RULE NO: RULE TITLE
59A-7.020: Definitions

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. 35 No. 45, November 13, 2009 issue of the Florida Administrative Weekly.

59A-7.021 Laboratory Licensure – Qualifications, Licensure, Operation and Application.

(1) The application for licensure shall include the following information applicable to the laboratory operation:

(a) The application for an initial licensure, including changes of ownership and additions of specialty and subspecialty shall contain:

1. through 10. No change.

11. Information Such other information requested on AHCA Form 3170-2004B, Initial Clinical Laboratory Licensure Application, September, 2009, or AHCA Form 3170-2004C, Change of Licensed Owner Application, September 2009, or ACHA Form 3170-2004D, Addition of Specialty, Subspecialty or change in Specialty, September 2009, and AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009, necessary in carrying out the purpose of this part as stated in Section 483.021, F.S., and Sections 408.805, 408,806, 408.807, 408.810, and 408.813, F.S. as applicable to the laboratory operation. AHCA Forms 3170-2004B, 3170-2004C and 3170-2004D, shall be obtained from the agency, are and is incorporated by reference herein and are available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/applications.shtml.

(b) The application for renewal licensure shall contain:

1. through 6. No change.

7. Information Such other information requested on AHCA Form 3170-2004, Clinical Laboratory License Renewal Application, REV September 2009, and or AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009, necessary in carrying out the purpose of this part as stated in Section 483.021, F.S., and Sections 408.805, 408.806, 408.807, 408.810, and 408.813, F.S., as applicable to the laboratory operation. AHCA Form 3170-2004, Clinical Laboratory License Renewal Application, REV September, 2009, and AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009 shall be obtained from the agency and are is incorporated by reference herein and are available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/applications.shtml.

(c) In addition to information required under paragraphs 59A-7.021(1)(a) and (b), F.A.C., accredited laboratories surveyed by an approved accreditation program in lieu of the agency, as specified in Rule 59A-7.033, F.A.C., and Chapter 408, Part II, F.S., must also submit:

1. through 2. No change.

(2) through (9) No change.

(10) Laboratories are prohibited from performing testing for which they are not authorized as indicated on the clinical laboratory license. The performance of unauthorized testing shall result in administrative action as authorized under Section 483.221, and Sections 408.812, 408.813, 408.814, 408.815, 408.816, 408.817 and 408.831, F.S.

(11) No change.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 483.051, 483.091, 483.101(1), 483.111, 483.172, 483.181, 483.221, 483.23, 408.303, 408.804, 408.805, 408.806, 408.807, 408.808, 408.809, 408.810, 408.812, 408.813, 408.814, 408.815, 408.816, 408.817, 408.831 FS. History–New 11-20-94, Amended 7-4-95, 12-27-95, 3-25-03,_________.