The Council proposes the rule amendment to update electrolysis pre-licensure training programs to include laser and light-based training.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NOS.:RULE TITLES:

64B8-53.001Requirements for Electrolysis Training Programs Approved by the Board

64B8-53.002Curriculum Standards for Electrolysis Training Programs

64B8-53.003Required Equipment for Electrolysis Training Programs

PURPOSE AND EFFECT: The Council proposes the rule amendment to update electrolysis pre-licensure training programs to include laser and light-based training.

SUMMARY: Revision permits online and other home study courses for the didactic portion of the required training; requires existing pre-licensure training programs that offer instruction in use of the epilator only to also offer training in laser and light-based hair removal within one year; requires school approval prior to admitting students, as the facility must be inspected by the department; modifies curriculum hours; eliminates duplication by referring to equipment required by Rule 64B8-51.006; F.A.C. modifies title to remove board approval.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will 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 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. The SERC concludes that nine (9) of the twenty-five (25) approved training programs in Spring 2015 did not offer the 30-hour laser and light-based hair removal training course. These schools will incur additional costs associated with acquiring laser and related equipment and supplies; labor to develop, test and implement the laser portions of the curriculum; recruiting qualified laser instructors, or, developing and implementing training in laser for existing instructors. Using the highest estimated cost, multiplied times the nine epilator-only schools that would likely incur the most expense to comply, the estimated one-time cost for this transition is $90,000 in the aggregate within the next five years. Hence, 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: 478.43 (4), 478.50(4)(b) FS.

LAW IMPLEMENTED: 456.033, 478.43(4), 478.45(1)(e), 478.50(4)(b) 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: Allen Hall, Executive Director, Electrolysis Council/MQA, 4052 Bald Cypress Way, Bin # C05, Tallahassee, Florida 32399-3255

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B8-53.001 General Requirements for Pre-licensure Electrolysis Training Programs Approved by the Board

An pre-licensure electrolysis training program must demonstrate that it will comply with the following general requirements in order to shall be approved by the Council Board for pre-licensure training if the following requirements are met:

(1) No change.

(2)(a) No change.

(3)(b) The didactic portion of the required training may include online or home study courses. No home study or correspondence school or course will be considered in assessing an applicant’s qualifications for licensure.

(2) Applicants shall complete and submit to the Council the application entitled “New Facility or New Ownership Application for Electrology Facility Licensure”, form DOH/MQA/EP APP/REV-9/99, which is hereby incorporated by reference, copies of which may be obtained from the Council Office at 4052 Bald Cypress Way, BIN C05, Tallahassee, FL 32399. Approval by the Council is necessary before students are admitted.

(3) The facility where initial training is offered shall submit to the Council at least the following:

(a) A statement of the educational goals and objectives of the program;

(b) A detailed course outline or syllabus, including method of instruction, and testing materials;

(c) A current curriculum vitae of the course instructor(s);

(d) A sample certificate or diploma which includes the following which shall be filled in by the facility at the time of graduation:

Academic Hours	Traditional Classroom	Non-Traditional Classroom
Per subsection 64B8-53.002(1), F.A.C.
Successfully Completed	__________________	_________________
Clinical Hours	Traditional Classroom	Non-Traditional Classroom
Per subsection 64B8-53.002(2), F.A.C.
Successfully Completed	__________________	___________________

(e) A copy of the electrology facility license and the most recent Department of Health inspection sheet from the location where the training courses are to be offered demonstrating compliance with Rule 64B8-51.006, F.A.C.

(f) Proof of current, unencumbered licensure by the Commission for Independent Education, pursuant to Chapter 1005, F.S. Failure to maintain that license in good standing shall result in the loss of Council approval of the Program.

(g) Provide a copy of the application form submitted by students which shall include the following Notice in bold type no smaller than 14 points:

“Notice from the Florida Electrolysis Council Applicants for an Electrolysis License in the State of Florida are required to have completed a specifically outlined course of academic and clinical studies. Those studies must have been taken in a classroom setting in the physical presence of the instructor. Only such classroom education will be considered adequate for licensure. No credit shall be awarded applicants for home study, correspondence, or other distance education.

I confirm that I have read and understand the foregoing notice.

__________________________

Student SignatureDate”

(4) The content of the training program must meet the minimum curriculum standards set forth in Rule 64B8-53.002, F.A.C. The training program must provide the equipment listed in Rule 64B8-53.003, F.A.C. The training program shall be located in an electrology facility licensed under Rule 64B8-51.006, F.A.C. An electrolysis training program must meet the requirements for combining epilator, laser and light-based training contained by the rules in Chapter 64B6-53, F.A.C. within one year after all rules in chapter become effective. The content of the program must include the curriculum standards set forth in subsections 64B8-53.002(1) and (2), F.A.C. All curricula must harmonize with and not be contrary to the following statements:

(a) The procedures to be used for electrolysis involve the insertion of a sterile needle electrode into the hair follicle(s) of prepared skin. After the application of the selected current, the treated hair(s) is (are) removed with sterile forceps. After treatment is complete, the treated area of the skin is given post-treatment care.

(b) Electrolysis training programs shall be limited to training in the universally accepted procedures of electrolysis and shall not include extemporary procedures licensed by any other Florida Board. One example of such an extemporary procedure would be waxing the treated area after electrolysis. A Cosmetology license is required for certain types of waxing. A second example would be the intentional treatment of telangiectasis (spider veins) with the epilator. This type of vascular surgery may only be performed by a Florida licensed physician.

(5) Electrolysis training programs shall be strictly limited to training in hair removal and shall not include extemporary procedures licensed by any other Florida Board. Waxing and treatment of spider veins are two examples of such extemporary procedures. Only needle-type epilators shall be used in electrolysis training programs.

(6) All students in the clinical application phase of an electrolysis training program, as described in Rule 64B8-53.002(2), F.A.C., shall have access to the equipment needed for the procedure being taught. All students in the clinical application phase of an electrolysis training program shall have access to a full work station consisting of an epilator, treatment table, stool, and supplies. During the clinical application phase of instruction in an electrolysis training program, there shall be only one student assigned to each work station.

(7) An electrolysis training program in another state or jurisdiction which does not license the practice of electrolysis shall be  an approved electrolysis training program if it meets requirements substantially equivalent to those in Ch. 64B8-53, F.A.C. Each facility where electrolysis training programs are offered must meet the curriculum standards in Rule 64B8-53.002, F.A.C., and have the  equipment required by Rule 64B8-53.003, F.A.C.

(8) Students shall not be admitted to the training program until it is approved by the Council.

Each facility where electrolysis training programs are offered must be licensed as an electrology facility pursuant to Rule 64B8-51.006, F.A.C.

(9) The facility where initial training is offered shall submit to the Council at least the following:

(a) A statement of the educational goals and objectives of the program;

(b) A detailed course outline or syllabus, including method of instruction, and testing materials;

(c) A current curriculum vitae of the course instructor(s);

(d) A sample certificate of completion which states the number of classroom hours completed and the number of clinical hours completed. An electrolysis training program in another state or jurisdiction which does not license the practice of electrolysis shall be an approved electrolysis training program if it meets requirements substantially equivalent to those in subsections 64B8-53.001(1) and (2), F.A.C.

Rulemaking Specific Authority 478.43(1),(4), 478.50(4)(b) FS. Law Implemented 478.43(4), 478.45(1)(e), 478.50(4)(b) FS. History–New 9-29-93, Formerly 61F6-78.001, Amended 6-19-96, Formerly 59R-53.001, Amended 11-13-97, 2-15-07,       .

 

64B8-53.002 Curriculum Standards for Electrolysis Training Programs

In order to be approved by the Board, an electrolysis training program must meet the following curriculum standards:

(1) Academic instruction to be set out in school catalog.Hours

(a) Introduction to electrolysis techniques through Galvanic, Thermolysis15

and Blend, and laser and light-based modalities, history of permanent hair

removal, general treatment procedures.

(b) No change

(c) Laser and light-based hair removal physics.5

(d) Laser safety and precautions.5

(e)(c) Integumentary System (skin and appendages).6 10

(f)(d) Circulatory (blood and lymph) and nervous system.6 10

(g)(e) Endocrine system, including related diseases.6 10

(h)(f) Biology of hair growth.10

(i)(g) Skin assessment, including skin typing types, effects of

all modalities, specific current, effects of temporary removal.20 15

(j)(h) Study of blood-borne pathogens with emphasis on hepatitis (all types),5 10

and HIV/AIDS.

(k)(i) Microbiology of the skin (flora and fauna), sanitation and safety7 10

procedures including demonstrations in accordance with Rule 64B8-56.001, F.A.C.

(l)(j) Clinic and office management, communications, professional ethics,5 10

bookkeeping, and patient management.

(m)(k) Study of Chapter 64B8, F.A.C., as it relates to electrolysis, Chapter5 10

478, F.S., and Chapter 456, Part II, F.S.

(n)(l) Consultations including medical history, contraindications, complications20 5

Subtotal120 hours

(2) Clinical ApplicationHours

(a) No change

(b) No change

(c) No change

(d) Hands on Equipment Instruction (Laser and Light-Based Electrolysis)15 5

(e) Hands on Equipment Instruction (Thermolysis)10 5

(f) Hands on Equipment Instruction (Blend and Galvanic)10 5

(g) Client Pre/Post Treatment10 5

(h) Client Assessment15 10

(i) General Treatment Procedures for all modalities80 105

(j) No change

(k) Visuals/Library5 10

(l) No change

Subtotal200

Total320 hours

Rulemaking Specific Authority 478.43(1), (4), 478.50(4)(b) FS. Law Implemented 478.43(4), 478.45(1)(e), 478.50(4)(b) FS. History–New 9-29-93, Formerly 61F6-78.002, 59R-53.002, Amended 11-13-97,                          .

 

64B8-53.003 Required Equipment for Electrolysis Training Programs

(1) An electrolysis training program shall: have the following equipment in good working condition, in sufficient numbers, and supplies in sufficient amount to enable students to meet their learning objectives:

(a) Have a working U.S. FDA registered short wave epilator,

(b) Have a working U.S. FDA registered blend epilator, and

(c) Comply with the requirements of Rule 64B8-51.006(3), F.A.C. U.S. FDA registered galvanic epilator with multiple needle apparatus,

(d) Magnifying device or treatment lamp,

(e) Treatment table or treatment chair,

(f) Operator stool or chair,

(g) Autoclave with chemical biological indicators,

(h) Dry heat sterilizer with chemical biological indicators,

(i) Needles (e.g. probes) of various sizes,

(j) Forceps (e.g. tweezers),

(k) Needle holder tips,

(l) Ultrasonic cleaner with enzyme dissolving detergent,

(m) Covered holding containers for contaminated instruments,

(n) Sharps containers for disposal of used needles and other sharp instruments in accordance with the biomedical waste disposal requirements of Rule Chapter 64E-16, F.A.C.,

(o) Non-sterile disposable examination gloves,

(p) Waste receptacles,

(q) Soaps,

(r) Paper towels,

(s) Paper table coverings,

(t) Tuberculocidal hospital grade disinfectant detergent,

(u) Betadine, 3% U.S. Pharmaceutical grade hydrogen peroxide and 70% isopropyl alcohol or wrapped, single use wipes saturated with 70% isopropyl alcohol,

(v) Clean non-sterile materials such as cotton balls, cotton strips, cotton swabs, gauze pads, and gauze strips,

(w) Clean, covered containers for creams, lotions and ointments with single use spatulas or containers which are pump or tube type dispensers,

(x) Magnifying device which shall be a magnifying lamp, optical loupe or microscope.

(y) Reference books/textbooks in the following areas:

1. Electrolysis;

2. Dermatology;

3. Anatomy; and

4. Medical dictionary.

(2) Endodontic dry heat sterilizers, also known as glass bead sterilizers, shall not be used in place of an autoclave or dry heat sterilizer in paragraphs 64B8-53.003(1)(g) and (h), F.A.C.

Rulemaking Specific Authority 478.43(1), (4), 478.50(4)(b) FS. Law Implemented 456.033, 478.43(4), 478.45(1)(e), 478.50(4)(b) FS. History–New 11-16-93, Formerly 61F6-78.003, 59R-53.003, Amended 11-13-97, 10-12-98,                     .

 

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 3, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 11, 2016