The purpose of the rule amendment is to update the rule language to define the definition of manual pretesting.

 

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 the rule language to define the definition of manual pretesting.

SUMMARY: To update the 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) through (16) No change.

(17) Manual Pretesting means pre-analytical procedures, including specimen collection, labeling, and processing.  Additional duties may include slide preparation from a primary specimen, direct primary inoculation of microbiology cultures, cytopreparatory staining, preventative maintenance, and loading specimens onto automated instruments or systems which are verified by licensed personnel or autoverified by the laboratory information system.  It does not include any quality control procedures. means collecting and labeling specimens; initially separating specimens by centrifugation prior to testing; receiving specimens and requisitions, processing, sorting, accessioning, prior to testing and delivering specimens to the appropriate testing sites; specimen processing for storage and shipping to a reference laboratory; routine hematology and microbiology slide preparation from a primary sample; loading automated stainers; loading specimens onto automated sampling or processing systems; cytopreparatory staining; measuring and aliquoting specimens; and direct primary inoculation of microbiology cultures. Placement of specimens onto an automated instrument or system is considered a manual pretesting duty, provided it does not include any activity that initiates the analytic process.

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,  7-29-19,____.

 

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: September 6, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 14, 2019