Fresenius Medical Care Central Raleigh

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 38766 Based on a review of facility policy, observations, and staff interviews, the facility staff failed to prevent cross-contamination by not ensuring that personal protective equipment (PPE) was worn outside of the treatment area for 1 of 2 observations (RN #2). Findings included: A review on 07/24/2024 of the facility’s policy titled, “Personal Protective Equipment,” revised 11/06/2023, revealed “... Policy... All personal protective equipment shall be removed prior to leaving the treatment area...” Observation on 09/10/2025 at 1200 in the patient treatment area revealed RN #2 left the treatment area while wearing a gown used during the provision of care. RN #2 then went to the water room, returned to the treatment area, and resumed providing patient care. The observation revealed a sign on the door with “No PPE Beyond This Point.” The observation indicated that RN #2 failed to remove PPE (the gown) before leaving the treatment area, as per facility policy. An interview on 09/10/2025 at 12005 with RN #2 revealed that the RN should not have left the treatment area with the gown. The interview revealed “no PPE was allowed in the water room area”. An interview on 09/11/2025 at 1405 with the Charge Nurse confirmed that PPE was not allowed in the water room area and confirmed the findings. The interview revealed that all staff members were required to always follow the policies.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 38766 Based on a review of facility policy, observation, and staff interviews, the facility staff failed to ensure a patient lift or remove their dark shades during safety checks for 1 of 1 patient (Patient #1). The findings include: A review on 07/24/2024 of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/2023, revealed, “... During Treatment... General Observation/Mental Status...All patients must be under visual observation by clinical staff during treatment... For patients’ safety, staff must ask patients to lift or remove any medically justified eye covering during each 30-minute safety check to visually confirm alertness...” Observation on 09/09/2025 from 1125 and 1235 (70 minutes) revealed Patient #1 was at dialysis station #6. Observation revealed the patient wore sunglasses during the dialysis treatment. Observation showed that the staff entered the station at 1230 for safety check documentation. The observation revealed that the staff did not ask the patient to lift or remove the dark glasses so that the patient’s eyes could be visualized. An open medical record review on 09/10/2025 revealed that Patient #1 was admitted to the in-center facility on 06/06/2023. The review of orders indicated that on 12/03/2024, there was documentation allowing the patient to wear sunglasses during dialysis due to vision impairment. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that the patient had an order to wear the sunglasses during treatment; however, the staff was expected to have the patient lift or remove them during safety checks as per policy.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 38766 Based on review of policy and procedures, medical records, and staff interviews, the facility staff failed to ensure that standing blood pressures, pre- and post-hemodialysis treatments, were taken on ambulatory patients for 4 out of 11 patients’ treatment sheets reviewed (Patient #2, #1, #8, and #9). Findings included: Review on 009/10/2025 of the facility policy titled “Determination of Blood Pressure” published 02/07/2022 revealed “... Policy Incenter patients: Obtain blood pressure readings pre- and post-dialysis sitting and standing...” 1. Medical record review on 09/10/2025 of Patient #2 revealed a 70-year-old female patient admitted for hemodialysis on 05/08/2025. The review revealed the patient was ambulatory without an assistive device. Review of the treatment sheets dated 08/19/2025 through 08/30/2025 revealed no pretreatment or posttreatment standing blood pressure on 08/19/2025, 08/21/2025, 08/23/2025, 08/26/2025, 08/28/2025, and 08/30/2025. An interview on 09/11/2025 at 1330 with PCT #4 revealed that all ambulatory patients should have received pre- and post-treatment standing blood pressures. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that if patients were ambulatory, pre- and post-treatment blood pressure should have been taken. The interview revealed that the expectation was for the staff to always follow the facility’s policies. 2. Medical record review on 09/10/2025 of Patient #1 revealed a 73-year-old male patient admitted for hemodialysis on 05/08/2025. The review revealed the patient was ambulatory without an assistive device. Review of the treatment sheets dated 08/19/2025 through 08/30/2025 revealed no pretreatment standing blood pressure on 08/19/2025, 08/21/2025, 08/23/2025, 08/26/2025, 08/28/2025, and 08/30/2025. An interview on 09/11/2025 at 1330 with PCT #4 revealed that all ambulatory patients should have received pre- and post-treatment standing blood pressures. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that if patients were ambulatory, pre- and post-treatment blood pressure should have been taken. The interview revealed that the expectation was for the staff to always follow the facility’s policies. 3. Medical record review on 09/11/2025 of Patient #9 revealed a 66-year-old male patient admitted for hemodialysis on 05/08/2025. The review revealed the patient was ambulatory without an assistive device. Review of the treatment sheets dated 08/19/2025 through 08/30/2025 revealed no pretreatment or posttreatment standing blood pressure on 08/19/2025, 08/21/2025, 08/23/2025, 08/26/2025, and 08/28/2025. An interview on 09/11/2025 at 1330 with PCT #4 revealed that all ambulatory patients should have received pre- and post-treatment standing blood pressures. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that if patients were ambulatory, pre- and post-treatment blood pressure should have been taken. The interview revealed that the expectation was for the staff to always follow the facility’s policies. 4. Medical record review on 09/11/2025 of Patient #8 revealed a 48-year-old male patient admitted for hemodialysis on 04/23/2021. The review revealed the patient was ambulatory without an assistive device. Review of the treatment sheets dated 08/18/2025 through 08/29/2025 revealed no pretreatment standing blood pressure on 08/18/2025 and no pretreatment or posttreatment on 08/22/2025, 08/28/2025, and 08/29/2025. An interview on 09/11/2025 at 1330 with PCT #4 revealed that all ambulatory patients should have received pre- and post-treatment standing blood pressures. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that if patients were ambulatory, pre- and post-treatment blood pressure should have been taken. The interview revealed that the expectation was for the staff to always follow the facility’s policies.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 38766 Based on policy and procedure review, observations, and staff interviews, the facility failed to ensure staff perform skin antisepsis per policy before cannulation of 2 of 2 Arterio-venous fistula/graft (AVF/AVG) cannulation procedures observed (Station #10, PCT #1; Station #3, PCT #4). Findings include: Review on 09/24/2025 of the facility policy “Access Assessment and Cannulation,” Published: 05/05/2025, revealed “... Skin Disinfection... Perform skin antiseptic on one site at a time, allow to dry then cannulate. Do not touch cannulation sites after skin disinfection. Note: This minimizes the risk of contaminating the second site while cannulating the first site...” 09/10/2025 at 1225 in the patient treatment area revealed PCT #3 entered Station #3 to initiate access of an Arterio-venous fistula/graft (AVF/G) for hemodialysis treatment. PCT #3 performed hand hygiene and applied clean gloves. PCT #3 cleansed both access sites at one time with alcohol prep pads and proceeded with cannulation, one site after the other. The observation indicated that PCT #3 failed to perform skin antiseptics on one site at a time as required by policy. An interview on 09/10/2025 at 1230 with PCT #3 confirmed that both access sites were cleaned using the same alcohol prep pads for both access sites. The interview revealed that the PCT should have cleaned the site and allowed it to dry before cannulation and repeated the process for the other site. The interview corroborated this observation. An interview on 09/11/2025 at 1405 with the Charge Nurse revealed that the expectation was for the staff to always follow the facility’s policies.”