Crockett Dialysis Center

“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, record review, and staff interview, the facility staff failed to disinfect 2 of the 15 dialysis machines (machine #8TOS228455, and 8TOS228524 were not bleached within the seven-day timeframe. Also, the staff did not follow the facility’s policy, “Fresenius Dialysis Delivery System Cleaning and Disinfection.” This deficient practice had the likelihood of placing all patients being dialyzed on these machines at risk for potential harm, due to the use of bicarbonate during the dialysis process. Bicarbonate has a high potential for bacterial growth. Findings Include: A review of the October 2025 Machine Disinfect log revealed the following: * On 10/16/2025, dialysis machine #8TOS228524 (#14) was documented as out of service. There was no maintenance record that the machine had been disinfected prior to the machine being placed back in service. * On 10/09/2025, the scheduled bleach day, dialysis machine #8TOD228455 was not bleached until 10/10/2025, exceeding the seven-day timeframe. * On 10/16/2025, the scheduled bleach day, dialysis machine #8TOD228455 was not bleached until 10/17/2025, exceeding the seven-day timeframe. There was no documentation provided to support that dialysis machines #8TOD228455 and #8TOS228524 received disinfection before being placed back in service for patient use within the 7-day timeframe. A review of the facility’s policy titled, “Hemodialysis Machines: Acid Clean, Chemical Rinse and Heat Disinfection” dated 04/05/2021 revealed the following; “The purpose of this policy is to define the minimum requirements for acid clean, chemical rinse and heat disinfection of hemodialysis machines. Manufacturer’s instructions for use must be followed. * The following defines the minimum dialysis machine cleaning and disinfection requirements. The frequency and duration of system cleaning and disinfection will be scheduled to maintain microbiological contamination to conform with company policy and procedures. * At the end of each treatment day of use, the dialysis machine must be: * Acid cleaned with a set acid clean cycle of a minimum of 15 minutes. * If the machine was in conductivity, the acid clean program must be performed prior to heat disinfection or chemical rinse using either vinegar or citric acid. * Heat disinfection must be set to run a minimum of 20 minutes once the timer has started. * Chemical Rinse must be performed at a minimum of weekly (every 7-days) * The machine will automatically perform a HE Leak test upon the start of the Chemical Rinse program. * The machine will automatically perform a Diasafe test after the Chemical Rinse program ends. * When using a hemodialysis machine with SLED capability, a mandatory heat disinfection followed by a rinse must be completed every 12 hours when the same patient is being treated for continuous SLED treatment. * The chemical rinse program will be performed using bleach. * The dialysis machine must be chemically rinsed after a dialyzer blood leak. Operation of the machine in rinse mode during loop disinfection does NOT substitute the daily machine disinfection. * Presence testing for chlorine will be performed using WaterCheckTM RC Residual Chlorine Reagent Test Strips. * Color development must be dark brown/black color indicating at least 500ppm. * Residual testing for chlorine will be performed using WaterCheckTM RC Residual Chlorine Reagent Test Strips: * At the beginning of a treatment day that follows a chemical disinfection of the water treatment system. * Following hemodialysis machine chemical rinse. * Test strip must detect less than 0.5ppm of residual chlorine, the maximum allowable level as recommended by AAMI.” An interview with Staff #8 (Bio-Medical Technician) and Staff #20 (Area Bio-Medical) was conducted on 11/25/2025 at 2:00 PM. Staff #8 and Staff #20 acknowledged the finding that two dialysis machines had not received disinfection before being put back into service for patient use.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that the bulk storage 2K acid tank did not contain contaminated acid solution. This deficiency had the likelihood to cause harm to all patients receiving in-center hemodialysis at the facility. Findings include: During a tour of the water room on 11/25/2025 at 2:00 PM with Staff #8, the surveyor observed a white crystallized substance buildup on the transfer outlet and the drain valve at the bottom of the 2K acid tank. Additionally, a white crystallized substance was seen on the pump for the 2K acid tank. An interview with Staff #8 on 11/25/2025 at 2:00 PM confirmed that there was acid (white crystallized substance) buildup on the transfer outlet valve, transfer tubing, and the drain valve at the bottom of the acid tank. Also, the staff confirmed the presence of a white crystallized substance on the 2K acid pump.”

“PQ-STAFF NURSE-MEET STATE REQUIREMENTS CFR(s): 494.140(b)(4) Each nurse who provides care and treatment to patients must be either a registered nurse or a practical nurse who meets the practice requirements in the State in which he or she is employed. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, per Texas Occupations Code §301.351(c)(1)-(5), the facility staff failed to ensure that 1 (Staff # 18) of 1 licensed nurses was wearing an identification badge while providing patient care. Findings include: During a tour of the facility’s in-center treatment area on 11/25/2025 at 11:30 AM, the surveyor observed 1 licensed nurses (Staff # 18) providing care to hemodialysis patients. The staff member was not wearing a name badge with identification and title while providing patient care. A review of the Texas Occupations Code [TOC] §301.351(c)(1)-(5) revealed, “ ...While interacting with the public in a nursing role, each nurse shall wear a clearly legible insignia identifying the nurse as a registered or vocational nurse. The insignia may not contain information other than: (1) the registered or vocational nurse designation; (2) the nurse’s name, certifications, academic degrees, or practice position; (3) the name of the employing facility or agency, or other employer; (4) a picture of the nurse; or (5) any other information authorized by the board ...” The surveyor requested the facility’s policy, procedure or employee handbook regarding identification badges. There was no policy, procedure or employee handbook provided to the surveyor. An interview was conducted with Staff # 2, # 3, and # 4 on 11/25/2025 at 4:15 PM. Staff # 4 confirmed that Staff # 18 did not have an identification badge while providing patient care. Staff # 4 stated, “He does not have a badge on, his manager is going to request a badge”.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to: A. provide and monitor a sanitary environment to minimize the transmission of infectious agents within the dialysis center. The facility staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy. Cross Refer to Tag (V0111) B. change gloves and perform hand hygiene between contact with the patient and the dialysis equipment and computers. The facility staff failed to follow the “Personal Protective Equipment” policy. Cross Refer to Tag (V0113) C. ensure that 13 of 13 medications stored in the facility were properly secured and safeguarded from unauthorized access. The facility staff failed to follow the “Medication Preparation and Administration Policy”. Cross Refer to Tag (V0117) D. to identify 1 of 1 wet (wet with patient blood or other fluid) external transducer (pressure monitor) located on the hemodialysis machine labeled #5 at Station # 4. The facility staff failed to follow the “Maintenance of Transducer Protectors” policy. Cross Refer to Tag (V0120)”

“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 provide and monitor a sanitary environment to minimize the transmission of infectious agents within the dialysis center. The facility staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy. Findings include: During a tour of the facility’s in-center treatment area on 09/17/2025 at 10:45 AM, the surveyor observed the following infection control issues: There was a white spray bottle labeled “ISOLATION VINEGAR DO NOT REMOVE” sitting at the sink located in front of hemodialysis stations # 9 and # 10. The spray bottle was labeled for use in the isolation room and was on the main treatment floor. There was a build-up of dust, dirt, and other unknown particles inside of drawers, which were used to store sterile patient supplies. There was a thick build-up of dust, dirt, and other unknown particles on the emergency code cart. The oxygen cylinder stored with the emergency code cart was covered in unknown debris. There was a white “magic eraser” sitting on top of the code cart in front of the AED (automated external defibrillator). The “magic eraser” had been used and had a blue and black stain on the top portion of the sponge. The Hoyer lift (a device used to safely lift patients from one point to another) was covered in dust, dirt, and other debris. There were several places where the paint was peeling off of the lift, and the lift was rusting. The rust was flaking off and left sitting on the surface of the lift. A review of the facility’s “General Cleanliness and Infection Control Guidelines” with a date of 09/02/2025 revealed, “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 pleasing environment for patients, staff, and visitors .... Policy: All areas must be kept clean and organized, including but not 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 ...Faciliy 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 patient’s belongings should not be kept or stored behind the machine at the patient station ....All cleaning supplies should be stored in a designated area. Approved cleaning solutions shall be prepared daily or more frequently as per policy or manufacturer’s instructions for use. Solutions will be stored and labeled per policy. A written schedule of cleaning procedures shall be established, reviewed, documented annually in the governing body, and implemented, which sets forth the cleaning and method of decontamination considering the types of surfaces, soil, and tasks and procedures being performed per policy ....” An interview was conducted with Staff # 2 and # 3 on 09/17/2025 at 1:00 PM in the administrative conference room. The staff confirmed the infection control findings found within the facility’s 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: 48653 Based on observation, record review, and staff interview, 1 (Staff # 14) of 1 staff members failed to change gloves and perform hand hygiene between contact with the patient and the dialysis equipment and computers. The facility staff failed to follow the “Personal Protective Equipment” policy. This deficient practice had the likelihood of leading to the transmission of infectious agents between staff members and the patients. Findings include: During a tour of the facility’s in-center treatment area on 09/17/2025 at 11:10 AM, the surveyor observed Staff # 14 (PCT) typing at the keyboard of hemodialysis machine # 4, located at station # 10. Staff # 14 proceeded to administer subcutaneous lidocaine into the patient’s arm near the arteriovenous (AV) fistula. Upon completing the administration of the lidocaine, Staff # 14 used the same pair of gloves to type on the keyboard of machine # 4. The staff member did not change gloves or perform hand hygiene before cannulating the patient’s AV fistula. Staff # 14 then walked over to the nurses’ station and grabbed additional supplies before returning to station # 10 to provide additional patient care. Staff # 14 failed to change gloves and perform hand hygiene at the appropriate intervals in order to provide safe and sanitary patient care. A review of the facility’s policy, “Personal Protective Equipment,” with a date of 11/06/2023, revealed, “Purpose: The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use ...Policy: Employees who may have occupational exposure shall be provided, without cost, appropriate PPE, including gloves, fluid-resistant gowns, face shields, masks, eye protection with full side shields. Employees should use personal protective equipment in accordance with the type of patient contact expected and anticipated exposure ....A supply of clean, non-sterile gloves and a waste container shall be placed near each dialysis station or treatment area. Staff must remove gloves and wash hands after: Patient care, exposure to blood and body fluids, touching any surfaces within the patient station. If hands are not visibly soiled, an alcohol-based hand sanitizer may be used. Always perform hand hygiene after glove removal. Avoid touching surfaces with gloved hands that will be touched with ungloved hands ...” An interview was conducted with Staff # 2 and # 3 on 09/17/2025 at 1:00 PM in the administrative conference room. Staff # 2 and # 3 verbalized that the corporate educator had just been in the clinic to provide education to the staff. However, the staff were still not compliant with the facility’s policy and procedures after education was provided. Staff # 2 and # 3 confirmed the facility’s direct care staff failed to follow the facility’s policy regarding PPE.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interviews, the facility’s nursing staff failed to ensure that 13 of 13 medications stored in the facility were properly secured and safeguarded from unauthorized access. The facility staff failed to follow the “Medication Preparation and Administration Policy”. Findings include: During a tour of the facility’s medication room on 09/17/2025 at 11:00 AM, the surveyor observed that the door to the medication room was unlocked and was accessible to unauthorized personnel. The surveyor proceeded to open the drawers located inside the medication room and found 2 pre-filled TB syringes with an unknown solution inside. The syringes were not labeled with the contents. There were 10 pre-filled 10 ml (milliliter) syringes that were labeled as “heparin”. There was no date or time on the syringes to indicate when the heparin was drawn up, and there were no initials indicating who prepared the heparin. There was a multi-dose vial of lidocaine solution in the medication drawer that had been previously opened. There was no date or initials to indicate when and who opened the vial. During a tour of the in-center treatment area on 09/17/2025 at 11:10 AM, the surveyor observed a syringe labeled as “heparin” preloaded into hemodialysis machine # 6. There was no patient present at the hemodialysis station. A review of the facility’s “Medication preparation and Administration” policy with a date of 07/07/2025 revealed, “Purpose: To administer medications with the goals of staff and patients’ safety, optimal therapeutic response, and infection control ...The qualifications of medication administration are as follows: All doses of IV medication must be drawn up and administered by a clinical staff member whose practice includes the administration of parenteral medication and knowledge of aseptic technique. The person who prepares the medication must be the person who will administer the medication ....All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of the patient, date, time, and initials of the person who prepared the medication ...When preparing medications, if the vial is not used immediately in it is entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials. Label any multi-dose vial that is not used immediately and store in the vial accordingly ...” An interview was conducted with Staff # 2 and # 3 on 09/17/2025 at 1:00 PM in the administrative conference room. Staff # 2 and # 3 confirmed that the staff were not following facility policy for medication preparation, storage, and administration.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to identify 1 of 1 wet (wet with patient blood or other fluid) external transducer (pressure monitor) located on the hemodialysis machine labeled #5 at Station # 4. The facility staff failed to follow the “Maintenance of Transducer Protectors” policy. Findings include: During a tour of the facility’s in-center treatment area on 09/17/2025 at 10:35 AM, the surveyor observed a wet transducer on hemodialysis machine # 5. The external transducer had pink and red fluid inside it, and the patient’s pressures were elevated. The Staff member responsible for providing care to the patient being treated on that machine did not identify or correct the wet transducer until the surveyor pointed out the wet transducer at 11:15 AM, 40 minutes after the wet transducer was first observed by the surveyor. A review of the facility’s “Maintenance of Transducer Protectors” policy with a date of 11/07/2025 revealed, “Purpose: The purpose of this policy is to ensure accurate measurement of arterial and venous pressures and prevent cross-contamination during hemodialysis by maintaining clean, dry transducer protectors ...Policy: The transducer protector must be changed immediately when contaminated with saline or blood. If the back of the transducer protector is contaminated with blood, the internal transducer must be checked by biomedical staff prior to use of the machine for another patient for contamination and changed or disinfected as necessary ...” An interview was conducted with Staff # 16 on 09/17/2025 at 11:15 AM. Staff # 16 confirmed the transducer protector was wet and that the machine would be pulled when the patient was done with treatment.”

“ACID CONC MIX SYS-EMPTY ALL/PREV CORROSION CFR(s): 494.40(a) 5.4.4.2 Acid concentrate mixing systems: empty completely/prevent corrosion Acid concentrate mixing tanks should be designed to allow the inside of the tank to be completely emptied and rinsed according to the manufacturer’s instructions when concentrate formulas are changed. Acid concentrate mixing tanks should be emptied completely before mixing another batch of concentrate. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s biomedical staff failed to ensure that 1 (acid mixer # 1) of 1 acid mixer was maintained in accordance with the facility’s procedures for filter changes. Findings include: During a tour of the water treatment room on 09/17/2025 at 11:30 AM with Staff # 8, the surveyor observed that the filter on the acid mixer was extremely dirty and had not been changed every 6 batches. The filter was dark brown and black. The documentation on the wall indicated there had only been 3 batches of acid mixed since the filter was last changed. A review of the “Dry Acid Dissolution Unit Manual” revealed, “4.4- Filter Maintenance: The 1 micron filter should be changed under the following conditions: 1. After mixing 6 batches of Dry Acid Concentrate. 2. When the Dry Acid Dissolution Unit (DADU) requires disinfection....” An interview was conducted with Staff # 8 on 09/17/2025 at 11:30 AM. Staff # 8 confirmed the filter on the acid mixer had not been changed every 6 batches and stated, “I will do that, I am usually the one who changes it.””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility failed to ensure that direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 2 (# 1 and # 2) of 3 patient medical records reviewed. The facility staff failed to follow the facility policy, “Patient Assessment and Monitoring”. Findings include: Patient # 1 A review of Patient # 1’s treatment sheets dated 08/13/2025 revealed the following vital signs during hemodialysis treatment: “12:53 PM: Treatment initiated: Pulse: 133 1:18 PM: Pulse: 136 1:45 PM: Pulse: 136 3:00 PM: Pulse: 138 3:19 PM: Pulse: 127 3:38 PM: Pulse: 135 3:59 PM: Pulse: 141 4:17 PM: Treatment ended: Pulse: 140” The patient’s pulse remained elevated throughout treatment. There was no documentation by the PCT or the RN to indicate that the staff reported the patient’s elevated heart rate to the provider. Patient # 2 A review of Patient # 2’s treatment sheets dated 09/16/2025 revealed the following vital signs during hemodialysis treatment: “7:23 AM: Treatment initiated: Pulse: 105 7:42 AM: Pulse: 108 8:02 AM: Pulse: 112 8:24 AM: Pulse: 111 8:44 AM: Pulse: 115 9:02 AM: Pulse: 116 9:21 AM: Pulse: 113 9:43 AM: Pulse: 113 10:02 AM: Pulse: 115 10:23 AM: Pulse: 111 10:42 AM: Pulse: 111 11:01 AM: Pulse: 114 11:21 AM: Treatment ended. Pulse: 112” The patient’s pulse remained elevated throughout treatment. There was no documentation by the PCT or the RN to indicate that the staff reported the patient’s elevated heart rate to the provider. A review of the facility’s policy, “Patient Assessment and Monitoring” with a date of 05/01/2023 revealed, “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. Data Collection: Direct patient care staff may collect data such as weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT/LPN note any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgement for additional instruction. The registered nurse will assess/re-assess any findings addressed pre or during treatment as needed ...During treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed, but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 or more often as needed, but not to exceed 45 minutes or per state regulations. Follow the steps below for monitoring patient and machine parameters during treatment: Blood Pressure: Record blood pressure ...Report to the nurse: Systolic blood pressure greater than 180 mmHg. Diastolic blood pressure greater than 100 mmHg. Blood pressure less than or equal to 100 mmHg systolic. Pulse: Record pulse. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute. Report to the nurse patients whose heart rates have dropped below 60, risen above 100, or become irregular ....” An interview was conducted with Staff # 2 and # 3 on 09/17/2025 at 1:00 PM in the administrative conference room. The staff confirmed that there were patient vital signs that were outside of the facility’s set parameters that were not reported to the physician for further evaluation.”