The proposed rule amendments are intended to implement the statutory mandate set forth in subsection 458.309(3), F.S., with regard to the requirement for registration in facilities in which more than 1000 cc’s of supernatant fat is removed in ...

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO.: RULE TITLE:
64B8-9.009: Standard of Care for Office Surgery
64B8-9.0091: Requirement for Physician Office Registration; Inspection or Accreditation
PURPOSE AND EFFECT: The proposed rule amendments are intended to implement the statutory mandate set forth in subsection 458.309(3), 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.
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: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.
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: 458.309(1), (3), 458.331(1)(v) FS.
LAW IMPLEMENTED: 458.309(3), 458.331(1)(v), 458.351 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: Allison M. Dudley, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.

THE FULL TEXT OF THE PROPOSED RULE IS:

64B8-9.009 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 name of the physician who provided medical clearances, the surgeon’s name, diagnosis, CPT Codes, 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, list of medications used during surgery and recovery, and any adverse incidents, as identified in Section 458.351, F.S. The log and all surgical records shall be provided to investigators of the Department of Health upon request and must be maintained for six (6) years from the last patient contact.

(d) through (m)  No change.

(3) through (6)  No change.

Rulemaking Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.331(1)(v), 458.351 FS. History–New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-3-07, 3-25-10, 8-6-12,________.

 

64B8-9.0091 Requirement for Physician Office Registration; Inspection or Accreditation.

(1) Registration.

(a) Every licensed 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 more than five (5) minutes or any Level III office surgery, as fully defined in Rule 64B8-9.009, F.A.C., shall register the office with the Department of Health. It is the 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. Physicians participating in post-graduate training programs, and registered pursuant to Section 458.345, F.S., may provide services under the direct supervision of a Florida physician, licensed pursuant to Section 458.311 or 458.313, F.S., in an office surgery facility and under the auspices of their training program for a period of time not to exceed three months without registering pursuant to this rule.

(b) through (d)  No change.

(2)  through (3)  No change.

Rulemaking Authority 458.309(1), (3) FS. Law Implemented 456.069, 458.309(3) FS. History–New 5-15-00, Amended 9-18-01, 8-5-03, 9-1-03, 2-9-05, 8-22-06, 10-30-07,                  .

NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 12, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 30, 2012