Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 883828	(X3) Date Survey Completed 11/25/2025
Name of Provider or Supplier Anew Family Medical Pllc	Street Address, City, State 111 Front Street, Henderson, TN
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag	Summary Statement of Deficiencies (Each deficiency should be preceded by full regulatory or LSC identifying information)
E0000	An Emergency Preparedness survey was conducted on 9/23/2025 along with a recertification survey. The Rural Health Clinic (RHC) was found to have condition level deficiencies for non-compliance with the Emergency Preparedness (EP) regulations. The Front Desk (FD) personnel assisted by providing the RHC manuals for review until the arrival of the Officer Manager (OM). The entrance conference was held at 11:00 AM with the OM. The purpose of the visit was explained and a list of reuqest was provided. An exit conference was held on 9/23/2025, at 3:00 PM with the OM. She was informed of non-compliance with the EP regulations for RHC's and provided the opportunity to ask questions. Exit date amended to 11/25/25 per CMS guidance following federal government shutdown.
E0001	Establishment of the Emergency Program (EP) §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) [For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: [For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on facility policy review and interview, the Rural Health Clinic (RHC) failed to establish and maintain a comprehensive emergency preparedness program that meets the requirements. The findings included: 1. The Rural Health Clinic (RHC) failed to maintain an Emergency Preparedness (EP) plan that was reviewed and updated at least every 2 years. Refer to E-004 2. The RHC failed to maintain a documented community and facility-based risk assessment, utilizing an all-hazards approach. Refer to E-006 3. The RHC failed to maintain documentation of any reviews and updates to the Emergency Preparedness (EP) policies and procedures, based on review of the updated emergency plan at least every two years. Refer to E-0013 4. The RHC failed to develop, implement and update Emergency Preparedness (EP) policies and procedures to address a means to shelter in place for patients, staff, and volunteers who remain in the facility. Refer to E-0022 5. The RHC failed to update policies and procedures for maintaining confidentiality of medical records during an emergency. Refer to E-0023 6. The RHC failed to update policies and procedures for the use of volunteers during an emergency or other emergency staffing strategies. Refer to E-0024. 7. The RHC failed to maintain updated contact information for staff, physicians, volunteers and other health facilities as part of a written communication plan. Refer to E-0030 8. The RHC failed to update contact information for Federal, State, regional and local emergency preparedness officials every 2 years as part of a written communication plan. Refer to E-0031 9. The RHC failed to document a plan for an alternate and primary means to communicate with facility staff, Federal, State and local emergency management agencies. Refer to E-0032 10. The RHC failed to update a documented plan for sharing information and medical documentation for patients under the clinic's care, as necessary, with other health providers to maintain the continuity of care. Refer to E-0033 11. The RHC failed to develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in the regulations. The training and testing program must be reviewed and updated at least every 2 years. Refer to E-0036 12. The RHC failed to document initial training in Emergency Preparedness (EP) policies and procedures consistent with their roles in an emergency to all new and existing staff including volunteers, based on the clinic's risk assessment policies and procedures as well as the communication plan. Refer to E-0037 13. The RHC failed to document they had conducted exercises to test the emergency plan by participating in a full-scale exercise, community-based, every 2 years or conducting a facility-based functional exercise every 2 years. Refer to E- 0042
E0004	Develop EP Plan, Review and Update Annually §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on facility policy review and interview, the Rural Health Clinic (RHC) failed to maintain an Emergency Preparedness (EP) plan that was reviewed and updated at least every 2 years. The findings included: Review of the RHC's policy, "Emergency Preparedness Process", not dated revealed "The OFFICE MANAGER will be the Director of Emergency Preparedness... develop and maintain an emergency preparedness plan that will be reviewed and updated at least biennially..." During an interview on 9/23/2025, at 1:00 PM, the Office Manager (OM) verified the RHC failed to maintain periodic reviews that had been completed and updated with documented dates of the reviews of the emergency plan.
E0006	Plan Based on All Hazards Risk Assessment §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. [For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. [For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on interview, the Rural Health Clinic (RHC) failed to ensure a documented facility-based and community-based risk assessment was completed utilizing an all-hazards approach. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the RHC failed to maintain documented facility-based and community-based risk assessments that were completed utilizing an all-hazards approach.
E0013	Development of EP Policies and Procedures §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: Based on interview, the Rural Health Clinic (RHC) failed to maintain documentation of any reviews and updates to the Emergency Preparedness (EP) policies and procedures, based on review of the updated emergency plan at least every two years. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the RHC failed to maintain documentation of any reviews and updates of EP policies and procedures.
E0022	Policies/Procedures for Sheltering in Place §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: Based on interview, the Rural Health Clinic (RHC) failed to develop, implement and update Emergency Preparedness (EP) policies and procedures to address a means to shelter in place for patients, staff, and volunteers who remain in the facility. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified there was no documentation of updated EP policies and procedures to address a means to shelter in place for patients, staff, and volunteers who remain in the facility.
E0023	Policies/Procedures for Medical Documentation §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: Based on interview, the Rural Health Clinic (RHC) failed to update policies and procedures for maintaining confidentiality of medical records during an emergency. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the the RHC failed to maintain updated plans on how the facility would ensure patient records were secure and readily available to support continuity of care during an emergency.
E0024	Policies/Procedures-Volunteers and Staffing §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: Based on interview, the Rural Health Clinic (RHC) failed to update policies and procedures for the use of volunteers during an emergency or other emergency staffing strategies. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the Rural Health Clinic (RHC) failed to update policies and procedures for the use of volunteers during an emergency or other emergency staffing strategies.
E0030	Names and Contact Information §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: Based on interview, the Rural Health Clinic (RHC) failed to maintain updated contact information for staff, physicians, volunteers and other health facilities as part of a written communication plan. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the the RHC failed to maintain updated contact information for staff, physicians, volunteers and other health facilities as part of a written communication plan.
E0031	Emergency Officials Contact Information §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. [For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. [For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on interview, the Rural Health Clinic (RHC) failed to update contact information for Federal, State, regional and local emergency preparedness officials every 2 years as part of a written communication plan. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the RHC failed to maintain updated contact information for Federal, State, regional and local emergency preparedness officials as part of a written communication plan.
E0032	Primary/Alternate Means for Communication §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: Based on interview, the Rural Health Clinic (RHC) failed to document a plan for an alternate and primary means to communicate with facility staff, Federal, State and local emergency management agencies. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the RHC failed to reflect an updated documented plan for an alternate and primary means to communicate with clinic staff, Federal, State and local emergency management agencies, that best met their needs.
E0033	Methods for Sharing Information §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). [For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. [For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on interview, the Rural Health Clinic (RHC) failed to update a documented plan for sharing information and medical documentation for patients under the clinic's care, as necessary, with other health providers to maintain the continuity of care. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Officer Manager verified the Rural Health Clinic (RHC) failed to update a documented plan for sharing information and medical documentation for patients under the clinic's care, as necessary, with other health providers to maintain the continuity of care.
E0036	EP Training and Testing §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). [For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. [For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. [For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). [For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on interview, the rural health clinic (RHC) failed to develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in the regulations. The training and testing program must be reviewed and updated at least every 2 years. The findings included: During an interview on 9/23/2025, at 1:00 PM, the Office Manager verified the above the RHC failed to reflect updated staff training and testing every 2 years to evaluate the clinic's risk assessment.
E0037	EP Training Program §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). [For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. [For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. [For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. [For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. [For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. [For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. [For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. [For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on interview, the Rural Health Clinic (RHC failed to document initial training in Emergency Preparedness (EP) policies and procedures consistent with their roles in an emergency to all new and existing staff including volunteers, based on the clinic's risk assessment policies and procedures as well as the communication plan. The findings included: During an interview on 9/23/2025, at 11:00 PM, the Office Manager verified the above the RHC failed to document initial training to all employees on the Emergency Preparedness (EP) policies and procedures and ongoing training at least every two years. The clinic failed to document training for the EP program for all new employees. The clinic failed to maintain documentation of all emergency preparedness training and demonstrate staff knowledge of emergency procedures.
E0042	Integrated EP Program §416.54(e), §418.113(e), §441.184(e), §460.84(e), §482.15(f), §483.73(f), §483.475(e), §484.102(e), §485.68(e), §485.542(f), §485.625(f), §485.727(e), §485.920(e), §486.360(f), §491.12(e), §494.62(e). (e) [or (f)]Integrated healthcare systems. If a [facility] is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the [facility] may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must- [do all of the following:] (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. (2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered. (3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance [with the program]. (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following: (i) A documented community-based risk assessment, utilizing an all-hazards approach. (ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan, and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. This STANDARD is not met as evidenced by: Based on interview, the Rural Health Clinic (RHC) failed to document they had conducted exercises to test the emergency plan by participating in a full-scale exercise, community-based at least annually or conducting a facility-based functional exercise every 2 years. The findings included: During an interview on 9/23/2025, at 11:00 PM, the Office Manager verified the RHC failed to conduct exercises to test the emergency plan at least annually by participating in a full-scale exercise, community-based or conducted a facility-based functional exercise.
J0000	An unannounced recertification survey was completed on 9/23/2025 for the Conditions for Coverage for Rural Health Clinics. The entrance conerence was held at 11:00 AM with the OM. The purpose of the visit was explained, and a list of request was provided. An exit conference was held on 9/23/2025, at 3:00 PM with the OM. Deficiencies were cited under 42 CFR 491, Subpart A -Conditions of Participation for Rural Health Clinic. Condition level deficiency was cited under 491.11 Program Evaluation. Exit date amended to 11/25/25 per CMS guidance following federal government shutdown.
J0125	PROVISION OF SERVICES 491.9(b) Patient care policies. (3) The policies include: (iii) Rules for the storage, handling, and administration of drugs and biologicals. This STANDARD is not met as evidenced by: Based on observations and interview, the Rural Health Clinic (RHC) failed to maintain drugs according to standards set by the manufacturer, as a drug or biological is outdated after its expiration date. The findings included: 1. Observations on 9/23/2025 at 2:00 PM revealed the following medications were found in the unlocked emergency box: Nitro-spray (used for chest pain) - expired 6/20/2024; Nitrotab (used for chest pain)- expired 2024; Epi- pen (used for allergic reaction)- expired 2/2023; Glucose (treat low blood sugar)- expired 8/2025; Bayer aspirin (used to slow blood from clotting)- expired 4/2024; Diazepam (treats anxiety)- expired 1/2023. 2. During an interview on 9/23/2025 at 2:00PM, the Office Manager verified that the medications were expired and should be removed from the emergency box.
J0161	PROGRAM EVALUATION § 491.11 Program evaluation. (a) The clinic or center carries out, or arranges for, a biennial evaluation of its total program. (b) The evaluation includes review of: (1) The utilization of clinic or center services, including at least the number of patients served and the volume of services; (2) A representative sample of both active and closed clinical records; and (3) The clinic's or center's health care policies. (c) The purpose of the evaluation is to determine whether: (1) The utilization of services was appropriate; (2) The established policies were followed; and (3) Any changes are needed. This STANDARD is not met as evidenced by: Based on review of the Rural Health Clinic (RHC)'s Policy and Procedures and interview, the rural health clinic (RHC) failed to compete or arrange for, a biennial evaluation of its total program that included a review of policies and procedures, utilization of clinic or center services, including at least the number of patients served and the volume of services and a sample review of active and closed clinical records. The clinic was unable to provide documentation that the utilization of services was appropriate, the established policies were followed and any changes that were made or needed as a result of the evaluation. The findings included: Review of the Rural Health Clinic (RHC)'s Policy and Procedures revealed, "...Introduction to the Program Evaluation... In consideration of the above regulations a program evaluation committee was formed to evaluate the total rural health clinic program. This report reflects the proposed format of the program evaluation reports that will be performed biennially in the future. . ." Review of the Rural Health Clinic (RHC)'s Policy and Procedures and Evidence manuals revealed there was no documentation of program evaluation reports available for review. During an interview on 9/23/2025 at 1:00 PM, the Office Manager reported that evaluations were available for review.
J0162	PROGRAM EVALUATION 491.11(d) The clinic or center staff considers the findings of the evaluation and takes corrective action if necessary. This STANDARD is not met as evidenced by: Based on review of the Rural Health Clinic (RHC)'s Policy and Procedures, Evidence manuals and interview, the rural health clinic (RHC) failed to consider the findings of evaluations and take corrective action as needed. The findings included: Review of the Rural Health Clinic (RHC)'s Policy and Procedures, Evidence manuals and interview revealed there was no documentation of findings of evaluations and needed corrective actions. During an interview on 9/23/2025, at 1:00 PM, during the onsite survey, the Office Manager verified the RHC did not have documentation of a bi-annual program evaluation being completed that considered the findings and recommendations for change, if any, taken corrective actions as necessary, such as changes in policies or, with respect to clinical personnel, provision of additional training, changes in level of supervision, or even limiting or terminating clinical privileges.