Current through Register Vol. 61, No. 4, April 1, 2022
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
(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laboratory's license being withdrawn by the Division until satisfactory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.
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
Or. Admin. R.
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.
Stat. Auth.: ORS 438.320 & 438.435
Stats. Implemented: ORS 438.320 &