Renal CARE Group Sulphur Springs

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within 1 (In-Center Treatment Area) of 1 areas in the dialysis center. Also, the facility staff failed to follow the facility’s “General Cleanliness and Infection Control Guidelines” policy. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. Findings Include: During a tour of the facility on 06/02/2025 at 10:30 AM, the surveyor observed the following infection control issues; IN-CENTER TREATMENT AREA: * There was an accumulation of an unknown dried white substance on a cart at the entrance to the in-center treatment area. * There was an unknown dried white substance on the sides and handles of a cart with a wand rack. * There was an accumulation of an unknown dried white substance on the tri-station cart. * There was an unknown dried brown substance on the cabinet that stored gowns. * There was an accumulation of debris and an unknown dried brown substance in the clamp bin sitting at the nurse’s station that was noted as clean clamps. * There was an unknown dried brown substance on the intravenous pole, and there was an accumulation of dust on the base of the intravenous pole. * There was an accumulation of dust and debris inside the drawers of the plastic bins storing sterile supplies at the nurse’s station. * There were 5 Suture Removal trays with an expiration date of 10/31/2024 inside a drawer of a plastic storage bin at the nurse’s station. * There was a 60 milliliter syringe with an expiration date of 11/30/2023 inside a drawer of a plastic storage bin at the nurse’s station. *There was a cart by the exit door with an accumulation of a dried white substance on the handle and sides. The cart was cluttered with acid jugs, wands, and caps. *There were two 10 % Dextrose intravenous bags with an expiration date of 05/2025 in a drawer of the in-center crash cart. *There was a vial of Solu-Cortef 100 mg/vial with an expiration date of 04/2025 in the medication drawer of the in-center crash cart. * There were two 60 milliliter syringes with an expiration date of 11/30/2023 in a drawer of the in-center crash cart. *There was an accumulation of dust and debris inside the drawers of the Helmer Refrigerator. *There was an accumulation of dust on 3 of 3 air vents located in the in-center treatment area. * There were two wands lying directly on the countertop at the nurse’s station, next to an acid 1-gallon jug available for patient use. The surveyor was unable to determine if the wands were clean or dirty. A review of the facility’s policy, “General Cleanliness and Infection Control Guidelines” dated 05/05/2025 revealed the following: “PURPOSE: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. *All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices, and restrooms. *Walkways must be kept clear of debris and free of clutter. *Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection. *Eating, drinking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. *Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on countertops or bench tops where blood or other potentially infectious materials are present. *Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. *Facility staff are_ accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. *Supplies or the patient’s belongings should not be kept or stored behind the machine at the patient station. *Clean supplies may not be kept under dirty sinks. *Fans or air purifiers may not be used in treatment areas. (ex, floor fans, box fans, individual portable fans) *When transporting lab specimens from a home therapy training room to a central laboratory, staff should place the tubes in a sealed plastic bag or container and must wear clean gloves and a clean gown during the transport.” An interview was conducted with Staff #1 and Staff #7 on the afternoon of 06/02/2025. Staff #1 and Staff #7 confirmed the infection control and safety issues found in the in-center treatment area.”

“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: 48749 Based on observation, policy review, and staff interview, 2 (Staff #8 and Staff #19) of 2 direct care staff members failed to change gloves and perform hand hygiene between patient encounters and before touching dialysis equipment and sterile supplies. Also, the facility’s direct care staff failed to follow the facility’s “Cleaning and Disinfecting the Dialysis Station” policy. Findings include: During a tour of the facility’s in-center treatment area on 06/02/2025 at 10:00 AM with Staff #1 and Staff #7, the surveyor observed the following; Staff #8 (Registered Nurse), providing Central Venous Catheter (CVC) care to a patient at dialysis station #13, was observed changing gloves twice during the treatment without performing hand hygiene. Also, Staff #8 was observed touching their face with the same gloves worn to touch the patient and then touching the dialysis machine after touching their face. Staff #8 did not perform hand hygiene or change gloves. Staff #19 (Licensed Vocational Nurse) providing care to the patient at dialysis station # 5. Staff # 19 was observed touching the dialysis machine and keyboard with the same gloves that were used to touch the patient and to put up the footrest of the patient’s dialysis chair. Staff #19 did not perform hand hygiene or change gloves between patient contact and contact with the dialysis machine and chair. A review of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/2023, revealed the following; “PURPOSE: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. BACKGROUND: “The Centers for Medicare and Medicaid Services (CMS) has regulations that, in order to prevent cross-contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease ... Hand hygiene must be performed after contact with the electronic devices and before contact with the patient ...” An interview with Staff #1 and Staff #7 on 06/02/2025 at 11:50 AM confirmed Staff #8 and Staff #19 did not change gloves and complete hand hygiene at the appropriate times and intervals as required in the facility policy, “Cleaning and Disinfecting the Dialysis Station”.”

“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: 29191 Based on observations and staff interviews, the facility failed to ensure that staff adhered to proper Personal Protective Equipment (PPE) procedures, specifically by making certain that face masks were worn correctly to protect their mucous membranes from potential blood exposure. Findings include: * Observed, Staff #8 was performing the initial setup for station #13. Staff #8 initially had a face mask positioned below the chin. Staff #8 was seen with the mask on their face and then below the face and under their chin multiple times during patient care. Staff #8 was caring for four different patients using the same mask. * Observed, Staff #8 escorting a patient out of the facility with a facemask below the chin. Staff #8 returned to the in-center floor with the mask on. Staff #8 continued with patient care and did not change mask. An interview with Staff #7 on 06/02/2025 after 10:00 AM confirmed that Staff #8 was not adhering to proper PPE procedures by failing to wear the masks over their nostrils to protect the mucous membranes and by removing the mask after treating a patient.”

“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: 48749 Based on observation, record review, and staff interview, the facility’s direct care staff failed to ensure that proper cleaning and disinfection of the dialysis station and equipment was performed before the next patient’s treatment. Also, the facility staff failed to follow the facility’s “Cleaning and Disinfection of the Dialysis Station” and “General Cleanliness and Infection Control Guidelines” policies. During a tour of the facility’s in-center treatment area on 06/02/2025 at 10:00 AM with Staff #1 and Staff #7, the surveyor observed the following; Staff #19 was performing cleaning and disinfection of dialysis Station #5 following a patient’s hemodialysis treatment. The surveyor observed Staff #19 open the wings of the dialysis chair, clean, and promptly close the wings. The staff member did not allow for adequate drying time of the disinfectant before closing the wings on the chair. During turnover between the first hemodialysis session and the second hemodialysis session, the surveyor observed 3 patients hold the handrail on the scale when obtaining their weight for treatment. The facility staff did not clean and disinfect the scale handrail between each patient. A review of the facility’s policy, “Cleaning and Disinfection of the Dialysis Station,” dated 09/05/2023, revealed the following; “PURPOSE: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross-contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. PROCEDURE: 4. Clean all surfaces. Make the surfaces glistening wet and allow to air dry unless otherwise specified by the manufacturer .” A review of the facility’s policy, “General Cleanliness and Infection Control Guidelines” dated 05/05/2025 revealed the following: “PURPOSE: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. *All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices, and restrooms. *Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection.” During an interview with Staff #1 on 06/02/2025 at 11:00 AM, Staff #1 acknowledged that Staff #19 did not allow the chair to air dry prior to closing the wings. Staff #1 and Staff #7 acknowledged that the staff were not cleaning and disinfecting the handrail on the scale.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure that 1-gallon jugs were labeled with date, time, and initials. In addition, caps were not being used on the 2.5-gallon jugs that contained the dialysate solution. Also, the facility failed to follow the policy on “Acid Concentrate Storage and Handling.” Findings Included: During a tour of the in-center treatment floor on 06/02/2025 at 11:00 AM, there was a 1-gallon 2K 3CA jug observed sitting on a dialysis machine connected to the patient with no date, time, or staff initial at station #1. Also, the surveyor observed a 1-gallon jug of 3K 2.5CA on the counter with the 2 wands lying directly on the counter surface. A tiny live insect was lying with the wands. The surveyor observed that there were seven (7) 2.5-gallon jugs on the top shelf of the black cart. Each jug contained a different amount of dialysate solution, and there was a variety of dialysates. Among the 2.5-gallon jugs was a 1-gallon jug of 2K 3CA with a small amount of solution left inside. One of the jugs had an open cap, which presented a risk for contamination. On the bottom shelf of the black cart were five (5) 2.5-gallon jugs, three of which were without caps. An open container of wands was positioned on top of the 2.5-gallon jugs. There was no way to determine whether the jugs were clean or dirty. Acid concentrate is not susceptible to bacterial contamination, but every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards. A review of the facility’s policy titled “Acid Concentrate Storage and Handling” dated 09/03/2024 revealed the following: “The purpose of this policy is to provide direction for concentrate storage and handling. Concentrates must be stored in a secured area accessible only to authorized staff members, or in the home setting, as directed by the Home Therapies staff. * The concentrate containers must be kept in a climate-controlled area within the temperature ranges described on the container’s labeling. * Store concentrate formulas by type, formulation, and outer case identifiers, such as formula number. Container labels must be clearly visible, be in good condition and readable. * For ln-center facilities and Inpatient Services Programs: label shelving with formula type. * Storage areas must use appropriate HMIS/GHS labeling as stated in OSHA Hazard Communication Program. * Label all acid containers as outlined in the Concentrate Labeling Requirements policy. * Discontinued or expired concentrate formulas must be removed from inventory. * Unused acid concentrate that cannot be transferred or returned must be disposed of in accordance with state and local regulations. * Blending of unlike concentrate formulas is strictly prohibited. * For example, mixing a 2K concentrate with a 3K concentrate is prohibited. Every 30 days(+/-5 days) or at a minimum of monthly, the 2 ½ gallon acid concentrate container must be rinsed, and documentation of rinse must be recorded on the 2 ½ gallon Acid Concentrate Container Rinse Form. Follow the instructions below to rinse the 2 ½ gallon acid concentrate container: * Discard any remaining concentrate. * Inspect for foreign materials. * Thoroughly rinse inside and outside of container with reverse osmosis (RO) or deionized (DI) water. * Containers that are stored will be rinsed, allowed to air dry, and stored in a manner that will prevent accumulation of dust, dirt, or other contaminants.” An interview with Staff #1 on 06/02/2025 at 11:00 AM confirmed the 1-gallon jugs were not labeled per the policy and that there was a live insect on the counter by the wands. Also, Staff #1 confirmed that there were 2.5-gallon jugs with no caps, and unknown if the jugs were clean or dirty.”

“BICARB JUGS RINSED DAILY/STORED DRY CFR(s): 494.40(a) 6.5 Concentrate distribution: bicarb jugs rinsed daily/stored dry Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. Pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure the acid pick-up wands were being stored in a clean container. Also, the facility failed to follow the policy “Acid Concentrate Storage and Handling.” This deficient practice allowed for contamination due to the wands not being placed in a clean container. During a tour of the facility on 06/02/2025 at 10:30 AM, the surveyor observed acid pick-up wands lying horizontally in a clear container that had a plastic bag with paper inside it, with a new bicarbonate wand (indicating it was the original paperwork that comes with a new wand). Also, there was another empty plastic bag that was used, looking ( indicating the plastic bag had been there for a while). There was no label or lid on the container to determine if the wands were clean or dirty. The container of wands was on the bottom shelf of the black plastic cart sitting on top of some 2.5-gallon jugs. A review of the facility policy titled, “Acid Concentrate Storage and Handling” dated 9/03/2024 revealed the followed: * Remove the wand assembly, rinse wand with RO water. hang vertically and allow to dry. * Once wand is dry, store in a covered container labeled: “Clean Wands”. Also, the facility staff failed to follow the policy “Acid Concentrate Storage and Handling.” An interview with Staff #1 on 06/2/2025 at 11:00 AM confirmed that the acid pick-up wands were in a container with no label or lid, and there was no way to determine if the wands were clean.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 29191 Based on observations and staff interviews, the facility failed to ensure that the exit hallway was clear for the evacuation of patients and staff in case of an emergency. This deficient practice has the likelihood of causing harm to patients in an emergency. Findings include: Upon entering the facility’s back hallway on 06/02/2025 at 9:30 AM, surveyors observed two large black carts in front of the exit door. One of the black carts contained cardboard boxes. The other black cart held “Citru Clean” with four large 3-gallon jugs, several small containers, and two spray bottles. The bottom shelf had two rack holders of wands used to disinfect the dialysis machines. This cart was blocking the exit door and fire extinguisher that was mounted on the wall. An interview with Staff #7 on 06/02/2025 at 10:00 AM confirmed that the exit back hallway was blocked and was not quickly accessible for patients and staff to exit in case of an emergency, and that the fire extinguisher was blocked by a cart.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for the blood flow rate (BFR) and the dialysis flow rate (DFR) for 3 (Patient #2, #3, and #5) of 6 medical records reviewed. The facility staff failed to follow the facility’s “Patient Assessment and Monitoring” policy. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders, which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 58 in-center hemodialysis patients receiving care at the facility. Findings include: Patient # 2 A review of the treatment sheet dated 05/28/2025 revealed the following, “Dialysis Prescription: BFR (blood flow rate): 400 ml/min DFR (dialysis flow rate): 500 ml/min (milliliters per minute)” The patient’s set BFR (blood flow rate) throughout treatment was “265 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 3 A review of the treatment sheet dated 05/07/2025 revealed the following, “Dialysis Prescription: BFR: 400 ml/min DFR: 800 ml/min “ The patient’s set DFR throughout treatment was “500 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. In addition, a review of the treatment sheet dated 05/09/2025 revealed that Patient #3 completed treatment 1.1 kilograms over the prescribed target weight. There was no documentation found that the facility staff notified the Physician about ending treatment over the target weight for Patient #3. Patient # 5 A review of the treatment sheet dated 05/24/2025 revealed the following, “Dialysis Prescription: BFR: 400 ml/min DFR: 800 ml/min “ The patient’s set BFR throughout treatment was “260 ml/min”. The patient’s set DFR throughout treatment was “500 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR and DFR for this treatment date. A review of the facility’s policy, “Patient Assessment and Monitoring” dated 05/01/2023 revealed the following: “Purpose: The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during, and after treatment. Check machine settings and measurements: * Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. * Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. Post Treatment: Weight- Obtain the patient’s post weight. Ensure the post weight is consistent with the goal set of the machine.” An interview with Staff #7 on 06/03/2025 at 10:30 AM confirmed that the facility staff was not consistently following the physician’s order for blood flow rate and dialysis flow rate. Staff #7 confirmed that the facility staff did not notify the Physician about Patient #3’s leaving the facility over the target weight.”