Florida Statutes Part I - Clinical Laboratories (Ss. 483.011-483.26)

• 483.011 - Short Title.
  This part may be cited as “The Florida Clinical Laboratory Law.”History.—s. 1, ch. 67-248; s. 3, ch. 76-168; s. 1, ch. 77-457; ss. 2, 3,...
• 483.021 - Declaration Of Policy And Statement Of Purpose.
  The purpose of this part is to protect the public from the hazards of improper performance by clinical laboratories. Clinical laboratories provide essential services to...
• 483.031 - Application Of Part; Exemptions.
  This part applies to all clinical laboratories within this state, except:(1) A clinical laboratory operated by the United States Government.(2) A clinical laboratory that performs only waived...
• 483.035 - Clinical Laboratories Operated By Practitioners For Exclusive Use; Licensure And Regulation.
  (1) A clinical laboratory operated by one or more practitioners licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, or chapter...
• 483.041 - Definitions.
  As used in this part, the term:(1) “Agency” means the Agency for Health Care Administration.(2) “Clinical laboratory” means the physical location in which one or more of...
• 483.051 - Powers And Duties Of The Agency.
  The agency shall adopt rules to implement this part, which rules must include, but are not limited to, the following:(1) LICENSING; QUALIFICATIONS.—The agency shall provide for...
• 483.061 - Inspection Of Clinical Laboratories.
  (1) In addition to the requirements of s. 408.811, the agency shall ensure that each clinical laboratory subject to this part is inspected either onsite or...
• 483.091 - Clinical Laboratory License.
  A clinical laboratory may not send a specimen drawn within this state to any clinical laboratory outside the state for examination unless the out-of-state laboratory...
• 483.101 - Clinical Laboratory License.
  A license must be issued authorizing the performance of one or more clinical laboratory procedures or one or more tests on each specialty or subspecialty....
• 483.111 - Limitations On Licensure.
  A license may be issued to a clinical laboratory to perform only those clinical laboratory procedures and tests that are within the specialties or subspecialties...
• 483.172 - License Fees.
  (1) In accordance with s. 408.805, an applicant or a licensee shall pay a fee for each license application submitted under this part, part II of...
• 483.181 - Acceptance, Collection, Identification, And Examination Of Specimens.
  (1) A clinical laboratory may examine human specimens at the request only of a licensed practitioner or other person authorized by law to use the findings...
• 483.191 - Branch Offices, Representation Of Other Laboratories.
  A person may not represent or maintain an office or specimen collection station or other facility for the representation of any clinical laboratory situated in...
• 483.201 - Grounds For Disciplinary Action Against Clinical Laboratories.
  In addition to the requirements of part II of chapter 408, the following acts constitute grounds for which a disciplinary action specified in s. 483.221...
• 483.221 - Administrative Fines.
  (1) In accordance with part II of chapter 408, the agency may impose an administrative fine, not to exceed $1,000 per violation, for the violation of...
• 483.23 - Offenses; Criminal Penalties.
  (1)(a) It is unlawful for any person to:1. Operate, maintain, direct, or engage in the business of operating a clinical laboratory unless she or he has obtained...
• 483.245 - Rebates Prohibited; Penalties.
  (1) It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement in any form...
• 483.26 - Technical Advisory Panel.
  The Agency for Health Care Administration may establish a technical advisory panel to assist the agency in rule revisions that are necessary as a result...

Last modified: September 23, 2016