Dialyze Direct Sugarland

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s governing body failed to ensure expired medications are not stored, and in use in the skilled nursing facilities for care and services of patients. Observation of the hemodialysis treatment area in Facility #4 on 06/26/2025 beginning at 9:30 a.m. revealed the following expired medications were co-mingled with stocks in use: Medication Prep Area 2nd Drawer: 10- BD ChloraPrep Single Swabstick 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Catalog # 260100, Lot # 3151724 expiration 05/25 were located in a box in the 2nd drawer. There were no other swabsticks found in the treatment area. During the observation at 9:45 a.m. Registered Nurse (P) was performing catheter care on Patient #15 before the hemodialysis treatment. Registered Nurse (P) walked over to the Medication Prep Area, grabbed a BD ChloraPrep Single Swabstick from the box in the 2nd drawer of the Medication Prep Area, opened the swabstick and applied the antiseptic to the patient’s central venous catheter exit site. Observation of the hemodialysis treatment area in Facility #3 on 06/25/2025 beginning at 9:18 a.m. revealed the following medications supplies were co-mingled with stocks in use: Medication Prep Area: 6- Hospira Sterile Water for injection, USP 10 mL (for drug diluent use) Lot # GD8137 expiration 01 May 2025 Cross Reference V143 Based on observation, interview and record review, the facility failed to prevent potential contamination risks as evidenced by storing supplies underneath the clean and dirty sinks. Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: brown water spots and peeling paint on the ceiling. B) dust collection and residue on the Heating, Ventilation, and Air Conditioning (HVAC) intake vents. Based on observation, interview and record review, the facility failed to ensure the National Institute for Occupational Safety and Health guidelines and their policy and procedure were followed to maintain a safe environment to minimize and prevent transmission of infectious disease in that 2 of 2 observed sharps containers were observed to be overfilled. Cross Reference V111 & 121 Based on observation, interview and record review, the facility’s direct care staff failed to: clean and disinfect the back of hemodialysis machines, dialysate lines, and wall boxes in 1 of 3 staff observed: Licensed Vocational Nurse (Q) Cross Reference V122”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 48020 Based on record review and interview, facility’s leadership failed to update the Emergency Plan annually as required. Findings: Review of the emergency preparedness binder on 06/23/2025 revealed a Table of Review and Approval form that had the following documentation, “The Emergency Plan (EP) was originally written and approved on 8/30/2023. As of November 15, 2016, it is required by the Centers for Medicare and Medicaid Services (CMS) that the Emergency Plan must be reviewed annually. It should also be reviewed and updated when an event or law indicates that some or all of the EP should be changed.” The Surveyor requested documentation of the approved Emergency Plan for 2024 from Area Manager (A). No documentation was provided.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, facility’s governing body failed to ensure all staff contact information are kept on an updated emergency contact list in 2 of 2 staff observed: Area Manager (A), (B) Based on record review and interview, facility’s governing body failed to maintain physician and staff contact information in the Emergency Evacuation Kit and the Emergency Evacuation Preparedness Binder in 1 of 4 facilities: Facility #2 Findings: On 06/23/2025 - 06/26/2025 during the survey Area Manager (A) and (B) were observed working in their offices and providing records for the survey. Review of the facility’s “Emergency Contact Information” list of staff found in the emergency preparedness binder revealed Area Manager (A) and (B) names and contact information were not included on the list. Area Manager (A) was notified of the missing personnel from the emergency contact list. Area Manager (A) said, “I will get an updated list.” 30124 Review on 06/25/2025 at 11:45 a.m. along with Registered Nurse (F) of the Emergency Evacuation Kit and the Emergency Evacuation Preparedness Binder for Facility #2 failed to have contact information as required for the staff and patients’ physicians. Review of a document titled Emergency Evacuation Kit Check List for Facility #2 documented “Patients’ orders, and MD/Staff contact information may be stored in kit or maintained in the emergency binder/folder. Notation was made on the document that MD contact information and staff contact information was in the emergency binder. Interview on 06/25/2025 with Registered Nurse (F) confirmed the staff and physician contact list should have been in the kit or in the emergency binder, but the information could not be located. No additional information was received prior to exit.”

“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: 30124 Based on observation, record review and interview the facility failed to comply with the requirements of handling and storage of gas and flammable Liquids per the National Fire Protection Association (NFPA) 329, in accordance with NFPA 99, §9.6. Reviewed: As required by the Centers for Medicare & Medicaid Services (CMS), health care facilities must comply with the 2012 edition of the National Fire Protection Association’s NFPA 101®, Life Safety Code®, and the 2012 edition NFPA 99, Health Care Facilities Code. Review of the National Fire Protection Association compliance with NFPA 99, Health Care Facilities Code reads ...A critical aspect of oxygen use, and storage is related to identifying each cylinder as full or empty. In an emergency, it is critical for staff to easily identify which cylinders are full. NFPA 99 section 11.6.5.3 specifically required that empty cylinders be “marked to avoid confusion and delay if a full cylinder is needed in a rapid manner.” This can be accomplished through an integral pressure gauge, individual signage, or separated group signage (for cylinders being stored together). A cylinder is considered “full” provided it still has its seal from the supplier. Once the seal has been removed, the cylinder is no longer considered full and cannot be stored with full cylinders. NFPA 99 requires empty cylinders to be stored separately from full cylinders. Findings: Observation in Facility #1 on 06/23/2025 at 12:20 PM during a tour of the patient treatment area along with the Area Manager (A) the following was observed: Treatment Room #1 1 - oxygen cylinder was observed stored in a rack. The cylinder of oxygen was observed to have the seal removed with an unattached oxygen regulator hang from the oxygen cylinder. Treatment Room #2 1 - oxygen cylinder was observed stored in a rack. The cylinder of oxygen was observed to have the seal removed with an unattached oxygen regulator hang from the oxygen cylinder. Interview on 06/23/2025 at 12:50 PM with Area Manager (A) confirmed the above findings and stated he could not identify if the oxygen cylinders were full or empty.”

“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, interview and record review, the facility failed to prevent potential contamination risks as evidenced by storing supplies underneath the clean and dirty sinks. Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: brown water spots and peeling paint on the ceiling. B) dust collection and residue on the Heating, Ventilation, and Air Conditioning (HVAC) intake vents. Based on observation, interview and record review, the facility failed to ensure the National Institute for Occupational Safety and Health guidelines and their policy and procedure were followed to maintain a safe environment to minimize and prevent transmission of infectious disease in that 2 of 2 observed sharps containers were observed to be overfilled. Findings: Review of the Centers for Disease Control (CDC) Infection Control Guidelines for Disinfection and Sterilization in Healthcare Facilities (2008) reveals the following documentation: “Medical and surgical supplies should not be stored under sinks or in other locations where they can become wet. Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces.” Review on 6/24/2025 of the facility’s current policy and procedure titled “Disposal of Sharps Policy, Procedure”; Reference: #DD-CS-0072, approved Revision 3/31/2017. Purpose: To prevent injury and exposure to bloodborne infections for staff handling sharps including needles, syringes, knife blades and opened ampules of medications. Policy: Sharp containers shall be filled to three quarters filled and taped closed or lidded. NIOSH’s bloodborne pathogens standard establishes minimum design performance elements for sharps disposal containers[29 CFR 1910.1030(dX4XinXA)](2). This states that “during use, containers for contaminated sharps shall be: Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found Maintained upright throughout use; and Replaced routinely and not be allowed to overfill. Ensure containers are filled to recommended capacity prior to removal, but do not overfill. Filling above the file line or more than ¾ full can increase the risk of needlestick injury and bloodborne pathogen exposure. Review of the facility’s current policy titled: “Cleaning the Air Filter on the PureFlow Procedure”, Reference: #DD-EQ-0788; Approved Revision: 3/17/2017. Purpose: The Air Filter on the back of the CU protects the internal components from dust and other debris. Staff will clean or replace if needed every 3 months. Observations: Observation of the treatment area of Facility #3 on 06/25/2025 at 9:57 a.m. revealed the following: Underneath clean sink: - 1 unopened bottle of NIST Traceable Conductivity Standard Solution 7.86 g/l Sodium Chloride (NaCl) for the use with Myron L conductivity meters - 4 bottles of 5% Acetic Acid Solution (2 opened & 2 unopened) used to prevent the build-up bicarbonate precipitate in the dialysate lines of hemodialysis machines Underneath dirty sink: - 1 bottle of bleach - 4 empty disinfectant bottles used to bleach disinfect the hemodialysis machines - 3 rolls of biohazard bags - 1 roll of trash bags - 1 container lid Interview during observation with Registered Nurse (L) confirmed the findings above. Observation of the treatment area of Facility #4 on 06/26/2025 at 9:00 a.m. revealed the following: Brown water spots and peeling paint on the ceiling: - Above hemodialysis station #1 Dust collection and residue on the HVAC intake vents: - Above hemodialysis station #5 - Above the clean sink Interview during observation with Registered Nurse (P) confirmed the findings above. 30124 Observations: Tour of Facility #1 the afternoon of 06/23/2025 along with the Area Manager (A) the following was observed: Treatment Room #1 A biohazard sharps container was observed attached to the wall of the treatment area. Container was observed to have used syringes with needles attached and to be filled over the designated fill line of the container. Laboratory Area: A biohazard sharps container was observed attached to the wall of the laboratory area. Container was observed to have used syringes with needles attached and to be filled over the designated fill line of the container. Interview on 06/23/2025 with Area Manager (A) confirmed the above findings. Observation of the treatment area of Facility #2 on 06/25/2025 at 10:40 a.m. along with Registered Nurse (F) revealed the following: Underneath clean sink: - 3 bottles of Alcavis 50 High-Level Disinfectant Solution - 5 boxes of 3 ml syringes with 21-gauge, 1.5-inch needles (100 per box) - 2 boxes of alcohol prep pads - 3 box 4x4 individual wrapped sterile, 25 count per box - 1 box normal saline 10 ml prefilled syringes Underneath dirty sink: - 2 bottles of bleach - 4 vascular access clamps - 2 rolls of biohazard bags - 4 rolls of clear packaging tape - 1 Box of sterile 1 inch pressure dots 50 per box Interview during observation with Registered Nurse (F) confirmed the findings above. Observation of the treatment area of Facility #2 on 06/25/2025 at 1:00 p.m. along with Registered Nurse (F) revealed the following: Station #1 - Dialysis treatment chair observed with visible torn vinyl fabric on the arm of the chair, approximately 7 inches in length that exposed the foam padding of the chair. Accumulation of dust collection on air filters located on the back of NxStage PureFlow dialysis machine: Station #1 NxStage machine 49814, CU 50067 Station #2 NxStage machine 36138, CU 51660 Station #3 NxStage machine 34203, CU 50787 Interview during observation with Registered Nurse (F) confirmed the findings above. Interview on 6/26/2025 with the Area Manager (A) confirmed it was the responsibility of the Patient Care Technician at Facility #2 to check and clean or replace the filter as needed.”

“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: 30124 Based on observation, interview and record review the facility failed to ensure the National Institute for Occupational Safety and Health guidelines and their policy and procedure were followed to maintain a safe environment to minimize and prevent transmission of infectious disease in that 2 of 2 observed sharps containers were observed to be overfilled. Reviewed: Review on 6/24/2025 of the facility’s current policy and procedure titled “Disposal of Sharps Policy, Procedure”; Reference: #DD-CS-0072, approved Revision 3/31/2017. Purpose: To prevent injury and exposure to bloodborne infections for staff handling sharps including needles, syringes, knife blades and opened ampules of medications. Policy: Sharp containers shall be filled to three quarters filled and taped closed or lidded. NIOSH’s bloodbome pathogens standard establishes minimum design performance elements for sharps disposal containers[29 CFR 1910.1030(dX4XinXA)](2). This states that “during use, containers for contaminated sharps shall be: Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found Maintained upright throughout use; and Replaced routinely and not be allowed to overfill. Ensure containers are filled to recommended capacity prior to removal, but do not overfill. Filling above the file line or more than ¾ full can increase the risk of needlestick injury and bloodborne pathogen exposure. Findings: Tour of Facility #1 the afternoon of 06/23/2025 along with the Area Manager (A) the following was observed: Treatment Room #1 A biohazard sharps container was observed attached to the wall of the treatment area. Container was observed to have used syringes with needles attached and to be filled over the designated fill line of the container. Laboratory Area: A biohazard sharps container was observed attached to the wall of the laboratory area. Container was observed to have used syringes with needles attached and to be filled over the designated fill line of the container. Interview on 06/23/2025 with Area Manager (A) confirmed the above findings.”

“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 back of hemodialysis machines, dialysate lines, and wall boxes in 1 of 3 staff observed: Licensed Vocational Nurse (Q) Findings: Review of facility’s current policy and procedure: Cleaning and disinfection of Medical Devices and Equipment #DD-IC-0071 directs staff as follows: “POLICY “ Environmental surfaces shall be cleaned and disinfected after each patient use and at the end of the day. “ Environmental surfaces to be clean and disinfected include: o Patient chair o Surfaces of dialysis equipment o Adjacent tables and work surfaces” Licensed Vocational Nurse (Q) Station #6 Observation in Facility #3 on 06/25/2025 at 10:45 a.m. revealed Licensed Vocational Nurse (Q) terminally cleaning station #6 post hemodialysis treatment of a patient. Licensed Vocational Nurse (Q) failed to clean and disinfect the tap water and dialysate lines and wall box. Station #4 Observation in Facility #3 on 06/25/2025 at 11:00 a.m. revealed Licensed Vocational Nurse (Q) terminally cleaning station #4 post hemodialysis treatment of a patient. Licensed Vocational Nurse (Q) failed to clean and disinfect the tap water and dialysate lines and wall box. The Surveyor notified Licensed Vocational Nurse (Q) at 11:14 a.m. that she failed to clean and disinfect dialysis station #6 and #4. Licensed Vocational Nurse (Q) said, “Okay.””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s governing body failed to ensure expired medications are not stored, and in use in the facility for care and services of patients. Findings: Review of the Becton Dickinson and Company Certificate of Analysis for the ChloraPrep Single Swabstick Applicators revealed the following documentation: Catalog Number: 260100 Batch Number: 3151724 Manufacture Date: 2023/05/02 Expiration Date: 2025/05/31 Observation of the hemodialysis treatment area in Facility #4 on 06/26/2025 beginning at 9:30 a.m. revealed the following expired medications were co-mingled with stocks in use: Medication Prep Area 2nd Drawer: 10- BD ChloraPrep Single Swabstick 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Lot # 3151724 expiration 05/25 were located in a box in the 2nd drawer. There were no other swabsticks found in the treatment area. During the observation at 9:45 a.m. Registered Nurse (P) was performing catheter care on Patient #15 before the hemodialysis treatment. Registered Nurse (P) walked over to the Medication Prep Area, grabbed a BD ChloraPrep Single Swabstick from the box in the 2nd drawer of the Medication Prep Area, opened the swabstick and applied the antiseptic to the patient’s exit site. The Surveyor immediately notified Registered Nurse (P) that there were 10 expired ChloraPrep swabsticks removed from the box in the 2nd drawer prior to her using one on Patient #15. Registered Nurse (P) said, “Oh.” Observation of the hemodialysis treatment area in Facility #3 on 06/25/2025 beginning at 9:18 a.m. revealed the following expired medications were co-mingled with stocks in use: Medication Prep Area: 6- Hospira Sterile Water for injection, USP 10 mL (for drug diluent use) Lot # GD8137 expiration 01 May 2025 Interview during observation with Registered Nurse (L) confirmed the above expired medications.”

“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’s governing body failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients beyond the manufacturer’s directions for use. Findings: Review of BD BACTEC/Lytic/10 Anaerobic/F Anaerobic and BD BACTEC Plus Aerobic/F Blood Culture Vials Instructions for Use directs staff as follows: “DO NOT USE culture vials past their expiration date.” Observation of the hemodialysis treatment area in Facility #4 on 06/26/2025 beginning at 9:10 a.m. revealed the following expired supplies were co-mingled with stocks in use: Laboratory Area: 2- BD Bactec Lytic/10 Anaerobic/F Culture vials Lot # 4248996 expiration 2025-06-10 2- BD Bactec Plus Aerobic/F Culture vials Lot # 4248956 expiration 2025-06-10 Dialysate Kit labeled with expiration 5/7/25: 2- No urine additive yellow tubes Lot # A23113P7 expiration 2025-05-08 Supply Cart: 2 boxes- Cardinal Health alcohol prep pads, quantity 250, Lot # 22060269 expiration 2025-05 Supply Room: 2 boxes- NxStage CAR-172-C, quantity 6 cartridges, Lot # 30377055 expiration 2024-08-01 1 box- NxStage CAR-172-C, quantity 6 cartridges, Lot # 30377082 expiration 2024-08-01 3 boxes- NxStage SAK-404 Dialysate Sacks, quantity 2, Lot # 30181019 expiration 2024-12-17 2 boxes- NxStage CAR-172-C, quantity 6 cartridges, Lot # 30777105 expiration 2024-12-01 4 boxes- NxStage PureFlow Solution 5000 mL, quantity 2, Lot # Q2302351 expiration 2025-02-01 1 box- NxStage PAK-001 PureFlow SL Water Purification Pack, quantity 1, Lot # 40174065 expiration 2025-06-02 35- RPC Hubcaps Lot # 2200055 expiration 2025-04-02 9- RPC Hubcaps Lot # 2200078 expiration 2025-06-22 Interview during observation with Registered Nurse (P) confirmed the above expired supplies. Observation of the hemodialysis treatment area in Facility #3 on 06/25/2025 beginning at 10:25 a.m. revealed the following expired supplies were co-mingled with stocks in use: Supply Cabinets: 2- MasterGuard Plush fistula needles 17g Lot # 220429F5 expiration 2025-04-30 2- BD Bactec Lytic/10 Anaerobic/F Culture vials Lot # 4116699 expiration 2025-01-28 2- BD Bactec Plus Aerobic/F Culture vials Lot # 4116669 expiration 2025-01-29 2- BBL CultureSwab Plus Lot # 230095700 001 M07 expiration 2024-10-19 13- Dynarex 30 mL Syringe without Needle Lot # 44059 expiration 2024-08-29 2- Access Bio Care Start COVID-19 Antigen Home Test Lot # CP23A36 expiration 2024-10-30 Laboratory Area: New Patient Kit labeled with expiration of 2/3/25 each: 5- K2EDTA lavender tube Lot # B240133K expiration 2025-05-02 5- LH Lithium Heparin separator tube Lot # B24013KM expiration 2025-05-07 New Patient Kit labeled with expiration of 5/31/25: 1- LH Lithium Heparin separator tube Lot # B2403343 expiration 2025-05-31 1- Post sample yellow tube Lot # B24013KM expiration 2025-05-07 Mid-Month Kit labeled with expiration of 6/8/25: 1- K2EDTA lavender tube Lot # B24023NA expiration 2025-06-08 Monthly Kit labeled with expiration of 2/3/25: 3- K2EDTA lavender tube Lot # B24023NA expiration 2025-06-08 1- LH Lithium Heparin separator tube Lot # B240134 expiration 2025-04-01 2- Post sample yellow tube Lot # B24013KM expiration 2025-05-07 Interview during observation with Registered Nurse (L) confirmed the above expired supplies.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s interdisciplinary team failed to complete interdisciplinary care plan on patients in 7 of 15 sampled patients: Patient #s 13, 10, 1, 2, 3, 5, 6 Findings: Review of the facility’s current policy and procedure: Patient Plan of Care #DD-MR-0167 directs staff as follows: “PROCEDURE “ The plan of care shall be completed by the interdisciplinary team, including the patient if the patient desires. “ The complete plan of care shall be signed by team members, including the patient or the patient’s designee. o If the patient chooses not to sign the plan of care, this choice shall be documented on the plan of care, along with the reason the signature was not provided.” Patient #13 Observation on 06/26/2025 at 8:20 a.m. revealed Patient #13 was seated at the station in Facility #4 receiving the hemodialysis treatment on machine #38296 at a of blood flow rate 400 mL/min and a dialysate flow rate of 9.8 L/h via right central venous catheter. Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to the facility on 05/21/2025 with the diagnoses of end stage renal disease, hypertension and left ventricular hypertrophy, on home hemodialysis five times a week. Review of the patient’s clinical record revealed the following laboratory result dated 06/04/2025: Hemoglobin 7.9 g/dL. Review of the physician’s current progress note date 05/28/2025 revealed the following documentation: “Assessments ... Hemoglobin level of 9.6, indicating well-controlled anemia. -Continue current anemia management protocol.” Review of the patient’s IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 06/16/2025 included the most current laboratory results as of 06/04/2025. The IDT plan of care was not completed and signed by registered dietitian. The IDT plan of care was not signed by the physician. During the record review, surveyor requested documentation that the physician participated in the plan of care meeting. There was no documentation provided. Patient #10 Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to Facility #3 on 01/15/2025 with the diagnoses of end stage renal disease, hypertension and diabetes mellitus, on home hemodialysis three times a week. Review of the patient’s clinical record revealed the patient was admitted to the facility on 01/15/2025 with the diagnoses of end stage renal disease, hypertension and diabetes mellitus, on home hemodialysis three times a week. Review of the patient’s IDT plan of care revealed it was completed and signed by the registered nurse, registered dietitian and social worker on 02/14/2025. The IDT plan of care was not signed by the physician. During the record review, surveyor requested documentation that the physician participated in the plan of care meeting. There was no documentation provided. Interview with Registered Nurse (P) on 06/26/2024 at 10:59 a.m. in Facility #4 revealed that she participates in the patients’ IDT plan of care. When the Surveyor asked Registered Nurse (P) about the participation of the other members of the IDT, Registered Nurse (P) said, “Usually the registered dietitian attends in person, the social worker attends via teleconference and the physician completes a note.” 30124 Patient ID #1 Observation on 06/25/2025 revealed Patient #1 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 200 mL/min via right subclavian central venous catheter dialysis access. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/03/2024 with the diagnoses of ESRD on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 06/03/2024 with the diagnoses of ESRD, hypertension, CVA, history of ALS and hypertension. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 08/14/2024. The IDT plan of care was not completed and signed by the dietitian and the physician. Review of the patient’s yearly IDT plan of care revealed it was completed and signed by the registered nurse, registered dietitian and social worker on 06/25/2025. The IDT plan of care was not completed and signed by the physician. Patient ID #2 Observation on 06/25/2025 revealed Patient #2 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 400 mL/min via left upper arm arterial venous fistula. Review of the patient’s clinical record revealed the patient was admitted to the facility on 10/24/2024 with the diagnoses of ESRD currently on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records documents history non-insulin dependent diabetes mellitus, hypertension, hyperlipidemia, posttraumatic stress disorder, end-stage renal disease, malnutrition, pressure ulcers Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse, dietitian, and social worker on 02/28/2025. The IDT plan of care was not completed and signed by the physician. Patient # 3 Observation on 06/25/2025 revealed Patient #3 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 400 mL/min via a right tunneled internal jugular central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 10/24/2024 with the diagnoses of ESRD on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 10/24/2024 with the diagnoses of ESRD, anemia, nutritional deficiency, secondary hyperparathyroidism, hypertension, diabetes. Review of the patient’s 90-day IDT plan of care revealed it was completed and signed by the registered nurse, dietitian, and social worker on 02/28/2025. The IDT plan of care was not completed and signed by the physician. Review of the patient’s IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 06/23/2025. The IDT plan of care was not completed and signed by the dietitian and physician. Patient # 5 Patient received hemodialysis treatment at Facility #5 on a NxStage machine with blood flow rate of 400 mL/min via a right upper arterial venous graft. Review of the patient’s clinical record revealed the patient was admitted to the facility on 03/19/2025 with the diagnoses of ESRD on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 03/19/2025 with the diagnoses of ESRD, hyperparathyroidism, high blood pressure, previously failed transplant. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse, dietitian, and social worker on 04/29/2025. The IDT plan of care was not completed and signed by the physician. Patient #6 Patient received hemodialysis treatment at Facility #5 on a NxStage machine with blood flow rate of 400 mL/min via a right tunneled internal jugular central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 01/13/2025 with the diagnoses of AKI (acute kidney injury) on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 01/13/2025 with the diagnoses of AKI, anemia, diabetes mellitus, seizure disorder, peripheral vascular disease, right above knee amputation, chronic osteomyelitis, hyperkalemia, hypertension, wounds to bilateral heels and sacrum, limited mobility s/p MVA. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 03/29/2025. The IDT plan of care was not completed and signed by the dietitian and physician. Interview by phone on 06/26/2025 at 1:10 p.m. with the facility’s dietitian (E) stated that she is invited by email usually from the nurse to attend the IDT plan of care meeting. Staff (E) confirmed the meetings were held by teleconference and sometimes by a group call. Staff (E) confirmed she never recalls the physician participating in the call and if they need to contact the physician it is usually done by email, phone call are they address it with the nurse who notifies the physician. Interview by phone on 06/26/2025 at 1:35 p.m. with the facility’s social worker (C) confirmed she is invited to the IDT plan of care meeting usually by email from the nurse. Staff (C) confirms she participates in the meetings by teleconference or by phone and it is usually the social worker, nurse and dietitian on the calls. Staff (C) does not recall any physician participating in the IDT plan of care meetings.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s interdisciplinary team failed to complete initial interdisciplinary plan of care on patients in 5 of 15 sampled patients: Patient #s 13, 10, 1, 2, 6 Findings: Review of the facility’s current policy and procedure: Patient Plan of Care #DD-MR-0167 directs staff as follows: “PROCEDURE “ The plan of care shall be completed by the interdisciplinary team, including the patient if the patient desires. “ The complete plan of care shall be signed by team members, including the patient or the patient’s designee. o If the patient chooses not to sign the plan of care, this choice shall be documented on the plan of care, along with the reason the signature was not provided.” “ Implementation of the initial plan of care shall begin within the latter of 30 calendar days after admission to the Dialysis Services Facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. “ Implementation of monthly or annual updates of the plan of care shall be performed within 15 days of the completion of the additional patient assessments.” Patient #13 Observation on 06/26/2025 at 8:20 a.m. revealed Patient #13 was seated at the station in Facility #4 receiving the hemodialysis treatment on machine #38296 at a of blood flow rate 400 mL/min and a dialysate flow rate of 9.8 L/h via right central venous catheter. Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to the facility on 05/21/2025 with the diagnoses of end stage renal disease, hypertension and left ventricular hypertrophy, on home hemodialysis five times a week. Review of the patient’s clinical record revealed the following laboratory result dated 06/04/2025: Hemoglobin 7.9 g/dL. Review of the physician’s current progress note date 05/28/2025 revealed the following documentation: “Assessments ... Hemoglobin level of 9.6, indicating well-controlled anemia. -Continue current anemia management protocol.” Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 06/16/2025 included the most current laboratory results as of 06/04/2025. The initial IDT plan of care was not completed and signed by registered dietitian. The initial IDT plan of care was not signed by the physician. During the record review, surveyor requested documentation that the physician participated in the plan of care meeting. There was no documentation provided. Patient #10 Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to Facility #3 on 01/15/2025 with the diagnoses of end stage renal disease, hypertension and diabetes mellitus, on home hemodialysis three times a week. Review of the patient’s clinical record revealed the patient was admitted to the facility on 01/15/2025 with the diagnoses of end stage renal disease, hypertension and diabetes mellitus, on home hemodialysis three times a week. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse, registered dietitian and social worker on 02/14/2025. The initial IDT plan of care was not signed by the physician. During the record review, surveyor requested documentation that the physician participated in the plan of care meeting. There was no documentation provided. Interview with Registered Nurse (P) on 06/26/2024 at 10:59 a.m. in Facility #4 revealed that she participates in the patients’ IDT plan of care. When the Surveyor asked Registered Nurse (P) about the participation of the other members of the IDT, Registered Nurse (P) said, “Usually the registered dietitian attends in person, the social worker attends via teleconference and the physician completes a note.” 30124 Patient ID #1 Observation on 06/25/2025 revealed Patient #1 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 200 mL/min via right subclavian central venous catheter dialysis access. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/03/2024 with the diagnoses of ESRD on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 06/03/2024 with the diagnoses of ESRD, hypertension, CVA, history of ALS and hypertension. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 08/14/2024. The IDT plan of care was not completed and signed by the dietitian and the physician. Patient ID #2 Observation on 06/25/2025 revealed Patient #2 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 400 mL/min via left upper arm arterial venous fistula. Review of the patient’s clinical record revealed the patient was admitted to the facility on 01/24/2025 with the diagnoses of ESRD currently on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records documents history of End-stage kidney disease, anemia, nutritional deficiency, secondary hyperparathyroidism, hypertension, patient ventilator dependent with trach, acute respiratory failure, chronic obstructive pulmonary disease. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse, dietitian, and social worker on 02/28/2025. The IDT plan of care was not completed and signed by the physician. Patient #6 Patient received hemodialysis treatment at Facility #5 on a NxStage machine with blood flow rate of 400 mL/min via a right tunneled internal jugular central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 01/13/2025 with the diagnoses of AKI (acute kidney injury) on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 01/13/2025 with the diagnoses of AKI, anemia, diabetes mellitus, seizure disorder, peripheral vascular disease, right above knee amputation, chronic osteomyelitis, hyperkalemia, hypertension, wounds to bilateral heels and sacrum, limited mobility s/p MVA. Review of the patient’s initial IDT plan of care revealed it was completed and signed by the registered nurse and social worker on 03/29/2025. The IDT plan of care was not completed and signed by the dietitian and physician. Interview by phone on 06/26/2025 at 1:10 p.m. with the facility’s dietitian (E) stated that she is invited by email usually from the nurse to attend the IDT plan of care meeting. Staff (E) confirmed the meetings were held by teleconference and sometimes by a group call. Staff (E) confirmed she never recalls the physician participating in the call and if they need to contact the physician it is usually done by email, phone call are they address it with the nurse who notifies the physician. Interview by phone on 06/26/2025 at 1:35 p.m. with the facility’s social worker (C) confirmed she is invited to the IDT plan of care meeting usually by email from the nurse. Staff (C) confirms she participates in the meetings by teleconference or by phone and it is usually the social worker, nurse and dietitian on the calls. Staff (C) does not recall any physician participating in the IDT plan of care meetings.”

“H-PLAN FOR ER BACK-UP DIALYSIS CFR(s): 494.100(c)(1)(vii) Services include, but are not limited to, the following: (vii) Identifying a plan and arranging for emergency back-up dialysis services when needed. This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility failed to maintain the back-up agreement with a facility to provide dialysis treatments to it skilled nursing facility patients. Findings: Review of the emergency preparedness binder on 06/23/2025 revealed a back-up agreement between Dialyze Direct TX, LLC and Satellite Wellbound of Houston implemented August 20, 2015. Review of an internet search revealed Satellite Wellbound of Houston (bing.com) was listed as permanently closed. Review of Satellite Healthcare website (satellitehealthcare.com) revealed no locations were listed in Houston, Texas. Area Manager (A) was notified was notified that Satellite Wellbound of Houston was permanently closed during the record review. Area Manager (A) was notified said, “Okay, I will have to check into that.””

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility failed to delegate authority of the dialysis technician to perform cannulation of the patient’s vascular accesses, administration of heparin, lidocaine, normal saline, and oxygen for this facility in 3 of 3 observed patient care technicians: Patient Care Technician (M), (N), (H) Findings: Patient Care Technician (M) On 06/25/2025 Patient Care Technician (M) was observed on the treatment floor of Facility #3 providing care and services to patients in the facility. Review of the facility’s Personnel File Review form revealed Patient Care Technician (M) was hired to the facility on 06/12/2023. Review of Patient Care Technician (M’s) personnel and training file revealed there is no documentation of delegation by the facility’s medical director for Patient Care Technician (M) to cannulate patients’ vascular accesses and administer: intravenous heparin, intravenous normal saline, subcutaneous lidocaine, and oxygen. The Surveyor requested documentation of delegation by the facility’s medical director for Patient Care Technician (M) from Area Manager (A) and no documentation was provided. Patient Care Technician (N) On 06/25/2025 Patient Care Technician (N) was observed on the treatment floor of Facility #3 providing care and services to patients in the facility. Review of the facility’s Personnel File Review form revealed Patient Care Technician (N) was hired to the facility on 01/22/2024. Patient Care Technician (H) On 06/25/2025 Patient Care Technician (H) was observed on the treatment floor of Facility #2 providing care and services to patients in the facility. Review of the facility’s Personnel File Review form revealed Patient Care Technician (H) was hired to the facility on 11/13/2023. Interview with Area Manager (A) on 06/26/2025 at 3:35 p.m. confirmed the missing delegations by the facility’s medical director for the patient care technicians in question.”

“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 pre-dialysis nursing assessments prior to the hemodialysis treatments when patients were admitted to the facility in 3 of 15 sampled patients: Patient #s 14, 1, 6 B) conduct assessments before, during or after the hemodialysis treatment per the facility’s policy in 6 of 15 sampled patients: Patient #s 12, 9, 8, 10, 13, 11 Findings: Review of facility’s current policy and procedure: Pre-dialysis Nursing Assessment #DD-CS-0170 directs staff as follows: “POLICY The Dialysis Direct trained and qualified RN will complete and document a physical assessment of the patient prior to the initiation of the treatment or within the first hour of dialysis (as allowable by state law).” Review of the facility’s current policy and procedure: Clinical Parameters for Notification of the Registered Nurse #DD-CS-1123 directs staff as follows: “POLICY: 5. Post treatment findings reportable to the licensed nurse may include the following: “ Blood pressure: Systolic BP < 90 mm Hg or > 180 mm Hg (millimeters of mercury) “ Cardiac status: Chest pain or heart rate ?100 bpm or heart rate ?60 bpm” (beats per minute) “ Peripheral edema: Pitting edema >+1 pitting edema 6. Post treatment findings reportable to the licensed nurse may include the following: “ Blood pressure: Systolic BP < 90 mm Hg or > 180 mm Hg “ Cardiac status: Chest pain or heart rate ?100 bpm or heart rate ?60 bpm” “ Peripheral edema: Pitting edema >+1 pitting edema Review of the facility’s current policy and procedure: Intradialytic Assessment and Monitoring #DD-CS-0153 directs staff as follows: “PROCEDURE: “ The Dialysis Services Staff RN shall be responsible for evaluating the patient’s response to the dialysis treatment, performing patient assessment, including blood pressure, fluid status, heart rate and respiration ...” Review of the facility’s current policy and procedure: Care and Assessment of Patient Post-Hemodialysis #DD-CS-0139 directs staff as follows: “POLICY: Hemodialysis patients are to be assessed after each dialysis treatment. PROCEDURE: The dialysis RN shall be responsible for completing the post-hemodialysis nursing assessment, including but not limited to: 2. Assessment of vital signs and weight: a. Blood Pressure (Sitting and Standing**) ... **Standing blood pressure will be measured and recorded for all ambulatory patients.” Pre-dialysis Assessments: Patient #14 Observation on 06/26/2025 at 8:50 a.m. revealed Patient #14 was seated at the station in Facility #4 receiving hemodialysis treatment on machine #33933 at a blood flow rate of 350 mL/min and a dialysate flow rate of 9.8 L/h via right upper arm vascular access. Review of the patient’s clinical record revealed the patient was admitted to the facility on 04/16/2025 with the diagnoses of acute kidney injury, chronic kidney disease stage 4, seizures, type 2 diabetes, vascular dementia, and hypertension, on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 04/16/2025 at 7:00 a.m. and the Pre-dialysis Nursing Assessment was completed at 7:02 a.m. Interview during record review with Area Manager (B) on 06/25/2025 at 1:22 p.m. confirmed the Pre-dialysis Nursing Assessments was not completed before the initiation of the hemodialysis treatment for the patient above. Blood Pressure, Heart Rate, Oxygen Need Assessments: Patient #12 Observation on 06/25/2025 at 11:37 a.m. revealed Patient #12 was seated at the station in Facility #3 being discontinued from the hemodialysis treatment by Patient Care Technician (M). Patient Care Technician (M) took the patient’s post blood pressure which was observed to be 195/87 mmHg and then the patient was then picked up by the Skilled Nursing Facility (SNF) staff and left the treatment area. Patient Care Technician (M) failed to report the patient’s blood pressure to the registered nurse and the registered nurse did not complete the post treatment assessment during the surveyor’s observation. The Surveyor asked Registered Nurse (L) if she had been notified of Patient #12’s above parameter post blood pressure. Registered Nurse (L) said, “No, I was not notified.” Review of treatment sheet dated 06/25/2025 revealed the patient’s hemodialysis stop time was 11:30 a.m. and Registered Nurse (L) documented a note on the patient’s blood pressure of 195/87 mmHg at 13:22 p.m. after the patient left the treatment area. Patient #9 Observation on 06/25/2025 at 9:28 a.m. revealed Patient #12 was seated at the station in Facility #3 receiving the hemodialysis treatment on machine #TOS-113879 at a of blood flow rate 400 mL/min and a dialysate flow rate of 600 mL/min via right upper arm vascular. Review of the patient’s treatment sheet dated 06/20/2025 on 06/24/2025 revealed the following documentation: 7:55 a.m.: Registered Nurse (RN) documented the following comments in the Pre-treatment Assessment: Weights & Blood Pressure Trends Report reviewed Yes Cardiac RRR 8:03 a.m.: Patient Care Technician (PCT) documented pre-treatment blood pressure of 182/114 mmHg sitting and heart rate of 97 bpm 8:15 a.m.: documented blood pressure of 188/130 mmHg sitting and heart rate of 93 bpm - PCT documented “Tx started without complication, ufg 2.5” 8:30 a.m.: documented blood pressure of 153/107 mmHg sitting and heart rate of 80 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert” 9:00 a.m.: documented blood pressure of 157/117 mmHg sitting and heart rate of 100 bpm - PCT documented “Access visible, blood line secure, pt resting calmly with eyes closed, even chest rise and fall noted” 9:30 a.m.: documented blood pressure of 178/105 mmHg and heart rate of 65 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert” 10:00 a.m.: documented blood pressure of 190/112 mmHg and heart rate of 102 bpm - PCT documented “Access visible, blood lines secure, pt watching tv” 10:30 a.m.: documented blood pressure of 179/112 mmHg and heart rate of 103 bpm - PCT documented “Access visible, blood lines secure talking on the phone” 11:00 a.m.: documented blood pressure of 178/103 mmHg and heart rate of 99 bpm - PCT documented “Access visible, blood lines secure, pt watching tv” 11:30 a.m.: documented blood pressure of 178/107 mmHg and heart rate of 101 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert, talking on the phone” 11:50 a.m.: documented blood pressure of 154/100 mmHg and heart rate of 99 bpm - PCT documented “Tx completed with stable vitals, blood returned” Review of the patient’s treatment sheet dated 06/16/2025 on 06/24/2025 revealed the following documentation: 10:25 a.m.: documented blood pressure of 161/103 mmHg and heart rate of 90 bpm - PCT documented “Tx started without complication ufg 1.5” 11:00 a.m.: documented blood pressure of 169/101 mmHg and heart rate of 92 bpm - PCT documented “Access visible, blood lines secure, pt watching tv” 11:30 a.m.: documented blood pressure of 169/100 mmHg and heart rate of 96 bpm - RN documented “Access visible, blood lines secure, pt awake/alert” 12:00 p.m.: documented blood pressure of 178/100 mmHg and heart rate of 93 bpm - PCT documented “Resting without complaint” 12:30 p.m.: documented blood pressure of 181/107 mmHg and heart rate of 96 bpm - PCT documented “Access visible, blood lines secure, pt watching tv” 13:00 p.m.: documented blood pressure of 177/107 mmHg and heart rate of 105 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert” 13:30 p.m.: documented blood pressure of 177/106 mmHg and heart rate of 100 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert” 14:00 p.m.: documented blood pressure of 181/110 mmHg and heart rate of 103 bpm - PCT documented “Tx completed with stable vitals, blood returned” 14:03 p.m.: Patient Care Technician (PCT) documented post treatment blood pressure of 168/111 mmHg sitting and heart rate of 102 bpm There was no documentation that the PCT reported the patient’s above parameter blood pressures and heart rate rates to the registered nurse. There was no documented assessment of the patient’s above parameter blood pressures and heart rate rates by the registered nurse. The registered nurse did not perform a post treatment assessment on the patient. Patient #8 Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to Facility #7 on 02/17/2025 with the diagnoses of end stage renal disease and hypertension, on home hemodialysis five times a week. Review of treatment sheet dated 06/16/2025 revealed the following documentation: 8:36 a.m.: documented blood pressure of 153/91 mmHg and heart rate of 71 bpm - PCT documented “Secure Clip applied to venous line Tx started without complication, pt cannulated x1 arterial site with 17g needle w/o any difficulties, pt denies any problems at this time.” RN documented “CVC care provided. Some skin irritation noted. Tx started x1 CVC venous. Venous pressures WNL. Lin secured and CVC visible” 8:38 a.m.: documented blood pressure of 150/92 mmHg and heart rate of 71 bpm - PCT documented “3L Oxygen given Per Md Orders via nasal Cannula, Blood flow increase Per Md Orders.” 9:02 a.m.: RN documented the following comments in the Pre-treatment Assessment: Shortness of Breath No Lungs Clear Bilat There was no mention of the 3L of oxygen that was being administered nor was there any justification documented for administering the oxygen. 9:09 a.m.: documented blood pressure of 170/77 mmHg and heart rate of 93 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert, pt on personal tablet” 9:31 a.m.: documented blood pressure of 175/72 mmHg and heart rate of 92 bpm - PCT documented “Access visible, blood lines secure, pt awake/alert, pt on conference call with dietitian” 10:00 a.m.: documented blood pressure of 174/78 mmHg and heart rate of 65 bpm - RN documented “Pt sitting up listening to music. Pt denies complaints. Line/CVC/Access visible and secure.” 10:26 a.m.: documented blood pressure of 181/79 mmHg and heart rate of 85 bpm - Licensed Vocational Nurse (LVN) documented “Access visible, blood lines secure, pt awake/alert, blood lines secure, feet up per pt request.” 11:01 a.m.: documented blood pressure of 185/79 mmHg and heart rate of 82 bpm - RN documented “Pt sitting up watching phone and listening to headphones. No needs voiced when asked. Lines/CVC visible and secure.” 11:24 a.m.: documented blood pressure of 187/77 mmHg and heart rate of 81 bpm - LVN documented “Access visible, blood lines secure, pt awake/alert, blood lines secure, No s/s of pain or discomfort noted. feet up for comfort. 11:52 a.m.: documented blood pressure of 188/80 mmHg and heart rate of 82 bpm - RN documented “Tx completed. Goal achieved. Blood returned. Post CVC care provided. Needle d/c’d. Site held until hemostasis achieved. Pt care relinquished to SNF” (Skilled Nursing Facility). There was no documented assessment of the patient’s above parameter blood pressures or the need for oxygen by the registered nurse. Patient #10 Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to Facility #3 on 01/15/2025 with the diagnoses of end stage renal disease, hypertension and diabetes mellitus, on home hemodialysis three times a week. Review of treatment sheet dated 06/18/2025 revealed the following documentation: 7:59 a.m.: documented blood pressure of 165/104 mmHg and heart rate of 73 bpm - RN documented “Tx started without complication, Blood flow increase to 400 Per Md Orders” 8:04 a.m.: documented blood pressure of 150/97 mmHg and heart rate of 79 bpm 8:30 a.m.: documented blood pressure of 153/79 mmHg and heart rate of 81 bpm 9:00 a.m.: documented blood pressure of 181/81 mmHg and heart rate of 69 bpm - PCT documented “Access visible, blood lines secure, pt resting calmly with eyes closed, even chest rise and fall noted. 9:30 a.m.: documented blood pressure of 178/100 mmHg and heart rate of 77 bpm 10:00 a.m.: documented blood pressure of 196/106 mmHg and heart rate of 64 bpm - registered nurse documented “Access visible, blood lines secure, pt awake/alert. 10:30 a.m.: documented blood pressure of 177/98 mmHg and heart rate of 65 bpm 11:00 a.m.: documented blood pressure of 185/93 mmHg and heart rate of 65 bpm 11:30 a.m.: documented blood pressure of 177/87 mmHg and heart rate of 78 bpm 11:50 a.m.: documented blood pressure of 167/100 mmHg and heart rate of 97 bpm - PCT documented “Tx completed with stable vitals, blood returned” There was no documented assessment of the patient’s above parameter blood pressures by the registered nurse. Interview during record review with Area Manager (A) at 3:52 p.m. confirmed the registered nurses were not completing assessments when the patient’s condition required it for Patient #s 9, 8 and 10. Post Treatment Edema and Lung Assessments: Patient #9 Observation on 06/25/2025 at 9:28 a.m. revealed Patient #12 was seated at the station in Facility #3 receiving the hemodialysis treatment on machine #TOS-113879 at a of blood flow rate 400 mL/min and a dialysate flow rate of 600 mL/min via right upper arm vascular. Review of the patient’s treatment sheet dated 06/16/2025 on 06/24/2025 revealed the following documentation: 10:21 a.m.: RN documented the following comments in the Pre-treatment Assessment: Edema 1+ Location Lower Extremity There was no post assessment by the RN completed. There was no reassessment of the 1+ edema found during the pre-treatment assessment. Patient #13 Observation on 06/26/2025 at 8:20 a.m. revealed Patient #13 was seated at the station in Facility #4 receiving the hemodialysis treatment on machine #38296 at a of blood flow rate 400 mL/min and a dialysate flow rate of 9.8 L/h via right central venous catheter. Review of the patient’s treatment sheet dated 06/18/2025 on 06/24/2025 revealed the following documentation: 7:18 a.m.: RN documented the following comments in the Pre-treatment Assessment: Edema 2+ Location Lower Extremity 12:29 p.m.: The RN documented the post treatment assessment. There was no reassessment of the 2+ edema found during the pre-treatment assessment. Review of treatment sheet dated 02/17/2025 revealed the following documentation: 07:20 a.m.: RN documented the following comments in the Pre-treatment Assessment: Lungs Diminished Edema 2+ right arm Location Lower Extremity 10:19 a.m.: The RN documented the post treatment assessment. There was no reassessment of the diminished lung sounds and 2+ edema found during the pre-treatment assessment. Patient #11 Review of the patient’s clinical record on 06/24/2025 revealed the patient was admitted to Facility #3 on 02/07/2025 with the diagnoses of end stage renal disease, status post (s/p) liver transplant, s/p tracheostomy, NASH cirrhosis, on home hemodialysis three times a week. Review of treatment sheet dated 02/17/2025 revealed the following documentation: 11:41 a.m.: RN documented the following comments in the Pre-treatment Assessment: Edema 2+ Location Lower Extremity 15:48 p.m.: The RN documented the post treatment assessment. There was no reassessment of the 2+ edema found during the pre-treatment assessment. Review of treatment sheet dated 02/19/2025 revealed the following documentation: 11:28 a.m.: RN documented the following comments in the Pre-treatment Assessment: Lungs Crackles/Rhonci Edema 2+ right arm Location Upper Extremity 15:29 p.m.: The RN documented the post treatment assessment. There was no reassessment of the crackles/rhonci found in the lungs and 2+ edema found during the pre-treatment assessment. Review of treatment sheet dated 02/17/2025 revealed the following documentation: 10:21 a.m.: RN documented the following comments in the Pre-treatment Assessment: Edema 1+ Location Lower Extremity 16:38 p.m.: The RN documented the post treatment assessment. There was no reassessment of the 1+ edema found during the pre-treatment assessment. Interview during record review with Area Manager (A) at 3:52 p.m. confirmed the registered nurses were not completing reassessments of lung sounds and edema found during the pre-treatment assessment for Patient #s 9, 13 and 11. 30124 Pre-dialysis Assessments: Patient #1 Observation on 06/25/2025 at 8:50 a.m. revealed Patient #1 was observed in Facility #1 receiving hemodialysis treatment on a NxStage machine with blood flow rate of 200 mL/min via right subclavian central venous catheter dialysis access. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/03/2025 with the diagnoses of ESRD on home hemodialysis five times a week in a skilled nursing facility. Review of the patient’s clinical records revealed the patient was admitted to the facility on 06/03/2025 with the diagnoses of ESRD, hypertension, CVA, history of ALS and hypertension. Review of the patient’s clinical record revealed the treatment was initiated on 06/03/2025 at 8:30 a.m. with the initial nursing assessment completed on 06/03/2025 at 08:45 a.m. Patient #6 Record review of clinical records on 06/26/2025 revealed the patient was admitted to the Facility #5 on 01/13/2025 with the diagnosis offend-stage renal disease, diabetes mellitus, seizure disorder peripheral vascular disease and right above-knee amputation. Patient receiving hemodialysis treatment on a NxStage machine with blood flow rate of 200 mL/min via tunneled right internal jugular central venous catheter dialysis access. Hemodialysis ordered 5 x week. Review of the patient’s clinical record revealed the treatment was initiated on 01/13/2025 at 6:05 a.m. with the initial nursing assessment completed on 06/13/2025 at 07:36 a.m. Interview during record review with Area Manager (B) on 06/25/2025 at 1:22 p.m. confirmed the Pre-dialysis Nursing Assessments were not completed before the initiation of the hemodialysis treatment for the patients above.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by:”

“CFC-CARE AT HOME CFR(s): 494.100 This Condition is not met as evidenced by: 10802 Based on observation, record review and interview, home hemodialysis facility’s direct care staff failed to monitor home hemodialysis staff assisted patients’ weights pre and post hemodialysis treatments in 4 of 12 sampled patients. Patient #s 5, 9, 2, and 6 (B) Based on observation, record review and interview, facility’s governing body failed to provide the service of a social worker for staff assisted home hemodialysis patients receiving staff assisted home hemodialysis in nursing home facilities in 6 of 12 sampled patients from 2 nursing homes: Patient #s 1, 5, 8, 9, 2 and 4 (C) Based on observation, interview and record review, facility failed to ensure all members of the facility’s interdisciplinary team complete patients’ comprehensive interdisciplinary assessments plan of care on staff assisted home hemodialysis patients receiving hemodialysis treatment in nursing home facilities in 6 of 12 sampled patients: Patient #s 1, 5, 8, 9, 2 and 4 (D) Based on observation, interview and record review, the facility failed to ensure water is drawn from 2 of 2 patient hemodialysis training rooms stations observed in the home training facility and sent to the laboratory for cultures and endotoxin analysis. Findings: Observation, interviews and review of patients’ clinical record (treatment sheet) revealed no documentation of the facility’s staff monitoring of patient’s 5, 9, 2, and 6 weight pre- hemodialysis treatment and post hemodialysis treatment. Interview on 05/02/2024 at 6:10 a.m. with Registered Nurse (I) revealed she said patient’s weights are done pre- and post-hemodialysis treatment by the Nursing Home facility’s staff. Cross Reference V 581 Observation, interviews and review of patients’ clinical record ( home hemodialysis records) revealed the home hemodialysis facility’s social worker did not provide social services intervention and assessment of patient #s 1, 5, 8, 9, 2 and 4 who receive staff assisted home hemodialysis treatment in nursing facilities. Interview on 05/02/2024 at 12:12 p.m. via the telephone with the facility’s home hemodialysis social worker revealed she said she is assigned to 117 patients in 17 nursing home facilities which covers, Greater Houston Area, Austin, Dallas, Dallas Fort worth, and San Antonio. She states “as far as social work practice, I do feel more time is needed. More time is needed to look into patients missed treatment, the challenges facing young people in the nursing facilities and try to engage the family as much as possible. At this time there is a need for more help. My goal is to do more to meet the needs of the patients.” Cross Reference V 590 Review on 04/11/2019 of the Facility’s current policy and procedure on Comprehensive Interdisciplinary Assessment; # DD-CS-1300, Effective 12/01/2014 directs staff as follows: “The comprehensive assessment and plan of care must be developed by an interdisciplinary team ( IDT) consisting of at least the attending physician/ physician extender, treating the patient for ESRD, a registered nurse, a social worker, a registered dietician, and patient or patient designee, if patient chooses.” Review of Patient’s 1, 5, 8, 9, 2 and 4 sampled patients comprehensive interdisciplinary assessment plan of care revealed no documented involvement. Cross reference V 591 Water from 2 of 2 patient hemodialysis training rooms stations observed in the home training facility were not sent to the laboratory for cultures, endotoxin and water analysis. Interviewwith the facility’s Regional Director and record review revealed no water cultures or water analysis were done Cross reference V 595”

“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: 10802 Based on observation, interview and record review, the facility failed to ensure expired supplies are not stored in the facility’s training rooms and co- mingled with supplies not expired for patient usage. Findings: Observation on 04/30/2024 at 10:00 a.m. of the facility’s hemodialysis training rooms one and two, revealed the following expired supplies commingled with unexpired supplies: Home training room 1: 3 boxes 100 per box Nipro 10 mls syringes Lot number 20170415 expired 3/31/2022. Thirty-three micropore tape, lot # 202011BD expired 11/26/2020. Twenty-four sets Nxstage Express Fluid warmer disposable sets Lot number 60879166 expired 10/07/2023 Fifty Curity Cover 4X4 sponges Lot #19D105562 expired 4/1/2024. Thirteen bags 1000 mls normal saline Lot # 22KG02008 expired August 2023 One bottle conductivity solution 14.0Ms/ CM, Lot # MLC141694 expired 4/20/2023. Two Cath flow activator Lot # 3525033 expired September 2023 One bottle Amazon hand sanitizer 354 mls, Lot # 0560370 expired 2/20/2024. The Surveyors immediately notified the facility’s Regional Director of the expired supplies. He confirmed that the supplies in the training rooms were expired.”

“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: wash/sanitize hands after removal of contaminated gloves: 3 of 6 staff observed: Registered Nurse (F) and (G) and Licensed Vocational Nurse (K) Findings: Review of the facility’s current policy and procedure: Hand Hygiene Handwashing Policy, Procedure (#DD-IC-0074, approved 10/06/2020) directs the staff as follows: POLICY: “ All staff will use the hand-hygiene techniques, as set forth in the following procedure. o When entering the dialysis unit o When hands are soiled o Before each patient encounter o Before applying clean gloves o After coming in contact with patient’s intact skin, i.e., taking a patient’s blood pressure, pulse, lifting/moving the patient o After working on a contaminated body site and then moving to a clean body site on the same patient o After coming in contact with bodily fluids, dressings, mucous membranes, etc., and hands are not visibly soiled (i.e. handling sputum containers, bedpans, urinals, catheters) o After contact with medical equipment/supplies in patient areas o After removing gloves o Leaving an isolation area o After toileting “ Soap and water must be used when hands are visibly soiled “ If hands are not visibly soiled, hands may be disinfected with either an alcohol-based hand rub (ABHR) or soap and water ... Registered Nurse (F) Observation on 05/01/2024 at 6:08 a.m., revealed Registered Nurse (F) at nursing home facility #2 moved a patient from the wheelchair to the hemodialysis chair, applied the blood pressure cuff to the patient’s left upper arm, grabbed a thermometer from the clean counter with the contaminated gloves, took the patients temperature and returned the thermometer to the clean counter. With the same contaminated gloves, Registered Nurse (F) picked up alcohol pads from box on the clean counter, walked over and took the stethoscope off the hook and cleaned it with the alcohol, auscultated the patient, and returned the stethoscope without cleaning it. Subsequent observation at 8:47 a.m. revealed Registered Nurse (F) removed his contaminated gloves after disconnecting the hemodialysis blood lines of a patient after treatment. Registered Nurse (F) then grabbed clean gloves from the box and donned them without washing/sanitizing his hands. The Surveyor notified Registered Nurse (F) at 10:15 a.m. that he did not remove his contaminated gloves and wash/sanitize his hands before touching the thermometer, alcohol pads, and stethoscope. Registered Nurse (F) said, “I got you.” Registered Nurse (G) Observation on 05/01/2024 at 6:12 a.m., revealed Registered Nurse (G) at nursing home facility #2 performing a Central Venous Catheter (CVC) dressing change on a patient. Registered Nurse (G) applied disinfectant soaked 4X4 gauze to the CVC, removed her gloves and grabbed gloves out of a clean box on the clean counter. Registered Nurse (G) then moved the box of gloves from the clean counter and placed the box on top of the NxStage machine and continued to use gloves from the box. Registered Nurse (G) did not wash/sanitizer her hands after glove removal. The Surveyor notified Registered Nurse (G) at 10:13 a.m. that she did not remove her contaminated gloves and wash/sanitize her hands before donning clean gloves. Registered Nurse (F) said, “Yes, we have to sanitize after removing gloves.” Licensed Vocational Nurse (K) Observation on 05/02/2024 at 6:12 a.m., revealed Licensed Vocational Nurse (K) at nursing home facility #3 removing blood-filled 10 mL syringes from the Central Venous Catheter (CVC) of a patient. During the removal of the syringes, blood got on one of the gloves of Licensed Vocational Nurse (K). Licensed Vocational Nurse (K) discarded the blood-filled syringes, removed her gloves and used hand sanitizer and did not wash her hands with soap and water. Interview with Licensed Vocational Nurse (K) at 6:36 a.m. confirmed that blood was on her gloves after she removed the blood-filled syringes from the patient’s CVC, and she failed to wash her hands with soap and water. Surveyor: McLean, Marjorie Patient #8 On 05/01/2024 at 8:50 a.m. Patient #8 was observed in the treatment room of nursing home facility (#2). Registered Nurse ( F) was observed discontinuing hemodialysis treatment on the patient who had a central venous catheter in place which is utilized for hemodialysis treatment. Observation revealed the registered nurse donned a pair of clean gloves, applied a face mask to the patient’s face, touching the patient’s ears with his gloved hands. After masking the patient, registered nurse (F) removed his contaminated gloves and picked up clean gloves from the box of gloves stored on the bedside table. The registered nurse did not sanitize his hands after removing the contaminated gloves prior to picking up clean gloves from the box of clean gloves. The registered nurse then provided central venous catheter care to the patient and discontinued the patient’s external blood lines from the patient’s central venous catheter. The Surveyor immediately notified him of break in infection control technique of not washing or sanitizing his hands after removing the contaminated gloves. Registered Nurse (F) states “ I am sorry.” 10802”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 10802 Based on observation, interview , the hemodialysis facility’s registered nurses failed to wear face shield while initiating and discontinuing hemodialysis treatment on patients receiving hemodialysis treatment in 2 of 6 staff observed. Registered Nurse (F) and (G) Findings: Review of the facility’s current policy and procedure: Personal Protective Equipment PPE Policy (#DD-CS-0085, approved 3/17/2017) directs the staff as follows: POLICY: “ Staff shall wear personal protective equipment (PPE) appropriate to the anticipated potential exposure. “ Staff shall wear PPE during: o The initiation and termination of dialysis treatment o Manipulation of access needles and catheters Review of the facility’s current policy and procedure: Central Venous Catheter Care Policy, Procedure (#DD-CS-10121, approved 8/16/2021) directs the staff as follows: POLICY: Trained and qualified (___ facility) patient care personnel will adhere to the following procedure when performing central venous catheter care. Pre-treatment/Initiation of Treatment PPE Required for both initiation and termination of treatment: “ Masks for the patient and staff “ Gloves “ Gown “ Goggles or face shield Registered Nurse (F) Patient #9 On 05/01/2024 at 10:05 a.m. Patient #9 was observed in the treatment room of nursing home facility (#2). Registered Nurse ( F) was observed initiating hemodialysis treatment on the patient who had a central venous catheter in place which is utilized for hemodialysis treatment. During initiation of Patient #9’s hemodialysis treatment Registered Nurse (F) was not wearing a faceshield. Observation revealed while accessing the patient’s central venous catheter, blood from the patient’s central venous catheter spurted from the central venous catheter on to the clean field and the chest of the patient. During an interview on 05/01/2024 at 10:10 a.m. the Surveyor notified Registered Nurse (F) that he was not wearing a face shield while accessing the patient’s central venous catheter, and blood from the patient’s central venous catheter spurted from the catheter unto the clean field and chest of the patient, which also had the potential of getting unto his face. Registered Nurse (F) states” I believe I wear face shield for cannulation and not for catheter. 48020 Registered Nurse (G) Observation on 05/01/2024 at 9:58 a.m., revealed Registered Nurse (G) at nursing home facility #2 performing a Central Venous Catheter (CVC) dressing change on a patient. Registered Nurse (G) donned a face mask and not face shield to protect her eyes while opening the catheter lumens to withdraw the indwelling solution. The Surveyor notified Registered Nurse (G) at 10:13 a.m. that she did not protect her eyes from anticipated potential exposure. Registered Nurse (F) said, “I should wear a face shield.””

“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: 10802 Based on observation, interview and record review, the facility failed to offer Hepatitis B vaccinations to patients who are susceptible in 2 of 12 sampled patients: Patient #’s 3 and 6. Findings: Review of the facility’s current protocol/ policy # DD-CS-0316 effective 12/01/2014 directs staff as follows: Policy: “It is the Standard of Care in the outpatient dialysis unit that all patients are offered the following vaccinations within 30 days of current admission date when applicable. (1) Hepatitis B) “ “ Hepatitis B vaccine is to be offered to all new ESRD patients whose HBsAb is < 10 mIU/ ml.” Patient # 3 On 05/02/2024 at 10: 05 a.m Patient #3 was observed on the treatment unit of nursing home facility (#3). The patient was waiting for initiation of her hemodialysis treatment. the patient had a right double lumen central venous catheter in place. Interview with the patient during observation revealed she said she had a stroke and is currently getting therapy to walk. Review of the patient’s record and admission date provided by the facility’s administrative assistant revealed the patient was admitted to the hemodialysis facility on 05/24/2023 with diagnosis of anemia, diabetes mellitus, major depressive disorder, chronic pain syndrome, neuralgia neuritis, end stage renal disease on home staff assist hemodialysis. Review of the patient’s vaccination record revealed a hepatitis (B) result dated January 24 2024 for Hepatitis (B) antibodies less than 10 MIu ( patient susceptible to the virus). Review of the patient’s clinical record revealed no documentation that the patient was offered or administered the Hepatitis B vaccination. Review of the patient’s summary revealed the following entry “ immunizations ; none recorded.” On 05/02/2024 the patient’s clinical record was reviewed with the facility’s Regional Director (B) revealed he said there was no documentation that the patient was offered the Hepatitis vaccination. 48020 Patient #6 On 05/02/2024 at 07:00 a.m. patient #6 was observed in the hemodialysis unit of nursing home facility #3 receiving hemodialysis treatment via left forearm vascular access. Review of the patient’s clinical record (patient summary) revealed the patient was admitted to the facility on 01/29/2024 with the admitting diagnosis of Chronic diastolic heart failure, Type 2 diabetes mellitus, fluid overload, anemia in chronic kidney disease, hyperlipidemia, secondary hyperparathyroidism and end stage renal disease. Review of the patient’s vaccination record revealed a hepatitis (B) result dated February 2024 for Hepatitis (B) antibodies less than 10 MIu (patient susceptible to the virus). Review of the patient’s clinical record revealed no documentation that the patient was offered or administered the Hepatitis B vaccination. Review of the patient’s summary revealed the following entry “Immunizations: None Recorded.””

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, facility’s social worker failed to ensure home staff assisted hemodialysis patients complete kidney disease quality of life survey in 3 of 12 sampled patients: Patient #’s 1, 8, and 2 Findings: Patient #1 On 05/01/2024 at 5:59 a.m. Patient #1 was observed in the treatment room of nursing home facility (#2). The patient was receiving hemodialysis treatment via a right thigh graft, at a blood flow rate of 400 mls/ minute, dialysate flow rate of 179 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. Observation revealed the patient was alert and oriented to person, place, time, and situation. Interview with the patient during the observation revealed he said he has been on hemodialysis for approximately one year and that he moved from his home in another part of the city to be close to family. Review of the patient’s clinical record revealed a kidney disease quality of life survey on the patient’s record which was signed by the facility’s social worker on 04/30/2024 but there was no result or score on the document. Patient #8 On 05/01/2024 at 6:28 a.m. Patient #8 was observed in the treatment unit of nursing home facility (#2) receiving hemodialysis treatment via a right double lumen central venous catheter. Observation revealed the patient was alert and responsive to name and directive given by facility’s staff. Review of the patient’s clinical record revealed a kidney disease quality of life survey on the patient’s record which was signed by the facility’s social worker on 8/29/2024 but there was no result or score on the document. 48020 Patient #2 On 05/02/2024 at 6:36 a.m. patient #2 was observed in the hemodialysis unit of nursing home facility #3 at NxStage Pure Flow machine C339337091. The patient was receiving hemodialysis treatment at dialysate rate of 118 mL/min and blood flow rate of 200 mL/min via a left central venous catheter. Interview with Patient #2: the surveyor then introduced herself to the patient and the patient mouthed the word “hello” with her lips. The patient mouthed the word “okay” with her lips when the surveyor stated the purpose of the visit. Review of the patient’s clinical record (patient summary) revealed the patient was admitted to the facility on 01/29/2024 with the admitting diagnosis of Acute Kidney Injury/Failure, Anemia, Iron Deficiency, Anemia, Renal Failure and End Stage Renal Disease. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/26/2024 revealed the following documentation: Pre-Treatment Nursing Assessment: “Pt alert and oriented, denies c/o via head nodding.” Review of the Patient’s clinical record revealed the following social worker’s documentation: 04/28/2024 Re-Evaluation Interdisciplinary Assessment: “LMSW unable to assess Pt due to language barrier. KDQOL: “LMSW will seek translator in order to provide education on KDQOL and offer KDQOL to patient.””

“H-IDT RESP FOR SERVICES=IN-CENTER PTS CFR(s): 494.100 A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions of this part. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, home hemodialysis facility’s direct care staff failed to monitor home hemodialysis staff assisted patients’ weights pre and post hemodialysis treatments in 4 of 12 sampled patients. Patient #s 5, 9, 2, and 6 Findings: Review of the facility’s current policy and procedure: Clinical Parameters for Notification of the Registered Nurse and/or Nephrologist or APRN Policy, Procedure (#DD-CS-1123, approved 8/10/2022) directs the staff as follows: POLICY: 1. Patient data will be obtained and documented by the patient care staff (RN/PCT/LPN/LVN) 2. Findings that may preclude the initiation of dialysis will be reported to the licensed registered nurse and/or charge nurse immediately 3. The licensed registered nurse determines the need to intervene and assess the patient immediately, or as allowable by state law, and completes the assessment within the first hour of dialysis and collect any additional data needed. 4. Patient data reportable to the licensed nurse prior to initiation of treatment may include the following: “ Weight: >= 2.5 kg weight gain from previous treatment ... 5. Post treatment findings reportable to the licensed nurse may include the following: “ Respiratory status: Shortness of Breath “ Peripheral edema: Pitting edema >= +1 pitting edema 6. The licensed nurse notifies the physician as needed of changes in the patient’s condition. Patient #5 On 05/2/2024 at 6:05 a.m. Patient #5 was observed in the treatment room of nursing home facility (#3). The patient was receiving hemodialysis treatment via a right intra jugular double lumen central venous catheter, at a blood flow rate of 350 mls/ minute, dialysate flow rate of 118 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. Review of the patient #5’s clinical record ( treatment sheet) revealed a physician’s order for a target weight of 64 kg. Review of Patient #5’s clinical record ( treatment sheet) dated 04/29/2024 revealed the following documentation: Shortness of breath; yes Lungs; wheezes Edema ; 1+ Location generalized. “Pt alert and oriented to self, No weight provided by SNF today .Pt c/o SOB. Received breathing Tx this a.m. will monitor.” Review of the patient’s clinical record ( treatment sheet) dated 04/29/ 2024 revealed no post treatment assessment of the patient’s respiratory status to assess for wheezing of the lungs, shortness of breath and generalized edema. Review of the patient’s clinical record ( treatment sheet) revealed no documentation of the facility’s staff monitoring the patient’s weight pre- hemodialysis treatment and post hemodialysis treatment. Interview on 05/02/2024 at 6:10 a.m. with Registered Nurse (I) revealed she said patient’s weights are done pre- and post-hemodialysis treatment by the Nursing Home facility’s staff. Patient #9 On 05/01/2024 at 10:40 a.m. Patient #9 was observed in the treatment room in nursing home facility (#2.) The patient was receiving hemodialysis treatment via a left double lumen central venous catheter. The patient was alert and oriented to person, place, and situation. Review of the patient’s treatment sheet dated 04/15/2023 revealed a prescribed estimated dry weight of 84.50 kg, and pre- treatment weight of 84.1 kg. Review of the record revealed a documented post treatment weight of 91.0 kg. Documentation in the record were as follows: Post weight obtained by estimated Calculation ( pre- WT - Net fluid Removal) Interview on 05/01/2024 at 7: 50 a.m with Registered Nurse (G) revealed she said patients are weighed prior to coming to dialysis by the nursing home staff but patient’s weights are estimated post hemodialysis treatment. 48020 Patient #2 On 05/02/2024 at 6:36 a.m. patient #2 was observed in the hemodialysis unit of nursing home facility (#3 )at NxStage Pure Flow machine C339337091. The patient was receiving hemodialysis treatment at dialysate rate of 118 mL/min and blood flow rate of 200 mL/min via a left central venous catheter. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/30/2024 revealed the following documentation: “Weights Dry Weight 44.5 Kg Pre 55.3 Kg Last 46.2 Kg Gain 9.1 Kg Lost 1.0 Kg Post 54.3 Kg” Patient #2 gained 9.1 Kg since the last treatment on 04/29/2024. There is no documentation of the weights being monitored by the hemodialysis staff. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/29/2024 revealed the following documentation: “Weights Dry Weight 44.5 Kg Pre 47.0 Kg Last 50.3 Kg Gain -3.3 Kg Lost 0.8 Kg Post 46.2 Kg” Patient #2 reported to dialysis 3.3 kg below the dry weight since the last treatment on 04/26/2024. There is no documentation of the weights being monitored by the hemodialysis staff. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/26/2024 revealed the following documentation: “Weights Dry Weight 44.5 Kg Pre 50.3 Kg Last 50.4 Kg Gain -0.1 Kg Lost 0.0 Kg Post 50.3 Kg” Pre-Treatment Nursing Assessment: Lungs diminished Edema 1+ Location right lower extremity “Pt alert and oriented, denies c/o via head nodding.” Post Treatment Nursing Assessment: Documentation revealed no post treatment assessment of the patient’s respiratory or edema status. There is no documentation of the weights being monitored by the hemodialysis staff. Patient #6 On 05/02/2024 at 07:00 a.m. patient #6 was observed in the hemodialysis unit of nursing home (#3) receiving hemodialysis treatment via left forearm vascular access. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/30/2024 revealed the following documentation: “Weights Dry Weight 68.5 Kg Pre 78.0 Kg Last 76.5 Kg Gain 1.5 Kg Lost 1.9 Kg Post 76.1 Kg” Pre-Treatment Nursing Assessment: Lungs diminished Edema 1+ Location lower extremity “Pt alert and oriented. Transported via w/c. Denies c/o.” Post Treatment Nursing Assessment: Documentation revealed no post treatment assessment of the patient’s respiratory or edema status. There is no documentation of the weights being monitored by the hemodialysis staff. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/26/2024 revealed the following documentation: “Weights Dry Weight 68.5 Kg Pre 0.0 Kg Last 66.0 Kg Gain left blank Lost left blank Post 0.0 Kg Patient Weight: SNF did not provide” Interview on 05/02/2024 at 9:35 a.m. with Licensed Vocational Nurse (K) revealed she said the Nursing Home staff weigh the patients pre/post hemodialysis treatments.”

“H-COORDINATION OF CARE BY MEMBER OF IDT CFR(s): 494.100(c)(1)(ii) Services include, but are not limited to, the following: (ii) Coordination of the home patient’s care by a member of the dialysis facility’s interdisciplinary team. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, facility’s governing body failed to provide the service of a social worker for staff assisted home hemodialysis patients receiving staff assisted home hemodialysis in nursing home facilities in 6 of 12 sampled patients from 2 nursing homes: Patient #s 1, 5, 8, 9, 2, and 4 Findings: Patient #1 On 05/01/2024 at 5:59 a.m. Patient #1 was observed in the treatment room of nursing home facility #2. The patient was receiving hemodialysis treatment via a right thigh graft, at a blood flow rate of 400 mls/ minute, dialysate flow rate of 179 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. Observation revealed the patient was alert and oriented to person, place, time, and situation. Interview with the patient during the observation revealed he said he has been on hemodialysis for approximately one year and that he moved from his home in another part of the city to be close to family. Review of the patient’s clinical record ( Patient Summary) revealed, and review of the admission date provided by facility’s administrative assistant revealed the patient was admitted to the hemodialysis facility on 9/18/2023 with diagnosis of anemia iron deficiency, atrial fibrillation, congestive heart failure diastolic dysfunction, diabetes mellitus, fluid overload and end stage renal disease. Review of Patient #1’s hemodialysis social worker’s progress notes revealed the following documentation: 03/22/2024;” LMSW unable to assess Pt. Pt was unable to participate in assessment due to fatigue. Pt is inpatient at NH. NH assists with ADLs, transportation, and nursing.” 02/26/2024;” LMSW unable to assess Pt. Pt was unable to participate in assessment due to fatigue. Pt is inpatient at NH. NH assists with ADLs, transportation, and nursing.” 01/29/2024; “ LMSW unable to assess Pt. LMSW unable to assess pt due to SNF barrier. LMSW will seek assessment in February 2024. Pt is inpatient at SNF. SNF assists pt meals, transportation, nursing and ADL.” 12/29/2024;” LMSW attempted to assess pt. LMSW unable to assess Pt due to facility fire. Pt is inpatient at R--- NH. The facility provides assistance with meals, transportation, ADLs, and nursing.” 11/23/2024; “LMSW unable to assess Pt due to missed treatments. LMSW’s goal is to encourage Pt to attend treatment and provide education on consequences of missing treatment.” 10/19/2024: “LMSW unable to assess Pt. Pt missed treatment. LMSW’s goal is to provide education on consequences of missing treatments and encourage Pt to attend treatment.” Review of the patient’s clinical record (home record) revealed no documentation that the hemodialysis facility’s social worker assess and provided social services intervention since the patient’s admission to the facility. Interview via the telephone on 05/02/2024 at 12:10 p.m. with the hemodialysis facility’s social worker, the surveyor reviewed the patient’s clinical record (progress notes) with the social worker, revealed she states “ I saw the patient in person playing bingo at the facility, that’s something I need to improve.” Patient 5 On 05/2/2024 at 6:05 a.m. Patient #5 was observed was observed in the treatment room of nursing home facility (#3). The patient was receiving hemodialysis treatment via a right intra jugular double lumen central venous catheter, at a blood flow rate of 350 mls/ minute, dialysate flow rate of 118 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. The patient was alert and responsive to name and place. Interview with the patient during the observation revealed she said she was originally from a city in east Texas and has two sisters and a brother who live in Texas. Review of the patient’s clinical record (patient summary) and review of the admission date provided by facility’s administrative assistant revealed the patient was was admitted to the hemodialysis facility on 2/28/2022 with diagnosis of hypertension, anemia, congestive heart failure, diabetes mellitus, bipolar disorder, hyperparathyroidism and end stage renal disease on home staff assisted hemodialysis 5 times weekly. Review of the patient’s annual interdisciplinary assessment completed by the registered nurse on 1/ 26/2024 revealed the following findings: Physical barrier: no limitation Cognitive barrier ability to communicate : no limitation. Primary language : English Learning preference : verbal Review of Patient #5’s clinical record ( social worker’s) progress notes revealed the following documentation: 3/29/2024;”Pt is a 69 yo Black African American female. Pt lives with dementia and is not able to communicate effectively. LMSW unable to complete assessment as pt is unable to participate. SNF provides all ADL, assistance. LMSW to continue pt for needs.” 2/29/2024;”Pt is a 69 yo Black African American female. Pt lives with dementia and is not able to communicate effectively. LMSW unable to complete assessment as pt is unable to participate. SNF provides all ADL, assistance. LMSW to continue pt for needs.” 1/26/2024; “LMSW unable to assess PT due to hospitalization.” Review of the patient’s treatment sheet revealed the patient was admitted to hospital 1/26/2024 - 1/31/2024 for a total of 6 days. 12/29/2024; “Pt is a 68 yo black/ African American female . Pt lives with dementia and is not able to communicate effectively. LMSW unable to complete assessment as pt is unable to participate. SNF provides all ADL, assistance. LMSW to monitor pt for needs.” 11/27/2024; “Pt is a 68 yo black/ African American female . Pt lives with dementia and is not able to communicate effectively. LMSW unable to complete assessment as pt is unable to participate. SNF provides all ADL, assistance. LMSW to monitor pt for needs.” 10/29/2024; “Pt is a 68 yo black/ African American female . Pt lives with dementia and is not able to communicate effectively. LMSW unable to complete assessment as pt is unable to participate. SNF provides all ADL, assistance. LMSW to monitor pt for needs.” Interview via the telephone on 05/02/2024 at 12:08 p.m. with the hemodialysis facility’s social worker, the surveyor reviewed the patient’s clinical record (progress notes and comprehensive assessment ) with the social worker, revealed she states “ She does not remember me. I did speak with her. She lives with cognitive impairment. I saw the patient briefly . There need to be more detail social worker time spend with the patient.” Patient #8 On 05/01/2024 at 6:28 a.m. Patient #8 was observed in the treatment unit of nursing home facility (#2) receiving hemodialysis treatment via a right double lumen central venous catheter. Observation revealed the patient was alert and responsive to name and directive given by facility’s staff. Review of the patient’s clinical record ( patient summary) and review of the admission date provided by facility’s administrative assistant revealed the patient the patient was admitted to the facility on 3/21/2023 with admitting diagnosis of anemia renal failure, COVID 19 and fluid overload. Review of the patient’s annual interdisciplinary assessment completed by the registered nurse on 1/ 20/2024 revealed the following findings: Physical barrier: no physical barriers Cognitive barrier Ability to communicate unwillingness to learn. Primary language : English Learning preference : verbal Review of Patient #8’s clinical record ( social worker’s) progress notes revealed the following documentation: 4/5/2024; “LMSW unable to assess Pt due to hospitalization.” 2/26/2024; “LMSW unable to assess Pt due to hospitalization.” The record revealed the patient was admitted to hospital on 02/24/2024 and 04/04/2024 - 04/11/2024. 01/29/ 2024; “LMSW unable to assess Pt. “LMSW unable to assess Pt due SNF barrier. LMSW will seek assessment in February 2024. Pt is inpatient at SNF. SNF assists Pt with needs, transportation, nursing and ADLS.” 12/29/2023; “pt unable to participate in Ria. Pt is inpatient at R--- NH/ the facility assists with ADLS, nursing meals, transportation and medicine.” 11/20/2023: “ LMSW met with pt. SNF SW present. Pt is a 37 yo Caucasian male, who is a&ox2. Pt appears to have feces smeared on his shirt. LMSW provided supportive contact. Pt unable to participate in RIA. LMSW commended Pt on attended some treatments and encouraged pt to attend all treatments. LMSW encouraged Pt to refrain from profanity.” 10/26/2023:”LMSW called pt and received no answer. LMSW called SNF and attempted to call PT. LMSW received no answer. LMSW’s goal it is to visit with PT and provide supportive contact”. Interview via the telephone on 05/02/2024 at 12:05 p.m. with the hemodialysis facility’s social worker, the surveyor reviewed the patient’s clinical record (progress notes and comprehensive assessment ) with the social worker, revealed she states, “He had inappropriate behavior of using profanity to staff.” The surveyor asked the social worker what does documentation “ LMSW unable to assess Pt due SNF barrier” means. She said she was instructed to use telehealth but did not have capability to do so. Patient #9 On 05/01/2024 at 10:40 a.m. Patient #9 was observed in the treatment unit of nursing home facility (#2) receiving hemodialysis treatment via a left double lumen central venous catheter. The patient had a left below knee amputation and was receiving oxygen via nasal canulae. The patient was alert and oriented to person, place, and situation. Review of the admission date provided by facility’s administrative assistant revealed the patient was admitted to the facility on 8/16/2022. Review of Patient #9 clinical record ( social workers) progress notes revealed the following documentation: 03/22/2024; : “LMSW unable to assess Pt. Pt was unable to participate in assessment due to fatigue. Pt is in patient at NH. NH assists with ADLS meals, transportation, and nursing.” 1/22/2024; “LMSW unable to assess Pt due to hospitalization.” The record revealed the patient was hospitalized 01/14/2024 - 1/25/2024. 12/29/2023; “ LMSW met with patient during treatment. Pt continue to pend electric wheelchair assistance from SNF SW. Pt is in patient NH provides assistance with ADLs, nursing, meals, and transportation.” 11/22/2023; “LMSW met with patient during treatment. Pt requested assistance with an electric wheelchair. LMSW left a message with SNF form SNF SW. Pt is in patient at R-NH. R---- provides assistance with ADLs, nursing , meals transportation.” 10/30/2023: “Pt is in patient at SNF. SNF provides assistance with ADLs, nursing meals and transportation.” Review of the patient’s clinical record revealed no follow up by the social worker since documentation of 12/29/2024 of the patient’s request for an electric wheelchair. Interview on 05/02/2024 at 12:12 p.m. via the telephone with the facility’s home hemodialysis social worker revealed she said she is assigned to 117 patients in 17 nursing home facilities which covers, Greater Houston Area, Austin, Dallas, Dallas Fort worth, and San Antonio. She states “As far as social work practice I do feel more time is needed. More time is needed to looking into patients missed treatment, the challenges facing young people in the nursing facilities and try to engage the family as much as possible. At this time there is a need for more help. My goal is to do more to meet the needs of the patients.” 48020 Patient #2 On 05/02/2024 at 6:36 a.m. patient #2 was observed in the hemodialysis unit of nursing home facility (#3) at NxStage Pure Flow machine C339337091. The patient was receiving hemodialysis treatment at dialysate rate of 118 mL/min and blood flow rate of 200 mL/min via a left central venous catheter. Interview with the SNF nurse at 6:40 a.m. revealed the patient understands English, she speaks English at times but most of the time she nods her head in response to questions. The surveyor then introduced herself to the patient and the patient mouthed the word “hello” with her lips. The patient mouthed the word “okay” with her lips when the surveyor stated the purpose of the visit. Review of the patient’s clinical record (patient summary) revealed the patient was admitted to the facility on 01/29/2024 with the admitting diagnosis of Acute Kidney Injury/Failure, Anemia, Iron Deficiency, Anemia, Renal Failure and End Stage Renal Disease. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/26/2024 revealed the following documentation: Pre-Treatment Nursing Assessment: “Pt alert and oriented, denies c/o via head nodding.” Review of the Patient’s clinical record revealed the following social worker’s documentation: 01/29/2024: “LMSW unable to assess Pt or introduce herself and provide education on role and scope. LMSW attempted to speak with Pt. Pt declined to talk with this LMSW.” 02/27/2024: “LMSW unable to assess Pt due to language barrier. LMSW is seeking translator in Patient’s language of origin. Pt is inpatient at SNF, SNF assists with ADLs, meals, transportation, and nursing.” 02/29/2024 Initial Comprehensive Interdisciplinary Assessment: “LMSW unable to assess Pt. Pt missed treatment during LMSW visit attempt.” 03/27/2024: “LMSW unable to assess Pt due to language barrier. LMSW is seeking translator in Patient’s language of origin. Pt is inpatient at SNF, SNF assists with ADLs, meals, transportation, and nursing.” 04/28/2024 Re-Evaluation Interdisciplinary Assessment: “LMSW unable to assess Pt due to language barrier. KDQOL: “LMSW will seek translator in order to provide education on KDQOL and offer KDQOL to patient.” The record revealed the patient had documentation of contact with other members of the IDT on 02/29/202, 04/03/2024, and 04/30/2024 but no documentation of contact with a Social Worker between 01/29/2024 and 05/01/2024. Patient #4 Review of the patient’s clinical record (patient summary) revealed the patient was readmitted to nursing home facility #2 on 3/20/2024 with admitting diagnosis of Fluid Overload and End Stage Renal Disease. Review of the Patient’s clinical record revealed the following hospitalizations: 11/23/2023 - 11/30/2023, 12/07/2023 - 12/11/2023, 01/18/2024- 01/25/2024, 02/02/2024- 02/05/2024, 02/22/2024- 02/26/2024, 04/03/2024- 04/05/2024, 04/19/2024- 04/23/2024. Review of the Patient’s clinical record revealed the following social worker’s documentation: Re-Evaluation Interdisciplinary Assessment - Date Range 03/15/2024: “ 02/26/2024 - “Pt refused treatment. LMSW unable to assess. LMSW unable to assess Pt due to hospitalization.” “ 03/27/2024 - LMSW unable to assess Pt due to hospitalization. The patient’s clinical record nor the facility’s hospitalization log revealed a hospitalization for March 2024 for Patient #2. Unstable Comprehensive Interdisciplinary Assessment - Date Range 04/16/2024: “ 01/13/2024 - “LMSW unable to assess Pt due to hospitalization during visit attempt. LMSW unable to assess due to patient hospitalized during monthly visit.” “ 04/24/2024 - “LMSW unable to assess due to patient hospitalized during monthly visit.” The patient’s clinical record and the facility’s hospitalization log revealed the patient was discharged from the hospital on 04/23/2024. The record revealed the patient had documentation of contact with other members of the IDT on 04/24/2024 and 04/30/2024 but no documentation of contact with a Social Worker between 01/13/2024 and 05/01/2024.”

“H-HOME PT PLAN OF CARE DEV/UPDATED CFR(s): 494.100(b)(1)(iii) Services include, but are not limited to, the following: (iii) Development and periodic review of the patient’s individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs and meets the measurable and expected outcomes as specified in §494.90 of this part. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility failed to ensure all members of the facility’s interdisciplinary team complete patients’ comprehensive interdisciplinary assessments plan of care on staff assisted home hemodialysis patients receiving hemodialysis treatment in nursing home facilities in 6 of 12 sampled patients. Patient #s 1, 5, 8, 9, 2, and 4 Findings Review on 05/2/2024 of the Facility’s current policy and procedure on Comprehensive Interdisciplinary Assessment; # DD-CS-1300, Effective 12/01/2014 directs staff as follows: “The comprehensive assessment and plan of care must be developed by an interdisciplinary team ( IDT) consisting of at least the attending physician/ physician extender, treating the patient for ESRD, a registered nurse, a social worker, a registered dietician, and patient or patient designee, if patient chooses.” Patient #1 On 05/01/2024 at 5:59 a.m. Patient #1 was observed in the treatment room of nursing home facility (#2). The patient was receiving hemodialysis treatment via a right thigh graft, at a blood flow rate of 400 mls/ minute, dialysate flow rate of 179 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. Observation revealed the patient was alert and oriented to person, place, time, and situation. Interview with the patient during the observation revealed he said he has been on hemodialysis for approximately one year and that he moved from his home in another part of the city to be close to family. Review of the patient’s clinical record ( Patient Summary) revealed, and review of the admission date provided by facility’s administrative assistant revealed the patient was admitted to the hemodialysis facility on 9/18/2023 with diagnosis of anemia iron deficiency, atrial fibrillation, congestive heart failure diastolic dysfunction, diabetes mellitus, fluid overload and end stage renal disease. Review of the patient’s clinical record (90-day comprehensive interdisciplinary assessment plan of care) dated 12/30/2023 revealed the following documentation: “ 12/30/2023: “LMSW attempted to assess Pt. LMSW unable to assess Pt due to facility fire.” 02/07/2024 “ Pt unable to participate due to fatigue.” There is no documented assessment plan of care by the facility’s staff assisted home hemodialysis social worker. The record revealed documented assessment by other members of the interdisciplinary team on 12/21/2023 and 12/27/2023. Interview via the telephone on 05/02/2024 at 12:10 p.m. with the hemodialysis facility’s social worker, the surveyor reviewed the patient’s clinical record (progress notes, patient’s comprehensive interdisciplinary assessment plan of care ) with the social worker, revealed she states “ I saw the patient in person playing bingo at the facility, that’s something I need to improve.” Patient 5 On 05/2/2024 at 6:05 a.m. Patient #5 was observed was observed in the treatment room of nursing home facility (#3). The patient was receiving hemodialysis treatment via a right intra jugular double lumen central venous catheter, at a blood flow rate of 350 mls/ minute, dialysate flow rate of 118 mls/ minute. The patient was utilizing a Nxstage system 1 hemodialysis machine and a pure flow device for his hemodialysis treatment. The patient’s home hemodialysis treatment was assisted by the hemodialysis facility’s staff. The patient was alert and responsive to name and place. Interview with the patient during the observation revealed she said she was originally from a city in east Texas and has two sisters and a brother who live in Texas. Review of the patient’s clinical record (patient summary) and review of the admission date provided by facility’s administrative assistant revealed the patient was was admitted to the hemodialysis facility on 2/28/2022 with diagnosis of hypertension, anemia, congestive heart failure, diabetes mellitus, bipolar disorder, hyperparathyroidism and end stage renal disease on home staff assisted hemodialysis 5 times weekly. Review of the patient’s annual interdisciplinary comprehensive assessment completed by the registered nurse on 1/ 26/2024 revealed the following findings: Physical barrier: no limitation Cognitive barrier ability to communicate : no limitation. Primary language : English Learning preference : verbal Review of the patient’s annual comprehensive interdisciplinary assessment plan of care dated 1/30/2024 the social worker documented “ unable to assess patient due to hospitalization. “ Review of the patient’s treatment sheet revealed the patient was admitted to hospital 1/26/2024 - 1/31/2024 for a total of 6 days. Review of an assessment completed by the hemodialysis facility’s social worker on 4/28/2024 revealed the following documentation:” “Unable to participate due to impaired cognitive function.” Interview via the telephone on 05/02/2024 at 12:08 p.m. with the hemodialysis facility’s social worker, the surveyor reviewed the patient’s clinical record (progress notes and comprehensive assessment ) with the social worker, revealed she states “ She does not remember me. I did speak with her. She lives with cognitive impairment. I saw the patient briefly. There need to be more detail social worker time spend with the patient.” Patient #8 On 05/01/2024 at 6:28 a.m. Patient #8 was observed in the treatment unit of nursing home facility ( #2), receiving hemodialysis treatment via a right double lumen central venous catheter. Observation revealed the patient was alert and responsive to name and directive given by facility’s staff. Review of the patient’s clinical record ( patient summary) and review of the admission date provided by facility’s administrative assistant revealed the patient the patient was admitted to the facility on 3/21/2023 with admitting diagnosis of anemia renal failure, COVID 19 and fluid overload. Review of the patient’s annual interdisciplinary assessment completed by the registered nurse on 1/20/2024 revealed the following findings: Physical barrier: no physical barriers Cognitive barrier Ability to communicate unwillingness to learn. Primary language : English Learning preference : verbal Review of an assessment completed by the hemodialysis facility’s social worker on 1/29/2024 revealed the following documentation: “Unable to assess PT. LMSW unable to assess Pt due to SNF barrier. LMSW will seek assessment in February 2024”. Review of the record revealed documentation in the patient’s comprehensive interdisciplinary assessment plan of care completed by other members of the interdisciplinary team on 1/17/2024 and 1/25/2024. Review of an assessment completed by the hemodialysis facility’s social worker on 4/28/2024 revealed the following documentation: “Pt unable to participate in RIA due to cognitive function.” Patient #9 On 05/01/2024 at 10:40 a.m. Patient #9 was observed in the treatment unit of nursing home facility (#2) receiving hemodialysis treatment via a left double lumen central venous catheter. The patient had a left below knee amputation and was receiving oxygen via nasal canulae. The patient was alert and oriented to person, place, and situation. Review of the admission date provided by facility’s administrative assistant revealed the patient was admitted to the facility on 8/16/2022. Review of an assessment completed by the hemodialysis facility’s social worker on 2/7/2024 and 3/31/2024 revealed the following documentation:” “LMSW unable to assess PT, as Pt was too fatigued to participate in RIA.” There is no documented involvement in the patient’s comprehensive interdisciplinary assessment plan of care by the facility’s social worker. 48020 Patient #2 On 05/02/2024 at 6:36 a.m. patient #2 was observed in the hemodialysis unit of nursing home facility (#3) at NxStage Pure Flow machine C339337091. The patient was receiving hemodialysis treatment at dialysate rate of 118 mL/min and blood flow rate of 200 mL/min via a left central venous catheter. Interview with the SNF nurse at 6:40 a.m. revealed the patient understands English, she speaks English at times but most of the time she nods her head in response to questions. The surveyor then introduced herself to the patient and the patient mouthed the word “hello” with her lips. The patient mouthed the word “okay” with her lips when the surveyor stated the purpose of the visit. Review of the patient’s clinical record (patient summary) revealed the patient was admitted to the facility on 01/29/2024 with the admitting diagnosis of Acute Kidney Injury/Failure, Anemia, Iron Deficiency, Anemia, Renal Failure and End Stage Renal Disease. Review of the patient’s clinical record (Hemodialysis Treatment Information) dated 04/26/2024 revealed the following documentation: Pre-Treatment Nursing Assessment: “Pt alert and oriented, denies c/o via head nodding.” Review of the Patient’s clinical record revealed the following social worker’s documentation: 02/29/2024 Initial Comprehensive Interdisciplinary Assessment: “LMSW unable to assess Pt. Pt missed treatment during LMSW visit attempt.” 04/28/2024 Re-Evaluation Interdisciplinary Assessment: “LMSW unable to assess Pt due to language barrier. KDQOL: “LMSW will seek translator in order to provide education on KDQOL and offer KDQOL to patient.” The record revealed the patient had documentation of contact with other members of the IDT on 02/29/202, 04/03/2024, and 04/30/2024 but no documentation of contact with a Social Worker between 01/29/2024 and 05/01/2024. Patient #4 Review of the patient’s clinical record (patient summary) revealed the patient was readmitted to nursing home facility (#2) on 3/20/2024 with admitting diagnosis of Fluid Overload and End Stage Renal Disease. Review of the Patient’s clinical record revealed the following hospitalizations: 11/23/2023 - 11/30/2023, 12/07/2023 - 12/11/2023, 01/18/2024- 01/25/2024, 02/02/2024- 02/05/2024, 02/22/2024- 02/26/2024, 04/03/2024- 04/05/2024, 04/19/2024- 04/23/2024. Review of the Patient’s clinical record revealed the following social worker’s documentation: 03/27/2024 Re-Evaluation Interdisciplinary Assessment: “LMSW unable to assess Pt due to hospitalization.” The patient’s clinical record nor the facility’s hospitalization log revealed a hospitalization for March 2024 for Patient #2. 04/24/2024 Unstable Comprehensive Interdisciplinary Assessment: “LMSW unable to assess due to patient hospitalized during monthly visit.” The patient’s clinical record and the facility’s hospitalization log revealed the patient was discharged from the hospital on 04/23/2024. The record revealed the patient had documentation of contact with other members of the IDT on 04/24/2024 and 04/30/2024 but no documentation of contact with a Social Worker between 01/13/2024 and 05/01/2024.”

“H-MEET RD52:2004 CFR(s): 494.100(c)(1)(v) The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly, or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility failed to ensure water is drawn from 2 of 2 patient hemodialysis training rooms stations observed in the home training facility and sent to the laboratory for cultures and endotoxin analysis. Based on observation, interview and record review, the facility failed to ensure water is drawn from 2 of 2 patient hemodialysis training rooms stations and sent to the laboratory for chemical analysis Findings: Observation on 04/30/2024 at 10:30 a.m. of the facility revealed two training rooms with water boxes and Nxstage machines in place. One room is assigned as an isolation room and the other as a regular patient training room. Review of the facility’s licensure revealed the station is licensed for two hemodialysis stations. Interview on 04/30/2024 at 10: 35 a.m. with the facility’s chief executive officer and the facility’s training coordinator revealed they have not drawn water from the stations to be sent to the laboratory to be analyzed for cultures and endotoxin they do not train patients at the facility. During an interview on 05/02/2024 at 3:40 p.m. with Registered Nurse (L) the Surveyor requested evidence of the most current culture and endotoxin results for the stations. He said there was none. Water analysis Review of the facility’s policy and procedure reference #DD-CS-0316 Revised 8/10./2022 directs staff as follows: Source water Municipal: Initially to very source water meets the source Water Purity Requirements ft Pureflow SL as published in the NX Stage Pureflow Users Guide in Chapter 10: Specifications; Annually , thereafter. Standard AAMI Chemical Analysis. Source / Tap Water. Observation on 04/30/2024 at 10:30 a.m. of the facility revealed two training rooms with water boxes and Nxstage machines in place. One room is assigned as an isolation room and the other as a regular patient training room. Review of the facility’s licensure revealed the station is licensed for two hemodialysis stations. Interview on 04/30/2024 at 10: 35 a.m. with the facility’s chief executive officer and the facility’s training coordinator revealed they have not drawn water from the stations to be sent to the laboratory to be analysis. During an interview on 05/02/2024 at 3:40 p.m. with Registered Nurse (L) the Surveyor requested evidence of the most current water analysis results for the stations. He said there was none.”