To clarify that the Department of Health conducts inspections and to eliminate the requirement that the written protocols include a statement on liability coverage.

Notice of Proposed Rule

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-56.002Equipment and Devices; Protocols for Laser and Light-Based Devices

PURPOSE AND EFFECT: To clarify that the Department of Health conducts inspections and to eliminate the requirement that the written protocols include a statement on liability coverage.

SUMMARY: Clarify which entity conducts inspections and eliminate the requirement for liability coverage from the protocols.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST 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: This proposed amendment will reduce costs by eliminating the need for liability insurance. No person or interested party submitted additional information regarding the economic impact.

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: 478.43 FS.

LAW IMPLEMENTED: 458.331(1)(v), 458.348(3), 478.42(5), 478.43(4) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE ANNOUNCED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allen Hall, Executive Director, Electrolysis Council, 4052 Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3255, [phone]

 

THE TEXT OF THE PROPOSED RULE IS:

 

64B8-56.002 Equipment and Devices; Protocols for Laser and Light-Based Devices.

(1) through (3) No change.

(4)(a) The supervising physician and the electrologist shall develop jointly written protocols regarding the medical condition for individuals to receive laser and light-based hair removal or reduction treatment; specific conditions and the procedure for identifying conditions that require direct evaluation or specific consultation by the physician; treatment of routine minor problems resulting during or from laser and light-based hair removal or reduction; and detailed procedures to be followed in the event of emergency situations developing during the performance of or as a result of laser and light-based hair removal or reduction. These written protocols must be signed, dated, and maintained in a readily available location on the premises where the electrologist practices. One copy shall be maintained by the supervising physician and one copy must be filed with the Department of Health. The written protocols which are kept on the premises of the electrologist will be readily available for inspection and review by agents of the Department of Health or the Board of Medicine. The parties to a protocol must notify the Department within 30 days of the termination of their professional relationship.

(b) No change.

(c) The written protocol shall include a statement that the electrologist does and will maintain professional liability coverage that includes coverage for incidents arising from laser usage in an amount not less than $100,000.

(5) through (6) No change.

Rulemaking Specific Authority 478.43 FS. Law Implemented 458.331(1)(v), 458.348(3), 478.42(5), 478.43(4) FS. History–New 9-12-01, Amended 2-28-02, 7-23-06, 3-12-08,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Electrolysis Council

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 5, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 19, 2014