This rule is being promulgated to establish the procedures and forms required for licensure of Burn Unit Services in hospitals, as required in Section 408.0361(2), Florida Statutes.

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

Rule No.: RULE TITLE
59A-3.2085: Department and Services
PURPOSE AND EFFECT: This rule is being promulgated to establish the procedures and forms required for licensure of Burn Unit Services in hospitals, as required in Section 408.0361(2), Florida Statutes.
SUMMARY: This rule specifies and incorporates the guidelines regarding staffing, physician training and experience, operating procedures, equipment, physical plant and patient selection criteria to ensure patient quality and safety. The rule establishes application procedures and incorporates the application form to be used by hospitals.
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: 408.0361(2) FS.
LAW IMPLEMENTED: 408.0361(2) 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(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: October 25, 2010, 1:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room B, 2727 Mahan Drive, Tallahassee, FL 32308
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 5 days before the workshop/meeting by contacting: Kaylyn Boles, Health Facility Regulation at [phone], or at [e-mail]. 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: Bill McCort, Health Facility Regulation at [phone], or at [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-3.2085 Department and Services.

(1) through (17) No change.

(18) Burn Units.

(a) All licensed hospitals that operate burn units under Section 408.0361(2), F.S., shall comply with the guidelines published by the American College of Surgeons, Committee on Trauma. Hospitals are considered to be in compliance with the American College of Surgeons guidelines when they adhere to guidelines regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. he applicable guidelines, herein incorporated by reference, are “Guidelines for the Operation of Burn Centers,” in Resources for Optimal Care of the Injured Patient, Committee on Trauma, American College of Surgeons, (2006); Chapter 14, pages 79 through 86. These guidelines are available at: http://www.ameriburn.org/Chapter14.pdf. The determination of compliance with the guidelines is based on the burn unit providing evidence of verification from the American Burn Association.

(b) A hospital may apply for the initial licensure of a burn unit by submitting a hospital licensure application as specified in paragraph 59A-35.060(1)(h), Florida Administrative Code, indicating the addition of burn unit services, and attaching License Application Burn Unit Services, AHCA Form 3130-8012, August, 2010, incorporated herein by reference. Both of these forms are available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml. The applicant should complete this form indicating the date that burn unit services will begin and that the hospital is in partial compliance with “Guidelines for the Operation of Burn Centers” but has not received initial verification as a burn unit. A burn unit is considered to be in partial compliance with the guidelines until it demonstrates that it admits an annual average of 100 or more patients with acute burn injuries, averaged over a three-year period, and meets all other guidelines. During this initial licensure period, the hospital license will indicate that the burn unit is “provisional”. Upon completion of the verification process with the American Burn Association, the provisional status will be lifted, the burn unit will be fully licensed with the service listed on the hospital license. The license application form must be signed by the hospital’s Chief Executive Officer.

(c) Burn units that were in operation prior to June 30, 2004 shall be considered grandfathered and authorized to operate as a burn unit with service listed on their hospital license. The grandfathered licensure shall be effective for three years from the adoption of this rule but burn units that were in operation prior to June 30, 2004 shall be required to meet the promulgated licensure rules and receive verification from the American Burn Association within three years of the effective date of this rule.

(d) At the time of licensure renewal, burn unit operators shall submit current documentation from the American Burn Association that verifies the hospital’s adherence to the guidelines adopted by reference and effective as of the effective date of this rule.

(e) Each provider of burn unit services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

(f) Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

Rulemaking Authority 408.0361(2) FS. Law Implemented 408.0361(2) FS. History–New_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Jeffrey Gregg
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 13, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 9, 2010