Universal Kidney Center of Margate-Coral Springs LLC

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 51535 Based on record review and staff interview, the facility failed to develop a complete Emergency Preparedness Plan (EP) which must contain the following information: 1) Establishment of the Emergency Program 2) Written documentation of the programs for: fire, equipment fire failure, care related emergences, water supplies and natural disasters. 3) Evidence that the leadership identify hazards such as: hurricanes, floods, active shooter, fire, tornado, electrical failure, water interruptions, or a plan brought to the governing body nor updated or signed. 4) EP Program Patient Population risk- assessment is based on an all-hazards approach specific to geographic location 5) Emergency Program Patient Population 6) Evidence of a backup clinics agreements in the emergency book 7) Policies and procedures developed based on facility- and community-based risk assessment and communication plan, utilizing an all-hazards approach. policies and procedures have been reviewed and updated every two years. 8) Procedures for Tracking of Staff and Patients. 9) Safe Evacuation. 10) P & P for Sheltering. 11) Policies and procedures for Medical Docs. 12) Roles under a Waiver Declared by Secretary 13) Development of a communication plan. 14) Emergency Officials Contact Information 15) Primary/Alternate Means for Communication 16) Methods for Sharing Information 17) Sharing information on Occupancy Needs Survey Procedures 18) Emergency Preparedness Training & Testing 19) Orientation and training 20) Integrated Healthcare Systems. The findings included: A review of the facility’s “Emergency Plan” revealed that the facility does not have written documentation of an established comprehensive emergency preparedness plan for review that meets the emergency plan requirements. The binder provided to surveyor for review contained other information about emergency but minimum information about the emergency preparedness plan which must be reviewed and updated at least every 2 years. An interview was conducted with the Facility Administrator on 05/14/2025 at 3:30 PM, she was not able to provide written evidence of the emergency plan documents, verification of the plan reviewed and emergency plan updates. She acknowledged the above information.”

“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: 51535 Based on administrative record review, observation, and interview, the facility failed to have a readily available functional Emergency Kit, Emergency Evacuation Box, Emergency AED, Suction equipment, and failed to identify, and remove expired items in the emergency evacuation box. The findings included: Facility policy titled “Emergency Equipment” revised 05/25/2009, documents “The emergency box will be checked on a weekly basis by an assigned staff member. The Director of Nursing will assign the duty of checking the emergency equipment.” An observation conducted on 05/13/25 at 10:35 AM of the emergency evacuation kit revealed that the kit was secured with a plastic white zip tie, no date, not easily removed manually and required a knife to cut the zip tie to open kit. An observation conducted on 05/13/25 at 10:35 AM of the emergency evacuation box conducted with the Facility Administrator. The observation revealed the emergency box was not locked, in disrepair, rusty, dirty, copious amount of dust, and debris covered with white dried substance. Further review revealed expired supplies Alcohol pad (1 box) expired 06/2023, Gauze (2 boxes) expired 03/2023, Gloves size small (1 box) expired 05/20/2023. An interview conducted on 05/13/25 at 10:35 AM with the FA, she confirmed the above and removed the expired supplies from the emergency evacuation kit. An observation of the Automatic Emergency Defibrillator (AED) was conducted on 05/14/25 at 12:15 PM with the Charge Nurse (CN). The AED was observed with the pad unpackaged, without an expiration date, and brown discoloration on gel portion of AED pads. The CN was instructed to demonstrate that the AED equipment was operational, she could not get the emergency equipment to operate. Further review revealed there was no replacement AED pads in the facility. An interview conducted on 05/14/25 at 12:15 PM with the CN, she acknowledged the above. An observation of the emergency Suction equipment was conducted on 05/14/25 at 12:20 PM with the Charge Nurse (CN). The suction Yankauer and tubing was observed unpackaged and without expiration date. The CN was instructed to demonstrate that the emergency suction equipment was operational. She demonstrated proper use of the suction equipment. Further observation revealed there is no replacement suction tubing or yankauer in the facility. An interview conducted on 05/14/25 at 12:20 PM with the CN, she acknowledged the above.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 36734 Based on interview and record review, the facility failed to have an annual fire inspection conducted by the local fire department. The findings included: An interview was conducted with the facility’s Biomed Technician on 05/14/25 at 12:00 PM. The technician presented an annual fire inspection report dated 01/30/23. The technician stated they did not have a current annual fire inspection.”

“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: 36734 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by breeches in storage of supplies and other environmental issues. The findings included: A tour of the treatment area, conducted on 05/12/25 at 10:30 AM, revealed; a. Floor baseboards at the entrance were separated, with dirt and debris build-up between the separation. b. Hoyer lift with dirt/debris and white residue on the legs. c. A frayed wire was observed hanging from the ceiling. A tour of the supply room, conducted on 05/13/25 at 10:00 AM, revealed; a. Two opened boxes of cookies/crackers stored on a storage rack. b. Supplies in card board boxes stored on the floor. A tour of the water treatment room, conducted on 05/13/25 at 11:00 AM, revealed; a. Ceiling tiles with black mold-like substance. b. Brine tank with low salt level and black mold-like substance. An interview was conducted with the Biomed technician on 05/13/25 at 12:00 PM. The technician stated the frayed wire hanging from the ceiling was for head phones for the patient to listen to the television during treatment. The technician further stated the ceiling had a leak in the water treatment room, and he had not had the opportunity to replace the ceiling tiles. The technician further acknowledged the above.”

“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: 36734 Based on observation, interview, and policy review, the facility failed to encourage a patient to perform hand washing/hygiene after treatment for 2 of 4 patient observations (Patient #5 and #6); and failed to perform hand hygiene during patient treatment. The findings included: Review of Administrative policy “Hand Washing Technique”, published 05/27/1997, document, Handwashing is the most important factor in the prevention of cross-infection, hands must be washed in all the following instances: a. Before initiating patient treatment. b. Between handling of individual patients. c. During performance of normal duties (after initiating patient treatment, after completion of treatment, before administrating medications, etc.) 1. An observation of the conclusion of treatment was observed for Patient #5 on 05/12/25 at 11:00 AM. Patient #5 was observed exiting the treatment area. Staff did not encourage the patient to perform hand hygiene prior to exiting the treatment area. 2. An observation of the conclusion of treatment was observed for Patient #6 on 05/12/25 at 11:30 AM. Patient #6 was observed exiting the treatment area. Staff did not encourage the patient to perform hand hygiene prior to exiting the treatment area. An interview was conducted with the acting facility administrator (FA) on 05/14/25. The FA acknowledged the above. 51535 3. On 05/12/25 at 1:18 PM, an observation of Staff B, a patient care technician, terminating dialysis procedure at station #5 was conducted. Staff B left station #5 to silence an alarm at station #9. Staff B did not unglove or sanitize her hands prior to touching the dialysis machine to silence the alarm. Staff B then returned to station #5, and resumed providing patient care without changing gloves and performing proper hand hygiene.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 51535 Based on observation and interview, the facility failed to have a designated clean sink for hand washing for 1 of 3 sinks. The findings included: An observation of the facility’s treatment area was conducted on 05/12/25 at 10:30 AM. One of 3 sinks were observed without designation as clean or dirty. An observation of the facility’s treatment area was conducted on 05/14/25 at 12:20 PM with Biomedical Technician (BMT). One of 3 sinks were again observed without designation as clean or dirty. An interview conducted with the Biomedical Technician (BMT) at the time of observation,confirmed sink is nt designated as clean or dirty.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to maintain a dedicated clean area for the preparation, handling and storage of medications. The findings included: An observation of the charge nurse (CN) was conducted on 05/12/25 at 11:00 AM. The CN was observed with a stethoscope draped around her neck. The CN was observed using the stethoscope to examine a patient prior to treatment. The CN was then observed placing the stethoscope on the area at the nursing station that was the dedicated clean area for medications. An interview was conducted with the acting facility administrator (FA) on 05/14/25 at 12:00 PM. The FA acknowledged the above.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have a biohazard bin stored securely outside for 1 of 3 bins observed. The findings included: A review of the facility’s policy titled Biomedical Waste, dated 05/27/97 and revised 08/10/2021, documented the facility is considered a large quantity generator of medical waste. The medical waste is located in the back of the building. Stored in a locked container which affords protection from the environment and limits exposure to the public. It affords protection from animals and does not provide a breeding place or a food source for insects and rodents. An observation of 3 biohazard bins outside of the facility was conducted with the Biomed technician on 05/13/25 at 11:00 AM. One of the large red biohazard bins was observed unsecured. The Biomed technician acknowledged the biohazard bins stores outside the facility should be secured.”

“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 offer hepatitis vaccination for 2 of 4 sampled patients (Patient #2 and #3). The findings included: A review of the facility’s policy Administration of Hepatitis Vaccine, dated 05/27/97 and revise on 05/25/09, documented: CDC recommends “a protective level of anti hep B surface antigen greater than 10. Person determined to have anti hep B surface antigen of less than 10 after the primary vaccine series or that are immunosuppressed like chronic kidney disease patients should be revaccinated with a 3 dose series, followed by anti hep B surface level check one to two months after the 3rd dose.” 1. Record review revealed Patient #3 was admitted to the facility for treatment on 03/12/25. A review of the patient’s hep B surface antigen level was less than 5 on 03/19/25. Further record review did not reveal if the hepatitis vaccine was offered or declined. An interview was conducted with the acting facility administrator (FA) on 05/14/25 at 12:00 PM. The FA acknowledged the above. 51535 2. A review of the clinical record for Patient #2 revealed that the patient was admitted to the facility on 06/22/2016. On 04/12/25 the Hepatitis B Surface Antigen was less than 10. An interview was conducted on 05/14/25 at 1:40 PM with the Facility Administrator, who provided additional labs for Hepatitis B surface antigen, unable to locate information of the patient’s Hepatitis B antibody immune status.”

“H20 PURITY-ANSI/AAMI RD52:2004 CFR(s): 494.40(a) The facility must be able to demonstrate the following: Water and equipment used for dialysis meets the water and dialysate quality standards and equipment requirements found in the Association for the Advancement of Medical Instrumentation (AAMI) publication, “Dialysate for hemodialysis,” ANSI/AAMI RD52:2004. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552 (a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 75000 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. Copies may be purchased from the Association for the Advancement of Medical Instrumentation, 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795. This Standard is not met as evidenced by: 51535 Based on administrative record review and interview, the facility failed to have the medical director review and sign AAMI (Association for the Advancement of Medical Instrumentation) report for 6 of 6 months reviewed. The findings included: A review of the facility’s AAMI report log was conducted on 05/14/25 at 10:30 AM. Six of 6 months were reviewed without Medical Director signature to acknowledge AAMI results. An interview was conducted on 05/14/25 at 12:20 PM with Biomedical Technician who acknowledged the above.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 51535 Based on administrative record review and staff interview, the facility failed to provide evidence of monitoring, testing, and performing testing of free chlorine, chloramine, or total chlorine in a logbook/sheet. This is evidenced by the staff failure to provide documentation of chlorine testing. The findings included: Administrative records requests made on 05/12/25, 05/13/25, and 05/14/25 to the Biomedical Technician for the review of the facility’s chlorine testing logbook/sheet. The facility staff failed to provide evidence that chlorine was monitored and tested daily at the beginning of the dialysis treatment shift and every four hours during dialysis operations. The facility staff failed to provide documentation that they monitored and tested the water for free chlorine, chloramine, or total chlorine. However, there is no documentation that the staff monitored or tested the system. An interview was conducted on 05/14/25 at approximately 1:00 PM with the BioMed technician, who reported that the staff are responsible for recording and completing the daily chlorine testing log sheet and he will get the logbook/sheet for review. No additional attempts made for the reviewing of chlorine testing logbook/sheet.”

“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: 51535 Based on observation and interview, the facility failed to measure approximate PH with an independent method before starting treatment of the next patient for 1 of 2 patients observed. The findings included: 1) An observation of the treatment area was conducted on 05/14/25 at approximately:40 PM. Surveyor requested BMT (Biomedical Technician) to demonstrate the proper use of the Myron Meter. BMT observed collecting dialysate sample from Machine #5, then testing dialysate with the Myron Meter. Further observation revealed Myron Meter Solution for Calibrating the meter was expired 03/29/2024. 2) Surveyor request BMT to calibrate the Myron Meter. Further observation revealed BMT was not able to calibrate the Myron Meter to an acceptable range prior to conducting an independent PH test prior to the initiation of treatment. An interview was conducted with BMT on 05/14/25 at approximately 1:50 PM. BMT states “the Myron Meter Solution is expired, and this is the only one available at this facility. I will get another bottle of solution from our Boynton location by tomorrow morning.” There was no replacement solution in the facility.”

“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: 51535 Based on administrative record review and staff interview, the facility failed to consistently follow the established policy and procedures for Hemodialysis (HD) Machine cultured/tested at least annually for 2 of 5 machines reviewed. This is evidenced by the staff failure to ensure that each HD machine PMs (Preventative Maintenance) are completed annually and documented on the HD Machine PM logs. The findings included: The facility policy Appliances/Equipment PM Log, revised 07/22/2009, documented “Ensure the proper functioning of all equipment for the safety of all patients and personnel all appliances and equipment will be checked on a monthly basis.” Review of the facility’s HD Machine PM Log dates: 07/2024, 11/2024, 01/2025, 02/2025, 03/2025 revealed the facility did not provide annual PM maintenance on 2 of 5 machines. An interview was conducted on 05/14/25 at approximately 1:00 PM with the Biomedical Technician (Biomed Tech). The surveyor reviewed the documentation on the Log with the technician, and he confirmed the 2 machines did not have annual PMs. He states, “one machine was taken out of service and the other is a transfer machine from the sister dialysis facility.””

“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: 51535 Based on administrative record review, observation, and staff interview, the facility failed to ensure supplies were maintained and operated in accordance with the manufacturer’s recommendations, as evidenced by the failure of staff to ensure supplies are not readily available for use beyond the manufacturer’s documented expiration date and water monitoring equipment is functioning in accordance with manufacturers’ recommendations. The findings included: The facility policy “Policy on Expired Medications”, revised 05/12/2019, documented, 1) Medications should be checked monthly by nurses and pharmacists 2) Medications that will be expiring in 30 days should be pulled out of the drawer 3) Expired medications should be properly and safely discarded in the sharp container 1) An observation of the treatment floor conducted on 05/12/25 at 11:08 AM revealed the following: Catheter ports (10) expired 07/2020, Alcohol Prep Pad (50) expired 12/2024, Povidone-Iodine Prep Pad (50) expired 04/2024, Omnifix non-woven retention tape (1) expired 06/2013, Hand Sanitizer 1 Gallon (2) expired 06/2022, Gloves (2 boxes) expired 05/2023 currently in use to provide patient care. An interview conducted with the Charge Nurse who acknowledged the expired supplies at the time of the findings. 2) An observation of the supply area near the nurses station area conducted on 05/12/25 at 2:45 PM revealed the following: Dialyzers - Nipro Elisio-15H (7) expired 07/31/2020, F8 Hemoflow (3) expired 10/2014, F6 Hemoflow (1) expired 12/2001, and Rexeed-15 (2) expired 08/19/2016. An interview conducted with the Charge Nurse who acknowledged the expired supplies. 3) An observation of the laboratory conducted on 05/14/25 at 11:55 AM revealed red top vacutainer tubes (33) expired 08/30/2024, gold top vacutainer tube (50) expired 12/04/2023, Vacuette/blue (>50) 02/2019, Povidone 8 fluid ounce (3) expired 11/2022, FloQswab (5) 04/30/2023, Blood Culture Bottle (4) expired 02/22/2025, Tegaderm (1 Box) expired 2014. An interview conducted with the Charge Nurse who acknowledged the expired supplies. 4) An observation of the medication refrigerator conducted on 05/12/25 at 3:00 PM revealed the following: Pneumococcal Vaccine vial (10) expired 08/12/2024, Ceftazidime 1 GM/vial (5) expired 10/2024, Bamlanivimad 700mg/20ml (22) expired 11/2021. An Interview conducted with the Charge Nurse who confirmed the expired medications. 5) An observation conducted on 05/12/25 at 1:40 PM revealed Conductivity Standard Solution 14.0 mS/cm 32 ounces (2) expired 03/29/24 and 11/06/22. An interview conducted with the Biomedical Technician (Biomed Tech) conducted on 05/14/25 at 11:15 AM, he confirmed the solution has expired, states he will discard the solution, and go to Boynton Beach (sister unit) tomorrow (05/13/25) to obtain a bottle of the calibration solution to calibrate the Myron Meter.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 51535 Based on observation and staff interview, the facility failed to ensure patients were in view of staff during treatment including his/her face, vascular access site, and blood line connections. Facility also failed to ensure patients were observed and monitored throughout the dialysis treatment. This failure affected 1 out of 10 patients. The findings included: On 05/12/25 at 2:10 PM An observation of Station #6, Patient #4 receiving hemodialysis, patient face, access connections, and body torso is covered with a blanket. The surveyor observes staff members at the dialysis machine and documenting on the flow sheet, no verbal interaction, face to face observation, view of vascular access site and blood line connections with the patient for at least 30 minutes. An interview was conducted with Patient Care Technician (PCT) on 05/12/25 at 2:40 PM. The surveyor informed PCT of the observation patient face, access, and blood lines are not visible for at least 30 minutes (2:10 PM - 2:40 PM). She stated, “the patient does not like to be disturbed. He gets angry when we instruct him not to cover his face, access, and blood lines.” Patient removed the blanket from his face and she informed him of the safety concerns and he acknowledged understanding of the information she provided.”

“PR-INFORMED-ALL MODALITIES/SETTINGS CFR(s): 494.70(a)(7) The patient has the right to- (7) Be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis), and in-facility hemodialysis. The patient has the right to receive resource information for dialysis modalities not offered by the facility, including information about alternative scheduling options for working patients; This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to have documentation of patients informed about all treatment modalities and settings for 4 of 4 sampled patients (Patient #1, #2, #3, and #4). The findings included: A review of the facility’s policy Plan of Care, dated 05/27/99 and revised 04/27/2011 documented: the written plan of care represents the selection of a suitable treatment modality and dialysis setting. Patients transferred from another facility with existing plan of care will have their plan reviewed and updated if necessary. Patients with no pre-existing plan of care will be informed of the various modalities of treatment available for management of ESRD in order to develop a plan of care. 1. Patient #1 was admitted to the facility for in center hemodialysis treatment on 09/06/24. Record review did not reveal any education about other treatment modalities options. 2. Patient #3 was admitted to the facility for in center hemodialysis treatment on 03/12/25. Record review did not reveal any education about other treatment modalities options. 3. Patient #4 was admitted to the facility for in center hemodialysis treatment on 03/16/20. Record review did not reveal any education about other treatment modalities options. 51535 4. An interview was conducted with Patient #2 on 05/12/25 at 10:40 AM. The patient had been questioned if she had been informed of other modalities such as home dialysis. Patient #2 stated she had not been informed of any other modalities, but she is interested in learning more about the different dialysis options. A review of Patient #2’s medical records conducted on 05/13/25 revealed the patient was not educated on treatment options. An interview with the Facility Administrator (FA) on 05/13/25. The FA was unable to provide evidence of patients being informed of other modalities. FA acknowledge 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 for 1 of 4 sampled patients (Patient #3). The findings included: A review of the facility’s policy titled Comprehensive Interdisciplinary Plan, dated 05/27/97 and revised 04/27/2011 documented: “The plan is developed by a professional team consisting of the physician, nurse, dietitian and the social worker. Requirements for a comprehensive interdisciplinary plan: a. Initial nurse need to assess patient on first day of the treatment. b. 90th day after the initial treatment. c. Annually d. at least monthly for unstable patient” Record review revealed Patient #3 was admitted to the facility on 03/12/25. A record review revealed an initial comprehensive assessment dated 04/11/25. Further review of the assessment revealed there was no assessment from the physician or a social worker. An interview was conducted with the facility administrator (FA) on 05/13/25 at 12:00 PM. The FA acknowledged the above.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to complete a follow up comprehensive reassessment within 3 months after the completion of the initial assessment for 1 of 4 sampled patients (Patient #1). The findings included: A review of the facility’s policy titled Comprehensive Interdisciplinary Plan, dated 05/27/97 and revised 04/27/2011, documented: The plan is developed by a professional team consisting of the physician, nurse, dietitian and the social worker. Requirements for a comprehensive interdisciplinary plan: a. Initial nurse need to assess patient on first day of the treatment. b. 90th day after the initial treatment. c. Annually d. at least monthly for unstable patient Patient #1 was admitted to the facility on 09/06/24 for treatment. A review of the 90 day assessment dated 12/24/24 revealed no input from a social worker. An interview was conducted with the acting facility administrator (FA) on 05/13/25 at 12:00 PM. The FA acknowledged the above.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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- (1) At least annually for stable patients; This Standard is not met as evidenced by: 51535 Based on clinical and administrative record review and interview, the interdisciplinary team failed to complete an Annual Comprehensive Assessment for 2 of 4 sampled patients (Patient #2 and #4). This is evidenced by staff failure to complete the annual assessment for patient#2 and #4. The findings included: The facility’s policy Comprehensive Interdisciplinary Plan, revised 04/27/2011, documented, “the comprehensive interdisciplinary plan will include a review and assessment ...Comprehensive interdisciplinary plan developed by a professional team consisting of the physician, nurse, dietitian, and the social worker. Requirements for Comprehensive Interdisciplinary Plan A) Initial (nurse need to assess patient on first day of the treatment) B) 90th day after the initial treatment C) Annually D) At least monthly for unstable patients” 1. Review of clinical record for patient #2 on 05/13/25 revealed that the patient admitted to the facility 06/22/2016. Further review of clinical record revealed no completed comprehensive assessment for 2024 and 2025. An interview conducted with the FA 5/13/25 at 10:30 AM, who acknowledged the above. 36734 2. Record review revealed Patient #4 was admitted to the facility for treatment on 03/16/20. A review of the annual comprehensive assessment dated 03/14/25 revealed no input from the physician or social worker. An interview was conducted with the facility administrator (FA) on 05/14/25 at 12:00 PM. The FA acknowledged the above.”

“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 a comprehensive reassessment and a revision of the plan of care monthly for a patient deemed unstable for 1 of 4 sampled patients (Patient #1). The findings included: A review of the facility’s policy titled Comprehensive Interdisciplinary Plan, dated 05/27/97 and revised 04/27/2011 documented: The plan is developed by a professional team consisting of the physician, nurse, dietitian and the social worker. Requirements for a comprehensive interdisciplinary plan: a. Initial nurse need to assess patient on first day of the treatment. b. 90th day after the initial treatment. c. Annually d. at least monthly for unstable patient Patient #1 was admitted to the facility for treatment on 09/06/24. Patient #1 was deemed unstable due to frequent hospitalizations and no-shows. The last documented assessment was the 90 day assessment dated 12/24/24. An interview was conducted with the facility administrator (FA) on 05/14/25 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: 51535 Based on clinical, administrative record review and staff interview, the facility failed to provide evidence of an interdisciplinary develop a plan of care for each patient for 4 of 4 sampled patients reviewed (Patient #1, #2, #3, and #4). The findings included: The review of the facility policy Plan of Care, revised 04/27/2011, documented, “Plan of Care will be developed jointly by the physician, nurse, social worker, and dietitian. The Plan of Care is reviewed and updated annually.” 1. Clinical records review for Patient #1 revealed an incomplete Plan of Care, lacking a Social Worker signature and input. An interview conducted with the FA 5/13/25 at 10:30 AM, who confirmed the hard copy in chart labeled Plan of Care lacking Social Worker signature and input. 36734 2. Patient #1 was admitted to the facility on 09/06/24 for treatment. A review of the 90 day care plan dated 12/24/24 revealed no physician, social worker, or patient’s signature. 3. Patient #3 was admitted to the facility on 03/12/25 for treatment. A review of the initial care plan dated 04/11/25 revealed no physician or social worker’s signature. 4. Patient #4 was admitted to the facility on 03/16/20 for treatment. A review of the annual care plan dated 03/14/25 revealed no physician or social worker’s signature. An interview was conducted with the facility administrator (FA) on 05/13/25 at 12:00 PM. The FA acknowledged the above.”

“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: 36734 Based on record review and interview, the facility failed to complete routine lab work and ordered lab work for 3 of 4 sampled patients (Patient #1, #3, and #4). The findings included: A review of the facility’s policy titled Routine Lab Work, dated 05/27/97 and revised 05/25/2009 documented: Dialysis patients will receive the following lab studies on a routine basis monthly SMA 27, CBC with differential, and KT / V. Additional lab studies may be ordered by the attending nephrologist. 1. Patient #1 was admitted to the facility for treatment on 09/06/24. Record review revealed no lab work was obtained in 01/25 and 02/25. 2. Patient #3 was admitted to the facility on 03/12/25 for treatment. Record review revealed a physician order dated 03/29/25 for HgbA1c with next blood draw. A review of Patient #3’s labs results dated 04/09/25 and 05/07/25 did not reveal a lab result for a HgbA1C. 3. Patient #4 was admitted to the facility for treatment on 03/16/20. A review of the patient’s lab results revealed the last KT/V was done on 10/18/24 (6 months ago). An interview was conducted with the acting facility administrator (FA) on 05/13/25 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: 36734 Based on observation, record review, and interview, the facility failed to administer dialysis treatment as ordered for 1 of 4 sampled patients (Patient #4). The findings included: Patient #4 was admitted to the facility for treatment on 03/16/20. Record review revealed a dialysis order dated 02/07/25 to use dialyzer F180 for treatment. Patient #4 was observed receiving treatment on 05/14/25 at 11:00 AM. Further observation of the treatment received revealed a dialyzer F160 in use. An interview was conducted with the charge nurse (CN) on 05/14/25 at 11:05 AM. The CN acknowledged the above. The CN stated she co-signed for the incorrect treatment administered.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to have interdisciplinary team provide the necessary monitoring and social work interventions for 2 of 4 sampled patients (Patient #1 and #3). The findings included: 1. Patient #1 was admitted to the facility for treatment on 09/06/24. Record review revealed Patient #1 was deemed unstable due to frequent hospitalizations and missed treatments. Further record review did not reveal any social worker interventions. 2. Patient #3 was admitted to the facility for treatment on 03/19/25, new to dialysis. Record review did not reveal any social worker interventions. An interview was conducted with the acting facility administrator (FA) on 05/14/25 at 12:00 PM. The FA acknowledged the above.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement (QAPI) program with participation by the professional members of the interdisciplinary team. The findings included: A review of the facility’s QAPI program on 05/14/25 at 10:00 AM revealed there was no participation of a social worker. There was no data driven data related to transplantations and mental health.”

“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: 36734 Based on record review and interview, the facility failed to conduct an initial assessment prior to the start of treatment for 2 of 4 sampled patients (Patient #1 and #3). The findings included: A review of the facility’s policy titled Comprehensive Interdisciplinary Plan, dated 05/27/97 and revised 04/27/2011 documented: “ The plan is developed by a professional team consisting of the physician, nurse, dietitian and the social worker. Requirements for a comprehensive interdisciplinary plan: a. Initial nurse need to assess patient on first day of the treatment. b. 90th day after the initial treatment. c. Annually d. at least monthly for unstable patient” 1. Patient #1 was admitted to the facility for treatment on 09/06/24. Record review revealed an initial nursing assessment was not conducted prior to the initial treatment. 2. Record review revealed Patient #3 was admitted to the facility on 03/12/25. Further record review revealed an initial nursing assessment was not conducted prior to the initial treatment.”

“GOV-RN, MSW, & RD AVAIL TO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- The registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs; This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to have a social worker available to meet patient clinical needs for 4 of 4 sampled patients (Patient #1, #2, #3, and #4). The findings included: The facility policy Social Work Services, revised 04/25/2011, documented, “Social work services will be provided to patients and their families and will be directed at supporting and maximizing the psychosocial functioning and adjustment of the patient.” 1. Patient #1 was admitted to the facility for treatment on 09/06/24. Record review revealed no social worker interventions/notes since admission. 2. Patient #3 was admitted to the facility on 03/12/25 for treatment. Record review revealed no social worker intervention/notes since admission. 3. Patient #4 was admitted to the facility on 03/16/20 for treatment. Record review revealed no social worker intervention/notes for 2024 and 2025. 51535 4. Patient #2 was admitted to the facility for treatment on 06/22/16. Record review revealed no Social Worker interventions/notes for 2024 or 2025. An interview with FA on 05/12/25 at 11:00 AM acknowledging facility social worker is not available and is on maternity leave. There is no Social Worker replacement at the facility.”

“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: 40153 Based on interviews and record reviews, the facility failed to evaluate and address patients’ anemia and low Hemoglobin levels and failed to provide the ordered erythropoiesis-stimulating agents (ESA) to treat the anemia for 3 of 3 Patients reviewed (Patient #1, Patient #2 and Patient #3). The findings included: 1. A record review revealed Patient #1 was admitted on 06/22/18 for in-center Hemodialysis. A review of the monthly labs showed Patient #1 had low Hemoglobin level of 7.9 for November 2024 and 9.9 for December 2024. A review of Patient #1 ’ s standing orders dated 2/28/24 showed an order for Aranesp 60 mcg (micrograms) every month. It further showed that the hemoglobin level weekly is unstable, and Mircera is on hold. The treatment flow sheet dated 01/10/25 showed an order for Mircera 90 mcg every 2 weeks. A continued review of the treatment flow sheets showed that Patient #1 was not given any of the Mircera medication for the month of December 2024. It further revealed that Patient #1 was only given a partial dose Mircera 30 mcg on 11/18/24. 6.lab of 7 in November 2024 and 6.1 in December 2024. A review of the Standing order sheet (no date) showed an order for Aranesp of 30 mcg every week. The treatment sheet dated 01/20/25 revealed an order for Mircera 90 mcg once a month. A continued review of the treatment flow sheets showed that no Mircera was given for the months of January 2025, November 2024, or October 2024. One dosage of 30 mcg was only given on 12/20/24. 2. A record review for Patient #2 revealed an admission date to the facility on 12/13/19 for in-center Hemodialysis. A review of the labs showed a Hemoglobin 6.7 in November 2024 and 6.1 in December 2024. A review of the Standing order sheet (no date) showed an order for Aranesp of 30 mcg every week. The treatment sheet dated 01/20/25 revealed an order for Mircera 90 mcg once a month. A continued review of the treatment flow sheets showed that no Mircera was given for the months of January 2025, November 2024, or October 2024. One dosage of 30 mcg was only given on 12/20/24. In an interview conducted on 01/22/25 at 10:40 AM with Patient #2, she stated that she had not been getting her anemia medication for some time. She was concerned that they do not consistently draw the lab for Hemoglobin and had gone to the hospital for low Hemoglobin levels. 3. A chart review showed that Patient #3 was admitted to the facility on 10/02/2020 for in-center Hemodialysis. A review of the labs showed a Hemoglobin lab of 7.8 in November 2024 and 7.5 in December 2024. A review of the standing orders (no date) showed an order for Aranesp 25 units every other week. The treatment sheet dated 01/20/25 revealed an order for Mircera 90 mcg every 2 weeks. Further review of the treatment sheets showed that no Mircera was given for the month of November 2024, and 30 mcg was given once for the month of December 2024. In an interview conducted on 01/22/25 at 10:00 AM with the facility ’ s Administrator, she stated that they did not have the funds to purchase the necessary anemia medications per Physicians ’ orders. Some of the patients had to go to the hospital for blood transfusions because of low Hemoglobin levels. The Medical Director is aware of the issue, and they are in the process of finding a solution. In an interview with Staff A, the Registered Nurse stated that sometimes they do not have enough of the Anemia medication and that she gives a lower dosage to try and increase the low Hemoglobin levels. Staff A further acknowledged that the Hemoglobin labs should be done weekly and not once a month as per standing orders.”