(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. 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 blood 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 blood collection facility opens or closes.
(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; P.A. 21-121, S. 39.)
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.
Structure Connecticut General Statutes
Title 19a - Public Health and Well-Being
Chapter 368a - Department of Public Health
Section 19a-2a. - Powers and duties.
Section 19a-4. (Formerly Sec. 19-2a). - Commissioner to organize department and adopt regulations.
Section 19a-4i. - Office of Injury Prevention.
Section 19a-4j. - Office of Health Equity.
Section 19a-4k. - Advisory Commission on Multicultural Health.
Section 19a-4l. - Office of Oral Public Health.
Section 19a-5. (Formerly Sec. 19-4). - Powers and duties of commissioner.
Section 19a-6d. - Tobacco abuse reduction and health plan.
Section 19a-6e. - Traumatic brain injury patient registry.
Section 19a-6f. - Listing of certified medical assistants.
Section 19a-6i. - School-based health center advisory committee. Members. Duties. Report.
Section 19a-6o. - Palliative Care Advisory Council. Duties. Members. Report.
Section 19a-6p. - School-based health centers. Hours. Services. Reimbursement for services.
Section 19a-6q. - Chronic disease plan.
Section 19a-6s. - Provision of vaccines by clinical medical assistants under supervision.
Section 19a-6t. - Connecticut Rare Disease Advisory Council. Duties. Members. Report.
Section 19a-6u. - School-based health center expansion grant program.
Section 19a-7b. - Health Care Access Commission.
Section 19a-7c. - Subsidized nongroup health insurance product for pregnant women.
Section 19a-7d. - Primary care direct services program.
Section 19a-7e. - Health care for uninsured pregnant women demonstration project.
Section 19a-7g. - Childhood Immunization Advisory Council.
Section 19a-7h. - Immunization information system. Regulations.
Section 19a-7i. - Extension of coverage under the maternal and child health block grant.
Section 19a-7k. - Preventive dental care pilot program.
Section 19a-7o. - Hepatitis C and HIV-related testing.
Section 19a-7p. - Public health fee. Annual reporting requirement. Appeal. Penalties. Overpayment.
Section 19a-7s. - Evaluation of data re exemptions from immunization requirements. Report.
Section 19a-7u. - Pilot program to expand behavioral health care. Grants.
Section 19a-12c. - Professional assistance program account.
Section 19a-13. (Formerly Sec. 19-4n). - Regulated professions; definitions.
Section 19a-14. (Formerly Sec. 19-4o). - Powers of department concerning regulated professions.
Section 19a-14a. - Professional licenses. Investigations and disciplinary action.
Section 19a-14b. - Radon mitigators, diagnosticians and testing companies. Regulations.
Section 19a-14c. - Provision of outpatient mental health treatment to minors.
Section 19a-16e. - Scope of practice review committees. Membership. Duties.
Section 19a-16f. - Report to General Assembly on scope of practice review processes.
Section 19a-17. (Formerly Sec. 19-4s). - Disciplinary action by department, boards and commissions.
Section 19a-17a. - Review of medical malpractice awards and certain settlements.
Section 19a-17m. - Malpractice insurance purchase program.
Section 19a-17n. - Malpractice insurance purchase program. Regulations. Limitations.
Section 19a-18. (Formerly Sec. 19-4t). - Meaning of term “licensed” for insurance purposes.
Section 19a-19. (Formerly Sec. 19-4u). - Regulation of business practices.
Section 19a-21. (Formerly Sec. 19-4w). - Disposition of licensing fees.
Section 19a-22. (Formerly Sec. 19-4x). - Actions by department, boards and commissions; appeals.
Section 19a-23. (Formerly Sec. 19-4y). - Boards and commissions; records.
Section 19a-25a. - Regulations re electronic signatures for medical records.
Section 19a-25b. - Electronic prescribing systems authorized.
Section 19a-25c. - Medical records systems: Electronic and paper formats authorized.
Section 19a-25e. - Connecticut Health Information Network plan.
Section 19a-27. (Formerly Sec. 19-7a). - Test for rubella immunity. Regulations.
Section 19a-28. (Formerly Sec. 19-8). - Toxicology laboratory.
Section 19a-29. (Formerly Sec. 19-9). - Special laboratories.
Section 19a-29a. - Environmental laboratories.
Section 19a-31a. - Microbiological and biomedical biosafety laboratories.
Section 19a-32. (Formerly Sec. 19-10). - Department authorized to receive gifts.
Section 19a-32a. - AIDS research education account. Regulations.
Section 19a-32b. - Breast cancer research and education account.
Section 19a-32n. - Information and education re umbilical cord blood collection programs.
Section 19a-32o. - Short title: Connecticut Umbilical Cord Blood Collection Program Act.
Section 19a-32p. - Legislative findings and declaration of policy.
Section 19a-32q. - Connecticut Umbilical Cord Blood Collection Board. Membership. Meetings.
Section 19a-32r. - Board to establish and administer umbilical cord blood collection program.
Section 19a-32t. - Umbilical cord blood collection account.
Section 19a-32u. - Copies of independent audits to be submitted to General Assembly.
Section 19a-32v. - Reports to Governor and General Assembly.
Section 19a-33. (Formerly Sec. 19-10a). - Regulation of traffic at department facilities.
Section 19a-36a. - Regulations concerning food operators.
Section 19a-36g. - Food code. Definitions.
Section 19a-36j. - Food inspectors. Certification. Inspections.
Section 19a-36k. - Food-borne illness or outbreak. Investigation.
Section 19a-36l. - Inspection violations. Appeal process.
Section 19a-37h. - Water companies to provide multilingual tier 1 notices.
Section 19a-38. (Formerly Sec. 19-13b). - Water company to add fluoride to water supply.
Section 19a-39. (Formerly Sec. 19-13c). - Protection of wells.
Section 19a-40. (Formerly Sec. 19-14). - Supervision of vital statistics.
Section 19a-41. (Formerly Sec. 19-15). - Compilation of vital records and statistics. Regulations.
Section 19a-42. (Formerly Sec. 19-15a). - Amendment of vital records.
Section 19a-43. (Formerly Sec. 19-15b). - Reproduction of vital records.
Section 19a-44. (Formerly Sec. 19-15c). - Matching of birth and death certificates.
Section 19a-45b. - Medical home pilot program.
Section 19a-45c. - Evaluation and report required re medical home pilot program.
Section 19a-46. (Formerly Sec. 19-17). - Expert examinations and inspections.
Section 19a-48. (Formerly Sec. 19-19). - Care for children with cerebral palsy.
Section 19a-49. (Formerly Sec. 19-19a). - Services for persons with cystic fibrosis.
Section 19a-51. (Formerly Sec. 19-20a). - Pediatric Cardiac Patient Care Fund.
Section 19a-54. (Formerly Sec. 19-21a). - Registration of children with special health care needs.
Section 19a-54a. - Registry of data on infants exposed to AIDS medication.
Section 19a-55a. - Newborn screening account.
Section 19a-55b. - Information on newborn infant safe sleep practices.
Section 19a-56. (Formerly Sec. 19-21c). - Program for prevention of erythroblastosis.
Section 19a-57. (Formerly Sec. 19-21d). - Loans for purchase of hemodialysis treatment machines.
Section 19a-58. (Formerly Sec. 19-21e). - Pamphlet concerning hearing impairments in infants.
Section 19a-59. - Program to identify infants who are hard of hearing.
Section 19a-59b. - Maternal and child health protection program.
Section 19a-59e. - Media campaign for the reduction of adolescent pregnancies.
Section 19a-59h. - Maternal mortality review program. Confidentiality of information.
Section 19a-59i. - Maternal mortality review committee.
Section 19a-60. (Formerly Sec. 19-22). - Dental services for children.
Section 19a-60a. - Dental services for children of low-income families.
Section 19a-61. (Formerly Sec. 19-22b). - Services for children suffering from diabetes.
Section 19a-62. (Formerly Sec. 19-22c). - Services for children suffering from cancer.
Section 19a-69. (Formerly Sec. 19-27). - Distribution of biologic products.
Section 19a-70. (Formerly Sec. 19-28). - Priority of distribution in emergency.
Section 19a-71. (Formerly Sec. 19-29). - Observation and treatment of certain typhoid germ carriers.
Section 19a-72a. - State-wide stroke registry.
Section 19a-73a. - Establishment of comprehensive cancer plan for state.
Section 19a-73b. - Funding sources for comprehensive cancer program.
Section 19a-74. (Formerly Sec. 19-30). - Cancer.
Section 19a-75. (Formerly Sec. 19-30b). - State aid for health career educational programs.
Section 19a-77. - “Child care services” defined. Exclusions. Additional license.
Section 19a-77a. - Child day care services in retail stores.
Section 19a-79. (Formerly Sec. 19-43d). - Regulations. Exemptions. Waivers.
Section 19a-79a. - Pesticide applications at child care facilities.
Section 19a-80g. - Child care center waiting list fees and deposits.
Section 19a-80h. - Enrollment of certain children in preschool programs.
Section 19a-81. (Formerly Sec. 19-43f). - Hearing on denial of license.
Section 19a-83. (Formerly Sec. 19-43h). - Reports of licensees.
Section 19a-85. (Formerly Sec. 19-43j). - Appeal.
Section 19a-86. (Formerly Sec. 19-43k). - Injunction against illegal operation.
Section 19a-86a. - Accepting voluntary surrender of license as resolution of disciplinary action.
Section 19a-86b. - Validity of license during investigation or disciplinary action.
Section 19a-86c. - Failure to provide written notice of proposed closure. Penalty.
Section 19a-87g. - Notification of emergency situations to licensees of day care centers.
Section 19a-88a. - Regulations concerning retired nurses.
Section 19a-88c. - Regulations re retired dentists.
Section 19a-89. (Formerly Sec. 19-46). - Change of office or residence address.
Section 19a-89a. - Database on nursing personnel.
Section 19a-89b. - Fees for pool design guidelines and food compliance guide.
Section 19a-89c. - Auricular acupuncture pilot program.
Section 19a-89d. - Nurse staffing and patient care data.
Section 19a-89e. - Development of prospective nurse staffing plan by hospitals. Report.
Section 19a-90. (Formerly Sec. 19-47). - Blood testing of pregnant women for syphilis and HIV.
Section 19a-92a. - Regulation of persons engaged in tattooing. Penalty.
Section 19a-92g. - Body piercing.
Section 19a-102. (Formerly Sec. 19-59a). - Regulation of sale of turtles.
Section 19a-102a. - Regulation of sale of turtles.
Section 19a-102b. - Importation of turtles.
Section 19a-103. (Formerly Sec. 19-60). - Control of communicable diseases in institutions.
Section 19a-104. (Formerly Sec. 19-61). - Sale of rags to be used as wiping cloths; cleaning.
Section 19a-105. (Formerly Sec. 19-62). - Public toilets.
Section 19a-106. (Formerly Sec. 19-62a). - “Restroom” defined.
Section 19a-106a. - Customer access to employee restrooms in retail establishments.
Section 19a-107. (Formerly Sec. 19-63). - Towels in hotels and public lavatories.
Section 19a-108. (Formerly Sec. 19-64). - Common drinking cups.
Section 19a-110a. - Regional lead poisoning treatment centers.
Section 19a-111a. - Lead poisoning prevention program. Lead state agency.
Section 19a-111c. - Abatement of lead in dwellings. List of encapsulant products. Regulations.
Section 19a-111d. - Regulations.
Section 19a-111e. - Federal funds for lead poisoning prevention programs.
Section 19a-111g. - Pediatric lead testing and risk assessment. Exemption.
Section 19a-111h. - Review of lead poisoning data. Regulations.
Section 19a-111i. - Report re lead poisoning prevention efforts.
Section 19a-111k. - Applicability of OSHA standards to abatement and remediation of lead hazards.
Section 19a-111l. - Guidelines on mold abatement protocols.
Section 19a-112b. - Services to victims of sexual acts.
Section 19a-112c. - Educational materials for sexual assault victims.
Section 19a-112d. - Sexual assault victims account.
Section 19a-112g. - Sexual assault forensic examiners. Responsibilities.
Section 19a-112h. - Financial assistance for victims of sexual assault.
Section 19a-112i. - Community gun violence intervention and prevention program.
Section 19a-113a. - Cardiopulmonary resuscitation certification of lifeguards.
Section 19a-115. (Formerly Sec. 19-66f). - Regulation of medical test units.
Section 19a-116. (Formerly Sec. 19-66g). - Regulation of facilities which offer abortion services.
Section 19a-121. - HIV and AIDS: Grant program.
Section 19a-121a. - AIDS: Funding to local health departments.
Section 19a-121b. - Regulations.
Section 19a-121c. - HIV and AIDS: Public information program.
Section 19a-121d. - Grants for mass mailing of report on AIDS.
Section 19a-122. - Hospice care for the homeless.
Section 19a-122a. - Hospice care for the homeless. Termination of pilot program.
Section 19a-123. - Nursing pool: Definition.
Section 19a-123b. - Nursing pool: Written agreement with health care institution.
Section 19a-123c. - Regulation of rates charged by nursing pools.
Section 19a-123d. - Aggrievement. Penalties.
Section 19a-124. - Syringe services programs.
Section 19a-124a. - Donation of vans to entities operating needle exchange programs.
Section 19a-125. - Adolescent Health Council.
Section 19a-127l. - Quality of care program. Quality of Care Advisory Committee.
Section 19a-127o. - Patient safety organizations.
Section 19a-127p. - Requirement for hospitals to contract with patient safety organization.
Section 19a-131. - Public health emergency response authority. Definitions.
Section 19a-131a. - Declaration of public health emergency by Governor.
Section 19a-131b. - Orders of quarantine or isolation. Appeal of order. Hearing.
Section 19a-131c. - Enforcement of order of quarantine or isolation.
Section 19a-131d. - Entry into quarantine or isolation premises.
Section 19a-131e. - Orders of vaccination. Appeal of order. Hearing.
Section 19a-131f. - Authorization to administer vaccinations.
Section 19a-131g. - Public Health Preparedness Advisory Committee.
Section 19a-131h. - Registration of deaths.
Section 19a-131i. - Immunity from personal liability.
Section 19a-131k. - Mandatory distribution of potassium iodide.
Section 19a-133. - Declaration of racism as a public health crisis.
Section 19a-133a. - Commission on Racial Equity in Public Health. Membership. Powers and duties.
Section 19a-133d. - Educational materials re pulse oximeters.