Oregon

Oregon

Oregon State Licensing Requirements

State-Specific CLIA Applications

Chapter 333. Oregon Health Authority, Public Health Division. Division 24. Clinical Laboratories. 
https://oregon.public.law/rules/oar_333-024-0012#d-for-any-person-other-than-a-physician-or-clinician-to-direct

(1) It shall be unlawful:

(a) For any Owner or Director of a clinical laboratory to operate or maintain a clinical laboratory without a license or without a temporary permit issued under this rule or to perform or permit the performance of any laboratory specialty for which the laboratory is not licensed, unless the laboratory has been issued a valid certificate from the federal government under the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, 42.U.S.C. 201 and 263a, except as specified herein;

(b) For any person to serve in the capacity of Director of a high complexity clinical laboratory without being qualified as a Clinical Laboratory Director under OAR 333-024-0021 (Qualifications and Responsibilities of Directors for High Complexity Laboratories);

(c) For any person to serve in the capacity of Director of a moderate complexity clinical laboratory without being qualified as a Clinical Laboratory Director under OAR 333-024-0022 (Qualifications and Responsibilities for Director of Moderate Complexity Laboratories)and

(d) For any person other than a physician or clinician to direct or perform microscopic procedures listed in OAR 333-024-0016 (Licensure Categories)(1)(b) in a Physician Performed Microscopy Laboratory.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.