Fresenius Medical Care Southwest Houston Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48020 Based on observation and interview: the facility failed to maintain a sanitary environment as evidenced by: dust collection and residue on the clean supply carts, bleach carts, emergency evacuation carts in the treatment areas B) black buildup on light covers and vents in the conference room, lobby and staff lounge C) dead insects in the light covers throughout the facility and on the water room floor D) peeling paint and exposed sheetrock on the walls in the treatment area E) debris and dust lint piles on the floor in the storage and water rooms Cross Reference V111 Based on observation, interview and record review: the facility’s direct care staff failed to perform hand hygiene after removal of contaminated gloves per the facility’s policy in 2 of 7 staff observed: Registered Nurse (C), Patient Care Technician (B) B) the facility’s direct care staff failed to change gloves and perform hand hygiene after touching the biohazard waste receptacle and a bleach towel on the floor in 1 of 7 staff observed: Licensed Vocational Nurse (H) Cross Reference V113 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by: storing dirty biohazard and trash receptacles near patient wheelchairs and clean bleach carts B) removing their face shields and placing them on the clean supply carts in 1 of 7 staff observed: Patient Care Technician (B) C) setting up the hemodialysis machine while the rest of the station was being disinfected in 2 of 7 staff observed: Patient Care Technician (F) and Registered Nurse (G) D) cleaning and disinfecting the hemodialysis station after touching the biohazard waste lid and picking up clean bleach towels from the floor in 1 of 7 staff observed: Licensed Vocational Nurse (H) Cross Reference V117 Based on observation, interview and record review: the facility’s direct care staff failed to: clean and disinfect the blood pressure cuff holders, hand sanitizer/holders, tv and attached arms, back of hemodialysis machines, dialysate lines, chase counter tops and walls, and wall boxes in 4 of 7 staff observed: Patient Care Technician (B), (E), (F), Licensed Vocational Nurse (H) B) the facility’s direct care staff failed to clean and disinfect the plastic hemostat clamps according to policy C) the facility failed to ensure that infection control was maintained as evidenced by hemodialysis chairs with tape and tape residue in 22 of 28 chairs D) the facility failed to ensure that infection control was maintained as evidenced by hemodialysis chairs with tears in the vinyl in 1 of 28 chairs ready for use Cross Reference V122”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility failed to ensure patient’s nephrologist round and assess patient’s every two weeks in 3 of 23 sampled and closed record patients: Patient #s 1, 4, 12 Findings: Patient #1 Observation on 02/25/2025 at 7:26 a.m. revealed Patient #1 was seated at station #5 machine #0-7 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of a600 mL/min via left upper arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 02/26/2025 revealed physician the most current progress note was dated 1/28/2025. The physician also documented a visit while the patient was on hemodialysis on 09/03/2024, 09/28/2024, 10/01/2024, 10/29/2025, 11/05/2024, 11/19/2024, 12/03/2024 and 01/04/2025. There was no documented physician progress note every two weeks as required by the state regulations. Patient #4 Observation on 02/25/2025 at 8:14 a.m. revealed Patient #4 was seated at station #21 machine #22 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via left lower arm vascular access The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 02/26/2025 revealed physician the most current progress note was dated 1/28/2025. The physician also documented a visit while the patient was on hemodialysis on 09/03/2024, 09/28/2024, 10/01/2024, 11/05/2024, 11/19/2024, 12/03/2024 and 01/04/2025. There was no documented physician progress note every two weeks as required by the state regulations. Patient #12 Observation on 02/26/2025 at 8:51 a.m. revealed Patient #12 was seated at station #1 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via left upper arm vascular access The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 02/26/2025 revealed physician the most current progress note was dated 02/21/2025. The physician also documented a visit while the patient was on hemodialysis on 09/02/2024, 09/04/2024, 10/02/2024, 11/16/2024, 12/11/2024, 01/10/2024 and 02/05/2025. There was no documented physician progress note every two weeks as required by the state regulations. Interview during record review with Clinical Coordinator (A) and Clinical Manager (N) on 02/27/2025 at 2:57 p.m. confirmed the above findings.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48020 Based on observation and interview: the facility failed to maintain a sanitary environment as evidenced by: dust collection and residue on the clean supply carts, bleach carts, emergency evacuation carts in the treatment areas B) black buildup on light covers and vents in the conference room, lobby and staff lounge C) dead insects in the light covers throughout the facility and on the water room floor D) peeling paint and exposed sheetrock on the walls in the treatment area E) debris and dust lint piles on the floor in the storage and water rooms Findings: Review of the facility’s current policy and procedure: General Cleanliness and Infection Control Guidelines, reference # 47685 directs the staff as follows: Definitions Decontamination - The use of physical or chemical means to remove, inactive, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. Policy “ All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices ... “ Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection ... Observation of the treatment area on 02/25/2025 at 7:24 a.m. revealed the following: Treatment Area: Near Station #6: - Clean supply cart- top of the cart was dusty but had clean supplies sitting on it. There was a used 2x2 gauze sitting on the edge of the partially opened drawer near the bottom of the cart. - Countertops- paint was peeling and the sheetrock was exposed on the wall area where the countertops connect to the walls (near the fire door) leading to ineffective surface cleaning in the event of splash or spatter - Cabinets below conductivity meters- had brown residue dripped down the door and drawers Station #s 21 & 27: Paint was peeling and the sheetrock was exposed on the wall above the chase countertop leading to ineffective surface cleaning in the event of splash or spatter 1:10 and 1:100 Bleach solution stations (are considered clean): - Near station #6- countertop had white residue from the bleach solutions - Near station #23 & #27- cart had bleach residue and dust on them Medication Prep Area: - Countertop & upper cabinet door- had dirty residue form the medication labels - Evacuation carts- both had white residue on the lids, were dusty and had clear liquid, medication vial caps, IV bag rubber stoppers and dirt on the floor behind them - Floor- had a dirty, brown build underneath the cabinets - Trash receptacles and rollers- were dirty on the trash receptacle and dusty on the rollers Laboratory Area: - Refrigerator- had visible dust collecting on the top of it Light covers & vents: Black buildup on light covers and vents - Conference Room- 2nd & 3rd light covers and vent above the table - Lobby- light covers near the vents above the windows - Staff Lounge- middle light cover above table Dead insects in light covers - Conference Room- light as you enter the door - Lobby- light above the vending machine - Staff Lounge- light as you enter the door - Staff Restroom (female)- both lights - Treatment Area- lights along the perimeter above the hemodialysis treatment stations Storage Room: - Storage rack near the door- had visible dust on the supplies on the top shelf - Floor- had debris on the floor throughout and dirty lint piles behind the door and underneath the storage rack as you enter the door Water Room: - Bicarbonate tank- had a pen, dirty lint piles on the floor near the floor drain and on the drain cover - Near water softener and work carbon tank - had a dead insect on the floor between the water softener and worker carbon tank Walkthrough and interview on 02/25/2025 starting at 9:13 a.m. with Director of Operations (Q) confirmed the findings above.”

“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: 48020 Based on observation, interview and record review: the facility’s direct care staff failed to perform hand hygiene after removal of contaminated gloves per the facility’s policy in 2 of 7 staff observed: Registered Nurse (C), Patient Care Technician (B) B) the facility’s direct care staff failed to change gloves and perform hand hygiene after touching the biohazard waste receptacle and a bleach towel on the floor in 1 of 7 staff observed: Licensed Vocational Nurse (H) Findings: Review of the facility’s current policy and procedure: Hand Hygiene: published 11/06/2023, reference # 47664, directs the staff as follows: “Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water “ Entering and leaving the treatment area ... “ Immediately after removing gloves ... “ After contact with inanimate objects near the patient “ When moving from a contaminated body site to a clean body site of the same patient “ After contact with the dialysis wall box, concentrate, drain, or water lines “ After contact with other objects within the patient station or treatment space Hand hygiene after glove removal: Registered Nurse (C) Observation on 02/25/2025 at 10:25 a.m., revealed Registered Nurse (C) was standing at the clean supply cart in the center of the bay. Registered Nurse (C) removed her face shield and immediately put it back on her head. Registered Nurse (C) then reached into a box of clean gloves that was sitting on the clean supply cart, donned the gloves and walked over to the patient at station #19 to listen to his lungs with her stethoscope. Registered Nurse (C) failed to perform hand hygiene after touching her face shield and before reaching into a box of clean gloves. Subsequent observation at 11:04 a.m. revealed Registered Nurse (C) to adjust her face shield and reach into a box of clean gloves that was sitting on the clean supply cart, donned the gloves and rolled a patient in a wheelchair to station #6. Registered Nurse (C) failed to perform hand hygiene after touching her face shield and before reaching into a box of clean gloves. The Surveyor immediately notified Registered Nurse (C) that she failed to perform hand hygiene after touching her face shield and before reaching into a box of clean gloves. Registered Nurse (C) said, “Okay, sorry.” Patient Care Technician (B) Observation on 02/25/2025 at 10:40 a.m., revealed Patient Care Technician (B) was standing at the clean supply cart in the center of the bay. Patient Care Technician (B) removed her face shield, and laid it on the clean supply cart before putting it back on her head. Patient Care Technician (B) then reached into a box of clean gloves that was sitting on the clean supply cart, donned the gloves and walked over to hemodialysis machine at station #19 and began typing on the attached keyboard. Patient Care Technician (B) failed to perform hand hygiene after touching her face shield and before reaching into a box of clean gloves. The Surveyor immediately notified Patient Care Technician (B) that she failed to perform hand hygiene after touching her face shield and before reaching into a box of clean gloves. Patient Care Technician (B) said, “Okay.” Glove change and hand hygiene: Licensed Vocational Nurse (H) Station #23 Observation on 02/26/2025 at 10:39 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #23 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) disinfected the hemodialysis machine with a bleach towel, walked over to the biohazard waste receptacle, lifted the lid and threw the used bleach towel in the biohazard. Licensed Vocational Nurse (H) returned to station #23, picked up a clean bleach towel and began cleaning the hemodialysis chair. Licensed Vocational Nurse (H) repeatedly went to the biohazard waste receptacle and lifted the lid to throw away each towel that she used to clean station #23. Licensed Vocational Nurse (H) failed to remove her gloves and perform hand hygiene each time she touched the contaminated lid of the biohazard waste receptacle. Station #13 Observation on 02/26/2025 at 10:50 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #13 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) dropped a bleach towel on the floor, picked it up and threw it in the trash receptacle. Licensed Vocational Nurse (H) returned to station #13 picked up a clean bleach towel that was on top of the hemodialysis machine and began cleaning it. Licensed Vocational Nurse (H) failed to remove her gloves and perform hand hygiene after picking up the contaminated bleach towel from the floor. The Surveyor immediately notified Licensed Vocational Nurse (H) that she failed to remove her gloves and perform hand hygiene: each time she touched the contaminated lid of the biohazard waste receptacle at station #23 and after picking up the contaminated bleach towel from the floor at station #13. Licensed Vocational Nurse (H) said, “Okay.””

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by: storing dirty biohazard and trash receptacles near patient wheelchairs and clean bleach carts B) removing their face shields and placing them on the clean supply carts in 1 of 7 staff observed: Patient Care Technician (B) C) setting up the hemodialysis machine while the rest of the station was being disinfected in 2 of 7 staff observed: Patient Care Technician (F) and Registered Nurse (G) D) touching the biohazard waste lid and using the same gloves to pick up clean bleach towels to disinfect the hemodialysis station in 1 of 7 staff observed: Licensed Vocational Nurse (H) Findings: Review of facility’s current policy and procedure: Cleaning and Disinfecting the Dialysis Station, reference # 47806 directs staff as follows: “Vacating the Machine To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection the station and set up for the next patient.” Treatment Area: Observation of the treatment area on 02/25 /2025 at 7:24 a.m. revealed the following: 1:10 and 1:100 Bleach solution stations (are considered clean): - Near station #6- counter has an opened package of white towels sitting on the white residue from the bleach solutions. - Near station #23- cart had a biohazard waste receptacle near the front of the cart and a gray trash receptacle near the right side of the cart. There was no separation of clean bleach cart vs dirty biohazard and waste receptacles. - Near station #27- cart had a gray trash receptacle near the left side of the cart and a patient’s wheelchair stored on the other side of the waste receptacle. There was no separation of clean bleach cart and patient’s wheelchair vs dirty waste receptacle. Walkthrough and interview on 02/25/2025 starting at 9:13 a.m. with Director of Operations (Q) confirmed the findings above. Patient Care Technician (B) Observation on 02/25/2025 at 10:40 a.m., revealed Patient Care Technician (B) was standing at the clean supply cart in the center of the bay. Patient Care Technician (B) removed her face shield and laid it on the clean supply cart before putting it back on her head. The Surveyor immediately notified Patient Care Technician (B) that she failed to prevent cross contamination by removing their face shields and placing them on the clean supply cart. Patient Care Technician (B) said, “Okay.” Patient Care Technician (F) and Registered Nurse (G) Station #2 Observation on 02/26/2025 at 10:20 a.m. revealed Patient Care Technician (F) terminally cleaning station #2 post hemodialysis treatment of a patient. Patient Care Technician (F) cleaned the hemodialysis machine and left clean bleach towels sitting in the hemodialysis chair before walking over to another station to assist a patient. After Patient Care Technician (F) finished assisting the patient, she walked to the clean supply cart in the center of the bay to speak to Registered Nurse (G). During their conversation, Patient Care Technician (F) pointed her finger towards station #2 and Registered Nurse (G) picked up clean bloodlines and dialyzer from the clean supply cart, walked over to station #2 and began to set up the hemodialysis machine. Patient Care Technician (F) soon followed and began to clean and disinfect the hemodialysis chair while Registered Nurse (G) was setting up the hemodialysis machine. Patient Care Technician (F) and Registered Nurse (G) failed to prevent cross contamination by setting up the dialysis machine for the next patient during the cleaning and disinfection of the station. The Surveyor immediately notified Patient Care Technician (F) and Registered Nurse (G) that they failed to prevent cross contamination by setting up the hemodialysis machine while the station was being disinfected. Patient Care Technician (F) said, “Yes ma’am” and Registered Nurse (G) said, “You’re right.” Licensed Vocational Nurse (H) Station #23 Observation on 02/26/2025 at 10:39 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #23 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) disinfected the hemodialysis machine with a bleach towel, walked over to the biohazard waste receptacle, lifted the lid and threw the used bleach towel in the biohazard. Licensed Vocational Nurse (H) returned to station #23, picked up a clean bleach towel and began cleaning the hemodialysis chair. Licensed Vocational Nurse (H) repeatedly went to the biohazard waste receptacle and lifted the lid to throw away each towel that she used to clean station #23. Licensed Vocational Nurse (H) failed to remove her gloves and perform hand hygiene each time she touched the contaminated lid of the biohazard waste receptacle. Station #13 Observation on 02/26/2025 at 10:50 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #13 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) dropped a bleach towel on the floor, picked it up and threw it in the trash receptacle. Licensed Vocational Nurse (H) returned to station #13 picked up a clean bleach towel that was on top of the hemodialysis machine and began cleaning it. Licensed Vocational Nurse (H) failed to remove her gloves and perform hand hygiene after picking up the contaminated bleach towel from the floor. The Surveyor immediately notified Licensed Vocational Nurse (H) that she failed to remove her gloves and perform hand hygiene: each time she touched the contaminated lid of the biohazard waste receptacle at station #23 and after picking up the contaminated bleach towel from the floor at station #13. Licensed Vocational Nurse (H) said, “Okay.””

“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: 48020 Based on observation, interview and record review: the facility’s direct care staff failed to: clean and disinfect the blood pressure cuff holders, hand sanitizer/holders, tv and attached arms, back of hemodialysis machines, dialysate lines, chase counter tops and walls, and wall boxes in 4 of 7 staff observed: Patient Care Technician (B), (E), (F), Licensed Vocational Nurse (H) B) the facility’s direct care staff failed to clean and disinfect the plastic hemostat clamps according to policy C) the facility failed to ensure that infection control was maintained as evidenced by hemodialysis chairs with tape and tape residue in 22 of 28 chairs D) the facility failed to ensure that infection control was maintained as evidenced by hemodialysis chairs with tears in the vinyl in 1 of 28 chairs ready for use Findings: Review of facility’s current policy and procedure: Cleaning and Disinfecting the Dialysis Station, reference # 47806 directs staff as follows: “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses.” Cleaning Clamps Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution per the Mixing Bleach policy. “ Make sure the items are completely submerged, unclamped, and in open position when placed in the solution. “ Allow items to soak in the solution at least 10 minutes. “ Discard clamp when the metal rivet has visible rust or weakness of the clamp is noted. Review of the facility’s current policy and procedure: Mixing Bleach, reference # 47249, directs the staff as follows: Procedure: Follow the steps below for mixing bleach: 4. Label opaque container with “Bleach Solution”, strength of solution, date and time prepared, and preparer’s initials. Review of the Center for Disease Control (CDC) Dialysis Safety: Dialysis Wall Boxes and Drains states: “ wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections. Wall boxes are part of the immediate patient care environment and are considered contaminated or dirty.” The CDC’s Guidelines for Disinfection and Sterilization in Health-Care Facilities (2008) #2.b.i. strongly recommends the following: “Remove visible organic residue (e.g., residue of blood and tissue) and inorganic salts with cleaning. Use cleaning agents that are capable of removing visible organic and inorganic residues.” Review of the facility’s current policy and procedure: Cleaning and Disinfecting the Dialysis Station: published 09/05/2023 directs the staff as follows: Background The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. Review of the facility’s current policy and procedure: General Cleanliness and Infection Control Guidelines: published 11/04/2024 directs the staff as follows: Definitions Decontamination - The use of physical or chemical means to remove, inactive, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. Policy “ All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices ... “ Facilities must adhere Disinfection of the hemodialysis station: Patient Care Technician (B) Station #7 Observation on 02/25/2025 at 10:33 a.m. revealed Patient Care Technician (B) terminally cleaning station #7 post hemodialysis treatment of a patient. Patient Care Technician (B) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines and chase countertop and wall, and wall box. Station #6 Observation on 02/25/2025 at 10:50 a.m. revealed Patient Care Technician (B) terminally cleaning station #7 post hemodialysis treatment of a patient. Patient Care Technician (B) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines and chase countertop and wall, and wall box. The Surveyor notified Patient Care Technician (B) at 11:00 a.m. that she failed to clean and disinfect the dialysis station per policy at station #s 7 and 6. Patient Care Technician (B) said, “Okay.” Patient Care Technician (E) Station #30 Observation on 02/26/2025 at 10:03 a.m. revealed Patient Care Technician (E) terminally cleaning station #30 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to clean and disinfect the tv and attached arm and the back of the hemodialysis machine. Station #24 Observation on 02/26/2025 at 10:13 a.m. revealed Patient Care Technician (E) terminally cleaning station #24 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to clean and disinfect the blood pressure cuff holder, sanitizer/holder, chase countertop and wall, and wall box. Station #28 Observation on 02/26/2025 at 10:30 a.m. revealed Patient Care Technician (E) terminally cleaning station #28 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines, chase wall and wall box. The Surveyor notified Patient Care Technician (E) at 10:37 a.m. that she failed to clean and disinfect the dialysis station per policy at station #s 30, 24 and 28. Patient Care Technician (E) said, “Okay.” Patient Care Technician (F) Station #1 Observation on 02/26/2025 at 10:08 a.m. revealed Patient Care Technician (F) terminally cleaning station #2 post hemodialysis treatment of a patient. Patient Care Technician (F) failed to clean and disinfect the tv and attached arm. Station #2 Observation on 02/26/2025 at 10:20 a.m. revealed Patient Care Technician (F) terminally cleaning station #2 post hemodialysis treatment of a patient. Patient Care Technician (F) failed to clean and disinfect the tv and attached arm. The Surveyor immediately notified Patient Care Technician (F) that she failed to clean and disinfect the dialysis station per policy at station #s 1 and 2. Patient Care Technician (F) said, “Yes ma’am.” Licensed Vocational Nurse (H) Station #23 Observation on 02/26/2025 at 10:39 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #23 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) failed to clean and disinfect the blood pressure cuff holder, sanitizer/holder, back of the hemodialysis machine, dialysate lines, chase countertop and wall, and wall box. Station #13 Observation on 02/26/2025 at 10:50 a.m. revealed Licensed Vocational Nurse (H) terminally cleaning station #13 post hemodialysis treatment of a patient. Licensed Vocational Nurse (H) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines, chase countertop and wall, and wall box. The Surveyor immediately notified Licensed Vocational Nurse (H) that she failed to clean and disinfect the dialysis station per policy at station #s 23 and 13. Licensed Vocational Nurse (H) said, “Okay.” Disinfection of hemostats: Observation on 02/25/2025 at 7:36 a.m. of the bleach solution station near station #6 revealed a 1:100 bleach bucket with four plastic hemostat clamps soaking in the bleach solution. The bucket had a label with “02/10/2025 8AM SM” on it as the date and time that the bleach was prepared. There was no label with the current date and time the bleach was prepared for the date of 02/25/2025. Tape and tape residue: Observation of the hemodialysis treatment area on 02/25/2025 at 9:07 a.m. revealed the following: 22 Stations #s 1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 13, 15, 16, 21, 22, 23, 24, 25, 26, 27, 28, 29- dirty pieces of tape and tape residue on the tray tables and arms of the hemodialysis chairs. Tape residue compromises the cleanliness of the hemodialysis facility environment, but it also serves as a breeding ground for harmful bacteria and pathogens. 2 clean supply carts- dirty pieces of tape and tape residue on the countertops. Both clean supply carts were located in the center of the 2 of 3 and had clean supplies, medication lock boxes and boxes of gloves on the countertops. Tears in hemodialysis chair: Observation of the hemodialysis treatment area on 02/25/2025 at 10:10 a.m. revealed one hemodialysis chair with tears in the vinyl: Stations #25- hemodialysis chair has a vertical tear in the vinyl of the seat cushion. The vertical tear runs from the back of the seat cushion to the middle and some of the vinyl is missing exposing the material underneath. Walkthrough and interview on 02/25/2025 starting at 9:13 a.m. with Director of Operations (Q) confirmed the findings on the hemostats, tape and tape residue, and the tear in the hemodialysis chair.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview: the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 3 of 23 sampled and closed record patients: Patient #s 2, 4, 5 B) the registered nurses failed to document the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed in 8 of 23 sampled and closed record patients: Patient #s 1, 2, 3, 4, 5, 6, 10, 11 Findings: Review of the facility’s current Policy and Procedure on Pre-Treatment Safety Checks; Policy #47798 directs staff as follows: Policy The clinician initiating treatment must verify the prescribed set up matches the patient: “ Patient’s identity per policy “ Prescription o Dialyzer o Dialysate composition o Dialysate flow rate o Time o Goal set o Needle size o Temperature “ Special attention orders are followed “ Na modeling (SVS) and/or UFR profiling if applicable “ Heparin dose. If a heparin pump is used check to see if it is primed, turned on and set at the proper prescribed infusion rate. “ OLC volume “ Blood pressure and parameters are set Review of the facility’s current Policy and Procedure on Nursing Supervision and Delegation; Policy #45265 directs staff as follows: Policy The registered nurse must evaluate each patient preferably within an hour or according to state requirements to: ... “ Review accuracy and completeness of treatment and patient data “ Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Dialysate Composition Patient #2 Observation on 02/25/2025 at 7:40 a.m. revealed Patient #2 was seated at station #20 machine #0-1 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 800 mL/min via right upper arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Calcium Bath: Review of the patient’s clinical record located in the chairside computer with Patient Care Technician (D) at chairside, revealed a physician’s order dated 01/28/2024 for Calcium 2.5 (mEq/L). Interview during observation with Patient Care Technician (D), the Surveyor informed Patient Care Technician (D) that the dialysate calcium was not set on the hemodialysis machine as prescribed by the physician. Patient Care Technician (D) said, “Okay.” Machine Settings Treatment sheet review: Review of the treatment sheet dated 02/25/2025 revealed the patient’s hemodialysis treatment started at 7:00 a.m. The patient did not receive 40 minutes of the hemodialysis treatment at the prescribed dialysate calcium setting. Dialysate Flow Rate: Review of the patient’s treatment sheet dated 02/22/2025 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Autoflow 1.5 (600 mL/min) on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 800 mL/min and blood flow rate of 300 mL/min from 6:35 a.m. - 11:10 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Review of the patient’s treatment sheet dated 02/20/2025 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Autoflow 1.5 (600 mL/min) on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 800 mL/min and blood flow rate of 300 mL/min from 6:30 a.m. - 9:44 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Review of the patient’s treatment sheet dated 02/18/2025 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Autoflow 1.5 (600 mL/min) on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 800 mL/min and blood flow rate of 300 mL/min from 6:30 a.m. - 11:00 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Blood Flow Rate: Patient #4 Observation on 02/25/2025 at 8:14 a.m. revealed Patient #4 was seated at station #21 machine #22 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via left lower arm vascular access The patient was utilizing an Optiflux 180 non reuse dialyzer. Treatment sheet review: Review of the patient’s treatment sheet dated 02/13/2025 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min on the treatment sheet but received hemodialysis treatment at a blood flow rate of 300 mL/min from 6:30 a.m. - 10:30 a.m. There was no justification documented for the blood flow rate of 300 mL/min. Patient #5 Observation on 02/25/2025 at 8:16 a.m. revealed Patient #5 was seated at station #8 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of a600 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 160 non reuse dialyzer. Treatment sheet review: Review of the patient’s treatment sheet dated 02/18/2025 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min on the treatment sheet but received hemodialysis treatment at a blood flow rate of 300 mL/min from 7:54 a.m. - 11:29 a.m. There was no justification documented for the blood flow rate of 300 mL/min. Interview during record review with Clinical Coordinator (A) and Clinical Manager (N) on 02/27/2025 confirmed that Patient #2 did not receive the hemodialysis treatment at the prescribed dialysate flow rate and Patient #s 4 and 5 did not receive the hemodialysis treatment at the prescribed blood flow rate. Heparin Administration Patient #5 Observation on 02/25/2025 at 8:16 a.m. revealed Patient #5 was seated at station #8 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of a600 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 160 non reuse dialyzer. A syringe was engaged in the heparin pump for administering heparin. Subsequent observation at 8:20 a.m. with Patient Care Technician (B) at the chairside, the Surveyor asked Patient Care Technician (B) to reveal how much Heparin was being administered. Patient Care Technician (B) tapped the Heparin button on the hemodialysis machine and the hemodialysis machine revealed 0.0 units of Heparin had been administered. The Surveyor notified Patient Care Technician (B) that the patient was not being administered heparin. Patient Care Technician (B) said, I forgot to connect the Heparin.” The Surveyor asked Patient Care Technician (B) to reveal the physician’s order for the Heparin and the patient’s treatment time located in the chairside. The order revealed the patient is to be administered Heparin 800 units IVP per hour, turn off pump 60 minutes prior to end of treatment and the treatment time of three hours and thirty minutes which began at 7:41 a.m. The patient did not receive the prescribed Heparin administration for the initial 39 minutes of the hemodialysis treatment. Prescription Verification Patient #1 Observation on 02/25/2025 at 7:26 a.m. revealed Patient #1 was seated at station #5 machine #0-7 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of a600 mL/min via left upper arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 2.5 calcium, 33 bicarbonate, 137 sodium. Treatment sheet review: Review of the treatment sheet dated 02/25/2025 revealed the patient’s hemodialysis treatment started at 5:45 a.m. The registered nurse completed the pre-treatment nursing evaluation at 6:17 a.m. There was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/18/2025 and 02/20/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #2 Observation on 02/25/2025 at 7:40 a.m. revealed Patient #2 was seated at station #20 machine #0-1 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 800 mL/min via right upper arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Treatment sheet review: Review of the treatment sheet dated 02/22/2025 revealed the patient’s hemodialysis treatment started at 6:35 a.m. The registered nurse completed the pre-treatment nursing evaluation at 6:43 a.m. There was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/18/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #3 Observation on 02/25/2025 at 7:57 a.m. revealed Patient #3 was seated at station #27 machine #11 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via right upper arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Treatment sheet review: Review of the treatment sheet dated 02/25/2025 revealed the patient’s hemodialysis treatment started at 6:05 a.m. The registered nurse completed the pre-treatment nursing evaluation at 6:15 a.m. There was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/20/2025 and 02/18/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #4 Observation on 02/25/2025 at 8:14 a.m. revealed Patient #4 was seated at station #21 machine #22 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via left lower arm vascular access The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Review of the treatment sheet dated 02/20/2025 revealed the patient’s hemodialysis treatment started at 6:32 a.m. The registered nurse completed the pre-treatment nursing evaluation at 6:31 a.m. There was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/18/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #5 Observation on 02/25/2025 at 8:16 a.m. revealed Patient #5 was seated at station #8 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of a600 mL/min via left lower arm vascular access. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Treatment sheet review: Review of the treatment sheet dated 02/25/2025 revealed the patient’s hemodialysis treatment started at 7:41 a.m. The registered nurse completed the pre-treatment nursing evaluation at 7:55 a.m. There was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/18/2025 and 02/15/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review on patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #6 Observation on 02/25/2025 at 8:20 a.m. revealed Patient #6 was seated at station #26 machine #17 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and a dialysate flow rate of a700 mL/min via left lower arm vascular access. The dialysate settings were: 2 potassium, 3.5 calcium, 33 bicarbonate, 137 sodium. Treatment sheet review: Review of the treatment sheet dated 02/25/2025 revealed the patient’s hemodialysis treatment started at 7:05 a.m. The registered nurse completed the pre-treatment nursing evaluation at 7:15 a.m. There was no documentation by the registered nurse within an hour on treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #10 Review of the patient’s clinical record on 02/26/2025 revealed the patient was admitted to the facility 06/28/2024 with the diagnoses of end stage renal disease, hypertension, and diabetes without medications, on hemodialysis three times a week. Treatment sheet review: Review of the treatment sheet dated 02/07/2025 revealed the patient’s hemodialysis treatment started at 12:11 p.m. The registered nurse completed the pre-treatment nursing evaluation at 12:21 p.m. There was no documentation by the registered nurse within an hour on treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #11 Review of the patient’s clinical record on 02/26/2025 revealed the patient was admitted to the facility 07/24/2023 with the diagnoses of end stage renal disease and hypertension, on hemodialysis three times a week. Treatment sheet review: Review of the treatment sheet dated 02/24/2025 revealed the patient’s hemodialysis treatment started at 16:26 p.m. The registered nurse completed the pre-treatment nursing evaluation at 16:24 p.m. There was no documentation by the registered nurse within an hour on treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Review of the treatment sheet dated 02/19/2025 and 02/14/2025 revealed there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Interview during record review with Clinical Coordinator (A) and Clinical Manager (N) on 02/27/2025 confirmed that there was no documentation by the registered nurse within an hour of treatment initiation on the review of patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed on Patient #s 1, 2, 3, 4, 5, 6, 10 and 11.”

“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: 48020 Based on observation, record review and interview: the facility’s registered nurses failed to conduct assessments on admission or when patients experienced a change in condition before or during hemodialysis treatment per the facility’s policy in 2 of 23 sampled and closed patients: Patient #s 6, 10 B) the facility’s governing body failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients per policy. Findings: Review of the facility’s current policy and procedure on Storage of Supplies, published 04/05/2021 directs staff as follows: “Background Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated and damaged. Policy “ Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date.” Review of the facility’s current policy and procedure Expiration Dates Sterile Supplies, published 07/04/2012 directs staff as follows: “Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date.” Review of the facility’s current policy and procedure on Patient Assessment and Monitoring; Policy # 45284 directs staff as follows: o The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. Pre-Treatment Follow the steps below for obtaining pre-treatment assessment data: 2 During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed: Edema (As indicated by patient condition) Assess the patient for edema: “ Location: foot, ankle, lower leg and sacrum. “ Right, Left or Bilateral “ Severity (None, 1+, 2+, 3+ or 4+) Post-Treatment Lungs sounds Edema Heart sounds The registered nurse will assess/re-assess post treatment as indicated. Review of the facility’s current policy and procedure on Nursing Supervision and Delegation: Policy # 45265 directs staff as follows: Non-Delegated Tasks The following tasks that may NOT be delegated: Assessment of patient prior to treatment initiation for patients new to dialysis and receiving their first ever outpatient dialysis treatment (per the Comprehensive Interdisciplinary Assessment and Plan of Care policy) Assessments Patient #6 Observation on 02/25/2025 at 8:20 a.m. revealed Patient #6 was seated at station #26 machine #17 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and a dialysate flow rate of a700 mL/min via left lower arm vascular access. Review of the patient’s clinical record on 02/26/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 02/13/2025 revealed the following documentation: 6:55 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: Bilateral” 10:56 a.m.: registered nurse documented the post treatment assessment which revealed Notes: Pt left stable with no discomfort. Vitals within normal range on discharge. Denies chest pain or discomfort. Goal met. No signs of fluid overload or SOB. Access secured. Lungs clear.” The RN did not document a reassessment of edema found during the pretreatment assessment. Interview during record review with Clinical Coordinator (A) and Clinical Manager (N) on 02/27/2025 at 2:57 p.m. confirmed that Patient #6 did not receive a reassessment by the registered nurse on the edema found pretreatment. Patient #10 Review of the patient’s clinical record on 02/26/2025 revealed the patient was admitted to the facility 06/28/2024 with the diagnoses of end stage renal disease, hypertension, and diabetes without medications, on hemodialysis three times a week. Review of the patient’s clinical record on 02/05/2025 revealed the patient’s first treatment in the facility was on 06/28/20234. The patient’s hemodialysis treatment began at 12:29 a.m. The registered nurse documented the pretreatment assessment at 12:59 which revealed the following note: “New admission came aaox3, denies c/o of N/V/SOB. CVC patent and intact. BP is elevated. Pt is having history of HTN and Diabetic. Denies c/o of N/V/SOB. Vitals within normal range. Pt came below EDW. Goal set as tolerated. Will monitor.” There was no documented assessment of patient prior to treatment initiation. The Surveyor requested the initial assessment on the patient from Director of Operations (Q) on 12/26/2025 at 2:30 p.m. Director of Operations (Q) returned at 2:39 p.m. and stated that the assessment was completed after treatment initiation. Expired Supplies Treatment Area Observation of the hemodialysis treatment area on 02/25/2025 at 11:20 a.m. - 12:24 p.m. revealed the following expired supplies were co-mingled with stocks in use: Emergency cart: 1 - Med Source Yankauer Suction Set, Lot# 1504641, expiration date 2025-02-15 Emergency evacuation box: 1 box - Cardinal Health alcohol prep pads, Lot# 22020127, expiration date 2025-01 Clean supply carts in the center of the bays: Bay 3: 1 - Harmony JMS Safety A.V. Fistula Needle Set 15GX1”, Lot# 19211381, expiration date 2024-02-11 3 - Wing Eater JMS Safety A.V. Fistula Needle Set 14GX1”, Lot# 190913352, expiration date 2024-09-13 Buffer Zone Bay: 1 - Harmony JMS Safety A.V. Fistula Needle Set 15GX1”, Lot# 19211381, expiration date 2024-02-11 4 - Wing Eater JMS Safety A.V. Fistula Needle Set 14GX1”, Lot# 190913352, expiration date 2024-09-13 2 - Suture Removal Kit Tray, Lot# 21DBL130, expiration date 2023-08-31 Isolation Room: 1 - Mesa Labs Standard Buffer Solution 7.00 pH solution, Lot# ML-P7-1801, expiry 2025-01-12 Supply Room Observation of the supply room on 02/25/2025 at 1:02 p.m. revealed the following expired supplies were co-mingled with stocks in use: 5 boxes - BD Vacutainer Safety-Lok Blood Collection Set 50 count, Lot# 1E1821, expiration date 2024-05-31 3 boxes - BD Vacutainer Safety-Lok Blood Collection Set 50 count, Lot# 1F0421, expiration date 2024-06-30 3 boxes - BD Vacutainer Safety-Lok Blood Collection Set 50 count, Lot# 1M3021, expiration date 2024-12-31 Walkthrough and interview on 02/25/2025 starting at 11:20 a.m. with Director of Operations (Q) confirmed the findings above. Peritoneal dialysis training rooms Observation of the peritoneal dialysis training rooms on 02/27/2025 at 9:15 a.m. revealed the following expired supplies were co-mingled with stocks in use: Room near outside door: 3 - BD 3 ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle 20G x1, Lot# 00285530, expiration date 2024-12-31 Room near lobby: 2 - BD 3 ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle 20G x1, Lot# 00285530, expiration date 2024-12-31 Interview with Home Therapy Area Team Lead (T) on 02/27/2025 at 11:34 a.m. verified the above findings.”

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to wash/sanitize hands after removal of contaminated gloves in 1 of 4 staff observed: Patient Care Technician (D) and Patient #7 Findings: Review of the facility’s current policy and procedure: Hand Hygiene: published 11/06/2023, reference number 47664, version 8 directs the staff as follows: “Hand Hygiene Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed.” Patient Care Technician (D) Patient #7 Observation on 07/17/2024 at 10:12 a.m., revealed Patient #7 holding his vascular access with a gloved hand at station #20. After the bleeding ceased, Patient Care Technician (D) taped the patient’s vascular access site and removed the patient’s glove. The patient picked up his blanket and placed it in his bag, he was weighed by Patient Care Technician (D), and he left the treatment floor without washing/sanitizing his hands. The Surveyor notified Patient Care Technician (D) at 10:21 a.m. that the patient did not washed/sanitized his hands after removal of the contaminated glove he used to hold his vascular access site. Patient Care Technician (D) said, “Okay.””

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility failed to document the acid concentrate mixing: temperature and specific gravity, according to policy. Findings: Review of the facility’s policy and procedure on Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit published 09/05/2023 Reference #25910 version 7 directs staff as follows: Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature (in degrees Celsius) followed by a specific gravity test with a comparison of these results to either GranuFlo Dry Acid Table of Specific Gravities or Citrasate Dry Table of Specific Gravities. “ Specific Gravity testing will be performed according to the Dry Acid Specific Gravity Test Procedure located in the manufacturers’ IFU. “ Specific gravity of the batch must be within or equal to, the high and low range of the expected specific gravity values. “ Specific gravity from the DADU will be tested: o Once the mixing process is completed by the operator and verified by a second staff member. o If not immediately transferred a second specific gravity test must be performed immediately prior to transfer by the staff member performing the transfer. “ Specific gravity from the holding tank will be tested: o Following completion of transfer to a holding tank from the DADU. Review of the Facility’s Granuflo Mixing Log (Manufacturer Model: Fresenius - GranuFlo DU1, Serial Number DA132-1000093) on 07/17/2024 revealed the 2nd Test temperature and the 2nd specific gravity measurement was not documented on the following dates: 05/03/2024, 05/13/2024, 05/27/2024, 05/30/2024, 06/18/2024, 06/19/2024, and 06/22/2024. Interview with Biomedical Technician (I) on 07/17/2024 at 05:03 p.m. revealed he confirmed the second temperature, and second specific gravity were not documented for the dates in question.”

“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: 48020 Based on observation, record review and interview, the facility failed to: ensure Diasafe filters attached to 3 of 18 hemodialysis machines observed on the hemodialysis unit, were replaced based on manufacture’s recommendation for use: hemodialysis machine #s 217, 13, and 26 B) ensure accurate records of preventative maintenance based on manufacture’s recommendation for use: hemodialysis machine #s 5T0S138081, 5T0S138184, and 6T0S168799 C) ensure expired supplies are not stored, and in use in the facility for care and services of patients and staff Findings: Review of the manufacture’s direction for use manual, Chapter 6, page 275 of Fresenius 2008 T hemodialysis machine directs users as follows:” The Diasafe plus us filter is intended for the preparation of ultra-pure dialysate. If the machine has a Diasafe Plus us filter it should be replaced at least 90 days. You must also replace the filter if the Diasafe test fails or shows an external leak.” Review of the facility’s policy and procedure on Diasafe Filter Replacement Policy # 47413 published 05/02/2022 directs staff as follows: “The Diasafe plus filters will be replaced in accordance to manufacturer’s IFU.” Review of the manufacture’s Preventative Maintenance Procedures Part # #508033 directs uses as follows: “Preventative maintenance for 2008T Hemodialysis System is simple and straightforward. Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows: “2008T BlueStar Premium Machines 2008T BlueStar Premium machine are equipped with extended life components and can be identified by the 2008T BlueStar logo on the keyboard o Six months o Annually or after 4000 hours of operation o Concentrate (acid), Bicarbonate & UF Pumps with extended life components are rebuilt every 2 years or after 8000 hours of operation.” Review of the Bemis “Expiration Information: Canisters & Liners” revealed: “All Bemis Canisters and Liners include an expiration date on the carton label and individual product. Expiration is three (3) years from the date of manufacture. Canisters and Liners should not be used past the labeled expiration date. Structural integrity can be compromised by factors such as, heat, time, and light exposure. Placing a negative vacuum on a compromised canister/liner can result in product failure.” Hemodialysis machines: Observation on 07/17/2024 of the following Fresenius 2008 T hemodialysis machines revealed Diasafe filters plus in use at the back of the hemodialysis machines. Observation of labels on the Diasafe filters attached to these hemodialysis machines revealed the following: Replaced on 12/14/2023: Fresenius 2008T BlueStar hemodialysis machine #217 located at station #1 Fresenius 2008T BlueStar hemodialysis machine #13 located at station #24 Replaced on 01/30/2024: Fresenius 2008T BlueStar hemodialysis machine #26 located at station #18 Interview on 07/17/2024 at 4:12 p.m. with the Facility’s Area Technical Operations Manager revealed he said the Diasafe filters replacement information is in the clinical side of the computer system instead of the technical side. The Biomedical Technician should look both places including the back of the machine to keep track of when the Diasafe filters should be replaced. Hemodialysis machine serial #5T0S136729 Review of the facility’s equipment record revealed documentation of the following preventative maintenance preformed on hemodialysis machine #5T0S136729: 09/25/2023; Diasafe PM and Internal Transducer Inspection documented performed, machine hours 197,645. 01/18/2024; Diasafe PM and Internal Transducer Inspection documented performed, machine hours 29,201. 04/16/2024; Diasafe PM and Internal Transducer Inspection documented performed, machine hours 30,436. The record revealed the hours on the machine was documented well above the hour range of the subsequent Diasafe PM and Internal Transducer Inspections. Hemodialysis machine serial #5T0S138081 Review of the facility’s preventive maintenance log revealed documentation of the following preventative maintenance preformed on hemodialysis machine #5T0S138081: 10/03/2023; annual preventative maintenance documented performed, machine hours 26,401. 04/02/2024; annual preventative maintenance documented performed, machine hours 21,748. The record revealed the hours on the machine hours decreased over time and both were documented as “annual.” Hemodialysis machine serial #5T0S138184 Review of the facility’s preventive maintenance log revealed documentation of the following preventative maintenance preformed on hemodialysis machine #5T0S138184: 09/12/2023; annual preventative maintenance documented performed, machine hours 28,363. 03/25/2024; annual preventative maintenance documented performed, machine hours 19,233. The record revealed the hours on the machine hours decreased over time and both were documented as “annual.” Hemodialysis machine serial #6T0S168799 Review of the facility’s preventive maintenance log revealed documentation of the following preventative maintenance preformed on hemodialysis machine #6T0S168799: 12/13/2023; annual preventative maintenance documented performed, machine hours 26,155. 06/24/2024; annual preventative maintenance documented performed, machine hours 19,800. The record revealed the hours on the machine hours decreased over time and both were documented as “annual.” Interview on 07/17/2024 at 5:03 p.m. with the Facility’s Biomedical Technician revealed he said, “There is no excuse for it. It is my fault. I am able to go into both sides of the computer but every 90 days.” Regarding preventative maintenance, the Facility’s Biomedical Technician said, “These are clearly documentation errors.” Emergency “crash” cart: Observation on 07/17/2024 at 7:56 a.m. revealed a Bemis Hi Flow 1200 cc Suction Canister attached to the suction machine on top of the emergency “crash” cart expiration date of 12/2018. The Surveyor notified the Clinical Manager of the expired suction canister on the emergency “crash” cart. The Clinical Manager said, “I will replace it.” Supplies: Observation on 07/17/2024 upon entrance of and during a tour of the facility revealed the following expired hand sanitizer bottles in use for patient and staff hand hygiene: Conference Room: Observation of the conference room table revealed the following hand sanitizer: 1 bottle- Aniosgel 85 NPC: Lot #D15920S, expired 05/2024 Treatment Floor Observation of the treatment floor revealed the following hand sanitizer dispensers in use: 1 bottle- Aniosgel 85 NPC: Lot #D15920S, expired 05/2024 on machine #25 station #3 1 bottle- Aniosgel 85 NPC: Lot #D15920S, expired 05/2024 on machine #217 station #1 Observation at on 07/17/2024 at 7:20 a.m. revealed Clinical Coordinator (C) assessing the patient at station #1. Before she left the station, she used the Aniosgel 85 NPC hand sanitizer sitting in the holder on machine #217. The Surveyor immediately notified Clinical Coordinator (C) that the Aniosgel 85 NPC hand sanitizer was expired. Clinical Coordinator (C) said, “Okay, it’s expired?””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 4 of 15 sampled patients and closed records: Patient #s 1, 6, 12 and 15 Findings: Review of the facility’s current Policy and Procedure on Pre-Treatment Safety Checks; Policy #47798, published 02/06/2023 directs staff as follows: Policy The clinician initiating treatment must verify the prescribed set up matches the patient: “ Patient’s identity per policy “ Prescription o Dialyzer o Dialysate composition o Dialysate flow rate o Time o Goal set o Needle size o Temperature “ Special attention orders are followed “ Na modeling (SVS) and/or UFR profiling if applicable “ Heparin dose. If a heparin pump is used check to see if it is primed, turned on and set at the proper prescribed infusion rate. “ OLC volume “ Blood pressure and parameters are set Patient #1 On 07/17/2024 at 7:14 a.m., Patient #1 was seated at station #3 machine #25 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via right central venous catheter. The patient was utilizing an Optiflux 180 non reuse dialyzer. The dialysate settings were: 2 potassium, 2.6 calcium, 33 bicarbonate, 140 sodium. Observation with Patient Care Technician (D) of the patient’s physician’s order located in the chairside computer revealed an order for sodium 137. The Surveyor notified Patient Care Technician (D) of the discrepancy in the dialysate sodium setting. Patient Care Technician (D) stated, “Oh, that’s not right. Do you want me to change it?” Review of the patient’s clinical record revealed a physician’s order dated 05/31/2024 for Sodium (Na) setting: 137 (mEq/L). Patient #6 On 07/17/2024 at 9:25 a.m., Patient #6 was seated at station #27 machine #0-4 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of Autoflow 1.5 (approx. 525) mL/min via left vascular access. A syringe was engaged in the heparin pump administering heparin with approximately 1 mL left in the syringe. Subsequent observation at 9:38 a.m. with Patient Care Technician (G) at the chairside, the Surveyor asked Patient Care Technician (G) to reveal how much Heparin was being administered. Patient Care Technician (G) tapped the Heparin button on the hemodialysis machine and the screen did not respond. At 10:03 Clinical Coordinator (C) who was providing care to another patient, was able to get the screen to work and the hemodialysis machine revealed the patient was administered 1.2 units of Heparin. The Surveyor asked Clinical Coordinator (C) to reveal the physician’s order for the Heparin and the patient’s treatment time located in the chairside. The order revealed the patient is to be administered Heparin 500 units IVP per hour, turn off pump 60 minutes prior to end of treatment and the treatment time of four hours which began at 6:36 a.m. (Heparin pump stop time would be approximately 9:36 a.m.). The Surveyor notified Clinical Coordinator (C) that the patient should have received 1.5 units of Heparin 60 minutes prior to the completion of the hemodialysis treatment. Clinical Coordinator (C) said, “Okay, the pump must have not been set properly.” Review of physician’s order dated 11/24/2023 revealed the prescribed Heparin Sodium (Porcine) 1,000 Units/mL Systemic Infusion (Pump) 500 units IVP per hour, turn pump off 60 minutes prior to end of treatment, 3X Week. Review of the physician’s order dated 05/17/2024 revealed the prescribed treatment time of 4 hours and 0 minutes and a dialysate flow rate of Autoflow 1.5 mL/min. Treatment sheet dated 07/15/2024 Review of the patient’s treatment sheet dated 07/15/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Autoflow 1.5 mL/min but received hemodialysis treatment at a dialysate flow rate of 800 mL/min from 06:39 a.m. - 10:52 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Patient #12 Review of the patient’s clinical record on 07/17/2024 revealed the patient was admitted to the facility 01/23/2019. Review of the physician’s order dated 04/22/2024 revealed the prescribed blood flow rate of 450 mL/min. Treatment sheet dated 07/03/2024 Review of the patient’s treatment sheet dated 07/03/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 450 mL/min but received hemodialysis treatment at a blood flow rate of 400 mL/min from 17:59 p.m. - 21:30 p.m. There was no justification documented for the blood flow rate of 400 mL/min. Interview on 07/17/2024 at 6:04 p.m. with Clinical Coordinator (C) revealed she stated, “The is no explanation. The nurse did not document why the patient ran at 400 blood flow rate.” Patient #15 Review of the patient’s clinical record on 07/17/2024 revealed the patient was admitted to the facility 11/12/2022. Review of the physician’s order dated 12/13/2022 revealed the prescribed dialysate flow rate of Manual 600 mL/min. Treatment sheet dated 12/24/2022 Review of the patient’s treatment sheet dated 12/24/2022 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Manual 600 mL/min but received hemodialysis treatment at a dialysate flow rate of 500 mL/min from 11:11 a.m. - 15:12 p.m. There was no justification documented for the dialysate flow rate of 500 mL/min. Interview on 07/17/2024 at 5:56 p.m. with Clinical Coordinator (C) revealed she stated, “It looks like it was placed on autoflow instead of manual flow.””

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review facility’s registered nurse failed to administer pneumococcal vaccination to patients in 2 of 17 sampled patients and closed records: Patient #’s 9 and 15 Findings: Review of the facility’s current Policy and Procedure on Pneumococcal Vaccine for Adults; Policy #47714, published 02/05/2024 directs staff as follows: Policy “ The Corporate Medical Advisory Board (CMAB) Recommended Evaluation and Immunization Against Pneumococcal Infection Algorithm is recommended to assist the physician with the required vaccines based upon patient vaccination policy. “ Obtain a declination statement for any patient who declines the pneumococcal vaccine. “ Patients should be offered pneumococcal vaccination on an annual basis, at minimum ... “ The vaccine declination must be signed by the patient for each refusal and documented in the patient’s medical record. Vaccination Status: Source of Data “ Review vaccination status of all new patients to the facility. “ Review the following sources for vaccination status: o Medical records o Discharge summaries from the hospital o Correspondence from the primary care physician office o State vaccination registry o Speak with patient and/or family Documentation “ Document vaccine administration in the electronic medical record and maintain the consent or declination. o If the pneumonia vaccine is not administered, document the reason in the electronic medical record.” MRB Recommended Evaluation and Immunization Against Pneumococcal Infection 3.0 General Orders: This algorithm when ordered should be initiated when a patient is admitted to the clinic. “ For patients 19 years of age or older with ESRD “ Document vaccine order and administration in the electronic medical record. Maintain the signed consent or declination in the patient’s medical record. IF: Status is never vaccinated, or vaccination status is unknown THEN administer Prevnar20 (PVC 20) vaccine per policy. No further pneumococcal vaccinations are required. Discontinue algorithm. Patient #9 Review of the patient’s clinical record on 07/17/2024 revealed the patient was admitted to the facility 08/03/2022 with a diagnoses of end stage renal disease, hypertension, and diabetes. The patient’s last hemodialysis treatment was on 07/16/2024. Review of the patient’s clinical record revealed a physician’s order dated 08/03/2022, 08/04/2023, and 08/05/2024 for “CMAB recommended Algorithm for Pneumococcal Immunization- Eval and immunization against Pneumococcal infection V2.0. Every treatment clinic.” There was no evidence of a consent in the patient’s chart or that the patient was offered the pneumococcal vaccination on admission. Review of the patient’s clinical record (Pneumonia Immunization Tracking Assessment Form) revealed the current pneumococcal vaccination status as: “Vaccination Candidate” and the suggested actions are: “Admin PCV20 as ordered on or after 07/17/2024.” There was no documentation the patient was administered the pneumococcal vaccination. Interview with the Area Team Lead at 1:37 p.m.: the Surveyor requested documentation that the patient was offered the pneumococcal vaccination. At 2:54, the Area Team Lead revealed the patient signed a consent for 23-valent pneumococcal polysaccharide vaccine (PPSV23) pneumonia vaccination, but it was dated 07/03/2024. There was no documentation the patient signed a consent for the Prevnar 20 (PCV20) as recommended by the physician ordered algorithm nor was the patient offered the pneumonia vaccination when he was admitted to the clinic on 08/03/2022. Patient #15 Review of the patient’s clinical record on 07/17/2024 revealed the patient was admitted to the facility 11/12/2022 with a diagnoses of end stage renal disease, hypertension, type 2 diabetes, and Parkinson’s. The patient’s last hemodialysis treatment was on 12/24/2023. Review of the patient’s clinical record revealed a physician’s order dated 11/12/2022 for “CMAB recommended Algorithm for Pneumococcal Immunization- Eval and immunization against Pneumococcal infection V2.0. Every treatment clinic.” There was no evidence of a consent in the patient’s chart or that the patient was offered the pneumococcal vaccination on admission. Interview with the Area Team Lead at 2:54 p.m.: the Surveyor requested documentation that the patient was offered the pneumococcal vaccination. There was no documentation provided.”