Dialysis Care Center Leesburg,llc

“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: 51504 Based on record review and interview, the facility failed to follow the prescribed blood flow rate (BFR) and Dialysate Flow rate (DFR) for 3 of 7 patients receiving in-center hemodialysis ( Patient #1, Patient #6, and Patient #7) Findings Include: 1.) Record review of Patient #1’s dialysis treatment record, dated 2/19/2025, revealed Patient #1 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Record review of Patient #1’s blood flow rate revealed that Patient #1’s blood flow rate during dialysis treatment was set at 400 milliliters/minute seven times during his treatment on 2/19/2025. Record review of Patient #1’s dialysis treatment record failed to reveal documentation that was justified or explained why Patient #1’s blood flow rate had deviated from his prescribed blood flow rate. Record review of Patient #1’s dialysis treatment record, dated 2/26/2025, revealed Patient #1 was prescribed a dialysate flow rate (DFR) of 800 milliliters/minute. Record review of Patient #1’s dialysate flow rate revealed that Patient #1’s dialysate flow rate during dialysis treatment was set at 600 milliliters/minute seven times during his treatment on 2/26/2025. Record review of Patient #1’s dialysis treatment record failed to reveal documentation that was justified or explained why Patient #1’s dialysate flow rate had deviated from his prescribed dialysate flow rate Record review of Patient #1’s dialysis treatment record, dated 3/3/2025, revealed Patient #1’s was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Record review of Patient #1’s blood flow rate revealed that Patient #1’s blood flow rate during dialysis treatment was set at 400 milliliters/minute four times during his treatment on 3/3/2025. Record review of Patient #1’s dialysis treatment record failed to reveal documentation that was justified or explained why Patient #1’s blood flow rate had deviated from his prescribed blood flow rate. During an interview on 3/12 /2025 at 08:50 AM, Staff A, Registered Nurse (RN) stated “ There is no documentation of why the BFR rate was changed to 400 on 2/19/2025 and she should have documented why the BFR was changed”. During an interview on 3/12 /2025 at 9:00 AM with Staff A, Registered Nurse stated, “There is no documentation of why the DFR rate was changed to 600 on 2/26/2025 and that she was not alerted by Staff C, Patient Care Technician.” During an interview on 3/12/2025 at 09:22 AM with Staff C, Patient Care Technician stated “On 2/26/2025 “she changed the BFR to 600 and forgot to document that she informed the nurse.’’ During an interview on 3/12 /2025 at 10:18 AM with Staff C, Patient Care Technician stated “There is no documentation of why the BFR rate was changed to 400 on 3/3/2025 and she forgot to document why the BFR was changed”. Review of facilities policy and procedure titled “Hemodialysis Vascular Access Blood Flow Rate Standing Order” dated 1/15/2025 read “ ...procedures: 1. Ensure that all current orders are being consistently followed, i.e., treatment time, blood flow rate(BFR), dialysate flow rate (DFR), and frequency of dialysis ... Review of facilities policy and procedure titled “Monitoring During Dialysis Treatment” dated 1/15/2025 read “ .... 10. Check and record the following machine parameters and any problems” ... 11. Document all findings in the patient’s treatment record. Interventions and patient response will be documented in the treatment record if indicated.’’ 45576 2.) Record review of Patient #6’s dialysis treatment record, dated 3/3/2025 , revealed Patient #6’s was prescribed a dialysate flow rate (DFR) of 800 milliliters/minute. Record review of Patient #6’s dialysis treatment record revealed that Patient #6’s dialysate flow rate during dialysis treatment was changed to 500 milliliters/minute three times during his treatment on 3/3/2025. Record review of Patient #6’s dialysis treatment record failed to reveal documentation that was justified or explained why Patient #6’s dialysate flow rate had deviated from his prescribed dialysate flow rate. Record review of Patient #6’s treatment record, dated 3/7/2025, revealed Patient #6 was prescribed a blood flow rate (BFR) 400 milliliters/minute. Record review of Patient #6’s blood flow rate revealed that Patient #6’s blood flow rate during dialysis treatment was set at 350 milliliters/minute four times during his treatment on 3/7/2025 . Record review of Patient #6’s dialysis treatment record failed to reveal documentation that was justified or explained why Patient #6’s blood flow rate had deviated from his prescribed dialysis blood flow rate. Record review of Patient #7’s dialysis treatment record, dated 2/26/2025, revealed Patient #7’s prescribed a BFR 350 milliliters/minute. Record review of Patient #7’s BFR revealed that Patient #7’s blood flow rate during dialysis treatment was set at 300 milliliters/minute seven times during her treatment on 2/26/2025. Record review of Patient #7’s blood flow rate had deviated from her prescribed blood flow rate. During an interview on 3/12/2025 at 09:10 AM with Staff A, Registered Nurse stated, “There is no documentation of why the DFR rate was changed to 600 on 3/3/2025 and she should have documented why the DFR was changed from 800”. During an interview on 3/12/2025 at 09:22 AM with Staff C, Patient Care Technician stated “On 3/7/2025 she changed the BFR to 350 and forgot to document that she informed the nurse.” During an interview on 3/12/2025 at 12:04 PM the Dialysis Center Manager confirmed that BFR was 300 milliliters/minute for [Patient’s name] Patient #7 during treatment and should have been 350 milliliters /minute. Stated “ the technician has to tell the nurse if the BFR or DFR is changed for any reason and documentation must be noted of why the BFR or DFR is changed.” Review of the policy and procedure titled “ Hemodialysis Vascular Access Blood Flow Rate Standing Order” dated 1/15/2025 read “ ...procedures: 1. Ensure that all current orders are being consistently followed, i.e., treatment time, blood flow rate(BFR), dialysate flow rate (DFR), and frequency of dialysis ... Review of the policy and procedure titled “Monitoring During Dialysis Treatment” dated 1/15/2025 read “ .... 10. Check and record the following machine parameters and any problems” ... 11. Document all findings in the patient’s treatment record. Interventions and patient response will be documented in the treatment record if indicated.””

“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: 49777 Based on observation, interview, and record review of the facility failed to ensure 3 of 12 patients observed had access sites that remained visible to staff during treatments to maintain ongoing assessment of the hemodialysis access sites ( Patient #1, Patient #8 and Patient #12). Findings include: During an observation on 3/10/2025 at 9:20 AM, two patients [Patient #1 and Patient #8] of 12 patients receiving dialysis treatments had their access sites covered with blankets or personal clothing. During an observation On 3/12/2025, beginning at 10:30 AM, one Patient #12 had their access site covered with a blanket. There were no staff present to ensure that patients’ access sites were visible or to encourage patients to ensure their access sites remained visible during the dialysis treatment. During an interview on 3/10/2025 at 10:10 AM, Staff A, Registered Nurse (RN), confirmed Patient #8’s access site was covered by clothing and a blanket and stated “Access sites need to always be visible”. During an interview on 3/10/2024 at 10:40 AM, Staff B, RN, confirmed Patient #1’s access site was covered by a blanket and stated “Patients cover their sites. Their sites need to be always seen.” During an interview on 3/12/2025 at 1:30 PM, Staff D, Certified Clinical Hemodialysis Technician (CCHT) confirmed Patient #12’s access was covered by a blanket and stated “His site should not be covered. It needs not to be covered and visible at all times.” Record review of the facility policy and procedure titled “Monitoring During Dialysis Treatment, last review date of 1/15/2025, reads...3. All patients must be under visual observation by clinical staff during treatment. 4. Monitor the patient’s access to ensure no needle dislodgement, hemodialysis access is visible and all hemodialysis lines are intact.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 49777 Based on record review and interview, the facility failed to ensure that the patient was seen and evaluated at least quarterly to assess the patients response to traeatment and observe the care team for 1 of 10 patients reviewed (Patient #5) Findings include: Record review of Patient #5’s dialysis progress notes did not have documentation of an in-center quarterly visit conducted by his practitioners for the last four quarters. Review of a faxed document dated 3/11/2025 at 2:20 PM from Patient #5’s provider read, “I did not see him those months- apologies, I saw him in the hospital twice recently. I will have to adjust my schedule to catch him on the machine.” During an interview on 3/12/2025 at 2:55 PM, the Medical Director stated “I am aware Patient #5’s provider has not seen his patient in-center during his treatment at least quarterly and I will address this with him.””