Branson Dialysis

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(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. 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. This Standard is not met as evidenced by: 36473 Based on interview and policy review, the facility failed to document proof of reviews and updates of the emergency preparedness policies. These failures had the potential to effect all patients that presented to the facility for treatment. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1.During an interview on 09/30/25 at 3:40 PM, Staff D, Administrator, stated their policies should have been reviewed and updated every two years. 2.Although requested, the facility failed to provide a policy that gave direction for staff to review and update policies every two years.”

“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: 36473 Based on interview, record review and policy review the facility failed to ensure all members of the facility’s interdisciplinary team (IDT, physician, registered nurse, social worker and registered dietician) participated in the Quality Assessment and Performance Imporvement (QAPI) to monitor areas of improvement, determining potential root causes, development and evaluating plans for improvements in care. These failures had the potential to affect all patients’ health and safety outcomes. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1.During an interview on 09/30/25 at 2:19 PM, Staff D, Administrator, acknowledged the QAPI Committee meeting minutes did not have or include a staff sign-in sheet of staff attendance for the QAPI Committee meetings. 2.Review of the facility’s QAPI meeting minutes for the last six months showed no inclusion of registered nurses, social workers or dieticians. 3.Review of the facility’s policy titled, “Quality Assurance/Performance Improvement,” undated, showed the QAPI committee was to be made up of the IDT that consisted of the Medical Director, registered nurse, masters-prepared social worker and a registered dietician.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 36473 Based on observation, interview, record review, policy review and review of the Center for Disease Control and Prevention (CDC) guidelines the facility failed to ensure staff: - Performed routine serologic testing, surveillance of immunizations (pneumococcal, hepatitis B, influenza and tuberculosis screening) and followed the recommended CDC guidelines for all patients. (V112). - Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff provided care and treatments to patients (V113). - Wore gloves when indicated and performed hand hygiene before gloving, after glove removal and before re-gloving (V113). - Repeated the cleansing process of patients’ access sites before cannulation (insertion of a needle into the blood vessels to enable blood to be circulated between the patient and dialysis machine during dialysis treatment) when staff touched the area after the area was cleansed for three (#6, #13, and #15) patients out of six observations conducted of staff cannulating patients’ access sites (V113). - Appropriately disposed of bio-hazardous waste (blood and/or body fluids) for five out of five observations conducted of staff disposing bio-hazardous waste materials/items (used bloodlines, tubing, and dialyzer) after patients’ dialysis treatments (V121). - Consistently, thoroughly, and properly disinfected and cleansed patients’ dialysis stations at the end of a patient’s dialysis treatment and prior to the initiation of the next patient’s dialysis treatment for four out of four observations made of staff performing station disinfection (V122). - Tested and documented 28 of 28 In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) patients’ Hepatitis B Virus (HBV, a viral infection that can cause both short-term and long-term liver disease and primarily transmitted through contact with infected blood and bodily fluids) serologic status prior to admission to the hemodialysis unit (V124). The cumulative effect of these failures resulted in the overall non-compliance with §42 CFR 494.30 Condition: Infection Control and resulted in the facility’s failure to ensure safe infection control practices and effective infection prevention during dialysis treatments.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 36473 Based on record review and interview, the facility failed to show evidence in the Interdisciplinary (IDT, patient, attending physician, registered nurse, social worker and dietician) Plan of Care an evaluation of the patient’s suitability for transplant (V554), failed to show signatures acknowledging the patient’s participation in the Plan of Care (V556) and included infection prevention education in the patient’s Plan of Care for vaccination and serological testing for three patients (#1, #2 and #6) of three In-Center Hemodialysis patients reviewed (V562). The cumulative effect of these failures resulted in the overall non-compliance with §42 CFR 494.90 Condition: Patient Plan of Care and resulted in the facility’s failure to ensure patients received informative education regarding their individualized care during dialysis treatments. Refer to 2567 for further details.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 36473 Based on record review and interview, the facility failed to develop and implement a process to ensure the dialysis program monitored patient satisfaction and the results were used to identify opportunities for healthcare improvement (V636). The cumulative effect of these failures resulted in the overall non-compliance with §42 CFR 494.110 Condition: Quality Assessment and Performance Improvement and resulted in the facility’s failure to ensure patients had the opportunity to be acknowledged for their concerns or complaints to enhance their quality of care during dialysis treatments. Refer to 2567 for further details.”

“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: 36473 Based on interview and record review, the facility failed to perform fire drills, full scale drills, table top exercises or communication for community wide drills for emergency preparedness. This had the potential to effect all patients that presented to the facility for dialysis and potentially cause an increase in complications in the event of any emergencies. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. Although requested, the facility failed to provide documentation of any fire drills, full scale drills, table top exercises or communication with the local electric company, utility company and Emergency Management in the community. 2. During an interview on 07/29/25 at 10:00 AM, Staff C, Facility Manager, stated there had not been any drills conducted since 2022”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 36473 Based on interview, record review, policy review, and review of the Center for Disease Control and Prevention (CDC) guidelines, the facility failed to ensure staff performed routine serologic testing, surveillance of immunizations (pneumococcal, hepatitis B, influenza and tuberculosis screening) and followed the recommended CDC guidelines for all patients. These failures to ensure staff practiced appropriate infection control prevention had the potential for cross-contamination and the spread of infections to both patients and staff. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated patient and staff immunizations and histories should have all been documented for Influenza, Hepatitis B, Pneumonia and Covid. 2. Although requested, the facility failed to provide documentation and surveillance of all patient vaccinations. 3. Review of the facility’s policy titled, “Vaccination of Patients and Staff,” undated, showed the facility should educate all patients and staff on the benefits of vaccination due to dialysis patients were immunocompromised and highly susceptible to infections. 4. Review of the Centers for Disease Control and Prevention (CDC) “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” dated 04/27/01, showed the direction for staff to develop and maintain a centralized record-keeping system to record the results of patients’ vaccination status, serologic testing results for viral hepatitis, episodes of bacteremia or loss of the vascular access caused by infection and any adverse events.”

“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: 18018 Based on observation, policy review, and interview the facility failed to ensure staff: - Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff provided care and treatments to patients. - Wore gloves when indicated and performed hand hygiene before gloving, after glove removal and before re-gloving. - Repeated the cleansing process of patients’ access sites before cannulation (insertion of a needle into the blood vessels to enable blood to be circulated between the patient and dialysis machine during dialysis treatment) when staff touched the area after the area was cleansed for three (#6, #13, and #15) patients out of six observations conducted of staff cannulating patients’ access sites. These failures to ensure staff practiced appropriate infection control prevention had the potential for cross-contamination and the spread of infections to both patients and staff. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: HAND HYGIENE - GLOVE USE 1. Observations conducted on 07/28/25 showed: - At 9:34 AM, Staff J, Patient Care Technician (PCT), removed gloves but failed to perform hand hygiene before re-gloving. - At 9:42 AM, Staff J, PCT, prepared to disinfect patient Station #7. After Staff J removed all the disposable items from the patient Station, Staff J failed to perform hand hygiene after glove removal and before re-gloving. - At 9:44 AM, Staff J, PCT, removed gloves but failed to perform hand hygiene after removal of gloves. - At 1:00 PM, Staff B, Registered Nurse (RN), failed to perform hand hygiene before gloving to turn off the dialysis alarm at patient Station #6. - At 1:37 PM, Staff G, PCT, prepared to disinfect patient Station #4. After Staff G removed all the disposable items from the patient Station, Staff G failed to perform hand hygiene after glove removal and before re-gloving. At the completion of disinfecting the patient Station, Staff G removed gloves but failed to perform hand hygiene after Staff G removed the gloves. - At 2:25 PM, Staff G, PCT, prepared Patient #13 for cannulation of the patient’s Arteriovenous Fistula (AVF, a permanent access that is surgically created by sewing an artery to a vein, usually located in the arm) access sites. After Staff G assessed and palpated the patient’s assess sites, Staff G failed to remove gloves, perform hand hygiene and re-glove before Staff G applied antiseptic (maintained free of bacteria and/or germs) to the patient’s skin for cannulation. Wearing the same gloves worn to evaluate the patient’s access sites, Staff G retrieved additional supplies from the supply station. - At 2:41 PM, Staff A, PCT, failed to perform hand hygiene before gloving to turn off the dialysis alarm at patient Station #11. 2. Observations conducted on 07/29/25 showed: - At 8:45 AM, Staff H, PCT, turned off the dialysis alarm at patient Station #5 without wearing gloves. - At 8:49 AM, Staff H, PCT, failed to perform hand hygiene before gloving and after removal of gloves. - At 9:55 AM, Staff G, PCT, failed to perform hand hygiene before gloving to turn off the dialysis alarm at patient Station #5 and failed to perform hand hygiene after removal of gloves. - At 10:23 AM, Staff H, PCT, wrapped a glove around a finger to turn off the dialysis alarm at patient Station #1 and at 10:25 AM, Staff H wrapped a glove around a finger to turn off the dialysis machine alarm at patient Station #2. Staff H failed to place a glove on the hand to turn off the dialysis alarms at patient Stations #1 and #2. - At 10:25 AM, Staff H, PCT, prepared Patient #6 for cannulation of the patient’s AVF access sites. After Staff H assessed and palpated the patient’s assess sites, Staff H failed to remove gloves, perform hand hygiene and re-glove before Staff H applied antiseptic to the patient’s skin for cannulation. - At 10:26 AM, Staff I, RN, turned off a dialysis alarm without wearing gloves. - At 11:12 AM, Staff H, PCT, gloved without performing hand hygiene, removed gloves and failed to perform hand hygiene before re-gloving. - At 11:26 AM, Staff H, PCT, prepared Patient #5 for cannulation of the patient’s AVF access sites. After Staff H assessed and palpated the patient’s assess sites, Staff H failed to remove gloves, perform hand hygiene and re-glove before Staff H applied antiseptic to the patient’s skin for cannulation. - At 11:31 AM, Staff G, PCT, prepared Patient #14 for cannulation of the patient’s Arteriovenous Graft (AVG, a permanent access made by connecting an artery and a vein using synthetic material) access sites. After Staff G assessed and palpated the patient’s assess sites, Staff G failed to remove gloves, perform hand hygiene and re-glove before Staff G applied antiseptic to the patient’s skin for cannulation. - At 11:41 AM, Staff H, PCT, programmed the dialysis machine at patient Station #5 without wearing gloves. - At 11:44 AM, Staff J, PCT, prepared Patient #15 for cannulation of the patient’s AVF access sites. After Staff J assessed and palpated the patient’s assess sites, Staff J failed to remove gloves, perform hand hygiene and re-glove before Staff J applied antiseptic to the patient’s skin for cannulation. - At 11:57 AM, Staff H, PCT, turned off the dialysis alarm at patient Station #6 without wearing gloves and at 12:00 PM, Staff H, PCT, wrapped a glove around a finger and turned off the dialysis alarm at patient Station #6. Staff H failed to place a glove on the hand to turn off the dialysis alarms at patient Station #6. - At 12:18 PM, Staff H, PCT, removed gloves but failed to perform hand hygiene after glove removal and before re-gloving. 3. Review of the facility’s policy titled, “Hand Hygiene,” undated, showed staff directives: Hands will be decontaminated with alcohol-based hand rub or by washing hands with antimicrobial soap and water: - Before direct contact with patients; - After contact with a patient’s intact skin; - After removing gloves; - After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled; - After contact with equipment, computers, furniture or other items near the patient; and - Before inserting invasive devices (e.g. fistula, needles, IV catheters). Staffs’ failure to: - Perform hand hygiene after glove removal and before re-gloving increased the risk of staff contaminating the gloves during re-gloving. - Remove gloves, perform hand hygiene and re-glove after discarding used bloodlines and dialyzer (bio-hazard waste items) increased the risk of the gloves becoming contaminated with body fluids and/or blood and increased the risk of cross-contamination of all surfaces touched wearing the contaminated gloves during the patient Station cleaning/disinfection process. - Perform hand hygiene after glove removal and before retrieval of additional supplies from the supply station increased the risk of contamination of the remaining supplies. - Remove gloves, perform hand hygiene and re-glove before applying antiseptic to patients’ skin/access sties increased the risk of contamination to the skin/access sites from the gloves worn to assess/palpate the patients’ access sites. REPEAT THE CLEANSING PROCESS 4. Observation on 07/28/25 at 2:25 PM, showed Staff G, PCT, cannulated Patient #13’s AVF access sites for dialysis treatment. Staff G touched both bottom and top access sites, however, Staff G failed to repeat the skin antisepsis (process of preventing the growth of infectious germs, like bacteria, viruses and fungi) process before Staff G cannulated the patient’s access sites. 5. Observation on 07/29/25 at 10:25 AM, showed Staff H, PCT, cannulated Patient #6’s AVF access sites for dialysis treatment. Staff H touched both bottom and top access sites, however, Staff H failed to repeat the skin antisepsis process before Staff H cannulated the patient’s access sites. 6. Observation on 07/29/25 at 11:44 AM, showed Staff J, PCT, cannulated Patient #15’s AVF access sites for dialysis treatment. Staff J touched both bottom and top access sites, however, Staff J failed to repeat the skin antisepsis process before Staff J cannulated the patient’s access site. Staffs’ failure to repeat the skin antisepsis of patients’ access sites after being touched by staff increased the risk of contamination and allowing the introduction of bacteria during the cannulation process. 7. Review of the facility’s document titled, “Cannulation of A-V Fistula and Graft Checklist,” undated, showed staff directives: - Wash hands. - Don PPE (Personal Protective Equipment: gown, gloves and face shield). - Evaluate access. - Select site for needle insertion and clean skin with antiseptic. - Do not touch the puncture site with your fingers after disinfecting the skin. - Re-prep the access, if puncture site is accidentally contaminated. 8. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated staff should have been re-educated on hand hygiene practices.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 18018 Based on observation, policy review, and interview, the facility failed to ensure staff appropriately disposed of bio-hazardous waste (blood and/or body fluids) for five out of five observations conducted of staff disposing bio-hazardous waste materials/items (used bloodlines, tubing, and dialyzer) after patients’ dialysis treatments. This failed practice had the potential for increased risk for infections, cross contamination and exposure to blood and/or body fluids to both patients and staff. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five, the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. Observations conducted on 07/28/25, showed: - At 9:15 AM and 2:19 PM, Staff A, Patient Care Technician (PCT), removed used bloodlines and dialyzer from the dialysis machine located at patient Station #1 and carried the uncontained bio-hazardous waste items to the large red bio-hazardous cart located in POD 3. - At 9:50 AM and 1:20 PM, Staff G, PCT, removed used bloodlines and dialyzer from the dialysis machines located at patient Stations #9 and #4 and carried the uncontained bio-hazardous items to the large red bio-hazardous cart located in POD 2. 2. Observation on 07/29/25 at 10:30 AM, showed Staff J, PCT, removed used bloodlines and dialyzer from the dialysis machine and carried the uncontained bio-hazardous waste items to the large red bio-hazardous cart located in POD 2. Staffs’ failure to move the large red bio-hazardous cart to the patient Station to dispose of used bloodlines and dialyzer removed from the dialysis machine after a patient’s dialysis treatment increased the risk of splashing, spraying, splattering or generation of droplets and exposing both patients and staff to infections and cross-contamination when staff carried the uncontained bio-hazardous waste without being contained in a fluid resistant container. 3. Observations conducted on 07/28/25 and 07/29/25 showed the large red bio-hazardous cart located in POD 2 was located next to a black portable cart with supplies on the shelves that was used for patients. The large red bio-hazardous cart lid remained open throughout the patients’ treatments and increased the risk of contamination to various supplies on the cart when staff placed the uncontained used bio-hazardous items in the large red bio-hazardous cart. The black portable cart shelves contained the following supplies: two syringes with Lidocaine (local anesthetic medication used to numb specific areas of the body to prevent or manage pain during medical procedures - in dialysis used to numb access sites prior to inserting needles for dialysis treatment); a stack of clean barrier pads; various sized syringes; and a blue plastic bin with various supplies. There was no safety/splash guard between the large red bio-hazardous cart and the black portable cart with supplies to prevent contamination from splashing, spraying, or splattering onto the unprotected patient supplies when staff placed the used uncontained bio-hazardous items into the large red bio-hazardous cart. 4. Review of the facility’s policy titled, “Guidelines for the Handling and Disposal of Infectious Medical Waste,” undated, showed staff directives: To properly handle and discard trash and infectious waste so as to prevent transmission of disease through exposure to bloodborne pathogens and airborne exposure. Biohazard container should be kept away from the patients and lids are to remain in place except during turnaround. 5. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated staff should be re-educated on bringing the biohazard cart to the chair during the breakdown.”

“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: 18018 Based on observation, policy review, and interview, the facility failed to ensure staff consistently, thoroughly, and properly disinfected and cleansed patients’ dialysis Stations at the end of a patient’s dialysis treatment and prior to the initiation of the next patient’s dialysis treatment for four out of four observations made of staff performing Station disinfection. The failure to properly disinfect and clean patient Stations increased the potential for cross-contamination that could cause infection risks to all patients and staff. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five, and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. Observation on 07/28/25 at 1:27 PM, showed Staff G, Patient Care Technician (PCT), failed to cleanse/disinfect the following items at patient Station #4: - The dialysis machine’s supply lines and cords; - The prime bucket’s interior and exterior surfaces; - The supply/wall box; - The emergency kit attached to the intravenous (IV, in a vein) hooks; - Drop the dialysis chair side trays and clean/disinfect all surfaces/crevices of the side trays; - The blood pressure cord; - The oxygen concentrator used by the patient during dialysis treatment; - The IV hooks; and - The outside surface of the red sharps container. 2. Observation on 07/28/25 at 2:46 PM, showed Staff A, PCT, failed to cleanse/disinfect the dialysis machine’s supply lines and cords located at patient Station #1. 3. Observation on 07/29/25 at 09:42 AM, showed Staff J, PCT, failed to cleanse/disinfect the following items at patient Station #7: - The dialysis machine’s supply lines, cords, and back; - The prime bucket’s interior and exterior surfaces; - The supply/wall box and chase wall; and - The IV pole and hooks. 4. Observation on 07/29/25 at 11:06 AM, showed Staff G, PCT, failed to cleanse/disinfect the following items at patient Station #4: - The dialysis machine’s supply lines, cords, and back; - The prime bucket’s interior and exterior surfaces; - The supply/wall box and chase wall; and - The IV hooks and the emergency kit attached to the IV hooks. 5. Review of the facility’s policy titled, “Stripping and Cleaning the Dialysis Machine and Station,” dated 01/09/19, showed staff directives: - The Station includes all the following: Patient chair, dialysis machine, dialysate concentrate container, countertop behind the Station and computer keyboard. - Ensure chair is vacated. - Using 1:100 bleach solution wet wipe all machine top, front and sides surfaces, dialysate hoses, coupling connectors and outside surfaces of dialysate of machine and items in basket. - Empty priming containers and disinfect inside and out with 1:100 bleach solution. - Chair fully reclined, fresh disinfectant cloth used to visibly wet all external front facing and side chair surfaces, including down sides of each cushion and tops of side tables. - Wipe keyboard cover and mouse, TV remote, hand sanitizer bottle on dialysis machine and any other ancillary equipment used for patient care with 1:100 bleach solution. - Clean blood pressure equipment with 1:100 bleach solution. - Clean back counter with 1:100 bleach solution. - Remove any portable equipment from the Station after disinfecting it. - Put used pressure clamps and hemostats in the 1:100 bleach solution and let soak for at least 10 minutes. - Discard cloths/wipes; remove gloves and perform hand hygiene. 6. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated all staff should have been re-educated on station disinfection.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 18018 Based on interview, record review, policy review and the Centers for Disease Control and Prevention (CDC) guidelines, the facility failed to ensure staff tested and documented 28 of 28 In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) patients’ Hepatitis B Virus (HBV, a viral infection that can cause both short-term and long-term liver disease and primarily transmitted through contact with infected blood and bodily fluids) serologic status prior to admission to the hemodialysis unit. The failure to ensure staff practiced appropriate infection control prevention had potential for increased risk in the spread of infection to both patients and staff. The In-Center Hemodialysis census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated staff should have documented all testing and vaccinations for all patients. 2. Although requested, the facility failed to provide evidence that 28 of 28 In-Center Hemodialysis patients’ HBV serological testing and results/status was determined prior to admission to the dialysis clinic and before the delivery of patients’ first dialysis treatment. 3. Although requested, the facility failed to provide a policy on serological testing. 4. Review of the Centers for Disease Control and Prevention (CDC) “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” dated 04/27/01, showed the direction for staff to develop and maintain a centralized record-keeping system to record the results of patients’ vaccination status, serologic testing results for viral hepatitis, episodes of bacteremia or loss of the vascular access caused by infection and any adverse events. 36473”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 36473 Based on interview, record review, and policy review, the facility failed to inform and offer patients the option to participate in their Interdisciplinary (IDT, Nephrologist, Nurse, Social Worker and Dietician) Care Plan Meetings for three patients (#1, #2 and #6) out of three In-Center Hemodialysis patients reviewed. This failure had the potential to eliminate the patient’s right to know about their care and effected all patients that presented for treatment at the facility. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated all patients should have been notified of the IDT Care Plan Meetings. 2. Review of Patient #1’s Care Plan dated 05/27/25 showed no documented notification to the patient to participate in the IDT Care Plan Meetings. 3. Review of Patient #2’s Care Plan dated 06/18/25 showed no documented notification to the patient to participate in the IDT Care Plan Meetings. 4. Review of Patient #6’s Care Plan dated 05/28/25 showed no documented notification to the patient to participate in the IDT Care Plan Meetings. 5. Review of the facility’s policy titled, “Patient Assessment and Plan of Care,” undated, showed that patients were to be given the option and encouraged to participate in their assessment and care planning process.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 36473 Based on interview, record review and policy review, the facility failed to show evidence in the Interdisciplinary (IDT, patient, attending physician, registered nurse, social worker and dietician) Plan of Care an evaluation of the patient’s suitability for transplant for three patients (#1, #2 and #6) of three In-Center Hemodialysis patients reviewed. This failure increased the risk of patients ability to understand the transplant selection criteria and individual options available. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated Transplant status of each patient should have been included in the IDT Care Plans. 2. Review of Patient #1’s Care Plan dated 05/27/25 showed no documentation of the evaluation for Transplant suitability in the IDT Care Plan Meetings. 3. Review of Patient #2’s Care Plan dated 06/18/25 showed no documentation of the evaluation for Transplant suitability in the IDT Care Plan Meetings. 4. Review of Patient #6’s Care Plan dated 05/28/25 showed no documentation of the evaluation for Transplant suitability in the IDT Care Plan Meetings. 5. Review of the facility’s policy titled, “Patient Assessment and Plan of Care,” undated, showed there should be documentation of Transplant status: Plan or why not a candidate.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 36473 Based on record review and interview, the facility failed to show evidence acknowledging the patient’s participation in the Interdisciplinary (IDT, patient, attending physician, registered nurse, social worker and dietician) Plan of Care meeting for three patients (#1, #2 and #6) of three In-Center Hemodialysis patients reviewed. This failure prevented the acknowledgement of the patient’s review of their individualized healthcare plan. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated the IDT Plan of Care should have been signed by the patients 2. Review of Patient #1’s Plan of Care dated 05/27/25 showed no signature of the patient and/or patient representative in the IDT Plan of Care. 3. Review of Patient #2’s Plan of Care dated 06/18/25 showed no signature of the patient and/or patient representative in the IDT Plan of Care. 4. Review of Patient #6’s Plan of Care dated 05/28/25 showed no signature of the patient and/or patient representative in the IDT Plan of Care. 5. Review of the facility’s policy titled, “Patient Assessment and Plan of Care,” undated, showed members of the IDT Team involved in the Care Plan meetings were the patient or patient’s designee, Registered Nurse, Nephrologist, Social Worker and Dietician.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 36473 Based on interview, record review, and policy review, the facility failed to include infection prevention education in the patient’s Plan of Care for vaccination and serological testing in three patients (#1, #2 and #6) of three In-Center Hemodialysis patients reviewed. This failure had the potential for preventing patients from having a medical professional’s recommendations for infection prevention. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/29/25 at 1:30 PM, Staff C, Facility Manager, stated vaccinations and testing should have been included in patients IDT Plans of Care. 2. Review of Patient #1’s Plan of Care dated 05/27/25 showed no documentation of the patient’s vaccination history or serological testing in the IDT Plan of Care. 3. Review of Patient #2’s Plan of Care dated 06/18/25 showed no documentation of the patient’s vaccination history or serological testing in the IDT Plan of Care. 4. Review of Patient #6’s Plan of Care dated 05/28/25 showed no documentation of the patient’s vaccination history or serological testing in the IDT Plan of Care. 5. Review of the facility’s policy titled, “Patient Assessment and Plan of Care,” undated, showed there should be the patient’s immunization history per Centers for Disease Control and Prevention (CDC) recommendations for dialysis patients to include hepatitis, influenza, pneumococcus, evaluate for tuberculosis and evaluate Anti-HBs on all vaccines.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 36473 Based on record review and interview, the facility failed to develop and implement a process to ensure the complaint/grievance program reviewed, investigated, and resolved patient complaints in a reasonable timeframe to allow continuous improvements for the health and safety of all of the dialysis patients that presented to the facility for dialysis treatment. These failures prevented the facility to perform a thorough evaluation of their Quality Assessment and Performance Improvement (QAPI) program. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 57, the Home Hemodialysis census was five and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 26 for a total census of 88. Findings included: 1. During an interview on 07/28/25 at 8:18 AM, Staff C, Facility Manager, stated they had no complaint/grievance log and the last complaint was documented on 05/11/20. 2. During an interview on 07/28/25 at 9:10 AM, Patient #4 stated when they reported concerns about staff not being able to utilize clamps after removal of needles from the patient’s access sites, management staff did not provide the patient with an explanation or resolution to the concerns voiced related to use of clamps in the facility. 3. During an interview on 07/28/25 at 1:00 PM, Patient #9 stated they had not received any information on the process involved when a patient reported concerns to staff and the process involved. The patient stated in the past when they had voiced a concern to staff, staff did not follow-up or provide a resolution to the concern reported and the patient stated they did not feel comfortable to report concerns to staff. 4. During an interview on 07/29/25 at 11:51 AM, Patient #5 stated the new management does not listen to patients or understand them when they report concerns and does not do anything to alleviate patients’ anxiety/stress when they voice concerns about changes made at the dialysis facility related to patient care. 5. Review of the facility’s policy titled, “Grievance Procedure,” undated, showed the definition of grievance was a written or oral communication from a patient, and/or representative alleging that an ESRD service did not meet expectations with respect to safety, civility, patient rights and/or clinical standards of care. The internal procedure for complaints were: - To communicate grievance verbally or in written form to the Facility Manager. - The facility Manager was expected to report back to the patient and any actions taken within five days. - If grievance was not resolved or mutual agreement not reached, the Facility Manager should present the complaint to the Quality Assurance team that meets monthly. - If presented to the Quality Assurance team it should take 10-45 days and the patient would be notified of the results.”