OAR 333-024-0315
Testing for Substances of Abuse: Licensure

(1)

It shall be unlawful:

(a)

For any owner or director of a SOA or a clinical laboratory to perform medical or automated non-medical SOA screening tests without a license issued under this rule unless they have been certified for that testing under the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, 42.U.S.C. 201 and 263a;

(b)

For any person to serve in the capacity of director of an SOA screening laboratory without being qualified as a laboratory director under OAR 333-024-0320 (Testing for Substances of Abuse: Qualifications and Responsibilities of Directors)(1).

(2)

OAR 333-024-0305 (Testing for Substances of Abuse: Purpose and Scope) through 333-024-0350 (Testing for Substances of Abuse: Equipment and Facilities) apply to all SOA screening laboratories and laboratory personnel within the State of Oregon, except:

(a)

Laboratories screening for SOA operated by the United States Government;

(b)

Laboratories screening for SOA operated and maintained solely for research or teaching purposes, and that involve no direct patient or public health services;

(c)

State Police laboratories screening for SOA as a part of the criminal justice system;

(d)

Special category laboratories operated by state or local correctional agencies to monitor inmates and offenders on parole, probation, or post-prison supervision. These special category laboratories must follow the provisions of OAR 333-024-0360 (Testing for Substances of Abuse: Special Category Laboratories).

(3)

The Division shall issue and renew licenses to the owners of laboratories screening for SOA who demonstrate to the satisfaction of the Division that:

(a)

The SOA laboratory is in compliance with ORS 438.435 (Testing for substance of abuse);

(b)

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

(c)

The SOA laboratory meets the standards of the Division for safety, sanitary conditions, plumbing, ventilation, handling of specimens, maintenance of equipment and requirements of general hygiene to ensure protection of the public health.

(4)

Requirements for license application; fees, exemptions, expiration; and renewal are as follows:

(a)

The application for a license for an SOA screening laboratory shall be made on forms provided by the Division and shall be executed by the owner or one of the owners or by an officer of the firm or corporation owning the laboratory, or in the case of a county or municipality, by the public official responsible for operation of the SOA laboratory, or in the case of an institution, by the administrator of the institution. The application shall contain the names of the owner, the director or directors of the laboratory, the location and physical description of the SOA laboratory, and such other information as the Division may require;

(b)

Laboratories must pay an annual or biennial, non-refundable license fee, prior to issuance of a license, as described in OAR 333-024-0012 (Licensure)(5)(c);

(c)

A laboratory certified in toxicology for medical substance of abuse testing under the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 — Laboratory Requirements, may also perform that testing for non-medical purposes. No separate substance of abuse screening license or registry is required;

(d)

Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one or two year cycle following the date of issuance and shall be renewable in the manner prescribed by the Division;

(e)

All monies received by the Division for the licensure of SOA screening laboratories shall be credited to the Division account and shall be used for payment of the expenses of the Division in administering OAR 333-024-0005 (Purpose) through 333-024-0350 (Testing for Substances of Abuse: Equipment and Facilities).

(5)

A license issued to the owner of an SOA screening laboratory shall show on its face the names of the owners and directors, the location of the laboratory and the laboratory specialty authorized under the license. The license shall be displayed at all times in a prominent place in the laboratory.

(6)

A license issued to the owner of an SOA screening laboratory is not transferable. The license of the SOA laboratory is voided 30 days after a change of its director if it has only one director or if all directors change or a change in the ownership or in the location of the laboratory. In the case of death of a director, the Division shall be notified within five working days. The laboratory shall have 30 days to obtain another qualified director.

(7)

Subject to ORS 183.310 (Definitions for chapter) to 183.550, the Division may refuse to issue or renew the license or may suspend or revoke the license of any SOA laboratory, if it finds that the owner or director has:

(a)

Intentionally made false statements on an application for an SOA laboratory license or any other documents required by the Division, or made any misrepresentation in seeking to obtain or retain a license;

(b)

Demonstrated incompetence as defined in OAR 333-024-0325 (Testing for Substances of Abuse: Incompetence);

(c)

Intentionally falsified any report;

(d)

Referred a specimen, for examination, to an unlicenced clinical or SOA laboratory in this state, or a laboratory out of state not certified by the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 — Laboratory Requirements, or an equivalent out of state laboratory, unless the laboratory is exempt under section (2) of this rule;

(e)

Misrepresented the scope of laboratory service offered by the SOA laboratory or the laboratory specialty authorized by the license;

(f)

Rendered a substances of abuse report performed in another laboratory without designating the name and address of the laboratory in which the test was performed;

(g)

Knowingly had professional connection with or permitted the use of the name of the licensed laboratory or its director by a laboratory which is required to but has not obtained a license;

(h)

Failed to perform or cause to be performed within the time specified, analysis of test samples as stated in OAR 333-024-0340 (Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections)) or failed to report on the results of such analysis within the specified time;

(i)

Failed to permit within a reasonable time the entry or inspection as stated in OAR 333-024-0340 (Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections))(2) and (4);

(j)

Failed to continue to meet the requirements of this rule, inclusive; and

(k)

Violated any provision of OAR 333-024-0305 (Testing for Substances of Abuse: Purpose and Scope) through 333-024-0350 (Testing for Substances of Abuse: Equipment and Facilities).

(8)

Owner shall be responsible for all aspects of the laboratory.

(9)

The substance of abuse screening laboratory must be in compliance with requirements of the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 — Laboratory Requirements, if medical testing for substances of abuse is performed.

(10)

Entities performing only manual, non-automated SOA screens using easily portable screening tests must register with the Division and meet the requirements at OAR 333-024-0365 (Testing for Substances of Abuse: Substance of Abuse Registration).

(11)

Licensed clinical laboratories or SOA screening laboratories performing a combination of medical and manual, non-medical SOA screens are not required to register with the Division and must meet the requirements of OAR 333-024-0365 (Testing for Substances of Abuse: Substance of Abuse Registration)(5)(e) when performing tests which qualify for SOA registration.

(12)

Licensed clinical laboratories performing only manual, non-medical SOA screens using easily portable screening tests must register with the Division and meet the requirements of OAR 333-024-0365 (Testing for Substances of Abuse: Substance of Abuse Registration).

(13)

Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 — Laboratory Requirements, that perform medical and non-medical substance of abuse screening, must comply with 333-024-0305 (Testing for Substances of Abuse: Purpose and Scope) through 333-024-0350 (Testing for Substances of Abuse: Equipment and Facilities) and 333-024-0365 (Testing for Substances of Abuse: Substance of Abuse Registration)(5)(e).
[Publications: Publications referenced are available from the agency.]

Source: Rule 333-024-0315 — Testing for Substances of Abuse: Licensure, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0315.

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 333-024-0315’s source at or​.us