Board proposes to amend the rule to add language with regard to the scope of practice relative to specialty licenses held by clinical laboratory personnel.

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.: RULE TITLE:

64B3-10.005 Scope of Practice Relative to Specialty of Licensure

PURPOSE AND EFFECT: Board proposes to amend the rule to add language with regard to the scope of practice relative to specialty licenses held by clinical laboratory personnel.

SUMMARY: The proposed rule outlines scope of molecular pathology specialty.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.

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.

SPECIFIC AUTHORITY: 483.805(4) FS.

LAW IMPLEMENTED: 483.813 FS., 483.823 FS., 483.825 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: Joe Baker, Jr., 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:

 

64B3-10.005 Scope of Practice Relative to Specialty of Licensure.

The following rules are not intended to prevent collection and storage of specimens or the performance of manual pretesting procedures by persons who are exempt by statute or statutorily authorized within their scope of practice. Clinical laboratory personnel qualified as a physician director, a licensed director, supervisor, technologist or technician in the specialty or specialties indicated can perform testing identified as being within the specialty. Tests which are not yet classified shall be assigned by the Board upon review.

(1) through (11) No change.

(12) The purpose of the specialty of cytology is to process and interpret cellular material derived from the human body delineating data regarding human cytopathological disease. Cytology includes: (a) review and interpretation of gynecological cytology preparations in accordance with the provisions of Rule Chapter 64B3-7, F.A.C.; (b), and screening of non-gynecological cytology preparations where final review and interpretation is the responsibility of a qualified physician; and (c) process, perform, review and correlate diagnostic techniques ancillary to liquid based cytology.

(13) No change.

(14) The purpose of the specialty of molecular pathology is the use of molecular techniques for the characterization of gene expression (protein, RNA), genetic lesions (DNA) in cells, gene products (proteomics) and analysis genetics is to perform an analyses on human DNA, RNA and chromosomes to detect heritable or acquired disease-related genotypes, mutations, and phenotypes for clinical purposes. It includes the study of how the changes found lead to the disease process, monitoring of the effectiveness of therapy, and detection of residual disease. Techniques included are but not limited to immunohistochemistry, in situ hybridization, mutational analysis, protein analysis, polymerase chain reactions, cell culture and isolation, expression profiling, blotting and microarrays. Such purposes would include predicting risk of disease; identifying carriers; and establishing prenatal or clinical diagnoses or prognoses in individuals, families, or populations.

(15) through (19) No change.

Specific Authority 483.805(4) FS. Law Implemented 483.813, 483.823, 483.825 FS. History–New 2-7-95, Amended 3-28-95, 7-12-95, 12-4-95, Formerly 59O-10.005, Amended 3-19-98, 1-28-99, 11-24-99, 2-15-01, 2-20-02, 10-30-02, 4-27-04,________.

 

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

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Clinical Laboratory Personnel

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 7, 2005

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: November 10, 2005