Current through Register Vol. 42, No. 11, August 30, 2024
(1) Types of Designation.
(a) Regular Designation. A regular
designation may be issued by the Board after it has determined that an
applicant hospital has met all requirements to be designated as a trauma center
at the level applied for and is otherwise in substantial compliance with these
rules.
(b) Provisional Designation.
At its discretion, the Board may issue a provisional designation to an
applicant hospital that has met all requirements to be designated as a trauma
center at the level applied for, with exception to minor deviations from those
requirements that do not impact patient care or the operation of a trauma
region.
1. The provisional designation may be
used for an initial designation or for an interim change in designation status
to a lower level due to a trauma center's temporary loss of a component
necessary to maintain a higher designation level.
2. A trauma center must submit a written
corrective plan and interim operation plan for the provisional designation
period including a timeline for corrective action to the Office of EMS and
Trauma within 30 days of receiving a provisional designation.
3. A provisional designation shall not extend
beyond 15 months. After the expiration date of the 15 month provisional
designation period, an applicant hospital shall re-apply for regular
designation once all the requirements for the level applied for have been
met.
4. A trauma center may submit
a written request to the Office of EMS and Trauma that a provisional
designation be removed once all components of its corrective plan have been
achieved. Following its receipt of such a request, the Department will conduct
a focused survey on the trauma center. A regular designation shall be granted
in the event it is confirmed that all components of the corrective plan have
been achieved.
(c)
Automotive Designation.
1. Trauma centers
designated at Levels I-III by the American College of Surgeons (ACS) will be
issued a regular designation by the Board, at that same level, after submitting
an application and providing proof that the trauma center can meet ATS
anesthesiologist requirements. The ATS will determine if an on-site survey
revisit, to confirm resources, will be needed based upon the recommendation of
the RTAC and/or the STAC. A final decision as provided in Rule
420-2-2-.03(4)
(f)2, will not be required.
2. Trauma centers designated as a Level IV by
ACS must meet state Level III designation criteria as set out in Appendix A in
order to be issued a regular designation by the Board.
(2) Levels of Designation. There
shall be three levels of trauma center designation. The criteria of each level
is set out in Appendix A.
(3)
Application Provision. In order to become a trauma center, a hospital must
submit an application (attached to these rules as Appendix B) and follow the
application process provided in paragraph (4) below.
(4) The Application Process. To become
designated as a trauma center, an applicant hospital and its medical staff
shall complete the Department's "Application for Trauma Center Designation". An
applicant hospital shall submit the completed application via mail or hand
delivery to the address listed on the application. Within 30 days of receipt of
the application, the Department shall provide written notification to the
applicant hospital of the following:
(a) That
the application has been received by the Department;
(b) Whether the Department accepts or rejects
the application for incomplete information;
(c) If accepted, the date scheduled for
hospital inspection; and
(d) If
rejected, the reason for rejection and a deadline for submission of a corrected
"Application for Trauma Center Designation" to the Department.
(e) Upon receipt of a completed application
by the Department, an application packet containing a pre-inspection
questionnaire will be provided to the applicant hospital.
The pre-inspection questionnaire must be returned to the
Department one month prior to the scheduled inspection.
(f) The trauma center post-inspection process
will proceed as listed below:
1. The
inspection report will be completed two weeks after completion of the
inspection.
2. A State and Regional
review of the inspection report and a recommendation for or against designation
will be made ninety days after completion of the inspection.
3. A final decision will be made known to the
applicant hospital within 120 days of the completion of the
inspection.
4. Focus visits may be
conducted by the Department as needed.
(5) The Inspection Process. Each applicant
hospital will receive an onsite inspection to ensure the hospital meets the
minimum standards for the desired trauma center designation level as required
by these rules. The Department's Office of EMS and Trauma staff will coordinate
the hospital inspection process to include the inspection team and a scheduled
time for the inspection. The hospital will receive written notification of the
onsite inspection results from the Office of EMS and Trauma.
(6) Designation Certificates.
(a) A designation certificate will be issued
after an applicant hospital has successfully completed the application and
inspection process. The designation certificate issued by the Office of EMS and
Trauma shall set forth the name and location of the trauma center, and the type
and level of designation. The form of the designation certificate is attached
to these rules as Appendix C.
(b)
Separate Designations. A separate designation certificate shall be required for
each hospital when more than one hospital is operated under the same
management.
(7)
Designation Contract.
(a) A designation
contract will be completed after the hospital has successfully completed the
application and inspection process. The designation contract shall be issued by
the Office EMS and Trauma. It shall set forth the name and location of the
trauma center and the type and level of designation.
(b) Separate Designation Contracts. A
separate designation contract shall be required for each hospital when more
than one hospital is operated under the same management.
(c) The form of the designation contract is
attached to these rules as Appendix D.
(8) Basis for Denial of a Designation. The
Department shall deny a hospital application for trauma center designation if
the application remains incomplete after an opportunity for correction has been
made, or if the applicant hospital has failed to meet the trauma center
designation criteria as determined during the inspection.
(9) Suspension, Modification, and Revocation
of a Designation.
(a) A trauma center's
designation may be suspended, modified, or revoked by the Board for an
inability, failure, or refusal to comply with these rules.
(b) The Board's denial, suspension,
modification or revocation of a trauma center designation shall be governed by
the Alabama Administrative Procedure Act, §
41-22-1, et seq., Ala.
Admin. Code.
(c) Hearings.
Contested case hearings shall be provided in accordance with the Alabama
Administrative Procedure Act, §
41-22-1, et seq., and the Board's
Contested Case Hearing Rules, Chapter 420-1-3, Ala. Admin.
Code.
(d) Informal
settlement conferences may be conducted as provided by the Board's Contested
Case Hearing Rules, Chapter 420-1-3, Ala. Admin.
Code.
Authors: John Campbell, M.D., Choona Lang
Statutory Authority: Alabama Legislature, Act
299, Regular Session, 2007 Code of Ala. 1975, §
22-11D-1, et. seq.
