Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64J - Division of Emergency Preparedness and Community Support › Chapter 64J-2 - TRAUMA › Section 64J-2.012 - Process for the Approval of Trauma Centers

Current through Reg. 50, No. 138; July 16, 2024
(1) Beginning September 1, 1990, and annually
				thereafter, the department shall approve trauma centers in accordance with the
				schedule shown in Table I below; (Unless stated otherwise all dates given by
				calendar month and day refer to that date each year.)
Table I
Reference Section
							  64E-2.012, F.A.C.
PROCESS FOR APPROVAL OF TRAUMA
							 CENTERS
Task
S
E
P
O
C
T
N
O
V
D
E
C
J
A
N
F
E
B
M
A
R
A
P
R
M
A
Y
J
U
N
J
U
L
A
U
G
S
E
P
O
C
T
N
O
V
D
E
C
J
A
N
F
E
B
M
A
R
A
P
R
M
A
Y
J
U
N
J
U
L
Hospitals Submit Letters of Intent
DH Sends Applications to Hospitals
Hospitals Complete Applications
Hospitals Submit Applications
Preliminary Review of Applications by DH
Hospitals Respond to Deficiencies
Hospitals Informed of Provisional Status
In-Depth Review of Applications by DH
Revised Applications Submitted by Provisional Trauma
							 Centers
DH Final Review of Applications
Provisional Trauma Centers Notified of In-Depth
							 Review Findings
DH Conducts Site Visit Quality of Care
							 Assessments
DH Approves Trauma Centers
DH Notifies Hospitals of Approval as Trauma
							 Centers
(a) The
				department shall accept a letter of intent, DH Form 1840, January 2010, "Trauma
				Center Letter of Intent, " which is incorporated by reference and available
				from the department, as defined by subsection
				 64J-2.001(4),
				F.A.C., postmarked no earlier than September 1 and no later than midnight,
				October 1, from any acute care general or pediatric hospital. The letter of
				intent is non-binding, but preserves the hospital's right to complete its
				application by the required due date if an available position, as provided in
				Rule  64J-2.010, F.A.C., exists in the
				hospital's TSA. If the hospital does not submit a completed application or does
				not request an extension to complete its application by April 1 of the
				following year, in accordance with Rule
				 64J-2.013, F.A.C., the
				hospital's letter of intent is void;
(b) By October 15, the department shall send
				to those hospitals submitting a letter of intent an application package which
				will include, as a minimum, instructions for submitting information to the
				department for selection as a trauma center, DHP 150-9, Trauma Center
				Standards, which is incorporated by reference in Rule
				 64J-2.011, F.A.C., and available
				from the department, as defined by subsection
				 64J-2.001(4),
				F.A.C., and the requested application(s);
(c) No later than April 1 of the calendar
				year following the submission of a letter of intent, a hospital seeking
				approval as a trauma center shall submit to the department an original and 3
				copies of the respective application as indicated below. Each hospital in a TSA
				with a department-approved local or regional trauma agency shall, at the time a
				trauma center application is submitted to the department, submit a duplicate of
				the application to the trauma agency for review. Recommendations from the
				trauma agency shall be submitted to the department no later than April 7, as
				provided in Rule  64J-2.009, F.A.C.
1. To apply for approval as a Level I Trauma
				Center, applicants must submit all forms contained in the Level I Trauma Center
				Application Manual, January 2010. The manual and the forms contained therein
				are incorporated by reference and available from the department, as defined by
				subsection  64J-2.001(4),
				F.A.C. The manual contains the following forms:
a. DH Form 2032, January 2010, General
				Information for Level I Trauma Center Application,
b. DH Form 2032-A, January 2010, Level I
				Trauma Center Approval Standards Summary Chart,
c. DH Form 2032-B, January 2010, Application
				for Level I Trauma Center Approval Letter of Certification,
d. DH Form 2032-C, January 2010, Level I
				Trauma Center Surgical Specialties Certifications,
e. DH Form 2032-D, January 2010, Level I
				Trauma Center Non-Surgical Specialties Certifications,
f. DH Form 2032-E, January 2010, Level I
				Trauma Center General Surgeons Commitment Statement,
g. DH Form 2032-F, January 2010, Level I
				Trauma Center General Surgeons Available for Trauma Surgical Call,
h. DH Form 2032-G, January 2010, Level I
				Trauma Center Neurosurgeons Available for Trauma Surgical Call,
i. DH Form 2032-H, January 2010, Level I
				Trauma Center Neurological, Pediatric Trauma and Neurological, and
				Neuroradiology Statements,
j. DH
				Form 2032-I, January 2010, Level I Trauma Center Surgical Specialists On Call
				and Promptly Available,
k. DH Form
				2032-J, January 2010, Level I Trauma Center Emergency Department Physicians,
l. DH Form 2032-K, January 2010,
				Level I Trauma Center Anesthesiologists Available for Trauma Call,
m. DH Form 2032-L, January 2010, Level I
				Trauma Center C.R.N.A.s Available for Trauma Call; and,
n. DH Form 2032-M, January 2010, Level I
				Trauma Center Non-Surgical Specialists On Call and Promptly
				Available.
2. To apply
				for approval as a Level II Trauma Center, applicants must submit all forms
				contained in the Level II Trauma Center Application Manual, January 2010. The
				manual and the forms contained therein are incorporated by reference and
				available from the department, as defined by subsection
				 64J-2.001(4),
				F.A.C. The manual contains the following forms:
a. DH Form 2043, January 2010, General
				Information for Level II Trauma Center Application,
b. DH Form 2043-A, January 2010, Level II
				Trauma Center Approval Standards Summary Chart,
c. DH Form 2043-B, January 2010, Application
				for Level II Trauma Center Approval Letter of Certification,
d. DH Form 2043-C, January 2010, Level II
				Trauma Center Surgical Specialties Certifications,
e. DH Form 2043-D, January 2010, Level II
				Trauma Center Non-Surgical Specialties Certifications,
f. DH Form 2043-E, January 2010, Level II
				Trauma Center General Surgeons Commitment Statement,
g. DH Form 2043-F, January 2010, Level II
				Trauma Center General Surgeons Available for Trauma Surgical Call,
h. DH Form 2043-G, January 2010, Level II
				Trauma Center Neurosurgeons Available for Trauma Surgical Call,
i. DH Form 2043-H, January 2010, Level II
				Trauma Center Neurological, Pediatric Trauma and Neurological, and
				Neuroradiology Statements,
j. DH
				Form 2043-I, January 2010, Level II Trauma Center Surgical Specialists On Call
				and Promptly Available,
k. DH Form
				2043-J, January 2010, Level II Trauma Center Emergency Department Physicians,
l. DH Form 2043-K, January 2010,
				Level II Trauma Center Anesthesiologists Available for Trauma Call,
m. DH Form 2043-L, January 2010, Level II
				Trauma Center C.R.N.A.s Available for Trauma Call; and,
n. DH Form 2043-M, January 2010, Level II
				Trauma Center Non-Surgical Specialists On Call and Promptly
				Available.
3. To apply
				for approval as a Pediatric Trauma Center, applicants must submit all forms
				contained in the Pediatric Trauma Center Application Manual, January 2010. The
				manual and the forms contained therein are incorporated by reference and
				available from the department, as defined by subsection
				 64J-2.001(4),
				F.A.C. The manual contains the following forms:
a. DH Form 1721, January 2010, General
				Information for Pediatric Trauma Center Application,
b. DH Form 1721-A, January 2010, Pediatric
				Trauma Center Approval Standards Summary Chart,
c. DH Form 1721-B, January 2010, Application
				for Pediatric Trauma Center Letter of Certification,
d. DH Form 1721-C, January 2010, Pediatric
				Trauma Center Surgical Specialties Certifications,
e. DH Form 1721-D, January 2010, Pediatric
				Trauma Center Non-Surgical Specialties Certifications,
f. DH Form 1721-E, January 2010, Pediatric
				Center General Surgeons Commitment Statement,
g. DH Form 1721-F, January 2010, Pediatric
				Trauma Center General Surgeons Available for Trauma Surgical Call,
h. DH Form 1721-G, January 2010, Pediatric
				Trauma Center Neurosurgeons Available for Trauma Surgical Call,
i. DH Form 1721-H, January 2010, Pediatric
				Trauma Center Neurological, Pediatric Trauma and Neurological, and
				Neuroradiology Statements,
j. DH
				Form 1721-I, January 2010, Pediatric Trauma Center Surgical Specialists On Call
				and Promptly Available,
k. DH Form
				1721-J, January 2010, Pediatric Trauma Center Emergency Department Physicians,
l. DH Form 1721-K, January 2010,
				Pediatric Trauma Center Anesthesiologists Available for Trauma Call,
m. DH Form 1721-L, January 2010, Pediatric
				Trauma Center C.R.N.A.s Available for Trauma Call; and,
n. DH Form 1721-M, January 2010, Pediatric
				Trauma Center Non-Surgical Specialists On Call and Promptly
				Available.
(d)
				After considering the results of the local or regional trauma agency's
				recommendations, the department shall, by April 15, conduct a provisional
				review to determine completeness of the application and the hospital's
				compliance with the standards of critical elements for provisional status. The
				standards of critical elements for provisional review for Level I and Level II
				trauma center applications are specified in DHP 150-9, which is incorporated by
				reference in Rule  64J-2.011, F.A.C., as follows:
Level I
STANDARD
I.
				Administrative: A, E, and F,
II.
				Trauma Service: A, B.1, 5, 6, and 9, C, and D,
III. Surgical Services: A, B, C, and D,
IV. Non-Surgical Services: A, B,
				and C,
V. Emergency Department: A,
				B, C.1, D, and E.4,
VI. Operating
				Room and Post-Anesthesia Recovery Area: A.1, 2, and 3 and B.1 and 2,
VII. Intensive Care Unit and Pediatric
				Intensive Care Unit: B, C, D, and E,
VIII. Training and Continuing Education
				Programs: A, B, and C,
IX.
				Equipment: A, B, C, D, and E,
X.
				Laboratory Services: A and B,
XII.
				Radiological Services: A, B, and C,
XIII. Organized Burn Care: A,
XIV. Acute Spinal Cord and Brain Injury
				Management Capability: A,
XV. Acute
				Rehabilitative Services: B,
XVI.
				Psychosocial Support Services: A,
XVII. Outreach Programs: B, C, and
				E,
XVIII. Quality Management: A
				through H,
XIX. Trauma Research:
				B,
XX. Disaster Planning and
				Management.
Level II
STANDARD
I.
				Administrative: A, E, and F,
II.
				Trauma Service: A, B.1, 5, and 6, C, and D,
III. Surgical Services: A, B, C, and D,
IV. Non-Surgical Services: A, B,
				and C,
V. Emergency Department: A,
				B, C.1, D, and E.4,
VI. Operating
				Room and Post-Anesthesia Recovery Area: A.1, 2, and 3 and B.1 and 2,
VII. Intensive Care Unit: A, B, C, and D,
VIII. Training and Continuing
				Education Programs: A, B, and C,
IX. Equipment: A, B, C, D, and E,
X. Laboratory Services: A and B,
XII. Radiological Services: A, B, and C,
XIII. Organized Burn Care: A,
XIV. Acute Spinal Cord and Brain
				Injury Management Capability: A,
XV. Acute Rehabilitative Services: B,
XVI. Psychosocial Support
				Services: A,
XVII. Outreach
				Programs: B, C, and E,
XVIII.
				Quality Management: A through H,
XIX. Disaster Planning and Management.
Pediatric
STANDARD
I.
				Administrative: A, E, and F,
II.
				Trauma Service: A, B.1, 5, 6, and 9, C, and D,
III. Surgical Services: A, B, C, and D,
IV. Non-Surgical Services: A, B,
				and C,
V. Emergency Department: A,
				B, C.1, D, and E.4,
VI. Operating
				Room and Post-Anesthesia Recovery Area: A.1, 2, and 3 and B.1 and 2,
VII. Pediatric Intensive Care Unit: A, B, C,
				and D,
VIII. Training and
				Continuing Education Programs: A, B, and C,
IX. Equipment: A, B, C, D, and E,
X. Laboratory Services: A and B,
XII. Radiological Services: A, B, and C,
XIII. Organized Burn Care: A,
XIV. Acute Spinal Cord and Brain
				Injury Management Capability: A,
XV. Acute Rehabilitative Services: B,
XVI. Psychosocial Support
				Services: A,
XVII. Outreach
				Programs: B, C, and E,
XVIII.
				Quality Management: A through H,
XIX. Trauma Research B,
XX. Disaster Planning and
				Management.
(e) No later
				than April 15, each hospital whose application the department finds to be
				unacceptable or deficient during the department's provisional review, will be
				notified in writing of deficiencies and given the opportunity to submit
				additional clarifying or corrective information.
(f) The hospital shall submit the requested
				information to the department by close of business 5 working days after April
				15. Failure to provide the requested information, or failure to successfully
				address the deficiencies identified by the department, shall result in the
				denial of the hospital's application.
(g) The department shall send written
				notification to each applicant on or before May 1:
1. The department shall notify each hospital
				whose application it has found acceptable upon completion of the provisional
				review that the hospital shall operate as a Provisional trauma center beginning
				May 1,
2. The department shall
				inform each hospital whose provisional application it has denied of the
				remaining deficiencies in the application and shall inform the hospital that it
				may submit a letter of intent at the beginning of the next approval
				cycle.
(h) The department
				shall, between May 1 and June 30, complete an in-depth review of all sections
				of the Provisional trauma center's application. The department shall notify the
				hospital of any omissions, deficiencies, or problems and request additional
				information to be submitted by the hospital.
(i) To have additional information considered
				during the department's in-depth review of the application, the Provisional
				trauma center shall submit the requested additional information to the
				department no later than September 1.
(j) By September 30, the department shall
				determine whether the omissions, deficiencies, or problems have been corrected.
				The department shall notify each Provisional trauma center on or before October
				1 of any omissions, deficiencies, or problems that were not resolved by
				submission of the requested additional information.
(k) Provisional trauma centers are subject to
				a site visit from October 1 to May 30. Any Provisional trauma center that was
				notified by the department on or before October 1 at the conclusion of the
				in-depth review that omissions, deficiencies, or problems were not resolved
				shall be given 30 calendar days from the department's notification following
				the completion of the site visit to provide additional information, as
				discussed in Rule  64J-2.016, F.A.C.
(l) The department shall deny the application
				of any Provisional trauma center that has not corrected the omissions,
				deficiencies, or problems noted from the in-depth review within 30 calendar
				days from the department's notification following the completion of the site
				visit, as provided in Rule
				 64J-2.016, F.A.C., regardless of
				the findings of the out-of-state review team regarding the quality of trauma
				patient care and trauma patient management provided by the Provisional trauma
				center.
(m) By July 1, the
				department shall approve or deny trauma centers based upon the recommendations
				of the out-of-state review team, the result of the in-depth review and, if
				necessary, upon application of the additional criteria in subsection
				 64J-2.016(10),
				F.A.C.:
1. The department shall issue the
				certificate to the hospital upon approval as a trauma center.
2. The department shall issue a letter of
				denial to each hospital not approved as a trauma center, specifying the basis
				for denial and informing the hospital of the next available approval cycle, and
				the hospital's right to an administrative hearing pursuant to Sections
				 120.57 and
				 395.4025,
				F.S.