Changes to Chapter 483, Part I, Florida Statutes
Effective July 1, 2012
(underline indicates amended langauge)
483.23Offenses; 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 a clinical laboratory license from the agency or is exempt under s. 483.031.
2.Conduct, maintain, or operate a clinical laboratory, other than an exempt laboratory or a laboratory operated under s. 483.035, unless the clinical laboratory is under the direct and responsible supervision and direction of a person licensed under part III of this chapter.
3.Allow any person other than an individual licensed under part III of this chapter to perform clinical laboratory procedures, except in the operation of a laboratory exempt under s. 483.031 or a laboratory operated under s. 483.035.
4.Violate or aid and abet in the violation of any provision of this part or the rules adopted under this part.
(b) The performance of any act specified in paragraph (a) shall be referred by the agency to the local law enforcement agency and constitutes a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Additionally, the agency may issue and deliver a notice to cease and desist from such act and may impose by citation an administrative penalty not to exceed $5,000 per act. Each day that unlicensed activity continues after issuance of a notice to cease and desist constitutes a separate act.
(2)Any use or attempted use of a forged license under this part or part III of this chapter constitutes the crime of forgery.
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 whatsoever with any dialysis facility, physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a clinical laboratory licensed under this part. A clinical laboratory is prohibited from, directly or indirectly, providing through employees, contractors, an independent staffing company, lease agreement, or otherwise, personnel to perform any functions or duties in a physician's office, or any part of a physician's office, for any purpose whatsoever, including for the collection or handling of specimens, unless the laboratory and the physician's office are wholly owned and operated by the same entity. A clinical laboratory is prohibited from leasing space within any part of a physician's office for any purpose, including for the purpose of establishing a collection station.
(2)The agency shall adopt rules that assess administrative penalties for acts prohibited by subsection (1). In the case of an entity licensed by the agency, such penalties may include any disciplinary action available to the agency under the appropriate licensing laws. In the case of an entity not licensed by the agency, such penalties may include:
(a)A fine not to exceed $1,000;
(b)If applicable, a recommendation by the agency to the appropriate licensing board that disciplinary action be taken.
(3) The agency shall promptly investigate all complaints of noncompliance with subsection (1). The agency shall impose a fine of $5,000 for each separate violation of subsection (1). In addition, the agency shall deny an application for a license or license renewal if the applicant, or any other entity with one or more common controlling interests in the applicant, demonstrates a pattern of violating subsection (1). A pattern may be demonstrated by a showing of at least two such violations.
Licensed clinical laboratories were sent a letter on May 23, 2012 (letter in PDF format). Please note that in addition to the amendments to Chapter 483, Part I, Florida Statutes, this May 23, 2012 letter also addresses the changes to Chapter 408, Part II, Florida Statutes that impact clinical laboratories, which are also effective July 1, 2012.
If you are aware or have reason to believe that a clinical laboratory is in violation of these regulations, please call the Agency toll-free:
1-888-419-3456.
