The Florida Senate

483.011  Short title.

483.021  Declaration of policy and statement of purpose.

483.031  Application of part; exemptions.

483.035  Clinical laboratories operated by practitioners for exclusive use; licensure and regulation.

483.041  Definitions.

483.051  Powers and duties of the agency.

483.061  Inspection of clinical laboratories.

483.091  Clinical laboratory license.

483.101  Application for clinical laboratory license.

483.106  Application for a certificate of exemption.

483.111  Limitations on licensure.

483.131  Display of licenses.

483.172  License fees.

483.181  Acceptance, collection, identification, and examination of specimens.

483.191  Branch offices, representation of other laboratories.

483.201  Grounds for disciplinary action against clinical laboratories.

483.221  Administrative penalties.

483.23  Offenses; criminal penalties.

483.245  Rebates prohibited; penalties.

483.25  Injunction.

483.26  Technical advisory panel.

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, ch. 81-318; ss. 29, 30, ch. 83-276; s. 19, ch. 93-40; s. 25, ch. 93-178.

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 practitioners of the healing arts by furnishing vital information that is essential to a determination of the nature, cause, and extent of the condition involved. Unreliable and inaccurate reports can cause unnecessary anxiety, suffering, financial burdens, and even contribute directly to death. The protection of public and individual health requires licensure of clinical laboratories and the meeting of certain minimum standards, as well as certain other necessary safeguards as authorized by this part. The Legislature intends that, in keeping with federal law and regulations, clinical laboratories, regardless of location, size, or type, meet appropriate standards.

History.--s. 2, ch. 67-248; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 29, 30, ch. 83-276; s. 27, ch. 92-58; s. 19, ch. 93-40; ss. 1, 25, ch. 93-178.

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 tests and has received a certificate of exemption from the agency under s. 483.106.

(3)  A clinical laboratory operated and maintained exclusively for research and teaching purposes that do not involve patient or public health service.

History.--s. 3, ch. 67-248; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 1, ch. 77-225; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 1, 29, 30, ch. 83-276; s. 28, ch. 92-58; s. 19, ch. 93-40; ss. 2, 25, ch. 93-178.

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, or chapter 466, exclusively in connection with the diagnosis and treatment of their own patients, must be licensed under this part and must comply with the provisions of this part, except that the agency shall adopt rules for staffing, for personnel, including education and training of personnel, for proficiency testing, and for construction standards relating to the licensure and operation of the laboratory based upon and not exceeding the same standards contained in the federal Clinical Laboratory Improvement Amendments of 1988 and the federal regulations adopted thereunder.

(2)  Subsection (1) does not apply to a clinical laboratory operated by one or more practitioners who hold the facilities of the laboratory out as available for the performance of diagnostic tests for other practitioners or their patients. All provisions of this part apply to a clinical laboratory that receives any referred work or performs any work for patients referred by another practitioner.

History.--s. 3, ch. 93-178; s. 2, ch. 97-91.

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 the following services are performed to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical or physical condition.

(a)  Clinical laboratory services are the examinations of fluids or other materials taken from the human body.

(b)  Anatomic laboratory services are the examinations of tissue taken from the human body.

(c)  Cytology laboratory services are the examinations of cells from individual tissues or fluid taken from the human body.

(3)  "Clinical laboratory examination" means a procedure performed to deliver the services defined in subsection (2), including the oversight or interpretation thereof.

(4)  "Clinical laboratory proficiency testing program" means a program approved by the agency for evaluating the performance of clinical laboratories.

(5)  "Collection station" or "branch office" means a facility operated by a clinical laboratory where materials or specimens are withdrawn or collected from patients or assembled after being withdrawn or collected from patients elsewhere, for subsequent delivery to another location for examination.

(6)  "Hospital laboratory" means a laboratory located in a hospital licensed under chapter 395 that provides services solely to that hospital and that is owned by the hospital and governed by the hospital medical staff or governing board.

(7)  "Licensed practitioner" means a physician licensed under chapter 458, chapter 459, chapter 460, or chapter 461; a dentist licensed under chapter 466; a person licensed under chapter 462; or an advanced registered nurse practitioner licensed under part I of chapter 464; or a duly licensed practitioner from another state licensed under similar statutes who orders examinations on materials or specimens for nonresidents of the State of Florida, but who reside in the same state as the requesting licensed practitioner.

(8)  "Person" means the State of Florida or any individual, firm, partnership, association, corporation, county, municipality, political subdivision, or other entity, whether organized for profit or not.

(9)  "Validation inspection" means an inspection of a clinical laboratory by the agency to assess whether a review by an accrediting organization has adequately evaluated the clinical laboratory according to state standards.

(10)  "Waived test" means a test that the federal Health Care Financing Administration has determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder.

History.--s. 4, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 389, ch. 77-147; s. 1, ch. 77-457; s. 21, ch. 79-12; s. 135, ch. 79-164; ss. 2, 3, ch. 81-318; ss. 2, 29, 30, ch. 83-276; s. 77, ch. 85-81; s. 37, ch. 92-58; s. 19, ch. 93-40; ss. 4, 25, ch. 93-178; s. 144, ch. 99-397; s. 135, ch. 2000-318.

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 biennial licensure of all clinical laboratories meeting the requirements of this part and shall prescribe the qualifications necessary for such licensure. A license issued for operating a clinical laboratory, unless sooner suspended or revoked, expires on the date set forth by the agency on the face of the license.

(2)  STANDARDS OF PERFORMANCE IN THE EXAMINATION OF SPECIMENS.--The agency shall prescribe:

(a)  Overall standards of performance that comply with the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder, for a comprehensive quality assurance program. The purpose of the quality assurance program is to monitor and evaluate the ongoing and overall quality of a laboratory's total testing process.

(b)  Standards of performance in the examination of specimens for clinical laboratory proficiency testing programs using external quality control procedures. As part of a clinical laboratory proficiency testing program, clinical laboratory personnel may be required to analyze test samples and report on the results of such analyses. The agency may accept proficiency testing reports of organizations approved by the agency if the agency finds that the standards of such organizations are equal to or exceed those of the agency. The agency shall establish, by rule, criteria for satisfactory performance for a clinical laboratory that participates in an approved proficiency testing program.

(3)  SHIPMENT OF SPECIMENS.--The agency may prescribe requirements for collecting, transporting, handling, and storing specimens shipped by common carrier from clinical laboratories or collection stations. Each specimen must be sent to a laboratory for analysis as rapidly as possible, but no later than 12 hours after collection unless appropriate measures are taken to preserve the specimen, except that the 12-hour requirement does not apply to blood banks or to plasmapheresis centers in shipping samples. Specimens may be sent to any out-of-state clinical laboratory for examination if the laboratory holds a current license issued by the agency. When the specimen has been referred for examination to another laboratory, the report must include a clear statement that such findings were obtained in another laboratory and must specify its name and location.

(4)  CONSTRUCTION OF CLINICAL LABORATORIES.--A clinical laboratory must comply with all applicable local, county, state, and federal standards for the construction, renovation, maintenance, and repair of clinical laboratories, including standards for plumbing, heating, lighting, ventilation, electrical services, and similar conditions which standards will ensure the conduct and operation of the laboratory in a manner that will protect the public health.

(5)  SAFETY AND SANITARY CONDITIONS WITHIN A CLINICAL LABORATORY AND ITS SURROUNDINGS.--The agency shall establish standards relating to safety and sanitary conditions within a clinical laboratory and its surroundings, including standards for water supply; sewage; the handling of specimens; identification, segregation, and separation of biohazardous wastes as required by s. 381.0098; storage of chemicals; workspace; firesafety; and general measures that will protect the public health. The agency shall determine compliance by a clinical laboratory with the requirements of s. 381.0098 by verifying that the laboratory has obtained all required permits.

(6)  EQUIPMENT.--The agency shall establish minimum standards for clinical laboratory equipment essential to its proper operation, its calibration, and its adequacy for testing procedures.

(7)  POLICY AND PROCEDURE MANUAL.--The agency shall require that each clinical laboratory adopt and maintain a written policy and procedure manual that must address, but is not limited to:

(a)  The performance of all analytical methods used by the clinical laboratory, including specimen collection and preservation.

(b)  Instrument calibration.

(c)  Quality control systems, measures, and remedial actions.

(d)  Equipment performance evaluations.

(e)  Test performance.

(f)  Maintenance and filing of required records and reports.

(g)  Channels of communication.

(h)  Space, equipment, and supply requirements.

The policy and procedure manual must be readily available to laboratory personnel and must be followed by laboratory personnel.

(8)  STANDARDS FOR PATIENT TEST MANAGEMENT.--The agency shall adopt rules that prescribe standards for patient test management, including requirements for record retention and patient test reporting.

(9)  ALTERNATE-SITE TESTING.--The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt, by rule, the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. The elements to be addressed in the rule include, but are not limited to: a hospital internal needs assessment; a protocol of implementation including tests to be performed and who will perform the tests; criteria to be used in selecting the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals; documented inservice training as well as initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for identifying and tracking alternate-site testing by the central laboratory; and recordkeeping requirements. Alternate-site testing locations must register when the clinical laboratory applies to renew its license. For purposes of this subsection, the term "alternate-site testing" means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory.

History.--s. 5, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 390, ch. 77-147; s. 1, ch. 77-457; s. 136, ch. 79-164; s. 3, ch. 81-290; ss. 2, 3, ch. 81-318; ss. 3, 29, 30, ch. 83-276; s. 29, ch. 92-58; s. 19, ch. 93-40; ss. 5, 25, ch. 93-178.

483.061  Inspection of clinical laboratories.--

(1)  The agency shall ensure that each clinical laboratory subject to this part is inspected either onsite or offsite when deemed necessary by the agency, but at least every 2 years, for the purpose of evaluating the operation, supervision, and procedures of the facility to ensure compliance with this part. Collection stations and branch offices may be inspected either onsite or offsite, when deemed necessary by the agency. The agency may conduct or cause to be conducted the following announced or unannounced inspections at any reasonable time:

(a)  An inspection conducted at the direction of the federal Health Care Financing Administration.

(b)  A licensure inspection.

(c)  A validation inspection.

(d)  A complaint investigation, including a full licensure investigation with a review of all licensure standards as outlined in rule. Complaints received by the agency from individuals, organizations, or other sources are subject to review and investigation by the agency. If a complaint has been filed against a laboratory or if a laboratory has a substantial licensure deficiency, the agency may inspect the laboratory annually or as the agency considers necessary.

However, for laboratories operated under s. 483.035, biennial licensure inspections shall be scheduled so as to cause the least disruption to the practitioner's scheduled patients.

(2)  The right of entry and inspection is extended to any premises that is maintained as a laboratory without a license, but such entry or inspection may not be made without the permission of the owner or person in charge of the laboratory, unless an inspection warrant as defined in s. 933.20 is first obtained.

(3)  The agency shall inspect an out-of-state clinical laboratory under this section at the expense of the out-of-state clinical laboratory to determine whether the laboratory meets the requirements of this part.

(4)  The agency shall accept, in lieu of its own periodic inspections for licensure, the survey of or inspection by private accrediting organizations that perform inspections of clinical laboratories accredited by such organizations, including postinspection activities required by the agency.

(a)  The agency shall accept inspections performed by such organizations if the accreditation is not provisional, if such organizations perform postinspection activities required by the agency and provide the agency with all necessary inspection and postinspection reports and information necessary for enforcement, if such organizations apply standards equal to or exceeding standards established and approved by the agency, and if such accrediting organizations are approved by the federal Health Care Financing Administration to perform such inspections.

(b)  The agency may conduct complaint investigations made against laboratories inspected by accrediting organizations.

(c)  The agency may conduct sample validation inspections of laboratories inspected by accrediting organizations to evaluate the accreditation process used by an accrediting organization.

(d)  The agency may conduct a full inspection if an accrediting survey has not been conducted within the previous 24 months, and the laboratory must pay the appropriate inspection fee under s. 483.172.

(e)  The agency shall develop, and adopt, by rule, criteria for accepting inspection and postinspection reports of accrediting organizations in lieu of conducting a state licensure inspection.

History.--s. 6, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 391, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 5, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 6, 25, ch. 93-178; s. 3, ch. 97-91.

483.091  Clinical laboratory license.--A person may not conduct, maintain, or operate a clinical laboratory in this state, except a laboratory that is exempt under s. 483.031, unless the clinical laboratory has obtained a license from the agency. 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 has obtained a license from the agency. A license is valid only for the person or persons to whom it is issued and may not be sold, assigned, or transferred, voluntarily or involuntarily, and is not valid for any premises other than those for which the license is issued. However, a new license may be secured for the new location before the actual change, if the contemplated change complies with this part and the rules adopted under this part. Application for a new clinical laboratory license must be made 60 days before a change in the ownership of the clinical laboratory.

History.--s. 9, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 394, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 7, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 7, 25, ch. 93-178.

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.

483.106  Application for a certificate of exemption.--An application for a certificate of exemption must be made under oath by the owner or director of a clinical laboratory that performs only waived tests as defined in s. 483.041. A certificate of exemption authorizes a clinical laboratory to perform waived tests. Laboratories maintained on separate premises and operated under the same management may apply for a single certificate of exemption or multiple certificates of exemption. The agency shall, by rule, specify the process for biennially issuing certificates of exemption. Sections 483.011, 483.021, 483.031, 483.041, 483.172, 483.23, and 483.25 apply to a clinical laboratory that obtains a certificate of exemption under this section.

History.--s. 9, ch. 93-178; s. 65, ch. 98-171.

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 in which the clinical laboratory personnel are qualified. A license may not be issued unless the agency determines that the clinical laboratory is adequately staffed and equipped to operate in conformity with the requirements of this part and the rules adopted under this part.

History.--s. 11, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 396, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 9, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 10, 25, ch. 93-178.

483.131  Display of licenses.--A clinical laboratory license shall specify, on its face, the names of the owner or operator and directors of the laboratory; the procedures, specialties, or subspecialties authorized; the period for which it is valid; and the location at which such procedures must be performed. The clinical laboratory license and the licenses of all personnel in the laboratory must be displayed at all times in a prominent place in the clinical laboratory where the licenses may be viewed by the public.

History.--s. 13, ch. 67-248; s. 3, ch. 76-168; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 10, 29, 30, ch. 83-276; s. 78, ch. 85-81; s. 19, ch. 93-40; s. 25, ch. 93-178.

483.172  License fees.--

(1)  The agency shall collect fees for all licenses issued under this part. Each fee is due at the time of application and must be payable to the agency to be deposited in the Health Care Trust Fund administered by the agency.

(2)  The biennial license fee schedule is as follows:

(a)  If a laboratory performs not more than 2,000 tests annually, the fee is $400.

(b)  If a laboratory performs not more than 3 categories of procedures with a total annual volume of more than 2,000 but no more than 10,000 tests, the license fee is $965.

(c)  If a laboratory performs at least 4 categories of procedures with a total annual volume of not more than 10,000 tests, the license fee is $1,294.

(d)  If a laboratory performs not more than 3 categories of procedures with a total annual volume of more than 10,000 but not more than 25,000 tests, the license fee is $1,592.

(e)  If a laboratory performs at least 4 categories of procedures with a total annual volume of more than 10,000 but not more than 25,000 tests, the license fee is $2,103.

(f)  If a laboratory performs a total of more than 25,000 but not more than 50,000 tests annually, the license fee is $2,364.

(g)  If a laboratory performs a total of more than 50,000 but not more than 75,000 tests annually, the license fee is $2,625.

(h)  If a laboratory performs a total of more than 75,000 but not more than 100,000 tests annually, the license fee is $2,886.

(i)  If a laboratory performs a total of more than 100,000 but not more than 500,000 tests annually, the license fee is $3,397.

(j)  If a laboratory performs a total of more than 500,000 but not more than 1 million tests annually, the license fee is $3,658.

(k)  If a laboratory performs a total of more than 1 million tests annually, the license fee is $3,919.

(3)  The agency shall assess a biennial fee of $100 for a certificate of exemption and a $100 license fee for facilities surveyed by an approved accrediting organization.

History.--ss. 4, 30, ch. 83-276; s. 80, ch. 85-81; s. 14, ch. 91-282; s. 30, ch. 92-58; s. 19, ch. 93-40; ss. 11, 25, ch. 93-178; s. 4, ch. 97-91; s. 68, ch. 2000-158.

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 of clinical laboratory examinations. An individual forwarding a sample of the individual's own blood to a clinical laboratory, when such blood sample has been taken pursuant to a home access HIV test kit approved by the United States Food and Drug Administration, shall be considered a person authorized to request and use a clinical laboratory test for human immunodeficiency virus, for the purposes of this part.

(2)  The results of a test must be reported directly to the licensed practitioner or other authorized person who requested it. The report must include the name and address of the clinical laboratory in which the test was actually performed, unless the test was performed in a hospital laboratory and the report becomes an integral part of the hospital record.

(3)  The results of clinical laboratory tests performed by a clinical laboratory complying with this part and performed before a patient's admission to a facility licensed under chapter 395 must be accepted in lieu of clinical laboratory tests required upon a patient's admission to the facility and in lieu of tests that may be ordered for patients of the facility, except that the facility may not be required to accept transfusion compatibility test results. The agency shall establish, by rule, standards for accepting laboratory test results to specify acceptable timeframes for such laboratory tests to assure that the timeframes do not adversely affect the accuracy of the test.

(4)  All specimens accepted by a clinical laboratory must be tested on the premises, except that specimens for infrequently performed tests may be forwarded for examination to another clinical laboratory approved under this part. This subsection does not prohibit referring specimens to a clinical laboratory excepted under s. 483.031. However, the clinical laboratory director of the referring clinical laboratory must assume complete responsibility.

(5)  A clinical laboratory licensed under this part must accept a human specimen submitted for examination by a practitioner licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, or chapter 466, if the specimen and test are the type performed by the clinical laboratory. A clinical laboratory may only refuse a specimen based upon a history of nonpayment for services by the practitioner. A clinical laboratory shall not charge different prices for tests based upon the chapter under which a practitioner submitting a specimen for testing is licensed.

History.--s. 18, ch. 67-248; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 17, 29, 30, ch. 83-276; s. 81, ch. 85-81; s. 19, ch. 93-40; ss. 12, 25, ch. 93-178; s. 2, ch. 95-308; s. 5, ch. 97-91.

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 this state or any other state which makes examinations in connection with the diagnosis and control of diseases unless the clinical laboratory meets or exceeds the minimum standards of the agency and the rules adopted under this part.

History.--s. 19, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 400, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 13, 25, ch. 93-178.

483.201  Grounds for disciplinary action against clinical laboratories.--The following acts constitute grounds for which a disciplinary action specified in s. 483.221 may be taken against a clinical laboratory:

(1)  Making a fraudulent statement on an application for a clinical laboratory license or any other document required by the agency.

(2)  Permitting unauthorized persons to perform technical procedures or to issue reports.

(3)  Demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations and procedures or erroneous reporting.

(4)  Performing a test and rendering a report thereon to a person not authorized by law to receive such services.

(5)  Knowingly having professional connection with or knowingly lending the use of the name of the licensed clinical laboratory or its director to an unlicensed clinical laboratory.

(6)  Violating or aiding and abetting in the violation of any provision of this part or the rules adopted under this part.

(7)  Failing to file any report required by the provisions of this part or the rules adopted under this part.

(8)  Reporting a test result for a clinical specimen if the test was not performed on the clinical specimen.

(9)  Performing and reporting tests in a specialty or subspecialty in which the laboratory is not licensed.

(10)  Knowingly advertising false services or credentials.

(11)  Failing to correct deficiencies within the time required by the agency.

History.--s. 20, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 401, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 18, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 14, 25, ch. 93-178.

483.221  Administrative penalties.--

(1)(a)  The agency may deny, suspend, revoke, annul, limit, or deny renewal of a license or impose an administrative fine, not to exceed $1,000 per violation, for the violation of any provision of this part or rules adopted under this part. Each day of violation constitutes a separate violation and is subject to a separate fine.

(b)  In determining the penalty to be imposed for a violation, as provided in paragraph (a), the following factors must be considered:

1.  The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted; the severity of the actual or potential harm; and the extent to which the provisions of this part were violated.

2.  Actions taken by the licensee to correct the violation or to remedy complaints.

3.  Any previous violation by the licensee.

4.  The financial benefit to the licensee of committing or continuing the violation.

(c)  All amounts collected under this section must be deposited into the Health Care Trust Fund administered by the agency.

(2)  The agency may issue an emergency order immediately suspending, revoking, annulling, or limiting a license if it determines that any condition in the licensed facility presents a clear and present danger to public health or safety.

History.--ss. 21, 30, ch. 83-276; s. 19, ch. 93-40; ss. 15, 25, ch. 93-178.

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 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) constitutes a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(2)  Any use or attempted use of a forged license under this part or part III of this chapter constitutes the crime of forgery.

History.--s. 23, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 20, 29, 30, ch. 83-276; s. 31, ch. 92-58; s. 19, ch. 93-40; ss. 16, 25, ch. 93-178; s. 438, ch. 97-103; s. 4, ch. 2000-154.

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.

(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.

History.--s. 2, ch. 79-106; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 17, 25, ch. 93-178; s. 60, ch. 2001-277.

483.25  Injunction.--The operation or maintenance of an unlicensed clinical laboratory or the performance of any clinical laboratory procedure or operation in violation of this part is declared a nuisance, inimical to the public health, welfare, and safety. The agency, or any state attorney in the name of the people of the state, may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of any such clinical laboratory or the performance of any laboratory procedure or operation in violation of this part, until compliance with this part or the rules adopted under this part has been demonstrated to the satisfaction of the agency.

History.--s. 25, ch. 67-248; ss. 19, 35, ch. 69-106; s. 3, ch. 76-168; s. 2, ch. 77-48; s. 404, ch. 77-147; s. 1, ch. 77-457; ss. 2, 3, ch. 81-318; ss. 22, 29, 30, ch. 83-276; s. 19, ch. 93-40; ss. 18, 25, ch. 93-178.

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 of this act. This advisory input should be sought to expand public participation in agency decisions and to draw on the expertise of representatives from the various segments of health care which have an interest in laboratory procedures.

History.--s. 19, ch. 93-178.

483.28  Short title.

483.282  Declaration of policy and statement of purpose.

483.285  Application of part; exemptions.

483.288  Definitions.

483.291  Powers and duties of the agency; rules.

483.294  Inspection of centers.

483.30  Licensing of centers.

483.302  Application for license.

483.305  Requirements for advertisement.

483.308  Medical director of center.

483.311  Display of license.

483.312  Notice of fees charged.

483.314  Collection and transmittal of specimens.

483.317  Grounds for disciplinary action against centers.

483.32  Administrative penalties.

483.322  Offenses.

483.325  Criminal penalties.

483.328  Injunction.

483.28  Short title.--This part may be cited as "The Florida Multiphasic Health Testing Center Law."

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 1, 19, ch. 93-40; s. 25, ch. 93-178.

483.282  Declaration of policy and statement of purpose.--The purpose of this part is to protect the health, safety, and welfare of the people of this state from the hazards of improper performance by multiphasic health testing centers. Multiphasic health testing centers provide to people certain health testing services that are either performed at the center or involve the sending of specimens to a clinical laboratory. Unreliable or inaccurate reports and findings may cause unnecessary anxiety, suffering, and financial expense for individuals or may create a false and injudicious sense of security with respect to the state of an individual's health, and may even contribute directly to an individual's death. Therefore, the Legislature finds and declares that the protection of the public health requires the licensing of such centers, the establishment of certain minimum standards, and other necessary safeguards as authorized by this part.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 2, 19, ch. 93-40; s. 25, ch. 93-178.

483.285  Application of part; exemptions.--This part applies to all multiphasic health testing centers within the state, but does not apply to:

(1)  An entity operated by the United States Government or by the state or any political subdivision of the state.

(2)  An entity that limits screening to tests intended to identify specific physical disorders or conditions and that provides health services to the public free of charge or for a donation to be used for charitable purposes.

(3)  A hospital licensed under chapter 395.

(4)  An ambulatory surgical center licensed under chapter 395.

(5)  A home health agency licensed under part IV of chapter 400.

(6)  A health maintenance organization certified under part I of chapter 641.

(7)  A clinical laboratory registered under part I.

(8)  An office of a duly licensed practitioner of the healing arts for the diagnosis and treatment of her or his patients.

(9)  Screening conducted by a county medical society.

History.--s. 1, ch. 77-48; s. 207, ch. 79-400; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 3, 19, ch. 93-40; s. 25, ch. 93-178; s. 41, ch. 95-144; s. 439, ch. 97-103.

483.288  Definitions.--As used in this part:

(1)  "Agency" means the Agency for Health Care Administration.

(2)  "Multiphasic health testing center" or "center" means any fixed or mobile facility where specimens are taken from the human body for delivery to registered clinical laboratories for analysis and where certain measurements such as height and weight determinations, blood pressure determinations, limited audio and visual tests, and electrocardiograms are made.

(3)  "Center personnel" includes persons employed by a center, except persons employed to perform clerical or other administrative responsibilities.

(4)  "Consumer multiphasic health testing center" is a multiphasic health testing center that is open to the general public.

(5)  "Contract multiphasic health testing center" is a multiphasic health testing center that tests employees under the authorization of the medical director of a contracting employer or the medical director of the contract multiphasic health testing center.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 24, 29, 30, ch. 83-276; ss. 4, 19, ch. 93-40; s. 25, ch. 93-178.

483.291  Powers and duties of the agency; rules.--The agency shall adopt rules to implement this part, which rules must include the following:

(1)  LICENSING STANDARDS.--The agency shall license all multiphasic health testing centers meeting the requirements of this part and shall prescribe standards necessary for licensure.

(2)  FEES.--The agency shall establish annual fees, which shall be reasonable in amount, for licensing of centers. The fees must be sufficient in amount to cover the cost of licensing and inspecting centers.

(a)  The annual licensure fee is due at the time of application and is payable to the agency to be deposited in the Health Care Trust Fund administered by the agency. The license fee must be not less than $300 or more than $1,000.

(b)  The fee for late filing of an application for license renewal is $200 and is in addition to the licensure fee due for renewing the license.

(3)  ANNUAL LICENSING.--The agency shall provide for annual licensing of centers. Any center that fails to pay the proper fee or otherwise fails to qualify by the date of expiration of its license is delinquent, and its license is automatically canceled without notice or further proceeding. Upon cancellation of its license under this subsection, a center may have its license reinstated only upon application and qualification as provided for initial applicants and upon payment of all delinquent fees.

(4)  STANDARDS OF PERFORMANCE.--The agency shall prescribe standards for the performance of health testing procedures.

(5)  CONSTRUCTION OF CENTERS.--The agency may adopt rules to ensure that centers comply with all local, county, state, and federal standards for the construction, renovation, maintenance, or repair of centers, which standards must ensure the conduct and operation of the centers in a manner that will protect the public health.

(6)  SAFETY AND SANITARY CONDITIONS WITHIN THE CENTER AND ITS SURROUNDINGS.--The agency shall establish standards relating to safety and sanitary conditions within the center and its surroundings, including water supply; sewage; the handling of specimens; identification, segregation, and separation of biohazardous waste as required by s. 381.0098; storage of chemicals; workspace; firesafety; and general measures, which standards must ensure the protection of the public health. The agency shall determine compliance by a multiphasic health testing center with the requirements of s. 381.0098 by verifying that the center has obtained all required permits.

(7)  EQUIPMENT.--The agency shall establish minimum standards for center equipment essential to the proper conduct and operation of the center.

(8)  PERSONNEL.--The agency shall prescribe minimum qualifications for center personnel. A center may employ as a medical assistant a person who has at least one of the following qualifications:

(a)  Prior experience of not less than 6 months as a medical assistant in the office of a licensed medical doctor or osteopathic physician or in a hospital, an ambulatory surgical center, a home health agency, or a health maintenance organization.

(b)  Certification and registration by the American Medical Technologists Association or other similar professional association approved by the agency.

(c)  Prior employment as a medical assistant in a licensed center for at least 6 consecutive months at some time during the preceding 2 years.

History.--s. 1, ch. 77-48; s. 208, ch. 79-400; s. 2, ch. 81-318; ss. 25, 29, 30, ch. 83-276; ss. 5, 19, ch. 93-40; s. 25, ch. 93-178; s. 55, ch. 97-264.

483.294  Inspection of centers.--The agency shall, at least once annually, inspect the premises and operations of all centers subject to licensure under this part, without prior notice to the centers, for the purpose of studying and evaluating the operation, supervision, and procedures of such facilities, to determine their compliance with agency standards and to determine their effect upon the health and safety of the people of this state.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 6, 19, ch. 93-40; s. 25, ch. 93-178.

483.30  Licensing of centers.--

(1)  A person may not conduct, maintain, or operate a multiphasic health testing center in this state without obtaining a multiphasic health testing center license from the agency. The license is valid only for the person or persons to whom it is issued and may not be sold, assigned, or transferred, voluntarily or involuntarily. A license is not valid for any premises other than the center for which it is issued. However, a new license may be secured for the new location for a fixed center before the actual change, if the contemplated change is in compliance with this part and the rules adopted under this part. A center must be relicensed if a change of ownership occurs. Application for relicensure must be made 60 days before the change of ownership.

(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 employee, or other similarly titled individual who is responsible for the daily operation of the center, and of the financial officer, or other similarly titled individual who is responsible for the financial operation of the center, 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).

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 7, 19, ch. 93-40; s. 25, ch. 93-178; ss. 66, 71, ch. 98-171; s. 108, ch. 2000-349; s. 25, ch. 2001-53; s. 2, ch. 2001-67; s. 148, ch. 2001-277; s. 60, ch. 2004-267.

483.302  Application for license.--

(1)  Application for a license as required by s. 483.30 must be made to the agency on forms furnished by it and must be accompanied by the appropriate license fee.

(2)  The application shall contain:

(a)  A determination as to whether the facility will be fixed or mobile and the location for a fixed facility.

(b)  The name and address of the owner if an individual; if the owner is a firm, partnership, or association, the name and address of every member thereof; if the owner is a corporation, its name and address and the name and address of its medical director and officers and of each person having at least a 10 percent interest in the corporation.

(c)  The name of any person whose name is required on the application under the provisions of paragraph (b) and who owns at least a 10 percent interest in any professional service, firm, association, partnership, or corporation providing goods, leases, or services to the center for which the application is made, and the name and address of the professional service, firm, association, partnership, or corporation in which such interest is held.

(d)  The name by which the facility is to be known.

(e)  The name, address, and Florida physician's license number of the medical director.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 8, 19, ch. 93-40; s. 25, ch. 93-178.

483.305  Requirements for advertisement.--

(1)  Each center shall prominently display on its report of the tests, on all advertising and promotional materials, and in a place that is in clear and unobstructed public view within the center, a notice in block letters which reads: "Health screening tests may or may not alert you and your doctor to serious medical problems and are not intended to be a substitute for a physician's examination." The notice displayed within the center must be made up of block letters not less than 1 inch in height.

(2)  A center may not use advertisements or promotional materials that tend to deceive prospective purchasers concerning the personnel, equipment, care, and services, or the quality thereof, provided by the center.

(3)  Any violation of this section is subject to the Florida Deceptive and Unfair Trade Practices Act.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 9, 19, ch. 93-40; s. 25, ch. 93-178.

483.308  Medical director of center.--

(1)  Each center licensed under this part shall employ a medical director who is either a physician licensed under chapter 458 or an osteopathic physician licensed under chapter 459 and who, as part of her or his usual medical practice, interprets electrocardiograms. In a contract multiphasic health testing center, electrocardiograms and X rays must be read and interpreted by the medical director of the contract center or respectively by a board-certified cardiologist or radiologist authorized by the medical director to read and interpret the electrocardiograms and X rays and report results to the medical director. Such secondary authorization by the medical director of the contract multiphasic health testing center does not operate to cede liability or responsibility for the test results to the board-certified cardiologist or radiologist. The medical director need not be present at the center while it is in operation. However, the medical director is responsible for assuring the proper clinical operation of the center.

(2)  The medical director shall order all requests by the center for analyses to be conducted by clinical laboratories with respect to specimens collected at the center. The results of such analyses, together with the results of any measurements or other testing procedures performed at the center, including electrocardiographic interpretations, shall be released to the medical director. The medical director of a consumer multiphasic health testing center shall read, interpret, and sign the results before they are released by the center to the patient. The medical director of a contract multiphasic health testing center shall read, interpret, and sign the results before they are released to the patient or may authorize the medical director of the contracting employer to read, interpret, and sign the results before they are released to the patient. Such secondary authorization by the medical director of the contract multiphasic health testing center does not operate to cede liability or responsibility for the test results to the medical director of the contracting employer. As a part of the required interpretation of any results from analyses conducted by a clinical laboratory, the medical director is responsible for determining whether the results indicate further medical advice or intervention is necessary. If the medical director so determines, then a statement to that effect must be included with the results together with a statement that the patient should seek medical advice from her or his physician or the county medical society with specific reference to the society's name, address, and telephone number. Notification under this subsection must be made by regular mail.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 10, 19, ch. 93-40; s. 25, ch. 93-178; s. 21, ch. 97-98; s. 440, ch. 97-103.

483.311  Display of license.--The license of a center must specify, on its face, the names and addresses of the owner and the medical director, the period for which the license is valid, and, in the case of fixed centers, the location at which procedures are performed. The license must be displayed at all times in a prominent place at the center, where it may be viewed by the public.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 11, 19, ch. 93-40; s. 25, ch. 93-178.

483.312  Notice of fees charged.--A consumer multiphasic health testing center must display at all times in a prominent place at the center a list of all tests and the specific fees charged for those tests. The center must provide to each patient before the collection of a specimen or the administration of a test the specific fees charged for the test.

History.--s. 12, ch. 93-40.

483.314  Collection and transmittal of specimens.--

(1)  A center shall forward the specimens collected by it to a clinical laboratory for such analyses as are authorized by the medical director of the center. Multiphasic health testing centers are authorized to conduct dipstick urinalysis and fecal occult blood tests only if such tests are conducted by licensed registered nurses, practical nurses, medical technicians, medical assistants, or clinical laboratory technicians trained to perform and interpret these tests.

(2)  Consumer multiphasic health testing centers shall report the results of an analysis directly to the medical director of the center that requested it and shall forward the results to the person from whom the specimen was collected within 5 days after the date the specimen was collected. When test results deviate significantly from established ranges, indicating the presence of a potential pathological condition, the contract multiphasic health testing center must forward the results to the person from whom the specimen was collected and the person's designated physician within 5 days after the date the specimen was collected. Complete results of contract multiphasic health testing must be forwarded to the medical director of the contracting employer within 30 days after the date the specimen was collected.

(3)  A multiphasic health testing center may not collect specimens from the human body where prudent medical practice requires that such specimens only be collected during the course of a physical examination by a physician. The agency, which may consult with the Board of Medicine and the Board of Osteopathic Medicine, shall develop rules to implement this subsection.

(4)  A center may not perform or hold itself out to the public as providing for testing for the human immunodeficiency virus (HIV) unless it complies with s. 381.004.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 13, 19, ch. 93-40; s. 25, ch. 93-178.

483.317  Grounds for disciplinary action against centers.--The following acts constitute grounds for which a disciplinary action specified in s. 483.32 may be taken against a center:

(1)  Making a fraudulent statement on an application for a license or on any other document required by the agency pursuant to this part.

(2)  Permitting unauthorized persons to perform health testing procedures or to issue reports.

(3)  Demonstrating incompetence in the performance of health testing procedures or issuing erroneous reports.

(4)  Rendering a report on the results of any measurement or test to a person not authorized by law to receive such information.

(5)  Knowingly having professional connection with, or knowingly lending the use of the name of the licensed center or its medical director to, an unlicensed multiphasic health testing center.

(6)  Violating or aiding and abetting in the violation of any provision of this part or the rules adopted hereunder.

(7)  Failing to file any report required by the provisions of this part or the rules adopted hereunder.

(8)  Engaging in false, misleading, or deceptive advertising.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 26, 29, 30, ch. 83-276; ss. 14, 19, ch. 93-40; s. 25, ch. 93-178.

483.32  Administrative penalties.--

(1)(a)  The agency may deny, suspend, revoke, annul, limit, or deny renewal of a license or impose an administrative fine, not to exceed $500 per violation, for the violation of any provision of this part or rules adopted under this part. Each day of violation constitutes a separate violation and is subject to a separate fine.

(b)  In determining the amount of the fine to be levied for a violation, as provided in paragraph (a), the following factors shall be considered:

1.  The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted; the severity of the actual or potential harm; and the extent to which the provisions of this part were violated.

2.  Actions taken by the licensee to correct the violation or to remedy complaints.

3.  Any previous violation by the licensee.

4.  The financial benefit to the licensee of committing or continuing the violation.

(c)  All amounts collected under this section must be deposited into the Health Care Trust Fund administered by the agency.

(2)  The agency may issue an emergency order immediately suspending, revoking, annulling, or limiting a license when it determines that any condition in the licensed facility presents a clear and present danger to public health and safety.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 27, 29, 30, ch. 83-276; ss. 15, 19, ch. 93-40; s. 25, ch. 93-178.

483.322  Offenses.--It is unlawful for any person to:

(1)  Operate, maintain, direct, or engage in the business of operating a multiphasic health testing center unless the person has obtained a license for the center.

(2)  Conduct, maintain, or operate a center unless the center is under the direct and responsible supervision and direction of a medical director who meets the qualifications specified in s. 483.308(1).

(3)  Violate, or aid and abet in the violation of, any provision of this part or the rules adopted under this part.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 16, 19, ch. 93-40; s. 25, ch. 93-178.

483.325  Criminal penalties.--

(1)  The performance of any of the acts specified in s. 483.322 is a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(2)  Any use or attempted use of a forged license under this part is a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; s. 114, ch. 91-224; ss. 17, 19, ch. 93-40; s. 25, ch. 93-178.

483.328  Injunction.--The operation or maintenance of an unlicensed center or the performance of any health testing procedures or operations in violation of this part is declared a nuisance and inimical to the public health, welfare, and safety. The agency, or any state attorney in the name of the people of the state, may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of any such center or the performance of any health testing procedures or operations in violation of this part, until compliance with the provisions of this part or the rules adopted under this part has been demonstrated to the satisfaction of the agency.

History.--s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 18, 19, ch. 93-40; s. 25, ch. 93-178.

483.800  Declaration of policy and statement of purpose.

483.801  Exemptions.

483.803  Definitions.

483.805  Board of Clinical Laboratory Personnel.

483.807  Fees; establishment; disposition.

483.809  Licensure; examinations; registration of trainees; approval of curricula.

483.811  Approval of laboratory personnel training programs.

483.812  Public health laboratory scientists; licensure.

483.813  Clinical laboratory personnel license.

483.815  Application for clinical laboratory personnel license.

483.817  Renewal of clinical laboratory personnel license.

483.819  Inactive status.

483.821  Periodic demonstration of competency; continuing education or reexamination.

483.823  Qualifications of clinical laboratory personnel.

483.824  Qualifications of clinical laboratory director.

483.825  Grounds for disciplinary action.

483.828  Penalties for violations.

483.800  Declaration of policy and statement of purpose.--The purpose of this part is to protect the public health, safety, and welfare of the people of this state from the hazards of improper performance by clinical laboratory personnel. Clinical laboratories provide essential services to practitioners of the healing arts by furnishing vital information that is essential to a determination of the nature, cause, and extent of the condition involved. Unreliable and inaccurate reports may cause unnecessary anxiety, suffering, and financial burdens and may even contribute directly to death. The protection of public and individual health requires the licensure of clinical laboratory personnel who meet minimum requirements for safe practice. The Legislature finds that laboratory testing technology continues to advance rapidly. The Legislature also finds that a hospital training program under the direction of the hospital clinical laboratory director offers an opportunity for individuals already trained in health care professions to expand the scope of their careers. The Legislature further finds that there is an immediate need for properly trained personnel to ensure patient access to testing. Therefore, the Legislature recognizes the patient-focused benefits of hospital-based training for laboratory and nonlaboratory personnel for testing within hospitals and commercial laboratories and recognizes the benefits of a training program approved by the Board of Clinical Laboratory Personnel under the direction of the hospital clinical laboratory director.

History.--s. 32, ch. 92-58; s. 20, ch. 93-178; s. 162, ch. 97-264.

483.801  Exemptions.--This part applies to all clinical laboratories and clinical laboratory personnel within this state, except:

(1)  Clinical laboratories operated by the United States Government.

(2)  Laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health service whatsoever.

(3)  Persons engaged in testing performed by laboratories regulated under s. 483.035(1) or exempt from regulation under s. 483.031(2).

(4)  Respiratory therapists and respiratory care practitioners certified or registered under part V of chapter 468.

(5)  Advanced registered nurse practitioners licensed under part I of chapter 464 who perform provider-performed microscopy procedures (PPMP) in an exclusive-use laboratory setting.

History.--s. 32, ch. 92-58; s. 21, ch. 93-178; s. 6, ch. 97-91; s. 163, ch. 97-264; s. 136, ch. 2000-318.

483.803  Definitions.--As used in this part, the term:

(1)  "Board" means the Board of Clinical Laboratory Personnel.

(2)  "Clinical laboratory" means a clinical laboratory as defined in s. 483.041.

(3)  "Clinical laboratory examination" means a clinical laboratory examination as defined in s. 483.041.

(4)  "Clinical laboratory personnel" includes a clinical laboratory director, supervisor, technologist, blood gas analyst, or technician who performs or is responsible for laboratory test procedures, but the term does not include trainees, persons who perform screening for blood banks or plasmapheresis centers, phlebotomists, or persons employed by a clinical laboratory to perform manual pretesting duties or clerical, personnel, or other administrative responsibilities, or persons engaged in testing performed by laboratories regulated under s. 483.035(1) or exempt from regulation under s. 483.031(2).

(5)  "Clinical laboratory trainee" means any person having qualifying education who is enrolled in a clinical laboratory training program approved pursuant to s. 483.811 and who is seeking experience required to meet minimum qualifications for licensing in this state. Trainees may perform procedures under direct and responsible supervision of duly licensed clinical laboratory personnel, but they may not report test results.

(6)  "Department" means the Department of Health.

(7)  "Licensed practitioner of the healing arts" means a physician licensed under chapter 458, chapter 459, chapter 460, or chapter 461; a dentist licensed under chapter 466; or a person licensed under chapter 462.

(8)  "Public health laboratory scientist" means any licensed director, supervisor, technologist, or technician engaged in laboratory testing of human specimens in a state, county, or municipal public health laboratory.

History.--s. 32, ch. 92-58; s. 175, ch. 94-218; s. 7, ch. 97-91; s. 164, ch. 97-264; s. 145, ch. 99-397.

483.805  Board of Clinical Laboratory Personnel.--

(1)  There is created within the department the Board of Clinical Laboratory Personnel, composed of seven members appointed by the Governor and confirmed by the Senate.

(2)(a)  Five members of the board shall be persons licensed under this part, as follows:

1.  At least one member shall be a practicing clinical laboratory director.

2.  At least two members shall be practicing clinical laboratory supervisors.

3.  Two members shall be practicing clinical laboratory personnel.

(b)  Two members of the board shall be citizens of the state who have never been licensed health care practitioners and who are not, and have never been, licensed as clinical laboratory personnel and who are in no way connected with the practice of such profession.

(3)  Within 90 days after July 1, 1992, the Governor shall appoint two members for a term of 2 years, two members for a term of 3 years, and three members for a term of 4 years. As terms of the initial members expire, the Governor shall appoint successors for terms of 4 years and such terms shall expire on October 31. A member whose term has expired shall continue to serve on the board until such time as a replacement is appointed. No member shall serve for more than the remaining portion of a previous member's unexpired term, plus two consecutive 4-year terms of the member's own appointment thereafter.

(4)  The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part conferring duties upon it.

(5)  All provisions of chapter 456 relating to activities of regulatory boards shall apply to the board.

(6)  The board shall maintain its official headquarters in Tallahassee.

History.--s. 32, ch. 92-58; s. 176, ch. 94-218; s. 135, ch. 98-166; s. 155, ch. 98-200; s. 195, ch. 2000-160.

483.807  Fees; establishment; disposition.--

(1)  The board, by rule, shall establish fees to be paid for application, examination, reexamination, licensing and renewal, registration, laboratory training program application, reinstatement, and recordmaking and recordkeeping. The board may also establish, by rule, a delinquency fee. The board shall establish fees that are adequate to ensure the continued operation of the board and to fund the proportionate expenses incurred by the department in carrying out its licensure and other related responsibilities under this part. Fees shall be based on departmental estimates of the revenue required to implement this part and the provisions of law with respect to the regulation of clinical laboratory personnel.

(2)  The nonrefundable application fee may not exceed $200.

(3)  The examination fee shall be in an amount which covers the costs of obtaining and administering the examination and shall be refunded if the applicant is found ineligible to sit for the examination. The combined fees for initial application and examination may not exceed $200 plus the actual per applicant cost to the department for developing, administering, or procuring the licensure examination.

(4)  The initial license fee may not exceed $100.

(5)  The fee for licensure by endorsement may not exceed $100.

(6)  The biennial renewal fee may not exceed $150.

(7)  The fee for application for an inactive status license or for reactivation of an inactive status license may not exceed $50.

(8)  The initial application fee for registration of a trainee shall not exceed $20.

(9)  The initial application and renewal fee for approval as a laboratory training program may not exceed $300. The fee for late filing of a renewal application shall be $50.

(10)  All fees shall be established, collected, and deposited in accordance with s. 456.025.

History.--s. 32, ch. 92-58; s. 243, ch. 94-119; s. 136, ch. 98-166; s. 146, ch. 99-397; s. 196, ch. 2000-160; s. 9, ch. 2001-277.

483.809  Licensure; examinations; registration of trainees; approval of curricula.--

(1)  LICENSING.--The department shall provide biennial licensure of all clinical laboratory personnel who the board certifies have met the requirements of this part. The license of any person who fails to pay a required fee or otherwise fails to qualify within 60 days after the date of expiration of such license shall be automatically canceled without notice or further proceedings unless the individual has made application for inactive status pursuant to s. 483.819.

(2)  EXAMINATIONS.--The department shall conduct examinations required by board rules to determine in part the qualification of clinical laboratory personnel for licensure. The board by rule may designate a national certification examination that may be accepted in lieu of state examination for clinical laboratory personnel or public health scientists.

(3)  REGISTRATION OF TRAINEES.--The department shall provide for registration of clinical laboratory trainees who are enrolled in a training program approved pursuant to s. 483.811, which registration may not be renewed except upon special authorization of the board.

(4)  APPROVAL OF CURRICULUM IN SCHOOLS AND COLLEGES.--The board may approve the curriculum in schools and colleges offering education and training leading toward qualification for licensure under this part.

History.--s. 32, ch. 92-58; s. 165, ch. 97-264; s. 147, ch. 99-397.

483.811  Approval of laboratory personnel training programs.--

(1)  The board shall approve clinical laboratories for training programs upon presentation of satisfactory evidence that such laboratories are adequately staffed by qualified personnel and comply with rules adopted by the board to ensure that such laboratories provide training in clinical laboratory techniques adequate to prepare individuals to meet the requirements for licensure under this part.

(2)  The board shall adopt rules for training programs, including, but not limited to, rules relating to curriculum, educational objectives, evaluation procedures, personnel licensure requirements, preentry educational requirements, and length of clinical training.

(3)  A clinical laboratory operated by one or more practitioners who hold the facilities of the laboratory out as available for the performance of diagnostic tests for other practitioners or their patients is subject to the provisions of this part.

(4)  The board shall approve training programs for laboratory technicians in a hospital or clinical laboratory which programs are under the supervision of a clinical laboratory director. The training must be accepted in lieu of educational requirements for licensure, but a trainee must have a high school diploma or its equivalent. Any person who completes a training program must pass, before licensure, an examination given by the department.

(5)  The department may inspect laboratory personnel training programs.

(6)  If the board finds that an approved program no longer meets the required standards, the department may rescind the approval.

History.--s. 32, ch. 92-58; s. 22, ch. 93-178; s. 8, ch. 97-91; s. 5, ch. 2000-154.

483.812  Public health laboratory scientists; licensure.--

(1)  Applicants at the director level in the category of public health shall qualify under s. 483.824.

(2)  Applicants at the supervisor level in the category of public health who are certified by the National Registry in Clinical Chemistry or the American Society for Microbiology, licensed as a technologist, and have 5 years of pertinent clinical laboratory experience may qualify by passing the state-administered supervision and administration examination.

(3)(a)  A technologist applicant for licensure in the category of public health microbiology, with a baccalaureate degree in one of the biological sciences from an accredited institution, may use the American Society for Microbiology or the National Registry in Microbiology Certification in Public Health Microbiology to qualify for a technologist license in public health microbiology. Such a technologist may work in a public health microbiology laboratory.

(b)  A technologist applicant for licensure in the category of public health chemistry, with a baccalaureate degree in one of the chemical, biological, or physical sciences from an accredited institution, may use the National Registry of Clinical Chemistry Certification to qualify for a technologist license in public health chemistry. Such a technologist may work in a public health chemistry laboratory.

(c)  A technician applicant for licensure in the category of public health, with a baccalaureate degree in one of the chemical or biological sciences from an accredited institution, may obtain a 2-year conditional public health technician license, which may be renewed once. Such a technician may perform testing only under the direct supervision of a licensed pathologist, director, supervisor, or technologist.

(4)  A person licensed by the Board of Clinical Laboratory Personnel may work in a public health laboratory at the appropriate level and specialty.

History.--s. 166, ch. 97-264; s. 148, ch. 99-397.

483.813  Clinical laboratory personnel license.--A person may not conduct a clinical laboratory examination or report the results of such examination unless such person is licensed under this part to perform such procedures. However, this provision does not apply to any practitioner of the healing arts authorized to practice in this state or to persons engaged in testing performed by laboratories regulated under s. 483.035(1) or exempt from regulation under s. 483.031(2). The department may grant a temporary license to any candidate it deems properly qualified, for a period not to exceed 1 year.

History.--s. 32, ch. 92-58; s. 9, ch. 97-91; s. 167, ch. 97-264; s. 149, ch. 99-397.

483.815  Application for clinical laboratory personnel license.--An application for a clinical laboratory personnel license shall be made under oath on forms provided by the department and shall be accompanied by payment of fees as provided by this part. A license may be issued authorizing the performance of procedures of one or more categories.

History.--s. 32, ch. 92-58.

483.817  Renewal of clinical laboratory personnel license.--

(1)  The department shall renew a license upon receipt of a renewal application and fee and upon certification by the board that the licensee has demonstrated her or his competence.

(2)  The board shall adopt rules establishing a procedure for the biennial renewal of clinical laboratory personnel licenses.

History.--s. 32, ch. 92-58; s. 244, ch. 94-119; s. 441, ch. 97-103.

483.819  Inactive status.--

(1)  A licensee may request that her or his license be placed in an inactive status by making application to the department and paying a fee in an amount set by the board.

(2)  A license that has been inactive for more than 1 year may be reactivated upon application to the department. The board shall prescribe, by rule, continuing education requirements as a condition of reactivating a license. The continuing education requirements for reactivating a license may not exceed 15 classroom hours for each year the license was inactive and in no event may exceed 65 classroom hours for all years in which the license was inactive.

History.--s. 32, ch. 92-58; s. 245, ch. 94-119; s. 442, ch. 97-103.

483.821  Periodic demonstration of competency; continuing education or reexamination.--

(1)  As part of the license renewal procedure, the board, by rule, shall require each licensee periodically to demonstrate her or his competency by completing, each 2 years, not less than 10 or more than 30 hours of continuing education in programs approved by the board.

(2)  The board may allow a licensee to demonstrate her or his competency by reexamination in lieu of satisfying the continuing education requirement.

(3)  The board may, by rule, provide for continuing education or retraining requirements for candidates failing an examination two or more times.

History.--s. 32, ch. 92-58; s. 443, ch. 97-103; s. 150, ch. 99-397.

483.823  Qualifications of clinical laboratory personnel.--

(1)  The board shall prescribe minimal qualifications for clinical laboratory personnel and shall issue a license to any person who meets the minimum qualifications and who demonstrates that she or he possesses the character, training, and ability to qualify in those areas for which the license is sought.

(2)  Personnel qualifications may require appropriate education, training, or experience or the passing of an examination in appropriate subjects or any combination of these, but no practitioner of the healing arts licensed to practice in this state is required to obtain any license under this part or to pay any fee hereunder except the fee required for clinical laboratory licensure.

History.--s. 32, ch. 92-58; s. 444, ch. 97-103; s. 168, ch. 97-264.

483.824  Qualifications of clinical laboratory director.--A clinical laboratory director must have 4 years of clinical laboratory experience with 2 years of experience in the specialty to be directed or be nationally board certified in the specialty to be directed, and must meet one of the following requirements:

(1)  Be a physician licensed under chapter 458 or chapter 459;

(2)  Hold an earned doctoral degree in a chemical, physical, or biological science from a regionally accredited institution and maintain national certification requirements equal to those required by the federal Health Care Financing Administration; or

(3)  For the subspecialty of oral pathology, be a physician licensed under chapter 458 or chapter 459 or a dentist licensed under chapter 466.

History.--s. 10, ch. 97-91; s. 151, ch. 99-397; s. 65, ch. 2000-318.

483.825  Grounds for disciplinary action.--

(1)  The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):

(a)  Attempting to obtain, obtaining, or renewing a license or registration under this part by bribery, by fraudulent misrepresentation, or through an error of the department or the board.

(b)  Engaging in or attempting to engage in, or representing herself or himself as entitled to perform, any clinical laboratory procedure or category of procedures not authorized pursuant to her or his license.

(c)  Demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations or procedures or erroneous reporting.

(d)  Performing a test and rendering a report thereon to a person not authorized by law to receive such services.

(e)  Has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the activities of clinical laboratory personnel or involves moral turpitude or fraudulent or dishonest dealing. The record of a conviction certified or authenticated in such form as to be admissible in evidence under the laws of the state shall be admissible as prima facie evidence of such guilt.

(f)  Having been adjudged mentally or physically incompetent.

(g)  Aiding and abetting in the violation of any provision of this part or the rules adopted hereunder.

(h)  Reporting a test result when no laboratory test was performed on a clinical specimen.

(i)  Knowingly advertising false services or credentials.

(j)  Having a license revoked, suspended, or otherwise acted against, including the denial of licensure, by the licensing authority of another jurisdiction. The licensing authority's acceptance of a relinquishment of a license, stipulation, consent order, or other settlement, offered in response to or in anticipation of the filing of administrative charges against the licensee, shall be construed as action against the licensee.

(k)  Failing to report to the board, in writing, within 30 days that an action under paragraph (e), paragraph (f), or paragraph (j) has been taken against the licensee or one's license to practice as clinical laboratory personnel in another state, territory, country, or other jurisdiction.

(l)  Being unable to perform or report clinical laboratory examinations with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material or as a result of any mental or physical condition. In enforcing this paragraph, the department shall have, upon a finding of the secretary or his or her designee that probable cause exists to believe that the licensee is unable to practice because of the reasons stated in this paragraph, the authority to issue an order to compel a licensee to submit to a mental or physical examination by physicians designated by the department. If the licensee refuses to comply with such order, the department's order directing such examination may be enforced by filing a petition for enforcement in the circuit court where the licensee resides or does business. The department shall be entitled to the summary procedure provided in s. 51.011. A licensee affected under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that he or she can resume competent practice with reasonable skill and safety to patients.

(m)  Delegating professional responsibilities to a person when the licensee delegating such responsibilities knows, or has reason to know, that such person is not qualified by training, experience, or licensure to perform them.

(n)  Violating a previous order of the board entered in a disciplinary proceeding.

(o)  Failing to report to the department a person or other licensee who the licensee knows is in violation of this chapter or the rules of the department or board adopted hereunder.

(p)  Making or filing a report which the licensee knows to be false, intentionally or negligently failing to file a report or record required by state or federal law, willfully impeding or obstructing such filing or inducing another person to do so, including, but not limited to, impeding an agent of the state from obtaining a report or record for investigative purposes. Such reports or records shall include only those generated in the capacity as a licensed clinical laboratory personnel.

(q)  Paying or receiving any commission, bonus, kickback, or rebate, or engaging in any split-fee arrangement in any form whatsoever with a physician, organization, agency, or person, either directly or indirectly for patients referred to providers of health care goods and services including, but not limited to, hospitals, nursing homes, clinical laboratories, ambulatory surgical centers, or pharmacies. The provisions of this paragraph shall not be construed to prevent a clinical laboratory professional from receiving a fee for professional consultation services.

(r)  Exercising influence on a patient or client in such a manner as to exploit the patient or client for the financial gain of the licensee or other third party, which shall include, but not be limited to, the promoting, selling, or withholding of services, goods, appliances, referrals, or drugs.

(s)  Practicing or offering to practice beyond the scope permitted by law or rule, or accepting or performing professional services or responsibilities which the licensee knows or has reason to know that he or she is not competent to perform.

(t)  Misrepresenting or concealing a material fact at any time during any phase of the licensing, investigative, or disciplinary process, procedure, or proceeding.

(u)  Improperly interfering with an investigation or any disciplinary proceeding.

(v)  Engaging in or attempting to engage in sexual misconduct, causing undue embarrassment or using disparaging language or language of a sexual nature towards a patient, exploiting superior/subordinate, professional/patient, instructor/student relationships for personal gain, sexual gratification, or advantage.

(w)  Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.

(2)  The board may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or who is found guilty of violating any provision of s. 456.072(1).

(3)  In determining the amount of the fine to be levied for a violation, as provided in subsection (1), the following factors shall be considered:

(a)  The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of this part were violated.

(b)  Actions taken by the licensee to correct the violation or to remedy complaints.

(c)  Any previous violation by the licensee.

(d)  The financial benefit to the licensee of committing or continuing the violation.

History.--s. 32, ch. 92-58; s. 445, ch. 97-103; s. 169, ch. 97-264; s. 152, ch. 99-397; s. 46, ch. 2001-277; s. 22, ch. 2005-240.

483.828  Penalties for violations.--

(1)  Each of the following acts constitutes a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084:

(a)  Practicing as clinical laboratory personnel without an active license.

(b)  Using or attempting to use a license to practice as clinical laboratory personnel which is suspended or revoked.

(c)  Attempting to obtain or obtaining a license to practice as clinical laboratory personnel by knowing misrepresentation.

(2)  Each of the following acts constitutes a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083:

(a)  Knowingly concealing information relating to violations of this part.

(b)  Making any willfully false oath or affirmation whenever an oath or affirmation is required by this part.

(c)  Leading the public to believe that one is licensed as clinical laboratory personnel, or is engaged in licensed practice as clinical laboratory personnel, without holding a valid, active license.

History.--s. 170, ch. 97-264; s. 59, ch. 2000-318.

483.901  Medical physicists; definitions; licensure.

483.901  Medical physicists; definitions; licensure.--

(1)  SHORT TITLE.--This section may be cited as the "Florida Medical Physicists Act."

(2)  DECLARATION OF LEGISLATIVE POLICY.--The Legislature finds that the practice of medical physics by incompetent persons is a threat to the public health and safety. It is, therefore, the responsibility of this state to protect the public health and safety from the harmful effects of excessive and unnecessary radiation by ensuring that the practice of medical physics is entrusted only to persons who are licensed under this section.

(3)  DEFINITIONS.--As used in this section, the term:

(a)  "Council" means the Advisory Council of Medical Physicists in the Department of Health.

(b)  "Department" means the Department of Health.

(c)  "Diagnostic radiological physics" means the specialty of medical physics which deals with the diagnostic application and safe use of X rays, gamma rays from sealed sources, ultrasonic radiation, radio frequency radiation, or magnetic fields, and the use of equipment associated with the production, use, measurement, and evaluation of the radiation and the quality of the diagnostic image resulting from its production and use.

(d)  "License" means a certificate issued by the department which authorizes the holder to practice medical physics.

(e)  "Licensed medical physicist" means a person who holds a license issued under this section.

(f)  "Medical health physics" means the specialty of medical physics which deals with the safe use of X rays, gamma rays, electron or other charged particle beams, neutrons, radionuclides, and radiation from sealed sources, for both diagnostic and therapeutic purposes in human beings and the use of equipment required to perform appropriate tests and measurements that do not involve the direct application of radiation to humans for diagnostic or therapeutic procedures.

(g)  "Medical nuclear radiological physics" means the specialty of medical physics which deals with the therapeutic and diagnostic application and safe use of radionuclides, except those used in sealed sources for therapeutic purposes, and the use of equipment associated with the production, use, measurement, and evaluation of radionuclides.

(h)  "Medical physics" means the branch of physics which is associated with the practice of medicine. It includes the fields of diagnostic radiological physics, therapeutic radiological physics, medical nuclear radiological physics, and medical health physics.

(i)  "Physician" means a doctor of medicine, osteopathic medicine, podiatric medicine, dentistry, or chiropractic medicine who is licensed in this state and who prescribes a radiological procedure.

(j)  "Practice of medical physics" means the use of principles and accepted protocols of physics to ensure the correct quality, quantity, and placement of radiation during the performance of a radiological procedure prescribed by a physician which will protect the patient and others from harmful excessive radiation. The term includes radiation beam calibration and characterization quality assurance, instrument specification, acceptance testing, shielding design, protection analysis on radiation-emitting equipment and radiopharmaceuticals, and consultation with a physician to ensure accurate radiation dosage to a specific patient.

(k)  "Radiation" means ionizing or nonionizing radiation above background levels which is used to perform a diagnostic or therapeutic medical or dental radiological procedure.

(l)  "Radiological procedure" means a test, measurement, calculation, or radiation exposure used in the diagnosis or treatment of diseases or other medical or dental conditions in human beings that includes therapeutic radiation, diagnostic radiation, nuclear magnetic resonance, or nuclear medicine procedures.

(m)  "Therapeutic radiological physics" means that specialty of medical physics which deals with the therapeutic application and safe use of X rays, gamma rays, electron or other charged particle beams, neutrons, or radiation from radionuclide sources, and the use of equipment associated with the production, use, measurement, and evaluation of that radiation.

(4)  COUNCIL.--The Advisory Council of Medical Physicists is created in the Department of Health to advise the department in regulating the practice of medical physics in this state.

(a)  The council shall be composed of nine members appointed by the secretary of the department as follows:

1.  A licensed medical physicist who specializes in diagnostic radiological physics.

2.  A licensed medical physicist who specializes in therapeutic radiological physics.

3.  A licensed medical physicist who specializes in medical nuclear radiological physics.

4.  A physician who is board certified by the American Board of Radiology or its equivalent.

5.  A physician who is board certified by the American Osteopathic Board of Radiology or its equivalent.

6.  A chiropractic physician who practices radiology.

7.  Three consumer members who are not, and have never been, licensed as a medical physicist or licensed in any closely related profession.

(b)  The secretary of the department shall appoint the medical physicist members of the council from a list of candidates who are licensed to practice medical physics.

(c)  The secretary of the department shall appoint the physician members of the council from a list of candidates who are licensed to practice medicine in this state and are board certified in diagnostic radiology, therapeutic radiology, or radiation oncology.

(d)  The secretary of the department shall appoint the public members of the council.

(e)  As the term of each member expires, the secretary of the department shall appoint the successor for a term of 4 years. A member shall serve until the member's successor is appointed, unless physically unable to do so.

(f)  An individual is ineligible to serve more than two full consecutive 4-year terms.

(g)  If a vacancy on the council occurs, the secretary shall appoint a member to serve for a 4-year term.

(h)  A council member must be a United States citizen and must have been a resident of this state for 2 consecutive years immediately before being appointed.

1.  A member of the council who is a medical physicist must have practiced for at least 6 years before being appointed or be board certified for the specialty in which the member practices.

2.  A member of the council who is a physician must be licensed to practice medicine in this state and must have practiced diagnostic radiology or radiation oncology in this state for at least 2 years before being appointed.

3.  The public members of the council must not have a financial interest in any endeavor related to the practice of medical physics.

(i)  A council member may be removed from the council if the member:

1.  Did not have the required qualifications at the time of appointment;

2.  Does not maintain the required qualifications while serving on the council; or

3.  Fails to attend the regularly scheduled council meetings in a calendar year as required by s. 456.011.

(j)  Members of the council may not receive compensation for their services; however, they are entitled to reimbursement, from funds deposited in the Medical Quality Assurance Trust Fund, for necessary travel expenses as specified in s. 112.061 for each day they engage in the business of the council.

(k)  At the first regularly scheduled meeting of each calendar year, the council shall elect a presiding officer and an assistant presiding officer from among its members. The council shall meet at least once each year and at other times in accordance with department requirements.

(l)  The department shall provide administrative support to the council for all licensing activities.

(m)  The council may conduct its meetings electronically.

(5)  POWERS OF COUNCIL.--The council shall:

(a)  Recommend rules to administer this section.

(b)  Recommend practice standards for the practice of medical physics which are consistent with the Guidelines for Ethical Practice for Medical Physicists prepared by the American Association of Physicists in Medicine and disciplinary guidelines adopted under s. 456.079.

(c)  Develop and recommend continuing education requirements for licensed medical physicists.

(6)  LICENSE REQUIRED.--An individual may not engage in the practice of medical physics, including the specialties of diagnostic radiological physics, therapeutic radiological physics, medical nuclear radiological physics, or medical health physics, without a license issued by the department for the appropriate specialty.

(a)  The department shall adopt rules to administer this section which specify license application and renewal fees, continuing education requirements, and standards for practicing medical physics. The council shall recommend to the department continuing education requirements that shall be a condition of license renewal. The department shall require a minimum of 24 hours per biennium of continuing education offered by an organization recommended by the council and approved by the department. The department, upon recommendation of the council, may adopt rules to specify continuing education requirements for persons who hold a license in more than one specialty.

(b)  In order to apply for a medical physicist license in one or more specialties, a person must file an individual application for each specialty with the department. The application must be on a form prescribed by the department and must be accompanied by a nonrefundable application fee for each specialty.

(c)  The department may issue a license to an eligible applicant if the applicant meets all license requirements. At any time before the department issues a license, the applicant may request in writing that the application be withdrawn. To reapply, the applicant must submit a new application and an additional nonrefundable application fee and must meet all current licensure requirements.

(d)  The department shall review each completed application for a license which the department receives.

(e)  On receipt of an application and fee as specified in this section, the department may issue a license to practice medical physics in this state on or after October 1, 1997, to a person who is board certified in the medical physics specialty in which the applicant applies to practice by the American Board of Radiology for diagnostic radiological physics, therapeutic radiological physics, or medical nuclear radiological physics; by the American Board of Medical Physics for diagnostic radiological physics, therapeutic radiological physics, or medical nuclear radiological physics; or by the American Board of Health Physics or an equivalent certifying body approved by the department.

(f)  A licensee shall:

1.  Display the license in a place accessible to the public; and

2.  Report immediately any change in the licensee's address or name to the department.

(g)  The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):

1.  Obtaining or attempting to obtain a license by bribery, fraud, knowing misrepresentation, or concealment of material fact or through an error of the department.

2.  Having a license denied, revoked, suspended, or otherwise acted against in another jurisdiction.

3.  Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of medical physics.

4.  Willfully failing to file a report or record required for medical physics or willfully impeding or obstructing the filing of a report or record required by this section or inducing another person to do so.

5.  Making misleading, deceptive, or fraudulent representations in or related to the practice of medical physics.

6.  Willfully failing to report any known violation of this section or any rule adopted thereunder.

7.  Failing to perform any statutory or legal obligation placed upon a licensee.

8.  Aiding, assisting, procuring, employing, or advising any unlicensed person to practice medical physics contrary to this section or any rule adopted thereunder.

9.  Delegating or contracting for the performance of professional responsibilities by a person when the licensee delegating or contracting such responsibilities knows, or has reason to know, such person is not qualified by training, experience, and authorization to perform them.

10.  Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities the licensee knows, or has reason to know, the licensee is not competent to perform.

11.  Gross or repeated malpractice or the inability to practice medical physics with reasonable skill and safety.

12.  Judicially determined mental incompetency.

13.  Being unable to practice medical physics with reasonable skill and safety because of a mental or physical condition or illness or the use of alcohol, controlled substances, or any other substance which impairs one's ability to practice.

a.  The department may, upon probable cause, compel a licensee to submit to a mental or physical examination by physicians designated by the department. The cost of an examination shall be borne by the licensee, and the licensee's failure to submit to such an examination constitutes an admission of the allegations against the licensee, consequent upon which a default and a final order may be entered without the taking of testimony or presentation of evidence, unless the failure was due to circumstances beyond the licensee's control.

b.  A licensee who is disciplined under this subparagraph shall, at reasonable intervals, be afforded an opportunity to demonstrate that the licensee can resume the practice of medical physics with reasonable skill and safety.

c.  With respect to any proceeding under this subparagraph, the record of proceedings or the orders entered by the department may not be used against a licensee in any other proceeding.

14.  Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.

(h)  The department may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or who is found guilty of violating any provision of s. 456.072(1).

(i)  The department may not issue or reinstate a license to a person it has deemed unqualified until it is satisfied that such person has complied with the terms and conditions of the final order and that the licensee can safely practice medical physics.

(j)  Upon receipt of a complete application and the fee set forth by rule, the department may issue a physicist-in-training certificate to a person qualified to practice medical physics under direct supervision. The department may establish by rule requirements for initial certification and renewal of a physicist-in-training certificate.

(7)  FEES.--The fee for the initial license application shall be $500 and is nonrefundable. The fee for license renewal may not be more than $500. These fees may cover only the costs incurred by the department and the council to administer this section. By July 1 each year, the department shall advise the council if the fees are insufficient to administer this section.

(8)  DISPOSITION OF FEES.--The department shall deposit all funds received into the Medical Quality Assurance Trust Fund.

(9)  PENALTY FOR VIOLATIONS.--It is a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, to:

(a)  Practice or attempt to practice medical physics or hold oneself out to be a licensed medical physicist without holding an active license.

(b)  Practice or attempt to practice medical physics under a name other than one's own.

(c)  Use or attempt to use a revoked or suspended license or the license of another.

(10)  EXEMPTIONS.--This section does not apply to:

(a)  A physician who is licensed by this state to the extent that the physician practices within the scope of the physician's training, education, and licensure;

(b)  A person who is licensed under part IV of chapter 468 to the extent that the person practices within the scope of the person's training, education, and licensure;

(c)  A person who performs beam calibration and characterization, quality assurance, instrument specification, acceptance testing, shielding design, or protection analysis on radiation-emitting equipment or radiopharmaceuticals in connection with procedures that are not involved with the diagnosis or treatment of disease or other medical or dental conditions in humans;

(d)  A person who is employed by a federal or state regulatory agency and is performing duties within the scope of the person's employment;

(e)  A student or intern who practices medical physics in conjunction with a program at an accredited college or university to the extent that the student or intern is adequately supervised by a licensed medical physicist or licensed physician; or

(f)  A dentist or any person working under the dentist's supervision pursuant to chapter 466 to the extent that the dentist or the person supervised by the dentist is practicing within the scope of his or her training, education, and licensure.

History.--ss. 3, 5, ch. 95-231; s. 446, ch. 97-103; s. 171, ch. 97-264; ss. 137, 218, 247, 286, ch. 98-166; s. 153, ch. 99-397; s. 69, ch. 2000-158; s. 197, ch. 2000-160; s. 60, ch. 2000-318; s. 48, ch. 2001-277; s. 80, ch. 2002-1; s. 23, ch. 2005-240.