Fmc- Lexington Southwest

“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: 35949 Based on observation, interview, and review of facility policy, the facility failed to ensure observed staff performed hand hygiene before they touched patient care equipment (dialysis machine) and after they removed their gloves (Patient Care Technician [PCT] 3 and PCT4). Failure to perform hand hygiene provided a mode of cross-contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 39 patients who received dialysis treatments at the facility. The findings include: Review of the facility policy titled, “Hand Hygiene,” published 11/06/2023, revealed, “The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used.” In part, the table indicated hands will be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water” and “immediately after removing gloves.” Observation of the dialysis treatment area on 09/24/2025 at 2:32 PM revealed PCT4 lowered her personal protective equipment (PPE) face shield from the top of her head to her face with her bare hand. PCT4 entered Station 10, obtained and applied a pair of gloves from the chairside table, and touched the dialysis machine. During an immediate interview with PCT4 on 09/24/2025 at 2:39 PM, she confirmed she was trained and expected to perform hand hygiene before she touched patient care equipment. During a concurrent interview and observation of the water test in the water purification system area on 09/24/2025 at 2:44 PM, PCT3 wore a pair of gloves while performing the water test. After completion of the water test, PCT3 removed her pair of gloves and failed to perform hand hygiene. PCT3 confirmed she was trained and expected to perform hand hygiene after removing gloves. During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he confirmed staff should perform hand hygiene after they removed their gloves and before they touched patient care equipment. During an interview with the Clinic Manager on 09/24/2025 at 3:02 PM, she stated staff were trained and expected to perform hand hygiene before they touched patient care equipment and after they removed their gloves.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 35949 Based on observation, interview, and review of facility policy, the facility failed to dedicate and label all equipment and supplies used to care for dialysis patients positive for bloodborne pathogens in 1 of 1 isolation rooms. Failure to dedicate and label equipment and supplies used when treating dialysis patients who required bloodborne pathogen isolation had the potential to provide a mode for cross-contamination, the potential spread of bloodborne pathogens, and negatively impact the well-being of the 39 patients who received dialysis treatments at the facility. The findings include: Review of the facility policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen,” published 06/04/2025, revealed, “All supplies used in the isolation room/area such as clamps, blood pressure cuffs, testing reagents, etc. [et cetera, and other things], should be labeled ‘isolation’ and not routinely removed.” During a concurrent interview and observation of the isolation room on 09/22/2025 at 9:55 AM, the Precepting Clinical Manager (PCM) stated the following unlabeled and undedicated items to the suveyor: one dialysis machine, one dialysis chair, one waste basket, one biohazard bin, one oxygen concentrator, one centrifuge, and one stethoscope. The PCM confirmed the listed items in the isolation room were not labeled and dedicated for use only in the isolation room, per policy. During an interview with Patient Care Technician (PCT) 3 on 09/26/2025 at 3:53 PM, she confirmed items used in the isolation room should be labeled. During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he confirmed the items in the isolation room should be labeled and dedicated for use only in the isolation room.”

“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: 35949 Based on observation, interview, and review of facility policy, the facility failed to utilize an aseptic technique while preparing intravenous medications for administration during 1 of 1 observations. Failure to utilize an aseptic technique while preparing intravenous medications for administration provided an opportunity for contamination and the potential to impact the well-being of the 39 patients who received dialysis treatments at the facility. The findings include: Review of the facility policy titled, “Medication Preparation and Administration Procedure,” published 08/30/2024, revealed, “Select appropriate size syringe. Remove protective cap from vial and wipe the rubber stopper with alcohol prep pad. Do not touch stopper after cleaning. Use a new alcohol prep pad for each vial.” Observation of the medication preparation area at the nurses’ station on 09/24/2025 at 2:35 PM, revealed Patient Care Technician (PCT) 4 used a needle attached to a syringe to puncture the rubber stopper of an opened medication vial. PCT4 then obtained and opened a new medication vial and used another needle and syringe to puncture the rubber stopper. During an interview with PCT4 on 09/24/2025 at 2:39 PM, she stated she was trained to disinfect the rubber stopper prior to puncturing it with a needle. PCT4 stated she “just forgot” to do so. During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he confirmed staff were expected to disinfect the rubber stopper of the medication vial before puncturing it with a needle. During an interview with the Clinic Manager on 09/24/2025 at 2:40 PM, she confirmed staff were expected to “clean” the rubber stopper of the medication vial with an alcohol pad before puncturing “each time.””

“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: 35949 Based on observation, interview, record review, and review of facility policy, the facility failed to maintain a safe environment by not removing expired patient care supplies from their active inventory in 1 of 1 treatment areas. Failure to remove expired patient care supplies from the facility’s active inventory provided the potential for staff to use supplies no longer viable or deemed unusable by the manufacturer and had the potential to negatively affect the safety of the 39 patients who received dialysis treatments at the facility. The findings include: Review of the facility policy titled, “Checking and Maintaining the Cardiac Science Powerheart Automated External Defibrillator (AED),” published 06/19/2013, revealed, “Check the expiration date on the electrodes.” Review of a facility document titled, “Emergency Code Cart, Medications and Machine Hand Crank Checklist,” dated 09/2025, revealed no expiration date was documented for the “AED pads.” During a concurrent interview and observation of the code cart with the Clinic Manager on 09/22/2025 at 2:02 PM, one package of AED pads had an expiration date of 06/24/2025. She confirmed the past expiration date and stated, “We dispose of it,” when asked what the facility’s practice was when expired supplies/items were found in the active inventory. During an interview with Patient Care Technician (PCT) 3 on 09/26/2025 at 3:53 PM, she stated she was expected to discard when supplies/items were found to be past their expiration date. During an interview with Registered Nurse (RN) 2 on 09/26/2025 at 2:25 PM, she confirmed expired supplies should “come off the [treatment] floor.” During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he confirmed staff were expected to “discard” items and supplies when found to be past their expiration date.”

“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: 35949 Based on observation, interview, record review, and review of facility policy, the facility failed to follow the bloodline manufacturer’s instructions for use (IFU) by not maintaining the arterial drip chamber fluid levels at approximately 90% full and the venous drip chamber fluid levels at approximately 70% full during 4 of 4 observations, and failed to follow the manufacturer’s IFU for maintaining the integrity of the water purification system during 3 of 3 observations. Failure to maintain all equipment in a safe and functional condition and follow the manufacturers’ IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and well-being of the 39 patients who received in-center dialysis treatments at the facility. The findings include: Review of the facility policy titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 05/05/2025, revealed, “Fill the Pre-pump arterial chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 85% - 95% full and tighten cap.” Further review revealed, “Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75%.” Review of the facility policy titled, “Equipment Installation -Operation-Maintenance-Repair-And Disposal,” published 07/30/2025, revealed, “This policy applies to all equipment that: *Removes, infuses, touches, measures, controls, or has the potential to affect the outcome of patient treatments or dialysis fluid. *Is deemed essential in performing dialysis in a safe manner; and/or *Is essential to the safe operation of the facility. This includes but is not limited to: *Medical Equipment, *Electrical Systems, *Plumbing Equipment/Systems, *Meters or Measurement Devices, *Television Mounting Hardware, *Concentrate Production and Delivery Equipment, *Water Purification Equipment, *HVAC [heating, ventilation, and air conditioning] Systems, *Life Safety Equipment/Systems, *Dialysis Chairs, *Physical Plant (ceilings, floors, etc.).” Further review revealed, “Unless otherwise directed by company policy and procedures, all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions for use (IFU).” Review of the manufacturer’s IFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” undated, revealed, “c. Maintain fluid level in arterial chamber at approximately 90% full and venous chambers at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks will also cause the chamber levels to fluctuate.” Review of the manufacturer’s IFU titled, “Installation, Testing, Maintenance Instructions,” undated, revealed, “Troubleshooting” in part, and, “Continuous discharge of the relief valve signifies a failure of some part of the device.” Review of the posting adhered to the wall above the backflow preventer titled, “Water System Component Identification Backflow Preventer Device,” undated, revealed, “Backflow devices should not demonstrate continual leaks or drips from the discharge port.” 1. Observation of the hemodialysis treatment area on 09/24/2025 at 1:47 PM revealed the arterial drip chamber fluid levels were less than (<) 90% full in Stations 3, 4, 6, 7, 9, and 16, and the venous drip chamber fluid levels were greater than (>) 70% full in Stations 3, 4, 6, 7, 10, 15, and 16. Observation of the hemodialysis treatment area on 09/24/2025 at 2:10 PM revealed the arterial drip chamber fluid levels were < 90% full in Stations 3, 4, 7, 8, 9, 12, and 16, and the venous drip chamber fluid levels were > 70% full in Stations 3, 4, 7, 9, 10, 12, and 16. Observations of the hemodialysis treatment area on 09/26/2025 at 9:02 AM and 9:12 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 3, 4, 5, 6, 9, 10, 14, 15, and 17, and the venous drip chamber fluid levels were > 70% full in Stations 2, 3, 4, 6, 9, 10, 13, 14, 15, 16, and 17. During an interview with Patient Care Technician (PCT) 3 on 09/26/2025 at 9:16 AM, she stated the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s IFU. During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he stated staff were expected to follow the bloodline manufacturer’s IFU and “should always” maintain the drip chamber fluid levels according to the manufacturer’s IFU. During an interview with the Clinic Manager on 09/26/2025 at 9:14 AM, she reviewed the manufacturer’s IFU and stated the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s IFU. 2. Observation of the water purification system on 09/22/2025 at 9:45 AM revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. Observation of the water purification system with the Clinic Manager on 09/24/2025 at 3:03 PM, revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. During a concurrent interview and observation of the water purification system with the Biomedical Technician on 09/26/025 at 8:44 AM, revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. He stated the integrity of the closed water purifications system should be maintained and the discharge port should not leak as per the wall posting.”

“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: 35949 Based on interview, record review, and review of facility policy, the facility failed to follow the individualized dialysis treatment as prescribed by the medical provider for 5 of 5 sampled patients (Patient (P) 1, P2, P3, P4, and P5). Failure to follow the medical providers’ dialysis treatment had the potential to negatively impact the effectiveness of the prescribed dialysis treatment for the 39 patients who received dialysis treatments at the facility. The findings include: Review of a facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: *Check prescribed blood flow [rate] is being achieved or reason is documented in medical record if unable to meet prescribed blood flow [rate].” 1. Review of P1’s treatment sheet dated 09/22/2025 revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). P1’s BFR was documented at 300 mL/min from 5:10 AM until 7:03 AM. There was no rationale documented why the prescribed BFR was not achieved. 2. Review of P2’s treatment sheet dated 09/08/2025 revealed a BFR of 450 mL/min. P2’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 3. Review of P3’s treatment sheet dated 09/03/2025 revealed a BFR of 450 mL/min. P3’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/05/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented between 350 mL/min and 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/10/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented between 350 mL/min and 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/12/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 350 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/15/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 350 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/17/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 350 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/19/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented between 300 mL/min and 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Review of P3’s treatment sheet dated 09/22/2025 revealed a prescribed BFR of 450 mL/min. P3’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 4. Review of P4’s treatment sheet dated 09/08/2025 revealed a prescribed BFR of 450 mL/min. P4’s BFR was documented between 350 mL/min and 400 mL/min from 6:01 AM until the treatment was terminated at 8:42 AM. There was no rationale documented why the prescribed BFR was not achieved. Review of P4’s treatment sheet dated 09/15/2025 revealed a prescribed BFR of 450 mL/min. P4’s BFR was documented as 400 mL/min from 7:31 AM until the treatment was terminated at 9:14 AM. There was no rationale documented why the prescribed BFR was not achieved. Review of P4’s treatment sheet dated 09/17/2025 revealed a prescribed BFR of 450 mL/min. P4’s BFR was documented as 400 mL/min from 6:30 AM until the treatment was terminated at 8:59 AM. There was no rationale documented why the prescribed BFR was not achieved. Review of P4’s treatment sheet dated 09/22/2025 revealed a prescribed BFR of 450 mL/min. P4’s BFR was documented as 400 mL/min from 6:32 AM until the treatment was terminated at 9:03 AM. There was no rationale documented why the prescribed BFR was not achieved. 5. Review of P5’s treatment sheet dated 09/17/2025 revealed a prescribed BFR of 400 mL/min. P5’s BFR was documented between 300 mL/min and 350 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. During an interview with Patient Care Technician (PCT) on 09/26/2025 at 3:53 PM, she stated, “We are expected to document a reason why” the prescribed BFR was not achieved. During an interview with Registered Nurse (RN) 2 on 09/26/2025 at 2:25 PM, she stated documentation such as, “decreased secondary to arterial or venous pressures” should be written by the staff when the prescribed BFR was not achieved. During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he stated staff should be “documenting reasons why” the prescribed BFR was not achieved. During an interview with the Clinic Manager on 09/26/2025 at 9:14 AM, she stated there “needs to be a note” on the treatment sheet written by staff when the prescribed BFR was not achieved.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35949 Based on interview, record review, and review of facility policy, the facility failed to monitor patients’ vital signs and machine parameters according to the expectations in their policy for 4 of 5 sampled patients (Patient (P) 1, P2, P3, and P5). Failure to monitor patients’ vital signs and/or machine parameters according to the facility’s policy during dialysis treatments provided an opportunity for changes to the patients’ vital signs, blood flow rate, dialysate flow rate, and/or arterial and venous pressures to be unrecognized and unaddressed and negatively impact the care provided to the 39 patients who received dialysis treatments at the facility. The findings include: Review of a facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “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 minutes or more often as needed but not to exceed 45 minutes or per state regulations.” 1. Review of P1’s treatment sheet dated 09/22/2025 revealed machine parameters were not documented for 61 minutes, from 5:31 AM until 6:32 AM. 2. Review of P2’s treatment sheet dated 09/12/2025 revealed the patient’s vital signs and machine parameters were not documented for 60 minutes, from 2:02 PM until 3:02 PM. 3. Review of P3’s treatment sheet dated 09/15/2025 revealed machine parameters were not documented for 48 minutes, from 2:48 PM until 3:36 PM. 4. Review of P5’s treatment sheet dated 09/17/2025 revealed machine parameters were not documented for 60 minutes, from 12:01 PM until 1:01 PM. Review of P5’s treatment sheet dated 09/19/2025 revealed the patient’s vital signs were not documented for 61 minutes, from 10:31 AM to 11:32 AM, and machine parameters were not documented for 57 minutes, from 10:31 AM until 11:28 AM. Review of P5’s treatment sheet dated 09/22/2025 revealed machine parameters were not documented for 61 minutes, from 12:04 PM until 1:05 PM. During an interview with Patient Care Technician (PCT) 3 on 09/26/2025 at 3:15 PM, she stated a patient’s vital signs and machine parameters were to be documented every “half an hour, up to [every] 45 minutes.” During an interview with Registered Nurse (RN) 2 on 09/26/2025 at 2:25 PM, she stated a patient’s vital signs and machine parameters should be documented “every 30 minutes.” During an interview with the Medical Director on 09/26/2025 at 2:59 PM, he confirmed staff were expected to document a patient’s vital signs and machine parameters “every 30 minutes.” During an interview with the Clinic Manager on 09/26/2025 at 9:14 AM, she stated staff were trained and expected to document a patient’s vital signs and machine parameters “every 30 minutes and no more than every 45 minutes.””