Connecticut General Statutes 19a-565 – Clinical laboratories. Regulation and licensure. Proficiency standards for tests not performed in laboratories. Report re blood collection facilities. 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.
Terms Used In Connecticut General Statutes 19a-565
- Blood collection facility: means a facility that performs blood component collection activities where blood is removed from a human being for the purpose of administering such blood or any of its components to any human being. See Connecticut General Statutes 19a-490
- 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 (1) diagnosis, prevention or treatment of any human disease or impairment, (2) assessment of human health, or (3) assessment of the presence of drugs, poisons or other toxicological substances. See Connecticut General Statutes 19a-490
- Commissioner: means the Commissioner of Public Health or the commissioner's designee. See Connecticut General Statutes 19a-490
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Hospital: means an establishment for the lodging, care and treatment of persons suffering from disease or other abnormal physical or mental conditions and includes inpatient psychiatric services in general hospitals. See Connecticut General Statutes 19a-490
- month: means a calendar month, and the word "year" means a calendar year, unless otherwise expressed. See Connecticut General Statutes 1-1
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- Person: means any individual, firm, partnership, corporation, limited liability company or association. See Connecticut General Statutes 19a-490
- source plasma: means the liquid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use and does not include single donor plasma products intended for intravenous use, and "plasmapheresis" means a procedure in which blood is removed from a blood donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the blood donor at the time of the donation. See Connecticut General Statutes 19a-490
- Source plasma donation center: means a facility where source plasma is collected by plasmapheresis. See Connecticut General Statutes 19a-490
(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 include a requirement that a registered nurse or advanced practice registered nurse licensed under chapter 378 be onsite during the hours of operation 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. 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.