ORS 438.040 Laboratory license; out-of-state laboratory permit; qualifications of director

It is unlawful:

For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a license issued under ORS 438.110 or without a temporary permit issued under ORS 438.150 or to perform or permit the performance of any laboratory specialty for which the laboratory is not licensed except as specified under ORS 438.050, unless the laboratory has been issued a valid certificate from the federal government under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a).

For an out-of-state laboratory to perform health screen testing in Oregon without a permit issued under ORS 438.150 (5).

For any person to serve in the capacity of director of a clinical laboratory without being qualified as a clinical laboratory director under ORS 438.210.