OAR 333-024-0012: Certification

(1) It shall be unlawful: (a) For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a certificate 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 certified, unless the laboratory has been issued a valid certificate from the federal government under the Clinical Laboratory Improvement Amendments (CLIA) 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; (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; and (d) For any person other than a physician or clinician to direct or perform microscopic procedures listed in OAR 333-024-0016(1)(b) in a physician performed microscopy laboratory. (2) OAR 333-024-0005 through 333-024-0055 and OAR 333-024-0260 and OAR 333-024-0265 apply to all clinical laboratories and laboratory personnel within the State of Oregon, except: (a) Clinical laboratories operated by the United States government; or (b) Clinical laboratories operated and maintained purely for research or teaching purposes, and that involve no patient or public health services. (3) It shall be unlawful for an out-of-state laboratory to perform health screen testing in Oregon without a permit issued as provided in OAR 333-024-0380. (4) The Public Health Division (Division) shall facilitate the issuance and facilitate the renewal of waived, physician performed microscopy, moderate and high complexity certificates for any or all clinical laboratory specialties to the owners of clinical laboratories who demonstrate to the satisfaction of the Division that: (a) The clinical laboratory is in compliance with the Clinical Laboratory Improvement Amendments of 1988 (P.L 100-578, 42 U.S.C 201 and 263a) and OAR 333-024-0005 through 333-024-0055, OAR 333-024-0260, OAR 333-024-0265, OAR 333-024-0305 through 333-024-0360 and OAR 333-024-0370 through 333-024-0400; (b) The laboratory is equipped to perform within the scope of its certificate; (c) The clinical laboratory retains complete laboratory records as stated in OAR 333-024-0050; and (d) The clinical laboratory meets the standards of the Division for safety, disposal of hazardous and infectious waste, ventilation, handling of specimens, and maintenance of equipment to ensure protection of the public health. (5) Subject to ORS 183.160 and ORS 183.310 to 186.450, the Division may refuse to facilitate the issuance or facilitate the renewal of the certificate or may suspend or revoke the certificate of any clinical laboratory, if it finds that the owner or director has: (a) Intentionally made false statements on an application for a clinical laboratory certificate or any other documents required by the Division, or made any misrepresentation in seeking to obtain or retain a certificate; (b) Demonstrated incompetence as defined in OAR 333-024-0055; (c) Intentionally falsified any report; (d) Referred a specimen for examination to a clinical laboratory not certified or accredited under the provisions of ORS 438.040, or other authorized CLIA exempt state laboratory certification program; (e) Misrepresented the scope of laboratory service offered by the clinical laboratory or the clinical laboratory specialties authorized by the certificate; (f) Rendered a report on clinical laboratory work actually performed in another clinical laboratory without designating the name and address of the clinical laboratory in which the test was performed; (g) Knowingly had professional connection with or permitted the use of the name of the certified clinical laboratory or its director by a clinical laboratory that is required to but has not obtained a certificate; (h) Failed to perform or cause to be performed within the time specified analysis of test samples as stated in OAR 333-024-0040(1) or failed to report on the results of such analysis within the specified time; (i) Failed to permit within a reasonable time the entry or inspection as stated in OAR 333-024-0040(4), (6), (7), (9), (10), (11) and (12); (j) Failed to continue to meet requirements of this rule, inclusive; (k) Violated any provision of OAR 333-024-0005 through 333-024-0055 and OAR 333-024-0260 and OAR 333-024-0265. (6) The owner or director must notify the Division within 30 days of a change of laboratory name and technical supervisor. [Publications: Publications referenced are available from the agency.]