64B3-13.001: Responsibilities of Directors
PURPOSE AND EFFECT: The purpose of this notice is to update the citations within subsection 64B3-13.001(3), F.A.C., so that the subsection conforms to the proposed amendments to Rule 64B3-5.007, F.A.C.
SUMMARY: The responsibilities associated with directing a clinical laboratory performing highly complex testing.
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: 483.800, 483.813, 483.823, 483.825 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN 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:
64B3-13.001 Responsibilities of Directors.
(1) through (2) No change.
(3) A director not certified by the American Board of Pathology in clinical pathology qualified pursuant to paragraph 64B3-5.007(2)(a), F.A.C., or by the American Board of Oral Pathology, the American Board of Pathology, or the American Osteopathic Board of Pathology subsection 64B3-5.007(3), F.A.C., who is directing a clinical laboratory performing highly complex testing, shall ensure a co-director certified by the American Board of Pathology in clinical pathology qualified under paragraph 64B3-5.001(1)(a), F.A.C., or by the American Board of Oral Pathology, the American Board of Pathology, or the American Osteopathic Board of Pathology subsection 64B3-5.001(3), F.A.C., is available to provide clinical consultation and technical supervision consistent with the scope and volume of highly complex testing being performed as defined in 42 C.F.R. 493.10 and 42 C.F.R. 493.17 which are incorporated by reference. Directors certified by the American Board of Oral Pathology, the American Board of Pathology, or the American Osteopathic Board of Pathology qualifying pursuant to subsection 64B3-5.001(3), F.A.C., shall provide clinical consultation only in the specialty area(s) for which they are board certified or have 4 years of pertinent clinical laboratory experience.
(4) through (7) No change.
Specific Authority 483.805(4) FS. Law Implemented 483.800, 483.813, 483.823, 483.825 FS. History–New 12-6-94, Amended 3-28-95, Formerly 59O-13.001, Amended 4-7-02, 5-24-07, _________.