Prattville Community Dialysis

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 40119 Based on review of facility Hepatitis Management forms, facility policy, and interview, it was determined the facility failed to ensure all susceptible patients were vaccinated or a declination form was obtained per policy. This affected 12 of 35 Incenter Hemodialysis patients reviewed and had the potential to negatively affect all 35 patients served by the facility. Findings include: Facility Policy: Hepatitis B Testing for Patients Policy Number: 716 Date: Not documented Purpose: To prevent the spread of Hepatitis B among patients and staff... This policy will also provide guideline for determination of immune status and need for vaccine. ...3. All patients who are determined susceptible, will be offered the Hepatitis B vaccine series per policy. 4. Patients who are considered susceptible (titers below 10 mIU/ml [multigenerational units per milliliter])... 7. If a patient is considered protected, but annual testing shows that the titers have fallen below the susceptible standard (10 mIu/ml), he/she will be offered a booster dose of Hepatitis B vaccine... 1. Review of the facility Hepatitis Management forms revealed 29 patients of the facilities 35 HD patients were tested for Hepatitis B surface antibodies (Anti-HBs). Further review of the facility Hepatitis Management forms revealed 15 of the 29 patients tested resulted in Anti-HBs of below 10 mIu/ml (susceptible). There was no documentation 12 of the 15 susceptible Hepatitis B patients had been offered, declined, and/or received the Hepatitis B vaccination and/or booster. An interview was conducted on 1/28/25 at 11:33 AM with Employee Identifier (EI) # 1, Chief Clinical Officer, who confirmed there was no documentation 12 of the 15 susceptible Hepatitis B patients had been offered, declined, and/or received the Hepatitis B vaccination and/or booster.”

“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: 40119 Prattville Community Dialysis is not in compliance with the Condition for Coverage for Establishment of the Emergency Preparedness Program (EPP) as evidenced by a failure to ensure the facility EPP was developed, evaluated, and updated annually, a process was in place for contact, and collaboration with local, tribal, regional, State and Federal emergency officials, and the facility conducted and analyzed the required testing of the EPP. For findings refer to E 0004, E 0009, E 0013, E 0029, and E 0039”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 40119 Based on review of medical records, facility policy, facility Hemodialysis (HD) Standing Orders, Vaccination History Report, staff observations, End Stage Renal Disease CORE Survey HD Care and Infection Control Practices, review of the facility Initial and Annual Skills Validation Checklist for CVC (central venous catheter) dressing change, and staff interview, it was determined the facility failed to ensure the staff followed infection control requirements per regulations and facility policies. Refer to V 113, V 117, V 122, V 124, and V 147.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 40119 Based on review of medical records, the Medication Discrepancy Report, facility policies and procedure, facility hemodialysis standing orders, and staff interview it was determined the facility failed to ensure facility policies and procedures, physician’s orders, and the patient’s Plan of Care was developed and followed during care delivery. These deficient practices had the potential to negatively affect the 36 patients currently receiving in-center hemodialysis at the facility. Refer to: V 543, V 544, V 546, V 547, V 552, and V 556.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 40119 Prattville Community Dialysis is not in compliance with the Condition for Coverage for Quality Assessment and Performance Improvement (QAPI) as evidenced by failure to demonstrate an effective QAPI program; failure to recognize and prioritize major problems which impact patient’s health and safety, and failure to take action to address identified problems. This deficient practice has the potential to affect 36 incenter hemodialysis patients served by this facility. Findings: refer to V 0628, V 0629, V 0630, V 0631, V 0632, V 0633, V 0634, V 0636 and V 0637.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 40119 Based on review of facility policy, medical records (MR), facility Medication Discrepancy Report, incident and grievance report documentation, facility Quality Assessment and Performance Improvement (QAPI) data, Adverse Occurrence (AO) Trends for Hemodialysis Year 2024, facility Online Incident Reporting System Report, facility Nutrition and Anemia Management Reports, facility Hemodialysis (HD) standing orders, facility Infections Report, Federal Drug Administration (FDA) It’s a Good Time to Get Your Flu (influenza) Vaccine, and interviews with patients and staff, it was determined the Medical Director failed to ensure: 1. Patients were informed, able to exercise their rights, and participate in planning his/her care: Refer to the Condition at V 450 and associated tags. 2. Staff and Medical Director followed policies for Patient Plan of Care: Refer to the Condition at V 540 and associated tags. 3. The facility Quality Assessment Performance Improvement Committee collected, reviewed, and evaluated facility quality data to improve patient care delivery: Refer to the Condition at V 625 and associated tags.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 40119 Based on review of facility policy, medical records (MR), facility Medication Discrepancy Report, incident and grievance report documentation, facility Quality Assessment and Performance Improvement (QAPI) data, Adverse Occurrence (AO) Trends for Hemodialysis Year 2024, facility Online Incident Reporting System Report, facility Nutrition and Anemia Management Reports, facility Hemodialysis (HD) standing orders, facility Infections Report, Federal Drug Administration (FDA) It’s a Good Time to Get Your Flu (influenza) Vaccine, and interviews with patients and staff, it was determined the Governing Body failed to provide sound fiscal operation and management of the facility and ensure: 1. Patients were informed of the lack of medications at the facility and missed doses of ordered medications. Refer to Conditions for Coverage (Cfc) and associated tags at V 450. 2. The delivery of patient care was safe and effective for patient outcome improvement and the the Interdisciplinary Team developed and implemented a Patient Plan of Care. Refer to Cfc and associated tags at V 540. 3. An active and effective QAPI Program was conducted and maintained. Refer to Cfc and associated tags at V 625. 4. The Medical Director complied with the facility bylaws and MD duties and responsibilities. Refer to Cfc and associated tags at V 710. This had the potential to affect all patients served by this facility. Findings include: Refer to V 0751 for findings.”

“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: 49603 Based on review of the facility policy, Emergency Management Plan (EMP) program documentation, and staff interview, it was determined the staff failed to ensure the facility EMP was evaluated and updated annually. This had the potential to negatively affect all patients served by the facility, visitors, and staff. Findings include: Facility Policy: Disaster and Emergency Preparedness Policy Number: RM 400 Revision Date: 11/15/17 Policy Physicians Choice Dialysis (PCD) is committed to developing an effective plan of response to serious disasters and to provide safe and proper care of patients and PCD employees. The plan should help enable each PCD facility to minimize injury and damage and quickly resume operations. Guidelines ... 13. The facility-specific Emergency Preparedness Plan will be reviewed annually and approved by the Program Coordinator. Review of facility documentation provided in the Emergency Preparedness binder revealed the Emergency and Disaster Preparedness Plan was reviewed and updated on 1/10/2020. An interview was conducted on 12/13/24 at 10:10 AM, with Employee Identifier # 1, Chief Clinical Officer, who confirmed there was no documentation the Emergency Preparedness Plan was reviewed and updated since 1/10/2020.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 49603 Based on review of the Emergency Preparedness (EP) manual and interview with staff, it was determined the facility failed to ensure a process was in place for contact, and collaboration with local, tribal, regional, State and Federal emergency officials. This had the potential to affect all persons served by the facility. Findings include: A review of the EP manual provided to the surveyor revealed no contact, information, or collaboration with local, State, and Federal emergency officials since January 2022. An interview was conducted on 12/13/24 at 10:10 AM with Employee Identifier # 1, Chief Clinical Officer, who confirmed there was no documentation of contact, information, or collaboration with local, State, and Federal emergency officials since January 2022.”

“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: 49603 Based on review of the facility’s Emergency Preparedness (EP) policies and procedures, and interview with the facility staff, it was determined the facility failed to ensure policies and procedures had been updated and/or reviewed at least every two (2) years. This had the potential to negatively affect all persons served by the facility. Findings include: Review of the EP documentation provided to the surveyor revealed the policies and procedures for EP were last revised on 11/15/2017. An interview was conducted on 12/13/24 at 10:10 AM with Employee Identifier # 1, Chief Clinical Offer, who confirmed the EP policies and procedures were not reviewed and updated at least every two years.”

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This Standard is not met as evidenced by: 49603 Based on staff interview and review of the Emergency Preparedness manual, it was determined the facility failed to develop a communication plan for its emergency preparedness program that was reviewed/approved at least every two years. This had the potential to affect all staff and patients served by the facility. Findings include: Review of the Emergency Management Plan for communication during an emergency revealed there was no documentation the Emergency Plan has been reviewed and updated. An interview was conducted on 12/10/24 at 10:10 AM with Employee Identifier # 1, Chief Clinical Officer, who confirmed there was no documentation the facility emergency program communication plan was reviewed, approved, and updated as needed at least every two years.”

“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: 49603 Based on review of the Emergency Preparedness manual, facility policy, and interview with staff, it was determined the facility failed to conduct and analyze the required testing of the Emergency Preparedness Plan. This deficient practice had the potential to affect all patients treated at this clinic. Findings include: Facility Policy: Disaster and Emergency Preparedness Policy Number: RM 400 Revision Date: 11/15/17 Policy Physicians Choice Dialysis (PCD) is committed to developing an effective plan of response to serious disasters and to provide safe and proper care of patients and PCD employees. The plan should help enable each PCD facility to minimize injury and damage and quickly resume operations. Guidelines ... 9. The area Facility Administrator and the Facility Administrator will assure that: ...B. Patients and employees will participate in quarterly evacuation drills. C. Each shift will have a minimum of one disaster drill annually. A review of the documentation provided of the Emergency Preparedness manual revealed no documentation of full-scale exercises, community-based exercises, or actual events. An interview was conducted on 12/13/24 at 10:10 AM, with Employee Identifier # 1, Chief Clinical Officer, who confirmed the clinic failed to document participation in Emergency Preparedness exercises or actual 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: 40119 Based on observations and staff interviews, it was determined the facility failed to ensure staff performed hand hygiene prior to obtaining new 1000 ml (milliliter) bag of Normal Saline (NS). This affected one of four observations for the preparation of the Hemodialysis (HD) machine and extracorporeal circuit, Patient Identifier (PI) # 9, and had the potential to negatively affect all 36 patients dialyzing at this facility. Findings include: 1. An observation was conducted on 12/10/24 at 9:25 AM to observe EI # 4, Certified Clinical Hemodialysis Technician (CCHT), prepare the HD machine and extracorporeal circuit for PI # 9 at station 8. After placing dialyzer on the treatment machine, EI # 4 exited the station and obtained a new 1000 ml bag of NS from the clean supply then re-entered the station and replaced the existing (used for priming the machine) bag of NS with the new bag without performing hand hygiene prior to obtaining the new NS bag, prior to reentering the station, and prior to hanging the new bag of NS. An interview was conducted on 12/13/24 at 10:33 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed staff failed to perform hand hygiene prior to obtaining the new NS bag, prior to reentering the station, and prior to hanging the new bag of NS.”

“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: 40119 Based on observation and interview, it was determined the facility failed to ensure single dose saline flushes were available for patient use, or saline flushes were prepared in a safe and sanitary manner. This deficient practice did affect one of two initiations of dialysis with a Central Venous Catheter (CVC), including Patient Identifier (PI ) # 9, one of three discontinuations of dialysis with a CVC including PI # 15, and had the potential to affect all patients dialyzing at this facility with a CVC. Findings include: 1. An observation was conducted on 12/10/24 at 10:11 AM with Employee Identifier (EI) # 8, Registered Nurse, for the initiation of dialysis with a CVC on PI # 9 at station 8. EI # 8 removed two 10 milliliter (ml) syringes from sterile packaging, connected each syringe to the red IV port on the treatment machine at station 8 and withdrew 10 ml of saline from the IV tubing. After the syringes were filled, EI # 8 placed both syringes back inside of the syringe packing and placed them on the clean field on the treatment chair and proceeded to perform CVC exit site care. EI # 8 then administered one of the 10 ml saline syringes, filled from the treatment machine IV tubing to each of the CVC lines. An interview was conducted on 12/10/24 at 10:30 AM with EI # 8, who verbalized the facility hasn’t had Saline flushes in a long time. EI # 8 verbalized some of the staff withdrew the flushes from one bag, but she/he just withdrew them from the machine. An interview was conducted on 12/12/24 at 4:00 PM with EI # 1, Chief Clinical Officer, who verbalized he/she has been unable to order the saline flushes for months due to them being out of stock. The surveyor requested the invoice of the last saline flush order and documentation of the facilities inability to order the saline flushes. EI # 1 failed to provide the documentation. An interview was conducted on 12/12/24 at 4:15 PM with EI # 2, Facility Administrator 1, who verbalized the facility has been able to get the saline flushes and her clinic just received two cases of the saline flushes on 11/26/24. 41624 2. An observation was conducted on 12/10/24 at 11:00 AM of discontinuation of dialysis with a CVC by EI # 8 for PI # 15 at station six. During the observation, EI # 8 withdrew saline from the IV tubing connected to the dialysis machine with a sterile syringe to allow EI # 8 to flush the CVC. EI # 8 stated to the surveyor during the observation that he/she would normally use a pre-filled normal saline syringe, but the facility did not currently have any in stock. An interview was conducted on 12/12/24 at 4:00 PM with EI # 1, who stated he/she had been unable to order the saline flushes for months due to them being out of stock. The surveyor requested the invoice of the last saline flush order and documentation of the facilities inability to order the saline flushes. EI # 1 failed to provide the documentation.”

“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: 40119 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station per the facility policy. This did affect two of three cleaning and disinfection of the dialysis station observations and had the potential to negatively affect all 36 patients dialyzing at the facility. Findings include: Facility Policy: Cleaning and Disinfection Policy Number: Hemodialysis Policy 787 Date: Not documented Purpose: To provide guidelines to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. To prevent the spread of infectious disease... ...All equipment and work surfaces shall be cleaned and decontaminated after completion of procedures. ...Clean dialysis station...after each patient treatment and before the next patient with a 1:100 bleach solution... Cleaning The Dialysis Machine Externally disinfect the dialysis machine with 1:100 bleach solution... 1. An observation was conducted on 12/10/24 at 9:42 AM to observe Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician (CCHT), clean and disinfect dialysis station five. EI # 4 failed to clean and disinfect the back of the dialysis machine, tubing from the machine to the wall box, the wall box, and the counter behind the treatment chair. After EI # 4 cleaned and disinfected the recliner chair and the right chair arm, both were immediately closed without allowing the chair and chair arm to air dry. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2, Facility Administrator 1, who confirmed staff failed to clean and disinfect the dialysis station per facility policy. 2. An observation was conducted on 12/10/24 at 11:54 AM to observe EI # 4 clean and disinfect dialysis station six. EI # 4 failed to clean and disinfect the wall box and counter behind the treatment chair. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean and disinfect the dialysis station per policy.”

“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: 40119 Based on review of medical records (MR), facility Hemodialysis (HD) Standing Orders, Vaccination History Report, and interviews, it was determined the facility failed to ensure patients were tested for Hepatitis B. This affected four of eight MRs reviewed, including Patient Identifier (PI) # 7, PI # 8, PI # 3, and PI # 6, and had the potential to affect all patients who dialyze at this facility. Findings include: HD Standing Orders Revised Date: 1/24 ...Hepatitis Management: ...HBsAB (hepatitis B surface antibody) testing is to be done quarterly for patients with antibody level less than 10. HBsAG (hepatitis B surface antigen) testing to be done monthly for patients with antibody level less than 10. HBsAB and HBsAG testing is to be done at least annually for patients with antibody level (greater than or equal too) 10. 1. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the HD Comprehensive Interdisciplinary Assessment dated 4/8/22 revealed a patient HBsAB level of over 1000 on 3/21/22. Review of the MR revealed no documentation of a HBsAB and HBsAG since 3/21/22. Review of the Vaccinations History Report dated 1/1/24 to 12/12/24 revealed no documentation of a HBsAB and HBsAG. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed there was no documentation of a HBsAB and HBsAG since 3/21/22. 2. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the laboratory testing dated 1/15/24 revealed a HBsAB of less than 4 and a negative HBsAG. Review of the MR revealed no documentation of HBsAB testing since 1/15/24. Review of the laboratory testing dated 12/3/24 revealed a negative HBsAG. There was no documentation of monthly HBsAG between 1/15/24 and 12/3/24. An interview was conducted via email on 12/20/24 at 2:52 PM with EI # 1, Chief Clinical Officer, who confirmed there was no documentation the HBsAB was performed quarterly and HBsAG was performed monthly per standing orders. 41624 3. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of ESRD. Review of the MR revealed no documentation a HBsAB and HBsAG had been completed. Review of the Vaccinations History Report dated 1/1/24 to 12/12/24 revealed no documentation of a HBsAB and HBsAG. The facility failed to routinely test PI # 3 for Hepatitis B Virus as ordered. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2 who confirmed there was no documentation of a HBsAB and HBsAG to allow the facility to appropriately manage PI # 3’s Hepatitis B status. 4. PI # 6 was admitted to the facility on 2/5/24 with a diagnosis of ESRD. Review of the MR revealed no documentation a HBsAB and HBsAG had been completed, including prior to or time of admission. Review of the Vaccinations History Report dated 1/1/24 to 12/12/24 revealed no documentation of a HBsAB and HBsAG. The facility failed to determine the Hepatitis B status of PI # 6 prior to admission to the facility and failed to routinely test PI # 6 for Hepatitis B Virus as ordered once admitted. An interview was conducted on 12/13/24 at 10:08 AM with EI # 2 who confirmed there was no documentation of PI # 6’s Hepatitis B status at time of admission, and no documentation of a HBsAB and HBsAG to allow the facility to appropriately manage PI # 6’s Hepatitis B status.”

“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: 41624 Based on observations, End Stage Renal Disease (ESRD) CORE Survey Hemodialysis Care and Infection Control Practices, review of the facility Initial and Annual Skills Validation Checklist for CVC (central venous catheter) dressing change, initiation/discontinuation of treatment, and interviews, it was determined the facility failed to ensure staff performed CVC exit site care, treatment initiation and termination per the facility CVC skills validation requirements. This affected three of three observations of discontinuation of dialysis with a CVC, including Patient Identifier (PI) # 10, PI # 3, and PI # 15, two of two observations of CVC exit site care, including PI # 9 and PI # 14, and two of two observations of initiation of dialysis with a CVC, including PI # 9 and PI # 14, and had the potential to negatively affect all patients dialyzing with CVC’s. Findings include: ESRD CORE Survey Hemodialysis Care and Infection Control Practices, Version 1.6 Initiation of Dialysis with Central Venous Catheter Action ...Disinfect CVC hubs, using an appropriate antiseptic... Central Venous Catheter Exit Site Care Action ...Cleanse area around CVC exit site with antiseptic; allow to dry before applying dressing... Discontinuation of Dialysis with Central Venous Catheter Action ...Disinfect CVC connections with appropriate antiseptic... Facility CVC Initial and Annual Skills Validation Checklist: (includes dressing change, initiation of treatment, and treatment termination) Date, none documented. A. Dressing change...Performed PRIOR to treatment initiation... ...8. Use approved disinfectant to disinfect exit site...Use gentle back and forth friction. Clean the exit site...for a minimum of 15 seconds. 9. Allow solution to dry for a minimum of 15 seconds. B Initiation of Treatment... ...4. Using a new sterile alcohol pad, scrub thread of the CVC (hub) vigorously using back and forth friction for 15 seconds-let dry for 15 seconds. 5. Connects...syringe to arterial limb. 6. Using a new sterile alcohol pad, scrub thread of the CVC (hub) vigorously using back and forth friction for 15 seconds-let dry for 15 seconds. 7. Connects...syringe to the venous limb... C. Termination of Treatment... ...7. Using a new alcohol pad, scrubs arterial luerlock threads for 15 seconds... 8. Using a new alcohol pad, scrubs venous luerlock threads for 15 seconds... 1. An observation was conducted on 12/9/24 at 1:34 PM with Employee Identifier (EI) # 8, Registered Nurse, for the discontinuation of dialysis with a CVC on PI # 10 at station seven. EI # 8 disinfected the blue and red CVC hubs individually with an alcohol wipe for two seconds each then proceeded to withdraw a blood sample from each hub. EI # 8 then disinfected the blue and red CVC hubs individually again with an alcohol wipe for two seconds before then flushing each hub with saline. EI # 8 failed to perform a 15 second hub scrub with an alcohol wipe. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 , Facility Administrator 1, who confirmed staff failed to clean the CVC ports per the Facility Validation Checklist. 2. An observation was conducted on 12/10/24 at 8:48 AM of a discontinuation of dialysis with a CVC by EI # 8 for PI # 3 at station two. EI # 8 disinfected the blue and red CVC hubs individually with an alcohol wipe for four seconds before flushing each hub with saline. EI # 8 failed to perform a 15 second hub scrub with an alcohol wipe. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean the CVC ports per the Facility Validation Checklist. 3. An observation was conducted on 12/10/24 at 10:11 AM with EI # 8 for CVC exit site care on PI # 9 at station eight. EI # 8 disinfected the CVC exit site with Chloroprep (Chlorhexidine gluconate and Isopropyl Alcohol) for 10 seconds then applied the sterile dressing to the CVC exit site. EI # 8 failed to disinfect the CVC exit site for 15 seconds and allow the CVC exit site to dry for 15 seconds prior to the application of the sterile dressing. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean the CVC ports per the Facility Validation Checklist. 4. An observation was conducted on 12/10/24 at 10:23 AM with Employee Identifier EI # 8 for the initiation of dialysis with a CVC on PI # 9 at station eight. EI # 8 disinfected the blue and red CVC hubs individually with an alcohol pad for two seconds each then proceeded to withdraw a blood sample from each hub. EI # 8 then disinfected the blue and red CVC hubs individually again with an alcohol wipe for two seconds before then flushing each hub with saline. EI # 8 failed to perform a 15 second hub scrub with an alcohol wipe. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean the CVC ports per the Facility Validation Checklist. 5. An observation was conducted on 12/10/24 at 11:00 AM of a discontinuation of dialysis with a CVC by EI # 8 on PI # 15 at station six. EI # 8 disinfected the blue and red CVC hubs individually with an alcohol wipe for two seconds before flushing each CVC limb with saline. EI # 8 failed to scrub the hubs for 15 seconds as required by the CVC Skills Validation Checklist. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean the CVC hubs per the Facility Validation Checklist. 6. An observation was conducted on 12/10/24 at 11:18 AM of CVC exit site care for PI # 14 by EI # 8 at station seven. EI # 8 disinfected the CVC exit site with Chloroprep for seven seconds, allowed the site to dry four seconds, then applied the sterile dressing to the CVC exit site. EI # 8 failed to disinfect the CVC exit site for 15 seconds and allow the CVC exit site to dry for 15 seconds prior to the application of the sterile dressing. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to perform CVC exit site care per Facility Validation Checklist. 7. An observation was conducted on 12/10/24 at 11:23 AM for initiation of dialysis with a CVC by EI # 8 on PI # 14 at station seven. EI # 8 disinfected the blue and red CVC hubs individually with an alcohol wipe for two seconds before flushing each CVC limb with saline. EI # 8 failed to perform a 15 second hub scrub with an alcohol wipe. An interview was conducted on 12/13/24 at 10:33 AM with EI # 2 who confirmed staff failed to clean the CVC hubs per the Facility Validation Checklist. 49797 40119”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 49603 Based on observation and interview with facility staff, it was determined the facility failed to maintain the salt level to at least half of the brine tank. This has the potential to affect all 36 patients that dialyze at this facility. Findings include: On 12/9/24 at 2:09 PM, the surveyor observed the level of salt in the brine tank was approximately 1/4 to 1/5 full of salt from the bottom of the brine tank. Further observation revealed manufacturer’s instructions posted on the tank that read... Quality Checks: Check the brine tank level daily to be sure the tank is at least half filled with salt. An interview was conducted on 12/9/24 at 2:09 PM with Employee Identifier # 5, Certified Clinical Hemodialysis Technician, at which time, the surveyor pointed out the level of salt in the brine tank. EI # 5 confirmed the level of salt was low.”

“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: 41624 Based on observation, facility policy and procedure, and interview, it was determined the facility failed to ensure staff followed procedure when utilizing the Myron L Dialysate Conductivity Meter. This had the potential to affect all 36 patients dialyzing at this facility. Findings include: Facility Policy: Myron L Dialysate Conductivity Meter Use Policy Number: 970 Revision Date: None Purpose: To provide safe dialysis treatments for patients by ensuring that the dialysis delivery system produces dialysate with proper conductivity... Policy: ...2. Independent verification of the dialysate conductivity will be done per the Physicians Choice Dialysis policy... Procedure: ...When the testing is completed, rinse the cell cup and plunger with water. Rationale: RO (reverse osmosis) or deionized water is preferred for rinsing... 1. An observation was conducted on 12/10/24 at 8:57 AM of Preparation of the Hemodialysis Machine Extracorporeal Circuit by Employee Identifier (EI) # 7, Certified Clinical Hemodialysis Technician, at station one. This preparation included testing the conductivity of the dialysate utilizing a Myron L Dialysate Conductivity Meter. EI # 7 measured the conductivity of the dialysate, then turned the Myron L Meter upside down without rinsing with RO water and left the meter on the cart to drain. EI # 7 failed to follow policy/procedure and rinse the meter with RO water. An interview was conducted on 12/13/24 at 1:15 PM with EI # 1, Chief Clinical Officer, who confirmed EI # 7 did not follow facility policy and procedure while using the Myron L meter.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 49603 Based on review of facility personnel files, GranuFlo Dissolution Unit Log Sheets, and interview with facility staff, it was determined the facility failed to ensure staff responsible for acid batch testing were qualified. This affected one of six personnel files reviewed and had the potential to negatively affect all thirty-six patients dialyzing at this facility. Findings include: A review of the personnel file documentation for Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician, revealed an incomplete Risk Management Skills Checklist. Further review of the GranuFlo Dissolution Unit Log Sheet dated from June 2024 through November 2024 revealed EI # 4 performed acid batch testing and was not qualified. An interview conducted on 12/13/24 at 8:00 AM with EI # 1, Chief Clinical Officer, who was unable to provide documentation of the staff members training.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 40119 Based on observations, facility Equipment Repair Record, facility Quality Assessment and Performance Improvement (QAPI) monthly clinical audits, action plan, and interview, it was determined the facility failed to maintain functional use of the patient televisions in the dialysis treatment stations. This did affect one of seven patients interviewed, including Patient Identifier (PI) # 4, and had the potential to affect all of the 36 Hemodialysis (HD) patients who dialyze at the facility. Findings include: 1. During observations of care on 12/9/24 from 1:20 PM to 2:30 PM and 12/10/24 from 8:15 AM to 10:30 AM, the surveyor observed all 10 treatment station televisions were not in use by the patients and stored at the back of the treatment stations. Review of the QAPI monthly clinical audit dated January to October 2024 revealed the facility televisions were operational and in good repair. Review of the Equipment Repair Record revealed the televisions were working with no problems/issues on 9/27/24, 10/31/24, and 11/17/24. Review of the facility QAPI action plan dated September 2024 revealed documentation the patient televisions were not working, Biomed and the television provider were aware of the televisions not working and claimed the televisions could not be fixed. Further review revealed the televisions would be replaced when expansion occurs. There was no documentation of when expansion would occur. An interview conducted on 12/10/24 at 1:07 PM with PI # 4 revealed he/she had complained about the TVs not working several times and was told every time by Employee Identifier (EI) # 10, Biomed technician, that parts were ordered but nothing has been done. An interview was conducted on 12/10/24 at 3:42 PM with EI # 8, Registered Nurse, who verbalized in the three years of working at the facility the patient televisions have never worked due to being unable to get the parts to repair the televisions.”

“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: 40119 Based on review of facility policy, facility Medication Discrepancy Report, incident and grievance report documentation, and interviews with patients and staff, the facility staff failed to inform the patients of all aspects of his or her care which included failure to administer medications ordered by the Medical Director. Failure to inform patients of changes to their medication treatments, the failure to administer prescribed medications for the management of mineral metabolism and anemia, did not allow the patient’s rights and the ability to exercise their rights to be protected. This failure had the potential to not allow the patient the opportunity to make informed decisions about his/her care and had the potential to affect the 36 incenter hemodialysis patients at the facility. Findings include: Facility Policy: Patient Rights and Responsibilities Policy Number: 403 Date: Not documented Purpose: To comply with Federal Regulations that requires dialysis facilities to: ...Ensure that patients’ rights are respected and protected by the facility. Policy: ...All facility staff is responsible for ensuring that patients’ rights are respected and protected by the facility... Background: ...Patients’ rights: 1. To be informed of these rights...by written acknowledgement, or by documentation by staff in the medical record (MR)...in terms the patient could understand... 2. To be fully informed of all services available in the facility... 4. To receive from the patient’s physician (or) clinical practitioner(s), in terms...the patient understands, an explanation of his or her complete medical/health condition...recommended treatments...options...and expected result(s). If this information would be detrimental to the patient’s health, or if the patient is not capable of understanding the information, the explanation shall be provided to the next of kin...documented in the patient’s MR. 5. To participate in the planning of the patient’s care and treatment, and to refuse medication and treatment...documented in the patient’s MR. ...7. To voice grievance or recommend changes in...services to facility personnel, the governing authority...free from interference, coercion, discrimination, or reprisal. 8. To receive a full explanation of the...recommended treatment...risks and side effects, and other treatment/appointment options before giving consents to treatment/appointments(s)... 13. To exercise civil...liberties, including the right to independent personal decision... Review of the facility Medication Discrepancy Report dated 7/31/24 to 12/10/24 revealed 31 patients failed to receive prescribed medications, including Venofer, Mircera, CinaC (Cinacalcet), and Calcitriol due to the medication being held for not being in stock. Review of the facility Incident log revealed no missed medication dosages were documented in 2024. Review of the facility Grievance log revealed no complaints/grievances documented in 2024. Interviews were conducted on 12/10/24, 12/11/24, and 12/12/24 with seven of seven patients receiving incenter hemodialysis treatments. Seven of the seven patients interviewed verbalized they had not had any issues and/or problems with receiving incenter medication prescribed by the physician at the facility. No patients reported missed medications due to the medications not being available and out of stock at the facility. On 12/11/24 at 9:30 AM, Employee Identifier (EI) # 1, Chief Clinical Officer, asked to provide documentation the facility patients had been notified of the held Venofer, Mircera, CinaC, and Calcitriol. EI # 1 failed to provide documentation the 31 patients who failed to receive the prescribed medications were notified. An interview was conducted on 12/11/24 at 1:41 with EI # 1, Medical Director, who verbalized he/she was unsure if the patients were informed the facility did not have prescribed medications for their care available for administration during dialysis treatments.”

“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: 40119 Based on review of hemodialysis standing orders, medical records (MR), and interviews, it was determined the facility failed to offer and/or administer the flu vaccine to all patients per facility policy. This deficient practice did affect four of eight MR’s reviewed, including Patient Identifier (PI) # 3, PI # 4, PI # 6, and PI # 7, and had the potential to negatively affect all 36 patients dialyzing at this facility. Findings include: Hemodialysis (HD) Standing Orders Date Revised: 1/24 ...Influenza Vaccine: Effective during influenza season. Obtain patient consent... If patient declines vaccination, obtain signature on declination form. Provide patient with vaccine information sheet... Verify patient has not received vaccination from another facility... Verify dosage...Administer appropriate dosage for current year influenza vaccination... Review of the facility Vaccination History report revealed two patients had received the flu vaccine at an outside facility (pharmacy or physician office) one on 9/17/24 and one on 10/31/24. Review of the facility daily medication counts revealed the facility did not have the flu vaccine in stock from 9/1/24 to 12/3/24. On 12/3/24 the facility received 20 flu vaccines. Review of five of eight MRs, including the following patients, revealed no documentation the flu vaccine had been offered and/or administered to the patient from 9/1/24 through 12/13/24. PI # 3 who was admitted to the facility on 11/13/23 with a diagnosis of End Stage Renal Disease (ESRD). PI # 4 who was admitted to the facility on 7/12/23 with a diagnosis of ESRD. PI # 6 who was admitted to the facility on 2/5/24 with a diagnosis of ESRD. PI # 7 who was admitted to the facility on 12/20/19 with a diagnosis of ESRD. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier # 2, Facility Administrator 1, who confirmed there was no documentation the facility offered and/or administered the flu vaccine per the facility policy.”

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 40119 Based on medical record (MR) review, facility policy, facility Patients Listed as Unstable form, and interview with facility staff, it was determined the facility failed to ensure: 1. The Registered Dietitian (RD) completed a Comprehensive Assessment monthly for unstable patient(s) and annually for stable patients per facility policy. 2. The RD performed dietary consults when ordered by the physician. This affected four of eight MRs reviewed, including PI (Patient Identifier) # 7, PI # 8, PI # 3, and PI # 5, and had the potential to negatively affect all 36 patients dialyzing at this facility. Findings include: Facility Policy: General Policy for Patient Assessment and Plan of Care (POC) Policy Number: Not documented Date: Not documented The patient assessment and POC must be developed and implemented by an interdisciplinary team (IDT) consisting of a minimum... qualified registered dietitian... Patients who are deemed unstable should be assessed and reviewed monthly until their status is stable. Components of the patient assessment: The comprehensive assessment must include the following: Current health status including co-morbid conditions. ...Prescribed lab testing... Evaluation of factors associated with renal bone disease. Evaluation of nutritional status by a qualified dietitian... Comprehensive patient assessment/POC frequency: ...Existing experienced dialysis patients...annually... 1. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the facility Patients Listed as Unstable form revealed PI # 7 was unstable from May to November 2024. Review of the MR revealed no documentation of a comprehensive RD assessment since 4/8/22. An interview was conducted on 12/12/24 at 2:10 PM with Employee Identifier (EI) # 9, Dietician, who verbalized being the facility dietician since August 2024. EI # 9 verbalized since August she/he does not take part in care planning and the IDT and has never been on-site at the facility. EI # 9 verbalized she/he will call the patient after reviewing the nutrition data and will talk to the patient if they pick up the phone. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed there was no documentation of a comprehensive RD assessment since 4/8/22. 2. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the facility Patients Listed as Unstable form revealed PI # 8 was unstable from May to November 2024. Review of the MR revealed no documentation of a comprehensive RD assessment since 9/11/23. An interview was conducted on 12/12/24 at 4:11 AM with EI # 2 who confirmed there was no documentation of a comprehensive RD assessment since 9/11/23. 41624 3. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24, signed by the physician, revealed an order for a dietician consult for a low phosphorus diet. The current phosphorus level was 10.2 milligrams per deciliter (mg/dl). Phosphorus goal was for level to be less than 7.0 mg/dl. Review of the MR revealed there was no documentation a consult for a low phosphorus diet was performed by the RD. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2 who confirmed there was no documentation staff performed the consult as ordered. 4. PI # 5 was admitted to the facility on 2/5/24 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24, signed by the physician, revealed an order for a dietician consult. Review of the MR revealed there was no documentation a consult was performed by the RD. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2 who confirmed there was no documentation staff performed the consult as ordered.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) 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- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 40119 Based on review of medical records (MR), facility policy, and staff interview, it was determined the facility failed to ensure the Interdisciplinary Team (IDT) completed initial and monthly comprehensive assessments and care plans for patients deemed unstable. This deficient practice did affect four of four unstable MR’s reviewed including, Patient Identifier (PI) # 7, PI # 8, PI # 3, and PI # 2 and had the potential to negatively affect all patients served by the facility. Findings include: Facility Policy: General Policy for Patient Assessment and Plan of Care (POC) Policy Number: Not documented Date: Not documented The patient assessment and POC must be developed and implemented by an IDT consisting of a minimum, the patient or patient’s designee...a registered nurse (RN), the patient’s attending physician..., qualified Master’s Social Worker (MSW), and qualified registered dietitian (RD)... Patients who are deemed unstable should be assessed and reviewed monthly until their status is stable. Components of the patient assessment: The comprehensive assessment must include the following: Current health status including co-morbid conditions. Evaluation of appropriateness of dialysis prescription... Blood pressure and fluid management needs Prescribed lab testing, immunization history, and medication history Evaluations of factors associated with anemia and potential treatment plan for anemia... Evaluation of factors associated with renal bone disease. Evaluation of nutritional status by a qualified dietitian. Evaluation of psychosocial needs by qualified social worker. Evaluation of dialysis access types and maintenance. Evaluation of the patient abilities, interest, preferences and goals... Evaluation of suitability for a transplant referral. Evaluation of family and other support systems. Evaluation of current patient physical activity level. Evaluation of referral to vocation and physical rehabilitation services. 1. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the facility Patients Listed as Unstable form revealed PI # 7 was unstable from May to November 2024. Review of the MR revealed no documentation of a comprehensive Physician, RD, and MSW assessment since 4/8/22 and comprehensive RN assessment since 12/13/23. Further review of the MR revealed no documentation a POC was developed since 4/8/22, of the reason and when the patient was made unstable, the clinical and/or psychosocial issues which contributed to the patient’s instability, and the interventions which would be used to address the issues contributing to the patient’s instability. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed there was no documentation of comprehensive assessments and POC per the facility policy for an unstable patient. 2. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the facility Patients Listed as Unstable form revealed PI # 8 was unstable from May to November 2024. Review of the MR revealed no documentation of a comprehensive Physician and MSW assessment and no documentation of a comprehensive RN and RD assessment since 9/11/23. Further review of the MR revealed no documentation a POC was developed since 9/11/23, of the reason and when the patient was made unstable, the clinical and/or psychosocial issues which contributed to the patient’s instability, and the interventions which would be used to address the issues contributing to the patient’s instability. An interview was conducted on 12/12/24 at 4:11 AM with EI # 2 who confirmed there was no documentation of comprehensive assessments and POC per the facility policy for an unstable patient. 41624 3. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of ESRD. Review of the facility Patients Listed as Unstable form revealed PI # 3 was unstable from July until September 2024. Review of the MR revealed no documentation a CIA was performed by the Physician, RN, RD, and MSW. Review of the MR revealed no documentation a POC was developed, the reason and when the patient was made unstable, the clinical and/or psychosocial issues which contributed to the patient’s instability, and the interventions which would be used to address the issues contributing to the patient’s instability. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2 who confirmed there was no documentation of monthly comprehensive assessments per facility policy for an unstable patient, and no POC had been developed. 49797 4. PI # 2 was admitted to the facility on 8/30/21 with a diagnosis of ESRD. Review of the facility Patients Listed as Unstable form revealed PI # 2 was unstable from June to November 2024 Review of the MR revealed no documentation of a comprehensive Physician, RD, and MSW assessment since 5/9/22. The RN documented an assessment on 12/2/24. There is no signature or date on the RN document. Further review of the MR revealed no documentation a POC was developed, the reason and when the patient was made unstable, the clinical and/or psychosocial issues which contributed to the patient’s instability, and the interventions which would be used to address the issues contributing to the patient’s instability. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3, Registered Nurse Peritoneal Dialysis Coordinator, who confirmed there was no documentation of comprehensive assessments and POC per the facility policy for an unstable patient.”

“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: 49797 Based on medical record (MR) reviews, facility hemodialysis standing orders and interviews, it was determined the facility failed to ensure: 1. Staff notified the physician the post dialysis weight was greater than three kilograms (kg) from the ordered Estimated Dry Weight (EDW). 2. Staff obtained and documented a physician order for a changed EDW. This affected, two of eight MRs reviewed, including Patient Identifier (PI) # 1 and PI # 3 and had the potential to affect all patients dialyzing at this facility. Findings include: Physicians Choice Hemodialysis (HD) Standing Orders Revision Date: 1/2024 General Orders: ...EDW, call MD (medical doctor) if patient is > (greater than) three kg post treatment. 1. PI # 1 was admitted to the facility on 9/10/24 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24 signed and dated by the physician revealed an order for EDW of 153 kg. Review of the following treatment sheets revealed: On 11/30/24 the post EDW was 157.7 kg On 12/3/24 the post EDW was 158.4 kg On 12/5/24 the post EDW was 156.9 kg. The MR had no documentation of physician notification for the dates listed. An interview was conducted on 12/13/24 at 8:49 AM with Employee Identifier # 3, Registered Nurse , Peritoneal Dialysis Coordinator, who confirmed the staff failed to notify the physician per the standing orders. 41624 2. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24, signed by the physician, revealed HD orders that included a target weight (EDW) of 65 kg. Review of the dialysis orders documented on seven dialysis treatment sheets dated 11/23/24 to 12/7/24 revealed the ordered EDW was 62 kg. Further review of the MR revealed there was no written physician order for the change to the EDW. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2, Facility Administrator 1, who confirmed there was no documentation an order was written to change the EDW.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 40119 Based on review of medical records (MR), facility policy, and staff interviews, it was determined the facility failed to ensure the staff followed the physician’s prescription for Blood Flow Rates (BFR) and documented the reason BFR was not as prescribed. This affected Patient Identifier (PI) # 7, PI # 2, and PI # 4, three of eight hemodialysis (HD) patients and had the potential to negatively affect all 36 patients dialyzing at this facility. Findings Include: Facility Policy: Intradialytic Treatment Monitoring Policy Number: Hemodialysis: Policy 1005 Date Published: Not documented Purpose: To provide an effective, safe, and comfortable dialysis treatment to every patient in accordance with his/her plan of care. Policy: ...2. At a minimum, obtain and document the following: ...machine parameters per flow sheet... ...4. Appropriate action is taken and documented, including patient response. ...6. All findings, interventions, and patient response will be documented in the patient’s medical record. 1. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Changed Order Report dated 10/15/24 revealed an order for HD with a BFR of 350. Review of the treatment sheet (TS) dated 11/26/24 revealed the treatment was initiated at 10:44 AM with a BFR of 350 until 11:31 AM when the BFR was changed to 300. The BFR of 300 continued until the treatment was terminated at 2:46 PM. There was no documentation of the reason the BFR was not at the prescribed rate of 350. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed the staff failed to follow the physician’s prescription for BFR and documented the reason BFR was not as prescribed per the facility policy. 49797 2. PI # 2 was admitted to the facility on 8/30/2021 with a diagnosis of ESRD. Review of the HD Order dated 1/29/24 revealed an order for HD with a BFR of 350. Review of the following TS’s revealed: TS dated 11/11/24, the treatment from 10:13 AM until 2:05 PM was not at the prescribed BFR. TS dated 11/15/24, the treatment from 10:32 AM to 2:02 PM was not at the prescribed BFR. TS dated 11/29/24, the treatment from 10:10 AM to 1:32 PM was not at the prescribed BFR. TS dated 12/2/24, the treatment from 10:33 AM to 2:17 PM was not at the prescribed BFR. TS dated 12/6/24, the treatment from 10:30 AM to 1:32 PM was not at the prescribed BFR. TS dated 12/19/24, the treatment from 9:56 AM to 1:31 PM was not at the prescribed BFR. There was no documentation of the reason the BFR was not at the prescribed rate of 350. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3, Registered Nurse Peritoneal Dialysis (PD) Coordinator, who confirmed the staff failed to follow the physician’s prescription for BFR or document the reason BFR was not as prescribed per the facility policy. 3. PI # 4 was admitted to the facility on 7/12/23 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note signed and dated 11/19/24 by the physician revealed a BFR order of 400, start date of 7/12/24. Review of the following TS revealed: TS dated 11/12/24, the treatment from 10:26 AM to 1:32 PM was not at the prescribed BFR. TS dated 11/14/24, the treatment from 10:08 AM to 1:45 PM was not at the prescribed BFR. TS dated 11/16/24, the treatment from 10:13 AM to 1:55 PM was not at the prescribed BFR. TS dated 11/21/24, the treatment from 10:15 AM to 1:33 PM was not at the prescribed BFR. TS dated 11/23/24, the treatment from 10:15 AM to 1:51 PM was not at the prescribed BFR. TS dated 11/25/24 treatment from 10:10 AM to 1:55 PM was not at the prescribed BFR. TS dated 11/27/24, the treatment from 8:52 AM to 11:53 AM was not at the prescribed BFR. TS dated 11/30/24, the treatment from 11:02 AM to 1:32 PM was not at the prescribed BFR. TS dated 12/3/24, the treatment from 10:31 AM to 2:00 PM was not at the prescribed BFR. TS dated 12/7/24, the treatment from 10:17 AM to 1:49 PM was not at the prescribed BFR. There was no documentation of the reason the BFR was not at the prescribed rate of 400. An interview was conducted on 12/13/24 at 8:47 AM with EI # 3, who confirmed the staff failed to follow the physician’s prescription for BFR or document the reason BFR was not as prescribed per the facility policy.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 40119 Based on review of the facility Medication Discrepancy Report, medical records (MR), and interviews, it was determined the facility failed to ensure staff 1. Administered medications for management for mineral metabolism as ordered by the physician. 2. Notified the physician of the missed doses of medication ordered for the management of mineral metabolism. 3. Notified the patients of the missed doses of medication ordered for the management of mineral metabolism. This deficient practice affected five of eight MRs reviewed, including Patient Identifier (PI) # 7, PI # 2, PI # 4, PI # 3, and PI # 5, and did affect 25 of 36 patients on the current census. Findings include: 1. Review of the Medication Discrepancy Report, dated 7/31/24 to 12/10/24, revealed 22 patients did not receive Calcitriol and 14 patients did not receive Cinacalcet (CinaC) as ordered for mineral metabolism. There was a total of 448 missed Calcitriol doses and 325 missed CinaC doses. 2. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Physician Order dated 6/19/24 revealed an order for CinaC60 every HD (hemodialysis). Review of the Physician Order dated 11/6/24 revealed an order for CinaC30 every HD. Review of Treatment Sheet (TS) dated 11/20/24 revealed Calcitriol 0.5 mcg (micrograms) and CinaC60 were held due to being out of stock. There was no documentation the physician was notified of the held Calcitriol and CinaC60. Review of TS dated 11/26/24 revealed CinaC60 was held due to being out of stock. CinaC30 was administered. There was no documentation provided the physician was notified of the held CinaC60. Review of TS’s dated 11/29/24, 12/2/24, 12/4/24, 12/6/24, and 12/9/24 revealed CinaC60 and CinaC30 were held due to being out of stock. There was no documentation the physician was notified of the held CinaC60 and CinaC30. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed CinaC and Calcitriol for mineral metabolism were not administered as ordered and there was no documentation the physician was notified of the held medications ordered for mineral metabolism. 49797 3. PI # 2 was admitted to the facility on 8/30/21 with a diagnosis of ESRD. Review of the Prescribed Medications report dated 12/10/24 revealed an order for Calcitriol 0.5 mcg every HD. Review of TS dated 11/8/24, 11/11/24, 11/13/24, 11/15/24, 11/18/24, and 11/20/24, revealed Calcitriol 0.5 mcg was held due to being out of stock. There was no documentation the physician was notified of the held Calcitriol. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3, Registered Nurse, Peritoneal Dialysis Coordinator, who confirmed Calcitriol was not administered as ordered and there was no documentation the physician was notified of the held medications. 4. PI # 4 was admitted to the facility on 7/12/23 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24 signed by the physician revealed an order for Calcitriol 0.5 mcg every HD start date 7/17/24. Review of TS dated 11/8/24, 11/12/24, 11/14/24, 11/16/24, and 11/19/24 revealed Calcitriol 0.5 mcg was held due to being out of stock. There was no documentation the physician was notified of the held Calcitriol. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3, who confirmed Calcitriol was not administered as ordered and there was no documentation the physician was notified of the held medications. 41624 5. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Note dated 11/19/24, signed by the physician, revealed an order to administer CinaC 120 mg, a medication to aid in managing phosphorus levels, every HD with start date 5/18/24. Review of TS dated 11/27/24, 11/30/24, 12/3/24, 12/5/24, and 12/7/24 revealed CinaC was held due to being out of stock, a total of five doses. Review of PI # 3’s laboratory results revealed the patient had a phosphorus level of 10.2 milligrams per deciliter (mg/dl) on 11/19/24, and 9.5 mg/dl on 12/3/24. Phosphorus goal is to maintain a blood level less than 7 mg/dl. There was no documentation the physician was notified of the held CinaC. There was no documentation PI # 3 was notified the medications were not received as ordered. An interview was conducted on 12/13/24 at 8:58 AM with EI # 2 who confirmed CinaC was not administered as ordered and there was no documentation the physician nor PI # 3 was notified of the held medications. 6. PI # 5 was admitted to the facility on 11/22/21 with a diagnosis of ESRD. Review of the 10/9/24 Progress Note Report Dialysis Medications revealed orders with start date 8/14/24 for oral Calcitriol 0.5 mcg every dialysis. There was also an order with start date 6/19/24 for CinaC 30 mg every dialysis. These medications are utilized to help manage phosphorus levels with a goal of less than 7 mg/dl. Review of Treatment Sheets dated 10/7/24 to 12/9/24 revealed PI # 5 missed eight doses of Calcitriol and 12 doses of CinaC due to being out of stock. Review of PI# 5’s laboratory results revealed PI # 5 had a phosphorus level of 8.2 mg/dl on 11/4/24 and 11/18/24. There was no documentation the physician was notified of the held Calcitriol or CinaC. There was no documentation PI # 5 was notified the medications were not received as ordered. An interview was conducted on 12/13/24 at 9:14 AM with EI # 2 who confirmed Calcitriol and CinaC were not administered as ordered and there was no documentation the physician nor PI # 5 was notified of the held medications.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 40119 Based on review of medical records (MR), Medication Discrepancy Report, and interviews, it was determined the facility failed to ensure staff administered Venofer and/or Mircera for anemia management as ordered by the physician and failed to notify the physician of missed medications. This deficient practice affected seven of eight records reviewed, including Patient Identifier (PI) # 13, PI # 7, PI # 8, PI # 2, PI # 4, PI # 6, and PI # 5 and did affect 28 of 36 patients on the current census. Findings include: 1. Review of the Medication Discrepancy Report, dated 7/31/24 to 12/10/24, revealed 22 patients did not receive Mircera and 22 patients did not receive Venofer ordered for anemia management. There was a total of 99 missed Mircera doses and 642 missed Venofer doses which affected 28 of 36 patients. An interview was conducted on 12/9/24 at 2:14 PM with Employee Identifier (EI) # 8, Registered Nurse (RN), who verbalized the facility had been having problems with not having Venofer and Mircera since around July or August 2024. EI # 8 verbalized if a patient’s hemoglobin was low the facility would send them to the hospital. A medication count observation was performed on 12/10/24 at 8:25 AM which revealed two vials of Venofer 100 mg (milligrams) available for administration to the patients. Review of the nursing medication labels dated 12/10/24 revealed nine patients would require Venofer 100 mg on 12/10/24. A second medication count observation was performed on 12/10/24 at 3:35 PM which revealed there were 10 vials of Venofer 100 mg available for administration to the patients. There was no documentation of an invoice and/or documentation where the vials came from. An interview was conducted on 12/10/24 at 3:42 PM with EI # 8 who verbalized the 10 additional vials of Venofer arrived at the facility around 2:30 to 2:45 PM. EI # 8 verbalized even though she/he continued to let the administration at the facility know there was not going to be enough Venofer for all the patients on 12/10/24. 2. Review of the Medication Discrepancy Report dated 12/10/24 revealed PI # 13 missed the ordered dose of Venofer 100 mg on 12/10/24. Review of the treatment sheet dated 12/10/24 for PI # 13 revealed the Venofer 100 mg was held due to being “out of stock”. Review of the nursing medication labels dated 12/11/24 (Wednesday) through 12/14/24 (Saturday) revealed 32 patients would require Venofer 100 mg. The facility failed to have an additional 22 doses of Venofer 100 mg required for all patients to receive the prescribed Venofer dose through the week. A medication count observation was performed on 12/11/24 at 7:37 AM which revealed there were 10 vials of Venofer 100 mg available for administration to the patients. An interview was conducted on 12/10/24 at 3:42 PM with EI # 8 who confirmed PI # 13’s ordered dose of Venofer was missed due to the medication not being in stock. 3. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Physician order dated 5/31/24 revealed an order for Venofer 100 mg (milligrams) every hemodialysis (HD) and Mircera 30 mcg (micrograms) monthly. Further review revealed Venofer was discontinued on 11/23/24. Review of the Medication Discrepancy Report from 7/31/24 to 10/16/24 revealed the patient missed 34 of 34 ordered doses of Venofer. Further review revealed 33 of the 34 missed Venofer doses were held due to being out of stock and 1 of the 34 ordered doses did not document the reason of the missed dose. Further review of the Medication Discrepancy Report from 7/31/24 to 10/16/24 revealed the patient missed 2 of 3 ordered doses of Mircera due to the Mircera being out of stock. Review of the MR revealed the patient’s hemoglobin (hgb), laboratory value used for anemia, was 6.8 g/dl (grams per deciliter) on 10/11/24. Goal is above 10 g/dl. Review of the Physician order dated 10/17/24 revealed an order to schedule the patient for a blood transfusion of one unit of PRBC’s (Packed Red Blood Cells) due to anemia. Review of the nursing note dated 10/17/24 revealed the patient was scheduled for the blood transfusion on 10/22/24. Review of the MR revealed the patient’s hgb was 7.9 g/dl on 10/23/24. Review of the physician order dated 11/8/24 revealed an order for Mircera 30 mcg (micrograms) every other week. Review of the Treatment Sheets (TS) from 10/23/24 to 11/18/24 revealed the patient missed 12 of 12 ordered doses of Venofer, which were held due to being out of stock. Further review revealed the patient missed 1 of 1 ordered dose of Mircera, which was held due to being out of stock. There was no documentation provided the physician was notified of the held Venofer and Mircera doses. Review of the MR revealed the patient’s hgb after the blood transfusion was 7.9 g/dl on 10/23/24 and decreased to 7.5 g/dl on 11/18/24, resulting in a 0.4 g/dl decrease of the hgb after the blood transfusion. An interview was conducted on 12/13/24 at 11:47 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed staff failed to administer ordered Venofer and Mircera to PI # 7 due to the medications not being in stock and there was no documentation the physician was notified of the missed Venofer and Mircera doses. 4. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the Physician order dated 6/1/24 revealed an order for Venofer 100 mg every HD and Mircera 75 mcg every other week. Further review revealed Mircera was discontinued on 12/7/24. Review of the Medication Discrepancy Report from 7/31/24 to 11/9/24 revealed the patient missed 26 of 44 ordered doses of Venofer due to the Venofer being out of stock and missed 5 of 7 ordered doses of Mircera due to the Mircera being out of stock. Review of the MR revealed the patients hgb was 6.5 g/dl on 11/7/24. Goal is above 10 g/dl. Review of the Physician order dated 11/9/24 revealed an order to schedule the patient for a blood transfusion of one unit of blood due to low hgb. There was no documentation of the actual blood transfusion in the patients MR. Review of the Core Survey Clinial Outcomes revealed the patient’s hgb was 8.3 on 11/12/24. An interview was conducted on 12/12/24 at 4:11 PM with EI # 2 who confirmed staff failed to administer ordered Venofer and Mircera to PI # 8 due to the medications not being in stock and there was no documentation the physician was notified of the missed Venofer and Mircera doses. 49797 5. PI # 2 was admitted to the facility on 8/30/2021 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 10/28/24 revealed Venofer 100 mg every HD with a start date of 5/31/24 and Mircera 150 MCG IV push every other week- 3rd dialysis with a start date of 5/31/24 was ordered. Review of the MR revealed on 11/29/24 Venofer 100 mg IV push every other week was ordered, and on 11/8/24 Mircera 60 MCG IV push every other week- 3rd dialysis was ordered. Review of the Medication Discrepancy Report from 7/31/24 to 12/10/24 revealed the PI # 2 missed 48 of 52 ordered doses of Venofer. 47 of the held doses had the remark of out of stock listed, one had no remark documented. Further review of the Medication discrepancy report revealed the patient missed 7 of 8 ordered doses of Mircera due to Mircera not in stock. Review of the MR revealed the patient’s hgb was 6.6 g/dl on 10/23/24. Goal is above 10 g/dl. Review of Verbal Order dated 10/28/24 revealed an order to send the patient to the hospital for type, cross, and transfusion of one unit of PRBC, due to Anemia. Review of the MR revealed PI # 2’s hgb increased to 7.7 g/dl on 11/4/24 after the blood transfusion. The 12/2/24 hgb results are 7.2 g/dl, resulting in a 0.5 g/dl decrease of the hgb after the blood transfusion. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3 RN Peritoneal Dialysis (PD) Coordinator , who confirmed staff failed to administer ordered Venofer and Mircera to PI # 2 due to the medications not being in stock and there was no documentation the physician was notified of the missed Venofer and Mircera doses. 6. PI # 4 was admitted to the facility on 7/12/23 with a diagnosis of ESRD. Review of the Changed Order Report dated 12/11/24 revealed Venofer 100 mg IV push every HD and Mircera 50 Mcg IV push every other week -3rd dialysis started on 6/1/24 and discontinued on 11/8/24. Review of the TS from 10/8/24 to 11/2/24 revealed the patient missed 11 of 11 ordered doses of Venofer, which were held due to being out of stock. Further review revealed the patient missed 2 of 2 ordered doses of Mircera, which was held due to being out of stock. There was no documentation provided the physician was notified of the held Venofer and Mircera doses. An interview was conducted on 12/13/24 at 8:47 AM with EI # 3, who confirmed staff failed to administer ordered Venofer and Mircera to PI # 4 due to the medications not being in stock and there was no documentation the physician was notified of the missed Venofer and Mircera doses. 41624 7. PI # 6 was admitted to the facility on 2/5/24 with a diagnosis of ESRD. Review of the Changed Order Report printed 12/11/24 revealed an order for Mircera 75 mcg IV push every other week with start date 6/1/24 and discontinued date of 11/8/24. There was a new order for Mircera 75 mcg monthly with start date 11/9/24. Review of the TS from 10/8/24 to 12/10/24 revealed PI # 6 missed two doses of Mircera which were held due to being out of stock. There was no documentation the physician was notified of the held Mircera doses. Review of PI # 6’s hgb lab results, an indicator of anemia if result less than 10 g/dl, revealed PI # 6 had a hgb of 7.1 g/dl on 10/8/24, 7.2 g/dl on 10/24/24, and 7.1 g/dl on 11/5/24. PI # 6 received the ordered dose of Mircera 75 mcg on 11/9/24, and his/her hgb increased to 7.6 g/dl on 11/19/24. PI # 6 began receiving Venofer 100 mg, newly ordered on 11/26/24, every dialysis treatment, and his/her hgb continued to improve with hgb 7.8 g/dl on 12/3/24. An interview was conducted on 12/13/24 at 10:08 AM with EI # 2, who confirmed staff failed to administer the ordered Mircera to PI # 6 due to the medication not being in stock and there was no documentation the physician was notified of the missed Mircera doses. 8. PI # 5 was admitted to the facility on 11/22/21 with a diagnosis of ESRD. Review of the MR revealed PI # 5 had a hgb of 8.5 g/dl on 10/7/24, and 7.8 g/dl on 10/23/24. Review of the Progress Note Report dated 10/9/24 revealed an order for Mircera 75 mcg IV push monthly on the last Friday of the month. Review of the TS from 10/7/24 to 12/9/24 revealed PI # 5 missed one dose of Mircera on 10/25/24, held due to being out of stock. There was no documentation the physician was notified of the held Mircera dose. An interview was conducted on 12/13/24 at 9:14 AM with EI # 2, who confirmed staff failed to administer the ordered Mircera to PI # 6 due to the medication not being in stock and there was no documentation the physician was notified of the missed Mircera doses.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 40119 Based on review of medical records (MR), facility policy, and interviews, it was determined the facility failed to ensure staff documented and incorporated a standardized mental and physical assessment tool, KDQOL (Kidney Disease Quality of Life) by the time of the first reassessment and/or annually. This deficient practice did affect five of eight MR’s reviewed, including Patient Identifier (PI) # 7, PI # 8, PI # 1, PI # 2, and PI # 4, and had the potential to affect all patients at this facility. Findings Include: Facility Policy: General Policy for Patient Assessment and Plan of Care. Policy Number: Not documented Date: Not documented ...Components of the patient assessment: ...Evaluation of psychosocial needs by qualified social worker. ...Evaluation of the patient’s abilities, interest, preferences and goals... Comprehensive patient assessment/plan of care frequency: ...A follow up comprehensive reassessment must occur on all new patients within three (3) months... Existing experienced dialysis patients...annually... Plan of Care Components: ...Psychosocial Status...Oversee measurement of appropriate psychosocial status using the KDOQI (KDQOL) tool at regular intervals or more frequently as needed. 1. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of End Stage Renal Disease. Review of the HD (Hemodialysis) Re-evaluation Interdisciplinary Assessment dated 12/13/23 revealed the “annual 4/17/23 KDQOL scoring” with the next KDQOL due on 4/17/24. Review of the MR revealed no KDQOL survey and no refusal to complete the survey due on 4/17/24. An interview was conducted on 12/11/24 at 10:04 AM with Employee Identifier (EI) # 6, Medical Social Worker, who confirmed the KDQOL was to be completed annually with plan of care. An interview was conducted on 12/13/24 at 11:47 AM with EI # 2, Facility Administrator 1, who confirmed there was no documentation the KDQOL had been completed since 4/17/23. 2. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the MR revealed no documentation of a KDQOL. An interview was conducted on 12/12/24 at 4:11 AM with EI # 2 who confirmed there was no documentation the KDQOL had been completed. 49797 3. PI # 1 was admitted to the facility on 9/10/24 with a diagnosis of ESRD. Review of the MR revealed no documentation a KDQOL had been performed and no refusal to complete the survey since admission 9/19/24. An interview was conducted on 12/13/24 at 8:49 AM with EI # 3, RN Peritoneal Dialysis Coordinator who confirmed there was no documentation the KDQOL had been completed. 4. PI # 2 was admitted to the facility on 8/30/21 with a diagnosis of ESRD. Review of the MR revealed no documentation a KDQOL had been performed since 12/9/22 and no refusal to complete the survey. An interview was conducted on 12/13/24 at 8:45 AM with EI # 3, who confirmed there was no documentation the KDQOL had been completed. 5. PI # 4 was admitted to the facility on 7/12/23 with a diagnosis of ESRD. Review of the MR revealed no documentation a KDQOL had been performed and no refusal to complete the survey since admission 7/12/23. An interview was conducted on 12/13/24 at 8:47 AM with EI # 3, who confirmed there was no documentation the KDQOL had been completed.”

“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: 41624 Based on medical record (MR) review, facility policy and interview, it was determined the facility failed to ensure members of the interdisciplinary team (IDT) performed their individual assessments, developed a plan of care (POC) for every patient, and each IDT member and patient signed the POC. This affected five of eight MRs reviewed including, Patient Identifier (PI) # 3, PI # 6, PI # 5, PI # 7, and PI # 8, and had the potential to negatively affect all patients who dialyzed at this facility. Findings include: Facility Policy: General Policy for Patient Assessment And POC Policy Number: None Revised Date: None The patient assessment and POC must be developed and implemented by an IDT consisting of a minimum, the patient or patient’s designee (if patient desires), a registered nurse (RN), the patient’s attending physician or physician extender, qualified Master’s Social Worker (SW) and qualified registered dietician (RD). The patient’s POC will be guided and developed based on the Comprehensive Patient Assessment... ...Each facility shall establish a process for tracking the status of the patient’s assessment and POC to ensure timely review and completion. 1. PI # 3 was admitted to the facility on 11/13/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the MR revealed there was no documentation of the individual assessments by the IDT members and no documentation a POC had been developed from the assessments. The IDT failed to document individual assessments and develop a POC for PI # 3. An interview was conducted on 12/13/24 at 8:58 AM with Employee Identifier (EI) # 2, Facility Administrator 1, who confirmed there was no documentation of the IDT assessments and POC for PI #. 2. PI # 6 was admitted to the facility on 2/5/24 with a diagnosis of ESRD. Review of the MR revealed there was no documentation of the individual assessments by the IDT members and no documentation a POC had been developed from the assessments. The IDT failed to document individual assessments and develop a POC for PI # 6. An interview was conducted on 12/13/24 at 10:08 AM with EI # 2 who confirmed there was no documentation of the IDT assessments and POC for PI # 6. 3. PI # 5 was admitted to the facility on 11/22/21 with a diagnosis of ESRD. Review of the MR revealed there was no documentation of the individual assessments by the IDT members and no documentation a POC had been developed from the assessments. The IDT failed to document individual assessments and develop a POC for PI # 5. An interview was conducted on 12/13/24 at 9:14 AM with EI # 2 who confirmed there was no documentation of the IDT assessments and POC for PI # 5. 40119 4. PI # 7 was admitted to the facility on 12/20/19 with a diagnosis of ESRD. Review of the HD Comprehensive Interdisciplinary Assessment (CIA) dated 4/8/22 revealed documentation of a RN, SW, and RD comprehensive assessment and POC. There was no documentation of a physician comprehensive assessment and POC and date and time the RN, SW, and RD completed the assessment. Further review of the HD CIA revealed no documentation of a patient, physician, RN, RD, or SW signature. There was no documentation of CIA and POC since 4/8/22. An interview was conducted on 12/13/24 at 11:47 AM with EI # 2 who confirmed the CIA and POC was not completed and signed per policy. 5. PI # 8 was admitted to the facility on 5/11/23 with a diagnosis of ESRD. Review of the HD CIA dated 9/11/23 revealed documentation of a RN and RD comprehensive assessment and POC. There was no documentation of a physician or SW comprehensive assessment and POC and date and time the RN and RD completed the assessment. Further review of the HD CIA revealed no documentation of a patient, physician, RN, RD, or SW signature. An interview was conducted on 12/12/24 at 4:11 PM with EI # 2 who confirmed the CIA and POC was not completed and signed per policy.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 40119 Based on review of facility policies, facility Quality Assessment and Performance Improvement (QAPI) data, medical records (MR), and staff interview, it was determined the facility failed to ensure the QAPI committee: 1. Tracked, trended, and/or analyzed complete and consistent patient quality indicators and/or other aspects of performance, including MR audit results, KDQOL (Kidney Disease Quality of Life), Mortality, Transplantation, and Hospital admissions/readmissions. 2. Ensured facility social worker was included in the QAPI Committee. This deficient practice had the potential to negatively affect all 36 patients dialyzing at the facility. Findings Include: Facility Policy: General Policy for Patient Assessment and Plan of Care. Policy Number: Not documented Date: Not documented ...The completion of assessments and Plan of Care will be monitored through regular MR audits and the audit results will be reviewed in QAPI meeting(s). ...Components of the patient assessment: ...Evaluation of psychosocial needs by qualified social worker. ...Evaluation of the patient’s abilities, interest, preferences and goals... Comprehensive patient assessment/plan of care frequency: ...A follow up comprehensive reassessment must occur on all new patients within three (3) months... Existing experienced dialysis patients...annually... Plan of Care Components: ...Psychosocial Status...Oversee measurement of appropriate psychosocial status using the KDOQI (KDQOL) tool at regular intervals or more frequently as needed. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date: Not documented ...Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool... Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. ...The social worker...is responsible for: ...Reporting on psychosocial issues... Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality...MR Audit Summary QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: A. Improvement will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... 1. Review of the Monthly MR Audit forms for January to October 2024 revealed the audit was completed by a FA of another facility. Further review revealed 16 of 18 patient initials identified, from January to June, were not initials of patients on the facility census. There was no documentation of identifying patient information for the MR’s audited from August to October. The facility failed to track and trend complete and consistent patient data for the monthly MR audits in QAPI. 2. Review of the KDQOL data revealed 29 of 29 patients KDQOL’s were due and completed with no refusals or exclusions. Review of the five of eight MR’s reviewed revealed no documentation the KDQOL was completed by the time of the first reassessment and/or annually per the facility policy. The facility failed to document accurate data, and failed to track and trend conisistent data for the KDQOL in QAPI. 3. Review of the facility mortality data revealed the facility had one death in June 2024. There was no documentation the cause of death was identified and a review of the data related to the cause of death were tracked, trended, and analyzed to identify potential areas for improved patient outcomes. The facility failed to track and trend complete and consistent mortality data in QAPI. 4. Review of the facility transplantation QAPI data revealed the facility transplant list was zero for January to October 2024 with a goal of above or equal to 21.4 percent. Review of the September and October 2024 QAPI management review revealed documentation there were two patients on the transplant list, which would be 5.56 percent. The facility failed to track and trend complete and consistent transplantation data in QAPI. 5. Review of the Suspected Cause of Hospitalizations QAPI data revealed zero hospitalizations for infection of dialysis access/CVC (Central Venous Catheter) infection from January to October 2024. Review of the MR for Patient Identifier (PI) # 1 revealed documentation the patient was admitted to the facility on 9/10/24 and also admitted to an outside hospital the same day. Review of the outside hospital discharge summary dated 9/13/24 revealed the discharge diagnosis was an Infected Right Groin Temporary Catheter... which was removed during the hospitalization. The facility failed include the hospitalization for a CVC infection in the facility QAPI program. Review of the facility hospitalization data for May to October 2024 revealed there were seven admissions for Cardiovascular Disorders. Review of the QAPI data revealed no documentation of analysis of the factors leading to the seven admissions for Cardiovascular Disorders and no action plan developed for the trend of hospitalization with Cardiovascular Disorders. Review of the hospital readmission data for January to October 2024 revealed zero patients were readmitted within 30 days of the last hospitalization. Review of the facility list of patients readmitted within 30 days of discharge from the hospital from 7/10/24 to 10/29/24 revealed documentation of four patients who required readmission to the hospital within 30 days. Further review revealed two of the four patients were readmitted with Cardiovascular Disorders. The facility failed to track and trend complete and consistent hospital readmission data in QAPI. An interview was conducted on 12/11/24 at 10:04 AM with Employee Identifier (EI) # 6, Medical Social Worker, hired on 9/11/23, who verbalized she/he has not participated in a QAPI meeting either in person or via phone since starting at the facility. An interview was conducted on 12/13/24 with EI # 1, Chief Clinical Officer, who confirmed the FA documented on the MR audits was not the FA for the facility and “they pass those sheets around” referring to the different facility FA’s. An interview was conducted on 12/9/24 at 5:00 PM with EI # 1 who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024.”

“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: 40119 Based on review of facility policy, facility QAPI (Quality Assessment Performance Improvement Program) data, and staff interview, it was determined the facility failed to ensure the QAPI Committee: 1. Analyzed Adequacy patient data. 2. Implemented an action plan for Adequacy prior to 10/1/24. 3. Implement and Monitored the action plan for Adequacy to evaluate effectiveness of the plan. This deficient practice had the potential to negatively affect all 36 patients dialyzing at the facility. Findings Include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops, and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: 1. Evaluating clinical outcomes monthly using Graphs, Outcome Trending Reports, and any CMS or Network generated facility report... 2. Identify commonalities among patients who do not reach the minimum expected patient targets. 3. Develop a plan to address those causes. 4. Implement the plan. 5. Monitor the effectiveness of the plan. 6. Adjust portions of the plan that are not successful. A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: ...Patient Care Outcomes... 1. Review of the facility QAPI data from June to October 2024 revealed: the Kt/v (lab for adequacy) data above or equal to 1.2 revealed the following: Facility goal documented as above or equal to 97.74 % (percent) monthly. June 2024 - 100.0% July 2024 - 97.3 % August 2024 - 90.0 % September 2024 - 87.5 % October 2024 - 91.8 % Review of the facility QAPI data from July to October 2024 revealed no documentation of identifying information of the patient outliers or the patients were analyzed to determine the barriers to achieving increased adequacy. The facility failed to analyze Adequacy patient data. Review of the facility missed and shortened treatments action plan dated 10/1/24 and 11/1/24 revealed plan actions of meeting with the patients with missed and/or shortened treatments to identify barriers, education of the patients on the importance of following the dialysis prescription, complications which develop due to missing treatments, and fluid management. The facility failed to implement an action plan for Adequacy prior to 10/1/24 when the adequacy lab values were out of goal range since July 2024. Further review of the facility missed and shortened treatments action plan dated 11/1/24 revealed no documentation of meeting with the patients with missed and/or shortened treatments to identify barriers, education of the patients on the importance of following the dialysis prescription, complications which develop due to missing treatments, and fluid management. The facility failed to implement and monitor the action plan for Adequacy to evaluate effectiveness of the plan. An interview was conducted on 12/9/24 at 5:00 PM with Employee Identifier (EI) # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. A second interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 40119 Based on review of facility policy, facility QAPI (Quality Assessment Performance Improvement Program) data, facility Nutrition Report, and staff interview, it was determined the facility failed to ensure the QAPI Committee: 1. Tracked and trended complete and consistent patient data for nutritional status. 2. Implemented an action plan for nutritional status prior to 10/1/24. 3. Ensured facility dietician was included in the QAPI Committee. This deficient practice had the potential to negatively affect all 36 patients dialyzing at the facility. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops, and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. ...The Dietitian is a professional member of the interdisciplinary team and is responsible for: Notification of improvement opportunities. Reporting on nutrition and nutrition related issues and improvement projects. QAPI activities as determined by the QAPI Committee. Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: 1. Evaluating clinical outcomes monthly using Graphs, Outcome Trending Reports, and any CMS or Network generated facility report... 2. Identify commonalities among patients who do not reach the minimum expected patient targets. 3. Develop a plan to address those causes. A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. 1. Review of the facility QAPI data from January to October 2024 revealed the following nutrition data for Albumin above or equal to 4.0 g/dl (grams per deciliter): Facility goal documented as above 65.8 % (percent). January 2024 - 60.00 % February 2024 - 39.39 % March 2024 - 42.86 % April 2024 - 35.29 % May 2024 - 48.57 % June 2024 - 40.54 % July 2024 - 45.95 % August 2024 - 40.00 % September 2024 - 48.70 % October 2024 - 52.60 % Review of the facility QAPI data from January to October 2024 revealed no documentation an action plan was developed for Albumin until 10/1/24 when the facility had been below goal of 65.8 % since January 2024. Review of the Nutrition patient list QAPI data dated September 2024 and October 2024 revealed Patient Identifier (PI) # 12, one of seven patients with an albumin less than 4.0 g/dl, had a 3.8 g/dl Albumin level and had not received education on “protein sources.” There was no documentation of the reason the patient had not been provided the education or a plan to resolve the lack of education. Review of the facility Nutrition Report revealed inaccurate albumin values were documented on the September and October 2024 Nutrition patient list QAPI data in four of seven patients with an Albumin less than 4.0 g/dl. Two of the four patients with an inaccurate albumin value reported on the September 2024 nutrition patient list QAPI data had a decline in the albumin value in October. Review of the facility nutrition management Albumin action plan dated 10/1/24 and 11/1/24 revealed an action of “education with patients with regards to compliance in.” There was no documentation of what the patients would be educated on and the cause of the low Albumin in the patients. The QAPI committee failed to develop an action plan to address the causes of the patient’s nutritional status. An interview was conducted on 12/9/24 at 5:00 PM with Employee Identifier (EI) # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. An interview was conducted on 12/12/24 at 2:10 PM with EI # 9, Dietician, who verbalized being the facility dietician since August 2024. EI # 9 confirmed she /he has not participated in any QAPI meetings since being hired. A second interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“QAPI-INDICATOR-CKD-MBD CFR(s): 494.110(a)(2)(iii) The program must include, but not be limited to, the following: (iii) Mineral metabolism and renal bone disease. This Standard is not met as evidenced by: 40119 Based on review of the facility’s Quality Assessment Performance Improvement (QAPI) data, patient laboratory (lab) values, facility policy, and staff interviews, it was determined the facility failed to ensure the QAPI Committee: 1. Monitored and analyzed complete and consistent patient data for bone and mineral data. 2. Developed and implemented an action plan for bone and mineral status, including a plan to obtain, maintain, and administer Calcitriol and Cinacalcet (oral medications used to treat low calcium levels) to patients for the management of calcium. This deficient practice did affect 25 of 36 patients on the current census and had the potential to negatively affect all 36 patients dialyzing at the facility. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services.... Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops, and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. ...Required QAPI Documents: Patient Care Outcomes...Clinical Variance Reports QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress... A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes... 1. Review of the Medication Discrepancy Report, dated 7/31/24 to 12/10/24, revealed 22 patients did not receive Calcitriol (12 of 22 patients were also prescribed Cinacalcet) and 14 patients did not receive Cinacalcet (11 of the 14 patients were also prescribed Calcitriol) ordered for calcium management. There was a total of 25 of 36 patients affected by the 448 missed Calcitriol doses and 325 missed Cinacalcet doses. Further investigation revealed the facility had failed to obtain and stock Calcitriol and Cinacalcet for the management of calcium on multiple dates from 7/31/24 to 12/10/24. Of the 25 patients affected by the missed Calcitriol and Cinacalcet doses since 7/31/24, 4 had out-of-range or increasing lab values. An interview was conducted on 12/9/24 at 2:14 PM with Employee Identifier (EI) # 8, Registered Nurse (RN), who verbalized the facility had been having problems with not having Cinacalcet since around July or August 2024. A medication count observation was performed on 12/9/24 at 1:21 PM which revealed Cinacalcet available for administration to the patients. Review of the Medication Discrepancy Report dated 12/9/24 and 12/10/24 revealed 10 patients did not receive Cinacalcet, eight patients on 12/9/24 and two patients on 12/10/24. A second medication count observation was performed on 12/10/24 at 8:25 AM which revealed Cinacalcet 30 mg approximately 225 tablets were then available for administration to the 24 patients who would require Cinacalcet throughout the week. 2. Review of the facility QAPI data from January to October 2024 revealed the following nutrition data for Calcium below or equal to 10.2 mg/dl (milligrams per deciliter): Facility goal documented as above or equal to 98.5 % (percent). January 2024 - 83.33 % February 2024 - 69.70 % March 2024 - 74.29 % April 2024 - 82.35 % May 2024 - 77.14 % June 2024 - 78.30 % July 2024 - 78.30 % August 2024 - 77.50 % September 2024 - 80.00 % October 2024 - 76.00 % Review of the nutrition data revealed the following data for Phosphorus above or equal to 7.1 mg/dl: Facility goal documented as below 12.1 % (percent). January 2024 - 26.67 % February 2024 - 40.00 % March 2024 - 34.29 % April 2024 - 27.27 % May 2024 - 40.00 % June 2024 - 13.00 % July 2024 - 13.00 % August 2024 - 25.00 % September 2024 - 25.00 % October 2024 - 15.00 % Review of the facility QAPI data from January to October 2024 revealed no documentation an action plan was developed for bone and mineral status when the facility had not met goals since January 2024 and had 25 of 36 patients affected by the missed Calcitriol and Cinacalcet doses. Review of patient calcium lab values from September revealed two patients with a calcium level of above 10.2 mg/dl were not reported as an outlier on the QAPI Bone Mineral Management report. Review of patient phosphorus lab values from September revealed two patients with a phosphorus level of above 7.1 mg/dl were not reported as an outlier on the QAPI Bone Mineral Management report. Further review revealed four patient’s phosphorus levels were documented incorrectly on the September QAPI Bone Mineral Management report, two of the four patients documented incorrectly on the September QAPI Bone Mineral Management report had an increased phosphorus value in October 2024. An interview was conducted on 12/9/24 at 5:00 PM with EI # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. A second interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 40119 Based on review of the facility’s Quality Assessment Performance Improvement (QAPI) data, facility Anemia Management Report, physician’s orders, facility policy, observation, and staff interviews, it was determined the facility failed to ensure the QAPI Committee: 1. Monitored and analyzed complete and consistent patient data for anemia data. 2. Developed an action plan to address the causes of the patient’s anemia status. 3. Developed and implemented an action plan to obtain, maintain, and administer Venofer (Intravenous (IV) iron) and Mircera (erythropoiesis-stimulating agent) to patients for the management of anemia. This deficient practice did affect 28 of 36 patients on the current census and had the potential to negatively affect all 36 patients dialyzing at the facility. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services.... Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops, and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. ...Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality...Clinical Variance Reports QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress... A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... 1. Review of the Medication Discrepancy Report, dated 7/31/24 to 12/10/24, revealed 22 patients did not receive Mircera (17 of 22 patients were also prescribed Venofer) and 22 patients did not receive Venofer (16 of the 22 patients were also prescribed Mircera) ordered for anemia management. There was a total of 28 of 36 patient affected by the 99 missed Mircera doses and 642 missed Venofer doses. Further investigation revealed the facility had failed to obtain and stock Venofer and Mircera for the management of anemia on multiple dates from 7/31/24 to 12/10/24. Of the 28 patients affected by the missed Mircera and Venofer doses since 7/31/24, 22 had out-of-range or decreasing lab values. Which resulted in three patients including, Patient Identifier (PI) # 2, PI # 7, and PI # 8, requiring a preventable blood transfusion due to the lack of anemia management by this facility. An interview was conducted on 12/9/24 at 2:14 PM with Employee Identifier (EI) # 8, Registered Nurse (RN), who verbalized the facility had been having problems with not having Venofer and Mircera since around July or August 2024. EI # 8 verbalized if a patient’s hemoglobin was low the facility would send them to the hospital. A medication count observation was performed on 12/10/24 at 8:25 AM which revealed there was two vials of Venofer 100 mg (milligrams) available for administration to the patients. Review of the nursing medication labels dated 12/10/24 revealed nine patients would require Venofer 100 mg on 12/10/24. A second medication count observation was performed on 12/10/24 at 3:35 PM which revealed there were 10 vials of Venofer 100 mg available for administration to the patients. An interview was conducted on 12/10/24 at 3:42 PM with EI # 8 who verbalized the 10 additional vials of Venofer arrived at the facility around 2:30 to 2:45 PM. EI # 8 verbalized even though she/he continued to let the administration at the facility know there was not going to be enough Venofer for all the patients on 12/10/24, the Venofer did not arrive until after Patient Identifier (PI) # 13 missed the Venofer 100 mg prescribed for the 12/10/24 treatment. Review of physician orders for PI # 13 revealed Venofer 100 mg every dialysis was ordered on 11/30/24. Review of the treatment sheet dated 12/10/24 for PI # 13 revealed the Venofer 100 mg was held due to being “out of stock”. A medication count observation was performed on 12/11/24 at 7:37 AM which revealed there were 10 vials of Venofer 100 mg available for administration to the patients. Review of the nursing medication labels dated 12/11/24 (Wednesday) through 12/14/24 (Saturday) revealed 32 patients would require Venofer 100 mg. The facility failed to have an additional 22 doses of Venofer 100 mg required for all patients to receive the prescribed Venofer dose through the week. 2. Review of the facility QAPI data from January to October 2024 revealed the anemia data revealed Hemoglobin less than or equal to 9.9 g/dl (grams per deciliter): Facility goal documented as less than 16.6 % (percent). January 2024 - 21.88 % February 2024 - 17.65 % March 2024 - 17.14 % April 2024 - 70.59 % May 2024 - 80.56 % June 2024 - 81.08 % July 2024 - 83.78 % August 2024 - 65.00 % September 2024 - 65.00 % October 2024 - 82.00 % Review of the facility QAPI data from January to October 2024 revealed no documentation an action plan was developed for Hemoglobin until 10/1/24 when the facility had been above the goal of 16.6 % since January 2024 and a significant increase was documented in April 2024. Review of the facility Anemia Management Report revealed inaccurate hemoglobin values were documented on the September 2024 QAPI Anemia Dialysis Outlier Report in 22 of 29 patients listed with a hemoglobin less than 9.9 g/dl. Of the 22 patients with inaccurate hemoglobin values, 19 patients had a decline in the hemoglobin value in October. Further review revealed there was no documentation of the hemoglobin value for 3 patients of the 29 patients listed on the QAPI Anemia Dialysis Outlier Report. The 3 patients without documentation of the hemoglobin value all had a decline in the hemoglobin value in October. Review of the facility anemia management action plan dated 10/1/24 and 11/1/24 revealed an action of “education with patients with regards to compliance in order to meet goal with optimal lab results.” There was no documentation of what the patients would be educated on and the cause of the low hemoglobin in the patients and a plan to obtain, maintain, and administer Venofer and Mircera to patients for the management of anemia. The QAPI committee failed to develop an action plan to address the causes of the patient’s anemia status. Further review of the facility anemia management action plan dated 11/1/24 revealed documentation of “ongoing” for the status, outcomes, and evaluation of the action plan. There was no documentation of the interventions completed since 10/1/24 and the outcomes/evaluation of the interventions. An interview was conducted on 12/9/24 at 5:00 PM with EI # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. A second interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“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: 40119 Based on review of facility policy, facility QAPI (Quality Assessment Performance Improvement Program) data, and staff interview, it was determined the facility failed to ensure the QAPI Committee: 1. Analyzed Arteriovenous Fistula (AVF) and Central Venous Catheter (CVC) patient data. 2. Implemented an action plan for AVF and CVC data. This deficient practice had the potential to negatively affect all 36 patients dialyzing at the facility. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: 1. Evaluating clinical outcomes monthly using Graphs, Outcome Trending Reports, and any CMS or Network generated facility report... 2. Identify commonalities among patients who do not reach the minimum expected patient targets. 3. Develop a plan to address those causes. A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. 1. Review of the facility QAPI data from January to October 2024 revealed AVF data revealed the following: Facility goal documented as above or equal to 65.93 % (percent). January 2024 - 47.0 % February 2024 - 44.0 % March 2024 - 47.0 % April 2024 - 47.0 % May 2024 - 47.0 % June 2024 - 49.0 % July 2024 - 45.0 % August 2024 - 41.0 % September 2024 - 41.0 % October 2024 - 44.0 % Review of the facility QAPI data from January to October 2024 revealed no documentation the patients without an AVF were analyzed to determine if the patient could have an AVF. There was no documentation of an action plan to increase the use of AVF. Review of the CVC greater than 90 days data revealed the following: Facility goal documented as below or equal to 9.19 %. January 2024 - 31.0 % February 2024 - 32.0 % March 2024 - 38.0 % April 2024 - 38.0 % May 2024 - 39.0 % June 2024 - 37.0 % July 2024 - 24.0 % August 2024 - 28.0 % September 2024 - 31.0 % October 2024 - 33.0 % Review of the facility QAPI data from January to October 2024 revealed no documentation the patients with a CVC were analyzed to determine if the patient continued to require the use of a CVC. There was no documentation of an action plan to decrease the use of CVC. An interview was conducted on 12/13/24 at 11:30 AM with Employee Identifier (EI) # 1, Chief Clinical Officer, who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 40119 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Adverse Occurrence (AO) Trends for Hemodialysis Year 2024, Medication Discrepancy Report, facility Online Incident Reporting System Report, policies, and interviews with staff it was determined the facility failed to ensure: a. Medication errors/omissions were documented as adverse events, tracked, trended, and analyzed by the QAPI committee monthly. b. Patient events were documented as adverse events, tracked, trended, and analyzed by the QAPI committee monthly. c. An action plan for minimizing the number of medication errors was developed and implemented by the QAPI Committee prior to 11/15/24. d. The QAPI Committee tracked potential negative patient outcomes resulting from medication errors/omissions such as blood transfusions and hospitalizations. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... A. Improvement projects will be prioritized by the QAPI Committee, considering the prevalence and severity of identified problems...which have potential to affect patient health and safety...The facility must take immediate, appropriate actions to address any serious threats and ensure patient safety. Incident Review: All Clinical Variance Reports will be reviewed by the QAPI Committee to ensure appropriate interventions... Facility Policy: Incident/Event Reporting Policy Number: RM 2000 Date: No Date Policy: A confidential incident report must be competed for any incident, accident or event that is not within the routine safe operation of the location/clinic...or could have resulted in a deviation from the expected plan of care... Purpose: To improve the management and treatment of the patient To provide a data base for problem analysis, correction, and continuing education... Guidelines: 8. The Facility Administrator (FA) will, on a regular basis, review all incidents with the facility Medical Director and report aggregate Clinical Variance Report information to the Safety and/or Quality Assurance Committees. 10...The following incidents must always be reported on a Clinical Variance Report: D. Any...medication reaction or medication errors Review of the QAPI program data for July to October 2024 and facility AO Trends for Hemodialysis 2024 report revealed Medication Errors Omissions/missed medications as zero and patient(s) transferred from dialysis facility to emergency room (ER) as zero. Review of the facility Online Incident Reporting System Report revealed a total of two events, a patient transfer to an ER on 9/25/24 a patient transfer to an ER on 10/16/24. Review of the Medication Discrepancy Report dated 7/31/24 to 12/11/24, a 121-page document, revealed 31 patients did not receive prescribed medications as ordered during dialysis treatments. There was no documentation the QAPI committee was provided data regarding the number of medications ordered by the physician that were missed/omitted and the patient(s) who were transferred from the dialysis facility to an ER from July to October 2024. Review of the facility action plan dated 10/15/24 revealed a plan for “inadequate stock of medications: (i.e., Mircera, Venofer, Calcitriol, Sensipar).” Further review of the action plan dated 10/15/24 revealed the start dates of the plan interventions from 11/15/24 to 11/25/24. There was no documentation of an intervention which started immediately. Review of the IDT QAPI Program Meeting Minutes, located in the November 2024 section of the facility QAPI binder, revealed a sign in sheet with no date or time of the QAPI meeting or month for which the data was reviewed. Further review of the facility action plan dated 10/15/24 revealed documentation of “review of October medications that were not given due to shortage of stock” then a comment of “review of medications not given (attached to sheet)” There was no documentation of an attached sheet with the medications not given during October. An interview was conducted on 12/9/24 at 5:00 PM with Employee Identifier (EI) # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. A second interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“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: 40119 Based on review of the facility policy, QAPI (Quality Assessment Performance Improvement) data, patient grievance log, patient, and staff interviews, it was determined the facility failed to evaluate patient satisfaction and document patient grievances. This did affect one of seven patients interviewed, including Patient Identifier (PI) # 4, and had the potential to affect all care provided to persons served by this clinic. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services.... Responsibility: ...QAPI Committee members include but are not limited to...Technical Services Representative (biomed technician). ...Required QAPI Documents: ...Patient Satisfaction Survey Results (semiannually)... Elements of QAPI: ...Patient Satisfaction Survey Results... Review of the QAPI program data and the Patient Grievance Logs for January to October 2024 revealed documentation of zero patient grievances. Further review of the QAPI program data for January to October 2024 revealed zero patient satisfaction surveys had been completed with a goal of 80 percent to be returned. An interview conducted on 12/10/24 at 1:07 PM with PI # 4 who revealed he/she had complained about the TVs not working several times and was told every time by Employee Identifier (EI) # 10, Biomed technician, that parts were ordered but nothing has been done. An interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data or patient grievance other than what was in the facility QAPI and grievance binders.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 40119 Based on review of facility policy, Hemodialysis (HD) standing orders, Federal Drug Administration (FDA) It’s a Good Time to Get Your Flu (influenza) Vaccine, facility QAPI (Quality Assessment Performance Improvement Program) data, facility Infections Report and staff interview, it was determined the facility failed to ensure the QAPI Committee: 1. Tracked and trended complete and consistent infection control data. 2. Tracked and trended complete and consistent patient data for all patients Hepatitis B serological and flu vaccination status. 3. Implemented an action plan to ensure all patients Hepatitis B serological status was tracked and trended. 4. Implemented an action plan to obtain and administer Flu Vaccines. 5. Monitored the effectiveness of the action plan for Flu Vaccines. This deficient practice did affect six of eight MRs reviewed, including Patient Identifier (PI) # 1, PI # 3, PI # 4, PI # 6, PI # 7 and PI # 16 and had the potential to negatively affect all 36 patients dialyzing at the facility. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops, and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... QAPI Meeting Requirements: ...Completion and analysis of the QAPI trending tools. Completion and review of the results of required self-audits... QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: 1. Evaluating clinical outcomes monthly using Graphs, Outcome Trending Reports, and any CMS or Network generated facility report... 2. Identify commonalities among patients who do not reach the minimum expected patient targets. 3. Develop a plan to address those causes. 4. Implement the plan. 5. Monitor the effectiveness of the plan. 6. Adjust portions of the plan that are not successful. A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality... HD Standing Orders Date Revised: 1/24 ...Influenza Vaccine: Effective during influenza season. Obtain patient consent... If patient declines vaccination, obtain signature of declination form. Provide patient with vaccine information sheet... Verify patient has not received vaccination from another facility... Verify dosage...Administer appropriate dosage for current year influenza vaccination... FDA It’s a Good Time to Get Your Flu Vaccine Current as of Date: 10/15/24 Flu viruses typically spread in fall and winter...Getting vaccinated in the fall can lower your chances of getting the flu... A Flu Vaccine is the Best Prevention...people ages 6 months and older get a flu vaccine, ideally by the end of October... 1. Review of the facility QAPI data from January to October 2024 revealed: A. Review of the Vascular Access Infection QAPI data and the QAPI Infection Trending Log revealed zero CVC (Central Venous Catheter) infection from January to October 2024. Review of the MR for Patient Identifier (PI) # 1 revealed documentation the patient was admitted to the facility on 9/10/24 and also admitted to an outside hospital the same day. Review of the outside hospital discharge summary dated 9/13/24 revealed the discharge diagnosis was an Infected Right Groin Temporary Catheter... which was removed during the hospitalization. The facility failed include the CVC infection of PI # 1 in the facility QAPI program. B. Review of the Drug Resistant Organism Infection QAPI data revealed the facility documented one non-dialysis infection in February 2024. There was no documentation of an infection through October 2024. Review of the QAPI Infection Trending Log revealed zero wound infections from January to October 2024. Review of the facility Infections Report revealed two patients had a wound infection, PI # 16 on 6/25/24 and one unsampled patient on 10/23/24, which were treated with Vancomycin. The facility failed include the two wound infections in the facility QAPI program. C. Review of the QAPI facility total count of Hepatitis B antibody postive patient from January to October 2024 revealed no documentation for 19 of the 36 facility Hemodialysis (HD) patients Hepatitis B antibody status. Review of four of eight MR’s, including PI # 3, PI # 6, PI # 7, and PI # 8, revealed no documentation of the patients Hepatitis B antibody status. Further review of the facility QAPI data from January to October 2024 revealed no documentation of an action plan to to ensure all patients Hepatitis B serological status was monitored and evaluated. The facility failed to track and trend complete and consistent patient data for all patient Hepatitis B serological status and developed an action plan to ensure all patients Hepatitis B serological status was tracked and trended. D. Further review of the vaccinations data revealed zero percent of the 36 HD patients were vaccinated for flu from January to October 2024. Review of the facility Vaccination History report revealed two patients had received the flu vaccine at an outside facility (pharmacy or physician office) one on 9/17/24 and one on 10/31/24. Review of four of eight MRs revealed the facility had failed to offer and/or administer the flu vaccine from September to 12/10/24, including PI # 3, PI # 4, PI # 6, and PI # 7. The facility failed to track and trend complete and consistent patient data for flu vaccination status. Review of the facility daily medication counts revealed the facility did not have the flu vaccine in stock from 9/1/24 to 10/31/24. Review of the facility action plan “Blood pressure - Fluid Management - Vaccines” dated 10/1/24 and 11/1/24 revealed comments of “continue to monitor and educate patients as needed...Charge nurse (to) monitor vaccination status of all pts (patients)...offer vaccines as indicated.” There was no documentation of a plan to obtain and administer Flu Vaccines. Further review of the facility action plan “Blood pressure - Fluid Management - Vaccines” dated 11/1/24 revealed no documentation the action plan was monitored for effectiveness. E. Review of the Monthly Infection Control Observation Audits for June 2024, July 2024, August 2024, and October 2024 revealed documentation the audit was completed by a Facility Administrator (FA) of another facility on 10/17/2022. An interview was conducted on 12/9/24 at 5:00 PM with Employee Identifier (EI) # 1, Chief Clinical Officer, who verbalized the facility had not had a QAPI committee meeting from January to September 2024. The QAPI meetings for 2024 were held in October and November 2024. A second interview was conducted on 12/13/24 at 9:55 AM with EI # 1 who confirmed the FA documented on the infection control observation audits was not the FA for the facility and “they pass those sheets around” referring to the different facility FA’s. A third interview was conducted on 12/13/24 at 11:30 AM with EI # 1 who confirmed there was no additional QAPI data other than what was in the facility QAPI binder.”

“MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY CFR(s): 494.150 The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. This Standard is not met as evidenced by: 40119 Based on review of medical records (MR), facility policy, Medical Staff By-Laws, and interview, it was determined the Medical Director failed to ensure: 1. Patients were informed of all aspects of his or her care which included failure to receive medications ordered by the Medical Director and included in the patient Plan of Care. 2. Patient Comprehensive Assessments were completed, and Plans of Care were developed for all patients through collaboration of the Interdisciplinary Team (IDT). 3. Medications required for patient care were available at the facility, including Venofer, Mircera, Calcitriol, and Cinacalcet and were administered per physician orders. 4. An active and effective Quality Assessment Performance Improvement (QAPI) program was conducted at the facility, with meetings and discussion of all aspects of patient care, including tracking and trending of patient outcomes, and facility adverse occurrences. This affected all patients being dialyzed at this facility. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD)...are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include...MD... The MD is the chairperson of the QAPI Committee and is respnsible for the overall effectiveness of the facility QAPI program and communication with the governing body of the status of QAPI activities. Facility Publication: Medical Staff By-Laws Date: 10/08 ...Purpose... The purpose of the Medical Staff shall be: 1. To insure (ensure) that all patients admitted to the facility shall receive the best possible care. ...5. To insure (ensure) compliance with all applicable state and federal laws, rules and regulations relating to medical care of dialysis patients. ...Officers: ...Medical Director shall be appointed by the Governing Body of the facility. ...Duties of the Officer: The Medical Director shall serve as the official channel of communication between the medical staff and the governing body... The medical staff shall be responsible for the professional work of the faciltiy including patient care... the Medical Director shall be responsible for... 1. Insuring (ensuring) the proper coordination and functioning of all services. 2. ...Supervising the operation and maintenance of the equipment and acquisition of supplies for the unit. ...5. Maintaining all records relating to the care and treatment of unit patients... An interview was conducted on 12/11/24 at 1:41 PM with Employee Identifier (EI) # 11, Medical Director. EI # 1 confirmed he/she was unsure if the patients were informed the medications ordered during dialysis treatments as part of the Plan of Care were not available for administration at the facility. EI # 1 reported he/she was aware the facility was having problems obtaining and administering the ESA (erythropoiesis-stimulating agent) and iron due to the nurses letting him/her know monthly. EI # 1 reported the issue with obtaining the ESA and iron started occurring intermittently this year. EI # 1 verbalized he/she would tell the nurse to get the ESA and/or iron and they would work on it. EI # 1 verbalized when the problem started, about the middle of the year, he/she told the Facility Administrator (FA) and the Nurse Practioners to tell the patient to go to an outpatient center to get the ESA. EI # 1 verbalized some of the patients did go and some chose not too. EI # 1 verbalized he/she was not aware of which patients actually went because he/she did not keep track of it. EI # 1 reported he/she did tell the facility nurse, FA, and the Chief Clinical Officer the medications were needed and texted the owner the medications were not at the facility. EI # 1 verbalized the text to the owner was prior to 8/17/24 because that was the last date on his/her phone and he/she no longer had the text. EI # 1 reported the interdisciplinary team meetings were done at patient chairside every month with the nurse attending. EI # 1 verbalized sometimes the social worker and dietician would attend but he/she didn’t believe the facility had a dietician for the last two or three months. EI # 1 reported his/her role in the facility QAPI program was to listen to what was said and make comments. EI # 1 reported he/she believed the last QAPI meeting was in October 2024 but prior to then it wasn’t done monthly as it was suppose to be done.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 40119 Based on review of facility policy, Bylaws of Governing Body of the Dialysis Facility, medical records (MR), facility Medication Discrepancy Report, facility Quality Assessment and Performance Improvement (QAPI) data, it was determined the Governing Body (GB) failed to ensure Patient’s Rights were adhered to, care was provided in accordance with facility policies, the QAPI Committee was active and effective, the Medical Director (MD) complied with the bylaws and MD duties and responsibilities, and the facility maintained a sufficient amount of medications required for patient care delivery. This affected all 36 incenter hemodialysis (HD) patients. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not documented Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’ Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The MD, Chief Clinical Officer, Director of Operation, and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program. The Governing Body of the facility...establish, maintain, support, and document... an ongoing QAPI program... The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include... MD... The Chief Clinical Officer is the facillator of the QAPI meeting and shares responsibility with the FA...for the day-to-day oversight and implementation of the QAPI Program activities... Facility Publication: Bylaws of Governing Body of the Dialysis Facility Date: Not documented ...Purpose... The primary purpose of the facility is to provide dialysis and support services to patients with End Stage Renal Disease (ESRD). ...Management...Operational Management of Facility The Governing Body shall maintain responsibility for the governance and operation of the facility. The Governing Body shall: a. Adopt, enforce, and review annually for appropriateness, rules and regulations relative to...it’s own governance...the health and safety of facility patients...the protection of the patients’ personal and property rights...the general operation of the facility. ...Quality of Care...The Governing Body shall ensure the health and safety of facilty patient and shall: a. Oversee...the MD’s obligations as delineated in the facility’s Medical Staff Bylaws... b. ...Oversee the MD’s execution of patient care policies... i. ...ensure the facility provides quality care to it’s patients... Medical Records. The Governing Body shall: ...d. Ensure compliance by all member of the Medical Staff with the facilty’s Medical Staff Bylaws, rules and regulations, and policies concerning MR. ...Governing Body and Chief Executive Officer (CEO). ...Meetings. a. The Governing Body shall meet at least annually... b. Minutes of the meetings shall be prepared and retained... Administrator/CEO...The Administrator shall at a minimum: a. Provide overall management of the facility... b. Enforce the rules and regulations relative to the level of health care and safety of patients, and to the protection of their personal and property rights. ...f. Implement policies of the facility and coordinate the provision of services... Review of the Medication Discrepancy Report, dated 7/31/24 to 12/10/24, a 123-page document, revealed 33 of the 36 facility HD patients did not receive prescribed medications as ordered during dialysis treatments. Review of MRs revealed seven of eight patients had medications prescribed, not administered, documented as “Held,” “Not in supply,” “Not in stock”, and/or facility protocols were not followed. Interviews with seven HD patients and staff revealed all patients were not informed of the lack of medications and missed doses of ordered medications, therefore, were not given the opportunity to exercise their patient rights to participate in their care. Review of the facility QAPI program data and interviews revealed the lack of an organized, active, and effective QAPI program and lack of action by the QAPI Committee to improve patient outcomes. An interview was conducted on 12/13/24 at 11:04 AM with Employee Identifier (EI) # 1, Chief Clinical Officer, who was asked to provide the annual documentation of the Governing Body meeting minutes. EI # 1 failed to provide documentation of a Governing Body meeting.”