OAR 333-024-0365
Testing for Substances of Abuse: Substance of Abuse Registration

(1)

It shall be unlawful for any entity to perform any on-site test for non-medical substance of abuse screening tests prior to filing a registration form with the Division and payment of the registration fee, except laboratories:

(a)

Owned and operated by the U.S. Government;

(b)

Performing pure research;

(c)

Performing substance of abuse tests for forensic purposes only;

(d)

Performing substance of abuse tests from autopsy specimens;

(e)

Identified as teaching facilities only training students in test performance;

(f)

Owned and operated by the Oregon State Police performing substance of abuse screens for forensic purposes.

(2)

SOA registration is not transferable to another entity.

(3)

It shall be unlawful for a registered substance of abuse entity to perform medical testing.

(4)

Clinical and SOA screening laboratories must meet the requirements under (5)(e) of this rule when performing tests which qualify for SOA registration.

(5)

Registration shall be on a form provided by the Division and shall contain:

(a)

The entity name and address;

(b)

Name of legal owner and tax identification number;

(c)

Telephone number;

(d)

Name of individual contact at each on-site facility operated by the entity; and

(e)

Signature of the operator certifying that:

(A)

Only SOA kits approved by the Food and Drug Administration (FDA) or alcohol screening tests that meet the requirements of the conforming products list found in the United States Department of Transportation National Highway Traffic Safety Administration Docket No. 94-004 and meet the standards of the United States Department of Transportation Alcohol Testing Procedure, 49 C.F.R. part 40, in effect on October 23, 1999, are used;

(B)

Tests are administered according to the manufacturer’s package insert;

(C)

Custody chain procedures are written and followed;

(D)

Operators of the SOA on-site screening facility are trained in the use of the SOA screening tests by the manufacturer; and

(E)

When the SOA on-site facility obtains a positive result on a specimen and the entity indicates that the test result is to be used to deny or deprive any person of employment or any benefit, or may otherwise result in adverse employment action, the same specimen shall be submitted to a clinical laboratory licensed under ORS 438.110 (Standards for issuance and renewal of laboratory license) or 438.150 (Temporary permit), or certified under the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, 42 .U.S.C. 201 and 263a for that testing, or an equivalent out of state laboratory and the presence of a substance of abuse confirmed, using a different analytical method, prior to the release of the on-site test result.

(6)

Evidence of registration with the Division shall be posted at the entity location shown on the registration form and at each on-site facility.

(7)

The annual fee for filing a registration form with the Division is $50 for each entity. The fee cycle shall be January 1 through December 31, beginning 1998.

(8)

All monies received by the Division for the registration of SOA entities shall be credited to the Division account and shall be used for payment of the expenses of the Division in administering OAR 333-024-0365 (Testing for Substances of Abuse: Substance of Abuse Registration).

(9)

A list of registered entities is available, upon request, from the Division.

(10)

SOA entities may examine specimens submitted by persons other than medical personnel and shall report the result of any SOA test to the person or company who requested the test except as indicated in number (11) of this rule.

(11)

A copy of the SOA test results must be provided to the employee or pre-employee from whom the specimen was collected, after the employee or pre-employee submits a written request and proof of identity to the registered SOA entity.

(a)

When a written request is given to the SOA entity in person:

(A)

The employee or pre-employee must present two proofs of identity to the registered SOA entity, which must include one of the following picture identification cards: state driver’s license, state identification card, passport or a resident alien card from the U.S. Department of Immigration and Naturalization Service.

(B)

The employee or pre-employee must sign and date a form for release of laboratory records.

(b)

When a written request for SOA test results is received by mail:

(A)

The request must be accompanied by a signed and dated form for release of laboratory test results and a notarized statement of the employee’s or pre-employee’s identity and mailing address.

(B)

The laboratory will make a copy of the pertinent SOA test results and send this copy by registered or certified mail, or other bonded courier that would assure the confidentiality of the results, to the address requested by the notarized statement.

(C)

A copy of the signed release form and picture identification or the notarized statement, shall be maintained by the registered SOA entity for two years.

Source: Rule 333-024-0365 — Testing for Substances of Abuse: Substance of Abuse Registration, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0365.

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 333-024-0365’s source at or​.us