Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 1, 2024 and completed offsite on October 2, 2024, BRMC Family Practice was identified to have had the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
491.12(d)(2) STANDARD
EP Testing Requirements
Name - Component - 00
§416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2).
*[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]:
(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.
*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.
*[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.
*[For PACE at §460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
*[For LTC Facilities at §483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.
*[For ICF/IIDs at §483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
*[For HHAs at §484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
*[For OPOs at §486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.
*[ RNCHIs at §403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
Observations:
Based on document review and employee interviews (EMP), it was determined the facility failed to provide documentation demonstrating the individual facility specific compliance with the emergency testing requirements and the facility is unable to provide documentation to show they have incorporated any necessary improvements into the overall emergency preparedness program for one (1) of one (1) programs reviewed.
Findings Included:
Document review on October 1, 2024, at approximately 11:00 a.m. revealed the facility lacked documentation of a facility annual and biennual specific emergency preparedness testing process and an emergency preparedness action review plan as part of of the healthcare system's unified emergency preparedness program.
Interview with the facility clinical director (EMP1) and the facility manager (EMP2) on October 1, 2024 at approximately 3:00 p.m. revealed that the facility participates in a healthcare system unified education module for an emergency preparedness program and confirmed the facility lacked written documentation verifying that the facility medical director fully participated in the development and implementation of the integrated health care system Emergency Preparedness Plan. EMP1 revealed that there is not a representative/employee that attends meetings, and there is no other facility specific documentation that was available for surveyor review.
Plan of Correction:The Facility has completed a site-specific Emergency Preparedness Plan that includes annual and Biannual emergency testing processes and emergency action review. This will be included as part of the health care systems unified Emergency Preparedness Program. The Plan includes full participation by the Rural Health Clinic's Medical Director. The Medical Director will sign off on the development and implementation of the plan. The site-specific plan will be available in a binder at the Rural Health Clinic.
The Site Supervisor and/or Clinical Director will attend the systems Emergency Preparedness Planning meetings moving forward. The completed site specific EPP will be reviewed annually at the system wide Emergency Preparedness Plan meeting when the unified Emergency Preparedness Plan is reviewed. The Plant Services Manager will be responsible for completing and reporting on the biannual site-specific emergency preparedness testing process and review.
All site-specific staff will be required to complete a read and sign on the updated site-specific Emergency Preparedness Plan with the site supervisor.
The Clinical Director will verify all items are being completed on a biannual basis. This will be added to the agenda and reviewed at the Rural Health Clinic Committee meetings. The Clinical Director and/or Site Supervisor will attend the BRMC Regulatory Meeting monthly and report biannual on this finding.
491.12(e) STANDARD
Integrated EP Program
Name - Component - 00
§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.
Observations:
Based on document review and staff interview (EMP) it was determined that the facility failed to provide documentation verifying that the facility fully participated in the development and implementation of the integrated health care system Emergency Preparedness Plan and documented the facilities active involvement, in one (1) of one (1) plans reviewed.
Findings include:
Document review on October 1, 2024 at approximately 11:00 a.m. revealed the facility lacked written documentation verifying the facility participated in the development and implementation of the integrated health care system Emergency Preparedness Plan.
Interview with the facility clinical director (EMP1) and the facility manager (EMP2) on October 1, 2024 at approximately 3:00 p.m. revealed that the facility participates in a healthcare system unified education module for an emergency preparedness program and confirmed the facility lacked written documentation verifying that the facility medical director fully participated in the development and implementation of the integrated health care system Emergency Preparedness Plan. EMP1 revealed that there is not a representative/employee that attends meetings, and there is no other facility specific documentation that was available for surveyor review.
Plan of Correction:The Facility has completed a site-specific Emergency Preparedness Plan that includes annual and Biannual emergency testing processes and emergency action review. This will be included as part of the health care systems unified Emergency Preparedness Program. The Plan includes full participation by the Rural Health Clinic's Medical Director. The Medical Director will sign off on the development and implementation of the plan. The site-specific plan will be available in a binder at the Rural Health Clinic.
The Site Supervisor and/or Clinical Director will attend the systems Emergency Preparedness Planning meetings moving forward. The completed site specific EPP will be reviewed annually at the system wide Emergency Preparedness Plan meeting when the unified Emergency Preparedness Plan is reviewed. The Plant Services Manager will be responsible for completing and reporting on the biannual site-specific emergency preparedness testing process and review.
All site-specific staff will be required to complete a read and sign on the updated site-specific Emergency Preparedness Plan with the site supervisor.
The Clinical Director will verify all items are being completed on a biannual basis. This will be added to the agenda and reviewed at the Rural Health Clinic Committee meetings. The Clinical Director and/or Site Supervisor will attend the BRMC Regulatory Meeting monthly and report biannual on this finding.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted onsite October 1, 2024 and completed offsite October 2, 2024, BRMC Family Practice was identified to have had the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.10(a)(3)(i)-(iv) STANDARD
PATIENT HEALTH RECORDS
Name - Component - 00
491.10(a) Records system.
(3) For each patient receiving health care services, the clinic . . .. maintains a record that includes, as applicable:
(i) Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;
(iii) All physician's orders, reports of treatments and medications, and other pertinent information necessary to monitor the patient's progress;
(iv) Signatures of the physician or other health care professional.
Observations:
Based on review of Clinica Records (CR) and interview with clinic manager (EMP2) and the clinical director (EMP1) the clinic failed to ensure each record contained the social data of each patient receiving health care services for eighteen (18) of twenty (20) records reviewed. (CR #s: 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 19 and 20); and failed to ensure a treatment consent form was completed by the patient prior to services being rendered for twenty (20) of twenty (20) records reviewed (CR#1-CR#20).
Findings include:
Review of Medical records completed on October 1, 2024 between approximately 11:00am and 1:15pm revealed the following:
CR#1, service date: 7/3/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#2, service date: 7/11/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#3, service date: 7/22/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#4, service date: 8/1/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#5, service date: 8/9/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#6, service date: 8/19/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered.
CR#7, service date: 8/27/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#8, service date: 9/10/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#9, service date: 9/20/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#10, service date: 9/24/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#11, service date: 7/1/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#12, service date: 7/10/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered.
CR#13, service date: 7/24/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#14, service date: 7/31/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#15, service date: 8/6/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#16, service date: 8/14/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#17, service date: 8/21/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#18, service date: 8/30/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#19, service date: 9/5/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
CR#20, service date: 9/17/24 did not contain an updated signed consent form for service within the prior twelve months to those treatment services being rendered and did not contain complete documented evidence that social data was obtained by the practitioner.
Interview with EMP1 completed October 2, 2024 at approximately 3:00PM confirmed the above findings.
Plan of Correction:Nurses and Providers will be educated by completing a Read and Sign on policy 9210.135 "Scope of Practice – Bradford Family Rural Health Center" and the document will be saved within the Rural Health Clinic Binder. The policy listed above includes requirements for documentation from nurses and providers.
The current consent form was reviewed and updated to include a consent for treatment section. This form will be updated and distributed as appropriate to meet compliance. Staff will be educated by the site supervisor when distributed to present the new consent to the patients, properly educate patients on what the consent means, and then obtain a signature. Education will be completed via Read and Sign and will be kept with the facility documentation for future on-site visits for review. All new employees will be educated on the consent as part of the onboarding process. The consent will be imported to the patient chart as completed.
The Site Supervisor and/or Clinical Director will audit 10 random charts per week to ensure compliance. Audits will include reviewing for updated consent, and completion of required documentation. This will continue until compliance is 90% for 4 consecutive weeks. After 90% compliance is reached for 4 consecutive weeks audits will decrease to 10 random audits per months to ensure sustained compliance. The Clinical Director and/or Site Supervisor will attend the BRMC Regulatory Meeting monthly to report out audit findings.
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