(1) In addition to the license of a clinical laboratory required by ORS 438.040, the Department of Human Services may issue a temporary permit valid for a period, to be determined by the department, 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).
(2) In issuing the temporary permit, the department may require that:
(a) Plans for compliance with applicable laws and rules be submitted with the application for the temporary permit;
(b) During the period in which the temporary permit is in effect periodic reports be submitted on the progress of the plans for compliance; and
(c) Special temporary provisions specified by the department upon application of the temporary permit be maintained for the protection of the public.
(3) If at any time the department 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 department shall cancel the temporary permit.
(4) One renewal of the temporary permit may be granted if deemed to be in the best interest of public health by the department. The fee for renewal is the respective required fee as described in ORS 438.130 (2).
(5) The department may issue permits for health screen testing.
(6) The department by rule shall specify:
(a) Appropriate quality assurance procedures;
(b) Personnel qualifications;
(c) Standards for counseling and referral of persons being tested;
(d) Tests a health testing service may conduct;
(e) The procedure for applying for a permit; and
(f) The procedure for reporting to the department the location of all health screening facilities.
(7) The department by rule may specify the maximum length of time a health screen testing service may remain in one location. [1969 c.685 §9; 1989 c.776 §2; 2007 c.71 §122]
Section: Previous 438.055 438.060 438.070 438.110 438.120 438.130 438.140 438.150 438.160 438.210 438.220 438.310 438.320 438.410 438.420 NextLast modified: August 7, 2008