Dci - Little Rock Renal Services LLC

“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: 44854 Based on review of the presented Emergency Preparedness Manual and interview, it was determined there was no evidence an emergency preparedness program was developed or implemented since the effectiveness of the Emergency Preparedness final rule on 11/15/16. The cumulative effects of the failed practices did not assure staff could react and respond to emergency events to protect the safety of all in-center hemodialysis patients, home hemodialysis and peritoneal dialysis patients and all staff and have the ability to collaborate with Federal, State and local emergency preparedness requirements. it was determined the facility failed to create and review policies and procedures on a biennial basis for disaster drills. The findings were: A. There was no evidence facility failed to created and reviewed policies and procedures on a biennial basis for disaster drills. See E0013 for details. B. There was no evidence a tracking system was developed to identify location of patients and staff during an emergency; there was no evidence policies and procedures were developed to address staff responsibilities and needs of the patients in the event of an emergency. See E0018 for details. C. There was no evidence policies and procedures were developed to address staff responsibilities and needs of the patients in the event of an emergency, identification of evacuation locations and primary and alternate means of communication with external sources for assistance. See E0020 for details. D. There was no evidence policies and procedures were developed to address sheltering in place for patients, staff and volunteers who remain in the facility based on the risk assessment and emergency plan. See E0022 for details. E. There was no evidence policies and procedures were developed to assure there was a system in place to preserver patient information, protect the confidentiality of patient information and secure and maintain availability of records. See E0023 for details. F. There was no evidence policies and procedures were developed for the use of volunteers in an emergency to facilitate the process of identifying the skill level of each volunteer; there was no evidence policies and procedures were developed to address strategies for staffing during and emergency event. See E0024 for details. G. There was no evidence policies and procedures were developed to address the arrangements with other facilities or providers to accept patients in the event of an emergency. See E0025 for details. H. There was no evidence policies and procedures were developed to address the facility’s role in emergencies where the President declares a major disaster or the Health and Human Service Secretary declares a public health emergency. See E0026 for details. I. There was no evidence policies and procedures were developed on how to obtain emergency medical assistance when needed. See E0027 for details. J. There was no evidence th facility developed an emergency preparedness communication plan on how the facility coordinates patient care within the facility, across healthcare providers, with state and local public health departments and how facility interacts and coordinates with emergency management agencies. See E0029 for details. K. There was no evidence of a communication plan that included contact information for staff, entities providing services under arrange, patients’ physicians, other (facilities) and volunteers. See E0030 for details. L. There was no evidence of a Communication Plan to include alternate means of communication in order to communicate with staff and emergency preparedness officials . See E0032 for details.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44854 Based on observation, policy review, and interview, it was determined the facility failed to ensure patients’ faces and vascular access sites were not covered and were visible to direct patient care staff. The failed practice did not allow the direct patient care staff to visualize the face and vascular access site to assure patient safety during the dialysis treatment. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census. See V407 for details.”

“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: 37145 Based on review of policies and procedures and interview, it was determined the facility failed to create and review policies and procedures on a biennial basis for disaster drills. The failed practice placed the patients, staff and visitor at risk of delay in response in the event of a disaster. The failed practice had the likelihood to affect all patients, staff and visitors. Findings follow: A. A request was made on 10/31/23 for a policy and procedure for conducting disaster drills. B. In an interview with the Nurse Educator on 11/01/23 at 2:12 PM, she confirmed the facility did not have a policy and procedure regarding conducting disaster drills.”

“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: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined the facility failed to develop policies and procedures for a patient tracking system for patients and staff during an emergency. The failed practice had the likelihood to affect all patients, staff, and visitors, because the patient’s and staff’s status and location in the event of transfer from the facility could not be accounted for. Findings included: A. Review of the Emergency Preparedness Manual on 11/01/23 showed there was no evidence of a policy and procedure for a tracking system for patients and staff during an emergency. B. The findings of A were confirmed in an interview with the Nurse Educator on 11/01/23 at 2:13 PM.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(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:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], 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 RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined there was no evidence the emergency preparedness plan included where patients and staff were to meet outside the facility during an evacuation of the building; staff responsibilities and needs of patients. The failed practice did not ensure the staff and patients were aware of where to meet outside the facility to assure everyone exited the building. The failed practice of not outlining staff responsibilities did not assure a smooth evacuation from the building. The failed practice of not knowing each patient’s needs during an evacuation had the likelihood for treatment complications to go untreated. The failed practice had the likelihood to affect all patients and all staff. The findings were: A. Review of the Emergency Preparedness Manual showed there was no evidence the emergency preparedness plan included where patients and staff were to meet outside the facility during an evacuation of the building; staff responsibilities and needs of patients. B. During an interview on 11/01/23 at 2:17 PM, the Clinic Manager confirmed the findings in A.”

“Policies/Procedures for Sheltering in Place CFR(s): §403.748(b)(4), §416.54(b)(3), §418.113(b)(6)(i), §441.184(b)(4), §460.84(b)(5), §482.15(b)(4), §483.73(b)(4), §483.475(b)(4), §485.68(b)(2), §485.542(b)(4), §485.625(b)(4), §485.727(b)(2), §485.920(b)(3), §491.12(b)(2), §494.62(b)(3). (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:] [(4) or (2),(3),(5),(6)] A means to shelter in place for patients, staff, and volunteers who remain in the [facility]. *[For Inpatient Hospices at §418.113(b):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (i) A means to shelter in place for patients, hospice employees who remain in the hospice. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined the facility failed to develop a policy and procedure which identified the area in the building staff and patients should shelter in place in the event of an emergency. The failed practice did not ensure the staff were aware of where to direct patients in the event of an emergency. The failed practice had the likelihood to affect the health and safety of all patients, staff and visitors. Findings included: A. Review of the Emergency Preparedness Manual on 11/01/23 showed there was no evidence of a policy and procedure which identified the area of the building designated as the shelter in place area in the event of an emergency. B. The findings of A were confirmed in an interview with the Nurse Educator on 11/01/23 at 2:17 PM.”

“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: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined there were no policies and procedures for medical documentation to ensure patient records were secure and readily available to support continuity of care during an emergency. The failed practice did not ensure the patients’ information was kept confidential, secure and readily available. The failed practice had the likelihood to affect al patients and staff. The findings were: A. Review of Disaster Manual showed there were no policies and procedures to assure the patients’ information was kept confidential, secure and readily available. B. During an interview on 11/01/23 at 2:17 PM, the Nurse Educator confirmed the findings in A.”

“Policies/Procedures-Volunteers and Staffing CFR(s): §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(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:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined there was no evidence the emergency preparedness plan included how to use licensed and non-licensed volunteers in an emergency or other emergency staffing strategy. The failed practice did not ensure volunteers would be screened for their skills and training to assure tasks were assigned according to their scope of practice or knowledge level. The failed practice had the likelihood to affect all patients on census, staff and visitors. The findings were: A. Review of the Emergency Preparedness Manual showed there was no evidence the emergency preparedness plan included how to use licensed and non-licensed volunteers in an emergency or other emergency staffing strategy. B. During an interview on 11/01/23 at 2:17 PM, the Nurse Educator confirmed the findings in A .”

“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: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined the facility failed to have a policy and procedure in place for the arrangement with other facilities to receive patients in the event of cessation of operations. The failed practice did not ensure the patient’s continued dialysis treatments in the event the facility ceased to operate. The failed practice had the-likelihood to affect all patients on census. Findings included: A. Review of the Emergency Preparedness Manual on 11/01/23 showed there was no evidence the facility addressed arrangements being made with other facilities to continue dialysis treatments in the event the facility ceased to operate. There was no evidence of agreements with other facilities for the transfer of patients in the event the facility ceased to operate. B. The findings were confirmed in an interview with the Nurse Educator on 11/01/23 at 2:18 PM.”

“Roles Under a Waiver Declared by Secretary CFR(s): §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.542(b)(7), §485.625(b)(8), §485.920(b)(7), §494.62(b)(7). [(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:] (8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. *[For RNHCIs at §403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined there was no evidence policies and procedures were developed to address the facility’s role in emergencies: 1. When the President declared a disaster under the Stafford Act; 2. When the Health and Human Services Secretary declares an emergency; and 3. What coordination efforts were required during a declared emergency in which a waiver of federal requirements under section 1135 of the Act had been granted by the Secretary. The failed practices did not ensure the coordination efforts with the local emergency preparedness department during a declared emergency. The failed practices had the likelihood to affect all patients on the census and staff. Findings included: A. Review of the Emergency Preparedness Manual on 11/01/23 showed there was no evidence policies and procedures were developed to address the facility’s role in emergencies when the President declares a disaster under the Stafford Act, when the Health and Human Services Secretary declares an emergency and what coordination efforts were required during a declared emergency in which a waiver of federal requirements under section 1135 of the Act had been granted by the Secretary. B. The findings of A were confirmed in an interview with the Nurse Educator on 11/01/23 at 2:18 PM.”

“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: 37145 Based on review of the presented Emergency Preparedness Manual and interview, it was determined there was no evidence policies and procedures were developed on how to obtain emergency medical assistance when needed. The failed practice did not ensure staff was aware of how to contact emergency medical personell in the event of a disaster. The failed practice had the likelihood to affect all patients, visitors and staff. The findings were: A. Review of the presented Emergency Preparedness Manual showed there was no evidence policies and procedures were developed on how to obtain emergency medical assistance when needed. B. During an interview on 11/01/23 at 2:18 PM, the Nurse Educator confirmed the findings in A.”

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined there was no evidence the facility developed and maintained an Emergency Preparedness Communication Plan and updated every two years. Failure to develop and maintain a communication plan did not ensure staff had access to current communication information in the event of a disaster or emergency to activate and implement the plan. The failed practice had the likelihood to affect all patients, staff, and the community in the event of a disaster or an emergency. Findings follow: A. Review of the Emergency Preparedness Manual on 11/01/23 showed no evidence the facility developed and maintained an Emergency Communication Plan and reviewed and updated it every two years. B. Findings in A were verified on 11/01/23 at 2:18 PM with the Nurse Educator.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual, it was determined the facility failed to include the name and contact information for staff, entities providing services under arrangement, physicians, and volunteers if utilized. Failure to include names and contact information for staff, contracted entities, physicians, other facilities, and volunteers did not ensure the facility was able to respond in a quick and coordinated manner in the event of a facility or community disaster or emergency. The failed practice had the likelihood to affect all patients, staff, and the community in the event of an emergency. Findings follow: A. Review of the Emergency Preparedness Manual on 11/01/23, did not show names and contact information for the facility staff, contracted entities, physicians, other facilities, and volunteers. B. On 11/01/23 at 2:18 PM the Nurse Educator verified findings in A.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 37145 Based on review of the Emergency Preparedness Manual and interview, it was determined the facility did not develop a Communication Plan to include alternate means of communication in order to communicate with staff and emergency preparedness officials in the event of the loss of normal communications systems. Failure to develop a Communication Plan did not allow quick and appropriate communication between facility staff and emergency preparedness staff in the event of a loss of normal communication systems. The failed practice had the likelihood to affect all patients, staff, and visitors in the event of an emergency. Findings follow: A. Review of the Emergency Preparedness Manual on 11/01/23, showed there was no policy in place addressing a plan for alternate communication in the event of a loss of the primary means of communication. B. On 11/01/23 at 2:18 PM, the Nurse Educator verified the finding in A.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44854 Based on observation and interview, it was determined four of four (Certified Clinical Hemodialysis Technician (CCHT) #1-#4) direct care staff wore their PPE (Personal Protective Equipment) from the treatment area (potentially contaminated) into the waiting room. The failed practice had the likelihood to promote the spread infection. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census, visitors and staff. The findings were: A. Review of the policy titled,”Personal Protective Equipment in the Dialysis Setting,” revised 05/15/18, showed PPE was to never be worn outside the patient care area. B. Observation on 10/30/23 at 9:20 AM showed CCHT #2-#3 was wearing their PPE worn in the treatment area into the waiting room to assist patients. C. Observation of shift change on 11/01/23 from 9:45 AM to 11:55 AM showed CCHT #1 - #4 wore their PPE from the treatment area into the waiting room to assist patients.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44854 Based on observation and interview, it was determined the facility failed to maintain the physical environment to ensure the safety of the patient and staff in that there was a build-up of dirt and grime on the floor throughout three of three (Treatment, Water and Storage) Rooms. There were areas throughout the Treatment, Water and Storage Room that the flooring was cracked and/or not sealed which did not allow for effective cleaning and disinfection. The failed practices did not ensure the safety, functionality, cleanliness, and integrity of all surfaces. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census and all staff. Findings follow. A. Observation on 10/30/23 from 8:40 AM to 10:00 AM showed: 1) The floor in the Treatment, Water and Storage Rooms had a build-up of trash, dirt, and grime. 2) There were areas throughout the Treatment, Water and Storage Rooms that were cracked and/or not sealed which did not allow for effective cleaning and disinfection. B. During the observation on 10/30/23 from 8:40 AM to 10:00 AM, Chief Biomed Technician confirmed the findings in A.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 37145 Based on observation, review of manufacturer’s directions for use and interview, it was determined one of one opened bottle of Assure Platinum glucose test strips were not dated as to when opened to assure they had not expired. The failed practice had the likelihood to affect the laboratory results and had the likelihood to affect any patient on which a blood glucose was drawn. Findings included: A. Review of Assure Platinum glucose test strips manufacturer’s directions for use “Storage and Handling,” showed to write the date on the vial label and use the test strips within 3 months of first opening the vial. B. Observation of the Assure Platinum test strips on 10/30/23 at 9:10 AM showed there was no date of opening to determine the test strip 3 month expiration date. C. During an interview on 10/30/23 at 9:10 AM, the Nurse Educator confirmed the findings in A and B. Based on review of the Phoenix Meter Daily Log, policy and procedure review and interview, it was determined the facility failed to perform daily verification of two of two (#1 and #2) Phoenix meters prior to use for nine (09/04/23, 09/09/23, 09/11/23, 09/15/23, 09/16/23, 09/29/23, 10/09/23, 10/17/23, and 10/18/23) of 61 (09/01/23 through 10/31/23) days of use. The failed practice did not ensure the Phoenix meters were reading within established parameters and placed the patients at risk of receiving a dialysate bath outside of established parameters. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census. Findings included: A.Review of the facility’s policy titled, “Phoenix Meter Disinfection, Calibration, Use and Storage,” showed: 1. Each dialysis machine’s conductivity, pH, and temperature must be tested before starting each dialysis treatment and documented on the flow sheet. 2. Connect the meter to the conductivity standard solution. Draw solution through the cell and expel it. Repeat this process. On the second draw observe the reading as the solution is flowing. Conductivity must read between 13.9 and 14.1 mS. Document reading in the Phoenix meter log. Rinse with RO (reverse osmosis) water 3. Connect the meter to the pH standard solution. Draw solution through the cell and expel it. Repeat this process. On the second draw, draw the syringe 1/3 to ½ full and observe the reading as the reading stabilizes. pH must read between 6.9 and 7.1 ph units. Document reading in the phoenix meter log. . B. In an interview on 11/01/23 at 11:10 AM, the Chief Bio Med Technician confirmed the findings in A. The Nurse Manager confirmed the dates where no results were documented on the log and stated, “If it wasn’t documented it probably wasn’t done.” C. Review of the Phoenix Meter Daily Log for Phoenix meters #1 and #2 from 9/01/23 to 10/31/23 showed there was no evidence the Phoenix meters were verified against a 14.0 mS conductivity and 7.0 pH standard solutions on (09/04/23, 09/09/23, 09/11/23, 09/15/23, 09/16/23, 09/29/23, 10/09/23, 10/17/23, and 10/18/23. The findings were confirmed in an interview with the Chief Bio Med Technician and the Nurse Manager on 11/01/23 at 11:10 AM. 44854 Based on observation, policy and procedure review and interview, it was determined 19 of 19 (Stations #1-#19) blood pressure (BP) cuffs were not maintained in that there was a build-up of threads in the hook portion of the Velcro which did not allow for effective cleaning and disinfection. The failed practice promoted the spread of infection from cross contamination. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census and staff. The findings included: A. Review of policy titled, “Routine Disinfection in the Hemodialysis Unit,” revised 02/25/2020, showed, “any reusable equipment taken into the dialysis station was considered contaminated and must be cleaned.” B. Observation of shift change on 11/01/23 from 9:30 AM to 12:15 PM showed BP cuffs at Station #1-#19 had a build-up of threads in the hook portion of the Velcro which did not allow for effective cleaning and disinfection between patients. C. During an interview on 11/01/23 at 1:45 PM, the Clinic Manager confirmed the findings in A.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 44854 Based on observation, policy review, and interview, it was determined the facility failed to ensure patients’ faces and vascular access sites were not covered and were visible to direct patient care staff. The failed practice did not allow the direct patient care staff to visualize the face and vascular access site to assure patient safety during the dialysis treatment. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients on census. The findings were: A. Review of policy titled “Management of Needle Dislodgement During Hemodialysis,” revised 02/25/21, showed the following: 1) Patients must be in view of staff during hemodialysis treatment to ensure patient safety. 2) If a patient chooses to use a blanket or other covering, their vascular access site, bloodline connections, and face must be visible throughout the treatment. B. Observation on 10/30/23 at 9:00 AM, showed the patient’s vascular access site at Stations #2, #13, #14, and #19 were not visible to the staff as the patient had vascular access site covered with a blanket. C. During the interview and observation on 10/30/23 at 9:30 AM, the Nurse Manager confirmed the findings in B. D. Observation on 11/01/23 at 10:30 AM, showed the patient’s vascular access site at Stations #3, #9, #15, #19, and #21 was not visible to the staff as the patient had a blanket over their vascular access site. E. During the interview and observation on 11/01/23 at 11:30 AM, the Nurse Manager confirmed the findings in D.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44854 Based on clinical record review, policy review, and interview, it was determined the Registered Nurse (RN) failed to assess the blood pressure (BP) for seven of seven (#1-#7) in-center hemodialysis patients. The failed practice placed patients at risk for complications related to un-managed blood pressure. The failed practice had the likelihood to affect all 100 in-center hemodialysis patients. The findings were: A. Review of policy titled, “Management of Hypertension during Hemodialysis,” revised 01/20/19, showed the following: 1) A licensed nurse must assess patient for hypertension. 2) Notify physician for further orders if symptomatic hypertension is noted during dialysis or BP is out of established parameters of Systolic BP (SBP) > (greater than) 180 mm Hg (millimeters of mercury) and Diastolic BP (DBP) > 100 mm Hg. B. Review of MAT (Measures Assessment Tool) showed the Euvolemic and pre- BP was to be <140/90 and post BP < 130/80 C. During an interview on 11/02/23 at 1:30 PM, the Nurse Educator confirmed findings in A and B. D. Patient #1 1) Review of six treatment flowsheets (TFS), five of six treatments, 10/16/23-10/27/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment systolic BP. BP Examples: a) 10/16/23 - Pretreatment 157/72 b) 10/18/23 - Pretreatment 161/73 c) 10/20/23 - Pretreatment 180/75 d) 10/23/23 - Pretreatment 167/83 e) 10/27/23 - Pretreatment 158/87 2) There was no evidence of an RN assessment for HTN (Hypertension). 3) During interview on 11/02/23 at 10:20 AM, the Clinic Manager confirmed the findings in D. E. Patient #2 1) Review of six treatment flowsheets (TFS), four of six treatments, 10/17/23-10/28/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 10/17/23 - Pretreatment 151/110 intradialytic, 156/100 and post treatment 152/101 b) 10/19/23 - Pretreatment 148/99 and post treatment 164/107 c) 10/21/23 - Pretreatment 150/99 intradialytic 152/101 and/or post treatment 155/96 d) 10/28/23 - Pretreatment 149/96 2) There was no evidence of an RN assessment for HTN (Hypertension). 3) During interview on 11/02/23 at 10:45 AM, the Clinic Manager confirmed the findings in E. F. Patient #3 1) Review of six treatment flowsheets (TFS), five of six treatments, 04/13/23-04/25/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 04/13/23 - Pretreatment 150/83, intradialytic 178/102, and post treatment 174/100 b) 04/1523 - Pretreatment 185/102, intradialytic 199/128, and post treatment 183/95 c) 04/18/23 - Pretreatment 185/103, intradialytic 189/107, and post treatment 198/113 d) 04/20/23 - Pretreatment 171/92, intradialytic 173/102, and post treatment 198/96 e) 04/22/23 - Pretreatment 218/119, intradialytic 206/123, and post treatment 221/108 e) 04/25/23 - Pretreatment 184/104, intradialytic 188/103, and post treatment 174/90 2) There was no evidence of an RN assessment for HTN (Hypertension). 3) During interview on 11/02/23 at 11:15 AM, the Clinic Manager confirmed the findings in F. G. Patient #4 1) Review of six treatment flowsheets (TFS), five of six treatments, 10/19/23-10/28/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 10/19/23 - Pretreatment 164/114, intradialytic 187/129, and post treatment 157/118 b) 10/21/23 - Pretreatment 164/114, intradialytic 171/103, and post treatment 156/102 c) 10/24/23 - Pretreatment 142/99, intradialytic 164/106, and post treatment 168/110 d) 10/26/23 - Intradialytic 160/109 and post treatment 144/77 e) 10/28/23 - Pretreatment 166/107, intradialytic 160/100, and post treatment 149/98 2) There was no evidence of an RN assessment for HTN (Hypertension). 3) During interview on 11/02/23 at 10:20 AM, the Clinic Manager confirmed the findings in G. H. Patient #5 1) Review of six treatment flowsheets (TFS), six of six treatments, 10/03/23-10/28/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 10/03/23- Pretreatment 169/124, intradialytic 163/119, and post treatment 163/121 b) 10/10/23- Intradialytic 141/111 and post treatment 149/118 c) 10/12/23- Pretreatment 166/119, intradialytic 150/112, and post treatment 166/125 d) 10/24/23- Pretreatment 160/110, intradialytic 151/103, and post treatment 166/125 e) 10/26/23- Pretreatment 153/110, intradialytic 149/102, and post treatment 147/103 f) 10/28/23 Pretreatment 157/109 and post treatment 144/94 2) There was no evidence of an RN assessment for HTN (Hypertension). 3) During interview on 11/02/23 at 11:30 AM, the Clinic Manager confirmed the findings in H. I. Patient #6 1) Review of six treatment flowsheets (TFS), six of six treatments, 10/10/23-10/26/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 10/10/23- Pretreatment 159/95, intradialytic 178/102, and post treatment 171/104 b) 10/14/23- Pretreatment 187/108, intradialytic 173/99, and post treatment 172/105 c) 10/19/23- Pretreatment 158/108, intradialytic 163/97, and post treatment 158/95 d) 10/21/23- Pretreatment 162/115, intradialytic 174/100, and post treatment 168/98 e) 10/24/23- Pretreatment 181/101, intradialytic 163/103, and post treatment 183/111 f) 10/26/23 Pretreatment 169/104, intradialytic 160/100, and post treatment 167/88 2) There was no evidence of an RN assessment for HTN (Hypertension) for review. 3) During interview on 11/02/23 at 10:20 AM, the Clinic Manager confirmed the findings in I. J. Patient #7 1) Review of six treatment flowsheets (TFS), six of six treatments, 09/23/23-10/14/23, showed no evidence the Registered Nurse (RN) assessed the patient’s Pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 9/23/23- Pretreatment 189/101, intradialytic 144/110, and post treatment 140/66 b) 09/28/23- Pretreatment 175/99, intradialytic 196/97, and post treatment 166/100 c) 10/03/23- Pretreatment 197/76, intradialytic 154/102, and post treatment 180/84 d) 10/07/23- Pretreatment 160/98, intradialytic 162/108, Pretreatment 153/110, intradialytic 149/102, and post treatment e) 10/10/23- Pretreatment 170/95 intradialytic 173/124, and post treatment 169/112 f) 10/14/23 Pretreatment 181/100, intradialytic 174/112, and post treatment 172/106 2) There was no evidence of an RN assessment for HTN (Hypertension) for review. 3) During interview on 11/02/23 at 11:40 AM, the Clinic Manager confirmed the findings in J.”

“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: 44854 Based on clinical record review, policy review, and interview, it was determined the Interdisciplinary Team (IDT) failed to modify the patient’s plan of care for seven of seven (#1-#7) patients when the patients’ blood pressure was outside established parameters. The failed practice placed patients at risk for complications related to un-managed blood pressure and fluid volume. The failed practice had likelihood to affect all 100 in-center hemodialysis. The findings were: A. Review of policy titled, “Management of Hypertension during Hemodialysis,” revised 01/20/19, showed the following: 1) A licensed nurse must assess patient for hypertension. 2) Notify physician for further orders if symptomatic hypertension is noted during dialysis or BP is out of established parameters of Systolic BP(SBP) > (greater than) 180 mm/Hg (millimeters of mercury and Diastolic BP (DBP) > 100 s mm/Hg. B. Review of MAT (Measures Assessment Tool) shows the Euvolemic and pre- BP was to be <140/90 and post BP < 130/80 C. During an interview on 11/02/23 at 1:30 PM, the Nurse Educator confirmed findings in A and B. D. Patient #1 1) Review of six treatment flowsheets (TFS), five of six treatments, 10/16/23-10/27/23, showed BP examples: a) 10/16/23-Pretreatment 157/72 b) 10/18/23- Pretreatment 161/73 c) 10/20/23- Pretreatment 180/75 d) 10/23/23- Pretreatment 167/83 e) 10/27/23- Pretreatment 158/87 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 10:20 AM, the Clinic Manager confirmed the findings in D. E. Patient #2 1) Review of six treatment flowsheets (TFS), four of six treatments, 10/17/23-10/28/23, showed BP Examples: a) 10/17/23-Pretreatment 151/110 intradialytic, 156/100 and post treatment 152/101 b) 10/19/23- Pretreatment 148/99 and post treatment 164/107 c) 10/21/23- Pretreatment 150/99 intradialytic 152/101 and/or post treatment 155/96 d) 10/28/23- Pretreatment 149/96 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 10:45 AM, the Clinic Manager confirmed the findings in E. F. Patient #3 1) Review of six treatment flowsheets (TFS), five of six treatments, 04/13/23-04/25/23, showed BP Examples: a) 04/13/23-Pretreatment 150/83, intradialytic 178/102, and post treatment 174/100 b) 04/1523- Pretreatment 185/102, intradialytic 199/128, and post treatment 183/95 c) 04/18/23- Pretreatment 185/103, intradialytic 189/107, and post treatment 198/113 d) 04/20/23- Pretreatment 171/92, intradialytic 173/102, and post treatment 198/96 e) 04/22/23- Pretreatment 218/119, intradialytic 206/123, and post treatment 221/108 e) 04/25/23- Pretreatment 184/104, intradialytic 188/103, and post treatment 174/90 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 11:15 AM, the Clinic Manager confirmed the findings in F. G. Patient #4 1) Review of six treatment flowsheets (TFS), five of six treatments, 10/19/23-10/28/23, showed BP Examples: a) 10/19/23- Pretreatment 164/114, intradialytic 187/129, and post treatment 157/118 b) 10/21/23- Pretreatment 164/114, intradialytic 171/103, and post treatment 156/102 c) 10/24/23- Pretreatment 142/99, intradialytic 164/106, and post treatment 168/110 d) 10/26/23- Intradialytic 160/109 and post treatment 144/77 e) 10/28/23- Pretreatment 166/107, intradialytic 160/100, and post treatment 149/98 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 11:30 AM, the Clinic Manager confirmed the findings in G. H. Patient #5 1) Review of six treatment flowsheets (TFS), six of six treatments, 10/03/23-10/28/23, showed BP Examples: a) 10/03/23- Pretreatment 169/124, intradialytic 163/119, and post treatment 163/121 b) 10/10/23- Intradialytic 141/111 and post treatment 149/118 c) 10/12/23- Pretreatment 166/119, intradialytic 150/112, and post treatment 166/125 d) 10/24/23- Pretreatment 160/110, intradialytic 151/103, and post treatment 166/125 e) 10/26/23- Pretreatment 153/110, intradialytic 149/102, and post treatment 147/103 f) 10/28/23 Pretreatment 157/109 and post treatment 144/94 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 11:40 AM, the Clinic Manager confirmed the findings in H. I. Patient #6 1) Review of six treatment flowsheets (TFS), six of six treatments, 10/10/23-10/26/23, showed BP Examples: a) 10/10/23- Pretreatment 159/95, intradialytic 178/102, and post treatment 171/104 b) 10/14/23- Pretreatment 187/108, intradialytic 173/99, and post treatment 172/105 c) 10/19/23- Pretreatment 158/108, intradialytic 163/97, and post treatment 158/95 d) 10/21/23- Pretreatment 162/115, intradialytic 174/100, and post treatment 168/98 e) 10/24/23- Pretreatment 181/101, intradialytic 163/103, and post treatment 183/111 f) 10/26/23 Pretreatment 169/104, intradialytic 160/100, and post treatment 167/88 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 12:00 PM, the Clinic Manager confirmed the findings in I. J. Patient #7 1) Review of six treatment flowsheets (TFS), six of six treatments, 09/23/23-10/14/23, showed BP Examples: a) 9/23/23- Pretreatment 189/101, intradialytic 144/110, and post treatment 140/66 b) 09/28/23- Pretreatment 175/99, intradialytic 196/97, and post treatment 166/100 c) 10/03/23- Pretreatment 197/76, intradialytic 154/102, and post treatment 180/84 d) 10/07/23- Pretreatment 160/98, intradialytic 162/108, Pretreatment 153/110, intradialytic 149/102, and post treatment e) 10/10/23- Pretreatment 170/95 intradialytic 173/124, and post treatment 169/112 f) 10/14/23 Pretreatment 181/100, intradialytic 174/112, and post treatment 172/106 2) There was no evidence the IDT modified the POC (Plan of Care) related to the patient’s BPs outside of established parameters. 3) During interview on 11/02/23 at 12:40 M, the Clinic Manager confirmed the findings in J.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 37145 Based on review of Facility Quality Management Meetings and interview, it was determined in six of six (May, June, July, August, September, October 2023) months, there was no evidence the Interdisciplinary Team (IDT) selected Blood Pressure (BP) and Fluid management for development of measures, performance of root cause analysis and implementation of an action plan to improve outcomes for in-center hemodialysis. The failed practice did not assure outcomes were improved with sustainability of the outcomes. The failed practice had the likelihood to affect all 100 In-Center hemodialysis patients. The findings were: A. Review of the Facility Quality Management Meetings from May 2023 to October 2023 showed there was no evidence the IDT selected BP and Fluid management for development of measures, performance of root cause analysis and implementation of an action plan to improve outcomes for in-center hemodialysis. B. In an interview with the Nurse Educator on 11/01/23 at 8:30 AM, the findings in A were confirmed.”

“QAPI-INDICATOR-CKD-MBD CFR(s): 494.110(a)(2)(iii) The program must include, but not be limited to, the following: (iii) Mineral metabolism and renal bone disease. This Standard is not met as evidenced by: 37145 Based on review of Facility Quality Management Meetings and interview, it the Interdisciplinary Team (IDT) failed to analyze and adjust their action plans for in-center hemodialysis for six of six (April through September 2023) months reviewed for phosphorus. The failed practice did not allow the Interdisciplinary Team to implement new corrective action plans to improve the outcomes for phosphorus. The failed practice had the potential to affect all 100 in-center hemodialysis patients on census. The findings follow: A. Review of the Facility Quality Management Meetings for April 2023 showed the following: 1. The facility goal of under 14.3 % of patients with phosphorus level greater than 7.0 was not achieved. 2. The percentage of patients with a phosphorus level less than 7.0 was 50.0 %. 3. Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4. Problem: There are patients that have phosphorous levels above 7.0. 5. New Action Step: Assessed psychosocial factors that contribute to adherence to diet; medication and treatment prescription (Registered Dietitian) reinforced the importance of adherence to diet; medication and treatment prescription B. Review of the Facility Quality Management Meetings for May 2023 showed the following: 1. The facility goal of under 14.3 % of patients with phosphorus level greater than 7.0 was not achieved. 2. The percentage of patients with a phosphorus level less than 7.0 was 58 %. 3. Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4. Problem: There are patients that have phosphorous levels above or equal to 7.0. 5. New Action Step: RD (Registered Dietitian) reinforced the importance of adherence to diet; medication and treatment prescription. C. Review of the Facility Quality Management Meetings for June 2023 showed the following: 1) The Incenter-Hemo Phosphorous score was 58.7 %; the facility goal of 60% was not achieved. 2) The facility goal of less than 14.3 % of patients with a phosphorous level greater than 7.0 was not achieved. 3) Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4) Problem: There are patients that have phosphorous levels above or equal to 7.0. . 5) New Action Step: RD reviewed the food items to avoid and the importance of taking the binders with every meal and snack. D. Review of Facility Quality Management Meetings for July 2023 showed the following: 1. The Incenter-Hemo Phosphorous score was 58.0 %; the facility goal of 60% was not achieved. 2) The facility goal of less than 14.3 % of patients with a phosphorous level greater than 7.0 was not achieved. 3) Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4) Problem: There are patients that have phosphorous levels above or equal to 7.0. . 5) New Action Step: RD reviewed the food items to avoid and the importance of taking the binders with every meal and snack. E.Review of the Facility Quality Management Meetings for August 2023 showed the following: 1. The Incenter-Hemo Phosphorous score was 57.8 %; the facility goal of 60% was not achieved. 2 The facility goal of less than 14.3 % of patients with a phosphorous level less than 7.0 was achieved. 3) Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4) Problem: There are patients that have phosphorous levels above or equal to 7.0. 5) New Action Step: Patients were reminded of the importance of taking their binders with every meal and snack. F. Review of the Facility Quality Management Meetings for September 2023 showed the following: 1. The Incenter-Hemo Phosphorous score was 54.3 %; the facility goal of 60% was not achieved. 2 The facility goal of less than 14.3 % of patients with a phosphorous level less than 7.0 was achieved. 3. Process Improvement Goal(s): Goal of 60 % of patients with phosphorus equal to or less than 7.0 was not achieved. 4. Problem: There percentage of patients with a phosphorous level between 2.6 and 5.5 did not meet the goal. 5. New Action Step: Reinforced the importance of following the renal diet order. G. There was no evidence the Interdisciplinary Team analyzed the Actions and Interventions to determine if the actions were effective to determine if new Actions and Interventions were to be implemented. There was no evidence the Interdisciplinary Team adjusted the Action and Interventions to improve phosphorus outcomes. H. The findings of A through G were confirmed in an interview with the RD on 11/01/23 at 3:00 PM.”