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Substitute House Bill No. 6733

Public Act No. 23-31 13 of 74

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, [to establish reasonable standards governing exemptions from the licensing provisions of this section, clinical laboratory] 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 [insure] 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 [, firm or corporation] 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,