Title 902 | Chapter 028 | Regulation 040REG
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 28:040.Kentucky's Trauma System Registry and Data Bank System.
Section 1.
(1)
(2)
(3)
(4)
Section 2.
Trauma Center Registries.(1)
All trauma centers designated by the Commissioner for(a)
Establish and maintain a trauma registry that is compatible with the current NTDB standards established in the National Trauma Data Standard Data Dictionary available from the American College of Surgeons at https://www.facs.org/quality-programs/trauma/quality/national-trauma-data-bank/national-trauma-data-standard/; and(b)
Have a secure, on-line system that is NTDB and HIPAA compliant.(2)
An individual trauma center registry shall have its new or updated trauma data uploaded electronically at least quarterly to the KTDB(3)
Trauma Registry. The inclusion criteria for the KTDBSection 2.
Kentucky Trauma Data Bank.(1)
The department shall maintain a single statewide Kentucky Trauma Data Bank (KTDB) to be the statewide repository for trauma registry data submitted by each designated trauma center.(2)
A request for data from the KTDB shall be directed to the Kentucky Commissioner for Public Health.(3)
A request for a report on a specific trauma center shall be addressed to the trauma coordinator or trauma program manager of the trauma center in question.(4)
Pursuant to KRS 211.494(6), data obtained through a trauma registry shall be considered protected health information.Section 3.
(1)
(2)
STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: August 26, 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, KY 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 criteria for use of a trauma registry and the Kentucky Trauma Data Bank by a trauma center in the Kentucky trauma care 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). It is necessary that the Department for Public Health to have timely and accurate data on the number and types of traumas that occurs throughout the state.
(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 program.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation will ensure the timely and accurate collection of data related to trauma care in Kentucky.
(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 updates the requirements for the trauma registry and the Kentucky Trauma Data Bank and adds the requirement that all designated trauma care centers report timely and accurate data.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to ensure the timely and accurate collection of data related to trauma care in Kentucky.
(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 program.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure all designated trauma centers in Kentucky are reporting timely and accurate trauma care data.
(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:
All hospitals designated as a trauma center will need to be aware of the data reporting requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There will be no cost to the hospitals to report the require data elements.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Designated hospitals will have timely and accurate data on the provision of trauma care.
(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 cost.
(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 the amendment to 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 not applied as the requirements of this administrative regulation are applied equally to the regulated entities.
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 does not impact the expenditures of the department.
Revenues:
The amendment to this administrative regulation does 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?
There will be no change in expenditures, revenue, or cost savings in subsequent years.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affected 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, the Kentucky Trauma Advisory Committee, and the Kentucky Injury Prevention Research Center.
(a) Estimate the following for the first year:
Expenditures:
Expenditures to the regulated entities will be minimal as the required data can be reported electronically.
Revenues:
The amendment to this administrative regulation will not generate revenue for the regulated entities.
Cost Savings:
Reporting data electronically to the Kentucky Trauma Data Bank will result in minimal cost savings for the regulated entities.
(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:
There will be minimal cost savings to the regulated entities to report the required data electronically.
(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)
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 cost associated with the amendment to this administrative regulation will not exceed $500,000.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
45 C.F.R. Parts 160, 162 and 164.
(2) State compliance standards.
KRS 211.494(6) requires that all data obtained through the trauma registry or other data collected shall be confidential. The personal identifying information that is collected through the trauma registry shall not be subject to discovery or introduction into evidence in any civil action.
(3) Minimum or uniform standards contained in the federal mandate.
45 C.F.R. Parts 160, 162, and 164 cover the administrative data standards and related requirements for electronic data submission of protected health information. 45 C.F.R. 164.302 requires that any covered entity or business associate comply with the applicable standards, implementation specifications, and requirements for the electronic submission of protected health information of the covered entity. All data shared through the Kentucky trauma system registry must comply with all applicable parts of 45 C.F.R. Parts 160, 162, and 164.
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
No, this administrative regulation does not impose any stricter requirements, or additional of different responsibilities or requirements.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
Not applicable.
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Office of the Commissioner
(Amendment)
902 KAR 28:040.Kentucky's Trauma Registry and Data Bank System.
Section 1.
Trauma Center Registries.(1)
All trauma centers designated by the Commissioner for Public Health in the Kentucky Trauma Care System shall:(a)
Establish and maintain a trauma registry that is compatible with the current NTDB standards established in the National Trauma Data Standard Data Dictionary available from the American College of Surgeons at https://www.facs.org/quality-programs/trauma/quality/national-trauma-data-bank/national-trauma-data-standard/; and(b)
Have a secure, on-line system that is NTDB and HIPAA compliant.(2)
An individual trauma center registry shall have its new or updated trauma data uploaded electronically at least quarterly to the KTDB.(3)
Trauma Registry. The inclusion criteria for the KTDB shall be specified in the Kentucky Trauma Hospital Reference Manual incorporated by reference in 902 KAR 28:030, Section 3.Section 2.
Kentucky Trauma Data Bank.(1)
The department shall maintain a single statewide Kentucky Trauma Data Bank (KTDB) to be the statewide repository for trauma registry data submitted by each designated trauma center.(2)
A request for data from the KTDB shall be directed to the Kentucky Commissioner for Public Health.(3)
A request for a report on a specific trauma center shall be addressed to the trauma coordinator or trauma program manager of the trauma center in question.(4)
Pursuant to KRS 211.494(6), data obtained through a trauma registry shall be considered protected health information.STEVEN J. STACK, MD, MBA, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: August 26, 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, KY 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 criteria for use of a trauma registry and the Kentucky Trauma Data Bank by a trauma center in the Kentucky trauma care 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). It is necessary that the Department for Public Health to have timely and accurate data on the number and types of traumas that occurs throughout the state.
(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 program.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation will ensure the timely and accurate collection of data related to trauma care in Kentucky.
(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 updates the requirements for the trauma registry and the Kentucky Trauma Data Bank and adds the requirement that all designated trauma care centers report timely and accurate data.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to ensure the timely and accurate collection of data related to trauma care in Kentucky.
(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 program.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure all designated trauma centers in Kentucky are reporting timely and accurate trauma care data.
(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:
All hospitals designated as a trauma center will need to be aware of the data reporting requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There will be no cost to the hospitals to report the require data elements.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Designated hospitals will have timely and accurate data on the provision of trauma care.
(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 cost.
(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 the amendment to 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 not applied as the requirements of this administrative regulation are applied equally to the regulated entities.
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 does not impact the expenditures of the department.
Revenues:
The amendment to this administrative regulation does 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?
There will be no change in expenditures, revenue, or cost savings in subsequent years.
(3) Identify affected local entities (for example: cities, counties, fire departments, school districts):
There are no affected 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, the Kentucky Trauma Advisory Committee, and the Kentucky Injury Prevention Research Center.
(a) Estimate the following for the first year:
Expenditures:
Expenditures to the regulated entities will be minimal as the required data can be reported electronically.
Revenues:
The amendment to this administrative regulation will not generate revenue for the regulated entities.
Cost Savings:
Reporting data electronically to the Kentucky Trauma Data Bank will result in minimal cost savings for the regulated entities.
(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:
There will be minimal cost savings to the regulated entities to report the required data electronically.
(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)
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 cost associated with the amendment to this administrative regulation will not exceed $500,000.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
45 C.F.R. Parts 160, 162 and 164.
(2) State compliance standards.
KRS 211.494(6) requires that all data obtained through the trauma registry or other data collected shall be confidential. The personal identifying information that is collected through the trauma registry shall not be subject to discovery or introduction into evidence in any civil action.
(3) Minimum or uniform standards contained in the federal mandate.
45 C.F.R. Parts 160, 162, and 164 cover the administrative data standards and related requirements for electronic data submission of protected health information. 45 C.F.R. 164.302 requires that any covered entity or business associate comply with the applicable standards, implementation specifications, and requirements for the electronic submission of protected health information of the covered entity. All data shared through the Kentucky trauma system registry must comply with all applicable parts of 45 C.F.R. Parts 160, 162, and 164.
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
No, this administrative regulation does not impose any stricter requirements, or additional of different responsibilities or requirements.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
Not applicable.