Fmc - Pikeville

“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 4 (Certified Clinical Hemodialysis Technicians [CCHT] #6, #7, and #9, and Registered Nurse [RN] #3) of 7 observed staff performed hand hygiene after removing gloves and before touching patient care equipment (dialysis machine, blood pressure cuff). 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 63 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings included: A facility policy titled, “Hand Hygiene,” published 11/06/2023, indicated, “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 identified that, immediately after removing gloves and/or when entering and leaving the treatment area, hands were to be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water.” Observations of the dialysis treatment area on 08/28/2024 with the Clinical Manager (CM) revealed the following: - At 10:02 AM, CCHT #7 was observed exiting Station 3 while wearing a pair of gloves. CCHT #7 removed the pair of gloves and adjusted her personal protective equipment (PPE) face shield. - At 10:09 AM, CCHT #7 was observed obtaining patient care supplies from a common storage area while wearing a pair of gloves. CCHT #7 entered Station 3, placed the supplies on the chairside table, and touched the dialysis machine. - At 10:22 AM, CCHT #6 was observed in a designated dirty area while wearing a pair of gloves. CCHT #6 exited the designated dirty area, entered Station 14, and touched the dialysis machine. - At 10:24 AM, CCHT #9 was observed exiting Station 10 while wearing a pair of gloves. CCHT #9 removed the pair of gloves and obtained and applied a new pair of gloves. CCHT #9 entered Station 10 and touched the dialysis machine. - At 11:05 AM, CCHT #9 was observed obtaining a cup from a common storage area while wearing a pair of gloves. CCHT #9 entered Station 1 and touched the dialysis machine. - At 11:07 AM, CCHT #9 was observed exiting Station 2 while wearing a pair of gloves. CCHT #9 removed the pair of gloves and obtained and applied a new pair of gloves. CCHT #9 entered Station 1 and touched the blood pressure cuff. Observation of the water purification and storage area on 08/28/2024 with the Biomedical Technician revealed the following: - At 3:55 PM, CCHT #6 and RN #3 were observed performing a water test while each wore a pair of gloves. After performing the water test, CCHT #6 and RN #3 removed their gloves and prepared to leave the area. When interviewed immediately after performing the water test, CCHT #6 and RN #3 confirmed there was no hand hygiene (sanitizer and/or hand washing sink) available for use in the water purification and storage area. During an interview on 08/28/2024 at 11:08 AM, CCHT #6 confirmed he did not remove his pair of gloves and perform hand hygiene after exiting the designated dirty area before entering Station 14 and before touching the dialysis machine. CCHT #6 confirmed he was trained and expected to perform hand hygiene before touching patient care equipment. During an interview on 08/28/2024 at 11:17 AM, CCHT #9 confirmed she did not perform hand hygiene after removing her pair of gloves and before touching the dialysis machine. CCHT #9 confirmed she was trained and expected to perform hand hygiene after removing gloves and before touching patient care equipment. During an interview on 08/28/2024 at 12:00 PM, the CM confirmed staff were trained and expected to perform hand hygiene after removing gloves and before touching patient care equipment. During an interview on 08/28/2024 at 6:29 PM, CCHT #7 confirmed she was trained and expected to perform hand hygiene after removing gloves and before touching patient care equipment. During an interview on 08/29/2024 at 10:05 AM, the Medical Director confirmed staff should perform hand hygiene after removing gloves and before touching patient care equipment.”

“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 facility policy review, 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 room. Failure to dedicate and label equipment and supplies used when treating dialysis patients requiring bloodborne pathogen isolation had the potential to provide a mode for cross-contamination and the potential spread of bloodborne pathogens and negatively impact the well-being of the 63 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings included: A facility policy titled “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+),” published 11/06/2023, indicated, “All supplies used in the isolation room/area such as clamps, blood pressure cuffs, testing reagents, etc., should be labeled ‘isolation’ and not routinely removed.” An observation of the isolation room on 08/28/2024 at 7:55 PM with the Clinical Manager (CM) revealed the following unlabeled and undedicated items: two boxes of gloves, a dialysis chair, and a bottle of bleach. During an interview on 08/28/2024 at 7:55 PM, the CM confirmed the listed items in the isolation room were unlabeled and undedicated. The CM stated the items should be labeled and dedicated for use only in the isolation room. During an interview on 08/29/2024 at 10:05 AM, the Medical Director confirmed all items in the isolation room should be labeled and dedicated for use only in the isolation room.”

“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 by not maintaining 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. 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 49 patients who received in-center dialysis treatments at the facility. Findings included: A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 06/28/2024, indicated, “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 indicated, “Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65%-75% full.” The manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” indicated, “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 08/26/2024 at 11:35 AM, revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 2, 6, 7, 9, 13, 14, 15, 18, 19, and 21, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 2, 6, 7, 9, 11, 13, 14, 15, 18, and 19. Observation of the hemodialysis treatment area on 08/28/2024 at 10:01 AM, revealed the arterial drip chamber fluid levels were < 85% full in Stations 1, 2, 4, 6, 7, 8, 9, 10, 12, 13, 15, 16, 17, 18, and 21, and the venous drip chamber fluid levels were > 75% full in Stations 1, 2, 4, 7, 8, 9, 10, 11, 15, 16, 17, and 21. Observation of the hemodialysis treatment area on 08/28/2024 at 10:14 AM, revealed the arterial drip chamber fluid levels were < 85% full in Stations 2, 4, 6, 7, 8, 9, 10, 11, 12, 15, 16, 17, 18, and 21, and the venous drip chamber fluid levels were > 75% full in Stations 4, 7, 9, 10, 11, 12, 15, 17, and 21. During an interview on 08/28/2024 at 10:14 AM, the CM reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 08/29/2024 at 10:05 AM, the Medical Director confirmed the staff should follow the manufacturer’s DFU.”