Munster Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure bleach solution was made in 1:100 concentration, and bleach solution was covered (Please see V111); failed to ensure hand hygiene was performed (Please see V113); failed to ensure equipment was disinfected (Please see V116); failed to ensure aseptic technique was performed for intravenous medication (Please see V143); failed to ensure infection control standards were maintained during central venous catheter access care (Please see V146); and failed to ensure catheter related blood stream infections were documented on infection monitoring log (Please see V148). The cumulative effective of the systemic problems had resulted in the dialysis facility’s inability to ensure the provision of quality of health care in a safe environment for the condition for coverage 494.30 Infection Control.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to track fluid and blood pressure management, and failed to montior water quality testing log completion (Please see V628); failed to analyze and track adverse events (Please see V634); failed to analyze and document peritoneal dialysis catheter related infections (Please see V637); and failed to ensure improvement plans were implemented for identified infections (Please see V638). The cumulative effect of the systemic problems had resulted in the dialysis facility’s inability to ensure the provision of quality of heatlh care in a safe environment for the condition of participation 494.110 Quality Assessment and Performance Improvement.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to include a process for cooperation and collaboration with local, regional, state, and federal emergency preparedness officials to maintain an integrated response during a disaster or emergency situation in 1 of 1 dialysis facility. Findings include: 1. A policy, revised 05/2022, titled, “Emergency Preparedness Overview,” indicated annually the dialysis facility Clinic Manager would contact the local emergency management agency to ensure the agency was aware of the dialysis facility’s needs in the event of an emergency. The policy indicated that the record of the contact with the emergency management agency would be kept in the emergency binder. A record review, on 04/03/2025, of the emergency management binder failed to include documentation of contact with local and federal emergency management officials. During an interview, on 04/03/2025, beginning at 11:30 AM, the Clinic Manager, Administrative Staff 1, indicated she had not contacted emergency management officials.”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 51199 Based on observation and interview, the dialysis facility failed to have a system of medical documentation that secured and maintained availability of patient records in 1 of 1 dialysis facility emergency kit observed. Findings include: 1. During an observation, on 04/02/2025, beginning at 12:00PM, a review of the dialysis facility emergency preparedness kit failed to evidence a current list of patients/demographics/dialysis prescription. Patient Demographic Reports, dated 06/14/2021 and 08/06/2024, were found in the emergency preparedness kit. During an interview, on 04/02/2025, beginning at 12:30PM, RN 1 indicated that patient information and prescriptions for the emergency preparedness kit should be printed, updated monthly by an RN, and placed in the emergency preparedness kit.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure a sanitary environment to minimize the transmission of infectious agents in preparation of 4 of 8 containers of 1:100 concentration bleach/water solutions, failed to ensure lids covered bleach/water solution containers in 3 of 3 observations on dialysis treatment floor (on 04/02/2025 from 9:50 AM to 12:00 PM, on 04/04/2025 from 10:45 AM to 11:45 AM, and on 04/04/25 from 2:20 PM to 2:55 PM) and failed to ensure reuseable clamps were fully submerged in a disinfection solution in 2 of 3 observations on dialysis treatment floor (04/02/2025 and 04/04/2025). Findings include: 1. A revised policy, dated 06/20/2024, titled, “Cleaning and Disinfection of Equipment, Supplies and Treatment Area,” indicated equipment, work surfaces, and treatment areas would be disinfected using a 1:100 bleach/water solution, and bleach solutions must be covered with a lid to prevent contamination. The policy indicated reusable supplies would be disinfected after each patient use, and care would be taken to ensure all surfaces of all items are fully covered by the bleach to include but not limited to fistula clamps. The policy indicated 1:100 concentration of bleach/water solution would include 10 milliliters [ml] of 5.25% to 6% bleach solutions would be mixed with 1000ml, 20 ml of bleach would be mixed with 2000 ml of water, 40 ml of bleach would be mixed with 4000 ml of water, or 60 ml of bleach would be mixed with 6000 ml of water. 2. During an observation, on 04/02/2025, beginning at 9:50 AM until 12:00 PM, a container, filled with an off white fluid, labeled 1:100 bleach solution, located at a clean sink near stations #10 to #14; and a container, filled with an off white fluid, labeled 1:10 bleach solution, located at a dirty sink near stations #10 to #14, the lids were off of the bleach solution and propped against the side of the containers. During an interview, on 04/02/2025, beginning at 12:15 PM, PCT 6 indicated the lids of the bleach should be on the containers. 3. During an observation, on 04/02/2025, beginning at 9:50 AM, a container labeled 1:100 bleach solution, filled with an off-white fluid, located at a dirty sink near stations #15 to #19, had an unsubmerged clamp with 1 arm of the clamp not in the bleach solution. 4. During an observation, on 04/02/2025, beginning at 12:00 PM, a container labeled 1:100 bleach solution for clean supplies, filled with an off-white fluid, that contained blue clamps and fistula clamps indicated mixing instructions were to add 25 ml of bleach to 2475ml of water were located at a sink labeled dirty near station #4 to #8. During an observation, on 04/02/2025, beginning at 12:00 PM, a container labeled 1:10 bleach solution for clean supplies, filled with an off-white fluid, indicated mixing instructions were to add 100 ml of bleach to 900 ml of water were located at a sink labeled clean near station #4 to #8. During an interview, on 04/02/2025, beginning at 12:00 PM, PCT 7 indicated for both containers, located near station #4 to #8, labeled 1:10 and 1:100 bleach solution, she added 10 ml of bleach to 2000 ml of water and showed the measurement containers used to add bleach and water. 5. During an observation, on 04/02/2025, beginning at 12:15 PM, a container, filled with an off-white fluid, was labeled 1:100 bleach solution and a container, filled with an off-white fluid, was labeled 1:10 bleach solution. During an interview, on 04/02/2025, beginning at 12:15 PM, PCT 6 indicated she made the bleach solution labeled 1:100 bleach solution with 50 ml of bleach and the water was not measured to a specific amount, and indicated she made the bleach solution labeled 1:10 bleach solution with 60 ml of bleach and the water was not measured to a specific amount. 6. During an interview, on 04/02/2025, beginning at 1:40 PM, biomed tech 1 indicated the dialysis facility did not have bleach test strips to monitor the concentration of the bleach solution. 7. During an interview, on 04/02/2025, beginning at 1:45 PM, the Clinical Manager, Administrative Staff 1, indicated the dialysis facility staff was to make bleach concentration solution 1:100 and was not to make 1:10 bleach concentration solution. The Clinical Manager indicated PCT 6 and PCT 7 did not mix the bleach concentration solution correctly, and the PCT’s should follow instructions written on the containers. 51199 8. During an observation, on 04/04/2025, from 10:47AM to11:45AM, two containers of 1:100 bleach solution were left uncovered, with the lids on the counter beside the container. 9. During an observation, on 04/04/2025, from 2:20PM to 2:55PM, two containers of 1:100 bleach solution were left uncovered, with the lids on the counter beside the container. 10. During an interview, on 04/07/2025, beginning at 1:00PM, PCT 3 indicated that bleach solutions on the treatment floor should be covered. 11. During an observation, on 04/04/2025, from 2:20PM to 2:55PM, a container of clamps were soaking in a bleach solution, but not fully covered in the bleach solution. During an interview, on 04/07/2025, beginning at 1:00, PCT 3 indicated that instruments needed to be fully submerged in the bleach solution.”

“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, record review, and interview, the dialysis facility failed to ensure staff removed their gloves and performed hand hygiene (hand sanitizing with an alcohol-based antiseptic or hand washing) between patients and stations and after glove removal in 2 of 2 observations of PCT 6, in 1 of 3 observations of PCT 7, and in 3 of 5 observations of initiation of hemodialysis [HD] (a process to clean the blood of a patient whose kidneys do not work normally) with a Central Venous Catheter [CVC] (large catheter into a vein) (PCT 2 and PCT 6), and in 1 of 2 station cleaning observed (PCT 4). Findings include: 1. A revised policy, dated 11/29/2022, titled, “Infection Control,” indicated hands should be washed after gloves are removed, between patient contact, and after touching blood, body fluids, and contaminated items. The policy indicated antiseptic hand cleaners may be used in place of soap and water if hands are not soiled, during emergencies, or if there has been no exposure to or contact with blood or potentially infectious materials. 2. A revised policy, dated 09/01/2023, titled “CVC: Dressing Change” indicated that hand hygiene and donning clean gloves should be performed after discarding the old dressing. 3. During an observation, on 04/02/2025 beginning at 10:50 AM, PCT 6 was at Station #11 with Patient #9, and was wearing gloves. During the observation, PCT 6 removed her gloves, exited Station #11, and entered the medication preparation area without performing hand hygiene. PCT 6 drew up heparin (blood thinner) in a syringe from a multiidose vial, then donned gloves, entered station #11, placed the heparin into the pump, PCT 6 then removed her gloves and exited station #11, went to the preparation area for supplies and without performing hand hygiene, donned gloves and reentered station #11. 4. During an observation, on 04/02/2025 beginning at 11:00 AM, PCT 6 was at Station #11 and drew labs from Patient #9’s CVC; PCT 6 removed her gloves and without performing hand hygiene, donned new gloves and exited Station #11. During the observation, PCT 6 opened the laboratory refrigerator door and placed the lab vial in the refrigerator, PCT 6 then removed her gloves and without performing hand hygiene donned new gloves, entered Station #14 and touched supplies that were on the chair’s tray. 5. During an observation, on 04/02/2025, beginning at 12:30 PM, PCT 7 was at Station #3 with Patient #7, and discontinued 1 line of Patient’s arteriovenous fistula/graft [access for HD]. During the observation, PCT 7 removed the HD machine’s bloodlines, discarded the bloodlines in the biohazard waste bag, without performing hand hygiene or changing gloves, then picked up Patient’s lab vial from the chairside tray and carried it to the laboratory refrigerator, without performing hand hygiene or changing gloves she then opened the laboratory refrigerator door. 51199 6. During an observation, on 04/04/2025, beginning at 11:15AM, at Station #13, PCT 2 brought supplies to the dialysis station, and failed to perform hand hygiene prior to donning new gloves when initiating HD with a CVC for Patient #18. 7. During an observation, on 04/04/2025, beginning at 11:12AM, at Station #13, PCT 2 removed the old dressing from Patient #18, and failed to remove gloves, perform hand hygiene, and don new gloves before disinfecting the CVC site. 8. During an observation, on 04/04/2025, beginning at 11:18AM, at Station #11, PCT 6 removed the old dressing from Patient #17, and failed to remove gloves, perform hand hygiene, and don new gloves before disinfecting the CVC site. 9. During an observation, on 04/02/2025, beginning at 10:25AM, PCT 4 cleaned and disinfected Station #23. PCT 4 removed the bloodlines, emptied the prime waste receptacle, and failed to remove gloves, perform hand hygiene, and don new gloves prior to beginning disinfection of the HD machine. 10. During an interview, on 04/02/2025, beginning at 11:11AM, PCT 4 indicated that hand hygiene should occur before and after glove changes, and that glove changes should occur after touching contaminated items. 11. During an interview, on 04/02/2025, beginning at 12:15 PM, PCT 6 indicated hand hygiene should occur between different patients, when changing gloves, between stations, and if the HD machine was touched.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis failed to ensure all staff [PCT 7] cleaned and disinfected nondisposable equipment taken into a dialysis station before being taken to a common clean area in 1 of 1 observations of preparation of a hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] station (Station #5). Findings include: 1. A revised policy, dated 06/20/2024, titled, “Cleaning and Disinfection of Equipment, Supplies and Treatment Area,” indicated reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. 2. During an observation, on 04/02/2025, beginning at 11:20 AM, PCT 7 was at Station #5 with Patient #10, PCT 7 conducted a conductivity test with a phoenix meter in Station #5, then returned the phoenix meter to a counter, near a sink labeled clean, and failed to clean the phoenix meter after exiting Station #5 or before placing the phoenix meter near a clean sink counter. During an interview, on 04/02/2025, beginning at 12:00 PM, PCT 7 indicated phoenix meters were cleaned at the end of each treatment day and were not decontaminated after use or between patients’ stations.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure the staff demonstrated aseptic techniques when dispensing and administering intravenous medications from vials in 2 of 2 observations (PCT 6). Findings include: 1. A revised policy, dated 03/07/2025, titled, “Medications: Handling, Administration, Storage and Disposal,” indicated aseptic technique was to be used to prepare medications. The policy indicated medication vials were to be disinfected with an alcohol pad before each entry by a needle. 2. During an observation, on 04/02/2025 beginning at 10:50 AM, PCT 6 exited Station #11, removed their gloves, did not perform hand hygiene and entered the medication preparation area. PCT 6 did not clean the top of the heparin multi-dose vial and inserted a syringe to draw up the heparin, PCT 6 then inserted another syringe to draw up a 2nd syringe of heparin; PCT 6 did not clean the top of the heparin multi-dose vial prior to insertion of the syringes. 3. During an interview, on 04/02/2025, beginning at 12:15 PM, PCT 6 indicated the top of a multi-dose heparin vial should be cleaned with an alcohol swab prior to inserting a syringe and indicated the heparin vial top would need to be cleaned once before the first syringe was inserted, and not recleaned if second syringe was inserted.”

“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, record review, and interview, the dialysis failed to ensure staff followed standard infection control precautions when providing central venous catheter (CVC) [catheter into vein] access care for hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally) in 3 of 3 observations of CVC exit site care (PCT 5, PCT 6, and PCT 7) and failed to ensure staff placed a clean field under a CVC in 1 of 2 observations of HD discontinuation of a CVC (PCT 4). Findings include: 1. A revised policy, dated 09/01/2023, titled, “CVC: Dressing Change,” indicated during initiation of treatment the old dressing from the catheter site should be discarded with contaminated gloves, hand hygiene should be performed, new gloves should be donned, and the exit site should be cleaned. 2. A revised policy, dated 10/22/2024, titled “CVC: Initiation & Discontinuation of Treatment” indicated that after performing hand hygiene and donning new gloves, a clean field should be placed under the catheter limbs/caps. 3. During an observation, on 04/02/2025, beginning at 10:50 AM, PCT 6 was at Station #11, with Patient #9, initiating access of a CVC for HD. During the observation, PCT 6 removed her gloves, exited Station #11, went to the preparation area for supplies and without performing hand hygiene donned new gloves, removed the dressing to Patient’s CVC site, cleaned the CVC exit site, applied a new dressing, removed her gloves, without performing hand hygiene donned new gloves, removed the hub to the red line, cleaned the hub with an alcohol swab, inserted a syringe, removed the hub to the blue line and cleaned the hub with an alcohol swab, threw supplies away in the garbage, she removed her gloves, without performing hand hygiene donned new gloves, drew labs from the red line, removed her gloves and without performing hand hygiene applied new gloves. 4. During an observation, on 04/02/2025, beginning at 11:00 AM, PCT 7 was at Station #4, with Patient #18, initiating access of a CVC for HD. During the observation, PCT 7 was wearing gloves and removed the CVC site dressing, without performing hand hygiene or glove change cleaned the CVC exit site, applied a new dressing and then removed gloves and performed hand hygiene. 5. During an observation, on 04/02/2025, beginning at 11:35 AM, PCT 5 was at Station #10, with Patient #6, initiating access of a CVC for HD. During the observation, PCT 5 was wearing gloves and removed the CVC site dressing, removed the lines dressing, without performing hand hygiene or glove change cleaned the CVC exit site, performed hand hygiene, changed gloves and applied a new exit site dressing. 6. During an interview, on 04/02/2025, beginning at 12:15 PM, PCT 6 indicated during CVC exit site care the dressing should be removed, the exit site should be cleaned, and then gloves should be changed and the caps should be cleaned. 51199 7. During an observation, on 04/04/2025, beginning at 2:49PM, at Station 23, PCT 4 performed hand hygiene, donned clean gloves, and reinfused the extracorporeal circuit without placing a clean field under the CVC ports for Patient #19.”

“IC-MONITOR CATH-RELATED BSI RATES/SURV CFR(s): 494.30(a)(2) Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. I. Surveillance A. Conduct surveillance ...to determine CRBSI rates, monitor trends in those rates, and assist in identifying lapses in infection-control practices. C. Investigate events leading to unexpected life-threatening or fatal outcomes. This includes any process variation for which a recurrence would likely present an adverse outcome. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to monitor blood stream infection rates to monitor trends in those rates to assist in identifying lapses in infection control practices in 1 of 2 clinical records reviewed with a documented blood stream infection (Patient #6). Findings include: 1. A revised policy, dated 01/13/2025, titled, “Quality Assurance and Performance Improvement [QAPI],” indicated infection data must be collected and documented monthly using a QAPI reporting tools to collect and review data timely, identify problems and begin interventions. 2. A Hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] Treatment Flowsheet, dated 03/24/2025, indicated Patient #6 complained of central venous catheter (CVC) [catheter into vein] tenderness and redness and blood cultures were taken. 3. A microbiology culture for Patient #6, dated 03/24/2025, indicated blood cultures positive for staphylococcus epidermidis (a bacteria that can cause infections in immunocompromised patients) from the central venous catheter. 4. A Dialysis Order Report, dated 03/25/2025, indicated Vancomycin (antibiotic) intravenous was ordered for 1 dose. 5. A Dialysis Order Report, dated 04/02/2025, indicated Vancomycin was ordered for 3 treatments with a start date of 04/04/2025. 6. An Infection Log, for March 2025, failed to include Patient #6 blood stream infection. 7. During an interview on 04/07/2025, beginning at 2:30 PM, the Clinical Manager, Administrative Staff 1, indicated the dialysis facility tracked dialysis related infections to include HD access, CVC and exit site infections. The Clinical Manager indicated Patient #6’s CVC related infection should have been included on the March 2025 infection log and was not included.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure that a saturated salt solution existed in the brine tank in 2 of 2 months of Water System Log Sheet reviewed. Findings include: 1. A Water System Log Sheet, dated 02/01/2025 to 02/28/2025, indicated that the brine tank level was greater than half full on 02/01/2025 and on the remaining operating days the brine tank was not half full. The Water Sytem Log Sheet indicated that no salt was added to the brine tank on any day during the month of February 2025. 2. A Water System Log Sheet, dated 03/01/2025 to 03/31/2025, indicated that the brine tank level was not half full during the operating days. The Water System Log Sheets indicated that salt was added on 03/29/2025. 3. During an interview, on 04/03/2025 beginning at 10:50AM, Biomed [BM] 1 indicated that staff had refused to fill the brine tank for various reasons. BM 1 indicated that he often filled the brine tank with salt approximately weekly and did not document any instances that he added salt.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure staff monitored the reverse osmosis [RO] system, daily, to ensure the RO met system requirements in 2 of 8 weeks of Water System Log reviewed. Findings include: 1. A revised job description for PCT, dated 07/2024, indicated the PCT should perform water treatment testing, monitoring, and documentation as assigned. 2. A revised Water System Log Sheet, dated 02/05/2024, indicated that log sheet should be filled out daily while the system was operating. 3. A Water System Log Sheet, dated from 02/01/2025 through 02/28/2025, failed to evidence the RO system was monitored before dialysis began and was documented on February 03, 07, and 14, of 2025. 4. A Water System Log Sheet, dated from 03/01/2025 through 03/31/2025, failed to evidence the RO system was monitored before dialysis began and was documented on March 10, 12, 14, and 21, of 2025. 5. During an interview on 04/03/2025, beginning at 10:50AM, Biomed Technician [BM] 1 indicated he had not noticed the logs for February and March of 2025 were incomplete. BM1 indicated staff should have monitored and documented the RO monitoring, before care began on each patient care day.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure a safe treatment environment when lights were off during period when patients’ hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] treatments occured during 1 of 2 dialysis treatment floor observations days. Findings include: 1. A revised job description, dated 10/2024, titled, “Charge Registered Nurse,” indicated the essential function of the RN would include but not limited to ensuring safe and efficient care of all patients. 2. During an observation, on 04/02/2025 beginning at 10:20 AM throguh 12:30 PM, the HD treatment floor peripheral lighting was off, the center lights over work station located in center of Station #1 to Station #14, and the center lights over work station located in center of Station #15 to Station #28 were on. 3. During an interview, on 04/03/2025, beginning at 4:00 PM, the Clinical Manager, Administrative Staff 1, indicated all lights should be on during HD treatment and did not notice the lights were off on 04/02/2025. 4. During an interview, on 04/07/2025, beginning at 1:00 PM, PCT 3 indicated when the lights are off on the HD treatment floor it was hard to see, there was a dimmer for the lights, the staff tried not to turn off the lights because the staff could not see well enough to pay attention to exit sites.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure each patient’s vascular access site, and patient’s face were able to be seen by a staff member throughout the hemodialysis (HD) [a process to clean the blood of a patient whose kidneys do not work normally) treatment in 2 of 3 observations of the HD treatment floor (Patient #7, Patient #8, Patient #12, and Patient #19). Findings include: 1. A revised policy, dated 11/29/2022, titled, “Monitoring and Documentation of Patient Care During Treatment,” indicated the patient’s vascular access would remain uncovered and readily visible throughout the course of the patient’s treatment. The policy indicated if the patient refused to allow the access to remain uncovered and visible, the staff would enter a detailed note at the first observation that explained the patient’s refusal, and would be reported to the center manager, attending physician, and medical director for intervention. 2. During an observation, on 04/02/2025 beginning at 10:20 AM through 12:00 PM, observed the following: Patient #7 was in Station #3, receiving their HD via their left arm arteriovenous fistula/graft (AVF/AVG) [hemodialysis access]; their access was covered with a blue chux (disposable plastic covering). Observed beginning at 10:20 AM to 11:00 AM, Patient #8 was receiving their HD at Station #15, via their left arm AVF/AVG; their access site was covered with a blanket. 3. During an interview, on 04/02/2025 beginning at 12:00 PM, PCT 7 indicated Patient #7 would cover their left arm AVG site with a chux due to being cold. 4. During an interview, on 04/07/2025 beginning at 1:00 PM, PCT 3 indicated Patient #8 would keep their arm covered due to being cold. PCT 3 relayed patients’ access site should be in view, and indicated she did not document when Patient refused to uncover their access site; she indicated the treatment sheet should have documentation of Patient’s refusal to uncover their access site. 5. During an interview on 04/07/2025 beginning at 1:30 PM, RN 4 indicated HD accesses should not be covered, and patient faces should not be covered during HD treatment. RN 4 indicated if a patient refused to keep HD access covered education would be provided, and the physician and clinical manager would be notified. 51199 5. During an observation, on 04/02/2025 at 10:57AM, Patient #12 had a blanket covering their face until 11:37 AM when PCT 3 began speaking to Patient #12. 6. During an observation, on 04/04/2025 beginning at 2:20 PM, at Station # 23 Patient #19’s Central Venous Catheter [CVC] (catheter into large vein) was covered with a blue chux. The chux covered the entire patient chest starting at the neck and ending at the abdomen. The chux remained covering the CVC site until 2:49 PM when Patient #19 was disconnected from the HD machine.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure patient right to respect and dignity during hemodialysis [HD] (a process to filter the blood in a patient whose kidneys do not work normally) treatment in 1 of 2 observation days of the treatment floor (Patient #14) Findings include: 1. A Patient Rights document, signed by Patient #14, indicated that each patient has the right to be treated with consideration and respect, including the right for privacy in treatment, interviews, and examination to the extent possible. 2. During an observation, on 04/02/2025, beginning at 10:53 AM, Patient #14 arrived ambulatory to Station #25 and pulled his/her pants down to his/her knees, and remained standing, in their underwear, at the station for 1 minute before sitting down. During the observation, Patient #14 was noted to have arteriovenous fistula [AVG] access for hemodialysis) to their left thigh. During the observation, PCT 1 spoke to Patient #14 who remained seated, uncovered, with his/her pants pulled down to their ankles during the conversation. During the observation, Patient remained seated with pants down to ankles until 11:34 AM when Patient covered self with blanket. During an interview, on 04/02/2025, beginning at 11:15AM, Patient #14 indicated that they have not been offered a privacy curtain. During an interview, on 04/02/2025, beginning at 12:14, PCT 1 indicated Patient #14 normally wore shorts to treatment and exposure was not usually an issue. During an interview, on 04/07/2025, beginning at 1:30PM, RN 4 indicated that Patient #14 had been offered a privacy screen in the past and refused.”

“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 ensure the evaluation of the appropriateness of the peritoneal dialysis [PD] prescription and target weight for 2 of 2 clinical records reviewed who received PD (Patient #2 and Patient #4). Findings include: 1. A Continuous Cycler PD Order, dated 03/06/2025, indicated Patient #4’s target weight was 74.1 kilograms (kg), 2500 milliliters (ml) fill volume, 4 exchanges 7 days per week. The dialysate sliding scale indicated if at or below target weight to use 1.5% dextrose, 1-2 pounds (lb.s) over target weight to alternate 1.5% with 2.5% dextrose, 1-3 lbs over target weight alternate 2.5% dextrose, 1-4 lbs over target weight alternate 2.5% with 4.25% dextrose, more than 4.1 lbs over target weight to notify the RN, and adjust time and volume based on training time. A Continuous Cyler PD Order, dated 03/28/2025, indicated Patient’s target weight was 74.1 kgs, 2500 ml fill volume, 4 exchanges 7 days per week. The dialysate sliding scale indicated at or below target weight to use 1/5% dextrose, 1-2 pounds (lbs) over target weight to alternate 1.5% with 2.5% dextrose, 1-3 lbs over target weight alternate 2.5% dextrose, 1-4 lbs over target weight alternate 2.5% with 4.25% dextrose, more than 4.1 lbs over target weight to notify the RN, and adjust time and volume based on training time. A Continuous Cycler PD Order, dated 10/17/2024 Patient’s target weight was 74.1 kgs. A Nursing Monthly Progress Note, dated 02/07/2025, indicated would continue to watch lab values and Patient was close to needing more fluid. A Nursing Visit Note, dated 03/03/2025, indicated Patient’s target weight was 74.1 kgs, and Patient’s weight on 03/03/2025 was 70.5 kgs. A Nursing Visit Note, dated 03/06/2025, indicated treatment flowsheets were reviewed from 02/01/2025 to 02/28/2025 and indicated Patient was not within target weight range. A Nursing Monthly Progress Note, dated 03/10/2025, indicated Patient’s target weight was 74.1kgs, average pre dialysis blood pressure was 96/65, and average weight gain was 0 kgs. A Nursing Visit Note, dated 03/11/2025, indicated Patient’s target weight was 74.1 kgs, weight at home was 68.6 kgs and had no edema. A Nursing Visit Note, dated 03/20/2025, indicated Patient’s target weight was 74.1 kgs, and Patient’s weight on 03/20/2025 was 69.1 kgs. A Nursing Progress Note Report, dated 03/12/2025, indicated Patient’s blood pressure was 75/47, with complaints of weakness, dizziness, shortness of breath and was sent to the emergency room. Home PD Treatment Report for 02/01/2025 to 03/31/2025 evidenced the following: Target weight was 75 kgs 02/01/2025 pre-treatment weight: 73 kgs 02/02/2025 pre-treatment weight 72 kgs 02/03/2025 pre-treatment weight 72 kgs 02/04/2025 pre-treatment weight 71 kgs 02/05/2025 pre-treatment weight 71 kgs 02/06/2025 pre-treatment weight 71 kgg 02/07/2025 pre-treatment weight 72 kgs 02/08/2025 pre-treatment weight 71 kgs 02/09/2025 pre-treatment weight 70 kgs 02/10/2025 pre-treatment weight 71 kgs 02/12/2025 pre-treatment weight 71 kgs 02/13/2025 pre-treatment weight 71 kgs 02/16/2025 pre-treatment weight 72 kgs Dialysate Utilized 03/01/2025 to 03/21/2025 was 1.5%. 03/06/2025 pre-treatment weight 71 kgs, pre-treatment blood pressure 93/59 03/07/2025 pre-treatment weight 70 kgs, pre-treatment blood pressure 109/76 03/09/2025 pre-treatment weight 67 kgs, pre-treatment blood pressure 107/70 03/10/2025 pre-treatment weight 68 kgs, pre-treatment blood pressure 109/73 03/11/2025 pre-treatment weight 68 kgs, pre-treatment blood pressure 123/62 03/14/2025 pre-treatment weight 70 kgs, pre-treatment blood pressure 113/70 03/17/2025 pre-treatment weight 67 kgs, pre-treatment blood pressure 136/88 Dialysate Utilized 03/24/2025 was 1.5% and 2.5% and pre-treatment weight was 70 kgs. Dialysate Utilized 03/26/2024 was 2.5% and 2.5% and pre-treatment weight 66 kgs. Dialysate Utilized 03/30/2025 was 1.5% and 2.5% and pre-treatment weight was 67 kgs. 2. During an interview on 04/07/2025, beginning at 12:00 PM, RN 3 indicated patients adjust their dialysate based on weight, if have shortness of breath, or edema and Patient’s target weight should have been adjusted. 51199 3. The clinical record for Patient #2 evidneced prescribed versus actual treatment records, dated from 02/01/2025 to 04/01/2025, indicate the following patient weights, which were above Patients’ target weight of 115 kilograms [kg]: A. 116.3kg on 02/02/2025 B. 116.1kg on 02/03/2025 C. 116.4kg on 02/04/2025 D. 121.2kg on 02/05/2025 E. 120.9kg on 02/06/2025 F. 121.1kg on 02/07/25 G. 120kg on 02/08/2025 H. 120.2kg on 02/09/2025 I. 120.9kg on 02/10/2025 J. 120.1kg on 02/11/2025 K. 119kg on 02/12/2025 L. 120kg on 02/13/2025 M. 119.3kg on 02/14/2025 N. 120.4kg on 02/15/2025 O. 119.5kg on 02/16/2025 P. 119.9kg on 02/17/2025 Q. 119.3kg on 02/18/2025 R. 118.2kg on 02/19/2025 S. 119.2kg on 02/20/2025 T. 119.8kg on 02/21/2025 U. 119.2kg on 02/22/2025 V. 120.2kg on 02/23/2025 W. 119kg on 02/24/2025 X. 119.9kg on 02/25/2025 Y. 120.2kg on 02/27/2025 Z. 121.1kg on 02/28/2025 AA. 120.1kg on 03/01/2025 BB. 119.1kg on 03/02/2025 CC. 120kg on 03/03/2025 DD. 116.8kg on 03/04/2025 EE. 116.5kg on 03/05/2025 FF. 116.7kg on 03/07/2025 GG. 116.5kg on 03/09/2025 HH. 116.5kg on 03/11/2025 II. 116.3kg on 03/14/2025 JJ. 116.4kg on 03/16/2025 KK. 117.2kg on 03/18/2025 LL. 116.4kg on 03/19/2025 MM. 119.9kg on 03/20/2025 NN. 119.1kg on 03/21/2025 OO. 120.1kg on 03/22/2025 PP. 119.9kg on 03/23/2025 QQ. 120kg on 03/24/2025 RR. 119.3kg on 03/25/2025 SS. 119.8kg on 03/26/2025 TT. 119.1kg on 03/27/2025 UU. 120.2kg on 03/28/2025 VV. 119kg on 03/29/2025 WW. 117.7kg on 03/30/2025 XX. 117.9kg on 03/31/2025 YY. 117.3 on 04/01/2025 A Nurse Visit Note, dated 02/05/2025, RN 3 reported Patient #2’s weight of 121.4kg, target weight of 115kg, and noted Patient 2 was within their target weight range. A Nurse Visit Note, dated 02/19/2025, RN 3 reports Patient’s weight of 118.6kg and target weight of 115kg. A Nurse Visit Note, dated 03/04/2025, RN 3 reports Patient’s weight of 117.2kg, target weight of 115kg, and noted that Patient 2 is within target weight range. A Nursing Visit Note, dated 03/20/2025, RN 3 reports Patient’s weight of 120.4kg, target weight of 115kg. 4. During an interview, on 04/07/2025 beginning at 12:40 PM, RN 3 indicated that she did not regularly evaluate weight /target weight and indicated not addressing Patient #2’s weight discrepancy was an error.”

“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 ensure patient hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] prescription orders were adhered to in order to achieve and sustain the prescribed dose of dialysis to manage patients’ fluid volume in 3 of 6 in center hemodialysis clinical records reviewed (Patient #1, Patient #6, Patient #16). Findings include: 1. A revised policy, dated 11/29/2022, titled, “Monitoring and Documentation of Patient Care During Treatment,” indicated two signatures were required before starting the patient’s prescription in the electronic documentation system. The policy indicated data that would be documented at least every 30 minutes would include but not limited to blood flow rate (BFR) and dialysate flow rate (DFR). The policy indicated if the patient’s prescription was not met for any reason a detailed progress note should be entered explaining why the prescription was not met and actions taken to address the situation. 2. A revised job description, dated 10/2024, titled, “Charge Registered Nurse,” indicated the RN would directly supervise patient care staff and enforce company policies and procedures. 3. A Dialysis Order Report, dated 03/24/2025, indicated Patient #6’s prescribed BFR was 350 and DFR was 500. A Treatment Flowsheet, dated 03/24/2025, indicated Patient’s BFR was 400 from start of HD treatment at 11:14 AM until end of HD treatment at 2:07 PM. The flowsheet failed to evidence documentation of the reason the BFR rate was not as prescribed. A Dialysis Order Report, dated 03/28/2025, indicated Patient #6’s prescribed BFR was 350 and DFR was 500. A Treatment Flowsheet, dated 03/31/2025, indicated Patient’s BFR was 300 from 10:30 AM until 12:59 PM. The flowsheet failed to evidence documentation of the reason the BFR rate was not as prescribed. During an interview, on 04/07/2025, beginning at 1:30 PM, RN 4 indicated Patient #6’s BFR was incorrect and the PCT should have documented the reason for the BFR change in prescription. 4. A Dialysis Order Report, dated 03/14/2025, indicated Patient #16’s prescribed BFR was 400 and DFR was 700. A Treatment Flowsheet, dated 03/31/2025, indicated Patients DFR was 500 from start of HD treatment at 5:56 AM until end of HD treatment at 9:48 AM. The flowsheet failed to evidence documentation of the reason the BFR rate was not as prescribed. During an interview, on 04/07/2025, beginning at 1:30 PM, RN 4 indicated Patient’s DFR was incorrect and could be a PCT entry error. 51199 5. A Treatment Flowsheet, dated 03/12/2025 for Patient #1, indicated the prescribed BFR was 350 -400. PCT 6 charted a BFR of 450 at 5:31AM and 6:01AM. A Treatment Flowsheet, dated 03/14/2025, indicated the prescribed BFR was 350 -400. PCT 6 charted a BFR of 450 at 5:31AM, 6:01AM, 6:31AM, 7:01AM, 7:31AM, and 8:01AM. A Treatment Flowsheet, dated 03/17/2025, indicated the prescribed BFR was 350-400. PCT 6 charted a BFR of 450 at 5:05AM, 5:31AM, and 6:01AM. A Treatment Flowsheet, dated 03/26/2025, indicated the prescribed BFR was 350-400. PCT 6 charted a BFR of 450 at 5:07AM at treatment initiation. PCT 5 verified the BFR of 450 for treatment initiation. A Treatment Flowsheet, dated 03/31/2025, indicated the prescribed BFR was 350-400. PCT 6 charted a BFR of 450 at 5:31AM. A Treatment Flowsheet, dated 04/02/2025, indicated the prescribed BFR was 350-400. PCT 6 charted a BFR of 450 at 5:15AM, 5:31AM, 6:01AM, and 6:16AM. 6. During an interview, on 04/07/2025 beginning at 2:15 PM, PCT 6 indicated that it was an error to run the BFR at 450 when the prescription was for 350-400.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure staff appropriate vascular access care when PCT 4 cleaned the arteriovenous fistula [AVF] (entry into the blood vessel for hemodialysis [HD])(a process to clean the blood of a patient whose kidneys do not work normally), then repalpated area prior to cannulation (needle insertion) in 1 of 3 AVF cannulations observed (Patient #18). Findings include: 1. A revised policy, dated 06/20/2024, titled “AVF/AVG Cannulation, Treatment Initiation and Termination” indicates that the needle insertion site should be disinfected and allowed to dry, and if the access is touched after being disinfected, it must be disinfected again before needle insertion. 2. During an observation, on 04/02/2025, beginning at 10:47AM, at Station #20, PCT 4 disinfected the cannulation site of Patient #18, allowed it to dry, and then palpated the cannulation site and inserted the needle. PCT 4 then palpated the second cannulation site and inserted the needle without disinfecting between palpation and needle insertion. PCT 4 failed to disinfect both cannulation sites after palpating the site prior to cannulation. 3. During an interview, on 04/02/2025, beginning at 11:11 AM, PCT 4 indicated that after disinfecting the cannulation site, needle insertion should occur next.”

“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 monitored patient’s vascular access to prevent access failure in 1 of 3 arteriovenous fistula (AVF)/arteriovenous graft (AVG) [hemodialysis [HD] [a process to filter the blood of a patient whose kidneys do not work normally] initiations observed (Patient #10). Findings include: 1. A revised policy dated, 04/2023, titled, “Cannulation and Treatment Initiation with AVF/AVG,” indicated initial assessment of the access would be performed prior to needle placement to include evaluation of the patency by checking for the presence of a thrill (felt vibrating sensation) and bruit (swishing sound) using a stethoscope and touching the access site. 2. During an observation, on 04/02/2025, beginning at 11:20 AM, PCT 7 was at Station #5 initiating HD treatment by accessing Patient #10’s AVF/AVG. During the observation, PCT 7 felt the access site, applied a tourniquet, and inserted the 1st and 2nd line for the HD treatment and failed to evidence the use of a stethoscope to auscultate (listen to) the AVF/AVG bruit. 3. During an interview, on 04/02/2025, beginning at 12:00 PM, PCT 7 indicated she would look and feel the AVF/AVG site and would cannulate (insert needles) and if she didn’t feel the thrill then she would use a stethoscope to listen for a bruit.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility’s Quality Assessment and Performance Improvement (QAPI) Program failed to measure, analyze and track quality indicators for patient outcomes related to fluid and blood pressure management in 1 of 1 facility, and failed to analyze the quality indicator of Water and Dialysate Quality data in 1 of 1 month of Water Treatment Sheet Logs reviewed (February 2025). Findings include: 1. A revised policy, dated 01/13/2025, titled, “Quality Assurance and Performance Improvement [QAPI],” indicated the QAPI program would look at indicators for patients and trend outcomes to identify commonalities among patients who do not reach expected targets. 2. A revised policy, dated 01/13/2025, titled “G09 Quality Assurance & Performance Improvement” indicated that the dialysis facility should regularly review data to identify areas for improvement and take appropriate action to improve outcomes and processes. 3. A Dialysis Facility Report, for 2023, indicated the dialysis facility ultrafiltration rate (removal of fluid from a patient) for hemodialysis (HD) [a process to filter the blood of a patients whose kidneys do not work normally] was 11.8% which was above the national average of 7.8%. 4. A Dialysis Visit Note, dated 01/29/2025, indicated Patient #6’s UFR was 18 with a goal less than 13. 5. During QAPI Program review, on 04/07/2025, beginning at 2:30 PM, the QAPI program failed to evidence an indicator for tracking fluid and blood pressure management. 6. During an interview, on 04/07/2025, beginning at 2:30 PM, the Clinical Manager, Administrative Staff 1, indicated the dialysis facility’s QAPI Program does not monitor fluid and blood pressure management. 51199 7. A review of the Quality Assurance and Performance Improvement [QAPI] water and dialysate quality data, dated February 2025, indicated that incomplete Water Treatment Sheet Logs were uploaded. The water and dialysate quality data did not contain information the incomplete logs were recognized or noted in the QAPI Technical Services section for the month of February. 8. During an interview, on 04/03/2025, beginning at 10:50AM, Biomed [BM] 1 indicated that he uploaded the incomplete Water Treatment Sheet Log, but did not notice that the logs were incomplete.”

“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 ensure adverse occurrences were included in the Quality Assessment and Performance Improvement [QAPI] program for 2 of 2 adverse events identified in clinical record review (Patient #6). Findings include: 1. A revised policy, dated 01/13/2025 and titled, “Quality Assurance and Performance Improvement [QAPI],” indicated the QAPI program would include medical injuries and error identification. The policy indicated the QAPI program would develop an improvement plan when indicated by data, implement an action plan. The policy indicated QAPI indicators would be continuously monitored for adverse events as these events occur. 2. A revised policy, dated 05/2022 and titled, “Incident/Event Reporting,” indicated an incident report would be completed for any incident, accident, or event that was not consistent with normal patient care or could have resulted in a deviation from the expected plan of care for a patient. 3. A Hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] Treatment Flowsheet, dated 10/30/2024, indicated the HD treatment for Patient #6 was terminated early due to altered mental status, Patient was unable to verbally respond or follow commands, had unilateral weakness noted to the left side, blood pressure dropped during treatment and Patient was sent to the emergency room via 911. An Incident Report Flowsheet, dated 10/01/2024 to 04/02/2025, failed to evidence an incident report completed for Patient’s change in status and being sent to the emergency room from the dialysis facility. 4. A HD Treatment Flowsheet, dated 02/10/2025, indicated Patient #6’s venous needle became infiltrated (blood leaks outside of the fistula into the surrounding skin) when Patient put arm behind back, had significant swelling chairside and ice was applied to the affected area. A Nurse Practitioner Dialysis Visit Note, dated 02/28/2025, indicated Patient moved during treatment and the venous area of her access infiltrated resulting in Patient being taken off treatment with 1 hour and 21 minutes remaining, the infiltration was extensive with swelling into the shoulder, ice applied, unable to re-cannulate Patient due to the size of infiltration estimated at 5 centimeters in diameter. A Nurse Practitioner Dialysis Visit Note, dated 03/17/2025, indicated Patient returned from hospitalization from 02/22/2025 to 03/13/2025 after hemorrhagic bleed of right upper extremity arteriovenous fistula (AVF) [dialysis access]. The Note indicated Patient had AVF revision 02/14/2025 and blood transfusion, and was using left central venous catheter [dialysis access] for hemodialysis. An Incident Report Flowsheet, dated 10/01/2024 to 04/02/2025, failed to evidence an incident report completed for the AVF infiltration. A QAPI Patient Safety Form, dated 01/01/2024 to 12/2024, failed to indicate an adverse event for October 2024. 5. During an interview, on 04/07/2025, beginning at 1:30 PM, RN 4 indicated incident reports/adverse events reports should be completed for severe infiltrations, hospitalizations after HD treatment, and Patient #6’s AVF infiltration and being sent to the emergency room from the dialysis facility should have had an incident report completed. 6. During an interview, on 04/03/2025, beginning at 2:30 PM, PCT 4 indicated PCT could fill out an adverse event report with the RN when an adverse event occurred such as patient loss of consciousness, blood loss, poor treatment, and if a patient was sent to the hospital from the dialysis facility.”

“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 analyze and document the incidence of peritoneal dialysis infections to identify trends to establish baseline information on infection incidence in 1 of 2 peritoneal catheter exit site infections identified. Findings include: 1. A revised policy, dated 01/13/2025, titled, “Quality Assurance and Performance Improvement [QAPI],” indicated the QAPI program would include infection control. The policy indicated infection data would be collected and documented monthly to review data timely, identify problems and begin interventions as indicated. The policy indicated the infection control portion of the QAPI program would analyze and document incidence of infection to establish baseline incidences and identify trends. 2. An Infection Report, dated 03/22/2024, for Patient #2, indicated the peritoneal dialysis catheter exit site culture dated, 03/06/2024, had staph aureus (bacteria) and was treated with Keflex (antibiotic) for 10 days, and on 03/21/2024 the infection was resolved. A Nursing Visit note, dated 03/06/2024, indicated the peritoneal catheter exit site was acutely inflamed. 3. An Infection Report, dated 03/22/2024, for Patient #22, indicated the peritoneal dialysis catheter exit site had staph aureus (bacteria) and was treated with Keflex, and on 03/21/2024 the infection was resolved. A Nursing Visit Note, dated 03/06/2024, indicated the peritoneal catheter exit site was acutely inflamed, with tenderness and bloody discharge. A Microbiology Report, collected 03/06/2024, reported results 03/09/2024, indicated the exit site culture showed heavy growth of staphylococcus aureus (bacteria). \ A QAPI Peritoneal Dialysis Infection Report, for March 2024, indicated there was 1 peritoneal dialysis catheter infection and failed to evidence the 2nd peritoneal dialysis catheter infection. 4. During an interview, on 04/07/2025, beginning at 3:35 PM, RN 3 indicated there were 2 peritoneal dialysis catheter related infections documented in March of 2024 and only 1 was reported to the QAPI Program.”

“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 failed to monitor its Quality Assessment and Performance Improvement (QAPI) Program to track, trend and develop improvement plans for peritoneal dialysis exit site infections to evaluate the success of the improvement plan in 1 of 1 QAPI peritoneal dialysis infection monitoring. Findings include: 1. A revised policy, dated 01/13/2025, titled, “Quality Assurance and Performance Improvement [QAPI],” indicated the program would trend outcomes, identify any commonalities among patients, develop an improvement plan when indicated, implement an action plan, and monitor the effectiveness of the plan. The policy indicated the QAPI program would include infection control and vascular access. 2. Infection Reports, dated March 2024, indicated Patient #2, and Patient #22 had staph aureus (bacteria) infections of the peritoneal catheter exit site and were prescribed Keflex (antibiotic). A QAPI Peritoneal Infection Report, dated March 2024, indicated 1 Patient had a peritoneal catheter exit site infection and indicated there were no correction actions implemented, and there was not any trends in non-vascular access-related infections. The QAPI Infection Control Report for peritoneal dialysis indicated the exit site infection rate was for March 2024 was 0; and for April, May, June and July 2024 was 0.17. 3. During an interview, on 04/07/2025, beginning at 3:35 PM, RN 3 indicated the QAPI program peritoneal catheter exit site infections should have had interventions, and an action plan implemented.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to maintain accurate records in 1 of 3 arteriovenous fistula/graft (AVF/AVG) [dialysis access] hemodialysis (HD) [a process to filter the blood of a patient whose kidneys do not work normally] initiations observed (Patient #10), in 2 of 2 AVF/AVG Patients observed with a covered HD access (Patient #7, Patient #8) and in 1 of 1 central venous catheter (CVC) [HD access] Patients observed with a covered HD access (Patient #19). Findings include: 1. A revised policy, dated 11/29/2022, titled, “Monitoring and Documentation of Patient Care During Treatment,” indicated the patient caregiver would ensure that all patient data was collected and recorded on the treatment record for each treatment. The policy indicated the data that would be documented would include but not limited to visibility of patients’ vascular access and interventions taken to address non-visibility of the access. The policy indicated patients’ vascular access would remain uncovered and visible throughout the course of patients’ treatments and if the patient refused to have the access uncovered the caregiver would enter a detailed note at the first observation that explained the patient’s refusal, and patient refusals to allow the access to remain uncovered would be reported to the manager, attending physician and medical director for intervention. The policy indicated that the visibility of the vascular access and interventions to address non-visible accesses would be documented at least every 30 minutes. 2. During an observation, on 04/02/2025, beginning at 10:20 AM to 12:00 PM, Patient #7, at Station #3, left arm AVF/AVG was covered with a chux (disposable plastic covering). A HD Treatment Flowsheet, dated 04/02/2025, PCT 7 documented access was visible at 10:29 AM, 11:00 AM, 11:30 AM, and 12:00 PM. During an interview, on 04/02/2025, beginning at 12:00 PM, PCT 7 indicated Patient #7 would cover left arm AVG site with a chux due to being cold. PCT 7 indicated Patient was educated to keep the AVG site uncovered. 3. During an observation, on 04/02/2025, beginning at 10:20 AM to 11:00 AM, Patient #8, at Station #15, left arm AVF/AVG was covered with a blanket, and at 10:20 AM Patient’s eyes were closed. A HD Treatment Flowsheet, dated 04/02/2025, PCT 3 documented access was visible at 10:31 AM. During an interview, on 04/07/2025, beginning at 1:00 PM, PCT 3 indicated Patient #8 would keep arm covered due to being cold, the access site should be in view, and she did not document when Patient refused to uncover the access site, but the treatment sheet should have documentation of Patient’s refusal to uncover the access site. 4. During an observation, on 04/02/2025, beginning at 11:20 AM, PCT 7 was at Station #5 initiating HD treatment by accessing Patient #10’s AVF/AVG. During the observation, PCT 7 felt the access site, applied a tourniquet, and inserted the 1st and 2nd line for the HD treatment and failed to evidence the use of a stethoscope to auscultate (listen to) the AVF/AVG bruit. A HD Treatment Flowsheet, dated 04/02/2025, indicated Patient’s AVF/AVG had a thrill and a bruit present. During an interview, on 04/02/2025, beginning at 12:00 PM, PCT 7 indicated she would look and feel the AVF/ AVG site and would cannulate (insert needles) and if she didn’t feel the thrill then she would use a stethoscope to listen for a bruit. 51199 5. During an observation on 04/04/2025, from 2:20PM to 2:49PM, Patient #19 was observed with their access not able to be visualized. A HD Treatment Flowsheet for Patient #19, dated 04/04/2025, indicated patient had a CVC HD access that was visible from treatment initiation at 11:47 AM until treatment ended at 2:48 PM. The Treatment Flowsheet indicated PCT 4 documented that access was visible at 2:31PM. 6. During an interview on 04/07/2025, beginning at 1:30 PM, RN 4 indicated that if access is covered, then staff should uncover access so it can be in view.”