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PURPOSE AND EFFECT: The agency is proposing to amend the rule to remove outdated references and previously repealed requirements, correct language that conflicts with statutory language, and remove language that duplicates statutory language.
SUMMARY: Revisions to update and correct and to remove duplicative 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: Review and analysis of statutory sections cited for this rule determined that the rule being amended is not consistent with statutory language cited as law implemented and included repetition of statutory language. Based on that analysis, the Agency has determined that no legislative ratification pursuant to subsection 120.541(3), F.S. is required for amendment of this rule.
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: 483.051 FS.
LAW IMPLEMENTED: 483.035, 483.051, 483.111 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: March 1, 2012, 2:30 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. 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 IS: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida
THE FULL TEXT OF THE PROPOSED RULE 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,_________.