Luxury Dialysis

“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, interview and record review, the facility failed to ensure that oxygen tanks were stored and identified according to the Federal and State laws that regulated medical gases according to “National Fire Protection Association (NFPA) 99, Standard for Health Care Facilities in three of three oxygen tanks observed. Record Reviewed: Review of “National Fire Protection Association (NFPA) 99, Standard for Health Care Facilities”(2005 edition): showed oxygen cylinders must be secured in racks or by chains, identified as full or empty and stored separately. NFPA 99 requires empty cylinders to be stored separately from full cylinders. This means partially full cylinders must be stored with the empty cylinders or stored separately from full or empty cylinders. “ 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. Findings: Observation on 01/28/2026 at 1:00 PM along with the Facility Administrator (B) three oxygen tanks were observed in the patient treatment area. The oxygen tanks were not identified according to Federal and State Laws. Oxygen cylinders were observed stored together and not identified as full or empty. 1 - oxygen cylinder was observed to have the seal had been broken with no regulator attached. Cylinder was not identified as full or empty. 1 - Oxygen cylinder was observed to have the seal intact with no regulator attached. Cylinder was not identified as full or empty. 1 - Oxygen cylinder was observed to have the seal broken off with a regulator attached. Cylinder was not identified as full or empty. Interview on 01/28/2026 at 1:00 PM with Facility Administrator (B), confirmed the oxygen cylinders were not identified as full or empty and were not stored separately.”

“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 staff failed to wear gloves while touching and moving the hemodialysis machine during the treatment in 1 of 5 staff observed: Biomedical Technician (G) B) the facility’s staff failed to perform hand hygiene after glove removal in 1 of 5 staff observed: Biomedical Technician (G) Findings: Review of facility’s current policy and procedure: Infection Control, policy # 05-10, date adopted: 02-01-2019 directs staff as follows: “Policy All personnel will observe Standard Precautions while doing any type of care that could result in exposure to blood, body fluids, excretion and secretion. All personnel who could potentially be exposed to blood, body fluids, excretion or secretion as part of their patient care duties will be trained in unit policy and procedure regarding Standard Precautions and will agree to observe them as a condition of continued employment at the facility. Directions: 4. Use appropriate barrier precautions. These include Gloves when contact with blood, body fluid, tissues, or contaminated surfaces are anticipated. Personal Protective Equipment (PPE) includes gowns (fully covering the arms and torso from the neck to thee knee), mask and protective eyewear if splattering is likely to occur and gloves. PPE is required for all dialysis treatment initiations and terminations and any other time exposure to blood, body fluids, excretion or secretion or contaminated items may be possible... 7. Hand hygiene is required after every direct contact with a patient and between patient contacts, even if the contact is casual. Gloves are not necessary for casual social contact with a patient, for example, staff members may touch the patient’s shoulder, take his/her arm, or shake hands without wearing gloves. However, gloves should always be worn anytime contact with blood or body fluids is anticipated.” Biomedical Technician (G) Observation in the hemodialysis treatment area on 01/28/2026 at 1:56 PM revealed Biomedical Technician (G) at station #4 using a gloved left hand and an ungloved right hand to move hemodialysis machine #9 so that the Surveyor could see the ultrafilter attached to the back of the machine and the readings on the portable reverse osmosis sitting behind the machine. Biomedical Technician (G) failed to prevent hand contamination by not wearing gloves on both hands while touching contaminated surfaces in the dialysis station. Subsequent observation revealed Biomedical Technician (G) remove the glove on his left hand, walk to the nurses station, reach into a box of clean gloves and don a glove on the left hand, walk to station #4 and reveal the dialysate readings on hemodialysis machine #4. Biomedical Technician (G) failed to perform hand hygiene after removing the contaminated glove from his left hand. The Surveyor notified Biomedical Technician (G) of the break in infection control related to glove use and hand hygiene. Biomedical Technician (G) said, “Okay.””

“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: 48020 Based on observation, interview and record review, the facility’s staff failed to wear impervious (not allowing fluid to pass through) lab coats while initiating and terminating hemodialysis treatments patients in 3 of 5 staff observed: Charge Nurse (D), Patient Care Technician (E) and (F) Findings: Review of facility’s current policy and procedure: Infection Control, policy # 05-10, date adopted: 02-01-2019 directs staff as follows: “Policy All personnel will observe Standard Precautions while doing any type of care that could result in exposure to blood, body fluids, excretion and secretion. All personnel who could potentially be exposed to blood, body fluids, excretion or secretion as part of their patient care duties will be trained in unit policy and procedure regarding Standard Precautions and will agree to observe them as a condition of continued employment at the facility. Directions: 4. Use appropriate barrier precautions. These include Gloves when contact with blood, body fluid, tissues, or contaminated surfaces are anticipated. Personal Protective Equipment (PPE) includes gowns (fully covering the arms and torso from the neck to thee knee), mask and protective eyewear if splattering is likely to occur and gloves. PPE is required for all dialysis treatment initiations and terminations and any other time exposure to blood, body fluids, excretion or secretion or contaminated items may be possible.” Non-impervious lab coats: Observation in the hemodialysis treatment area on 01/28/2026 at 1:09 PM revealed three staff (Charge Nurse (C), Patient Care Technician (E) and (F)) wearing a white cloth lab coats with the company logo while initiating and terminating hemodialysis treatments. Observation of one of the lab coats hanging on a hook near the break room revealed the lab coat was made with 65% polyester and 35% cotton. There was one staff wearing a white, disposable gown that was impervious. Interview with Facility Administrator (B) during the observation revealed that: the staff immediately replaces the white lab coats when they become soiled blood or body fluid, Tide Cleaners picks up the soiled lab coats weekly to be cleaned and returned to the facility, and they use the disposable, impervious gowns for visitors. When the Surveyor asked Facility Administrator (B) if the white lab coats were impervious Facility Administrator (B) stated, “The cleaners spray something on the jackets to prevent fluids from leaking through them.” The Surveyor asked the Facility Administrator (B) to pour water on the jacket to see if the jacket was impervious. Facility Administrator (B) poured 1/2 cup of water on the white lab coat below the front, right pocket. The water dripped through the jacket and the inside of the jacket was wet to the touch.”

“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 prevent transmission of dangerous pathogens by not properly cleaning and disinfecting the prime bucket, intravenous (IV) pole, stethoscope, tv attached arm, back of hemodialysis machine, and portable reverse osmosis system behind the machine in 1 of 5 staff observed: Patient Care Technician (E) Findings: Review of facility’s current policy and procedure: Infection Control, policy # 05-10, date adopted: 02-01-2019 directs staff as follows: “Policy All personnel will observe Standard Precautions while doing any type of care that could result in exposure to blood, body fluids, excretion and secretion. All personnel who could potentially be exposed to blood, body fluids, excretion or secretion as part of their patient care duties will be trained in unit policy and procedure regarding Standard Precautions and will agree to observe them as a condition of continued employment at the facility. Directions: 11. Clean surfaces, equipment, and facility appropriately. If blood, body fluids, excretion, or secretion spill occurs clean and disinfect the area immediately with 1:10 solution of bleach. Non disposable equipment (i.e., Dialysis chairs, BP cuffs, TV screen set are cleaned with bleach 1:100 dilution. All blood spills are cleaned up with cloths saturated with bleach 1:10 dilution. After all visible blood is cleaned, staff should use a new cloth or towel to apply disinfectant a second time.” Patient Care Technician (E) Station #10 Observation on 01/28/2026 at 2:40 PM revealed Patient Care Technician (E) terminally cleaning station #10 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to clean and disinfect the prime bucket, IV pole, stethoscope, tv attached arm, back of hemodialysis machine, and portable reverse osmosis system behind the machine. Station #12 Observation on 01/28/2026 at 3:02 PM revealed Patient Care Technician (E) terminally cleaning station #10 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to clean and disinfect the prime bucket, IV pole, tv attached arm, back of hemodialysis machine, and portable reverse osmosis system behind the machine. The Surveyor immediately notified Patient Care Technician (E) of the failure to properly clean and disinfect the prime bucket, IV pole, stethoscope, tv attached arm, back of hemodialysis machine, and portable reverse osmosis system at station #s 10 and 12. Patient Care Technician (E) said, “Uh-huh.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 30124 Based on observation, record review and interview, the facility failed to ensure policies and procedures were followed to ensure a safe environment, in that expired supplies are not stored, and in use in the facility for care and services of patients beyond the manufacturer’s directions for use. Based on observation, interview and record review, the facility failed to ensure: 1. Expired supplies were not available for use in the facility. 2. Supplies were labeled with an open date and disposed of per manufactures guidelines for use. Observation on 01/28/2026 of the patient treatment area the following was identified: 16 - BD Vacutainers, Safety Lock; Blood Collection Sets; 21 gauge, ¾ x 12, Lot # OA1021; Expiration date 01/31/2023. 2 - Open containers of Water Soft test strips, 100 count, Lot # 2509505003, Expiration 03/2027. No open date or use by date was identified on the container. Manufactures guidelines state, “Expires 4 months after opening”. 2 - Open containers of Water Check 2 Reagent Strips for Low Level Chlorine/Chloramine, 100 count, Lot# 2509405002, Expiration 03/2027. No open date or use by date was identified on the container. Manufactures guidelines state, “Expires 3 months after opening”. 1 - Open bottle PRO Advantage Isopropyl Rubbing Alcohol 70%, 16 fluid ounces, Lot# 64475, Expiration date 08/2025. Container was labeled as opened Jan 05, 2026. 1 - Container of EXSept Plus Antimicrobial Exit Site, Skin and Wound Cleaner, 17 fluid ounces, Expiration date 04/11/2027. Container labeled as opened 06/24/2025. Manufactures guidelines state, “Stable for up to 6 months after opening”. Interview on 01/28/2026 at 3:30 PM with Nursing Manager (C), confirmed the above findings.”

“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: 30124 Based on observation, record review and interview, the facility’s medical director failed to ensure policies and procedures were followed to ensure a safe environment, in that Dialysis Fluid Filters are not used past the manufacture’s specific service life in 3 of 12 hemodialysis machines used. (4, 6, 10). Policy Reviewed: Review of the facility’s current police on 1/28/2026 Titled “B Braun Dialog + Dialysis Machine Fluid Mode of Operation and Changing Procedure”, Policy #11-80, Date adopted 10-24-2022. Purpose: To provide guidance on use and mode of operation of Dialysis Fluid Filter and ensure good working conditions according to the manufacturer’s specifications. Policy: 1. Prior to each treatment, visually inspect the filters for external leaks. 2. Time of Filter Change. See relevant Data sheet the specified service life of the dialysis fluid filter in use. The filter must be changed when The number of therapies set in the service program has been reached. The set number of operating hours has been reached. The test of the dialysate system preparation is not passed, and leaks are discovered at the filter. The set date of expiration on the Dialysis Filter. 3. The dialysis fluid filter may only be operated with permeate or dialysate. 4. The dialysis fluid filter must be changed at the latest when the “Filter change” warning window is displayed on the screen. 5. The dialysis machine supervises remaining operating hours of the filter as well as performed therapies. Operating hours are hours in Therapy as well as hours in Preparation and Disinfection. When either the operating hours or the number of therapies is reached, a warning window will be displayed on the screen. It informs the user about the upcoming filter change. The warning window appears in case that 60 operating hours or 10 therapies remain. It is displayed when the user changes from Program Selection to Preparation. And it lasts for 1 minute. The number of hours or therapies is set by the technician in the TSM. It is recommended to change the filter after 150 therapies or 900 operating hours. Review of the manufacturer’s Technical Data sheet titled “Diacap Ultra Dialysis Fluid Filter” from B Braun, Version 11/2023 reads: Membrane Specifications, Lifetime: 150 treatments/approx. 900 hours. The Diacap® Ultra pyrogen filter is used with the Dialog+® Hemodialysis System to produce ultra-pure dialysate in B Braun’s closed system solution which is designed to reduce the risk of contaminated dialysis fluid and its associated complications. The Diacap Ultra dialysis fluid filter is intended to filter bacteria and endotoxins from dialysate used for hemodialysis treatments. Observation on 01/28/2026 of the patient treatment care area along with the Biomedical Technician Manager (G) the following was observed: Patient ID #7 was observed on 01/26/2026 receiving his hemodialysis treatment at Station #4, Machine #9. Machine was observed to an alert on the machine flashing, “Continue with expired filter - 1 day overdue”. Patient # 8 was observed on 01/26/2026 receiving his hemodialysis treatment at Station #6, Machine # 6. Hemodialysis machine was observed to have an alert on the machine flashing “Continue with expired filter”. Observation of station #8 the surveyor observed the hemodialysis machine set up and ready for use. Machine was observed to have an alert on the machine flashing, “Continue with expired filter - 10 days overdue”. Interview on 01/28/2026 at 2:30 PM with the Biomedical Technician Manager (G) confirmed the above finding and stated the filters should have been changed.”