64B8-9.009: Standard of Care for Office Surgery
PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify Level II office surgery with regard to sedation and to require automated external defibrillators (AEDs) in offices which perform Level II and Level III office surgery.
SUMMARY: The proposed rule amendment adds language to clarify sedation which characterizes Level II office surgery. In addition, the proposed rule amendments require automated external defibrillators (AEDs) in offices which perform Level II and Level III office surgery.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The Board prepared two Statements of Estimated Regulatory Costs for the rule. With regard to the change in subparagraph (4)(a)1., of the rule, any physician who is administering medication that alters the level of consciousness will incur the costs of registering as a Level II office surgery facility if they have not already done so. Those facilities which are required to register to comply with the rule will incur costs of $150 for registration and $1500 for a Department inspection if the facility is not accredited by one of the nationally recognized accrediting agencies. With regard to the requirement for AEDs for Level II and Level III office surgery facilities, the Board estimates that the cost will range between $1500 and $2000 for an AED system. There are currently 341 registered offices and those offices which do not currently have an AED will be required to purchase one.
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: 458.309(1), 458.331(1)(v) FS.
LAW IMPLEMENTED: 458.331(1)(g), (t), (v), (w), 458.351 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Jr., 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) through (3) No change.
(4) Level II Office Surgery.
(a) Scope.
1. Level II Office Surgery is that in which peri-operative medication and sedation are used by any means altering the level of consciousness intravenously, intramuscularly, or rectally, thus making intra and post-operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat.
2. No change.
(b) Standards for Level II Office Surgery.
1. through 2. No change.
3. Equipment and Supplies Required.
a. through g. No change.
h. Defibrillator or an Automated External Defibrillator unit (AED).
h. through k. renumbered i. through l. No change.
(5) No change.
(6) Level III Office Surgery.
(a) No change.
(b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following:
1. through 2. No change.
3. Equipment and Supplies Required.
a. through c. No change.
d. Defibrillator or an Automated External Defibrillator unit (AED).
d. through e. renumbered e. through f. No change.
4. No change.
Rulemaking Specific Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.331(1)(g), (t), (v), (w), 458.351 FS. HistoryNew 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,________.
