RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
STATUTORY AUTHORITY: 211.494(8)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the hospital designation process for Kentucky’s trauma system.
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) Hospitals 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 http://www.facs.org/trauma/verifivisitoutcomes.html and is included in the Reference Guide of Classification, 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) Hospitals in Kentucky that volunteer to become part of the trauma care system shall make application to the Commissioner of Public Health using the:
(a) KYTAC1, 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) KYTAC2, Hospital Application for Kentucky Trauma Center Designation, if the facility is seeking designation as a Level I, II, or III trauma center.
(3) Designation shall be for a three (3) year period following trauma center verification and hospitals shall be reverified to maintain trauma designation.
(4) Only hospitals which 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. Designation by the Commissioner for Public Health. (1) The commissioner shall:
(a) Upon receipt of the application and request to ACS COT, review any ACS COT correspondence regarding the results of any consultation site visit, or the trauma center verification visit and shall review a copy of any certificates issued by ACS COT, within thirty (30) days of receipt of the document at the hospital;
(b) Upon receipt of a copy of the ACS COT certificate of trauma center designation, issue a certificate of designation in the Kentucky Trauma Care System; and
(c) Upon agreement of both the applying hospital and the ACS COT, direct a representative of the department or the KyTAC to participate as an observer during the site visit.
(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. State Designation for Existing Trauma Centers.
(1) A hospital that has been voluntarily verified as a Level I, Level II, or Level III Trauma Center by ACS COT prior to the effective date of this administrative regulation that seeks designation as a Kentucky Trauma Care System Level I, Level II, or Level III trauma center, shall submit a completed KYTAC2 application form to the commissioner along with a copy of the ACS COT verification letter and certificate.
(a) The application for designation in the Kentucky system shall be made within six (6) months of the effective date of this administrative regulation.
(b) Upon receipt of the application and ASC verification letter and certificate, a trauma center designation certificate shall be issued by the commissioner and shall be posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.
(c) The period of Kentucky designation shall be concurrent with the expiration date of the ACS COT verification.
(d) The initial fee for trauma center designation as specified in 902 KAR 28:060 shall be waived for the initial designation cycle for a hospital that has been voluntarily certified by ACS COT prior to the effective date of this administrative regulation.
(2) A hospital previously designated as a Level I, Level II, or Level III trauma center seeking redesignation by the Commissioner shall file a completed KYTAC2 application form concurrent with the application or request to ACS COT for a reverification site visit.
(3) A hospital that does not meet the requirements of subsection (1) of this section and that is preparing for initial voluntary trauma center designation as a Level I, Level II, or Level III trauma center shall apply to the commissioner for designation following successful completion of the ACS COT verification process.
(4) The period of redesignation shall be concurrent with the expiration date of the ACS COT verification.
(5) The fee for redesignation shall be the same as the fee for initial designation as specified in 902 KAR 28:060.
Section 4. Level IV Trauma Center Designation. (1) Initial designation.
(a) Once the facility has completed the Level IV Consultation or Verification Program pursuant to Section 1 of this administrative regulation, the original completed KYTAC1 application form 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 the requirements of this administrative regulation and 902 KAR 28:030, a certificate of trauma center designation shall be:
a. Issued by the commissioner; and
b. Posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.
2. 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) Designation shall be for a three (3) year period following completion of the trauma center verification process.
(2) Redesignation. Within six (6) 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 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 which 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 back 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 6. Incorporation by Reference. (1) The following material is incorporated by reference:
(a) KYTAC1, "Hospital Application for Level IV Verification and Kentucky Designation as a Trauma Center", April 2012;
(b) KYTAC2, "Hospital Application for Kentucky Trauma Center Designation", April 2012; and
(c) "American College of Surgeons Verification Review Committee Reference Guide of Classification", January 2012.
(2) This material 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. (26 Ky.R. 668; Am. 1008; eff. 11-15-1999; 38 Ky.R. 1676; 1860; eff. 6-1-2012.)