59A-7.035: Staffing Requirements
PURPOSE AND EFFECT: The agency is proposing to amend the rule that addresses who must supervise in clinical laboratories.
SUMMARY: Revisions to better align the requirements of supervision in clinical laboratories with recent revisions to Chapter 64B3, Florida Administrative Code are being reviewed.
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: 483.051 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: May 11, 2009, 2:00 p.m. 4:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308; (850)487-3109
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 IV, F.S., for all specialties and subspecialties in which the laboratory is licensed.
(a) No change.
1. The laboratory director, if qualified, is authorized to perform the duties of the general supervisor, and clinical laboratory testing personnel, or delegate these responsibilities to personnel meeting the qualifications set forth in Chapter 483, Part III IV, F.S., and Chapter 64B3 59O, F.A.C.
2. through 5. No change.
5. If the director is to be continuously absent from the laboratory for more than one month, it shall be the directors and owners responsibility to make arrangements for a qualified substitute director. Such arrangements must be documented in writing and available for review by the agency.
6. The director must ensure that the laboratory employs personnel qualified under Chapter 483, Part III IV, F.S., and Chapter 64B3 59O, F.A.C., to provide consultation, supervise and accurately perform tests and report test results according to this Rule and within the limitations described in Section 483.111, F.S.
(b) The laboratory must have at least one director who is qualified under Chapter 483, Part III IV, F.S., and provides, in addition to responsibilities specified under paragraph 59A-7.035(1)(a), F.A.C., clinical consultation as required for Clinical Consultants prescribed under the Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder as described in subsection 59A-7.020(6), F.A.C.
(2) Supervisor. The laboratory must have one or more supervisors.
(a) The supervisor must be licensed under Chapter 483, Part III IV, F.S., in accordance with Chapter 64B3, F.A.C., for all tests performed in the laboratory all specialties in which the laboratory performs tests except that the supervision of respiratory care practitioners, clinical laboratory personnel, and other persons performing blood gas analysis and specimen collection for the purpose of such analysis shall be specified in rules pursuant to Chapter 483, F.S.
(b) If the requirement of paragraph 59A-7.035(2)(a), F.A.C., is not met, the laboratory is authorized to be staffed with one or more supervisors licensed under Chapter 483, Part III IV, F.S., such that all licenses combined provide supervisory coverage for all specialties and subspecialties in which the laboratory is licensed.
(c) No change.
(3) Clinical Laboratory Personnel. In addition to the personnel specified in subsections 59A-7.035(1) and (2), F.A.C., each laboratory must be staffed with technologists or technicians, as applicable, licensed under Chapter 483, Part III IV, F.S. Blood gas analysis procedures are permitted to be performed by an individual licensed as a respiratory care practitioner or a respiratory therapist pursuant to Chapter 468, F.S.
(4) Exclusive Use Laboratories shall be staffed with:
(a) A director qualified under Chapter 483, Part III IV, 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 IV, F.S., and Chapter 64B3 59O, F.A.C.
(5) Plasmapheresis centers performing only waived tests, total protein by refractometer or ABO and Rh typing shall be staffed with:
(a) A director qualified under Chapter 483, Part III IV, 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, or technician, as applicable, as provided under Chapter 483, Part III IV, F.S.
(6) Sites performing testing authorized under Rule 59A-7.034, F.A.C., must be staffed with personnel qualified under subsection 59A-7.034(5), F.A.C., under the direct supervision of the clinical laboratory director, supervisor or technologist qualified under Chapter 483, Part III IV, F.S.
(7) Laboratories located outside Florida and licensed under Chapter 483, Part I, F.S., and facilities issued a certificate of exemption under Section 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(6), F.A.C. Such personnel shall not be required to be licensed under Chapter 483, Part III IV, F.S.
Rulemaking Specific Authority 483.051 FS. Law Implemented 483.031, 483.035, 483.051, 483.111 FS. HistoryNew 11-20-94, Amended 12-27-95, ________.
