Fmc - Rcg Gainesville

“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: 50523 Based on observation, staff interviews, a review of facility policy and procedures (P&P), and a review of the recommendations of the Centers for Disease Control and Prevention (CDC), it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCT AA and PCT BB) observed, practiced infection control techniques to prevent transmission of infection among chronic hemodialysis patients by first making sure that the hemodialysis chair was vacated by the patient before beginning disinfection. This deficient practice increased the risk for cross-contamination and transmission of dangerous pathogens, potentially affecting negatively, the health and safety of 16 of 16 patients who were receiving hemodialysis treatment at Station (S) 5, S6, S7, S8, S9, S11, S12, S13, S15, S16, S18, S20, S21, S22, S23 and S24), who were dialyzing at the time of this observation. The facility census was 84. Findings include: During an observation in the Patient Treatment Room on 8/25/25 between 10:45 a.m. and 12:41 p.m., the following was revealed: - PCT AA was observed disinfecting the hemodialysis machine for the next patient at S21, while Patient (P)#1 was still seated at his hemodialysis chair (at S21), holding his vascular access site to achieve hemostasis (cessation of bleeding). This breach in infection control technique had the potential for cross contamination. - PCT BB repeated this breach in infection control techniques by disinfecting the hemodialysis machine for the next patient at S15, then proceeded to set up a new treatment by connecting new bloodlines and a new dialyzer for the next patient, while P#2 was still seated at his hemodialysis chair (at S15), holding his vascular access site to achieve hemostasis. - During an interview on 8/25/25 at 12:31 p.m., PCT AA stated that disinfection and setup of a new machine for the next patient should not begin until the previous patient had vacated the hemodialysis chair. - During an interview on 8/25/25 at 12:38 p.m., PCT BB stated that the current patient had to leave the station before the machine was disinfected and prepared for the next treatment. - During an interview on 8/25/25 at 1:45 p.m., The Director of Operations (DO) acknowledged the above findings and stated that all Direct Care Givers (PCTs and Registered Nurses) would be educated and inserviced on proper cleaning and disinfection of the dialysis station before seating a new patient. - A review of Policy: 47806 Version 14 titled, “Cleaning and Disinfecting the Dialysis Station” with latest revision date of September 5, 2023, stated: Vacating the Machine To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient. - The CDC recommends that cleaning and setting up a hemodialysis machine should not begin until the previous patient has completely vacated the station. Performing these tasks while a patient is still in the chair creates a high risk of cross-contamination and is a violation of infection control standards.”

“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: 33921 Based on observation, patient and staff interviews, a review of facility Policy and Procedures (P& P), and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCTs AA and CC) observed, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes and after touching contaminated equipment; and failure of three of three Patients (P), (P#8, P#9, and P#10) observed to perform hand hygiene prior to treatment and after holding access sites. Failure to perform infection control techniques such as hand hygiene, increased the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect 14 of 14 patients (P), (P#5, P#6, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, and P#22), who were undergoing hemodialysis treatment at the time of this observation and eight of eight Direct Patient Care Staff (Registered Nurses - RNs AA, BB, and CC), Patient Care Technicians (PCTs AA, BB, CC, DD and EE), who were present during this observation. The facility in-center census was 82. Findings were: During observation in the Patient Treatment Room on 9/3/24 between 10:25 a.m. and 12:10 p.m., the following was revealed: - PCT AA was observed preparing P#10 for initiation of hemodialysis treatment at Station (S), (S13). PCT AA took off her dirty gloves and without performing hand hygiene, she obtained clean supplies from the supply cabinet. - At 10:46 a.m., PCT CC was observed during discontinuation of P#11’s hemodialysis treatment at S7. PCT CC removed P#11’s arterial needle and realized that P#11 did not have gloves to hold his access site. Without changing gloves (dirty) and without performing hand hygiene, PCT CC grabbed clean gloves from the glove box (clean) for P#11 to use. - At 10:55 a.m., PCT CC was observed setting up the dialysis machine at S8. PCT CC touched her face mask three times wearing the same contaminated gloves, then she removed her mask (dirty) and placed it in her pocket (clean). PCT CC continued setting up the machine without changing gloves and without performing hand hygiene. Then wearing the same contaminated gloves, PCT CC went to S5 to document patient data. PCT CC discarded her dirty gloves and donned on clean gloves without performing hand hygiene between glove changes, then continued setting up the machine at S8. - At 11:16 a.m., PCT CC was observed checking the pH (acidity) of the dialysate at S8. PCT CC then removed her dirty gloves and donned new clean gloves without performing hand hygiene between glove changes. PCT CC proceeded to discontinue treatment of P#12 at S6. After clamping P#12’s venous lines (dirty), PCT CC went to obtain another bag of Normal Saline from the supply cart (clean), wearing the same contaminated gloves (dirty). - PCT CC acknowledged the above observations on 9/3/24 at approximately 12:00 p.m. - Patients (P#8 and P#9) did not perform hand hygiene after holding their access sites at the end of their treatment and before leaving the Patient Treatment Room. P#8 and P#9 were not reminded to wash their hands by PCT BB who assisted them to the weighing station. - P#10 did not perform hand hygiene upon entering the Patient Treatment Room and prior to the initiation of his hemodialysis treatment at S13. P#10 stated on 9/3/24 at 11:45 a.m., that he forgot to wash his hands. - A review of the facility’s Policy with Reference Number: 47664, titled, “Hand Hygiene” and published on 11/06/2023, Volume 8, stated: ... Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water, when: - Before and after direct contact with patients - Entering and leaving the treatment area - Before performing any invasive procedure... - Immediately after removing gloves - After contact with body fluids... - After contact with inanimate objects near the patient - When moving from a contaminated body site to a clean body site of the same patient - After contact with the dialysis wall box... - After contact with other objects within the patient station or treatment space... Hand Hygiene: Patients - Patients should perform hand hygiene if able, prior to and after each dialysis treatment... - To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ...”

“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: 33921 Based on observations, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s policies and procedures (P & P), it was determined that the Infection Control Committee failed to ensure that all Direct Patient Care (DPC) Staff, (Registered Nurses - RNs AA, BB, and CC, and Patient Care Technicians - PCTs AA, BB, CC, DD, and EE), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of three of 20 sharps containers observed at Stations (S) (18, 20, and 24) between patient use; and to ensure that two of two Patient Care Technicians (PCTs AA and CC) observed, while performing pre-dialysis assessment, utilized appropriate infection control techniques to prevent cross contamination. This failure could lead to the transmission of dangerous pathogens through cross contamination; and had the potential to negatively affect the health and safety of 14 of 14 patients (P), (P#5, P#6, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, and P#22), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 82. Findings were: During observation in the Patient Treatment Room on 9/3/24 between 10:25 a.m. and 12:10 p.m., the following was observed: - The covers of Sharps Containers at Stations 18, 20, and 24, had two to three dried up drops of blood ranging from approximately 0.5 cm (centimeter) to 1.5 cm. - RN BB was notified of this observation on 9/3/24 at 11:30 a.m. She acknowledged this observation and proceeded to wipe them off. - PCT CC disinfected her stethoscope with an alcohol pad (without wearing gloves), while at the supply cart. Wearing a new pair of gloves, PCT CC used the stethoscope to auscultate (listen to the sound of the patient’s access), (dirty) at S8. Wearing the same contaminated gloves (dirty), PCT CC disinfected the bell of the stethoscope with a hand sanitizer at S8 after auscultating patient, then slung it at the back of her neck (clean). - PCT AA disinfected her stethoscope with an alcohol pad prior to auscultating patient’s access (dirty) at S13, then slung the stethoscope at the back of her neck (clean) without disinfecting it after use. - PCT AA stated on 9/3/24 at 11:30 a.m., that she didn’t think about disinfecting the stethoscope after use. A review of facility policy with Reference Number 47806, titled, “Cleaning and Disinfecting the Dialysis Station”, with published date of 9/05/2023, version 14, stated: - The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station. Work Surface Cleaning and Disinfection with Visible Blood equal to (=) or less than (<) (sic) 10 mL (milliLiter - sic) and Other Potentially Infectious Material using Bleach Solutions: ... Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, and a review of facility records, it was determined that the facility failed to ensure that one of one Patient Care Techinician (PCT BB) observed and interviewed, who was assigned the task of testing the water quality used for dialysis, understood and maintained knowledge of the acceptable range of the Total Chlorine Test result using RPC (K100-0118 (/F) Ultra-Low Total Chlorine Test Strips. A lack of understanding and knowledge of the acceptable and unacceptable levels of Total Chlorine in the water used for dialysis had the potential for risk to all hemodialysis patients of hemolysis (destruction of red blood cells), if PCT BB did not know when to alert the management personnel (i.e., Charge Nurse, Biomed Technician) when a Chlorine Breakthrough (total chlorine levels in the water exceed the maximum safe level of 0.1 mg/L (milligrams per liter) may occur. During observation of PCT BB’s demonstration of Total Chlorine Test using RPC (K100-0118 (/F) Ultra-Low Total Chlorine Test Strips, on 9/3/24 at 11:45 a.m., PCT BB demonstrated the procedure correctly according to the manufacturer’s Directions for Use (DFU), however, PCT BB was not able to provide the correct information for acceptable and unacceptable levels of Total Chlorine in the water used for dialysis. PCT BB stated on 9/3/24 at 11:50 a.m., that the acceptable range was 0.0 to 0.02. PCT BB did not know what to do if the Total Chlorine Test strip showed greater than (>) 0.10 ppm (parts per million). A review of facility Policy and Procedure with Reference Number: 25909, titled, “Carbon Filtration Chlorine Breakthrough Action Plan for Central Water”, with published date of 05/02/2022, version 7, stated: Policy: Each facility/program will take corrective action when the total chlorine levels in water exiting the carbon filters or reverse osmosis (RO) machine(s) are equal to or greater than the 0.10 ppm action level set for total chlorine. Breakthrough Procedure: WARNING: Patient treatments may NOT be conducted if the chlorine levels exiting either the polisher carbon filter (or polisher bank of filters), the reverse osmosis machine or the purified water distribution system are equal to or greater than 0.10 ppm. A review of PCT BB’s personnel records showed the following: - Hire date - 12/11/23 - Annual Water Treatment Competency date - 8/29/24 - Annual Water Treatment Exam date - 8/29/24 - Total Chlorine Test Training - 2/21/24”