Dialyze Direct Fl

“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 have evidence all susceptible patients were offered or vaccinated against hepatitis B for 3 of 10 records reviewed (Patient #2, #6, and #7). The findings included: A review of the policy titled Vaccination Protocol Policy, with approved revision dated 06/01/24, documented: The immunization history of all ESRD (End Stage Kidney Disease) patients admitted to the outpatient dialysis centers and all home dialysis programs will be evaluated and documented in the patient medical record within 30 days of admission. Hepatitis B vaccine is to be offered to all ESRD patients whose hepatitis B antibody is less than 10. 1. Record review revealed Patient #2 was admitted to the facility for home hemodialysis (HHD) ,at a skilled nursing facility, on 07/14/25. A review of Patient #2’s labs dated 07/14/25 revealed a hepatitis antibody level <4. The facility had no evidence a hepatitis B vaccine was offered to Patient #2 at the facility. 2. Record review revealed Patient #6 was admitted to the facility for HHD at a nursing facility on 4/08/25. The facility had no evidence a hepatitis B vaccine was offered to Patient #6 at the facility. 3. Record review revealed Patient #7 was readmitted to the facility for HHD at a nursing facility on 09/02/25. A review of Patient #7’s labs dated 07/07/25 revealed a hepatitis antibody level < 7. The facility had no evidence a hepatitis B vaccine was offered to Patient #7 at the facility. An interview was conducted with the Regional Manager (RM) on 09/18/25 at 12;00 PM. The RM acknowledged the above. The RM stated the Consent For Or Declination Of Administration Of Hepatitis B Vaccination Or Booster was obtained from patients at their respective nursing facility and should be uploaded in the electronic medical records.”

“RO-CHEMICAL ANALYSIS-FREQUENCY CFR(s): 494.40(a) 6.2.7 Reverse osmosis: Chemical analysis: frequency Chemical analysis for the contaminants listed in 4.1.1 (Table 1) should be done when the RO system is installed, when membranes are replaced, and at not less than annual intervals thereafter to ensure that the limits specified in 4.1.1 are met (see Table 1). Chemical analyses should be done when seasonal variations in source water suggest worsening quality or when rejection rates fall below 90 %. This Standard is not met as evidenced by: 51535 Based on administrative record review and staff interview, the facility failed to provide evidence of chemical analysis on 3 of 5 machines reviewed. The findings included: On 09/17/2025 at 10:00 AM, a review of the facility’s AAMI reports revealed that the facility staff failed to provide evidence of documentation for 3 of 5 home hemodialysis machines sampled which includes the following Pure Flow (PF): Machine PF#20829 (Port Charlotte) Machine PF#47699(Port Charlotte) Machine PF#1606 (Carrington-St. Pete) Review of the facility policy Water and Dialysate Evaluation and Testing Guideline for PureFlow SL Policy, Procedure-Home, Reference: DD-CS-7063, approved revision: 3/1/2024,” Initially: test each PAK in use within the first month of initiating the use of PureFlow SL units. Annually: PAK water will be tested from each PAK in use every January. More Frequently, if needed, to verify results are within the AAMI limits, i.e.., after interruptions of source of water service.” An interview was conducted on 09/17/2025 at approximately 1:00 PM with the Clinical Educator, who reported that the clinical staff is responsible for completing the Initial and Annual water chemical analysis. She acknowledged there is no evidence of documentation of an annual chemical analysis report which is due initially within the first month of use and every January thereafter.”

“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: 51535 Based on administrative record review and staff interview, the facility failed to follow the established policy and procedures in obtaining bacteriological and endotoxin testing prior to use for 1 of 5 machines reviewed. This is evidenced by the staff failure to ensure chemical, bacteriological, and endotoxin testing are completed prior to use. The findings included: Review of the facility’s machine Environmental Testing Results sheet date. There is no evidence of bacteriological and endotoxin testing results for the following: Machine PF#20829 (Port Charlotte) A review of the facility policy Water and Dialysate Evaluation and Testing Guideline for PureFlow SL Policy, Procedure-Home, Reference: DD-CS-7063, approved revision: 3/1/2024,” Initially: test each PAK in use within the first month of initiating the use of PureFlow SL units. Annually: PAK water will be tested from each PAK in use every January. More Frequently, if needed, to verify results are within the AAMI limits, i.e.., after interruptions of source of water service.” An interview conducted on 09/17/2025 at 1:30 PM with the Clinical Educator who confirmed that there is no documentation available for review on the above machine for chemical analysis, bacteriological and endotoxin testing.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 51535 Based on observation and interview, the facility failed to prominently display a copy of a current Dialysis Facility Performance Certificate. The findings included: On 09/15/2025 at 11:15 AM, during an observation of the lobby area, the surveyor noted the Certificate of Dialysis Facility Performance expired 12/31/2024. An interview was conducted with the Regional Manager on 09/18/25 at 2:00 PM, who acknowledged the above information.”

“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: 22651 Based on Observation, interview, and policy review the Dialysis Center failed to perform an physical comprehensive assessment prior to the initiation of treatment 1 (Patient #4) of 4 patients sampled. The agency’s Policy: PRE-DIALYSIS NURSING ASSESSMENT POLICY, PROCEDURE APPROVED REVISION: 10/1/2020 PROCEDURE: The assessment shall include an evaluation of the following: General condition of the patient: Patient sensorium Skin color, temperature, integrity Respiratory rate and lung sounds Edema, including location and degree Patient physical complaints Pain Assessment Pre-dialysis weight Heart rate - apical and peripheral pulses Blood pressure sitting and standing (where possible) Vascular access The findings include: On 9/16/25 at 12:45 PM observed patient #4 at station #4. The Patient Care Technician (PCT) did the patient’s blood pressure, and heart rate. The PCT proceed to the patient’s dialysis access site; located on Left Upper Arm. The access site was cleaned. The PCT inserted the Arterial and Venous lines and proceed to start the treatment. On 9/16/25 at 1:00 PM during interview with the Registered Nurse, she said, we had several patients schedule to go on at this time. I have not done patient #4’s Nursing assessment yet. I wanted to get everyone started with dialysis first.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 51535 Based on clinical record review, administrative record review, and staff interview, the facility failed to ensure the evaluation of factors associated with anemia, such as hematocrit, hemoglobin, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This is evidenced by 1 of 10 sampled home hemodialysis patients (Patient #8). There is no evidence of the Interdisciplinary Team (IDT) evaluating the patient for low hemoglobin and hematocrit level. The findings included: Review of the clinical record on 09/17/25 at 1:50 PM for patient # 8 revealed that the patient was admitted to the facility on 09/04/25. laboratory (Lab) results dated 09/08/25: hemoglobin (HGB) 8.3, Hematocrit (HCT) 27.2, Ferritin 2008, Iron Saturation (FeSat) 13. Further review of the home records revealed that the patient was not evaluated for anemia (low hgb/hct levels) in a timely manner and failed to provide evidence of an evaluation by IDT members. A review of the facility policy Anemia Management Policy, Reference: DD-CS-0133, approved revision: 3/31/2017, “Each patient’s hematologic status shall be evaluated for determination of his/her individual anemia management needs.” An interview was conducted on 09/17/25 at 2:00 PM with the Clinical Educator Nurse, who confirmed that the laboratory values were not addressed by IDT members.”

“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: 36734 Based on record review and interview, the facility failed to conduct a monthly unstable assessment and care plan for a patient deemed unstable for 1 of 10 sampled patients (Patient #3). The findings included: Record review revealed Patient #6 was admitted to the facility for home hemodialysis (HHD) at a nursing facility on 06/27/25. A review of Patient #3’s comprehensive interdisciplinary assessment (CIA) dated 07/17/25 deemed the patient unstable due to low hemoglobin, hospitalization, and removal of arm access/wound. Further review of Patient #3’s records did not reveal any further assessment/care plan. An interview was conducted with the Regional Manager (RM) on 09/18/25 at 1:00 PM. The RM acknowledged the above.”

“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: 36734 Based on record review and interview, the facility failed to have evidence a patient participated in their plan of care as evidenced by lack of patient signature for 3 of 10 sampled patients (Patient #1, #2, and #5). The findings included: 1. Record review revealed Patient #1 was admitted to the facility for home hemodialysis (HHD) at a nursing facility on 07/22/25. A review of Patient #1’s care plan dated 08/09/25 revealed there was no patient signature provided to ensure the patient participated in the care plan. 2. Record review revealed Patient #2 was admitted to the facility for home hemodialysis (HHD) at a nursing facility on 07/14/25. A review of Patient #2’s care plan dated 07/21/25 revealed there was no patient signature provided to ensure the patient participated in the care plan. 3. Record review revealed Patient #5 was admitted to the facility for home hemodialysis (HHD) at a nursing facility on 06/17/25 A review of Patient #2’s care plan dated 7/11/25 revealed there was no patient signature provided to ensure the patient participated in the care plan. An interview was conducted with the Regional manager (RM) on 09/18/25 at 1:00 PM. The RM acknowledged the above.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51535 Based on record review and staff interviews, the facility failed to provide an initial nursing assessment prior to the first home hemodialysis treatment for 2 of 10 patients reviewed (Patient #8 and #7). The findings included: 1. On 09/17/25 at 2:00 PM record review revealed Patient #8 started Home Hemodialysis (HHD) on 09/04/2025. There is no documentation in the patient medical record of the completion of an Initial Nurse Assessment. 2. record review revealed Patient #7 was admitted to the facility for HHD at a nursing facility on 09/02/25. Further review of Patient #7’s record revealed there was not an initial nursing assessment conducted prior to the initiation of the first treatment. An interview was conducted with the Clinical Educator nurse 09/17/25 at 2:30 PM, she confirmed that the patients (#8,7) do not have an initial nursing assessment completed prior to the initiation of the first treatment.”