Davita Chapel Woods Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 4/30/25 at 12:58 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) finding with the likelihood to cause harm to 10 of 10 hemodialysis patients who were receiving hemodialysis treatment at Station (S) 2 , S6, S7, S9, S10, S12, S13, S14, S16, and S17 who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT BB) observed, who was assigned the task of testing the water quality, failed to perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Regional Operations Manager and the Facility Administrator were informed of the IJ finding on 4/30/25 at 12:58 p.m. The noncompliance related to the IJ was identified to have existed on 4/30/25 at 12:58 p.m. The IJ situation was abated on 4/30/25 at 2:00 p.m., when the facility implemented their “IJ Abatement Plan” that included staff training, return demonstration, successful completion of skills competency checklists, and conducted a Governing Body meeting. The facility also failed to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the machine’s dialysate (dialysis solution) pH (acidity) according to the manufacturer’s DFU and facility P&P. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 67. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT BB) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the machine’s dialysate pH, according to the manufacturer’s DFU and facility P&P.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 50523 Based on a review of medical records, staff interviews, and review of Policy and Procedures (P&P), it was determined that the Interdisciplinary Team (IDT) failed to ensure that one of one patient (P) (P#1) sampled, who presented for hemodialysis treatments with extremely elevated blood pressure (BP) which remained elevated throughout dialysis treatment and at the time of discharge, received medical care/interventions to prevent adverse effects relative to volume status/excess fluid accumulation. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. On 5/1/25 at 2:11 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.90 - Patient Plan of Care, resulted in an Immediate Jeopardy (IJ) with the likelihood to contribute to P#1’s cardiac arrest. The Facility Administrator, Regional Operations Manager, and the Manager of Clinical Services were informed of the IJ finding on 5/1/25 at 2:11 p.m. The noncompliance related to the IJ was identified to have existed on 5/1/25 at 2:11 p.m. The IJ situation was abated on 5/1/25 at 4:50 p.m., when the facility implemented their “IJ Abatement Plan” that included staff training, audits of sample patient charts to ensure that clinical interventions, documentation and MD notifications were made if BP was abnormal, monitoring plan, and a Governing Body meeting was conducted. The facility census was 67. Findings include: Cross References: V 543 - Failure of the IDT to ensure that one of one patient (P#1) sampled, who experienced extremely elevated blood pressure (BP) readings before, during, and after dialysis, received medical care/interventions to prevent adverse effects relative to volume status/excess fluid accumulation.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, a review of records, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 67 patients who dialyzed at this facility. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT BB) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the machine’s dialysate pH, according to the manufacturer’s DFU and facility P&P. V 543 - Failure of the facility to ensure that one of one patient (P#1) sampled, who presented for hemodialysis treatments with extremely elevated blood pressure (BP) which remained elevated throughout dialysis treatment and at the time of discharge, received medical care/interventions to prevent adverse effects relative to volume status/excess fluid accumulation.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 50523 Based on observation, a review of medical records and facility Policy and Procedures (P&P), and staff interviews, it was determined that the Infection Control Committee failed to ensure that two of two Registered Nurses (RN) (RN AA and RN BB) who cared for Hepatitis B (a serious liver infection) Surface Antigen positive (HBsAg+) patient, did not care for Hepatitis B Virus (HBV) susceptible patients at the same time. This failure increased the risk for cross-contamination through transmission of HBV by contact, to six of six susceptible patients (P) (P#3, P#4, P#5, P#6, P#7 and P#8) who were assigned to Stations (S) nearest to Isolation Room (S3, S4, S5 and S6). Findings include: A review of the “Teammate and Patient Schedule” for April 2025 revealed the following: On 4/2/25: - RN AA was assigned to care for patients in Pod 4 (S 3, S4, S5 and S6) on the first shift and second shift. Most of the patients in this pod had a Central Venous Catheter (CVC - A flexible tube inserted into a vein and threaded into a large vein above the right side of the heart) access, which required initiation and termination of dialysis and catheter care by an RN or Licensed Practical Nurse (LPN). - P#3 was assigned to dialyze in S4 on first shift. P#4 and P#5 were assigned to dialyze in S3 and S4 on second shift. All three patients had CVC. - A review of medical records showed P#3, P#4 and P#5 had Hepatitis B Surface Antibody (HBsAb) of < (less than) 4 mIU/mL, indicating susceptibility to HBV. During the same period of hemodialysis treatment, RN AA also provided care to P#2, who was dialyzing in the Isolation Room and had a positive Hepatitis B Surface Antigen (HBsAg) result. P#2 also had a CVC. On 4/4/25, 4/7/25, and 4/25/25: - RN BB was assigned to P#3 and P#6 who dialyzed in S6 and S5 respectively on the first shift. Both patients had CVC. - RN BB was assigned to P#4, P#7, and P#8 who dialyzed in S3, S4, and S5 on the second shift. All three patients had CVC. - A review of medical records showed P#3, P#4, P#6, P#7, and P#8 had HBsAb of < 4 mIU/mL, indicating susceptibility to HBV. During the same period of hemodialysis treatment, RN BB also provided care to P#2 in the Isolation Room. On 4/30/25: - RN AA was the only RN scheduled and had to render care to all scheduled patients with CVC. - P#3 dialyzed on the first shift in S6 and P#4 dialyzed on the second shift in S3. Both patients had CVC’s and were susceptible. RN AA also during the same period of hemodialysis treatment, rendered care to P#2 in the Isolation Room. During an interview on 5/1/25 at 4:53 p.m., the Regional Operations Manager and the Facility Manager were notified and acknowledged the above findings. A review of Policy: 1-05-02 titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” dated April 2024, showed the following: Admission Screening 8. If HBsAb was <10 mIU/mL, a patient is considered susceptible to hepatitis B virus. 21. Teammate Assignment a. Teammates caring for confirmed or suspected hepatitis B surface antigen (HBsAg) positive patient(s) do not care for surface antibody negative (susceptible) patients simultaneously and will only be assigned to care for surface antibody positive (immune) patients.”

“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: 50523 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 4/30/25 at 12:58 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to 10 of 10 hemodialysis patients who were receiving hemodialysis treatment at Stations (S) 2 , S6, S7, S9, S10, S12, S13, S14, S16, and S17 who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT BB) observed, who was assigned the task of testing the water quality, failed to perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of a patient’s red blood cells (hemolysis). The Regional Operations Manager and the Facility Manager were informed of the IJ finding on 4/30/25 at 12:58 p.m. The noncompliance related to the IJ was identified to have existed on 4/30/25 at 12:58 p.m. The IJ situation was abated on 4/30/25 at 2:00 p.m., when the facility implemented their “IJ Abatement Plan” that included staff training, return demonstration, successful completion of skills competency checklists, monitoring plan, and Governing Body Meeting was conducted. The facility census was 67. Findings include: During observation of PCT BB’s performance of the Total Chlorine test on 4/30/25 between 12:04 p.m. and 12:10 p.m., the following was observed: - PCT BB performed the Total Chlorine Test using RPC Ultra Low Total Chlorine Test strip (K100-0118). PCT BB proceeded to collect the sample of water in a 100 milliliter (mL) cup, swished the test strip for 60 seconds and immediately compared the test strip to the color chart. When asked how many seconds was she supposed to wait until comparing test strip to color chart, PCT BB stated “Immediately”. The Charge Nurse/ Registered Nurse (CN/RN AA) who verified the procedure, agreed with PCT BB. A review of the manufacturer’s DFU showed the following: Test Procedure 4) Wait 20 seconds for the test strip color to develop. 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample. A review of Procedure: 1-18-05 titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip” with latest revision date of October 2023 showed the following: 1. Fill the sample cup to the line marked 100 mL with the sample. 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds .... dipping the strip, move it back and forth at a constant gentle rate. 3. Remove the test strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop... 5. After the 20 second wait period, immediately compare strip. The Facility Administrator was notified of the above findings on 4/30/25 at 12:58 p.m. The IJ was abated on 4/30/25 at 2:00 p.m. upon completion of the following: - The Group Facility Administrator immediately began conducting re-education/staff in-service with all Direct Patient Care Staff with a return demonstration, and skills competency checklists on 4/30/25 at 1:00 p.m. - PCT BB as well as RN AA, PCT AA, and PCT CC demonstrated/performed the correct procedure for testing the water for Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100-0118 according to the manufacturer’s DFU and facility P&P specifically, waiting 20 seconds for the color to develop before comparing the test strip to the color chart and obtained results of 0.1ppm (parts per million) total chlorine in water used for dialysis. Thus, the water was determined to be safe for dialysis. - The Governing Body meeting was conducted and approved by the Facility Administrator, Regional Operations Director, and Medical Director. - Audits of staff performing chlorine testing was conducted and will be ongoing.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 50523 Based on observation, staff interviews, and a review of records, it was determined that the facility failed to ensure that there was a safe environment for 10 of 10 patients who were receiving hemodialysis treatment [at Station (S) 2, S6, S7, S9, S10, S12, S13, S14, S16, and S17] at the time of this observation, as evidenced by failure of three of three Patient Care Technicians (PCT) (PCT AA, PCT BB and PCT CC) observed, to correctly verify the hemodialysis machine’s dialysate (dialysis solution) pH (acidity), according to the manufacturer’s Directions for Use (DFU) and facility Policy and Procedures. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 67. Findings include: During observation in the Patient Treatment Room on 4/30/25 between 10:01 a.m. and 12:00 p.m., the following was revealed: - PCT CC was observed while she verified the machine’s final dialysate pH at S2. PCT CC swished the test strip (RPC E-Z Chek K100-0117CT - 6.8 - 8.5 Test Strip) in the sample for 17 seconds without looking at a clock and immediately compared the test strip to the color chart. During an interview on 4/30/25 at 10:55 a.m., PCT CC stated she usually checks the machine’s pH by swishing the test strip in the sample for 15 seconds while counting in her head and then immediately compares it to the color chart. - PCT AA was observed initiating dialysis treatment on a patient at S9. PCT AA did not verify the final dialysate pH prior to the initiation of dialysis. During an interview on 4/30/25 at 11:40 a.m., PCT AA stated she forgot to check the pH at S9 before initiating the patient’s treatment. - PCT BB was observed while she checked the dialysate pH at S12. PCT BB dipped the test strip in the sample and compared the test strip to color chart after 15 seconds. During an interview on 4/30/25 at 12:00 p.m., PCT BB stated she always dips the test strip in the sample and then wait for 15 seconds while looking at the clock before comparing it to color chart. The Facility Administrator was notified of the above findings on 4/30/25 at 12:58 p.m. A review of “Fresenius Medical Care 2008T Hemodialysis Machine Operator’s Manual” showed the following DFU: Page 75 - Recirculation and Final Set-Up Procedure 2. Check the conductivity and pH of the dialysate... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If conductivity and pH are not within these limits, do not initiate dialysis. A review of facility Procedure: 1-21-09 titled, “Testing pH for Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips” with the latest revision date of February 2024 showed the following: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart.”

“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: 50523 Based on a review of medical records, staff interviews, and review of Policy and Procedures (P&P), it was determined that the Interdisciplinary Team failed to ensure that one of one patient (P) (P#1) sampled, who presented for hemodialysis treatments with extremely elevated blood pressure (BP) which remained elevated throughout dialysis treatment and at the time of discharge, received medical care/interventions to prevent adverse effects relative to volume status/excess fluid accumulation. P#1’s last hemodialysis treatment was initiated with a BP of 190/134 mmHg (millimeters of mercury) and was discharged home from this facility with a BP of 225/133 mmHg. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg before dialysis and below 130/80 mmHg after dialysis. This was according to the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services - Version 2.5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. On 5/1/25 at 2:11 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.90 - Patient Plan of Care, resulted in an Immediate Jeopardy (IJ) with the likelihood to contribute to P#1’s cardiac arrest. The Facility Administrator, Regional Operations Manager, and the Manager of Clinical Services were informed of the IJ finding on 5/1/25 at 2:11 p.m. The noncompliance related to the IJ was identified to have existed on 5/1/25 at 2:11 p.m. The IJ situation was abated on 5/1/25 at 4:50 p.m., when the facility implemented their “IJ Abatement Plan” that included staff training, audits of sample patient charts to ensure that clinical interventions, documentation and MD notifications were made if BP was abnormal, monitoring plan, and a Governing Body meeting was conducted. The facility census was 67. Findings include: A review of the “Treatment Details Report” dated 3/7/25 - 4/2/25 showed the following: P#1 had an order for clonidine (medication used to treat high BP) 0.1mg (milligram) by mouth as needed. The order did not include parameters. On 3/7/25: - P#1’s BP was 200/120 mmHg during initiation of dialysis treatment at 10:58 a.m. - At 11:27 a.m., P#1’s BP was 186/116 mmHg. - At 11:56 a.m., P#1’s BP was 192/111 mmHg. - At 12:26 p.m., P#1’s BP was 180/106 mmHg. - At 12:28 p.m., P#1’s BP was 172/106 mmHg. - At 12:56 p.m., P#1’s BP was 169/109 mmHg. - At 13:26 p.m., P#1’s BP was 173/109 mmHg. - At 13:56 p.m., P#1’s BP was 177/108 mmHg. -P#1 was discharged home with a BP of 177/108 mmHg and was 1.4 kg (kilogram) over her target weight (estimated dry weight of 47.5 kg). The Physician Assistant (PA) was made aware of the elevated BP reading during the initiation of treatment and clonidine 0.1mg was administered. There was no documentary evidence that the PA nor the physician/Medical Director (MD) was notified that P#1’s BP remained elevated throughout dialysis and after treatment. On 3/11/25: - P#1’s BP was 211/120 mmHg during initiation of dialysis treatment at 12:14 p.m. - At 12:17 p.m., P#1’s BP was 204/127 mmHg. - At 12:44 p.m., P#1’s BP was 187/112 mmHg. - At 13:14 p.m., P#1’s BP was 185/110 mmHg. - At 13:44 p.m., P#1’s BP was 189/105 mmHg. - At 14:14 p.m., P#1’s BP was 189/115 mmHg. - At 14:33 p.m., P#1’s BP was 198/121 mmHg. - At 14:37 p.m., P#1’s BP was 200/119 mmHg. - P#1 was discharged home with a BP of 200/119 mmHg and was 3.9 kg over her target weight. It was documented at 16:01 p.m., that P#1 refused the offer of 0.1mg clonidine. There was no documentary evidence that the MD nor the PA was notified of P#1’s extremely elevated BP readings before, during, and after dialysis treatment. On 3/14/25: - P#1’s BP was 209/114 mmHg during initiation of dialysis treatment at 10:59 a.m. - At 11:30 a.m., P#1’s BP was 178/97 mmHg. - At 11:59 a.m., P#1’s BP was 185/102 mmHg. - At 12:29 p.m., P#1’s BP was 187/100 mmHg. - At 12:59 p.m., P#1’s BP was 205/110 mmHg. - At 13:29 p.m., P#1’s BP was 204/114 mmHg. - At 14:00 p.m., P#1’s BP was 210/101 mmHg. - P#1 was discharged home with a BP of 210/101 mmHg and was 5.5 kg over her dry weight. It was documented at 12:29 p.m., that P#1 accepted the offer of 0.1mg clonidine. However, P#1’s BP remained extremely elevated throughout dialysis and after treatment. There was no documentary evidence that the MD nor the PA was notified of P#1’s persistently elevated BP readings and the post dialysis weight of 5.5 kg over her dry weight. P#1 had 12.13 lbs. (pounds) of excess fluid in her body. On 3/18/25: - P#1’s BP was 207/123 mmHg during initiation of dialysis treatment at 9:32 a.m. - At 10:03 a.m., P#1’s BP was 221/123 mmHg. - At 10:33 a.m., P#1’s BP was 228/118 mmHg. - At 10:39 a.m., P#1’s BP was 223/125 mmHg. - At 10:41 p.m., P#1’s BP was 197/115 mmHg. - P#1 was discharged home with a BP of 197/115 mmHg and was 7.8 kg (17.2 lbs.) over her target weight. It was documented at 10:49 a.m. that P#1 refused the offer of 0.1mg clonidine. There was documentation that showed MD adjusted and reviewed the hypertensive (high BP) medication plan with P#1 on 3/18/25. However, there was no documented reason for the early termination of P#1’s dialysis treatment. On 3/22/25: - P#1’s BP was 204/126 mmHg during initiation of dialysis treatment at 11:18 a.m. - At 11:19 a.m., P#1’s BP was 199/118 mmHg. - At 11:49 a.m., P#1’s BP was 195/116 mmHg. - At 12:19 p.m., P#1’s BP was 191/114 mmHg. - At 12:48 p.m., P#1’s BP was 194/119 mmHg. - At 13:19 p.m., P#1’s BP was 207/121 mmHg. - At 13:30 p.m., P#1’s BP was 198/116 mmHg. - At 13:49 p.m., P#1 BP was 202/126 mmHg. - At 14:07 p.m., P#1 BP was 211/130 mmHg. - At 14:10 p.m., P#1 BP was 216/118 mmHg. - P#1 was discharged home with a BP of 216/118 mmHg and was 4.5 kg over her target weight. It was documented at 14:25 p.m. that P#1 refused the offer of 0.1mg clonidine. There was no documentary evidence that the MD nor the PA was notified of P#1’s persistent and extremely high BP readings. On 4/2/25: - P#1’s BP was 198/134 mmHg during initiation of dialysis treatment at 11:28 a.m. - At 12:01 p.m., P#1’s BP was 241/133 mmHg. - At 12:31 p.m., P#1’s BP was 222/118 mmHg. - At 13:00 p.m., P#1’s BP was 236/130 mmHg. - At 13:31 p.m., P#1’s BP was 198/156 mmHg. - At 14:01 p.m., P#1’s BP was 225/133 mmHg. - P#1 was discharged home with a BP of 225/133 mmHg and was 6.3 kg over her target weight. P#1 had 13.86 lbs. of excess fluid in her body. There was a lack of documented clinical interventions that addressed P#1’s volume status before, during, and after dialysis treatment. There was no documentary evidence that the MD nor the PA was notified of P#1’s extremely elevated BP readings and of P#1’s weight after treatment. A review of P#1’s “Treatment Details Report” and “Hospital Admission Records” dated 3/23/25 and 4/2/25 revealed the following: - P#1 received hemodialysis treatment at this facility on 3/22/25 and was discharged home with a BP of 216/118 mmHg. P#1 presented to the hospital on 3/23/25 and complained of chest pain, palpitations, nausea and vomiting. P#1 was hospitalized for management of hypertensive urgency and acute right lower extremity pain. P#1 was discharged from the hospital on 3/29/25. - P#1 received hemodialysis treatment at this facility on 4/2/25 and was discharged home at 2:01 p.m. with a BP of 225/133 mmHg. Later that day, at 5:22 p.m., P#1 presented to the Emergency Department with a primary diagnosis of cardiac arrest. P#1 was pronounced expired on 4/3/25 at 11:27 a.m. During an interview on 5/1/25 at 10:03 a.m., Registered Nurse (RN) DD stated that when a patient presents with an abnormal BP, RNs are required to notify the patient’s provider for further instructions. RN BB stated that the provider is responsible for determining whether the patient should proceed with dialysis or be referred to the Emergency Room. During a telephonic interview with the MD on 5/1/25 at 10:35 a.m., she confirmed what RN BB stated above regarding the RNs responsibility and obligation on addressing abnormal BP readings. The MD stated she wasn’t notified by the facility regarding P#1’s abnormal BP readings pre, intra or post hemodialysis treatment. The MD also stated she recommended that patients with a systolic (top number) pressure over 200 mmHg before or after treatment, be sent out by EMS (Emergency Medical Services) to the Emergency Room for further evaluation. On 5/1/25 at 12:55 p.m., RN CC stated when a patient’s BP is evaluated outside of normal range, he offers PRN (as needed) 0.1mg clonidine and contacts the patient’s provider. During a telephonic interview with the PA on 5/1/25 at 1:50 pm., she agreed with the MD and confirmed that the facility has never called her pertaining to P#1’s abnormal BP readings pre and post hemodialysis treatment. The PA stated when she rounded at the facility, she observed and addressed P#1’s elevated BP while receiving dialysis. A review of Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” dated April 2024 showed the following: Pre-Treatment Data Collection/Assessment Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment collection will be documented and immediately reported to the licensed nurse. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. Abnormal Findings: Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic (bottom number) greater than or equal to 100 mmHg Blood pressure - Intradialytic: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic greater than or equal to 100 mmHg or less than 50 mmHg Blood Pressure Post Treatment: - If the patient can stand: o Standing systolic BP greater than 140 mmHg or less than 90 mmHg o Standing diastolic BP greater than 90 mmHg or less than 50 mmHg If the patient is not able to stand, document reason and sitting BP: Sitting BP for patients that cannot stand: o Sitting systolic BP greater than 140 mmHg or less than 90 mmHg o Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg Heart or Pulse Rate Pre/Intra/Post: - Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat. The IJ was abated on 5/1/25 at 4:50 p.m., upon completion of the following: - The Manager of Clinical Services conducted re-education/staff in-service with all Direct Patient Care Staff on 5/1/25. The education included but was not limited to Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”. - Monitoring plan was started, and medical record audits will be ongoing to sustain compliance. - The Governing Body meeting was conducted on 5/1/25 and was approved by the Facility Administrator, Regional Operations Director, and Medical Director. .”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50523 Based on a review of medical records and facility Policy and Procedures (P&P) and staff interview, it was determined that the Medical Director failed to ensure that all Direct Patient Care Staff (Nurses and Patient Care Technicians) adhered to facility P&P relative to Refusal of Care/Treatment Against Medical Advice (AMA) for one of one patient (P) (P#2) sampled. The facility had 67 in-center hemodialysis patients. Findings include: - A review of P#2’s “Treatment Details Report” from February 2025 to April 2025 showed P#2’s prescribed hemodialysis treatment time (duration), was three hours and 30 minutes, three times a week. - On 3/3/25, P#2 dialyzed for three hours and nine minutes and on 4/28/25, P#1’s hemodialysis treatment duration was three hours and 17 minutes. P#2’s hemodialysis treatment was ended early due to “Patient Choice”. There was a lack of documented reasons for P#2’s refusal to complete his prescribed dialysis treatment on 3/3/25 and 4/28/25. - A review of facility Policy: 1-01-10 titled, “Refusal of Care/ Treatment Against Medical Advice” with the latest revision date of October 2022 showed the following: 2. If a patient refuses care/treatment, the RN will document the event in the patient’s medical record. Documentation will include, as appropriate, the following: - A description of the care/ treatment that was refused by the patient; - The patient’s stated reason for refusing care/ treatment ... - A description of all other interventions planned to address the patient’s refusal of care/ treatment, including recommendations to the patient; and - A copy of the refusal of care/ treatment Against Medical Advice form signed by the patient. During an interview on 5/1/25 at 4:59 p.m., the Facility Administrator stated that staff will be informed and an inservice will be conducted regarding proper documentation on AMA.”