Fresenius Medical Care - Madison Capitol

“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: 29963 Based on record review and interview, the facility failed to have an updated comprehensive Emergency Preparedness plan in an all-inclusive format for facility staff to easliy reference in an emergent situation that included the required emergency preparedness policies and procedures related to identified hazards specific to location of facility; failed to have a policy to track the location of staff and patients; failed to have a documented transfer agreement with another facility; failed to have a policy on how to contact emergency medical services; failed to ensure supplies in the evacuation bag were not expired; failed to have a policy with a communication plan that included the ability to provide the local authorities regarding occupancy information and facility needs; and failed to complete one full scale community-based exercise within past two years in 1 of 1 Emergency Preparedness program reviewed. Findings include: Facility staff failed to maintain an all-inclusive format for facility staff to easily reference in an emergent situation related to facility risk assessment with identified hazards related to specific location of facility. See Tag 0013 Facility staff failed to provide a policy for a system to track the location of on-duty staff, sheltered patients, and or relocated patients. See Tag 0018 Facility staff failed to provide a transfer agreement with another facility to assume patient care. See Tag 0025 Facility staff failed to provide a policy that directed staff on how to contact emergency medical services. See Tag 0027 Facility staff failed to ensure supplies in the evacuation bag were not expired. See Tag 0028 Facility staff failed to complete one full scale community-based exercise within the past two years. See Tag 0039 The cumulative effect of these failures has the potential to affect all staff who work at this facility and all patients who receive care at this facility including the 103 in-center dialysis patients and 18 home program dialysis on census at the time of the survey.”

“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: 29963 Based on record review and interview, the facility failed to have policies and procedures which addressed actions to take in emergency situations that were identified as hazards in the facility risk assessment related to specific location of facility in 1 of 1 Emergency Preparedness Plan. Findings include: A review of facility policy #25907 Version 11, titled, “Guidelines for Emergency Preparedness” dated 07/03/2023 revealed, “The purpose of this policy is to provide guidelines for emergency preparedness on In-Center and Home Therapies to help protect patients and staff in emergency situations.” During a review of facility Emergency Preparedness Binder on 07/24/2024 at 9:00 AM, there was no policy in the binder to provide directives to the staff in an emergency situation. During an interview with Clinic Manager A on 07/24/2024 at 9:15 AM, when asked about missing elements in the emergency preparedness binder, Clinic Manager A was not able to present the policies which addressed actions to take in emergency situations that were identified as risks and stated, “I agree, I do not have policies that address the risks that were identified.””

“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: 29963 Based on record review and interview, the facility staff failed to provide a policy for a system to track the location of on-duty staff, sheltered patients, and or relocated patients in 1 of 1 Emergency Preparedness Plan. Findings include: A review of facility policy #25907 Version 11, titled, “Guidelines for Emergency Preparedness” dated 07/03/2023 revealed, “The purpose of this policy is to provide guidelines for emergency preparedness on In-Center and Home Therapies to help protect patients and staff in emergency situations... Tracking Patients and Staff: During an emergency, if there is an interruption in service due to facility closure, the facility is responsible for tracking staff and patients...” During a review of facility Emergency Preparedness Binder on 07/24/2024 at 9:00 AM, there was no policy in the binder to provide directives to the staff on the proper procedure to complete safe tracking of patients and staff during an emergency situation. During an interview with Clinic Manager A on 07/24/2024 at 9:15 AM, when asked about a system to track the location of the staff and patients, Clinical Manager A stated, “I do not have a policy.””

“Arrangement with Other Facilities CFR(s): §403.748(b)(7), §418.113(b)(5), §441.184(b)(7), §460.84(b)(8), §482.15(b)(7), §483.73(b)(7), §483.475(b)(7), §485.625(b)(7), §485.920(b)(6), §494.62(b)(6). [(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:] *[For Hospices at §418.113(b), PRFTs at §441.184,(b) Hospitals at §482.15(b), and LTC Facilities at §483.73(b):] Policies and procedures. (7) [or (5)] The development of arrangements with other [facilities] [and] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For PACE at §460.84(b), ICF/IIDs at §483.475(b), CAHs at §486.625(b), CMHCs at §485.920(b) and ESRD Facilities at §494.62(b):] Policies and procedures. (7) [or (6), (8)] The development of arrangements with other [facilities] [or] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For RNHCIs at §403.748(b):] Policies and procedures. (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of non-medical services to RNHCI patients. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to provide a transfer agreement with another facility to assume patient care in 1 of 1 Emergency Preparedness Plan. Findings include: A review of facility policy #25907 Version 11, titled, “Guidelines for Emergency Preparedness” dated 07/03/2023 revealed, “The purpose of this policy is to provide guidelines for emergency preparedness on In-Center and Home Therapies to help protect patients and staff in emergency situations... Continuity of Care: Fresenius Kidney Care has an emergency back up agreement in place. FKC patients may need to dialyze at a different facility in an emergency situation... The Director of Operations must complete the Dialysis Unit Emergency Back Up Agreement- Addendum Form, identifying alternative back-up facilities in case of an emergency...” During a review of facility Emergency Preparedness Binder on 07/24/2024 at 9:00 AM, there was no dialysis unit emergency back up agreement. During an interview with Clinic Manager A on 07/24/2024 at 9:15 AM, when asked about the dialysis unit back up agreement, Clinic Manager A stated, “I am sure we have one, but I do not have a copy to provide to you.””

“Dialysis Emergency Medical System Assistance CFR(s): §494.62(b)(8) 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:] (8) How emergency medical system assistance can be obtained when needed. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to provide a policy on how the staff would obtain an emergency medical services assistance when needed in 1 of 1 Emergency Preparedness Plan. Findings include: A review of facility policy #25907 Version 11, titled, “Guidelines for Emergency Preparedness” dated 07/03/2023 revealed, “The purpose of this policy is to provide guidelines for emergency preparedness on In-Center and Home Therapies to help protect patients and staff in emergency situations...” During a review of facility Emergency Preparedness Binder on 07/24/2024 at 9:00 AM, there was no policy in the binder to provide directives to the staff on the proper procedure to obtain an emergency medical system during an emergency situation. During an interview with Clinic Manager A on 07/24/2024 at 9:15 AM, when asked about the policy for obtaining emergency medical assistance, Clinic Manager A stated, “I do not have a policy.””

“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: 43264 Based on record review, interview and observation, the facility failed to ensure all staff are aware of the location of emergency supplies and equipment and failed to replace expired emergency supplies and equipment in 1 of 1 evacuation kits observed in total sample of 2 emergency equipment/supply kits observed. Findings Include: A review of facility policy, titled “Emergency Medications, Equipment and Supplies”, dated 05/01/2023, revealed: “...Emergency Evacuation Box...All staff must know the location of the evacuation box...Items approaching expiration must be reordered and replaced prior to the actual expiration date...” During an interview with Registered Nurse (RN) H on 07/24/2024 at 10:10 AM, when asked where the emergency evacuation kit was located, RN H stated “I don’t know.” During an interview with Patient Care Technician (PCT) B on 07/24/2024 at 10:11 AM, PCT B stated she was “not sure” where the emergency evacuation kit was located as it was recently re-stocked and moved. During observation of the emergency evacuation kit on 07/24/2024 at 10:15 AM, observed two packages of “Masterguard Plus Hemodialysis Fistula Needle Sets” with an expiration date of 06/30/2024 and one box of “XL (extra large) Latex Free-Powder Free Gloves” with an expiration date of 03/24/2024. During an interview with Administration Assistant U on 07/24/2024 at 11:03 AM, Administration Assistant U confirmed that the two packages of fistula needle sets and one box of XL gloves in the emergency evacuation kit were expired and should have been replaced prior to their expiration date.”

“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: 29963 Based on record review and interview, the facility staff failed to complete one full scale community-based exercise, or a facility based functional exercise every two years for 1 of 1 Emergency Preparedness Plan. Findings include: A review of facility policy #25907 Version 11, titled, “Guidelines for Emergency Preparedness” dated 07/03/2023 revealed, “Annually, each facility MUST participate in a community-based disaster drill. If unable to participate document who you contacted in the community and why the clinic was unable to participate on the Facility Specific Disaster Safety Plan form. If the EOC (Emergency Operations Center) or similar agency has not performed a community-based drill or it was missed for that particular year, the DO (Director of Operations) should coordinate a dialysis facility area-based drill...” During a review of facility Emergency Preparedness Binder on 07/24/2024 at 9:00 AM, there was no evidence of a full-scale community-based exercise or a facility-based exercise for 2022, 2023, or 2024. During an interview with Clinic Manager A on 07/24/2024 at 9:15 AM, when asked about documentation for the full-scale exercise, Clinic Manger A stated, “I do not have any documentation of a full-scale community-based exercise or a facility based exercise for 2022, 2023, or 2024.””

“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: 47413 Based on record review, observation and interview, the facility staff failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 1 of 2 patients (Patient #20) observed holding access sites in a total universe of 16 observations of patient care. Findings Include: A review of the facility’s policy titled, “Termination of Treatment Using an Arteriovenous Fistula... Version 5” last published 02/07/2022 revealed, “... Perform hand hygiene... prior to leaving the patient station...” During an observation on 07/24/2024 starting at 9:03 AM, Patient #20 was holding pressure on their access site with their gloved hand. Once hemostasis was achieved, Patient #20 removed the glove and exited the facility. No hand hygiene was completed by Patient #20 or offered to Patient #20. During an interview on 07/24/2024 at 12:54 PM with Clinical Manager A, when asked if patients should perform hand hygiene after holding their access site prior to exiting the facility, Clinical Manager A stated, “Yes.””

“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: 47413 Based on observation, record review and interview, the facility staff failed to complete disinfection of all equipment in the dialysis station for 1 of 1 dialysis stations (Station #10, Pod 5, previously Patient #21) observed being cleaned in a total of 16 observations. Findings Include: A review of the facility policy titled, “Cleaning and Disinfecting the Dialysis Station Version 14” published 09/05/2023 revealed, “... Definition: Dialysis Station: .... Dialysis machine/cycler and attachments such as IV pole... Procedure: 4. Clean all surfaces... While wiping, remember to wipe all surfaces of the machine including... IV pole...” During an observation on 07/23/2024 at 11:20 AM, PCT (Patient Care Technician) F was observed cleaning the dialysis machine at Station #10 Pod 5, after Patient #21 vacated the station following treatment and did not wipe down the hooks on the top of the IV pole. During an interview on 07/24/2024 at 12:53 PM, the observation findings were discussed with Clinical Manager A who stated that cleaning the hooks on the IV pole are part of cleaning the dialysis machine.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 43037 Based on record review, observation and interview, the facility failed to ensure open multi-dose vials were stored properly in 9 of 9 opened vials and failed to ensure medications were not expired in 4 of 9 opened multi-dose vials in a total of 1 medication storage location observed. Findings include: A review of facility policy, “Expiration Dates Sterile Supplies” Version 1 revealed, “...This policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date...Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached their expiration date...” A policy regarding expiration and storage of the medication was requested, but not received. An observation of the medication room refrigerator was conducted on 7/23/2024 at 3:19 PM with Registered Nurse (RN) Q in attendance. 9 opened multi-dose vials of Heparin (anticoagulant medication) were observed in the refrigerator. No full, unopened vials of Heparin were observed in the refrigerator. Dates on the opened vials were 5/24/24, 6/6/2024 x 2 vials, 6/14/2024, 6/29/24, 7/1/24, 7/4/24, 7/18/24 and 1 vial with an illegible date. All vials were marked with a manufacturer’s notation that read, “Do not refrigerate.” When RN Q was asked how long the vials should be kept, RN Q stated, “30 days.” RN Q then stated, “These shouldn’t even be in here.” RN Q stated that facility nursing practice is to date the vials upon opening them for the first time. An interview was conducted with Clinical Manager A on 7/23/2024 at 5:15 PM. When asked why the Heparin was stored in the refrigerator, Manager A stated that the Heparin currently in use is from a different manufacturer than in the past and the “old” Heparin needed to be stored in the refrigerator. When asked how long multi-dose vials of Heparin can be kept once opened, Manager A stated, “28 days.””

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 43037 Based on record review and interview, facility staff failed to document batches of mixed bicarbonate and post-mixing conductivity testing per policy in 1 of 1 bicarbonate mixing system. Findings include: A review of facility policy “Bicarbonate Concentrate Mixing” Version 8 revealed, “...Bicarbonate concentrate quality assurance will include verification of the following:...The facility must perform bicarbonate concentrate conductivity testing according to “Bicarbonate Concentrate Conductivity Testing” policy prior to using...Results of bicarbonate concentrate mixing, testing and quality assurance will be documented in the computerized Maintenance Management System (CMMS)...” A review of Clinical Logs for the past 3 months revealed documentation of mixing of “additional” batches (second batch of the day) of bicarbonate (bicarb) and post-mixing conductivity testing were missing on 4/5/24, 4/6/24, 4/11/24, 4/12/24, 4/20/24, 5/2/24, 5/4/24, 5/7/24, 5/11/24, 5/25/24, 6/1/24, 6/3/24, 6/4/24, 6/7/24, 6/8/24, 6/10/24, 6/11/24, 6/12/24, 6/14/24, 6/15/24, 6/22/24 and 6/29/24. During an interview on 7/23/2024 at 5:00 PM, the log results were discussed with and confirmed by Area Technical Operations Manger I and Biomedical Technician J. When asked how many batches of bicarbonate are mixed daily, Manager I stated, “Two.” During an interview on 7/23/2024 at 5:15 PM, the log results were discussed with and confirmed by Clinical Manager A and Operations Director D. When asked what expectations of documentation of “additional” batches of bicarbonate mixing and conductivity testing were, Manager A and Director D stated that the log should be completed each time a batch is made.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 43037 Based on observation and interview staff failed to maintain a safe and sanitary environment free from potential infection risk in 1 of 1 treatment area in a total of 1 treatment area observed. Findings Include: A review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines Version 7” last published 07/01/2024 revealed, “... The purpose of this policy is to provide guidance for (Facility system name) staff on preventing the spread of infectious disease and maintaining a clean, safe and aesthetically pleasant environment for patients, staff and visitors...All areas must be kept clean and organized, including but not limited to treatment areas...” Observation on 07/23/2024 starting at 11:15 AM revealed the following findings: · Treatment chairs at stations 14 and 25 had cracked vinyl on the front of the headrest exposing the internal fabric/stuffing of the chairs. · Wallpaper in multiple locations on the treatment floor were peeling or torn back from the wall surface. · Floor molding was pulled away from the wall and/or broken off in multiple areas, exposing the subfloor or particle board wall behind it. · Countertop edging was broken or loose in multiple areas exposing the bare particle board underneath. Some areas were taped over to hold countertop laminate in place. · Ceramic tiles were broken or missing in multiple areas leaving sharp edges and exposed wall. · Painted surfaces at Isolation stations A, B and C were chipped along framework and doorways. · Countertop at the Dirty sink area displayed evidence of bleach erosion leaving a rough and pitted surface of the countertop with rust colored staining at the edge of the sink. · The cabinet space under the dirty sink had rust colored staining along with the presence of crusty debris. Operations Director D, Clinical Manager A and Area Technical Operations Manager I were interviewed during a tour of the treatment floor environmental issues on 7/24/2024 at 2:15 PM. All staff present agreed that the environmental issues posed safety and infection control risks. A policy regarding physical plant environment was requested. Director D, Manager A and Operations Manager I were not able to locate one. Manager A stated, “We don’t have one.””

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 43037 Based on record review and interview, facility staff failed to ensure patients had updated goal dates in their plans of care in 4 of 10 patients (Patients #4, 6, 8 & 10) in a sample of 10 medical records reviewed. 29963 Findings Include: A review of the facility’s policy #45283 Version 6 titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/2023 revealed, “The Plan of Care must include measurable and expected outcomes and an estimated timetable to achieve these outcomes.” A review of the facility’s policy titled, “Medical Record Documentation Standards Version 4” last published 02/05/2024 revealed, “... The dialysis facility must monitor and maintain complete, accurate, and accessible records on all patients...” A review of Patient #4’s medical record revealed the following “Plan of Care; Areas of Focus” listed as: “Albumin Management” with an expired “Goal Date” of 5/31/2024. A review of Patient #6’s medical record revealed the following “Plan of Care; Areas of Focus” listed as: “Mineral Metabolism/Bone Disease” “Body Weight” and “Albumin Management” all with expired “Goal Dates” of 2/29/2024. A review of Patient #8’s medical record revealed the following “Plan of Care; Areas of Focus” listed as: “Patient will verbalize decreased pain levels” with an expired “Goal Date” of 02/29/2024. “Patient will not be hospitalized”, “Change in Mental Status; Identify cause and provide treatment” and “Vaccinate Patient” all with expired “Goal Dates” of 02/14/2024. A review of Patient #10’s medical record revealed the following “Plan of Care; Areas of Focus” listed as: “Maintain PD catheter/No HD catheter”,”Kt/V>= 1.7 (PD)”, “Patient will not be hospitalized”, “Patient will verbalize decreased pain levels”, “Prevent falls or minimize injuries related to falls”, “Vaccinate Patient”, “Patient/family will verbalize understanding of treatment options”, “Patient’s blood sugar and A1C results will be within normal range or as specified by the physician”, “Achieve BP Control as specified by the patient’s physician”, and “HGB 10-12 g/dl” all with expired “Goal Dates”of 05/31/2024. During interviews on 07/24/2024 at 8:50 AM and at 11:50 AM, the following medical record findings were discussed with and confirmed by Clinical Manager A who stated, “Those goal dates should be updated. Yes, those care plan dates are expired.””

“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: 29963 Based on record review and interview, the facility staff failed to ensure blood pressure readings outside of ordered parameters were reported to the nurse for further assessment per policy, in 2 of 8 (Patient #1 & 8) in-center medical records reviewed and failed to ensure intradialytic blood pressure monitoring was completed per facility policy in 4 of 8 in-center medical records reviewed (Patient #1, 4, 6 & 8) in a total universe of 10 medical records reviewed. Findings Include: A review of the facility’s policy titled, “Nursing Supervision and Delegation Version 6” last published 11/06/2023 revealed, “... Guidelines for PCT (Patient Care Technician)...: When to Refer a Patient to the Team Leader/Charge Nurse for Further Assessment: ... Blood Pressure: A systolic blood pressure greater than 180 mm/Hg (millimeters of mercury) and / or diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the treatment...” A review of the facility’s policy titled, “Patient Assessment and Monitoring Version 4” last published 05/01/2023 revealed, “... During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes... Blood Pressure: Report to the nurse: Systolic blood pressures greater than 180 mm/Hg; Diastolic blood pressure greater than 100 mm/Hg: Blood Pressure less than or equal to 100 mm/hg systolic...” Examples of Blood Pressures Out of Physician ordered Parameters: A review of Patient #1’s treatment sheet dated 07/05/2024 revealed PCT R documented at 2:21 PM a blood pressure of 81/34 and 95/57 and at 3:37 PM a blood pressure of 90/40. There was no documentation of blood pressure being noted as outside of parameters, notification of the Registered Nurse or that the Registered Nurse documented and assessed for Patient #1. A review of Patient #8’s treatment sheet dated 07/18/2024 revealed PCT C documented at 4:01 PM a blood pressure of 147/112 and at 4:33 PM a blood pressure of 158/143. There was no documentation of blood pressure being noted as outside of parameters, notification of the Registered Nurse, or that the Registered Nurse assessed Patient #8 as a result. During an interview on 07/24/2024 at 11:40 AM, the medical record review findings were discussed with and confirmed by Clinical Manager A who stated, “That must have been an incorrect blood pressure, the patient should have been recuffed and rechecked, or the nurse should have been notified.” Examples of missing intradialytic blood pressures: A review of Patient #1’s medical record revealed on the treatment sheet dated 07/17/2024, an intradialytic blood pressure was documented at 3:30 PM and then again at 4:32 PM (62 minutes later). A review of Patient #4’s medical record revealed on the treatment sheet dated 7/10/2024, an intradialytic blood pressure was documented at 2:00 PM and then again at 3:08 PM (68 minutes later). A review of Patient #6’s medical record revealed on the treatment sheet dated 7/15/2024, an intradialytic blood pressure was documented at 5:55 AM and then again at 7:04 AM (69 minutes later). On the treatment sheet dated 7/22/2024, an intradialytic blood pressure was documented at 6:08 AM and then again at 7:02 AM (54 minutes later). A review of Patient #8’s medical record revealed on the treatment sheet dated 07/16/2024, an intradialytic blood pressure was documented at 2:31 PM and then again at 4:49 PM (108 minutes later). During an interview on 07/24/2024 at 11:40 AM, the medical record findings were discussed with and confirmed by Clinical Manager A who stated, “Blood pressures need to be documented a minimum of every 30 minutes per policy, not to exceed 45 minutes.””

“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: 29963 47413 Based on record review and interview, the facility staff failed to complete documentation of why physician orders were not followed for prescribed blood flow rates 3 of 8 in-center medical records reviewed (Patients #1 5, 8) in a total universe of 10 medical records reviewed. Findings Include: A review of the facility’s policy #45284 Version 4 titled, “Patient Assessment and Monitoring” last published 05/01/2023 revealed, “... Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed flow rate...” Example of Blood Flow Rate (BFR) not met: A review of Patient #1’s medical record revealed a physician order for the BFR of 450 mL/min (milliliters per minute). The treatment sheet dated 07/12/2024 revealed the BFR was set at 350 mL/min for the part of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. The treatment sheet dated 07/15/2024 revealed the BFR was set at 330 mL/min for the part of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. The treatment sheet dated 07/17/2024 revealed the BFR was set at 360 mL/min for the part of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. A review of Patient #5’s medical record revealed a physician order for the BFR of 450 mL/min. The treatment sheet dated 07/09/2024 revealed the BFR was set at 400 mL/min for part of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. A review of Patient #8’s medical record revealed a physician order for the blood flow rate of 450 mL/min. The treatment sheet dated 07/09/2024 revealed the BFR was set at 400 mL/min for part of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. During an interview on 07/24/2024 at 11:50 AM, the medical record findings were discussed with and confirmed by Clinical Manager A who stated, “They need to be documenting if the blood flow rate is not at the prescribed rate.””