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: 31 1 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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 2 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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 3 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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. 30 31 4 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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 5 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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: 31 6 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 HB 1115 550-143-97 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. 11 12 ***************************************** 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. 24 25 26 27 28 29 30 31 7