Sec. 19a-30. (Formerly Sec. 19-9a). Clinical laboratories. Regulation and licensure. Proficiency standards for tests not performed in laboratories.
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, in its Public Health Code, adopt regulations and 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 set forth in
the Public Health Code and shall be subject to inspection by said department, including
inspection of all records necessary to carry out the purposes of this section.
(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 one hundred dollars shall accompany each application
for a license or for renewal thereof, except in the case of a 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. 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 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.
(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 nor more than three hundred
dollars for each offense.
(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.)
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.
See Sec. 20-7a re billing for clinical laboratory services.