Davita South Austin Dialysis Center

“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: 43999 Based on review of documentation and interview, it was determined the facility Charge Nurses were assigned patient care duties contrary to Texas ESRD Rules and Regulations. Findings: Review of the staff/patient daily assignments for 6/16 & 17/2025, revealed the RN who was also the CN was assigned direct patient care along with the other RN who was assigned to administer medications. Direct patient care included : initiation and termination of patients that have a central venous catheter (CVC) as well as administration of some medications, assessments, and other CN duties to include emergencies. Floor observation 6/16/25 identified 2 RN and 5 PCTs . One RN is scheduled as the CN, they other RN is assigned as medication nurse. Staff #8 interviewed 6/16/25 and stated the two RNs scheduled daily share direct patient care. The Clinical Coordinator is sometimes available to assist, but also is scheduled direct patient care 2 -3 days a week. Staff # 3 interviewed 6/17/25 stated there is normally only two RNs scheduled on Saturdays, and they share direct patient care. In an interview on 6/17/25 with staff #Director of Operations confirmed CN/RN (staff #10) does provide direct patient care.Based on review of documentation and interview, it was determined the facility Charge Nurses were assigned patient care duties contrary to Texas ESRD Rules and Regulations.”

“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: 43999 Based on observation and staff interview, the facility failed to 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. Findings: During a tour of the facility’s building with Staff # 2 &10 on 06/16/2025 the surveyor observed the following physical environment issues: - Calcium buildup at all wall boxes with brownish colored stains in the treatment area. - Wash clothes used for disinfection of equipment not in container - All treatment chairs side tables with tape residual - Mold observed on clean sink faucet across from station 3 - 12 patient chairs with tears observed, office and nursing station chairs with tears - Water room had pipes going into the ceiling that were not sealed by the ceiling tiles. An interview with Staff #2 on 06/16/2025 confirmed the above findings.”

“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: 43999 Based on observation, interview and record review, the facility’s direct care staff failed to wear gloves and perform hand hygiene when between each patient or station. Findings: Facility policy titled, “Infection Control Overview” , published 05/02/2022 stated in part, All dialysis programs will incorporate the FKC infection control program, which is comprehensive in nature...All infection control policies for patient care are consistent with recommendation of the Centers for Disease Control (CDC). All infection control policies will adhere to CMS and OSHA rules and regulations.” On 6/16/25, staff # 9 & # 11 did not put on disposable gloves ( put index finger in one finger of the glove) before resetting a patient’s machine alarms then used the same one finger gloved hand to reset another patient’s machine. The staff did not sanitize hands. One patient entered the treatment room, weighed and used the thermometer at the weigh station without disinfecting it after use and other staff used the same thermometer without disinfecting it . The patient and the staff did not use gloves when handling the thermometer and did not sanitize hands before or after use. Staff #15 confirmed on 6/16/25 that patients and staff use the thermometer and do not disinfect between use and this does not follow the infection control procedures.”

“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: 43999 Based on observation and staff interview, the facility failed to follow standard infection control precautions for cleaning and disinfection of contaminated surfaces. Findings: On 6/16/25, during observation of the facility treatment floor the following was observed: - Six sharps containers in ( stations 3,4, 8,11,18, 20) had dried blood on the tops of the containers. - Dried blood observed on two patient’s chairs at Station #3 & #4 . During the observation of the treatment are on 6/16/25 the above was confirmed by Staff #2. The dried blood was immediate cleaned.”

“QA-GENERAL/RECORDS/TREND ANALYSIS CFR(s): 494.50(b)(1) 14 Quality assurance: general/records/trend analysis The criteria chosen as the internal standards of a facility shall be documented in its policy and/or procedure manual. Process review should be part of the activity of the individual carrying out the process, and oversight of that review by another qualified member of the staff or a group of staff members should affirm, modify, or repeat these observations to confirm or improve the process. Clinical outcomes serve as the most important indicator of quality of all dialysis treatment practices including reuse. Final oversight is the responsibility of the medical director. See Table 2 for a summary of the audit schedule. 14.1 Records A record of review, comments, trend analysis, and conclusions arising from QA practices serve as a foundation for future review and as documentation to external evaluation. This Standard is not met as evidenced by: 43999 Based on interview and review of documentation, the facility failed to document review, comments, trend analysis, and conclusions arising from QA practices . Findings: Review on 6/17/25 of the facility QAPI (Quality Assurance and Performance Improvement) meeting notes for March , April and May 2025 did not provide documentation that reflect facility actions plans, monitoring or followup to improve patient outcomes. During an interview on the afternoon of 6/17/25, Staff #2 and #5, acknowledged that the existing QAPI program did not provide documentation of actions plans, re evaluation and revisions”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 43999 Based on a review of facility policies, documentation on patient medical records, and staff interviews, the facility failed to meet the standard of Texas Administrative Code Title 25, §117.45 when (a) the plan of care for 3 of 3 patients (#21, #22, and #23) did not (7) reflect that 3 of 3 facility staff (#8, # 14, and #15), recognized or addressed deviations from the plan of care - when the maximum prescribed ultrafiltration rate (UFR) was exceeded and (A) implement any changes in interventions to avoid exceeding this UFR. Findings : Review of Incenter Hemodialysis Policies & Procedures DaVita Inc., Policy 1-03-08, titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, which states in part: 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ....The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation .... Prescription components include but are not necessarily limited to: ...d. UFR and Max UFR ....” Review of documentation for patient #21 revealed the following: Current physician order as of 4/15/25 specifies a maximum Ultrafiltration Rate (UFR) of 13 mL/kg/hr (milliliters/kilogram/hour). From the “Fluid and BP management report”. 6/06/25 - UFR = 14.1 mL/kg/hr. No documentation to reflect staff #14 recognized or addressed the UFR above 13 mL/kg/hr. 6/13/25 - UFR = 15.7 mL/kg/hr. No documentation to reflect staff #8 recognized or addressed the UFR above 13 mL/kg/hr. Review of documentation for patient #22 revealed the following: Current physician order as of 4/15/25 specifies a maximum UFR of 16 mL/kg/hr. From the “Fluid and BP management report”. 6/07/25 - UFR = 18.7 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 16 mL/kg/hr. 6/10/25 - UFR = 20.4 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 16 mL/kg/hr. Review of documentation for patient #23 revealed the following: Current physician order as of 6/10/25 (and previous order of 6/3/25) specifies a maximum UFR of 13 mL/kg/hr. From the “Fluid and BP management report”. 6/07/25 - UFR = 17.8 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 13 mL/kg/hr. 6/10/25 - UFR = 16.3 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 13 mL/kg/hr. 6/12/25 - UFR = 16.1 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 13 mL/kg/hr. 6/17/25 - UFR = 14.2 mL/kg/hr. No documentation to reflect staff #15 recognized or addressed the UFR above 13 mL/kg/hr. In an interview on 06/17/25, staff #7 confirmed that on the dates reviewed above, the UFR for these patients exceeded the prescribed UFR.”

“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: 43999 Based on facility documentation, observation and interviews the facility’s medical director failed to ensure staff follow their current policy and procedures Findings: Facility “ Policy: 1-03-08 titled “TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT in part states: 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient ‘s medical record.” On 6/17/25 , review of patients # 2 & #19 treatments sheets revealed the following : Patient (pt) #2 06/09/25: 1032 - B/P (blood pressure) 177/115 by RN #17, no intervention initiated 1100 - B/P 206/126 by PCT # 9, no RN notification, no assessment 1230 - B/P 198/120 by PCT #11, no RN notification, no assessment 1400 - B/P 197/118 by PCT # 9, no RN notification, no assessment 1430 - B/P 183/116 by PCT # 9, no RN notification, no assessment 1432 - B/P 184/110 by PCT #9, no RN notification, treatment terminated 06/11/25 1100 - B/P 174/106 by PCT #13, no RN notification, no assessment 1130 - B/P 170/107 by PCT #9, no RN notification, no assessment 1230 - B/P 169/103 by PCT #13, no RN notification, no assessment 1438 - B/P 193/117 by PCT #13 treatment discontinued,.no RN notification, no assessment Patient #19 06/11/25: 1230 - B/P (blood pressure) 154/136 by PCT #17, no RN notification, no assessment 1238 - B/P 130/56 by PCT # 17, no RN notification, no assessment 1303 - B/P 185/149 by PCT #17, no RN notification, no assessment 1304 - B/P 87/45 by PCT # 17, no RN notification, no assessment 1330 - B/P 111/58 by PCT #17, no RN notification, no assessment 1402 - B/P 171/154 by RN #15, comments recheck b/p, no other interventions,treatment terminated 06/13/25 1132 - B/P 151/49 by PCT #18, no RN notification, no assessment 1202 - B/P 101/37 by PCT #18, no RN notification, no assessment 1330 - B/P 137/56 by PCT #18, no RN notification, no assessment On 6/17/25, Staff # 2 & # 7 confirmed facility staff did not follow policy and procedures to notify RN when patient status changes during treatment. Incenter Hemodialysis Policies & Procedures DaVita Inc., Policy: 1-01-09; “TITLE: PRESCRIBED TREATMENT TIME NOT MET”, which states in part:: “A. COMPLETION OF THE EARLY TERMINATION OF TREATMENT AGAINST MEDICAL ADVICE FORM 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice [AMA] form any time the patient requests to terminate their treatment earlier than the prescribed run time. B. PRESCRIBED TREATMENT TIME NOT MET 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs.” Review of documentation for patient #20 revealed the following: 04/02/25 - Treatment terminated 47 minutes early. No documentation that staff #3 notified physician. 04/04/25 - Treatment terminated 14 minutes early. No documentation that staff #8 obtained a signed AMA form or that patient refused to sign an AMA form. 04/14/25 - Treatment terminated 20 minutes early. No documentation that staff #8 obtained a signed AMA form or that patient refused to sign an AMA form. 04/23/25 - Treatment terminated 33 minutes early. No documentation that staff #3 notified physician, obtained a signed AMA form, or that patient refused to sign an AMA form. Review of documentation for patient #21 revealed the following: 06/13/25 - Treatment terminated 28 minutes early. No documentation that staff #8 obtained a signed AMA form or that patient refused to sign an AMA form. Review of documentation for patient #22 revealed the following: 06/07/25 - Treatment terminated 18 minutes early. No documentation that staff #15 obtained a signed AMA form or that patient refused to sign an AMA form. 06/10/25 - Treatment terminated 1 hour and 6 minutes early. No documentation that staff #15 notified physician. In an interview on 6/17/25, Staff # 2 and #7 confirmed that patients are required to sign AMA forms if terminating treatments more than 30 min early. Staff # 2 and #7 also stated that patients are not required to sign AMA form if terminating treatments less than 15 minutes early. However, staff could not provide written documentation of above and stated that this policy probably came from a 6- to 7-year-old Governing Body that is now archived. .”