The Department proposes to amend these rules to develop an inclusive, sustainable trauma system that allocates trauma center need necessary to establish reasonable access to high quality trauma services.

DEPARTMENT OF HEALTH

Division of Emergency Preparedness and Community Support

RULE NOS.:RULE TITLES:

64J-2.010 Allocation of Trauma Centers among the Trauma Service Areas (TSAs)

64J-2.012 Process for the Approval of Trauma Centers

64J-2.013 Extension of Application Period

64J-2.016 Site Visits and Approval

PURPOSE AND EFFECT:  The Department proposes to amend these rules to develop an inclusive, sustainable trauma system that allocates trauma center need necessary to establish reasonable access to high quality trauma services.

SUMMARY: The rule allocates the minimum trauma center need for all trauma service areas (TSAs) around the state, revises the process and standards for selecting trauma centers, and clarifies that an allocation of minimum need  under rule 64J-2.010 does not affect the ability of an existing verified trauma center to renew its certificate to operate as a trauma center. The rule also removes hearing rights provisions that are redundant to provisions in Chapter 120, Florida Statutes.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, and the analysis undertaken in reviewing the checklist the agency has determined that this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in paragraph 120.541(2)(a), F.S.

Any person who wishes to provide information regarding the statement of estimated regulatory costs, or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 395.402, 395.4025, 395.405 FS.

LAW IMPLEMENTED: 395.1031, 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Leah Colston, Bureau Chief, Bureau of Emergency Medical Oversight, 4052 Bald Cypress Way, Bin #A20, Tallahassee, Florida 32399-1722

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64J-2.010 Allocation of Trauma Centers Among the Trauma Service Areas (TSAs).

(1) The need for Level I, and Level II and Pediatric Ttrauma Ccenters shall be determined and allocated among the trauma service areas (TSAs) based upon the following:

(a) The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment.

1. through 2. No change.

3. Community Support

a. Letters of support for an additional trauma center from 25 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before July April 1 annually.

b. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before July April 1 annually.

4. through 6. No change.

(b) The following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs:

1. through 4. No change.

(2) An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015.

(3) Subject to application of the statutory limit on trauma centers described in paragraph 395.402(4)(c), F.S., tThe minimum number of trauma centers allocated for each TSA based upon the 2015 Amended Trauma Service Area Assessment, dated January 6, 2016 March 24, 2014, located which can be found at http://www.floridahealth.gov/%5C/licensing-and-regulation/trauma-system/_documents/tsa-2016.pdf www.FLHealth.gov/licensing-and-regulation/trauma-system/_documents/trauma-area-service-assessment.pdf is as follows:

 

TSA	Counties	Trauma Centers
1	Escambia, Okaloosa, Santa Rosa, Walton	1
2	Bay, Gulf, Holmes, Washington	1
3	Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla	1
4	Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union	1
5	Baker, Clay, Duval, Nassau, St. Johns	2 1
6	Citrus, Hernando, Marion	1 2
7	Flagler, Volusia	1
8	Lake, Orange, Osceola, Seminole, Sumter	3
9	Pasco, Pinellas	2
10	Hillsborough	1
11	Hardee, Highlands, Polk	1
12	Brevard, Indian River	1
13	DeSoto, Manatee, Sarasota	2
14	Martin, Okeechobee, St. Lucie	1
15	Charlotte, Glades, Hendry, Lee	1
16	Palm Beach	1
17	Collier	1
18	Broward	1 2
19	Dade, Monroe	2 3

 

(4) The allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., provided the following conditions are met:

(a) During the most recent verification cycle, the trauma center has continuously provided trauma services and has not notified the department that it has substantially reduced or terminated trauma services pursuant to subsection 395.4025(8), F.S.

(b) The trauma center applies for renewal in the timeframe outlined in subsection 64J-2.015(1), F.A.C.

(c) The trauma center demonstrates compliance with the trauma center standards upon completion of the timeframes described in subsection 64J-2.015(2), F.A.C.

Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402, 395.4025 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022, Amended 7-29-14,            .

 

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; (uUnless stated otherwise all dates given by calendar month and day refer to that date each year): .)

Table I

Reference Section 64JE-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 at http://www.flrules.org/Gateway/reference.asp?No=Ref-#### and 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, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open 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) No change.

(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 at http://www.flrules.org/Gateway/reference.asp?No=Ref-#### and from the department, as defined by subsection 64J-2.001(4), F.A.C. The manual contains the following forms:

a. through n. No change.

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 at http://www.flrules.org/Gateway/reference.asp?No=Ref-#### and from the department, as defined by subsection 64J-2.001(4), F.A.C. The manual contains the following forms:

a. through n. No change.

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 at http://www.flrules.org/Gateway/reference.asp?No=Ref-#### and from the department, as defined by subsection 64J-2.001(4), F.A.C. The manual contains the following forms:

a. through n. No change.

(d) through (j) No change.

(k) Provisional trauma centers are subject to a site visit from October 1 to May 30. Any Provisional Ttrauma Ccenter 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) No change.

(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(11)(10), F.A.C.:

1. No change.

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) through (4) renumbered (2) through (3) No change.

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

 

64J-2.013 Extension of Application Period.

(1) through (6) No change.

(7) The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA.

(8) If the hospital’s request for extension is denied, the hospital may, within 30 days of receipt of the notification of denial, request a hearing to contest the decision of the department, in accordance with Chapter 120.57, F.S.

(9) through (11) renumbered (8) through (10) No change.

(11) (12) A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial.

(13) through (14) renumbered (12) through (13) No change.

Rulemaking Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 12-10-92, Amended 12-10-95, Formerly 10D-66.1095, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.025, Amended 11-5-09, 4-20-10,            .

 

64J-2.016 Site Visits and Approval.

(1) through (4) No change.

(5) Evaluation of the Quality of Trauma Patient Care and Trauma Patient Management:

(a) through (d) No change.

(e) Notwithstanding any standard provided in rule 64J-2.011, and DH Pamphlet (DHP) 150-9, January 2010, Trauma Center Standards, each Level I  Trauma Center and Level I Provisional Trauma Center shall, upon request by the department, provide evidence of an admitted patient volume level of at least 1,200 trauma patients yearly, or at least 240 admitted trauma patients yearly with an ISS score higher than 15. For hospitals that have not operated as a provisional Level I Ttrauma Ccenter or as a Level I Ttrauma Ccenter for at least a year, these volumes may be measured on a quarterly basis with the annual volume requirements prorated. 

(e) Reviewers shall study the trauma case reviews and trauma quality management committee meeting minutes to evaluate the overall effectiveness of the quality management program.

(6) No change.

(7) The department shall evaluate the results of the site visit review and the in-depth application review of each Provisional Ttrauma Ccenter between June 1 and July 1. All applicant hospitals shall be notified simultaneously of their approval or denial to become a trauma center on or before July 1. The department’s selection will be based on the results of the site visit and the in-depth application review. In those situations where the number of in which there are more trauma centers and or Provisional Ttrauma Ccenters exceeds the number of trauma centers allowed by paragraph 395.402(4)(c), F.S. than available positions in the TSA, the criteria in subsection (11) of this rule section shall be applied for final selection.

(8) The department shall notify each Provisional Ttrauma Ccenter of the results of the site visit within 30 working days from completion of the site visit. The department shall include in the notice any problems that the Provisional Ttrauma Ccenter was informed of at the conclusion of the department’s in-depth application review. If the Provisional Ttrauma Ccenter desires to provide additional information regarding the results of the site visit or in-depth application review to the department to be considered during the final evaluation between June 1 and July 1, the information must be provided in writing and be received by the department within 30 calendar days of the hospital’s receipt of the department’s notice. If the Provisional Ttrauma Ccenter does elects not to respond to the department’s notice within 30 calendar days, the department shall make the final determination of approval or denial based solely on information collected during the applicant’s site visit and in-depth application review.

(9) through (10) No change.

(11) If the number of Provisional Ttrauma Ccenters found eligible for selection by the department – when added to the number of existing trauma centers – in a given TSA exceeds the maximum number permitted, as provided in paragraph 395.402(4)(c), F.S. subsection 64J-2.010(3), F.A.C., the following criteria shall be applied independently and consecutively to all Provisional Ttrauma Ccenters in the TSA until application of the criteria results in the number of trauma centers authorized in paragraph 395.402(4)(c), F.S subsection 64J-2.010(3), F.A.C., for that TSA. When that occurs, the remaining criteria shall not be considered. The criteria to be applied are as follows:

(a) A hospital located in a TSA without a Level I or Level II recommended to be a Ttrauma Ccenter in the department-approved local or regional trauma agency plan pursuant to subparagraph 64J-2.007(2)(d)3., F.A.C., shall be given preference for selection approval preference over any hospital which was not recommended.

(b) A hospital shall be given selection preference based on the level of service they intend to provide according to the following sequence:

1. through 2. No. change.

3. A Provisional Level II Ttrauma Ccenter will be given preference over a Provisional pediatric Ttrauma Ccenter in TSA having only one allocated trauma center position, and in a TSA with more than one allocated trauma center position if there already exists an approved Level I trauma center, Level II trauma center with pediatrics, or a pediatric trauma center, or if in the instant selection process a Level I trauma center, Level II trauma center with pediatrics, or pediatric trauma center is to be selected.

(c) An applicant hospital with the greatest number of severely injured patients discharged in a geographic location that is most conducive to access by the greatest number of people to be served within a TSA shall be given preference for selection.

(d) A hospital representing the best geographic distribution with respect to terrain, population served and projected service population in a given TSA shall be given preference for selection.

(d)(e) No change.

(e) A hospital recommended to be a trauma center in the department-approved trauma agency plan shall be given approval preference over any hospital which was not recommended.

(12) The department shall inform, in writing, each Provisional Ttrauma Ccenter denied approval as a trauma center of its opportunity to request a hearing in which to contest the denial in accordance with Section 120.57, F.S.

Rulemaking Authority 395.4025, 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 8-3-88, Amended 12-10-92, 10-2-94, 12-10-95, Formerly 10D-66.112, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.028, Amended 11-5-09, 4-20-10,            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Leah Colston, Bureau Chief, Bureau of Emergency Medical Oversight.

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 31, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 31, 2016