The Board proposes the rule amendment to clarify language, add a time limit to comply with requirement in provision (4)(m) of the rule, add provision (4)(t) to the rule, and to update reference to Rule 64B8-51.006, F.A.C.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-55.002Citations

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify language, add a time limit to comply with requirement in provision paragraph (4)(m) of the rule, add provision paragraph (4)(t) to the rule, and to update reference to Rule 64B8-51.006, F.A.C.

SUMMARY: The rule amendment is needed to clarify language, add a time limit to comply with requirement in provision (4)(m) of the rule, add provision (4)(t) to the rule, and to update reference to Rule 64B8-51.006, F.A.C.

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: 456.077(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 FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allen Hall, Executive Director, Electrolysis Council, 4052 Bald Cypress Way, Bin #C05, Tallahassee, Florida 32399-3253

 

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) though (g) No change.

(h) The presence of aAnimals in the room wherein electrolysis is	(h) First time violation – a $150.00 fine, second
performed except those trained to assist the	time violation – a $300.00 fine.
hearing impaired, visually impaired or physically
impaired as provided by Section 413.08, F.S. (64B8-51.006(3)(e)(d), F.A.C.)
(i) Failure to have any one of the following items/equipment in the	(i) First time violation – a $150.00 fine, second
facility (the failure to have any one of the items/equipment shall	time violation – a $300.00 fine.
constitute a separate citation):
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 Rule 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 Departement 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 each person who has received electrolysis treatment book.	(j) First time violation – a $150.00 fine, second
(64B8-51.006(3)(g)(f), F.A.C.)	time violation – a $300.00 fine.
(k) No change.
(l) Failure to have any one of the following	(l) First time violation – a $50.00 fine, second
items/equipment (the failure to have any one of the	time violation – a $100.00 fine, third time
items/equipment shall constitute a separate	violation – $200.00 fine.
violation):
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 compartment.
(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 device 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 (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.	(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.	First time violation $150, Subsequent violation $300.
(64B8-51.006(3)(h)9.(g), 8., F.A.C.)
(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	First time violation $300, Subsequent violation $600.
Facility, as required by Section 501.122, F.S..
(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 F.A.C. 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: Electrolysis Council

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 FAR: October 3, 2013