Fmc - Hoffman Estates

“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: 50411 Based on document review, observation, and interview, it was determined that for 4 of 5 staff (E#3, E#5, E#6, and E#7) observed initiating dialysis treatments for patients, the Facility failed to ensure that staff performed appropriate hand hygiene as required.. Findings include: 1. The Facility’s policy titled, “Hand Hygiene” (effective 11/6/2023) was reviewed on 5/22/2024 and required, “...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: Before and after direct contact with patients,... After contact with inanimate objects near the patient...” 2. Observational tour of the dialysis treatment area was conducted on 5/20/2024, between approximately 9:00 AM and 10:45 AM. - At approximately 9:11 AM, a Patient Care Technician/PCT (E#3) came onto the treatment floor and put on a previously used gown and faceshield. E#3 then put on new gloves without first performing hand hygiene, and then proceeded to provide patient care. - At approximately 9:13 AM, a PCT (E#7) discontinued dialysis treatment for a patient. E#7 removed the first dialysis needle with gloved hands and placed an access clamp over the site. E#7 then went to grab a glove from a clean box to give to the patient to wear. E#7 did not remove E#7’s gloves and perform hand hygiene prior to retrieving the glove from the clean supply area. - At approximately 9:20 AM, a PCT (E#5) was preparing to initiate dialysis for a patient. As E#5 was preparing to cannulate (insertion of dialysis access needle) the patient, E#5 touched E#5’s face shield with a gloved hand to adjust it and then proceeded to cannulate the patient without performing hand hygiene as required. - At approximately 9:24 AM, PCT (E#6) returned to the treatment floor and put on a previously used gown and faceshield. E#6 then put on new gloves without first performing hand hygiene, and then proceeded to provide patient care. 3. An interview was conducted with Registered Nurse (E#2) on 5/20/2024, at approximately 11:46 AM. E#2 stated that PPE (personal protective equipment) such as faceshields and gowns are considered dirty and staff should wash hands after putting them on. E#2 stated that gloves should be changed and hands sanitized when going to from dirty to clean tasks or areas.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 50411 Based document review, observation, and interview, it was determined that for 1 of 2 Staff (E#5) observed initiating dialysis treatment, the Facility failed to ensure that staff performed arteriovenous fistula (AVF) / graft (AVG) access site cannulation (needle insertion) according to infection control guidelines/policies. Findings include: 1. The Facility’s Policy titled, Access Assessment and Cannulation (published 5/6/2024), was reviewed on 5/22/2024, and required that “...Skin Disinfection ...Step 2 Perform skin asepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. Note: This method minimizes the risk of contaminating the second site while cannulating the first site...” 2. During a tour of the dialysis treatment area, on 5/20/2024, the following was observed: - At approximately 9:20 AM, a Patient Care Technician/PCT (E#5) was preparing a patient’s AVG for dialysis treatment. E#5 disinfected the first access site with an alcohol pad as required. E#5 then proceeded to palpate (touch) the first access with a gloved finger before inserting the needle. E#5 did not disinfect the access after touching it. 3. An interview was conducted with PCT (E#3) on 5/22/2024 at approximately 10:30 AM. E#3 stated that the arteriovenous fistula or graft (AVF/AVG) site has to be disinfected prior to cannulation and should not be touched prior to cannulation. E#3 stated that if the site is touched, it has to be disinfected again prior to cannulation.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 3 of 6 months (February, March and May 2024) reviewed, the Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water treatment system. This had the potential to affect the 67 in-center dialysis patients on census. Findings include: 1. The Facility’s policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems” (dated 3/16/2023), was reviewed and required, “...microbiological samples will be collected no less than monthly...Samples will be collected prior to disinfection and within 96 hours of system disinfection... Sample should be taken as close as practical but before the start of a disinfection cycle...” 2. The Facility’s RO (water purification system) Disinfection Logs from December 2023 to May 2024 was reviewed and indicated that the RO was disinfected weekly on Thursdays. 3. The Facility’s Water Culture/Endotoxin Logs from December 2023 to May 2024 were reviewed and indicated that water culture and endotoxin samples were collected on Friday (day after disinfection) for the months of February (2/16/2024), March (3/8/2024), and May (5/10/2024). 4. An interview was conducted with Biomedical Technician (E#4) and Area Technical Operations Manager (E#8) on 5/21/2024, at approximately 1:30 PM. E#4 stated that the patient care technicians are the ones who perform the weekly disinfection of the RO. E#4 stated that E#4 comes in once a month to draw samples for cultures and endotoxins. E#4 stated that E#4 tries to obtain the samples by the morning of the day of disinfection (Thursday) or at least within 96 hours of disinfection. E#4 stated that Fridays are not an ideal day to draw due to the fact that the samples need to reach the lab within 48 hours or it will be canceled. E#8 stated that samples should be collected that would represent the worst case scenario (longest period as practical from the last disinfection). E#8 stated that the samples should not be collected on Friday following a Thursday RO disinfection as this would be more in the post-disinfection phase.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 1 of 2 patient (Pt. #7) observed with vascular access clamps, the Facility failed to ensure that vascular access sites were assessed when clamps were in use. Findings include: 1. The Facility’s policy titled, “Venipuncture Site Clamps” (dated 7/5/2022), was reviewed and required, “...While the clamp remains on the access, check for thrill [a vibration felt over a blood vessel indicating blood flow] every 10 minutes...” 2. During a tour of the dialysis treatment area on 5/20/2024, between 9:02 AM and 9:18 AM, a patient had a clamp on the access site post-dialysis treatment. During this time (approximately 16 minutes), the access site was not assessed for a thrill. At 9:18 AM, a Patient Care Technician (E#6) removed the clamp from the site but did not assess for a thrill (by palpating/touching the site). 3. An interview was conducted with Patient Care Technician (E#3) on 5/22/2024, at approximately 10:30 AM, E#3 stated that typically clamps shouldn’t be on for more than 5 minutes at a time as it can ruin the access site. E#3 stated that if it needs to be used longer than 5 minutes, the staff should be checking the patient’s condition and to see if the site is still bleeding. E#3 stated that while they are putting on the clamp, they should check for the thrill. E#3 stated that checking for the thrill requires using the fingers to palpate the site and can take 15-20 seconds to make sure that the thrill is present and palpable from the access site.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that the Facility’s Medical Director (MD#1) failed to ensure that staff adhered to policies and procedures by ensuring expired supplies and medications were not available for use. This had the potential to affect the 67 in-center dialysis patients on census. Findings include: 1. The Facility’s policy titled, “Expiration Dates Sterile Supplies” (dated 7/4/2012), was reviewed and required, “...checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date...” 2. During a tour of the Facility on 5/20/2024, the following was observed: - At approximately 11:00 AM, 1 of 1 bottle of Minncare (water purification system disinfectant) residual test strips observed in the water treatment room had an expiration date of 4/29/2024 (bottle was labeled with an opened date of 2/9/2024). - At approximately 11:10 AM, 1 of 2 Tuberculin (tests for Tuberculosis/lung infection) vial in the medication refrigerator had an opened date of 4/6/2024, and the manufacturer’s instructions on the box required to discard the vial 30 days after opening. - At approximately 11:12 AM, 10 of 10 vials of COVID (respiratory infection) vaccines in the medication refrigerator had an expiration date of 2/23/2024 (10-week refrigeration expiration date). - At approximately 11:15 AM, 1 of 3 boxes of glucometer (tests for blood sugar level) control solutions in the nursing cart had an expiration date of 2/19/2024. 3. An interview was conducted with Registered Nurse (E#2) on 5/20/2024, at approximately 11:15 AM. E#2 stated expired supplies and medications should be discarded and not available for use. E#2 stated that they may have held onto the COVID vaccines to send back to the manufacturer, and stated that they should have been kept separated from the other patient medications and/or clearly labeled that they were not for use. 4. A telephone interview was conducted with the Medical Director (MD#1) on 5/22/2024, at approximately 10:50 AM. MD#1 stated that MD#1 works closely with the Clinic Manager and Charge Nurse to ensure that the clinic is running smoothly and policies are implemented and followed. MD#1 stated that ensuring supplies are not expired should apply to all supplies at the Facility, not just sterile ones. MD#1 stated that it’s important to make sure supplies like water testing strips are not expired to ensure reliable results are obtained.”