RULE NO.: RULE TITLE:
59A-7.035: Staffing Requirements

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 38 No. 5, February 3, 2012 issue of the Florida Administrative Weekly.

Changes are limited to corrections to (4) where subsection 7 of Rule 59A-7.020, F.A.C., was incorrectly referenced and to (6) where subsection 8 of Rule 59A-7.034, F.A.C., was incorrectly referenced and are in response to written comments submitted by the staff of the Joint Administrative Procedures Committee (JAPC).

59A-7.035 Staffing Requirements.

(1) The laboratory must be staffed with a director(s) who meets the qualifications specified under Chapter 483, Part III, F.S., for all specialties and subspecialties in which the laboratory is licensed.

(a) through (3) No change.

(4) Exclusive Use Laboratories shall be staffed in accordance with CLIA as defined under subsection 59A-7.020(8)(7), F.A.C.

(a) A director qualified under Chapter 483, Part III, F.S., and at least one director qualifying under paragraph 59A-7.035(1)(b), F.A.C.; and

(b) Clinical laboratory personnel licensed as a clinical laboratory director, supervisor, technologist, technician or exclusive use technician or registered as a trainee as provided under Chapter 483, Part III, F.S., and Chapter 64B3, F.A.C.

(5) Plasmapheresis centers performing only waived tests, total protein by refractometer or ABO and Rh typing shall be staffed with:

(a) through (b) No change.

(6) Sites performing testing authorized under Rule 59A-7.034, F.A.C., must be staffed with personnel qualified under subsection 59A-7.034(7)(8), (5), F.A.C., under the direct supervision of the clinical laboratory director, supervisor or technologist qualified under Chapter 483, Part III, F.S.

(7) Laboratories located outside Florida and licensed under Chapter 483, Part I, F.S., and facilities issued a certificate of exemption under Chapter 483.106, F.S., must meet personnel qualification requirements established under the Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder as described in subsection 59A-7.020(8)(6), F.A.C. Such personnel shall not be required to be licensed under Chapter 483, Part III, F.S.

Rulemaking Authority 483.051 FS. Law Implemented 483.031, 483.035, 483.051, 483.111 FS. History–New 11-20-94, Amended 12-27-95, 7-27-09,_________.