Or. Admin. R. 333-024-0340 - External Quality Control (Proficiency Testing Program and On-Site Inspections)

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Licensed SOA laboratories shall:
(a) At the laboratory's own expense, be required to participate satisfactorily in the proficiency testing programs of the College of American Pathologists, or the American Association of Bioanalysts, or such other substantially equivalent testing program as may be approved by the Division involving substances of abuse testing and make available to the Division all test results;
(b) Be required to participate satisfactorily if required in the proficiency testing programs conducted by the Division involving substances of abuse testing;
(c) Analyze test samples submitted by the Division prior to, during, or subsequent to inspection if requested to the Division;
(d) Achieve satisfactory results on test samples in agreement with reference laboratories or within stated acceptable limits and which results shall be reviewed by the Division. Continued or consistent failure two out of three periods may result in the laboratory's license being withdrawn by the Division until satisfactory performance is demonstrated; and
(e) Ensure that proficiency samples are tested by regularly assigned personnel using routine methods. A specified time shall be allowed for such testing and reporting of results.
(2) Biennial on-site inspections may be conducted by representatives of the Division at reasonable times during the laboratory's normal business hours without advance notice. The representative shall inspect the facilities, personnel policies, procedures, materials, staff qualifications, equipment and records.
(3) The owner or director of an SOA laboratory may be required to submit reports on the operations and procedures of the laboratory.
(4) Additional inspections may be performed without notice to verify correction of deficiencies, investigate complaints, review unsatisfactory proficiency testing and verify personnel qualifications or other monitoring of compliance with OAR 333-024-0305 through 333-024-0350.

Notes

Or. Admin. R. 333-024-0340
HD 28-1988, f. & cert. ef. 12-7-88; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; HD 13-1997, f. & cert. ef. 10-16-97

Stat. Auth.: ORS 438.320 & 438.435

Stats. Implemented: ORS 438.320 & 438.435

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