Sugarland 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, interview and record review, the facility failed to ensure the National Institute for Occupational Safety and Health guidelines were followed to maintain a safe environment to minimize and prevent transmission of infectious disease in 1 of 4 direct care staff observed: Patient Care Technician (C) Findings: Review of NIOSH’s bloodborne pathogens standard establishes minimum design performance elements for Engineering and work practice controls [29 CFR 1910.1030(d)(2)(i). This states that: “Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used.” Patient Care Technician (C) Station #3 Observation on 07/14/2025 at 8:31 a.m. revealed Patient Care Technician (C) at station #3 post hemodialysis treatment of a patient. Patient Care Technician (C) removed both vascular access needles from the patient and drop them into the sharps disposable container without engaging the needle safety of each needle. Subsequent observation at 9:18 a.m. of the sharps disposable container attached to hemodialysis machine #22 at station #3 revealed vascular access needles without the safety covering the needles. Subsequent observation at 9:19 a.m. of the sharps disposable container attached to hemodialysis machine #19 at station #2 revealed vascular access needles without the safety covering the needles. The Surveyor notified Patient Care Technician (C) at 10:00 a.m. of the potential for needlestick by not engaging the needle’s safety on the vascular access needles. Patient Care Technician (C) said, “I could stick myself. Yes, it is about safety.””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to wash/sanitize hands after removal of contaminated gloves in 2 of 6 staff observed: Patient Care Technician (C) and Patient #’s 1, 2 Findings: Review of the facility’s current policy and procedure: IC6 Hand Washing and Gloves for Patient Use directs the staff as follows: Implementation: “8. Gloves are to be used while performing intended procedures, then discarded. Handwashing is done before and after each procedure. Any break in gloves requires handwashing and new gloves before proceeding. Rationale: To prevent any entry area for infectious agents or cross contamination between patients.” Patient Care Technician (C) Patient #1 Observation on 07/14/2025 at 8:27 a.m., revealed Patient #1 holding his vascular access with a gloved hand at station #1. After the bleeding ceased, Patient Care Technician (C) taped the patient’s vascular access site. The patient removed his glove, pressed down the tape over his vascular access with his hands, picked up his personal items, was weighed, and left the treatment floor without being encouraged to wash/sanitize his hands. Patient #2 Observation on 07/14/2025 at 8:37 a.m., revealed Patient #2 holding his vascular access with a gloved hand at station #3. After the bleeding ceased, Patient Care Technician (C) taped the patient’s vascular access site and removed the patient’s glove. Patient #2 picked up his personal items, was weighed, and left the treatment floor without being encouraged to wash/sanitize his hands. Interview with Patient Care Technician (C) at 08:41 a.m. confirmed the above findings.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by: removing paper flowsheets from the top of the hemodialysis machines and placing them in a clean area in 1 of 6 staff observed: Registered Nurse (K). B) touching clean paper flowsheets with contaminated gloves in 2 of 6 staff observed: Registered Nurse (K), (I). C) cleaning and disinfecting the hemodialysis station with contaminated gloves after touching the biohazard waste lid in 1 of 6 staff observed: Registered Nurse (I). Cross Reference V117 Based on observation, interview and record review, the facility’s direct care staff failed to: document the daily disinfection of the hemodialysis machines used for patient care. B) clean and disinfect the back of hemodialysis machines, dialysate lines, chase counter tops and walls, and wall boxes in 2 of 6 staff observed: Patient Care Technician (G), (J). Cross Reference V122 Based on observation, record review and interview, the facility’s governing body failed to ensure expired medications are not stored, and in use in the facility for care and services of patients per policy. Cross Reference V143 Based on observation, interview and record review, the facility’s nurses failed to implement infection control measures by not using aseptic technique in connection of a central venous catheters in 1 of 2 sampled nurses observed: Registered Nurse (K), Patient #s 10, 8, 9. Cross Reference V147”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 48020 Based on observation, record review and interview, the facility failed to protect the patients by not verifying the conductivity and pH of the dialysate through independent means on machine #8 before beginning treatment. Testing the hemodialysis machine dialysate conductivity with an independent meter to the range of 0.4 mS/cm of the theoretical conductivity value of 12 and 16 mS/cm is necessary to protect hemodialysis patients from red cell hemolysis or crenation. Testing the hemodialysis machine dialysate pH with an independent meter to the pH range of 6.9 and 7.6 is necessary to protect patients from metabolic acidosis or alkalosis. An Immediate Jeopardy: A threat to the health and safety of facility’s patients was identified on the morning of 06/03/2025. The facility’s administrative staff was informed on 06/03/2025 at 12:55 p.m. that a threat to the health and safety of all patients receiving hemodialysis treatment was identified in the facility, in that during observation of Patient #1, the review of the paper flowsheet hanging from the clipboard on hemodialysis machine #8’s intravenous (IV) pole revealed the Machine Conductivity, Independent Conductivity and Independent PH were left blank. The independent verification of dialysate conductivity and pH prior to the initiation of the hemodialysis treatment was not completed as required by the facility’s policy. Cross Reference V250 Based on observation, record review and interview, the staff assigned water room duties, failed to document the water hardness testing on the water softener as per the facility’s policy. Review of the facility’s log to document the “End of Day Hardness Test Result” and “Initials for End of Day Hardness Test” were missing for the following dates: 04/08/2025, 04/12/2025, 04/15/2025, 05/03/2025, 05/06/2025, 05/10/2025, 05/15/2025 and 05/20/2025. Cross Reference V191”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s registered nurses failed to check the Automated External Defibrillator (AED) device, suction machine and oxygen tank and fill out the Crash Cart Checks log sheet. Findings: Observation of the Emergency (Crash) Cart on 06/03/2025 at 2:00 p.m. revealed a Phillips HeartStart AED, a Drive suction machine and an oxygen tank attached. Review of the facility’s Crash Cart Checks log on 06/03/2025 revealed no documentation that the Automated External Defibrillator (AED) or suction machine were functional and no initials of the person performing the emergency equipment checks on 4/22/2025, 5/3/2025, 5/8/2025, 5/13/2025, 5/15/2025, 5/20/2025, 5/22/2025 and 5/24/2025. Interview with Facility Administrator (L) confirmed the missing documentation on the Crash Cart Checks sheet. She also confirmed the checks should be performed each operational day.”

“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: 48020 Based on observation, interview and record review, the facility governing body failed to ensure all direct care staff participated in mock medical emergency (i.e. cardiopulmonary arrest) drills in 3 of 3 direct care personnel files reviewed: Charge Nurse (B), Patient Care Technician (C), RN-Clinical Manager (F) Findings: Charge Nurse (B) On 06/03/2025 and 06/05/2025 Charge Nurse (B) was observed on the treatment floor providing care and services to hemodialysis patients. Review of Charge Nurse (B’s) personnel and training file revealed she was hired on 05/01/2025. There was no documentation of participation in a mock medical emergency drill. Patient Care Technician (C) On 06/03/2025 and 06/05/2025 Patient Care Technician (C) was observed on the treatment floor providing care and services to hemodialysis patients. Review of Charge Nurse Patient Care Technician (C’s) personnel and training file revealed she was hired on 09/30/2024. There was no documentation of participation in a mock medical emergency drill. RN-Clinical Manager (F) On 06/03/2025 - 06/05/2025 RN-Clinical Manager (F) was on the treatment floor talking to staff and hemodialysis patients. Review of RN-Clinical Manager (F’s) personnel and training file revealed she was hired on 04/01/2025. There was no documentation of participation in a mock medical emergency drill. On 06/05/2025, the Surveyor requested from Facility Administrator (L) evidence that the above direct care staff participated in mock medical emergency drills. No documentation was provided.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, patients’ attending nephrologists failed to: round and assess patient’s every two weeks in 8 of 11 sampled patients: Patient #s 1, 2, 3, 5, 7, 8, 9, 10 B) complete monthly comprehensive progress notes on patients addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response in 8 of 11 sampled patients: Patient #s 1, 2, 3, 5, 7, 8, 9, 10 Findings: Patient #1 Observation on 06/03/2025 at 7:19 a.m. revealed Patient #1 was seated at station #1 machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left lower arm vascular access. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/06/2025. There was no documented physician progress note every two weeks as required by the state regulations. Patient #2 Observation on 06/03/2025 at 7:28 a.m. revealed Patient #2 was seated at station #3 machine #22 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 800 mL/min via left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/06/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 12/03/2024, 12/07/2024, 12/21/2024, 12/28/2024, 01/07/2025, 01/14/2025, 01/20/2025, 01/28/2025, 02/08/2025, 02/11/2025, 02/18/2025 and 02/27/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for December 2024 - February 2025. Patient #3 Observation on 06/03/2025 at 7:32 a.m. revealed Patient #3 was seated at station #4 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via right upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/10/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 12/03/2024, 12/07/2024, 12/21/2024, 12/28/2024, 01/07/2025, 01/14/2025, 01/20/2025, 01/28/2025, 02/08/2025, 02/11/2025, 02/18/2025 and 02/27/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for December 2024 - February 2025. Patient #5 Observation on 06/03/2025 at 7:42 a.m. revealed Patient #5 was seated at station #7 machine #6 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via a right central venous catheter. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/06/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 12/28/2024, 01/09/2025, 01/14/2025, 01/20/2025, 01/29/2025, 02/08/2025, 02/11/2025, 02/18/2025 and 02/27/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for December 2024 - February 2025. Patient #7 Observation on 06/03/2025 at 7:56 a.m. revealed Patient #7 was seated at station #15 machine #29 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via a right central venous catheter. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/03/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 12/03/2024, 12/07/2024, 12/21/2024, 12/28/2024, 01/07/2025, 01/14/2025, 01/20/2025, 01/28/2025, 02/06/2025, 02/11/2025, 02/18/2025 and 02/27/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for December 2024 - February 2025. Patient #8 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/07/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 01/06/2025, 01/20/2025, 02/07/2025, 02/10/2025, 02/17/2025, 02/24/2025 and 05/07/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for January, February and May 2025. Patient #9 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/07/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 01/06/2025, 01/13/2025, 01/20/2025, 01/27/2025, 02/03/2025, 02/10/2025, 02/17/2025, 02/24/2025 and 05/07/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for January, February and May 2025. Patient #10 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record (physician’s progress notes) on 06/04/2025 revealed the most current progress note was dated 05/07/2025. There was no documented physician progress note every two weeks as required by the state regulations. Review of the patient’s clinical record also revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 01/06/2025, 01/13/2025, 01/20/2025, 01/27/2025, 02/03/2025, 02/10/2025, 02/17/2025, 02/24/2025 and 05/07/2025. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no monthly comprehensive progress notes documented for January, February and May 2025. Interview with RN-Clinical Manager (F) on 06/05/2025 at 10:55 a.m. confirmed that the attending physicians did not complete the monthly comprehensive progress notes for the dates in question.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by: removing paper flowsheets from the top of the hemodialysis machines and placing them in a clean area in 1 of 6 staff observed: Registered Nurse (K) B) touching clean paper flowsheets with contaminated gloves in 2 of 6 staff observed: Registered Nurse (K), (I) C) cleaning and disinfecting the hemodialysis station with contaminated gloves after touching the biohazard waste lid in 1 of 6 staff observed: Registered Nurse (I) Findings: Review of facility’s current policy and procedure: Infection Control Policy # IC 01 states: “Cross-Contamination The company will provide for adequate measures to prevent cross-contamination of patients and staff.” Registered Nurse (K) Station #24 Observation on 06/04/2025 at 8:48 a.m. revealed Registered Nurse (K) was observed at station #24 disconnecting a patient’s CVC after the completion of the hemodialysis treatment. Registered Nurse (K) with his contaminated gloves, grabbed the flowsheet from the clipboard hanging from machine #23, walked to the scale to weigh the patient, removed his gloves, applied hand sanitizer, walked to the nurse’s station, placed the flowsheet on the counter to document, and then placed the flowsheet into the tray on the clean counter. Registered Nurse (K) did not remove his gloves and wash/sanitize his hands before grabbing the paper flowsheet attached to the clipboard. Subsequent observation of Registered Nurse (K) at 9:22 a.m. revealed Registered Nurse (K) providing catheter care and initiating hemodialysis on a patient. During the observation, Registered Nurse (K) walked from station #24 with his contaminated gloves and grabbed two green hemostats from the clean drying station and applied them to the patient’s hemodialysis bloodlines. Registered Nurse (K) then grabbed the clipboard with flowsheet that was hanging on the hemodialysis machine intravenous pole with his contaminated gloves, touched the hemodialysis machine several times and documented on the paper flowsheet and hung the clipboard back on the hemodialysis machine. Registered Nurse (K) did not remove his gloves and wash/sanitize his hands before grabbing the green hemostats and in between touching the hemodialysis machine and documenting on the paper flowsheet attached to the clipboard. Station #22 Observation 06/04/2024 at 9:40 a.m. revealed Registered Nurse (K) at station #22 providing CVC care to a patient in preparation for the initiation of hemodialysis treatment. Registered Nurse (K) then grabbed the clipboard with flowsheet that was hanging on the hemodialysis machine intravenous pole with his contaminated gloves, touched the hemodialysis machine several times and documented on the paper flowsheet and hung the clipboard back on the hemodialysis machine. Registered Nurse (K) did not remove his gloves and wash/sanitize his hands in between touching the hemodialysis machine and documenting on the paper flowsheet attached to the clipboard. Interview with Registered Nurse (K) at 10:00 confirmed the deficient practices. Registered Nurse (I) Station #21 Observation on 06/04/2025 at 8:33 a.m. revealed Registered Nurse (I) at station #21 grabbing the clipboard with flowsheet that was hanging on the hemodialysis machine intravenous pole with her contaminated gloves, touching the hemodialysis machine several times and documenting on the paper flowsheet before hanging the clipboard back on the hemodialysis machine. Registered Nurse (I) did not remove her gloves and wash/sanitize her hands in between touching the hemodialysis machine and documenting on the paper flowsheet attached to the clipboard. Subsequent of Registered Nurse (I) at 8:37 a.m. revealed Registered Nurse (I) at station #21 documenting on paper flowsheet attached to the clipboard after the patient vacated the station. Registered Nurse (I) removed the dirty hemodialysis bloodlines from the hemodialysis machine, walked to the biohazard waste receptacle, lifted the biohazard lid and discarded the bloodlines. Registered Nurse (I) then returned to the hemodialysis machine, picked up a clean bleach towel with the contaminated gloves and wiped the Sharp’s container attached to the machine. Registered Nurse (I) did not remove her gloves and wash/sanitize her hands in between disposing of the dirty bloodlines and picking up the clean bleach towel to clean and disinfect the Sharp’s container. Interview with Registered Nurse (I) at 8:47 a.m. confirmed the deficient practices. Station #8 Observation on 06/04/2025 at 8:56 a.m. revealed Registered Nurse (I) at station #8 performing an assessment on the patient with gloves donned on her hands. Registered Nurse (I) grabbed the clipboard with flowsheet that was hanging on the hemodialysis machine intravenous pole with her contaminated gloves, touched the hemodialysis machine several times and documented on the paper flowsheet and hung the clipboard back on the hemodialysis machine. Registered Nurse (I) did not remove her gloves and wash/sanitize her hands in between touching the patient and hemodialysis machine and documenting on the paper flowsheet attached to the clipboard. Interview during observation with RN-Clinical Manager (F) beginning at 8:33 a.m. confirmed the failure to prevent cross-contamination by removing paper flowsheets from the top of the hemodialysis machines and placing them in a clean area and by touching clean paper flowsheets with contaminated gloves.”

“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: document the daily disinfection of the hemodialysis machines used for patient care. B) clean and disinfect the back of hemodialysis machines, dialysate lines, chase counter tops and walls, and wall boxes in 2 of 6 staff observed: Patient Care Technician (G), (J). Findings: Review of facility’s current policy and procedure: Disinfecting Patient Equipment # IC 04 directs staff as follows: “POLICY It is the policy of Sugar Land Dialysis that all patient care equipment shall be thoroughly cleaned and disinfected by assigned personnel. Single use items shall be discarded unless SLD management and the manufacturer have approved the disinfecting process and reuse. Sugar Land Dialysis shall define the process of handling disposal and or disinfection of patient care equipment. SPECIAL INSTRUCTIONS In compliance with the Center for Disease Control, routine disinfecting shall be done on all dialysis equipment using a 1:100 ration Bleach solution.” Daily machine disinfection Observation of the hemodialysis treatment area on 06/03/2025 - 06/04/2025 revealed the facility has 24 stations with hemodialysis machines. The following hemodialysis machines were observed to be in use for patient care: Fresenius 2008T - #s 2, 5, 8; Fresenius 2008K - #s 6, 15, 22, 23, 25, 29, 30. Review of the facility’s machine disinfection log on 06/05/2025 revealed the log is used for daily disinfection documentation. Documentation on 05/15/2025 revealed that heat disinfection was completed for hemodialysis machines #s 14, 18, 20. The disinfection for the other machines used that day were not documented. Review of the facility’s patient chair assignment for 05/15/2025 revealed that there were 16 patients assigned to receive hemodialysis treatment. Interview with Biomedical Technician (E) on 06/05/2025 at 08:45 a.m. confirmed the missing disinfection documentation for the dates in question. Station disinfection Patient Care Technician (G) Station #2 Observation on 06/03/2025 at 8:45 a.m. revealed Patient Care Technician (G) terminally cleaning station #2 post hemodialysis treatment of a patient. Patient Care Technician (G) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines and chase countertop and wall, and wall box. Station #3 Observation on 06/03/2025 at 8:49 a.m. revealed Patient Care Technician (G) terminally cleaning station #3 post hemodialysis treatment of a patient. Patient Care Technician (G) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines and chase countertop and wall, and wall box. The Surveyor notified Patient Care Technician (G) at 8:54 a.m. that he failed to clean and disinfect the dialysis station per policy at station #s 2 and 3. Patient Care Technician (G) said, “Okay.” Patient Care Technician (J) Station #21 Observation on 06/04/2025 at 8:41 a.m. revealed Patient Care Technician (J) terminally cleaning station #21 post hemodialysis treatment of a patient. Patient Care Technician (J) failed to clean and disinfect the back of the hemodialysis machine, dialysate lines and chase countertop and wall, and wall box. The Surveyor immediately notified Patient Care Technician (J) that she failed to clean and disinfect the dialysis station per policy at station #21. Patient Care Technician (J) said, “Okay.””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s governing body failed to ensure expired medications are not stored, and in use in the facility for care and services of patients per policy. Findings: Review of the facility’s current Policy and Procedure on Storage of Concentrates and Heparin #MED13 directs staff as follows: “STORAGE OF CONCENTRATES AND HEPARIN 1. All drugs and acid concentrates should be dated in ink with the person opening the container initialing and dating it. 3. Heparin should be used if it is over ten days old ...” Treatment Area Observation of the hemodialysis treatment area on 06/03/2025 beginning at 12:06 p.m. revealed the following expired supplies were co-mingled with stocks in use: Bay 2 clean supply drawers: 13- Dynarex Triple Antibiotic Ointment Lot # 51729 expiration 12/24 1- opened Heparin 30,000 USP 30 mL Lot # A6E4611M expiration 2026-09, no open or discard date on the bottle 4- Zoledronic Acid Injection 5mg/100mL 1x100 mL Bag Lot # 00199 expiration AUG 2022 Medication refrigerator: 1- opened vial Epogen 20,000 units/2 mL Lot # 1177482 expiration 31 Jul 2027, no open or discard date Bay 5 clean supply drawers: 2- unlabeled, fluid-filled 3 mL syringes stored with saline flushes 1- opened Heparin 30,000 USP 30 mL Lot # A6E4611M expiration 2026-09, no open or discard date on the bottle 1- opened Heparin 50,000 USP 10 mL Lot # A6C5411K1 expiration 2026-09, no open or discard date on the bottle Evacuation cart: 1- Heparin Sodium Injection 50,000 USP 10 mL Lot # 6124232 expiration 05/23 Interview during observation with Facility Administrator (L) at 12:46 p.m. confirmed the findings above.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s nurses failed to implement infection control measures by not using aseptic technique in connection of a central venous catheters in 1 of 2 sampled nurses observed: Registered Nurse (K), Patient #s 10, 8, 9 Findings: Registered Nurse (K) Patient #10 On 06/04/2024 at 9:15 a.m., Patient #10 was observed at station #21 receiving central venous catheter (CVC) care before the hemodialysis treatment. Registered Nurse (K) was observed providing CVC care to the patient in preparation for the initiation of hemodialysis treatment. Observation revealed Registered Nurse (K) created a clean field to be used during CVC care, but the blue underpad was not completely opened and not all supplies were contained on the clean field. The portions of the pile of gloves were touching the arm of the hemodialysis chair and the thumb rests of the saline-filled syringes used to flush the lumens of the CVC were touching the chairside table. Registered Nurse (K) Patient #8 On 06/04/2024 at 9:27 a.m., Patient #8 was observed at station #24 receiving central venous catheter (CVC) care before the hemodialysis treatment. Registered Nurse (K) was observed providing CVC care to the patient in preparation for the initiation of hemodialysis treatment. Observation revealed Registered Nurse (K) created a clean field to be used during CVC care, but the blue underpad was not completely opened and not all supplies were contained on the clean field. The portions of the pile of gloves were touching the arm of the hemodialysis chair and the thumb rests of the saline-filled syringes used to flush the lumens of the CVC were touching the chairside table. Registered Nurse (K) Patient #9 On 06/04/2024 at 9:40 a.m., Patient #9 was observed at station #22 receiving central venous catheter (CVC) care before the hemodialysis treatment. Registered Nurse (K) was observed providing CVC care to the patient in preparation for the initiation of hemodialysis treatment. Observation revealed Registered Nurse (K) created a clean field to be used during CVC care, but the blue underpad was not completely opened and not all supplies were contained on the clean field. The portions of the pile of gloves were touching the arm of the hemodialysis chair and the thumb rests of the saline-filled syringes used to flush the lumens of the CVC were touching the chairside table. Interview with Registered Nurse (K) at 10:00 a.m. confirmed the deficient practice.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the staff assigned water room duties, failed to document the water hardness testing on the water softener as per the facility’s policy. Findings: Review of the facility’s current policy and procedure: RPC TOTAL HARDNESS TESTING # BM001 directs the staff as follows: “PURPOSE: To verify the functionality of prior regeneration and capacity to treat a sufficient volume of water to supply the facility for the entire treatment day. POLICY: Water softeners shall be tested at the end of each treatment day.” Observation of the water treatment room on 06/03/2025 revealed a water softener in use for the hemodialysis treatments. Review of the facility’s log to document the “End of Day Hardness Test Result” and “Initials for End of Day Hardness Test” were missing for the following dates: 04/08/2025, 04/12/2025, 04/15/2025, 05/03/2025, 05/06/2025, 05/10/2025, 05/15/2025 and 05/20/2025. Interview with Biomedical Technician (H) on 06/05/2025 at 8:45 a.m. confirmed the water harness testing results were not documented for the dates in question.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, facility’s direct care staff failed to protect the patients by not verifying the dialysate solution with an independent meter for conductivity and pH, prior to initiation of hemodialysis treatment on Patient #1, hemodialysis machine #8. Testing the hemodialysis machine dialysate conductivity with an independent meter to the range of 0.4 mS/cm of the theoretical conductivity value of 12 and 16 mS/cm is necessary to protect hemodialysis patients from red cell hemolysis or crenation. Testing the hemodialysis machine dialysate pH with an independent meter to the pH range of 6.9 and 7.6 is necessary to protect patients from metabolic acidosis or alkalosis. Findings: Review of the facility’s current policy and procedure on Verification of Dialysate Conductivity and pH Policy BM 32, directs staff as follows: “POLICY 1. Unless more frequent testing is required by state, local or network regulations, verification of dialysate conductivity and pH using an independent test method will be done daily prior to the initiation of treatment ... 3. Documentation of independent verification of dialysate conductivity and pH will be done on the Equipment Log for each delivery system used each time the tests are done. 4. No hemodialysis delivery system will be used for patient treatments if independent confirmation of dialysate conductivity and pH indicates that the system’s dialysate composition falls outside acceptable parameters ...” Station 1 Machine #8 Observation on 06/03/2025 at 7:19 a.m. revealed Patient #1 was seated at station #1 machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left lower arm vascular access. Review of the paper flowsheet hanging from the clipboard on hemodialysis machine #8’s intravenous (IV) pole revealed the Date, Machine #, Temperature, Machine Conductivity, Independent Conductivity, Independent PH and Checked by were all left blank. Review of the paper flowsheet hanging from the clipboard on hemodialysis machine #8’s IV pole revealed Patient #1’s hemodialysis treatment was initiated at 5:15 a.m. Patient Care Technician (C) failed to perform the independent verification of dialysate conductivity and pH prior to the initiation of the hemodialysis treatment on Patient #1 as required by the facility’s policy. Interview during the observation with Patient Care Technician (C) confirmed that the independent verification of dialysate conductivity and pH prior to the initiation of the hemodialysis treatment was not completed. Patient Care Technician (C) said, “I usually do it.” Testing the hemodialysis machine dialysate conductivity with an independent meter to the range of 0.4 mS/cm of the theoretical conductivity value of 12 and 16 mS/cm is necessary to protect hemodialysis patients from red cell hemolysis or crenation. Testing the hemodialysis machine dialysate pH with an independent meter to the pH range of 6.9 and 7.6 is necessary to protect patients from metabolic acidosis or alkalosis. The potential exists for all patients to be affected by the deficient practice if the dialysate conductivity is above the range of 0.4 mS/cm of the theoretical conductivity value of 12 and 16 mS/cm and the dialysate pH is above the range of 6.9 and 7.6. In those cases, the staff must discontinue use of the hemodialysis delivery system and the Nurse Director must be immediately notified if the dialysate composition falls outside of the acceptable parameters.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s governing body: failed to ensure expired supplies are not stored and in use for calibration and quality control testing of the blood glucose monitoring device. B) failed to ensure expired supplies are not stored, and in use in the facility for care and services of patients beyond the manufacturer’s directions for use. Findings: Expired glucometer testing supplies: Review of the facility’s current policy and procedure: Glucometer Testing directs the staff as follows: “I. Policy Summary This of this policy is to set forth the requirements to ensure the proper functioning of the glucometer through weekly quality control test ... III. Policy Text A. The glucometer will be tested weekly on the Mondays the clinics are open test results are to be documented on the glucometer quality control record in addition glucometer should be tested: ... V. Procedures A. All Glucometer. Follow manufacturer instruction on glucometer care and use. B. Control Testing Test Strips 1. Check and record lot number and expiration date on the glucometer quality control log (discard if expired) 2. And to test port.” C. Control Solutions 1. Check and record lot number and expiration date of each solution control level 1 and 2 2. Shake solution gently and squeeze a drop onto a piece of unused foil or plastic wrap 3. Touch edge of test strip tip to control solution ...” Review of the manufacturer’s direction for use package insert: Assure Dose Control Solution directs the staff as follows: “STORAGE AND HANDLING: “ Use before the expiration date printed on the bottle. “ Use the control solution within 90 days (3 months) of first opening. It is recommended that you write the date of opening on the control solution bottle label (“Date Opened”) opened as a reminder to dispose of the open solution after 90 days.” Observation of the glucometer station on 06/03/2025 at 10:59 a.m. revealed a container on the cabinet with an Assure Platinum Glucose Meter and a box with an opened bottle of test strips and quality control solutions with the following: Assure Platinum Blood Glucose Test Strips: Lot # 052124A expiration 2026-02-05 Opened date 2/27/25 - Expiration date 5/27/2025 written on the outside of the bottle Assure Dose Normal/High Control Solution: Lot # 040924A expiration 2025-08-17 Opened date 2/27/25 - Expiration date 5/27/2025 written on the outside of the box The box contained the following bottles: Normal (Level 1) Solution: Lot # 081723A expiration 2025-08-17, range 85-103 High (Level 2) Solution: Lot # 081823A expiration 2025-08-18, range 211-263 Review of the glucometer quality control log revealed the Assure Platinum Level 1 and Level 2 control solutions were used to confirm the meter was properly working on 05/28/2025, 05/30/2025 and 06/02/2025 with the Lot # 070723B. This lot number was different from the lot number on the opened bottle of solutions at the glucometer station with an open date of 02/27/2025: Lot # 040924A. Interview during the observation with Biomedical Technician (H) at 11:03 a.m. confirmed the expired Assure Platinum Glucose Meter quality control testing solutions and test strips. Review of the glucometer quality control log from 03/01/2025 - 06/02/2025, revealed Lot # 070723B was documented to confirm the meter was properly working. The documented control solutions had the following ranges: Normal (Level 1) Solution: range 83-104 and High (Level 2) Solution: range 203-253. These ranges were different than the ranges for the opened solutions found at the glucometer station with an open date of 02/27/2025: Normal (Level 1) Solution: range 85-103 and High (Level 2) Solution: range 211-263. Interview during record review with RN-Clinical Manager at 11:15 a.m. confirmed the above findings. Expired laboratory and ancillary supplies: Review of BD BACTEC/Lytic/10 Anaerobic/F Anaerobic and BD BACTEC Plus Aerobic/F Blood Culture Vials Instructions for Use directs staff as follows: “DO NOT USE culture vials past their expiration date.” Review of Starswab II Specimen Collection and Transport System instructions for use directs the staff as follows: “Features *The Starswab II® Collection and Transport Systems are intended for the collection and transportation of biological specimens from the patient to laboratory where direct microscopic examination and further culturing and diagnoses can be performed *Shelf life is 24 months *Amies Clear is a modified Amies gel that provides excellent survival for a wide range of bacteria and is compatible with gram stain *Tube label shows code, lot number, and expiration date *Spiral media chamber keeps sample immersed and protected during transport” Observation of the hemodialysis treatment area on 06/03/2025 beginning at 12:06 p.m. revealed the following expired supplies were co-mingled with stocks in use: Lab Area: 4- BD Bactec Lytic/10 Anaerobic/F Culture vials Lot # 4143064 expiration 2025-02-26 4- BD Bactec Plus Aerobic/F Culture vials Lot # 417467 expiration 2025-03-24 4- Pretium Canada Packaging ULC- Starswab II culture swabstick Lot # 2H11A expiration 2024-08-11 2- Pretium Canada Packaging ULC- Starswab II culture swabstick Lot # 2H19A expiration 2024-08-19 3- Pretium Canada Packaging ULC- Starswab II culture swabstick Lot # 2B113A expiration 2025-02-13 4- Pretium Canada Packaging ULC- Starswab II culture swabstick Lot # 3E01A expiration 2025-05-01 Bay 2 clean supply drawers: 3- Molnlycke Mepore adhesive surgical dressings Lot # 21120745 expiration 2024-02-28 1- Exel Int 20 mL disposable syringe Lot # 180612 expiration 2023-05-12 1- BD 30 mL disposable syringe Lot # 9303161 expiration 2024-10-31 Emergency cart: 2- Hudson RCI Adult Nasal Cannula Lot # 74C2001193 expiration 2025-03-16 Evacuation cart: 1- Nipro Priming Set Lot # 022817AKS expiration 2022-02-27 Interview during observation with RN-Clinical Manager (F) verified the above supplies were expired.”

“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 6 of 11 sampled patients: Patient #s 5, 9, 7, 1, 3, 6 Findings: Review of the facility’s current Policy and Procedure on Pre-Dialysis Assessment: Policy HD 05 directs staff as follows: “POLICY All patient undergoing hemodialysis should be pre-assessed by licensed hemodialysis nurse prior to the initiation of each treatment, this baseline information is necessary for assessing the patient’s response to the hemodialysis procedure ... PRESCRIPTION VERIFICATION: 1. Dry weight 2. Prescribed dialyzer 3. Prescribed dialysate 4. Prescribed blood flow 5. Prescribed dialysate flow 6. Treatment time 7. Heparinization/loading dose 8. Any other orders as prescribed by the nephrologist” Heparin Administration Patient #5 Observation on 06/03/2025 at 7:42 a.m. revealed Patient #5 was seated at station #7 machine #6 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via a right central venous catheter. The patient was utilizing an Optiflux 180 non reuse dialyzer. A syringe was engaged in the heparin pump for administering heparin. During the observation with Patient Care Technician (D) at the chairside, the Surveyor asked Patient Care Technician (D) to reveal how much Heparin was being administered. Patient Care Technician (D) tapped the Heparin button on the hemodialysis machine and the hemodialysis machine revealed 0.0 units of Heparin had been administered. The Surveyor notified Patient Care Technician (D) that the patient was not being administered heparin. Patient Care Technician (D) said, “It’s a catheter patient and we do give Heparin to catheter patients.” Review of the patient’s flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed a physician’s order for Heparin maintenance: 1,000 units per hour IV, Stop at the end. The patient is prescribed 3 hours and 45 minutes of treatment time which began at 5:24 a.m. The patient did not receive the prescribed Heparin administration for 2 hours and 18 minutes of the hemodialysis treatment. Patient #9 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. The patient was utilizing an Optiflux 160 non reuse dialyzer. A syringe was engaged in the heparin pump for administering heparin. During the observation with Patient Care Technician (J) at the chairside, the Surveyor asked Patient Care Technician (J) to reveal how much Heparin was being administered. Patient Care Technician (J) tapped the Heparin button on the hemodialysis machine and the hemodialysis machine revealed 0.5 units of Heparin were being administered per hour. Review of the patient’s flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed a physician’s order for Heparin maintenance: 1,000 units per hour IV, Stop at the end. The Surveyor notified Patient Care Technician (D) that the patient was not being administered heparin according to the physician’s order. Patient Care Technician (J) said, “Oh, it should have been 1.0.” Dialysate Flow Rate Patient #7 Observation on 06/03/2025 at 7:56 a.m. revealed Patient #7 was seated at station #15 machine #29 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 800 mL/min via a right central venous catheter. The patient was utilizing an Optiflux 160 non reuse dialyzer. Review of the patient’s flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed documentation which indicated the patient was prescribed a dialysate flow rate of 500 mL/min but received hemodialysis treatment at a dialysate flow rate of 800 mL/min from 4:47 a.m. - 7:56 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Interview during observation with RN-Clinical Manager (F) on 06/03/2025, the Surveyor informed RN-Clinical Manager (F) that the dialysate flow rate was not set on the hemodialysis machine as prescribed by the physician. RN-Clinical Manager (F) said, “Okay.” Treatment Time Patient #1 Observation on 06/03/2025 at 7:19 a.m. revealed Patient #1 was seated at station #1 machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left lower arm vascular access. Review of the patient’s flowsheet dated 05/22/2025 revealed the prescribed duration of dialysis of 3.5 hours. The Time documentation indicated the hemodialysis treatment began at 5:06 a.m. and ended at 8:30 a.m. which is a treatment duration of 3 hours and 24 minutes instead of the prescribed 3.5 hours. There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Patient #3 Observation on 06/03/2025 at 7:32 a.m. revealed Patient #3 was seated at station #4 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via right upper arm vascular access. Review of the patient’s flowsheet dated 05/29/2025 revealed the prescribed duration of dialysis of 3.15 hours. The Time documentation indicated the hemodialysis treatment began at 4:40 a.m. and ended at 7:38 a.m. which is a treatment duration of 2 hours and 58 minutes instead of the prescribed 3.15 hours. There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Patient #6 Observation on 06/03/2025 at 7:50 a.m. revealed Patient #6 was seated at station #13 machine #2 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via right arm vascular access. Review of the patient’s flowsheet dated 05/24/2025 revealed the prescribed duration of dialysis of 3.5 hours. The Time documentation indicated the hemodialysis treatment began at 6:05 a.m. and ended at 9:28 a.m. which is a treatment duration of 3 hours and 23 minutes instead of the prescribed 3.5 hours. There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Interview during record review on 06/05/2025 at 10:55 a.m. with RN-Clinical Manager (F) confirmed Patient #s 5, 7, 1, 3 and 6 did not receive their hemodialysis treatments as prescribed for the dates in question.”

“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: 48020 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 7 of 11 patients observed: Patient #s 1, 2, 3, 4, 5, 6, 7 Findings Patient #1 On 06/03/2025 at 7:19 a.m. Patient #1 was observed on the treatment floor of the facility at station #1. The patient was asleep and receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. During the observation, Charge Nurse (B) walked to station #1 with a medication cup in hand, awakened Patient #1 to notify him that she was giving him his medication, placed the medication cup on the chairside table and walked away. Patient #1 went back to sleep and did not take the medication. Observation of the patient’s chairside table revealed the medication cup with three orange capsules and a label outside of the cup that read “Calcitriol” left unsecured at the chairside. The medication was not in view of Charge Nurse (B) while she was giving care to the other patients. Review of the patient’s flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed a physician’s order for Calcitriol 2.0 mcg every treatment by mouth. Subsequent observation of Patient #1 at 8:44 a.m. revealed the medication cup labeled Calcitriol was still on the chairside table while the patient was being discontinued from the hemodialysis treatment. Review of the patient’s flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed documentation by the registered nurse that the patient was administered Calcitriol 2.0 mcg at 7:30 a.m. The registered nurse documented that the patient was administered the medication although the medication was left on the chairside table. Patient #2 On 06/03/2025 at 7:28 a.m. Patient #2 was observed on the treatment floor of the facility at station #3. The was receiving hemodialysis treatment at a blood flow rate of 300 mL/min and dialysate flow rate of 800 mL/min. Observation of hemodialysis machine #22 revealed a medication cup with three orange capsules and a label outside of the cup that read “Calcitriol” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Calcitriol 2.0 mcg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 2.0 mcg at 7:15 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. Patient #3 On 06/03/2025 at 7:32 a.m. Patient #3 was observed on the treatment floor of the facility at station #4. The was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. Observation of hemodialysis machine #25 revealed a medication cup with a green tablet and a label outside of the cup that read “Cinacalcet” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Cinacalcet 90 mg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Cinacalcet 90 mg at 6:20 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. Patient #4 On 06/03/2025 at 7:37 a.m. Patient #4 was observed on the treatment floor of the facility at station #6. The was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. Observation of hemodialysis machine #15 revealed a medication cup with orange capsules and a label outside of the cup that read “Calcitriol” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Calcitriol 0.5 mcg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 0.5 mcg at 6:46 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. Patient #5 On 06/03/2025 at 7:42 a.m. Patient #5 was observed on the treatment floor of the facility at station #7. The was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. Observation of hemodialysis machine #6 revealed a medication cup with an orange capsule and a label outside of the cup that read “Calcitriol” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Calcitriol 0.25 mcg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 0.25 mcg at 5:45 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. Patient #6 On 06/03/2025 at 7:50 a.m. Patient #6 was observed on the treatment floor of the facility at station #13. The was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 800 mL/min. Observation of hemodialysis machine #2 revealed a medication cup with orange capsules, a green tablet and a label outside of the cup that read “Cinacalcet” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Calcitriol 0.75 mcg and Cinacalcet 90 mg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 0.75 mcg and Cinacalcet 90 mg at 6:30 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. Patient #7 On 06/03/2025 at 7:56 a.m. Patient #7 was observed on the treatment floor of the facility at station #15. The was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min. Observation of hemodialysis machine #29 revealed a medication cup with an orange capsule and a label outside of the cup that read “Calcitriol” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the IV pole of the hemodialysis machine revealed a physician’s order for Calcitriol 0.50 mcg every treatment by mouth. The flowsheet also revealed documentation by the registered nurse that the patient was administered Calcitriol 0.50 mcg at 5:15 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 Charge Nurse (B) on 06/03/2025 at 8:58 a.m.: the Surveyor notified her that the oral medications were left unattended at the chairside and on top of the hemodialysis machines and were signed off as given. Charge Nurse (B) said, “Yes ma’am.””

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, facility’s registered nurses failed to administer total prescribed dosage of the medication (Ferrlecit) prescribed by the physician for management of anemia for patients receiving hemodialysis treatment in 2 of 11 sampled patients: #s 1, 4 Findings: Patient #1 Observation on 06/03/2025 at 7:19 a.m. revealed Patient #1 was seated at station #1 machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left lower arm vascular access. Observation of hemodialysis machine #8 revealed a 10 mL syringe with dark liquid and a label outside of the syringe that read “Ferrlecit” sitting on top of the machine. 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 flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed a physician’s order for Ferrlecit 125 mg every Tuesday IV push. Subsequent observation at 8:44 a.m. revealed Patient Care Technician (C) was observed discontinuing the patient’s hemodialysis treatment. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication to the patient. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Ferrlecit remained in the medication administration lumen and was discarded with the external blood lines. Patient #1 did not receive the complete dosage of the medication prescribed for anemia management. The surveyor immediately notified Charge Nurse (B) of residual Ferrlecit in the venous chamber medication Y-port lumen. Charge Nurse (B) said, “Yes, ma’am.” Review of the patient’s clinical record revealed the following laboratory result dated: 5/20/2025- Hemoglobin = 7.1 g/dL (CMS Measurement Assessment Tool- recommended goal for end stage renal dialysis patients = greater than 10 g/ dL) 5/6/2025- Hemoglobin = 7.0 g/dL Iron = 61 ug/dl (Ascend laboratory reference range 65-175 ug /dl) Transferrin = 152 mg/dL (Ascend laboratory reference range 215-365 mg/dL) Transferrin saturation = 29% (Ascend laboratory reference range 22-52 %) 4/22/2025- Hemoglobin = 7.3 g/dL 4/8/2025- Hemoglobin = 8.8 g/dL Patient #4 Observation on 06/03/2025 at 7:37 a.m. revealed Patient #4 was seated at station #6 machine #15 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left lower arm vascular access. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication to the patient. Review of the patient’s flowsheet located on the clipboard hanging from the intravenous (IV) pole of the hemodialysis machine revealed a physician’s order for Ferrlecit 62.5 mg every Tuesday IV push. The flowsheet also revealed documentation by the registered nurse that the patient was administered Ferrlecit 62.5 mg at 6:46 a.m. The registered nurse documented that the patient was administered the medication although residual medication was left in the lumen of the medication port. Patient #4 did not receive the complete dosage of the medication prescribed for anemia management. Review of the patient’s clinical record revealed the following laboratory result dated: 5/20/2025- Hemoglobin = 9.8 g/dL (CMS Measurement Assessment Tool- recommended goal for end stage renal dialysis patients = greater than 10 g/ dL) 5/6/2025- Hemoglobin = 8.8 g/dL Transferrin saturation = 17% (Ascend laboratory reference range 22-52 %) Interview during record review on 06/05/2025 at 10:55 a.m. with RN-Clinical Manager (F) confirmed the above findings.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s quality assessment performance committee failed to participate in and develop a robust comprehensive quality assessment improvement program, which identifies deficient areas of care and services of dialysis patients, conduct root cause analysis, and develop and implement plans to address all aspect of care and services of patients who receive hemodialysis treatment. Findings: Review of the facility’s current policy and procedure: Quality Assurance directs the staff as follows: “POLICY Sugar Land Dialysis shall maintain a planned systematic organization wide approach to designing, measuring, assessing and improving its performance. Outcome measurements of these performance improvement activities will be monitored on a continuous basis and all results will be reported at least annually to the Advisory Board (Quality Council). OBJECTIVES OF THE PROGRAM * To assess and evaluate the quality of client care services and appropriateness of care using structural process and outcome measures. * To identify deviations from facility and professional standards and pursue improvement opportunities by collecting and evaluating information. * To identify address track and resolve problems and client care services and satisfaction to ensure resolution and or improvement. * To increase awareness of each staff member of their role within the organization and foster involvement and participation in quality improvement program. * To meet state and federal regulatory and accreditation standards. SPECIAL INSTRUCTIONS 1. The program will reflect participation by all services and levels of staff and will subscribe to compliance with internal and external standards including the Medicare Conditions of Participation.” Interdisciplinary Team Participation Review of the Quality Assessment and Performance Improvement (QAPI) binder revealed the most current meeting minutes was dated 05/16/2025 for April 2025 data. The sign-in sheet to document Interdisciplinary Team (IDT) participation in the meeting held on 05/16/2025 was not signed by the medical director, facility administrator or social worker. Review of the QAPI binder revealed there were no sign-in sheets to document participation in the QAPI meetings by the IDT for November 2024, December 2024, January 2025 and February 2025. Interview with Facility Administrator (L) 06/05/2025 at 3:49 p.m. confirmed the missing documentation of IDT participation as evidenced by sign-in sheets. Physicians Visit of In-center Hemodialysis Patients Review of a sample of patients’ clinical record revealed documentation which indicated 8 of 11 sampled patients did not see their Nephrologist every two weeks as required by state regulations. Review of the QAPI meeting minutes revealed no documentation which indicated this issue was identified from November 2024 - April 2025. Review of a sample of patients’ clinical record revealed documentation which indicated 8 of 11 sampled patients did not receive a monthly comprehensive physician progress note addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment evaluation. Review of the QAPI meeting minutes revealed no documentation which indicated this issue was identified from November 2024 - April 2025. On 06/05/2025 at 4:15 p.m., the facility’s QAPI plans were reviewed with Facility Administrator (L) and RN-Clinical Manager (F) who confirmed that the plans did not address the identified deficient practices.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 48020 Based on observation, record review, and interview, per the Texas Administrative Code (TAC), Title 26 §117.62(f), the facility’s governing body failed to ensure all direct care staff take and pass the competency examination in 1 of 3 direct care personnel files reviewed: Patient Care Technician (C) Findings: Patient Care Technician (C) Patient Care Technician (C) was observed on the treatment floor of the facility on 06/03/2025 providing care and services to patients, i.e., cannulating patients’ vascular accesses and administering Heparin and Normal Saline to patients. Review of Patient Care Technician (C’s) personnel file revealed she was hired to the facility on 09/30/2024. The most current skills assessment was completed on 10/15/2024. A competency exam on file was dated 02/10/2025 and graded with a score of 75%. The score does not meet the required 80% needed to pass the training competency examination per state regulations. Interview with Facility Administrator (L) on 06/05/2025 at 2:45 p.m. confirmed the documented score was not the required passing score of 80%.”

“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 Predialysis Assessments when patients were admitted to the facility for hemodialysis treatments in 5 of 11 sampled patients: Patient #s 3, 6, 8, 9, 10 Findings: Review of facility’s current policy and procedure: Predialysis Assessment # HD 1 directs staff as follows: “All patients undergoing hemodialysis shall be pre-assessed by a licensed hemodialysis nurse prior to the initiation of each treatment, this baseline information is necessary for assessing the patient’s response to the hemodialysis procedure.” Patient #3 Observation on 06/03/2025 at 7:32 a.m. revealed Patient #3 was seated at station #4 machine #25 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via right upper arm vascular access. Review of the patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 07/02/2024 with the diagnoses of end-stage renal disease and hypertension, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed no documentation of an admission nursing assessment. Patient #6 Observation on 06/03/2025 at 7:50 a.m. revealed Patient #6 was seated at station #13 machine #2 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via right arm vascular access. Review of the patient’s clinical record revealed the patient was admitted to the facility on 07/02/2024 with the diagnoses of end-stage renal disease and hypertension, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed no documentation of an admission nursing assessment. Patient #8 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 09/09/2024 with the diagnoses of end-stage renal disease and diabetes, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed no documentation of an admission nursing assessment. Patient #9 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 11/20/2024 with the diagnoses of end-stage renal disease and hypertension, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed no documentation of an admission nursing assessment. Patient #10 Observation on 06/04/2025 at 9:52 a.m. revealed Patient #9 was seated at station #22 machine #5 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 600 mL/min via a right central venous catheter. Review of the patient’s clinical record revealed the patient was admitted to the facility on 06/05/2024 with the diagnoses of end-stage renal disease, hypertension and diabetes, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed no documentation of an admission nursing assessment. Interview with RN-Clinical Nurse Manager (F) on 06/05/2025 at 10:55 p.m. confirmed there were no admission nursing assessments on the patients above.”

“GOV-ADM RESP FOR RELATIONSHIP W/ESRD NW CFR(s): 494.180(a)(3) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (3) The relationship with the ESRD networks; This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility failed to schedule the initial coaching call with End Stage Renal Disease Network 14 as requested. Findings: Pre- survey communication with the End Stage Renal Disease Network 14, revealed the facility has not scheduled the initial coaching call for May or June to decrease hospitalizations and ER visit utilization. On 06/04/2025 at 1:17 p.m., Facility Administrator (L) was notified that the facility had not set up the coaching call with End Stage Renal Disease Network 14 for May or June. Facility Administrator (L) said, “We will get in touch with them today.””

“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: 10802 Based on observation, interview and record review, facility’s registered nurse failed to ensure a patient’s physician was notified that the patient was discharged from the facility above her target weight in 1 of 8 sampled patients. Patient #s 7 . Findings: Patient #7 On 06/3/2024 at 7:24 a.m. Patient #7 was observed on the treatment unit of the facility at station number 13. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 800 mls/ minute via a left upper arm vascular access. Review of patient #7’s treatment sheet dated 06/03/2024 revealed documentation which indicated the patient’s target weight of 126.5 kg, pre -treatment weight of 133.0 kg and post weight of 129.7 kg. Review of the patient’s post treatment weight revealed the patient was discharged from the facility 3.2 kg above the target weight. There was no documentation that the patient’s physician was notified of the patient discharged from the facility above his target weight. On 06/03/2024 The Surveyor notified the Facility’s Administrator that the patient was discharged 3.2 kg over target weight and that the physician was not notified. The Facility’s Administrator concurred with the assessment.”

“MD RESP-ENSURE IVD P&P FOLLOWED CFR(s): 494.150(c)(2)(ii) The medical director must- (2) Ensure that- (ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in §494.180(f). This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the Facility’s Medical Director failed to ensure all direct care staff providing hemodialysis treatment to patients are assessed for skill competency in 1 of 8 direct care staff personnel records reviewed: Patient Care Technician (E) Findings: Certified Clinical Care Technician (E) On 06/03/2024, Certified Clinical Care Technician (E) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of Certified Clinical Care Technician (E’s) personnel and training file revealed Certified Clinical Care Technician (E) is a float staff member. The most current skills competency assessment signed by the employee, Facility Administrator and Medical Director was on 04/10/2023. Review of the facility’s patient schedule revealed Certified Clinical Care Technician (E) provided care and services to hemodialysis patients on: 05/15/2024, 05/22/2024, 05/24/2024, 05/27/2024, 05/29/2024, and 05/31/2024. Interview with Facility Administrator (F) on 06/04/2024 confirmed the skills competency assessment for Certified Clinical Care Technician (E) was expired and a reassessment had not been completed.”

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 10802 Based on record review and interview, (A) the facility failed to review its emergency preparedness plan. (B) the facility’s staff fail to evaluate hazard /risk of its facility and develop and implement a plan to address identified risk/ hazard based on the assessment. (C) facility governing body failed to compile a list of patients receiving hemodialysis at the facility including patients’ names, care plan and special needs of the patients to be utilized during emergency evacuation of the facility. (D) facility’s governing body fail to ensure emergency supplies which were expired were not available for use and that the emergency evacuation boxes and crash cart were readily available for use in an emergency. (E) the facility fail to notify its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. Findings: Review on 03/06/2024 of the facility’s emergency plan provided by the facility’s administrator, revealed there was no evidence to reflect the emergency plan was updated every two years. Cross reference E 0004 Review of the facility’s emergency plan provided by the Facility’s Administrator revealed no evidence that the facility’s staff evaluate risk/ hazard to facility, and develop and implement plans to address identified risk/ hazard. On 03/06/2024 at 1:00 p.m. The Surveyor requested evidence that the facility evaluate risk/ hazard to facility, staff and develop and implement plans to address identified risk/ hazard. None was provided. Cross Reference E 0006 Review of the facility’s emergency log revealed the facility did not compile a list of patients receiving hemodialysis at the facility including patients’ names, care plan and special needs of the patients to be utilized during emergency evacuation of the facility. Cross Reference E 18 Observation on 03/04/2024 of the facility’s emergency evacuation boxes and emergency crash cart revealed they were stocked with expired supplies. Cross reference E 0028 On 03/06/2024 at 1:00 P.M the Surveyor requested evidence that the facility notified its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. No evidence was provided. Cross reference E 0032”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 48020 Based on observation, interview and record review, facility’s registered nurse failed to ensure medication ( Ferrlecit) prescribed by the physician for management of anemia for patients receiving hemodialysis treatment, total prescribed dosage of the medication were administered to patients in 7 of 15 sampled patients; #s 6, 10, 11, 4, 14, 7, 5. (B) facility’s interdisciplinary team failed to complete interdisciplinary care plan on patients in 5 of 15 sampled patients. Patient #s 6, 10, 15, 7, 8 (C) patient’s attending nephrologist failed to complete monthly comprehensive progress notes on patients addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response in 10 of 15 sampled patients, Patient #s 11, 1, 3, 6, 13, 4, 9, 8, 7, 5. Findings: Observation on 03/04/2024 during the survey revealed, 7 of 15 patients prescribed for administration of Ferrlecit (iron supplement) portion of the intravenous medications were left in the lumen of the medication administration port and were discarded at the end of the patient’s hemodialysis treatment. Cross reference V 549 Review of 5 of 15 sampled patients ’ clinical record revealed the facility’s interdisciplinary team failed to complete interdisciplinary care plan on patients. Cross Reference V 5 59 Review of 10 of 15 sampled hemodialysis patients’ clinical records revealed the patients’ attending nephrologist did not conduct visits on patients during the month of February 2024. Review of the patients’ progress notes for the months of November 2023 - January 2024 revealed the physician’s progress notes on 10 of 15 sampled patients did not address adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. During interviews on 03/06/2024 with the Facility’s Administrator when asked why the patients did not have a visit from the patient’s Nephrologist. No reasons were given. Cross reference V 560”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 10802 Based on record review and interview, the facility’s quality assessment performance improvement committee; (A) failed to conduct root cause analysis, develop and implement a plan to address dialysis adequacy in facility’s patients. (B) failed to implement a root cause analysis and plan to address an upward trend in hospitalization related to patients’ vascular accesses. Findings: Review on 03/6/202027 of the facility’s quality assessment performance meeting minutes and data revealed the following data: Facility’s goal 75% of patients with KT/V > 1.2 Dialysis adequacy KT/V October 2023 + 87.71 Dialysis adequacy KT/V November 2023 + 82.14 Dialysis adequacy KT/V October 2023 + 68.85 Facility’s goal 75% of patients’ with URR > 65 Dialysis adequacy URR October 84.21 Dialysis adequacy URR November 76.79 Dialysis adequacy URR December 70.30 The facility’s Quality Assessment Performance Improvement Committee did not conduct root cause analysis, develop and implement a plan to address dialysis adequacy in facility’s patients. Cross Reference V 629 Review of the facility quality assessment performance improvement meeting data and minutes revealed the following data: November 2023 : Meeting held December 12, 2023; three patients admitted to hospital for access related condition. December 2023 : Meeting held 1/26/2024; six patients admitted to hospital for access related conditions. There was no quality assessment performance improvement meeting held by facility for February 2024. The facility’s quality assessment performance improvement committee did not conduct root cause analysis and plan to address an upward trend in hospitalization related to patients’ vascular accesses. Cross reference V 633”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility failed to review its emergency preparedness plan, conduct tabletop drills with patients and staff based on hazards identified. Findings: Review on 03/06/2024 of the facility’s emergency plan provided by the facility’s administrator, revealed there was no evidence to reflect the emergency plan was updated every two years. (A) On 03/4/2024 at 1:30 p.m. the Surveyor notified the Facility’s Administrator that there was no documentation that the emergency plan was reviewed and that facility’s direct care staff participated in the Tabletop Exercise. No evidence was provided.”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility’s staff fail to evaluate hazard /risk of its facility and develop and implement a plan to address identified risk/ hazard based on the assessment. Findings: Interview with the Facility Administrator on 03/4/2024 during the entrance conference revealed she said the facility has 54 patients who receive hemodialysis treatment in the facility on three shifts from 4:30 a.m. - to 5:00 p.m. on Mondays Wednesdays and Fridays. Observation on 03/4/2024 - 03/06/2024 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on three shifts on Monday Wednesday and Friday. Review of the facility’s emergency plan provided by the Facility’s Administrator revealed no evidence that the facility’s staff evaluate risk/ hazard to facility, develop and implement plans to address identified risk/ hazard. On 03/06/2024 at 1:00 p.m. during an interview with the Facility’s Administrator, The Surveyor requested evidence that the facility’s staff evaluate risk/ hazard to facility, develop and implement plans to address identified risk/ hazard. None was provided.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility governing body failed to compile a list of patients receiving hemodialysis at the facility including patients’ names, care plan and special needs of the patients to be utilized during emergency evacuation of the facility. Findings: Interview with the Facility Administrator on 03/4/2024 during the entrance conference revealed she said the facility has 54 patients who receive hemodialysis treatment in the facility on three shifts from 4:30 a.m. - to 5:00 p.m. on Mondays Wednesdays and Fridays. Observation on 03/4/2024 - 03/06/2024 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on three shifts on Monday Wednesday and Friday. Review of the facility’s emergency plan provided by the Facility’s Administrator revealed no evidence that the facility’s staff compile a list of patients receiving hemodialysis at the facility including patients’ names, care plans and special needs of the patients to be utilized during emergency evacuation of the facility. During an interview with the Facility’s Administrator on 03/06/2024 the Surveyor requested to review the list of patients receiving hemodialysis at the facility including patients’ names, care plans and special needs of the patients to be utilized during emergency evacuation of the facility. None was provided.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 10802 Based on observation, interview and review of labels on facility’s emergency supplies, facility’s governing body fail to ensure emergency supplies which were expired were not available for use and that the emergency evacuation boxes and crash cart were readily available for use in an emergency. Findings: Observation and review on 03/04/2024 of the facility storage area and, evacuation boxes revealed the following expired supplies in stock for patient usage. Storage area near station #9 1 bottle Residual Chlorine Strip Lot #142111 expired on 11/30/2023. Evacuation boxes 2 bottles -500 mls bottles Alcavis, Product number 15501, expired 7/13/2023 1 bottle 100 mls bottle ExSept Plus, product code 15501, expired 6/19/2022 2 vials Heparin 30,000 units, 30 mls, Lot # A 61208 M, expired 2/2023 1 vial Heparin 50,000 10 mls, Lot number 6124232, expired 5/2022 2 packets 1000 mls Normal Saline, Lot number 210G02078, expired April 2022. 2 packets Syslog Mini Safety AV fistula needle sets, Lot # 170215321 expired 2/15/ 2017. 25 Nipro 18-gauge needles; Lot # 8E9, expired 4/30/2023. 1 Purell hand sanitizer expired 7/2023 Emergency crash cart 3 packets 1000 mls Normal Saline; Lot number 220602007 ,expired April 2023. 3 Nipro Excel 3 mls needles; Lot # 170908 expired 8/8/2022. 1 Yankauer Suction catheter, Lot #201803204 expired 3/19/2023. 4 Nipro 10 mls disposable syringes ; Lot # 20170526, expired 4/30/2022. 3 Nipro 10 mls disposable syringes ; Lot # 20170815, expired 7/31/2022. During observation the facility’s Regulatory compliance personnel was present and observed the expired supplies. He checked the supplies and confirmed that they were expired.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility failed to notify its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. Findings: Interview with the Facility Administrator on 03/4/2024 during the entrance conference revealed she said the facility has 54 patients who receive hemodialysis treatment in the facility on three shifts from 4:30 a.m. - to 5:00 p.m. on Mondays Wednesdays and Fridays Observation on 03/4/2024 - 03/06/2024 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on three shifts. Review of the Facility’s emergency management record provided by the Facility’s Administrator, revealed no documentation that the facility notified its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. On 03/06/2024 at 1:00 P.M the Surveyor requested evidence that the facility notified its area emergency management center of its existence, the type of patients served and the need base of the patients in an emergency. No evidence was provided.”

“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, record review, and interview, the facility’s governing body failed to ensure expired hand sanitizer is not in use in the facility for care and services of patients and staff. Findings: Review of Germ-X hand sanitizer FAQs on germx.com (manufacturer website) revealed: “We recommend that Germ-X hand sanitizers are not used after the expiration date and should be disposed of at that point. Germ-X products are safe and effective when used as stated on the label and before expiration.” Review of PURELL hand sanitizer FAQs on gojo.com (manufacturer website) revealed: “Typically, PURELL Hand Sanitizer products expire 36 months after manufacture ... We always recommend not using product by its printed expiration date.” Observation of the nurse’s stations revealed the following expired supplies were co-mingled with stocks in use: 4 bottles hand sanitizer - 1 Original Hand Sanitizer Lot # B1P077, expired 03/2022 1 Germ-X Lot # 04592, expired 06/2022 1 Purell Lot # 377929, expired 08/2023 1 Purell Lot # KG1206280, expired 12/2023 Interview with Patient Care Technician (A) on 03/04/2024 at 07:40 a.m.: when asked about the expired Original Hand Sanitizer bottle at the nurse’s station, Patient Care Technician (A) said, “You are going to find many of the hand sanitizer bottles expired because they refill them.””

“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: wash/sanitize hands after removal of contaminated gloves in 4 of 6 staff observed: Patient Care Technician (A), (H), (B), Nephrologist (P), B) encourage patients to wash/sanitize hands after removal of contaminated gloves in 2 of 2 staff observed: Patient Care Technician (A) and Registered Nurse (D) and Patient #’s 5, 12. Findings: Review of the facility’s current policy and procedure: Hand Washing and Gloves for Patient Use directs the staff as follows: Implementation: 8. Gloves are to be used while performing intended procedures, then discarded. Handwashing is done before and after each procedure. Any break in gloves requires handwashing and new gloves before proceeding. Rationale: To prevent any entry area for infectious agents or cross contamination between patients. Patient Care Technician (A) Observation on 03/04/2024 at 8:45 a.m., revealed Patient Care Technician (A) tearing down the blood lines on machine #22 at station #1, post hemodialysis treatment of a patient. Patient Care Technician (A) removed the contaminated gloves, walked to the nurse’s station, grabbed clean gloves from the box of gloves and donned them. He then picked up a bag of laboratory tubes and handed it to another staff member who took the bag to the dialysis station for the next patient. Patient Care Technician (A) did not wash/ sanitize hands after removing the contaminated gloves. Patient #5 Observation on 03/04/2024 at 9:11 a.m., revealed Patient #5 holding his vascular access site with a gloved hand at station #1. After the bleeding ceased, Patient Care Technician (A) taped the patient’s vascular access site. The patient removed the contaminated glove, picked up his personal items, weighed himself and left the treatment floor without washing/sanitizing his hands. Patient Care Technician (A) did not encourage the patient to wash/ sanitize his contaminated after removing the contaminated glove used to hold his vascular access site. The Surveyor notified Patient Care Technician (A) at 09:15 a.m. that he and the patient did not wash/sanitize their hands after removal of contaminated gloves. Patient Care Technician (A) said, “Okay.” Registered Nurse (D) Observation on 03/04/2024 at 08:40 a.m., revealed Patient #12 holding his vascular access with a gloved hand at station #2. After the bleeding ceased, Patient Care Technician (A) taped the patient’s vascular access site. The patient picked up his personal items, Registered Nurse (D) followed the patient to the weight scale to weigh him, and the patient left the treatment floor without washing/sanitizing his hands. The Surveyor notified Registered Nurse (D) at 08:42 a.m. the patient did not wash/sanitize his hands after holding his access and removing his gloves. Registered Nurse (D) said, “Okay.” Nephrologist (P) Observation on 03/04/2024 at 9:25 a.m., revealed Nephrologist (P) visiting with the patient at station #6. Nephrologist (P) removed his gloves and laid them on to the clean supply counter and grabbed clean gloves from the box. He used the hand sanitizer, donned the clean gloves, and picked up the gloves he had just removed, threw them into the waste basket, and picked up the clip board lying on machine #8 at station #5. The Surveyor notified Nephrologist (P) at 9:25 a.m. that he failed to wash/sanitize his hands after removal of his gloves. Nephrologist (P) said, “I’m sorry about that.” 10802 Patient Care Technician (H) On 03/04/2024 at 8:25 a.m. Patient Care Technician (H ) was observed at station #14, hemodialysis machine # 19. The patient care technician was wearing a pair of gloves which she used to open the panel of random patient # 16’s hemodialysis machine and visualize data of the patient. After opening the panel on the patient’s hemodialysis machine, Patient Care Technician (H) used her contaminated gloves to enter information on the patient’s clinical record stored in a protective shield on the hemodialysis machine intravenous pole. After documenting the patient’s information on the clinical record, Patient Care Technician (H) walked over to station #13 while wearing the contaminated gloves used on station #14 and opened the panel of the Random Patient (#17’s) hemodialysis machine, visualized the patient’s data and entered information of the patient’s clinical record stored in a protective shield on the hemodialysis intravenous pole. The patient care technician did not remove her contaminated gloves and wash/ sanitize her hands in between patients’ hemodialysis machines and records to be stored in the patient’s hard charts. The Surveyor immediately notified her of the observation of not removing her contaminated gloves and washing or sanitizing her hands in between touching patients’ hemodialysis machine. The patient care technician did not respond. Patient Care Technician (H) On 03/04/2024 at 8:30 a.m. Patient Care Technician (H) was observed at station #13, the chairside of Random Patient #17. The patient care technician was discontinuing hemodialysis treatment on the patient. Patient Care Technician (H) removed her contaminated gloves, sanitize, walked over to the clean area, and picked up clean white clamps to apply to the patient’s vascular access site and applied a pair of clean gloves which she used to apply the clamp to the patient’s vascular access site. After applying the clamp and reinforcing the patient’s vascular access dressing, Patient Care Technician (H) used her contaminated gloves to pick up patient’s bag and placed patient’s blanket into the patient’s bag. The Patient Care Technician did not remove the contaminated gloves and wash/ sanitize her hands after reinforcing the patient’s vascular access dressing. The Surveyor immediately notified her of the observation of not removing her contaminated gloves and washing/ sanitizing her hands in between touching station numbers 13 and 14’s hemodialysis machines and handling the patient’s personal belongings with her contaminated hands. Patient Care Technician (H) became argumentative about the observation. The facility’s regulatory compliance personnel was present during the interview. Patient Care Technician (B) On 03/04/2024 at 8:45 a.m. Patient Care Technician (B) was observed at station #19, hemodialysis machine # 25. The patient care technician was wearing a pair of gloves which she used to reset the hemodialysis machine of a patient receiving hemodialysis treatment . Observation revealed Patient Care Technician ( B) after removing her contaminated gloves walked over to the clean supply cupboard located on the dialysis unit, opened the drawer with her hands and removed clean dressing from the drawer. The patient care technician did not wash/ sanitize her hands after removing her contaminated gloves used to reset the patient’s hemodialysis machine. The Surveyor immediately notified Patient Care Technician (B) that she did not wash/ sanitize her hands after removing the contaminated gloves . Patient Care Technician (B) states “ oh.” Nephrologist (P) On 03/04/2024 at 9:20 a.m. Nephrologist (P) was observed at the chairside of Patient #13 who was receiving hemodialysis treatment. Observation revealed the nephrologist wearing a pair of gloves examined the legs and feet of Patient #13 for signs of edema. After examining the patient’s legs and feet, Nephrologist (P) removed his contaminated gloves used to examine the patient, walked over to the clean supply cupboard, and removed a pair of gloves from a clean box of gloves stored on the cupboard with his contaminated hands. Nephrologist (P) did not wash/ sanitize his hands after removing the contaminated gloves used to examine the patient’s legs and feet. The Surveyor immediately notified Nephrologist (P) that observation of him revealed he did not wash/ sanitize his hands after removing the contaminated gloves. Nephrologist (P) states “ I was wearing gloves, so I thought I do not have to wash my hands.””

“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: 10802 Based on observation, interview and record review, facility’s direct care staff failed to clean/ disinfect prime bucket, back of hemodialysis machine, chase, hoses, water box and television console during terminally cleaning of contaminated hemodialysis units and prevent cross contamination of hemodialysis unit while setting up hemodialysis unit for future patients in 2 of 6hemodialysis units observed terminally cleaned; Hemodialysis units #s 22 and 9 B) failed to disinfect the plastic hemostat clamps by soaking them in 1:100 bleach in the opened position. Findings: Review of the facility ’ s current policy and procedure on Disinfecting Patient Equipment # IC 04 directed staff as follows: “ It is the policy of Sugar Land Dialysis that all patient care equipment shall be thoroughly cleaned and disinfected by assigned personnel. Single use items shall be discarded unless SLD management and the manufacturer have approved the disinfecting process and reuse.” SPECIAL INSTRUCTIONS “In compliance with Center for Disease Control, routine disinfecting shall be done on all dialysis equipment using 1:100 bleach solutions. “ Hemodialysis station 22, Registered Nurse (G) On 03/04/2024 at 8:47 a.m. Registered Nurse ( G) was observed terminally cleaning hemodialysis station #22. The registered nurse was terminally cleaning the hemodialysis station post hemodialysis treatment of a patient. Observation revealed during terminal cleaning of the hemodialysis station Registered Nurse (G) did not clean and disinfect the prime bucket. Subsequent observation on 03/04/2024 at 9:05 a.m. after terminally cleaning the station, Registered Nurse (G) was observed preparing the hemodialysis machine in the station for an on coming patient. Observation revealed Registered Nurse (G) donned clean gloves, picked up the garbage can which was not terminally cleaned with his gloved hands. The registered nurse used his contaminated gloved hands to open the packets with external blood line, Normal Saline and dialyzer and proceeded to string and prime the external blood lines of the machine using his contaminated gloves used to pick up the contaminated garbage can. During an interview on 03/04/2024 at (9: 07 a.m. with Registered Nurse (G) the Surveyor notified him of break in infection control technique of him not terminally cleaning / disinfecting the prime bucket and that he used his contaminated gloved hands to open the packets with external blood lines, Normal Saline and dialyzer and proceeded to string and prime the external blood lines of the machine using his contaminated gloves. Registered Nurse (G) states “Thanks.” Hemodialysis station #9, Patient Care Technician (M) On 03/04/2024 at 2:15 p.m. Patient Care Technician (M) was observed on the hemodialysis unit at station # 9. The patient care technician was terminally cleaning the contaminated unit previously utilized by a patient for hemodialysis treatment. Observation revealed during terminal cleaning of the hemodialysis unit, the patient care technician did not clean and disinfect prime bucket, back of hemodialysis machine, chase, hoses, water box and television console. During an interview on 03/04/2024 at 2:30 p.m. with Patient Care Technician (M) the surveyor asked if she was finished cleaning the unit, she states “yes.” Further observation reveled the hemodialysis machine was attached to a container for acid and vinegar cleaning for end of day disinfection. The Surveyor informed Patient Care Technician (M) that she was disinfecting the internal pathway of the dialysis for end of day cleaning while she did not clean and disinfect prime bucket, back of hemodialysis machine, chase, hoses, water box and television console. 48020 Observation of Laboratory Area Observation on 03/04/2024 at 09:35 a.m. of the laboratory area revealed a 1:100 bleach bucket with plastic hemostat clamps soaking in the bleach solution not in the opened position. During observation, Patient Care Technician (B) walked over and placed green hemostats into the 1:100 bleach solution in the closed position. The Surveyor notified Patient Care Technician (B) of the plastic hemostat clamps soaking in the bleach not in the opened position. Patient Care Technician (B) said, “Oh, they are supposed to be opened.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 48020 Based on observation, interview, the facility’s governing body failed to ensure expired supplies are not stored, and in use in the facility for hemodialysis machine residual chlorine and dialyzer blood leak testing. Based on observation, interview and record review of labels on supplies, facility’s direct care staff failed to ensure expired supplies were not available for use in the facility for care and services of patients. Findings: Review of manufacturer’s instruction for use product insert for RP E-Z Chek Residual Chlorine test strips revealed: “Storage and Handling “ Do not use a test strip (from an opened bottle) after the expiration date.” Review of manufacturer’s instruction for use product insert for Hach Blood Leak Reagent Strips revealed: “Storage ...Use within 6 months after first opening the bottle. Do not use the test strips (from an opened or unopened bottle) after the expiration date.” Observation of the nurse’s stations revealed the following expired supplies were co-mingled with stocks in use: 3 bottles - RP E-Z Chek Residual Chlorine test strips Lot # 14211, expired 11/30/2023 1 bottle - Hach Blood Leak Reagent Strips Lot # 7289, expired 09/2020 Interview with Patient Care Technician (A) on 03/04/2024 at 07:40 a.m. revealed that the facility uses the Hach Blood Leak reagent strips. When notified that the strips were expired Patient Care Technician (A) said, “we use these when we have one.” Interview with Patient Care Technician (L) on 03/04/2024 at 07:46 a.m. revealed that the facility uses the RP E-Z Chek Residual Chlorine test strips. When notified that the strips expired Patient Care Technician (L) said, “Wow, and we use them.” 10802 Observation and review on 03/04/2024 of the facility storage area, evacuation boxes revealed the following expired supplies in stock for patient usage. Storage area near station #9 1 bottle Residual Chlorine Strip Lot #142111 expired on 11/30/2023. Water room 11:55 a.m. 1 bottle Residual Chlorine Strip Lot #142111 expired on 11/30/2023. Storage room I bottle except plus product code 15107 expired 2/6/2023. During observation the facility’s Regulatory compliance personnel was present and observed the expired supplies. He checked the supplies and confirmed that they were expired.”

“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: 10802 Based on observation, interview and record review, facility’s registered nurse failed to ensure patients’ hemodialysis treatments were administered based on physician’s prescribed dialysate rate in 3 of 15 sampled patients; Patient #s 1, 2 and 3 Findings: Patient #1 On 03/04/2024 at 7:06 a.m. Patient #1 was observed at station #23 hemodialysis machine # 18. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute via right double lumen central venous catheter. Review of the patient’s prescription on the patient’s treatment sheet located at the patient’s chairside, revealed a physician’s order for dialysate flow rate of 800 mls/ minute. The surveyor immediately notified Registered Nurse (G) that the patient’s dialysate flow rate was not set at the prescribed rate. Registered Nurse (G) said “thanks.” Review of the patient’s treatment sheet dated 03/04/2024 revealed the patient’s hemodialysis treatment was initiated by a registered nurse at 05:14 a.m. Review of the patient’s treatment sheet dated 03/04/2024 and timed 7:30 a.m. revealed the following documentation by Registered Nurse (G) “Dialysate flow rate raised to 800 per prescription.” This documentation was made after the surveyor’s observation. Patient #2 On 03/04/2024 at 7:20 a.m. Patient #2 was observed at station #20 hemodialysis machine # 24. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute via an arteriovenous fistula. Review of the patient’s prescription on the patient’s treatment sheet located at the patient’s chairside, revealed a physician’s order for dialysate flow rate of 800 mls/ minute. Review of the patient’s prescription located in the patient’s hard chart revealed a physician’s order dated 12/27/2023 for dialysate flow rate of 700 to 800 mls / minute. The surveyor immediately notified Registered Nurse (G) that the patient’s dialysate flow rate was not set at the prescribed rate. Registered Nurse G states “thanks.” Review of the patient’s treatment sheet dated 03/04/2024 revealed the patient’s hemodialysis treatment was initiated by a registered nurse at 04:49 a.m. Review of the patient’s treatment sheet dated 03/04/ 2024 and timed 7:30 a.m. revealed the following documentation by Registered Nurse (G) “DFR !800 per prescription.” Patient #2 On 03/06/2024 at 7:15 a.m. Patient #2 was observed at station #20 hemodialysis machine # 24. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via an arteriovenous fistula. Review of the patient’s prescription on the patient’s treatment sheet located at the patient’s chairside, revealed a physician’s order for dialysate flow rate of 800 mls/ minute. Review of the patient’s prescription located in the patient’s hard chart revealed a physician’s order dated 12/27/2023 for dialysate flow rate of 700 to 800 mls / minute. The surveyor immediately notified Licensed Vocational Nurse (R) that the patient’s dialysate flow rate was not set at the prescribed rate. Licensed Vocational Nurse ( R) said “ok.” Review of the patient’s treatment sheet dated 03/04/2024 revealed the patient’s hemodialysis treatment was initiated by a licensed vocational nurse at 04:49 a.m. Patient #3 On 03/04/2024 at 7:32 a.m. Patient #3 was observed at station #17 hemodialysis machine # 26. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via an arteriovenous fistula. Review of the patient’s prescription on the patient’s treatment sheet located at the patient’s chairside, revealed a physician’s order for dialysate flow rate of 700 mls/ minute. Review of the patient’s prescription located in the patient’s hard chart revealed a physician’s order dated 1/20/2024 for dialysate flow rate of 700 mls / minute. The surveyor immediately notified Registered Nurse (G) that the patient’s dialysate flow rate was not set at the prescribed rate. Registered Nurse (G) states “thanks.””

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review facility’s registered nurse failed to offer/administer/verify pneumococcal vaccinations of patients in 4 of 15 sampled patients: Patient #’s 4, 8, 7 and 13 Findings: Review of the Physician Standing Orders directs the registered nurse as follows: “Vaccination Order: Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Review of the following patients’ hemodialysis prescription revealed the physician’s orders were not followed: Patient #4 Observation on 03/04/2024 at 7:06 a.m., Patient #4 was observed at station #8, hemodialysis machine #15 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record revealed an admission physician’s standing order dated 01/03/2022: “Vaccination Order: Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Review of the patient’s clinical record revealed the patient was not offered/ administered the pneumococcal vaccination. Review of the facility’s Patient Vaccination Record binder revealed no record for the patient was found. Patient #8 Observation on 03/04/2024 at 7:14 a.m., Patient #8 was observed at station #5, hemodialysis machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left double lumen central venous catheter. Review of the patient’s clinical record revealed an admission physician’s standing order dated 09/02/2021: “Vaccination Order: Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Review of the patient’s clinical record revealed the patient was not offered/ administered the pneumococcal vaccination. Review of the facility’s Patient Vaccination Record binder revealed no record for the patient was found. Patient #7 Observation on 03/04/2024 at 7:16 a.m., Patient #7 was observed at station #27, hemodialysis machine #4 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record revealed an admission physician’s standing order dated 05/24/2023: “Vaccination Order: Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Review of the patient’s clinical record revealed the patient was offered the pneumococcal vaccination via a signed consent. Review of the facility’s Patient Vaccination Record binder revealed the patient stated that he received the pneumococcal vaccination at CVS but no record from CVS was found in the patient chart. Interview on 03/06/20243 at 11:45 a.m. with Clinical Coordinator (K) revealed he said, “I am just starting to get the vaccinations together.” 10802 Patient #13 On 03/04/2024 at 9:20 a.m. Patient #13 was observed on the dialysis unit of the facility. The patient was receiving hemodialysis treatment utilizing hemodialysis machine #4 at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute. Review of the Patient’s clinical record revealed the patient was admitted to the facility on 3/10/2023. Review of the patient’s clinical record revealed an admission physician’s standing order for “Vaccination Order: Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Review of the patient’s clinical record revealed the patient’s clinical record and facility’s vaccination log revealed no documentation that the patient was offered the Pneumococcal vaccination. Interview on 03/06/20243 at 11:45 a.m. with Registered Nurse (K) revealed he said, “I am just starting to get the vaccinations together.””

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility’s interdisciplinary team failed to conduct comprehensive assessment on patients annually in - 3 sampled patients ; Patient #s 6, 10, 15 Findings: Patient #6 On 03/04/2024 at 1:32 p.m. Patient #6 was observed at station #14, hemodialysis machine #19. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a right double lumen central venous catheter. Review of the Patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 2/21/2020. Review of the patient’s interdisciplinary comprehensive assessment plan of care provided by facility’s administrative assistant, revealed the most current interdisciplinary comprehensive assessment plan of care was signed by the social worker on 2/18/2022, signed by the registered nurse, 4/4/2022, signed by the patient 4/4/2022. It was signed by the physician but not dated. The Surveyor requested an annual interdisciplinary comprehensive assessment plan of care from the facility’s administrative assistant. She said she did not have an annual interdisciplinary comprehensive assessment plan of care on file. Patient #10 On 03/04/2024 at 2:00 p.m. Patient #10 was observed at station #13 hemodialysis machine #3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls minute and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Review of the Patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 12/19/2022 with diagnosis of hypertension and end stage renal disease for in- center hemodialysis three times weekly. Review of the patient s clinical record revealed an assessment printed 08/21/2023, signed by the registered nurse and social worker but not dated. The portion of the interdisciplinary assessment for the social worker was blank, there was no documented assessment by the facility’s social worker. Patient #15 Review on 03/6/2024 of patient #15’s clinical record ( demographic data) revealed the patient was admitted to the facility on 2/18/2021 with diagnosis of end stage renal disease on in- center hemodialysis three times weekly. Review of the patient’s most current laboratory values revealed the following hemoglobin level: February 19, 2024 hemoglobin level 6.2 gm/ dl February 5, 2024 hemoglobin level 7.7 gm/dl Albumin level: December 4/ 2023 : albumin 2.4 January 8 2024 :2.7 albumin February 19/ 2024: 6.2 Center for Medicare services Measurement assessment tool goal 4.0. Review of the patient’s interdisciplinary comprehensive assessment plan of care provided by facility’s administrative assistant, revealed the most current interdisciplinary comprehensive assessment plan of care was signed by the social worker on 8/7/2023, completed by registered nurse but not dated, nutritional assessment completed by the registered dietician but not dated. There was no documented assessment by the Patient’s nephrologist. The comprehensive Care Plan was signed by the registered nurse and registered Dietician. There was no documented involvement by the patient’s attending physician ( nephrologist) and the patient.”

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility’s registered nurse failed to ensure medication ( Ferrlecit) prescribed by the physician for management of anemia for patients receiving hemodialysis treatment, total prescribed dosage of the medication were administered to patients in 7 of 15 sampled patients; #s 6, 10, 11, 4, 14, 7, 5. Findings: Patient #6 On 03/04/2024 at 1:32 p.m. Patient #6 was observed at station #14, hemodialysis machine #19. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a right double lumen central venous catheter. Observation revealed a 10 ml syringe was observed attached to the medication administration port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication to the patient. Review of the patient’s clinical record (treatment sheet ) dated 03/04/2024 revealed a prescription for Ferrlecit 62.5 mg intravenously weekly. Review of the patient’s clinical record revealed a physician’s order dated 1/5/2024 for Ferrlecit 62.5 mg every first and third Monday. Subsequent observation at 1:40 p.m. revealed Registered Nurse ( G) was observed discontinuing the patient’s hemodialysis treatment. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Ferrlecit remained in the medication administration lumen and was discarded with the external blood lines. Patient (#6) did not receive the complete dosage of the medication prescribed for anemia management. The surveyor immediately notified Registered Nurse (G ) of the medication left in the medication lumen. Registered Nurse (G) states “ thanks for the information.” Review of the patient’s clinical record revealed the following laboratory result dated 2/5/2024 : Hemoglobin 9.7 g/dl ( CMS Measurement Assessment Tool) recommended goal for end stage renal dialysis patients = greater than 10 g/ dl. Iron = 26 ug/dl ( laboratory reference range 50- 170 ug /dl) Transferrin saturation = 19 %. Laboratory reference range 22-52 % Patient #10 On 03/04/2024 at 2:00 p.m. Patient #10 was observed at station #13 hemodialysis machine #3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls minute and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Observation revealed a 10 ml syringe was observed attached to the medication administration port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication intravenously to the patient. Review of the patient’s clinical record (treatment sheet ) dated 03/04/2024 revealed a prescription for Ferrlecit 62.5 mg intravenously weekly. Review of the patient’s clinical record revealed a physician’s order dated 12/18/2023 for Ferrlecit 62.5 mg every first and third Monday. Subsequent observation at 2:10 p.m. revealed Patient Care Technician (H) was observed discontinuing the patient’s hemodialysis treatment. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Ferrlecit remained in the medication administration lumen and was discarded with the external blood lines. Patient #10 did not receive the complete dosage of the medication prescribed for anemia management. The surveyor notified patient care technician (H) of medication left in the lumen of the medication port. Patient Care Technician (H) states “ I will tell the nurse.” Patient #11 On 03/04/2024 at 2:32 p.m. Patient #11 was observed at station #9 hemodialysis machine # 6. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a double lumen central venous catheter. Observation revealed a 10 ml syringe was observed attached to the medication administration port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication. Review of the patient’s clinical record (treatment sheet ) dated 03/04/2024 revealed a prescription for Ferrlecit 125 mg intravenously every Monday. Review of the patient’s clinical record revealed a physician’s order dated 1/5/2024 for Ferrlecit 125 mg every Monday. Subsequent observation at 2:55 p.m. revealed Registered Nurse (K) was observed discontinuing the patient’s hemodialysis treatment. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Ferrlecit remained in the medication administration lumen and was discarded with the external blood lines. Patient #11 did not receive the complete dose of the medication prescribed for anemia management. The surveyor immediately notified Registered Nurse (K) of the medication Ferrlecit in the Lumen of the medication administration port. Registered Nurse states “you are right, I did not know that it should not be left there.” 48020 Patient #4 On 03/04/2024 at 07:06 a.m., Patient #4 was observed at station #8, hemodialysis machine #15. The patient was receiving hemodialysis treatment at a blood flow rate of 450 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Observation revealed a 10 mL syringe of Ferrlecit attached to the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 03/04/2024 revealed a medication prescription for Ferrlecit 62.5 mg every first and third Monday. Review of the physician’s order dated 12/11/2023 revealed the prescribed Ferrlecit dose of 62.5 mg IVP every first and third Monday. Subsequent observation at 8:13 a.m. revealed Patient Care Technician (L) remove the blood lines from the hemodialysis machine #15 and discard them in the biohazard with residual Ferrlecit in the venous chamber medication Y-port. Patient #4 did not receive the complete dosage of the medication prescribed for anemia management. Interview with Patient Care Technician (L) on 03/04/2024 at 8:15 a.m.: the Surveyor notified Patient Care Technician (L) the residual Ferrlecit in the venous chamber medication Y-port. Patient Care Technician (L) stated, “Okay, the nurse shouldn’t leave it in there.” Patient #14 On 03/04/2024 at 07:08 a.m., Patient #14 was observed at station #7, hemodialysis machine #4. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left arteriovenous fistula. Observation revealed a 10 mL syringe of Ferrlecit attached to the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 03/04/2024 revealed a medication prescription for Ferrlecit 62.5 mg every Monday. Review of the physician’s order dated 12/11/2023 revealed the prescribed Ferrlecit dose of 62.5 mg IVP every Monday. Subsequent observation at 8:28 a.m. revealed Patient #14 sitting at station #7 with his vascular access taped after hemodialysis treatment. Observation of machine #4 with residual Ferrlecit in the venous chamber medication Y-port. Patient #14 did not receive the complete dosage of the medication prescribed for anemia management. Interview with Registered Nurse (C) on 03/04/2024 at 8:30 a.m.: the Surveyor notified Registered Nurse (C) of leaving residual Ferrlecit in the venous chamber medication Y-port of Patient #14. Registered Nurse (C) said he had not been taught how to remove the residual Ferrlecit from the venous chamber medication Y-port. Patient #7 On 03/04/2024 at 07:16 a.m., Patient #7 was observed at station #4, hemodialysis machine #27. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Observation revealed a 10 mL syringe of Ferrlecit attached to the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 03/04/2024 revealed a medication prescription for Ferrlecit 125 mg every Monday. Review of the physician’s order dated 12/11/2023 revealed the prescribed Ferrlecit dose of 125 mg IVP every Monday. Subsequent observation at 8:37 a.m. revealed Patient Care Technician (A) remove the blood lines from the hemodialysis machine #27 and discard them in the biohazard with residual Ferrlecit in the venous chamber medication Y-port. Patient #7 did not receive the complete dosage of the medication prescribed for anemia management. Review of the patient’s clinical record revealed a laboratory result dated 02/19/2024: “ Hemoglobin: 9.7 g/dL (CMS Measurement Assessment Tool recommended goal for end stage renal dialysis patients = greater than 10 g/dL) Review of patient’s clinical record revealed a laboratory result dated 02/05/2024: “ Iron: 62 ug/dL (Ascent Laboratory Reference Range = 65-175 ug/dL) “ Transferrin: 149 mg/dL (Ascent Laboratory Reference Range = 215-365 mg/dL) Patient #5 On 03/04/2024 at 07:24 a.m., Patient #5 was observed at station #1, hemodialysis machine #22. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Observation revealed a 10 mL syringe of Ferrlecit attached to the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 03/04/2024 revealed a medication prescription for Ferrlecit 125 mg every Monday. Review of the physician’s order dated 11/11/2023 revealed the prescribed Ferrlecit dose of 125 mg IVP every Monday. Subsequent observation at 8:45 a.m. revealed Patient Care Technician (A) remove the blood lines from the hemodialysis machine #22 and discard them in the biohazard with residual Ferrlecit in the venous chamber medication Y-port. Patient #5 did not receive the complete dosage of the medication prescribed for anemia management.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility’s interdisciplinary team failed to complete interdisciplinary care plan on patients in 5 of 15 sampled patients. Patient #s 6, 10, 15, 7, 8 Findings: Patient #6 On 03/04/2024 at 1:32 p.m. Patient #6 was observed at station #14, hemodialysis machine #19. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a right double lumen central venous catheter. Review of the patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 2/21/2020. Review of the patient’s interdisciplinary comprehensive assessment plan of care provided by facility’s administrative assistant, revealed the most current interdisciplinary comprehensive assessment plan of care was signed by the social worker on 2/18/2022, signed by the registered nurse, 4/4/2022, signed by the patient 4/4/2022. It was signed by the physician but not dated. The Surveyor requested a revised plan of care from the facility’s administrative assistant. She said she did not have a updated interdisciplinary comprehensive assessment plan of care on file for the patient. Patient #10 On 03/04/2024 at 2:00 p.m. Patient #10 was observed at station #13 hemodialysis machine #3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls minute and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Review of the Patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 12/19/2022 with diagnosis of hypertension and end stage renal disease for in- center hemodialysis three times weekly. Review of the patient’s laboratory results revealed the following findings: 2/05/ 2024: Transferrin saturation = 18;laboratory reference range 22- 52 % iron 40 ug /dl. laboratory reference range 65- 175 ug/ dl, and phosphorus 8. Review of the patient’s most current interdisciplinary care plan revealed it was printed 08/21/2023. Review of the patient’s interdisciplinary care plan revealed no involvement documented by the facility’s social worker. The portion of the record interdisciplinary care plan conference was signed by the patient only but not dated. There was no documentation of the interdisciplinary staff’s involvement in the conference. Patient #15 Review on 03/6/2024 of Patient #15’s clinical record ( demographic data) revealed the patient was admitted to the facility on 2/18/2021 with diagnosis of end stage renal disease on in- center hemodialysis three times weekly. Review of the patient’s most current laboratory values revealed the following hemoglobin level: February 19, 2024, hemoglobin level 6.2 gm/ dl February 5, 2024, hemoglobin level 7.7 gm/dl Center for Medicare Services Measurement Assessment Tool Reference Range , greater than 10 g/dl. Albumin level: December 4/ 2023 : albumin 2.4 January 8, 2024 :2.7 albumin February 19/ 2024: 6.2 Center for Medicare services Measurement assessment tool goal 4.0. Laboratory values on the care plan was dated 6/5/2023 albumin 3.0 and hemoglobin 9.7. 6/19/2023 hemoglobin 9.9 g/ dl. The most current interdisciplinary comprehensive was signed by the registered nurse and registered Dietician. There was no documented involvement by the patient’s attending physician and the patient. On 03/06/2024 the Surveyor requested from the Facility’s Administrative Assistant documentation that the patient’s interdisciplinary plan of care was updated to reflect the patient’s current outcomes. She said she would request the plan from the Charge Nurse. Subsequent interview on 03/06/2024 with the facility’s Administrative Assistant revealed she state “ we do not have another plan.” 48020 Patient #7 On 03/04/2024 at 07:16 a.m., Patient #7 was observed at station #4, hemodialysis machine #27. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 09/19/2022. Review of the patient’s Comprehensive Interdisciplinary Patient Assessment (CIPA)/ Plan of Care (POC) revealed the CIPA/POC was signed and dated by the social worker on 02/21/2024. The registered nurse, registered dietitian, and patient signed the CIPA/POC but did not document the date of their signatures. The CIPA/POC was not signed or dated by the physician. The date of the conference was not documented. Patient #8 Observation on 03/04/2024 at 7:14 a.m., Patient #8 was observed at station #5, hemodialysis machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left double lumen central venous catheter. Review of the patient’s clinical record (demographic data) revealed the patient was admitted to the facility on 06/01/2009. Review of the patient’s Comprehensive Interdisciplinary Patient Assessment (CIPA)/ Plan of Care (POC) revealed the CIPA/POC was signed by the patient, registered nurse, social worker, registered dietitian, and physician. The CIPA/POC was printed on 01/28/2022 but date of the conference was not documented nor were any of the signatures dated. On 03/05/2024, the Surveyor requested the patient’s updated CIPA/POC from the Office Coordinator and said she would look for it. On 03/06/2024, the Surveyor again requested the patient’s updated CIPA/POC from the Office Coordinator and she stated, “we do not have one.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review patients’ attending nephrologists failed to complete monthly comprehensive progress notes on patients addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response in 10 of 15 sampled patients, Patient #s 11, 1, 3, 6, 13, 4, 9, 8, 7, 5. Findings: Patient #11 On 03/04/2024 at 2:32 p.m. Patient #11 was observed at station #9 hemodialysis machine # 6. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a double lumen central venous catheter. Review of The Patient’s laboratory results revealed the following values: 2/20/2024 : Kt/V = 0.52, target range 1.2. 2/5/2024 : Kt/V = 0.45, target range 1.2. 2/05/2024 : urea reduction ratio = 29 , target range>= to 65% Review of the patient’s hospitalization record revealed documentation which indicated the patient was admitted to the hospital on 11/16/2023 for insertion of right internal jugular catheter and acute blood loss secondary to bleeding from the internal jugular catheter. Review of the patient’s clinical record ( physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/1/2023, 11/6/2023, 11/17/2023, 11/22/23, 12/4/2023, 12/13/2023, 12/18/2023, 12/22/2023, 1/03/2024, 1/10/2024, 1/15/ 2024 and 1/22/2024. The encounters involved chief complaint, review of systems, physical exam, and plan. Documentation on all encounters by the physicians indicated the patient is stable. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Interview on 03/05/2024 at 1:20 p.m. with the Facility’s Administrator revealed she said the patient is non- compliant with coming for scheduled hemodialysis treatment. This was not addressed in the physician’s progress notes. Patient #1 On 03/04/2024 at 7:06 a.m. Patient #1 was observed at station #23 hemodialysis machine # 18. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via right double lumen central venous catheter. Review of the patient’s clinical record ( physician progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/1/2023, 11/6/2023, 11/17/2023, 11/11/23, 12/4/2023, 12/ 18/2023, 12/22/2023, 1/03/2024, 1/10/2024, 1/15/2024, and 1/22/2024. The encounters involved chief complaint, review of systems, physical exam, and plan. The encounters did not involve documentation on the patient, addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #3 On 03/04/2024 at 7:32 a.m. Patient #3 was observed at station #17 hemodialysis machine # 26. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via an arteriovenous fistula. Review of The patient’s laboratory results, potassium level dated 2/27/2024 revealed potassium level of 6.0 mEq/L, Laboratory range 3.4- 5.5 mEq/L Review of the patient’s clinical record ( physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/1/2023, 11/6/2023, 11/13/2023, 11/22/23, 12/4/2023, 12/11/2023, 12/16/2023, 12/22/2023, 1/03/2024, 1/10/2024, 1/15/2024, and 1/22/2024. The encounters involved chief complaint, review of systems, physical exam, and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #13 On 03/04/2024 at 9:20 a.m. Patient #13 was observed on the dialysis unit of the facility. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute. Review of the patient’s clinical record ( physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/1/2023, 11/3/2023, 11/4/2023, 11/22/23, 12/4/2023, 12/13/2023, 12/18/2023, 12/22/2023, 1/03/2024, 1/10/2024, 1/12/2024, 1/15/ 2024 and 1/22/2024. The encounters involved chief complaint, review of systems, physical exam, and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #6 On 03/04/2024 at 1:32 p.m. Patient #6 was observed at station #14 hemodialysis machine #19. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls minute and dialysate flow rate of 500 mls/ minute via a right double lumen central venous catheter. Review of the patient’s clinical record ( physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/3/2023, 11/6/2023, 11/13/2023, 11/24/23, 12/4/2023, 12/15/2023, 12/18/2023, 12/22/2023, 1/03/2024, 1/5/2024, 1/12/2024, 1/15/ 2024 and 1/22/2024. The encounters involved chief complaint, review of systems, physical exam, and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, bone mineral metabolism and treatment response. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. During interviews on 03/06/2024 with the Facility’s Administrator when asked why the patients did not have a visit from the patient’s Nephrologist. No reasons were given. 48020 Patient #4 Observation on 03/04/2024 at 7:06 a.m., Patient #4 was observed at station #8, hemodialysis machine #15 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/03/2023, 11/06/2023, 11/13/2023, 11/24/23, 12/04/2023, 12/11/2023, 12/18/2023, 12/22/2023, 01/03/2024, 01/10/2024, 01/15/2024 and 01/22/2024. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #9 Observation on 03/04/2024 at 7:12 a.m., Patient #9 was observed at station #6, hemodialysis machine #13 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min via a left double lumen central venous catheter. Review of the patient’s clinical record (physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/03/2023, 11/13/2023, 11/29/23, 12/04/2023, 12/15/2023, 12/18/2023, 12/22/2023, 1/03/2024, 01/10/2024, 01/15/2024 and 01/22/2024. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #8 Observation on 03/04/2024 at 7:14 a.m., Patient #8 was observed at station #5, hemodialysis machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left double lumen central venous catheter. Review of the patient’s clinical record (physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/01/2023, 11/06/2023, 11/17/2023, 11/22/23, 12/01/2023, 12/11/2023, 12/18/2023, 12/22/2023, 01/03/2024, 01/10/2024, 01/15/2024 and 01/22/2024. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #7 Observation on 03/04/2024 at 7:16 a.m., Patient #7 was observed at station #4, hemodialysis machine #27 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/03/2023, 11/06/2023, 11/13/23, 11/22/23, 12/04/2023, 12/11/2023, 12/18/2023, 12/22/2023, 1/03/2024, 01/10/2024, 01/15/2024 and 01/22/2024. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Patient #5 Observation on 03/04/2024 at 7:24 a.m., Patient #5 was observed at station #1, hemodialysis machine #22 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) revealed documentation which indicated that the patient’s nephrologist rounded on the patient on 11/01/2023, 11/06/2023, 11/13/23, 11/22/23, 12/04/2023, 12/11/2023, 12/18/2023, 12/22/2023, 1/03/2024, 01/10/2024, 01/15/2024 and 01/22/2024. The encounters involved chief complaint, review of systems, physical exam, impression and plan. The encounters did not involve documentation on the patient’s record addressing adequacy, vascular access, anemia management, nutritional status, treatment response, and bone mineral metabolism. There were no physician’s encounter or monthly comprehensive progress notes documented for February 2024. Interview with Registered Dietitian (F) on 03/06/2024 at 11:35 a.m. revealed she said that she did not know why the doctors did not come for their visits during February. Interview with Facility Administrator (J) on 03/06/2024 at 3:33 a.m. revealed she said that she did not know why the doctors did not make rounds during February.”

“QAPI-INDICATOR-ADEQUACY OF DIALYSIS CFR(s): 494.110(a)(2)(i) The program must include, but not be limited to, the following: (i) Adequacy of dialysis. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s quality assessment performance improvement committee failed to conduct root cause analysis, develop, and implement a plan to address dialysis adequacy in patients. Findings: Review on 03/6/2024 of the facility’s quality assessment performance meeting minutes and data revealed the following data: Facility’s goal 75% of patients with KT/V > 1.2 Dialysis adequacy KT/V October 2023 + 87.71 Dialysis adequacy KT/V November 2023 + 82.14 Dialysis adequacy KT/V October 2023 + 68.85 Facility’s goal 75% of patients’ with URR > 65 Dialysis adequacy URR October 84.21 Dialysis adequacy URR November 76.79 Dialysis adequacy URR December 70.30 Review of the record revealed no documented root cause analysis done to address facility’s patients not meeting goal for adequacy. There was no plan developed and implemented to address the facility not meeting goal for patient’s adequacy. On 03/06/2024 at 11:30 a.m. the Surveyor reviewed the facility’s quality assessment performance data and meeting minutes with the facility’s administrative staff who confirmed that the facility’s quality assessment performance improvement committee did not conduct root cause analysis and develop plans to address patients’ adequacy of dialysis.”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s quality assessment performance improvement committee failed to implement a root cause analysis and plan to address an upward trend in hospitalization related to patients’ vascular accesses. Findings: Review of the facility quality assessment performance improvement meeting data and minutes revealed the following data: November 2023 : Meeting held December 12, 2023; three patients admitted to hospital for access related condition. December 2023 : Meeting held 1/26/2024; six patients admitted to hospital for access related conditions. There was no quality assessment performance improvement meeting held by facility for February 2024. Review of the quality assessment performance improvement meeting data and minutes revealed no root cause analysis or plan developed and implemented to decrease the number of patients admitted to the hospital for vascular access related condition. On 03/06/2024 at 11:30 a.m the Surveyor reviewed the facility’s quality assessment performance data and meeting minutes with the facility’s administrative staff who confirmed that the facility’s quality assessment performance improvement committee did not conduct root cause analysis and develop plans to address upward trends in patients admissions to hospital for vascular access related conditions.”

“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, interview and record review facility’s Registered nurses failed to conduct pre-treatment, intradialytic treatment, and post treatment assessments on patients in 3 of 15 sampled patients: Patient #s 14, 5, 15. Findings: Texas Board of Nursing RN Scope of practice. Rule 15.28. Assessment The comprehensive assessment is the first step, and lays the foundation for the nursing process. The comprehensive assessment is the initial and ongoing, extensive collection, analysis and interpretation of data. Nursing judgment is based on the assessment findings. The RN uses clinical reasoning and knowledge, evidence- based outcomes, and research as the basis for decision-making and comprehensive care. Based upon the comprehensive assessment the RN determines the physical and mental health status, needs, and preferences of culturally, ethnically, and socially diverse patients and their families using evidence-based health data and a synthesis of knowledge. Surveillance is an essential step in the comprehensive assessment process. The RN must anticipate and recognize changes in patient conditions and determines when reassessments are needed. Patient Diagnosis/Problem Identification/Planning The second step in the nursing process is analyzing data gathered during the assessment and problem identification. The role of the RN is to synthesize comprehensive assessment data to identify problems, formulate goals/outcomes, and develop plans of care for patients, families, populations, and communities using information from evidence-based practice and published research in collaboration with these groups and the interdisciplinary health care team, as appropriate for their educational background and scope. The third step in the nursing process is planning. The RN synthesizes the data collected during the comprehensive assessment to identify problems, participate in the patient diagnoses, and to formulate goals, teaching plans and outcomes. A nursing plan of care for patients is developed by the RN, who has the overall responsibility to coordinate nursing care for patients. Teaching plans address health promotion, maintenance, restoration, and prevention of risk factors. The RN utilizes evidence-based practice, published research, and information from patients and the interdisciplinary health care team during the planning process. Implementation Implementing the plan of care is the fourth step in the nursing process. The RN may begin, deliver, assign, or delegate certain nursing tasks within the plan of care for patients within legal, ethical, and regulatory parameters and in consideration of health restoration, disease prevention, patient independence, wellness, and promotion of healthy lifestyles. The RN ’ s duty to patient safety when making assignments to other nurses or when delegating tasks to unlicensed staff is to consider the education, training, skill, competence, and physical and emotional abilities of those to whom the assignments or delegation is made. The RN is responsible for reasonable and prudent decisions regarding assignments and delegation. The RN scope of practice may include the supervision of LVNs or other RNs. Supervision of LVN staff is defined as the process of directing, guiding, and influencing the outcome of an individual ’ s performance and activity.5 The RN may have to directly observe and evaluate the nursing care provided depending on the LVN ’ s skills and competence, patient conditions, and level of urgency in emergent situations. The RN may determine when it is appropriate to delegate tasks to unlicensed personnel and maintains accountability for how the unlicensed personnel perform the tasks. The RN is responsible for supervising the unlicensed personnel when tasks are delegated. The proximity of supervision is dependent upon patient conditions and skill level of the unlicensed personnel. In addition, teaching and counseling are interwoven throughout the implementation phase of the nursing process. Evaluation and Re-assessment A critical and final step in the nursing process is evaluation. The RN evaluates and reports patient outcomes and responses to therapeutic interventions in comparison to benchmarks from evidence-based practice and research findings, and plans any follow-up care and referrals to appropriate resources that may be needed. The evaluation phase is one of the times when the RN reassesses patient conditions and determines if interventions were effective and if any modifications to the plan of care are necessary. Review of the facility’s current Policy and Procedure on Predialysis Assessment directs staff as follows: “Procedure: Assess, evaluate and document the following: neuro status, pulmonary status, circulatory status Specific notations should include at least: ... 5. Blood Pressure: Acceptable findings: <90 diastolic or <150 systolic Unacceptable findings; >150 systolic or >90 diastolic And <90 systolic or <40 diastolic” Patient #14 On 03/04/2024 at 07:08 a.m., Patient #14 was observed at station #7, hemodialysis machine #4. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min via a left arteriovenous fistula. Vital signs were as follows: blood pressure 159/70 pulse rate of 76 beats per minute. Treatment sheet dated 03/04/2024: Review of the patient’s clinical record (treatment sheet) dated 03/04/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 158/66 sitting, pulse of 80 beats per minute. The pre-treatment assessment by the registered nurse revealed no documentation of the time it was performed or no mention of the elevated blood pressure the patient presented with pre-treatment. 04:49 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 156/65 and pulse rate of 80 beats per minute 05:00 a.m.: documented blood pressure of 178/61 and pulse rate of 77 beats per minute 05:30 a.m.: documented blood pressure of 159/65 and pulse rate of 76 beats per minute 06:00 a.m.: documented blood pressure of 167/64 and pulse rate of 75 beats per minute 06:30 a.m.: documented blood pressure of 169/75 and pulse rate of 75 beats per minute 07:00 a.m.: documented blood pressure of 159/70 and pulse rate of 76 beats per minute 07:30 a.m.: documented blood pressure of 157/77 and pulse rate of 73 beats per minute 08:00 a.m.: documented blood pressure of 180/73 and pulse rate of 73 beats per minute 08:21 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 177/53 and pulse rate of 79 beats per minute Post treatment vital signs: blood pressure of 161/76 sitting, 170/59 standing, pulse of 88 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor was an intradialytic assessment by the registered nurse performed. The post treatment assessment by the registered nurse revealed no documentation of the time it was performed and no mention of the elevated blood pressures. Treatment sheet dated 02/14/2024: Review of the patient’s clinical record (treatment sheet) dated 02/14/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 184/85 sitting, pulse of 82 beats per minute. The pre-treatment assessment by the registered nurse revealed no documentation of the time it was performed or no mention of the elevated blood pressure the patient presented with pre-treatment. 13:08 p.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 183/93 and pulse rate of 80 beats per minute 13:30 p.m.: documented blood pressure of 183/71 and pulse rate of 81 beats per minute 14:00 p.m.: documented blood pressure of 178/59 and pulse rate of 83 beats per minute 14:30 p.m.: documented blood pressure of 171/60 and pulse rate of 81 beats per minute 15:00 p.m.: documented blood pressure of 169/62 and pulse rate of 80 beats per minute 15:38 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 183/78 and pulse rate of 79 beats per minute Post treatment vital signs: blood pressure of 125/72 sitting and pulse rate of 88 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor was an intradialytic assessment by the registered nurse performed. 15:38 p.m.: post treatment assessment by the registered nurse revealed no documentation of the time it was performed and no mention of the elevated blood pressures. Patient #5 On 03/04/2024 at 07:24 a.m., Patient #5 was observed at station #1, hemodialysis machine #22. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min via a left upper arm vascular access. Vital signs were as follows: blood pressure 174/101 pulse rate of 68 beats per minute. Treatment sheet dated 03/04/2024: Review of the patient’s clinical record (treatment sheet) dated 03/04/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 167/98 sitting, pulse of 72 beats per minute. The pre-treatment assessment by the registered nurse revealed no documentation of the time it was performed or no mention of the elevated blood pressure the patient presented with pre-treatment. 05:09 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 165/97 and pulse rate of 73 beats per minute 05:30 a.m.: documented blood pressure of 169/99 and pulse rate of 69 beats per minute 06:00 a.m.: documented blood pressure of 173/95 and pulse rate of 71 beats per minute 06:30 a.m.: documented blood pressure of 175/101 and pulse rate of 72 beats per minute 07:00 a.m.: documented blood pressure of 173/97 and pulse rate of 67 beats per minute 07:30 a.m.: documented blood pressure of 174/101 and pulse rate of 68 beats per minute 08:00 a.m.: documented blood pressure of 178/105 and pulse rate of 67 beats per minute 08:39 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 192/103 and pulse rate of 71 beats per minute Post treatment vital signs: blood pressure of 188/106 sitting, 190/106 standing, pulse of 75 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor and intradialytic assessment by the registered nurse. 08:45 a.m.: post treatment assessment by the registered nurse revealed “Patient to take BP med at home.” Treatment sheet dated 02/28/2024: Review of the patient’s clinical record (treatment sheet) dated 02/28/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 191/118 sitting, pulse of 77 beats per minute. 04:45 a.m.: The pre-treatment assessment by the registered nurse revealed no documentation on the elevated blood pressure the patient presented with pre-treatment. 04:49 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 186/111 and pulse rate of 72 beats per minute 05:15 a.m.: documented blood pressure of 177/101 and pulse rate of 70 beats per minute 05:30 a.m.: documented blood pressure of 175/103 and pulse rate of 72 beats per minute 06:00 a.m.: documented blood pressure of 189/109 and pulse rate of 72 beats per minute 06:30 a.m.: documented blood pressure of 192/109 and pulse rate of 70 beats per minute 07:00 a.m.: documented blood pressure of 189/106 and pulse rate of 73 beats per minute 07:30 a.m.: documented blood pressure of 194/104 and pulse rate of 67 beats per minute 08:00 a.m.: documented blood pressure of 209/113 and pulse rate of 70 beats per minute 08:10 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 198/110 and pulse rate of 70 beats per minute Post treatment vital signs: blood pressure of 201/104 sitting, 189/110 standing, pulse of 76 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor was an intradialytic assessment by the registered nurse performed. 08:10 a.m.: post treatment assessment by the registered nurse revealed no documentation on the elevated blood pressures. Treatment sheet dated 02/26/2024: Review of the patient’s clinical record (treatment sheet) dated 02/26/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 180/111 sitting, pulse of 74 beats per minute. 04:55 a.m.: The pre-treatment assessment by the registered nurse revealed no documentation on the elevated blood pressure the patient presented with pre-treatment. 05:00 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 170/104 and pulse rate of 72 beats per minute 05:30 a.m.: documented blood pressure of 178/103 and pulse rate of 71 beats per minute 06:00 a.m.: documented blood pressure of 177/103 and pulse rate of 69 beats per minute 06:30 a.m.: documented blood pressure of 182/110 and pulse rate of 64 beats per minute 07:00 a.m.: documented blood pressure of 186/109 and pulse rate of 65 beats per minute 07:30 a.m.: documented blood pressure of 195/112 and pulse rate of 68 beats per minute 08:00 a.m.: documented blood pressure of 198/110 and pulse rate of 71 beats per minute 08:30 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 205/115 and pulse rate of 71 beats per minute Post treatment vital signs: blood pressure of 196/110 sitting, 195/115 standing, pulse of 76 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor was an intradialytic assessment by the registered nurse performed. 08:35 a.m.: post treatment assessment by the registered nurse revealed no documentation on the elevated blood pressures. Treatment sheet dated 02/23/2024: Review of the patient’s clinical record (treatment sheet) dated 02/23/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 191/116 sitting, pulse of 72 beats per minute. 04:45 a.m.: The pre-treatment assessment by the registered nurse revealed no documentation on the elevated blood pressure the patient presented with pre-treatment. 04:48 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 184/114 and pulse rate of 72 beats per minute 05:00 a.m.: documented blood pressure of 194/112 and pulse rate of 70 beats per minute 05:30 a.m.: documented blood pressure of 188/111 and pulse rate of 71 beats per minute 06:00 a.m.: documented blood pressure of 183/107 and pulse rate of 68 beats per minute 06:30 a.m.: documented blood pressure of 203/114 and pulse rate of 72 beats per minute 07:00 a.m.: documented blood pressure of 193/106 and pulse rate of 69 beats per minute 07:30 a.m.: documented blood pressure of 198/117 and pulse rate of 76 beats per minute 08:00 a.m.: documented blood pressure of 213/117 and pulse rate of 67 beats per minute 08:18 a.m.: the patient’s hemodialysis treatment was terminated by the patient care technician with a documented blood pressure of 212/117 and pulse rate of 71 beats per minute Post treatment vital signs: blood pressure of 196/110 sitting, 195/115 standing, pulse of 68 beats per minute. There was no documentation of the elevated blood pressure being reported to the registered nurse nor was an intradialytic assessment by the registered nurse performed. 08:20 a.m.: post treatment assessment by the registered nurse revealed no documentation on the elevated blood pressures. Interview with Facility Administrator (J) at 12:57 p.m.: the Surveyor notified Facility Administrator (J) of the unreported and unassessed high blood pressure of patients. Facility Administrator (J) stated the nurses are supposed to document their assessments on the back of the treatment sheet. 10802 Patient # 15 On 03/06/2024 at 10:00 a.m Patient # 15 was observed on the treatment floor of the facility. The patient was receiving hemodialysis treatment, at a blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute via a double lumen central venous catheter. Observation on the hemodialysis machine #24’s blood pressure data, revealed the patient’s recorded blood pressure of 166/93. Review of the patient’s pre- treatment assessment revealed it was documented by the licensed vocational nurse assigned to the patient. The record revealed no pre- treatment assessment by the registered nurse. Documented pre treatment blood pressure 186/92 and pulse rate of 98 beats per minute. Review of the patient’s treatment sheet dated 03/06/2024 revealed the following findings: The patient’s hemodialysis treatment was initiated by the licensed vocational nurse assigned to the patient on 3/06/2024 at 09.58 a.m. with documented blood pressure of 166/58 and pulse rate of 98 beats per minute, at a blood flow rate of 400 mls /per minute and dialysate flow rate of 500 mls/ minute. Patient’s documented parameters during hemodialysis treatment were as follows: 10:00 a.m.: blood pressure 160/92, pulse rate 98 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 10:30 a.m.: blood pressure 166/94, pulse rate 97 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:00 a.m.: blood pressure 176/96, pulse rate 96 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:30 a.m.: blood pressure 178/104, pulse rate 96 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 12:00 p.m.: blood pressure 175/104, pulse rate 97 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 12:30 p.m.: blood pressure 179/96, pulse rate 96 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:00 p.m.: blood pressure 180/108, pulse rate 100 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:29 p.m.: blood pressure 174/109, pulse rate 103 beats per minute, blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. The patient’s hemodialysis treatment ended . Review of the patient’s post- treatment assessment revealed it was documented by the licensed vocational nurse assigned to the patient. The record revealed no post- treatment assessment by the registered nurse. Documented post treatment blood pressure 187/107 and 170/105 and pulse rate of 98 beats per minute. There was no documentation the patient’s physician was notified of the patient’s elevated blood pressure. On 03/06/2024 at 2:00 p.m. the Surveyor notified the Facility’s Regulatory affairs personnel on the lack of assessment on the patient by the registered nurse. He said he did not know the reason why this was not done.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 10802 Based on observation, interview and record review the facility governing body (A) failed to ensure Facility’s Medical Director and Attending Physician receive orientation on the medical staff bylaws, policies and procedures and the facility’s quality assessment performance program; in 2 of 2 physicians’ personnel and credential files reviewed. Nephrologist Q and Physician (P) (B) Failed to ensure facility’s staff receive orientation to the facility and work responsibilities prior to providing care and services to hemodialysis patients in 6 of 8 of sampled staff record reviewed ; CCHT B, H, L, A, Registered Nurse (G), and Clinical Coordinator (K) Findings: Medical Director (Q) Interview on 03/04/2024 during the facility’s entrance conference with the facility’s administrator revealed Nephrologist (Q ) is the Medical Director of the facility. Review of the Facility’s Medical Director’s credential and personnel file, revealed no documentation that the Facility’s Medical Director receive orientation on the medical staff bylaws, policies and procedures and the facility’s quality assessment performance program; On 03/06/2024 at 2:00 p.m., the Surveyor requested evidence from the Facility’s Administrator that the facility’s Medical Director was trained on the medical staff bylaws, policies and procedures and the facility’s quality assessment performance program; None was provided. Attending Physician (P) On 03/04/2024 at attending Physician (P) was observed on the hemodialysis unit Physician (P) was conducting rounds on patients receiving hemodialysis treatment. Review of the Facility’s Attending physician (P’s) credential and personnel file, revealed no documentation that the physician receive orientation on the medical staff bylaws, policies and procedures and the facility’s quality assessment performance program; On 03/06/2024 at 2:00 p.m., the Surveyor requested evidence from the Facility’s Administrator that the facility’s Medical Director was trained on the medical staff bylaws, policies and procedures and the facility’s quality assessment performance program; None was provided. Certified Clinical Hemodialysis Technician (B) On 03/04/2024 Certified Clinical Hemodialysis Technician (B) was observed on the hemodialysis unit. The Certified Clinical Hemodialysis Technician was providing care and services ( cannulating patients vascular access and administering heparin) to hemodialysis patients. Review of Certified Clinical Hemodialysis Technician (B’s) personnel and training file revealed the Certified Clinical Hemodialysis Technician (B) was hired to the facility on 2/26/2023 as a Certified Clinical Hemodialysis Technician (B). Review of Certified Clinical Hemodialysis Technician (B’s) personnel and training file revealed no evidence that the Facility provided orientation to the staff. On 03/06/2024 at 1:40 p.m. the Surveyor requested documentation from the Facility’s Administrator that Certified Clinical Hemodialysis Technician (B)was provided with orientation to the facility. (No evidence was provided.) Certified Hemodialysis Technician (H) On 03/04/2024 Certified Clinical Hemodialysis Technician (H) was observed on the hemodialysis unit. The Certified Clinical Hemodialysis Technician was providing care and services ( cannulating patients vascular access and administering heparin) to hemodialysis patients. Review of Certified Clinical Hemodialysis Technician (H’s) personnel and training file revealed Certified Clinical Hemodialysis Technician (H) was hired to the facility on 10/25/2021 as a Certified Clinical Hemodialysis Technician. Review of Certified Clinical Hemodialysis Technician (H’s) personnel and training file revealed no evidence that the Facility’s provided orientation to the staff. On 03/06/2024 at 1:40 p.m. the Surveyor requested documentation from the Facility’s Administrator that Certified Clinical Hemodialysis Technician was provided with orientation to the facility. (No evidence was provided.) Certified Patient Care Technician (L) Review of Certified Clinical Hemodialysis Technician (L’s) personnel and training file revealed Certified Clinical Hemodialysis Technician (L) was hired to the facility on 1/11/2021 as a Certified Clinical Hemodialysis Technician. Review of Certified Clinical Hemodialysis Technician (L’s) personnel and training file revealed no evidence that the Facility’s provided orientation to the staff. On 03/06/2024 at 1:40 p.m. the Surveyor requested documentation from the Facility’s Administrator that Certified Clinical Hemodialysis Technician (B) (H) and (L) were provided orientation to the facility. (No evidence was provided.) 48020 Certified Clinical Care Technician (A) On 03/04/2024, Certified Clinical Care Technician (A) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of Certified Clinical Care Technician (A’s) personnel and training file revealed Certified Clinical Care Technician (A) he was hired to the facility on 01/11/2021 and there was no evidence that an orientation to the facility was provided.. Registered Nurse (G) On 03/04/2024 and 03/06/2024 Registered Nurse (G) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Registered Nurse (G’s) personnel and training file revealed Registered Nurse (G) was hired 02/15/2024 and there was no evidence that an orientation to the facility was provided. Clinical Coordinator (K) On 03/04/2024 Clinical Coordinator (K) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Clinical Coordinator (K’s) personnel and training file revealed Clinical Coordinator (K) was hired 11/13/2023 and there was no evidence that an orientation to the facility was provided. On 03/06/2024 at 1:41 p.m. the Surveyor requested documentation from the Facility’s Administrator of the completed facility orientation for Certified Clinical Care Technician (A), Registered Nurse (G), and Clinical Coordinator (K).”