Davita Miramar Kidney Center

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 40153 Based on interviews and record review, the facility failed to develop an emergency preparedness plan that is based on the facility-based and community-based risk assessment using an “all-hazards” approach. The findings included: A review of the facility emergency preparedness plan for 2024, and 2025, revealed that no Hazard Vulnerability Assessment or another all-hazards approach was developed to ensure that the facility has the capacity to address a broad range of related emergencies. In an interview conducted on 08/21/25 at 11:30 AM with the facility’s Administrator, she acknowledged that she did not have a Hazard Vulnerability Assessment completed. This Surveyor said that the above assessment should be specific to the location of the facility considering the types of hazards most likely to occur in the area, but should also include unforeseen emergencies.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 51535 Based on observation and administrative record review, the clinical staff failed to implement infection control practices to minimize the risk of infection and cross contamination. This is evidenced by the facility failure to ensure staff utilized proper hand hygiene, along with glove changes, during initiation, termination and throughout the treatment. The Findings Included: An observation on 08/20/25 at 10:32 AM, Patient Care Technician (PCT) providing CVC exit site care to Patient #5 at station #9. PCT changed gloves three times during the exit site care without performing proper hand hygiene between glove change. Review of Administrative policy “Infection Control for Dialysis Facility”, revised April 2023, document, all teammates, Physicians, and Non- Physicians (NPP) will perform hand hygiene, prior to gloving and immediately after removal of gloves.”

“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 for obtaining water cultures prior to disinfection. This is evidenced by the staff failure to ensure that water and dialysate cultures are taken prior to disinfection for 5 of 6 months reviewed. The findings included: Review of the facility’s Disinfection and culture log for 3/2025, 4/2025, 5/2025, 6/2025, 7/2025 and 8/2025 revealed that the facility disinfection was completed prior to obtaining cultures for 5 of 6 months reviewed. The staff completed the log as dated: Disinfection date:8/4/25, 7/7/25, 6/2/25, 5/5/25, 4/7/25, 3/10/25 Culture date: 8/5/25, 7/9/25, 6/3/25, 5/7/25, 4/8/25, 3/10/25 The facility policy, Water Culture Policy, published April 2025, documented, “Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution system. Monthly is defined as within a calendar month.” An interview conducted on 08/21/2025 at 10:30 AM with the Biomedical Technician (Biomed Tech). The surveyor reviewed the documentation on the Log with the technician and he confirmed the above information in the printed logs.”

“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 a sanitary environment as evidenced by 3 of 4 under the sink cabinets were observed unsanitary, and with expired supplies. The findings included: A tour of the facility’s treatment area was conducted on 08/20/25 at 11:00 AM. The tour revealed 3 of 4 under the sink cabinets were observed with dirt and debris and dust. The tour further revealed; an opened bottle of peroxide with an expiration date of 01/25, a 3 K (potassium) bottle of dialysate not dated, and 4 bags of red blood tubes with an expiration date of 5/31/25. A second observation of the facility’s 4 under the sink cabinets was conducted on 08/21/25 at 12:00 PM. The same 3 of 4 under the sink cabinets were observed with dirt and debris and dust. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:30 PM. The FA acknowledged the above.”

“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 interviews and chart review, the facility failed to monitor vaccination status (Hepatitis B, Pneumonia) for 2 of 4 medical records reviewed (Patient #1 and Patient #4). The findings included: A review of the facility ’ s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” dated 01/05/2002 showed the following: an order will be obtained for Hepatitis B vaccination, and the patient provided the consent form for the patient to consent to the vaccination or decline. If the Hepatitis B antibody levels are less than 10, the patient should be vaccinated or revaccinated with a complete primary series. 1. A medical record review revealed Patient #4 was admitted to the facility on 10/03/2014 for In-center hemodialysis. A Hepatitis lab taken on 08/11/2025 showed Patient #4 had no immunity with a result of less than 3 (immunity is above 10). Further chart review revealed a refusal form for Hepatitis B on 08/29/2018, but no other consent forms were given/offered to Patient #4 after 08/29/2018. A chart review revealed Patient #4 was given the Pneumonia vaccine on 03/08/2019. No other pneumonia vaccines were offered after 03/08/2019, currently is past the 5-year coverage period. In an interview conducted on 08/21/25 at 12:35 PM with the facility ’ s Administrator, she acknowledged that the Hepatitis B and Pneumonia vaccinations were not offered again to Patient #4. 36734 2. Record review revealed Patient #1 was admitted to the facility for treatment on 09/20/24. Patient #1 had declined hepatitis B vaccination on 09/20/24. A review of Patient #1’s lab results revealed the patient had immunity on 10/31/24 (level 115). Patient #1 did not have immunity on 05/13/25 and 06/17/25 (level was < 3). Further record review did not indicate if the hepatitis B vaccine was offered to Patient #1. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:00 PM. The FA acknowledged the above.”

“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: 36734 Based on record review and interview, the facility failed to complete an initial comprehensive assessment in a timely manner for 2 of 4 patients reviewed (Patient # 1 and #2). The findings included: 1. Record review revealed Patient #1 was admitted to the facility on 09/20/24. Further record review did not reveal an initial comprehensive assessment was conducted for Patient #1. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:00 PM. The FA acknowledged the above. 51535 2) Review of the clinical record on 08/21/25 at 12: 45 for patient #2 revealed a start date of 06/09/25. Further review of the record revealed that the initial Plan of Care (POC) has not been completed as of 08/21/25. An interview conducted with Facility Administrator on 8/21/25 at 1:00 PM. She acknowledged the above information stating “I do not have a signed POC form.””

“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 complete an unstable care plan for 1 of 4 patients reviewed (Patient #3). The findings included: Record review revealed Patient #3 was admitted to the facility on 05/30/20 for treatment. Further record review revealed Patient #1 had recently had multiple hospitalizations, not achieving estimated weight, had terminated treatments against medical advice, and a low nutritional status. A review of Patient #3’s last care plan dated 04/17/25 revealed the patient was deemed stable. There was not an unstable care plan generated even though Patient #3 met the criteria for an unstable patient. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:00 PM. The FA acknowledged the above.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to complete an initial comprehensive assessment in a timely manner for 2 of 4 patients reviewed (Patient # 1 and #2). The findings included: 1. Record review revealed Patient #1 was admitted to the facility on 09/20/24. Record review revealed an initial comprehensive assessment was conducted on 12/06/24. Further record review did not reveal a completed care plan was conducted as there was no signature page for the patient and interdisciplinary team (IDT). An interview was conducted with the Facility Administrator (FA) on 08/21/25 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 clinical record review, administrative policy, and interview, the clinical staff failed to ensure dialysis prescription was followed for 1 of 4 charts reviewed. The failure included deviation of the prescribed Blood Flow Rate (BFR) and lack of documentation for the clinical rationale for not following the dialysis treatment prescription. The findings included: The clinical record review conducted on 08/21/25 revealed Patient #2 has physician orders for dialysis treatment for Blood Flow Rate (BFR) of 400. Treatment Records dated: 08/18/25 notes Patient #2 did not receive the prescribed BFR 400 for 2 hours and 26 minutes of 3 hours 30 minutes of treatment. The treatment records do not provide an explanation for the deviation from the dialysis prescription. 08/15/25 notes Patient #2 did not receive the prescribed BFR 400 for 59 minutes of 3 hours 30 minutes of treatment. The treatment records do not provide an explanation for the deviation from the dialysis prescription An administrative policy, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised April 2024, “Blood Flow Rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with nursing assessment or as allowable by state law.” An Interview with the Manager of Clinical Service conducted on 08/21/25 at approximately 14:00 PM, she acknowledged the above findings. The clinical record does not provide documentation to validate the reason for the change in blood flow.”

“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 did not complete an annual care plan for 1 of 4 patients reviewed (Patient #3). The findings included: Record review revealed Patient #3 was admitted to the facility for treatment on 05/30/20. Further record review revealed an annual care plan dated 08/23/24 for Patient #3. An observation of the annual care plan revealed a missing physician signature. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:00 PM. The FA acknowledged the above.”

“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 interviews and record review, the facility failed to ensure that monthly physicians ’ notes were completed for 3 of 4 patients reviewed (Patient #3, Patient #2, and Patient #4). The findings included: A review of the facility ’ s policy titled “Progress Note Policy” dated 03/02/2017 showed the following: The attending Nephrologist is required to record progress notes at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times. 1. A chart review revealed Patient #4 was admitted to the facility on 10/03/2014 for In-center hemodialysis. A chart review revealed that monthly care notes by the Physician were completed on 07/19/25, 6/30/25, and 06/01/25. No other monthly Physician ’ s notes were provided for the last 6 months. In an interview conducted on 08/21/25 at 1:00 PM with the facility ’ s Administrator, she said Patient #4 ’ s Physician ’ s documents are on a different computerized system and that she can reach out to the office to obtain those notes. 36734 2. Patient #3 was admitted to the facility on 05/30/20 for treatment. A review of the last 6 months of progress notes revealed there were no physician progress notes for Patient #3. An interview was conducted with the Facility Administrator (FA) on 08/21/25 at 12:00 PM. The FA acknowledged the above. 51535 3. Record review on 08/21/2025 at 12:45 PM revealed Patient #2 started In Center Hemodialysis (ICHD) on 06/09/2025. A review of clinical records revealed the absence of physician notes available for review for the months of June 2025, July 2025, and August 2025. An interview with the Clinical Manager on 08/21/25 at 1:PM, she acknowledges the patient’s care chart does not have monthly physician notes available for review.”