(1) The Department of Human Services 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 department shall issue and renew licenses required under ORS 438.040 for any or all clinical laboratory specialties to the owners of clinical laboratories who demonstrate to the satisfaction of the department that:
(a) The clinical laboratory is in compliance with ORS 438.010 to 438.510 and the rules of the department adopted under ORS 438.450;
(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 department by rule may require; and
(d) The clinical laboratory meets the standards of the department 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]
Section: Previous 438.010 438.030 438.040 438.050 438.055 438.060 438.070 438.110 438.120 438.130 438.140 438.150 438.160 438.210 438.220 NextLast modified: August 7, 2008