Fmc - Champaign - Urbana Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 45565 Based on observation, document review, and interview, it was determined the facility failed to ensure infection prevention and control measures were followed to prevent the potential for cross contamination. Findings include: 1. On 5/21/24 at approximately 11:10 AM, an observational tour was conducted of the treatment area. It was noted that 23 of 25 dialysis treatment chairs vinyl was torn with the foam exposed on the armrests, chair seat, and chair backs. 2. During the observational tour an interview was conducted with the Clinic Manager (E #2). E #2 stated, “We know our current chairs have holes in them and have ordered new chairs but are not sure of the arrival date. I can check on that and let you know.” 3. On 5/23/24, the policy titled “Equipment Installation-Operation-Maintenance-Repair-and Disposal” was reviewed. The policy states, “Repairs... If the faulty equipment poses a risk to the patient or staff, the device will be immediately removed from service.......” 4. On 5/22/24 at approximately 10:15 AM, and interview was conducted with the Facility Administrator (E #1). E #1 stated, “We have put the word out to other facilities to see if anyone has extra chairs. Ours new chairs have been on order but it may be another 30-60 days before they arrive. I will let you know what I find out on possibly getting chairs from our other facilities.” On 5/22/24 at approximately 2:45 PM, E #1 stated, “We have a total of 21 chairs coming from different facilities to use until our new ones arrive. They will start arriving on 5/24/24.””

“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: 45565 Based on observation, document review, and interview the Facility failed to ensure 4 of 7 bleach filled containers, used for disinfecting dialysis chairs/machines, were properly tabled and covered. Findings include: 1. During the observation tour of the treatment area on 5/21/2024 at approximately 10:30 AM - 11:30 AM, the following was noted: a. 1 jug of 1:100 (1 ml bleach: 99 ml of water) of bleach water solution did not have a lid covering it. b. 3 opaque containers were not labeled with the strength of the bleach/water solution c. 3 opaque containers were not covered with a lid. All containers lacked a lid to cover the solution from 10:30 AM - 11:30 AM. This had the potential to allow for the bleach solution to evaporate and lose its proper disinfection strength and prevents complete disinfection of dialysis stations/chairs. 2. On 5/22/2024 at approximately 1:00 PM, the policy titled “Mixing Bleach” (published 8/5/2020) was reviewed. The policy states, “4. Label opaque container with “Bleach Solution”, strength of solution, date and time prepared and your initials. 5. Cover opaque container with lid” 3. On 5/21/2024 at approximately 11:00 AM, during the observational tour, an interview was conducted with the Clinic Manager (E #2), E #2 agreed the containers should have been covered with lids securely fastened to prevent evaporation of the solution and that the lids should have been marked with the solution strength.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45565 Based on observation, document review, and staff interview, it was determined the facility failed to ensure outdated biological’s were not available for patient use. Findings Include: 1. On 5/21/2024 at approximately 12:30 PM, an observational tour of the treatment area, medication preparation area/ store room was conducted. The following was observed: a. Medication Preparation/ Store Room: 1) 3 Boxes of BD Blood Culture kits expired on 7/19/23 2) 1 Box of BD Safety Glide Needles expired on 12/31/23 2. On 5/21/2024 at approximately 3:30 PM, The policy “Storage of Supplies” (published 4/5/21) was reviewed. The policy states, “Policy... Supplies must be rotated First-in-First-out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date.” 3. On 5/21/2024 at approximately 1:00 PM, E #2 reviewed the expired biological’s and agreed the biological’s were expired. E #2 stated the expired biological’s should have not been available for patient use.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 30383 A. Based on document review and staff interview, it was determined for 2 of 4 (Pt #3, Pt #7) patient records reviewed for BFR (Blood Flow Rate) and DFR (Dialysate Flow Rate), the ESRD Facility failed to ensure the patient’s BFR and/or DFR was achieved and maintained in accordance with the dialysis prescription. Findings include: 1. The Facility policy titled “Patient Assessment and Monitoring” (published 05/01/2023) was reviewed on 5/22/24 at approximately 1:30 PM. The policy requires, “Check machine settings and measurements: check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” 2. On 5/22/24 at approximately 1:30 PM, Pt #3’s record was reviewed. Pt #3 was admitted to the facility on 10/22/19 with a diagnosis of ESRD. Pt #3’s clinical record contained a physician order dated 2/8/2024 that noted the BFR of 450 ml/min and DFR of 800 ml/min. Pt #3’s treatment sheets (7 of 10 treatments) indicated the following: 2/20/24 BFR ran at 0 (zero) at 03:56 PM 2/22/24 BFR ran at 300-400 during most of the treatment and at 03:56 PM DFR ran at 057 2/27/24 BFR ran at 400 throughout the dialysis treatment duration 3/2/24 BFR ran at 150 at 3:05 PM 3/5/24 BFR ran at 250 and DFR ran at 100 at 12:46 PM 3/7/24 BFR ran at 400 at 12:51 PM and 200 at 3:30 PM 3/9/24 DFR ran at 100 at 12:45 PM The record lacked documentation as to why the prescribed blood flow was not ran. 3. On 5/23/2024 at approximately 11:15 AM, Pt #7’s record was reviewed. Pt #7 was admitted to the facility on 1/19/2023 with a diagnosis of ESRD. Pt #7’s clinical record contained a physician order dated 12/12/2023 that noted the Blood Flow Rate (BFR) of 400. Pt #7’s treatment sheet dated 5/7/2024, 5/14/2024, and 5/18/2024 (3 of 12 treatments) indicated Pt #7 was dialyzed at a BFR of 350-450. The record lacked documentation as to why the prescribed blood flow was not ran. 4. On 05/23/2024 at 1:00 PM, an interview with the Facility Administrator (E #1) was conducted. E #1 reviewed the treatment record of Pt #7 and verbally agreed the BFR was not achieved and there was no documentation in the records indicating why. B. Based on document review and interview, it was determined that for 1 of 10 (Pt. #10) hemodialysis patients’ records reviewed, the facility failed to ensure that the prescribed treatment time was followed per physician’s order. Findings include: 1. The clinical record of Pt. #10 was reviewed on 5/23/24. Pt. #10 was admitted to the facility with a Diagnosis of End Stage Renal Disease (ESRD). The clinical record noted a physician’s order dated 3/22/24 and 4/26/24 with dialysis length of time of 5 hours and 40 minutes. Four of the twelve dialysis treatment records noted hours of treatment was 47 to 51 minutes over the ordered time. The record lacked any change in the physician orders for treatment time. 2. The policy titled “Patient Assessment and Monitoring” (published 05/01/23), was reviewed on 5/22/24 at approximately 1:30 PM. The policy noted “...3. Contact the physician as needed for additional orders...” 3. During an interview with the Facility Administrator (E#1) on 5/23/24 at approximately 11:00 AM. E#1 verbally confirmed the lack of the change in the physician’s order for the longer treatment times.”

“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: 30383 Based on document review and interview, it was determined that for 3 of 10 (Pt #1, Pt#4, Pt#5), clinical records reviewed, the Medical Director failed to ensure that staff notified the doctor of shortened treatments, as required per policy. Findings include: 1. The Facility’s policy titled, Early Termination or Arriving Late for Treatment” (Published 11/7/22), was reviewed and required, “ ...Early Termination ...The RN is responsible to notify the physician, and document on the “AMA”, or Against Medical Advice form ...Against Medical Advice Forms ...Signed with each early termination event and filed in the patient’s medical record.” 2. The clinical record for Pt #1 was reviewed on 5/21/24. The clinical record indicated that for 5 of 12 treatments reviewed, the treatments were shortened ranging from 30 minutes to 3 hours. The treatment sheets and clinical record lacked Against Medical Advice forms for the shortened treatments. 3. On 5/23/2024 at 11:30 AM an interview was conducted with the Facility Administrator (E #1). E #1 reviewed the clinical record of Pt #1 and verbally agreed the clinical record lacked Against Medical Advice forms for the shortened treatments. 4. The clinical record for Pt #4, was reviewed on 5/22/24. The clinical record indicated that for 1 of 10 treatment records reviewed, the treatment on 5/15/2024 was shortened, per patient choice, by 1 hour and 27 minutes. The treatment sheets and nursing notes for that date were reviewed and lacked documentation indicating that the Medical Director/Attending Nephrologist was notified of the shortened treatment. Unable to locate AMA form for early termination of treatment, as required by policy. 5. The clinical record for Pt #5, was reviewed on 5/22/24. The clinical record indicated that for 1 of 5 treatment records reviewed, the treatment on 4/25/2024 was shortened, per patient choice, by 2 hours and 8 minutes. The treatment sheets and nursing notes for that date were reviewed and lacked documentation indicating that the Medical Director/Attending Nephrologist was notified of the shortened treatment. Unable to locate AMA form for early termination of treatment, as required by policy. 6. On 5/23/2024 at 1:00 PM an interview was conducted with the Facility Administrator (E #1). E #1 reviewed the clinical record of Pt #1 and verbally agreed the clinical record lacked Against Medical Advice forms for the shortened treatments.”