Fla. Admin. Code Ann. R. 64J-2.012 - Process for the Approval of Trauma Centers

(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.

(2) Each hospital denied provisional status or not approved as a trauma center may, within 30 days of receipt of the denial notice, request a hearing in which to contest the findings of the department.

(3) The department shall deny, suspend, or revoke the approval of any Provisional trauma center which misrepresents a material fact in its application for trauma center approval, including the site survey process.

(4) In the event a trauma center intends to terminate its trauma services, it shall give advance notice of its intent to terminate to the department via a letter signed by its CEO or designee. The letter shall be addressed to the Division Director, Division of Emergency Medical Operations, and shall reference and comply with Section 395.4025(8), F.S. The letter shall include an explanation of the specific reason or reasons why the trauma center wants to terminate its trauma services. The termination will be effective 6 months from receipt of the letter by the department unless a longer time is specified in the letter. Upon termination, the hospital shall cease operating or holding itself out as a trauma center.

Notes

Fla. Admin. Code Ann. R. 64J-2.012

Rulemaking Authority 395.405 FS. Law Implemented 395.1031, 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS.

New 8-3-88, Amended 12-10-92, 12-10-95, Formerly 10D-66.109, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.024, Amended 11-5-09, 4-20-10.

New 8-3-88, Amended 12-10-92, 12-10-95, Formerly 10D-66.109, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.024, Amended 11-5-09, 4-20-10.