Sec.19a-36-D22. Application for licensure

(a) In applying for licensure, the applicant shall set forth the name and location of the laboratory, a complete statement of its ownership including the names and addresses of all owners and the agent for service of process and the agent's address, the name of the director, a list of laboratory tests and examinations for which licensure is sought and such other information as to ownership, quarters, facilities, personnel and proposed operations as the department may require. Application for renewal of licensure shall delineate changes made in the preceding licensure period. When applying for renewal of licensure under this section, the applicant shall simultaneously apply for renewal of any additional registration required by sections 19a-36-A25 through 19a-36-A33 of the regulations of Connecticut State Agencies, and such renewal, when granted, shall be considered to be in force for the issuance of such certificates of approval as are required by section 19a-36-A33 of the regulations of Connecticut State Agencies. The applicant shall, as part of each application, agree to abide by such standards of operation as are made a part thereof.

(b) The following clinical laboratories are exempt from licensure:

(1) laboratories owned and operated by the United States or any agency of the federal government;

(2) laboratories that perform tests or examinations for research purposes only;

(3) laboratories that perform tests or examinations for forensic purposes only; and

(4) laboratories that perform tests or examinations that are exempt for CLIA purposes.

(Adopted effective June 4, 1996)