American Kidney Center of Madison, LLC

“CFC-CARE AT HOME CFR(s): 494.100 This Condition is not met as evidenced by: 44230 Based on record review and observation, the facility failed to ensure trained/qualified home personnel were providing care and oversight for 1 of 1 home program hemodialysis patient (Patient #6) (See V0590, V0584, and V0595 ) and failed to ensure home peritoneal dialysis patients self-monitoring data sheets were completed since admission and reviewed by the facility personnel (See V0587) for 3 of 6 peritoneal dialysis patients reviewed. (Patient #7, #8, #9) The cumulative effect of these systemic problems has resulted in the dialysis center’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 42 CFR 494.100 Care at home.”

“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: 44230 Based on observation, record review, and interview, the facility failed to ensure hand hygiene was completed with glove changes for 1 of 3 RNs observed. (RN 2) Findings Include: 1. A policy titled, “Hand Washing Technique, Hand Hygiene, and Glove Change” dated 01/01/2017 indicated but was not limited to, “Indications for handwashing and hand antisepsis ... Decontaminate hands before having before having direct contact with patients ... after contact with a patient’s intact skin (e.g., when taking a pulse or blood pressure, and lifting a patient) ... after contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressing ... if moving from a contaminated body site to a clean body site during patient care ... after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient ... after removing gloves ... All personnel will wear gloves while performing procedures which have the potential for exposure to blood, dialysate, and any other potentially infectious substances. This will include procedures such as ... touching the dialysis blood lines, dialyzer, or machine ... If computers are used at bedside hand hygiene is imperative before contact with the patient regardless of whether contact with the computer occurred through gloved or ungloved hands”. 2.During an observation of the in-center treatment floor on 01/24/2025 at 9:44 AM, RN 2 opened the treatment floor door and entered the lobby with gloved hands. RN 2 assisted Patient #4 by pushing the wheelchair the patient was sitting in to station #5. He then helped Patient #4 into the dialysis chair and placed a blood pressure cuff on the patient. RN 2 proceeded to touch the dialysis machine with contaminated gloves. and failed to remove his gloves or perform hand hygiene. RN 2 removed the Patient #4’s CVC from beneath the patient’s clothing and placed a clean field beneath the CVC (a thin, flexible tube inserted into a large vein near the heart). RN 2 opened the clean/sterile supplies on the chairside table and placed them on the clean field with contaminated gloves. RN 2 removed his gloves without performing hand hygiene and retrieved sterile gauze from the supply cabinet. RN 2 donned new gloves without performing hand hygiene, touched the CVC and supplies with the gloved hands, and walked to the nurse’s station to retrieve a clean mask for the patient from the supply cabinet. He removed his gloves and began typing on the station laptop without performing hand hygiene. RN 2 donned new gloves. Once he connected the dialysis blood lines, RN 2 removed one glove and started the treatment on the dialysis machine with an ungloved hand. He removed the other glove without performing hand hygiene. 3. During an interview on 01/24/2025 at 10:00 AM, RN 2 indicated he does not sanitize his hands between gloves changes due to difficulty donning new gloves with wet hands. RN 2 further indicated he should change his gloves when contaminated, wear gloves when touching the dialysis machine and hand hygiene should be performed when removing gloves prior to using the laptop. RN 2 acknowledged that he entered the supply cabinet to retrieve clean supplies twice with dirty gloves donned and/or failing to perform hand hygiene when contaminated gloves were removed. RN 2 indicated he normally does not put patients on but did today due to a PCT off for surgery. 4. During an interview on 01/24/2025 at 10:25, RN 3 indicated that gloves should not be worn when retrieving supplies from the supply cabinet. Gloves should be worn when touching the patient or dialysis machine/equipment. Gloves that become contaminated should be removed and discarded and hands washed or sanitized. Prior to donning new gloves, hands are to be washed and/or sanitized.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 44230 Based on observation and interview, the facility failed to ensure designated clean sinks located in the home department and in-center hemodialysis treatment floor provided warm/hot water for hand washing in 1 of 1 facility observed. Findings Include: 1. During an observation on 01/23/2025 at 10:45 AM, the designated clean sink on the treatment floor lacked access to warm water.. 2. During an observation on 01/23/2025 at 11:58 AM, the home dialysis department treatment and exam rooms designated clean sinks lacked access to warm water. 3. During an interview on 01/23/2025 at 2:35 PM, the Chief Biomed indicated he was unaware of the lack of warm/hot water at hand washing sinks located in both the home department and in-center treatment floor. He was aware that it takes time for the warm water from the hot water heater located in the back of the building to reach the handwashing sinks. A booster has not been installed likely due to cost. Acknowledged that surveyor tested water at sinks allowing water to run for approximately 45 second to 1 minute resulting in no hot/warm water. He was aware that the sink sensor located at the medication counter on the in-center floor was malfunctioning and unable to be used. He was notified Monday by staff and will be ordering the part needed for the repair.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 44230 Based on record review and interview, the agency failed to obtain the patients complete HBV serological status including an anti-HBc (Core) test prior to admission in 1 of 1 new admission. (Patient #1) Findings Include: A policy titled, “Hepatitis-B Vaccine: Patients” dated 01/01/2017 indicated but was not limited to, “All patients will be tested for Hepatitis-B antigen and antibody prior to acceptance into the dialysis program”. A clinical record review for Patient #1, admission date, 12/16/2024, was completed on 01/27/2025 and failed to evidence Hepatitis B Surface Antibody and Core testing prior to admission. An untitled document for Patient #1 indicated a Hepatitis B Surface Antigen test was drawn on 11/25/2024. A document titled, “Ascend Clinical” for Patient #1, dated 12/16/2024 included results for a Hepatitis B Surface Antigen test, and Hepatitis B Surface Antibody test. During an interview on 11/28/2025 the Director of Operations and CM indicated a Hepatitis B Surface Antigen was drawn prior to admission for Patient #1. On admission, 12/16/2024, a Hepatitis B Surface Antigen and Antibody were drawn, however, the Hepatitis Core was mistakenly scheduled to be drawn with January 2025 labs instead of the admission labs. Both were unsure of how this mistake happened.”

“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: 44230 Based on observation, record review, and interview, the facility failed to ensure standard infection control procedures and/or facility policies were followed related to CVC (Central Venous Catheter) infection prevention in 1 of 2 CVC initiations observed. (Patient #4) Findings Include: A policy titled, “In-Center Hemodialysis Catheter Care” revised 11/26/2018 indicated but was not limited to, “It is the policy of this facility that steps are taken to minimize the risk of infection to the hemodialysis catheter and other accesses, and observe for signs of infection and facilitate prompt treatment ... Hemodialysis Catheter Exit Site Care Procedure: ... A. Apply Mask to patient and nurse B. Wash hands, Apply Non-sterile gloves C. Remove old dressing and assess catheter site according to policy and procedure. 1. Observe for redness, swelling, tenderness, or discharge. 2. If any of the above is noted, notify the patient’s physician ... Clean the exit site: ... To cleanse the connection between any CVC catheter hub and cap use four pads: 1. Hold up the catheter at the connection site with one pad. 2. Use second pad to clean from the catheter connection up catheter limb for 10 cm, use one pad for each limb. 3. Cleanse first hub connection site and cap vigorously with first pad and discard then using a new pad cleanse the second hub connection. 4. Do not drop a connection site once it is cleaned ... Recognize signs and symptoms of infection”. A policy titled, Preparing the HD Catheter for the Start of Treatment” dated 01/02/2017 indicated but was not limited to, “2. Wash hands and put on clean gloves. 3. Remove tape from end of catheter limbs if present. 4. Remove dirty gloves and wash hands and put on clean gloves. 5. Open 4 x 4 gauze package and soak with Anasept or Betadine liquid. 6. Wrap each catheter limb with the soaked gauze. Soak for 5 minutes. 7. Remove the soaked 4 x 4 soaked gauze pads from the catheter limbs. 8. Be sure catheter clamps are closed. Remove catheter clamps from the end of venous catheter limb. Attach 10 cc syringe. 9. Remove catheter cap from end of arterial catheter limb, attach 10cc syringe. 10. Open venous clamp on catheter limb, pull plunger of syringe and withdraw 3-5 ml of blood into syringe. Pull 5-10 ml from limbs on LAB draw day. Close catheter clamp. 11. Open arterial clamp on catheter limb, pull plunger of syringe and withdraw 3-5 ml of blood into syringe. Pull 5-10 ml from limbs on LAB draw days. Close catheter clamp. 12. Remove blood filled syringe from arterial limb, discard. Attach 10 cc saline filled syringe. Open clamp, flush catheter limb with saline, close clamp. Repeat this step for the venous limb. 13. Remove dirty gloves, wash hands, and put on clean gloves. 14. Continue with the manufacturer’s procedure to initiate Hemodialysis treatment. During an observation on 01/24/2025 at 9:44 AM, RN 2 initiated a CVC catheter for Patient #4 and without performing hand hygiene removed the arterial CVC cap, cleaning the tip with an alcohol pad for 3 seconds. RN 2 attached the 10 ml (milliliter) syringe and withdrew 5-10 ml of blood from the arterial limb. He removed the blood-filled syringe and placed it on the clean field of supplies on the chairside table. Next, RN 2 placed a blood collection adaptor on the end of the arterial line and inserted a blood collection tube. After collecting the blood, he removed the blood tube and adaptor and placed them on the chairside table. During this process, the heparin syringe label inadvertently adhered to the blood collection adaptor. RN 2 removed the heparin syringe and noticed that it rolled further down the clean field attached to the patient’s chest, where it remained until used. When RN 2 couldn’t find the heparin syringe, he placed the opened arterial end of the CVC on the clean field without a cap. He walked around the patient’s chair and machine, looking both on and around the chair, machine, and floor. After locating the syringe on the patient’s CVC clean field, RN 2 picked it up and attached it to the arterial limb, injecting the contents. He then removed the syringe and placed it on the chairside table before connecting the arterial dialysis line. Next, RN 2 removed the blue (venous) cap, sanitized it for 3 seconds with an alcohol pad, withdrew 5-10 ml of blood, disconnected the syringe, and placed it on the chairside table. He then connected the venous dialysis lines to the venous CVC lines. RN 2 started the treatment and discarded the used supplies. He asked Patient #4 if they preferred to have the CVC dressing change completed now or after treatment. Patient #4 replied, “after treatment.” RN 2 failed to observe the CVC exit site prior to starting the treatment, did not disinfect the dialysis catheter according to policy, neglected to complete appropriate hand hygiene and glove changes, and failed to provide standard precautions while assessing and completing the CVC hemodialysis treatments. During an interview on 01/24/2025 at 10:00 AM, RN 2 indicated that he knows he should not have placed the open CVC line down on the clean field when he misplaced the heparin syringe. A new syringe should have been attached. He further indicated he doesn’t usually do “tech” work but was doing so today due to a PCT being off for surgery but stated that was no excuse. RN 2 indicated he does not sanitize his hands between glove changes due to wet hands making it more difficult to apply clean gloves. Hands should be sanitized before and after glove use, from dirty areas to clean areas, and when touching the dialysis machine. RN 2 indicated he did not assess Patient #4’s CVC exit site for signs and symptoms of infection prior to starting treatment and that it was the patient’s preference to complete that procedure, exit site dressing change, after treatment. He further indicated this patient has become upset with attempts to change the dressing prior to start of treatment. RN 2 stated he should have assessed the exit site prior to starting treatment to ensure there was no infection present but didn’t think to do that. During an interview on 01/24/2025 at 10:25 AM, RN 3 indicated hand sanitation is required before and after glove changes and when going from a dirty to clean area. Gloves must be worn when touching the dialysis machine. The CVC exit site must be assessed prior to starting treatment to ensure there are no signs or symptoms of infection. She is familiar with Patient #4 not wanting his/her dressing changed prior to treatment but with reminders Patient #4 complies with an exit site assessment prior to start of treatment and a dressing change completed after treatment. During an interview on 01/24/2025 at 11:00 AM the CM and Director of Operations (DO) were informed of RN 2’s lack of infection control with a CVC observed and overall infection control concerns observed. Both indicated that RN 2 was cited for infection control violations with the last recertification survey, and they are taking this breach of infection control very seriously and this concern would be addressed. During an interview on 01/24/2025 at 11:23 PM the CM and DO indicate the policy provided was for patients with Tego caps (CVC catheter caps changed once weekly) and these types of caps are not currently used at this facility. All CVC’s use sterile red/blue caps changed with each treatment. This policy was requested by surveyor, and it was advised there was no policy for CVC red/blue caps and that the policy needed to be updated. The policy titled; “Preparing the Dialysis Catheter for the Start of Treatment” indicated using Betadine (antiseptic) soaks. The CM indicated the facility no longer does Betadine soaks and only uses alcohol pads and further indicated this policy needs updated.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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- (1) At least annually for stable patients; This Standard is not met as evidenced by: 44230 Based on record review and interviews, the facility failed to ensure the 90-day assessment and Plan of Care (POC) were completed for 1 of 3 home peritoneal dialysis patients reviewed. (Patient #8) Findings Include: The clinical record for Patient #8 was reviewed and indicated an admission date of 08/12/2024 to the home department for peritoneal dialysis. An initial assessment was completed by the IDT with a POC developed and implemented on 09/11/2024. No further IDT assessments or POC’s were completed beyond this date. During an interview on 01/28/2025 at 2:00 PM, the Home Program Manager indicated that an initial care plan was completed for Patient #8, however the 90-day POC was not completed and could not provide a reason why.”

“H-TRAINING CONDUCTED BY QUALIFIED RN CFR(s): 494.100(a)(2) The training must- (2) Be conducted by a registered nurse who meets the requirements of §494.140(b)(2); This Standard is not met as evidenced by: 44230 Based on record review and interview, the facility failed to ensure the home nurse completing oversight of home hemodialysis record flowsheets were qualified/trained 1 of 1 home nurse reviewed. (RN 5) Findings Include: A policy titled, “Home Hemodialysis Policies and Procedures” dated 07/2020 indicated but was not limited to, “Home Patient Record Keeping ... Home records will be reviewed by home program nursing staff during patient monthly clinic visits to identify trends or omissions”. The clinical record review of Patient #6 evidenced the following: A document titled, “HHD Order” dated 02/01/2024 indicated Patient #6’s NxStage treatment order. The order included 5 treatments per week, Maximum Ultrafiltration Removal of 6.6 Liters. A document titled, “HHD Order” dated 02/01/2024 indicated Patient #6’s NxStage treatment order. The order included 5 treatments per week, Maximum Ultrafiltration Removal of 6.6 Liters. NxStage treatment sheets dated 11/20/2024 - 01/14/2025. All treatment sheets completed were reviewed, dated, and authenticated by RN 5. During an interview on 01/27/2025 at 11:30 AM, RN 5 indicated that she was the only home nurse located at this facility. Patient #6 currently receives NxStage services within the home department. She was unsure who initially trained him/her, either an RN located at Entity 1 or the Home Program Manager. She has not been trained on NxStage to date. There was a plan to “retrain” Patient #6 with NxStage assistance, but this did not happen because NxStage is only interested in training new patients. RN 5 reviews all the treatment sheets completed by Patient #6 despite a lack of training. RN 5 did indicate experience with In-center hemodialysis. Patient #6 will call NxStage if they have problems with treatment. If RN 5 is unable to answer any questions asked by Patient #6, he/she will contact a home nurse at Entity 1. During an interview on 01/29/2025 at 8:35 AM, RN 5 indicated not knowing if Patient #6 was checking chlorine when using the NxStage machine or if knowing if he/she has chlorine strips for testing in the home. She indicated that Patient #6 uses bagged dialysis solution but did not understand the difference between the SAK (prefilled bags where home water is added) and Express bags (prefilled bags where home water is not added). Her understanding was the patient was using Express bags, therefore not needing to check chlorine prior to treatment. RN 5 indicated that she reviews the flowsheets monthly and missed that as Patient #6 is documenting either N/A with each treatment or leaving it blank. RN 5 did indicate that Patient #5 has to make a new batch of dialysate (SAK) at each treatment. RN 5 was unaware of the maximum amount of fluid that could be pulled with each NxStage treatment for Patient #6. RN 5 was unaware of the missed treatments, of the incomplete records turned in each month, the lack of patient and/or patient caregiver signature and initials, the lack of total fluid removal calculation and the lack of access information recorded on the data sheets. During an interview on 01/29/2025 at 8:45 AM, the CM indicated that RN 5 has not been trained on NxStage and had stepped in to assist the home department when the previous home nurse left. The CM expressed concerns about the lack of involvement with the Home Program Manager. During an interview on 01/29/2025 at 10:01 AM, Patient #6 was interviewed via phone. Patient #6 indicated that his spouse completes his treatments. The spouse will use a cup and a strip to check something prior to each treatment but did not know what that test was for. Patient #6 indicated using 60 liters of fluid each treatment and a new SAK would be set up each treatment day. He/she can pull 6-7 Liters of fluid each treatment and indicated his Estimated Dry Weight (EDW) was 172 kilograms. His/her spouse also completes the treatments sheets. Both the patient and spouse received training initially by a nurse out of Entity 1 in the home. He/she could not recall their name. Patient #6 is seen monthly in the facility by the Interdisciplinary Team. Patient #6 indicated the spouse was unavailable for an interview. During an interview on 01/29/2025 at 10:15 AM, the Home Training Manager indicated she was unaware that the chlorine documentation was a current issue. She thought it was resolved. Patient #6 can remove up to 2 kilograms per hour. The treatment sheets should be signed/initialed by the caretaker completing the treatments. Patient #6 uses a new SAK with each treatment, 60 liters, so a chlorine test should be completed prior to each treatment. She indicated that once RN 5, (who was not trained on NxStage) reviews the flowsheets and signs and dates them, they are scanned into the medical record and is reviewed again trained Entity 1’s home staff. She was unable to provide any documentation that this review occurred. The last home visit documented was in 2022, however the Home Program Manager indicated she was recently in the home to provide education on drawing up water samples but failed to document the visit. The SAK, PAK, and TAP water testing is to be completed quarterly. The only resulting labs found in 2024 were in August. She indicated that water was drawn and sent in November of 2024 but did not result as it was collected in the wrong tubes. The Home Program Manager indicated that Patient #6 and his/her caregiver collect the samples and bring them into the facility where RN 5 labels them and send them off to the lab. RN 5 was not trained on NxStage and may not know the appropriate lab tubes. HHD NxStage policies and procedures were requested for review. During an interview on 01/29/2025 at 11:50 the Home Program Manager provided the surveyor with the NxStage manual and advised that the NxStage policies and procedures were adopted by the governing body. This documentation was requested. During an interview on 01/29/2025 at 12:03 PM, the Home Program Manager indicated that NxStage water training was completed with Patient #6 during the recent home visit but was not documented in the clinical record. Could not provide a specific date. She was tearful and indicated that she works 60-70 hours per week and depends on staff to complete patient care correctly.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 44230 Based on record review and interview, the facility failed to ensure patients receiving Home PD completed self-monitoring data for treatments completed in the home for review every 2 months for 3 of 6 PD patients reviewed. (Patient #7, #8, #9) Findings Include: 1. A policy titled, “Patient Training Guidelines” revised 01/09/2028 indicated but was not limited to, “During the training session, the following topics will be discussed and any associated procedures will be demonstrated ... Recoding of exchange/treatment data on log sheet ... Recording treatment and health status information for home dialysis patients includes documentation of the dialysis process, using hemodialysis or peritoneal dialysis specific treatment records ... Home Dialysis Monitoring ... The dialysis facility will obtain and maintain treatment records, flow sheets and medications administered. The records will be reviewed at a minimum of every 2 months. The patient’s plan of care will address any problems with obtaining these records. 2. A policy titled, “Home Peritoneal Dialysis Patient Record Keeping” dated 08/2022 indicated but was not limited to, “ ... Home treatment records will be reviewed by home training nurse during patient monthly clinic visits to identify trends or omissions. Copies of the home treatment records will be kept in the medical record ... Patients will document treatments via paper home treatment record or data cards. The home training nurse will document on the patient’s home treatment records their review of the records as well as document review of the home treatment records in the medical record as part of the monthly clinic visit”. 3. A policy titled, “Patient Care- Training, Home Dialysis Monitoring, and Support Services” dated 01/01/2018 indicated but was not limited to, “Retrieve and review the complete self-care monitoring data and other information from the self-care patients or their designated caregiver(s) at least every two months and retrain this information in the medical record ... The dialysis facility will maintain a recordkeeping system that ensures continuity of care and patient privacy”. 4. A policy titled, “Peritoneal Dialysis Program Policies & Procedures Manual” dated 08/2022 indicated but was not limited to, “ ... Review home records and include date and signature of home training nurse. Document intervention(s) within the medical records as needed. Review home records to identify any potential problems with therapy. All home patients are expected to record weight, BP, dialysis solution usage for each exchange/treatment, and ultrafiltration (UF). Look for trends in BP, UF and weight to detect any potential problems with fluid gain, dehydration or true body weight changes”. 5. A review of Patient #7’s clinical record, admission date of 02/19/2024, evidenced the following: Zero self-monitoring treatment sheets were found in the clinical record since admission. A document titled “CAPD Order” dated 04/30/2024 for Patient #7 indicated a physician PD order for CAPD (Continuous Ambulatory Peritoneal Dialysis) seven days a week and to include 2 exchanges a day. A document titled “Patient Acknowledgement of Need for Treatment Documentation” signed and dated by Patient #7 on 02/19/2024 indicated acknowledgement by the patient of the requirement to bring monthly documentation of dialysis treatments performed in the home to the clinic for review each month. A document titled, “Nursing Progress Notes Report” dated 01/22/2025 entered by RN 5 indicated a phone call to Patient #7 to remind him/her to bring in his/her documentation. A document titled, “Nursing Progress Notes Report” dated 01/13/2025 entered by RN 5 indicated a phone call to Patient #7 to educate on the importance of accurate documentation of treatments completed. Patient #7 indicated missing 2 treatments in the past month. A document titled, “Nursing Progress Notes Report” dated 12/16/2024 entered by RN 5 indicated Patient #7 was educated on importance of providing flowsheets and accurate documentation from flowsheets. A document titled, “Nursing Progress Notes Report” dated 11/19/2024 entered by RN 5 indicated that treatment sheets were reviewed and discussed with Patient #7. A document titled, “Nursing Progress Notes Report” dated 10/15/2025 entered by RN 5 indicated Patient #7 completed a clinic visit however flow sheets were not brought for review. A document titled, “Nursing Visit” dated 09/17/2024 entered by RN 5 indicated that Patient #7’s treatment sheets were reviewed and discussed with the patient. A document titled, “Nursing Visit” dated 07/16/2024 entered by Entity 1 RN 7 indicated that Patient #7’s treatment sheets were reviewed and discussed with the patient. A document titled, “Nursing Visit” dated 06/18/2024 entered by RN 5 indicated that Patient #7’s treatment sheets were reviewed and discussed with the patient. A document titled, “Nursing Visit” dated 04/16/2024 entered by RN 5 indicated that Patient #7’s treatment sheets were reviewed and discussed with the patient. A document titled, “Nursing Visit” dated 03/20/2024 entered by RN 5 indicated that Patient #7’s treatment sheets were reviewed and discussed with the patient. A document titled, “Dialysis Visit Note” dated 12/17/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the Advanced Practice Registered Nurse (APRN) for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 11/19/2024 indicated that Patient #7’s dialysis flowsheets were reviewed but also indicated the patient did not bring in his home records. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 10/15/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 09/17/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 08/20/2024 indicated that Patient #7’s dialysis flowsheets were reviewed by Physician 1. A document titled, “Dialysis Visit Note” dated 07/16/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 06/18/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 05/21/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 04/16/2024 indicated that Patient #7’s dialysis flowsheets were reviewed. The note was transcribed by the APRN for Physician 1, both present during the visit. A document titled, “Dialysis Visit Note” dated 03/20/2024 indicated that Patient #7’s dialysis flowsheets were reviewed by the APRN. A document titled, “Interdisciplinary Assessment & Plan of Care” dated 03/04/2024 indicated an initial Plan of Care (POC) was completed by the home nurse, social worker, dietician, and Physician/APRN. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. A document titled, “CIPA Plan of Care” dated 05/10/2024 indicated a 90-day POC was completed by the home nurse, social worker, dietician, and Physician/APRN. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. A document titled, “CAPD Daily Record” was provided by the Director of Operations on 01/27/2025. The document was brought in by Patient #7 on 01/27/2025 and indicated treatments completed between 02/23/2024 - 03/12/2024, 4/30/2024 - 06/09/2024. The treatments sheet evidenced inconsistent and incomplete documentation of vital signs and treatments performed. During an interview on 01/28/2025 at 10:25 AM, Patient #7 indicated he/she was trained to complete dialysis flowsheets and has blank forms to complete in the home. He/she indicated that this wasn’t being done due to either losing the sheets and/or not completing them due to the stress in his life. Patient #7 further indicated his/her lab appointments are sometimes being done at this facility and at Entity 1’s facility but always sees the physician here each month. Patient #7 indicated being aware of the requirement to complete self-monitoring data for the nurse to review to ensure his safety and will do better at completing them. 6. A review of Patient #8’s clinical record, admission date of 08/12/2024, evidenced the following: Zero self-monitoring treatment sheets were found in the clinical record since admission. A document titled “CAPD Order” dated 12/20/2024 for Patient #8 indicated a physician PD order for CAPD seven days a week and to include 1 exchange a day. A document titled “Patient Acknowledgement of Need for Treatment Documentation” signed and dated by Patient #8 on 08/12/2024 indicated acknowledgement by the patient of the requirement to bring monthly documentation of dialysis treatments performed in the home to the clinic for review each month. A document titled, “CIPA Plan of Care” dated 09/11/2024 for Patient #8 indicated an initial POC was completed by the home nurse, social worker, dietician, and Physician/APRN. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. Documents titled, “Nursing Visit” dated 01/21/2025 and 08/20/2024 for Patient #8 indicated treatment sheets were reviewed by RN 5 and discussed with the patient. A document titled, “Nursing Monthly Assessment” dated 12/20/2024 for Patient #8 indicated that patient is compliant with treatments by RN 5. Documents titled, Nursing Monthly Assessment” dated 11/19/2024 and 10/22/2024 for Patient #8 indicated that treatment flowsheets were reviewed and discussed with patient by RN 5. A document titled, “Dialysis Visit Note” dated 08/20/2024, 09/17/2024, 10/15/2024, 11/19/2024, and 12/17/2024 for Patient #8 indicated dialysis flowsheets were reviewed by Physician 1 and APRN. Documents titled, “Nursing Progress Notes Report” dated 12/17/2024, 11/19/2024, and 10/15/2024 for Patient #8 indicated treatment flowsheets were reviewed and discussed by RN 5. A document titled, “Nursing Progress Notes Report” dated 01/27/2025 for Patient #8 indicated upon review of 6-month trend it was noted that that Patient #8 was not bringing in treatment flowsheets for review each month. The patient and caregiver were educated and advised of new requirement of bringing in completed documentation every 2 weeks. A new care plan was opened to address patient non-compliance concerns. Note entered by RN 5. A document titled, “Peritoneal Dialysis Daily Record” indicated treatments completed between 01/01/2025 - 01/31/2025 that indicated a review date by the Home Program Manager on 01/28/2025. During an interview on 01/28/2025 at 1:23 PM, the Home Program Manager indicated that Patient #8 brought in treatment records today dated 01/01/2025 - 01/28/2025. Patient #8’s caregiver indicated that the forms were completed using his/her personal notebook log and noted that the UF recorded each day was 1500 milliliters. She is unsure how accurate this data is as this would be unlikely but wanted to provide it. During an interview on 01/28/2025 at 3:30 PM, Patient #8 was called with the use of an interpreter provided by the dialysis facility. RN 5 was present and assisted with the call. Unable to speak with Patient #8 as the call was not answered. No message was left. During an interview on 01/28/2025 at 3:39 PM, Patient #8’s caregiver was called with the use of an interpreter provided by the dialysis facility. RN 5 was present and assisted with the call. The caregiver indicated that Patient #8 has difficulty remembering things and treatments are completed by him/herself and with Patient #8’s niece. Her role is to complete the treatments, and it is the niece’s role to document them. The caregiver then indicated that if I had any further questions I needed to speak with the niece and ended the call. The niece was called but did not answer, unable to leave a message. During an interview on 01/28/2025 at 4:00 PM, RN 5 indicated being unable to complete a phone interview with Patient #8 due to being very hard of hearing. 7. A review of Patient #9’s clinical record, admission date of 09/20/2023, evidenced the following: Zero self-monitoring treatment sheets were found in the clinical record since admission. A document titled “CAPD Order” dated 04/30/2024 for Patient #9 indicated a physician PD order for CAPD seven days a week and to include 2 exchanges a day. A document titled “CAPD Order” dated 07/23/2024 for Patient #9 indicated a physician PD order for CAPD seven days a week and to include 1 exchange a day. A document titled “Patient Acknowledgement of Need for Treatment Documentation” signed and dated by Patient #9 on 09/20/2023 indicated acknowledgement by the patient of the requirement to bring monthly documentation of dialysis treatments performed in the home to the clinic for review each month. A document titled, “CIPA Plan of Care” dated 09/11/2024 for Patient #9 indicated an initial POC was completed by the home nurse, social worker, dietician, and Physician/APRN. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. A document titled, “CIPA Plan of Care” dated 11/08/2023 for Patient #9 indicated an initial POC was completed by the home nurse, social worker, dietician, and Physician/APRN evidenced by signatures including Patient #9. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. A document titled, “CIPA Plan of Care” dated 01/10/2024 for Patient #9 indicated a 90-day POC was completed by the home nurse, social worker, dietician, and Physician/APRN evidence by signatures including Patient #9. The POC evidenced a lack of documentation related to Patient #7’s incomplete self-monitoring dialysis treatment sheets. A document titled, “Nursing Monthly Assessment” dated 10/23/2024 indicated Patient #9 was doing well with dialysis and has no compliance issues documented by RN 5. Documents titled, “Nursing Visit” dated 08/20/2024, 07/23/2024, 06/19/2024, 05/18/2024m 04/10/2024, 03/13/2024, and 02/14/2024 indicated Patient #9’s treatment sheets were reviewed and discussed with the patient by RN 7 and/or RN 5. Documents titled, “Nursing Progress Notes Report” dated 11/20/2024 & 12/18/2024 indicated Patient #9’s treatment sheets were reviewed and discussed with the patient by RN 5. A document titled, “Nursing Progress Notes Report” dated 12/6/2024 indicated Patient #9 was provided education regarding the importance of proper documentation and accurate flowsheets and that Patient #9 understood and apologized. This note was documented by RN 5. A document titled, “Nursing Progress Notes Report” dated 01/27/2025 indicated Patient #9’s treatment sheets were not being completed and/or provided to staff for review after a 6-month review. Education was provided to Patient #9 on the importance of documentation for patient safety. A new requirement was discussed regarding documentation to be completed and returned to the facility every 2 weeks to address non-compliance concern. This note was documented by the Home Program Manager. Documents titled, “Dialysis Visit Note” dated 03/13/2024, 02/14/2024, 04/10/2024, 05/08/2024, 06/19/2024, 07/23/2024, 08/20/2024, 09/11/2024, 10/23/2024, 11/20/2024, and 01/15/2025 indicated Patient #9’s dialysis flow sheets were reviewed by Physician 2 and APRN. During an interview on 01/27/2025 at 11:30 AM, RN 5 indicated that she is the only home nurse full time at this facility. She monitors all PD and HHD patients and their treatments. She has never received NxStage (home hemodialysis machine) training and has one HHD patient currently using the NxStage machine. During an interview on 01/28/2025 at 3:37 PM, Patient #9 was called with RN 5 present. Patient #9 indicated being trained on how to complete home dialysis flowsheets and understands he/she is supposed to complete them monthly and turn in review to the facility for review. He/she currently has blank flowsheets in the home to record treatments going forward. Patient #9 indicated a lack of flowsheets turned into the facility due to losing them and a recent move where flowsheets were misplaced. 8 . During an interview on 01/27/2025 at 4:35 PM, RN 5 indicated being aware of Patient #6, #7, and #8 self-monitoring treatment sheets were not completed but does not know the procedure to follow to obtain those records. RN 5 indicated using a template with notes indicating treatment sheets were reviewed and discussed with the patients but should be updating the template with accurate up-to-date information. She has recently been documenting in the clinic notes patient education regarding completing treatment sheets and need to return to facility for review. RN 5 indicated that patients sign a patient responsibility form upon admission that indicates the requirement for completing self-monitoring data sheets and returning them to the clinic for the nurse to review. She indicated she did reach out to the Home Program Manager that indicated to continue educating the patient. No further interventions were provided. She didn’t know what else to do. Patient #7 completes all his lab draw appointments at Entity 1 due to it being closer to his/her home but completes his physician appointments at this facility due to Medicaid requirement. When asked who is responsible for monitoring the patient treatment sheets, RN 5 stated “I guess, me”. RN 5 indicated she started this position on August 29, 2024, after returning from maternity leave. Home visits are made upon admission and when/if the residence changes. She was unaware of the need for completed home visits when concerns were identified, including infections, and/or modality changes. 9. During an interview on 01/28/2025, the Advanced Practice Registered Nurse indicating making a template in the Electronic Medical Record that automatically inserts “treatment sheets reviewed”. She indicated that all Physician visits were completed with her present and she scribes for the Physicians. She took full accountability for the “mistake” of incorrect documentation and will in the future update the template as appropriate. She is aware of Patient #7, #8, and #9 not completing the dialysis flowsheets and turning them in to the facility for review. This was discussed at each appointment, but she failed to document it. 10. During an interview on 01/28/2025 at 11:54 AM, Physician 1 indicated being aware that Patient #7 wasn’t completing and/or bringing in his/her treatment sheets for review each month but was unaware of this concern with Patient #8. Physician 1 indicated that this was not being documented in his monthly note but should have been. He plans to document this concern in the future. 11. During an interview on 01/28/2025 at 1:33 PM, the Administrator indicated not being aware that Patients #7, #8, and #9 were not completing and turning in their home treatment sheets for review. She indicated she provides oversight of the facility from Entity 1 location as she is there one week per month. Her role is more on the financial side and the role of the Director of Operations was developed to assist with more of the patient side. 12. During an interview on 01/27/2025 at 4:00 PM, the Director of Operations indicated that the expectation for the home patients is to complete self-monitoring data and turn it in to staff for review at minimum every 2 months. She was unaware that self-monitoring records were not being completed for Patient #6, #7, and #8. The expectation if this is not happening is to educate the patient, complete a home visit to retrieve, care plan patient monthly as unstable, notify the IDT, and possibly remove the patient from the home dialysis program. 13. During an interview on 01/24/2025 at 4:00 PM, the Director of Operations indicated that home dialysis record completion is a condition to remain in the home to ensure health and safety for the patients. She was unaware of the missing treatment records for Patient #7, #8, and #9. 14. During an interview on 01/24/2025 at 4:00 PM, the CM indicated being unaware of Patient #7, #8, and #9’s self-monitoring data flowsheets not being completed since admission.”

“H-COORDINATION OF CARE BY MEMBER OF IDT CFR(s): 494.100(c)(1)(ii) Services include, but are not limited to, the following: (ii) Coordination of the home patient’s care by a member of the dialysis facility’s interdisciplinary team. This Standard is not met as evidenced by: 44230 Based on record review and interview, the facility failed to ensure coordination of care to be provided for 1 of 1 home hemodialysis patient reviewed. (Patient #6) Findings Include: A review of Patient #6’s clinical record failed to ensure the coordination of care between the facility and Entity 1 to ensure the health and safety of the patient. NxStage (home hemodialysis modality) treatment sheets dated 11/20/2024 - 01/14/2024 evidenced total chlorine checks marked N/A (non-applicable) or were left blank. A review of nine weeks of treatments evidenced frequently missed treatments without documentation of this concern addressed by the facility or Entity 1. A review of the water and dialysate testing for Patient #6 evidenced product water, dialysate, and AAMI testing completed on only once in 2024, on 08/23/2024. During an interview on 01/29/2025 at 11:00 AM, the Director of Operations indicated that the trained NxStage nursing staff, including the Home Program Manager, located at Entity 1 assist RN 5 with Patient #6, specifically due to RN 5’s lack of training with that specific modality. She was unsure if there was a contract with Entity 1 designating responsibility between the two facilities and further indicated that Entity 1 is also owned by the same company. No contract was provided.”

“H-MEET RD52:2004 CFR(s): 494.100(c)(1)(v) The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly, or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits. This Standard is not met as evidenced by: 44230 Based on record review and interview the facility failed to ensure monitoring of the quality of water and dialysate to include product water, dialysate, and chlorine/chloramine testing for 1 of 1 Home Hemodialysis patients reviewed. (Patient #6) Findings Include: A policy titled, NxStage Operational and Training Policies” revised 01/01/2024 indicated but was not limited to, “Facility will follow all Manufacturer’s Procedures as written in NxStage Manual under Policy number 01.601df”. An adopted policy titled, “Testing Dialysate for Microbiological Quality” indicated but was not limited to, “Quarterly testing of dialysate for microbiological quality (bacteria and endotoxin) will be performed at the end of SAK life.” An adopted policy titled, “Testing for Product Water Quality” indicated but was not limited to, “Initial and annual testing of product water for chemical analysis (AAMI panel) should be performed near or the end of PAK life ... The acceptability of the incoming concentrations for free chlorine and chloramines in the patient’s source water for use with the PureFlow SL can be easily verified by using commercially available test strips for total chlorine. Following the test strip manufacturer’s instructions check for the total chlorine result for the source water is less than or equal to 4.0 mg/L”. An adopted policy titled, “Table 3: PureFlow SL (PFSL) testing requirements per CMS guidelines applicable in the U.S. only” indicated product water from a private water supply should be collected/tested initially and quarterly. Dialysate Product water should be collected/tested at minimum quarterly. A document titled, “HHD Order” dated 02/01/2024 indicated Patient #6’s NxStage treatment order. The order included 5 treatments per week. A document titled, “Ascend Environmental Testing Results” indicated a Dialysate Colony and Endotoxin count were collected on 08/23/2024. Both counts were within limits. No other product water or dialysate testing had resulted in 2024. A review of Patient #6’s NxStage treatment sheets dated 11/20/2024 - 01/14/2024 evidenced total chlorine checks marked N/A (non-applicable) or were left blank. During an interview on 01/27/2025 at 11:30 AM, RN 5 indicated that she is the only home nurse full time at this facility. She monitors all PD and HHD patients and their treatments. She has never received NxStage (home hemodialysis machine) training and has one HHD patient currently using the NxStage machine. During an interview on 01/27/2025 at 11:30 AM, RN 5 monitors Patient #6’s NxStage treatments by reviewing the flowsheets monthly evidenced by her signature and date of review. She was unsure who initially trained him/her, either an RN located at Entity 1 or the Home Program Manager. She has not been trained on NxStage to date. There was a plan to “retrain” Patient #6 with NxStage assistance, to obtain the necessary training but this did not happen because NxStage is only interested in training new patients. RN 5 reviews all the treatment sheets completed by Patient #6 despite a lack of training. RN 5 did indicate experience with In-center hemodialysis. Patient #6 will call NxStage if they have problems with treatment. If RN 5 is unable to answer any questions asked by Patient #6, he is then directed to contact a home nurse at Entity 1. During an interview on 01/29/2025 at 8:35 AM, RN 5 indicated not knowing if Patient #6 was checking chlorine when using the NxStage machine or if knowing if he/she has chlorine strips for testing in the home. She indicated that Patient #6 uses bagged dialysis solution but did not understand the difference between the SAK (prefilled bags where home water is added) and Express bags (prefilled bags where home water is not added). Her understanding was the patient was using Express bags, therefore not needing to check chlorine prior to treatment. RN 5 indicated that she reviews the flowsheets monthly and missed that as Patient #6 is documenting either N/A with each treatment or leaving it blank. RN 5 did indicate that Patient #6 has to make a new batch of dialysate (SAK) at each treatment. RN 5 indicated that Patient #6 brings water and dialysate samples to the clinic when collected for RN 5 to send out to be resulted. During an interview on 01/29/2025 at 8:45 AM, the CM indicated that RN 5 has not been trained on NxStage and had stepped in to assist the home department when the previous home nurse left. The CM expressed concerns about the lack of involvement with the Home Program Manager. During an interview on 01/29/2025 at 10:01 AM, Patient #6 was interviewed via phone. Patient #6 indicated that his spouse completes his treatments. The spouse will use a cup to obtain a sample and a strip to check “something” prior to each treatment but did not know what that test was for. Patient #6 indicated using 60 liters of fluid each treatment and a new SAK would be set up each treatment day. His/her spouse completes the treatments sheets. Both the patient and spouse received training initially by a nurse out of Entity 1 in the home but could not recall their name. He/she indicated the spouse was unavailable for an interview. During an interview on 01/29/2025 at 10:15 AM, the Home Training Manager indicated she was unaware that the chlorine documentation was a current issue and thought it had been resolved. Patient #6 uses a new SAK with each treatment, 60 liters, so a chlorine test should be completed prior to each treatment. She indicated that once RN 5, (who was not trained on NxStage) reviews the flowsheets and signs and dates them, they are scanned into the medical record and are reviewed again by Entity 1’s home staff trained. She was unable to provide any documentation that this review occurred. The Home Program Manager indicated she was recently in the home to provide education on drawing up water samples but failed to document the visit. She indicated that other samples were drawn twice this year, however Patient #6 collected the water and dialysate in the incorrect tubes resulting in the tests being cancelled. Does not recall getting a notification from the lab of the cancelled tests. The SAK, PAK, and TAP water and dialysate testing is to be completed quarterly. The only resulting labs found in 2024 were in August which included the product water, dialysate, and AAMI’s. She indicated that water was drawn and sent in November of 2024 but did not result as it was collected in the wrong tubes. The Home Program Manager indicated that Patient #6 and his/her caregiver collect the samples and bring them into the facility where RN 5 labels them and sends them off to the lab. RN 5 was not trained on NxStage and may not know the appropriate lab tubes even though it is listed on the label. During an interview on 01/29/2025 at 11:50 the Home Program Manager provided the surveyor with the NxStage manual and advised that the NxStage policies and procedures were adopted by the governing body. No other facility policies were available. This documentation was requested. During an interview on 01/29/2025 at 12:03 PM, the Home Program Manager indicated that NxStage water training was completed with Patient #6 during the recent home visit but was not documented in the clinical record. Could not provide a specific date. She was tearful and indicated that she works 60-70 hours per week and depends on staff to complete patient care correctly.”