12, indicated a patient at risk for involuntary discharge must be considered ‘unstable’ and reassessed by the interdisciplinary team (IDT). The patient’s plan of care should be revised “to demonstrate interventions or resources agreed upon by the patient or determined necessary by the interdisciplinary team to resolve barriers or other issues contributing to the disruptive behavior.” The policy indicated a behavioral agreement “should be considered” when “the patient’s behavior has escalated beyond the ability to be handled by an informal resolution process ... individual consultation with the patient’s attending physician, clinical manager, [social worker] or a team meeting, patient/family meeting or patient education has not resulted in positive improvement in the patient’s behavior ... the patient’s behavior has potential to harm the patient or others ... the patient’s behavior will potentially result in termination of dialysis services if not modified or stopped.” The behavioral agreement was to “define what responsibilities or expectations the patient will need to meet to continue to receive services in the facility” and should indicate “consequences of continued disruptive behavior,” including “possible discharge.” The policy indicated once a behavioral agreement was implemented, the IDT would review the “progress of a patient’s Behavioral Agreements on a monthly basis until the patient’s behavior is either resolved, stabilized, or worsens to the extent that involuntary discharge is considered.” The policy defined verbal abuse as “use of words, written or spoken, that demean, insult, belittle or degrade a person.” 3. During an interview with Patient #3 on 2/14/24 beginning at 9:09 AM, Patient reported that on 02/09/24, Patient Care Technician (PCT) 1 scratched and slapped him/her while setting up Patient’s dialysis treatment. Patient reported he/she had previously filed a complaint with the facility against PCT 1, so the technician was only supposed to “push the buttons” on the patient’s dialysis machine and not provide direct patient care, however on 2/09/24, the facility was short-staffed and PCT 1 had to set up the patient’s dialysis treatment. Administrator came to Patient’s chairside shortly after to discuss the alleged incident. Patient #3 reported during his/her conversation with Administrator, the employee told Patient he/she was aware Patient had filed complaints before with the SA. Patient #3 reported Administrator denied the alleged incident between the Patient #3 and PCT 1 occurred and Patient asked how Administrator would like if their family member was being assaulted? Patient #3 reported Administrator became angry at Patient’s comment regarding his/her family member. While leaving the treatment floor, Administrator yelled “take [him/her] off [the dialysis treatment.].” Patient #3 reported on 2/12/24, he/she was notified by the facility he/she was being involuntarily discharged due to being “violent, aggressive” and “hitting, spitting.” The review of an audio recording of Patient #3 and Administrator’s interaction on 02/09/24 evidenced during the interaction, Administrator stated he/she was aware Patient had made complaints to the SA. When Patient denied he/she had filed complaints with the SA, Administrator stated “yes you have ... I know everything.” Administrator stated the alleged assault by PCT 1 did not occur, as if it had, the technician would be “in a police car.” Patient #3 stated PCT 1 wanted to “beat the garbage out of me ... we could have had a fight. I’ve had people assault me before.” Administrator responded, “And you beat them up.” Patient denied saying he/she had beat anyone up and patient hoped “somebody beat [the Administrator’s family member] up like [PCT 1]’s doing.” Administrator stated his/her family member was dead and Patient #3 responded stating “And maybe that’s why.” Administrator was heard yelling “So my [family member] is dead and [Patient #3] thinks [the family member]’s dead because [the family member] got beat up. You have lost your mind.” Additional staff members could be heard coming to the chairside and telling Administrator to walk away. Administrator could then be heard yelling in the distance “take [Patient #3] off [his/her dialysis treatment].” During an interview with Employee H on 02/14/24 beginning at 11:24 AM, the employee reported on 02/9/24, Patient #3 called the local police regarding the alleged assault by PCT 1. The employee reported a police officer and ambulance came to the facility and spoke with Patient at his/her chairside. Employee H reported the police officer also spoke with PCT 1, other employees including him/herself, and other patients, regarding the alleged incident. During an interview with Medical Director on 2/14/24 beginning at 1:25 PM, the physician reported he/she attempted to speak with Patient #3 on 02/12/24 regarding the incidents on 2/09/24 but Patient refused. Medical Director reported the facility had issues with Patient’s behaviors in the past, but the physician was not aware of Patient being verbally or physically abusive towards staff. The physician had met with Patient #3 and Family Member A “on several occasions” to discuss Patient’s behaviors within the past 6 months, however the meetings “didn’t resolve anything.” Medical Director reported he/she did not document the meetings. Medical Director was not aware of the facility enacting a behavioral agreement with Patient #3 prior to 02/12/24. During an interview with Medical Social Worker (MSW) 1 on 02/14/24 beginning at 3:20 PM, the social worker reported the facility had concerns with Patient #3’s inappropriate behaviors in past. The social worker reported the facility IDT had tried to have meetings with Patient #3 regarding his/her behavior, but Patient would not come to the meetings. The social worker reported he/she did not document attempts to conduct meetings as the clinic manager was responsible for setting up these meetings. MSW 1 reported the facility had not made a behavioral agreement with Patient #3 prior to 02/12/24 because the staff hoped Patient’s behavior would improve. During an interview with Administrator on 02/14/24 beginning at 3:54 PM, Administrator reported the facility had tried previously to enact a behavioral contract with Patient #3, however Patient did not attend the IDT meeting. Administrator could not recall when this occurred. Administrator reported on 02/09/24, a local police officer came to the facility after being called by Patient #3. Per Administrator, the police office informed the facility staff he/she would not file a report as the patient’s allegations were unsubstantiated. Administrator reported he/she spoke with Patient #3 at his/her chairside regarding the alleged incident and Patient became “snappy,” stated he/she should have hit PCT 1, and repeatedly brought up Administrator’s deceased family member. Administrator reported Patient’s “volume started increasing” and 2 employees came over to the chairside and advised Administrator to walk away. The employee reported as he/she was leaving the treatment floor, Administrator advised facility staff to end Patient #3’s treatment early due to Patient saying he/she “should have” hit PCT 1. Later that day, Administrator met with MSW 1 and Corporate Employees 1 and 2 to discuss the incident. Administrator reported during the meeting, the facility and corporate staff determined Patient #3 was to be involuntarily discharged. Administrator reported during a meeting with Patient, Medical Director, MSW 1, Corporate Employee 2, and Administrator, Patient #3 was notified of the involuntary discharge and initiation of a behavioral agreement. The medical record evidenced the IDT last held a plan of care meeting for Patient #3 on 3/28/23. The plan of care failed to evidence the IDT noted any disruptive or abusive behaviors by Patient towards staff and/or other patients. During a follow-up interview with Administrator on 2/15/24 at 8:45 AM, Administrator reported Patient #3’s plan of care was due to be updated in February 2024 and facility was waiting on all members of the interdisciplinary team (IDT) to update his/her portions of the comprehensive assessment before it could hold a Plan of Care meeting. The record included a “Patient Discharge Letter,” dated 02/12/24, which indicated Patient was to be involuntarily discharged, effective 3/12/24, for “behavior that is disruptive and abusive to the extent that it impairs the delivery of care to you or the ability of the facility to operate effectively; the facility can no longer meet your documented needs.” The letter indicated on 02/09/24, Patient #3 called the local police department “because [he/she] stated a PCT tried to assault [him/her]. When the staff attempted to talk to [patient, he/she] became verbally aggressive, loud, and disruptive and stated [he/she] should have hit the PCT.” The record included a “Behavioral Agreement” for Patient #3, signed by Clinic Manager 2 and Medical Director on 02/12/24. The behavioral agreement indicated Patient needed to “be considerate of other patients and staff,” including not using “swear words, threats, or other foul language to degrade, hurt, or be disrespectful to staff or other patients” and “not acting in a way that makes other people in the clinic uncomfortable or afraid for their safety, such as kicking, hitting, threatening, cursing, and yelling.” The behavioral agreement was to be “reviewed by the Clinic Manager on a monthly basis” with Patient. The behavioral agreement failed to evidence the patient’s impending involuntary discharge. The record indicated prior to Patient #3’s involuntary discharge notification on 02/12/24, the last documented nursing comprehensive assessment was completed on 4/05/23. The record included a Clinical Note documented on 11/16/22 at 10:30 by MSW 1. The note indicated the social worker spoke with Patient #3 and Family Member A regarding “issues” Patient #3 was having at the facility. MSW 1 noted Patient #3 and Family Member A had multiple complaints about the facility, including “problems with a PCT” and “numerous complaints against the staff.” The note indicated MSW 1 informed the clinic manager of Patient’s complaints. The social worker noted the clinic manager had stated several patients had complained about Patient #3 and the patient’s “behaviors. [Patient #3] was observed throwing a blood pressure cuff and yelling and hitting dialysis chair.” The record included a Progress Note documented on 11/19/22 by MSW 1. The note indicated ESRD Physician 1, Former Clinic Manager B, and MSW 1 met with Patient #3 and Family Member A. The note indicated Patient had several complaints regarding his/her care and facility staff. ESRD Physician 1 summarized Patient’s treatment and “problems with low blood pressure.” The physician suggested Patient #3 consider an alternative treatment modality. MSW 1 documented Former Clinic Manager B was to “talk to staff for their version of incident.” The record failed to evidence details regarding the “incident” to which the note referred. The record included a Progress Note documented on 11/30/22 by MSW 1. The note indicated Administrator and MSW 1 met with Patient #3 to discuss “current incident.” Patient #3 reported he/she felt like the facility staff did not like him/her and Patient had “issues regarding [his/her] care.” MSW 1 documented the facility provided Patient #3 with educational materials on alternative treatment modalities, Patient’s rights and responsibilities, and “Thriving without Fear/Managing Retaliation.” The record failed to evidence details regarding the “incident” mentioned, any follow-up by facility staff regarding the 11/19/22 or 11/30/22 meetings with Patient, nor Patient’s responses to the 11/19/22 and/or 11/30/22 meetings. The record included a Clinical Note documented on 2/13/23 by Administrator. The note indicated Administrator spoke with Patient #3 and Family Member A regarding Patient and family member’s multiple concerns. Family Member A reported he/she had overheard a technician telling Patient #3 to “just get in the damn chair.” Administrator asked Patient if he/she wanted to transfer to another dialysis unit and Patient declined. The note indicated Patient #3 and Family Member A “began to get very agitated and rude” to Administrator during the conversation. Administrator documented he/she advised Patient #3 to “practice patience, be kind, and respectful to all staff at all times, as the PCT today that took care of Patient was crying and upset by the way [he/she] was treated by Patient.” Patient reported he/she was not rude nor yelled at the employee. Administrator documented after the discussion with Patient #3 and Family Member A, the technician reported he/she feared providing care to Patient #3 due to Patient being “rude and condescending and [the technician was] scared to make a mistake as [he/she] might be reported to leadership.” The record failed to evidence any follow-up nor documenttion of Patient’s response to the meeting, including if there was any improvement to Patient’s reported behaviors. The review of the facility’s adverse event log evidenced an event documented on 3/22/23 by PCT 1. The event report indicated Patient #3 “became loud and argumentative” with the technician and refused to allow the technician to continue working with Patient. During an interview with PCT 1 on 2/14/24 beginning at 12:00 PM, the technician reported he/she had “issues” with Patient #3 prior to the 2/09/24 alleged incident. PCT 1 reported in 2023, Patient became upset when the technician would not put the patient’s shoes on. PCT 1 reported Patient #3 filed a complaint regarding the 2023 incident and since then, the technician would limit his/her work with Patient #3 to only managing the patient’s dialysis machine. Patient #3’s medical record included a Progress Note documented on 3/22/23 by MSW 1. The note indicated PCT 1 reported during treatment, Patient #3 “became verbally abusive because [Patient] disagreed” about his/her dialysis prescription orders. Patient reported he/she did not want PCT 1 to continue to work with him/her. The social worker documented they would “continue to monitor/assist as needed.” The record failed to evidence staff conducted any further follow-up regarding the incident. The facility’s adverse event log evidenced an event documented on 5/31/23 by RN 1. The event report indicated Patient #3 was “loud and argumentative and yelling with techs.” Patient reportedly “continued ranting in waiting room” about RN 1. The facility’s adverse event log evidenced an event documented on 6/07/23 by PCT 2. The event report indicated Patient #3 pushed the technician away and would not allow the technician to perform care to Patient’s central venous catheter (CVC). The report indicated Patient was “loud and argumentative.” Patient #3’s medical record included a Clinical Note documented on 6/13/23 by Administrator. The note indicated Administrator called both Patient #3 and Family Member A to attempt to schedule a meeting with the IDT, however Administrator was unable to reach either Patient or family member. The note failed to evidence the reason for the meeting. The record failed to evidence documentation of any further attempts to conduct a meeting between the IDT and Patient #3. The record included a Progress Note documented on 10/23/23 by MSW 1. The note indicated Clinic Manager 2 reported Patient #3 would “not listen to staff ... regarding [his/her] treatment. [Patient #3] will not adhere to treatment orders. [Patient #3] is calling staff murderers and killers and most staff are afraid to work with [him/her. The clinic manager] is trying to have a meeting ....” The record failed to evidence when the IDT held or attempted to hold a meeting with Patient #3 regarding his/her reported behaviors. The record included a Progress Note documented on 12/01/23 by MSW 1. The note indicated Clinic Manager 2 reported Patient #3 had “snatched an item” out of RN 3’s hands and had been “disruptive.” The note indicated the social worker would “continue to monitor/assist as needed.” The record failed to evidence the IDT held or attempted to hold a meeting with Patient #3 regarding his/her reported behaviors. During an interview with MSW 1 on 2/15/24 beginning at 11:07 AM, the social worker reported the facility attempted to conduct a meeting with Patient #3 regarding his/her behavior after the October or December incidents but could not recall when the attempted meeting occurred. MSW 1 reported Clinic Manager 2 was responsible for setting up the meeting, so the social worker did not document these attempts. MSW 1 reported Patient did not attend the meeting. The social worker could not recall any further interventions were performed by the facility regarding Patient’s behavior. The record included a Progress Note documented on 2/12/24 by MSW 1. The note indicated a meeting was held with “managers” regarding possible involuntary discharge of Patient #3. MSW 1 documented “per meeting with management, [Corporate Employee 1], clinic will start involuntary discharge.” The record included a second Progress Note documented on 2/12/24 by MSW 1. The note indicated the IDT met with Patient #3. During the meeting, Patient #3 was given a notification of involuntary discharge “due to disruptive behaviors and threats to staff” and Patient was given a behavioral agreement. The review of the facility’s adverse event log between 2/14/23 - 2/14/24 evidenced 2 adverse events involving Patient #3 dated 02/09/24. The log included: a. An adverse event for “hemolysis” documented by PCT 1 at 9:19 AM. The event report indicated after performing Patient #3’s CVC care, the technician secured Patient #3’s CVC lines to Patient’s left shoulder. Patient began to pull the lines and “direct where [he/she] would like to place the tape.” PCT 1 documented he/she asked Patient to loosen the arterial line “to prevent the machine from alarming due to noticing restriction.” Patient #3 “became argumentative,” telling the technician “that is not the reason for the machine alarming,” and asking the technician to “just do what [he/she] was asked to do.” PCT 1 documented he/she placed tape where Patient requested and Patient “yelled out ... I know you just didn’t hit me! Back away from me!’ The event report indicated the technician [sic] “confessed that [he/she] did not hit [Patient #3],” left Patient’s station, and informed the facility’s management. PCT 1 documented Patient #3 “called the police to make a report.” Review of Patient #3’s clinical record evidenced Patient’s dialysis treatment began on 2/09/24 at 7:04 AM. Review of the police report filed regarding the police investigation of PCT 1’s alleged assault against Patient indicated the assault was initially reported to the police at 7:09 AM. The police officer’s last radio log was at 8:16 AM to report the investigation was complete. Patient #3’s treatment floor sheet indicated the patient’s treatment ended at 8:57 AM, which was after Patient and Administrator spoke. b. An adverse event for “Dialysis Weight/[Ultrafiltration] Goal Variance” documented by Administrator at 3:11 PM. The event report indicated Patient #3 “had a behavioral occurrence while at treatment ... [Patient] had an outburst, called the police alleging that [he/she] was assaulted by a PCT. [Patient #3] threatened stating that [he/she] ‘should’ve fight [sic] [the technician] back.’ [Patient #3’s] treatment was immediately ended.” The event report indicated Patient #3 was discharged. 4. The review of the facility’s list of unstable patients for November 2023 - February 2024, provided by the Administrator on 2/15/24, failed to evidence Patient #3 was listed as “unstable” for any of these months.”

“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: 42524 Based on observation, record review, and interview the dialysis facility failed to ensure patient pre/post and intradialytic blood pressure were being assessed and managed in 2 of 2 in-center hemodialysis records reviewed with abnormal blood pressures (Patients #4 and #16). Findings include: 1. An agency policy titled “Charge Nurse Notification Protocol,” indicated the nurse should be notified of pretreatment systolic blood pressures (SBP) of >200 or < 90 and Diastolic BP > 100 or <50. During treatment, the nurse should be notified of SBP > 160 or < 90. Pulse >100 or < 60. Post treatment the nurse should be notified of SBP > 160 or < 90. Pulse >100 or < 50, SBP drops of 25 points or more, and DBP drops of 15 points or more. 2. An agency policy revised 9/1/2023, titled “Patient Assessment Pre & Post Dialysis indicated the nurse responsible will be notified if the vital signs are not within normal limits. 3. Clinical record review for Patient #4, start of care 12/30/2011, included a review of the dialysis treatment sheets from 1/31/2024 through 2/9/2024 and evidenced the following: On 2/9/2024, the documentation evidenced Patient #4’s pretreatment BP was 192/136 sitting and 212/249 standing; at 6:37 AM was 151/109 and pulse was 114; at 8:30 AM, BP was 182/107, and pulse was 150; at 9:00 AM, BP was 173/103 and pulse was 128; at 9:32 BP was 161/116; at 10:03 AM, BP was 166/115 and post-treatment BP was 175/104 sitting and 181/107 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 4. Clinical record review for Patient #16, start of care 9/22/2014, included a review of the dialysis treatment sheets from 2/2/2024 through 2/14/2024 and evidenced the following: On 2/6/2024, the documentation evidenced Patient #16’s BP at 10:54 AM was 197/91; at 11:02 AM, BP was 195/97. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 2/15/2024, the documentation evidenced Patient #16’s BP at 10:39 AM was 139/108; at 11:30 AM, BP was 196/100; at 12:08 PM, BP was 195/89; and at 2:08 PM, BP was 187/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 5. During an interview on 2/21/2024 at 9:45 AM, RN 5 indicated any abnormal blood pressure parameters for the patient should be reported to the Physician. She indicated the PCTs alert the RN for any blood pressure that is abnormal for the patient.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 42617 Based on record review and interview, the interdisciplinary team (IDT) failed to ensure the patient’s plan of care was individualized, included measurable interventions, outcomes, or goals, evidenced interventions the patient and/or IDT was conducting to address disruptive behaviors, and the IDT met at least annually to review and update the plan of care, for 8 of 9 active in-center hemodialysis records reviewed (Patient #3, 4, 7, 10, 11, 14, 16, and 17). Findings include: 1. A review of facility policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/3/2023, indicated the stable patient’s plan of care should be updated annually. The IDT was expected to “interact and share information from the comprehensive assessment to facilitate the development of the plan of care.” The policy indicated the plan of care must include “measurable and expected outcomes and an estimated timetable to achieve these outcomes.” 2. A review of facility policy titled “Disruptive Patient Behavior and Use of Behavioral Agreement,” dated 4/04/12, indicated a patient at risk for involuntary discharge must be considered ‘unstable’ and reassessed by the interdisciplinary team (IDT). The patient’s plan of care should be revised “to demonstrate interventions or resources agreed upon by the patient or determined necessary by the interdisciplinary team to resolve barriers or other issues contributing to the disruptive behavior.” 3. A review of Patient #3’s medical record included a Progress Note documented on 2/12/24 by MSW 1. The note indicated the IDT met with Patient #3 and notified Patient of his/her involuntary discharge from the facility “due to disruptive behaviors and threats to staff.” The record evidenced Patient’s current plan of care, dated 3/28/23. The plan of care failed to evidence the IDT noted any disruptive or abusive behaviors by Patient towards staff and/or other patients. During an interview with Administrator on 2/15/24 at 8:45 AM, Administrator reported Patient #3’s plan of care was due to be updated in February 2024 and facility was waiting on all members of the IDT to update his/her portions of the comprehensive assessment before it could hold a Plan of Care meeting. A review of the facility’s list of unstable patients for November 2023 - February 2024, provided by the Administrator on 2/15/24, failed to evidence Patient #3 was listed as “unstable” for any of these months. 4. A review of Patient #7’s medical record evidenced the IDG last completed a plan of care meeting to review the patient’s plan of care on 12/19/22. During an interview with Administrator on 2/22/24 beginning at 11:35 AM, Administrator reported all members of the IDT completed their portions of Patient’s comprehensive assessment and updated the plan of care according to the assessments, in November 2023. Administrator reported the IDG did not hold a meeting to review the plan of care due to staffing issues and the facility discovered Patient #7 did not have an updated POC in “early February.” Administrator reported the IDG was in the process of updating Patient’s comprehensive assessment and Patient was scheduled for his/her annual POC review in February 2024. 5. A review of Patient #11’s medical record included a plan of care dated 3/23/23. The plan of care evidenced an area of focus for Diabetes Management which indicated the goal was for Patient’s A1C (blood test which shows the patient’s average blood sugar levels over a 3 month period) results to be within the “normal range or as specified by the Physician.” The plan of care’s intervention for this focus area included “to add, adjust, or discontinue diabetes medications” and failed to be individualized for Patient. The plan of care evidenced an area of focus for Blood Pressure and fluid management, with a goal to achieve BP control “as specified by the patient’s physician.” The plan of care failed to evidence what was the “physician-specified” blood pressure goal. The plan of care’s intervention for this focus area included to “add, adjust, and to discontinue BP medications” and failed to evidence individualized Patient goals. 47022 6. A review for Patient #10’s medical record included a plan of care dated 07/31/2023. The plan of care included a goal for Patient to “verbalize decreased pain levels.” Registered Nurse (RN) 4 completed the nursing portion of Patient’s comprehensive assessment on 7/07/23 which indicated Patient denied pain and indicated no follow up plan was required. A review of Patient #10’s treatment sheets dated 02/02/2024, 02/07/2024, 02/09/2024, 02/12/2024, and 02/14/2024 failed to evidence Patient with complaints / reports of pain. 42524 7. A review for Patient #4’s medical record included a plan of care dated 7/31/2023. The plan of care evidenced Patient had an area of focus for Diabetes Management documented 8/8/2022, which indicated the Patient’s A1C (blood test which measures blood sugar levels over 3-month period) results would be in the “normal range or as specified by the Physician.” The plan of care’s intervention for this focus area included “to add, adjust, or discontinue diabetes medications” and failed to evidence the plan was individualized for Patient. 8. A review for Patient #14’s medical record included a plan of care dated 01/29/2024. The plan of care evidenced an area of focus for Diabetes Management which indicated the Patient’s A1C results would be in the “normal range or as specified by the Physician.” The plan of care’s intervention for this focus area included “to add, adjust, or discontinue diabetes medications” and failed to evidence the plan was individualized for Patient. The plan of care evidenced an area of focus for Blood Pressure and fluid management, with a goal to achieve BP control “as specified by Patient’s physician.” The plan of care failed to evidence what was the “physician-specified” blood pressure goal. The plan of care’s intervention for this focus area included to “add, adjust, and to discontinue BP medications” and failed to evidence the plan was individualized for Patient. 9. A review for Patient #16’s medical record included a plan of care dated 4/28/2023 which evidenced Patient had areas of focus for “Dialysis Adequacy PD issues” and “Dialysis Access PD patient.” The record indicated Patient #16 was no longer on PD dialysis and was receiving in-center hemodialysis. The plan of care evidenced an area of focus for Diabetes Management which indicated the Patient’s A1C results would be in the “normal range or as specified by the Physician.” The plan of care’s intervention for this focus area included “to add, adjust, or discontinue diabetes medications” and failed to evidence the plan was individualized for Patient. The plan of care evidenced an area of focus for Blood Pressure and fluid management, with a goal to achieve BP control “as specified by the patient’s physician.” The plan of care failed to evidence what the “physician-specified” blood pressure was. The plan of care’s intervention for this focus area included to “add, adjust, and to discontinue BP medications.” This area of focus failed to be individualized for the patient. 10. A review for Patient #17’s medical record included a plan of care dated 9/25/2023. The plan of care evidenced the patient had an area of focus for Dialysis Adequacy Peritoneal dialysis (PD) issues. The record evidenced Patient #17 was no longer on PD dialysis and was receiving in-center hemodialysis. The plan of care evidenced an area of focus for Blood Pressure (BP) and fluid management, with a goal to achieve BP control “as specified by the patient’s physician.” The plan of care failed to evidence what the “physician-specified” blood pressure was. The plan of care’s intervention for this focus area included to “add, adjust, and to discontinue BP medications.” This area of focus failed to be individualized for the patient. 11. During an interview on 2/22/2024 at 4:07 PM, the Clinic Manager reported the patient’s plan of care was updated yearly unless a patient was unstable. Clinic Manager 2 reported the IDG did not update the plan of care for stable patients. The system used to create plans of care has interventions and goals the IDG could pick from for each patient, but these could not be edited. Clinic Manager 2 reported once a goal or intervention is added to the plan of care, if it is removed, it could not be subsequently re-added. The employee reported he/she did not know how the facility would be to make the plan of care individualized as patients’ goals and interventions could change throughout the year.”

“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: 42524 Based on record review and interview, the dialysis facility failed to ensure the physician was notified when an in-center hemodialysis (ICHD) patient was below their Estimated Dry Weight (EDW) prior to treatment or when an ICHD patient’s post-treatment weight was greater than/less than 1 kilogram of the ordered EDW for 4 of 9 active ICHD patient records reviewed (Patient #4, 14, 16, 17), failed to ensure staff followed facility policies specific to the treatment of orthostatic hypotension for 2 of 2 active ICHD patient records reviewed with orthostatic hypotension (Patient #9 and 10), and failed to ensure patients were assessed and/or monitored per policy in 6 of 9 active ICHD patient records reviewed. (Patient #4, 9, 10, 14, 16, and 17). Findings include: 1. The review of a facility policy titled “Volume Management in ESRD [End Stage Renal Disease] Patients on Hemodialysis,” dated 9/7/2021, indicated “If any of the following patient clinical conditions occur refer to the volume algorithm if applicable or consult with the physician for appropriate fluid interventions: ... Pre-treatment weight is less than or equal to EDW .... EDW order should be updated post-treatment adjustments and patient fluid status ... the clinical care team must be diligent in determining the EDW and routinely assess and adjust this metric ... EDW order should be updated post-treatment to reflect treatment adjustments and patient fluid status ... The assessment of EDW remains a clinical judgment of a clinical judgment of a clinician and clinical care team ... Obtain blood pressure and pulse at least every 30 minutes or more often as needed.” 2. The facility policy titled “Patient Assessment and Monitoring,’’ dated 5/1/2023, indicated “If the [Patient Care Technician (PCT) / Licensed Practical Nurse (LPN)] notes any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or if the patient was hospitalized, the patient care technician MUST report the changes to a registered nurse [RN] Any abnormal finding confirmed by the RN will be reported to the attending physician ... Maintain the patient post-treatment weight and ensure the post weight is consistent with the goal set of the machine ... Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes per state regulations ... The Registered Nurse will assess/reassess post-treatment as indicated.” 3. The review of a facility policy titled “Guidelines for Recognizing and Treating Orthostatic (Postural) Hypotension,” dated 02/07/2022, indicated orthostatic hypotension was a drop in blood pressure [BP] from sitting to standing that was equal to or great than 20 mm Hg [millimeters of mercurgy, the measurement of blood pressure] systolic [top number of a blood pressure reading] or 10 mm Hg diastolic [bottom number of a blood presure reading], the registered nurse would notify the nephrologist when orthostatic hypotension was not relieved by intervention, if the patient exhibits signs or symptoms of orthostatic hypotension the following steps should be followed: instruct the standing patient to sit back down in the dialysis chair and place the patient into modified Trendelenburg position, administer normal saline in bolus doses of 100-200 mL or otherwise prescribed by the patient’s physician, evaluate patient’s condition, take blood pressure and pulse after each normal saline administration, if after a total of 200mL of normal saline does not resolve the patient’s signs and symptoms notify the registered nurse, reevaluate the patient’s vital signs, if the patient continued to have blood pressure changes or symptoms of orthostatic hypotension the physician must be notified. 4. The review of a facility policy titled “Nursing Supervision and Delegation,” dated 5/1/23, indicated the following task may not be delegated: assessment of each patient preferably within one hour of treatment initiation in the clinic setting. 5. The clinical record review for Patient #4, start of care 12/30/2011, included a review of the dialysis treatment sheets from 1/31/2024 through 2/9/2024 and evidenced the following: The Flowsheets dated 2/1/2024, 2/2/2023, 2/7/2024, and 2/9/2024 failed to evidence Patient #4 was assessed by the nurse within the first hour of treatment. The flowsheet dated 2/1/2024 documented Patient #4’s EDW was 81.5 kilograms (kg), his/her pretreatment weight was 79.7 kg, and his/her post-treatment weight was 77.8 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/2/2024 documented Patient #4’s EDW was 80.5 kg, his/her pretreatment weight was 81.6 kg, and his/her post-treatment weight was 78.4 kg. The agency failed to notify the Physician the Patient was under the prescribed dry weight. The flowsheet dated 2/5/2024 documented Patient #4’s EDW was 80.5 kg, and his/her post-treatment weight was 73.2 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. 6. The clinical record review for Patient #17, start of care 5/20/2022, included a review of the dialysis treatment sheets from 2/2/2024 through 2/14/2024 and evidenced the following: The Flowsheets dated 2/5/2024 and 2/7/2024, failed to evidence Patient #17 was assessed by the nurse within the first hour of treatment. The flowsheet dated 2/2/2024 documented Patient #17’s EDW was 91 kg, his/her pretreatment weight was 94.9 kg, and his/her post-treatment weight was 92.5 kg. The agency failed to notify the Physician the Patient was over their prescribed dry weight. The flowsheet dated 2/15/2024 documented Patient #17’s EDW was 91 kg, his pretreatment weight was 94.4 kg, and his post-treatment weight was 92.2 kg. The agency failed to notify the Physician the Patient was over their prescribed dry weight. The flowsheet dated 2/5/2024 documented Patient #17’s EDW was 91 kg, his pretreatment weight was 96.1 kg, and his post-treatment weight was 95.6 kg. The agency failed to notify the Physician the Patient was over their prescribed dry weight. During an interview on 2/22/2024 at 3:07 PM, RN 4 indicated the patient should be assessed in the first hour of treatment. The nurse indicated he/she notifies the Physician when patients do not meet their weight goal but sometimes it is not documented. 7. The clinical record review for Patient #16, start of care 9/22/2014, included a review of the dialysis treatment sheets from 2/2/2024 through 2/14/2024 and evidenced the following: The flowsheet dated 2/6/2024 documented Patient #16’s EDW was 74 kg, his/her pretreatment weight was 72.6 kg, and his/her post-treatment weight was 71 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/8/2024 documented Patient #16’s EDW was 74 kg, his/her pretreatment weight was 76.2 kg, and his/her post-treatment weight was 71.5 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/10/2024 documented Patient #16’s EDW was 74 kg, his/her pretreatment weight was 77.5 kg, and his/her post-treatment weight was 75.4 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The Flowsheets dated 2/10/2024, 2/13/2024, and 2/17/2024, each failed to evidence Patient #16 was assessed by the nurse within the first hour of treatment. The flowsheet dated 2/13/2024 documented Patient #16’s EDW was 74 kg, his/her pretreatment weight was 71.6 kg, and his/her post-treatment weight was 70.6 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/17/2024 documented Patient #16’s EDW was 74 kg, his/her pretreatment weight was 72.6 kg, and his/her post-treatment weight was 705 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. 8. The clinical record review for Patient #14, start of care 12/27/2023, included a review of the dialysis treatment sheets from 2/1/2024 through 2/15/2024 and evidenced the following: The flowsheet dated 2/6/2024 indicated Patient #14’s EDW was 114.5 kg, his/her pretreatment weight was 124.4 kg, and his/her post-treatment weight was 120.8 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/8/2024 indicated Patient #14’s EDW was 114.5 kg, his/her pretreatment weight was 126.1 kg, and his/her post-treatment weight was 122.2 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/10/2024 indicated Patient #14’s EDW was 114.5 kg, his/her pretreatment weight was 122.7 kg, and his/her post-treatment weight was 118.8 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The flowsheet dated 2/15/2024 indicated Patient #14’s EDW was 118.8 kg, his/her pretreatment weight was 126.1 kg, and his/her post-treatment weight was 122.2 kg. The agency failed to notify the Physician the Patient was under their prescribed dry weight. The Flowsheet dated 2/15/2024 failed to evidence Patient #14 was assessed by the nurse within the first hour of treatment. During an interview on 2/21/2024 at 2:20 PM, RN 5 indicated the patient should be assessed in the first hour of treatment. The nurse indicated the Physician was notified if the patient was consistently not meeting their weight goal so the nurse could btain an order to change the weight. 47022 9. The clinical record review for Patient #9, start of care 04/18/2017, included a review of the dialysis treatment sheets dated 01/31/2024-02/14/2024 and evidenced the following: The flowsheet dated 01/31/2024 evidenced Patient #9’s pre-dialysis blood pressure was 152/61 sitting and 147/58 standing and Patient’s post-dialysis blood pressure was 145/68 sitting and 125/68 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. The flowsheet dated 02/08/2024 evidenced Patient #9’s hemodialysis start time was 6:33 AM; the documentation indicated the nurse assessment was complated at 8:55 AM. The flowsheet dated 02/14/2024 evidenced Patient #9’s BP pre-dialysis BP was 159/68 sitting and 158/68 standing and Patient’s post dialysis BP was 166/69 sitting and 123/64 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. 10. The clinical record review for Patient #10, start of care 11/21/2020, included a review of the dialysis treatment sheets dated 02/02/2024-02/14/2024 and evidenced the following: The flowsheet dated 02/02/2024 evidenced Patient #10’s BP pre-dialysis was 158/92 sitting and 134/106 standing and Patient’s post dialysis BP was 135/71 sitting and 105/55 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. The flowsheet dated 02/07/2024 evidenced Patient #10’s hemodialysis start time was 10:27 AM; the documentation indictaed the RN completed Patient’s assessment at 4:04 PM, more than 5 hours after initiation of dialysis treatment. The flowsheet dated 02/09/2024 evidenced Patient #10’s BP pre-dialysis was 122/47 sitting and 97/64 standing and Patient’s post dialysis BP was 149/84 sitting and 117/67 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. The flowsheet dated 02/12/2024 evidenced Patient #10’s BP pre-dialysis was 107/51 sitting and 115/57 standing and Patient’s post dialysis BP was 142/76 sitting and 120/85 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. The flowsheet dated 02/14/2024 evidenced Patient #10’s BP pre-dialysis was 121/67 sitting and 120/70 standing and Patient’s post dialysis BP was 149/80 sitting and 110/57 standing. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of orthostatic hypotension. 11. During an interview on 02/22/2024 at 4:26 PM, the Administrator reported the facility’s policies and procedures should be followed and documented for orthostatic hypotension. The Administrator indicated RN evaluations should be completed within the 1st hour of start of hemodialysis treatment.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure the in-center hemodialysis (ICHD) patient’s dialysis prescription specific to the blood flow rate (BFR) was followed during treatment for 3 of 9 ICHD records reviewed (Patient #9, 10, 11). Findings include: 1. During an observation on 2/20/24 at 10:30 AM at Station #13, Patient #11 was observed receiving dialysis treatment. The patient’s observed BFR was 400 ml/min. Registered Nurse (RN) 5 was in the station at the time of the observation, reported he/she “questioned” the patient’s dialysis settings, and reported he/she would speak with the technician regarding the settings. A clinical record review for Patient #11 included a review of the dialysis treatment sheets from 2/6/24 - 2/17/24 and evidenced the following: The flowsheet dated 2/13/24 indicated Patient #11’s prescribed blood flow rate (BFR, the speed the dialysis machines cycles the patient’s blood through the system) was 450 millilters per minute (ml/min). During treatment, Patient #11’s documented BFR was 400 ml/min. The flowsheet failed to evidenced documentation of why Patient did not receive the prescribed BFR. 47022 2. A clinical record review for Patient #9 included a review of the dialysis treatment sheets from 01/31/2024-02/14/2024 and evidenced the following: The flowsheet dated 02/05/2023 indicated Patient #9’s prescribed BFR was 450 ml/min. During treatment, Patient #9’s documented BFR was 400 ml/min. The documentation failed to evidence why Patient did not receive the prescribed BFR. 3. A clinical record review for Patient #10, included a review of the dialysis treatment sheets from 02/02/2024 - 02/14/2024 and evidenced the following: The flowsheet dated 02/07/2024 indicated Patient’s prescribed BFR was 500 ml/min. During treatment, Patient’s documented BFR was 400 ml/min. The documentation failed to evidence why Patient did not receive their prescribed BFR. 4. During an interview on 02/22/2024 at 4:32 PM, the Administrator indicated the BFR should be set according to the patient’s prescription order. If the BFR order was not followed, the treatment sheet should evidence the reason the prescription order was not being followed, such as elevated arterial pressures on a patient with a central venous catheter.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 42524 Based on record review and interview the dialysis center failed to provide the necessary care for patients to achieve appropriate albumin levels in 4 of 4 records reviewed of Patients below albumin goals (Patient #4, #14, #16, and #17). The findings include: 1. The review of a facility policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/3/2023, indicated “If the patient-specific expected outcome as determined by the attending physician, IDT and patient for the plan of care is not achieved within the identified time frame the interdisciplinary team must adjust the patient ‘s plan of care and document changes made to the plan of care and implement the plan of care changes to address the identified issues.” 2. The clinical record review for Patient #4 evidenced a plan of care dated 7/31/2023, with an area of focus for albumin management (the amount of protein in the blood), with a goal for albumin levels to be greater than or equal to 4.0. The document evidenced Patient #4 was not meeting his/her Albumin goal, and interventions were to “initiate/continue oral nutritional supplement per policy.” An undated document titled “Lab Results ....” evidenced Patient #4 had Albumin levels on 11/23/2023 which was 3.6, on 12/18/2023 the level was 3.2, and on 02/9/24 their level was 3.7; each value was below the target level of 4.0. 3. The clinical record review for Patient #14 evidenced a plan of care dated 12/27/2023 that evidenced an area of focus for albumin management with a goal for albumin levels to be greater than or equal to 4.0; the document evidenced Patient #14 was not meeting their Albumin goal, and interventions were to “initiate/continue oral nutritional supplement per policy.” An undated document titled “Lab Results ....” evidenced Patient #4 had Albumin levels on 11/27/2023 was 2.7 which was below the target level of 4.0. 4. The clinical record review for Patient #16 evidenced a plan of care dated 12/27/2023 with an area of focus for albumin management with a goal for albumin levels to be greater than or equal to 4.0; the document evidenced Patient #16 was not meeting his/her Albumin goal, and interventions were to “initiate/continue oral nutritional supplement per policy.” An undated document titled “Lab Results ....” evidenced Patient #16 had Albumin levels on 11/20/2023 and was 2.6, on 12/26/2023 the level was 2.7, on 1/2/2024 the level was 3.0 and 2/10/24 the level was 2.6. Each valuse was below the target level of 4.0. During an interview on 2/22/2024, Clinic Manager 2 indicated the interventions are chosen from a list and they are working with the patient to reach his/her albumin goals. 5. The clinical record review for Patient #17 evidenced a plan of care dated 4/28/2023 with an area of focus for albumin management with a goal for albumin levels to be greater than or equal to 4.0; the document evidenced Patient #17 was not meeting his/her Albumin goal, and interventions were to “initiate/continue oral nutritional supplement per policy.” An undated document titled “Lab Results ....” evidenced Patient #17 had Albumin levels on 11/19/2023 and the level was 2.6; on 12/6/2023 the level was 2.8 and on 01/15/2024 the level was 2.6. Each value was below the target level of 4.0. During an interview on 2/21/2024 at 3:02 PM, Dietitian 1 indicated Patient #17 did not like a lot of the supplements so Dietician was educating Patient on better protein sources and trying to find a supplement he/she will use.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 42524 Based on record review and interview the dialysis facility failed to provide the necessary care for patients to achieve appropriate hemoglobin level for 1 of 1 Patient that was not meeting their anemia goals (Patients #14). The findings include: The review of a facility policy titled Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/3/2023, stated “If the patient-specific expected outcome as determined by the attending physician, IDT and patient for the plan of care is not achieved within the identified time frame the interdisciplinary team must adjust the Patient’s plan of care and document changes made to the plan of care and implement the plan of care changes to address the identified issues.” The clinical record review for Patient #14 evidenced a plan of care {POC] dated 01/29/2024 with an area of focus for anemia management, with a goal for hemoglobin (Hgb) levels to be 10-11. The POC indicated Patient #14 met the goal of 10-11. The POC was not updated to reflect the current POC goal. An undated document titled “Lab Results ....” evidenced the Patient #14 had hemoglobin levels on 1/4/2024 was 8.3, 1/6/2024 was 8.7, 1/9/2024 was 9, 1/23/2024 was 6.8, 1/30/2024 was 7.0, and 2/6/2024 was 7.2, all of which were below the target level of 10-11. During an interview on 02/20/2024 at 2:02 PM, Registered Nurse (RN) 4 indicated Patient #14 was receiving Venofer and Mircera (medications given to treat low Hemoglobin in dialysis patients). The nurse indicated Patient’s physician was aware of the low hemoglobin; indicated Patient hemoglobin goal was met in December of 2022. RN 4 indicated their EMR does not permit them to accurately update Patient’s POC and that the current POC does not reveal that the Patient is below their hemoglobin goal of 10 - 11 and the POC does not include the interventions in place to achieve this goal.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to ensure the plan of care was reviewed and signed by the patient, and if the patient declined to sign, this would be indicated on the plan of care for 9 of 9 active in-center hemodialysis records reviewed (Patient #3, 7, 9, 10, 11, 14, 15, 16, and 17). Findings include: 1. A review of facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23, indicated the patient must sign the plan of care “to acknowledge the information in the plan.” If the patient declined to sign the plan of care, the facility should document the “reason for refusal.” 2. The clinical record for Patient #3’s evidenced a plan of care dated 3/28/23; the plan of care failed to evidence either the Patient signed the plan of care or had declined to sign. During an interview with Patient #3 on 2/16/24 beginning at 10:55 AM, the patient reported since receiving dialysis at the facility in 2021, he/she had not been notified by the facility of an Interdisciplinary Team (IDT) meeting to review Patient’s plan of care nor had the facility reviewed the patient’s plan of care with him/her. Patient reported he/she had not been asked by the facility to sign a plan of care. 3. The review of Patient #7’s medical record evidenced the IDG last completed a plan of care meeting to review the patient’s plan of care on 12/19/22. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 4. A review of Patient #11’s medical record included a plan of care dated 3/23/23. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. During an interview with Patient #11 on 2/22/24 beginning at 12:50 PM, the patient reported facility staff had reviewed Patient’s plan of care with him/her but could not recall if he/she signed it. 47022 5. A review of Patient #9’s medical record included a plan of care dated 1/29/24. The plan of care failed to evidence Patient signed the plan of care nor that they had declined to sign. 6. A review of Patient #10’s medical record included a plan of care dated 7/21/23. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 42524 7. A review of Patient #14’s medical record included a plan of care dated 12/27/23. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 8. A review of Patient #15’s medical record included a plan of care dated 1/29/24. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 9. A review of Patient #16’s medical record included a plan of care dated 4/28/23. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 10. A review of Patient #17’s medical record included a plan of care dated 9/25/23. The plan of care failed to evidence either Patient signed the plan of care or had declined to sign. 11. During an interview on 2/20/2024 at 10:03 AM, the Administrator indicated the facility did not have any of the above patients’ signed plans of care. Administrator reported there was a new secretary and he/she sent all the signed plans of care to Iron Mountain (place for medical document storage).”

“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: 42617 Based on observation, record review, and interview, the Medical Director failed to ensure all policies and procedures were followed by staff for 4 of 4 observations of staff performing cannulation of an arteriovenous (AV) fistula (Patient Care Technicians (PCT) 2, 3, 7, 9) Findings include: 1. The review of facility policy #45178 titled “Access Assessment and Cannulation,” dated 07/05/2022, indicated prior to treatment, the patient should be asked to wash his or her access area with soap. Staff should wash the access area if the patient was unable to clean their access. After assessing the fistula site by listening with a stethoscope for a bruit and feeling the site for a thrill, staff should remove his/her gloves, perform hand hygiene, and don new gloves. The policy indicated when disinfecting the fistula cannulation site with a 70% alcohol pad, povidone iodine pad, or 2% chlorhexidine and 70% alcohol pad, staff should clean the site for 30 seconds and allow to dry prior to cannulation. Staff should not touch the cannulation sites after disinfection. 2. During an observation at Station #7 on 2/19/24 beginning at 9:37 AM, PCT 2 was observed initiating Patient #24’s dialysis by accessing an arterial-venous (AV) fistula. PCT 2 was observed cleaning the patient’s first cannulation site using a 70% alcohol pad for 20 seconds then cleaned the second cannulation site using a 70% alcohol pad for 23 seconds. 3. During an observation at Station #17 on 2/19/24 beginning at 9:45 AM, PCT 7 was observed initiating Patient #25’s dialysis by accessing an AV fistula. PCT 7 was observed cleaning the patient’s first cannulation site using a 70% alcohol pad for 10 seconds then cleaned the second site using a 70% alcohol pad for 3 seconds. PCT 7 felt for a thrill over the cleaned sites, removed his/her gloves, then left the treatment floor. At 9:48 AM, PCT 7 returned to the treatment floor with his/her stethoscope, entered Station #17, auscultated and felt Patient #25’s fistula sites for a bruit and thrill, then cannulated the first site. PCT 7 attempted to cannulate Patient #25’s second fistula site but was unsuccessful. The technician failed to clean the cannulation site after leaving the station and reassessing the site. During an interview with PCT 7 on 2/20/24 beginning at 9:59 AM, the technician reported each AV fistula cannulation site should be cleaned for 30 seconds with alcohol or betadine. PCT 7 reported if the process of initiating dialysis is interrupted, the access sites should be cleaned again prior to cannulation. The technician stated independent patients should clean the AV fistula site with soap and water at the designated sink upon arrival to the ICHD treatment floor and staff should clean the fistula sites with soap and water for dependent patients prior to beginning cannulation procedures. 4. During an observation at Station #10 on 2/19/24 beginning at 11:20 AM, PCT 3 was observed bringing Patient #39 into the treatment area via wheelchair and transferring Patient into the chair via Hoyer lift. The technician began to initiate Patient’s dialysis by accessing an AV fistula, failing to clean the dependent patient’s site prior. PCT 3 auscultated the fistula site with a stethoscope, prepared supplies, and cleaned the first cannulation site with a disinfectant wipe for 10 seconds. PCT 3 failed to change gloves and perform hand hygiene prior to disinfecting the cannulation site. The technician allowed the area to dry for 4 seconds prior to cannulation. PCT 3 left the station to assist with another patient. At 11:25 AM, PCT 3 returned to Station #10 and cleaned Patient #39’s second cannulation site with a disinfectant wipe for 8 seconds. During an interview with PCT 3 on 2/19/24 beginning at 4:04 PM, the technician reported a dependent patient’s AV fistula site should be cleansed with Except disinfectant prior to initiating cannulation procedures. PCT 3 reported after assessing the site for a thrill and bruit, each cannulation site should be cleaned for 30 seconds with Betadine or alcohol. The technician reported the disinfectant should be allowed to dry prior to cannulating. 5. During an observation at Station #3 on 2/19/24 beginning at 11:30 AM, PCT 7 was observed walking with Patient #30 into the treatment area, obtaining the patient’s pre-treatment weight, and walking with the patient to Station #3. The technician failed to remind the patient to clean his/her AV fistula site with soap and water prior to entering the station. At 11:46 AM, PCT 9 auscultated Patient’s AV fistula site, cleaned the first site with a disinfectant wipe for 6 seconds, and then cleaned the second site with a disinfectant wipe for 9 seconds. PCT 9 failed to clean the patient’s fistula site with soap and water and failed to change gloves and perform hand hygiene prior to disinfecting the cannulation site. After disinfecting the sites, PCT 9 felt the first access site for a thrill twice prior to cannulation. During an interview with PCT 9 on 2/19/24 beginning at 3:59 PM, the technician reported when cannulating an AV fistula site, each site should be cleaned for 30 seconds with a disinfectant wipe. PCT 9 reported independent patients may clean their AV fistula site prior to arriving at the dialysis facility. If a patient is dependent, the technician would clean the fistula site with soap and water prior to initiating cannulation procedures. 6. During an interview with Administrator and Clinic Manager 2 on 2/20/24 beginning at 4:20 PM, the clinic manager reported the patient should clean his/her AV fistula site with soap and water upon entering the ICHD treatment floor. Clinic Manager 2 stated the patient cleaning the site prior to arrival at the facility was not acceptable. If the patient was unable to wash their own fistula site, staff should do perform the cleaning at the station prior to initiating cannulation procedures. Clinic Manager 2 also reported each fistula site should be disinfected for 30 seconds prior to cannulation.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility’s Governing Body failed to oversee the involuntary discharge of an in-center hemodialysis patient and ensure all staff followed all policies and procedures specific to involuntary dischage for 1 of 1 patient in which the facility had initiated an involuntary discharge in February 2024 (Patient #3). Findings include: 1. The policy titled “Routine and Involuntary Patient Discharge,” dated 9/04/19, indicated the Governing Body must ensure all staff followed the facility’s patient discharge and transfer policies and procedures. The medical director was to ensure no patient was involuntarily discharged unless “the facility can no longer meet the patient’s documented medical needs ... the patient’s behavior is deemed disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired.” The policy indicated a patient at risk for involuntary discharge must be reassessed by the interdisciplinary team (IDT) and the IDT should document in the patient’s medical record “the reassessments, ongoing problem(s), and effort(s) made to resolve the problem(s).” For involuntary discharges due to disruptive or abusive behavior, the facility should consult the “Disruptive Patient Behavior and Use of Behavioral Agreement” policy “at the first sign of disruptive or abusive behavior that does not rise to the level of a severe and immediate threat to the health and safety of others.” The policy indicated prior to an involuntary discharge, “there must be evidence in the patient’s medical record of the IDT’s efforts to help the patient resolve any conflict or psychological issues contributing to the behavior.” For involuntary discharges due to the facility’s inability to meet the patient’s needs, the facility should consider “all reasonable alternatives for continuing to provide care to the patient in the facility.” The facility should conduct a meeting between the IDT and the patient and/or patient’s representative “to discuss the patient’s current status and barriers to providing a safe treatment environment for the patient” and discuss other treatment modalities and other locations that provide dialysis, such as a nursing home. The patient’s medical record should include “documentation of all efforts to manage the patient’s care and outcomes as well as all discussions with the patient and his/her representative.” 2. The policy titled “Disruptive Patient Behavior and Use of Behavioral Agreement,” dated 4/04/12, indicated a patient at risk for involuntary discharge must be considered ‘unstable’ and reassessed by the interdisciplinary team (IDT). The patient’s plan of care should be revised “to demonstrate interventions or resources agreed upon by the patient or determined necessary by the interdisciplinary team to resolve barriers or other issues contributing to the disruptive behavior.” The policy indicated a behavioral agreement “should be considered” when “the patient’s behavior has escalated beyond the ability to be handled by an informal resolution process ... individual consultation with the patient’s attending physician, clinical manager, [social worker] or a team meeting, patient/family meeting or patient education has not resulted in positive improvement in the patient’s behavior ... the patient’s behavior has potential to harm the patient or others ... the patient’s behavior will potentially result in termination of dialysis services if not modified or stopped.” The behavioral agreement was to “define what responsibilities or expectations the patient will need to meet to continue to receive services in the facility” and should indicate “consequences of continued disruptive behavior,” including “possible discharge.” The policy indicated once a behavioral agreement was implemented, the IDT would review the “progress of a patient’s Behavioral Agreements on a monthly basis until the patient’s behavior is either resolved, stabilized, or worsens to the extent that involuntary discharge is considered.” The policy defined verbal abuse as “use of words, written or spoken, that demean, insult, belittle or degrade a person.” 3. During an interview with Patient #3 on 2/14/24 beginning at 9:09 AM, Patient reported that on 02/09/24, Patient Care Technician (PCT) 1 scratched and slapped him/her while setting up Patient’s dialysis treatment. Patient reported he/she had previously filed a complaint with the facility against PCT 1, so the technician was only supposed to “push the buttons” on the patient’s dialysis machine and not provide direct patient care, however on 2/09/24, the facility was short-staffed and PCT 1 had to set up the patient’s dialysis treatment. Administrator came to Patient’s chairside shortly after to discuss the alleged incident. Patient #3 reported during his/her conversation with Administrator, the employee told Patient he/she was aware Patient had filed complaints before with the SA. Patient #3 reported Administrator denied the alleged incident between the Patient #3 and PCT 1 occurred and Patient asked how Administrator would like if their family member was being assaulted? Patient #3 reported Administrator became angry at Patient’s comment regarding his/her family member. While leaving the treatment floor, Administrator yelled “take [him/her] off [the dialysis treatment.].” Patient #3 reported on 2/12/24, he/she was notified by the facility he/she was being involuntarily discharged due to being “violent, aggressive” and “hitting, spitting.” The review of an audio recording of Patient #3 and Administrator’s interaction on 02/09/24 evidenced during the interaction, Administrator stated he/she was aware Patient had made complaints to the SA. When Patient denied he/she had filed complaints with the SA, Administrator stated “yes you have ... I know everything.” Administrator stated the alleged assault by PCT 1 did not occur, as if it had, the technician would be “in a police car.” Patient #3 stated PCT 1 wanted to “beat the garbage out of me ... we could have had a fight. I’ve had people assault me before.” Administrator responded, “And you beat them up.” Patient denied saying he/she had beat anyone up and patient hoped “somebody beat [the Administrator’s family member] up like [PCT 1]’s doing.” Administrator stated his/her family member was dead and Patient #3 responded stating “And maybe that’s why.” Administrator was heard yelling “So my [family member] is dead and [Patient #3] thinks [the family member]’s dead because [the family member] got beat up. You have lost your mind.” Additional staff members could be heard coming to the chairside and telling Administrator to walk away. Administrator could then be heard yelling in the distance “take [Patient #3] off [his/her dialysis treatment].” During an interview with Employee H on 02/14/24 beginning at 11:24 AM, the employee reported on 02/9/24, Patient #3 called the local police regarding the alleged assault by PCT 1. The employee reported a police officer and ambulance came to the facility and spoke with Patient at his/her chairside. Employee H reported the police officer also spoke with PCT 1, other employees including him/herself, and other patients, regarding the alleged incident. During an interview with Medical Director on 2/14/24 beginning at 1:25 PM, the physician reported he/she attempted to speak with Patient #3 on 02/12/24 regarding the incidents on 2/09/24 but Patient refused. Medical Director reported the facility had issues with Patient’s behaviors in the past, but the physician was not aware of Patient being verbally or physically abusive towards staff. The physician had met with Patient #3 and Family Member A “on several occasions” to discuss Patient’s behaviors within the past 6 months, however the meetings “didn’t resolve anything.” Medical Director reported he/she did not document the meetings. Medical Director was not aware of the facility enacting a behavioral agreement with Patient #3 prior to 02/12/24. During an interview with Medical Social Worker (MSW) 1 on 02/14/24 beginning at 3:20 PM, the social worker reported the facility had concerns with Patient #3’s inappropriate behaviors in past. The social worker reported the facility IDT had tried to have meetings with Patient #3 regarding his/her behavior, but Patient would not come to the meetings. The social worker reported he/she did not document attempts to conduct meetings as the clinic manager was responsible for setting up these meetings. MSW 1 reported the facility had not made a behavioral agreement with Patient #3 prior to 02/12/24 because the staff hoped Patient’s behavior would improve. During an interview with Administrator on 02/14/24 beginning at 3:54 PM, Administrator reported the facility had tried previously to enact a behavioral contract with Patient #3, however Patient did not attend the IDT meeting; Administrator could not recall when this occurred. Administrator reported on 02/09/24, a local police officer came to the facility after being called by Patient #3. Per Administrator, the police officer informed the facility staff he/she would not file a report as Patient’s allegations were unsubstantiated. Administrator reported he/she spoke with Patient #3 at his/her chairside regarding the alleged incident and Patient became “snappy,” stated he/she should have hit PCT 1, and repeatedly brought up Administrator’s deceased family member. Administrator reported Patient’s “volume started increasing” and 2 employees came over to the chairside and advised Administrator to walk away. The employee reported as he/she was leaving the treatment floor, Administrator advised facility staff to end Patient #3’s treatment early due to Patient saying he/she “should have” hit PCT 1. Later that day, Administrator met with MSW 1 and Corporate Employees 1 and 2 to discuss the incident. Administrator reported during the meeting, the facility and corporate staff determined Patient #3 was to be involuntarily discharged. Administrator reported during a meeting with Patient, Medical Director, MSW 1, Corporate Employee 2, and Administrator, Patient #3 was notified of the involuntary discharge and initiation of a behavioral agreement. The medical record evidenced the IDT last held a plan of care meeting for Patient #3 on 3/28/23. The plan of care failed to evidence the IDT noted any disruptive or abusive behaviors by Patient towards staff and/or other patients. During a follow-up interview with Administrator on 2/15/24 at 8:45 AM, Administrator reported Patient #3’s plan of care was due to be updated in February 2024 and facility was waiting on all members of the interdisciplinary team (IDT) to update his/her portions of the comprehensive assessment before it could hold a Plan of Care meeting. The record included a “Patient Discharge Letter,” dated 02/12/24, which indicated Patient was to be involuntarily discharged, effective 3/12/24, for “behavior that is disruptive and abusive to the extent that it impairs the delivery of care to you or the ability of the facility to operate effectively; the facility can no longer meet your documented needs.” The letter indicated on 02/09/24, Patient #3 called the local police department “because [he/she] stated a PCT tried to assault [him/her]. When the staff attempted to talk to [patient, he/she] became verbally aggressive, loud, and disruptive and stated [he/she] should have hit the PCT.” The record included a “Behavioral Agreement” for Patient #3, signed by Clinic Manager 2 and Medical Director on 02/12/24. The behavioral agreement indicated Patient needed to “be considerate of other patients and staff,” including not using “swear words, threats, or other foul language to degrade, hurt, or be disrespectful to staff or other patients” and “not acting in a way that makes other people in the clinic uncomfortable or afraid for their safety, such as kicking, hitting, threatening, cursing, and yelling.” The behavioral agreement was to be “reviewed by the Clinic Manager on a monthly basis” with Patient. The behavioral agreement failed to evidence the patient’s impending involuntary discharge. The record indicated prior to Patient #3’s involuntary discharge notification on 02/12/24, the last documented nursing comprehensive assessment was completed on 4/05/23. The record included a Clinical Note documented on 11/16/22 at 10:30 by MSW 1. The note indicated the social worker spoke with Patient #3 and Family Member A regarding “issues” Patient #3 was having at the facility. MSW 1 noted Patient #3 and Family Member A had multiple complaints about the facility, including “problems with a PCT” and “numerous complaints against the staff.” The note indicated MSW 1 informed the clinic manager of Patient’s complaints. The social worker noted the clinic manager had stated several patients had complained about Patient #3 and the patient’s “behaviors. [Patient #3] was observed throwing a blood pressure cuff and yelling and hitting dialysis chair.” The record included a Progress Note documented on 11/19/22 by MSW 1. The note indicated ESRD Physician 1, Former Clinic Manager B, and MSW 1 met with Patient #3 and Family Member A. The note indicated Patient had several complaints regarding his/her care and facility staff. ESRD Physician 1 summarized Patient’s treatment and “problems with low blood pressure.” The physician suggested Patient #3 consider an alternative treatment modality. MSW 1 documented Former Clinic Manager B was to “talk to staff for their version of incident.” The record failed to evidence details regarding the “incident” to which the note referred. The record included a Progress Note documented on 11/30/22 by MSW 1. The note indicated Administrator and MSW 1 met with Patient #3 to discuss “current incident.” Patient #3 reported he/she felt like the facility staff did not like him/her and Patient had “issues regarding [his/her] care.” MSW 1 documented the facility provided Patient #3 with educational materials on alternative treatment modalities, Patient’s rights and responsibilities, and “Thriving without Fear/Managing Retaliation.” The record failed to evidence details regarding the “incident” mentioned, any follow-up by facility staff regarding the 11/19/22 or 11/30/22 meetings with Patient, nor Patient’s responses to the 11/19/22 and/or 11/30/22 meetings. The record included a Clinical Note documented on 2/13/23 by Administrator. The note indicated Administrator spoke with Patient #3 and Family Member A regarding Patient and family member’s multiple concerns. Family Member A reported he/she had overheard a technician telling Patient #3 to “just get in the damn chair.” Administrator asked Patient if he/she wanted to transfer to another dialysis unit and Patient declined. The note indicated Patient #3 and Family Member A “began to get very agitated and rude” to Administrator during the conversation. Administrator documented he/she advised Patient #3 to “practice patience, be kind, and respectful to all staff at all times, as the PCT today that took care of Patient was crying and upset by the way [he/she] was treated by Patient.” Patient reported he/she was not rude nor yelled at the employee. Administrator documented after the discussion with Patient #3 and Family Member A, the technician reported he/she feared providing care to Patient #3 due to Patient being “rude and condescending and [the technician was] scared to make a mistake as [he/she] might be reported to leadership.” The record failed to evidence any follow-up nor documenttion of Patient’s response to the meeting, including if there was any improvement to Patient’s reported behaviors. The review of the facility’s adverse event log evidenced an event documented on 3/22/23 by PCT 1. The event report indicated Patient #3 “became loud and argumentative” with the technician and refused to allow the technician to continue working with Patient. During an interview with PCT 1 on 2/14/24 beginning at 12:00 PM, the technician reported he/she had “issues” with Patient #3 prior to the 2/09/24 alleged incident. PCT 1 reported in 2023, Patient became upset when the technician would not put the patient’s shoes on. PCT 1 reported Patient #3 filed a complaint regarding the 2023 incident and since then, the technician would limit his/her work with Patient #3 to only managing the patient’s dialysis machine. Patient #3’s medical record included a Progress Note documented on 3/22/23 by MSW 1. The note indicated PCT 1 reported during treatment, Patient #3 “became verbally abusive because [Patient] disagreed” about his/her dialysis prescription orders. Patient reported he/she did not want PCT 1 to continue to work with him/her. The social worker documented they would “continue to monitor/assist as needed.” The record failed to evidence staff conducted any further follow-up regarding the incident. The facility’s adverse event log evidenced an event documented on 5/31/23 by RN 1. The event report indicated Patient #3 was “loud and argumentative and yelling with techs.” Patient reportedly “continued ranting in waiting room” about RN 1. The facility’s adverse event log evidenced an event documented on 6/07/23 by PCT 2. The event report indicated Patient #3 pushed the technician away and would not allow the technician to perform care to Patient’s central venous catheter (CVC). The report indicated Patient was “loud and argumentative.” Patient #3’s medical record included a Clinical Note documented on 6/13/23 by Administrator. The note indicated Administrator called both Patient #3 and Family Member A to attempt to schedule a meeting with the IDT, however Administrator was unable to reach either Patient or family member. The note failed to evidence the reason for the meeting. The record failed to evidence documentation of any further attempts to conduct a meeting between the IDT and Patient #3. The record included a Progress Note documented on 10/23/23 by MSW 1. The note indicated Clinic Manager 2 reported Patient #3 would “not listen to staff ... regarding [his/her] treatment. [Patient #3] will not adhere to treatment orders. [Patient #3] is calling staff murderers and killers and most staff are afraid to work with [him/her. The clinic manager] is trying to have a meeting ....” The record failed to evidence when the IDT held or attempted to hold a meeting with Patient #3 regarding his/her reported behaviors. The record included a Progress Note documented on 12/01/23 by MSW 1. The note indicated Clinic Manager 2 reported Patient #3 had “snatched an item” out of RN 3’s hands and had been “disruptive.” The note indicated the social worker would “continue to monitor/assist as needed.” The record failed to evidence the IDT held or attempted to hold a meeting with Patient #3 regarding his/her reported behaviors. During an interview with MSW 1 on 2/15/24 beginning at 11:07 AM, the social worker reported the facility attempted to conduct a meeting with Patient #3 regarding his/her behavior after the October or December incidents but could not recall when the attempted meeting occurred. MSW 1 reported Clinic Manager 2 was responsible for setting up the meeting, so the social worker did not document these attempts. MSW 1 reported Patient did not attend the meeting. The social worker could not recall any further interventions were performed by the facility regarding Patient’s behavior. The record included a Progress Note documented on 2/12/24 by MSW 1. The note indicated a meeting was held with “managers” regarding possible involuntary discharge of Patient #3. MSW 1 documented “per meeting with management, [Corporate Employee 1], clinic will start involuntary discharge.” The record included a second Progress Note documented on 2/12/24 by MSW 1. The note indicated the IDT met with Patient #3. During the meeting, Patient #3 was given a notification of involuntary discharge “due to disruptive behaviors and threats to staff” and Patient was given a behavioral agreement. The review of the facility’s adverse event log between 2/14/23 - 2/14/24 evidenced 2 adverse events involving Patient #3 dated 02/09/24. The log included: a. An adverse event for “hemolysis” documented by PCT 1 at 9:19 AM. The event report indicated after performing Patient #3’s CVC care, the technician secured Patient #3’s CVC lines to Patient’s left shoulder. Patient began to pull the lines and “direct where [he/she] would like to place the tape.” PCT 1 documented he/she asked Patient to loosen the arterial line “to prevent the machine from alarming due to noticing restriction.” Patient #3 “became argumentative,” telling the technician “that is not the reason for the machine alarming,” and asking the technician to “just do what [he/she] was asked to do.” PCT 1 documented he/she placed tape where Patient requested and Patient “yelled out ... I know you just didn’t hit me! Back away from me!’ The event report indicated the technician [sic] “confessed that [he/she] did not hit [Patient #3],” left Patient’s station, and informed the facility’s management. PCT 1 documented Patient #3 “called the police to make a report.” Review of Patient #3’s clinical record evidenced Patient’s dialysis treatment began on 2/09/24 at 7:04 AM. Review of the police report filed regarding the police investigation of PCT 1’s alleged assault against Patient indicated the assault was initially reported to the police at 7:09 AM. The police officer’s last radio log was at 8:16 AM to report the investigation was complete. Patient #3’s treatment floor sheet indicated the patient’s treatment ended at 8:57 AM, which was after Patient and Administrator spoke. b. An adverse event for “Dialysis Weight/[Ultrafiltration] Goal Variance” documented by Administrator at 3:11 PM. The event report indicated Patient #3 “had a behavioral occurrence while at treatment ... [Patient] had an outburst, called the police alleging that [he/she] was assaulted by a PCT. [Patient #3] threatened stating that [he/she] ‘should’ve fight [sic] [the technician] back.’ [Patient #3’s] treatment was immediately ended.” The event report indicated Patient #3 was discharged. 4. The review of the facility’s list of unstable patients for November 2023 - February 2024, provided by the Administrator on 2/15/24, failed to evidence Patient #3 was listed as “unstable” for any of these months. 5. The review of the faciliy’s Governing Body meeting minutes failed to evidence the Governing Body was overseeing Patient #3’s involuntary discharge and ensuring all requirments for involuntary discharge according to the facility’s policies were met prior to the facility notifying Patient of a pending involuntary dishcharge.”