Davita Pine Park Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48020 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: white crystallized buildup on the floor underneath the chase cabinets B) debris on the floor of the lobby and hemodialysis treatment area. Findings: Lobby: Observation of the treatment area on 09/09/2025 at 8:49 AM revealed one trash bag with trash in it, various pieces of paper and candy wrappers on the floor below the receptionist window at the time the surveyors entered the facility. Hemodialysis Treatment Area: Observation of the treatment area on 03/13/2025 at 9:36 AM - 9:52 AM revealed the following: White crystallized buildup on the floor underneath the chase cabinets: - Hemodialysis station #s 1-24 Station #12: floor had two caps underneath the hemodialysis machine and debris in front of the hemodialysis chair. Station #9: floor had used alcohol prep pad in front of hemodialysis machine. Station #7: floor had cap underneath the hemodialysis chair and used alcohol prep pad near biohazard container. Station #4: floor had one roll of used paper tape underneath the chase cabinet Station #23: floor had debris in front of the hemodialysis machine and used roll of tape behind the half wall. Station #22: floor had a Criterion Non-woven sponge wrapper in between the patient’s hemodialysis chair and half wall. Station #15: floor had a used roll of tape in between the hemodialysis chair and machine. Interview during observation with Manager of Clinical Services (F) confirmed the findings above. 30124 Observation of the treatment floor on the morning of 09/09/2025 at 9:15 AM the following was observed in the patient treatment area. Station #2 Brownish red droplets on the outer surface of the sharpes container. Station #19 Brownish red droplets on the red biohazard garbage container lateral side. Station #22 Brownish red droplets on the hemodialysis station wall adjacent to treatment chair and on the back wall of the station. Station # 24 Brownish red droplets on the outside lateral survace of the sharps container and sharps rolling cart.”

“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 perform hand hygiene after removal of contaminated gloves per the facility’s policy in 1 of 5 staff observed: Patient Care Technician (I) Findings: Review of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: HAND HYGIENE 1. All teammate, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes ..., f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... 3. Use of an alcohol-based hand rub may be substituted for handwashing. a. Hand washing will be performed if hands are visibly contaminated with blood or body fluids and when caring for patients on isolation precautions for Clostridium difficile ...” Patient Care Technician (I) Observation on 09/10/2025 at 9:57 AM, revealed Patient Care Technician (I) walk to the biohazard container and remove the lid and sat it on the stand. Patient Care Technician (I) then removed her contaminated gown and gloves and put them in the biohazard container, walk to the clean supply area where gowns and stored, grabbed a gown with her contaminated hands and donned the gown without performing hand hygiene. During an interview with Patient Care Technician (I) at 10:41 AM, the Surveyor notified Patient Care Technician (I) that she failed to perform hand hygiene after removing her contaminated gown and gloves and before touching the clean gown. Patient Care Technician (I) said, “Okay.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect the stethoscopes, prime buckets and laminates hanging on the intravenous (IV) poles, back of hemodialysis machines, dialysate lines, chase countertops or wall boxes in 3 of 5 staff observed: Registered Nurse (H), Licensed Vocational Nurse (J) and Patient Care Technician (I) Findings: Review of facility’s current policy and procedure: INFECTION CONTROL FOR DIALYSIS FACILITIES #1-05-01, Revision Date: April 2023 directs staff as follows: “DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. a. Prior to routine disinfection, remove all visible blood i. For visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. ii. After all visible blood is cleaned with the 1:10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time iii. Cleaning of visible blood should be performed when first observed b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time iv. Items disinfected via submersion will be fully submerged c. Spray bottles containing cleaning solutions are single use and cannot be reused or refilled. This practice does not include contracted housekeeping services. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area Teammates will monitor and address wall box residue/build up and patency issues. ii. Priming containers are to be emptied prior to disinfection. Drain line and water supply line should not be placed with ends in prime containers or in a position where they can drip into or contaminate the prime bucket.” Registered Nurse (H) Station #19 Observation on 09/10/2025 at 9:53 AM revealed Registered Nurse (H) terminally cleaning station #19 post hemodialysis treatment of a patient. Registered Nurse (H) failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole. Immediately after the observation, the Surveyor notified Registered Nurse (H) at 10:09 AM that she failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole. Registered Nurse (H) said, “I cleaned the IV pole but I forgot to clean other things.” Licensed Vocational Nurse (J) Station #14 Observation on 09/10/2025 at 10:36 AM revealed Licensed Vocational Nurse (J) terminally cleaning station #14 post hemodialysis treatment of a patient. Licensed Vocational Nurse (J) failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole, the back of the hemodialysis machine, chase countertop and wall box. Immediately after the observation, the Surveyor notified Licensed Vocational Nurse (J) at 10:48 AM that she failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole, the back of the hemodialysis machine, chase countertop and wall box. Licensed Vocational Nurse (J) said, “Okay, I will reclean it.” Patient Care Technician (I) Station #11 Observation on 09/10/2025 at 10:36 AM revealed Patient Care Technician (I) terminally cleaning station #11 post hemodialysis treatment of a patient. Patient Care Technician (I) failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole, chase countertop and wall box. Immediately after the observation, the Surveyor notified Patient Care Technician (I) at 10:59 AM that she failed to clean and disinfect the stethoscope, prime bucket and laminates hanging on the IV pole, chase countertop and wall box. Patient Care Technician (I) said, “Yes ma’am, I am about to redo it.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 30124 Based on observation, interview and record review the facility, per the Texas Adminstrative Code (TAC), Title 26 117.41(h) staff failed to ensure 2 of 12 patients (#14, #15) hemodialysis access site and face were not covered while receiving hemodialysis treatment remained visible during hemodialysis treatment. Allowing patients to cover access sites and line connections with blankets provides an opportunity for accidental needle dislodgement or disconnection to go undetected. This practice placed patients of the facility at risk for potential needle dislodgement and/or disconnection which could result in exsanguination and harm. Allowing patients to cover eyes prevents facility staff from observation of eyes which may roll upward or back or remain open with a vacant stare during loss of consciousness. Policy Reviewed: Review of the facility’s current policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, Policy: 1-03-08. Purpose: To obtain ad document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. The information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and reviewing the patient’s response to the treatment and status prior to discharge. Intradialytic Data Collection Assessment: b. At a minimum, obtain and document the following: v. Vascular access visible and line connections intact. C. The vascular access site, blood lines connections and the patient’s face should be visible throughout the dialysis treatment. Findings: Based on observation of patients receiving hemodialysis on the morning of 09/09/2025 the following was observed. Patient ID #14 Observation on 09/09/2025 at 9:10 AM revealed Patient ID #14 was seated at station #19, machine #19 receiving hemodialysis treatment at blood flow rate of 350 mls/min and a dialysate flow of 600 via a left upper arm fistula. Patient #14 dialysis access was not visible and observed to be covered by a blanket. Surveyor spoke with the patient concerning her covered access and the patient immediately uncovered her access. Patient #15 Observation on 09/09/2025 at 09:15 AM revealed Patient ID #15 was receiving dialysis at station #20, machine #20 via a central venous catheter. Patient was observed wearing a knitted stocking cap with the cap pulled passed her eyes to the bridge of her nose. Surveyor informed Patient Care Technician, staff ID #E of the patient’s eyes not visible. Staff ID# immediately went over to patient ID #15 and educated the patient and moved the cap above the patient’s eyes. Interview on 09/09/2025 with Patient Care Staff Staff ID #E confirmed the above findings and educated the patients.”

“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 9 sampled patients and 2 of 14 closed records: Patient #s 17, 7, 9. Findings: Review of facility’s current policy and procedure: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT, #1-03-08, Revision Date: October 2015, directs staff as follows: 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting)” Patient #17 Observation on 09/09/2025 at 9:10 a.m. revealed Patient #17 was seated at station #13 machine #13 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via right central venous catheter. The patient was utilizing an Elisio-17H non reuse dialyzer. Review of the patient’s Treatment Detail Report dated 09/04/2025 on 09/10/2025 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 500 mL/min from 6:26 AM - 10:08 AM. There was no justification documented for the dialysate flow rate of 500 mL/min. Patient #7 Review of the patient’s clinical record on 09/09/2025 revealed the patient was admitted to facility on 05/13/2019 with the diagnoses of end stage renal disease, type 2 diabetes mellitus, coronary artery disease, atrial fibrillation, breast cancer, cholelithiasis, deep vein fibrosis, hyperlipidemia, chronic obstructive pulmonary disease, cerebrovascular accident, pacemaker and hypertension, on in-center hemodialysis three times a week. Review of the patient’s flowsheet dated 12/24/2020 revealed documentation which indicated the patient was prescribed a dialysate flow rate of 800 mL/min but received hemodialysis treatment at a dialysate flow rate of 600 mL/min from 8:40 AM - 12:36 PM. There was no justification documented for the dialysate flow rate of 600 mL/min. Patient #9 Review of the patient’s clinical record on 09/09/2025 revealed the patient was admitted to facility on 03/25/2020 with the diagnoses of end stage renal disease, coronary artery disease, hyperlipidemia, congestive heart failure and hypertension, on in-center hemodialysis three times a week. Review of the patient’s flowsheet dated 08/15/2020 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 13:00 PM - 15:15 PM. There was no justification documented for the dialysate flow rate of 600 mL/min. Interview during record review with Clinical Coordinator (A) on 09/10/2025 at 2:30 PM, the Surveyor informed Clinical Coordinator (A) that the dialysate flow rate was not set on the hemodialysis machine as prescribed by the physician for the patients above. Clinical Coordinator (A) said, “Okay.””

“PA-ASSESS RENAL BONE DISEASE CFR(s): 494.80(a)(5) The patient’s comprehensive assessment must include, but is not limited to, the following: (5) Evaluation of factors associated with renal bone disease. This Standard is not met as evidenced by: 30124 Based on observation, record review and interview,the facility’s registered nurses failed to ensure renal bone disease medication prepared for patients are not left unsecured at patients’ chairside and are administered as prescribed by the physician in 1 of 12 patients observed: Patient #14. Review on 09/10/2025 of the facility’s current policy titled “Medication Policy”, Policy: 1-06-01, Revision Date October 2023. Purpose: To provide guidance for Medication management in the facility and to provide guidance for safe and aseptic preparation of all medications Policy: 9. Medications are administered as prescribed and then documented in the patient’s medical record. No medications are given without an order from the physician or non-physician practitioner (NPP). Medication orders must include the patient name, drug name, dose, route, frequency, date and time the order was received. Findings: Patient #14 On 09/09/2025 at 9:10 a.m. Patient #14 was observed on the treatment floor of the facility at station #19. The was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 600 mL/min. Observation of hemodialysis station #19 revealed a medication cup with three tablets with no label outside of the cup setting at the chairside. Patient #14 was asked if she knew what the medications were and confirmed it was her calcium and vitamin D. The medication was left unsecured and was not in view of the nurses while they gave care to the other patients. Review of the patient’s hemodialysis flowsheet revealed a physician’s order for Calcitriol 0.75 mcg, oral, three times a week and Cinacalcet HCL 120 mg, oral, three times a week. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 0.75 mcg and Calcitriol 0.75 mcg at 7:30 a.m. The registered nurse documented that the patient was administered the medication although the medication was left unsecured on top of the hemodialysis machine. Interview with the Charge Nurse, staff (A) on 9/10/2025 at 2:30 p.m. confirmed the medications were left unattended at the chairside and were signed off as given.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s registered nurses failed to conduct pre-dialysis nursing assessments prior to the hemodialysis treatments when patients were admitted to the facility in of sampled patients: Patient #s 17 Findings: Review of facility’s current policy and procedure PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT, # 1-03-08, Revision Date: October 2015, directs staff as follows: “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge.” Patient #17 Observation on 09/09/2025 at 9:10 AM revealed Patient #17 was seated at station #13 machine #13 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via right central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/26/2025 with the diagnoses of end stage renal disease, renal cyst, hypothyroidism, osteoporosis, asthma, gastroesophageal reflux disease, generalized anxiety disorder, major depressive disorder, and hypertension, on in-center hemodialysis three times a week. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 06/26/2025 at 8:09 AM and the Initial Patient Nursing Assessment was completed at 8:17 AM. Interview during record review with Clinical Coordinator (A) on 09/09/2025 at 2:52 PM confirmed the Initial Patient Nursing Assessment was not completed before the initiation of the hemodialysis treatment for the patient above. 30124 Patient #14 Observation on 09/09/2025 at 9:10 AM revealed Patient ID #14 was seated at station #13, machine 13 receiving hemodialysis treatment at blood flow rate of 350 mls/min and a dialysate flow of 600 via a left upper arm fistula. Review of the patient’s clinical record revealed the patient was admitted to the facility on 5/31/2024. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 05/31/2024 at 17:13 PM and the Initial Patient Nursing Assessment was completed at 17:57 PM. Patient #19 Review of the patient’s clinical record revealed the patient was admitted to the facility on 8/02/2025. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 08/02/2025 at 11:30 AM and the Initial Patient Nursing Assessment was completed at 12:29 PM. Patient #20 Review of the patient’s clinical record revealed the patient was admitted to the facility on 7/07/2025. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 07/07/2025 at 17:38 PM and the Initial Patient Nursing Assessment was completed at 18:24 PM. Patient #21 Review of the patient’s clinical record revealed the patient was admitted to the facility on 6/16/2025. Review of the patient’s treatment record revealed the treatment was initiated on the patient on 06/16/2025 at 16:44 PM and the Initial Patient Nursing Assessment was completed at 17:01 PM.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility failed to ensure the initial Plan of Care was completed in the required time of 30 days or 13 treatments of first outpatient dialysis treatment as required for 2 of 9 records reviewed (Patient ID #17, #21). Policy reviewed: Review on 09/10/2025 of the facility’s current policy and procedure titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, Policy: 1-14-01, Revision Date October 2024. Purpose: To provide guidance for the development of patient assessment and plan of care for IDT teammates. Policy: 10. An initial Plan of Care, based on the finding from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” Findings: Patient #17 Observation on 09/09/2025 at 9:10 a.m. revealed Patient #17 was seated at station #13 machine #13 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via right central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/26/2025 with the diagnoses of end stage renal disease, renal cyst, hypothyroidism, osteoporosis, asthma, gastroesophageal reflux disease, generalized anxiety disorder, major depressive disorder, and hypertension, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed the following laboratory result dated 07/01/2025: Albumin 3.2, 07/29/2025: Hemoglobin 8.5 g/dL. Review of the patient’s initial interdisciplinary plan of care revealed the “Plan of Care CFC Due Date: 07/26/2025” but the plan of care was completed on 08/21/2025. Interview with Clinical Coordinator (A) on 09/09/2024 at 2:52 PM confirmed the initial plan of care was not completed within 30 days or 13 treatments as required. 30124 Record Review for Patient ID #21 Review of patient Plan of Care documents due date documented as 07/16/2025. Plan of Care meeting date for Patient ID #21 documented as 07/30/2025. Interview 0n 09/10/2025 at 1430 p.m. with facility’ Manager of Clinical Services, Registered Nurse, staff ID #F confirmed the initial Plan of Care for Patient ID#21 was not completed within the first 30 days as required.”

“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 registered nurses failed to conduct assessments pretreatment and during the hemodialysis treatment per the facility’s policy in 4 of 23 sampled patients and closed records: Patient #s 17, 18, 8, 12 Findings: Review of facility’s current policy and procedure PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT, # 1-03-08, Revision Date: October 2015, directs staff as follows: “PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific 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: o Systolic greater than 180 mm/Hg or less than 90 mm/Hg o Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg” Parameters established by the facility’s Governing Body: “Intradialytic PCT report to RN: Blood Pressure SBP greater than 180 DBP greater than 100 RN reports to MD: STOP TX FOR PERSISTENT BP LESS THAN 90/50 UNLESS ORDER HAS BEEN OBTAINED TO RUN IN 80’S PCT report to RN: SBP less than 100 DBP less than 50 RN reports to MD: STOP TX FOR PERSISTENT BP’S GREATER THAN 200/100 CHANGES ><20 MMHG FROM ADMISSION BASELINE Pulse PCT report to RN: >100 OR <50 or any significant change in pulse Change greater than 30 bpm of pre-treatment parameter” Patient #17 Observation on 09/09/2025 at 9:10 a.m. revealed Patient #17 was seated at station #13 machine #13 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via right central venous catheter. Review of the patient clinical record on 09/09/2025 revealed the following documentation: Treatment sheet dated 08/26/2025: 06:33 AM: documented blood pressure of 181/75 mmHg and heart rate of 82 bpm - RN documented “Treatment started without complications; BP elevated; Pt reported feeling well.” 07:01 AM: documented blood pressure of 168/63 mmHg and heart rate of 78 bpm 07:31 AM: documented blood pressure of 131/83 mmHg and heart rate of 80 bpm - PCT documented “bp trending down; recheck” 07:37 AM: documented blood pressure of 167/71 mmHg and heart rate of 74 bpm 08:02 AM: documented blood pressure of 173/56 mmHg and heart rate of 83 bpm 08:33 AM: documented blood pressure of 148/64 mmHg and heart rate of 92 - bpm - PCT documented “SBP trending down; PT asymptomatic; retake BP” 08:36 AM: documented blood pressure of 159/74 mmHg and heart rate of 91 bpm - PCT documented “Patient appears to be tolerating treatment well at this time; BP improved; PT asymptomatic” 09:04 AM: documented blood pressure of 128/46 mmHg and heart rate of 74 bpm - PCT documented “BP trending down; PT asymptomatic; retake bp” 09:05 AM: documented blood pressure of 143/44 mmHg and heart rate of 91 bpm - PCT documented “Patient appears to be tolerating treatment well at this time; BP improved; PT asymptomatic” 09:31 AM: documented blood pressure of 136/59 mmHg and heart rate of 71 bpm - PCT documented “Patient awake; alert; and states no complaints at this time; Patient face; vascular access; and blood line connections visible” 10:01 AM: documented blood pressure of 117/62 mmHg and heart rate of 118 bpm - RN documented “Patient appears to be tolerating treatment well at this time” 10:15 AM: documented blood pressure of 147/41 mmHg and heart rate of 62 bpm - RN documented “Treatment terminated; DBP low. Pt asymptomatic” There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse until the registered nurse terminated the hemodialysis treatment at 10:15 AM. This was 1 hour and 10 minutes after the first low diastolic blood pressure was captured by the hemodialysis machine at 9:05 AM. 10:20 AM: RN documented “Manual Entry: Pt. became unresponsive to verbal command while rinsing blood back.; placed on O2@3L NC; O2sat was 88%; increased to 6l; NC; O@sat improved to 93%.; Given total 800ml saline bolus.; Placed in supine position; pt was breathing deep.; informed team mate to call EMS; Pt. became more responsive; Alert to self.; Blood sugar level was 114” Patient #18 Observation on 09/09/2025 at 9:10 a.m. revealed Patient #17 was seated at station #13 machine #13 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via right central venous catheter. Review of the patient clinical record on 09/10/2025 revealed the following documentation: Treatment sheet dated 09/06/2025: Treatment Parameter Orders NOTIFY NURSE FOR POST ASSESSMENT IF BP Diastolic DBP above 120 mmHg DBP below 50 mmHg 10:52 PM: documented blood pressure of 132/83 mmHg and heart rate of 94 bpm - PCT documented “Treatment terminated” Post-Treatment Vitals: Sitting Blood Pressure - 123/89 mmHg Heart Rate - 92 BPM Standing Blood Pressure - 107/47 mmHg Heart Rate - 101 BPM Observations Time - 10:55 (CDT) Date - 09/06/2025 Temperature - 97.7 F Dialyzer Appearance - Clear Mobility - Ambulates- No Assistance Needed Ambulatory - No Assistance Needed The Post Treatment Nurse Assessment was submitted as “Completed” at 12:48 CDT. There was no documented assessment of the patient’s below parameter blood pressure by the registered nurse prior to the patient leaving the facility at 10:55 AM. Treatment sheet dated 09/04/2025: Treatment Parameter Orders NOTIFY NURSE FOR POST ASSESSMENT IF BP Diastolic DBP above 120 mmHg DBP below 50 mmHg 10:54 PM: documented blood pressure of 131/74 mmHg and heart rate of 87 bpm - PCT documented “Treatment terminated” Post-Treatment Vitals: Sitting Blood Pressure - 108/56 mmHg Heart Rate - 93 BPM Standing Blood Pressure - 116/48 mmHg Heart Rate - 100 BPM Observations Time - 11:37 (CDT) Date - 09/04/2025 Temperature - 98.2 F Dialyzer Appearance - Streaked Mobility - Ambulates- No Assistance Needed Ambulatory - No Assistance Needed The Post Treatment Nurse Assessment was submitted as “Completed” at 12:47 CDT. There was no documented assessment of the patient’s below parameter blood pressure by the registered nurse prior to the patient leaving the facility at 11:37 AM. Treatment sheet dated 09/02/2025: Treatment Parameter Orders NOTIFY NURSE FOR POST ASSESSMENT IF BP Diastolic DBP above 120 mmHg DBP below 50 mmHg 10:44 PM: documented blood pressure of 166/88 mmHg and heart rate of 97 bpm - PCT documented “Treatment terminated” Post-Treatment Vitals: Sitting Blood Pressure - 122/58 mmHg Heart Rate - 105 BPM Standing Blood Pressure - 137/48 mmHg Heart Rate - 109 BPM Observations Time - 11:19 (CDT) Date - 09/02/2025 Temperature - 98.1 F Dialyzer Appearance - Streaked Mobility - Ambulates- No Assistance Needed Ambulatory - No Assistance Needed The Post Treatment Nurse Assessment was submitted as “Completed” at 15:55 CDT. There was no documented assessment of the patient’s below parameter blood pressure by the registered nurse prior to the patient leaving the facility at 11:19 AM. Patient #8 Review of the patient’s clinical record on 09/09/2025 revealed the patient was admitted to the facility on 04/20/2016 with the diagnoses of end stage renal disease, type 2 diabetes, Barrett’s Esophagus, gout, hypertension, cerebrovascular accident, coronary artery disease, pacemaker, on in-center hemodialysis three times a week. Review of the patient clinical record on 09/09/2025 revealed the following documentation: Treatment sheet dated 09/07/2020: Pre-Treatment Vitals Blood Pressure Sit: 232/109 Pulse: 81 11:43 AM: documented blood pressure of 237/98 mmHg and heart rate of 81 bpm - PCT documented “Treatment Initiated, 200ML normal saline prime given” 11:53 AM: documented blood pressure of 220/85 mmHg and heart rate of 81 bpm - RN documented “BP checked, hypertension noted, asymp in-center BP med given” 11:54 AM: The RN documented the Pretreatment Assessment: TEMP 97.70 F RESP Clear, unlabored GI No complaints Cardiac Elevated SBP, Asymp ...” There was no documented assessment of the patient’s above parameter blood pressure by the registered nurse prior to the start of the hemodialysis treatment. Patient #12 Review of the patient’s clinical record on 09/09/2025 revealed the patient was admitted to the facility on 01/25/2019 with the diagnoses of end stage renal disease, type 2 diabetes, seizure disorder, hyperlipidemia, hypertension, on in-center hemodialysis three times a week. Review of the patient clinical record on 09/09/2025 revealed the following documentation: Treatment sheet dated 05/11/2020: 11:47 AM: documented blood pressure of 145/82 mmHg and heart rate of 105 bpm - PCT documented “Treatment initiated, 200ML normal saline prime given” 12:34 PM: documented blood pressure of 94/26 mmHg and heart rate of 39 bpm - PCT documented “Readjusting cuff” 12:35 PM: documented blood pressure of 111/39 mmHg and heart rate of 36 bpm - PCT documented “Readjusting cuff” 12:37 PM: documented blood pressure of 103/66 mmHg and heart rate of 34 bpm - PCT documented “UF Goal lowered to 1.4kg and BFR lowered to 300 due to low HR, RN notified” 13:02 PM: documented blood pressure of 99/54 mmHg and heart rate of 34 bpm - PCT documented “HR trending low, pt denies any complaint, RN notified” 13:32 PM: documented blood pressure of 126/52 mmHg and heart rate of 31 bpm - PCT documented “Readjusting cuff” 13:37 PM: documented blood pressure of 126/52 mmHg and heart rate of 31 bpm - PCT documented “HR trending low, pt denies any complaint, RN notified” 14:11 PM: documented blood pressure of 133/59 mmHg and heart rate of 48 bpm - PCT documented “Manual BP taken” 14:44 PM: documented blood pressure of 112/20 mmHg and heart rate of 114 bpm - PCT documented “Readjusting cuff” 14:47 PM: documented blood pressure of 111/67 mmHg and heart rate of 114 bpm - RN documented “Treatment TX; with 300ML, NS rinse back; to assist with volume and BP; sternal rub to arouse pt, pt pale, unresponsive; 911; call admin; 2L NC O2 crash; cart present; Pt in HD chair, board under pt, AED no shock, need initiate CPR, Pt off machine, CPR start ...” There was no documentation that the PCT reported the patient’s below parameter blood pressures and heart rates to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures and heart rate by the registered nurse until the patient became unresponsive. Treatment sheet dated 05/08/2020: 11:52 AM: documented blood pressure of 111/30 mmHg and heart rate of 106 bpm - PCT documented “Treatment initiated, 200ML normal saline prime given” 11:56 AM: documented blood pressure of 128/68 mmHg and heart rate of 105 bpm - RN documented “BP improved, HR elevated, asymptomatic, monitoring” 12:01 PM: documented blood pressure of 74/59 mmHg and heart rate of 105 bpm - PCT documented “Retaking BP” 12:02 PM: documented blood pressure of 101/53 mmHg and heart rate of 108 bpm - PCT documented “BP WNL” 12:15 PM: documented blood pressure of 113/54 mmHg and heart rate of 49 bpm - PCT documented “No complaints” 12:31 PM: documented blood pressure of 143/50 mmHg and heart rate of 38 bpm - PCT documented “Alert, monitor vitals, CN informed” 12:36 PM: documented blood pressure of 136/30 mmHg and heart rate of 36 bpm - PCT documented “Alert, monitor vitals, CN informed” 12:46 PM: documented blood pressure of 134/23 mmHg and heart rate of 30 bpm - PCT documented “Retaking BP” 12:54 PM: documented blood pressure of 97/25 mmHg and heart rate of 32 bpm - PCT documented “Readjusting cuff” 12:56 PM: documented blood pressure of 109/55 mmHg and heart rate of 30 bpm - PCT documented “HR noted, BFR lowered to 300 for HR support per nurse, will continue to monitor” 13:04 PM: documented blood pressure of 133/88 mmHg and heart rate of 47 bpm - PCT documented “HR noted, Pt denies complaint, will continue to monitor” 13:17 PM: documented blood pressure of 137/97 mmHg and heart rate of 59 bpm - PCT documented “No complaints” 13:31 PM: documented blood pressure of 120/75 mmHg and heart rate of 68 bpm - PCT documented “No complaints” 14:02 PM: documented blood pressure of 61/36 mmHg and heart rate of 41 bpm - PCT documented “Readjusting cuff” 14:04 PM: documented blood pressure of 80/50 mmHg and heart rate of 114 bpm - PCT documented “UF off due to low BP, RN notified” 14:16 PM: documented blood pressure of 116/49 mmHg and heart rate of 111 bpm - PCT documented “UF on” 14:30 PM: documented blood pressure of 97/56 mmHg and heart rate of 112 bpm - PCT documented “BP noted, Pt denies complaint, will continue to monitor 14:46 PM: documented blood pressure of 88/46 mmHg and heart rate of 111 bpm - PCT documented “Readjusting cuff” 14:57 PM: documented blood pressure of 102/48 mmHg and heart rate of 109 bpm - PCT documented “DBP noted, Pt denies any complaint, will continue to monitor” 15:01 PM: documented blood pressure of 96/65 mmHg and heart rate of 113 bpm - PCT documented “BP noted, Pt denies any complaint, will continue to monitor 15:16 PM: documented blood pressure of 71/41 mmHg and heart rate of 113 bpm - PCT documented “UF off due to low BP, RN notified 15:30 PM: documented blood pressure of 71/59 mmHg and heart rate of 110 bpm - PCT documented “UF remains off” 15:38 PM: documented blood pressure of 84/49 mmHg and heart rate of 111 bpm - PCT documented “UF remains off” 15:47 PM: documented blood pressure of 79/54 mmHg and heart rate of 114 bpm - PCT documented “BP noted, Pt complains of lower back pain, UF remains off, RN notified” 16:00 PM: documented blood pressure of 102/51 mmHg and heart rate of 108 bpm - RN documented “Treatment terminated, wit 300 ML normal saline rinse back.” There was no mention of the out of parameter blood pressures, heart rate and turning off of the ultrafiltration. Interview during record review with Clinical Coordinator (A) on 09/10/2025 at 2:52 PM confirmed that the nursing assessments were not being completed according to the facility’s policy. Clinical Coordinator (A) said, “Okay.””

“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: 37322 Based on observation, record review and interview, the facility failed to ensure proper labeling of a gas oxygen-E metal tanks in the unit the facility failed to meet the standards at Texas Administrative Code (TAC), 101. Title 494.20. NFPA (National Fire Protection Association) requires empty and full cylinders that are stored together, must be segregated from full cylinders. Partially full cylinders must not be stored with the empty cylinders and stored separately from full or empty cylinders. Observation on 03/28/2025 at 11:33 AM during initial facility tour of the medical gas revealed the storage of four (4) full and one (1) empty E oxygen tanks that were stored together in the dialysis suite. Record Review of facility policy “Routine Administration of Oxygen” effective 11/01/2021 and stated: the purpose of this policy guidance for safe use and handling of oxygen cyclinders when used in emergency situations in the dialysis facility. The findings were validated by staff (ID #1) during rounds.”

“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: 30124 Based on observation, interview and record review the facility’s direct care staff failed to prevent cross contamination by failing to change gloves and perform appropriate hand hygiene after contact with contaminated items. Findings: Review on 03/28/2025 of the facility’s current policy titled “Infection Control for Dialysis Facilities”; Policy: 1-05-01, Revision date April 2023. Purpose: To minimize the spread of infections or blood born pathogens in the dialysis environment. Hand Hygiene: 1. All teammates, Physicians and Non-Physician will perform hand hygiene. a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infections material, d. after patient and dialysis delivery system contact, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. a. Gloves should be change when: ii. When going from a “dirty” area or task to a clean” area or task. During a tour of the facility’s patient treatment area on 03/28/2025 at 12:20 PM, the surveyor along with the facility administrator, staff ID #C observed patient care technician, staff ID #I cleaning hemodialysis machine #25 at station #10 with a bleach disinfection towel. Staff ID #C was observed to have dropped the bleach disinfection towel on the floor. Staff ID #C reached down and picked up the dropped contaminated towel with her gloved hands, threw the towel in the garbage and picked up a new clean towel without removing her contaminated gloves and disinfecting her hands. She continued back to the machine to finish cleaning the machine. Interview on 03/28/2025 at 12:30 PM with staff #I confirmed that she should have removed her removed her soiled gloves and disinfected her hands before getting a new bleach towel and continuing to clean and disinfect the hemodialysis machine. The facility administrator, staff ID #C was with the surveyor during observation. He provided on the spot education to the staff member explaining the breaches in infection control and expectations.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 30124 Based on observation, interview and record review, the facility’s direct care staff: failed to clean and disinfect the wall drain boxes per the facility’s policy in 1 of 4 staff observed: Patient Care Technician (I). Policy Reviewed: Review on 03/28/2025 of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: DISINFECTION 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system ...” On 03/28/2025 at 12:20 PM, the surveyor along with the facility administrator, staff ID #C observed patient care technician, staff ID #I cleaning hemodialysis machine #25 at station #10. Staff ID # I failed to clean/disinfect the wall drain box. Interview on 03/28/2025 at 12:30 PM with staff #I confirmed that she should have also cleaned and disinfected the wall drain box but was nervous and forgot.”

“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: 30124 Based on observation, record review and interview, the facility failed to ensure Diasafe filters attached to 27 hemodialysis machines at the facility, were replaced based on manufacture’s recommendation for use in 27 of 27 hemodialysis machine #s 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, and 27. Findings: Review on 03/28/2025 of the manufacturer’s directions for use manual, Chapter 6; page 186; Replacing the Diasafe Plus Filter, “The Diasafe Plus filter is intended for the preparation of ultra-pure dialysate. If the machine has a Diasafe Plus filter, it should be replaced at least every 90 days (3 months). You must also replace the filter if the Diasafe test fails or shows and external leak.” Review on 03/28/2025 of the facility’s policy and procedure titled “Fresenius 2008 Series Automated Diasafe Plus Filter Integrity Test”, Procedure: 70-5-161. Revision Date: October 2024 directs staff as follows: “The use of a Diasafe Plus filter is not to exceed 90 days”. Observation along with the facility administrator, staff ID #C on 03/28/2025 at 12:15 PM of the hemodialysis treatment area Fresenius 2008 K hemodialysis machines revealed Diasafe filters plus in use on the back of the hemodialysis machines. Observation of labels on the Diasafe filters attached to these hemodialysis machines revealed they were last replaced on 11/21/2024. Review on 03/28/2025 of the biomedical scheduled Diasafe filter replacement documentation along with biomedical staff ID #M confirmed 27 of the 27 2008K hemodialysis at the facility had their Diasafe filters last replaced on 11/21/2025, not the required 90-day replacement as required. Interview at 12:20 PM with staff ID # M confirmed he had not changed any of the Diasafe filters plus on the facility’s since 11/21/2025.”