Fresenius Kidney Care Hamptons at Boca Raton

“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: 40153 Based on observations, interviews, and record reviews, the facility failed to properly disinfect the dialysis chair and non-disposable equipment after dialysis treatments for two of two observations. The findings included: A review of the facility titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/2023, showed the following: The area includes the dialysis machine, chair/bed, and other reusable equipment or supplies utilized during dialysis treatment, patient training, and patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: the dialysis machine/cycler and attachments such as the IV pole, BP cuff, hand sanitizer/holder, organizer, chair, and bed. In an observation conducted on 04/29/24 at 2:20 PM, Staff D, a Registered Nurse, was observed cleaning Station 2 ’ s chair after a dialysis treatment. Further observation did not show that Staff D cleaned the side crevasses of the dialysis chair. In an observation conducted on 04/29/24 at 2:33 PM, Staff J, a Registered Nurse, cleaned Station 16 after the dialysis treatment. Further observation showed that Staff J did not clean the television monitor. In a detailed interview conducted on 05/01/24 at 12:00 PM, with the facility ’ s Clinical Manager, he was fully briefed on the findings and the urgent need for corrective action.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47207 Based on observation and interviews, the facility failed to ensure that the staff had cleaned and inspected the area beneath the sink in the lab area as evidenced by failure to remove dirty objects and fluids from beneath the sink in the lab area. The findings included: On 4/30/2024 at 9:15 AM, while inspecting the lab area, the surveyor noticed that one of two sinks had an empty used tray for dirty fistula clamps on one side, a jug of bleach and another jug with liquid in it as well as an dirty tray filled with a sand-like substance. The surveyor returned to the lab area on 5/01/2024 at 9:30 AM with the Clinical Manager (CM)/ Staff A of the facility. The surveyor asked the CM/ Staff A if he was aware of the above findings, he responded, “Oh, no I guess we hadn’t checked” and promptly removed the items from under the sinks.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 47207 Based on observations and interviews. the facility failed to provide a complete and accurate log of the items to be found in the emergency evacuation cart. The findings included: A review of the Emergency Evacuation Cart on 5/01/2024 at 09:40 AM with the Clinical Manager (CM)/ Staff A revealed there was no physical log of the inventory available. The CM / Staff A stated that this was found on the facility’s website and that he would produce it. The CM / Staff A came back with the visiting CM / Staff B who stated that there was a problem, she would have one of her staff attempt to print it out, however, at approximately 11:30 AM, both the CM / Staff A and Visiting CM / Staff B came back stating they could not produce an accurate (timed and dated) itemized inventory of the contents of the Emergency Evacuation Cart.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 40153 Based on observation and interview, the facility failed to obtain an immunization history regarding pneumonia and hepatitis B vaccines for 2 of the six patients reviewed for vaccinations (Patient #2 and Patient #4). The findings included: A review of the facility ’ s policy titled “Patient Vaccination for Hepatitis B” dated 02/07/2022 showed the following: Patients who are candidates for the hepatitis B vaccine and decline should be offered the vaccine on an annual basis, at minimum. Provide patient education as needed. The patient must sign a vaccine declination each year the vaccine is offered and refused. Each offering of the vaccine should be documented in the patient ’ s medical record. A review of the facility ’ s policy titled “Pneumococcal Vaccine for Adults Setting”, dated 02/05/2024, showed the following: Patients should be offered pneumococcal vaccination on an annual basis, at minimum. Provide patient education as needed. The vaccine declination must be signed by the patient for each refusal and documented in the patient ’ s medical record. Patient #2 was admitted to the facility on 02/19/24 for In-Center hemodialysis. Record review revealed that Patient #2 was negative for hepatitis B. No documentation was provided to show the hepatitis vaccine was offered to Patient #2. Patient #4 was admitted to the facility on 02/09/24 for In-Center hemodialysis. A record review revealed no documentation regarding Patient #4 ’ s pneumonia status. In an interview conducted on 05/01/24 at 12:00 PM, with the facility ’ s Clinical Manager, he was told of the findings.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 40153 Based on record review and interview, the facility failed to develop an initial care plan for 1 of 6 patients reviewed (Patient #4). The findings included: A review of the facility ’ s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 documents the following: An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Patient #4 was admitted to the facility on 02/09/24 for In- Center hemodialysis. A record review did not reveal an initial care plan was completed for Patient #4. In an interview conducted on 05/01/24 at 12:00 PM, with the facility ’ s Clinical Manager, he was told of the findings.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 40153 Based on record review and interview, the facility failed to initiate an unstable care plan for 1 of 6 patients reviewed (Patient #5). The findings included: A review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23, revealed the following: Unstable patients must be reassessed by the IDT monthly. Monthly Unstable assessment and any POC updates related to the reason the patient is considered unstable must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic. The following are unstable criteria: More than 3 hospital admissions in the last 30 days. A record review revealed that Patient #5 was admitted for In-Center hemodialysis on 08/01/2021 and had three hospitalizations in January 2024. The findings were told to him in an interview conducted on 05/01/24 at 12:00 PM with the facility’s Clinical Manager.”

“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: 40153 Based on record review and interview, the facility failed to have monthly physician progress notes for two of the six patients reviewed (Patient #6 and Patient #3). The findings included: A review of the facility ’ s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 documents the following: The dialysis facility must ensure that all in-center patients are seen by the medical practitioner (i.e., physician, advanced practice registered nurse, providing ESRD care at least monthly. A minimum, monthly medical progress notes (which also denote the site a of the visit) must be in every patient ’ s medical record that document the physician or a non-physician practitioner has seen each patient. 1. A record review revealed Patient #6 was admitted to the facility on 04/08/2022 for In-Center -Center hemodialysis. Further review revealed no monthly doctor ’ s notes completed for Patient #6 since November of 2023. In an interview conducted on 05/01/24 at 12:00 PM, with the facility ’ s Clinical Manager, he was told of the findings. 47207 2. Patient # 3 was admitted to the facility 6/20/2023 for In-Center hemodialysis. A medical record review completed 4/30/2024 revealed no MD notes for the months of 11/2023 through 4/30/2024. An interview with the visiting clinical manager and clinical manager on 4/30/2024 at 3:30 PM verified that the MD had not completed monthly progress notes for this patient from 11/2023 to the present. They both stated they had difficulty with this physician in completing his documentation.”