Crown Dialysis Center of Palm Beach 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: 36734 Based on interview and record review, the facility failed to review and update the Emergency Preparedness Plan. The findings included: A review of the facility’s emergency preparedness plan was conducted with the Facility Administrator (FA) via telephone on 02/19/25 at 12:00 PM. Further review of the plan revealed there was no documentation of when the plan was last reviewed and updated. The FA acknowledged there was no documentation of when the plan was last reviewed and updated.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 36734 Based on interview and record review, the facility failed to have evidence the local emergency preparedness agency was contacted at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. The findings included: A review of the facility’s emergency preparedness plan was conducted with the Facility Administrator (FA) via telephone on 02/19/25 at 12:00 PM. Further review of the plan revealed there was no evidence the local emergency preparedness agency was contacted at least annually to confirm that the agency was aware of the dialysis facility’s needs in the event of an emergency. The FA acknowledged the above..”

“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 observation and interview, the facility failed to have readily functional emergency suction equipment available and failed to ensure staff is competent in the proper use of the emergency suction equipment. The findings included: An observation of the emergency cart was conducted on 02/19/25 at 10:30 AM with the Staff D. The staff member was instructed to demonstrate that the emergency suction equipment was operational. She could not get the emergency equipment to operate. She filled the suction canister with water. She then stated that she was missing the yankauer suction catheter which was removed from the cart because it had expired. She states that the facility does not have a yankauer and she has ordered the yankauer for delivery. An interview conducted with the RN at the time of observation, she confirmed the above information.”

“BICARB CONC DISTRIB-WKLY DISINFECT/DWELL/CONC CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc Bicarbonate concentrate delivery systems should be disinfected on a regular basis to ensure that the dialysate routinely achieves the level of bacteriological purity [required by these regulations]. For piped distribution systems, the entire system, including patient station ports, should be purged of bicarbonate concentrate before disinfection. Each patient station port should be opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg” in the system. Appropriate dwell times and concentrations should be used as recommended by the manufacturer of the concentrate system. If this information is not available, bleach may be used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended by the manufacturer for disinfecting piping systems. 6.5 Concentrate distribution: The interval between disinfection should not exceed 1 week. If the manufacturer does not supply disinfection procedures, the user must develop and validate a disinfection protocol. 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 regarding Bicarbonate System Disinfection for 2of 2 months reviewed. This is evidenced by the staff failure to ensure that each bicarbonate disinfection is completed on a weekly basis and documented on the bicarbonate disinfection log. The findings included: The facility policy regarding Disinfection of the Bicarbonate Delivery System-Bleach, published 11/07/2010 documented regarding Disinfection Procedures, “On a weekly basis, the bicarbonate delivery system will be rinsed with a vinegar solution to remove bicarbonate residue followed by a disinfection with bleach. Performance of disinfection procedure shall be documented on the bicarbonate system disinfection log.” Review of the facility’s Disinfection of the Bicarbonate Delivery System-Bleach Log for December 2024 and January 2025 revealed that the facility disinfection of the bicarbonate delivery system was completed beyond one week during December and January. The staff completed the log as dated: 12/17/24-12/26/24 (9 days) 01/14/25 - 1/23/25 (9 days) An interview was conducted on 02/17/25 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 that for December 2024 and January 2025 the disinfection of the bicarbonate system occurred more than seven days.”

“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: 36734 Based on observation and interview, the facility failed to measure approximate pH with an independent method before starting the treatment of the next patient. for 2 of 5 patients observed (Patient #6 and #7). The findings included: 1. An observation of the treatment area was conducted on 02/17/25 at 10:00 AM. Staff B, a patient care technician (PCT), was observed initiating treatment to Patient #7. Further observation revealed Staff B did not conduct an independent ph test prior to the initiation of treatment. An interview was conducted with Staff A on 02/17/25 at 12:00 PM. Staff A acknowledged the above. 2. An observation of the treatment area was conducted on 02/17/25 at 10:30 AM. Staff A, a PCT, was observed initiating treatment to Patient #6. Further observation revealed Staff A did not conduct an independent ph test prior to the initiation of treatment.”

“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 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: 1) Observation of the treatment floor, laboratory, and storage supply room conducted on 02/17/25 at 11:10 AM revealed the following: a clear bag containing approximately 10-15 red top blood collection tubes expired 01/30/25 and located on the shelf in the storage supply room. 2) An observation conducted on 02/17/25 at 11:15 AM revealed a non-functioning pressure gauge water monitor located in the water treatment room. The monitor gauge is visually stained with a dark brown and cloudy residue which obscures its pressure readings. An interview with the Biomedical Technician (Biomed Tech) conducted on 02/17/25 at 11:15 AM, he confirmed the items were expired and he is aware of the non-functioning water pressure monitor gauge. He reports that he will discard the expired blood collection tubes, and he has placed an order (02/16/25) for a new water pressure monitor gauge.”

“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 conduct an initial assessment in a timely manner for 2 of 5 clinical records reviewed (Patient #3 and #5). The findings included: A review of the facility’s policy titled Interdisciplinary Team Patient Aassessments, dated 10/15/08 and revised on 11/30/18, documented: “ An initial assessment will be done for all patients and completed by all disciplines within the latter of 30 calendar days or 13 outpatient sessions beginning with the first outpatient session.” 1. Record review revealed Patient #3 was admitted to the facility for treatment on 03/18/24. Further record review revealed an initial assessment dated 06/11/24, over 2 months late. An interview was conducted with the Administrative Assistant (AA) on 02/18/25 at 12:00 PM. The AA acknowledged the above. 2. Record review revealed Patient #5 was admitted to the facility for treatment on 01/13/25. Further record review revealed as of 02/18/25, an initial assessment had not been conducted for Patient #5. An interview was conducted with the Administrative Assistant (AA) on 02/18/25 at 12:00 PM. The AA 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 conduct an assessment for a patient deemed unstable in a timely manner for 1 of 5 sampled patients (Patient #1). The findings included: A review of the facility’s policy titled Interdisciplinary Team Patient Assessments, dated 10/15/08 and revised on 11/30/18, documented: “Patient reassessment will be conducted at least monthly for unstable patients including, but not limited to, patients with the following diagnosis: Extended or frequent hospitalizations, marked deterioration in health status, significant change in psychological needs, or concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis.” Record review revealed Patient #1 was admitted to the facility on 08/02/19. Further record review revealed an assessment dated 08/29/24 that documented the reason for assessment was unstable status. The next assessment for Patient #1 was dated 12/11/24 for unstable status. An interview was conducted with the Administrative Assistant on 02/18/25 at 12:00 AM. The AA acknowledged Patient #1 was deemed unstable due to hospitalizations. The AA further acknowledged missing assessments for 09/24, 10/24, 11/24, as well as 01/25.”

“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: 51535 Based on clinical, administrative record review and staff interview, the facility failed to provide evidence of assessment and action to address elevated blood pressure pre, during, and post dialysis treatment. This failure affected 1 of 5 sampled patients reviewed (Patient #2). The facility also failed to notify the physician of the abnormally high blood pressure before, during, and after treatment. The facility staff also failed to notify the charge nurse of the episode of high blood pressure. The findings included: Record review of patient #2, whose notes record the following dialysis treatment data: 02/05/25 (156/99) 02/07/25 (154/106) 02/12/25 (164/95) 02/17/25 (167/105) The review of the facility policy regarding hypertension, published 10/15/2008, documented, “notify the physician if the blood pressure is >140/90 or is significantly higher than usual for that patient.” An interview was conducted with the Nurse Practitioner (NP) on 02/18/25 at 1:00 PM. The surveyor reviewed the abnormally high blood pressures with the NP, and he acknowledged the elevated blood pressures.”

“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 record review and interview, the facility failed to administer the prescribed treatment for 1 of 5 sampled patients (Patient #1). The findings included: Record review revealed Patient #1 was admitted to the facility for treatment on 08/02/19. Patient #1 had treatment orders dated 12/28/24 for a dialysate flow rate (DFR) of 800 for a 4 hour treatment 3 times a week. A review of Patient #1’s treatment flowsheets dated 02/13/25 and 02/15/25 documented the patient was administered a DFR of 600 for the entire 4 hour treatments. Further review of Patient #1’s record did not reveal any documentation of why the prescribed order was not followed, or notification of the physician. An interview was conducted with the Administrative Assistant (AA) on 02/18/25 at 12:00 PM. The AA acknowledged the above.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to administer medication as ordered for 1 of 5 sampled patients (Patient #1). The findings included: Patient #1 was admitted to the facility on 08/02/19 for treatment. Record review revealed an order dated 02/13/25 for Sevelamer (phosphate binder) 800 milligram, to give 201,600 milligrams (mg) one time only. A review of Patient #1’s treatment flowsheet dated 02/13/25 revealed Sevelmer 201,600 mg was administered at 10:18 AM. A review of Patient #1’s treatment flowsheet dated 02/15/25 revealed Sevelmer 201,600 mg was administered at 10:13 AM. An interview was conducted with the Administrative Assistant (AA) on 02/18/25 at 12:00 PM. The AA stated Patient #1 was not administered to patient #1 on 02/13/25 or 02/15/25. The AA further stated Patient #1 was provided with a months worth of medication on 12/13/25 to be taken at home, and it was documented as such for billing purposes. The AA stated the documented 12/15/25 dose was in error.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 36734 Based on interview and record review, the facility failed to measure, analyze, and track quality indicators. The findings included: A telephone interview was conducted with the Facility Administrator (FA) on 02/19/25 at 12:00 PM to review the facility’s Quality Assurance and Performance Improvement (QAPI) program, a systematic approach to maintain and improve safety and quality. The FA stated the facility’s interdisciplinary team meets monthly for QAPI review. A review of 6 months of QAPI documentation revealed a lack in tracking quality indicators of patient modality choice and transplant referral results, infection prevention and control, mortality, morbidity, patient satisfaction and grievances/complaints, and vascular access. The FA acknowledged the above.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to conduct an initial nursing assessment prior to the start of treatment for 2 of 5 sampled patients (Patient #3 and #5). The findings included: A review of the facility’s policy titled Initial Nurse Systems Assessment, dated 10/15/08 and revised on 11/19/18 , documented: “The director of nursing and registered nurses will provide appropriate initial physical evaluation assessment before the new patient start the first treatment in the facility. Documentation will be added with “Permanent” note in the patient chart.” 1. Patient #3 was admitted to the facility for treatment on 03/18/24. Record review revealed an initial nursing assessment was not conducted on Patient #3 prior to the initiation of the first treatment. 2. Patient #5 was admitted to the facility for treatment on 01/13/25. Record review revealed an initial nursing assessment was not conducted on Patient #5 prior to the initiation of the first treatment. An interview was conducted with the Administrative Assistant (AA) on 02/19/25 at 10:00 AM. The AA acknowledged the above.”