Connecticut General Statutes/Title 19a/Chapter 368v/Section 19a-565

CGS § 19a-565. (Formerly Sec. 19a-30). Clinical laboratories, blood collection facilities and source plasma donation centers. Regulation and licensure. Proficiency standards for tests not performed in laboratories. Prohibitions. Penalties. Regulations.

(a) As used in this section, “business entity” means a corporation, association, trust, estate, partnership, limited partnership, limited liability partnership, limited liability company, sole proprietorship, joint stock company, nonstock corporation, John Dempsey Hospital and The University of Connecticut Health Center.

(b) The Department of Public Health shall adopt regulations, in accordance with the provisions of chapter 54, governing clinical laboratories, blood collection facilities and source plasma donation centers. Such regulations shall establish reasonable standards for entities exempt from licensure as a 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 ensure public health and safety. Such regulations shall provide that a responsible physician, as defined in 21 CFR 630.3, as amended from time to time, may serve as the director of a blood collection facility or source plasma donation center. On or before October 1, 2023, the Commissioner of Public Health shall implement policies and procedures necessary to administer the provisions of this section while in the process of adopting such policies and procedures as regulations, provided the department posts such policies and procedures on the eRegulations System prior to adopting them. On or before October 1, 2024, the commissioner shall update the department's policies and procedures to include policies and procedures consistent with the provisions of this subsection. Policies and procedures implemented pursuant to this section shall be valid until final regulations are adopted in accordance with the provisions of chapter 54.

(c) No person or business entity shall establish, conduct, operate or maintain a clinical laboratory, blood collection facility or source plasma donation center unless such laboratory, facility or center is licensed or approved by said department in accordance with its regulations. Each blood collection facility or plasmapheresis center, as defined in section 19a-36-A47 of the regulations of Connecticut state agencies, that is registered with the department on or before October 1, 2023, shall apply to the department for an initial license pursuant to the provisions of this section not later than thirty days after the date that procedures for such licensure are implemented by the department pursuant to subsection (b) of this section. On and after the date on which procedures for licensure are implemented by the department pursuant to the provisions of said subsection, the department shall not renew any blood collection facility or plasmapheresis center registration. Each clinical laboratory, blood collection facility or source plasma donation center shall comply with all standards for such facilities 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.

(d) Each initial or renewal application for licensure of a clinical laboratory, blood collection facility or source plasma donation center shall be made in a form and manner prescribed by the commissioner and shall be executed by the owner or owners or by a responsible officer of the firm or corporation owning such laboratory, facility or donation center and be accompanied by the fee required pursuant to the provisions of subsection (f) of this section. A mobile or temporary blood collection facility shall not be required to obtain a license if such person or business entity operating such facility is licensed as a blood collection facility. A licensed source plasma donation center shall not be required to obtain a clinical laboratory license to perform any pre-donation screening test required by Title 21, Chapter I of the Code of Federal Regulations. A hospital licensed under this chapter shall not be required to obtain a license as a blood collection facility for blood component collection activities that take place on the hospital campus, as defined in section 19a-508c.

(e) After the department receives an initial or renewal application for licensure pursuant to subsection (d) of this section, it shall conduct any inspections or investigations that are deemed necessary by the commissioner to determine the applicant's eligibility for licensure. As a condition of licensure, the commissioner may require the applicant to sign a consent order providing reasonable assurances of compliance with federal and state laws and regulations. The commissioner may deny licensure of an applicant if the commissioner determines that the applicant has previously failed to comply with federal and state laws and regulations or that licensure would pose a threat to the health, safety and well-being of the public. Licensure pursuant to the provisions of this section shall not be effective until the applicant receives notice of such licensure, including the effective date and term of such licensure, from the department.

(f) 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 months. Renewal applications shall be made biennially within the twentieth month of the current license. Any change in ownership of an entity licensed pursuant to the provisions of this section shall be made in compliance with section 19a-493. If any such entity changes its director, it shall notify the commissioner in a form and manner prescribed by the commissioner. If any such entity intends to expand or alter its facility, it shall notify the commissioner in a form and manner prescribed by the commissioner prior to such expansion or alteration. The licensed clinical laboratory shall report to the Department of Public Health, in a form and manner prescribed by the commissioner, the name and address of each specimen collection facility owned and operated by the clinical laboratory, prior to the issuance of a new license, prior to the issuance of a renewal license or whenever a specimen collection facility opens or closes.

(g) 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 the licensed clinical laboratory, blood collection facility or source plasma donation center has engaged in fraudulent practices, fee-splitting inducements or bribes, including, but not limited to, in the case of a clinical laboratory, violations of subsection (h) 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.

(h) 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.

(i) No clinical laboratory, blood collection facility or source plasma donation center shall terminate the employment of an employee because such employee reported a violation of this section to the Department of Public Health.

(j) Any person or business entity operating a clinical laboratory, blood collection facility or source plasma donation center 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.

(k) 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.

Short History

(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; P.A. 21-121, S. 39; P.A. 22-58, S. 23; P.A. 23-31, S. 9; P.A. 24-7, S. 1.)

Long History

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; P.A. 21-121 amended Subsec. (d) by adding provision re reporting of name and address of blood collection facilities, effective July 1, 2021; P.A. 22-58 amended Subsec. (a) by redefining “clinical laboratory”; Sec. 19a-30 transferred to Sec. 19a-565 in 2023; P.A. 23-31 added references to blood collection facilities and source plasma donation centers throughout, replaced references to firms or corporations with “business entity” throughout, amended Subsec. (a) by deleting definition of “clinical laboratory” and defining “business entity”, substantially revised Subsec. (b) re regulations, including by requiring regulation requiring onsite presence of registered nurse or advanced practice registered nurse, and adding provision re policies and procedures, designated existing provisions re licensure requirement for clinical laboratories in Subsec. (b) as new Subsec. (c), substantially revised new Subsec. (c), including by adding provisions re applications for initial licensure and deleting provisions re investigations, hearings and subpoenas, redesignated existing Subsec. (c) as new Subsec. (d)and substantially revised same by adding references to initial or renewal applications, deleting provision re laboratories located in institutions, replacing “on forms provided by said department” with “in a form and manner prescribed by the commissioner”, deleting existing provisions re contents of application and inspections and investigations after submission of application, and adding provisions re application fee and licensure exemptions, added new Subsec. (e) re inspections and investigations after submission of application, redesignated existing Subsec. (d) as new Subsec. (f) and amended same by deleting “nor more than twenty-seven” and “from the deadline for applications established by the commissioner”, replacing “twenty-fourth month” with “twentieth month”, deleting Subdivs. (2) and (3), adding provisions re changes of ownership and expansions and alterations to facilities, and replacing “blood collection facility” with “specimen collection facility”, redesignated existing Subsec. (e) as new Subsec. (g), redesignated existing Subsecs. (f) to (i) as new Subsecs. (h) and (i) and Subsecs. (j) and (k), and made technical and conforming changes throughout (Revisor's note: In new Subsec. (d), an incorrect reference to “chapter 386v” was deemed by the Revisors to be a reference to “chapter 368v” and changed editorially to “this chapter”); P.A. 24-7 amended Subsec. (b) by deleting provision re regulations to include requirement that registered nurse or advanced practice registered nurse be onsite during hours of operation of blood collection facility or source plasma donation center, adding provision requiring regulations to include provision allowing responsible physician to serve as director of blood collection facility or source plasma donation center and adding provision requiring commissioner to update department policies and procedures, effective May 9, 2024.