Atlantis Manati

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 51782 Based on observations made of the treatment area, during the first and second shift of 04/23/2025 from 8:00 AM through 1:30 PM, it was determined that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents within and between units related to the lack of adherence of “standard precautions”. Findings include: Operational Clinical Manager (employee #4) provided facility’s policy on 04/24/2025 at 10:39 AM. Document # 8.09 was reviewed on 11/14/2023, “Dialysis Machine Cleaning, Disinfecting and labeling”. Policy states on page 3, that do not use the strip if it turns green before testing, the expiration date, or 3 months after it is opened. 1. During observations conducted in the hemodialysis treatment area, on 04/24/2025 from 8:00 AM through 1:30 PM, and interview with facility nursing supervisor (employee #1) the following was observed: a) On 03/24/2025, at 10:27 A.M., one (1) container of Water Check Residual Chlorine, Lot number 2310481002, Expiration date 2025-04, it was observed with the opening date and the employee’s initials unreadable. Operational Clinical Manager (employee #4) provided facility’s policy on 04/23/2025 at 2:38 PM. Document # 8.16 was reviewed on 02/09/2024, “Storage of Patient Belongings”. Policy states in page 1, section #1 that as patients enter the dialysis unit, belongings from luggage or bags will be retrieve before reaching the treatment area. In section # 2 states that the patient might be assisted by nurses who will instruct about the designated area where luggage/bags will be left. 2. During observations conducted in the hemodialysis treatment area, the following were observed: a. On 04/23/2025, at 8:45 AM., the left-lateral side table of the chair was observed with bag personal belongings hanging at station 31 during dialysis treatment. b. On 04/23/2025, at 9:47 AM., the right-lateral side table of the chair observed bag personal belongings hanging at station 40 during dialysis treatment. c. On 04/23/2025, at 12:09 PM., the right-lateral side table of the chair observed bag personal belongings hanging at station 25 during dialysis treatment. Operation Clinical Manager (Employee #4) provided the facility policy on 4/23/2025 at 2:38 PM. Document #8.03 was revised on 09/05/2023, “Effective Use of Personal Protective Equipment (PPE)”. The policy states on page 2 that when staff must gown, and page 4 states how staff to safely remove gowns. 3. During observations conducted in the hemodialysis treatment area, on 04/24/2025 from 8:00 AM through 1:30 PM, the following was observed: a. On 04/23/2025, at 10:49 AM was observed (employee #7) wearing gowns accompanying a patient out of the dialysis treatment unit to the waiting room. b. On 04/23/2025, at 10:50 AM was observed (employee #8) wearing gowns accompanying a patient out of the dialysis treatment unit to the waiting room. In an interview with a nursing supervisor (employee #1) stated that he had been orienting that they could not come out of the dialysis area wearing a gown and proceed to the waiting room door. During an interview with Operational Clinical Manager (employee #4) on 04/24/2025 at 10:25 AM, stated that the use of the gown is exclusive for inside the treatment unit, and they should not leave the unit wearing gowns. Operation Clinical Manager (Employee #4) provided the facility policy on 4/23/2025 at 2:50 PM. Document #4.02 was revised on 01/22/2023, “Needle Placement and Removal/AVF, Graft & Hero Vascular Access Device”. The policy states on page 4 in section 5 before needle placement, perform hand hygiene. 4. During observations conducted in the hemodialysis treatment area on 04/24/2025 at 12:35 PM through 12:55 PM, the following was observed: a) It was observed that during the arteriovenous fistula initiation procedure with (patient #24); (employee #11) after assessing vascular access and verifying the patency, she did not remove gloves and did not wash her hands; she used the same gloves to disinfect the vascular access and performed the cannulation. b) It was observed that during the arteriovenous fistula initiation procedure with (patient #23); (employee #10) after assessing vascular access and verifying the patency, she did not remove gloves and did not wash her hands; she used the same gloves to disinfect the vascular access and performed the cannulation. 47384 5. Patient belongings were observed stored in an aluminum container, the belongings were observed on top of each other and some of the straps were directly touching the floor.”

“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: 47384 Based on observations made in the treatment area on the first and second shift on 04/23/2025, it was determined that the facility failed to ensure that the staff and all paramedics washed their hands and then put on disposable gloves and Personal Protective Equipment (PPE) when entering and touching patients’ equipment at the dialysis station. Findings include: 1. Nursing staff fail to ensure that paramedic personnel transport patients follow the proper handwashing protocol upon entering and leaving the unit and correct use and disposal of PPE. 51782 The Clinical Operations Manager (Employee #4) provided the facility policy on 4/23/2025 at 2:38 PM. Document #8.03 was revised on 9/5/2023, “Effective Use of Personal Protective Equipment (PPE).” The policy states on page 3 that gloves must be changed when moving from a dirty to a clean location or task with the same patient (e.g., gloves must be changed after touching the HD machine and before touching the vascular access of the patient with it.) 2. During observations conducted in the hemodialysis treatment area, on 04/24/2025 from 8:00 AM through 1:30 PM, the following was observed: a. On 04/23/2025, at 10:00 AM., during the fistula disconnection procedure with (patient #22), the registered nurse (employee #9) is observed, after putting on clean gloves, touching a chair to sit down, then proceded to remove needles with contaminated gloves.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 51829 Based on observation during the connection process of the second shift, the facility failed to ensure adherence to best infection prevention and control practices to prevent and minimize infections. Findings include: The Clinical Operations Manager (Employee # 14) provided the facility policy Document #8.03, “Effective Use of Personal Protective Equipment (PPE),” reviewed on 9/5/2023. Was discuss with Employee #14 on 4/23/2025 at 2:00 PM. The facility’s policy states on page 1 the use of a face shield during procedures involving blood exposure. 1.On 04/24/2025 at 12:50 PM, during a facility visit in the direct patient care area, the following was identified: a. The biomedical technician intervenes, without using a face shield, with a machine connected to the patient, which poses risk of blood exposure.”

“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: 47384 Based on observations made in the treatment area on 04/24/2025, it was determined that the facility failed to perform the cleaning and disinfection of contaminated surfaces, medical devices, and equipment. Findings include: During visual observation of the treatment area approximately at 8:25 AM, drain area on the wall box behind dialisys machine were observer with stains compatible with water hardness and brown stains in need of cleaning.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 51782 Based on observations, interview with the biomedical (employee #12), and review of policies/procedures, it was determined that the facility failed to ensure that 2 out of 2 registered nurses (RN) (employee #9 and employee #10) follow policies and procedures when checking pH of water used for dialysis, before starting the treatment on a patient. Findings include: 1.The following was observed while personnel were preparing hemodialysis machines for the second shift on 04/23/2025 from 12:15 AM through 1:00 PM: a) On 04/24/2025 at 12:26 PM, registered nurse (RN) (employee #9) observed performed the pH and conductivity test on the hemodialysis machines located at station #40. RN # 9 upon performing the pH on the machine, inserted the strip to reactivate with the pH of the dialysate, but did not wait ten (10) seconds to perform the pH reading. b) On 04/24/2025 at 12:50 P.M., the registered nurse (RN) (employee # 10) observed the pH and conductivity test performed on the hemodialysis machines located at station # 27. RN # 10 when performing the pH test on the machine, did not use the osmometer, she moistened the strip with the machine’s sleeve, once she moistened she did not wait ten (10) seconds to take the pH reading.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 47384 Based on the documentation of water treatment and crops carried out on the machines and water system, it was identified that the facility failed to have well documented Microbial monitoring methods. Findings include: The internal policy “Microbiological Testing of Water and Dialysis” was reviewed on 4/24/2025 at approximately 1:30 PM, it establishes that the results must be documented, but documentation could not be validated. During the evaluation of the analysis records performed on dialysis machines, it was identified that the biomedical staff did not have a chronological record of the processes, recognizing ranges outside the parameters in machine cultures.”

“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: 47384 Based on observations and interviews performed during the tour of the physical environment, it was determined that the facility failed to be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Findings include: 1. Cross Tees on the isolation room were observed with rust and covered metallic adhesive tape. 2. Water stains in acoustic tiles were observed near station #5 and in front of the entrance door of the water treatment unit. 3. Two (2) air conditioning units in the treatment area were observed with rust in the air vents areas. 4. UV light fly trap machines (2) were observed with missing bulbs or in operational: a. Biomedical Room b. ILT-6 5. Two (2) patients were observed using electrical blankets; this represents a fire risk. 6. The parking lot that has four (4) accessible handicapped parking located in front of the unit, approximately fifty feet away from the dialysis unit entrance. On 04/23/25 at 11:30 AM it was observed that the Ambulance unit was parked on marked handicapped space impeding patients to park.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first shift and second shift of 04/23/2025 and 04/24/2025 from 8:00 AM through 3:30 PM, it was determined that the facility failed to maintain Life Safety measures that comply with NFPA 101 (Life Safety Code), NFPA 99 (Health Care Facilities Code) which could affect all patients receiving treatment and staff. Findings include: During visual observation of the treatment area approximately at 8:25 AM, two (2) stretchers were observed obstructing the means of egress through exit leading to the front parking. It does not comply with NFPA 101 7.2.5.”

“PE-LSC-SPRINKLERS CFR(s): 494.60(e)(2) (2) Notwithstanding paragraph (d)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the Life Safety Code, section 21.1.6.1, which were constructed after January 1, 2008, and those housed in high rise buildings over 75 feet in height, which were constructed after January 1, 2008. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first and second shift on 04/23/2025 and 04/24/2025 from 8:00 AM through 3:30 PM, it was determined that the facility failed to maintain Life Safety measures that complies with NFPA 101 (Life Safety Code), NFPA 99 (Health Care Facilities Code) which could affect all patients receiving treatment and staff. Findings include: 1. Loaded sprinklers were observed in the patient’s waiting area and inside the treatment area. All sprinkler heads should be revised and cleared of dust. 2. Observation and interview of the facility technical warehouse revealed 15 sprinkler heads (14 Upright Sprinkler Head and 1 GREEN bulb sprinkler head), that do not comply with the requirement to have the same temperature classification in the same compartment. 3. Flow sensor meter was observed detached from main raiser. 4. Approximately at 10:20 AM during observation of the wet pipe system, a pressure gauge dated 2012 was observed. After the record review no evidence of calibration for the gauge was found. 5. No tag or record of internal inspection of piping for the wet pipe system ( 5 year ) was provided.”

“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: 51782 Based on twenty-one (21) records reviewed (RR), review of policies and procedures and interview with Operational Clinical Manager (employee #4), it was determined that the facility failed to follow established procedures after identifying patients’ high blood pressure (BP) or low blood pressure (BP) during dialysis treatment for 2 out of 21 records reviewed (RR #1 and #10) Findings include: During the flowsheet review performed on 04/24/2025 and 04/25/2025 at 9:00 AM to 3:30 PM the following were found: 1. RR# 1 is a 70-year-old female admitted to the facility on 03/30/2024 with a diagnostic End Stage Renal Disease (ESRD). During the record review performed on 04/24/2025 at 9:44 AM, the hemodialysis treatment three times a week for three hours and thirty minutes, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) of 74.5 kilograms (kg). a. On 04/17/2025 at 12:30 PM, it was revealed that the Blood Pressure (BP) was 197/69mg/Hg, at 12:35 PM it was revealed that the BP was 198/71 mg/Hg, at 2:00 PM it was revealed that the BP was 182/90 mg/Hg and at 2:30 PM it was revealed that the BP was 185/63 mg/Hg. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 20423 2. RR #10 is a 69-year-old female patient admitted to the facility on 11/06/2024 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 04/23/2025 at 3:29 PM, it was found that patients have hemodialysis treatment three days a week for 3 hours, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) 800, Dialyzer with 180 NRe Optiflux and patient EDW 62 kilogram (kg). a. On 04/14/2025 at 6:30 PM, it was revealed that the Blood Pressure (BP) was 95/31 millimeters of mercury (mm/Hg). No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identifying low blood pressure.”

“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: 51782 Based on twenty-one (21) records reviewed (RR) on 04/23/2025 through 04/24/2025, it was determined that the facility failed to follow physician’s orders in the Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) during dialysis treatment and documentation in the management of the patients BFR and DFR for 3 out of 21 records reviewed (R.R #4, #7 and #12). Findings include: 1. RR# 12 is a 72-year-old female admitted to the facility on 07/24/2023 with a diagnostic End Stage Renal Disease. During the record review performed on 04/24/2025 at 8:31 AM, the hemodialysis treatment two times a week for three hours and thirty minutes, Dialyzer 160 NRE Optiflux, Blood Flow Rate (BFR) of 380, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 73 kilograms (kg). a. On 04/21/2025 at 12:40 PM the DFR was decrease to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physicians. 20423 2. RR #4 is a 54-year-old female patient admitted to the facility on 02/17/2025 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 04/24/2025 at 10:29 PM, it was found that patient has hemodialysis treatment three days a week for four hours BFR of 350, DFR of 700, Dialyzer with 160 NRe Optiflux and patient Dry Weight (EDW) 76.50 kilogram (kg). a. On 04/04/2025 at 1:15 PM through 2:03 PM, the patient receives hemodialysis treatment with BFR on 300 due to patient refer chest pain and refuses increase the BFR to 350, however no evidence was found that the physician was notified. b. On 04/11/2025 at 5:15 PM through 8:40 PM patient receive hemodialysis treatment with BFR on 325 due to patient refuse increase the BFR to 350, however no evidence was found that the physician was notified. c. On 04/14/2025 at 4:55 PM through 8:30 PM the patient receives hemodialysis treatment with BFR on 325, no evidence was found of the justification to decrease the BFR or that the physician was notified. d. On 04/18/2025 at 1:30 PM through 3:30 PM the patient receives hemodialysis treatment with BFR on 325 patient was oriented related to the importance of maintaining the BFR in 350, and patient refused to increase the BFR to 350, however no evidence was found that the physician was notified. No evidence was found of the justification from the nurse documented or authorized decrease the BFR from the physician. 3. RR #7 is a 68-year-old female patient admitted to the facility on 09/21/2024 with diagnosis of ESRD. During the record review performed on 04/24/2025 at 12:40 PM, it was found that the patient has hemodialysis treatment three days a week for 3 hours BFR of 375, DFR of 700, Dialyzer with 160 NRe Optiflux and patient Dry Weight (EDW) 53.50 kg. a. On 04/15/2025 at 5:05 PM through 8:00 PM the patient receives hemodialysis treatment with DFR on 500, no evidence was found of the justification to decrease the DFR or that the physician was notified. No evidence was found of the justification from the nurse documented or authorized decrease the DFR from the physician.”