Fmc - Tri-Counties Dialysis Center

“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: 48224 Based on record review and interview, the dialysis facility failed to ensure the EP Plan addressed the patient population and services the facility could provide in an emergency (See Tag E0007); failed to develop a system to track the location of on-duty staff and patients, whether sheltered in place or relocated during an emergency (See Tag E0018); failed to maintain the availability of patient records in case of a facility emergency (See Tag E0023); failed to ensure the emergency cart was checked monthly for expired supplies and the facility failed to have an emergency evacuation box available for transport in an emergency (See Tag 0028); failed to ensure the EP Plan included a procedure to release patient information in the event of an emergency (See Tag E0033); failed to ensure the EP Plan included a process for communicating the facility’s occupancy needs to local authorities (See Tag E0034); and failed to participate in a full-scale community-based exercise (See Tag E0039). Findings include: The cumulative effect of these systemic problems had the potential to impact all 18 active patients which resulted in the facility being found out of compliance with Condition for Coverage 42 CFR 494.62 for Emergency Preparedness.”

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(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:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[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 all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to ensure the EP Plan addressed the patient population and services the facility could provide in an emergency for 1 of 1 facility. Findings include: 1. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to address the patient population and the services the facility could provide in an emergency. 2. During an interview on 12/13/24 beginning at 2:58 PM, the CM relayed the EP Plan did not include a way to address the services to be provided in an emergency.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to develop a system to track the location of on-duty staff and patients, whether sheltered in place or relocated during an emergency for 1 of 1 facility. Findings include: 1. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to include a system to track staff and patients during an emergency. 2. During an interview on 12/13/24 beginning at 2:58 PM, the CM relayed the EP Plan did not include information on how to track staff and patients during an emergency specific to the clinic.”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to maintain the availability of patient records in case of a facility emergency for 1 of 1 facility. Findings include: 1. The facility policy “Emergency and Disaster Responsibility Guidelines,” dated 8/02/17, indicated Clinical Manager was responsible for maintaining a current listing of patients which included their local, emergency, and evacuation contact information. 2. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to include a patient list. 3. During an interview on 12/12/24 beginning at 2:30 PM, the CM confirmed the EP Plan did not include a patient list.”

“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: 48224 Based on observation record review and interview the dialysis facility failed to ensure the emergency cart was checked monthly for expired supplies and the facility failed to have an emergency evacuation box available for transport in an emergency for 1 of 1 facility reviewed. Findings include: 1. The facility policy “Emergency Medications, Equipment and Supplies,” last updated 5/01/23, indicated the emergency cart must be checked monthly or after use for contents, expiration dates, cleanliness, and proper functioning of all equipment; an itemized log must be kept indicating the contents and expiration dates of the contents and cardiac arrest medications should be grouped together in the code cart. All staff must know the location of the evacuation box and who is responsible to grab it during an emergency evacuation. 2. During an observation of the locked emergency crash cart on 12/12/24 beginning at 9:40 AM, one package of oxygen tubing was observed to be discolored and expired as of 8/22/22. The ICHD unit failed to maintain an emergency evacuation box, including cardiac arrest medications grouped together. 3. During an interview on 12/12/24 beginning at 9:48 AM, the CM stated the crash cart is checked monthly for expired supplies. 4. During an interview on 12/12/24 beginning at 2:35 PM, the CM relayed the dialysis facility does not have an emergency evacuation box. She relayed the required emergency supplies are kept in the crash cart and medications are kept in the locked medication cabinet on the ICHD treatment floor. When asked how staff would know what to take in an emergency, she relayed all the emergency medications are together on the side.”

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to ensure the EP Plan included a procedure to release patient information in the event of an emergency for 1 of 1 facility. Findings Include: 1. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to include information on how the facility planned to release patient information during an emergency. 2. During an interview on 12/13/24 beginning at 2:58 PM, the CM confirmed the EP Plan did not include information on how to release patient information during an emergency and did not include a patient list.”

“Information on Occupancy/Needs CFR(s): §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(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: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to ensure the EP Plan included a process for communicating the facility’s occupancy needs to local authorities for 1 of 1 facility. Findings include: 1. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to include information on how the facility planned to communicate occupancy needs to local authorities during an emergency. 2. During an interview on 12/13/24 beginning at 2:58 PM, the CM confirmed the EP Plan did not include information on how to communicate with local authorities during an emergency.”

“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: 48224 Based on record review and interview, the dialysis facility failed to participate in a full-scale community-based exercise in the past 2 years for 1 of 1 facility. Findings Include: 1. The review of the facility document titled” Fresenius Kidney Care 6656-Tri Counties-JV Emergency Plan,” last updated 5/02/24, failed to include documentation of a full-scale community-based exercise completed in the past 2 years. 2. During an interview on 12/13/24 beginning at 2:58 PM, the CM relayed she attended a solar eclipse preparation training on 3/15/24 and she thought this was a community-based exercise. 3. During an interview on 12/17/24 beginning at 8:33 AM, the CM confirmed the facility had not participated in a community-based exercise in the past 2 years.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 44714 48224 Based on observation, policy review and interview, the dialysis facility failed to maintain a sanitary environment within the ICHD treatment area during 2 of 2 days of ICHD treatment area observations, which had the potential to affect 18 active ICHD patients. Findings include: 1. The policy “Cleaning and Disinfecting the Dialysis Station,” last updated 9/05/23, indicated bleach solution will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air. 2. During the flash tour observation on 12/11/24 beginning at 8:53 AM, 2 bleach containers sitting on a counter within the ICHD treatment floor did not have the lids secured. 3. 3. During the treatment floor observations on 12/13/2024 between 8:50 AM - 11:10 AM and 3:00 PM - 3:40 PM, bleach solution containers were observed uncovered on 4 occasions when not in use. 4. During an interview on 12/13/24 beginning at 2:58 PM, the CM relayed the bleach containers should have the lid closed when not in use. 5. During an interview on 12/13/2024 at 3:40 PM, PCTs 1 and 2 indicated all staff were responsible for to keep the lids on the bleach. PCT 2 indicated keeping the lid on the bleach kept it from breaking down.”

“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: 44714 Based on observation, policy review, and interview, the agency failed to ensure employees followed standards of practice for hand hygiene to reduce the spread of infections for 2 of 2 PCTs observered (PCT 1, 2). Findings include: 1. The agency policy on hand hygiene, dated 11/6/2023, imdicated hand hygiene should be performed nefore and after patient contact, immediately after removing gloves, and after contact with body fluid or potentially contaminated objects. 2. During a treatment floor observation on 12/11/2024 at 10:21 AM in Station 4, PCT 2 was observed decannuating Patient #2’s fistula. The PCT had a glove on the left hand and no glove on the right hand. PCT 2 retrieved gauze pads from the supply drawer with the ungloved right hand. PCT 2 took the gauze pads to Station 4, placed a glove on her right hand, and removed Patient’s dialysis needle. PCT 2 failed to complete hand hygiene immediately after removing the right - hand glove. During an interview on 12/13/2024 at 3:15 PM, PCT 2 indicated they removed soiled gauze from Patient #2’s station with a gloved right hand, pulled the right glove off in a way to keep the soiled gauze within the glove. PCT 2 indicated they retrieved clean gauze and took it to Patient #2’s station. PCT 2 indicated they put a glove on the right hand. When asked, PCT 2 indicated they did not complete hand hygiene prior to donning a new right - hand glove. PCT 2 indicated they should have removed both gloves and used hand sanitizer prior to putting on 2 new gloves. 3. During a treatment floor observation on 12/13/2024 at 8:31 AM, PCT 1 used hand sanitizer, grabbed two gloves, touched their ear, then donned the gloves. At 8:45 AM, PCT 1 used hand sanitizer, donned a glove on left hand, touched her face with ungloved right hand, then donned a glove on the right hand. During an interview on 12/13/2024 at 3:05 PM, PCT 1 indicated they had a bad habit of touching their face. PCT 1 indicated they should have used the hand sanitizer on both hands and donned 2 new gloves after touching their face. 48224”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 48224 Based on record review and interview, the dialysis facility failed to ensure an approved isolation agreement or waiver was in place for 1 of 1 ESRD facility. Findings include: The policy “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+),” last updated 11/06/23, indicated facilities existing prior to 10/14/2008 which do not currently accept or treat HBsAg positive patients must have a transfer agreement with a local chronic facility which has capacity for isolation. If there is no local facility available to accept such transfers, the existing facility must establish an isolation room or area for use with HBsAg positive patients. 1. During the entrance conference on 12/11/24 beginning at 11:13 AM, the CM stated the dialysis facility had an isolation waiver. 2. The review of the document “Transfer Agreement-Hepatitis B Antigen Positive Patients” created 8/18/14 included a letter from Centers for Medicare & Medicaid Services (CMS) dated 3/16/22 indicated the dialysis facility was denied a waiver request. 3. During the entrance conference on 12/11/24 beginning at 11:13 AM, the CM stated the dialysis facility had an isolation waiver to send all HBsAg+ patients to another dialysis facility. 4. During an interview on 12/17/24 beginning at 11:12 AM, the Administrator indicated the dialysis facility had not reapplied for the isolation room waiver. They would send the patient to another clinic with an isolation room in place.”

“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: 48224 Based on record review and interview, the dialysis facility failed to ensure the Registered Nurse (RN) was notified of blood pressures (BP) and heartrate (HR) outside of parameters and failed to ensure the physician was notified of not meeting estimated dry weight (EDW) orders during ICHD treatment for 2 of 5 ICHD clinical records reviewed (Patient #8 and 9). Findings include: 1. The facility policy “Hypertension,” last updated 9/07/21, indicated staff will recognize, report and immediately address systolic blood pressures (top number of BP) greater than 180 mm/Hg and/or diastolic blood pressures (bottom number) greater than 100 mm/Hg. 2. The facility policy “Patient Assessment and Monitoring,” last updated 5/01/23, indicated the pulse should be reported to the nurse when heart rates have dropped below 60, risen above 100 or become irregular. 3. Patient #8’s ICHD treatment sheets, dated 11/27/24 to 12/11/24, were reviewed and evidenced the following: a. On 11/27/24, Patient’s pre-treatment blood pressure was 168/91 and the ICHD treatment began at 10:41 AM. The BP check at 12:09 PM indicated BP of 188/92. The clinical record failed to evidence the PCT notified the RN of the high BP. The BP check at 2:42 PM indicated BP of 194/104. The clinical record failed to evidence the PCT notified the RN of the high BP. b. On 12/04/24, Patient #8’s post dialysis weight was 65.2 kg (1.3 kg below ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address EDW. c. On 12/06/24, Patient’s pre-treatment blood pressure was 146/86 and the ICHD treatment began at 10:38 AM. The BP check at 2:41 PM indicated BP of 86/45. Patient #8’s post dialysis weight was 65.1 kg (1.4 kg below ordered EDW). The clinical record failed to evidence the PCT notified the RN of the low BP and failed to evidence the RN notified the physician and/or performed interventions to address EDW at the end of treatment. d. On 12/09/24, Patient’s pre-treatment blood pressure was 156/90 and the ICHD treatment began at 10:44 AM. The BP check at 12:03 PM indicated BP of 182/98. The clinical record failed to evidence the PCT notified the RN of the high BP. The BP check at 1:05 PM indicated BP of 187/95. The clinical record failed to evidence the PCT notified the RN of the high BP. During an interview on 12/16/24 beginning at 1:07 PM, RN 2 verified the above findings for Patient #8 and relayed the PCT should have notified the RN when the BP and EDW were out of range. 4. Patient #9’s ICHD treatment sheets, dated 11/27/24 to 12/13/24, were reviewed and evidenced the following: a. On 11/29/24, Patient #9’s post dialysis weight was 70.9 kg (1.9 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address EDW. b. On 12/02/24, Patient’s pre-treatment heart rate was 60 and the ICHD treatment began at 12:20 PM. The HR check at 12:31 PM indicated HR of 46. The clinical record failed to evidence the PCT notified the RN of the low HR. The HR check at 1:00 PM indicated HR of 41. Patient #9’s post dialysis weight was 71.6 kg (2.6 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address low HR and EDW at the end of treatment. c. On 12/04/24, Patient #9’s post dialysis weight was 71.1 kg (2.1 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address EDW. d. On 12/09/24, Patient #9’s post dialysis weight was 73.7 kg (4.7 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address EDW. e. On 12/11/24, Patient #9’s post dialysis weight was 74.1 kg (5.1 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address EDW. f. On 12/13/24, Patient’s pre-treatment blood pressure was 140/78 and the ICHD treatment began at 11:43 AM. The BP check at 3:23 PM indicated BP of 183/80. The clinical record failed to evidence the PCT notified the RN of the high BP The post-treatment BP was 198/84. Patient #9’s post dialysis weight was 71.5 kg (2.5 kg above ordered EDW). The clinical record failed to evidence the RN notified the physician and/or performed interventions to address high BP and EDW at the end of treatment. During an interview on 12/16/24 beginning at 1:17 PM, RN 2 verified the above findings for Patient #9 and relayed the PCT should have notified the RN when the HR, BP and EDW were out of range. 5. During an interview on 12/13/24 beginning at 2:58 PM, the CM relayed the PCT should notify the RN when the BP is out of parameters when the systolic is below 100 millimeters of mercury (mmHg) or greater than 180 mmHg. 6. During an interview on 12/16/24 beginning at 2:04 PM, the CM relayed the PCT should notify the RN when the HR is low unless the patient has special parameters ordered and the RN should have collaborated with the physician regarding the EDW not being met.”

“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: 48224 Based on record review and interview, the dialysis facility failed to ensure the MD was notified and aware of shortened run times when patient requested to leave Against Medical Advice (AMA) for 1 of 1 ICHD patient records reviewed with shortened run times (Patient #9). Findings include: 1. The facility policy “Early Termination or Arriving Late for Treatment,” last updated 11/07/22, indicated the RN is responsible to notify the physician, and document on the “AMA” form and if the patient frequently requests to end their treatment before the prescribed time, the RN should discuss the patient’s reasons for frequently terminating early. 2. Patient #9’s ICHD treatment sheets, dated 11/27/24 to 12/13/24, were reviewed and evidenced a physician ordered total run time of 3 hours and 30 minutes during the dialysis treatments. a. On 12/09/24, the ICHD treatment began at 11:20 AM. The total run time was 1 hour and 10 minutes. RN 1 documented the shortened run time reason as patient request and an AMA form was signed by RN 1 and PCT 1. The AMA form was not signed by Patient #9. The clinical record for Patient #9 failed to include documentation that the physician was notified regarding the shortened run time. b. On 12/11/24, the ICHD treatment began at 11:33 AM. The total run time was 1 hour and 4 minutes. RN 1 documented the shortened run time reason as patient request and an AMA form was signed by RN 1 and PCT 1. The AMA form was not signed by Patient #9. The clinical record for Patient #9 failed to include documentation that the physician was notified regarding the shortened run time. 3. During an interview on 12/16/24 beginning at 2:04 PM, the CM relayed verified the clinical record for Patient #9 failed to evidence documentation of the physician being notified when the patient requested to end treatment.”

“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: 44714 48224 Based on record review and interview, the dialysis facility failed to ensure the POC was reviewed and signed by the patient for 2 of 5 ICHD records reviewed (Patient’s #4 and 9). Findings include: 1. The facility policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” last updated 7/03/23, indicated the patient must sign the plan of care meant to acknowledge the information in the plan. 2. The review of Patient #4’s clinical record included a POC dated 9/16/2024. The POC failed to evidence Patient’s signature or a statement indicating Patient #4 chose not to sign the POC. 3. The review of Patient #8’s clinical record included a POC dated 7/08/24. The POC failed to evidence Patient’s signature or a statement indicating Patient #4 chose not to sign the POC. 4. During an interview on 12/16/24 beginning at 2:04 PM, the CM indicated the POC should be reviewed and signed by the patient and she verified the clinical records for Patient’s #4 and 8 failed to include POC’s that had been signed by the patient.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 48224 Based on record review and interview, the medical director failed to ensure all new employees were screened for tuberculosis (TB, a contagious respiratory infection upon hire for 1 of 1 personnel file reviewed of a PCT (PCT 1). Findings include: 1. The facility policy “Employee Tuberculosis Testing,” last updated 2/05/24, indicated all new employees were to be screened for TB upon hire by completing a two-step tuberculin skin test (TST), Interfreon-Gamma Release Assay (IGRA), or chest X-ray. 2. The personnel file for PCT 1 indicated a hire date of 10/17/22 and the employee’s duties included direct patient contact. The file for PCT 1 failed to evidence the employee had been screened for TB upon hire. 3. During an interview on 12/16/24 beginning at 2:50 PM, the Clinical Manager indicated PCT 1’as personnel file failed to include a TB test was performed upon hire.”