Fmc Carolina

“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: 51637 Based on observations made of the treatment area, during the first shift of 03/11/2025 from 8:30 AM through 11:55 AM , it was determined that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents within and between units related to the lack of adherence of “standard precautions”. Findings include: On March 11, 2025, at 12:21PM with the clinical manager (employee #8) was evaluated the policy “Cleaning and Disinfecting the Dialysis Station” which was published on 09/05/2025 with reference number 47806 and states: “Dialysis wall boxes and the area/wall around the wall must be routinely cleaned at the end of each treatment day or immediately if splattered with blood” 1. During the observations made in the treatment area from 8:30AM through 11:55AM the following was observed: a. Two treatment stations (49 and T18) were observed with drops of blood on the machine and on the floor, which were not immediately disinfected. 2. Four biohazard trash cans were observed open after being used. 51782 Clinical Manager (employee #8) provided facility’s policy Version 8 last update on 05/02/2024, Testing of Residual Bleach Using Water Check, RC Residual Chlorine Reagent Test Strips on 03/12/2025 at 1:47 PM. Policy stated in page 3, in section 3 that the personal inspect the bottle of Water Check, RC Test Strips to ensure: the bottle is dated, initiated and not expired. 3. During observations conducted in the hemodialysis treatment area, on 03/11/2025 from 8:50 AM through 12:00 PM, and interview with facility nursing supervisor (employee #9) the following was observed: a. On 03/11/2025, at 9:30 A.M., one (1) container of Water Check Residual Chlorine, Lot number 25407321021, Expiration date 2027-01, it was observed with the opening date and the employee’s initials unreadable. 4. During observations conducted in the hemodialysis treatment area, the following was observed: a. On 03/11/2025, at 8:40 AM., the right-lateral side table of the chair was observed stuck at station 25 during dialysis treatment. b. On 03/11/2025, at 9:45 AM., the right-lateral side table of the chair was observed stuck at station 28 during dialysis treatment. 47384 5. Approximately at 8:45 AM it was observed that the stretcher placed in the treatment area had a white particulate showing that it lacked cleaning and disinfection. 6. Excessive dust was observed on the floor in the area where patient walkers are placed, near treatment station #5. 7. In the isolation room, white particulate matter was observed covering the connection sleeves of the treatment machine, the rear part of the machine, and the floor. 8. Drops of blood were observed on the floor next to the chair at treatment station #40. Nursing staff did not clean the area immediately after noticing. 9. Approximately 6 boxes containing vacutainers and collection tubes were observed directly on the floor in the warehouse area.”

“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: 51637 Based on the observations made of the treatment area, during the first shift of 03/11/2025 from 8:30 AM through 11:55 AM , it was determined that the facility failed to monitor the performance of the job duties of the biomedical technician (employee #7). Findings include: On March 12, 2025, at 10:01AM with the biomedical technician supervisor (employee #6) the job description of the biomedical technician (employee #7) was evaluated and does not state that the removal of the lines from the dialysis machine is part of his responsibilities or duties. 1.During the observations made in the treatment area it was observed at 12:21 PM that the biomedical technician was removing the lines from a dialysis machine.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first shift of 03/11/2025 from 8:30 AM through 4:00PM , it was determined that the facility failed to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Findings include: 1. At approximately 11:15 AM, two patient transport companies (Transmedic and Firemedical) were observed unloading their patients on the street, crossing through a high-traffic area without using the designated mezzanine. This does not ensure patients’ safety, as the street is in uneven condition, posing a fall hazard. 2. At approximately 11:30 AM it was observed that the patient in treatment station #43 had connected to a receptacle behind dialysis machine a white electrical extension cord to charge her phone. This represents an electrical hazard.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first shift of 03/11/2025 from 8:30 AM through 4:00PM, it was determined that the facility failed to ensure that the building in which dialysis services are furnished are constructed and maintained. Findings include: Damaged gypsum board (water damage and calcification) was observed on column behind the nurse’s station and in front of treatment station #5. This column is connected to the medication room that also presents wall damage on the inside and outside next to the entrance door area.”

“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: 47384 Based on observations made of the treatment area, during the first shift of 03/11/2025 from 8:30 AM through 4:00 PM, it was determined that the facility failed to maintain a program to ensure that all equipment is maintained and operated in accordance with the manufacturer’s recommendations. Findings include: 1. Approximately at 8:55 AM a sphygmomanometer was observed with an out of service tape next to a treatment station. 2. Approximately at 9:05 AM inside the Isolation Room it was observed that the juncture between lid and base of the Diasafe cover showed black mold like stains. 3. Approximately at 10:10 AM it was observed that the drain on treatment station #44 was obstructed by particulate and did not drain properly. This particulate was observed in the base of the drain station. 4. Approximately at 10:30 AM it was observed dialysis machine in station #43 did not have protective cover for the Diasfe cartridge. 5. Approximately at 11:00 AM it was observed that dialysis machine #29 was leaking water from the side.”

“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: 51782 Based on observations made in the treatment area and review of policies and procedures, it was determined that the facility failed to ensure that patients receive treatment in a manner that allows staff to have full view of patient’s access sites for the first shift at patient’s stations #39. This deficient practice affects 1 out of 42 patients observed receiving treatment. Findings include: The Clinical Manager (employee #8) provided facility’s policy Version 4 last update on 05/01/2023, Patient assessment and Monitoring on 03/12/2025 at 10:09 AM. Policy stated in page 5, in section of Access, that the general observations from staff to the patient must include to observe that access connections are secure and visible, and personnel must ensure vascular access remains uncovered throughout the treatment. 1. During observations of the hemodialysis treatment area on 03/11/2025 from 8:50 AM through 12:00 PM the following was observed: a. Patient #22 located on station #39, was observed with his right subclavian catheter vascular access covered with a shirt and blanket while receiving treatment.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first shift and second shift of 03/11/2024 from 8:30 AM through 3:30 PM, it was determined that the facility failed to maintain Life Safety measures that comply with NFPA 101 (Life Safety Code) and NFPA 99 (Health Care Facilities Code) provisions which could affect all patients receiving treatment and staff. Findings include: 1. Fire extinguisher was observed blocked by treatment chair next to fire emergency exit. 2. At the moment of the survey there was no written evidence that the three (3) fire doors in the facility had been inspected. After further observation, none of the fire doors or frames had the fire rating decal to validate fire rating. To ensure that fire doors are working properly NFPA 80 (Standard for Fire Doors and Other Opening Protectives) section 5.2.1 mandates that fire doors should be inspected and tested at least once a year.”

“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: 51637 Based on nineteen records reviewed (RR) and review of Policy and Procedure (P&P), it was determinate that the facility failed to monitor and document the patient high blood pressure (BP) and low blood pressure dialysis treatment for 4 out of 19 records reviewed (RR #6, RR#7, RR#8, RR#9). Findings include: On March 12, 2025, at 9:00AM with the clinical manager (employee #8) the policy was evaluated “Patient Assessment and Monitoring” which was published on 05/01/2023 with reference number 45284 and states that the blood pressure must be reported if systolic is greater than 180mm/Hg or less than 100mm/Hg and if diastolic is greater than 100mm/Hg. 1. RR #6 is a 40-year-old female patient admitted on 12/14/2020 with Type 1 Diabetes Mellitus with diabetic chronic kidney disease. During the record review performed on 03/11/2025 at 3:30PM, hemodialysis treatment is three times a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 360, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 78 kilograms (kg). a. On 03/04/2025 at 7:03PM it was reported that during and post the treatment the BP was 184/93mm/Hg and at 8:33PM it was reported that the BP was 180/92mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 03/05/2025 at 2:33PM it was reported that during the treatment the BP was 193/83mm/Hg, at 3:08PM it was reported that the BP was 182/79mm/Hg and at 3:38PM it was reported that the BP was 185/77mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 2. RR #7 is a 66-year-old female patient admitted on 01/15/2025 with Type 2 diabetes with diabetic chronic kidney disease. During the record review performed on 03/11/2025 at 3:00PM, hemodialysis treatment is three times a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 69 kilogram (kg). a. On 02/26/2025 at 5:20PM it was reported that during and post the treatment the BP was 181/89mm/Hg, at 5:21PM it was reported that the BP was 191/109mm/Hg, at 5:37PM it was reported that the BP was 186/106mm/Hg, and at 9:21PM it was reported that the BP was 187/87mm/Hg. No evidence was found of the nursing documentation of physician report. b. On 03/03/2025 at 5:18PM it was reported that during and post the treatment the BP was 195/109mm/Hg, at 5:19PM it was reported that the BP was 198/107mm/Hg, at 5:29PM it was reported that the BP was 185/105mm/Hg, at 6:05PM it was reported that the BP was 178/104mm/Hg, at 6:26PM it was reported that the BP was 181/107mm/Hg, at 7:09PM it was reported that the BP was 176/106mm/Hg, at 7:26PM it was reported that the BP was 177/101mm/Hg and at 9:50PM it was reported that the BP was 180/102mm/Hg. No evidence was found of the nursing documentation of physician report. c. On 03/10/2025 at 5:05PM it was reported that during and post the treatment the BP was 190/109mm/Hg, at 5:07PM it was reported that the BP was 193/107mm/Hg, at 5:38PM it was reported that the BP was 196/111mm/Hg, at 6:04PM it was reported that the BP was 188/101mm/Hg, at 6:34PM it was reported that the BP was 185/102mm/Hg, at 7:02PM it was reported that the BP was 193/108mm/Hg, at 7:35PM it was reported that the BP was 189/106mm/Hg and at 8:00PM it was reported that the BP was 188/107mm/Hg. No evidence was found of the nursing documentation of physician report. d. On March 12, 2025, at 10:52am in an interview with the clinical manager (employee #8) she states that the doctor already has conscious of the high blood pressure however, she found no evidence that the nurse had written in the file that these pressures had been reported to the doctor. 3. RR #8 is a 69-year-old male patient admitted on 04/20/2024 with Type 1 and 2 diabetes with diabetic chronic kidney disease. During the record review performed on 03/11/2025 at 2:30PM, hemodialysis treatment is three times a week for three hours and forty-five minutes, Dialyzer 160NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 75.5 kilogram (kg). a. On 02/27/2025 at 4:28PM it was reported that during the treatment the BP was 94/57mm/Hg, at 5:33PM it was reported that the BP was 82/53mm/Hg, at 7:30PM it was reported that the BP was 92/57mm/Hg, and at 8:07PM it was reported that the BP was 98/69mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 03/01/2025 at 5:34PM it was reported that during the treatment the BP was 95/50mm/Hg, at 6:41PM it was reported that the BP was 97/60mm/Hg, at 7:40PM it was reported that the BP was 98/58mm/Hg, and at 8:07PM it was reported that the BP was 98/69mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. c. On 03/04/2025 at 12:57PM it was reported that during the treatment the BP was 96/55mm/Hg, at 2:08PM it was reported that the BP was 89/57mm/Hg, at 2:34PM it was reported that the BP was 95/59mm/Hg, at 3:04PM it was reported that the BP was 94/59mm/Hg, at 3:39PM it was reported that the BP was 94/58mm/Hg, at 4:02PM it was reported that the BP was 95/62mm/Hg and at 4:35PM it was reported that the BP was 96/60mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. d. On March 12, 2025, at 10:52am in an interview with the clinical manager (employee #8) she states that the doctor did not order any treatment without first having a consultation with the specialist to which the patient has an appointment with his cardiologist scheduled for April, however, she found no evidence that the nurse had written in the file that these pressures had been reported to the doctor. 4. RR #9 is a 38-year-old male patient admitted on 08/18/2023 with Hypertensive chronic kidney disease. During the record review performed on 03/11/2025 at 2:00PM, hemodialysis treatment is three times a week for three hours and forty-five minutes, Dialyzer 200NRe Optiflux, Blood Flow Rate (BFR) of 450, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 117 kilogram (kg). a. On 03/06/2025 at 6:43PM it was reported that during the treatment the BP was 93/61mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 5. On March 12, 2025, at 10:52AM in an interview with the clinical manager (employee #8) she states that she found no evidence that the nurse had written in the file that these pressures had been reported to the physician.”

“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: 15884 Based on review of the treatment flowsheets on 03/11/2025 at 1:50 PM it was identified that the facility failed to follow physicians’ orders in the Blood Flow Rate (BFR) and DFR during the dialysis treatment and documented their intervention in the management of the patients BFR and Dialysis Flow Rate (DFR). This deficient practice is identified in 7 out of 19 records reviewed (RR), (RR #7, #8, #9, 12, #15, #17, and #19 ). Findings include: During the flowsheet review performed on 03/11/2024 at 1:30 PM to 4:00 PM the following was found: Upon review of the facility’s policy Title: Patient Assessment and Monitoring during hemodialysis treatments last update on 09/05/2023, on 03/12/2025 at 9:30 AM. Policy stated on the procedures that before and during hemodialysis treatment personnel perform safety checks in order to ensure machine parameters maintain blood flow rate ordered is being achieved or reason for not is documented on the medical record. 1. RR#12 is a 15 years-old male transient (who receives dialysis at a temporary location, while traveling) patient admitted to the facility on 03/03/2022 with a diagnosis of End Stage Renal Disease and Hypertensive Chronic Kidney. This patient’s hemodialysis treatment order dated 03/03/2024 establishes that this patient must receive treatment by Arterio Venous on Right Upper Arm Fistula with a of BFR 400 and DFR Manual of 800 ml/min. Review of hemodialysis flowsheet dated 03/03/2025 and 03/07/2025 with the agency Clinical Manager (employee #8) on 03/11/2025 at 3:55 PM evidenced that treatment was given on 03/03/2025 with a BFR of 350 and on 03/07/2025 with a BFR of 375 throughout the shift. 2. RR#15 is a 82 years-old male patient admitted to the facility on 10/19/2023 with a diagnosis of End Stage Renal Disease and Hypertensive Chronic Kidney. This patient’s hemodialysis treatment order dated 02/03/2025 05/23/2024 establishes that this patient must receive treatment by Arterio Venous on Left Upper Arm Fistula with a BFR 350 and DFR Manual of 800 ml/min. Review of hemodialysis flowsheet dated 03/11/2025 with the agency Clinical Manager (employee #8) on 03/11/2025 at 3:45 PM evidenced that treatment was given on 03/10/2025 and 02/28/2025 with a BFR of 300 throughout the shift. Facility Manager (employee #8), stated in an interview on 03/12/2025 at 9:15 AM that after review of medical record of case #12 and case #15 that she did not find a rationale documented for the change of the BFR on both cases. 3. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change on prescription and parameters administered were not according with the physician order. 51637 During the record review performed on 03/11/2025 between 1:30PM trough 3:30PM the following was found: 4. RR #7 is a 66-year-old female patient admitted on 01/15/2025 with Type 2 diabetes with diabetic chronic kidney disease. During the record review performed on 03/11/2025 at 3:00PM, hemodialysis treatment is three times a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 69 kilogram (kg). a.On 02/26/2025 at 5:21PM, 5:37PM, 6:05PM, 6:32PM, 7:04PM, 7:39PM, 8:04PM and 8:31PM, the DFR was decrease to 500. At 7:04PM, 7:39PM and 8:04PM the BFR was decrease to 350. No evidence was found of the justification on the nurse note or authorized decrease from the physician. b.On 03/10/2025 at 6:34PM, 7:02PM and 7:35PM the BFR was decrease to 380. No evidence was found of the justification on the nurse note or authorized decrease from the physician. 5.RR #8 is a 69-year-old male patient admitted on 04/20/2024 with Type 1 and 2 diabetes with diabetic chronic kidney disease. During the record review performed on 03/11/2025 at 2:30PM, hemodialysis treatment is three times a week for three hours and forty-five minutes, Dialyzer 160NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 75.5 kilogram (kg). a.On 03/08/2025 the entire treatment from 4:19PM to 8:08PM the DFR was decrease to 500. The nurse documented that the dialysis machine had technical problems as justification for the decrease in DFR. No evidence was found of the nurse’s note with the authorized decrease from the physician. b.On 03/12/2025 at 8:35AM in an interview with the clinical manager (employee #8) she stated that the day was Saturday and there were no biomedical technicians at the facility to repair the machine. c.On 03/12/2025 at 9:56AM in an interview with the biomedical technician supervisor (employee #6) he stated that there were 5 more machines available for use, but in fact there was no biomedical technician at the facility who could set it up and change it. 6.RR #9 is a 38-year-old male patient admitted on 08/18/2023 with Hypertensive chronic kidney disease. During the record review performed on 03/11/2025 at 2:00PM, hemodialysis treatment is three times a week for three hours and forty-five minutes, Dialyzer 200NRe Optiflux, Blood Flow Rate (BFR) of 450, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 117 kilogram (kg). a. On 03/04/2025 at 4:32PM, 4:50PM, 5:11PM and 5:32PM the BFR was decrease to 415. No evidence was found of the justification on the nurse note or authorized decrease from the physician. In an interview on 03/12/2025 at 9:00AM with the clinical manager (employee #8) she stated that after review of medical record of RR #7 and case #9 she did not find a rationale documented for the change of the DFR and BFR on both cases. 17959 7. RR#17 is a 61 years-old female patient admitted to the facility on 03/25/2021 with a diagnosis of End Stage Renal Disease. During the record review performed on 03/11/2025 at 2:45 PM it was found that this patient had hemodialysis order dated 02/27/2025 establishes that this patient must receive treatment by Access AV Graft Synthetic - Standard ( PTFE) Upper Arm-Left Arterial needle Size - 16g1. BFR 350 and DFR Manual of 800 ml/min. Dialyzer Optiflux 160 NRe Optiflux. Patient Dry weight (EDW) 58.00 kilogram (Kg). During review of the most 6 hemodialysis flowsheets on 03/11/2025 at 2:40 PM for dated 02/25/2025, 02/27/2025, 03/01/2025, 03/04/2025, 03/06/2025, 03/06/2025 and 03/08/2025 it was identified that: On 02/25/2025 at 11:28 AM the BFR was between 200, not 350 as ordered by the physician. No evidence was found related to the justification to decrease the BFR and no evidence was found that the physician was notified and authorized decrease the BFR. On 03/08/2025 the DFR was maintained in 200, not at 800 as ordered by the physician. No evidence was found related to the justification to decrease the DFR and no evidence was found that the physician was notified and authorized decrease the DFR. 9. R.R #19 is a 78 year old male patient admitted to the facility on 09/01/2022 with a diagnosis of End Stage Renal Disease, Type 11Diabetes Mellitus, Diabetic Chronic Kidney Disease and VIH Migratory State. During the record review performed on 03/12/2025 at 1:30 PM it was found that this patient had hemodialysis order dated 08/29/2024 to receive hemodialysis treatment three times a week for 3 hours 45 minutes by Access AV Graft Synthetic Standard (PTFE) Right Upper Arm active status with a BFR of 400 and DFR of 800, Dialyzer Optiflux 160 NRe Optiflux. Patient Dry weight (EDW) 70 kilogram (Kg). The patient Plan of Care was performed on 08/29/2024 and lack of the date when the patient signed the POC. During review of the most 6 recent treatment sheets on 03/12/2025 at 1:30 PM, it was identified that: a. On 03/08/2025 the BFR placed 350 per four times and 300 per six times not at 400 as ordered by the physician. According to the nurse note (employee # 5) the patient has arterial collapse. No evidence was found related to the justification to decrease the BFR and no evidence was found that the physician was notified and authorized decrease the BFR. b. On 02/27/2025 the BFR was maintained in 350 at 12:35 PM per one. On 02/27/2025 on 300 per six times and on 02/25/2025 was maintained on 350 per eight times not at 400 as ordered by the physician. No evidence was found related to the justification to decrease the BFR and no evidence was found that the physician was notified and authorized decrease the BFR per employee #3. c.The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change on prescription and parameters administered were not according with the physician order.”

“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: 15884 Based on the review of facility’s QAPI program activities and performance improvement in the facility manager (employee #8), it was determined that the facility failed to act upon information collected and promote improvement and to evaluate the plan for such improvement. Findings include: 1. During the review of the quality assessment and improvement QAPI program activities on 03/12/2025 at 8:30 AM for the natural year 2024 and the months of January and February, of 2024, it was identified that facility identify opportunities to improve the documentation of the management and monitor of glucometer reactive per facility policy for equipment calibration and maintenance. 2. Accordingly with information provided by facility biomedical technician (employee #6) on interview on 03/12/2025 at 10:15 AM the management and monitor of glucometer reactive per facility policy for equipment calibration and maintenance are documented on an electronic format on the computer since approximately several years ago. He stated that when technical services performed quality checks of the electronic documentation of registry logs for other processes and procedures review the appropriateness of the documentation of the glucometer electronic log. The review of the appropriate documentation of this log is reported to the QAPI committee on a monthly basis. 3. Accordingly with information provided by facility clinical manager (employee #8) on interview on 03/12/2025 at 10:25 AM every month on year 2024 except for the month of April 2024, reported and discussed errors during the documentation process of the glucometer electronic log. She stated that those errors correspond to discrepancies on the reactive levels and date of strips expiration. She stated that every month findings were notified to facility nursing supervisor personnel because this is a task assigned to nursing personnel. She explains that nursing supervisors must retrain and discuss with nursing personnel from whom this task is assigned the findings in order to improve this documentation. She explains that despite efforts established in order to improve the documentation this has not been achieved. No detailed information who evidence different approaches planned to be implemented. This in order to improve the documentation in the glucometer electronic log based on strategies implemented that may not be successful were not included as part of facility improvement plans.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51637 Based on review of the treatment flowsheets on 03/11/2025, it was determined that the facility failed to ensure that the medical records contain complete information related with reasons to not documented the standing blood pressure post the hemodialysis treatment. This deficient practice is identified in 4 out of 19 medical records reviewed. (#7, #8,#9 and #10). Findings include: Upon review of the facility’s policy “Patient assessment and monitoring” last update on 05/01/2023 with reference number 45284, on 03/11/2025 at 2:48PM. Policy clearly stated on the procedures that the register nurse who evaluates the patient must document the blood pressure before and after each treatment. 1. RR #7 is a 66-year-old female patient admitted on 01/15/2025 with Type 2 diabetes with diabetic chronic kidney disease. a. During the record review performed on 03/11/2025 at 3:00 PM it was found that during patient hemodialysis treatment flow sheets dated 02/28/2025 03/03/2025 and 03/10/2025 the standing blood pressure post treatment was not documented. 2. RR #8 is a 69-year-old male patient admitted on 04/20/2024 with Type 1 and 2 diabetes with diabetic chronic kidney disease. a. During the record review performed on 03/11/2025 at 2:30 PM it was found that during patient hemodialysis treatment flow sheets dated 02/25/2025, 02/27/2025, 03/01/2025, 03/04/2025, 03/06/2025 and 03/08/2025 the standing blood pressure post treatment was not documented. 3. RR #9 is a 38-year-old male patient admitted on 08/18/2023 with Hypertensive chronic kidney disease. a .During the record review performed on 03/11/2025 at 2:00 PM it was found that during patient hemodialysis treatment flow sheets dated 02/25/2025, 03/01/2025 and 03/04/2025 the standing blood pressure post treatment was not documented. 4. RR #10 is a 49-year-old male patient admitted on 06/19/2024 with Type 2 diabetes mellitus with ESRD. a. During the record review performed on 03/11/2025 at 1:30 PM it was found that during patient hemodialysis treatment flow sheets dated 02/28/2025, 03/05/2025, 03/08/2025 and 03/10/2025 the standing blood pressure post treatment was not documented. 5.Clinical Manager (employee #8), stated in an interview on 03/12/2025 at 10:50 AM that after reviewing the medical record that did not find a rationale documented for standing blood pressure omitted. 6.The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change.”

“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: 47384 Based on the observational tour of the facility, and interview with facility ATOM (employee #9), it was determined that the facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents. Findings include: 1. Trash cans with isolated gowns were observed with overflowing used gowns. 2. Excessive dust on the countertops behind treatment station. 3. IV bag caps were observed on the floor throughout the unit floor 4. Blood drop was observed on medical screen that was together with sanitized medical screens 5. Sharp container on the medicine room was observed with medicine vails surpassing the limit line. 47632 6. During the observations made in the medicine room with the Charge Nurse on 06/13/2024 at 1:30 PM, the following was found: a. On 06/13/2024 at 1:53 PM a vial of Doxercalciferol 4mcg/2ml was observed open without date and signature of the nursing staff. b. According to the manufacturer: Store the opened multidose vial for up to 3 days and discard unused portion of multiple-dose vial after 3 days. c. On 06/13/2024 at 1:55 PM three 32-ounce bottles of LiquaCel were observed open without date and signature of the nursing staff. d. According to the manufacturer: Use LiquaCel® within 90 days after opening. e. On 06/13/2024 at 2:01 PM two bottles of Clonidine Hydrochloride 0.1 mg of 100 tablets were observed open without date and signature of the nursing staff. f. On 6/13/2024 at 2:02 PM two bottles of Calcitriol 0.5 mcg of 100 caplets were observed open without date and signature of the nursing staff. g. On 06/13/2024 at 2:08 PM a pot of Antacid Calcium Carbonate 750 mg of 96 tablets was observed open without date and signature of the nursing staff.”

“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: 15884 Based on the observational tour, review of policies and procedures, and interview with facility clinical manager (employee #1), it was determined that the facility failed to ensure a safe delivery of care following facility dress code. This deficiency was identified in 4 out of 9 nurses observed providing services to patients. Findings include: Review of the facility’s policy Title Employee Dress Code effective on 06/18/2021, policy clearly stated that no jewelry or other accessories can be worn that will pose a safety risk or interfere with the performance of job duties including dangling jewelry or accessories. 1. The following was observed during three disconnections and two connections performed by nursing staff on 06/13/2024 from 9:00 AM till 1:30 PM: a. During observations made of the disconnection process during the first shift at station #46, it was observed that registered nurse (RN) (employee #5) had two gold bracelets on left wrist. b. During observations made of the disconnection process during the first shift at station #10, it was observed that registered nurse (RN) (employee #5) had a gold bracelet on right wrist. c. During observations made of the connection process during the second shift at station #18, it was observed that registered nurse (RN) (employee #7) had a bracelet on right wrist. d. During observations made of the connection process during the second shift at station #31, it was observed that registered nurse (RN) (employee #8) had a Pandora charm bracelets on right wrist. 2. Facility clinical manager (employee #1), stated on interview on 06/13/2024 at 2:27 PM as per policy of dress code established that no jewelry or other accessories can be worn that will pose a safety risk or interfere with the performance of job duties including dangling jewelry or accessories. She also stated that dangling jewelry of any kind is not allowed with no exceptions due to the risk of spreading germs of the healthcare environment on surfaces that the personnel touch. 3. The facility failed to follow established dress code provisions in order to promote the safe delivery of care.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 15884 Based on observations made of the treatment area, during the first shift of 06/13/2024 from 8:35 AM through 1:20 PM , it was determined that the facility failed to ensure that patients follows instructions related with the hazards of eating while on dialysis for 2 out of 40 observations at patient’s stations #24 and #47. Findings include: Review of facility’s Policy &Procedures, # 45279 FMS Clinical Services Eating and drinking hot liquids policy last updated on 02/01/2023 established that only physician prescribed liquid nutritional supplements approved by the Registered Dietitian shall be consumed while on dialysis. The physician prescribed solid supplements must be consumed in the patient waiting area prior to or following the dialysis treatment. 1. During observations performed on 06/13/2024 from 8:35 AM through 1:20 PM at the hemodialysis treatment areas, it was observed that two out of forty patients were eating sweet and salty snacks while receiving their hemodialysis treatment at stations (#24 and #47). 2. Facility failed to discourage the consumption of food (salty snacks & candy) while on hemodialysis treatment to comply with infection standards and facility policies and procedures.”

“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: 47384 Based on the observational tour and review of procedures, with facility ATOM (employee #9), it was determined that the facility failed to ensure correct testing for free chlorine, chloramine, or total chlorine. Findings include: 1. At the time of the chlorine testing it was observed that the nurse performing the strip test did not have a controlled movement of the strip which permitted the strip to touch the borders of the flask. 2. After the strip was removed, the nurse touched the film on the strip which can affect the sample taken.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47384 Based on the observational tour of the facility, and interview with facility ATOM (employee #9), it was determined that the facility failed to maintain the building in which dialysis services are furnished to ensure the safety of the patients, the staff and the public. Findings include: During observations made on 06/13/2024 from 9:00 AM through 12:00 PM, the following was found: 1. It was observed that the door to the isolation room rubbed against the floor. The self closing system was also noted to need adjustment as the door does not close flushly. 2. Uneven baseboards were observed in the area where they join the counters. 3. Broken and out of square drawers were observed in the medical equipment counters. 47632 4. During the observations made in the chart carts with the Charge Nurse on 06/13/2024 at 2:30 PM, the following was found: a. On 06/13/2024 at 2:32 PM the chart cart located in front of station # 43 was observed with dust on the top and between the drawers. b. On 06/13/2024 at 2:40 PM the chart cart located in front of nursing station #2 was observed with dust on the surface. c. On 06/13/2024 at 2:40 PM in the laboratory area, dust was observed on the top of the refrigerator.”

“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: 47384 Based on the observational tour of the facility, and interview with facility ATOM (employee #9), it was determined that the facility failed to ensure that the equipment is maintained and operated in accordance with the manufacturer’s recommendations. Findings include: During observations made on 06/13/2024 from 9:00 AM through 2:00 PM, the following was found: 1. Broken vinyl was observed on the headrest of treatment chairs. 2. Dialysis machine marked as “Isolation Room” was found in the regular treatment area 3. Approximately around 91:30 AM the bicarbonate tank was observed with a low level, this triggered the alarm on 24 dialysis machines in the unit, when investigated, the secondary tank was still mixing and had 6 minutes left to complete process. 4. After review of Dialysis machines PM it was noted the clock hours in some machines did not follow the correct sequence.”

“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: 15884 Based on the observational tour and review of policies and procedures, and interview with facility clinical manager (employee #1), it was determined that the facility failed to ensure that patients receive treatment in a manner that allows staff to have full view of patient’s access sites for the first shift and second shift during on 06/13/2024 from 8:35 AM thru 1:20 PM at patient’s stations #6, #22, #32 and #43). This deficient practice affects 4 out of 40 patients observed receiving treatment. Findings include: Review of the facility’s policy #45284 Patient Assessment and Monitoring last update on 05/01/2023, 06/13/2024 at 2:00 PM, Policy clearly stated that during dialysis personnel in charge must observe connections and ensure access remains uncovered throughout the treatment. This policy stated that the cannulation site/catheter insertion site and the line connections must remain visible. 1. During observations of the hemodialysis treatment area on 06/13/2024 from 8:35 AM thru 1:20 PM the following was observed: a. Patient located on station #6 was observed face and line connections located on right chest catheter covered with blankets while receiving treatment. b. Patient located on station #22 was observed with line connections located on right chest catheter covered with blankets while receiving treatment. c. Patient located on station #32 was observed with line connections located on his left arm vascular access and line connections covered a blanket while receiving treatment. d. Patient located on station #43 was observed with her left arm vascular access and line connections covered with a blanket while receiving treatment. 2. Facility clinical manager (employee #1), stated on interview on 06/13/2024 at 2:17 PM as per policy established that if nursing identifies that vascular access and line connections are not visible, they must request to their patient to uncover the vascular access. She stated that policy established indicates that nursing personnel must educate and explain to the patient as a manner that the patient understand about the risks associate if not maintain the vascular access visible at all time during the treatment. 3. The facility failed to promote policies and procedures that establish that access sites are to be left uncovered to allow complete visibility by the nursing staff, during hemodialysis treatment.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, on 06/14/2024, it was determined that the facility failed to comply with provisions of the Life Safety Code. Findings include: 1. Fire extinguisher were observed obstructed by patient walkers and wheelchairs 2. Trash cans were observed obstructing the exit pathway.”

“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: 47632 Based on nineteen records reviewed (RR) and review of Policy and Procedure (P&P), it was determinate that the facility failed to monitor and document the patient high blood pressure (BP) dialysis treatment for 7 out of 19 records reviewed (RR #1, RR#5, RR#9, RR# 10, RR# 17, RR#18 and RR#19). Findings include: 1. RR# 1 is a 67-year-old female patient admitted on 01/21/2020 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 10:00 AM, hemodialysis treatment three a week for three hours and forty-five minutes, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 94. kilogram (kg). a. On 05/30/2024 at 10:04 AM it was revealed that the BP was 121/45mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 06/04/2024 at 8:35 AM it was revealed that the BP was 100/50mg/Hg, at 9:02 AM the BP was 120/52mg/Hg, and at 9:31 AM the BP was 119/54mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. c. On 06/08/2024 at 7:05 AM it was revealed that the BP was 135/53mg/Hg, and at 8:03 AM the BP was 115/51mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. d. On 06/11/2024 at 7:05 AM it was revealed that the BP was 135/53mg/Hg, and at 8:03 AM the BP was 115/51mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 2. RR# 5 is an 89-year-old male patient admitted on 05/12/2022 with End Stage Renal Disease. During the record review performed on 06/13/2024 at 3:54 PM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) 76.5 kilogram (kg). a. On 06/06/2024 at 12:01 PM it was revealed that the BP was 141/107mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 3. RR# 9 is a 54-year-old male patient admitted on 05/02/2022 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 8:35 AM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 102.5 kilogram (kg). a. On 06/03/2024 at 6:00 AM it was revealed that the BP was 192/99mg/Hg, and at 6:36 AM the BP was 176/100mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 06/05/2024 at 5:45 AM it was revealed that the BP was 183/97mg/Hg, and at 5:47 AM the BP was 181/97mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 4. RR# 10 is a 41-year-old male patient admitted on 09/12/2022 with End Stage Renal Disease. During the record review performed on 06/13/2024 at 4:25 PM, hemodialysis treatment three a week for four hours, Dialyzer 200NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 143 kilogram (kg). a. On 06/05/2024 at 7:08 AM it was revealed that the BP was 175/103mg/Hg, and at 7:09 AM the BP was 148/100mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 5. RR# 17 is a 55-year-old female patient admitted on 10/20/2017 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 9:26 AM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 70 kilogram (kg). a. On 05/27/2024 at 7:05 AM it was revealed that the BP was 113/46mg/Hg, and at 7:37 AM the BP was 93/59mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 05/29/2024 at 6:53 AM it was revealed that the BP was 104/53mg/Hg, at 8:03AM the BP was 77/43mg/Hg, at 9:13 AM the BP was 93/56mg/Hg, and at 10:05 AM the BP was 94/58mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. c. On 06/03/2024 at 6:23 AM it was revealed that the BP was 91/70mg/Hg, at 7:34 AM the BP was 77/43mg/Hg, at 8:31 AM the BP was 91/51mg/Hg, at 8:57 AM the BP was 92/48mg/Hg, and at 9:36 AM the BP was 84/47mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. d. On 06/05/2024 at 7:04 AM it was revealed that the BP was 94/54mg/Hg, at 7:33 AM the BP was 94/43mg/Hg, at 8:05 AM the BP was 83/47mg/Hg, at 8:34 AM the BP was 86/46mg/Hg, at 9:15 AM the BP was 83/55mg/Hg, and at 9:38 AM the BP was 90/52mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. e. On 06/07/2024 at 6:27 AM it was revealed that the BP was 88/64mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. f. On 06/10/2024 at 6:34 AM it was revealed that the BP was 90/48mg/Hg, at 7:01 AM the BP was 82/46mg/Hg, at 7:32 AM the BP was 89/49mg/Hg, at 8:05 AM the BP was 93/52mg/Hg, at 8:40 AM the BP was 81/57mg/Hg, at 9:03 AM the BP was 89/53mg/Hg, at 9:33 AM the BP was 78/46mg/Hg, and at 9:46 AM the BP was 96/50mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 6. RR# 18 is an 82-year-old male patient admitted on 10/13/2023 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 11:39 AM, hemodialysis treatment three a week for three hours, Dialyzer 160NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 62 kilogram (kg). a. On 05/18/2024 at 4:50 PM it was revealed that the BP was 195/87mg/Hg, at 4:51 PM the BP was 222/99mg/Hg, and at 5:03 PM the BP was 94/58mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b. On 05/23/2024 at 4:39 PM it was revealed that the BP was 181/86mg/Hg, and at 4:42 PM the BP was 182/81mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. 7. RR# 19 is a 73-year-old male patient admitted on 08/17/2020 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 8:59 AM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) 66 kilogram (kg). a. On 06/05/2024 at 12:30 PM it was revealed that the BP was 186/86mg/Hg, and at 1:05 PM the BP was 181/85mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. b.On 06/07/2024 at 12:19 PM it was revealed that the BP was 191/83mg/Hg, at 12:20 PM the BP was 182/79mg/Hg, and at 12:32 PM the BP was 187/87mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension. c. On 06/10/2024 at 1:01 PM it was revealed that the BP was 191/89mg/Hg. No evidence was found of the nursing intervention or the documentation for hypertension and hypotension.”

“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: 15884 Based on review of the treatment flowsheets on 06/13/2024 at 1:50 PM it was identified that the facility failed to follow physicians’ orders in the BFR and DFR during the dialysis treatment and documented their intervention in the management of the patients BFR and DFR. This deficient practice is identified in 6 out of 19 records reviewed (RR), (RR#8, #10, #12, RR#15, #18 and #19). Findings include: 1.RR#12 is a 59-year-old male patient admitted to the facility on 05/10/2024 with a diagnosis of End Stage Renal Disease and Diabetes Mellitus. This patient’s hemodialysis treatment order dated 05/23/2024 establishes that this patient must receive treatment by Arterio Venous on Left Upper Arm Fistula with a of BFR 415 and DFR Autoflow 1.5. Review of hemodialysis flowsheet dated 06/06/2024 with the agency Clinical Manager (employee #1) on 06/13/2024 at 2:50 PM evidenced that treatment was given on 06/06/2024 with a BFR of 400 throughout the shift. 2.RR#15 is a 67years-old male patient admitted to the facility on 05/19/2022 with a diagnosis of End Stage Renal Disease and Diabetes Mellitus. This patient’s hemodialysis treatment order dated 04/11/2024 establishes that this patient must receive treatment by Arterio Venous on Left Upper Arm Fistula with a of BFR 350 and DFR of 800. Review of hemodialysis flowsheet dated 05/30/2024 with the agency Clinical Manager (employee #1) on 06/13/2024 at 3:00 PM evidenced that treatment was given on 05/30/2024 with a BFR of 400 throughout the shift. 3. Facility Manager (employee #1), stated in an interview on 06/13/2024 at 3:15 PM that after review of medical record of case #12 and case #15 that she did not find a rationale documented for the change of the BFR on both cases. 4. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change on prescription and parameters administered were not according with the physician order. 47632 5. RR# 8 is a 63-year-old female patient admitted on 06/01/2021 with End Stage Renal Disease. During the record review performed on 06/13/2024 at 3:14 PM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 375, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 62 kilogram (kg). a. On 05/04/2024 at 1:00 PM, 1:37 PM, 2:00 PM, 2:34 PM, 3:00 PM, 3:33 PM, and 3:43 PM the DFR was decreased to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physician. 6. RR# 10 is a 41-year-old male patient admitted on 09/12/2022 with End Stage Renal Disease. During the record review performed on 06/13/2024 at 4:25 PM, hemodialysis treatment three a week for four hours, Dialyzer 200NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 143 kilogram (kg). a. On 05/31/2024 at 7:03 AM, 7:05 AM, 7:38 AM, 8:07 AM, 8:35 AM, 9:01 AM, 9:36 AM, 10:03 AM, 10:35 AM, 11:00 AM and 11:31 AM the DFR was decrease to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physician. 7. RR# 18 is an 82-year-old male patient admitted on 10/13/2023 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 11:39 AM, hemodialysis treatment three a week for three hours, Dialyzer 160NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) 62 kilogram (kg). a. On 05/21/2024 at 11:53 AM, 12:17 PM, 12:44 PM, 1:06 PM, 1:26 PM, 2:04 PM, 2:32 PM, and 2:53 PM the DFR was decrease to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physician. b. On 05/23/2024 at 5:01 PM, 5:32 PM, 6:05 PM, 6:38 PM, 7:03 PM, 7:32 PM, and 7:44 PM the BFR was decrease to 300. No evidence was found of the justification on the nurse note or authorized decrease from the physician. c. On 05/25/2024 at 11:36 AM, 12:03 PM, 12:41 PM, 1:11 PM, 1:25 PM, and 2:04 PM, the BFR was decrease to 300. No evidence was found of the justification on the nurse note or authorized decrease from the physician. d. On 05/28/2024 at 1:01 PM, 1:26 PM, 2:03PM, 2:31PM, and 3:16 PM, the BFR was decrease to 300. No evidence was found of the justification on the nurse note or authorized decrease from the physician. e. On 05/30/2024 at 5:05 PM, 5:42 PM, 5:58 PM, 608 PM, 6:47 PM, and 7:15 PM, the BFR was decrease to 300. No evidence was found of the justification on the nurse note or authorized decrease from the physician. 8. RR# 19 is a 73-year-old male patient admitted on 08/17/2020 with End Stage Renal Disease. During the record review performed on 06/14/2024 at 8:59 AM, hemodialysis treatment three a week for four hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) 66 kilogram (kg). a. On 05/31/2024 at 12:15 PM, 12:17 PM, 12:39 PM, 1:07 PM, 1:30 PM, 2:00 PM, 2:42 PM, 3:01 PM, 3:35 PM and 4:14 PM the BFR was increased to 800. No evidence was found of the justification on the nurse note or authorized increase from the physician. b. On 06/12/2024 at 12:07 PM, 12:45 PM, and 1:17 PM the BFR was increased to 800. No evidence was found of the justification on the nurse note or authorized increase from the physician.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 15884 Based on review of policies and procedures, and interview with facility clinical manager (employee #1), it was determined that the facility failed to ensure that treatment flowsheets include accurate and pertinent documentation related with patient’s ambulation status. This deficiency was identified in 2 out of 19 records reviewed (RR), (RR#3 and RR#14). Findings include: 1.RR#3 is a 62-year-old female patient admitted to the facility on 05/10/2024 with a diagnosis of End Stage Renal Disease and Sickle Cell Anemia. Review of hemodialysis flowsheet dated 05/31/2024 and 06/05/2024 with the agency Clinical Manager (employee #1) on 06/13/2024 at 3:10 PM evidenced that personnel did not document that the standing blood pressure pre and post treatment was taken on 05/31/2024 and 06/05/2024. Nursing personnel document that this patient ambulates without assistance on flowsheets dated 05/31/2024 and 06/05/2024. 2.RR#14 is a 72-year-old female patient admitted to the facility on 05/02/2019 with a diagnosis of End Stage Renal Disease and Diabetes Mellitus. Review of hemodialysis flowsheet dated 06/01/2024 and 06/06/24 with the agency Clinical Manager (employee #1) on 06/13/2024 at 3:20 PM evidenced that personnel did not document that the standing blood pressure pre and post treatment was taken on 06/01/2024 and 06/06/2024. Nursing personnel document that this patient ambulates without assistance on flowsheets dated 06/01/2024 and 06/06/24. 3. Facility Manager (employee #7), stated on interview on 06/13/2024 at 3:30 PM that after review medical record #3 and #14 did not find the rationale or explanation of the reason why the standing blood pressure pre and post treatment was not taken on 05/31/2024 and 06/05/2024 on case RR#3 and on 06/01/2024 and 06/06/2024 on case RR#14. 4. The facility failed to ensure that the medical record includes complete and pertinent information related with the patient’s individual treatment blood pressure and response pre and post hemodialysis treatment.”