Heritage Dialysis Center, LLC

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 37349 Based on observation, interview and document review, the facility failed to meet the Condition of Water and Dialysate Quality (42 CFR 494.40). Findings include: 1. The facility failed to maintain a microbial count lower than 200 colony forming units (CFU) in the water system. This placed all hemodialysis patients at risk for exposure to bacteria in the water and to a potential pyrogenic reaction (febrile phenomenon caused by infusion of contaminated solution, and commonly manifested by cold, chill and fever) during dialysis. Please refer to V 178. 2. The facility failed to ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4) rinsed the conductivity meter between dialysate samples. Please refer to V 250.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 37349 Based on interview and document review, the facility failed to meet the Condition of Quality Assessment Performance Improvement (42 CFR 494.110) to ensure patient safety and improve care. Findings include: The facility failed to ensure that technical services reported the water quality results that exceeded the allowable limit to the Quality Assurance and Performance Improvement (QAPI) committee to continuously monitor, take actions to improve performance and track performance to ensure that the results are sustained. Please refer to V 638.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 37349 Based on interview and record review, the Governing Body failed to ensure that the Condition of Governance was met. Findings include: 1. The Governing Body failed to adopt a policy related to microbial results that exceed the allowable limit resulting in the Condition of Water and Dialysate Quality not being met. Please refer to V 751. 2. The Governing Body failed to enforce the facility policy related to Quality Assurance Performance Improvement (QAPI), resulting in the Condition of Water and Dialysate Quality not being met. Please refer to V 751.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure 2 of 3 staff (Certified Clinical Hemodialysis Technician [CCHT] #3 and Registered Nurse [RN] #1) observed, removed potentially contaminated personal protective equipment (PPE) (gowns) before preparing intravenous medication; and 2.) ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both clean and dirty areas on the dialysis treatment floor Findings include: Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. Review of the facility policy, titled, Medication: Handling, Administration, Storage and Disposal, last revised 1/13/25, included the following: * Medications are to be prepared in a clean area. Aseptic technique is used to prepare all parenteral medications. 1. The facility failed to ensure 2 of 3 staff (CCHT #3 and RN #1) observed, removed potentially contaminated personal protective equipment (PPE) (gowns) before preparing intravenous medication. a. On 5/27/25 at 10:15 A.M., during observation of medication preparation and administration, the surveyor observed CCHT #3 enter the medication preparation area, wearing a gown that had been worn in and out of dialysis stations to care for patients. At no time did CCHT#3 remove their gown prior to entering the medication preparation area. She prepared the intravenous medication and proceeded to administer the medication to a patient in station 9. b. On 5/27/25 at 1:00 P.M., during observations of the treatment floor, the surveyor observed RN #1 in the medication preparation area preparing medications to be administered to patients wearing a gown that had been worn in and out of dialysis stations to care for patients. During an interview on 5/27/25 at 1:00 P.M., RN #1 said that gowns should not be worn in the medication preparation area. During an interview on 5/27/25 at 1:15 P.M., the Clinic Manager said that gowns should not be worn in the medication preparation area. 2. The facility failed to ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both clean and dirty areas on the dialysis treatment floor. During an observation of the treatment floor on 5/27/25 at 9:00 A.M., the surveyor observed multiple hooks, along the wall, outside of the isolation room. There were 10 face shields and 2 gowns hanging on the hooks. The face shields were overlapping and stacked on top of each other, causing concern for potential cross contamination. The 2 gowns, which had been worn by staff on the treatment floor, were overlapping the face shields, causing concern for potential cross contamination. During further observation of the dialysis unit the surveyor observed hooks on the wall next to the janitor closet. On the hooks, 4 face shields were overlapping and stacked on top of each other, causing concern for potential cross contamination. During an observation of the treatment floor on 5/28/25 at 8:10 A.M., the surveyor observed 10 face shields on hooks outside of the isolation room overlapping and stacked on top of each other. There was one pair of goggles hanging on a hook on top of a face shield, all causing concern for potential cross contamination. During further observation of the dialysis unit, the surveyor observed 2 gowns overlapping multiple face shields on hooks next to the janitor closet, causing concern for potential cross contamination. During an interview on 5/27/25 at 1:00 P.M., Registered Nurse (RN) #2 said that PPE should be separated when hung on the hooks. During an interview on 5/28/25 at 3:35 P.M., the Clinic Manager said that PPE should not be overlapping each other on the hooks. 37349”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 37349 Based on observation, interview and policy review, the facility failed to ensure that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #1) inspected the side of the transducer protector that faces the dialysis machine after it had become wetted and needed to be replaced to ensure that the dialysis machine had not become contaminated with blood. Findings include: Review of the facility policy, titled, Changing Wet Transducer Protectors, effective 6/12/24, included the following: * Remove the wet transducer protector from the machine and check the back of the transducer protector for any signs of blood. * Caution! If the back of the transducer protector is contaminated with blood, the machine must be tagged and removed from service after the treatment is complete. Technical services will need to inspect the internal components of the machine for contamination before returning it to service. On 5/27/25 at 10:05 A.M., the surveyor observed CCHT #1 attempting to troubleshoot the dialysis machine in station #3 that was alarming. The dialysis machine had a transducer protector that was wetted with blood. CCHT #1 removed the wetted transducer protector and discarded it without inspecting the back of it to determine if it was contaminated. He put a new transducer protector in place and it became wetted with blood when CCHT #1 attempted to restart the dialysis treatment. The machine began to alarm again and CCHT #1 proceeded to disconnect the patient from the dialysis machine. He removed the tubing, dialyzer, and transducer protector from the dialysis machine and discarded the system without inspecting the back of the second transducer protector to determine if it was contaminated. During an interview on 5/27/25 at 11:55 A.M., CCHT #1 said that the dialysis machine was taken out of service and that he told Technical Services that the machine was alarming. He said he should have looked at the back of the transducer protector to be sure blood had not broken through the transducer protector. He said he should have let technical services know that he did not inspect the transducer so technical services would know to inspect the internal components of the machine.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to 1.) ensure 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1) observed, adequately cleaned and disinfected contaminated surfaces within the dialysis station, increasing the risk of cross contamination of blood borne pathogens, 2.) ensure 9 of 18 blood pressure (BP) cuffs were free from debris to allow for proper disinfection, and 3.) ensure that bleach containers remained covered to maintain efficacy of the bleach solution. Findings Include: Review of the facility policy, Cleaning and Disinfection of Equipment, Supplies and Treatment Area, last revised 6/20/24, indicated the following: *All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to the: Dialysis machine Chair, including the top and bottom of the chair side table(s) Bedside table Television, phone Counters and wall boxes *Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling of chemical containers and must be covered with a lid to prevent contamination. 1. The facility failed to ensure 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1) observed, adequately cleaned and disinfected contaminated surfaces within the dialysis station, increasing the risk of cross contamination of blood borne pathogens. On 5/27/25 at 9:20 A.M., the surveyor observed CCHT #1 disinfect station 12 for the next patient. He was observed to disinfect the hemodialysis machine and hemodialysis chair using 1:100 bleach soaked pads. CCHT #1 failed to disinfect the IV pole and IV prongs. He also failed to disinfect the stethoscope hanging from the IV pole. During an interview on 5/27/25 at 9:30 A.M., CCHT #1 said he always cleans the IV pole and stethoscope but he must have forgotten. 2. The facility failed to ensure 9 of 18 blood pressure (BP) cuffs were free from debris to allow for proper disinfection. On 5/27/25 at 9:00 A.M., during an observation of the treatment floor, the surveyor observed 9 of 18 BP cuffs, including those at station 2,3,4,7,8,9,11,16, and 17, were laden with lint and debris embedded in the Velcro of the BP cuff, making it difficult to adequately disinfect between patients. During an interview on 5/27/25 at 1:00 P.M., Registered Nurse (RN) #2 said the BP cuffs are always an issue because they build up lint from the patient’s clothing. She said they used to have protector sleeves that slid over the patient’s arm and that helped decrease the amount of lint from accumulating on the BP cuff. She said the build up of lint does make it harder to disinfect. 37349 3. The facility failed to ensure that bleach containers remained covered to maintain efficacy of the bleach solution. On 5/27/25 from 8:35 A.M. to 10:30 A.M., during observations of the treatment floor, the surveyor observed an open container across from station 5. The container was labeled 1:100 bleach and multiple staff were observed to soak cloths in the solution and enter stations to disinfect the dialysis stations in between patient use. During an interview on 5/28/25 at 1:30 P.M., the Clinic Manager said that bleach containers should be covered.”

“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: 37349 Based on observation, interview and policy review, the facility failed to ensure that 1 staff member (Registered Nurse [RN] #1 maintained aseptic technique during administration of an intravenous (IV) medication. Findings include: Review of the facility policy, titled, IV Medication Administration, effective 5/1/23, included the following: * Aseptically connect IV tubing to Leur lock on normal saline line, using the venous medication infusion Leur lock line. On 5/27/25 at 9:30 A.M., the surveyor observed RN #1 administer an IV antibiotic to Patient #8 after his/her dialysis treatment had ended. She disconnected the venous line from the dialysis machine and attached a saline filled syringe to flush the venous line. The tip of the line came in contact with Nurse #1’s glove. She placed the line down on the tray table with the tip in contact with the tray table. She then removed the cap of the antibiotic line and placed the open line down on the tray table with the tip in contact with the tray table. She then left the station and returned with alcohol pads. She proceeded to use an alcohol pad to disinfect the tip of the line that was connected to the patient. Without disinfecting the line that was connected to the antibiotic she connected the two lines, set the IV pump and proceeded to administer the IV medication. During an interview on 5/27/25 at 1:00 P.M., RN #1 said she should use aseptic technique to administer IV medications and she missed disinfecting one of the lines before connecting.”

“BACT OF H20-MAXIMUM & ACTION LEVELS CFR(s): 494.40(a) 4.1.2 Bacteriology of water: max & action levels Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. This Standard is not met as evidenced by: 37349 Based on interview and document review, the facility failed to maintain a microbial count lower than 200 colony forming units (CFU) in the water system. This placed all hemodialysis patients at risk for exposure to bacteria in the water and to a potential pyrogenic reaction (febrile phenomenon caused by infusion of contaminated solution, and commonly manifested by cold, chill and fever) during dialysis. Findings include: Review of the Centers for Disease Control Dialysis Safety website, dated March 26, 2024, included the following: * Water use in Dialysis. By reducing risk from water in the healthcare setting many infections and outbreaks can be avoided. During an average week of hemodialysis, a patient can be exposed to 300-600 liters of water, providing multiple opportunities for potential patient exposure to waterborne pathogens. Adverse patient outcomes including outbreaks associated with water exposure in dialysis settings have resulted from patient exposure to water including improper formulation of dialysate with water containing high levels of chemical or biological contaminants, contamination of injectable medications with tap water and reprocessing of dialyzers with contaminated water. For the health and safety of hemodialysis patients, it is vital to ensure the water used to perform dialysis is safe and clean . *The Association for the Advancement of Medical Instrumentation (AAMI) in conjunction with the International Standards Organization (ISO) have established chemical and microbiological standards for the water used to prepare dialysate, substitution fluid, or to reprocess hemodialyzers for renal replacement therapy. The AAMI standards address the allowable and action threshold levels of water contaminants, bacterial cell counts, and endotoxins. *AAMI standards indicated that at a minimum the colony forming unit (CFU) allowable limit is less than 200 CFU, with a preferred recommendation of less than 100 CFU; the action level is greater than or equal to 50 CFU. Review of the facility Microbiology results for November 2024, indicated the following: 11/6/24 Bicarb Distribution System Feed had 158 CFU, exceeding the AAMI preferred recommended allowable limit. 11/6/24 Distribution Loop 4 return had 108 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for December 2024, indicated the following: 12/2/24 Bicarb Distribution System Feed had 176 CFU, exceeding the AAMI preferred recommended allowable limit. 12/2/24 Distribution Loop 4 return had 192 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for March 2025, indicated the following: 3/5/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Bicarb Distribution System Feed had 120 CFU, exceeding the AAMI preferred recommended allowable limit. 3/5/25 Distribution Loop 4 return was greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Distribution Loop 4 return had 206 CFU, exceeding the AAMI allowable limit. 3/5/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for April 2025, indicated the following: 4/4/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Pyrogen Filter Outlet has greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for May 2025, indicated the following: 5/23/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. During an interview on 5/28/25 at 12:30 P.M., the Clinic Manager said that she was aware that the microbial results were above allowable levels. She said that the sample collection techniques had been observed and ruled out as a cause for the elevated results. During an interview on 5/28/25 at 1:30 P.M., the Clinic Manager and Regional Operations Manager, Biomedical Technician (Biomed) and the Facility Technical Manager said there is no policy to address water levels that exceed acceptable limits, they only have a policy to address water levels that are above action level.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 37349 Based on observation, interview and policy review, the facility failed to ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4) rinsed the conductivity meter between dialysate samples. Findings include: Review of the facility policy, titled, Checking Conductivity and pH of Dialysate, last revised 6/20/24, included the following: * Collect a dialysate sample. * Fill the cell cup to just above the top electrode with the sample. * When the pointer stops, IMMEDIATELY read and release the button. * Discard dialysate sample in dirty sink or prime waste bucket. * Rinse cell cup with reverse osmosis water. On 5/27/25 at 10:40 A.M., the surveyor observed CCHT #4 take a dialysis sample from station #5 to the conductivity station. When the test was completed he discarded the sample and without rinsing the meter went back to station #5 to record the results. During an interview on 5/27/25 at 10:41 A.M., CCHT #4 said that he should have rinsed the meter.”

“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: 27189 Based on observation and interview, the facility failed to maintain a safe and sanitary environment in the water treatment/dialysate preparation room/area. Findings include: The Water treatment/dialysate preparation room houses the water purification and dialysate preparation systems that prepare the solutions for use in the hemodialysis treatment of the patient. On 5/27/25 at 8:45 A.M., during the flash tour of the water treatment room, the surveyor observed the following: *The floor of the room/area was wet with puddles of water present in front of the Reverse Osmosis machine and in front of the Bicarbonate station. *There was an excessive amount of acid build-up (white, flaky,crystalline in appearance) directly under and on the pressure gauge valve, and down the piping in the acid room leading to/from the two holding tanks. *The blue base on which the acid solution holding tanks sit on, were noted to have dirt and debris buildup. * There were several small areas of broken flooring around the drain in front of the bicarbonate station. *The eye wash station had a build up of dust and debris. One of the four caps was not secured and did not cover the washing port as required. *The water drains through out the water treatment/dialysate preparation room were noted to be laden with rust and debris. During an interview on 5/27/25 at 2:00 P.M. the Biomedical Technician was made aware of the environmental concerns noted during the flash tour on 5/27/25 at 8:45 A.M. He said that the acid build-up was probably due to a leak at the junction of the pressure valve and pipe and was going to see if that was causing the acid to leak and build up on the valves and pipe. During the exit conference on 5/28/25 at 4:30 P.M. the surveyor relayed the concerns to the administrative team about the condition of the water treatment/dialysate preparation room/area during the flash tour performed on 5/27/25.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44223 Based on observation, interview and manufacturers directions for use (MDFU), the facility failed to ensure all equipment solutions were maintained according to MDFU and not used when out of date. Findings include: Review of the MDFU, titled, DialyGuard by Mesa Labs, not dated, indicated the following: *Combination Solution-Conductivity solution and pH solution combined in one bottle. Used for the calibration of conductivity/pH meters. -Shelf Life of Opened Bottle: 30 days from date of opening. *pH Buffer Solutions-used for the calibration of conductivity/pH meters. -Shelf Life of Opened Bottle: 90 days from date of opening *Conductivity Solutions-used for the calibration of conductivity/pH meters. -Shelf Life of Opened Bottle: 30 days from date of opening On 5/27/25 at 9:15 A.M., during the flash tour of the dialysis treatment area, the surveyor observed the pH and conductivity testing station. The surveyor observed the following bottles of solutions: *1 bottle labeled Standard pH buffer 10 pH solution with an expiration date of 5/15/25. *1 bottle labeled Standard pH buffer 4 pH solution with an expiration date of 4/19/25. *1 bottle labeled Conductivity Standard Solution with an expiration date of 5/19/25. *1 bottle labeled pH Calibration Buffer Solution pH 7.0 with an open date of 1/20/25 with no expiration date. During an interview on 5/27/25 at 1:00 P.M., Registered Nurse (RN) #2 said the staff member that opens in the morning is in charge of preparing the pH and conductivity testing station. She said that it is the expectation that expiration dates are checked. RN #2 said that these solutions are expired and should have been replaced.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 27189 Based on record review, and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) for 2 patients (#1 and #5) out of a total sample of 7 patients. Findings include: 1. Patient #1 was admitted to the facility in December 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician’s orders dated 4/24/25, indicated the BFR was to be delivered at a rate of 450 ml/min. Review of 9 hemodialysis treatment flow sheets, dated 4/29/25 through 5/27/25, indicated the BFR had not been delivered as prescribed for 7 of 9 treatments as follows: * 4/29/25 - The BFR was delivered at a rate of 300-450 ml/min, not consistently at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/3/25- The BFR was delivered at a rate of 400-450 ml/min, not consistently at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/10/25- The BFR was delivered at a rate of 300-450 ml/min, not consistently at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/13/25- The BFR was delivered at a rate of 400 ml/min, not at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/15/25- The BFR was delivered at a rate of 350 ml/min, not at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/22/25- The BFR was delivered at a rate of 400 ml/min, not at the rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 5/27/25- The BFR was delivered at a rate of 200-400 ml/min, not consistently delivered at a rate of 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 5/28/25 at 12:25 P.M., the Clinic Manager (CM) and the Regional Operations Manager said if the BFR is not delivered as prescribed, there should be documentation indicating why the BFR was not delivered as prescribed by the physician. The medical record had no documentation as to the justification of why the BFR had not been delivered at the prescribed rate. 44223 2. Patient #5 was admitted to the facility in December 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 5/9/25, 5/12/25, and 5/23/25, indicated the dialysis order included a BFR to be delivered at a rate of 450 ml/min. Review of 9 hemodialysis flow sheets, dated 5/7/25-5/26/25, indicated the BFR had not been delivered as prescribed for 7 of 9 treatments, including the following: *5/12/25 - The BFR was delivered at a rate of 250 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/14/25 - The BFR was delivered at a rate of 250-400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/16/25 - The BFR was delivered at a rate of 200-350 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/19/25 - The BFR was delivered at a rate of 250-375 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/21/25 - The BFR was delivered at a rate of 300-400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/23/25- The BFR was delivered at a rate of 300-400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/26/25- The BFR was delivered at a rate of 300-400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 5/28/25 at 12:20 P.M., the Clinic Manager said when staff adjust the BFR they must inform the nurse and it must be documented in the medical record why the BFR was adjusted.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 44223 Based on record review, interview, and policy review, the facility failed to ensure the care plan was signed by the patient or the patient’s designee, or if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided, to ensure the patient had involvement with his/her plan of care for 1 patient (#5), out a total sample of 7 patients. Findings Include: Review of the facility policy, titled, Treatment Plans, last revised 5/2022, indicated the following: *The treatment plan is developed by the centers interdisciplinary team (IDT) which includes, but not limited to: -physician treating the patient for kidney disease -Registered nurse with knowledge of the patient -dietitian -social worker -patient and/or patient’s representative if desired by the patient -Care Coordinator (Center Manager) to facilitate the provision of patient care required by external disciplines such as Behavioral Health and Primary Care *The patient will be an integral part of the planning process and will be a part of the interdisciplinary meeting whenever possible. If the patient is not able or chooses not to attend the meeting, the treatment plan will be discussed with him/her by a member of the health care team and the patient’s signature obtained on the treatment plan. *The interdisciplinary team must meet as team to review the comprehensive patient assessment and develop the treatment plan. If any team member cannot meet with the group in person it is acceptable to meet with the group via phone or video conference as long as the absent member is able to participate in discussion of the assessment data and development of the treatment plan. For Patient #5, the facility failed to ensure that the timeliness of the patient’s involvement in his/her plan of care occurred by signing the 90 Day Assessment and Plan of Care review and acknowledgement form. The facility failed to include a time frame on when the care plan should be signed. Patient #5 was admitted to the facility in December 2024 with a diagnosis of ESRD, requiring hemodialysis treatments 3 times a week. Review of the clinical record indicated the 90 day CIA and POC were initiated on March 24, 2025. Review of the Care Plan Meeting Acknowledgement form included 2 signatures from Patient #5. The first signature was dated 3/24/25 and indicated that the patient was made aware that the IDT was completing an electronic version of the patient’s Comprehensive Assessment and Plan of care. There was no indication on the form whether the patient participated in the plan of care meeting. The second signature was dated 5/28/25 and indicated that the patient was made aware that if he/she did not participate in the plan of care meeting the IDT would review it with the patient. There was no documented evidence that the plan of care was reviewed with the patient. Review of the IDT Approval Signature section of the POC included the electronic signatures of the nurse, dietitian, social worker, and physician. The signatures of the nurse, social worker, and physician indicated they signed the care plan review between May 7 and May 28 2025, more than one month after the care plan was initiated on March 24, 2025. During an interview on 5/28/25 at 3:55 P.M., the Clinic Manager said that care plans should be signed within 30 days of the care plan being reviewed. She said that the nurse, social worker, and physician did not sign within an appropriate time frame.”

“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: 37349 Based on interview and document review the facility failed to ensure that technical services reported water quality results that exceeded the allowable limit to the Quality Assurance and Performance Improvement (QAPI) committee to continuously monitor, take actions to improve performance, and track performance to ensure that the results are sustained. Findings include: Review of the facility policy, titled, Quality Assurance and Performance Improvement, last revised 1/13/25, included the following: * Regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes. * When discussing data/issues related to their specific roles/job function, the following staff should be included in the QAPI meeting: Biomedical Technician. * At a minimum, the QAPI program must include: water and dialysate quality, equipment maintenance. * The center must immediately correct any identified problems that threaten the health and safety of patients. *Examples of such conditions that require immediate correction include, but are not limited to: dangerous levels of contaminants in product water. Review of the Association for the Advancement of Medical Instrumentation (AAMI) standards indicated that at a minimum the colony forming unit (CFU) allowable limit is less than 200 CFU, with a preferred recommendation of less than 100 CFU; the action level is greater than or equal to 50 CFU. Review of the facility Microbiology results for December 2024, indicated the following: 12/2/24 Bicarb Distribution System Feed had 176 CFU, exceeding the AAMI preferred recommended allowable limit. 12/2/24 Distribution Loop 4 return had 192, exceeding the AAMI preferred recommended allowable limit. Review of the QAPI document for December 2024 indicated that Technical Services was required to review a 3 month trend of Microbiology results. Further review failed to indicate that was completed despite microbiology results that exceeded the allowable limit. There was no plan to correct and sustain an improvement in water quality. Review of the facility Microbiology results for March 2025, indicated the following: 3/5/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Bicarb Distribution System Feed had 120 CFU, exceeding the AAMI preferred recommended allowable limit. 3/5/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Distribution Loop 4 return had 206 CFU, exceeding the AAMI allowable limit. 3/5/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the QAPI document for March 2025 indicated that Technical Services was required to review a 3 month trend of Microbiology results. Further review failed to indicate that was completed despite microbiology results that exceeded the allowable limit. There was no plan to improve and sustain an improvement in water quality. Review of the facility Microbiology results for April 2025, indicated the following: 4/4/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 the Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 the Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the QAPI document for April 2025 indicated that Technical Services was required to review a 3 month trend of Microbiology results. Further review failed to indicate that was completed despite microbiology results that exceeded the allowable limit. There was no plan to improve and sustain an improvement in water quality. During an interview on 5/28/25 at 1:30 P.M., the Clinic Manager, Regional Operations Manager, Biomedical Technician (Biomed) and the Facility Technical Manager said there is no policy to address water levels that exceed allowable limits, they only have a policy to address water levels that are action level. During an interview on 5/28/25 at 3:30 P.M., the Regional Operations Manager said that the company was aware that the Biomed was not completing the required review and action plans for QAPI. She said that the company gave him additional training in February 2025. Despite training in February the QAPI review and action plan was still not completed for March or April despite results exceeding allowable levels.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44223 Based on record review, interview, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of a heparin (blood thinning medication) bolus to initiate dialysis treatment for 2 patients (#5 and #3), out of a total sample of 7 patients. Findings Include: Review of the facility’s policy titled, AVF-AVG Cannulation, Treatment Initiation and Termination, last revised on 6/20/24, indicated the following: *If ordered administer the heparin bolus as prescribed to the patients via the venous needle. Allow the heparin to circulate systemically for 3-5 minutes before initiating the hemodialysis treatment. *Heparin must reach systemic circulation to prevent clots during the treatment. 1. For Patient #5, the Medical Director failed to ensure staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after heparin bolus to initiate dialysis treatments. Patient #5 had a physician’s order to administer a heparin bolus 1000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 5/7/25 through 5/26/25, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 5/12/25 treatment started at 2:44 P.M., heparin was documented as administered at 4:10 P.M., 1 hour and 26 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/19/25 treatment started at 2:42 P.M., heparin was documented as administered at 2:57 P.M., 15 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/21/25 treatment started at 2:30 P.M., heparin was documented as administered at 2:37 P.M., 7 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/23/25 treatment started at 2:25 P.M., heparin was documented as administered at 7:22 P.M., 4 hours and 57 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 5/28/25 at 12:20 P.M., the Clinic Manager said staff should be waiting the 3-5 minutes after infusing heparin before treatment is started. She said that documentation should be completed at the time the heparin is given. 37349 2. For Patient #3, the Medical Director failed to ensure staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after heparin bolus to initiate dialysis treatments. Patient #3 had a physician’s order to administer a heparin bolus 1000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 5/8/25 through 5/27/25, indicated for 7 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 5/10/25 treatment started at 10:21 A.M., heparin was documented as administered at 10:25 A.M., 4 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/13/25 treatment started at 10:23 A.M., heparin was documented as administered at 10:25 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/15/25 treatment started at 10:04 A.M., heparin was documented as administered at 10:22 A.M., 18 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 5/17/25 treatment started at 10:23 A.M., heparin was documented as administered at 10:42 A.M., 19 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. * On 5/20/25 treatment started at 10:03 A.M., heparin was documented as administered at 10:25 A.M., 22 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. * On 5/22/25 treatment started at 10:08 A.M., heparin was documented as administered at 10:12 A.M., 4 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. * On 5/24/25 treatment started at 10:00 A.M., heparin was documented as administered at 10:17 A.M., 17 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 5/28/25 at 12:20 P.M., the Clinic Manager said staff should be waiting the 3-5 minutes after infusing heparin before treatment is started. She said that documentation should be completed at the time the heparin is given.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 37349 Based on interview and document review, the Governing Body failed 1.) to adopt a policy related to microbial results that exceed the allowable limit; and 2.) to enforce the facility policy related to Quality Assurance Performance Improvement (QAPI), resulting in the condition of Water and Dialysate Quality and the Condition of Quality Assessment and Performance Improvement not being met, therefore putting the health care and safety of every patient at risk. Findings include: Review of the Governing Body By-Laws, effective 5/23/17, included the following: * Adopts effective administrative rules and regulations that are designed to safeguard the health and safety of patients, and to govern the general operations of the Facility in accordance with legal requirements. * Ensures that the policies and procedures of the Facility are reviewed and approved at least annually and that they are enforced. 1. The Governing Body failed to adopt a policy related to microbial results that exceed the allowable limit. Review of the Association for the Advancement of Medical Instrumentation (AAMI) in conjunction with the International Standards Organization (ISO) have established chemical and microbiological standards for the water used to prepare dialysate, substitution fluid, or to reprocess hemodialyzers for renal replacement therapy. The AAMI standards address the allowable and action threshold levels of water contaminants, bacterial cell counts, and endotoxins. Review of AAMI standards indicated that at a minimum the colony forming unit (CFU) allowable limit is less than 200 CFU, with a preferred recommendation of less than 100 CFU; and the action level is greater than or equal to 50 CFU. Review of the microbial reports indicated that for 5 of 7 months the results exceeded the recommended and/or allowable limit, including the following: Review of the facility Microbiology results for November 2024, indicated the following: 11/6/24 Bicarb Distribution System Feed had 158 CFR, exceeding the AAMI preferred recommended allowable limit. 11/6/24 Distribution Loop 4 return had 108 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for December 2024, indicated the following: 12/2/24 Bicarb Distribution System Feed had 176 CFU, exceeding the AAMI preferred recommended allowable limit. 12/2/24 Distribution Loop 4 return had 192 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for March 2025, indicated the following: 3/5/25 Bicarb Distribution System Feed was greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Bicarb Distribution System Feed had 120 CFU, exceeding the AAMI preferred recommended allowable limit. 3/5/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Distribution Loop 4 return had 206 CFU, exceeding the AAMI allowable limit. 3/5/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for April 2025, indicated the following: 4/4/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for May 2025, indicated the following: 5/23/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. During an interview with the Clinic Manager at 12:30 P.M., she said that she was aware that the microbial results were above allowable levels. She said that the sample collection techniques had been observed and ruled out as a cause for the elevated results. During an interview on 5/28/25 at 1:30 P.M., the Clinic Manager and Regional Operations Manager, Biomedical Technician (Biomed) and the Facility Technical Manager said there is no policy to address water levels that exceed allowable limits, they only have a policy to address water levels that are above action level. 2. The Governing Body failed to enforce the facility policy related to Quality Assurance Performance Improvement (QAPI). Review of the facility policy, titled, Quality Assurance and Performance Improvement, last revised 1/13/25, included the following: * Regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes. * When discussing data/issues related to their specific roles/job function, the following staff should be included in the QAPI meeting: Biomedical Technician. * At a minimum, the QAPI program must include: water and dialysate quality, equipment maintenance. * The center must immediately correct any identified problems that threaten the health and safety of patients. Examples of such conditions that require immediate correction include, but are not limited to: dangerous levels of contaminants in product water. Review of the QAPI documents from November 2024 to April 2025 failed to include 3 month trend of Microbiology Results and failed to include an action plan to improve water quality despite levels exceeding allowable levels in 4 of 6 months, including November 2024, December 2024, March 2025 and April 2025. Review of AAMI standards indicated that at a minimum the colony forming unit (CFU) allowable limit is less than 200 CFU, with a preferred recommendation of less than 100 CFU; and the action level is greater than or equal to 50 CFU. Review of the microbial reports indicated that for 4 of 6 months the results exceeded the recommended and/or allowable limit, including the following: Review of the facility Microbiology results for November 2024, indicated the following: 11/6/24 Bicarb Distribution System Feed had 158 CFR, exceeding the AAMI preferred recommended allowable limit. 11/6/24 Distribution Loop 4 return had 108 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for December 2024, indicated the following: 12/2/24 Bicarb Distribution System Feed had 176 CFU, exceeding the AAMI preferred recommended allowable limit. 12/2/24 Distribution Loop 4 return had 192 CFU, exceeding the AAMI preferred recommended allowable limit. Review of the facility Microbiology results for March 2025, indicated the following: 3/5/25 Bicarb Distribution System Feed was greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Bicarb Distribution System Feed had 120 CFU, exceeding the AAMI preferred recommended allowable limit. 3/5/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 3/26/25 Distribution Loop 4 return had 206 CFU, exceeding the AAMI allowable limit. 3/5/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for April 2025, indicated the following: 4/4/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 4/4/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. 4/7/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. Review of the facility Microbiology results for May 2025, indicated the following: 5/23/25 Bicarb Distribution System Feed had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Distribution Loop 4 return had greater than 300 CFU, exceeding the AAMI allowable limit. 5/23/25 Pyrogen Filter Outlet had greater than 300 CFU, exceeding the AAMI allowable limit. During an interview on 5/28/25 at 3:30 P.M., the Regional Operations Manager said that the company was aware that the Biomed was not completing the required review and action plans for QAPI. She said that the company gave him additional training in February 2025. Despite training in February the QAPI review and action plan was still not completed for March or April despite results exceeding allowable levels.”