To revise the Florida Trauma Center Standards – DH Pamphlet 150-9, forms, and applicable rules.

DEPARTMENT OF HEALTH
Division of Emergency Medical Operations

RULE NO: RULE TITLE
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 Hospital Denied Approval
PURPOSE AND EFFECT: To revise the Florida Trauma Center Standards – DH Pamphlet 150-9, forms, and applicable rules.
SUMMARY: The following is a summary of the proposed revisions to the Trauma Center Standards, DOH Pamphlet 150-9, which is incorporated by reference in Rules 64J-2.011- 2.017, F.A.C., and applicable rules:
1) Adds an additional state required performance outcome indicator for all trauma centers to track the percentage of traumatic C1, C2 and/or C3 spinal cord injury patients who are admitted or transferred to the trauma center ICUs that are eligible for and receive the diaphragm pacer surgery;
2) Reduces the number of indicators the trauma centers must identify and monitor relevant to their respective facility from seven to six;
3) Requires the trauma centers to maintain written policies and procedures for the implementation of the preventive ulcer program standards of care (Sample policies and procedures are provided); and
4. Technical revisions to change the date of the pamphlet and forms, and to comply with statutory language in Section 395.401(2), F.S.
The revisions to the rules include technical changes to the date of the DOH Pamphlet 150-9 as referenced in Rules 64J-2.011- 2.017, F.A.C, clarification of the trauma centers’ compliance date of the new standards, and clarification of the process for the approval of trauma centers.
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: 395.401, 395.405 FS.
LAW IMPLEMENTED: 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 HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: Thursday, February 11, 2010, 2:00 p.m. – 5:00 p.m. EST
PLACE: Department of Health, Division of Emergency Medical Operations, Capital Circle Office Complex, 4052 Bald Cypress Way, Conference Room 301, Tallahassee, FL 32399-1738; Conference Call Number: [phone], Conference Code: 2354440. If a hearing is not requested, the hearing noticed above will not be held. Written comments may be submitted in lieu of a request for a hearing at the address below, Email: [e-mail] or by Fax: [phone].
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 24 hours before the workshop/meeting by contacting: Janet Collins at the following email address: [e-mail] or by Fax: [phone]. 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, [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

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, _______ 2010 January 2008, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4), F.A.C. Any hospital that has been granted Provisional trauma center status or has been granted a 7-year Certificate of Approval to operate as a verified trauma center at the time this rule is amended must be in full compliance with the revised standards one year from the date the rule is amended. On or after the effective date of the amended rule, completed applications for Provisional trauma center status that do not demonstrate full compliance with these standards shall be denied. Trauma centers must be in full compliance with these standards by January 1, 2009.

(2) To be a Level I trauma center, a hospital shall be a state licensed general hospital and shall:

(a) Meet and maintain after receiving provisional status and during the 7 year approval period the standards for a Level I trauma center as provided in DHP 150-9, _____ 2010 January 2008;

(b) through (d) No change.

(3) To be a Level II trauma center, a hospital shall:

(a) Meet and maintain after receiving provisional status and during the 7 year approval period the standards for a Level II trauma center, as provided in DHP 150-9, _____2010 January 2008;

(b) through (d) No change.

(4) To be a pediatric trauma center, a hospital shall:

(a) Meet and maintain after receiving provisional status and during the 7 year approval period the standards for a pediatric trauma center, as provided in DHP 150-9, ______ 2010 January 2008;

(b) through (d) No change.

(5) The standards published in DHP 150-9, ______2010 January 2008, are subject to revision at any time through rule promulgation. Any hospital that has been granted Provisional trauma center status or has been granted a 7 year Certificate of Approval as a trauma center shall comply with all revisions to the standards published in DHP 150-9, beginning on the date the amended rule becomes effective.

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) and Table 1 No change.

(a) The department shall accept a letter of intent, DH Form 1840, _____ 2010 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), 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 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 a completed an 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, _____ 2010 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), 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, _____ 2010 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), F.A.C. The manual contains the following forms:

a. DH Form 2032, _____ 2010 January 2008, General Information for Level I Trauma Center Application;

b. DH Form 2032-A, _____ 2010 January 2008, Level I Trauma Center Approval Standards Summary Chart;

c. DH Form 2032-B, _____ 2010 January 2008, Application for Level I Trauma Center Approval Letter of Certification;

d. DH Form 2032-C, _____ 2010 January 2008, Level I Trauma Center Surgical Specialties Certifications;

e. DH Form 2032-D, _____ 2010 January 2008, Level I Trauma Center Non-Surgical Specialties Certifications;

f. DH Form 2032-E, _____ 2010 January 2008 2008, Level I Trauma Center General Surgeons Commitment Statement;

g. DH Form 2032-F, _____ 2010 January 2008, Level I Trauma Center General Surgeons Available for Trauma Surgical Call;

h. DH Form 2032-G, _____ 2010 January 2008, Level I Trauma Center Neurosurgeons Available for Trauma Surgical Call;

i. DH Form 2032-H, _____ 2010 January 2008, Level I Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements;

j. DH Form 2032-I, _____ 2010 January 2008, Level I Trauma Center Surgical Specialists On Call and Promptly Available;

k. DH Form 2032-J, _____ 2010 January 2008, Level I Trauma Center Emergency Department Physicians;

l. DH Form 2032-K, _____ 2010 January 2008, Level I Trauma Center Anesthesiologists Available for Trauma Call;

m. DH Form 2032-L, _____ 2010 January 2008, Level I Trauma Center C.R.N.A.s Available for Trauma Call; and

n. DH Form 2032-M, _____ 2010 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, _____ 2010 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), F.A.C. The manual contains the following forms:

a. DH Form 2043, _____ 2010 January 2008, General Information for Level II Trauma Center Application;

b. DH Form 2043-A, _____ 2010 January 2008, Level II Trauma Center Approval Standards Summary Chart;

c. DH Form 2043-B, _____ 2010 January 2008, Application for Level II Trauma Center Approval Letter of Certification;

d. DH Form 2043-C, _____ 2010 January 2008, Level II Trauma Center Surgical Specialties Certifications;

e. DH Form 2043-D, _____ 2010 January 2008, Level II Trauma Center Non-Surgical Specialties Certifications;

f. DH Form 2043-E, _____ 2010 January 2008, Level II Trauma Center General Surgeons Commitment Statement;

g. DH Form 2043-F, _____ 2010 January 2008, Level II Trauma Center General Surgeons Available for Trauma Surgical Call;

h. DH Form 2043-G, _____ 2010 January 2008, Level II Trauma Center Neurosurgeons Available for Trauma Surgical Call;

i. DH Form 2043-H, _____ 2010 January 2008, Level II Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements;

j. DH Form 2043-I, _____2010 January 2008, Level II Trauma Center Surgical Specialists On Call and Promptly Available;

k. DH Form 2043-J, _____ 2010 January 2008, Level II Trauma Center Emergency Department Physicians;

l. DH Form 2043-K, _____ 2010 January 2008, Level II Trauma Center Anesthesiologists Available for Trauma Call;

m. DH Form 2043-L, _____ 2010 January 2008, Level II Trauma Center C.R.N.A.s Available for Trauma Call; and

n. DH Form 2043-M, _____ 2010 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, _____ 2010 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), F.A.C. The manual contains the following forms:

a. DH Form 1721, _____ 2010 January 2008, General Information for Pediatric Trauma Center Application;

b. DH Form 1721-A, _____ 2010 January 2008, Pediatric Trauma Center Approval Standards Summary Chart;

c. DH Form 1721-B, _____ 2010 January 2008, Application for Pediatric Trauma Center Letter of Certification;

d. DH Form 1721-C, _____ 2010 January 2008, Pediatric Trauma Center Surgical Specialties Certifications;

e. DH Form 1721-D, _____ 2010 January 2008, Pediatric Trauma Center Non-Surgical Specialties Certifications;

f. DH Form 1721-E, _____ 2010 January 2008, Pediatric Center General Surgeons Commitment Statement;

 g. DH Form 1721-F, _____ 2010 January 2008, Pediatric Trauma Center General Surgeons Available for Trauma Surgical Call;

h. DH Form 1721-G, _____ 2010 January 2008, Pediatric Trauma Center Neurosurgeons Available for Trauma Surgical Call;

i. DH Form 1721-H, _____ 2010 January 2008, Pediatric Trauma Center Neurological, Pediatric Trauma and Neurological, and Neuroradiology Statements;

j. DH Form 1721-I, _____ 2010 January 2008, Pediatric Trauma Center Surgical Specialists On Call and Promptly Available;

k. DH Form 1721-J, _____ 2010 January 2008, Pediatric Trauma Center Emergency Department Physicians;

l. DH Form 1721-K, _____ 2010 January 2008, Pediatric Trauma Center Anesthesiologists Available for Trauma Call;

m. DH Form 1721-L, _____2 010 January 2008, Pediatric Trauma Center C.R.N.A.s Available for Trauma Call; and

n. DH Form 1721-M, _____ 2010 January 2008, 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, _____ 2010 January 2008, as follows:

Level I – No change.

Level II – No change.

Pediatric – No change.

(e) through (m)2. 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) No change.

(2) To be considered for an extension, a hospital must submit an application in accordance with the requirements in 64J-2.012, F.A.C., together with a request for extension. The request for extension must contain the following:

(a) The specific date the hospital desires to have the department begin the provisional review of the hospital’s application;

(b) A reference to each standard, or specific part of a standard, in DHP 150-9, _____ 2010 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), 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, _____ 2010 January 2008, Level I Trauma Center Certificate of Approval, DH Form 2043-Z, _____ 2010 January 2008, Level II Trauma Center Certificate of Approval, or DH Form 1721-Z, _____ 2010 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), 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, _____2010 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), 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, _____ 2010 January 2008.

(2) All renewing trauma centers shall receive an on-site survey after the department’s receipt of the completed DH Form 2032R, _____ 2010 January 2008. The department shall notify each trauma center of the results of the site survey within 30 working days from completion of the site survey. If the trauma center desires to provide additional information regarding the results of the site survey to the department to be considered, 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 trauma center 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 survey.

(3) 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, _____ 2010 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), F.A.C., and to determine the quality of trauma care provided by the hospital.

(2) through (3) No change.

(4) The reviewers shall assess each applicant hospital’s compliance with the standards published in DHP 150-9, _____ 2010 January 2008, by means of direct observation, review of call schedules, and review of patient charts. Reviewers also shall assess the quality of trauma patient care and trauma patient management by reviewing facility trauma mortality data, by reviewing patient charts and by reviewing trauma case summaries and minutes of trauma quality management committee meetings pursuant to Standard XVIII of DHP 150-9, _____ 2010 January 2008.

(5)(a) through (b) No change.

(c) Patient charts to be reviewed shall be selected by the department from cases meeting the criteria listed in Standard XVIII B.2., published in DHP 150-9, _____ 2010 January 2008. A minimum of 75 cases shall be selected for review in each facility. If the cases total less than 75, then all cases are subject to review.

(d) through (e) No change.

(6) The reviewers shall rate a Provisional trauma center which they have reviewed as either acceptable, acceptable with corrections, or unacceptable. The rating shall be based on each facility’s substantial compliance with the standards published in DHP 150-9, _____ 2010 January 2008, and upon the performance of each Provisional trauma center in providing acceptable trauma patient care and trauma patient management which resulted in acceptable patient outcomes.

(7) 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, _____ 2010 January 2008, which is 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 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 M. Viamonte Ros. M.D., M.P.H.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 5, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: November 12, 2009