Fresenius Medical Care Northern Wake

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 38766 Based on facility policy review, clinical record review, and staff interview, the facility failed to complete a three-month comprehensive reassessment in 1 of 5 sampled patients receiving hemodialysis treatment at the facility (#8). The findings include: A review on 10/30/2024 of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care” published on 07/03/2023 revealed “... CIA and POC for Patients New to Dialysis ...A follow-up CIA must occur within 90 days. The POC should be adjusted as appropriate and implemented within 15 days of reassessment...” An open medical record review on 10/30/2024 for patient #8 revealed that the patient was originally admitted to the facility on 03/14/2024. The review revealed that the facility completed the initial comprehensive assessment of the patient dated 03/26/2024. Further review of the clinical record revealed that the facility failed to complete a follow-up comprehensive reassessment (90-day assessment) within three months after the completion of the initial assessment on 03/26/2024. An interview on 10/30/2024 at 1110 with the CM revealed that the facility should have completed the three-month reassessment for the patient, but that it was an oversight that the initial assessment was marked as an annual assessment. The interview revealed that the clinic will prioritize the patient’s 90-day assessment to be done during the clinic’s next scheduled plan of care meeting.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 38766 Based on policy review, medical record review, and staff interviews, the facility staff failed to ensure a patient recorded treatment data as prescribed on the treatment sheets for 1 of 4 home dialysis patients (Patient #4). Findings included: A review on 10/31/2024 of the facility’s policy titled “Review and Documentations of Home Therapies Patient Health Data” published on 05/01/2023, revealed “...Review and Documentation of Health Date ...At a minimum, the home therapies nurse will perform a comprehensive monthly review of all treatment data, regardless of the method of data admission. Datta review will be discussed with the patient and/or care partner during the patient’s regular clinic visit and concerns will be addressed and documented accordingly...” An open medical record review on 10/31/2024 for Patient #4 revealed the patient was admitted to the home hemodialysis program on 10/17/2022. The order review revealed that the patient was prescribed four days a week of treatment. A review of the treatment flow sheets between 077/15/2024 and 10/08/2024 revealed no documented pre-treatment sitting blood pressure on 07/26/2024, 08/22/2024, 08/23/2024, 09/05/2024, 09/07/2024, 09/09/2024, 10/01/2024, 10/03/2024, 10/05/2024, and 10/08/2024. The review revealed no documented pre-treatment standing blood pressure on 07/29/2024, 08/17/2024, 08/20/2024, 08/22/2024, 08/23/2024, 09/05/2024, 09/07/2024, 09/09/2024, /01/2024, 10/03/2024, 10/05/2024, and 10/08/2024. The review revealed no documented post-treatment sitting blood pressure on 08/07/2024, 09/07/2024, 10/01/2024, and 10/05/2024. The review revealed no documented post-treatment standing blood pressure on 09/07/2024, 10/01/2024, and 10/05/2024. The review of nursing notes between 07/03/2024 and 10/24/2024 revealed no evidence that reeducation was provided by the registered nurse to Patient #4 on the reasons for patients to document daily blood pressure before and after each treatment. An interview on 10/31/2024 at 1150 with the CMHT and the Home Area Team Lead revealed that there was no reeducation documentation from the home therapy nurse regarding the missing data. The interview revealed that the staff was expected to review the treatment data collected by the patient at every clinic visit and at a minimum, every month and reeducate the patient on any missing data.”

“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: 38766 Based on policy review, observation, and staff interview, the facility staff failed to properly label medication syringes in six (6) of six (6) observed pre-drawn syringes. Findings included: A review on 10/29/2024 of the facility’s policy titled, Medication Preparation and Administration” published 02/06/2021 revealed “...Labeling Reconstituted medication Solutions and Syringes All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication...” Observation on 10/29/2024 between 1040 and 1220 of the treatment areas revealed a medication preparation area near the nursing station. Observation revealed a total of 6 (six) syringes of Heparin (medication used to decrease the clotting ability of the blood) were stored in a locked drawer. The observation revealed the labels on the six syringes did not contain the preparation time or the initials of the staff who prepared them. The observation revealed the staff did not label the syringes according to policy. An interview on 10/29/2024 at 1200 with Registered Nurse #1 revealed that the nurse was unaware of when and by whom the syringes were prepared. The interview revealed that the staff should not put pre-filled syringes in the draw without the staff’s initials and preparation time. An interview on 10/30/2024 at 1000 with the Clinical Coordinator further reinforced the expectation for staff to adhere to all policies and procedures. The Clinical Coordinator reported that the staff did not follow the facility policy regarding medication labeling.”