Or. Admin. Code § 333-024-0320

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0320 - Qualifications and Responsibilities of Directors

(1) The director of a substances of abuse screening laboratory shall meet one of the following qualifications:

(a) Is a pathologist certified in clinical pathology by the American Board of Pathology, the American Osteopathic Board of Pathology, or is eligible for such certification;

(b) Is a physician with two or more years of clinical chemistry experience, with one year in toxicology;

(c) Has an earned degree of Doctor of Science (ScD), Doctor of Public Health (DrPH) or Doctor of Philosophy (PhD) in chemistry or biochemistry and has two or more years of clinical chemistry training or experience with one year in toxicology;

(d) Is certified or is eligible for certification by the American Board of Clinical Chemistry or by the American Board of Forensic Toxicology;

(e) Has an earned master of science degree in medical technology, chemistry, or biochemistry and has three or more years of clinical chemistry training or experience, with one year of pertinent experience in toxicology;

(f) Has a bachelor of science, bachelor of technology or bachelor of arts degree in medical technology, chemistry or biochemistry, and has four or more years of clinical chemistry training or experience, with one year experience in toxicology;

(g) Has directed substance of abuse screening for at least 12 months within the four years preceding January 1, 1987, and has at least two years of pertinent experience in toxicology.

(2) The director of an SOA screening laboratory shall be responsible for the quality of the work. This shall include, but not be limited to, the following:

(a) Monthly review and documentation of quality control data;

(b) Review and documentation of external proficiency testing within 30 days of receipt of the final report;

(c) Review and documentation of procedure manuals and relevant texts initially and also whenever there is a change in method or policy;

(d) Validation of new procedures prior to reporting test results;

(e) Review and documentation of preventive maintenance of equipment;

(f) Review of additional quality assurance items;

(g) Assure that qualified technical personnel perform the tests; and

(h) Assure the competency of all testing personnel annually.

(3) The director of an SOA screening laboratory shall require the submitter to indicate the need for confirmatory testing as described in ORS 438.435(6).

(4) A person shall not serve individually as director of more than five substances of abuse screening laboratories.

(5) Those individuals qualifying under 333-024-0320(1)(g) must have applied to the Division by January 1, 1989.

Or. Admin. Code § 333-024-0320

HD 28-1988, f. & cert. ef. 12-7-88; HD 5-1992, f. & cert. ef. 5-15-92; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; HD 13-1997, f. & cert. ef. 10-16-97

Stat. Auth.: ORS 438.050, 438.130, 438.435(4), 438.435(5) & 438.435(6)

Stats. Implemented: ORS 438.210, 438.220 & 438.435