Title 902 | Chapter 028 | Regulation 020REG
PROPOSED
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PREVIOUS VERSION
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CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Office of the Commissioner
(Amendment)
902 KAR 28:020.Kentucky trauma system designation process.
Section 1.
Hospital Trauma Center Designation. A hospital shall receive designation as a trauma center by the Department for Public Health following successful completion of the verification and review process established in this administrative regulation and 902 KAR 28:030.(1)
Each hospital(a)
The criteria established by the American College of Surgeons Verification Review Committee that is available at https://www.facs.org/quality-programs/trauma/quality/verification-review-and-consultation-program/(b)
The standards for Level IV designation established in 902 KAR 28:030.(2)
Each hospital(a)
KYTAC-Application-1(b)
KYTAC-Application-2(3)
(a)
1.
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following trauma center verification.2.
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit by either ACS COT or a Kentucky verification team.(b)
Each hospital(4)
Only those hospitals thatSection 2.
Level I, II, or III Designation(1)
Upon being notified that the ACS COT has been requested to conduct a Level I, II, or III trauma center verification visit, and with the agreement of both the applying hospital and the ACS COT, the commissioner shall direct a representative of the department or the KyTAC to participate as an observer during the site visit.(2)
The commissioner shall issue a certificate of designation in the Kentucky trauma care system concurrent with the recommendations and time period specified in the ACS COT documents upon receipt of the KYTAC-Application-2, the appropriate fees, and a copy of the ACS COT documents indicating satisfactory verification to their latest standards.(3)(a)
(b)
(c)
(2)
The state-issued designation certificate shall be posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.Section 3.
(1)
(a)
(b)
(c)
(d)
(2)
(3)
(4)
(5)
Section 4.
Level IV Trauma Center Designation.(1)
Designation process(a)
Once the facility has completed the Level IV(b)
1.
If the facility meets all the requirements of this administrative regulation and 902 KAR 28:030, a certificate of trauma center designation shall be:a.
Issued by the commissioner for a three (3) year period following completion of the trauma center verification process except as provided by subparagraph 2. of this paragraph; andb.
Posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.2.
If the facility has a deficiency that is not deemed critical to the effective functioning of the trauma center, the commissioner may issue a provisional designation certificate for a period of time less than three (3) years to provide time to address or correct the deficiency. The commissioner shall send a written notice informing the facility of that determination, and the facility may be subject to a subsequent audit or re-verification of the finding to confirm that it was satisfactorily addressed. The facility may appeal the decision in accordance with 902 KAR 28:060.3.
If the facility does not meet the requirements of this administrative regulation and 902 KAR 28:030, the commissioner shall send a written notice to the facility informing the facility of that determination. The facility may appeal the decision in accordance with 902 KAR 28:060.(c)
1.
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following satisfactory completion of the trauma center verification process.2.
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit in accordance with paragraph (b)2. of this subsection.(2)
Redesignation. At least four (4)Section 4.Section 5.
Designation Suspension or Revocation.(1)
A designated trauma center hospital that is unable to meet the applicable minimum required criteria of a Level I, Level II, or Level III trauma center as established by ACS COT, or a Level IV trauma center as established in 902 KAR 28:030, shall notify the commissioner within five (5) business days of the event that(2)
If the commissioner becomes aware of a significant change in the status of the trauma care program at a designated hospital that may potentially affect its designation status, the commissioner may:(a)
Request confirmation of continued designation status from the hospital; or(b)
Assign a representative of KyTAC or a designee to conduct a site visit to review the status of the trauma program and report the findings(3)
The commissioner may consult with KyTAC and the ACS COT on information received from the hospital and site visit, and may:(a)
Suspend the hospital's designation;(b)
Place the facility into a probationary status pending resolution within thirty (30) days of the disciplinary action; or(c)
Revoke the hospital's designation.(4)
If the designation is revoked, and if the facility seeks redesignation, the facility shall correct the identified problems, and request, at its expense, a focused review to demonstrate that each problem has been corrected.(5)
Following the review required by subsection (4) of this section, the commissioner shall:(a)
Reinstate the designation;(b)
Request that the facility reapply for verification at a lower level;(c)
Deny redesignation; or(d)
Refer the matter to KyTAC for determination of other appropriate action.(6)
A hospital not able to meet trauma center criteria at the initial designation level shall not hold designation as a trauma center until reverified at an appropriate level and redesignated.Section 5.Section 6.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
KYTAC-Application-1(b)
KYTAC-Application-2(c)
(2)
This material:(a)
May be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissioner's Office, 275 East Main Street, Frankfort, Kentucky 406012, Monday through Friday, 8 a.m. to 4:30 p.m.; and(b)
Is available online at https://www.kyha.com/kentucky-trauma-system/.STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: August 15, 2024
FILED WITH LRC: September 9, 2024 at 11:20 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on November 25, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by November 18, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until November 30, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-7476; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Julie Brooks or Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the voluntary hospital designation process for Kentucky's trauma system.
(b) The necessity of this administrative regulation:
According to the Kentucky Hospital Association, trauma is the leading killer of those 45 or younger. Injury death rates in Kentucky are 1/3 higher than the U.S. average, making Kentucky the second deadliest state in the nation. Trauma is the costliest disease, even more than cancer or cardiovascular disease. Rural trauma is more deadly than urban trauma (traffic injury mortality is inversely proportional to population density).
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 211.494 authorizes the Department for Public Health to establish a statewide trauma care system that is designed to reduce or prevent death and disability from trauma, provider optimal care for trauma victims, minimize the economic impact of lost wages and productivity for trauma patients, and contain the costs associated with trauma care.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures hospitals seeking voluntary designation as part of the statewide trauma care system are aware of the application process based on the level of designation being sought.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendment to this administrative regulation clarifies the process for levels I, II, III, and IV designation, and updates the material incorporated by reference.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to ensure hospitals in Kentucky are following the most up to date guidelines and processes when seeking designation as a trauma center.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 211.494 authorizes the Department for Public Health to establish a statewide trauma care system that is designed to reduce or prevent death and disability from trauma, provide optimal care for trauma victims, minimize the economic impact of lost wages and productivity for trauma patients, and contain the costs associated with trauma care.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure hospitals seeking voluntary designation as part of the statewide trauma care system are aware of the application process based on the level of designation being sought.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation impacts the twenty-one (21) hospitals currently designated as a level I, II, III, or IV trauma center and all future hospitals that may seek trauma center designation.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Hospitals that are currently designated as a trauma center will need to be aware of the process to renew the designation. Hospitals seeking new designation will need to be aware of the application review and approval process based on the level of designation.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
The costs associated with complying with this administrative regulation vary depending on the level of designation. Level I, II, and III hospitals pay $500 fee every three years and cover the costs associated with the ACS COT site visit. Level IV hospitals will pay $500 fee every three years and cover the costs of each site review team member.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Hospitals that receive trauma center designation will be able to provide a needed service to the communities they serve.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This is an ongoing program, there are no initial costs to implement.
(b) On a continuing basis:
There is no change in cost for the administrative body to implement the amendment to this administrative regulation.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
This administrative regulation is supported by funds available through the trauma care system fund established by KRS 211.496.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
An increase in fees or funding is not necessary to implement this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established in this administrative regulation.
(9) TIERING: Is tiering applied?
Tiering is applied. Hospitals seeking Level I, II, or III designation are required to meet the standards of the American College of Surgeons Committee on Trauma. Hospitals seeking Level IV designation must meet the state issued standards.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 211.494.
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Cabinet for Health and Family Services, Department for Public Health is the promulgating agency.
(a) Estimate the following for the first year:
Expenditures:
The amendment to this administrative regulation will not impact the expenditures of the department.
Revenues:
The amendment to this administrative regulation will not generate revenue for the department.
Cost Savings:
The amendment to this administrative regulation will not result in cost savings for the department.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affective local entities.
(a) Estimate the following for the first year:
Expenditures:
Not applicable.
Revenues:
Not applicable.
Cost Savings:
Not applicable.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable.
(4) Identify additional regulated entities not listed in questions (2) or (3):
Additional regulated entities include the twenty-one (21) hospitals currently designated as trauma centers, all hospitals that will apply for designation, and the Kentucky Trauma Advisory Committee.
(a) Estimate the following for the first year:
Expenditures:
Expenditures for designated trauma hospitals will be dependent on each hospital’s level of trauma care designation.
Revenues:
The amendment to this administrative regulation will not impact the designated trauma center revenue.
Cost Savings:
The amendment to this administrative regulation will not result in cost savings for the designated trauma centers.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
There will be no change in expenditures, revenue, or cost savings in subsequent years.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
The amendment to this administrative regulation will have minimal fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
The amendment to this administrative regulation clarifies the process for levels I, II, III, and IV designation, and updates the material incorporated by reference. The costs associated with complying with this administrative regulation vary depending on the level of designation. Level I, II, and III hospitals pay $500 fee every three years and cover the costs associated with the ACS COT site visit. Level IV hospitals will pay $500 fee every three years and cover the costs of each site review team member.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
The amendment to this administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The potential cost for the regulated entities is less than $500,000 every three (3) years.
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Office of the Commissioner
(Amendment)
902 KAR 28:020.Kentucky trauma system designation process.
Section 1.
Hospital Trauma Center Designation. A hospital shall receive designation as a trauma center by the Department for Public Health following successful completion of the verification and review process established in this administrative regulation and 902 KAR 28:030.(1)
Each hospital seeking designation in the Kentucky trauma care system shall adhere to:(a)
The criteria established by the American College of Surgeons Verification Review Committee that is available at https://www.facs.org/quality-programs/trauma/quality/verification-review-and-consultation-program/, if the facility is seeking designation as a Level I, II, or III trauma center; or(b)
The standards for Level IV designation established in 902 KAR 28:030.(2)
Each hospital in Kentucky that volunteers to become part of the trauma care system shall make application to the Commissioner of Public Health using the:(a)
KYTAC-Application-1, Hospital Application for Level IV Verification and Kentucky Designation as a Trauma Center, if the facility is seeking designation as a Level IV trauma center; or(b)
KYTAC-Application-2, Hospital Application for Kentucky Trauma Center Designation, if the facility is seeking designation as a Level I, II, or III trauma center.(3)
(a)
1.
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following trauma center verification.2.
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit by either ACS COT or a Kentucky verification team.(b)
Each hospital shall be reverified to maintain trauma designation.(4)
Only those hospitals that are designated trauma centers under the provisions of 902 KAR 28:010 through 28:060 shall be recognized by the commonwealth as belonging to the Kentucky Trauma Care System and may hold themselves out to the public as a trauma center.Section 2.
Level I, II, or III Designation.(1)
Upon being notified that the ACS COT has been requested to conduct a Level I, II, or III trauma center verification visit, and with the agreement of both the applying hospital and the ACS COT, the commissioner shall direct a representative of the department or the KyTAC to participate as an observer during the site visit.(2)
The commissioner shall issue a certificate of designation in the Kentucky trauma care system concurrent with the recommendations and time period specified in the ACS COT documents upon receipt of the KYTAC-Application-2, the appropriate fees, and a copy of the ACS COT documents indicating satisfactory verification to their latest standards.(3)
The state-issued designation certificate shall be posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.Section 3.
Level IV Trauma Center Designation.(1)
Designation process.(a)
Once the facility has completed the Level IV verification and review process pursuant to Section 1 of this administrative regulation, the original completed KYTAC-Application-1 shall be forwarded to KyTAC. KyTAC shall conduct a review of the facility's compliance with this administrative regulation and 902 KAR 28:030 and make recommendations to the commissioner within sixty (60) days of receipt of the application.(b)
1.
If the facility meets all the requirements of this administrative regulation and 902 KAR 28:030, a certificate of trauma center designation shall be:a.
Issued by the commissioner for a three (3) year period following completion of the trauma center verification process except as provided by subparagraph 2. of this paragraph; andb.
Posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.2.
If the facility has a deficiency that is not deemed critical to the effective functioning of the trauma center, the commissioner may issue a provisional designation certificate for a period of time less than three (3) years to provide time to address or correct the deficiency. The commissioner shall send a written notice informing the facility of that determination, and the facility may be subject to a subsequent audit or re-verification of the finding to confirm that it was satisfactorily addressed. The facility may appeal the decision in accordance with 902 KAR 28:060.3.
If the facility does not meet the requirements of this administrative regulation and 902 KAR 28:030, the commissioner shall send a written notice to the facility informing the facility of that determination. The facility may appeal the decision in accordance with 902 KAR 28:060.(c)
1.
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following satisfactory completion of the trauma center verification process.2.
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit in accordance with paragraph (b)2. of this subsection.(2)
Redesignation. At least four (4) months preceding the expiration of a designation certificate, the hospital shall initiate the process established in 902 KAR 28:030 for reverification and redesignation.Section 4.
Designation Suspension or Revocation.(1)
A designated trauma center hospital that is unable to meet the applicable minimum required criteria of a Level I, Level II, or Level III trauma center as established by ACS COT, or a Level IV trauma center as established in 902 KAR 28:030, shall notify the commissioner within five (5) business days of the event that caused the facility to fall below minimum criteria.(2)
If the commissioner becomes aware of a significant change in the status of the trauma care program at a designated hospital that may potentially affect its designation status, the commissioner may:(a)
Request confirmation of continued designation status from the hospital; or(b)
Assign a representative of KyTAC or a designee to conduct a site visit to review the status of the trauma program and report the findings to the commissioner within thirty (30) days of assignment.(3)
The commissioner may consult with KyTAC and the ACS COT on information received from the hospital and site visit, and may:(a)
Suspend the hospital's designation;(b)
Place the facility into a probationary status pending resolution within thirty (30) days of the disciplinary action; or(c)
Revoke the hospital's designation.(4)
If the designation is revoked, and if the facility seeks redesignation, the facility shall correct the identified problems, and request, at its expense, a focused review to demonstrate that each problem has been corrected.(5)
Following the review required by subsection (4) of this section, the commissioner shall:(a)
Reinstate the designation;(b)
Request that the facility reapply for verification at a lower level;(c)
Deny redesignation; or(d)
Refer the matter to KyTAC for determination of other appropriate action.(6)
A hospital not able to meet trauma center criteria at the initial designation level shall not hold designation as a trauma center until reverified at an appropriate level and redesignated.Section 5.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
KYTAC-Application-1, "Hospital Application for Level IV Verification and Kentucky Designation as a Trauma Center", January 2024; and(b)
KYTAC-Application-2, "Hospital Application for Kentucky Trauma Center Designation", January 2024.(2)
This material:(a)
May be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissioner's Office, 275 East Main Street, Frankfort, Kentucky 406012, Monday through Friday, 8 a.m. to 4:30 p.m.; and(b)
Is available online at https://www.kyha.com/kentucky-trauma-system/.STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: August 15, 2024
FILED WITH LRC: September 9, 2024 at 11:20 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on November 25, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by November 18, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until November 30, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-7476; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Julie Brooks or Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the voluntary hospital designation process for Kentucky's trauma system.
(b) The necessity of this administrative regulation:
According to the Kentucky Hospital Association, trauma is the leading killer of those 45 or younger. Injury death rates in Kentucky are 1/3 higher than the U.S. average, making Kentucky the second deadliest state in the nation. Trauma is the costliest disease, even more than cancer or cardiovascular disease. Rural trauma is more deadly than urban trauma (traffic injury mortality is inversely proportional to population density).
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 211.494 authorizes the Department for Public Health to establish a statewide trauma care system that is designed to reduce or prevent death and disability from trauma, provider optimal care for trauma victims, minimize the economic impact of lost wages and productivity for trauma patients, and contain the costs associated with trauma care.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures hospitals seeking voluntary designation as part of the statewide trauma care system are aware of the application process based on the level of designation being sought.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
The amendment to this administrative regulation clarifies the process for levels I, II, III, and IV designation, and updates the material incorporated by reference.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to ensure hospitals in Kentucky are following the most up to date guidelines and processes when seeking designation as a trauma center.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 211.494 authorizes the Department for Public Health to establish a statewide trauma care system that is designed to reduce or prevent death and disability from trauma, provide optimal care for trauma victims, minimize the economic impact of lost wages and productivity for trauma patients, and contain the costs associated with trauma care.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure hospitals seeking voluntary designation as part of the statewide trauma care system are aware of the application process based on the level of designation being sought.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation impacts the twenty-one (21) hospitals currently designated as a level I, II, III, or IV trauma center and all future hospitals that may seek trauma center designation.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Hospitals that are currently designated as a trauma center will need to be aware of the process to renew the designation. Hospitals seeking new designation will need to be aware of the application review and approval process based on the level of designation.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
The costs associated with complying with this administrative regulation vary depending on the level of designation. Level I, II, and III hospitals pay $500 fee every three years and cover the costs associated with the ACS COT site visit. Level IV hospitals will pay $500 fee every three years and cover the costs of each site review team member.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Hospitals that receive trauma center designation will be able to provide a needed service to the communities they serve.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This is an ongoing program, there are no initial costs to implement.
(b) On a continuing basis:
There is no change in cost for the administrative body to implement the amendment to this administrative regulation.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
This administrative regulation is supported by funds available through the trauma care system fund established by KRS 211.496.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
An increase in fees or funding is not necessary to implement this administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established in this administrative regulation.
(9) TIERING: Is tiering applied?
Tiering is applied. Hospitals seeking Level I, II, or III designation are required to meet the standards of the American College of Surgeons Committee on Trauma. Hospitals seeking Level IV designation must meet the state issued standards.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 211.494.
(2) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Cabinet for Health and Family Services, Department for Public Health is the promulgating agency.
(a) Estimate the following for the first year:
Expenditures:
The amendment to this administrative regulation will not impact the expenditures of the department.
Revenues:
The amendment to this administrative regulation will not generate revenue for the department.
Cost Savings:
The amendment to this administrative regulation will not result in cost savings for the department.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affective local entities.
(a) Estimate the following for the first year:
Expenditures:
Not applicable.
Revenues:
Not applicable.
Cost Savings:
Not applicable.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
Not applicable.
(4) Identify additional regulated entities not listed in questions (2) or (3):
Additional regulated entities include the twenty-one (21) hospitals currently designated as trauma centers, all hospitals that will apply for designation, and the Kentucky Trauma Advisory Committee.
(a) Estimate the following for the first year:
Expenditures:
Expenditures for designated trauma hospitals will be dependent on each hospital’s level of trauma care designation.
Revenues:
The amendment to this administrative regulation will not impact the designated trauma center revenue.
Cost Savings:
The amendment to this administrative regulation will not result in cost savings for the designated trauma centers.
(b) How will expenditures, revenues, or cost savings differ in subsequent years?
There will be no change in expenditures, revenue, or cost savings in subsequent years.
(5) Provide a narrative to explain the:
(a) Fiscal impact of this administrative regulation:
The amendment to this administrative regulation will have minimal fiscal impact.
(b) Methodology and resources used to determine the fiscal impact:
The amendment to this administrative regulation clarifies the process for levels I, II, III, and IV designation, and updates the material incorporated by reference. The costs associated with complying with this administrative regulation vary depending on the level of designation. Level I, II, and III hospitals pay $500 fee every three years and cover the costs associated with the ACS COT site visit. Level IV hospitals will pay $500 fee every three years and cover the costs of each site review team member.
(6) Explain:
(a) Whether this administrative regulation will have an overall negative or adverse major economic impact to the entities identified in questions (2) - (4). ($500,000 or more, in aggregate)
The amendment to this administrative regulation will not have an overall negative or adverse major economic impact.
(b) The methodology and resources used to reach this conclusion:
The potential cost for the regulated entities is less than $500,000 every three (3) years.