Laboratories

ORS 438.110
Standards for issuance and renewal of laboratory license


(1)

The Oregon Health Authority shall establish four levels of laboratory licenses as follows:

(a)

A high complexity laboratory license;

(b)

A moderate complexity laboratory license;

(c)

A physician performed microscopy laboratory license; and

(d)

A waived laboratory license.

(2)

The authority shall issue and renew licenses required under ORS 438.040 (Laboratory license) for any or all clinical laboratory specialties to the owners of clinical laboratories who demonstrate to the satisfaction of the authority that:

(a)

The clinical laboratory is in compliance with ORS 438.010 (Definitions for ORS 438.010 to 438.510) to 438.510 (Prohibited acts) and the rules of the authority adopted under ORS 438.450 (Rules);

(b)

The laboratory is adequately equipped to perform proficiently within the scope of its license;

(c)

The clinical laboratory has facilities for retaining and does retain complete laboratory records for an appropriate length of time as the authority by rule may require; and

(d)

The clinical laboratory meets the standards of the authority for safety, sanitary conditions, plumbing, ventilation, handling of specimens, maintenance of equipment and requirements of general hygiene to insure protection of the public health. [1969 c.685 §5; 1971 c.650 §18; 1993 c.109 §5; 1999 c.341 §3; 2001 c.104 §171; 2009 c.595 §701]

Source

Last accessed
Jun. 26, 2021