The Florida Senate

483.101  Application for clinical laboratory license.--

(1)  An application for a clinical laboratory license must be made under oath by the owner or director of the clinical laboratory or by the public official responsible for operating a state, municipal, or county clinical laboratory or institution that contains a clinical laboratory, upon forms provided by the agency.

(2)  Each applicant for licensure must comply with the following requirements:

(a)  Upon receipt of a completed, signed, and dated application, the agency shall require background screening, in accordance with the level 2 standards for screening set forth in chapter 435, of the managing director or other similarly titled individual who is responsible for the daily operation of the laboratory and of the financial officer, or other similarly titled individual who is responsible for the financial operation of the laboratory, including billings for patient services. The applicant must comply with the procedures for level 2 background screening as set forth in chapter 435, as well as the requirements of s. 435.03(3).

(b)  The agency may require background screening of any other individual who is an applicant if the agency has probable cause to believe that he or she has been convicted of a crime or has committed any other offense prohibited under the level 2 standards for screening set forth in chapter 435.

(c)  Proof of compliance with the level 2 background screening requirements of chapter 435 which has been submitted within the previous 5 years in compliance with any other health care licensure requirements of this state is acceptable in fulfillment of the requirements of paragraph (a).

(d)  A provisional license may be granted to an applicant when each individual required by this section to undergo background screening has met the standards for the Department of Law Enforcement background check but the agency has not yet received background screening results from the Federal Bureau of Investigation, or a request for a disqualification exemption has been submitted to the agency as set forth in chapter 435 but a response has not yet been issued. A license may be granted to the applicant upon the agency's receipt of a report of the results of the Federal Bureau of Investigation background screening for each individual required by this section to undergo background screening which confirms that all standards have been met, or upon the granting of a disqualification exemption by the agency as set forth in chapter 435. Any other person who is required to undergo level 2 background screening may serve in his or her capacity pending the agency's receipt of the report from the Federal Bureau of Investigation. However, the person may not continue to serve if the report indicates any violation of background screening standards and a disqualification exemption has not been requested of and granted by the agency as set forth in chapter 435.

(e)  Each applicant must submit to the agency, with its application, a description and explanation of any exclusions, permanent suspensions, or terminations of the applicant from the Medicare or Medicaid programs. Proof of compliance with the requirements for disclosure of ownership and control interests under the Medicaid or Medicare programs may be accepted in lieu of this submission.

(f)  Each applicant must submit to the agency a description and explanation of any conviction of an offense prohibited under the level 2 standards of chapter 435 by a member of the board of directors of the applicant, its officers, or any individual owning 5 percent or more of the applicant. This requirement does not apply to a director of a not-for-profit corporation or organization if the director serves solely in a voluntary capacity for the corporation or organization, does not regularly take part in the day-to-day operational decisions of the corporation or organization, receives no remuneration for his or her services on the corporation or organization's board of directors, and has no financial interest and has no family members with a financial interest in the corporation or organization, provided that the director and the not-for-profit corporation or organization include in the application a statement affirming that the director's relationship to the corporation satisfies the requirements of this paragraph.

(g)  A license may not be granted to an applicant if the applicant or managing employee has been found guilty of, regardless of adjudication, or has entered a plea of nolo contendere or guilty to, any offense prohibited under the level 2 standards for screening set forth in chapter 435, unless an exemption from disqualification has been granted by the agency as set forth in chapter 435.

(h)  The agency may deny or revoke licensure if the applicant:

1.  Has falsely represented a material fact in the application required by paragraph (e) or paragraph (f), or has omitted any material fact from the application required by paragraph (e) or paragraph (f); or

2.  Has had prior action taken against the applicant under the Medicaid or Medicare program as set forth in paragraph (e).

(i)  An application for license renewal must contain the information required under paragraphs (e) and (f).

(3)  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. A separate license is required of all laboratories maintained on separate premises even if the laboratories are operated under the same management. Upon receipt of a request for an application for a clinical laboratory license, the agency shall provide to the applicant a copy of the rules relating to licensure and operations applicable to the laboratory for which licensure is sought.

History.--s. 10, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 395, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 8, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 8, 25, ch. 93-178; ss. 64, 71, ch. 98-171; s. 107, ch. 2000-349; s. 25, ch. 2001-53; s. 2, ch. 2001-67; s. 148, ch. 2001-277; s. 61, ch. 2004-267.