CODING: Words stricken are deletions; words underlined are additions.House Bill 1115
Florida House of Representatives - 1997 HB 1115
By Representatives Saunders, Peaden, Barreiro,
Dawson-White and King
1 A bill to be entitled
2 An act relating to clinical laboratory
3 personnel; amending s. 408.033, F.S.; providing
4 an exemption from certain health care
5 facilities assessments for clinical
6 laboratories operated by practitioners for
7 exclusive use; amending s. 483.035, F.S.;
8 requiring the Agency for Health Care
9 Administration to adopt rules relating to
10 personnel of such laboratories; amending ss.
11 483.101, 483.106, F.S.; deleting a requirement
12 that application for a clinical laboratory
13 license or certificate of exemption be made
14 under oath; amending s. 483.172, F.S.;
15 providing for expiration of the agency's
16 authority to collect a fee from certain
17 laboratories; amending ss. 483.801, 483.813,
18 F.S.; providing for an exemption from
19 regulation for certain practitioners and
20 persons employed by certain laboratories;
21 amending s. 483.803, F.S.; revising the
22 definition of "clinical laboratory personnel";
23 amending s. 483.811, F.S.; providing
24 application of regulatory provisions to certain
25 clinical laboratories; creating s. 483.824,
26 F.S.; providing qualifications of a clinical
27 laboratory director; providing an effective
28 date.
29
30 Be It Enacted by the Legislature of the State of Florida:
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1 Section 1. Paragraph (a) of subsection (3) of section
2 408.033, Florida Statutes, is amended to read:
3 408.033 Local and state health planning.--
4 (3) FUNDING.--
5 (a) The Legislature intends that the cost of local
6 health councils and the Statewide Health Council be borne by
7 application fees for certificates of need and by assessments
8 on selected health care facilities subject to facility
9 licensure by the Agency for Health Care Administration,
10 including abortion clinics, assisted living facilities,
11 ambulatory surgical centers, birthing centers, clinical
12 laboratories except community nonprofit blood banks, clinical
13 laboratories operated by practitioners for exclusive use
14 regulated under s. 483.035, home health agencies, hospices,
15 hospitals, intermediate care facilities for the
16 developmentally disabled, nursing homes, and multiphasic
17 testing centers and by assessments on organizations subject to
18 certification by the agency pursuant to chapter 641, part III,
19 including health maintenance organizations and prepaid health
20 clinics.
21 Section 2. Subsection (1) of section 483.035, Florida
22 Statutes, is amended to read:
23 483.035 Clinical laboratories operated by
24 practitioners for exclusive use; licensure and regulation.--
25 (1) A clinical laboratory operated by one or more
26 practitioners licensed under chapter 458, chapter 459, chapter
27 460, chapter 461, chapter 462, or chapter 466, exclusively in
28 connection with the diagnosis and treatment of their own
29 patients, must be licensed under this part and must comply
30 with the provisions of this part, except that the agency shall
31 adopt rules for staffing, for personnel, including education
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1 and training of personnel, for proficiency testing, and for
2 construction standards relating to the licensure and operation
3 of the laboratory based upon and not exceeding the same
4 standards contained in the federal Clinical Laboratory
5 Improvement Amendments of 1988 and the federal regulations
6 adopted thereunder.
7 Section 3. Section 483.101, Florida Statutes, is
8 amended to read:
9 483.101 Application for clinical laboratory
10 license.--An application for a clinical laboratory license
11 must be made under oath by the owner or operator of the
12 clinical laboratory or by the public official responsible for
13 operating a state, municipal, or county clinical laboratory or
14 institution that contains a clinical laboratory, upon forms
15 provided by the agency. A license must be issued authorizing
16 the performance of one or more clinical laboratory procedures
17 or one or more tests on each specialty or subspecialty. A
18 separate license is required of all laboratories maintained on
19 separate premises even if the laboratories are operated under
20 the same management. Upon receipt of a request for an
21 application for a clinical laboratory license, the agency
22 shall provide to the applicant a copy of the rules relating to
23 licensure and operations applicable to the laboratory for
24 which licensure is sought.
25 Section 4. Section 483.106, Florida Statutes, is
26 amended to read:
27 483.106 Application for a certificate of
28 exemption.--An application for a certificate of exemption must
29 be made under oath by the owner or operator of a clinical
30 laboratory that performs only waived tests as defined in s.
31 483.041. A certificate of exemption authorizes a clinical
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1 laboratory to perform waived tests. Laboratories maintained
2 on separate premises and operated under the same management
3 may apply for a single certificate of exemption or multiple
4 certificates of exemption. The agency shall, by rule, specify
5 the process for biennially issuing certificates of exemption.
6 Sections 483.011, 483.021, 483.031, 483.041, 483.172, 483.23,
7 and 483.25 apply to a clinical laboratory that obtains a
8 certificate of exemption under this section.
9 Section 5. Subsection (4) of section 483.172, Florida
10 Statutes, is amended to read:
11 483.172 License fees.--
12 (4) Upon October 1, 1993, and until the agency is
13 granted state exemption status by the Health Care Financing
14 Administration, laboratories that are licensed under the
15 Clinical Laboratory Improvement Amendments of 1988 may not be
16 assessed the fees specified in subsections (2) and (3) by the
17 agency. During that period, a fee must be assessed to those
18 laboratories to cover the cost of state activities beyond
19 those required under the Clinical Laboratory Improvement
20 Amendments of 1988. This fee is $100 biennially. The
21 authority to collect the fee set forth in this subsection
22 expires July 1, 1997.
23 Section 6. Section 483.801, Florida Statutes, is
24 amended to read:
25 483.801 Exemptions.--This part applies to all clinical
26 laboratories and clinical laboratory personnel within this
27 state, except:
28 (1) Clinical laboratories operated by the United
29 States Government.
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1 (2) Laboratories operated and maintained exclusively
2 for research and teaching purposes, involving no patient or
3 public health service whatsoever.
4 (3) Persons engaged in testing performed by
5 laboratories regulated under s. 483.035(1) or exempt from
6 regulation under s. 483.031(2).
7 (4) Respiratory therapists and respiratory care
8 practitioners certified or registered under part V of chapter
9 468.
10 Section 7. Subsection (3) of section 483.803, Florida
11 Statutes, is amended to read:
12 483.803 Definitions.--As used in this part, the term:
13 (3) "Clinical laboratory personnel" includes a
14 clinical laboratory director, supervisor, technologist, blood
15 gas analyst, or technician who performs or is responsible for
16 laboratory test procedures, but the term does not include
17 trainees, persons who perform screening for blood banks or
18 plasmapheresis centers, phlebotomists, or persons employed by
19 a clinical laboratory to perform manual pretesting duties or
20 clerical, personnel, or other administrative responsibilities,
21 or persons engaged in testing performed by laboratories
22 regulated under s. 483.035(1) or exempt from regulation under
23 s. 483.031(2).
24 Section 8. Subsection (3) of section 483.811, Florida
25 Statutes, is amended to read:
26 483.811 Approval of laboratory personnel training
27 programs.--
28 (3) A clinical laboratory operated by one or more
29 practitioners who hold the facilities of the laboratory out as
30 available for the performance of diagnostic tests for other
31 practitioners or their patients is subject to the provisions
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1 of this part. The board shall adopt rules for the licensure,
2 education, and training of personnel in laboratories operated
3 pursuant to s. 483.035 based upon and not exceeding the
4 standards contained in the federal Clinical Laboratory
5 Improvement Amendments of 1988 and the federal regulations
6 adopted thereunder. This subsection does not apply to a
7 clinical laboratory operated by one or more practitioners who
8 hold the facilities of the laboratory out as available for the
9 performance of diagnostic tests for other practitioners or
10 their patients. If a clinical laboratory receives any
11 referred work, or performs any work for patients referred by
12 another practitioner, all provisions of this part apply.
13 Section 9. Section 483.813, Florida Statutes, is
14 amended to read:
15 483.813 Clinical laboratory personnel license.--A
16 person may not conduct a clinical laboratory examination or
17 report the results of such examination unless such person is
18 licensed under this part to perform such procedures. However,
19 this provision does not apply to any practitioner of the
20 healing arts authorized to practice in this state or to
21 persons engaged in testing performed by laboratories regulated
22 under s. 483.035(1) or exempt from regulation under s.
23 483.031(2). The department may grant a temporary license to
24 any candidate it deems properly qualified, for a period not to
25 exceed 6 months.
26 Section 10. Section 483.824, Florida Statutes, is
27 created to read:
28 483.824 Qualifications of clinical laboratory
29 director.--A clinical laboratory director must meet one of the
30 following requirements:
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1 (1) Be a physician licensed under chapter 458 or
2 chapter 459;
3 (2) Hold an earned doctoral degree in a chemical,
4 physical, or biological science from an accredited
5 institution; or
6 (3) For the subspecialty of oral pathology, be a
7 physician licensed under chapter 458 or chapter 459 or a
8 dentist licensed under chapter 466.
9 Section 11. This act shall take effect upon becoming a
10 law.
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13 SENATE SUMMARY
14 Exempts clinical laboratories operated by practitioners
for exclusive use from the health care facilities
15 assessment that funds the local and statewide health
councils. Requires the Agency for Health Care
16 Administration to adopt rules relating to personnel of
such laboratories. Removes a requirement that application
17 for a clinical laboratory license or certificate of
exemption be made under oath. Provides that the agency's
18 authority to collect a biennial $100 fee from
laboratories licensed under the federal Clinical
19 Laboratories Improvement Amendments of 1988 expires on
July 1, 1997. Revises the definition of "clinical
20 laboratory personnel" and provisions relating to
exemptions from regulation, to exempt persons engaged in
21 testing performed by exempt or exclusive-use
laboratories. Specifies qualifications for clinical
22 laboratory directors. Revises provision describing
certain clinical laboratories to which the provisions of
23 pt. IV of ch. 483, F.S., apply.
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