University Kidney Center Bluegrass, LLC

“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 facility policy review, the facility failed to ensure its patient care staff performed hand hygiene prior to touching patient care equipment (dialysis machine) before patient contact. Observation revealed four staff who included Certified Clinical Hemodialysis Technicians (CCHTs), #6, #7, #8, and Registered Nurse (RN) #4, failed to perform hand hygiene: before they touched the dialysis machine; before patient contact; after they removed their gloves; and before they touched patient care supplies. The failure provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 70 patients receiving dialysis treatments and/or home therapy oversight at the facility. The findings include: Review of the facility policy titled, “G40 Infection Control,” revised 11/29/2022, revealed, “8. Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items.” Observation of the dialysis treatment area on 11/13/2024 with the Clinic Manager (CM) revealed the following: - At 9:55 AM, CCHT #6 was observed typing on a computer keyboard near the nurses’ station while holding a pair of gloves in her left hand. CCHT #6 was observed to apply the pair of gloves, enter Station 13, and touch the dialysis machine. - At 9:58 AM, CCHT #6 was observed typing on a computer keyboard near Station 15. CCHT #6 was observed to obtain and apply a pair of gloves, enter Station 15, and touch the dialysis machine. - At 10:25 AM, CCHT #6 was observed in Station 14 while wearing a pair of gloves. CCHT #6 was observed to apply a personal protective equipment (PPE) mask with her gloved hands and then to touch Patient #8. - At 10:45 AM, CCHT #7 was observed in Station 12 while wearing a pair of gloves. CCHT #7 was observed to exit the station, remove the pair of gloves, and touch his PPE eyewear. - At 10:54 AM, CCHT #8 was observed in Station 12 while wearing a pair of gloves. CCHT #8 was observed to exit the station, remove the pair of gloves, and type on a computer keyboard near Station 12. During interview at 10:56 AM, CCHT #8 confirmed she had not performed hand hygiene after removing her gloves; however, had been trained and was expected to do that. - At 11:09 AM, RN #4 was observed touching her hair then obtaining and applying a pair of gloves. RN #4 was observed to then enter Station 7 and touch the dialysis machine. During interview at 11:12 AM, RN #4 confirmed she had not performed hand hygiene after touching her hair and before applying her gloves. She confirmed however, she had been trained and was expected to perform hand hygiene before she touched patient care equipment. - At 11:17 AM, CCHT #7 was observed in Station 5 while wearing a pair of gloves, touching his PPE mask and eyewear with his gloved hands. CCHT #7 was then observed to touch the patient care supplies on the chairside table. During interview at 11:22 AM, CCHT #7 acknowledged he had touched his PPE mask and eyewear with his gloved hands. He acknowledged however, he had been trained and was expected to perform hand hygiene after he removed his gloves and before he touched patient care supplies. During interview on 11/13/2024 at 11:25 AM, the CM confirmed staff were trained and expected to: perform hand hygiene before they touched patient care equipment; before patient contact; after they removed their gloves; and before they touched patient care supplies. During interview on 11/15/2024 at 10:03 AM, the In-Center Medical Director confirmed staff were expected to: perform hand hygiene before they touched patient care equipment; before patient contact; after they removed gloves’ and before they touched patient care supplies.”

“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: 35949 Based on observation, interview, and facility policy review, the facility failed to prevent inaccurate arterial and venous pressure readings and possible blood cross contamination by not immediately removing the external transducer protector (TP, a filter which helped prevent the passage of bacteria, viruses, particulate matter, and fluid/blood to the dialysis machine by way of the arterial and venous pressure ports) when they became wet with blood or other fluid, during 1 of 1 observations. The failure had the potential to cause inaccurate pressure readings and possible contamination of the dialysis machine’s transducer component and the potential to expose the 38 in-center patients to blood-borne pathogens. The findings include: Review of the facility policy titled, “G40 Infection Control,” revised 11/29/2022, revealed, “15. If the dialysis machine uses transducer protectors, the transducer protectors shall be changed between each patient treatment and whenever they are found to be wet during a patient treatment.” Observation of the treatment area on 11/15/2024 from 9:25 AM until 9:55 AM, with the Clinic Manager (CM), revealed a wet external TP on the venous pressure port of the dialysis machine located in Station 5. During interview on 11/15/2024 at 9:45 AM, Certified Clinical Hemodialysis Technician #7 confirmed he had been trained and was expected to change the external TP when it became wet. During interview on 11/15/2024 at 9:55 AM, the CM confirmed staff had been trained and were expected to remove external TPs when they became wet. During interview on 11/15/2024 at 10:03 AM, the In-Center Medical Director confirmed staff were expected to change the external TP when they became wet.”

“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, manufacturer’s directions for use (DFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments. Observation revealed the facility failed to maintain the arterial drip chamber fluid levels at 85% - 95% full and the venous drip chamber fluid levels at 65% - 75% full during 3 of 3 observations. The failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 38 patients who received in-center dialysis treatments at the facility. The findings include: Review of the facility procedure titled, “IC30 Bloodline Setup with Dry Pack Dialyzer,” effective 06/12/2024, revealed, “Actions: 25. Using a blue clamp (or other color Kelly clamp) the arterial [line] below the “T”, then open the end cap of the pigtail to fill the arterial [drip] chamber to the suggested fill level. Close the end cap and remove the Kelly clamp. Comments/Rationale: Blood chamber fill volume: Combisets: 85- 95% full.” Further review revealed “Actions: 28. Open the clamp on the venous drip chamber access port line. Open the end cap to fill the venous [drip] chamber to the suggested fill level. Close the end cap and close the clamp. Comments/Rationale: Blood chamber fill volume: Combisets: 65% - 75% full.” Review of the manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” revealed, “2. During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks [sic] will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 11/13/2024 at 9:54 AM revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 1, 5, 8, 9, 10, 11, 14, and 16, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 1, 2, 5, 8, 9, 10, 11, 14, and 16. Observation of the hemodialysis treatment area on 11/15/2024 at 9:25 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 1, 3, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16, and the venous drip chamber fluid levels were > 75% full in Stations 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16. Observation of the hemodialysis treatment area on 11/15/2024 at 9:35 AM, with the Clinic Manager (CM), revealed the arterial drip chamber fluid levels were < 85% full in Stations 1, 2, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16, and the venous drip chamber fluid levels were > 75% full in Stations 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16. During interview on 11/15/2024 at 9:45 AM, Certified Clinical Hemodialysis Technician #7 stated he had been trained to fill the arterial and venous drip chambers “to the line.” During interview on 11/15/2024 at 9:55 AM, the CM confirmed the drip chamber fluid levels were not being maintained according to the manufacturer’s DFU. The CM also confirmed staff were expected to maintain the drip chamber fluid levels according to the manufacturer’s DFU. During interview on 11/15/2024 at 10:03 AM, the In-Center Medical Director confirmed the staff were expected to follow the manufacturer’s DFU. During interview on 11/15/ 2024 at 1:40 PM, Registered Nurse (RN) #3 confirmed the arterial drip chamber fluid levels “should be higher than the venous” drip chamber fluid levels.”

“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 facility policy review, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 2 of 2 sampled in-center patients, Patients #1 and #2. The failure had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 38 in-center patients who received dialysis treatments at the facility. The findings include: Review of the facility policy titled, “IC08 Monitoring & Documentation of Patient Care During Treatment,” revised 11/29/2022, revealed, “15. Information that must be entered manually includes, but is not limited to: note documenting the current patient status at each check, reasons for and response to any PRN [as needed] medication administration, IV [intravenous] fluid administration, interventions for unexpected situations, such as slowing blood flow for access problem, target weight change, decrease in UFR [ultrafiltration], etc. [et cetera, and other similar things], any follow-care arrangements made for follow-up care after the patient’s treatment, changes in the patient’s condition compared to pre-dialysis, early sign-off (Each time a patient signs off early the nurse must document a detailed progress note that includes counseling of the potential risks of discontinuing treatment early), if the patient’s prescription was not met for any reasons (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” 1. Review of Patient #1’s treatment sheet dated 10/28/2024, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). However, review revealed Patient #1’s BFR was documented as 350 mL/min during the entire treatment, with no rationale documented why the prescribed BFR was not achieved. Review of Patient #1’s treatment sheet dated 10/30/2024, revealed a prescribed BFR of 450 mL/min and a prescribed dialysate flow rate (DFR) of 800 mL/min. However, review revealed Patient #1’s BFR was documented as 350 mL/min and the DFR was documented as 500 mL/min during the entire treatment, with no rationale documented why the prescribed BFR and DFR were not achieved. Review of Patient #1’s treatment sheet dated 11/04/2024, revealed a prescribed BFR of 450 mL/min and a prescribed DFR of 800 mL/min. However, review revealed Patient #1’s BFR was documented as 350 mL/min and the DFR was documented as 500 mL/min during the entire treatment, with no rationale documented why the prescribed BFR and DFR were not achieved. Review of Patient #1’s treatment sheet dated 11/13/2024, revealed a prescribed DFR of 800 mL/min. However, record review revealed Patient #1’s DFR was documented as 500 mL/min during the entire treatment, with no rationale documented why the prescribed DFR were not achieved. 2. Review of Patient #2’s treatment sheet dated 11/08/2024, revealed a prescribed BFR of 400 mL/min. However, review revealed Patient #2’s BFR was documented as 450 mL/during the entire treatment, with no rationale documented why the prescribed BFR was not achieved. During interview on 11/14/2024 at 10:10 AM, the Clinic Manager confirmed staff were trained and expected to follow the physicians’ orders and document reasons for changes to a patients’ prescription. During interview on 11/15/2024 at 10:03 AM, the In-Center Medical Director confirmed staff were expected to document reasons for not following the physicians’ orders. During interview on 11/15/2024 at 1:40 PM, Registered Nurse (RN) #3 stated reasons for changes to the physicians’ orders “should be documented on the treatment sheet.” During interview on 11/15/2024 at 2:11 PM, Certified Clinical Hemodialysis Technician #6 stated she was expected to “chart it” when changes were made to the physicians’ orders.”