64B8-51.006: Rule Governing Licensure and Inspection of Electrology Facilities
PURPOSE AND EFFECT: To bring the rule into compliance with current standards for Electrology facilities to clarify existing language for a clear understanding of facility requirements, and to update the application.
SUMMARY: This proposed rule change incorporates recommendations made by the Florida Department of Health, Division of Environmental Health, which previously performed inspections of electrolysis facilities. Inspections are now conducted by the Division of Medical Quality Assurance Investigative Services Unit. Application history questions are clarified.
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 this rule at its Council meeting, the Council, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary. No person or interested party submitted additional information regarding the economic impact at that time. The Council has determined that this will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within 1 year after implementation of the rule. These rule amendments will not require ratification by the Legislature.
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), 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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allen Hall, Executive Director, Electrolysis Council, 4052 Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3258
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) No change.
(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, 11/10 11/09, entitled “Application for Electrolysis Facility Licensure,” effective 11/10 11/09, which can be obtained from the Council at The Florida Department of Health, Electrolysis Council, Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3256, and available on the web at: http://www.doh.state.fl.us/mqa. 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.
(a) through (b) No change.
(c) Electrology facilities shall comply with Section 381.0098, F.S. and Chapter 64E-16, F.A.C.
(d)(c) Restroom 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, and well-lighted and free from adequately ventilated to remove objectionable odors.
(e)(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 as provided by Section 413.08, F.S.
(f)(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;
4. A treatment table or treatment chair with a non-porous surface capable of being disinfected;
5. Disposable paper drapes or sanitary cloth drapes stored in a closed container or compartment;
6. Sanitary waste receptacles for the disposal of used gloves, paper supplies, cotton balls, and other noninfectious items;
7. Single use, disposable towels;
8. A sharps container, as defined in Chapter 64E-16, F.A.C., for disposal of used needles/probes.;
9. A treatment lamp or magnifier lamp capable of being cleaned with disinfectant;
10. A magnifying device which shall be a magnifier lamp, optical loupe or microscope capable of being cleaned and disinfected;
11. Tuberculocidal hospital grade disinfectant registered by the Environmental Protection Agency, household bleach or wiping cloths pre-saturated with disinfectant for wiping non-porous surfaces;
12. If eye shields are used, eye shields capable of being cleaned with disinfectant;
13. Covered containers for sterile needles/probes and forceps/tweezers. which containers are capable of being cleaned and sterilized;
14. Betadine, 3% U.S. Pharmaceutical grade hydrogen peroxide, or 70% isopropyl alcohol, or wrapped single use wipes saturated with 70% isopropyl alcohol.;
15. Clean, non-sterile materials such as Ccotton balls, cotton strips, cotton swabs, gauze pads, or and gauze strips.;
16. If Ccloth towels which have been are used, they shall be laundered, and sanitized, and which are stored in a closed container or compartment., and there shall be a covered sanitary container for holding used cloth towels;
17. A clean covered container for holding used cloth towels.
18.17. A sterilizer which shall be either Aan 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.;
19.18. Monthly records of spore destruction test. sterilizer biological test monitoring which shall be made available to the Agency or Department upon request;
20.19. A holding container for soaking and cleaning contaminated instruments.; and
21.20. Non-sterile disposable examination gloves.
(g)(f) An appointment record, which lists the name of each person who has received electrolysis treatment, book shall be maintained and kept on the electrology facility premises which lists the name of each person who has received electrolysis treatment.
(h)(g) In electrology facilities wherein laser equipment is used for hair removal, the following shall be provided:
1. All requirements stated in Rule 64B8-51.006, F.A.C.
2.1. Proof of certification for of 30 hours of continuing education in laser hair removal for all electrologists using laser equipment in the facility.
3.2. Proof of certification as Certified Medical Electrologist for all electrologists using laser equipment in the facility.
4.3. Proof of registration for each of laser device located within the electrology facility as required by Section 501.122, F.S.
5.4. Written designation of laser safety officer.
6.5. Appropriate sign on door of laser room.
7.6. Lock on door of laser room.
8.7. Protective eyewear for all persons in laser room during operation of laser.
9.8. Fire extinguisher in vicinity of laser room.
10.9. Cold water and ice.
10. At least one piece of properly registered laser equipment located within the electrology facility.
(4) Inspections. The Department shall inspect all electrology facilities in the following manner:
(a) All licensed facilities shall be inspected once every two years per biennium.
(b) All facilities applying for initial licensure shall be inspected prior to licensure.
(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.
(b) The department may approve the transfer of a license from one facility to another. 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 the most recent 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 forms prescribed by the Department, as referenced in paragraph (2)(b) of this rule., which application must be processed by the Council office;
2. Surrender the current license with the application; and $100 inspection fee.
3. Obtain Pay $100 to have the new location inspectioned to determine compliance with Rule 64B8-51.006, F.A.C. The electrology facility may 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, providing the applicant has received notification from the Electrolysis Council that the application has been processed. The required inspection must be performed within the 60 day period or electrolysis services must cease until the inspection is performed.
(6) Renewal of Facility Licensure. Facility licensure shall be renewed every two years 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.
(7) No change.
Rulemaking Authority 456.037, 478.43(1), (4), 478.51(3) FS. Law Implemented 456.037(2), (3), (5), 478.49, 478.51 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,__________.