Davita Wellington Circle Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44223 Based on observations, staff interviews, and policy review, the facility failed to meet the condition of infection control. 4 of 9 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #5, In Center, CCHT #8, Dialysis Den #2, Registered Nurse [RN] #5, In Center, and RN #7, Dialysis Den #2) implemented adequate infection control measures to ensure the health and safety of all patients. Findings Include: 1. The facility failed to ensure that 1 staff member (CCHT #5) observed In Center, and 1 of 2 staff members (CCHT #8) observed at Dialysis Den #2, implemented adequate infection control practices, related to glove use and hand hygiene, to reduce the risk of spread of infection while caring for a patient. Refer to V113. 2. The facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure proper infection control practices were followed during the preparation of intravenous (IV) medications for 2 of 2 staff (RN #7 and CCHT #8) observed during medication preparations at Dialysis Den #2; 2.) ensure 1 of 2 staff members (RN#7) observed at Dialysis Den #2, removed potentially contaminated personal protective equipment (PPE) (gown) before preparing intravenous (IV) medications; 3.) ensure contaminated PPE did not come into contact with clean surfaces at the Dialysis Den #2; and 4.) ensure that patient belongings were not stored in clean areas at Dialysis Den #1. Refer to V117. 3.) The facility failed to ensure that biohazardous waste was covered with a tight fitting lid at Dialysis Den #1. Refer to V121. 4.) The facility failed to ensure that 1 staff members (CCHT #8) observed at Dialysis Den #2, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk for cross contamination of blood borne pathogens. Refer to V122. 5.) The facility failed to ensure timely administration of the hepatitis B vaccine series for 1 of 1 applicable patients (#10), susceptible to the hepatitis B virus, out of 10 records reviewed, out of a total sample of 14 patients. Refer to V126. 6.) The facility failed to ensure that 1 of 2 staff observed In Center (RN #5), and 1 of 2 staff observed at Dialysis Den #2 (CCHT #8), performed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#13) In Center and 1 of 2 applicable patients (#11) at Dialysis Den #2, with a Central Venous Catheter (CVC). Refer to V147.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 10249 Based on review of the Quality Assessment Performance Improvement Plan (QAPI, referred to by the center as the Facility Health Meeting (FHM) Comprehensive Report Summary), staff interviews, facility contract, and policy review, the facility failed to be in compliance with the Condition of Quality Assessment Performance Improvement (42 CFR 494.110) to ensure patient safety and improve care. Findings include: 1.) The facility failed to ensure monthly infection control audits were conducted at Dialysis Den #2 to be consistently measured, analyzed, and a plan was developed based on results of these monthly reports. Refer to V637. 2.) The facility failed to ensure there was communication of quality assurance data between the Center and the Long Term Care Facility to ensure incorporation of the renal dialysis services provided to home hemodialysis (HHD) patients into the Center’s Quality Assessment and Performance Improvement (QAPI) program. Refer to V638.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #5) observed In Center, and 1 of 2 staff members (CCHT #8) observed at Dialysis Den #2, implemented adequate infection control practices, related to glove use and hand hygiene, to reduce the risk of spread of infection while caring for a patient. Findings Include: Review of the facility policy titled, Infection Control For Dialysis Facilities, revised April 2023, included the following: All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene: *Upon entering and exiting the patient treatment area. *Prior to gloving and immediately after removal of gloves. *After contamination with blood or other infectious material. *After patient and dialysis delivery system contact. *After interacting with wall boxes (i.e. plugging/unplugging acid/bicarb lines from dialysis machine, changing acid types, when exchanging a dialysis machine). *Between patients even if the contact is casual. *Before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. 1. During an observation of the In Center treatment floor on 12/3/24 at 8:50 A.M., the surveyor observed CCHT #5 at station 12 preparing a patient for the disconnection of dialysis treatment. CCHT #5 applied gloves and prepared the patient’s right arm by putting a clean drape under the arm. CCHT #5 then removed the blood pressure (BP) cuff from the patient’s left arm, contaminating his gloves. CCHT #5 then proceeded to remove the arterial line from the patient’s right arm with his contaminated gloves. He did not remove his gloves, perform hand hygiene, or apply new gloves after removing the BP cuff. After removing the arterial line, CCHT #5 then placed his gloved right hand on the biohazard container and pulled it into the station, further contaminating his gloves. After placing the biohazard container next to the dialysis chair, CCHT #5 proceeded to remove the venous line from the patient’s right arm. CCHT #5 did not remove his gloves, perform hand hygiene, or apply new gloves before removing the venous line from the patient’s right arm. During an interview on 12/3/24 at 9:05 A.M., CCHT #5 said he should have removed his gloves, washed his hands, and then applied new gloves after removing the BP cuff and touching the biohazard container. 2. During an observation of Dialysis Den #2 on 12/3/24 at 1:15 P.M., the surveyor observed CCHT #8 initiate dialysis treatment for a patient. CCHT #8 removed her gloves and put on new gloves 4 times without performing hand hygiene. Specifically, after she washed the access site, after assessing the access site, and after cannulating the arterial and venous access sites. 3. During an observation of Dialysis Den #2 on 12/3/24 at 4:00 P.M., the surveyor observed CCHT #8 disconnect a patient from dialysis treatment. During discontinuation, CCHT #8 removed her gloves and put on new gloves 1 time without performing hand hygiene. Specifically, after she disconnected the blood lines. 4. During an observation of Dialysis Den #2 on 12/3/24 at 4:30 P.M., the surveyor observed CCHT #8 disconnect a patient from dialysis treatment. During discontinuation, CCHT #8 removed her gloves, and put on new gloves 3 times without performing hand hygiene. Specifically, after she disconnected the blood lines, after she removed the venous line, and after she removed the arterial line. 5. During an observation of Dialysis Den #2 on 12/3/24 at 5:15 P.M., the surveyor observed CCHT #8 at station 1 cleaning and disinfecting the dialysis equipment within the station. During the observation, CCHT #8 changed her gloves 3 times, however failed to perform hand hygiene prior to donning new clean gloves. During an interview on 12/3/24 at 4:40 P.M., CCHT #8 said that she should have performed hand hygiene after removing her gloves. During an interview on 12/3/24 at 5:50 P.M., the Regional Operations Manager (ROM) said that hand hygiene should be performed any time gloves are removed.”

“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, staff interview, and policy review, the facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure proper infection control practices were followed during the preparation of intravenous (IV) medications for 2 of 2 staff (Registered Nurse [RN] #7 and Certified Clinical Hemodialysis Technician [CCHT] #8) observed during medication preparations at Dialysis Den #2; 2.) ensure 1 of 2 staff members (RN#7) observed at Dialysis Den #2, removed potentially contaminated personal protective equipment (PPE) (gown) before preparing IV medications; 3.) ensure contaminated PPE did not come into contact with clean surfaces at Dialysis Den #2; and 4.) ensure that patient belongings were not stored in clean areas at Dialysis Den #1. Findings Include: 1. The facility failed to ensure ensure proper infection control practices were followed during the preparation of IV medications for 2 of 2 staff (RN #7 and CCHT #8) observed during medication preparations at Dialysis Den #2. Review of the facility policy, titled Preparation and Administration of Parenteral Medications, revised 4/2024, indicated the following: *Prior to each medication preparation, disinfect medication preparation surface area with 1:100 bleach solution and disposable wipes. a. During an observations at Dialysis Den #2 on 12/3/24 at 12:30 P.M., the surveyor observed RN #7 prepare an IV medication for administration. RN #7 did not disinfect the medication preparation area with 1:100 bleach solution prior to preparing the medication, per the facility policy. b. During observations at Dialysis Den #2 on 12/3/24 at 4:30 P.M., the surveyor observed CCHT #8 prepare an IV medication for administration. CCHT #8 did not disinfect the medication preparation area with 1:100 bleach solution prior to preparing the medication, per facility policy. During an interview on 12/3/24 at 5:50 P.M., the Regional Operations Manager (ROM) said the medication preparation area should have been disinfected before medications were prepared. 2. The facility failed to ensure 1 of 2 staff members (Registered Nurse [RN] #7) observed at Dialysis Den #2, removed potentially contaminated PPE (i.e. gown) before preparing intravenous (IV) medications. 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: * The 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. During an observations at Dialysis Den #2 on 12/3/24 at 12:30 P.M., the surveyor observed RN #7 enter the medication preparation area, labeled clean, wearing a gown that had been worn in and out of dialysis treatment stations to care for patients. RN #7 failed to remove her gown prior to entering the medication preparation area. RN #7 proceeded to prepared the IV medication. During an interview on 12/3/24 at 5:40 P.M., the ROM said RN #7 she should have removed her gown before entering the medication preparation area because that area is considered clean. 3. The facility failed to ensure contaminated PPE did not come into contact with clean surfaces at Dialysis Den #2. Review of the facility policy, titled, Infection Control for Dialysis Facilities, revised 4/2023, indicated the following: Gloves should be changed: *When soiled with blood, dialysate, or other body fluids. *When going from “dirty” area or task to a “clean” area or task. *When moving from a contaminated body site to a clean body site of the same patient. *After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system. *The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas. a. During an observation at Dialysis Den #2 on 12/3/24 at 12:50 P.M., the surveyor observed RN #7 remove her faceshield and place it on top of her computer keyboard. RN #7 failed to disinfect the faceshield prior to placing it on the computer (which is considered a clean surface). During an interview on 12/3/24 at 1:00 P.M., RN #7 said she did not realize that the computer and cart were considered clean areas. During an interview on 12/3/24 at 5:40 P.M., the ROM said the computer and cart are considered clean surfaces and RN #7 should not have placed her contaminated faceshield on top of the computer. b. During an observation of the treatment floor at Dialysis Den #2, on 12/3/24 at 1:15 P.M., the surveyor observed CCHT #8 at station 4 initiate dialysis treatment for a patient with an arteriovenous graft (AVG). During the observation, CCHT #8 completed initiation of the treatment and without removing her contaminated gloves, proceeded to use the computer keyboard to document patient information. CCHT #8 failed to remove her gloves and perform hand hygiene prior to touching a clean surface. c. During an observation of the treatment floor at Dialysis Den #2 on 12/3/24 at 4:30 P.M., the surveyor observed CCHT #8 at station 4 put on a pair of gloves and assist the patient by putting the legs of the dialysis chair down. CCHT #8 then proceeded, with her gloves hands, to push the computer to the other side of the treatment floor. CCHT #8 failed to remove her gloves and perform hand hygiene prior to touching the clean surface of the computer stand. During an interview on 12/3/24 at 4:40 P.M., CCHT #8 said she should have changed her gloves and performed hand hygiene before touching clean surfaces. During an interview on 12/3/24 at 5:40 P.M., the ROM said that CCHT #8 should not have touched the clean surfaces with gloved hands. 37349 4. The facility failed to ensure that potentially contaminated patient belongings were not stored in clean areas at Dialysis Den #1. Review of the facility policy, titled Infection Control for Dialysis Facilities, revised April 2023, included the following: * Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. During the flash tour of Dialysis Den #1 on 12/4/24 at 8:40 A.M., the surveyor observed 4 wheelchairs being stored in an area, as you enter the den, labeled as “clean sink”. One (1) of the wheelchairs was noted to be labeled with a patient name and had ripped arm rests and a ripped seat cushion. This wheelchair was in contact with the clean sink and soap dispenser. During an interview on 12/4/24 at 1:25 P.M., the Senior Regional Operations Manager said that patient wheelchairs should not be in the clean sink area.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, the facility failed to ensure that biohazardous waste was covered with a tight fitting lid at Dialysis Den #1. Findings include: Review of the facility policy, titled Segregation of Medical Waste, revised October 2023, included the following: * Medical waste containers are defined as: a.) a labeled plastic container with a foot mechanism to open the lid; b.) a labeled medical waste transfer container with a wheeled based tray and foot mechanism to open the lid; or c.) a labeled plastic container with no foot mechanism to open the lid. When using option c, the following infection control practices need to be followed: Lid should be tight fitting. During observations of the treatment floor at Dialysis Den #1 on 12/4/24 from 8:40 A.M. to 1:30 P.M., the surveyor observed a biohazard container in the center of the room. It was a labeled plastic container with no foot mechanism to open the lid. Throughout the entire observation there was a red bag inside the plastic container and the lid was left in the open position. Staff disposed of used dialysis blood lines in the open biohazard container. During an interview on 12/4/24 at 1:25 P.M., the Senior Regional Operations Manager said that biohazard containers should have a closed lid.”

“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: 10249 Based on observations, interview, and policy review, the facility failed to ensure that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #8) observed at Dialysis Den #2 adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk for cross contamination of blood borne pathogens. Findings include: Review of the facility policy, titled, Infection Control for Dialysis Facilities, revised April 2023, indicated the following, but not limited to: Disinfection *Use an appropriate disinfectant such as 1:100 bleach solutions for routine disinfection of environmental surfaces. *Disinfection should be completed by using a swiping motion with friction. *Sufficient disinfection should be applied so that the surfaces are visibly wet. *At the end of each treatment, the dialysis station will be cleaned and disinfected. *Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuff) and frequently contacted by healthcare personnel (e.g., control panel, top, front, sides of dialysis machine; touch screens, countertops). *The wall box, drain, and water supply lines are considered part of the dialysis station delivery system. *Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If items cannot be cleaned and disinfected it will be dedicated for use on a single patient. During an observation at Dialysis Den #2 on 12/3/24 at 5:15 P.M., the surveyor observed CCHT #8 clean and disinfect station 1 for the next patient. She was observed to disinfect the hemodialysis machine and chair with a 1:100 bleached soaked pad. CCHT #8 was observed taking the contaminated blood pressure cuff and placing it on the dirty dialysis seat. She then proceeded to wipe one side of the cuff with the bleach soaked pad, then flipped over the cuff placing the clean side of the cuff on the dirty seat re-contaminating the cuff. CCHT #8 then wiped the second side of the cuff, and then place it on top of the clean dialysis machine. CCHT #8 also failed to clean and disinfect the TV screen and arm, and the portable RO (reverse osmosis) machine. There was a cardboard box, with a black cloth cushion on top of the box, located within the splash zone. The box was not cleaned or removed during the disinfection process. During an interview on 12/3/24 at 5:30 P.M., CCHT #8 said the patient did not use the TV so she didn’t think she needed to clean it. She further said that she usually does clean the portable RO at the end of the day. CCHT #8 said she did not know what to do with the cardboard box and cushion, that was located in the station.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44223 Based on clinical record review, staff interview, and policy review, the facility failed to ensure timely administration of the hepatitis B vaccine series for 1 of 1 applicable patients (#10), susceptible to the Hepatitis B virus, out of 10 records reviewed, out of a total sample of 14 patients. Findings Include: Review of the facility policy, titled, Hepatitis B Surveillance,Vaccination, Infection Control Measures And Isolation Guidance, revised 4/2024, included the following: POLICY: *HBV serological status (i.e., the results of Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody [total anti-HBc or HBcAb], and Hepatitis B Surface Antibody [anti-HBs or HBsAb]) of all patients should be known before admission to the hemodialysis facility. * If the hepatitis B surface antigen (HBsAg) status is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for hepatitis B infection. *The facility Medical Director will be made aware of pending admissions for all hepatitis B surface antigen (HBsAg) positive patients. *All patients will be routinely tested [as required by the schedule for routine surveillance testing for Hepatitis B Virus. *Results will be reviewed promptly to verify that patients are managed appropriately based on their testing results. HEPATITIS B VACCINATION *An order will be obtained for hepatitis B vaccination. The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in Patient Registration Packet found in Reggie). The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record. Patient #10 was admitted to Dialysis Den #2 in September 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis three times a week. Review of the Vaccination and Surveillance Report indicated Patient #10’s most recent hepatitis B status as susceptible and not vaccinated. The report included the following: *Negative hepatitis B surface antigen (HBsAg) test on 11/26/24 *Hepatitis B core antibody test result less than 3 on 9/19/24 (less than 10 indicates susceptibility to the hepatitis b virus). Review of the clinical record indicated no evidence of hepatitis B vaccine administration prior to admission. Further review of the medical record failed to include evidence that Patient #10 had been offered the hepatitis b vaccine. The record failed to include a signed hepatitis B vaccine consent/declination form. During an interview on 12/5/24 at 7:15 A.M., the Facility Administrator said there was no hepatitis B consent/declination form available for the patient.”

“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: 38141 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members observed In Center (Registered Nurse [RN] #5), and 1 of 2 staff observed at Dialysis Den #2 (Certified Clinical Hemodialysis Technician [CCHT] #8), implemented adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#13) In Center and 1 of 2 applicable patients (#11) at Dialysis Den #2, with a Central Venous Catheter (CVC). Findings include: Review of the facility policy titled, Central Venous Catheter (CVC) with Clean guard HD Antimicrobial End Cups Procedure, with revision date of October 2024, indicated the following: *Perform hand hygiene. *Put on PPE and provide a mask to the patient. *Place patient in a comfortable supine position, as flat as possible. Verify patient’s clothing is secured away from the exit site/work area (securing the patient’s clothing away from the work area minimizes the risk of cross-contamination). *Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap. 1. During an observation of the In Center treatment area on 12/4/24 at 11:00 A.M., the surveyor observed RN #5 as she prepared Patient #13 for initiation of his/her dialysis treatment. RN #5 obtained supplies which included a swab stick and sterile bordered dressing. RN #5 placed a clean barrier under the CVC limbs, moved Patient #13’s button-down shirt away from the dressing, then she removed the old dressing, which she discarded into the trash. She then removed her gloves, performed hand hygiene, and donned new gloves and disinfected the exit site. As she applied the dressing, Patient #13’s shirt moved onto the exit site and touched the area where the catheter tunneled under the skin, which recontaminated the area. RN #5 moved Patient #13’s shirt back, touching the site with her gloved hand, and applied the new dressing to the exit site. RN #5 failed to repeat the disinfection process after the area was recontaminated. During an interview on 12/4/24 at 11:20 A.M., RN #5 said she should have secured Patient #13’s shirt prior to the dressing change, and that she should have repeated the disinfection process. 10249 2. During an observation at Dialysis Den #2 on 12/3/24 at 12:30 P.M., the surveyor observed CCHT #8 as she prepared Patient #11 for initiation of his/her dialysis treatment via a CVC. CCHT #8 performed disinfection of the exit site, waited 60 seconds, then applied the dressing. CCHT #8 failed to disinfect the CVC limbs before applying the dressing, per facility policy. During an interview on 12/3/24 at 12:55 P.M., CCHT # 8 said she did not wipe the limbs of the CVC.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure that 2 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #8 and Registered Nurse [RN] #7) conducted dialysate pH testing after the acid concentrate was changed during treatment for 2 of 2 observations at Dialysis Den #2. Findings Include: Review of the facility policy titled, Testing pH Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate, revised October 2024, included the following: *Trained teammates will test pH and if applicable, conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment and/or when changing the acid concentrate formulation or bicarbonate container during the course of a treatment. 1. During an observation at Dialysis Den #2 on 12/3/24 at 2:40 P.M., the surveyor observed RN #7 enter station 1 and switch the dialysate bath from 2 Potassium (K) to 3K. RN #1 continued the dialysis treatment and walked away from the station without checking the pH of the final dialysate. 2.) During an observation at Dialysis Den #2 on 12/3/24 at 2:45 P.M., the surveyor observed CCHT #8 enter station 5 and switch the dialysate bath from 2K to 3K. CCHT #8 continued the dialysis treatment and walked away from the station without checking the pH of the final dialysate. During an interview on 12/3/24 at 2:50 P.M., RN #7 said she did not check the pH after changing the dialysate and she was not sure if she had to. She said she would have to review the policy for the correct procedure.”

“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: 10249 Based on observation, interview, and record review, 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) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) for 1 of 4 patient prescriptions (#14) observed; and for 1 of 9 applicable patient (#7) records reviewed, out of total sample of 14 patients. Findings include: 1. For Patient #14, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the DFR. Patient #14 was admitted to the facility in August 2021, with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 12/3/24, indicated the DFR was to be delivered at a rate of 700. During an observation of the In Center treatment floor on 12/3/24 at 8:25 A.M., the surveyor observed Patient #14 receiving dialysis treatment, and the machine was set at a DFR rate of 600, and not 700 as ordered. During an interview on 12/3/24 at 8:30 A.M., Certified Clinical Hemodialysis Technician (CCHT) #5 verified the patient’s prescription and said he had set up the dialysis machine and was not sure why he set the DFR to 600, but it should be running at 700. During an interview on 12/3/24 at 8:35 A.M., RN #1 said the rate should have been set to 700 and not 600. 27189 2. For Patient #2, the dialysis staff failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR. Patient #2 was admitted to the facility in July 2022 with diagnoses which included End Stage Renal Disease (ESRD), requiring hemodialysis 3 times a week. Review of the Physician orders, dated 11/8/24, indicated the BFR was to be delivered at a rate of 350. Review of the 9 Treatment Details Report, dated 11/3/24 through 12/3/24, indicated the BFR had not been delivered as prescribed on 2 of 9 Treatment Details Report as follows: * 11/8/24 - The BFR was delivered at a rate of 400, not 350 as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 11/13/24 - The BFR was delivered at a rate of 400, not 350 as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 12/5/24 at 12:40 P.M., the Facility Administrator said staff must follow the physician’s order for the BFR. She further said that if for some reason the staff cannot deliver the ordered BFR rate, they should document the justification and/or physician notification on the Treatment Details Report.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 38141 Based on observation, interview, and policy review, the facility failed to ensure staff (Certified Clinical Hemodialysis Technician [CCHT] #5) evaluated a vascular access to ensure functionality by the way of listening for a bruit the length of the access (swooshing sound heard with a stethoscope place over the access) for 1 of 2 applicable In Center patients (#12) with an arteriovenous fistula/graft (AVF/G) access. Findings include: Review of the facility policy titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles”, last revised October 2022, included the following: *Perform inspection, auscultation, and palpation on entire length of the access. Determine presence of bruit and thrill. The presence of bruit and thrill indicates flow through the access. During an observation of the In Center treatment floor, on 12/3/24 at 10:15 A.M., the surveyor observed CCHT #5 as he was preparing Patient #12 for his/her dialysis treatment via an AVF. CCHT #5 palpated the vascular access with his fingertips for the presence of thrill, disinfected the fistula sites, and inserted the needle into the lower access, and then the upper access. CCHT #5 did not assess Patient #12’s AVF access for the presence of bruit. During an interview on 12/3/24 at 11:30 A.M., CCHT #5 said he knew the patient well, and that Patient #12’s AVF access was not new and did not feel he needed to listen for the bruit.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 38141 Based on record review, interview, and policy review, the facility failed to ensure the Interdisciplinary Team (IDT) periodically reviewed and revised the written, individualized Plan of Care (POC) that includes services to address the patient’s needs and changes in the patient’s condition for 1 of 10 patient’s (#2) records reviewed, out of a total sample of 14 patients. Findings include: Review of the facility policy titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, with a revised date of October 2024, indicated the following: *The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. *The care plan will address, but not limited to, the following: -Psychosocial status which addresses necessary monitoring and social work interventions. Included are counseling and referrals for other social services to assess patients in achieving and sustaining an appropriate psychosocial status as measured by standardized quality of life tool. For Patient #2, the facility failed to develop and implement a plan of care to address Patient #2’s psychosocial needs. Patient #2 was admitted to the facility in January 2018 with diagnoses including End Stage Renal Disease (ESRD). Review of Social Worker (SW) progress noted indicated the following: -On 9/27/24, Patient #2 requested to meet with the SW. Patient #2 reported that he/she has been “hearing voices in my head”. Patient #2 stated that the voices are often saying negative things such as “how much time do you have on dialysis”. Patient #2 stated the voices do not tell him/her to hurt himself/herself and that he/she is not in danger of hurting himself/herself or others. Patient #2 stated that the voices “come and go” and he/she wants help in dealing with them. -On 10/7/24, Patient #2’s sister is actively searching for a primary care physician and will make an appointment. SW will continue to meet with Patient #2 to provide support. -On 10/15/24, SW contacted Patient #2’s sister to invite her and Patient #2 to a care plan meeting being held on 10/29/24 with the clinical team to discuss Patient #2’s recent reports of hearing voices. Review of Patient #2’s Plan of Care, dated 11/4/24, indicated the following problem list. *Adequacy *Anemia *Fluid Management *Mineral/Bone Disorder *Nutrition During an interview on 12/4/24 at 9:15 A.M., the SW said that Patient #2 told her about hearing voices about his/her dialysis treatment. SW said the voices did not tell him/her to hurt/harm himself/herself, or others. SW said that Patient #2 lives with his/her brother and sister and that Patient #2 does not have a primary care physician (PCP) and is in the process of looking for one. SW said that Patient #2 need to see a PCP first to be evaluated by a psychiatrist. SW said that Patient #2’s sister told her that she found a PCP, but Patient #2 refused to go. SW said that she discussed/offered a therapist that Patient #2 could see, but he/she refused. SW said she met with Patient #2 for weekly counseling as her plan/intervention since he/she refused to see a PCP or a therapist, however failed to document these meetings in the clinical record. SW said that she should have updated the care plan, and should have documented the plan and interventions. During an interview on 12/5/24 at 8:45 A.M., the Facility Administrator said she was aware of Patient #2’s concerns of hearing voice. She said it was discussed at the IDT meetings and the SW should have updated the plan of care, and the weekly meeting should have been documented.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 10249 Based on review of the Quality Assessment Performance Improvement (QAPI)Program (referred to by the center as the Facility Health Meeting (FHM) Comprehensive Report Summary), staff interviews, and policy review, the facility failed to ensure monthly infection control audits were conducted at Dialysis Den #2 to be consistently measured, analyzed, and a plan was developed based on results of these monthly reports. Findings Include: Review of the facility policy titled, Continuous Quality Improvement Program, revised April 2021, indicated the following, but is not limited to: PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. *The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: - Infection Control including: Incidence of infections *Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for under performance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review of the FHM Comprehensive Report Summary from 7/2024 through 11/2024 indicated that monthly infection control visual audits were not completed for 4 of 4 months at Dialysis Den #2, therefore staff were unable to track, trend, or analyze within the FHM committee. During the survey conducted at Dialysis Den #2 on 12/3/24, the surveyors observed infection control breaches which included: * Staff failed to consistently perform hand hygiene. * Staff failed to don/doff appropriate personal protective equipment (PPE). * Staff failed to remove potentially contaminated personal protective equipment (PPE) (gowns). * Staff failed to adequately clean and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination with blood borne pathogens. * Staff failed to ensure timely administration of hepatitis B vaccine series for 1 susceptible patients. * Staff failed to implement adequate infection control practices during exit site care for a patient with a Central Venous Catheter (CVC). During an interview on 12/4/24 at 3:30 P.M., the Facility Administrator (FA) said there are no monthly infection control audits completed at Dialysis Den #2 due to staffing, therefore could not be reviewed during QAPI. She further said that currently there are no permanent nurses, only airlift staff or floats. During an interview on 12/5/24 at 9:55 A.M., via telephone, The Regional Operations Manager (ROM) said they do not track or conduct monthly infection control audits at Dialysis Den #2 because they have not had a full time nurse to complete the audits. The ROM further said the launch date of the den was 7/26/24 and she took over in August 2024. During an interview on 12/5/24 at 10:15 A.M., the Regional Facility Administrator said that she started in October 2024 and had a FHM meeting in November 2024. She said moving forward she will be responsible to monitoring the quality assurance program at Dialysis Den #2, but will not be conducting the monthly visual infection control audits because she said she is not a nurse. During an interview on 12/10/24 at 10:55 A.M., via telephone, the Medical Director for Dialysis Den #2 said they do have FHM monthly meetings to discuss many triggers/indicators for a dialysis unit, however they do not discuss infection control. He also said a nurse does not attend the meetings because there is a lack of continuity of nurses at the den.”

“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: 10249 Based on document review, staff interviews, and policy review, the facility failed to ensure there was communication of quality assurance data between the Center (Company) and the Long Term Care Facility to ensure incorporation of the renal dialysis services provided to home hemodialysis (HHD) patients into the Center’s Quality Assessment and Performance Improvement (QAPI) program (referred to by the center as the Facility Health Meeting (FHM) Comprehensive Report Summary). Findings include: -Review of the Agreement between the Center and the Long Term Care Facility, with a commencement date of July 26, 2024, indicated the following, but not limited to: *Company and Long Term Care Facility will communicate to ensure incorporation of the renal dialysis services provided to HHD Residents into the Center’s Quality Assessment and Performance Improvement (“QAPI”) program. The QAPI program will include at least: 1) monitoring HHD Resident outcomes in clinical areas; 2) technical operations; 3) Company testing of water and dialysate quality; and 4) adverse events. Company and Long Term Care Facility will ensure the immediate reporting of any unexpected/adverse events during dialysis to the HHD Resident, his or her Nephrologist, NF (nursing facility) staff, and their responsible party. -Review of the In center policy titled, Continuous Quality Improvement Program, dated April 2021, indicated the following but is not limited to: PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. *Each Dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: Facility Medical Director, Facility Administrator (FA), Registered nurse, Biomed Technician, Registered Dietitian, Social Worker. *The Facility Administrators conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions of Coverage) with the CQI committee to review issues and indicators regarding facility;s management and performance. FHMs are conducted monthly. Written documentation and plans of action will be documented within the FHM application known as the Facility Health Records and will be maintained in a confidential manner. Copies of the QI meetings minutes will be provided upon request to CMS. *The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Patient Safety, including - Review of sentinel events - Review of trends of adverse patient occurrences including falls and blood loss - Review of product, equipment, or medication notices or recalls - Infection Control, including - Incidence of infections - Vaccination rates for Hepatitis B, Influenza, and Pneumococcal - Adequacy of Dialysis (Kt/V) - Nutritional Status (Albumin) - Mineral Metabolism and Renal Bone Disease - Anemia Management - Vascular Access - Growth and Capacity - Mortality - review of deaths - Hospitalizations and Emergency Ambulance Transfers - Patient Satisfaction and Grievances, including KDQOL - Other indicators as reflected in the Facility Health Record application *Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for under performance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review of the FHM Comprehensive Report Summary from 7/2024 through 11/2024 for Dialysis Den #2 indicated that the Medical Director, the Social Worker and the Dietician met. There was no evidence of communication with the Center Facility Administrator or the Long Term Care Facility. During an interview on 12/4/24 at 3:30 P.M., The Center Facility Administrator (FA) said she is not invited to Dialysis Den #2’s FHM Meeting and no FHM information from Dialysis Den #2 is brought to the monthly FHM meetings at the center. During an interview on 12/5/24 at 9:55 A.M., the Regional Operation Manager (ROM) said the launch date for opening Dialysis Den #2 was July 2024 and she took over in August 2024. She said she checks in weekly with the Center FA about day to day activities of the den, however the information from the FHM is not provided to the Center FA to be incorporated in the Center’s QAPI. During an interview on 12/5/24 at 10:15 A.M., the Regional FA said she took over QAPI in November at Dialysis Den #2, but has not provided the Center FA or Long Term Care Facility with any QAPI information. During an interview on 12/10/24 at 10:55 A.M. via telephone, the Medical Director of Dialysis Den #2 said they have FHM monthly meetings, and the last one was held 11/26/24, however he was not sure if the QAPI data was provided to the Facility Administrator or Long Term Care Facility and incorporated into the Center’s QAPI program.”

“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: 10249 Based on observation, interview, record review, and policy review, the Medical Director failed to ensure that 1.) 1 of 1 staff (Certified Clinical Hemodialysis Technician [CCHT] #8) observed at Dialysis Den #2, administering heparin (a blood thinner used to minimize blood loss due to clotting of the dialysis system during treatment), followed the facility policy related to heparin administration and waited 3-5 minutes after administration to initiate dialysis treatment; 2.) 1 of 1 staff member (CCHT #8) observed at Dialysis Den #2, followed the policy related to CVC initiation and notified the RN/physician when reversing treatment lines for 1 patient (Patient #11); and 3.) 1 of 1 staff member observed administering medications at Dialysis Den #1 (Registered Nurse (RN) #7) followed the facility policy related to labeling medications that are not administered immediately after preparation. Findings include: 1. The Medical Director failed to ensure that CCHT #8 followed the facility policy related to heparin administration and waited 3-5 minutes after administration to initiate dialysis treatment. Review of the facility policy titled, Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure, last revised October 2024, indicated the following, but not limited to: *Attach heparin loading dose to venous limb, as applicable. Unclamp and gently flush back and forth 3-5 times into catheter. Reclamp. *After a minimum of 3-5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate bloodlines tips or catheter. Review of the facility policy titled, Anticoagulation, last revised September 2024, indicated the following, but not limited to: *To anticoagulant the patient, the initial loading dose of heparin is administered through the venous fistula needle, or venous port of the CVC at least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment. For Patient #11, the Medical Director failed to ensure CCHT #8 followed the facility policy related to heparin administration and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated that Patient #11 had a physician’s order to administer a heparin bolus of 3000 units, every dialysis treatment. During an observation at Dialysis Den #2, on 12/3/24 at 12:30 P.M., the surveyor observed CCHT #8 initiate dialysis treatment for Patient #11 through a CVC. CCHT #8 was observed to administer a heparin bolus at 12:48 P.M., then initiate treatment at 12:50 P.M.. She did not wait 3-5 minutes, per the facility policy. During an interview on 12/3/24 at 12:55 P.M., CCHT #8 said she usually waits 3-5 minutes before starting the treatment. She said the policy says to wait 3-5 minutes. 2. The Medical Director failed to ensure that CCHT #8 follow the policy related to CVC initiation and notified the RN/physician when reversing treatment lines for Patient #11. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2024, included the following: *Attach sterile 10 ml syringes to the arterial and venous limbs. *Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. Proceed to step 20 if both limbs are patent. If they are not patent, proceed with step 19. *If unable to aspirate from either arterial or venous limb, attach a 10 ml saline filled syringe to affected limb and gently infuse saline. Re-attempt to aspirate. If able to infuse saline into arterial limb but unable to aspirate, check venous limb for patency. If venous limb is patent, use venous limb for arterial source for this one treatment only. Notify the RN/physician of access insufficiency. If unable to infuse or aspirate from arterial limb, check venous limb, check venous limb for patency, DO NOT use catheter. Notify RN/physician. On 12/3/24 at 12:30 P.M. at Dialysis Den #2, the surveyor observed CCHT #8 initiate dialysis treatment or Patient #11 via a CVC. CCHT #8 was observed to complete the disinfection process, administer a heparin bolus, then immediately connect the bloodlines in reverse and start the treatment. CCHT #8 failed to notify the nurse prior to treatment to evaluate the patient prior to reversing the bloodlines. During an interview on 12/3/24 at 12:55 P.M., CCHT #8 said that Patient #11 recently had their CVC replaced. CCHT #8 also said the patient does not have an order to reverse the lines, but if she didn’t reverse the lines the alarm goes off on the dialysis machine. 37349 3. The Medical Director failed to ensure that RN #7, followed the facility policy related to labeling medications that are not administered immediately after preparation. Review of the facility policy, titled Medication Policy, revised October 2023, included the following: * If medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of the medication, date, time prepared, dose, and initials of teammate preparing the medication. During the flash tour of Dialysis Den #1 on 12/4/24 at 8:40 AM., the surveyor observed a syringe in the medication preparation area labeled with patient name, name of the medication and dose of the medication. The label failed to include the date, time prepared and initials of the teammate who had prepared the medication. On 12/4/24 at 12:11 P.M., the surveyor observed RN #7 administer the medication to a patient. During an interview on 12/4/24 at 12:20 P.M., RN #7 said she prepared the medication during the first shift, and that the medication was good for 4 hours after preparation. She was not sure of the time, but estimated it to be somewhere around 9:00 A.M. During an interview on 12/4/24 at 1:25 P.M., the Senior Regional Operations Manager said that medication labels should include the initials of the staff member, date and time of preparation, if not administered immediately after preparation.”

“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: 10249 Based on record review, review of the Governing Body bylaws and minutes, policy review, and staff interview, the facility’s Governing Body (GB) failed to ensure the enforcement of rules and regulations relative to its own governance, and to health care and safety of patients, by failing to ensure there was communication of quality assurance data between the Center (Company) and the Long Term Care Facility to ensure incorporation of the renal dialysis services provided to home hemodialysis (HHD) residents into the Center’s Quality Assessment and Performance Improvement (QAPI) program. Findings include: -Review of the Governing Body Bylaws, adopted October 4, 2019, included the following: * The GB shall have the following members: Facility Administrator, Regional Operations Director, Facility Medical Director and if neither the Facility Administrator or Regional Operations Director is a licensed nurse, then the licensed nurse responsible for overseeing nursing services at the Facility shall be a fourth member of the committee. * The GB shall maintain responsibility for the governance and operation of the facility. * The GB shall designate a Chairperson of the Quality Improvement Committee who shall work in cooperation with the GB to implement all quality improvement plans. -Review of the Agreement between the Center (Company) and the Long Term Care Facility, with a commencement date of July 26, 2024, indicated the following, but not limited to: *Company and Long Term Care Facility will maintain communication regarding the safety and cleanliness of the nursing home dialysis environment and resolutions of any related issues. Company and Long Term Care Facility will communicate to provide safe and sanitary environment for dialysis including communications on: infection control practices, room types specifics (isolation/roommate selection), monitoring/mitigating hazards, prohibiting intrusions into dialysis environment during treatment, cleaning and disinfecting all dialysis equipment and usable supplies, and protecting the personal dialysis equipment supplies of the HHD Resident from unauthorized access. *Company and Long Term Care Facility will communicate to ensure incorporation of the renal dialysis services provided to HHD residents into the Center’s Quality Assessment and Performance Improvement (QAPI) program. The QAPI program will include at least: 1) monitoring HHD Resident outcomes in clinical areas; 2) technical operations; 3) Company testing of water and dialysate quality; and 4) adverse events. Company and Long Term Care Facility will ensure the immediate reporting of any unexpected/adverse events during dialysis to the HHD Resident, his or her Nephrologist, NF (nursing facility) staff, and their responsible party. Review of the governing body minutes, dated July 1, 2024 through November 21, 2024, indicated there was no documented discussion of Dialysis Den #2 after July 26, 2024, other than it’s hour of operation. During an interview on 12/4/24 at 3:30 P.M., The Center Facility Administrator (FA) said she is not invited to Dialysis Den #2’s Facility Health Meeting (FHM) and no FHM information from Dialysis Den #2 is brought to the monthly FHM meetings at the center. As a result of this survey it was determined that the Conditions of Infection Control and Quality Assurance Performance Improvement were not met.”