The proposed rule amendments are intended to add the American Red Cross as an entity which provides certification in basic life support. Additionally, the Board intends to remove requirement that Vasopressin be stocked on the crash cart.  

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    DEPARTMENT OF HEALTH

    Board of Medicine

    RULE NO.:RULE TITLE:

    64B8-9.009Standard of Care for Office Surgery

    PURPOSE AND EFFECT: The proposed rule amendments are intended to add the American Red Cross as an entity which provides certification in basic life support. Additionally, the Board intends to remove requirement that Vasopressin be stocked on the crash cart.

    SUMMARY: The proposed rule amendments add the American Red Cross as an entity which provides certification in basic life support. Additionally, the requirement that Vasopressin be stocked on the crash cart is being deleted.

    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 concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board 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), 458.331(1)(v) FS.

    LAW IMPLEMENTED: 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: Claudia Kemp, 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) through (2) No change.

    (3) Level I Office Surgery.

    (a) No change.

    (b) Standards for Level I Office Surgery.

    1. Training Required. Surgeon’s continuing medical education should include: proper dosages; management of toxicity or hypersensitivity to regional anesthetic drugs. One assistant must hold current certification in an American Heart Association, or American Safety and Health Institute, or American Red Cross approved Basic Life Support course, and the surgeon must hold current certification in an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course.

    2. through 4. No change.

    (4) Level II Office Surgery.

    (a) No change.

    (b) Standards for Level II Office Surgery.

    1. No change.

    2. Training Required.

    a. No change.

    b. One (1) assistant must be currently certified in and by an American Heart Association, or American Safety and Heart Institute, or American Red Cross approved Basic Life Support course and the surgeon must be currently certified in and by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course.

    3. Equipment and Supplies Required.

    a. Full and current crash cart at the location the anesthetizing is being carried out. Medicines shall be stored per the manufacturer’s recommendations and multi-dose vials shall be dated once opened. The crash cart must include, at a minimum, the following intravenous or inhaled medications:

    I.  through XIX.  Renumbered as (I) through (XIX) No change.

    XX. Vasopressin 40 units;

    (XX) XXI. A calcium channel blocker class drug; and,

    (XXI) XXII. Intralipid 20% 500 ml solution (only if non-neuraxial regional blocks are performed).

    In the event of a drug shortage, the physician is allowed to substitute a therapeutically equivalent drug that meets the prevailing standard of care. The office must maintain documentation of its unsuccessful efforts to obtain the required drug.

    b. through j. No change.

    4. 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. Training Required.

    a. No change.

    b. One assistant must be currently certified by an American Heart Association, or American Safety and Health Institute, or American Red Cross approved Basic Life Support course and the surgeon must be currently certified by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course.

    2. through 4. 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, 11-22-12, 1-9-13, 3-3-13, 7-22-14, 4-6-15,                           .

     

    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: June 3, 2016

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 22, 2016

Document Information

Comments Open:
7/7/2016
Summary:
The proposed rule amendments add the American Red Cross as an entity which provides certification in basic life support. Additionally, the requirement that Vasopressin be stocked on the crash cart is being deleted.
Purpose:
The proposed rule amendments are intended to add the American Red Cross as an entity which provides certification in basic life support. Additionally, the Board intends to remove requirement that Vasopressin be stocked on the crash cart.
Rulemaking Authority:
458.309(1), 458.331(1)(v) FS.
Law:
458.331(1)(v), 458.351 FS.
Contact:
Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.
Related Rules: (1)
64B8-9.009. Standard of Care for Office Surgery