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.
Credits
1951, Sept. 26, P.L. 1539, No. 389, § 11. Amended 1961, Aug. 4, P.L. 920, No. 400, § 1; 2013, Dec. 18, P.L. 1232, No. 122, § 2, imd. effective.
35 P.S. § 2161, PA ST 35 P.S. § 2161
Current through 2023 Regular Session Act 32. Some statute sections may be more current, see credits for details.
