OAR 333-024-0320
Testing for Substances of Abuse: 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 (Testing for substance of abuse)(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 (Testing for Substances of Abuse: Qualifications and Responsibilities of Directors)(1)(g) must have applied to the Division by January 1, 1989.

Source: Rule 333-024-0320 — Testing for Substances of Abuse: Qualifications and Responsibilities of Directors, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0320.

333‑024‑0005
Purpose 333‑024‑0010
Definitions 333‑024‑0012
Licensure 333‑024‑0016
Licensure Categories 333‑024‑0020
Licensure for Performance of Laboratory Specialties 333‑024‑0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333‑024‑0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333‑024‑0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333‑024‑0026
Equipment and Facilities 333‑024‑0035
Internal Quality Control for Moderate and High Complexity Laboratories 333‑024‑0037
Specialty and Subspecialty Quality Control 333‑024‑0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333‑024‑0043
Quality Assurance 333‑024‑0045
Venereal Disease Testing 333‑024‑0050
Records and Reports 333‑024‑0053
Accreditation Organizations and Accredited Laboratories 333‑024‑0055
Incompetence 333‑024‑0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333‑024‑0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333‑024‑0305
Testing for Substances of Abuse: Purpose and Scope 333‑024‑0310
Testing for Substances of Abuse: Definitions 333‑024‑0315
Testing for Substances of Abuse: Licensure 333‑024‑0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333‑024‑0325
Testing for Substances of Abuse: Incompetence 333‑024‑0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333‑024‑0335
Testing for Substances of Abuse: Internal Quality Assurance 333‑024‑0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333‑024‑0345
Testing for Substances of Abuse: Confirmatory Testing 333‑024‑0350
Testing for Substances of Abuse: Equipment and Facilities 333‑024‑0360
Testing for Substances of Abuse: Special Category Laboratories 333‑024‑0365
Testing for Substances of Abuse: Substance of Abuse Registration 333‑024‑0370
Health Screen Testing: Purpose 333‑024‑0375
Health Screen Testing: Definitions 333‑024‑0380
Health Screen Testing: Permits 333‑024‑0385
Health Screen Testing: Testing Site Schedule 333‑024‑0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333‑024‑0395
Health Screen Testing: Tests Performed 333‑024‑0400
Health Screen Testing: Quality Assurance 333‑024‑1000
Newborn Screening: Purpose 333‑024‑1010
Newborn Screening: Definitions 333‑024‑1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333‑024‑1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333‑024‑1030
Newborn Screening: Timing for Collecting Specimens 333‑024‑1040
Newborn Screening: Manner of Submitting Specimens 333‑024‑1050
Newborn Screening: Religious Exemption from Newborn Testing 333‑024‑1060
Newborn Screening: Improperly Collected Specimens 333‑024‑1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333‑024‑1080
Newborn Screening: Result Reporting and Follow-up 333‑024‑1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333‑024‑1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333‑024‑1110
Newborn Screening: Failure to Comply 333‑024‑2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0320’s source at or​.us