Davita Dialysis Associates of the Palm Beaches

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 22517 Based on administrative record review and staff interview, the facility staff failed to consistently follow the established policy and procedures regarding mixing acid for 1 of 2 months reviewed. This is evidenced by the permanent record failed to provide evidence that the staff completed the record completely for each mixed batch of acid. The findings included: Review of the facility’s policy regarding Acid Concentrate Mixing and Handling Dry Acid Dissolution Unit, published 09/05/2023 documented regarding Batch Records, “Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation.” The facility’s policy regarding Dri-Sate Dry Acid Concentrate Mixing System, Policy: 1-20-07, Revision Date: April 2023, documented, “A Dri-Sate Batch Production Record is fully completed for each batch of dry acid concentrate that is produced.” Review of the Citric Complete Batch Production Record Sheets for March, revealed the staff failed to followed the facility’s policy for verification and ensuring that the documentation was complete on the following sheets: a. On 03/05/25 the Patient Care Technician documented that 100 gallons of acid was mixed. However, the sheet does not document that the mixed batch was verified by the Licensed Nurse for what was mixed, procedure, testing for specific gravity and transferring of the mixed concentration to the neutralization container prior to connecting transfer hose and transferring of the mixed batch to the storage tank. b. On 03/04/25 the Patient Care Technician documented that 100 gallons of acid was mixed, however, the sheet does not document the the date and time the mixed batch was transferred to the storage tank. c. A undated sheet documented that the Patient Care Technician mixed 100 gallons of acid. An interview was conducted on 04/02/25 at approximately 1:30 PM with the Patient Care Technician, Staff A, who stated he was the staff who mixed the acid mixture and he further confirmed that the documentation was incomplete.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 22517 Based on administrative record review and staff interview, the facility staff failed to provide evidence that the water cultures sample is collected before the water system and dialysis machines are disinfected for 1 of 6 months reviewed. The findings included: The facility’s policy regarding Water Culture, policy # 2-06-01, Revision date April 2021 documented, “Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distributions systems. Monthly is defined as within a calendar month.” In reviewing the facility’s cultures and disinfection records, the staff obtained most cultures and disinfected the system on the same day. An interview was conducted with the BioMed Technician (BMT) on 04/01/25 at approximately 11:15 AM, who stated the time the batch ticket summary denotes the time the cultures were obtained, and he documents the time he began the disinfection. Further review of the monthly cultures and disinfection revealed that the batch ticket summary documented that the water cultures were collected on 01/06/25 at 8:02 AM from the following sites, First Water Out, Bicarb Water Out, Dry Acid Water Out, Last Water Out and 2 dialysis machines. However, the Water System Disinfection Log documented that the Time Disinfection Started was 01/03/25 at 7:30 AM. Thus indicating the system was disinfected prior to obtaining the cultures. Another interview was conducted on 04/01/25 at 3:25 PM with the BMT, who confirmed that the date stamp on the culture was correct. Accordingly, the disinfect was done before the cultures were collected for the month.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 22517 Based on clinical and administrative record review and staff interview, the facility failed to ensure the current health status for 2 of 4 patients sampled and 2 of 3 patients (Patient #1 and #4) reviewed for hospitalization. This is evidenced by the staff failed to ensure the post transitional assessment is completed or the documentation of the patient’s hospitalization is noted and identified. The findings included: Review of the facility’s procedure for Transition of Care: Post-Hospitalization Checklist (ICHD) documented “Complete the steps below during your patients’ first week back from the hospital in order to help prevent readmissions. The Pillars of Transition of Care and notes the Dialysis Prescription adjustment, medication management and care coordination. The procedure provides guidance for what the staff is to do within 2 treatments, within 7 days and ongoing. 1) Review of the clinical record for Patient #1 revealed that the patient was admitted to the facility on 09/30/19 and was hospitalized 12/09/24 - 12/31/24 (22 days) for Altered Mental Status. The clinical record did not provide documentation of the patient’s extended hospitalization. Further review revealed on 01/17/25 the patient had a Resection of infected and exposed nonfunctional left brachial axillary AV graft. Also noted in the clinical record was a 01/29/25 annual assessment. The assessment noted that the patient did not have a hospitalization and did not provide evidence of the patient’s extended hospitalization. An interview was conducted on 04/01/25 at approximately 3:00 PM with the Facility Administrator and Charge Nurse. They confirmed that the clinical record did not provide evidence of the patient’s extended hospitalization nor were medical records regarding the hospitalization obtained at this time. 2) Review of the clinical record for Patient # 4 revealed that the patient was admitted to the facility on 08/11/23 and had hospitalizations for Infections on 12/10/24 -12/18/24 and 03/14/25 - 03/21/25. Further review of the clinical record did not provide evidence of the patient’s hospitalization being noted or identified for the 03/14/25 hospitalization. An interview was conducted on 04/02/25 at approximately 1:45 PM with the Charge Nurse, who confirmed that the patient returned to the facility on 03/24/25 and the nurse failed to document that the patient was hospitalized on the treatment sheet and there is no progress note documenting the hospitalization. An interview was conducted on 04/02/25 at 2:00 PM with the Facility Administrator, who stated she did not know why the patient’s hospitalization did not appear on the hospitalization log provided to the surveyor.”

“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: 22517 Based on clinical and administrative record review and staff interview, the facility failed to ensure the monthly comprehensive interdisciplinary assessment and a revision of the plan of care was completed at least monthly for 1 of 4 sampled patients (Patient #4), who was identified as unstable. The findings included: Review of the clinical record for Patient #4 revealed that the patient was admitted to the facility on 08/11/23. The facility completed an Annual Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) on 12/09/24. The patient’s Plan of Care noted that the patient was deemed unstable and the patient had a personal priority to add to their plan of care. The physician noted that the patient is experiencing “recurrent cellulitis, needing antibiotic and persistent increased interdialytic weight gain (IDWG), counseled constantly.” Further review of the clinical record on 04/02/25 failed to document the facility completed another CIA and POC for Patient #4 subsequent to the 12/09/24 unstable POC. An interview was conducted with the Facility Administrator, Charge Nurse and Social Worker on 04/02/25 at approximately 3:00 PM, who confirmed that the 12/09/24 POC identified the patient as unstable, however, this was missed and the facility did not complete another CIA and POC.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 22517 Based on clinical and administrative record review and staff interview, the facility failed to ensure the appropriate time monitoring during treatments for patient with hypertension and failed to provide evidence of follow-up regarding a patient with hypotensive episodes for 2 of 4 sample patients (Patient #1 and #2). This is evidenced by the staff failure to provide monitoring every 30 minutes or sooner for a patient experiencing elevated blood pressure (Patient # 2) and staff failure to provide evidence of collaborative follow-up for a patient who consistently experienced episodes of low blood pressure before and during treatments ( Patient #1). The findings included: 1) Review of the clinical record for Patient #1 revealed that the patient was admitted to the facility on 09/30/19 and review of the treatment sheets from 03/03/25 to 03/31/25 revealed the patient experienced multiple hypotensive episodes pre-treatment, on treatment initiation and throughout her treatments recording blood pressures as low as 49/31 with most treatments recording systolic blood pressures (SBP) less than 100. An interview was conducted with the Charge Nurse (CN) on 04/02/25 at 10:10 AM. The surveyor reviewed with the CN regarding the patient’s low blood pressure. He confirmed that the patient often comes into the facility with her blood pressure being low and the patient blood pressure will drop during treatment. The staff will readjust the blood pressure cuff, and/or turn off the ultrafiltration. He further stated that the patient is prescribed Midodrine to be given at the skilled care facility. Midodrine is medication prescribed to treat low blood pressure (hypotension). It works to stimulate nerve endings in blood vessels, causing the blood vessels to tighten. As a result, blood pressure is increased. The surveyor informed the nurse that the records for Midodrine for the dialysis center and the skilled care facility (SNF) are contradictory and he was unaware of what was exactly being administered. The dialysis facility documents that the patient is receiving Midodrine HCL one tablet three times a week on Monday, Wednesday, and Friday. However review of the Order Summary report from the skilled care facility documents a 01/20/25 order prescribing for the patient to receive Midodrine HCL 5 mg give 2 tablets by mouth three times a day for Hypotension. Hold for SBP above 130. The CN confirmed he was uncertain what the patient is receiving at the SNF and would have to follow-up with the facility and the physician to determine the plan to treat the patient persistent hypotensive episodes. 51535 2) Clinical record review for Patient #2 revealed that the patient was admitted to the facility on 11/08/24 and was prescribed to receive dialysis treatment three times a week for 3 hours and 30 minutes. Further review of the treatment sheets from 03/03/25 to 03/31/25 failed to provide evidence that the staff consistently monitored the patient’s blood pressure every 30 minutes. Additionally, the patient experienced extended time periods of elevated blood pressures and the staff failed to monitor the patient every 30 minutes on 4 of 10 treatments as follows: a. On 03/07/25 the staff failed to monitor the patient’s blood pressure from 6:36 AM to 7:32 AM, 56 minutes. b. On 03/14/25, the staff documented at 8:32 AM , the patient’s blood pressure was 193/118. However, there is no evidence that the staff monitored the patient’s blood pressure again until 9:49 AM, 1 hour and 17 minutes. The 9:49 AM Blood Pressure was documented as 141/87. c. On 03/17/25, the staff failed to monitor the patient’s blood pressure from 8:01 AM to 9:01 AM, 1 hour. d. On 03/26/25, the staff failed to monitor the patient’s blood pressure from 9:09 AM to 9:56 AM, 47 minutes Review of the facility policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revision date April 2024, documented, vital signs and treatment monitoring “non-nocturnal treatments are at least every thirty (30) minutes.” An interview was conducted on 04/02/25 at 10:35 AM with the Registered Nurse (RN), who confirmed that the vital signs were not monitored every 30 minutes, and the blood pressure was abnormally high.”

“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: 22517 Based on observation, clinical record review and staff interview, the facility failed to ensure the dialysis prescription was consistently followed for 1 of 4 sampled patients (Patient #4). This is evidenced by the clinical staff failure to follow the dialysis prescription for the prescribed Blood Flow Rate (BFR) and Dialysis Flow Rate (DFR) and failed to document the clinical rationale for not following the prescribed treatment prescription. The findings included: Review of the clinical record for Patient #4 revealed the patient was admitted to the facility on 08/11/23. On 03/04/25 physician prescription prescribed for the patient to receive treatment three times a week for 4 hours and prescribed a Blood Flow Rate of 400 and a Dialysate Flow Rate of 500. An observation on the treatment floor on 04/02/25 at 1:40 PM with the Charge Nurse for Patient # 4 revealed that the patient was actively receiving dialysis treatment. Review of the dialysis prescription and the current treatment being administered revealed the patient’s Dialysis Flow Rate of 800. The CN confirmed that the patient was not receiving the prescribed DFR and was unable to provide an explanation as to why the prescription was not being followed. Additionally, further review of the treatment sheets from 03/03/25 to 03/31/25 revealed the staff failed to follow the physician prescription for the Dialysis Flow Rate for 8 treatments as follows and the staff did not provide an explanation why the physician order was not followed: a. On 03/03/25, the staff documented a DFR of 800 for the 4 hour treatment. b. On 03/05/25, the staff documented a DFR of 800 for the 4 hour treatment. c. On 03/07/25, the staff documented a DFR of 800 for the 4 hour treatment. d. On 03/10/25, the staff documented a DFR of 800 for the 4 hour treatment. e. On 03/14/25, the staff documented a DFR of 800 for the 4 hour treatment. f. On 03/24/25, the staff documented a DFR of 800 for the 4 hour treatment. g. On 03/26/25, the staff documented a DFR of 800 for the 4 hour treatment. h. On 03/31/25, the staff documented a DFR of 800 for the 4 hour treatment.”

“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: 51535 Based on clinical record review and staff interview, the staff failed to document the patient education regarding the risks and benefit of Erythropoiesis Stimulating Agent (ESA) used for managing anemia. The FDA issued a warning for ESA regarding serious adverse events and ESA has been found to be detrimental to some patients when administered in high doses. This failure affected 1 of 5 patients reviewed for anemia management (Patient #3). The findings included: Review of the clinical record for patient #3 revealed that the patient was admitted to the facility on 03/10/25. On 03/14/25 the physician prescribed Mircera 50 mcg IVP (intravenous push) every 2 weeks. Further review of the clinical record failed to provide evidence that the physician provided the patient education regarding the risks and benefits of Erythropoiesis Stimulating Agent (ESA) used for managing anemia. An interview was conducted on 04/02/25 at 1:40 PM with the Facility Administrator, who confirmed that they were unable to locate information that the patient was provided education regarding the risk and benefit of ESA.”