The agency is proposing to amend the rule that incorporates the laboratory licensure application and identifies information needed in laboratory applications.

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

Rule No.: RULE TITLE
59A-7.021: Laboratory Licensure - Qualifications, Licensure, Operation and Application
PURPOSE AND EFFECT: The agency is proposing to amend the rule that incorporates the laboratory licensure application and identifies information needed in laboratory applications.
SUMMARY: Revisions to laboratory applications that are incorporated by reference to consolidate the application forms.
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: 483.051, 483.101, 483.111, 483.172, 483.221, 483.23, 408.804, 408.805, 408.806, 408.807, 408.812, 408.813, 408.814, 408.815, 408.816, 408.817, 408.831 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: October 5, 2010, 2:00 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room B, 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, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

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. Name, mailing and street address of the laboratory.

2. Specialties and subspecialties performed.

3. A list of equipment.

4. The number of hours the director spends in the laboratory.

5. Names, mailing and street addresses of specimen collection stations, branch offices and other facilities representing the clinical laboratory.

6. Name and source of proficiency testing programs.

7. Annual volume of tests anticipated to be performed.

8. Location and type of alternate-site testing in hospital facilities.

9. The name, address and employer or tax identification number of the laboratory owner.

10. A current certificate of status or authorization pursuant to Chapter 607, 608, 617 or 620, F.S.

11. Such other information requested on the application for licensure as specified in paragraph 59A-35.060(1)(aa), F.A.C. AHCA Form 3170-2004 -B, Initial Clinical Laboratory Licensure Application, September, 2009, AHCA Form 3170-2004C, Change of Licensed Owner Application, September 2009, ACHA AHCA Form 3170-2004D, Addition of Specialty, Subspecialty or change in Specialty, September 2009, 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 Forms 3170-2004B, 3170-2004C and 3170-2004D, shall be obtained from the agency 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. Name, mailing and street address of the laboratory.

2. Specialties and subspecialties performed.

3. Names, mailing and street addresses of specimen collection stations, branch offices and other facilities representing the clinical laboratory.

4. Annual volume of tests performed.

5. Location and type of alternate-site testing in hospital facilities.

6. The name and employer or tax identification number of the laboratory owner.

7. Information requested on the application for licensure as specified in paragraph 59A-35.060(1)(aa), F.A.C., Clinical Laboratory License Renewal Application, REV September 2009, and AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009. AHCA Form 3170-2004, AHCA Form 3170 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 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. Proof of current accreditation or licensure by the approved accreditation program; and

2. Proof of authorization for the approved accreditation program to submit to the agency such records or other information about the laboratory required for the agency to determine compliance with Chapter 59A-7, F.A.C. and Chapter 483, Part I, F.S.

(2) through (11) No change.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 483.051, 483.101, 483.111, 483.172, 483.221, 483.23, 408.804, 408.805, 408.806, 408.807, 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, 3-1-10,_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Karen Rivera
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Secretary Arnold
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 25, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 23, 2010