Davita Pinnacle Dialysis of Boca Raton

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to properly maintain emergency oxygen tanks for 2 of 2 tanks at the crash cart, and failed to properly store 6 of 13 oxygen tanks in the storage room. The findings included: An observation of the facility’s crash cart in the treatment area was conducted on 01/07/26 at 11:00 AM. Two oxygen tanks were observed adjacent to the crash cart in tank holders. Further observation of the two oxygen tanks revealed they were both empty. A side by side observation of the two oxygen tanks with the charge nurse confirmed the two oxygen tanks were empty. An observation of the storage room was conducted on 01/07/26 at 11:10 AM. In the storage room, a cluster of 13 oxygen tanks were observed at the door entrance. Six of the oxygen tanks were observed free standing (not in a tank holder). Further observation of the cluster of oxygen tanks revealed some were empty and some were full. An interview was conducted with the Facility Administrator (FA) on 01/07/26 at 11:20 AM. The FA acknowledged empt oxygen tanks should not be with the crash cart. The FA further acknowledged oxygen tanks should be stored in a tank holder, and empty tanks should be stored separately from full tanks.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to ensure a patient that was susceptible to Hepatitis B (Hep B) received the Hep B series vaccination for 1 of 7 sampled patients (Patient #1). The findings included: Record review revealed Patient #1 was admitted to the facility for treatment on 07/08/25. a review of Patient #1’s labs revealed a Hepatitis antibody level of 7 (<10 is susceptible of contracting Hepatitis B) on 07/24/25. Further record review revealed Patient #1 consented to receive Hep B vaccine on 09/18/25. Patient #1 received the first of four doses on 09/18/25. Further record review did not reveal Patient #1 received any other Hep B vaccinations, nor was there an explanation of why the patient did not receive the remaining 3 vaccines. An interview was conducted with the Facility Administrator (FA) on 01/07/26 at 12:00 PM. The FA acknowledged the above.”

“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: 36734 Based on observation and interview, the facility failed to maintain 2 of 2 lab refrigerators in a sanitary manner, and failed to have a secured floor drainage cover. The findings included: An observation of the lab area was conducted on 01/05/26 at 1:00 PM. Two refrigerators were observed with a heavy build-up of ice in the freezer section. An observation of the treatment area was conducted on 01/07/26 at 1:10 PM. A floor drain cover was observed loose and raised and a potential trip hazard. An interview was conducted with the Facility Administrator (FA) on 01/07/26 at 12:00 PM. The FA acknowledged the above.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 51535 Based on administrative policy, clinical record review, and interview, the clinical staff failed to ensure dialysis prescription were followed for patient #6 which is 1 of 7 patients reviewed. The failure included deviation of the prescribed Dialysate Flow Rate (DFR) and lack of documentation for the clinical rationale for not following the dialysis treatment prescription. The findings included: An administrative policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised 04/2024 revealed “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” The clinical record review conducted on 01/06/26 revealed physician orders for dialysis treatment for Dialysis Flow Rate (DFR) of 800 milliliters per minute (ml/min) . The treatment records dated 01/03/26, 12/27/25, and 12/24/25 indicate the patient did not receive the prescribed DFR 800 ml/min during 2 hours of 4 hours 15 minutes treatment. The treatment records do not provide an explanation for the deviation from the dialysis prescription. Interview with the Registered Nurse (RN) conducted on 01/06/26 at 1:33 PM, she acknowledged the DFR noted on the treatment sheet at 500 ml/min was not the prescribed rate.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to provide evidence of obtaining consent for and providing education of the risk versus benefits of receiving an Erythropoiesis stimulating agent (ESA), medication to stimulate red blood cell production, prior to the administration of an ESA for 4 of 7 sampled patients (Patient #1, #3, #4, and #6). The findings included: 1. Record review revealed Patient #1 was admitted to the facility for treatment on 07/08/25. Further record review revealed Patient #1 was prescribed and receiving Micera (an ESA) every 3 to 4 weeks. Further record review did not reveal evidence the patient consented to receive the medication or evidence the patient was educated on the risk versus benefit of receiving the medication. 2. Record review revealed Patient #3 was admitted to the facility for treatment on 10/25/22. Further record review revealed Patient #3 was prescribed and receiving Micera (an ESA) every 3 to 4 weeks. Further record review did not reveal evidence the patient consented to receive the medication or evidence the patient was educated on the risk versus benefit of receiving the medication. 3. Record review revealed Patient #4 was admitted to the facility for treatment on 11/10/25. Further record review revealed Patient #4 was prescribed and receiving Micera (an ESA) every 3 to 4 weeks. Further record review did not reveal evidence the patient consented to receive the medication or evidence the patient was educated on the risk versus benefit of receiving the medication. An interview was conducted with the Facility Administrator (FA) on 01/07/26 at 12:00 PM. The FA acknowledged the above. 51535 EX#4- Review of the clinical record on 01/06/26 for patient # 6 revealed that the patient was admitted to the facility on 06/19/23. The physician prescribed Epogen 20,000-unit, intravenous push (IVP) three times per week (12/2025). Further review of the clinical record failed to provide evidence of the patient being provided education regarding the risks and benefits of Erythropoiesis Stimulating Agent (ESA) used for managing anemia. An interview was conducted on 01/7/26 at 12:00 PM with the (FA) Facility Administrator, who confirmed that they were unable to locate a signed copy that indicates the patient received education regarding the risk and benefit of ESA.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 51535 Based on clinical record review and staff interview, the facility failed to provide evidence of developing an initial and or annual plan of care. This failure affected 4 of 7 sample patients reviewed (Patient #1, # 2, #3, #4). The findings included: A clinical records review on 01/06/25 at 3:10 PM of patient #2 revealed an incomplete Plan of Care. Patient admitted 03/09/22. 08/25 (unstable not dated) Plan of Care 09/25 (unstable Plan of Care) Plan of Care missing, not in chart 10/25 (unstable-not dated) Plan of Care 11/25 (stable) Plan of Care missing signatures and date. An interview conducted with FA 01/7/25 at 12:00 PM, who acknowledge the hard copy labeled Plan of Care, does not have signatures and or dates on the hard copy. 36734 3. Record review revealed Patient #1 was admitted to the facility for treatment on 07/08/25. A review of an initial care plan for Patient #1 revealed a care plan for 08/25. Further review of the care plan revealed the care plan was signed by all interdisciplinary team (IDT) members and the patient, but was dated by none. 4. Record review revealed Patient #3 was admitted to the facility for treatment on 10/25/22. A review of an unstable care plan for 10/2025 revealed the care plan was signed by the IDT members and the patient, but was dated by none. 5. Record review revealed Patient #4 was admitted to the facility for treatment on 11/10/25. A review of an initial care plan for Patient #4 revealed a care plan for 12/25. Further review of the care plan revealed the care plan was signed by all interdisciplinary team (IDT) members and the patient, but was dated by none. An interview was conducted with the Facility Administrator (FA) on 01/07/26 at 12:00 PM. The FA acknowledged the above.”