59A-7.035: Staffing Requirements
PURPOSE AND EFFECT: The agency is proposing to amend the rule to remove outdated references and previously repealed requirements, correct language that conflicts with statutory language, and remove language that duplicates statutory language.
SUBJECT AREA TO BE ADDRESSED: Revisions to update, correct and remove duplicative language.
RULEMAKING AUTHORITY: 483.051 FS.
LAW IMPLEMENTED: 483.035, 483.051, 483.111 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: June 28, 2011, 2:00 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
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(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(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,________.