Angelo Kidney Connection

“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: While touring the facility on 6/3/25 the following was observed: 1. Chipped paint and sheet rock exposed behind patient stations,1,4,5,9 & 11. 2. Molding missing on cabinets throughout the facility and broken edging on cabinets. Floor tiles throughout the treatment area with unsealed tiles that have dirty residual buildup identified. 3. Divider partition between clean/dirty sink with rusted hinges. Interview 6/4/25 with Staff # 1 and staff #2 confirmed the above findings.”

“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: 43999 Based on observation and staff interviews the facility failed to ensure that dialysis machines are maintained and operated in accordance with the manufacturer’s recommendations related to annual preventative maintenance. Findings: B BRAUN machine Manufacturer Guidelines partly states: “1. Preventive Maintenance (every 2 years): B. Braun states that its Dialog+ Hemodialysis Machines require preventive maintenance every two years. This is highlighted as a benefit compared to competitor machines that may need annual maintenance... 3. Importance of Following Manufacturer Guidelines: · Proper maintenance, including cleaning, is crucial for extending the device’s lifespan, ensuring patient safety, and optimizing equipment performance. · Only trained personnel should perform maintenance and service procedures. · The B Braun Dialog Service Manual contains detailed procedures for cleaning, maintenance, and calibration. It is essential to refer to the specific manual for your model as maintenance tasks and frequencies may vary.” The facility was unable to provide documentation of completed annual Preventive Maintenance (PM) on five hemodialysis machines, Two due in March 2025, 1 due in April 2025 and 2 due in May 2025. There was no documented evidence that the recommended every 2 year preventative maintenance on the B- Braun machines was performed. In an interview on 6/4/25, staff #2 confirmed the above findings.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 43999 Based on a review of documentation and interview, the facility failed to contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. Findings : In interview on 04/23/24, the facility administrator stated the facility had not contacted the local emergency preparedness agency since 2020. The administrator stated the agency stated they did not have to contact them yearly. Documentation provided showed the last contact with the local emergency preparedness was in 2020, over 4 years ago.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 43999 Based on a review of documentation and interview, the facility failed to conduct exercises to test the emergency plan at least annually. Per requirements ESRD facilities must: i. Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; (B) If the ESRD facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ESRD facility is exempt from engaging in its next required community-based or individual, facility-based functional exercise for 1 year following the onset of the actual event. ii. Conduct an additional exercise at least every 2 years opposite the year the full scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. iii. Analyze the ESRD facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ESRD facility’s emergency plan, as needed. Findings: In interview on 04/23/24, the facility administrator stated the facility had no documented disaster drills for 2023 or 2024. Email correspondence provided by the facility indicated they last contacted the local community emergency contact in 2020 to request a drill or tabletop exercise in 2020.”

“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 that the facility failed to comply with State and local laws and regulations. A. Physician did not see the patients in the dialysis facility at a minimum of every 2 weeks during their hemodialysis treatment time. B. Review of the facility’s 2023 patient death reporting tool reviewed 11 deaths in 2023 and 3 deaths in 2024. Surveyor requested all Texas HHSC Incident Reports for Death reported in the year of 2023 to April 24,2024, none were provided. C. The facility failed to ensure that home dialysis patients were seen by the prescribing physician, advanced practice registered nurse, or physician’s assistant no less than one time a month. The prescribing physician shall see the patient at least one time every three months, if an advanced practice registered nurse, or physician’s assistant sees the patient on a monthly basis. D. The facility failed to complete discharge summaries within 30 days of leaving the facility. Findings : A. During medical record review of 10 patient medical records in the facility on 4/23/24 it was noted the physician only documented seeing the patients once a month during their treatment time. The NP(Nurse Practioner) documented 2-3 times a month on the 10 patients. B. The facility failed to report to the TDH (Texas Department of Health and Human Services Commission) the death of dialysis patients for January 2023 through April 24,2023 within the 10 working days. C. Review of 2 of 2 peritoneal home dialysis patients revealed they did not have monthly notes documented by a physician or nurse practitioner for 2024: -Patient #11 had nurse practitioner notes on 02/21/24 and 03/18/24, 04/22/24 physician note. Missing a note for January 2024. -Patient #12 had a physician note on 01/15/24 and a nurse practitioner note on 02/21/24, physician note on 04/22/24. Missing a note for March 2024. D. Review of medical records for discharged patients at the facility in 2024, revealed there was no discharge summary on 4 of the 4 patients closed medical records. In an interview 04/23/24, the Facility Administrator verified the above findings.”

“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, it was determined that the facility failed to monitor the environment to minimize the transmission of infectious agents within the unit and to the public. Findings: Observation in the treatment area on 4/23 & 24/24 revealed the following: - All patient treatment flowsheets on clipboards were stored on each machine, when documenting the staff would remove gloves, document and replace the clip board back on the machine. Interview with the CN revealed the dialysis machine was considered “dirty” at all times, and thus the clipboards with the treatment sheets would be considered “dirty” when stored on the machine. - The lab area with the centrifuge had clean supplies, binder and paper sitting on the container. - A used bottle of acid was found sitting on the counter designated for clean supplies. - the clean handwashing sink at the medication station had clean supplies stored underneath cabinet. - Two biohazard boxes with contaminated treatment supplies were stored under the clean cabinets with no top closure. - Clean bleach wipes were open and sitting exposed on counter top. - Packaged dialyzer in machine holder on each machine, Bicarb bag and plastic trash can sitting in each patient treatment chair on the day no patients were at the facility. Staff interviewed 4/24/24 regarding this practice, they stated , “ We place them there for the next day’s treatment.” -The supply storage area had shipping boxes open with clean supplies which could lead to cross contamination. The above findings were acknowledged by the Facility Administrator and the CN(Charge Nurse) 4/24/24.”

“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 interview the facility failed to follow standard infection control precautions in accordance with State and local laws yo minimize the transmission of infectious agents. Findings: While touring the facility on 4/23/24 the following was noted: 1. Chipped paint and sheet rock exposed behind patient stations,1,4,5,9 & 11. The floors and the wall bases were dirty. 2. Floors tiles throughout the treatment area with unsealed tiles that have dirty residual buildup identified. 3. A cabinet door in the lab area had a broken handle. 4. The hazardous waste storage room had clean supplies stored up against the biohazard waste boxes. 5. Eight ceiling tiles in the treatment room had stains that appear to be some type of leak. 6. Dirty sink area with rusty drain and rust noted around sink bowl 7. Five chairs on the treatment floor with ripped upholstery. Interview 4/23/24 with Facility Administrator confirmed the above findings.”

“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 record review and interview the facility failed to provide oversight of the QAPI (Quality Assessment and Performance Improvement) process to confirm, evaluate and improve the process. (Quality Assessment and Performance Improvement) Findings: Review of the 2024 QAPI reports revealed the facility had not established an action plan with followup evaluation and revisions related to patients missed treatments. There was no evidence the facility evaluated and revised as needed , the patient missed treatments in the monthly QAPI. January 2024 103 out of 365 treatments missed February 2024 57 out of 353 treatments missed March 2024 60 out of 392 missed treatments In an interview with the Facility Administrator 4/24/24, it was acknowledged there was no evaluation and revision made to the monthly missed treatments. Based on record review and interview the facility failed to analyze and trend actions plans implemented for patients missed treatments. Citing 3 months (January - March 2024) of QAPI (Quality Assessment and Performance Improvement)”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 43999 Based on review of documentation the facility registered nurse (RN ) failed to perform assessment when patient needs changed during treatment. Findings: Facility: “PROBLEM-CAUSE-SOLUTION CHART partly stated, PROBLEM- Hypotension CAUSE 1. Excess ultra-filtration 2. Antihypertensive therapy SYMPTOMS 1. Gradual or rapid drop in blood pressure 2. Syncope 3. Nausea and/ or vomiting SOLUTION 1. Trendelenburg position 2. Reduce ultra-filtration pressure and give NS PRN. Notify MD. 3. Reduce blood flow rate after MD orders. 4. Careful monitoring of blood pressure when patient on antihypertensives “ Review of patient treatments flowsheets 4/24/24 during observation on the dialysis treatment floor revealed 3 of 3 patient treatments flowsheets noted patient’s experienced hypotension during treatment with no nurse notification or intervention documented for the patient complication. Another 3 of 3 patients access and bloodline connections was covered under covering during treatment with no documentation of interventions taken by staff. The above findings were confirmed in an interview with the Charge Nurse 4/24/24 during observation on the treatment floor. there was no intervention documented on the patient’s treatment flowsheets of nurse notification or interventions taken to correct the patient hypotension.”