University Kidney Center Hikes Lane LLC

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to use aseptic technique when administering medications from single-use vials for 4 of 4 sampled patients reviewed for aseptic medication administration, (Patient (P) #2, #7, #8, and #9) . The findings include: Review of the facility policy titled, “G48 Medications, A: Handling Administration, Storage & Disposal,” revised 01/13/2025, revealed, “Medication vials are disinfected with alcohol pad before each entry by a needle.” During an observation of parenteral (intravenous, intramuscular, or subcutaneous injection) medication administration on 01/13/2025 at 12:10 PM, Registered Nurse (RN) #9 failed to disinfect the septum (thin, flexible barrier that sealed the opening) of the single-use vial before withdrawing Venofer (an intravenous [IV] medication used to treat iron deficiency) with a syringe and administering the medication to P #7. During an observation of parenteral medication administration on 01/13/2025 at 12:15 PM, RN #9 failed to disinfect the septum of a second single-use vial before withdrawing Venofer with a syringe and administering the medication to P #2. During interview on 01/13/2025 at 12:18 PM, RN #9 stated, “The top of the vial is covered by a cap, so we don’t need to disinfect it During observation of parenteral medication administration on 01/14/2025 at 10:00 AM, RN #10 failed to disinfect the septum of a single-use vial before withdrawing Venofer with a syringe and administering the medication to P #8. During observation of parenteral medication administration on 01/14/2025 at 10:15 AM, RN #10 failed to disinfect the septum of a second single-use vial before withdrawing Venofer with a syringe and administering the medication to P #9. During an interview on 01/14/2025 at 10:18 AM, RN #10 stated, “We don’t need to disinfect single-use vials.” During an interview on 01/15/2025 at 4:39 PM, the Clinic Manager (CM) stated the top of a single dose medication vial should be swabbed with alcohol prior to entering with a needle to withdraw medication. During an interview on 01/16/2025 at 11:20 AM, the Medical Director stated the septum of a single dose vial should be disinfected (as per policy) prior to withdrawing medication.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on interview and record review, the facility failed to report to the provider a patient’s vital signs according to ordered parameters for 1 (Patient (P) #4) of 5 sampled patients reviewed for reporting vital signs. The findings include: Review of facility policy “IC07A Charge Nurse Notification Protocol” revised 01/13/2025 revealed “This protocol is for guidance, please refer to your patients’ standing orders for further instructions.” Review of Patient #4’s medical record revealed a “Dialysis Order Report,” dated 11/19/2024, which noted, “IF SBP” [systolic blood pressure] was greater than (>) 200 millimeters of mercury (mmHg) and less than (<) 220 mmHg, “ok to start patient.” Continued review revealed if after 30 minutes the patient’s SPB was still > 200 mmHg, “give 0.1 mg [milligrams] clonidine” (an anti-hypertensive medication), and if the patient’s “pre SBP >220” mmHg, “call MD (medical doctor).” Review of P #4’s “HD [hemodialysis] Treatment Flowsheet,” dated 12/26/2024, revealed the patient had a sitting pre-dialysis blood pressure of “236/117.” Per review, the flowsheet included a nurse’s note, documented by Registered Nurse (RN) #7, indicating, “Patient is hypertensive and asymptomatic.” Continued review of the Flowsheet revealed P #4 Pt stated [they] forgot to take [their] blood pressure (B/P) medication. Further review revealed P #4 took the BP medication prior to treatment starting. Additionally, further review revealed no documentation of notification to the MD regarding the patient’s blood pressure. Review of Patient #4’s “HD Treatment Flowsheet,” dated 01/07/2025, revealed a pre-dialysis standing B/P of “223/133” and a sitting B/P of “218/111.” Per review of the Flowsheet, revealed it included a nurse’s note, documented by RN #10, indicating, “Pts bp high - asymptomatic - always high when” they arrive. Continued review of RN #10’s note revealed P #4’s B/P “goes down during tx” [treatment].” Further review revealed P #4 took [their] BP meds prior to coming to the clinic. Additionally, further review revealed no documentation of notification to the MD regarding the patient’s blood pressure. During an interview on 01/14/2025 at 3:05 PM, the Clinic Manager (CM) stated there was no evidence in the medical record of staff notifying the doctor of the patient’s pre-treatment systolic blood pressure being greater than 220. During an interview on 01/16/2025 at 10:28 AM, RN #7 stated reasons they would call a provider included a patient having an elevated B/P, elevated heart rate, or if the patient was vomiting. RN #7 stated “they” were familiar with the ordered physician notification parameters. The RN reported P #4 took B/P medication prior to treatment; however, sometimes forgot and then took the medication once at the clinic. RN #7 stated the provider should be notified of the patient’s elevated B/P, even if the patient had not taken their B/P medication. During an interview on 01/16/2025 at 11:20 AM, the Medical Director stated the expectation was for staff to call if a patient’s vital signs met the ordered reporting parameters. The Medical Director stated, if the patient forgot to take their B/P medication prior to treatment, she preferred to be called by staff to provide clarification.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to monitor vascular access for 1 of 5 sampled patients reviewed for vascular access monitoring, (Patient (P) #1). The findings include: Review of facility policy titled “IC07 Patient Assessment: Pre & Post Dialysis, last revised 06/20/2024, revealed pre- and post-dialysis assessments included, but were not limited to, “Access: patency, signs of infection, access care provided.” Review of P #1’s “HD [hemodialysis] Treatment Flowsheet” records dated 12/27/2024, 12/29/2024, 12/31/2024, 01/03/2025, 01/07/2025, and 01/08/2025, revealed the patient had both a central venous catheter (CVC, a catheter tubing inserted into a vein in the neck, chest, arm, or groin and ending at a large vein near the heart) and an arteriovenous fistula (AV fistula, a surgical connection between an artery and a vein). Continued review revealed P #1’s CVC was located in the right internal jugular vein of the neck and was the access in use. Per review, the AV fistula located in the patient’s left upper arm was not an access in use. Further review revealed only P #1’s CVC was included in the pre-access assessment. In interview on 01/14/2025 at 9:51 AM, the Clinic Manager (CM) stated there was no evidence in P #1’s medical record of assessment of the patient’s “maturing” AV fistula for each treatment by the floor staff. The CM reported the expectation was for staff to assess the maturing AV access; however, there was nowhere in the facility’s electronic medical record (EMR) for them to document that assessment. The CM further stated there was only a space in the EMR provided to document an assessment of the access currently being used for treatment. In interview on 01/16/2025 at 10:07 AM, the Advanced Practice Registered Nurse (APRN) stated she expected the nurses to assess a “maturing access” at each treatment. In interview on 01/16/2025 at 11:20 AM, the Medical Director stated when a patient had a “maturing AV fistula” the physician and APRN should assess the access at each visit with the patient. The Medical Director further stated the dialysis technician or nurse should assess the patient’s maturing access at every treatment. During an interview on 01/16/2025 at 12:05 PM, Registered Nurse (RN) #7 stated the facility’s expectation was for staff to assess a “maturing AV fistula” at each treatment even if the access was not being used. During an interview on 01/16/2025 at 12:05 PM, Licensed Practical Nurse (LPN) #12 stated the facility’s expectation was for staff to assess a “maturing AV fistula” at each treatment. The LPN said however, there was not a place to document a “maturing AV fistula” assessment in the facility’s EMR, and staff would have to add a “free text note” of their assessment of the “maturing AV fistula.””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50873 Based on interview and facility document and policy review, the facility failed to track, trend, and analyze the percentage of eligible patients completing the Kidney Disease Quality of Life Instrument (KDQOL, a survey tool to measure the impact of kidney disease on quality of life). That deficiency had the potential to impact all 46 patients receiving care at the facility. The findings include: Review of the facility policy titled, “G09 Quality Assurance & Performance Improvement (QAPI),” revised 01/13/2025, revealed, “1. Each [Facility Initials] care center will implement this policy to ensure that Quality Assurance and Performance Improvement (QAPI) as defined in the Federal Conditions for Coverage is performed.” Review of a facility document titled, “QAPI - Psychosocial & Transplant,” dated 2024, revealed KDQOL reporting included the completed number of surveys for each month. Per review, the document revealed no evidence of the percentage of eligible patients who completed the survey, was tracked, trended, or analyzed for the year. In interview on 01/15/2025 at 4:20 PM, the Clinic Manager (CM) stated there was no documented evidence the facility tracked, trended, or analyzed the percentage of eligible patients who completed the KDQOL survey. The CM further stated the numbers on the “QAPI - Psychosocial & Transplant” document indicated the number of completed surveys for each month. In interview on 01/16/2025 at 9:25 AM, the Master of Social Work (MSW) stated she used to report on the KDQOL the percentage of eligible patients completing the survey each month. She said she also used to report the refusals and refusal rates, during the facility’s QAPI meetings. The MSW reported however, since changing to the new QAPI system she had not done that. She further stated she had access to that information and used it to perform her job duties. In interview on 01/16/2024 at 11:20 AM, the Medical Director confirmed the percentage of eligible patients completing the KDQOL survey had not been reviewed in QAPI (as required).”