Fkc North Wilmington

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 22676 Based on observation, staff interview, review of facility documents, and policy review, the facility failed to meet the Conditions for Coverage (CFC) when the facility did not 1. Ensure patients’ hemodialysis access sites were visible for one of three days of the survey. The patient and the access site (faces, needle insertion sites and line connections) must always be visible to staff during treatment, to ensure the lines and needles do not become dislodged or disconnected. Excessive blood loss can result from needle dislodgement, resulting in dire consequences such as severe hypotension, hospitalization, blood transfusions, and death, and could affect all 53 in-center hemodialysis patients receiving care at the facility. Following confirmation of the Immediate Jeopardy (IJ) with the State Survey Agency, the Covering Director of Operation and the Covering Facility Administrator were informed on 09/26/24 at 3:45 PM that an IJ at V407 was identified. The facility was informed it failed to meet the CfC for Physical Environment. A copy of the IJ template was provided by email at that time. The facility provided an acceptable plan for removal on 09/26/24 at 4:15 PM. The surveyor validated the facility implementation of the plan for removal. The Covering Director of Operations and the Covering Facility Administrator were notified that the interventions identified in the removal plan were reviewed and verified as implemented, and the IJ was removed at 09/27/24 at 3:40 PM. Finding Include: 1. The facility failed to ensure that Patient 1’s face and access were constantly in view and that the patient was not in a non-see-through privacy barrier alone and not constantly attended. Refer to Tag V407.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 22676 Based on observation, interview, facility policy review, and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that the wall boxes (dispensing outlets) of 16 of 16 dialysis (Station 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16) stations observed were clean and free of a build-up of a dark yellow substance. This deficient practice had the potential to cause bacteria to grow in the wall boxes and could potentially affect the 53 patients receiving in-center hemodialysis at the facility. Findings include: During an observation of all wall boxes on 09/26/24 at 10:45 AM, at Stations 1, 2, 2, 3, 4, 6, 7, 8. 9, 10, 11, 12, 13, 14, 15, and 16, revealed a dark yellow sediment build-up on the bottom of the wall boxes. During an interview on 09/26/24 at 12:30 PM the Area Biomedical Technician Manager confirmed the above findings. He/she stated the staff were supposed to clean the wall boxes daily. Review of the facility policy titled, “Cleaning and Disinfection of the Dialysis Station”, dated 09/05/23, indicated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given, to removing build-up and/or cleaning splatter and spray of concentrate solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.” Review of the “CDC Dialysis Safety” located on the CDC website at www.cdc.gov titled, “Wall boxes and Drains” page last reviewed: October 25, 2019, indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities. . . More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“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: 22676 Based on observation, staff interview, review of facility documents, and policy review, the facility failed to ensure the patient’s face and access were visible by having the patient seated in a non-see-through barrier for all times for one of three days of the survey. The patient and the access site (faces, needle insertion sites and line connections) must always be visible to staff during treatment, to ensure the lines and needles do not become dislodged or disconnected. Excessive blood loss can result from needle dislodgement, resulting in dire consequences such as severe hypotension, hospitalization, blood transfusions, and death, and could affect all 53 in-center hemodialysis patients receiving care at the facility. Findings: Observation in the treatment unit on 09/26/24 from 9:40 through 10:50 AM revealed the following information: At 9:55 AM, Patient (P) 1 at Station 12 was observed behind a non-see-through barrier that covered all the way around the patient with only a small corner section open. The patient could only be seen standing in front of the corner opening. Patient Care Technician (PCT) 8 was seen coming out of the patient barrier at 9:59 AM. The staff were all observed caring for other patients in the bay and were not seen back in the barrier with P1 until 10:25 AM. Staff could not visualize the patients’ face and access, unless they were in the barrier with the patient. Inability to observe the patient has the potential for patient access to become dislodged resulting in increased bleeding and potentially death. Review of P1’s treatment sheet for 09/26/24 revealed that staff was present in the barrier at 9:57 AM and the patient blood pressure was noted to be 89/58. They were not back in the barrier until 10:28 AM and the patient’s blood pressure was still low at 82/64. During an interview with PCT8 on 09/26/24 at 10:40 AM, he/she stated the patient was in the barrier because he was COVID-19 positive. He/she confirmed that the patient could not be seen unless standing directly in front of the corner opening. In an interview with Charge Nurse (CN) 7 on 09/26/24 at 10:45 AM, he/she stated they had been instructed to use the non-see-through privacy barriers for COVID-19 positive patients. He/she stated they were told they could not use the isolation room even though they currently do not have a positive hepatitis B patent. He/she agreed the patients could not be visualized through the non-see-through privacy barriers. He/she stated the facility did not have a positive hepatitis B patient on census. Review of the facility’s policy titled, “Guidance on Dialysis and Infection control Practices of COVID-19 in Fresenius Care (FKC) Dialysis Clinic,” date 04/30/24 indicated, “COVID-19 positive patients may be cohorted and treated within their home clinic treatment shifts with appropriate infection control precautions in place. The patients that are cohorted should be separated by a minimum of 6 feet from the nearest patient in all directions and ideally by a physical barrier, separate pod, or other top barriers between classifications of patients. COVID-19 positive patients and PUI [persons under investigation] patients may be treated in an unused isolation room within the clinic, following other infection control guidelines within this policy: Hepatitis B isolation rooms should only be used for patients with COVID-19 symptoms if: The patient is hepatitis B surface antigen positive OR the facility has no patient on census with a hepatitis B infection who require treatment in the isolation room. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “All patients must be under direct visual observation by clinical staff during treatment. The lighting in the dialysis facility must allow for the ability to observe patients in the treatment area. Ensure each patient’s face is visible and uncovered ...””

“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: 22676 Based on medical record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for one of six sampled in-center dialysis patients (Patient (P8). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 53 patients receiving in-center dialysis treatments at this facility. Findings include: A review of P8’s electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) and Dialysate Flow Rate (DFR) of 600 ml/min. A review of two of six “Post Treatment” flowsheets from 06/11/24 through 09/12/24 in the EMR indicated the following: a. On 06/11/24, the DFR was documented at 800 ml/min from 12:47 PM until 1:37 PM. b. On 09/12/24, the BFR was documented at 450 ml/min from 1:30 PM through 3:40 PM. There was no documentation for the change to the prescribed DFR and BFR. During an interview on 09/27/24 at 3:15 PM, the Covering Facility Administrator 3 confirmed the above findings and confirmed that the staff did not follow the physician’s order for dialysis treatment. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check Machines settings and measurements: Check prescribed blood flow is being archived or reason is documented in the medical record if unable to meet prescribed blood flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being delivered ...””