Usrc Alvin Dialysis

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 48020 Based on observation, record review, and interview, the facility’s governing body failed to ensure all direct care staff complete the annual competencies in 2 of 3 direct care personnel files reviewed: Patient Care Technician (D), (E) Findings: Review of the facility’s current policy and procedure: Schedule of Competency Completion: policy # EO-9001 directs the staff as follows: “PURPOSE: To provide guidance for employees’ initial and annual skills competency completion. POLICY: 1. The Facility Administrator (FA) or Senior Management will ensure each employee’s record, including float and PRN staff, contain the required completed education and competencies within the designated time frames. 2. An audit of each employee’s record will be performed at least by annually per the quality management workbook schedule or more frequently as needed. 3. Follow local or state requirements where applicable ... 4. All compliance and regulatory training will be assigned via the learning management system (LMS). Required clinical courses and competency exams will be assigned to all new hires and annually according to the LMS Course Release Schedule posted on the Portal.” Patient Care Technician (D) Patient Care Technician (D) was observed on the treatment floor of the facility on 06/09/2025 providing care and services to patients, i.e., cannulating patients’ vascular accesses and administering Heparin and Normal Saline to patients. Review of Patient Care Technician (D’s) personnel file revealed she was hired to the facility on 05/15/2023. The most current Hemodialysis Knowledge Exam - Annual on file was dated 05/08/2024. The most current Water and Dialysate Quality Control Testing - Annual on file was dated 05/06/2024. Both competency examinations were expired and do not meet the requirements of the facility’s policy. Patient Care Technician (E) Patient Care Technician (E) was observed on the treatment floor of the facility on 06/09/2025 providing care and services to patients, i.e., cannulating patients’ vascular accesses and administering Heparin and Normal Saline to patients. Review of Patient Care Technician (D’s) personnel file revealed she was hired to the facility on 04/29/2024. The most current Hemodialysis Knowledge Exam - Annual on file was dated 05/08/2024. The most current Water and Dialysate Quality Control Testing - Annual on file was dated 05/06/2024. Both competency examinations were expired and do not meet the requirements of the facility’s policy. Interview with Clinical Specialist (L) on 06/09/2025 at 12:00 p.m. confirmed the expired competency exams.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s governing body failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients per policy. Observation of Patient #2 during peritoneal dialysis training revealed a bag of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2000 mL had an expiration date of July 2024. Observation during a tour of the facility on 04/28/2025 - 04/30/2025 revealed expired supplies and medications were co-mingled with stocks in use in the: a. Treatment Area b. Medication Prep Area c. PD Supply Storage Rack outside of training room d. Inventory Room e. Peritoneal Dialysis Office Cross Reference V715”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility governing body failed to ensure all staff participated in quarterly fire drill in the facility in 1 of 6 staff files reviewed: Peritoneal Dialysis Registered Nurse (G) Findings: Review of the facility’s current policy and procedure: Fire Prevention and Fire Drills (Policy # C-EM-0011) directs the staff as follows: “POLICY: 3. Fire Drills: will be conducted every 3 months and documentation of the drill will be recorded on C-FORMS-0480 Fire Drill Report. Documentation and assessment will provide information on steps that need practice and improvement for increased staff and patient safety.” Peritoneal Dialysis Registered Nurse (G) On 04/29/2025 and 04/30/2025, Peritoneal Dialysis Registered Nurse (G) was observed training a peritoneal dialysis patient in the training room. Peritoneal Dialysis Registered Nurse (G’s) personnel and training record revealed no documentation that Peritoneal Dialysis Registered Nurse (G) participated in facility’s quarterly fire drills. Review of the C-FORMS-0480 Fire Drill Report revealed fire drills were held at the facility on 01/17/2025 and 04/02/2025. The reports did not include Peritoneal Dialysis Registered Nurse (G’s) signature. Interview with Peritoneal Dialysis Registered Nurse (G) on 04/30/2025 10:09 a.m. revealed that she said “No, I have not participated in the fire drill recently.” On 04/30/2025 the Surveyor notified the Facility’s Administrator that there was no documentation that Peritoneal Dialysis Registered Nurse (G) participated in quarterly fire drills. No evidence was provided.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility failed to ensure patient’s nephrologist round and assess patients every two weeks in 2 of 7 sampled patients: Patient #s 1, 4 Findings: Patient #1 Observation on 04/28/2025 at 7:50 a.m. revealed Patient #1 was seated at station #3 machine #4 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 700 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 04/29/2025 revealed the physician documented a visit while the patient was on hemodialysis on 02/14/2025, 02/28/2025, 03/05/2025, 04/04/2025, 04/11/2025 and 04/28/2025. There was no documented physician progress note every two weeks as required by the state regulations. Patient #4 Review of the patient’s clinical record on 04/29/2025 revealed the patient was admitted to the facility 04/10/2024 with the diagnoses of end stage renal disease and polycystic kidney disease, on hemodialysis three times a week. The record revealed the physician documented a visit while the patient was on hemodialysis on 01/27/2025, 03/21/2025, 04/04/2025 and 04/28/2025. There was no documented physician progress note every two weeks as required by the state regulations. Interview during record review with Facility Administrator (B) and Clinical Specialist (K) on 04/29/2025 confirmed Patient #s 1 and 4 did not have a documented physician progress note every two weeks as required.”

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to wash/sanitize hands after removal of contaminated gloves in 1 of 2 staff observed: Patient Care Technician (D) and Random Patient #5 Findings: Review of the facility’s current policy and procedure: Infection Control and Precautions for All Patients (policy # C-IC-0010) directs the staff as follows: “PROCEDURE 10. Hand Hygiene: Refer to policy C-IC-0060 Hand Hygiene a. Patient and visitors must perform hand hygiene before and after entering patient treatment area and after removal of PPE, if applicable. If patient is unable to perform independently, staff will assist.” Patient Care Technician (D) Random Patient #5 Observation on 04/28/2025 at 11:10 a.m., revealed Random Patient #5 holding her vascular access with a gloved hand at station #6. After the bleeding ceased, Patient Care Technician (D) taped the patient’s vascular access site and the patient removed her glove. The patient picked up her belongings, she was weighed by Patient Care Technician (D), and she left the treatment floor without washing/sanitizing her hands. The Surveyor notified Patient Care Technician (D) at 10:21 a.m. that the patient did not washed/sanitized his hands after removal of the contaminated glove she used to hold her vascular access site. Patient Care Technician (D) said, “Okay.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by storing a biohazard waste receptacle next to the Hoyer Lift. Findings: Review of the facility’s current policy and procedure: Infection Control and Precautions for All Patients (policy # C-IC-0010) directs the staff as follows: “PROCEDURE 3. Clean areas will be clearly designated and separated from contaminated areas and unused supplies and equipment.” Hoyer Lift Observation of the hemodialysis treatment area on 04/28/2025 at 11:32 a.m. revealed a biohazard waste receptacle stored next to the Hoyer Lift outside of the isolation room. Subsequent observation during shift changeover revealed Patient Care Technician (F) repeatedly remove his gloves, use the foot lever to open the biohazard waste receptacle and throw his gloves into the receptacle. On the last occasion, the lid of the biohazard waste receptacle became hung up on the foam covered handle of the Hoyer Lift and the lid did not drop down over the receptacle once the foot lever was released. Interview with the Patient Care Technician (F) during the observation confirmed the above findings.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 1 of 7 sampled patients: Patient #4 Findings: Review of the facility’s current policy and procedure: Initiation of Dialysis Treatment (policy # C-TI-0010) directs the staff as follows: “POLICY ... 5. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: d. Correct prescription (e.g., dialyzer, acid concentrate, bicarbonate, sodium, temperature, heparin (if ordered), and any Special Instructions (if applicable) ... PROCEDURE ... 13. Prior to walking away from patient’s dialysis machine, verify all prescribed orders are followed ... Prescription orders and safety measures include, but are not limited to verifying the following ... c. Correct dialysate flow rate” Patient #4 Review of the patient’s clinical record on 04/29/2025 revealed the patient was admitted to the facility 04/10/2024 with the diagnoses of end stage renal disease and polycystic kidney disease, on hemodialysis three times a week. Machine Settings Dialysate Flow Rate: Review of the patient’s treatment sheet dated 04/18/2025 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 800 mL/min on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 600 mL/min from 14:01 p.m. - 17:59 p.m. There was no justification documented for the dialysate flow rate of 600 mL/min. Review of the patient’s treatment sheet dated 04/14/2025 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 800 mL/min on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 11:47 a.m. - 15:50 p.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Interview during record review with Facility Administrator (B) and Clinical Specialist (K) on 04/29/2025 confirmed Patient #4 did not receive the hemodialysis treatment according to the physician’s orders for the dates in question.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility failed to ensure patient’s nephrologist round and assess patients monthly in 1 of 7 sampled patients: Patient #4 Findings: Patient #4 Review of the patient’s clinical record on 04/29/2025 revealed the patient was admitted to the facility 04/10/2024 with the diagnoses of end stage renal disease and polycystic kidney disease, on hemodialysis three times a week. The record revealed the physician documented a visit on 01/27/2025, 03/21/2025, 04/04/2025 and 04/28/2025. There was no documented monthly physician progress note for the month of February 2025. Interview during record review with Facility Administrator (B) and Clinical Specialist (K) on 04/29/2025 confirmed Patient #4 did not have a documented physician progress note for the month of February 2025.”

“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: 48020 Based on observation, record review and interview: the facility’s governing body failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients per policy. B) the facility’s registered nurses failed to conduct post treatment assessments prior to discharging the patients per the facility’s policy in 3 of 5 sampled in-center hemodialysis patients: Patient #s Patient #s 1, 2, 3 Findings: Expired Supplies Review of the facility’s current policy and procedure: Baxter Ultrabag Exchange Procedure (policy # HT-PP-0160) directs the staff as follows: PROCEDURE: PREPARATION 5. Inspect solution bag according to SEAL: Strength, Expiration, Amount, Leaks Review of the facility’s current policy and procedure: Facility Space/Design and Safety Requirements (policy # C-AD-0380) directs the staff as follows: POLICY: 16. Ensure all supplies, medications and testing strips are checked at least monthly for expiration. If medication/supply only gives the month and year for expiration date, item is good until the end of the month (e.g., 04/2023). Expired items will be discarded appropriately prior to or day of expiration. Review of the facility’s current policy and procedure: Emergency Evacuation (policy # C-EM-0010) directs the staff as follows: POLICY: 5. Emergency Evacuation Kits/Boxes: a. Each facility will have evacuation kits/boxes with emergency supplies which are: iii. Checked monthly for expiration dates and documented on C-EM-0014a Emergency Evacuation Supply checklist. Checklists will be filed and kept on site for one year ... c. Contents of emergency evacuation kits/boxes should match the contents listed on C-EM-0014a Emergency Evacuation Supply Checklist. Expired Supplies Peritoneal Dialysis Training Room Patient #7 Observation on 04/29/2025 at 10:20 a.m. revealed Patient #2 was seated in the dialysis chair receiving peritoneal dialysis training instructions from Peritoneal Dialysis Registered Nurse (G). There were two bags of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2000 mL on the table. Peritoneal Dialysis Registered Nurse (G) picked up the opened bag of Dianeal that had been warmed in preparation to be infused into the patient. Peritoneal Dialysis Registered Nurse (G) checked the temperature of the Dianeal bag and it had not reached the required temperature of 96.8F - 98.6F and needed to be taken back to the warmer. Before taking the Dianeal bag to the warmer, Peritoneal Dialysis Registered Nurse (G) decided to teach the patient how to inspect the Dianeal bag by the use of the acronym SEAL: Strength, Expiration, Amount, Leaks. During inspection of the Dianeal bag, it was discovered that the Dianeal had an expiration date of July 2024. Observation of the unopened bag of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2000 mL had an expiration date of 2025/12. Immediate interview with Peritoneal Dialysis Registered Nurse (G) in the peritoneal dialysis supply room revealed her to say, “I don’t know how this bag got in here? Maybe during the shortage when they asks patients to bring back supplies otherwise there are none that say 2024. Observation of the peritoneal dialysis supply room during the interview revealed no other bags were expired. The opened box of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2000 mL had an expiration date of 2025/12. Treatment Area Observation of the hemodialysis treatment area on 04/28/2025 beginning at 08:17 a.m. revealed the following expired supplies were co-mingled with stocks in use: Emergency cart: Top of emergency cart: 1 - Bemis High Flow Solo 800 cc suction canister attached to the suction machine, Ref# 8002 055, expiration date 2024-07-01 Drawer 1: 1- Nitrostat 0.4 mg/tablet opened bottle, Lot# FX2968, expiration date 2023-10-31 1 - Med Stream Dressing Change Tray, Lot# 213077767, expiration date 02 25 (02/2025) Emergency evacuation kits/box: 10 - Elcam Medical bloodline recirculators, Lot# 2200042, expiration date 2025-03-31 12 rolls - Micropore Plus paper tape, Lot# 104295617, expiration date 2025-02-03 Interview with Charge Nurse (C) on 04/28/2025 at 8:50 a.m. confirmed that she is responsible for checking the emergency cart and evacuation kit each month. She said, “I did not know that I missed Nitrostat.” Subsequent interview at 8:53 revealed Charge Nurse (C) to say, “Nitro is not on the list and that’s why I am missing it. I have some in the drawer (pointing to Med Prep area) that I give patients.” Clean supply drawers along the perimeter of the nursing station: Subsequent observation of the hemodialysis treatment area on 04/28/2025 at 10:45 a.m. revealed the following expired supplies were co-mingled with stocks in use: Bay 1: 7 - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets 14GX1”, Lot# 220112F2, expiration date 2025-01-31 Bay 2: 8 - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets 14GX1”, Lot# 220112F2, expiration date 2025-01-31 Bay 3: 6 - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets 14GX1”, Lot# 220112F2, expiration date 2025-01-31 Interview with Patient Care Technician (E) at 10:54 a.m. confirmed the direct care staff are responsible for stocking the fistula needles in the drawers. When Patient Care Technician (E) was notified that all 14 gauge fistula needles were expired in the drawers in the treatment area she said, “We stock the needles but we do not recheck the expiration dates once they have been put on the shelf in the supply room. The expiration date should have been checked before the supplies are put on the shelf in the back.” Patient Care Technician (E) also confirmed that Patient #4 is cannulated with 14 gauge fistula needles for his hemodialysis treatments. Medication Prep Area Observation of the medication prep area on 04/28/2025 at 8:58 a.m. revealed the following expired medication were co-mingled with medications in use: 50 vials - Ceftazidime injection, USP 1 gram per vial, Lot # 110740C, expiration date 03 25 (03/2025) 9 tubes - Insta Glucose, Lot # 021301, expiration date 02/2025 25 vials - Lidocaine Hydrochloride Injection, USP 1%, Lot # HC92580, expiration date 01 MAR 2025 4 bottles - Auryxia 210 mg tablets, quantity 25 tablets/bottle, Lot # AU5671, expiration date 02/2025 Interview during observation with Charge Nurse (C) revealed the Auryxia bottles are sample bottles distributed by the physicians and not by the registered nurses. PD Supply Storage Rack outside of training room Observation of the inventory room on 04/28/2025 at 9:53 a.m. revealed the following expired supplies were co-mingled with stocks in use: 17 - K-Shield Winged Collection sets 23Gx19mm, Lot # 220216P4, expiration date 2025-01-31 Inventory Room Observation of the inventory room on 04/28/2025 at 10:05 a.m. revealed the following expired supplies were co-mingled with stocks in use: 1 box (250 count) - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets, 17GX1”, Lot# 2211026F10, expiration date 2024-10-31 1 box (250 count) - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets, 17GX1”, Lot# 220029F8, expiration date 2025-01-31 60 - NxStage Master Guard Plus TwinPack+ Hemodialysis Fistula Needle Sets 14GX1”, Lot# 220112F2, expiration date 2025-01-31 1 - Nipro SafeTouch Tulip Safety Fistula Needle 17GX1.5”, Lot# 19C30D, expiration date 2024-02-28 1 box (100 count) - RPC bloodline recirculators, Lot # 2200032, expiration date 2025-03-17 52 - RPC bloodline recirculators, Lot # 2200044, expiration date 2025-03-31 7 - BD Vacutainer UA Preservative Tube, Ref# 364992, expiration date 2025-03-31 Walkthrough and interview on 04/28/2025 with Clinical Specialist (K) confirmed the findings above. Peritoneal Dialysis Office Observation of the peritoneal dialysis office on 04/30/2025 at 10:20 a.m. revealed the following expired supplies were co-mingled with stocks in use: Emergency evacuation kits/box: 1 bottle - Heparin Sodium Injection, USP 30,000 USP units per 30 mL, Lot# A6C0210M, expiration date 12/2024 Emergency cart: 1 - Bemis Hydrophobic 800 cc suction canister in the bottom drawer, Ref# 424410, expiration date 2021-07-01 Interview with Clinical Specialist (K) on 04/30/2025 at 10:31 a.m. verified the above findings. Post Assessments Review of the facility’s current policy and procedure: Post Dialysis Assessment (policy # C-TP-0060) directs the staff as follows: PURPOSE: To assess the patient post treatment and address any identified issues prior to discharging patient. ASSESSMENT: 1. Post dialysis patient assessment includes but is not limited to: a. Vital signs - blood pressure sitting and standing, pulse rate and rhythm, temperature, respirations rate and quality ... d. Sense of well-being e. Mental status ... g. Other conditions or complications Review of the facility’s current policy and procedure: Intradialytic Monitoring of Patient (policy # C-ID-0010) directs the staff as follows: MONITORING Direct care staff will monitor the following parameters during each dialysis treatment: PATIENT: 2. Vital signs: Obtained and documented at least every 30 minutes and reported to charge nurse if outside of standing orders and /or reportable parameters, refer to C-FORMS-0081 Reportable Parameters to CN. 3. Volume status: Indicated by changes in BP and HR parameters, lung sounds and presence or reduction of edema ... INTERVENTION: 2. RN may adjust the treatment plan based on the patient’s response, which must be documented and charge nurse notified. Review of the facility’s Reportable Parameters to Charge Nurse directs the staff as follows: PCT/CCHT/LPN: Report to Charge Nurse: PRE-DIALYSIS, INTRA-DIALYSIS, POST-DIALYSIS Pulse <50 or > 120 beats per minute Post Assessments Patient #1 Observation on 04/28/2025 at 7:50 a.m. revealed Patient #1 was seated at station #3 machine #4 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 700 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 04/29/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 04/23/2025 revealed the following documentation: 6:22 a.m.: documented pre-treatment blood pressure of 117/62 mmHg and pulse rate of 45 beats per minute - registered nurse documented “heart rate 45/mt ... patient denies any c/o and verbalized he did take clonidine this morning ... DR.__ informed pre tx and tx started as per his order with decreased machine temp (temperature) to 35.5 and given O2 2L/mt to this patient ... will monitor closely 6:28 a.m.: documented blood pressure of 115/60 mmHg and pulse rate of 44 beats per minute - patient care technician documented “ treatment started without problems ...” 6:29 a.m.: documented blood pressure of 115/63 mmHg and pulse rate of 44 beats per minute - registered nurse documented “Patient still has bradycardia with out any symptoms ... will monitor” 7:00 a.m.: documented blood pressure of 125/72 mmHg and pulse rate of 46 beats per minute - vital signs were signed off by patient care technician 07:30 a.m.: documented blood pressure of 122/64 mmHg and pulse rate of 46 beats per minute - vital signs were signed off by patient care technician 08:02 a.m.: documented blood pressure of 123/71 mmHg and pulse rate of 48 beats per minute - vital signs were signed off by patient care technician 08:30 a.m.: documented blood pressure of 125/69 mmHg and pulse rate of 47 beats per minute - vital signs were signed off by patient care technician 09:00 a.m.: documented blood pressure of 130/72 mmHg and pulse rate of 50 beats per minute - vital signs were signed off by patient care technician 09:28 a.m.: documented blood pressure of 137/67 mmHg and pulse rate of 51 beats per minute - patient care technician documented “Treatment completed ...” 18:43 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Ambulatory LOC (Level of Consciousness): Alert CVS (Cardiovascular System): Regular Lung Sounds: Clear Edema: None Notes: Heart rate was on low side throughout the tx without any symptoms 46/mt, 48/mt, 45/mt and as per Dr.__ UF (ultrafiltration) was on throughout the tx ... MD seen this patient during today’s tx ...heart rate got better post tx, 52/mt (minute) ...denies any other c/o post tx ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” The patient’s treatment ended at 9:28 AM and the post assessment was documented at 18:43 PM. The RN did not conduct the post assessment prior to the patient being discharged. Patient #2 Observation on 04/28/2025 at 7:58 a.m. revealed Patient #2 was seated at station #6 machine #10 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 04/29/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 04/28/2025 revealed the following documentation: 06:54 p.m.: registered nurse documented the pre-treatment assessment which revealed Mode Admit: Wheelchair LOC: Alert CVS: Regular Lung Sounds: Other - Diminished on bases Edema: Facial (Trace), Abdominal (+1) Notes: aaox3 ...no sob or chest pain reported ...no s/s of access infection ...set uf goal for 3.4 kg as tolerated ...educated the importance of fluid management ...will monitor closely 7:05 a.m.: documented blood pressure of 185/97 mmHg and pulse rate of 71 beats per minute 07:39 a.m.: documented blood pressure of 111/73 mmHg and pulse rate of 73 beats per minute - patient care technician documented “Patient resting and eyes closed ...” 07:51 a.m.: documented blood pressure of 94/54 mmHg and pulse rate of 73 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 07:54 a.m.: documented blood pressure of 105/61 mmHg and pulse rate of 76 beats per minute - registered nurse documented “bp trending down ...patient denies any symptoms ...UF turned off now ...given 5 mg midodrine to stabilize bp ...will monitor closely” 07:54 AM - 9:08 AM Ultrafiltration remained off 09:08 a.m.: documented blood pressure of 105/69 mmHg and pulse rate of 75 beats per minute - patient care technician documented “Patient tolerating treatment well. Sitting in chair with feet elevated and back of chair reclined. Access visualized and no problems noted. Machine/Lines checked. Respirations regular. UF goal at 2200.” The registered nurse was not notified of the change in UF goal. 09:40 a.m.: documented blood pressure of 116/70 mmHg and pulse rate of 73 beats per minute - patient care technician documented “Patient resting and eye closed ...” 10:06 a.m.: documented blood pressure of 124/63 mmHg and pulse rate of 77 beats per minute - patient care technician documented “Patient resting and eye closed ...” 10:46 a.m.: documented blood pressure of 124/63 mmHg and pulse rate of 77 beats per minute - patient care technician documented “Late Entry: Patient resting and eye closed ...” 11:04 a.m.: documented blood pressure of 97/47 mmHg and pulse rate of 74 beats per minute - patient care technician documented “Dialysis ended ...” 14:06 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Wheelchair LOC: Alert CVS: Regular Lung Sounds: Clear Edema: Abdominal (Trace) Notes: Only pulled 1.7 kg today since patient’s bp was running low during tx today ...(no symptoms were present) CN given MIDODRINE 5mg (2 of them) during today’s tx ...patient left 1 kg over post tx ...denies any other c/o post tx ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” There was no reassessment by the registered nurse of the patient’s blood pressure after administering midodrine during the hemodialysis treatment. The patient’s treatment ended at 11:04 AM and the post assessment was documented at 14:06 PM. The RN did not conduct the post assessment prior to the patient being discharged. Review of treatment sheet dated 04/25/2025 revealed the following documentation: 7:01 a.m.: documented blood pressure of 139/72 mmHg and pulse rate of 76 beats per minute 7:32 a.m.: documented blood pressure of 119/64 mmHg and pulse rate of 79 beats per minute 08:09 a.m.: documented blood pressure of 90/37 mmHg and pulse rate of 81 beats per minute - registered nurse documented “blood pressure dropped ...patient awake and alert ...denies any symptoms now ...UF turned off, given 100 cc NSS (normal saline solution) by tech ...given 5 mg midodrine @ 8:10 am ...will monitory closely” 08:19 a.m.: documented blood pressure of 108/48 mmHg and pulse rate of 77 beats per minute - registered nurse documented “bp coming up, more stable now ...UF remains off ...will monitor closely” 08:31 a.m.: documented blood pressure of 93/51 mmHg and pulse rate of 75 beats per minute - registered nurse documented “bp still on low side ...uf remains off ...patient denies any c/o now ...” 09:01 a.m.: documented blood pressure of 118/48 mmHg and pulse rate of 74 beats per minute - vital signs were signed off by patient care technician 09:37 a.m.: documented blood pressure of 143/69 mmHg and pulse rate of 90 beats per minute - vital signs were signed off by patient care technician 10:01 a.m.: documented blood pressure of 93/56 mmHg and pulse rate of 79 beats per minute -patient care technician documented “retaking bp” 10:05 a.m.: documented blood pressure of 105/47 mmHg and pulse rate of 79 beats per minute - patient care technician documented “pt is asymptomatic” 10:31 a.m.: documented blood pressure of 126/45 mmHg and pulse rate of 82 beats per minute - vital signs were signed off by patient care technician 10:43 a.m.: documented blood pressure of 125/39 mmHg and pulse rate of 81 beats per minute - patient care technician documented “Treatment completed” 17:50 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Wheelchair LOC: Alert CVS: Regular Lung Sounds: Clear Edema: Facial (Trace) Notes: pulled only 1.5 kg today due to low bp during today’s tx ...(without any symptoms) ...administered 5 mg midodrine (2 of them) during tx today ...denies any other c/o post tx ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” There was no reassessment by the registered nurse of the patient’s blood pressure after the hemodialysis treatment. The patient’s treatment ended at 10:43 AM and the post assessment was documented at 17:50 PM. The RN did not conduct the post assessment prior to the patient being discharged. Review of treatment sheet dated 04/21/2025 revealed the following documentation: 09:01 a.m.: documented blood pressure of 107/54 mmHg and pulse rate of 77 beats per minute - patient care technician documented “Patient resting and eyes closed” 09:30 a.m.: documented blood pressure of 97/43 mmHg and pulse rate of 77 beats per minute - registered nurse documented “bp trending down ...patient denies any c/o now ...awake and alert ...uf goal decreased to 3.2 kg and given 5 mg midodrine now ...will monitor” 10:30 a.m.: documented blood pressure of 89/50 mmHg and pulse rate of 73 beats per minute - patient care technician documented “Late Entry: Computer is down” 10:51 a.m.: documented blood pressure of 107/49 mmHg and pulse rate of 75 beats per minute - patient care technician documented “Treatment completed” 17:19 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Wheelchair LOC: Alert CVS: Regular Lung Sounds: Clear Edema: Facial (Trace), Abdominal (Trace) Notes: able to pull only 2.8 kgs today due to hypotension during tx as always even if CN administered midodrine 5 mg (2 of them) during tx today ...patient left 2.3 kg over EDW post tx ...offer extra tx tomorrow...patient denied ...informed of all risks ...denies any other c/o post tx ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” There was no reassessment by the registered nurse of the patient’s blood pressure after the hemodialysis treatment. The patient’s treatment ended at 10:51 AM and the post assessment was documented at 17:19 PM. The RN did not conduct the post assessment prior to the patient being discharged. Patient #3 Observation on 04/28/2025 at 11:49 a.m. revealed Patient #3 was seated at station #12 machine #16 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 700 mL/min via left lower arm vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record on 04/29/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 04/28/2025 revealed the following documentation: 11:33 a.m.: documented blood pressure of 154/80 mmHg and pulse rate of 61 beats per minute - registered nurse documented “Pre Dialysis patient feels drowsi [sic] and dizzi [sic] ...c/o that he couldn’t sleep last night ...checked blood sugar 130 ...bp was 128/83 initially ...DR___ informed and starting tx as per his order ...ordered cuf [sic] half the new bp medication he started on this patient ...will monitor closely” 11:42 a.m.: documented blood pressure of 175/102 mmHg and pulse rate of 60 beats per minute - patient care technician documented “ ...pt complained of nausea. cnn (charge nurse notified), md notified. meds readjusted.” 11:44 a.m.: documented blood pressure of 178/99 mmHg and pulse rate of 60 beats per minute - patient care technician documented “bp stable. pt states he feels much better, cnn ...” 12:03 p.m.: documented blood pressure of 184/97 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 12:05 p.m.: documented blood pressure of 179/99 mmHg and pulse rate of 60 beats per minute - patient care technician documented “bp trending, pt is asymptomatic, cnn” 12:31 p.m.: documented blood pressure of 191/106 mmHg and pulse rate of 62 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 12:38 p.m.: documented blood pressure of 182/112 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp on high side ...patient denies any c/o ...given 0.1 clonidine if bp reading remains high ...will monitor closely” 13:04 p.m.: documented blood pressure of 187/110 mmHg and pulse rate of 61 beats per minute - registered nurse documented “patient still has high bp with out any symptoms ...will give another dose of clonidine if bp reading remains high ...will monitor closely” 13:32 p.m.: documented blood pressure of 181/105 mmHg and pulse rate of 60 beats per minute - patient care technician documented “pt htn, asymptomatic” 13:42 p.m.: documented blood pressure of 178/98 mmHg and pulse rate of 61 beats per minute - registered nurse documented “bp coming down ...patient denies any c/o ...will monitor closely” 14:02 p.m.: documented blood pressure of 181/106 mmHg and pulse rate of 61 beats per minute - registered nurse documented “bp remains high again with out any symptoms ...DR.__ informed ...as per him given another dose of 0.1 mg clonidine now ...will monitor closely” 14:32 p.m.: documented blood pressure of 192/110 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp sill on high side ...patient denies any c/o ...DR.__ already informed about patient’s high bp ...will monitor closely” 14:44 p.m.: documented blood pressure of 190/107 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Dialysis ended ...” 15:10 p.m.: documented post treatment vital signs were BP Sitting 190/107 mmHg and pulse rate of 60 beats per minute; BP Standing 189/113 mmHg and pulse rate of 69 beats per minute 19:30 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Ambulatory LOC: Alert CVS: Regular Lung Sounds: Clear Edema: None Notes: tx started with a stable bp of 148/85 ...blood pressure got high during tx to 181/106, 187/110, 191/106, 192/110 without any significant symptoms of hypertension ...DR.__ informed multiple times and as per him given 0.1 mg clonidine (2 of them) during tx today ...post tx bp also remains high 190/107 ...as per MD offer Nitroglycerine to patient ...patient denied (informed all risks) and stated he going to take his home bp medication at home ...patient refused to go to hospital for evaluation ...CN informed patient to go to ER if bp remains high at home ...to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up ...denies any c/o post tx.” The patient’s treatment ended at 14:44 PM, the post treatment vital signs were completed at 15:10 and the post assessment was documented at 17:19 PM. The RN did not conduct the post assessment prior to the patient being discharged. Review of treatment sheet dated 04/21/2025 revealed the following documentation: 11:33 a.m.: documented blood pressure of 187/124 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 11:36 a.m.: documented blood pressure of 194/114 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp on high side ...patient denies any c/o ...trying to pull 3 kgs, if bp won’t drop will administer clonidine on next bp reading ...will monitor closely” 12:02 p.m.: documented blood pressure of 169/87 mmHg and pulse rate of 64 beats per minute - registered nurse documented “bp better now, patient awake and alert ...access visualized ...will monitor closely” 12:32 p.m.: documented blood pressure of 194/114 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp on high side ...denies any c/o ...given 0.1 mg clonidine at this time to stabilize the bp” 13:07 p.m.: documented blood pressure of 182/96 mmHg and pulse rate of 61 beats per minute - patient care technician documented “Patient resting and eyes closed ...” 13:33 p.m.: documented blood pressure of 192/95 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Patient watching TV while dialysis in progress ...” 13:58 p.m.: documented blood pressure of 173/88 mmHg and pulse rate of 62 beats per minute - registered nurse documented “bp coming down ...patient ok., access visualized ...will monitor closely” 14:02 p.m.: documented blood pressure of 186/98 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Treatment completed ...” 18:15 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Ambulatory LOC: Alert CVS: Regular Lung Sounds: Clear Edema: None Notes: bp was running high during tx today ...194/114, 182/96, 192/95, 190/97 ...patient denies any symptoms and CN given 0.1 clonidine (2 of them) during today’s tx and DR.__ was aware ...post tx sitting bp was high 190/97 but came back to normal 157/87 when patient stand up ...DR.__ notified, as per him his office going to call for Olmesartan 20mgXbid for this patient in his pharmacy ...patient already taking carvedilol 12.5 mgXbid for bp too ...denies any c/o post treatment ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” The patient’s treatment ended at 14:02 PM, the post treatment vital signs were completed at 14:19 and the post assessment was documented at 18:15 PM. The RN did not conduct the post assessment prior to the patient being discharged. Review of treatment sheet dated 04/18/2025 revealed the following documentation: 11:09 a.m.: documented blood pressure of 173/105 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Access visualized and lines secured” 11:32 a.m.: documented blood pressure of 189/103 mmHg and pulse rate of 62 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 11:35 a.m.: documented blood pressure of 185/109 mmHg and pulse rate of 61 beats per minute - registered nurse documented “bp on high side ...assessed this patient @11:38am, denies any c/o now ...refused to get clonidine now ...will monitory closely” 12:04 p.m.: documented blood pressure of 167/79 mmHg and pulse rate of 63 beats per minute - registered nurse documented “bp better and coming down ...patient ok ...access visualized ...will monitor closely” 12:32 p.m.: documented blood pressure of 179/98 mmHg and pulse rate of 62 beats per minute - vital signs were signed off by patient care technician 13:02 p.m.: documented blood pressure of 168/93 mmHg and pulse rate of 66 beats per minute - vital signs were signed off by patient care technician 13:32 p.m.: documented blood pressure of 190/92 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp on high side ...readjusted and rechecking bp” 13:34 p.m.: documented blood pressure of 183/87 mmHg and pulse rate of 60 beats per minute - registered nurse documented “bp still on high side, given 0.1 mg clonidine now ...will monitor closely” 14:02 p.m.: documented blood pressure of 188/101 mmHg and pulse rate of 61 beats per minute - patient care technician documented “Possible error in bp, cuff readjusted and retaking” 14:04 p.m.: documented blood pressure of 183/95 mmHg and pulse rate of 60 beats per minute - patient care technician documented “bp trending, pt is asymptomatic, cnn” 14:06 p.m.: documented blood pressure of 177/99 mmHg and pulse rate of 60 beats per minute - patient care technician documented “Treatment completed ...” 14:27 p.m.: documented post treatment vital signs were BP Sitting 188/88 mmHg and pulse rate of 60 beats per minute; BP Standing 171/95 mmHg and pulse rate of 67 beats per minute 19:06 p.m.: registered nurse documented the post treatment assessment which revealed Mode Discharged: Ambulatory LOC: Alert CVS: Regular Lung Sounds: Clear Edema: None Notes: started the treatment with a stable bp of 145/72 ...blood pressure got high during tx as usual 189/103, 185/109, 188/101, without any symptoms and CN given 0.1 mg clonidine during today’s tx ...but bp fluctuates throughout the tx, patient denied to take second dose of clonidine (CN requested to get a home med list for this patient and he never bring it, informed all risks ...post tx bp was 188/88 and it came down to 171/95 when he stand up ...denies any c/o post treatment ... discharged stable with normal vital signs ...advised [sic] patient to watch fluid intake ...advised [sic] patient to go to ER if he will have sob or chest pain at home ...verbalized understanding ...will follow up.” The patient’s treatment ended at 14:06 PM, the post treatment vital signs were completed at 14:27 and the post assessment was documented at 19:06 PM. The RN did not conduct the post assessment prior to the patient being discharged. Interview during record review on 04/29/2025 beginning at 9:30 a.m. with Clinical Specialist (K) confirmed Patient #s 1, 2 and 3 did not have their post assessments conducted by the registered nurse prior to being discharged for the dates in question.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 48020 Based on observation, record review, and interview, the governing body failed to ensure the charge nurse was not assigned direct patient care duties. Findings: Observation in the in-center hemodialysis patient treatment area on 04/28/2025 at 7:30 a.m. there were four direct care staff (1 Charge Nurse, 3 patient care technicians) giving care to 8 patients and one patient was in the lobby. Charge Nurse (C) was the only registered nurse in the building. Observation on 04/28/2025 and 04/30/2025 revealed Charge Nurse (C) was providing CVC (central venous catheter) care to patients in the facility. Review of the facility’s patient schedule dated 4/21/2025 was provided by Charge Nurse (C) on 04/28/2025 at 07:35 a.m. The patient schedule revealed Charge Nurse (C) and Patient Care Technicians (D), (E) and (F) were assigned to provide patient care. The number of first shift patients included 11 patients, second shift included 10 patients and third shift included 2 patients. Interview with Charge Nurse (C) on 04/30/2025 at 10:05 a.m. confirmed she is assigned charge nurse duties and provides direct patient care when she works including on the dates of 04/28/2025 and 04/30/2025.”

“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: 48020 Based on observation, interview and record review, the facility’s governing body failed to ensure documentation in patient’s medical records was accurate and reflects the correct vascular access location of patients in 1 of 6 sampled patients. Patient #3 Findings: Patient # 3 On 05/15/2024 at 7:15 a.m., Patient #3 was observed at station #2 machine #19 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via left lower arm vascular access. Review of the patient’s clinical record in the chairside computer revealed Patient #3’s vascular access to be documented as “AV Fistula left upper arm.” Review of the patient’s clinical record (Standing Orders- Hemodialysis (HD)) dated 05/03/2024, revealed the following: “Current Order: Access Type- AV Fistula, Access Site- Left Upper Arm, Created- 08/14/2019, Current Status- Currently Used.” Review of the patient’s flowsheets (treatment sheets) from 04/24/2024 - 05/15/2024 revealed the following: “Access Site #1: Left Upper Arm, Access Type #1: AV Fistula.” Interview on 05/15/2024 at 8:08 a.m. with the Charge Nurse (C) confirmed Patient 3’s vascular access location was documented incorrectly as upper arm instead of lower arm.”

“CFC-PATIENTS- RIGHTS CFR(s): 494.70 This Condition is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to develop and implement a policy to apply restraints to the arm of patients, document justification for the use of restraint and develop a plan of care to address the use of restraint. and in 1 of 6 sampled patients: Patient #1. Cross reference V 452 (B) Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 2 of 6 sampled patients: Patient #s 1 and 2. Cross reference V 463 Patient #1 On 04/08/2024 at 07:53 a.m., Patient #1 was seated at station #4 machine 13 receiving hemodialysis treatment. Patient #1’s right arm was taped to the hemodialysis chair arm rest with two long strips of tape. The record review revealed no policy to apply restraints to the arm of patients, no justification for the use of restaints, and no plan of care to address the use of restraints. Review of Patient #1’’s treatment sheet dated 03/20/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 600 mL/min but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 6:43 a.m. - 9:44 a.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Patient #2 On 04/08/2024 at 8:35 a.m., Patient #2 was seated at station #5 machine #12 receiving hemodialysis treatment. Review of the patient’s treatment sheet dated 04/05/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 700 mL/min but received hemodialysis treatment at a dialysate flow rate of 600 mL/min from 8:11 a.m. - 11:22 a.m. There was no justification documented for the dialysate flow rate of 600 mL/min.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility governing body failed to ensure all patients participated in quarterly fire drill in the facility in 4 of 6 sampled patient: Patient #’s 1, 2, 3, and 6. Findings: Review of the facility’s current policy and procedure: Fire Prevention and Fire Drills (Policy # C-EM-0011, revision date 07/2023) directs the staff as follows: “POLICY: 3. Fire Drills: will be conducted every 3 months and documentation of the drill will be recorded on C-FORMS-0480 Fire Drill Report. Documentation and assessment will provide information on steps that need practice and improvement for increased staff and patient safety.” Review of the C-FORMS-0480 Fire Drill Report revealed the last fire drill was conducted on 01/05/2024 and no there was no patient participation documented for the fire drill. Also, the quarterly fire drill that was due in October 2023 (quarter four) was not completed. Patient #1 On 04/08/2024 at 07:53 a.m., Patient #1 was seated at station #4 machine # 13 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min via a right upper are vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed the patient was admitted to the facility on 10/25/2019. The clinical record revealed no documentation of fire drill participation in quarter four of 2023 (due October 2023) or on 01/24/2024. Patient #2 On 04/08/2024 at 8:35 a.m., Patient #2 was seated at station #5 machine #12 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 700 mL/min via a right upper are vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed the patient was admitted to the facility on 09/21/2022. The clinical record revealed no documentation of fire drill participation in quarter four of 2023 (due October 2023) or on 01/24/2024. Patient #3 Review of Patient #3’s clinical record revealed the patient was admitted to the facility on 08/15/2022. The clinical record revealed no documentation of fire drill participation in quarter four of 2023 (due October 2023) or on 01/24/2024. Patient #6 Review of the Patient #6’s clinical record revealed the patient was admitted to the facility on 12/07/2020. The clinical record revealed no documentation of fire drill participation in quarter four of 2023 (due October 2023) or on 01/24/2024. Interview with Facility Administrator (B) on 04/09/2024 at 10:50 a.m.: the surveyor notified Facility Administrator (B) of the missing documentation of patient participation in fire drills for quarter four of 2023 and on 01/05/2024. Facility Administrator (B) said, “Okay, we will get the fire drill done.””

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s registered nurses failed to check the status of the Automated External Defibrillator (AED) device and fill out AED check sheet on every operational day as per the policy. Findings: Review of the facility’s current policy and procedure: AED Equipment Use and Maintenance Guidelines directs the staff as follows: “PROCEDURE: 4. Every operational day, the charge nurse or designee trained in BLS/AED use per Staff Education Guidelines, must check the AED device and fill out AED check sheet, see C-FORMS-0390 AED/Emergency Cart Daily Checklist.” Observation of the AED check sheet binder on 04/08/2024 at 2:22 p.m. revealed on 03/29/2024 and 04/15/2024 the facility treated patients, but the status indicator check and the initials on the C-FORMS-0390 AED/Emergency Cart Daily Checklist were left blank. Interview on 04/08/2024 at 5:10 p.m. with the Facility Administrator (B) confirmed the missing documentation on the AED check sheet. There was no verification provided that the AED was checked and ready for patient use on these days.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility failed to notify its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. Findings: Review of the facility’s current policy and procedure: Emergency Evacuation directs the staff as follows: “PROCEDURE 1. Communication: the following communication must occur to ensure the safety of patients during an emergency situation and/or evacuation: a. On an ANNUAL BASIS, FA must send a letter (see C-EM-0040a Emergency Evacuation Letter) to the county and/or local disaster management agency. i. The communication outlines patients’ and dialysis facility’s needs in the event of an emergency. ii. A copy of the letter and confirmation of sending must be filed in the facility’s Emergency Preparedness binder.” Interview with the Facility Administrator on 04/08/2024 during the entrance conference revealed she said the facility has 17 patients who receive hemodialysis treatment in the facility on three shifts from 6:15 a.m. to 5:00 p.m. on Mondays, Wednesdays, and Fridays. Observation on 04/08/2024 - 04/09/2024 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on two shifts. Review of the Facility’s emergency management record provided by the Facility’s Administrator, revealed no up-to-date documentation that the facility notified its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. The last notification found was on 11/03/2022. On 04/09/2024 at 08:27 a.m. the Surveyor requested evidence from Facility Administrator (B) that the facility notified its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. No evidence was provided.”

“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: 48020 Based on observation, interview, the facility’s governing body failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients. Findings: Review of the facility’s current policy and procedure: Blood Glucose Testing directs the staff as follows: “PROCEDURE Checking Glucometer Performance 1. Refer to manufacturer’s instructions provided with glucometer to perform control solution testing. 2. Follow the manufacturer’s guidance for proper storage, expiration and use by dates of the control solution and test strips. a. Document date new control solution bottles and test strips are opened on each bottle or test strip container. NOTE: DO NOT use control solution or test strips past manufacturer expiration date or after use by date ... 4. Document glucometer control solution testing on C-FORMS-0371” Review of the manufacturer’s manual directs revealed: SAFETY INSTRUCTIONS FOR USING TEST STRIPS “ Do not use Assure Prism multi-Blood Glucose Test Strips beyond the expiration date as this may cause inaccurate results. Review of the facility’s current policy and procedure: Phoenix-Phoenix XL Cleaning and Calibration directs the staff as follows: “Tri-Station Maintenance: Daily: ¢ Rinse and refill RO and Bleach bottles with fresh solutions. ¢ Label bottles with initials, date & time solutions were changed. ¢ Verify expiration dates on all calibration and cleaning solutions ...” Review of the manufacturer’s instructions for use revealed: “Storage and Handling: “ For CalRite® QC Standard Solutions, consult bottle label for the expiration period after opening. Always document the Opened Date, Discard Date, and Initials on the bottle label. Review of PURELL hand sanitizer FAQs on gojo.com (manufacturer website) revealed: “Typically, PURELL Hand Sanitizer products expire 36 months after manufacture ... We always recommend using product by its printed expiration date.” Observation of Glucometer Storage Drawer Observation of the glucometer storage drawer revealed the following opened bottle: “ 1 Assure Prism Glucose Test Strips, Batch Code TD09MAXZA, Use by Date 12/29/2023 Interview with Facility Administrator (B) on 04/08/2024 at 5:08 p.m.: the surveyor notified Facility Administrator (B) that the opened bottle of glucometer tests strips were expired. Facility Administrator (B) said, “Okay.” Observation of Phoenix Meter Tri-Station Observation of the Phoenix Meter Tri-Station on 04/08/2024 at 08:09 a.m. revealed the following opened bottles: “ 1 CalRite QC Standard Solutions 1 us/cm Conductivity Solution, Lot #21071823A, expires 07/28/2024 “ 1 CalRite QC Standard Solutions 100 us/cm Conductivity Solution, Lot #21071823A, expires 04/28/2024 “ 1 CalRite QC Standard Solutions 10.00 pH Standard Buffer Solution, Lot #13072123A, expires 07/28/2024 “ 1 CalRite QC Standard Solutions 4.00 pH Standard Buffer Solution, Lot #10071423A, expires 07/28/2024 “ 1 CalRite QC Standard Solutions 50 us/cm Conductivity Solution, Lot #26071223B, expires 07/28/2024 “ 1 CalRite QC Standard Solutions 14.0 us/cm Conductivity Solution, Lot #25062223A, expires 06/28/2024 “ 1 CalRite QC Standard Solutions 7.00 pH Standard Buffer Solution, Lot #12042423A, expires 04/28/2024 The bottles did not contain the opened date, discard Date, and initials on the bottle label as directed by the facility’s policy and the manufacturer’s instruction for use. There was no documentation to validate when the solutions were opened. Interview with Patient Care Technician (D) on 04/08/2024 at 12:03 p.m. revealed the solutions were in used on the morning of the observation. Interview with the Area Biomed Manager (I) on 04/0/2024 at 2:12 p.m.: the surveyor showed Area Biomed Manager (I) the opened bottles CalRite QC solutions with no opened and discard dates marked on the bottles. Area Biomed Manager (I) stated, “That’s interesting, I wonder why they did that.” Observation of the treatment floor Observation of the treatment floor revealed the following hand sanitizer dispensers in use: “ 1 Purell Hand Sanitizer Dispenser hanging outside of the Unit Clerk’s office, expired 05/2023 “ 1 Purell Hand Sanitizer Dispenser hanging near the patient weigh scale expired 05/2023 “ 1 Purell Hand Sanitizer Dispenser hanging on the wall of the nurse’s station near the entrance by the emergency cart, expired 05/2023 “ 1 Purell Hand Sanitizer Dispenser hanging on the wall of the lab area, expired 05/2023 Interview with Unit Clerk (A) on 04/08/2024 at 08:30 a.m.: the surveyor notified Unit Clerk (A) of the expired hand sanitizer in the Purell dispensers on the treatment floor. Unit Clerk (A) said, “I will get those changed out.””

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to develop and implement a policy to apply restraints to the arm of patients, document justification for the use of restraint and develop a plan of care to address the use of restraint. and in 1 of 6 sampled patients: Patient #1. Findings: Patient #1 On 04/08/2024 at 07:53 a.m., Patient #1 was seated at station #4 machine 13 receiving hemodialysis treatment, at a blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min via a right upper are vascular access. The patient was utilizing an Optiflux 180 non- reuse dialyzer. Patient #1’s right arm was taped to the hemodialysis chair arm rest with two long strips of tape. Registered Nurse (C ) who was at chairside with the surveyor said, “the patient is being restrained with the paper tape due to dementia.” Subsequent observation at 8:34 a.m. revealed Patient #1’s right arm continued to be taped to the hemodialysis chair armrest with the two long pieces of tape. Subsequent observation at 9:03 a.m. revealed Patient #1’s right arm was no longer taped to the hemodialysis chair armrest with the two long pieces of tape. Review of the patient’s clinical record revealed no documented signed consent or physician order for the restraints or attempt of utilizing a least restrictive method. There was no documentation of staff monitoring the patient’s arm, release of the restraint and range of motion provided after release. There was no plan of care documentation to address the justification for the restraints, when to apply the restraints and how often to release the restraints when in use. Treatment sheet dated 04/08/2024 Review of the flowsheet on 04/08/2024 revealed no documentation of blood flow checks during the hemodialysis treatment on the patient’s restrained right arm. The nursing assessment pre and post treatment made no mention of the why the patient’s arm was being restrained. Interview with Clinical Services representative (H) on 04/08/2024 at 3:42 p.m. revealed the facility does not have a signed consent, order, or note about the restraints that were applied to Patient #1 nor does the company have a policy addressing patient restraint use. Phone interview with Nephrologist (J) on 04/08/2024 at 1:40 p.m. revealed he said, “I gave a verbal order to use paper tape to tape the patient’s arm down because the patient has dementia and a low hemoglobin. We did not want the patient to pull out his needles as he has in the past.” The surveyor notified Nephrologist (J) that the patient’s clinical record did not contain a signed physician order, consent, plan of care to address why the restraints were needed, how long they were to be applied and when to apply the restraints. Nephrologist (J) said, “Okay.””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 2 of 6 sampled patients: Patient #s 1 and 2. Findings: Review of the facility’s current policy and procedure: Initiation of Dialysis Treatment directs the staff as follows: POLICY: 1. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: d. Correct prescription (dialyzer, concentrate, DFR, etc.) PROCEDURE: 14. Prior to walking away from patient’s dialysis machine, verify all prescribed orders are followed. If unable to follow any part of the patient’s prescription after troubleshooting, notify the charge nurse and document notification. Charge nurse will notify the physician if indicated and document any follow up or new orders. a. Blood flow is at prescribed rate b. Heparin pump (if used) is turned on and delivering the correct dose c. Correct dialysate flow rate d. Dialysis machine temperature e. Bloodlines are secured f. Access, bloodline connections, and face are visible g. Fluid removal goal is programmed correctly. Patient #1 On 04/08/2024 at 07:53 a.m., Patient #1 was seated at station #4 machine receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min via a right upper are vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 02/09/2024 for dialysate flow rate 600 mL/min. Treatment sheet dated 03/20/2024 Review of the patient’s treatment sheet dated 03/20/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 600 mL/min but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 6:43 a.m. - 9:44 a.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Interview with Facility Administrator (B) on 04/09/2024 at 7:57 a.m.: the Surveyor notified Facility Administrator (B) Patient #1 did not receive hemodialysis treatment at the prescribed dialysate flow rate on 03/20/2024. Facility Administrator (B) said, “Okay.” Patient #2 On 04/08/2024 at 8:35 a.m., Patient #2 was seated at station #5 machine #12 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 700 mL/min via a right upper are vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 01/08/2024 for dialysate flow rate 700 mL/min. Treatment sheet dated 04/05/2024 Review of the patient’s treatment sheet dated 04/05/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 700 mL/min but received hemodialysis treatment at a dialysate flow rate of 600 mL/min from 8:11 a.m. - 11:22 a.m. There was no justification documented for the dialysate flow rate of 600 mL/min. Interview with Facility Administrator (B) on 04/09/2024 at 8:01 a.m.: the Surveyor notified Facility Administrator (B) Patient #2 did not receive hemodialysis treatment at the prescribed dialysate flow rate on 04/05/2024. Facility Administrator (B) said, “I didn’t check.””

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility failed to ensure all direct care staff providing hemodialysis treatment to patients are assessed for skills competency in 1 of 3 direct care staff personnel records reviewed: Registered Nurse (C). B) Failed to delegate authority of the dialysis technician to perform cannulation of the patient’s vascular accesses, administration of heparin, lidocaine, normal saline, and oxygen in 1 of 3 direct care staff personnel records reviewed: Certified Patient Care Technician (D). Findings: Registered Nurse (C) On 04/08/2024 Registered Nurse (C) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of the facility’s staff schedule revealed Registered Nurse (C) was borrowed from another facility and scheduled to work in this facility on 04/08/2024. Review of Registered Nurse (C’s) personnel and training file revealed an annual skills checklist that expired on 04/03/2024. On 04/09/2024 at 9:16 a.m. the surveyor requested documentation from Facility Administrator (B) of Registered Nurse (C’s) up-to-date annual skills checklist. No evidence was provided. Certified Clinical Care Technician (D) On 04/08/2024, Certified Clinical Care Technician (D) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of the facility’s staff schedule for the last two weeks revealed Certified Clinical Care Technician (D) was borrowed from another facility and was scheduled to work in this facility on March 1, 4, 8, 22, 27 and April 1, 8, 2024. Review of Certified Clinical Care Technician (D’s) personnel and training file revealed there is no documentation of delegation by the facility’s medical director for Certified Clinical Care Technician (D) to cannulate patients’ vascular accesses and administer: intravenous heparin, intravenous normal saline, subcutaneous lidocaine, and oxygen. On 04/09/2024 at 9:16 a.m. the surveyor requested documentation from Facility Administrator (B) of the Facility’s Medical Director’s delegation of Certified Clinical Care Technician (D) to cannulate patients’ vascular accesses and administer: intravenous heparin, intravenous normal saline, subcutaneous lidocaine, and oxygen. No evidence was provided.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the Facility’s Administrator failed to ensure all staff completed the facility’s orientation prior to providing care and services to hemodialysis patients in 2 of 5 staff personnel records reviewed: Registered Nurse (G) and Patient Care Technician (D). Findings: Registered Nurse (G) On 04/08/2024 Registered Nurse (G) was observed to call a peritoneal dialysis patient into the training room. Review of Registered Nurse (G’s) personnel and training file revealed she was hired to the facility on 11/07/2023. Review of Registered Nurse (G’s) personnel and training file revealed no documentation of an orientation to the facility was completed. Interview of Registered Nurse (G) on 03/09/2024 at 9:15 a.m. revealed she did not participate in the facility’s orientation. Certified Clinical Care Technician (D) On 04/08/2024, Certified Clinical Care Technician (D) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Subsequent observation revealed Certified Clinical Care Technician (D) performing the water total chlorine check. Review of the facility’s staff schedule for the last two weeks revealed Certified Clinical Care Technician (D) was borrowed from another facility and was scheduled to work in this facility on March 1, 4, 8, 22, 27 and April 1, 8, 2024. There was no evidence that an orientation to the facility was provided. Interview of Facility Administrator (B) 04/09/2024 at 8:21 a.m. confirmed that Registered Nurse (G) and Certified Clinical Care Technician (D) did not receive an orientation to the facility.”