322557-Home Dialysis of Santa Fe,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 staff performed hand hygiene during 13 of 13 observations, before touching patient care equipment (dialysis machine, dialysis chair, clipboards, access lines, bloodlines), when exiting and/or entering the treatment area, and after removing gloves. 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 72 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings included: The facility’s policy titled, “Infection Control Guidelines,” effective 09/2017, indicated, “7. Thorough hand hygiene must be done after gloves are removed and between each patient contact, as well as after touching blood, body fluids, secretions, excretions, and contaminated items; before and after direct contact with patients, before performing any invasive procedure, such as initiation of treatment or administration of parenteral medications; when moving from a contaminated body site to a clean body site of the same patient (sic) immediately after gloves are removed; after contact with inanimate objects, including medical equipment or environmental surfaces at the patient stations; before entering and on exiting the patient treatment area; and before leaving the working environment is mandatory.” Observations of the dialysis treatment area on 07/31/2024 with the Clinical Manager revealed the following: - At 8:30 AM, Registered Nurse (RN) #3 was observed typing on a computer keyboard located at the nurses’ station. RN #3 exited the nurses’ station and obtained and applied a pair of gloves. RN #3 entered Station 2 and touched the dialysis machine display. - At 8:45 AM, Certified Clinical Hemodialysis Technician (CCHT) #6 was observed obtaining and applying a pair of gloves and exiting the treatment area. CCHT #6 touched the door handle to open the door to the facility lobby area and then re-entered the treatment area. CCHT #6 entered Station 7 and touched the dialysis machine. - At 8:55 AM, RN #3 was observed in Station 2, reaching under his personal protective equipment (PPE) gown to obtain a pen from his personal clothing with a gloved hand. RN #3 then obtained a clipboard from the top of the dialysis machine, wrote on the clipboard, and returned the clipboard to the top of the dialysis machine. - At 9:00 AM, CCHT #6 was observed obtaining and applying a pair of gloves. CCHT #6 touched her PPE eyewear, entered Station 7, and touched the dialysis access lines. - At 9:03 AM, CCHT #6 was observed in Station 7 wearing a pair of gloves. CCHT #6 picked up a piece of paper from the floor then touched the bloodlines attached to the dialysis machine. - At 9:04 AM, RN #3 was observed exiting Station 2. RN #3 removed a pair of gloves then touched his PPE eyewear. - At 9:10 AM, RN #3 was observed obtaining a clipboard from the nurses’ station while wearing a pair of gloves. RN #3 entered Station 2, reached under his PPE gown, and obtained a pen from his personal clothing. RN #3 then touched the machine display, exited the station, and returned the clipboard to the nurses’ station. - At 9:17 AM, CCHT #6 was observed obtaining and applying a pair of gloves. CCHT #6 touched the bathroom door in the hallway then touched the door handle to open the door to the facility lobby. CCHT #6 re-entered the treatment area, entered Station 1, and touched the blood pressure cuff. - At 9:23 AM, RN #3 was observed exiting Station 1. RN #3 removed a pair of gloves, obtained a PPE face shield, and gave the PPE face shield to CCHT #6, who was in Station 1. - At 9:35 AM, RN #3 was observed in the medication preparation area opening the supply storage cabinets. RN #3 obtained and applied a pair of gloves, obtained a clipboard from the nurses’ station, and entered Station 2. RN #3 placed the clipboard on top of the dialysis machine and then touched the dialysis chair. - At 11:27 AM, CCHT #6 was observed exiting Station 6 while wearing a pair of gloves. CCHT #6 touched her PPE eyewear, obtained a patient care supply from the clean storage area near the medication preparation area, and re-entered Station 6. CCHT #6 then touched the clipboard stored on top of the dialysis machine. - At 11:28 AM, RN #3 was observed in Station 3 while wearing a pair of gloves. RN #3 placed his gloved hands on the back of his PPE gown. RN #3 then touched the bloodlines attached to the dialysis machine. - At 11:35 AM, CCHT #6 was observed in Station 6 with her gloved hand placed on the hip area of her PPE gown. CCHT #6 then touched the dialysis machine. During an interview on 07/31/2024 at 1:10 PM, CCHT #6 confirmed she was trained and expected to perform hand hygiene before touching patients, before touching patient care equipment, and after removing her gloves. During an interview on 07/31/2024 at 2:20 PM, the Clinical Manager confirmed staff were trained and expected to perform hand hygiene before touching patients, before touching patient care equipment, and after removing their gloves. During an interview on 07/31/2024 at 4:20 PM, RN #3 confirmed he was trained and expected to perform hand hygiene before touching patients, before touching patient care equipment, and after removing his gloves.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 35949 Based on observation, interview, and facility policy review, the facility failed to disinfect items removed from the treatment stations during 4 of 4 observations. Failure to disinfect items removed from the treatment stations provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 72 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings included: The facility’s policy titled “Infection Control Guidelines,” effective 09/2017, indicated, “28. Any item taken to a patient’s dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient’s dialysis station, including those placed on top of the dialysis machines, should be disposed of, dedicated for use only on a single patient, or cleaned and disinfected (tourniquets, clamps, hemostats) before being returned to a common clean area or used for other patients. Unused medications or supplies (e.g., syringes, alcohol swabs) taken to the patient’s stations should not be returned to a common clean area or used on other patients.” Observations of the treatment area on 07/31/2024 with the Clinical Manager revealed the following: - At 9:05 AM, Certified Clinical Hemodialysis Technician (CCHT) #6 was observed entering Station 7 and obtaining a clipboard stored on top of the dialysis machine with gloved hands. CCHT #6 exited the station with the clipboard and placed the clipboard on the nurses’ station desk. - At 9:10 AM, Registered Nurse (RN) #3 was observed obtaining a clipboard from the nurses’ station with gloved hands and entering Station 2. RN #3 reached under his personal protective equipment (PPE) gown and obtained a pen from his personal clothing. RN #3 touched the dialysis machine display and exited the station with the clipboard. RN #3 then gave the clipboard to CCHT #6, who was seated at the nurses’ station desk. - At 9:32 AM, CCHT #6 was observed in Station 1 obtaining a clipboard stored on top of the dialysis machine with gloved hands. CCHT #6 touched the dialysis machine, exited the station with the clipboard, and placed the clipboard on the nurses’ station desk. - At 11:54 AM, RN #3 was observed removing used dialysate containers from the top of the dialysis machine located in Station 8. RN #3 placed the used dialysate containers on a cart in the treatment area with unused dialysate containers. During an interview on 07/31/2024 at 1:10 PM, CCHT #6 confirmed she was trained to disinfect items taken from the treatment stations. During an interview on 07/31/2024 at 2:20 PM, the Clinical Manager confirmed staff were trained and expected to disinfect items removed from the treatment stations. During an interview on 07/31/2024 at 4:20 PM, RN #3 confirmed he was trained to disinfect items removed from the treatment stations.”

“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: 35949 Based on interview and personnel record review, the facility failed to implement an ongoing training program that included documented annual skills evaluation for water testing for 3 (Registered Nurse [RN] #4, RN #5 and Certified Clinical Hemodialysis Technician [CCHT] #6) of 4 staff members responsible for water testing. Failure to annually evaluate and document staff skills for water testing competency had the potential to miss staff skills that were not in compliance with the manufacturers’ directions for use. Findings included: On 07/31/2024 at 12:12 PM, the Clinical Manager stated the facility did not have a policy for annual skills competency evaluations for staff for water testing. During an interview on 07/30/2024 at 12:42 PM, the Clinical Manager revealed she was responsible for training staff and did not perform annual skills testing for water. She stated she only performed skills testing upon hire of new employees. The Clinical Manager confirmed all floor staff were responsible for water testing before each dialysis treatment. Review of personnel records for RN #4 revealed an “Orientation/Skills Checklist: Ultra Low Total Chlorine Test Strip,” completion date of 09/02/2022. Review of personnel records for RN #5 revealed an “Orientation/Skills Checklist: Ultra Low Total Chlorine Test Strip,” completion date of 07/27/2022. Review of personnel records for CCHT #6 revealed an “Orientation/Skills Checklist: Ultra Low Total Chlorine Test Strip,” completion date of 02/03/2021. During an interview on 07/31/2024 at 2:20 PM, the Clinical Manager stated she was not aware of the requirement for annual skills competency for water testing and thus had not performed the annual testing.”