Pcd Auburn

“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: 30952 Physicians Choice of Auburn 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 evaluated, and updated at least every two years, a facility and community based all hazard risk assessment was conducted at least every two years, the Emergency Preparedness policies and procedures were reviewed and updated at least every two years, the Communication Plan was reviewed/updated at least every two years, staff and ER contact information was updated and current, training/testing program was reviewed and or updated at least every two years, and the facility conducted and analyzed the required testing of the EPP. For findings refer to E 004, E 006, E 013, E 0028, E 029, E 030, E 036, and E 039.”

“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: 30952 Based on review of the facility Emergency Preparedness Plan (EPP), and interview, it was determined the facility failed to ensure the EPP program plan was evaluated and updated annually per the facility EP plan policy, or at least every two years per the regulations. This had the potential to affect all patients served by this facility, staff and visitors. Findings include: Emergency Preparedness (EP) Plan for Physicians Choice Dialysis Auburn Date 1/28/22 ...Section 6-Governance The Governing Body is responsible for review of (the) Disaster Plan at least ANNUALLY. Updates will be made to the plan following any disaster and subsequent evaluation... Review of the facility EP Plan documentation revealed the date of last review, approval, and implementation was 1/28/22. There was no documentation an annual review and update had been completed for the facility EP plan. An interview was conducted on 7/16/25 at 12:52 PM with Employee Identifier # 1, Facility Administrator, who confirmed the facility had failed to conduct an evaluation and update of the EP Plan since opening in 2022.”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 30952 Based on review of the facility Emergency Preparedness (EP) Plan, and interview, it was determined the facility failed to ensure a Hazard Vulnerability Analysis (HVA) evaluation and update was performed annually per the facility EP plan, or at least every two years per the regulations. This had the potential to affect all patients served by this facility, staff and visitors. Findings include: Emergency Preparedness (EP) Plan for Physicians Choice Dialysis Auburn Review and Approval for Implementation Date 1/28/22 ...Section 6-Governance The Governing Body is responsible for review of (the) Disaster Plan at least ANNUALLY. Updates will be made to the plan following any disaster and subsequent evaluation... Review of the facility EP documentation revealed a HVA dated January 2020, which identified the major risk for disasters in Physicians Choice Dialysis of Midwest City (not Auburn). There was no documentation the staff performed an evaluation of the facility/community risks annually, or at least every two years. An interview was conducted on 7/16/25 at 12:52 PM with Employee Identifier # 1, Facility Administrator, who confirmed the facility had failed to conduct an evaluation/update of the Auburn facility HVA, annually or at least every two years as required.”

“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: 30952 Based on review of the facility’s Emergency Preparedness (EP) Plan policies and procedures documentation, and interview with staff, it was determined the facility failed to ensure EP policies and procedures were reviewed/updated at least every two (2) years. This had the potential to negatively affect all persons served by the facility. Findings include: Review of the Physicians Choice Dialysis of Auburn Emergency Preparedness Manual revealed EP policies and procedures were last reviewed and approved for implementation on 1/28/22. An interview was conducted on 7/16/25 at 12:59 PM with Employee Identifier # 1, Facility Administrator, who confirmed the facility EP policies and procedures had not been reviewed and approved for implementation at least every two years as required.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 30952 Based on observations, and interviews with staff, it was determined the facility failed to ensure emergency supplies were not expired. This had the potential to negatively affect all patients who dialyze at the facility. Findings include: An observation of the facility Emergency Cart and contents was conducted on 7/14/25 at 9:15 AM on the incenter patient treatment floor. The automated external defibrillator (AED) Pad-Pak-1 (defibrillator and battery pack), stored inside the AED case, expired 6/1/24. An interview was conducted on 7/14/25 at 9:20 AM with Employee Identifier (EI) # 4, Registered Nurse (RN), who confirmed the Pad Pak-1, available for patient use, was expired. Review of the facility Emergency Evacuation Box contents revealed eleven of eleven normal saline prefilled syringes expired 5/6/2025. An interview was conducted on 7/14/25 at 10:52 AM with EI # 3, RN, who confirmed the saline flush syringes had expired.”

“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: 30952 Based on review of the facility Emergency Preparedness (EP) Plan, and staff interview, it was determined the facility failed to ensure a communication plan for the EP Plan had been updated and/or reviewed at least every two years. This had the potential to negatively affect all patients served by the facility. Findings include: Review of the facility EP documentation revealed no documentation of an emergency preparedness communication plan that complies with Federal, State and local laws had been reviewed/updated since 1/28/22. An interview was conducted on 7/16/25 at 2:59 PM with Employee Identifier # 1, Facility Administrator, who confirmed the facility had not reviewed/updated the EP Communication Plan at least every two years as required.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 30952 Based on review of the facility Emergency Preparedness (EP) Plan documentation, and interview with staff, it was determined the facility failed to maintain current and accurate contact information for use during emergencies. This had the potential to affect all patients served by this facility. Findings include: Review of the facility EP communication document titled, “Emergency Phone Numbers” dated January 2020, revealed the incorrect Facility Administrator (FA) and Dietician contact name/number, and included physician contact information for the Medical Director only. There were no additional nephrologists providing patient care to incenter and home therapy patients, and no staff contact information for the home therapy nurse, the incenter Patient Care Technician, and Registered Nurses. Review of the facility document titled, “Chain of Command”, dated January 2020 included the wrong staff member identified as Facility Administrator (FA), and the alternate contact identification was left blank. Review of the facility documents titled, “ER (Emergency) Contact Information, County Emergency Management Form, and Facility-Emergency Contact Information, dated 7/28/21, revealed incorrect information documented for the facility FA and FA’s contact number. The facility communication contact documentation was not updated, not current, and not complete. An interview was conducted on 7/16/25 at 12:50 PM with Employee Identifier # 1, FA, who confirmed the facility had failed to maintain a current and complete facility contact ER information needed for use during an emergency.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 30952 Based on review of the facility Emergency Preparedness (EP) Plan documentation, and staff interview, it was determined the facility failed to ensure training, testing, and the orientation plan for the emergency operations plan was reviewed and updated at least every two years. This had the potential to negatively affect all patients served by the facility and staff. Findings include: On 7/16/25 at 11:35 AM, the surveyor reviewed the facility EP Plan documentation reviewed/approved on 1/28/2022. There was no documentation the EP training, testing plan, and orientation program plan, based on risks identified in the facility hazard risk assessment, was reviewed and updated, at least every two years. An interview was conducted on 7/16/25 at 2:59 PM, with Employee Identifier # 1, Facility Administrator. who confirmed the EP testing and training program was last reviewed and updated on 1/28/22, and not at least every two years per requirement.”

“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: 30952 Based on review of the facility Emergency Preparedness (EP) Plan documentation, and staff interview, it was determined the facility failed to conduct and document a full-scale community/facility-based exercise, actual event, or table top exercise. This had the potential to negatively affect all patients served by the facility and staff. Findings include: Physicians Choice Dialysis of Auburn, Emergency Preparedness Manual Approval Form/Date 1/28/22 ...Section 5-Local Disaster Plan Participation in Auburn Emergency Management area emergency disaster plan will be attempted. Letter to emergency management...circulated annually... Review of the EP Plan revealed no documentation the facility conducted or participated in a full-scale community-based, facility-based exercise, or an actual emergency event within the past two years. An interview was conducted on 7/16/25 at 2:59 PM with Employee Identifier # 1, Facility Administrator, who reported the facility had only conducted quarterly fire drills, and the facility had failed to conduct or document a full-scale community/facility-based exercise, or actual event, within the past two years.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 30952 Based on observation, Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, facility policy, water treatment log, and staff interviews, it was determined the facility staff failed to display the current CMS (Centers for Medicare and Medicaid Services) Performance Score Certificate (PSC) in a prominent area in the facility visible to patients and families, and failed to submit unusual occurrence reports to the State Survey Agency (SSA). This affected the three incenter hemodialysis (HD) patients, and the fifteen home Peritoneal Dialysis (PD) patients who receive support from the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health (ADPH) Chapter 420-5-5 End Stage Renal Disease Treatment (ESRD) and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences (UO) which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the ADPH... as required. Examples of unusual occurrences include: ... Any condition in the facility, including the water treatment system, which would necessitate the temporary or long-term closure of the dialysis facility (excluding inclement weather). Facility HD Policy 810 Subject: Chlorine/Chloramine Monitoring: Water Date: No date documented. ...Purpose: To provide patient safety by ensuring proper function of chlorine/chloramine removal devices of the water system. Policy: ...2. To meet AAMI (Association for Advanced Medical Instrumentation) Water Standards of maximum allowable levels...the total chlorine level of water must be less than or equal to 0.1 mg/L (milligram/Liter) ... 1. A tour of the facility lobby was conducted on 7/14/25 at 8:15 AM. There was no 2025 PSC posted in a prominent location visible for patients and families. An interview was conducted on 7/14/25 at 9:25 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the 2025 PSC was not displayed in an area visible to incenter and home therapy patients and families. 2. Review of the facility Total Chlorine (TC) Log documentation revealed on 7/4/24 at 9:30 AM the TC test result was 0.2 which was greater than maximum allowable result, 0.1 mg/L. An interview was conducted on 7/16/25 at 10:25 AM with EI # 1 and EI # 2, Chief Biomedical Technician, who confirmed the 0.2 TC result required two dialysis treatments to be terminated early on 7/4/25. EI # 1 confirmed staff failed to submit an UO to the SSA agency for the 7/4/25 water treatment condition, which resulted in interrupted dialysis treatments.”

“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: 30952 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure staff: 1. Turned off the faucet with a paper towel after hand washing. 2. Performed hand hygiene, and donned clean gloves, after Arteriovenous Fistula/Graft (AVF/AVG) access site evaluation, before access site antisepsis and dialysis needle insertion. These deficient practices affected one of two observations conducted during dialysis station disinfection, and Patient Identifier (PI) 6, PI # 5, in two of two observations for access of AVF/AVG for initiation of dialysis and had the potential to negatively affect all patients who dialyze at this facility. Findings include: Policy Number: Hemodialysis Policy 789 Subject: Infection Control: Hand Hygiene Date: No date documented. Hand Washing Policy: ...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...before invasive devices (fistula needles...) Sink Policy... ...Hands free sinks are preferred...For sinks with faucet controls, turn off water with a clean single use paper towel. Avoid direct contact with contaminated sink handles... 1. An observation was conducted on 7/14/25 at 11:35 AM with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician, after cleaning/disinfection of dialysis station 5. After station disinfection, EI # 5 performed handwashing at the clean sink and turned off the faucet with clean hands and not a paper towel. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility sink/hand hygiene policy and turn off faucets with a paper towel. 2. An observation was conducted on 7/16/25 at 7:35 AM with EI # 5, to initiate treatment for PI # 6 at station 2. After auscultating access sites with a stethoscope, EI # 5 failed to remove his/her gloves, perform hand hygiene, and don clean gloves before access site antisepsis, and needle insertion. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, who confirmed staff should perform hand hygiene, don clean gloves after access site evaluation, and before antisepsis, and needle insertion. 3. An observation was conducted on 7/16/25 at 7:50 AM with EI # 3, Registered Nurse, to initiate treatment for PI # 5 at station 7. After auscultating the access sites with a stethoscope, EI # 3 failed to remove his/her gloves, perform hand hygiene, and clean gloves before access site antisepsis, and needle insertion. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, who confirmed staff should perform hand hygiene after evaluation of the access site.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 30952 Based on observation, review of facility policy, and interview, the facility failed to ensure staff wore required personal protective equipment (PPE) when there was a potential for blood spurting/splattering. This affected Patient Identifier (PI) # 6, in one of two observations of discontinuation of dialysis with an Arteriovenous fistula/graft (AVF/AVG) and had the potential to negatively affect all patients with an AVF/AVG. Findings include: Facility Hemodialysis Policy 700-1 Subject; Personal Protective Equipment Date: No date documented. ...Policy: ...PPE, such as a full-face shield or masks and protective eyewear with full side shield...will be worn to protect and prevent employees from blood or other potentially infectious material reaching the employee’s skin, eyes, mouth...when performing procedures during which spurting or splattering of blood might occur...initiation...termination of dialysis...). 1. An observation was conducted on 7/14/25 at 11:25 AM at station 9 with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician, to discontinue dialysis with an AVF for PI # 6. During the entire procedure, EI # 5 failed to wear a full-face shield or eye protection as required per facility PPE policy. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed staff should wear face/eye protection during treatment termination.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interview with staff, it was determined the facility failed to ensure non-disposable equipment brought to the dialysis station was disinfected before being returned to a common area or taken to another dialysis station. This affected Patient Identifier (PI) # 6, in one of two treatment discontinuations with an Arteriovenous Venous Fistula/Graft (AVF/AVG), and PI # 5, one of one treatment discontinuation with a Central Venous Catheter (CVC), and PI # 4, in one of one observation for treatment initiation with a CVC, and had the potential to affect all patients who dialyze at the facility. Findings include: Facility Hemodialysis Policy: 732 Subject: Disinfection of Non-Delivery System Equipment Date: No date documented. Purpose: To prevent the transmission of infectious agents through contact with equipment surfaces, dialyzers...and any reusable supplies. Policy: 1. Universal precautions...are used when disinfecting and cleaning reusable supplies and equipment surfaces. ...4. All equipment surfaces...will be disinfected after each treatment... ...9. All surfaces or reusable equipment...frequently touched will be cleaned and disinfected... 1. An observation of care was conducted for discontinuation of dialysis with an AVF/AVG on 7/14/25 at 11:25 AM at station 9 for PI # 6 and on 7/14/25 at 12:25 PM at station 7 for PI # 5 during discontinuation of dialysis with a CVC. Employee Identifier (EI) # 4, Registered Nurse, retrieved the thermometer from the front cart adjacent to the scales, took the thermometer to station 9 and station 7, scanned the patient’s foreheads, and returned the thermometer to the cart without first cleaning/disinfecting the reusable equipment. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed reusable equipment must be disinfected after use, between patients. 2. An observation was conducted on 7/16/25 at 7:25 AM at station 6 for initiation of treatment with a CVC for PI # 4 with EI # 4. After patient assessment, EI # 4, placed the stethoscope on the counter without first cleaning/disinfecting the stethoscope. EI # 4 failed to clean the reusable equipment after patient use. An observation for access of an AVF for dialysis initiation was conducted on 7/16/25 at 7:50 AM with EI # 3, RN. EI # 3 retrieved the stethoscope not disinfected after use at station 6, entered station 7, and assessed PI # 5 with the dirty stethoscope. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed reusable equipment must be disinfected after use, between patients.”

“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: 30952 Based on observations, facility policy and procedure, the Centers for Medicare and Medicaid End Stage Renal Disease (ESRD) Core Survey Observations of Hemodialysis (HD) Care and Infection Control Worksheet, Version 1.6, and staff interviews, it was determined staff failed to ensure all surfaces in the dialysis station were cleaned and disinfected after patient treatments. This affected two of two observations of dialysis station cleaning and disinfection and had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility Hemodialysis Procedure 700 B Subject: Cleaning Individual Patient Televisions and Direct Touch Systems Date: No date documented. ...Policy: ...The television shall be cleaned after each patient’s treatment.... with 1:100 (one part bleach, 100 parts water) ... ESRD Core Survey Observations of HD Care and Infection Control Worksheet # 6, Version 1.6 Cleaning and Disinfection of the Dialysis Station Action ...Non-disposable items: .... counters around the dialysis station wiped wet with disinfectant... 1. An observation for cleaning and disinfection of dialysis station 5 was conducted on 7/14/25 at 11:15 AM with Employee Identifier (EI) 3, Registered Nurse. EI # 3 failed to disinfect the television and counters surrounding the dialysis station. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed the television, whether in use of not, must be cleaned, and counters must be wiped with bleach cloths. 2. An observation for cleaning and disinfection of dialysis station 9 was conducted on 7/14/25 at 11:35 AM with EI # 5, Certified Clinical Hemodialysis Technician. EI # 5 failed to wipe the counters surrounding the dialysis station with disinfectant. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, who confirmed the dialysis station counters should be disinfected.”

“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: 30952 Based on review of medical records (MR), the facility Hepatitis B (viral infection that causes inflammation and swelling of the liver) Management document, facility policy, and interviews, it was determined the facility failed to ensure all susceptible patients received the Hepatitis (Hep) B vaccinations or a declination was obtained and documented per facility policy. This affected two of three Peritoneal Dialysis (PD) patient record reviews, including Patient Identifier (PI) # 1, PI # 3, and had the potential to negatively affect all patients served by the facility. Findings include: Facility Policy 6013 Subject: Hepatitis B Vaccine Administration Date: No date documented. Purpose: To protect patients from the Hepatitis B virus. To ensure proper administration of the vaccine to patients. Policy: ...2. The Facility Administrator (FA)...will ensure... all susceptible patients are offered the Hep B vaccination vaccine. ...4. The Hep B VIS (vaccine information sheet) must be completed and filed in....the patient’s MR... 5. Patients are considered susceptible to Hep B if they are HBsAg (hepatitis B surface antigen, a protein found on the surface of the Hepatitis B virus (HBV), and its presence in the blood indicates an active HBV infection, either acute or chronic ) negative and have Anti-HBs titers (a measures the level of hepatitis B surface antibodies in your blood, indicating your immune status to the hepatitis B virus) <( less than) 10 mIu/ml (milli-international units per milliliter). 6. The vaccine is administered to patient as a series of three.... injections... 10. Administration of each dose of Hep B vaccine will be documented in the patient record... 1. PI # 1 was admitted to PD home services on 6/14/23 with diagnosis including End Stage Renal Disease (ESRD). Review of the PD Hep B Management form revealed PI # 1’s Anti-HBs surface antibodies were negative, < 4 (susceptible) on 7/10/25. Review of the MR documentation revealed no consent for Hep B vaccine, no vaccine declination, and no documentation PI # 1 received the Hep B vaccination series. An interview was conducted on 7/15/25 at 3:50 PM with Employee Identifier (EI) # 8, PD Nurse, who confirmed there was no documentation PI # 1 declined the Hep B vaccination Series, and no documentation PI # 1 received the Hep B vaccine. 2. PI # 3 was admitted to PD home services on 6/14/23 with diagnosis including ESRD. Review of the PD Hep B Management form revealed PI # 3’s HBAG were negative, < 4 (susceptible) on 4/15/25, HBSAG negative on 5/12/25, and 6/5/25 and no titer value was documented. Review of the MR documentation provided revealed no consent for Hep B vaccine, no Hep B vaccine declination, and no documentation PI # 3 received the Hep B vaccination series. An interview was conducted on 7/15/25 at 3:25 PM with EI # 8 who confirmed there was no documentation PI # 3 declined the Hep B vaccination series, and no documentation PI # 1 received the Hep B vaccines.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 30952 Based on the review of the facility procedure, water treatment logs, and interview, it was determined the facility failed to ensure staff checked the water hardness at the end of each treatment day and documented the water hardness results were acceptable. This had the potential to affect all patients dialyzed by the facility. Findings include: Facility Procedure: Water Procedure Procedure: 04B Revised Date: 2/16/18 44. Perform the pm (evening) water softener hardness testing utilizing the PCD (Physician Choice Dialysis) approved hardness test kit. Record the result... Review of the PCD Water Treatment Log documentation revealed no PM water hardness test documentation on 5/14/25 and 6/13/25. An interview was conducted on 7/14/25 at 10:25 AM with Employee Identifier # 2, Chief Biomedical Technician, who confirmed there was no documentation staff performed end of day water hardness checks on 5/14/25 and 6/13/25.”

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 30952 Based on review of facility policy and procedure, documents titled, Total Chlorine (TC) Log, and Chlorine Breakthrough Check Log Primary Tank, medical records (MR), and interviews, it was determined the facility failed to ensure staff followed their own policy for chlorine breakthrough. This affected Patient Identifier (PI) # 4, and PI # 2, and had the potential to affect all patients who dialyze at facility. Findings include: Facility Hemodialysis (HD) Policy 810 Subject: Chlorine/Chloramine Monitoring: Water Date: No date documented. ...Purpose: To provide patient safety by ensuring proper function of chlorine/chloramine removal devices of the water system. Policy: ...2. To meet AAMI (Association for the Advancements in Medical Instrumentation) Water Standards of maximum allowable levels...the TC level of water must be less than or equal to 0.1 mg/L (milligram/Liter) ... 8. In facilities with two or more pairs of carbon tanks, the sample is obtained after the first (primary) bank of tanks. 9. If the first water sample meets the standard, no further testing is required. If the results are not acceptable proceed to step #15. 10. Test results are documented on the Total Chlorine/Chloramine Test Log...date, time, result...signature of staff...performing the test... 15. If the sample from the primary (first) carbon tank.... revealed a TC level that exceeded 0.1 mg/L (milligram/liter), notify the Chief Technician (CT) and Facility Administrator (FA)...and repeat the test immediately... 16. If the TC level of the second carbon tank(s) is less than 0.1 mg/L, then dialysis treatments may proceed. The CT...and FA...must be notified and arrangements made to replace the first carbon tank... 18. If the outflow of the final carbon tank...has TC values greater than 0.1 mg/L... the water will not be used for dialysis treatments...The FA...facility Medical Director (MD), Director of Operations and CT shall be notified immediately. Facility Hemodialysis (HD) Procedure 810B Subject: Chlorine Breakthrough Check Log: Primary Tank Date: No date documented. Facility, Date, Test Time. Secondary Tank 1 (ppm-parts per million), Secondary Tank 2 ppm, Signature (staff performing test; Licensed Staff Signature, Testing to be performed every 30 minutes... Review of the facility TC Log dated 7/4/25 revealed at 9:30 AM, two staff, Employee Identifier (EI) # 3, Registered Nurse (RN), and EI # 4, RN documented the TC result 0.20, which exceeded allowable limits. There was no documentation staff tested the TC of the second carbon tank. There was no documentation of actions taken in response to the primary tank TC results on 7/4/25. Review of facility HD Treatment Sheets dated 7/4/25 revealed PI # 4 and PI # 2 were dialyzing on 7/4/25 at 9:30 AM. An interview was conducted on 7/15/25 at 9:25 AM with EI # 1, FA, and EI # 2, Chief Biomedical Technician, who confirmed on 7/4/25 TC results exceeded AAMI standards, and there was no documentation staff tested TC at the second tank when the primary tank TC results exceed AAMI standards, and no documentation staff notified the FA, MD, and CT of the TCL results.”

“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: 30952 Based on observations, the manufacturer’s directions of use (DFU) for the pH (potential of hydrogen) reagent strips, and interviews with the staff, the facility failed to ensure staff followed the DFU for testing the dialysate pH. This affected two of three observations for preparation of the hemodialysis (HD) for dialysis treatments, and included Patient Identifier (PI) # 5, PI # 6, and had the potential to affect all patients who receive HD treatments at the facility. Findings include: HACH Sterichek Bicarb (Bicarbonate) pH Reagent Strips ...Directions Use care in collecting the sample. Agitation of the sample will accelerate the loss of carbon dioxide and cause an increase in pH. 1. Dip pad in sample solution for one second. 2. Remove and read immediately if testing sample warmed to 32-40 degrees Celsius... 1. An observation was conducted 7/16/25 at 6:35 AM at station 7 for preparation of the HD machine for dialysis treatment for PI # 5 with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician. EI # 5 collected a dialysate sample from the HD machine, placed the pH strip into the dialysate solution, and swished the test strip back and forth four times, then read the pH result. EI # 5 failed to follow DFU and dip the test strip in the solution for one second, remove and read results. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, Facility Administrator, who confirmed staff failed to follow the DFU when testing dialysate pH. 2. An observation was conducted 7/16/25 at 7:30 AM at station 2 for preparation of the HD machine for dialysis treatment for PI # 6 with EI # 3, Registered Nurse. EI # 3 collected a dialysate sample from the HD machine, placed the pH strip into the dialysate solution, and swished the test strip back and forth two times, then read the pH result. EI # 3 failed to follow DFU and dip the test strip in the solution for one second, remove and read results. An interview was conducted on 7/16/25 at 8:58 AM with EI # 1, who confirmed staff failed to follow the DFU when testing dialysate pH.”

“CH/CHL BREAKTHROUGH-NOTIFY MED DIRECTOR CFR(s): 494.40(b)(2)(ii) (ii) If the test results from the last component or carbon tank are greater than the parameters for chlorine or chloramine specified in paragraph (b)(2)(i) of this section the facility must- (C) Immediately notify the medical director This Standard is not met as evidenced by: 30952 Based on review of the facility policy, Total Chlorine (TC) Log documentation, and interviews with staff, it was determined the facility failed to ensure staff notified the Medical Director of a chlorine breakthrough. This affected Patient Identifier (PI ) # 4, PI # 2, and had the potential to affect all hemodialysis (HD) patients treated at the facility. Findings include: Facility Hemodialysis (HD) Policy 810 Subject: Chlorine/Chloramine Monitoring: Water Date: No date documented. ...Purpose: To provide patient safety by ensuring proper function of chlorine/chloramine removal devices of the water system. Policy: ...2. To meet AAMI (Association for the Advancements in Medical Instrumentation) Water Standards of maximum allowable levels...the TC level of water must be less than or equal to 0.1 mg/L (milligram/Liter) ... 8. In facilities with two or more pairs of carbon tanks, the sample is obtained after the first (primary) bank of tanks. 9. If the first water sample meets the standard, no further testing is required. If the results are not acceptable proceed to step #15. 10. Test results are documented on the Total Chlorine/Chloramine Test Log...date, time, result...signature of staff...performing the test... 15. If the sample from the primary (first) carbon tank.... revealed a TC level that exceed 0.1 mg/ L, notify the Chief Technician (CT) and Facility Administrator (FA)...and repeat the test immediately... 16. If the TC level of the second carbon tank(s) is less than 0.1 mg/L, then dialysis treatments may proceed. The CT...and FA...must be notified and arrangements made to replace the first carbon tank... Review of the facility TC Log dated 7/4/25 revealed at 9:30 AM, two staff, Employee Identifier (EI) # 3, Registered Nurse (RN), and EI # 4, RN documented the TC result 0.20. An interview was conducted on 7/15/25 at 9:25 AM with EI # 1, FA, and EI # 2, Chief Biomedical Technician, who confirmed staff discontinued dialysis treatments on 7/4/25 for PI # 4, and PI # 2 after the TC results exceeded AAMI standards. An interview was conducted on 7/16/25 at 8:25 AM with EI # 4, who reported she/he repeated the TC test at the first carbon tank then at the final carbon tanks and all TC tests exceeded the allowable result. EI # 4 reported the FA and CT were notified, and the two patients were placed in bypass (diverting the dialysate from treatments), and treatments was terminated. EI # 4 confirmed there was no documentation the TC was retested after the first TC test, and no documentation the FA, MD, and CT were notified of the TC breakthrough on 7/4/25. An interview was conducted on 7/16/25 at 5:00 PM with EI # 1, who confirmed there was no documentation the Medical Director was notified on 7/4/25 the secondary chlorine tank TC results exceeded the maximum allowable results.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30952 Based on observations, review of facility procedure, and staff interviews, the facility failed to ensure staff rinsed the Myron L meter cell cup and plunger after dialysate testing in three of three observations for preparation of the hemodialysis (HD) machine. This affected the facility’s three HD patients, Patient Identifier (PI) # 5, PI # 4, and PI # 6. Findings include: Facility HD Procedure 970A Subject: Myron L. Dialysate Conductivity Meter Use Date: No date documented Procedure ...aspirate the dialysate sample from the machine...Place the sample into the dipper end of the cell plunger and pour the sample into the Cell Cup. ...When the testing is completed, rinse the Cell Cup and plunger with water... Rationale RO (reverse osmosis) or Deionized water is preferred for rinsing, but tap water is acceptable. 1. Observations of staff performing final dialysate conductivity testing was conducted on 7/16/25 and revealed the following: At 6:35 AM, Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician, tested final dialysate from station 7 for PI # 5. EI # 5 failed to rinse the Myron L cell cup and plunger with water after testing was complete. At 6:37 AM, EI # 4, Registered Nurse (RN), tested final dialysate from station 6 for PI # 4. EI # 4 failed to rinse the Myron L cell cup and plunger with water after testing was complete. At 7:30 AM, EI # 3, RN, tested final dialysate from station 2 for PI # 6. EI # 3 failed to rinse the Myron L cell cup and plunger with water after testing was complete. An interview was conducted on 7/16/25 at 8:28 AM with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility procedure for use of the Myron L meter and rinse the meter with water after use.”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), the Renal Dietician (RD) job description, and staff interviews, it was determined the facility failed to ensure patients monthly nutritional progress was monitored by the RD. This affected two of two incenter hemodialysis (HD) patient record reviews, including Patient Identifier (PI) # 4, PI # 5, and had the potential to affect all incenter HD patients who dialyze at the facility. Findings include. Job Description Renal Dietician (RD) Date 7/26/19 ...Summary of Responsibilities The RD provides services to HD and Peritoneal Dialysis patients and their families...to support and maximize the nutritional functioning...of the patient. Core Responsibilities 1. Adheres to organization and departmental policies and procedures. Patient Care 1. Assess the nutritional status of the patient... 4. Monitors nutritional status, lab values...response to nutrition related medications and therapy. 5. Reviews of lab tests each month with the patient and/or care giver. 6. Participated with the patient care team in the development and review of ...care plan programs, Revise and update nutritional recommendations...as needed. ...Documentation ...3. Required documentation...monthly nutritional progress report... 1. PI # 4 was admitted for HD on 9/23/24 with diagnoses including End Stage Renal Disease (ESRD). Review of the 90-day HD Interdisciplinary Assessment (IDT) dated 2/27/25 revealed the phosphorus was 12.4 on 2/14/25, and on 2/22/25 the RD documented phosphorus elevated, reviewed low phosphorus diet, encouraged good binder compliance. Will follow. Review of monthly lab results revealed the following: On 4/28/25 the phosphorus was 11.4. On 5/28/25 the phosphorus was 12.3. On 6/30/25 the phosphorus was 10.3. On 7/9/25 the phosphorus was 10.9. Review of the MR Progress Notes (PN) from 3//1/25 to 7/14/25 revealed no documentation the RD monitored PI # 4’s monthly nutritional progress report. There was no RD follow up documented. A phone interview was conducted on 7/15/25 at 3:25 PM with Employee Identifier (EI) # 9, RD, who reported monthly telehealth visits are conducted after labs result. EI # 9 reported he/she did not know if monthly nutritional PNs had been documented. An interview was conducted on 7/16/25 at 9:36 AM with EI # 1, Facility Administrator, who confirmed no monthly nutritional PNs were documented. 2. PI # 5 was admitted for HD on 12/2/22 with diagnoses including ESRD. Review of the 90-day HD IDT dated 2/26/25 revealed the phosphorus was 6.5 on 2/10/25, and on 2/22/25 the RD documented, phosphorus elevated, reviewed low phosphorus diet, encouraged good binder compliance. Will follow. Review of monthly lab results revealed the following: On 4/14/25 the phosphorus was 6.3. On 5/14/25 the phosphorus was 5.0. On 6/4/25 the phosphorus was 4.3. Review of the MR PNs from 4/1/25 to 7/14/25 revealed no documentation the RD monitored PI # 5’s monthly nutritional progress report. There was no RD follow up documented. A phone interview was conducted on 7/15/25 at 3:25 PM with EI # 9, RD, who reported monthly telehealth visits are conducted after labs results. EI # 9 reported he/she did not know if monthly nutritional PNs had been documented. An interview was conducted on 7/16/25 at 9:35 AM with EI # 1, Facility Administrator, who confirmed no monthly nutritional PNs were documented.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility policy, and interviews with staff, it was determined the facility failed to ensure all staff completed the comprehensive interdisciplinary assessment (CIA) within the required timeframe. This deficient practice affected two of two incenter hemodialysis (HD) patient records reviewed, and included Patient Identifier (PI) # 4, PI # 5, and had the potential to affect all patients who dialyzed and received home dialysis support at this facility. Findings include: Facility Hemodialysis Policy 5002 Subject: Comprehensive Patient Assessment and Plan of Care Date: No Date documented. ...Comprehensive Patient Assessment/Plan of Care Frequency: ...A follow up comprehensive reassessment must occur on all new patients within three...months after the...initial assessment to adjust the patient’s Plan of Care (POC)...The POC must be updated and implemented within 15 days of reassessment. Comprehensive assessment and modifications to the POC must be conducted 12 months after...the 3 months assessment... reassessed annually thereafter on all stable patients. The modified Plan of Care must be implemented within 15 days of the reassessment... 1. PI # 4 was admitted for HD on 9/23/24 with diagnoses including End Stage Renal Disease (ESRD). Review of the 90-day HD Interdisciplinary (IDT) Assessment dated 2/27/25 revealed no date when the Social Worker (SW) completed the psychosocial assessment and no date when the physician completed the nephrologist assessment. An interview was conducted on 7/16/25 at 9:35 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed there was no documentation when the SW and physician completed their 90-day comprehensive assessments. 2. PI # 5 was admitted for HD on 12/2/22 with diagnoses including ESRD. Review of the Annual HD Comprehensive IDT Assessment dated 2/26/25 revealed no date the SW completed the psychosocial assessment and no date the physician completed the nephrologist assessment. An interview was conducted on 7/16/25 at 9:36 AM with EI # 1, who confirmed there was no documentation when the SW and physician completed their annual comprehensive assessments.”

“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: 30952 Based on medical record (MR) review, facility policy, and staff interview, it was determined the facility failed to ensure staff obtained an Early Termination or Arriving Late (AMA) form signed by the patient. This affected Patient Identifier (PI) # 5, PI # 4, two of two Hemodialysis (HD) record reviews, and had the potential to affect the three HD patients who dialyze at the facility. Findings include: HD Policy 410 Subject: Against Medical Advice (AMA) Date: No date documented. ...Policy: 1. When a patient refuses to follow a medical order that could result in ...harm or injury ...a licensed teammate will ...talk with the patient. 2. If the teammate is unable to convince the patient to follow the order, the teammate must complete the AMA form with the patient and obtain the patient’s signature. If the patient refuses to sign the form, refusal will be noted on the AMA form ... 3. The AMA form ...retained in the patient’s medical record ... 1. PI # 5 was admitted for HD on 12/2/22 with diagnoses including End Stage Renal Disease (ESRD). Review of the Treatment Sheets (TS) Reports dated 6/11/25 and 6/16/25 revealed dialysis orders for four-hour 30-minute dialysis treatments. Further review of the TSs dated 6/11/25 revealed PI # 5 completed a 4-hour five-minute treatment on 6/11/24 and completed a three-hour fifty-minute treatment on 6/16/25. There were no early termination of treatments documented. An interview was conducted on 7/16/25 at 9:36 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to complete documentation for early treatment termination. 2. PI # 4 was admitted for HD on 9/23/24 with diagnoses including ESRD. Review of the TS dated 7/9/25 revealed dialysis orders for a three-hour thirty -minute treatment. Further review of the 7/9/25 TS documentation revealed PI # 4 completed a two hour fifty-nine-minute treatment, and no early termination of treatment documentation was completed. An interview was conducted on 7/16/25 at 9:35 AM with EI # 1, who confirmed staff failed to complete documentation for early treatment termination.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observations, review of facility procedure, and interview with staff, it was determined the facility failed to ensure staff: 1. Performed access site antisepsis (cleaning) with an approved disinfectant to each access cannulation site, in two of two access of an AVF (arteriovenous fistula) initiation for dialysis observations. 2. Repeated access site antisepsis to each cannulation site when touched after skin antisepsis, which affected one of two access of an AVF initiation for dialysis observations. 3. Placed the paper tape above the needle insertion site then covered the insertion site with gauze and tape, in one of two access of AVF initiation for dialysis observations. This affected PI (Patient Identifier) # 6, PI # 5, and had the potential to negatively affect all hemodialysis patients who dialyzed at the facility. Findings include: Facility Hemodialysis Procedure 4200A Subject: Access Needles: Placement and Removal Date: No date documented. Placement of Fistula Needles: Procedure ...The needle insertion site is identified and the area cleaned with an approved disinfectant solution...using a circum-swab motions...moving outward... If the insertion site requires palpation after the site is disinfected, the above prepping procedure must be repeated. The second needle site is prepared as described in the step above.... 1. An observation of care for access of an AVF for initiation of dialysis was conducted on 7/16/25 at 7:35 AM, with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), at station 2 for PI # 6. EI # 5 cleaned the AVF needle cannulation site(s) with one alcohol pad. EI # 5 failed to clean the needle insertion site for the second needle with an approved disinfectant. An interview was conducted on 7/16/25 at 8:59 AM with EI # 1, Facility Administrator, who confirmed staff failed to perform access site antisepsis per facility procedure. 2. An observation of care for access of an AVF for initiation of dialysis was conducted on 7/16/25 at 7:50 AM with EI # 3, Registered Nurse, at station 7 for PI # 5. EI # 3 cleaned the AVF needle cannulation site(s) with one alcohol pad. EI # 3 failed to clean the needle insertion site for the second cannulation site with an approved disinfectant. EI # 3 placed a gloved finger on each cannulation insertion site after antisepsis, then cannulated the access sites. EI # 5 failed to repeat access site antisepsis after touching the sites. EI # 3 placed a piece of paper tape directly on top of both needle entry sites, and not above the needle sites, potentially contaminating the access sites. An interview was conducted on 7/16/25 at 8:59 AM with EI # 1, who confirmed staff failed to perform access site antisepsis and care of the access per the facility procedure.”

“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: 30952 Based on review facility policy, Incident/Event report documentation, and interview with staff, it was determined the facility failed to ensure a chlorine breakthrough that shortened hemodialysis (HD) dialysis treatments was documented as adverse events. The affected two of two patients who dialyzed on 7/4/25 and had the potential to affect all patients who receive incenter HD treatments at the facility. Findings include: Facility Policy RM (Risk Management) 900: Subject: Incident/ Event Reporting Date: No date documented. Policy: A confidential incident report must be completed for any incident, accident or event that is not within the routine safe operation of the location/clinic, particularly if it did, or could have resulted in a deviation from the expected plan of care for a patient or an injury to patient... Guidelines: ...10... The following incidents must always be reported on a Clinical Variance Report: ...F. Any incident of HD ...M. Any incident involving multiple patients...whether or not there was an adverse outcome... 1. Review of the facility documentation provided to the surveyor on 7/14/25 revealed there was no adverse events at the facility for the past six months. Review of the facility Total Chlorine (TC) Log dated 7/4/25 revealed at 9:30 AM, two staff documented the TC result 0.20, which exceeded AAMI (Association for the Advancements in Medical Instrumentation) Water Standards of maximum allowable levels as the TC level of water must be less than or equal to 0.1 mg/L (milligram/Liter). An interview was conducted on 7/16/25 at 3:30 PM with Employee Identifier # 1, Facility Administrator, who confirmed the chlorine breakthrough on 7/4/25 occurred during two patient HD treatments and was not reported as an incident/event. Staff failed to follow the incident/event reporting policy.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 30952 Based on review of the facility Peritoneal Dialysis (PD) Lab Report, the Centers for Medicare Services (CMS) Dialysis Facility Report (DFR) for End-Stage Renal Disease (ESRD) facilities (data report that summarizes facility-specific performance metrics for dialysis facilities, and compares the quality of care provided by different dialysis centers), the facility quality documentation, titled, Dimension Report Card Detail (DRCD), and staff interviews, it was determined the facility failed to analyze data gathered for PD patient outcomes for adequacy and phosphorus, develop and implement actions for performance improvement. This affected Patient Identifier (PI) # 1, PI # 3, in two of three PD records reviewed and had the potential to affect all PD patients served by the facility. Findings include: 1. Review of the PD lab Report revealed PI # 1’s adequacy results were < (less than) 1.7 on 5/6/25, and 6/5/25. Review of the CMS Quarterly (Q) Update for Fiscal Year (FY) 2025 DFR facility scores revealed 2024 Q1 was 27.0, Q2 was 22.6, and Q3 was 30.4. The facility 2024 PD adequacy scores were worse than the US average score of 5.0 ESRD patients with adequacy < (less than) 1.7. Review of the facility 2025 quality DRCD for PD Adequacy revealed the facility goal was < or equal (<=) to 5.6 % PD patients with adequacy < 1.7. Further review of the facility DRCD revealed the following: February 2025 No PD adequacy data was documented and analyzed. March 2025 25 % of patients had adequacy less than 1.7. April 2025 50 % of patients had adequacy less than 1.7. May 2025 67 % of patients had adequacy less than 1.7. The facility failed to meet their PD adequacy goal and failed to identify and prioritize PI activities to improve PD adequacy outcomes. An interview was conducted on 7/16/25 at 3:45 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the facility had not developed, and implemented performance improvement plans for PD adequacy outcomes. 2. Review of the PD Lab Report revealed PI # 1’s phosphorus results were > 7.0 on 5/6/25, 6/5/25, and 7/10/25, and PI # 3’s phosphorus > 7.0 on 5/19/25, and 6/5/25. Review of the CMS Q Update for FY 2025 DFR documentation for 2024 PD phosphorus scores > 7.0 (preferred score is <7.0), revealed the facility score was higher (worse) Q 3 at 20.4, and the CMS US 2023 score was 16.3. Review of the facility 2025 quality DRCD for PD phosphorus revealed the facility goal was 56.7 % >= (greater than equal to) 3.5, and less than equal to) to 5.5. Further review of the DRCD revealed PD phosphorus scores as follows: January 2025 28.57% > 7.1 and patient number meeting goal was 2 of 14. February 2025 26.67 % > 7.1 and patient number meeting goal was 5 of 15. March 2025 33.33 % > 7.1 and patient number meeting goal was 6 of 15. April 2025 35.71 % > 7.1 and patient number meeting goal was 4 of 14. May 2025 50.00 % > 7.1 and patient number meeting goal was 3 of 14. The facility failed to meet the PD phosphorus goal and failed to identify and prioritize PI activities to improve PD phosphorus outcomes. An interview was conducted on 7/16/25 at 3:45 PM with EI # 1, who confirmed the facility had not developed, and implemented performance improvement plans for PD phosphorus outcomes.”