Page 15

Substitute House Bill No. 6733

Public Act No. 23-31 15 of 74

[(c)] (d) Each initial or renewal 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,] blood collection facility or source plasma donation center shall be made [on forms provided by said department] 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 [the] such 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] 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 chapter 386v 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