Aqua Dialysis Lufkin LLC

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure a clean and sanitary environment was monitored and maintained in 3 (In-Center Treatment Area, Laboratory, Medication Preparation Area) of 3 clinical areas. Also, the facility staff failed to follow the facility policy, “Infection Control Policy”. This deficient practice had the likelihood to result in the transmission of infectious agents within the facility and between patients, staff members, and members of the public. The CDC (Centers for Disease Control) defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions that are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. During a tour of the facility’s clinical areas with Staff # 1 on 01/22/2025 at 1:00 PM, the surveyor observed the following infection control issues: In-Center Treatment Area: * The splash guard located at the clean sink was dirty with a build-up of white residue and splatter on the side of the guard. * Three drawers containing sterile patient supplies (Arteriovenous fistula needles and sterile gauze packs) were dirty with dust, dirt, and hair in the bottom of the drawers. * There were 3 expired hand sanitizer dispensers with an expiration date of “12/2024”. Laboratory: * There was no hand soap at the sink in the laboratory to facilitate proper hand washing. * Two hand sanitizer dispensers were empty without any alcohol inside. * There was no method for cleansing hands in the laboratory area. * The laboratory refrigerator was dirty with dust and dirt particles on the bottom shelf of the refrigerator. * There were 2 areas of wall damage above the sink in the laboratory. The sheetrock was partially exposed and could not be adequately cleaned and disinfected. Medication Preparation Area: * There was an unidentifiable sticky residue and splatter on the cabinets and drawers in the medication area. * The shelves inside the medication cabinets were dirty and had a build-up of dust and dirt particles on them. A review of the facility’s “Infection Control Policy” with a revision date of 01/29/2020 revealed, “ ...5. Hand washing- impeccable hand washing technique should be observed between caring for patients and after handling any blood or blood products .... Equipment/Supplies: 1. All equipment and supplies should be stored in a cool, dry area and kept off the floor ....11. Hand washing areas should be easily accessible. Separate sinks should be used for washing equipment ....” An interview was conducted with Staff # 1 on 01/22/2025 at 1:30 PM. Staff # 1 confirmed the infection control issues found in the clinical areas of the facility. Staff # 1 was present during the tour of the clinical areas.”

“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: 48653 Based on observation, record review, and staff interviews, the facility’s staff failed to ensure 2 (water bottle # 1 and # 2) of 2 personal water bottles were not stored in the dialysis in-center treatment area. Also, the facility’s staff failed to follow the policy, “Infection Control Policy”. During a tour of the facility’s in-center treatment area on 01/22/2025 at 1:00 PM with Staff # 1 (Facility Administrator), the surveyor observed a black refrigerator with a staff member’s personal water bottle (bottle # 1) inside. The surveyor observed a drawer containing sterile patient supplies with an opened water bottle (bottle # 2) inside. A review of the facility’s “Infection Control Policy” with a revision date of 01/29/2020 revealed, “Personnel Practices: ... 2. Staff should not smoke, eat, drink or apply cosmetics or lip balm in the dialysis treatment area ...” An interview with Staff # 1 on 01/22/2025 at 1:00 PM confirmed the presence of staff member’s water bottles in the in-center dialysis treatment area.”

“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: 29191 Based on observation and interview, the facility staff failed to follow the correct procedure for cleaning and disinfecting contaminated dialysis equipment and surfaces in the in-center treatment area. The facility staff failed to follow the facility policy, “Infection Control”. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies and equipment to be used that had been exposed to microbial contamination and unclean surfaces. During a tour of the facility’s in-center treatment area on 01/22/2025 at 1:30 PM the following was observed: Staff # 17 was cleaning and disinfecting the patient’s dialysis chair at station #20 and #21 with a bleach cleaning solution wipe. Staff # 17 did not allow the cleaning solution to dry completely before closing the wings on the dialysis chair. The manufacturer’s guidance for the disinfection of an item should be followed including appropriate dilution and contact time. When the surveyor opened the arms of the dialysis chair the bleach solution was running down the wing of the dialysis chair. The manufacturer’s guidance for the disinfection of an item should be followed including appropriate dilution and contact time. A review of facility policy, “Infection Control” dated 01/29/2020 revealed, “Disinfection and Sterilization: 4. Special attention is given to the entire area in which dialysis is performed including, the dialysis chair, dialysis machine (front, back, and sides), lines to the wall box, and trash cans in the immediate area. All surfaces require cleaning with 1:100 bleach solution unless blood is visible then 1:10 solution is used.” In an interview with Staff # 17 on 01/22/2025 at 1:45 PM the surveyor alerted Staff #17 that the wings of the dialysis chair should be allowed to dry before closing.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 29191 Based on observation and interview, the Bio-Medical staff failed to ensure the conductivity and pH solution bottles at 1 of 2 Tri-stations were sanitary and free of contamination for the staff to perform conductivity and check pH ranges at the dialysis machines. These findings had the likelihood to cause harm to all patients if the conductivity solution to verify the conductivity of the dialysis machines was not functioning within a closed circuit. A contaminated closed circuit would allow contaminants to enter the R/O and conductivity solution bottles. Findings include: The manufacturer’s instructions for the dialysis machines stated the conductivity should be checked with an independent device. The Phoenix meter’s instruction requires the use of various conductivity solutions. During a tour of the treatment floor on January 22, 2025, observed a black substance in the tubing of the pH solution and drain tubing of the R/O solution bottle in the “B” bay area of the in-center treatment floor. The normal setup for a tri-station would be a closed circuit. Connected to the closed circuit would be a syringe that allows the staff to draw solutions from the R/O solution and conductivity solutions. The system would be completely closed. There was a brown colored substance on the cap of the pH solution giving the bottle an unclean appearance. An interview with Staff #1 on 01/22/2025 at 1:30 PM acknowledged that the tri-station closed circuit was discolored with a black substance in the tubing and the drain tube of the R/O and conductivity solutions and the cap on the pH solution had a brown substance giving the cap an unclean appearance.”

“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: 48653 Based on observation and staff interviews, the facility’s staff failed to construct and maintain the physical building in which dialysis services were furnished in 2 (Water Room and Front Entrance Walkway) of 3 areas. During a tour of the facility’s building with Staff # 1 on 01/22/2025 at 1:45 PM, the surveyors observed the following physical environment issues: Water Room * The back wall of the water room had a 2-foot by 3-foot area that had water damage. The sheetrock was exposed and crumbling. When the surveyor went to touch the wall, a portion of it crumbled onto the floor. * There was a large amount of dried acid splatter on the wall and pipes behind the acid-holding tank. * There was an electrical outlet located behind the acid-holding tank that was brown and black. The outlet appeared to have been burned. The black and brown substance would not come off when the surveyor attempted to remove it with a paper towel. * The legs of the RO (reverse osmosis) machine were rusted and there were large areas of paint missing from the legs of the RO machine. * There was a corroded drainpipe that had a large build-up of rust on it. There was rust and other material from the drainpipe flaking onto the floor of the water room. * There appeared to be a large amount of standing moisture in the water room. There was a piece of paper posted on the wall that was crumpled as if it had been previously exposed to moisture. * The insulation wrapped around the water pipes was crumbling and falling off. The insulation had been taped with duct tape in many areas. Front Entrance Walkway * The walkway leading to the front entrance of the facility was black. There was a large build-up of black and white substance which appeared to be where dirty water had drained onto the walkway. The sidewalk was black due to the build-up of the substances. An interview with Staff # 1 on 01/22/2025 at 2:00 PM confirmed the presence of damage to the wall, piping, and equipment in the facility’s water room. Also, Staff # 1 confirmed the front walkway entrance appeared dirty and unkept.”

“MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY CFR(s): 494.150 The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. This Standard is not met as evidenced by: 48653 Based on record review and staff interviews, the facility’s medical director failed to ensure quality care was provided to 1 (Patient # 1) of 1 patient. Also, the facility’s direct care staff failed to follow the facility’s “Patient Reportable Parameters”. Patient # 1 A review of patient # 1’s medical record revealed the patient was admitted to the facility on 10/28/2024 with AKI (acute kidney injury) which required hemodialysis treatment. The patient had a complicated hospitalization before starting dialysis treatment at the facility. A review of Patient # 1’s treatment sheet dated 11/29/2024 revealed the following documentation by Staff # 9 (Charge Nurse): “Assessment Comments: Pt is stable on admissions. Pt. denies falls, pain or medical conditions/interventions ... 2:53 PM: Treatment Started ... Heart Rate (HR): 126; Blood Pressure (BP): 81/34 2:54 PM: BP low, chair placed in Trendelenburg position. Pt (patient) asymptomatic, RN (registered nurse) aware. Leave UF off. Cont. to monitor. 3:00 PM: BP remains low, RN notified. Pt states he feels fine. HR: 125; BP: 85/32 3:01 PM: BP cuff adjusted, BP re-checked, Nazeer notified. HR: 125; BP: 85/32 3:07 PM: Pt continues to rest quietly. HR: 125; BP: 81/35 3:10 PM: BP cuff adjusted, BP re-checked CN aware. HR: 125; BP: 82/33 3:14 PM: BP cuff adjusted, BP re-checked. HR: 125; BP: 89/39 3:30 PM: Pt asymptomatic no signs or symptoms of distress. HR: 120; BP: 91/46 4:00 PM: Resting quietly. HR: 119; BP: 123/46 4:30 PM: Pt. still responsive. BP rechecked. HR:114; BP: 72/17 4:35 PM: pt. still responsive, rechecking BP. BP set for every 15. Rechecking BP. RN aware. HR: none documented; BP: 61/21 4:38 PM: continues to rest. HR: 114; BP: 103/29 4:39 PM: CN aware of hypotension, will continue to monitor. HR: 118; BP: 81/24 4:42 PM: BP check. HR: 111; BP: 84/16 4:43 PM: Clinical Coordinator, Facility Administrator, and licensed vocational nurse at chairside when pt. reported, ‘I’m going to die of a heart attack.’ CN notified Dr. Nazeer of pt. status. New order: OK to stop treatment, do BMP (basic metabolic panel) for tomorrow. HR: 116; BP:78/31 5:00 PM: Treatment ended. HR: 116; BP: 76/29 Discharge Comments: 5:05 PM: Pt is stable at discharge.” A review of the facility’s “Patient Reportable Parameters” with a date of 1/24/2019 revealed, “Pre-Treatment: Blood Pressure: Systolic greater than 180 or less than 90. Diastolic greater than 100 or less than 50. Action: Report to charge nurse for evaluation and charge nurse to notify MD if the blood pressure is non-responsive to intervention and/or patient becomes symptomatic ...notify MD if symptoms persist or if the venous pressure remains higher or lower than acceptable limits ... Pulse: Greater than 100 or less than 50. Action: Report to charge nurse. Evaluate and report to MD as patient symptoms indicate ... Intra-Dialytic: Blood Pressure: Systolic greater than 180 or less than 90. Diastolic greater than 100 or less than 50 or any change greater than or less than 40 mmHg (millimeters of mercury) from last reading. Action: Report to charge nurse for evaluation and charge nurse to notify MD if the blood pressure is non-responsive to intervention and/or patient becomes symptomatic ...notify MD if symptoms persist or if the venous pressure remains higher or lower than acceptable limits ... Pulse: Greater than 100 or less than 50 or any significant change in pulse. Action: Report to charge nurse. Evaluate and report to MD as patient symptoms indicate ...” A review of notification records revealed Staff # 9 (Charge Nurse) notified Staff # 7 (Medical Director) on 11/29/2024 at 3:18 PM. The notification was as follows: “FYI: Patient # 1’s blood pressure trended down in the 80’s systolic and pulse is 120’s. UF off and was given 300 cc of Normal Saline. He denies any pain or discomfort.” There was no documentation to support Staff # 7 gave new orders for Patient # 1. Patient # 1 was discharged from the facility with a blood pressure of 76/29 mmHg (millimeters of mercury) and a heart rate of 116 bpm (beats per minute) after reporting to the facility’s clinical staff and leadership, “I’m going to die of a heart attack”. A further review of Patient # 1’s medical records revealed the patient went to the local hospital via ambulance on the evening of 11/30/2024 after being found unresponsive and covered in vomit on the floor of his residence (rehab facility). Patient # 1 was admitted to the Intensive Care Unit (ICU) with severe hypotension (low blood pressure) and later passed away on 12/02/2024. An interview with Staff # 1 and # 7 on 01/22/2025 at 11:00 AM confirmed the patient should have been sent to the emergency room for further evaluation and treatment when the patient’s blood pressure did not respond to nursing interventions. Staff # 7 stated, “He should have been sent to the emergency room.””