ORS 438.040: Clinical laboratory qualifications and certifications.

(1) The Oregon Health Authority shall verify the qualifications of each clinical laboratory in this state and shall issue or facilitate the issuance of a certificate to a clinical laboratory that satisfies the requirements of the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a).

      (2) A clinical laboratory may not operate in this state without a certificate issued by the authority or the federal government under this section.