Fla. Admin. Code R. 64B8-51.006

Current through Reg. 50, No. 244; December 17, 2024
Section 64B8-51.006 - Rule Governing Licensure and Inspection of Electrology Facilities
(1) Definitions. An electrology facility is that portion of any establishment or place wherein electrolysis is performed. An electrology facility may be part of a residence.
(2) Electrology Facility Licensure.
(a) The owner of an electrology facility is required to obtain a license for the electrology facility. However, physicians licensed under Chapter 458 or 459, F.S., who are operating an electrology facility on the premises of their medical practice location are not required to obtain an electrology facility license and electrologists employed by physicians licensed under Chapter 458 or 459, F.S., and practicing at the physician's medical practice location are not required to obtain an electrology facility license.
(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 "Application for Electrolysis Facility Licensure" (revised 05/20), which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-12220, 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.
1. At the time of services, each client shall be protected from view of the public, and any other clients at the facility. This requirement shall not apply when electrolysis training is undertaken in accordance with a training program approved by the Electrolysis Council.
2. There shall be a toilet and sink with hot and cold running water available to the electrology facility. The toilet and sink shall be kept clean and in working order when the electrology facility is open for business.
3. Electrolysis shall be conducted on 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. Disposable paper drapes or sanitary cloth drapes stored in a closed container or compartment,
b. Sanitary waste receptacles for the disposal of used gloves, paper supplies, cotton balls, and other noninfectious items,
c. Single use, disposable towels,
d. A treatment lamp or magnifier lamp capable of being cleaned with disinfectant,
e. A magnifying device which shall be a magnifier lamp, optical loupe or microscope capable of being cleaned and disinfected,
f. Tuberculocidal hospital grade disinfectant registered by the Environmental Protection Agency, household bleach or wiping cloths pre-saturated with disinfectant for wiping non-porous surfaces,
g. Betadine, 3% U.S. Pharmaceutical grade hydrogen peroxide, or 70% isopropyl alcohol, or wrapped single use wipes saturated with 70% isopropyl alcohol,
h. Clean, non-sterile materials such as cotton balls, cotton strips, cotton swabs, gauze pads, and gauze strips,
i. If cloth towels are used, they shall be cleaned prior to use on each client and stored in a closed container or compartment. Used cloths shall be kept in a separate closed container,
j. A holding container for soaking and cleaning contaminated instruments; and,
k. Non-sterile disposable examination gloves.
(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, as defined in subsection 64E-16.002(24), F.A.C., effective June 3, 1997, which is hereby incorporated by reference and can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-11261;
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.
(c) 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 laser or light-based equipment is used for hair removal, are listed below.
1. For electrologists who have completed a Council-approved needle-type epilation training program:
a. Proof of certification of 30 hours of continuing education in laser hair removal from a provider approved pursuant to Rule 64B8-52.004, F.A.C.; and
b. Proof of having passed the Society for Clinical and Medical Hair Removal test for certification as a Certified Medical Electrologist.
2. For electrologists who have completed a Council-approved combined needle-type epilation, laser and light-based hair removal training program:
a. Proof of completion from a combined training program; and
b. Proof of having passed the epilator and laser and light-based combined exam.
3. For devices required to be registered, proof of registration for each laser or light-based device in use at the facility as required by Section 501.122, F.S.
4. Written designation of laser safety officer.
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. Sign on door of laser room identifying when laser or light-based equipment is in use.
7. Lock on door of laser room.
8. Protective eyewear capable of being cleaned and disinfected shall be used by all persons in laser room during operation of laser or light-based equipment.
9. Fire extinguisher in vicinity of laser room.
10. Cold water and ice.
11. The written protocols required by paragraph 64B8-56.002(4)(a), F.A.C.
(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 electrologist, 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) 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 DH-MQA5008, entitled "Application for Inspection for Adding or Switching to a New Electrology Modality" (revised 10/2020), which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-12741, 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) 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 form prescribed by the Department, and approved and incorporated herein by reference by the Board as Form DH-MQA 5018, entitled "Application for Transfer of Electrolysis Facility Location" (revised 05/20), which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-12208, or the Department at the Florida Department of Health, Electrolysis Council, Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3256, which application must be processed by the Council office,
2. Surrender the current license with the application; and,
3. Pay $100 to have the new location inspected to determine compliance with Rule 64B8-51.006, F.A.C. The electrology facility license holder transferring the license shall be permitted to perform electrolysis in the new facility, only after the application has been processed by the Council office and notification provided to the licensee, prior to inspection for a period of 60 days commencing with the first day electrolysis is performed in the new facility. The required inspection must be performed within the 60 day period or electrolysis services must cease until the inspection is performed.
(7) Renewal of Facility Licensure. Facility licensure shall be renewed at the end of each biennium prescribed by the Department. The licensee shall receive ninety (90) days notice of the need to renew the facility license. The notice shall be sent to the licensee at the last known address of the facility. Failure to receive the notice will not excuse the licensee from the requirement to renew the facility license, and failure to renew shall result in the license becoming delinquent. If the delinquent licensee does not apply for renewal of the license within six months of the license becoming delinquent, the license shall become null and any subsequent licensure shall be as a result of applying and meeting all requirements for new licensure. A facility may not operate without a license. To timely renew the facility license, including the six month "grace period" provided for, the licensee must pay the renewal fee of $100 and the inspection fee of $100.

Fla. Admin. Code Ann. R. 64B8-51.006

Rulemaking Authority 456.037, 478.43(1), (4), 478.51(3), (11) FS. Law Implemented 456.037, 456.0635, 458.348(2), 478.43, 478.49, 478.51, 478.55 FS.

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, Amended by Florida Register Volume 40, Number 237, December 9, 2014 effective 12/25/2014, Amended by Florida Register Volume 43, Number 020, January 31, 2017 effective 2/16/2017, Amended by Florida Register Volume 44, Number 168, August 28, 2018 effective 9/11/2018, Amended by Florida Register Volume 45, Number 243, December 17, 2019 effective 12/31/2019, Amended by Florida Register Volume 46, Number 200, October 13, 2020 effective 10/29/2020, Amended by Florida Register Volume 47, Number 041, March 2, 2021 effective 3/14/2021.

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, 2-16-17, 9-11-18, 12-31-19, 10-29-20, 3-14-21.