(1) 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).
(2) For an out-of-state laboratory to perform health screen testing in Oregon without a permit issued under ORS 438.150 (5).
(3) 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. [1969 c.685 §3; 1999 c.341 §1; 2005 c.22 §298]
Structure 2021 Oregon Revised Statutes
Chapter 438 - Laboratories; Anatomical Material
Section 438.010 - Definitions for ORS 438.010 to 438.510.
Section 438.040 - Laboratory license; out-of-state laboratory permit; qualifications of director.
Section 438.050 - Application; exceptions.
Section 438.110 - Standards for issuance and renewal of laboratory license.
Section 438.120 - Standards for licensing specialties; exceptions.
Section 438.130 - License application; fees; expiration and renewal.
Section 438.160 - Refusal to issue or renew license; suspension or revocation of license or permit.
Section 438.210 - Qualifications of laboratory director.
Section 438.320 - Laboratory evaluation system; rules; quality control systems.
Section 438.430 - Examination of specimens; reports and results.
Section 438.435 - Testing for substance of abuse; rules; fees.
Section 438.510 - Prohibited acts.
Section 438.605 - Definitions for ORS 438.605 to 438.620, 448.280 and 448.285.
Section 438.610 - Standards for accreditation; rules.
Section 438.620 - Accreditation fees; disposition of fees.
Section 438.705 - Definitions for ORS 438.705 to 438.720 and 438.994.
Section 438.715 - Organization operations.
Section 438.720 - Rules; inspection of organization premises and records.