The proposed rule amendments are intended for substantial rewrite of citations.  

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    DEPARTMENT OF HEALTH

    Board of Medicine

    RULE NO.:RULE TITLE:

    64B8-55.002Citations

    PURPOSE AND EFFECT: The proposed rule amendments are intended for substantial rewrite of citations.

    SUMMARY: Substantial rewrite of citations.

    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 concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board 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: 456.077(1), (2), 478.51(3) FS.

    LAW IMPLEMENTED: 456.072(3), (4), 456.077(1), (2), 478.51, 478.52 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, Board of Medicine Electrolysis Council, 4052 Bald Cypress Way, Bin # A04, Tallahassee, Florida 32399-3253.

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

    Substantial rewording of Rule 64B8-55.002 follows.  See Florida Administrative Code for present text.

     

    64B8-55.002 Citations.

    (1) “Citation” means an instrument which meets the requirements set forth in Section 456.077, F.S., which is served upon a licensee for the purpose of assessing a penalty in an amount established by this rule.

    (2) In lieu of the disciplinary procedures contained in Section 456.073, F.S., the Department may issue a citation to the subject within six months after the filing of the complaint which is the basis for the citation.

    (3) All citations include a requirement that the subject correct the violation, if remediable, within a specified period of time not to exceed 60 days, and impose whatever obligations necessary to remedy the offense.

    (4) The Board designates the following as citation violations:

    (a) Failure to provide satisfaction including the costs incurred within 45 days of receipt of the Department’s notification of a check dishonored for insufficient funds.

     

    (a) $100.00 fine.

    (b) Failure to notify the Department of a change of address. (Section 456.035(1), F.S.; Rule 64B8-50.008, F.A.C.)

    (b) $100.00 fine.

    (c) Failure to protect clients during treatment from public view.

    (Rule 64B8-51.006(3)(a)1., F.A.C.)

    (c) 1. First violation – $150.00 fine

    2. Second violation – $300.00 fine

    3. Third and subsequent violations – See rule 64B8-55.001(3)(aa), F.A.C.

    (d) Failure to have a sink with hot and cold running water within or available to the electrology facility. (Rule64B8-51.006(3)(a)2., F.A.C.)

    (d) 1. First violation – $150.00 fine

    2. Second violation – $300.00 fine

    3. Third and subsequent violations – See rule 64B8-55.001(3)(aa), F.A.C.

    (e) Failure to provide, within or available to the electrology facility, a separate room containing toilet and sink with hot and cold running water. (paragraph 64B8-51.006(3)(a)2., F.A.C.)

    (e) 1. First violation – $150.00 fine

    2. Second violation – $300.00 fine

    3. Third and subsequent violations – See rule 64B8-55.001(3)(bb), F.A.C.

    (f) Failure to conduct electrolysis on a treatment table or treatment chair with a non-porous surface capable of being disinfected

     

    (f) 1. First violation – $150.00 fine

    2. Second violation – $300.00 fine

    3. Third and subsequent violations – See rule 64B8-55.001(3)(cc), F.A.C.

    (g) Failure to have any one of the following items/equipment in the facility (the failure to have any one of the items/equipment shall constitute a separate citation) (Rule 64B8-51.006(3)(a), F.A.C.):

    (g)1.a.Disposable paper drapes or sanitary cloth drapes stored in a closed container or compartment.

    b. Single use disposable towels.

    c. A treatment lamp or magnifier lamp capable of being cleaned with disinfectant.

    d. A magnifying device which shall be a magnifier lamp, optical loupe or microscope capable of being cleaned and disinfected.

    e. Tuberculocidal hospital grade disinfectant detergent registered by the Environmental Protection Agency, household bleach or wiping cloths pre-saturated with disinfectant for wiping nonporous surfaces.

    f. Betadine, 3% U.S. pharmaceutical grade hydrogen peroxide or 70% isopropyl alcohol or mapped single use wipes saturated with 70% isopropyl alcohol.

    g. Clean, non-sterile materials such as cotton balls, cotton strips, cotton swabs, gauze pads, and gauze strips.

    h. If cloth towels are used:

    1. Clean cloth towels prior to use on each client;

    2. Clean towels stored in a closed container or compartment, or

    3. Used towels stored in a separate closed container.

    i. Non-sterile disposable examination gloves.

     

    (g) 1.a. First violation – $50.00 fine

    b. Second violation –$100.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(dd), F.A.C.

     

    (g)2. a. Sanitary waste receptacles for the disposal of used gloves, paper supplies, cotton balls, and other non infectious items.

    b. A holding container for soaking and cleaning contaminated instruments.

     

    (g) 2.a. First violation – $150.00 fine,

    b. Second violation – $300.00 fine.

    c. Third and subsequent violations – See rule 64B8-55.001(3)(dd), F.A.C.

    (h) For facilities with epilator equipment, failure to have any one of the following items/equipment in the facility (the failure to have any one of the items/equipment shall constitute a separate citation) (Rule 64B8-51.006(3)(b), F.A.C.):

    (h)1. a. Needle holder tips.

    b. Covered containers for needles and forceps which containers are capable of being cleaned and Sterilized.

    (h) 1. a. First violation – a $50.00 fine,

    b. Second violation – $100.00 fine.

    c Third and subsequent violations.  See rule 64B8-55.001(3)(ee), F.A.C.

    (h)2. a. An FDA registered needle type epilation device in working order.

    b. Clean and sterile needles (e.g. probes) and forceps (e.g. tweezers).

    c. A sharps container for disposal of used needles.

    d. A sterilizer which shall be either an autoclave or a dry heat sterilizer and color change indicators for use with either sterilizer.

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

    (h) 2. a. First violation – $150.00 fine

    b. Second violation –$300.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(ee), F.A.C.

    (i) For facilities with laser or light-based equipment, failure to have any one of the following items/equipment in the facility (the failure to have any one of the items/equipment shall constitute a separate citation) (Rule 64B8-51.006(3)(c), F.A.C.):

    (i)1.a. Written designation of laser safety officer.

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

    c. Cold water and ice.

    d. Lock on door of laser room.

    e. Fire extinguisher in vicinity of laser room.

    (i) 1.a. First violation – $150.00 fine

    b. Second violation – $300.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(ff), F.A.C.

     

    (i)2. Written protocols that are signed, dated, maintained in a readily available location on the premises where the electrologist practices, and filed with the Department of Health as required by rule 64B8-56.002(4)(a), F.A.C.

     

    (i) 2.a. First violation – $200.00 fine

    b. Second violation – $400.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(ff), F.A.C.

     

    (i)3.a. At least one piece of properly registered laser equipment located within the electrology facility.

    b. Protective eyewear for all persons in laser room during operation of laser.

    (i) 3.a. First violation – $300.00 fine

    b. Second violation – $600.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(ff), F.A.C.

     

    (i)4. a. Proof of completion of 30 hours of post-licensure education or proof of combined training

    b. Proof of having passed the Society for Clinical and Medical Hair Removal test for certification as a Certified Medical Electrologist for all electrologists using laser or light-based equipment in the facility and completed training pursuant to 64B8-56.002(2)(a)1., F.A.C.

    (i) 4.a. First violation – $500.00 fine,

    b. Second violation – $1000.00 fine

    c. Third and subsequent violations – See rule 64B8-55.001(3)(ff), F.A.C.

     

     

    (j) Failure to display any one of the following documents in an area that is visible to the general public entering the facility (the failure to display any one of the documents shall constitute a separate citation) (Rule 64B8-51.006(4), F.A.C.):

    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.

    5. An appointment book.

    (j) 1. First violation – $50.00 fine

    2. Second violation – $100.00 fine

    3. Third violation - $200.00 fine

    4. Fourth and subsequent violations – 64B8-55.001(3)(gg), F.A.C.

     

    (k) Failure to comply with continuing education requirements.

    (Rule 64B8-52.002, F.A.C.)

    (k) First and subsequent violations – $250 fine.

    (l) Providing electrolysis services in an unlicensed facility.

    (l) First and subsequent violations – $250 fine.

    (m) Permitting an unlicensed person to provide electrolysis services.

    (m) First and subsequent violations – $250 fine.

    (n) Providing electrolysis services with a delinquent license or null/void license.

    (n) First and subsequent violations – $250 fine.

    (o) Unprofessional conduct, failure to conform to acceptable standards.

    (o) First and subsequent violations where no actual patient harm occurred – $250 fine.

    (p) Failure to timely pay required fees and fines.

    (p) First and subsequent violations, a $250 fine.

    (q) Advertising any discounted or free service without including the required statement, Section 456.062, F.S.

    (q) First and subsequent violations - $100.00 fine.

    (5) In addition to the penalties established in this rule, the Department shall recover the costs of investigation. The penalty specified in the citation shall be the sum of the penalty established by this rule plus the Department’s cost of investigation.

    (6) If the subject disputed any matter contained in the citation, within thirty days after service, the Department shall follow the procedure set forth in Section 456.073, F.S. Otherwise, the citation shall become a final order of the Board.

    Rulemaking Authority 456.077(1), (2), 478.51(3) FS. Law Implemented 456.072(3), (4), 456.077(1), (2), 478.51, 478.52 FS. History–New 11-16-93, Formerly 61F6-80.002, Amended 1-2-95, Formerly 59R-55.002, Amended 11-13-97, 10-12-98, 2-11-01, 2-20-02, 11-12-02, 7-16-03, 2-12-07, 2-15-17,____________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Medicine Electrolysis Council

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 5, 2021

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 3, 2021

     

Document Information

Comments Open:
5/21/2021
Summary:
Substantial rewrite of citations.
Purpose:
The proposed rule amendments are intended for substantial rewrite of citations.
Rulemaking Authority:
456.077(1), (2), 478.51(3) FS.
Law:
456.072(3), (4), 456.077(1), (2), 478.51, 478.52 FS.
Related Rules: (1)
64B8-55.002. Citations