Circle Medical Management

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 36774 Based on observation, document review, and interview, it was determined that the facility failed to comply with the Condition for Coverage, 42 CFR 494.60, Physical Environment. Findings include: 1. The facility failed to ensure that dialysis equipment, supplies, or training materials, were available. See deficiency at V-401 A. 2. The facility failed to ensure that the temperature within the room is comfortable. See deficiency at V-401 B. 3. The facility failed to ensure that a mechanism to call for help during emergency was available, as required. See deficiency at 402.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 36774 Based on observation, document review, and interview, the Facility failed to ensure that the CMS (Centers for Medicare and Medicaid Services) approval process for relocation of incenter hemodialysis, home hemodialysis, and home peritoneal dialysis program was followed, as required. This has the potential to affect 117 patients on the census. Findings include: 1. On 1/16/2025 at approximately 12:30 PM, an onsite visit to the dialysis facility was conducted. Between 1:00 PM through 2:00 PM, an observational tour of the dialysis treatment area was conducted. The dialysis treatment area had 24 stations (one isolation room for Hepatitis B+ patients) with 13 patients currently receiving dialysis treatments. 2. On 1/21/2025, the notices posted and provided to the facility’s patients prior to relocation were reviewed: - The document titled, “Important Notice” (undated) included, “(Name of Dialysis Facility) ... is MOVING!! Our new facility, located at 140 S. Ashland, the corner of Ashland and Adams is finally complete! It will be business as usual the week of 10/12/21 through 10/26, but starting Monday, October 28th, will begin dialysis treatments in the new facility. OUR PATIENT ENTRANCE is located at 1606 W. Adams ... Any questions can be directed via email to (E #7/Director of Support Services) ...” - The letters sent to patients (undated) included, “Hello Everyone! We want to thank you all for your patience during this time. We have great news: we are finally moving to our new building! Treatment at the new clinic will start on Monday, October 28th, 2024 ...” 3. On 1/21/2025 at approximately E #7 (Director of Support Services) stated that the facility sent the requested documents to the State before moving to its current address. E #7 stated that the relocation should be approved before the move. E #7 could not provide any documentation that the relocation of the facility to its current location was approved.”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 1 of 4 monthly dialysis water testing (December 2024) reviewed for presence of endotoxin and colony count, the facility failed to ensure that the required sample was tested, as required. Findings include: 1. On 1/16/2025, the monthly water testing for presence of endotoxin and colony count from October 2024 through January 2025, were reviewed. The testing conducted lacked monthly checking for presence of endotoxin and colony count for the RO (Reverse Osmosis/water purification) loop return in December 2024. 2. On 1/21/2025, the facility’s policy titled, “Drawing Endotoxin Samples” (3/2013) was reviewed and included, “ ... Policy: The water used to prepare concentrates and dialysate will be tested monthly for endotoxin levels. Samples will be obtained from various points within the water treatment system ...” 3. On 1/21/2025, the facility’s guidance for obtaining water samples for endotoxin and colony counts (undated) was reviewed and included, “ ... In Center dialysis new requirements: All RO need ‘dialysis water samples’ for ... endotoxins test ... monthly, 3 samples ... RO loop return ...” All RO need ... samples for colony counts ... monthly, 3 samples ... RO loop return ...” 4. On 1/16/2025 at approximately 3:00 PM and on 1/21/2025 at approximately 10:00 AM, an interview was conducted with E #3 (Biomedical Technician). E #3 stated that the result for the RO loop return is missing for December 2024, and should have been completed.”

“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: 36774 A. Based on observation, document review, and interview, it was determined that for 1 of 1 combined home peritoneal dialysis (HPD) and home hemodialysis (HHD) training room observed, the facility failed to ensure that dialysis equipment, supplies, or training materials, were available. This can potentially affect all 26 HPD patients on the census. Findings include: 1. On 1/21/2025 at approximately 9:00 AM, the facility’s home dialysis training room was observed. The training room had no supplies available e.g., dialysis machine/cycler, disconnection cap, tubing, or training materials for home peritoneal dialysis patients. 2. On 1/21/2025, the facility’s policy titled, “Services Available” was reviewed and included, “ ... Policy: 1. The Facility will provide ESRD (end stage renal disease) services to patients requiring renal replacement therapy ... 3. Services provided ... include: c. home dialysis from designated facilities ... g. designated Home Training Centers providing evaluation and patient teaching for home... peritoneal dialysis ...” 3. On 1/21/2025, the clinical record for Pt. #7 was reviewed. On 12/19/2024, Pt. #7 was admitted to the facility with a diagnosis of chronic kidney disease. The clinical record indicated that Pt. #1 required and received training on 1/13/2025, 1/14/2025, 1/15/2025, and 1/16/2025. 4. On 1/21/2025 at approximately 9:00 AM and 10:30 AM, E #1 (Director of Operations) and E #2 (Nurse Manager, Home Program) confirmed that the facility have only one training room for both HHD and HPD patients. E #2 stated that the dialysis training room at this location is not ready and do not have available equipment and supplies to train HPD patients. Because of this, E #2 stated that’s why Pt. #7 was trained at the doctor’s office. E #2 stated that services provided to home patients include provision of supplies, equipment, or materials needed during the training. B. Based on observation, document review, and interview, it was determined that for 1 of 1 combined HPD and HHD training room observed, the facility failed to ensure that the temperature within the room is comfortable. This can potentially affect any the 30 home dialysis patients on the census, staff and visitors. Findings include: 1. On 1/21/2025 at approximately 9:00 AM, the facility’s home dialysis training room was observed. The training room was cold, had no thermostat, or mechanism to check the temperature inside the room. 2. On 1/21/2025, the facility’s policy titled, “Physical Environment Dialysis Treatment Area” (11/2012) included, “ ... Purpose: To provide dialysis patients, staff, and the public a comfortable treatment environment ... Policy: The space for treating each patient must be sufficient to provide patient care and services ... 2. The facility must: a. Maintain a comfortable temperature within the Facility ...” 3. On 1/21/2025 at approximately 10:30 AM, an interview with E #2 (Nurse Manager, Home Program) was conducted. E #2 stated that there is no mechanism to tell if the temperature in the training room is comfortable for patients (or staff). E #2 stated, “Yes, it is cold in here.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 36774 Based on observation, document review, and interview, it was determined that for 1 of 1 combined home peritoneal dialysis (HPD) and home hemodialysis (HHD) training room observed, the facility failed to ensure that a mechanism to call for help during emergency was available, as required. This can potentially affect all 30 home dialysis patients on the census. Findings include: 1. On 1/21/2025 at approximately 9:00 AM, the facility’s home dialysis training room was observed. The training room had no call light or other mechanism for patients to call during emergencies. 2. On 1/21/2025, the facility’s policy titled, “Physical Environment Dialysis Treatment Area” (11/2012) was reviewed and included, “ ... Purpose: To provide dialysis patients, staff, and the public a comfortable treatment environment ... Policy: The space for treating each patient must be sufficient to provide patient care and services ... to accommodate medical emergency equipment ...” 3. On 1/21/2025 between approximately 10:30 AM and 11:00 AM, interviews were conducted with E #1 (Director of Operations) and E #2 (Nurse Manager, Home Dialysis Program). E #1 stated that the facility does not have a call light for patients to use. E #2 stated that the way to call for emergency assistance would be to yell, ask help from the incenter staff, and to call 911. On 1/22/2025 at approximately 10:15 AM, another interview was conducted with E #2. E #2 is not aware of any established process regarding use of hand-held call device for home dialysis patients.”