ORS 438.150 Temporary permit; fees; health screen testing permit; conditions and limitations; rules

In addition to the license of a clinical laboratory required by ORS 438.040, the Oregon Health Authority may issue a temporary permit valid for a period, to be determined by the authority, from the date of issuance in any or all clinical laboratory specialties upon payment of the respective required fees as described in ORS 438.130 (2).

In issuing the temporary permit, the authority may require that:

Plans for compliance with applicable laws and rules be submitted with the application for the temporary permit;

During the period in which the temporary permit is in effect periodic reports be submitted on the progress of the plans for compliance; and

Special temporary provisions specified by the authority upon application of the temporary permit be maintained for the protection of the public.

If at any time the authority determines that the clinical laboratory can no longer operate in a manner that protects the public health and safety or that the requirements imposed under subsection (2) of this section are not being maintained, the authority shall cancel the temporary permit.

One renewal of the temporary permit may be granted if deemed to be in the best interest of public health by the authority. The fee for renewal is the respective required fee as described in ORS 438.130 (2).

The authority may issue permits for health screen testing.

The authority by rule shall specify:

Appropriate quality assurance procedures;

Personnel qualifications;

Standards for counseling and referral of persons being tested;

Tests a health testing service may conduct;

The procedure for applying for a permit; and

The procedure for reporting to the authority the location of all health screening facilities.

The authority by rule may specify the maximum length of time a health screen testing service may remain in one location.