To streamline the time for payment of fines and completion of education for improved tracking of compliance and to reconcile citation grounds with language of rules pertaining to practice standards.

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO.: RULE TITLE:
64B8-55.002: Citations
PURPOSE AND EFFECT: To streamline the time for payment of fines and completion of education for improved tracking of compliance and to reconcile citation grounds with language of rules pertaining to practice standards.
SUMMARY: The changes update and clarify the language of specific citation violations and update references to specific rules and statutes.
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 amendment 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: 456.077(1), (2) FS.
LAW IMPLEMENTED: 456.072(3)(b), 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 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:

64B8-55.002 Citations.

(1) through (2) No change.

(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, unless otherwise specified in this rule and impose whatever obligations necessary to remedy the offense.

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

(a) through (g) No change.
(h) The presence of animals in the room wherein electrolysis is performed except those trained to assist the hearing impaired, visually impaired or physically impaired, as provided by Section 413.08, F.S.	(h) First time violation a $150.00 fine, second time violation a $300.00 fine.
(64B8-51.006(3)(e)(d), F.A.C.)
(i) 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):	(i) First time violation a $150.00 fine, second time violation a $300.00 fine.
1. An FDA registered needle type epilation device in working order.
(64B8-51.006(3)(f)(e)1., F.A.C.)
2. Clean and sterile needles (e.g. probes) and forceps (e.g. tweezers).
(64B8-51.006(3)(f)(e)2., F.A.C.)
3. Sanitary waste receptacles for the disposal of used gloves, paper supplies, cotton balls, and other non infectious items.
(64B8-51.006(3)(f)(e)6., F.A.C.)
4. A sharps container as defined in Chapter 64E-16, F.A.C. for disposal of used needles.
(64B8-51.006(3)(f)(e)8., F.A.C.)
5. A sterilizer which shall be either Aan autoclave or a dry heat sterilizer and color change indicators for use with either sterilizer.
(64B8-51.006(3)(f)18.(e)17., F.A.C.)
6. Monthly records of spore destruction tests sterilizer biological test monitoring which shall be made available to the Department upon request.
(64B8-51.006(3)(f)19.(e)18., F.A.C.)
7. A holding container for soaking and cleaning contaminated instruments.
(64B8-51.006(3)(f)20.(e)19., F.A.C.)
(j) Failure to maintain an appointment record which lists the name of each person who has received electrolysis treatment book. (64B8-51.006(3)(g)(f), F.A.C.)	(j) First time violation a $150.00 fine, second time violation a $300.00 fine.
(k) No change.
(l) Failure to have any one of the following items/equipment (the failure to have any one of the items/equipment shall constitute a separate violation):	(l) First time violation a $50.00 fine, second time violation a $100.00 fine, third time violation $200.00 fine
1. Needle holder tips. (64B8-51.006(3)(f)(e)3., F.A.C.)
2. A treatment table or chair with a nonporous surface capable of being disinfected.
(64B8-51.006(3)(f)(e)4., F.A.C.)
3. Disposable paper drapes or sanitary cloth drapes stored in a closed container or compartment.
(64B8-51.006(3)(f)(e)5., F.A.C.)
4. Single use disposable towels. (64B8-51.006(3)(f)(e)7., F.A.C.)
5. A treatment lamp or magnifier lamp capable of being cleaned with disinfectant.
(64B8-51.006(3)(f)(e)9., F.A.C.)
6. A magnifying device which shall be a
magnifier lamp, optical loupe or microscope capable of being cleaned and disinfected.
(64B8-51.006(3)(f)(e)10., F.A.C.)
7. Tuberculocidal hospital grade disinfectant detergent registered by the Environmental Protection Agency, household bleach or wiping cloths presaturated with disinfectant for wiping nonporous surfaces.
(64B8-51.006(3)(f)(e)11., F.A.C.)
8. If eye shields are used, eye shields capable of being cleaned with disinfectant.
(64B8-51.006(3)(f)(e)12., F.A.C.)
9. Covered containers for sterile needles and forceps which containers are capable of being cleaned and sterilized.
(64B8-51.006(3)(f)(e)13., F.A.C.)
10. Betadine, 3% U.S. pharmaceutical grade hydrogen peroxide or 70% isopropyl alcohol or mapped single use wipes saturated with 70% isopropyl alcohol.
(64B8-51.006(3)(f)(e)14., F.A.C.)
11. Clean, non-sterile materials such as Ccotton balls, cotton strips, cotton swabs, gauze pads, or and gauze strips.
(64B8-51.006(3)(f)(e)15., F.A.C.)
12. If cloth towels are used, lLaundered and sanitized cloth towels stored in a closed, sanitized container or
(64B8-51.006(3)(f)(e)16., F.A.C.)
13. If cloth towels are used, a A covered sanitary container for holding used cloth towels. (64B8-51.006(3)(f)17.(e)16., F.A.C.)
14. Non-sterile disposable examination gloves.
(64B8-51.006(3)(f)21.(e)20., F.A.C.)
15. An FDA registered needle-type epilation devise in working order. (64B8-51.006(3)(f)1., F.A.C.) (m) Failure to comply with continuing education requirements. (64B8-52.002, F.A.C.)	(m) First time violation $500 fine; and completion of all incomplete continuing education credits, all to be submitted within six (6) months of the citation.
(n) through (s) No change.
(t) Failure to comply with Section 381.0098, F.S. and Chapter 64E-16, F.A.C., pertaining to biomedical waste.	(t) For first time violation, a $250 fine

(5) The Board designates the following as electrology citations violations in laser or light based hair removal. Failure to have:

(a) Written designation of laser safety officer. (64B8-51.006(3),(h)5.(g)4., F.A.C.)	First time violation $150, Subsequent violations $300
(b) Appropriate sign on door of laser room as required by ANSI Standard Z136.1-2000, in effect on June 1, 2006, available from American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, N.Y. 10036. (64B8-51.006(3)(h)6.(g)5., F.A.C.)	First time violation $150, Subsequent violations $300.
(c) No change.
(d) Lock on door of laser room. (64B8-51.006(3)(h)7.(g)6., F.A.C.)	First time violation $150, Subsequent violation $300.
(e) Fire extinguisher in vicinity of laser room. (64B8-51.006(3)(h)9.(g) 8., F.A.C.)	First time violation $150, Subsequent violation $300.
(f) through (h) No change.
(i) Proof of registration for each At least one piece of properly registered laser device equipment located within the electrology facility, as required by Section 501.122, F.S.	First time violation $300, Subsequent violation $600.
(64B8-51.006 (3)(h)4.(g)3., F.A.C.)
(j) Protective eyewear for all persons in laser room during operation of laser.	First time violation $300, Subsequent violation $600.
(64B8-51.006(3)(h)8.(g),7., F.A.C.)
(k) Proof of completion of 30 hours of post-licensure education in laser hair removal for all electrologists using laser equipment in the facility. (64B8-52.004 and 64B8-51.006 (3)(h)2., F.A.C.)	First time violation $500, Subsequent violation $1,000.
(l) Proof of certification as Certified Medical Electrologist for all persons who use laser equipment in the facility, who are not exempt and are licensed electrologists.	First time violation $500, Subsequent violation $1,000.
(64B8-56.002(2)(b) and 64B8-51.006(3)(h)3., F.A.C.)

(6) through (7) No change.

Rulemaking Specific Authority 456.077(1), (2) FS. Law Implemented 456.072(3)(b), 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,_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 1, 2011
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 2, 2012