Bma - Starke

“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: 49777 Based on observation, interview, and record review the facility failed to ensure hand hygiene was performed while conducting observations of 8 of 10 patients, Patients #1, #2, #5,#16, #17, #18, #19, and #20 for acceptable infection control practices to include performing hand hygiene upon entering the dialysis treatment floor, after discontinuation of dialysis treatment, and/or prior to leaving the dialysis treatment room. Findings include: During an observation on 4/7/2025, at 9:48 AM, Patient #17 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #17 to wash or sanitize his hands before leaving the facility. During an observation on 4/7/2025, at 9:50 AM, Patient #18 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #18 to wash or sanitize his hands before leaving the facility. During an observation on 4/7/2025 at 9:55 AM, Patient #2 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #2 to wash or sanitize his hands before leaving the facility. During an observation on 4/7/2025 at 9:59 AM, Patient #19 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #19 to wash or sanitize his hands before leaving the facility. During an observation on 4/7/2025 at 10:26 AM, Patient #5 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #5 to wash or sanitize his hands before leaving the facility. During an observation on 4/7/2025 at 11:07 AM, Patient #1 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #1 to wash or sanitize his hands before leaving the facility. During an observation on 4/9/2025 at 9:38 AM, Patient #20 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #20 to wash or sanitize his hands before leaving the facility. During an observation on 4/9/2025 at 10:19 AM, Patient #16 was observed leaving the facility with no handwashing/sanitation completed. Facility staff were not observed to remind or encourage Patient #16 to wash or sanitize his hands before leaving the facility. During an interview on 4/7/2025 beginning at 10:30 AM, Staff A, Registered Nurse confirmed patients should sanitize their hands upon entering and before leaving the treatment area in accordance with facility infection control practices. Review of the facility policy titled “Hand Hygiene,” last reviewed 3/18/25 read, “Purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Hand Hygiene Patients - Patients should perform hand hygiene if able, prior to and after each dialysis treatment. Hand hygiene: Hands will be washed with antimicrobial soap and water or decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients. Entering and leaving the treatment area.””

“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: 49777 Based on record review and interview, the facility failed to follow the prescribed blood flow rate (BFR) for 6 patients, Patients #3, #5, #6, #7, #9 and #10, failed to follow the prescribed dialysate flow rate (DFR) for 3 patients, Patients #3, #8, and #13, and failed to follow the prescribed duration of treatment for 1 patient, Patient #13, of 10 in center hemodialysis patients reviewed. Findings include: 1) Review of Patient #3’s dialysis treatment record dated 3/17/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 450 milliliters/minute. Review of Patient 3’s dialysis Treatment Sheet dated 3/17/2025, documented Patient #3’s dialysate flow rate during dialysis treatment was set at 800 milliliters/minute nine times during the treatment on 3/17/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record dated 3/19/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 450 milliliters/minute. Review of Patient 3’s dialysis Treatment Sheet dated 3/19/2025, documented Patient #3’s dialysate flow rate during dialysis treatment was set at 800 milliliters/minute nine times during the treatment on 3/19/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record, dated 3/21/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 500 milliliters/minute. Review of Patient #3’s dialysis Treatment Sheet dated 03/21/2025, documented Patient #3’s dialysate flow rate during the dialysis treatment was set at 800 milliliters/minute seven times on 03/21/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record, dated 3/31/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 500 milliliters/minute. Review of Patient #3’s dialysate Treatment Sheet dated 03/31/2025, documented Patient #3’s dialysate flow rate during the dialysis treatment was set at 800 milliliters/minute nine times on 03/31/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record, dated 4/2/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 500 milliliters/minute. Review of Patient #3’s dialysate Treatment Sheet dated 4/2/2025 documented Patient #3’s dialysate flow rate during the dialysis treatment was set at 800 milliliters/minute ten times on 4/2/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record, dated 4/4/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 500 milliliters/minute. Review of Patient #3’s dialysate Treatment Sheet dated 4/4/2025 documented Patient #3’s dialysate flow rate during the dialysis treatment was set at 800 milliliters/minute eight times on 4/4/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record, dated 4/7/2025, documented Patient #3 was prescribed a dialysate flow rate (DFR) of 500 milliliters/minute. Review of Patient #3’s dialysate Treatment Sheet dated 4/7/2025 documented Patient #3’s dialysate flow rate during the dialysis treatment was set at 800 milliliters/minute nine times on 4/7/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s dialysate flow rate had deviated from the prescribed flow rate. Review of Patient #3’s dialysis treatment record dated 3/24/2025 documented Patient #3 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #3’s dialysis Treatment Sheet dated 3/24/2025 documented Patient #3’s flood flow rate during dialysis treatment was set at 350 milliliters/minute two times, 400 milliliters/minute three times, and 300 milliliters/minute one time during the treatment on 3/24/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #3’s dialysis treatment record dated 3/28/2025 documented Patient #3 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #3’s dialysis Treatment Sheet dated 3/28/2025 documented Patient #3’s flood flow rate during dialysis treatment was set at 400 milliliters/minute eight times during the treatment on 3/28/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #3’s blood flow rate had deviated from the prescribed dialysis blood flow rate. 2) Review of Patient #7’s dialysis treatment record, dated 3/24/2025, documented Patient #7 was prescribed a blood flow rate (BFR) of 400 milliliters/minute. Review of Patient #7’s Treatment Sheet dated 3/24/25 documented Patient #7’s blood flow rate during the dialysis treatment was set at 300 milliliters/minute four times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #7’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #7’s dialysis treatment record, dated 4/7/2025, documented Patient #7 was prescribed a blood flow rate (BFR) of 400 milliliters/minute. Review of Patient #7’s Treatment Sheet dated 4/7/2025 documented Patient #7’s blood flow rate during dialysis treatment was set at 375 milliliters/minute five times during the treatment on 4/7/2025. The Treatment Sheet failed to provide documentation that justified or explained why Patient #7’s blood flow rate had deviated from the prescribed dialysis blood flow rate. During an interview on 4/9/2025 beginning at 1:00 PM the Director of Operations and Clinical Manager B, confirmed Residents #3, and #7’s blood flow rate and dialysate flow rates were not provided as prescribed and lacked documentation to explain why there was a deviation during treatment. 51504 3) Review of Patient #13’s dialysis prescription treatment record, dated 3/28/25, documented Patient #13’s prescribed dialysate flow rate as 800 milliliters/minute. Review of Patient #13’s dialysis Treatment Sheet record, dated 3/28/25, documented the dialysate flow rate was set at 150 milliliters/minute five times during the dialysis treatment. The Treatment Sheet failed to provide documentation that justified or explained why Patient #13’s dialysate flow rate had deviated from the prescribed dialysate flow rate. During an interview on 4/8/25 at 3:04 PM the Director of Operations confirmed Resident #13’s dialysate flow rate was not provided as prescribed and lacked documentation to explain why there was a deviation during treatment. Review of Patient #13’s dialysis prescription treatment record, dated 3/28/25, documented Patient #13’s dialysis duration treatment time order for 4 hours. Review of Patient #13’s dialysis Treatment Sheet record dated 3/28/25, documented the treatment duration time as 3 hours and 10 minutes. The Treatment Sheet failed to provide documentation that justified or explained why Patient #13’s dialysis treatment duration was not completed as prescribed or an AMA (Against Medical Advice) form signed. Review of Patient #13’s dialysis prescription treatment record, dated 4/2/25, documented Patient #13’s dialysis duration treatment time order for 4 hours. Review of Patient #13’s dialysis Treatment Sheet record dated 4/2/25, documented the treatment duration time as 3 hours and 18 minutes. The Treatment Sheet failed to provide documentation that justified or explained why Patient #13’s dialysis treatment duration was not completed as prescribed or an AMA (Against Medical Advice) form signed. Review of Patient #13’s dialysis prescription treatment record, dated 4/4/25, documented Patient #13’s dialysis duration treatment time order for 4 hours. Review of Patient #13’s dialysis Treatment Sheet record dated 4/4/25, documented the treatment duration time as 3 hours and 16 minutes. The Treatment Sheet failed to provide documentation that justified or explained why Patient #13’s dialysis treatment duration was not completed as prescribed or an AMA (Against Medical Advice) form signed. During an interview on 4/8/25 at 3:04 PM, the Director of Operations confirmed Resident #13’s duration of dialysis treatment order was not achieved on 3/28/25, 4/2/25 and 4/4/25 and there was no documentation to explain why the prescribed 4 hour treatment duration time was not achieved for 3/28/25, 4/2/25 and 4/4/25 treatments. The Director of Operations confirmed there was no documented explanation or AMA forms signed by the patient for 3/28/25, 4/2/25 and 4/4/25 treatments. Record review of facility policy “Early Termination or Arriving Late for Treatment”, last review date 3/18/2025, read, “Early Termination - If a patient insists on terminating treatment early and this has not been previously approved by the patient’s physician, the patient must take full responsibility for consequences of the missed or shortened treatment. Against Medical Advice Forms are signed by the patient and witnessed by the supervising nurse upon completion of the above steps. Signed with each early termination event and filed in the patient’s medical record.” 4) Review of Patient #10’s dialysis treatment record, dated 3/24/2025, documented Patient #10 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #10’s Treatment Sheet dated 3/24/25 documented Patient #10’s blood flow rate during the dialysis treatment was set at 400 milliliters/minute two times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #10’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #10’s dialysis treatment record, dated 4/4/2025, documented Patient #10 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #10’s Treatment Sheet dated 4/4/25 documented Patient #10’s blood flow rate during the dialysis treatment was set at 400 milliliters/minute ten times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #10’s blood flow rate had deviated from the prescribed dialysis blood flow rate. 5) Review of Patient #9’s dialysis treatment record, dated 3/21/2025, documented Patient #9 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #9’s Treatment Sheet dated 3/21/25 documented Patient #9’s blood flow rate during the dialysis treatment was set at 400 milliliters/minute seven times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #9’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #9’s dialysis treatment record, dated 3/24/2025, documented Patient #9 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #9’s Treatment Sheet dated 3/24/25 documented Patient #9’s blood flow rate during the dialysis treatment was set at 400 milliliters/minute (mm) two times, 350 mm one time, and 300 mm three times during the dialysis treatment. The Treatment Sheet failed to provide documentation that justified or explained why Patient #9’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #9’s dialysis treatment record, dated 3/28/2025, documented Patient #9 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #9’s Treatment Sheet dated 3/28/25 documented Patient #9’s blood flow rate during the dialysis treatment was set at 400 mm four times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #9’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #9’s dialysis treatment record, dated 4/2/2025, documented Patient #9 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #9’s Treatment Sheet dated 4/2/2025 documented Patient #9’s blood flow rate during the dialysis treatment was set at 400 milliliters/minute nine times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #9’s blood flow rate had deviated from the prescribed dialysis blood flow rate. Review of Patient #9’s dialysis treatment record, dated 4/7/2025, documented Patient #9 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #9’s Treatment Sheet dated 4/7/2025 documented Patient #9’s blood flow rate during the dialysis treatment was set at 300 mm three times and 350 mm five times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #9’s blood flow rate had deviated from the prescribed dialysis blood flow rate. 6) Review of Patient #8’s dialysis prescription treatment record, dated 3/24/25, documented Patient #8’s prescribed dialysate flow rate as 800 milliliters/minute. Review of Patient #8’s dialysis Treatment Sheet record, dated 3/24/25, documented the dialysate flow rate was set at 500 milliliters/minute three times during the dialysis treatment. The Treatment Sheet failed to provide documentation that justified or explained why Patient #8’s dialysate flow rate had deviated from the prescribed dialysate flow rate. 7) Review of Patient #6’s dialysis treatment record, dated 3/17/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 3/17/25 documented Patient #6’s blood flow rate during the dialysis treatment was set at 500 mm eight times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #6’s dialysis treatment record, dated 3/19/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 3/19/25 documented Patient #6’s blood flow rate during the dialysis treatment was set at 500 mm eight times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #6’s dialysis treatment record, dated 3/21/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 3/21/25 documented Patient #6’s blood flow rate during the dialysis treatment was set at 500 mm eight times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #6’s dialysis treatment record, dated 3/28/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 3/28/25 documented Patient #6’s blood flow rate during the dialysis treatment was set at 400 mm three times, 450 one time, and 480 one time. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #6’s dialysis treatment record, dated 4/4/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 4/4/2025 documented Patient #6’s blood flow rate during the dialysis treatment was set at 500 mm eight times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. Review of Patient #6’s dialysis treatment record, dated 4/7/2025, documented Patient #6 was prescribed a blood flow rate (BFR) of 550 milliliters/minute. Review of Patient #6’s Treatment Sheet dated 4/7/2025 documented Patient #6’s blood flow rate during the dialysis treatment was set at 300 mm six times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #6’s blood flow rate deviated from the prescribed dialysis blood flow rate. 8) Review of Patient #5’s dialysis treatment record, dated 3/28/2025, documented Patient #5 was prescribed a blood flow rate (BFR) of 450 milliliters/minute. Review of Patient #5’s Treatment Sheet dated 3/28/2025 documented Patient #5’s blood flow rate during the dialysis treatment was set at 400 mm four times. The Treatment Sheet failed to provide documentation that justified or explained why Patient #5’s blood flow rate deviated from the prescribed dialysis blood flow rate. During an interview on 4/8/2025 at 3:04 PM, the Director of Operations and Clinical Manager B, confirmed Resident #5, #6, # 8, # 9, #10 and #13’s Blood flow rate and dialysate flow rates were not provided as prescribed and lacked documentation to explain why there was a deviation from the prescribed treatment. Record review of policy and procedure titled “Patient Assessment and Monitoring”, last review date 3/18/2025, read “Purpose: The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment. 3. Machine Parameters and Extracorporeal Circuit - Check machine settings and measurements. Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribe blood flow rate. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 51504 Based on record review and interviews, the facility failed to ensure the patient plan of care for 1 patient, Patient #13, of 10 sampled patients was signed by the patient or a reason the patient chose not to sign was not documented on the patient plan of care. Findings include: Review of the plan of care developed for Patient #13, dated 03/27/2025, failed to reveal documentation Patient #13 had signed the patient plan of care. There was no entry on the care plan documenting Patient #13 had declined to sign the plan of care. During an interview on 4/10/2025 at 3:23 PM, the Director of Operations confirmed Patient #13 had not signed their plan of care and there was no documentation the patient’s chose to not sign the plan of care. . Review of the policy and procedure titled “Comprehensive Interdisciplinary Assessment and Plan of Care” last reviewed 3/18/24, read, “Comprehensive Assessment Participation and Plan of Care Review. The patient’s level of participation is determined by the patient. The patient must sign the plan of care to acknowledge the information in the plan. If the patient chooses not to sign their plan of care the reason or refusal must be documented in the patient’s medical record.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 49777 Based on observation, record review and interview the facility failed to ensure the nephrologist conducted in-center visits for two dialysis patients, Patient #21 and #25, out of 6 sampled patients at least quarterly at the dialysis center during dialysis treatment to assess the patient’s response to treatment and to observe the team care. Findings include: Review of the record for Patient #21, did not have documentation of a quarterly in-center face to face visit during the first quarter of 2025. Review of the physician’s note dated 2/26/2025 read, “Spoke with patient over telephone.” The record did not contain an in-center face to face visit to assess the patient’s response to treatment and observe the team care during the first quarter of 2025. Review of the record for Patient #25 did not have documentation of a quarterly in-center face to face visits during the first quarter of 2025. Review of the physician’s notes dated 1/10/2025 and 2/28/2025 read, “Spoke with patient over telephone.” The record did not contain an in-center face to face visit to assess the patient’s response to treatment and observe the team care during the first quarter of 2025. During an interview on 4/8/2025 at 1:00 PM, the Director of Operations confirmed the physician should have a quarterly in-center visit with the patient and confirmed there was no documentation in Patient #21 and Patient #25’s record of an in-center visit for the first quarter of 2025. During an interview on 4/9/2025 at 2:35 PM, the Medical Director stated the clinical expectation for independent nephrologists is to see their patients at least once a quarter in-center and provide progress notes for the medical record. Letters were sent to the practitioners from the last survey.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 40559 Based on record review and interview, the facility failed to provide appropriate orientation and training to patients including emergency disconnect training for 2 Patients (Patient #3 and #16) out of 3 patients reviewed for orientation training. Findings include: Patient #3 was admitted to the facility for treatment on 3/1/24 with diagnoses including Type II Diabetes Mellitus with Diabetic Chronic Kidney disease and End Stage Renal Disease. Review of Patient #3’s electronic and paper file did not reveal education on emergency preparedness including emergency disconnect as part of his orientation training. Patient #15 was admitted to the facility for treatment on 3/1/24 with diagnoses including Type II Diabetes Mellitus with Diabetic Chronic Kidney disease and End Stage Renal Disease. Review of Patient #15’s electronic and paper file did not reveal education on emergency preparedness including emergency disconnect as part of his orientation training.” During an interview conducted on 7/17/24 at 9:30 AM, the Clinic Manager confirmed Patients #3 and #15 did not have documentation regarding emergency preparedness orientation training including emergency disconnect. Review of facility policy titled, “Patient Education,” dated 2/6/23 showed it read, “The purpose of this policy is to provide guidance on education provided to the patient to: Increase knowledge, skill and confidence in managing his/her ESRD ( End Stage Renal Disease)...Topic-Fire/ Emergency Evacuation and Take Off Procedures-Time Frame-within the 1st month for new patients and quarterly for existing patients.” 49777”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 40559 Based on record review and interview, the facility failed to ensure its staff operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements regarding fire drills conducted each quarter. Findings include: Review of the facility’s fire drill binder showed only one facility fire drill was conducted in April of 2024 for the year prior to current survey. During an interview conducted on 7/18/24 at 9:00 AM, with the facility’s Clinical Manager, he confirmed only one fire drill had been documented as being conducted in the last year and the facility policy was to conduct one quarter. Review of the facility policy titled, “Fire Drill,” shows it read, “The purpose of this policy is to guide FKC (Fresenius Kidney Care) staff when performing a fire drill...through the inclusion of the NFPA Life Safety Code...These requirements include a facility specific plan and the involvement of staff and patients in performing emergency drills...Fire Drills- Quarterly, all FKC facilities shall perform a fire drill for each shift of patients and staff...in addition to the drill, activation of the fire alarm once per staff shift shall occur to ensure the alarm system is working and simulation of emergency fire conditions. Ensure each shift of staff working in the facility are familiar with the signals and emergency action required during a fire.” 49777”

“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: 49777 Based on observation, interview and record review the facility failed to ensure 1 of 4 staff, Staff B, Registered Nurse Orientee, observed followed acceptable infection control practices during provision of dialysis treatment care to include sanitization of hands after doffing gloves and before donning new gloves. Findings include: during an observation on 7/15/2024 at 10:44 AM, Staff B, Registered Nurse Orientee, was observed donning gloves without sanitization of hands prior to donning gloves. Another RN asked for medication keys and Staff A put her gloved hand in her pocket to get the keys and then left the patient station and went to the medication station and drew up heparin for patient #2 at the medication station and then put the keys in her pocket with the same gloved hand, She did not doff the gloves until after heparin was administered to Patient #2. During an interview conducted on 7/15/2024 at 11:00 AM, the Clinical Manager confirmed staff should sanitize their hands after they doff used pair of gloves and before they don a new pair of gloves during dialysis care. Record review of the facility policy titled “Hand Hygiene”, published 11/06/2023, showed the policy read “The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination.” The policy defined responsibility as “All staff, patients, patient care givers, including physician’s and non-physician practitioners, social workers, dieticians and any other indirect patient care staff must follow the same requirements for hand hygiene.” The policy defined hand hygiene as “Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content.” The policy identified when hands should be washed with soap and water or when alcohol-based hand rubs could be used as hands would be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parental medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands or not visibly soiled, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain, or water lines and after contact with other objects within the patient station or treatment space.”

“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: 40559 Based on record review and interview the facility failed to follow the prescribed to follow the prescribed blood flow rate (DFR) for 5 patients, Patients #2, # 3, #9, #10 and patient # 13 out of five in-center hemodialysis patients reviewed. Findings: 1.) Patient #3 was admitted to the facility for treatment on 3/1/24 with diagnoses including Type II Diabetes Mellitus with Diabetic Chronic Kidney disease and End Stage Renal Disease. Review of Patient #3’s Patient Transfer form dated 7/15/24 shows a hemodialysis order which reads, “In CTR(incenter) HD (Hemodialysis) Mon/Wed/ Fri BFR (Blood Flow Rate) 400mL and DFR(dialysis Flow rate) 600mL (milliliters)...” Review of Patient #3’s Access Treatment Summaries dated 7/8/24 documented BFR increased to 450 one time at 10:35 AM and DFR at 800 mL for entire treatment and on 7/12/24 documented Blood flow rate dropped to 300 mL on 3 occasions (11:06 AM, 11:32 AM and 12:03 AM) during treatment. There was no documentation of notification or the Registered Nurse or reason why rates were not being administered as ordered. Patient #10 was admitted to the facility for treatment on 6/2/17 with diagnoses including Hypertensive kidney disease and End Stage Renal Disease. Review of Patient #10’s Patient Transfer form dated 7/15/24 shows a hemodialysis order which reads, “In CTR(incenter) HD (Hemodialysis) Mon/Wed/ Fri BFR (Blood Flow Rate) 450mL and DFR(dialysis Flow rate) 600mL (milliliters)...” Review of Patient #10’s Access Treatment Summaries dated 7/12/24 documented BFR/ DFR decreased to 300 mL/ 500 mL at 5:52 AM, 6:11, 6:30 and 7:00 AM, increased to 400mL/ 500 mL at 8:08 AM decreased to 350 mL/ 500 mL at 8:30 and 9:05 AM and on 7/10/24 documented Blood flow rate/ DFR was recorded as 400mL/600 mL at 5:58 and for the remainder of the treatment. There was no documentation of notification or the Registered Nurse or reason why rates were not being administered as ordered. 49777 Record review of Patient #2’s dialysis treatment orders, in effect 7/1/2024, revealed Patient #2 was prescribed a blood flow rate of 400. Record review of Patient #2’s dialysis treatment record, dated 7/1/24, revealed Patient #2’s blood flow rate was set at 450 five times during her dialysis treatment on 7/1/24. Record review of patient #2’s dialysis treatment record for 7/1/2024 failed to reveal documentation that justified or explained why Patient #2’s blood flow rate had deviated from her prescribed blood flow rate. Record review of patient #2’s dialysis treatment record, dated 7/3/24, revealed Patient #2’s blood flow rate was set at 300 three times and at 450 five times during her dialysis treatment on 7/3/2024. Record review of Patient #2’s blood flow rate record for 7/3/2024 failed to reveal documentation that justified or explained why Patient #2’s blood flow rate had deviated from her prescribed blood flow rate. Record review of patient #2’s dialysis treatment record, dated 7/12/2024, revealed Patient #2’s blood flow rate was set at 200 three times and at 225 once during her dialysis treatment on 7/12/2024. Record review of patient #2’s dialysis treatment record for 7/12/2024 failed to reveal documentation that justified or explained why Patient #2’s blood flow rate had deviated from her prescribed blood flow rate. Record review of patient #2’s dialysis treatment record, dated 7/15/2024, revealed Patient #2’s blood flow rate was set at 350 two times, at 325 two times and at 300 four times during her dialysis treatment on 7/15/2024. Record review of patient #2’s dialysis treatment record for 7/15/2024 failed to reveal documentation that justified or explained why Patient #2’s blood flow rate had deviated from her prescribed blood flow rate. During an interview on 7/17/24 beginning at 3:35 PM, Clinical Manager confirmed the blood flow rate for Patient #2 was not set at the BFR ordered by her physician during treatments on 7/1/20204, 7/3/24, 7/12/24 and 7/15/2024. The nurse manager stated, “A change from the patient’s blood flow rate should always be justified with documentation in the clinical record.” Record review of Patient #9’s dialysis treatment orders, in effect 7/10/2024, revealed Patient #9 was prescribed a blood flow rate of 400. Record review of Patient #9’s dialysis treatment record, dated 7/8/24, revealed Patient #9’s blood flow rate was set at 350 six times during his dialysis treatment on 7/8/24. Record review of patient #9’s dialysis treatment record for 7/8/2024 failed to reveal documentation that justified or explained why Patient #9’s blood flow rate had deviated from his prescribed blood flow rate. Record review of patient #9’s dialysis treatment record, dated 7/12/24, revealed Patient #9’s blood flow rate was set at 351 six times during his dialysis treatment on 7/12/2024. Record review of Patient #9’s blood flow rate record for 7/12/2024 failed to reveal documentation that justified or explained why Patient #9’s blood flow rate had deviated from his prescribed blood flow rate. During an interview on 7/17/24 beginning at 3:35 PM, Clinical Manager confirmed the blood flow rate for Patient #9 was not set at the BFR ordered by her physician during treatments on 7/8/20204 and 7/12/24. The nurse manager stated, “A change from the patient’s blood flow rate should always be justified with documentation in the clinical record.” Record review of Patient #13’s dialysis treatment orders, in effect 7/3/2024, revealed Patient #9 was prescribed a blood flow rate of 450. Record review of Patient #13’s dialysis treatment record, dated 7/8/24, revealed Patient #13’s blood flow rate was set at 400 four times during her dialysis treatment on 7/8/24. Record review of patient #13’s dialysis treatment record for 7/8/2024 failed to reveal documentation that justified or explained why Patient #13’s blood flow rate had deviated from her prescribed blood flow rate. Record review of patient #13’s dialysis treatment record, dated 7/15/24, revealed Patient #13’s blood flow rate was set at 350 one time and at 400 one time during her dialysis treatment on 7/15/2024. Record review of Patient #13’s blood flow rate record for 7/15/2024 failed to reveal documentation that justified or explained why Patient #9’s blood flow rate had deviated from her prescribed blood flow rate. During an interview on 7/17/24 beginning at 3:35 PM, Clinical Manager confirmed the blood flow rate for Patient #13 was not set at the BFR ordered by her physician during treatments on 7/8/20204 and 7/15/24. The nurse manager stated, “A change from the patient’s blood flow rate should always be justified with documentation in the clinical record.” Based on record review and interview the facility failed to follow the prescribed to follow the prescribed dialysate flow rate (DFR) for 1 patient, Patient #2, of 5 in center hemodialysis patients reviewed. Findings Include: Record review of Patient #2’s dialysis treatment orders, in effect 7/1/24, revealed Patient #2 was prescribed a dialysate flow rate of 800. Record review of patient #2’s dialysis treatment record, dated 7/1/2024, revealed Patient #2’s dialysate flow rate was set at 500 once during his dialysis treatment on 7/12/2024. Record review of patient #2’s dialysis treatment record for 7/12/2024 failed to reveal documentation that justified or explained why Patient #2’s dialysate flow rate had deviated from his prescribed blood flow rate. During an interview on 7/17/24 beginning at 3:35 PM, Clinical Manager confirmed the dialysate flow rate for Patient #2 was set at 500 once during treatments on 7/12/20204. The nurse manager stated, “A change from the patient’s dialysate flow rate should always be justified with documentation in the clinical record.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 49777 Based on observation, record review and interview the facility failed to ensure that the nephrologist conducted in-center visits for two dialysis Patients, #18 of #19 out of 5 sampled patients at least quarterly at the dialysis center during dialysis treatment to assess the patient’s response to treatment and to observe the team care. The five sampled patients have nephrologists that are independent practitioners. Findings include: On 7/16/2024 at 1:07 PM, reviewed the nephrologist physician assessment during record review of patient #18. Physician noted on January 19, 2024, spoke with patient over telephone; No office or in-center progress note for February, 2024, March, 2024 or June 2024. Rounding note was in record for April 19, 2024 and May 27, 2024. Record review for Patient #18 did not have documentation for quarterly in -center visits for two quarters for the period of January 2024 through July 2024. There was no documentation for two consecutive quarters that an in-center dialysis facility visit was conducted by the patient’s nephrologist while the patient is receiving dialysis to assess the patient’s response to treatment and to observe the team care. On 7/16/2024 at 1:15 PM, reviewed the nephrologist physician assessment during record review of patient #19. Physician noted on January 19, 2024, spoke with patient over telephone; No office or in-center progress note for February, 2024, March, 2024, May 2024 or June 2024. Rounding note was in record for April 19, 2024. Record review for Patient #19 did not have documentation for quarterly in -center visits for two quarters for the period of January 2024 through July 2024. There was no documentation for two consecutive quarters that an in-center dialysis facility visit was conducted by the patient’s nephrologist while the patient is receiving dialysis to assess the patient’s response to treatment and to observe the team care. During an interview conducted on 7/16/24 at 1:25 PM, with the clinical manager, stated that the nephrologist should have a monthly progress note (face to face) and confirmed that documentation was missing for two of the five sampled patients who have independent nephrologists. During an interview conducted on 7/17/24 at 1:53 PM, with clinical manager, stated that the clinical expectation for nephrologists is to see their patients face to face monthly and at least once a quarter in-center and provide progress notes for the medical record. She stated that she will address non-compliance with Patient #18’s and Patient #19’s nephrologist.”

“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: 49777 Based on record review and interview, the facility failed to monitor personnel issues, and patient modality choice and to ensure routine audits are conducted and discussed, and performance improvement actions taken, when indicated. Findings include: During record review of QAPI minutes, Personnel qualifications and issues were addressed in December and reported at 1/25/24 meeting that the social worker (SW) would see patients on Wednesdays in-center. No further discussion was noted in minutes for the period of January through June 2024. During record review of June QAPI minutes, glucometer issue for March, April, May was reported to QAPI but action plan specifics were not identified and glucometer issues not addressed at the time of occurrence for three months. During an interview conducted on 7/17/24 at 1:40 PM, with Administrator for East/West Gainesville, Clinical manager and Director of Operations (during QAPI review), when asked Why the technician waited three months to report a glucometer issues?, Who is responsible for the action plan, What is the action plan and time frame to implement and remonitor the glucometer issues? The three staff in attendance did not know.”

“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: 49777 Based on record review and interviews, the facility failed to ensure that social worker is available to meet patient needs. Findings Include: Duringan interview conducted on 7/15/24 at 10:10 AM, with Patient #1 , he stated that he does not see a social worker, only the dietitian. During an interview conducted on 7/16/24 at 9:25 AM, with clinical manager, stated there is a social worker vacancy and a social worker from Tampa is covering this facility by telephone. During an interview conducted on 7/16/24 at 11:00 AM, with regional social worker director , she stated she has a requisition in to fill the social worker position and has an interview this week. During an interview conducted on 7/16/24 beginning at 11:10 AM, with social worker she stated she works in Tampa and has 90 patients and is covering remotely by telephone for Starke during the months of June and July. The telephone connection was lost three times during the interview. The regional social worker director had to email Tampa social worker to call back via TEAMS due to poor telephone connection because regional director could not call her directly. During an interview conducted on 7/17/24 at 1:53 PM, with the medical director, she stated it is very difficult to staff positions for this area and stated they are scheduled to interview someone for the open social service position. Record review on 7/17/24 of the QAPI meeting minutes for December, 2023 noted that a social worker would be in center on Wednesdays to see patients. There is not a social worker seeing patients in center in person on Wednesdays. There is no additional social worker vacancy discussion in the minutes for January to present. The clinical director confirmed no documentation for staffing in the monthly minutes for 2024. During an interview conducted on 7/17/24 at 3:07 PM, with RN ( registered Nurse), She stated that social service patient needs are not met when contact is made by telephone. Patients do not trust to tell someone over the phone that they do not see or know that they have no food. She stated that the social worker needs to be in center to see patients and family members to better meet their needs and build rapport.”