The Council proposes the rule amendment to clarify the requirements for electrolysis facility licensure, inspection, and operation; allows for the operation of separate modalities, and requires only the equipment necessary for the modality practiced ...

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-51.006Rule Governing Licensure and Inspection of Electrology Facilities

PURPOSE AND EFFECT: The Council proposes the rule amendment to clarify the requirements for electrolysis facility licensure, inspection, and operation; allows for the operation of separate modalities, and requires only the equipment necessary for the modality practiced at the facility.

SUMMARY: The rule amendment clarifies the owner of an electrology facility must obtain a facility license while neither physicians nor their employees are required to obtain an electrology facility license; identifies facility requirements separately for each modality; not a change in position but rather a clarification that all electrologists practicing laser or light-based hair removal and reduction are required to have passed the CME certification test by SCMHR. Form DH5008-MQA-09/2015 is created to apply for inspection for adding or switching to a new electrology modality. Forms DH5018-MQA-07/2016, for transfer of electrolysis facility location, and DH-MQA 1213, for electrolysis facility licensure, are modified to update the facilities checklists.

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: 456.037, 478.43(1), (4), 478.51(3) FS.

LAW IMPLEMENTED: 456.037(2), (3), (5), 456.0635, 478.49, 478.51 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:

 

64B8-51.006 Rule Governing Licensure and Inspection of Electrology Facilities

(1) No change.

(2) Electrology Facility Licensure.

(a) The owner of an electrology facility is required to obtain a license for the elctrology facility. However, physicians licensed under Chapter 458 or 459, F.S., are not required to obtain an electrology facility license and electrologists employed by physicians licensed under Chapter 458 or 459, F.S., are not required to obtain an electrology facility license. No one may operate an electrology facility without a license to do so from the Department of Health.

(b) To obtain the license, the applicant shall provide information to the Department as required by this rule on a form provided by the Department and approved and incorporated herein by reference by the Board as Form DH-MQA 1213, entitled “State of Florida Application for Electrolysis Facility Licensure – New Facility or New Ownership” (revised 05-16-2016),” effective 3/13, which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-                02754 or the Department at The Florida Department of Health, Electrolysis Council, Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3256. The applicant must pay a $100 application fee, which is nonrefundable, $100 inspection fee, $100 licensure fee and a $5.00 unlicensed activity fee.

(3) Electrology Facility Safety and Sanitary Requirements. Paragraph (a) of this subsection applies to all electrology facilities regardless of the modalities used. Paragraph (b) of this rule applies to electrology facilities where epilators are used. Paragraph (c) of this rule applies to electrology facilities where laser or light-based equipment is used.

(a) Listed below are requirements to be followed, and material and equipment to be available, at each electrology facility where epilators or lasers/light-based equipment is used. An electrology facility shall be clean, sanitary, and well-lit. It shall also allow for circulation of air sufficient to eliminate odors.

1. At the time of services, each client shall be protected from view of the public, and any other clients at the facility. Any room wherein electrolysis is performed shall have four fixed, permanent walls at least six feet tall from the floor and shall have doors capable of being locked. Permanent walls means a vertical continuous structure of wood, plaster, masonry, or other similar building material, which is physically connected to the electrology facility floor. This requirement shall not apply when electrolysis training is undertaken in accordance with a training program approved by the Electrolysis Council. to electrology facilities which are located in an electrolysis training facility so long as the unwalled area where electrolysis is performed is used for instructional purposes only.

2. There shall be a toilet and sink with hot and cold running water available to within the electrology facility. The toilet and sink shall be kept clean and in working order when the electrology facility is open for business. This sink may also serve as the sink in the toilet and lavatory facilities required under paragraph (3)(c) of this rule.

(b) The following documents shall be displayed in an area that is visible to the general public entering the facility:

1. The electrology facility license.

2. The current license of the electrologist.

3. The most recent inspection sheet from the Department of Health.

4. A current copy of Rule 64B8-51.006, F.A.C.

(c) Toilet and Lavatory Requirements. Each electrology facility shall provide, on the premises or in the same building, a separate room containing toilet and lavatory facilities which shall have at least one toilet and one sink with running water, and shall be equipped with toilet tissue, soap dispenser with soap or other hand cleaning material, disposable towels or wall-mounted electric blow dryer and a waste receptacle. The toilet and lavatory facilities and all fixtures and components shall be clean, in good repair, well-lighted and adequately ventilated to remove objectionable odors.

(d) No animals shall be allowed to enter or be in the room wherein electrolysis is performed except those trained to assist the hearing impaired, visually impaired, or the physically impaired.

(e) The electrology facility shall have the following equipment:

1. An FDA registered needle-type epilation device in working order;

2. Clean and sterile needles/probes and forceps/tweezers;

3. Needle holder tips;

3.4. Electrolysis shall be conducted on a A treatment table or treatment chair with a non-porous surface capable of being disinfected;

4. The following supplies and equipment shall always be available at the electrology facility:

a.5. No change.

b.6. No change.

c.7. No change.

8. A sharps container for disposal of used needles/probes;

d.9. No change.

e.10. No change.

f.11. No change.

12. If eye shields are used, eye shields capable of being cleaned with disinfectant;

13. Covered containers for needles/probes and forceps/tweezers which containers are capable of being cleaned and sterilized;

g.14. No change.

h.15. No change.

i.16. If cloth towels are used, they shall be cleaned prior to use on each client and laundered and sanitized, which are stored in a closed container or compartment., and there shall be a covered sanitary container for holding used cloth towels; Used cloths shall be kept in a separate closed container;

17. A sterilizer which shall be either an autoclave or a dry heat sterilizer, and color change indicators for use with either sterilizer. The endodontic dry heat “glass bead sterilizer” shall not be used for instrument sterilization;

18. Unless the facility is new, monthly records of sterilizer biological test monitoring which shall be made available to the Department upon request;

j.19. No change

k.20. No change

(b) In addition to those specified in paragraph (3)(a), the requirements to be followed, and materials and equipment to be available, at each electrology facility where epilators are used are listed below.

1. An FDA registered needle-type epilation device in working order;

2. Clean and sterile needles/probes and forceps/tweezers;

3. Needle holder tips;

4. A sharps container for disposal of used needles/probes;

5. Covered containers for needles/probes and forceps/tweezers which containers are capable of being cleaned and sterilized;

6. A sterilizer which shall be either an autoclave or dry heat sterilizer, and color change indicators for use with either sterilizer. The endodontic dry heat “glass bead sterilizer” shall not be used for instrument sterilization; and

7. Unless the facility is new, quarterly records of sterilizer biological test monitoring, which shall be made available to the Department upon request;

(f) An appointment book shall be maintained and kept on the electrology facility premises which lists the name of each person who has received electrolysis treatment.

(c)(g) In addition to those specified in paragraph (3)(a), the requirements to be followed, and materials and equipment to be available at each electrology facility facilities wherein laser or light-based equipment is used for hair removal, the following shall be provided are listed below.

1. No change.

2. For all electrologists using laser or light-based equipment in the facility, proof Proof of having passed the Society for Clinical and Medical Hair Removal test for certification as a Certified Medical Electrologist, or proof of having passed a substantially equivalent test for certifications as determined by the Council for all electrologists using laser equipment in the facility.

3. No change.

4. No change.

5. A room or rooms specifically designated for use of the laser or light-based equipment which is where all use of such equipment shall take place.

6.5. Sign Appropriate sign on door of laser room identifying when laser or light-based equipment is in use.

7.6. No change.

8.7. Protective eyewear capable of being cleaned and disinfected shall be used by for all persons in laser room during operation of laser or light-based equipment.

9.8. No change.

10.9. No change.

11.10. No change.

(4) The following documents shall be available in each electrology facility:

(a) The electrology facility license, which shall be visible to the public;

(b) The current license of the electrolgist, which shall be visible to the public;

(c) The most recent inspection sheet from the Department of Health;

(d) A current copy of Rule 64B8-51.006, F.A.C.; and

(e) An appointment book shall be maintained and kept on the electrology facility premises which lists the name of each person who has received treatment. The appointment book shall be maintained for four (4) years. The appointment book may be an electronic record.

(5)(4) Inspections. The Department shall inspect all electrology facilities in the following manner:

(a) All licensed facilities shall be inspected once per biennium.

(b) All facilities applying for initial licensure shall be inspected prior to licensure.

(c) When an existing electrology facility adds a modality, either epilator or laser/light-based equipment, or switches from one of those modalities to the other, an inspection shall be conducted to determine whether the facility has properly registered equipment and the proper safety and sanitary equipment and materials.  The electrology facility shall notify the Department of the new modality by submitting to the Executive Director of the Electrolysis Council the form provided by the Council and approved and incorporated herein by the Board by reference as Form DH5008-MQA-09/2015, entitled “Application for Inspection for Adding or Switching to a New Electrology Modality” (effective 11/9/2015), which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-_________ or http://www.floridahealth.gov/licensing-and-regulation/electrolysis/, or the Department at The Florida Department of Health, Electrolysis Council, Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3256.  The facility must pass an inspection prior to implementing the new modality.

(6)(5) Transfer of Ownership or Location of the Electrology Facility.

(a) No license for an electrology facility may be transferred from the name of the original licensee to another. If a facility is sold, the new owner must apply to the Department for licensure and no electrolysis services may be performed in the facility after the sale until the new owner has received the required license from the Department. A person purchasing an electrology facility may apply to the Department for licensure prior to the date of purchase.

(b) An electrology facility license may be transferred from one location to another only upon approval by the Department which approval shall be granted upon compliance with all requirements set out below in subparagraphs 1. through 3. Only the licenses for electrology facilities which have passed inspection at the original location are eligible for transfer to another location. In order to begin practice at the new location, the electrology facility license holder must first perform all of the following procedures:

1. File a completed application for transfer prior to the date of the transfer on a forms prescribed by the Department, and approved and incorporated herein by reference by the Board as Form DH5018-MQA, entitled “State of Florida Application for Transfer of Electrolysis Facility Location” (revised 05-16-2016), which can be obtained from http://www.flrules.org/Gateway/reference.asp?No= Ref-      or the Department at the Florida Department of Health, Electrolysis Council, Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3256 as referenced in paragraph (2)(b) of this rule, which application must be processed by the Council office;

2. No change.

3. No change.

(7)(6) No change.

(7) No license for operation of an electrology facility may be transferred from the name of the licensee to the name of another person. If a facility is sold, the new owner must apply to the Department for licensure and no electrolysis services may be performed in the facility after the sale until the new owner has received the required license from the Department. A person purchasing an electrology facility may apply to the Department for licensure prior to the date of purchase.

Rulemaking Authority 456.037, 478.43(1), (4), 478.51(3), (11) FS. Law Implemented 456.037(2), (3), (5), 456.0635, 478.49, 478.51, 478.55 FS. History–New 11-16-93, Formerly 61F6-76.006, Amended 5-11-95, 6-26-96, Formerly 59R-51.006, Amended 12-23-97, 12-22-98, 2-17-00, 3-25-01, 4-8-02, 6-16-03, 7-29-10, 6-19-13, 12-25-14,                .

 

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