Current through Pa Acts 2024-53, 2024-56 through 2024-92
Section 2161 - 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. (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.Amended by P.L. 1232 2013 No. 122, § 2, eff. 12/18/2013.1951, Sept. 26, P.L. 1539, §11. Amended 1961, Aug. 4, P.L. 920, No. 400, § 1.