Sec. 19a-30. (Formerly Sec. 19-9a). Clinical laboratories. Regulation and licensure. Proficiency standards for tests not performed in laboratories.

(a) As used in this section, “clinical laboratory” means any facility or other area used for microbiological, serological, chemical, hematological, immunohematological, biophysical, cytological, pathological or other examinations of human body fluids, secretions, excretions or excised or exfoliated tissues, for the purpose of providing information for the diagnosis, prevention or treatment of any human disease or impairment, for the assessment of human health or for the presence of drugs, poisons or other toxicological substances.

(b) The Department of Public Health shall adopt regulations, in accordance with the provisions of chapter 54, to establish reasonable standards governing exemptions from the licensing provisions of this section, clinical laboratory operations and facilities, personnel qualifications and certification, levels of acceptable proficiency in testing programs approved by the department, the collection, acceptance and suitability of specimens for analysis and such other pertinent laboratory functions, including the establishment of advisory committees, as may be necessary to insure public health and safety. No person, firm or corporation shall establish, conduct, operate or maintain a clinical laboratory unless such laboratory is licensed or approved by said department in accordance with its regulations. Each clinical laboratory shall comply with all standards for clinical laboratories established by the department and shall be subject to inspection by said department, including inspection of all records necessary to carry out the purposes of this section. The commissioner, or an agent authorized by the commissioner, may conduct any inquiry, investigation or hearing necessary to enforce the provisions of this section or regulations adopted under this section and shall have power to issue subpoenas, order the production of books, records or documents, administer oaths and take testimony under oath relative to the matter of such inquiry, investigation or hearing. At any such hearing ordered by the department, the commissioner or such agent may subpoena witnesses and require the production of records, papers and documents pertinent to such hearing. If any person disobeys such subpoena or, having appeared in obedience thereto, refuses to answer any pertinent question put to such person by the commissioner or such agent or to produce any records and papers pursuant to the subpoena, the commissioner or such agent may apply to the superior court for the judicial district of Hartford or for the judicial district wherein the person resides or wherein the business has been conducted, setting forth such disobedience or refusal and said court shall cite such person to appear before said court to answer such question or to produce such records and papers.

(c) Each application for licensure of a clinical laboratory, if such laboratory is located within an institution licensed in accordance with sections 19a-490 to 19a-503, inclusive, shall be made on forms provided by said department and shall be executed by the owner or owners or by a responsible officer of the firm or corporation owning the laboratory. Such application shall contain a current itemized rate schedule, full disclosure of any contractual relationship, written or oral, with any practitioner using the services of the laboratory and such other information as said department requires, which may include affirmative evidence of ability to comply with the standards as well as a sworn agreement to abide by them. Upon receipt of any such application, said department shall make such inspections and investigations as are necessary and shall deny licensure when operation of the clinical laboratory would be prejudicial to the health of the public. Licensure shall not be in force until notice of its effective date and term has been sent to the applicant.

(d) A nonrefundable fee of two hundred dollars shall accompany each application for a license or for renewal thereof, except in the case of a clinical laboratory owned and operated by a municipality, the state, the United States or any agency of said municipality, state or United States. Each license shall be issued for a period of not less than twenty-four nor more than twenty-seven months from the deadline for applications established by the commissioner. Renewal applications shall be made (1) biennially within the twenty-fourth month of the current license; (2) before any change in ownership or change in director is made; and (3) prior to any major expansion or alteration in quarters.

(e) A license issued under this section may be revoked or suspended in accordance with chapter 54 or subject to any other disciplinary action specified in section 19a-17 if such laboratory has engaged in fraudulent practices, fee-splitting inducements or bribes, including but not limited to violations of subsection (f) of this section, or violated any other provision of this section or regulations adopted under this section after notice and a hearing is provided in accordance with the provisions of said chapter.

(f) No representative or agent of a clinical laboratory shall solicit referral of specimens to his or any other clinical laboratory in a manner which offers or implies an offer of fee-splitting inducements to persons submitting or referring specimens, including inducements through rebates, fee schedules, billing methods, personal solicitation or payment to the practitioner for consultation or assistance or for scientific, clerical or janitorial services.

(g) No clinical laboratory shall terminate the employment of an employee because such employee reported a violation of this section to the Department of Public Health.

(h) Any person, firm or corporation operating a clinical laboratory in violation of this section shall be fined not less than one hundred dollars or more than three hundred dollars for each offense. For purposes of calculating civil penalties under this section, each day a licensee operates in violation of this section or a regulation adopted under this section shall constitute a separate violation.

(i) The Commissioner of Public Health shall adopt regulations in accordance with the provisions of chapter 54 to establish levels of acceptable proficiency to be demonstrated in testing programs approved by the department for those laboratory tests which are not performed in a licensed clinical laboratory. Such levels of acceptable proficiency shall be determined on the basis of the volume or the complexity of the examinations performed.

(1961, P.A. 514; P.A. 76-272; P.A. 77-275; 77-614, S. 323, 587, 610; P.A. 78-303, S. 85, 136; P.A. 79-421, S. 1, 2; P.A. 83-200; P.A. 93-381, S. 9, 39; P.A. 94-174, S. 3, 12; P.A. 95-257, S. 12, 21, 58; June Sp. Sess. P.A. 09-3, S. 164; P.A. 15-242, S. 14.)

History: P.A. 76-272 made previous provisions Subsecs. (a) to (c) and (e), substituted definition of “clinical laboratory” for “private clinical laboratory”, specified areas of operation governed by regulations, replaced registration with licensure, required that facilities be open to inspection by health department, removed provision re commissioner's right to “enjoin the operation” of facilities in violation of provisions, inserted new Subsec. (d) re license fees, renewals, etc., imposed minimum fine of $100, raised maximum fine from $100 to $300 and removed provisions that each day of continued violation constitutes separate offense; P.A. 77-275 excluded facilities of dentists and podiatrists from consideration as clinical laboratory and made their exemption contingent upon filing affidavit, specifically allowed inspection of records in Subsec. (b), required that license application contain itemized rate schedule and disclosure of contractual relationships with physicians, inserted new Subsecs. (e) to (h) re revocation or suspension of license, solicitation of referrals, protection of employees reporting violations and required affidavits and relettered former Subsec. (e) as Subsec. (i); P.A. 77-614 and P.A. 78-303 replaced department of health with department of health services, effective January 1, 1979; P.A. 79-421 replaced “licensed practitioner of a healing art or a licensed dentist or podiatrist” with reference to practitioners licensed under specific chapters and included exemption for facilities which meet exemption standards in Public Health Code re volume or complexity of examinations in Subsec. (a), included regulations governing “exemptions from licensing provisions” in Subsec. (b), included certificates of approval in provisions and broadened Subsec. (h) to allow for broadened exemptions in Subsec. (a); Sec. 19-9a transferred to Sec. 19a-30 in 1983; P.A. 83-200 added Subsec. (j) to establish proficiency levels for laboratory tests not performed in a licensed clinical laboratory; P.A. 93-381 replaced department and commissioner of health services with department and commissioner of public health and addiction services, effective July 1, 1993; P.A. 94-174 added testing for the presence of drugs, poisons and toxicological substances to the list of facility uses and removed the exception for laboratories in practitioners offices in definition of “clinical laboratory”, deleted references to certificates of approval and deleted Subsec. (h) which had required practitioners exempted from licensing requirements to file affidavits as to qualifications of persons performing tests and number and type of tests performed, relettering remaining Subsecs. accordingly, effective June 6, 1994; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health, effective July 1, 1995; June Sp. Sess. P.A. 09-3 amended Subsec. (d) to increase fee from $100 to $200 and made a technical change in Subsec. (h); P.A. 15-242 amended Subsec. (a) to delete references to Public Health Code, add reference to provisions of Ch. 54 and add provisions re inquiry, investigation or hearing, amended Subsec. (d) to add “clinical” re laboratory and add “established by the commissioner” re applications, amended Subsec. (e) to add reference to other disciplinary action specified in Sec. 19a-17 and regulations adopted under section and amended Subsec. (h) to add provisions re calculating civil penalties.

Notation

See Sec. 20-7a re billing for clinical laboratory services.