Section 11. Inspection.--The department shall have the authority to:
(1) Investigate the facts submitted in an application for permit or renewal of a permit by any person to operate a clinical laboratory and conduct inspections as necessary.
(2) Promulgate regulations for the criteria and manner to investigate or inspect a clinical laboratory.
(3) Maintain access to and enter upon the premises of a clinical laboratory to enforce the provisions of this act.
(4) Exempt or limit out-of-State clinical laboratories from the department's inspection process provided the out-of-State clinical laboratory:
(i) is certified or accredited under section 353 of the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) and, to the extent applicable, by the state that has issued a license or permit to operate a clinical laboratory; and
(ii) provides proof to the department that the clinical laboratory applying for a permit or renewal of a permit has met the requirements for exemption of the inspection process under this section.
(11 amended Dec. 18, 2013, P.L.1232, No.122)