Fresenius Medical Care Aldersgate

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 32003 Based on NCBON position statement review, policy review, observation, and staff interview, the facility staff failed to validate heparin prepared by a technician for 1 of 2 observations. (Patient #1). The findings include: Review on May 30, 2025 of the position statement from the NCBON revised September 2021 revealed, “ ... 2. May assist the licensed nurse with the administration of heparin, lidocaine, and normal saline, provided there is an established written protocol which limits the delegation to the competent UAP (dialysis technician). ...” Review on May 30, 2025 of the facility’s policy, “North Carolina State Specific: Heparin Administration by Patient Care Technicians” published February 25, 2025 revealed, “ ...Validation Process [space] To validate heparin dose: The Licensed Nurse will watch the PCT draw up heparin into the syringe based on the information on the medication label. ...” Observation on May 29, 2025 at 10:35 AM revealed, PCT #1 went to the medication area and drew up two syringes of heparin without the nurse being present. The technician then went to dialysis station #15 with the intent to administer the solution to Patient #1 as a CVC pre-treatment. Sometime later, Nurse #1 went to the chairside to validate the dosage for the remaining syringe, as the technician had already administered the solution from 1 of 2 syringes to the patient. Observation revealed the nurse and the technician did not validate the solution and dosage at the same time. Interview on May 29, 2025 at 10:35 AM with Nurse #1 revealed, the nurse did not validate the heparin draw up for Patient #1 with PCT #1. Interview on May 29, 2025 at about 2:00 PM with the Clinical Manager and a visiting Clinical Manager revealed, PCT #1 and Nurse #1 were visiting staff and in the instance of the heparin draw up for Patient #1, the technician should have taken the medication vial and syringes to the nurse for verification. Open medical record review on May 30, 2025 revealed, Patient #1 was admitted to the in-center facility. Treatment sheet revealed on May 29, 2025 at 10:39 AM, PCT #1 signed off as administering 6,000 milliliters of heparin bolus and at 12:15 PM, Nurse #1 signed off as administering 2000 milliliters of intermittent heparin.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 32003 Based on policy review, observations, staff interview, clinic audit review, and medical record review, the facility staff failed to ensure patients performed hand hygiene prior to exiting the in-center treatment area for 2 of 2 patients (Patients #4 and #10). The findings include: Review on May 30, 2025 of the facility’s policy, “Hand Hygiene” published November 6, 2023 revealed, “Purpose ...Responsibility ...Policy [space] Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ...Soap and Soap Dispensers ...Alcohol Based Hand Rubs ...Additional Guidelines for Home Therapies ...Hand Hygiene: Patients [space] Patients should perform hand hygiene if able prior to and after each dialysis treatment. ...” 1. Observation on May 28, 2025 at 1:08 PM revealed, Patient #10 was located at dialysis station #8 holding manual pressure to an access site, with a gloved hand, after a technician removed the dialysis needles. Observation revealed, hemostasis was achieved, the patient removed the gloves and exited the in-center treatment area without performing hand hygiene. Interview on May 29, 2025 at about 4:30 PM with the Clinical Manager and a visiting Clinical Manager from a sister-facility revealed upon admission, patients underwent infection control and Emergency preparedness training via a video disc and documentation should be in the electronic medical record. Review on May 30, 2025 of the clinic audit checklist revealed, no data from hand hygiene audits were documented on the checklist from June 1, 2024 through May 28, 2025. Open medical record review on May 30, 2025 revealed, Patient #10 was admitted to the in-center facility 2024 and failed to reveal the patient received Infection control education. 2. Observation on May 29, 2025 at 10:30 AM revealed, Patient #4 was located at dialysis station #11 holding manual pressure to an access site, with a gloved hand, after a technician removed the dialysis needles. Observation revealed hemostasis was achieved, the patient removed the gloves and exited the in-center treatment area without performing hand hygiene. Interview on May 29, 2025 at about 4:30 PM with the Clinical Manager and a visiting Clinical Manager from a sister-facility revealed upon admission, patients underwent infection control and Emergency preparedness training via a video disc and documentation should be in the electronic medical record. Review on May 30, 2025 of the clinic audit checklist revealed, no data from hand hygiene audits were documented on the checklist from June 1, 2024 through May 28, 2025. Open medical record review on May 30, 2025 revealed, Patient #4 was admitted to the in-center facility 2023 and failed to reveal the patient received Infection control education.”

“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: 32003 Based on manufacture indications for use, observation, and staff interview, the facility staff failed to ensure Tubersol, a refrigerated medication was discarded 30-days after use for 2 of 3 vials. The findings include: Review on May 30, 2025 of [manufacture] instructions for use, “Tubersol” Copyright 2021 revealed, “DESCRIPTION ...CONTRAINDICATIONS ...ADVERSE REACTIONS ...USAGE ...STORAGE ...A vial of Tubersol which has been entered and in use for 30 days should be discarded. ...” Observation on May 28, 2025 at about 12:30 PM revealed, 2 of 3 uncapped vials of Tubersol were located in the medication refrigerator. One of the vials was dated as opened on April 10, 2025 and second vial was dated as opened on April 24, 2025. Observation revealed the medication refrigerator contained vials of Tubersol that were 30-days beyond use. Interview on May 28, 2025 at about 12:30 PM revealed the vials of Tubersol beyond 30-days of use should have been discarded.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 32003 Based on policy review, observation, staff interviews and medical record review, the facility staff failed to ensure a patient dialyzed on the correct dialysate composition for 1 of 3 patients (Patient #8). The findings include: Review on May 30, 2025 of the facility’s policy, “Patient Assessment and Monitoring” published May 1, 2023 revealed, “Purpose [space] The purpose of this policy is to provide guidance to [dialysis organization] direct patient care staff on assessment and monitoring patients before, during and after treatment. ...” Review revealed the policy did not provide information about dialyzing patients on the correct dialysate composition. Observation on May 28, 2025 at 12:35 PM with PCT #2 revealed, Patient #8 dialyzed at dialysis station #16. Chairside treatment verification revealed, the patient was prescribed 3.0 K / 2.5 CA dialysate composition, however, the patient was dialyzing on a 2.0 K / 2.5 Ca dialysate composition. Observation revealed the patient dialyzed on the incorrect dialysate composition. Interview on May 28, 2025 at 12:35 with PCT #2 revealed, Patient #8 dialyzed on the incorrect dialysate composition and the machine setup was performed by PCT #3. Interview on May 28, 2025 at about 4:30 PM with the Clinical Manager revealed Patient #8 dialyzed on the incorrect dialysate composition. Open medical record review on May 30, 2025 revealed Patient #8 was admitted to the facility in 2025. Treatment sheet review revealed on May 28, 2025, machine setup was performed by PCT #3, reviewed by Nurse #2 and patient treatment start time was 12:03 PM. Review revealed, the patient dialyzed 32-minutes on the incorrect dialysate composition.”

“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: 32003 Based on observation and interview, the facility staff failed to ensure liquid protein supplement was discarded within 90-days of opening for 1 of 1 observation (medication area). The findings include: Observation on May 28, 2025 at 1:25 PM revealed 1 of 3 liquid protein supplement---apple flavor was opened January 8, 2025 and not discard within 90-days of opening. Interview on May 28, 2025 at 1:25 PM with Nurse #2 revealed, 1 of 3 liquid protein supplements was out-of-date and everyone (all staff) was responsible for checking the dates.”