Laboratory Unit Rule Development


Interested Parties E-mail Group

The Laboratory Unit has set up an "Interested Parties E-mail Group" for individuals or groups that would like early notification of rule development or public meetings relative to the programs this unit administers. All Agency rules and meeting notices are published in the Florida Administrative Weekly. This e-mail group would be alerted to any notices or announcements prior to publication in the Florida Administrative Weekly relative to unit rule development or public meetings held regarding the following state licensed providers:

  • Clinical Laboratories
  • Drug-Free Workplace Laboratories
  • Multiphasic Health Testing Centers
  • Organ, Tissue and Eye Procurement Organizations

If you are interested in becoming a member of this e-mail group, please send a request to: LabStaff@ahca.myflorida.com and indicate that you wish to be added to the "Interested Parties E-mail Group".

Rule Workshops

As Rule Workshops are scheduled, information will be published here. Notices of Rule Workshops are published in the Florida Administrative Weekly and on this site (see below), announcing the Agency's intention to establish or amend a rule. Workshops are typically held in one of the Agency's conference rooms at Fort Knox III, 2727 Mahan Drive, Tallahassee, so that interested parties may provide informal advice and comments about the rule. Draft rule language is usually published in the Florida Administrative Weekly with the workshop notice. Written comments are welcome prior to, at, and after the workshop up to a date and time given during the workshop. Additional detail about the rule adoption process is found in Chapter 120, Florida Statues and Chapter 1B-30, Florida Administrative Code.

There are no rule workshops at this time.

Proposed Rules - Public Rule Hearings

Proposed rules are also published in the Florida Administrative Weekly, announcing the Agency's intention to establish or amend a rule. If a workshop has been held prior to this Notice, the rule text in the proposed rule incorporates advice from that meeting and other sources. A hearing is then scheduled so that interested parties may present formal testimony or documents about the rule content. Written comments may be submitted prior to or at the hearing, but not after. If the Agency elects to modify the rule in response to the hearing testimony or other materials submitted, the revised text will be published in the Florida Administrative Weekly as a Notice of Change. Additional detail about the rule adoption process is found in Chapter 120, Florida Statues and Chapter 1B-30, Florida Administrative Code.

 

59A-6.021: Surveys and Evaluations
59A-6.032: Advertising and Promotional Material
PURPOSE AND EFFECT: These two rules within Chapter 59A-6 will be repealed
SUMMARY: These two rules repeat statutory requirements and are not mandated by statute.
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 2, 2012, 1:00 - 3:00 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Dr. Building 3, Conference Room B, Tallahassee, FL 32308.

Notice of Proposed Rule appears in Vol 38/5, Florida Administrative Weekly February 3, 2012.

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 , F.S.
LAW IMPLEMENTED: 483.035 , 483.051 , 483.111 , F.S.
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: 2:30 p.m., on March 1, 2012
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida

Notice of Proposed Rule appears in Vol 38/5, Florida Administrative Weekly February 3, 2012.

2012 Adopted Rules

Rules 59A-7.038: Administrative Hearings and 59A-7.039: Administrative Enforcement
Final Adopted Rule effective February 20, 2012, and is available at:
https://www.flrules.org/gateway/RuleNo.asp?title=CLINICAL LABORATORIES&ID=59A-7.038
https://www.flrules.org/gateway/RuleNo.asp?title=CLINICAL LABORATORIES&ID=59A-7.039


Rule 59A-6.034: Administrative Enforcement
Final Adopted Rule effective February 20, 2012, and is available at:
https://www.flrules.org/gateway/RuleNo.asp?title=MULTIPHASIC HEALTH TESTING CENTER LICENSURE&ID=59A-6.034




Advisory Panels and Boards

Organ & Tissue Procurement and Transplantation Advisory Board: A14-member Advisory Board is established under section 765.543, Florida Statutes. Members of this board are appointed by the Secretary of the Agency and serve 3-year terms. The current Board members are serving terms from July of 2011 though July of 2014.

Among other things, this Advisory Board develops with and recommends to the Agency changes to the laws of this state or administrative rules or procedures to ensure that the statewide organ and tissue procurement and transplantation system is able to function smoothly, effectively, and efficiently, in accordance with the Federal Anatomical Gift Act and in a manner that assures the residents of this state that no person or entity profits from the altruistic voluntary donation of organs or tissues.


Clinical Laboratory Technical Advisory Panel: A 16-member Technical Advisory Panel was established under section 483.26, Florida Statutes, to assist the agency in determining if rule development is needed for rules relating to assessing administrative penalties for persons who pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement in any form whatsoever with any dialysis facility, physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a clinical laboratory licensed under Chapter 483, Part I, Florida Statutes.

There are currently two existing rules that address kickbacks and penalties for rebates: Subsection 59A-7.020(14) and section 59A-7.037, Florida Administrative Code.

For information on meetings of the Technical Advisory Panel, please visit: http://ahca.myflorida.com/mchq/health_facility_regulation/laboratory_licensure/TAP.shtml

The last meeting of this panel was held on August 24, 2010 with final business conducted September 15, 2010.




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