ORS 438.320 Laboratory evaluation system; rules; quality control systems

The Oregon Health Authority shall institute a laboratory evaluation system, as defined in ORS 438.010, and shall make such rules as are

necessary to insure quality control of laboratory work.

As part of this system, the authority may require each laboratory to:

Participate in on-site inspection and testing;

Analyze test samples submitted by the authority prior to, during or subsequent to the inspection; and

Contract with, at the laboratory’s own expense, an authority-approved source of test samples for such test samples to be submitted periodically to the laboratory and to be returned to that source for grading after testing. The test results shall be made available to the authority.

The procedures under subsection (2) of this section shall be referred to as external quality control. The samples are to be tested by regularly assigned personnel using routine methods. The test samples shall be confined to the specialty of the laboratory as indicated on the license. A specified time shall be allowed for such testing and reporting of the results and shall be the time required under conditions of normal operation.

In addition to external quality control, each clinical laboratory shall establish an internal laboratory quality control system pursuant to rules of the authority including but not necessarily limited to the testing of reference or control sera and other biological samples, verifying concurrent calibration standards and control charts recordings, and reporting on its control system as required by the authority.