This notice is to alert the public that the Department of Health, Office of Trauma did not receive a request for a rule development workshop from the June 5, 2009 F.A.W. Notice of Rule Development on the proposed revisions to the above referenced ...

DEPARTMENT OF HEALTH
Division of Emergency Medical Operations

RULE NO: RULE TITLE
64J-2.001: Definitions
64J-2.004: Adult Trauma Scorecard Methodology
64J-2.006: Trauma Registry
64J-2.011: Trauma Center Requirements
64J-2.012: Process for the Approval of Trauma Centers
64J-2.013: Extension of Application Period
64J-2.014: Certificate of Approval
64J-2.015: Process for Renewal of Trauma Centers
64J-2.016: Site Visits and Approval
64J-2.017: Application by Hospitals Denied Approval
PURPOSE AND EFFECT: This notice is to alert the public that the Department of Health, Office of Trauma did not receive a request for a rule development workshop from the June 5, 2009 F.A.W. Notice of Rule Development on the proposed revisions to the above referenced rules. Therefore, the Office of Trauma is moving forward with this Notice of Proposed Rulemaking to create a new definitions section in Chapter 64J-2, F.A.C., to include the definitions that apply to Chapter 64J-2, Trauma, F.A.C., with cross references to definitions in 64J-1.001, F.A.C., that apply to both EMS and Trauma rules.
SUMMARY: The proposed rule revisions include: Creation of Rule 64J-2.001 Definitions, F.A.C.; Transfer trauma related definitions from Rule 64J-1.001, F.A.C., to the new 64J-2.001, F.A.C. The only definition that is revised is the definition of “department.” In the new definition of ‘department” refers to the Office of Trauma. Creates cross references to definitions in 64J-1.001, F.A.C., that apply to both EMS and Trauma rules. Technical revisions throughout 64J-2, F.A.C., where the definition of “department” and “Glascow Coma Scale Score” are referenced. The references for “department” are changed from subsection 64J-1.001(8), F.A.C., to subsection 64J-2.001(4), F.A.C., and the reference for “Glascow Coma Scale Score” is changed from subsection 64J-1.001(10) to subsection 64J-2.001(6). Technical revision to correct an error in the table number “IV” to table number “I” in Rule 64J-2.012, F.A.C.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 381.0011(13), 395.401(2), 395.4025(13), 395.4036, 395.4045, 395.405(8), 401.45(5) FS.
LAW IMPLEMENTED: 381.0205, 395.1031, 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045, 395.405, 401.30, 401.35, 401.45, 765.401 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Janet Collins [phone], Ext. 2775. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan McDevitt, Office of Trauma, Department of Health, 4052 Bald Cypress Way, Bin C-18, Tallahassee, Florida 32399-1738, [phone], ext. 2760; Email: [e-mail]; Fax: [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

64J-2.001 Definitions.

In addition to the definitions provided in Sections 395.401, 395.4001, 401.107, and 401.23, F.S., the following definitions apply to rules under Chapter 64J-2. F.A.C.:

(1) Abbreviated Injury Score (AIS-90) – means a consensus derived, anatomically based system that classifies individual injuries by body region on a 6-point ordinal severity scale ranging from 1 to 6. The methodology for determining AIS-90 Code is found in the “Abbreviated Injury Scale 1990 – Update 98,” which is incorporated by reference and is available from the Association for the Advancement of Automotive Medicine, P. O. Box 4176, Barrington, IL 60011-4176.

(2) Application – means a completed application form, as specified by the department and is incorporated by reference in subparagraph 64J-2.012(1)(c)1., F.A.C., together with all documentation required by these rules.

(3) Burn – as defined in Rule 64J-1.001, F.A.C.

(4) Department – means the Florida Department of Health (DH), Office of Trauma, 4052 Bald Cypress Way, Bin C#18, Tallahassee, Florida 32399-1738, as referenced in Chapter 64J-2, F.A.C.

(5) Emergency Medical Services (EMS) Provider – as defined in Rule 64J-1.001, F.A.C.

(6) Glasgow Coma Scale Score – means the neurological assessment developed by G. Teasdale and B. Jennitte in “Assessment of Coma and Impaired Consciousness: A Practical Scale” Lancet, 1974; 2: 81-84, which is incorporated by reference and available from the department.

(7) ICD-9-CM – means the “International Classification of Disease, 9th Revision, Clinical Modification,” March, 1989, U.S. Department of Health and Human Services Publication No. (PHS) 89-1260; an internationally applied method by which diseases or groups of medical conditions or injuries are coded for the purpose of statistical analyses. This book is incorporated by reference and available for purchase from the American Hospital Association, Central Office on ICD-9-DM, 1(800)242-2626, AHA, Post Office Box 92683, Chicago, IL 60675-2683.

(8) Injury Severity Score (ISS) – means the sum of the squares of the highest AIS-90 code in each of the three most severely injured body regions. The method for computing ISS is found in the “Abbreviated Injury Scale 1990 – Update 98.”

(9) Patient Care Record – as defined in Rule 64J-1.001, F.A.C.

(10) Pediatric Trauma Patient – means a trauma patient with anatomical and physical characteristics of a person 15 years of age or younger.

(11) Transfer or transport – as defined in Rule 64J-1.001, F.A.C.

(12) Trauma – means a blunt, penetrating or burn injury caused by external force or violence.

(13) Trauma Alert – means a notification initiated by EMS informing a hospital that they are en route with a patient meeting the trauma alert criteria.

(14) Trauma Alert Patient – means a person whose primary physical injury is a blunt, penetrating or burn injury, and who meets one or more of the adult trauma scorecard criteria in Rule 64J-2.004, F.A.C., or the pediatric trauma scorecard criteria in Rule 64J-2.005, F.A.C.

(15) Trauma Patient – means any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.

(16) Trauma Registry – means a statewide database which integrates medical and system information related to trauma patient diagnosis and the provision of trauma care by prehospital, hospital, and medical examiners.

(17) Trauma Transport Protocols (TTPs) – means a document which describes the policies, processes and procedures governing the dispatch of vehicles, and the triage and transport of trauma patients, which is incorporated by reference in Rule 64J-2.003, F.A.C., and is available from the department, as defined by subsection 64J-2.001(4), F.A.C.

Rulemaking Authority 381.0011(13), 395.401(2), 395.4025(13), 395.4036, 395.4045, 395.405(8), 401.45(5) FS. Law Implemented 381.0205, 395.1031, 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045, 395.405, 401.30, 401.35, 401.45, 765.401 FS. History–New________.

 

64J-2.004 Adult Trauma Scorecard Methodology.

(1) through (1)(a) No change.

(b) In assessing the condition of each adult trauma patient, the EMT or paramedic shall evaluate the patient’s status for each of the following components: airway, circulation, best motor response (a component of the Glasgow Coma Scale which is defined and incorporated by reference in subsection 64J-2.001(6) 64J-1.001(10), F.A.C.), cutaneous, longbone fracture, patient’s age, and mechanism of injury. The patient’s age and mechanism of injury shall only be assessment factors when used in conjunction with assessment criteria included in subsection (3) of this section.

(2) through (7) No change.

Rulemaking Specific Authority 395.4045, 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.4045, 395.405, 401.30, 401.35 FS. History–New 8-3-88, Amended 12-10-92, 11-30-93, Formerly 10D-66.102, Amended 11-4-99, 2-20-00, Formerly 64E-2.01, Amended________.

 

64J-2.006 Trauma Registry.

Instructions for completing and submitting data are defined in the Florida Trauma Registry Manual, February 2008, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C.

Rulemaking Specific Authority 395.405 FS. Law Implemented 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405, 401.30, 401.35 FS. History–New 8-3-88, Amended 12-10-92, 11-30-93, Formerly 10D-66.103, Amended 7-14-99, 11-19-01, 6-3-02, 6-9-05, 4-25-06, 7-8-08, Formerly 64E-2.018, Amended________.

 

64J-2.011 Trauma Center Requirements.

(1) The standards for Level I, Level II and Pediatric trauma centers are published in DH Pamphlet (DHP) 150-9, January 2008, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C. Trauma centers must be in full compliance with these standards by January 1, 2009.

(2) through (5) No change.

Rulemaking Specific Authority 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, 12-10-95, Formerly 10D-66.108, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.023, Amended________.

 

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

Table I No change.

(a) The department shall accept a letter of intent, DH Form 1840, January 2008, “Trauma Center Letter of Intent”, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), 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 submit an 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 an application by April 1 of the following year, 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, January 2008, 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) 64J-1.001(8), F.A.C., and the requested application(s);

(c) No change.

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 2008. The manual and the forms contained therein are incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(4), F.A.C. The manual contains the following forms: DH Form 2032, January 2008, General Information for Level I Trauma Center Application; DH Form 2032-A, January 2008, Level I Trauma Center Approval Standards Summary Chart; DH Form 2032-B, January 2008, Application for Level I Trauma Center Approval Letter of Certification; DH Form 2032-C, January 2008, Level I Trauma Center Surgical Specialties Certifications; DH Form 2032-D, January 2008, Level I Trauma Center Non-Surgical Specialties Certifications; DH Form 2032-E, January 2008, Level I Trauma Center General Surgeons Commitment Statement; DH Form 2032-F, January 2008, Level I Trauma Center General Surgeons Available for Trauma Surgical Call; DH Form 2032-G, January 2008, Level I Trauma Center Neurosurgeons Available for Trauma Surgical Call; DH Form 2032-H, January 2008, Level I Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements; DH Form 2032-I, January 2008, Level I Trauma Center Surgical Specialists On Call and Promptly Available; DH Form 2032-J, January 2008, Level I Trauma Center Emergency Department Physicians; DH Form 2032-K, January 2008, Level I Trauma Center Anesthesiologists Available for Trauma Call; DH Form 2032-L, January 2008, Level I Trauma Center C.R.N.A.s Available for Trauma Call; and DH Form 2032-M, January 2008, 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 2008. The manual and the forms contained therein are incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C. The manual contains the following forms: DH Form 2043, January 2008, General Information for Level II Trauma Center Application; DH Form 2043-A, January 2008, Level II Trauma Center Approval Standards Summary Chart; DH Form 2043-B, January 2008, Application for Level II Trauma Center Approval Letter of Certification; DH Form 2043-C, January 2008, Level II Trauma Center Surgical Specialties Certifications; DH Form 2043-D, January 2008, Level II Trauma Center Non-Surgical Specialties Certifications; DH Form 2043-E, January 2008, Level II Trauma Center General Surgeons Commitment Statement; DH Form 2043-F, January 2008, Level II Trauma Center General Surgeons Available for Trauma Surgical Call; DH Form 2043-G, January 2008, Level II Trauma Center Neurosurgeons Available for Trauma Surgical Call; DH Form 2043-H, January 2008, Level II Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements; DH Form 2043-I, January 2008, Level II Trauma Center Surgical Specialists On Call and Promptly Available; DH Form 2043-J, January 2008, Level II Trauma Center Emergency Department Physicians; DH Form 2043-K, January 2008, Level II Trauma Center Anesthesiologists Available for Trauma Call; DH Form 2043-L, January 2008, Level II Trauma Center C.R.N.A.s Available for Trauma Call; and DH Form 2043-M, January 2008, 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 2008. The manual and the forms contained therein are incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C. The manual contains the following forms: DH Form 1721, January 2008, General Information for Pediatric Trauma Center Application; DH Form 1721-A, January 2008, Pediatric Trauma Center Approval Standards Summary Chart; DH Form 1721-B, January 2008, Application for Pediatric Trauma Center Letter of Certification; DH Form 1721-C, January 2008, Pediatric Trauma Center Surgical Specialties Certifications; DH Form 1721-D, January 2008, Pediatric Trauma Center Non-Surgical Specialties Certifications; DH Form 1721-E, January 2008, Pediatric Center General Surgeons Commitment Statement; DH Form 1721-F, January 2008, Pediatric Trauma Center General Surgeons Available for Trauma Surgical Call; DH Form 1721-G, January 2008, Pediatric Trauma Center Neurosurgeons Available for Trauma Surgical Call; DH Form 1721-H, January 2008, Pediatric Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements; DH Form 1721-I, January 2008, Pediatric Trauma Center Surgical Specialists On Call and Promptly Available; DH Form 1721-J, January 2008, Pediatric Trauma Center Emergency Department Physicians; DH Form 1721-K, January 2008, Pediatric Trauma Center Anesthesiologists Available for Trauma Call; DH Form 1721-L, January 2008, Pediatric Trauma Center C.R.N.A.s Available for Trauma Call; and DH Form 1721-M, January 2008, Pediatric Trauma Center Non-Surgical Specialists On Call and Promptly Available.

(d) through (m) No change.

(2) through (4) No change.

Rulemaking Specific 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________.

 

64J-2.013 Extension of Application Period.

(1) through (2)(a) No change.

(b) A reference to each standard, or specific part of a standard, in DHP 150-9, January 2008, 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) 64J-1.001(8), F.A.C., that the hospital is unable to meet;

(c) through (d) No change.

(3) through (14) No change.

Rulemaking Specific 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________.

 

64J-2.014 Certificate of Approval.

Each hospital approved as a trauma center shall be issued a DH Form 2032-Z, January 2008, Level I Trauma Center Certificate of Approval, DH Form 2043-Z, January 2008, Level II Trauma Center Certificate of Approval, or DH Form 1721-Z, January 2008, Pediatric Trauma Center Certificate of Approval, which are incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C. The certificates shall include:

(1) through (3) No change.

Rulemaking Specific 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, Formerly 10D-66.110, Amended 2-20-00, 4-15-01, 6-9-05, 3-5-08, Formerly 64E-2.026, Amended________.

 

64J-2.015 Process for Renewal of Trauma Centers.

(1) At least 14 months prior to the expiration of the trauma center’s certification, the department shall send, to each trauma center that is eligible to renew, a blank DH Form 2032R, January 2008, Trauma Center Application to Renew, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C., in accordance with the provisions of this section. Within 15 calendar days after receipt, the trauma center choosing to renew its certification shall submit to the department the completed DH Form 2032R, January 2008.

(2) through (4) No change.

Rulemaking Specific Authority 395.4025, 395.405 FS. Law Implemented 395.401, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 8-3-88, Amended 12-10-92, 1-23-96, Formerly 10D-66.111, Amended 3-15-98, 2-20-00, 6-9-05, 3-5-08, Formerly 64E-2.027, Amended________.

 

64J-2.016 Site Visits and Approval.

(1) Each Provisional trauma center shall receive an on-site evaluation to determine whether the hospital is in substantial compliance with standards published in DHP 150-9, January 2008, 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) 64J-1.001(8), F.A.C., and to determine the quality of trauma care provided by the hospital.

(2) through (12) No change.

Rulemaking Specific 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________.

 

64J-2.017 Application by Hospital Denied Approval.

Any hospital that was not approved as a trauma center based on the application of criteria in Rule 64J-2.016, F.A.C., may submit a completed Letter of Intent DH Form 1840, January 2008, which is available from the department, as defined by subsection 64J-2.001(4) 64J-1.001(8), F.A.C., postmarked no earlier than September 1 and no later than midnight October 1 of the following year.

Rulemaking Specific 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, 12-10-95, Formerly 10D-66.113, Amended 2-20-00, 6-9-05, 3-5-08, Formerly 64E-2.029, Amended________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Susan McDevitt, Director, Office of Trauma
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ana Viamonte Ros, M.D., M.P.H.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 25, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: June 5, 2009