Davita Tazewell County Dialysis

“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: 50688 Based on observation, document review, and interview, it was determined the Facility failed to ensure the use of aseptic technique during medication preparation. Findings include: 1. During an observation in the facility treatment area on 5/30/2025 at approximately 8:30 AM, aseptic technique was not used when preparing medication, as required by policy. 2. The Registered Nurse (E #6) was observed preparing medication for several patients by drawing up heparin into syringes from multi-use vials. E #6 did not perform hand hygiene prior to beginning the medication preparation. During the medication preparation, E #6 was also observed touching their hand to their chin and their nose, as well as reaching into the pocket of their pants to retrieve a pen, without performing hand hygiene after each of these occurrences. 3.The Facility’s policy titled, “ Medication Policy” (Published September 2007, Revised October 2023), was reviewed and requires, “21. An aseptic environment and aseptic technique is used when preparing medications. Careful attention to proper hand washing is performed at this time.” 3. On 5/30/2025 at approximately 9:20 AM, an interview was conducted with the Facility Administrator (E #1). E #1 verbally agreed hand washing should have been completed, as stated per policy.”

“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 A. Based on observation, document review, and interview, it was determined the Facility failed to ensure the proper cleansing of single and multidose vials to prevent the potential for cross-contamination. Findings include: 1. An observational tour was conducted on 5/28/2024 from 10:30 AM to 12:00 PM. At approximately 10:55 AM, Registered nurse (E#2) was observed at the medication preparation area. E #2 failed to clean the septum of the single dose vial of Venofer (100 mg per 5 ml), before inserting the needle to withdraw the medication. At approximately 11:10 AM, E #2 was observed withdrawing Heparin (30,000 USP Units/30 ml). E #2 failed to clean the septum of the multidose vial before inserting the needle to withdraw medication. 2. On 5/29/24 at approximately 10:10 AM, (E#2) was observed at the medication preparation area. E#2 failed to clean the septum of the multidose vial of Heparin (30,000 USP Units/30 ml), before inserting the needle to withdraw medication. 3. The policy titled “Medication Policy” (revised 10/23) was reviewed on 5/29/2024 at approximately 3:15 PM. The policy noted, “ ...21. An aseptic environment and aseptic technique is used when preparing medications...” 4. An interview with the Facility administrator (E #1) was conducted on 5/29/2024 at approximately 2:50 PM. E #1 verbally confirmed E#2 should have used an aseptic technique. B. 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 5/28/2024 at approximately 11:40 AM, during an observational tour of the storeroom area, three gallons on Naturalyte 1.0K acid were labeled as expired 7/2023 and were on a shelf available for patient use. 2. Upon review of policy “1-20-14 Acid concentrate neutralization and disposal policy-small batch (less than (<) five (5) gallons)”, the policy states, “3. ...The Facility Administrator or designee is responsible for verifying that all residual acid concentrate solutions are disposed of properly”. 3. An interview was conducted with BioMed technician (E #3) during the observational tour. E #3 confirmed that the acid needed neutralized and removed from clean storage area. C. Based on observation, document review, and interview, it was determined the facility failed to ensure open and discard dates for blood glucose control solutions and test strips were documented on the bottles, as required per policy. Findings include: 1. During an observational tour of the facility on 5/28/2024, the EmbracePro control solution bottles and test strip bottles in the patient treatment area did not have an open or discard dates written on the bottles, as required per policy. 2. The Facility’s policy titled, “ EmbracePro Blood Glucose Monitor: Quality Control (QC)” Prescribed Treatment Time Not Met” (Published February, 2020, Revised September, 2020), was reviewed and requires, “Discard control solutions 90 days after opening or on the expiration date printed on the bottle, whichever comes first. When opening a new control solution, write the open and discard dates on the side of the bottle along with the teammate initials”. The policy further requires “Do not use test strip past expiration date. Discard test strips four (4) months after opening or on the expiration date printed on the bottle, whichever comes first. When opening new test strips, write the open and discard dates on the side of the bottle along with teammate initials”. 3. On 5/29/2024 at 11:35 AM, an interview was conducted with the Facility Administrator (E #1). E #1 examined the control bottles and test strip bottles and verbally agreed the control solution bottles and test strip bottles lacked the open dates and discard dates.”

“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: 45565 Based on document review and staff interview, it was determined for 2 of 4 patient records reviewed, 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. On 5/28/24 at approximately 1:00 PM, Pt #1’s record was reviewed. Pt #1 was admitted to the facility on 05/23/2024 with a diagnosis of ESRD. Pt #1’s clinical record contained a physician order dated 5/23/2024 that noted, “BFR of 450 ml/min and DFR of 600 ml/min”. Pt #1’s treatment sheets dated 3/20/24, 3/22/24, 3/27/24, 3/29/24, 4/2/24, 4/5/24, 5/22/24, and 5/24/24 (9 of 12 treatments) indicated the following: 3/20/24 BFR ran at 200 ml/min at 10:53 AM and 300 ml/min at 1:31 PM 3/22/24 BFR ran at 420 ml/min at 1:01 PM and 1:31 PM, 400 ml/min at 2:01 PM, 350 ml/min at 2:31 PM, and 310 ml/min at 2:33 PM. The DFR ran at 500 ml/min the entire treatment 3/27/24 DFR ran at 500 ml/min at 11:02 AM and 11:31 AM 3/29/24 DFR ran at 500 ml/min at 11:01 AM and 11:31 AM 4/2/24 DFR ran at 500 ml/min the entire treatment 4/5/24 DFR ran at 500 ml/min the entire treatment 5/22/24 DFR ran at 500 ml/min at 10:00 AM 5/24/24 DFR ran at 500 ml/min at 10:10 AM and 10:35 AM Pt #1’s record lacked documentation as to why the prescribed blood flow/dialysis flow rates were not maintained or notification to the physician about changes to those rates along with patient response. 2. On 5/30/24 at approximately 10:30 AM, Pt #2’s record was reviewed. Pt #2 was admitted to the facility on 4/5/2024 with a diagnosis of ESRD. Pt # 2’s clinical record contained a physician order dated 5/07/2024 that noted, “BFR to run at 500ml/min and DFR to run at 500ml/min”. Pt #2’s treatment sheet dated 05/07/2024, indicated the following: 5/07/2024 BFR ran at 450 ml/min for the entire treatment period from 7:10 AM to 10:10 AM. Pt #2’s record lacked documentation as to why the prescribed blood flow/dialysis flow rates were not maintained or notification to the physician about changes to those rates along with patient response. 3. The Facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, And Nursing Assessment” (Policy 1-03-08, revised April 2024) was reviewed on 5/29/24 at approximately 2:30 PM. The policy required, “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. All findings, interventions and patient response will be documented in the patient’s medical record.” 4. An interview with Facility Administrator (E #1) was conducted on 5/29/24 at approximately 1:00 PM. E#1 stated, “the chart should reflect the reason for any changes to the DFR/BFR and notification to the physician of needed changes.””