The proposed rule amendments are intended to implement the statutory mandate set forth in subsection 459.005(2), F.S., with regard to the requirement for registration in facilities in which more than 1000 cc’s of supernatant fat is removed in ...  

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    DEPARTMENT OF HEALTH
    Board of Osteopathic Medicine

    RULE NOS.:RULE TITLES:
    64B15-14.007Standard of Care for Office Surgery
    64B15-14.0076Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation
    PURPOSE AND EFFECT: The proposed rule amendments are intended to implement the statutory mandate set forth in subsection 459.005(2), F.S., with regard to the requirement for registration in facilities in which more than 1000 cc’s of supernatant fat is removed in liposuction procedures.
    SUMMARY: The proposed rule amendments require logs to be maintained which document the removal of more than 1000 cc’s of supernatant fat is removed and requires those facilities to register with the Department.
    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.
    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.
    RULEMAKING AUTHORITY: 459.005, 459.015(1)(z), 459.026 FS.
    LAW IMPLEMENTED: 456.069, 459.005(2), 459.015(1)(g), (x), (z), (aa), 459.026 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: Anthony Jusevitch, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin # C06, Tallahassee, Florida 32399-3256


    THE FULL TEXT OF THE PROPOSED RULE IS:

    64B15-14.007 Standard of Care for Office Surgery.

    NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICAL DETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.

    (1) No change.

    (2) General Requirements for Office Surgery.

    (a) through (b)  No change.

    (c) The surgeon must maintain a log of all liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, and Level II and Level III surgical procedures performed, which must include a confidential patient identifier, time of arrival in the operating suite, the surgeons name, diagnosis, patient ASA classification, the type of procedure, the level of surgery, the anesthesia provider, the type of anesthesia used, the duration of the procedure, the type of post-operative care, duration of recovery, disposition of the patient upon discharge, during surgery, and recovery. The log and all surgical records shall be provided to investigators of the Department of Health upon request.

    (d) through (m)  No change.

    (3) through (6)  No change.

    Rulemaking Authority 459.005(1), 459.015(1)(z), 459.026 FS. Law Implemented 459.015(1)(g), (x), (z), (aa), 459.026 FS. History–New 11-29-01, Amended 2-23-03, 11-2-05, 6-4-09, 8-30-10,                     .

    64B15-14.0076 Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation.

    (1) Registration.

    (a) Every Florida licensed osteopathic physician who holds an active Florida license and performs liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Level II surgical procedures in Florida with a maximum planned duration of five (5) minutes or longer or any Level III office surgery, as fully defined in Rule 64B15-14.007, F.A.C., shall register with the Department of Health. It is the osteopathic physician’s responsibility to ensure that every office in which he or she performs liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.

    (b) through (d)  No change.

    (2) through (3)  No change.

    Rulemaking Authority 459.005(1), (2) FS. Law Implemented 456.069, 459.005(2) FS. History–New 2-12-02, Amended 11-20-03, 6-4-09, 7-19-10,                         .


    NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Osteopathic Medicine
    NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Osteopathic Medicine
    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 2, 2012
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 4, 2013

     

Document Information

Comments Open:
1/22/2013
Summary:
The proposed rule amendments require logs to be maintained which document the removal of more than 1000 cc’s of supernatant fat is removed and requires those facilities to register with the Department.
Purpose:
The proposed rule amendments are intended to implement the statutory mandate set forth in subsection 459.005(2), F.S., with regard to the requirement for registration in facilities in which more than 1000 cc’s of supernatant fat is removed in liposuction procedures.
Rulemaking Authority:
459.005, 459.015(1)(z), 459.026, FS.
Law:
456.069, 459.005(2), 459.015(1)(g), (x), (z), (aa), 459.026 FS.
Contact:
Anthony Jusevitch, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin # C06, Tallahassee, Florida 32399-3256.
Related Rules: (2)
64B15-14.007. Standard of Care for Office Surgery
64B15-14.0076. Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation