The purpose of the rule amendment is to update and correct the rule language.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.:RULE TITLE:

64B3-2.003Definitions

PURPOSE AND EFFECT: The purpose of the rule amendment is to update and correct the rule language.

SUMMARY: To update and correct rule language.

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: 483.805(4), 483.811(2) FS.

LAW IMPLEMENTED: 483.803, 483.811, 483.821, 483.823 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: Anthony B. Spivey, Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B3-2.003 Definitions.

(1) No change.

(2) Approved laboratory means a federally certified clinical laboratory licensed under Section 483.091, F.S., or federal or out-of-state laboratories which have standards equivalent to those prescribed in Chapter 483, Part I, F.S., and the rules promulgated thereunder.

(3) through (6) No change.

(7) Pertinent clinical laboratory experience is experience in a clinical laboratory as defined in Section 483.803(2) 041(2), F.S. If acquired in-state or in a state where licensure is required, experience must be accrued while licensed and working in a licensed laboratory unless otherwise authorized by the administrative rules of this Board. Experience acquired as a part of a training program may not be used as pertinent clinical laboratory experience. Exempt experience may not be utilized with the exception of experience in federal laboratories. Experience in industrial laboratories is not considered pertinent clinical laboratory experience. Experience in research laboratories is not considered pertinent clinical laboratory experience unless the research experience involved human subjects and used methodologies, quality control and quality assurance techniques comparable to those of clinical laboratories. If all of these requirements are met the Board will review the research experience to determine if it is relevant experience. If research experience was acquired under an exemption clause, it may not be utilized as pertinent clinical laboratory experience. Experience acquired in an exclusive use laboratory environment, waived laboratory environment or alternate site testing environment is generally unacceptable unless specifically authorized by rules of this Board.

(8)  thorugh (17) No change.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.803, 483.811, 483.821, 483.823 FS. History–New 11-4-93, Formerly 61F3-2.003, Amended 11-21-94, 11-30-94, 12-26-94, 5-3-95, 7-12-95, Formerly 59O-2.003, Amended 3-19-98, 12-13-98, 3-28-99, 9-12-99, 11-15-99, 3-24-02, 10-30-02, 2-1-04, 1-8-06, 8-14-06, 1-30-12, 2-7-13, 11-25-14, 2-23-16,                   .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Clinical Laboratory Personnel

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Clinical Laboratory Personnel

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 8, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 9, 2019