SOA Registration

Testing for Non-medical Substances of Abuse (SOA)

An 'SOA Registration' entity is one that:

1. Performs SOA screening tests on-site using easily portable, simple hand-held manual methods; and
2. Uses screening tests for non-medical purposes only, including but not limited to employment, pre-employment, screening of students, testing for insurance eligibility or eligibility for plasmapheresis.

OAR 333-024-0365(1) states, "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 Public Health Division (the "Division") of the Oregon Health Authority (OHA) and payment of the registration fee..."

CMS/CLIA September 5, 2008 Letter
Guidance regarding the circumstances when laboratories performing drug or alcohol screening and/or testing must be CLIA certified (pdf)

To Apply for a New "SOA Registration" License

call the Laboratory Compliance Program 503-693-4125 to request a packet. We will ask you about your testing kit and/or kit manufacturer to ensure FDA Approval has been granted for your testing product.

• FDA's 510(k) searchable database of approved products to verify test product has FDA Approval
• Change Notification form (pdf) - Includes "Additional Testing Locations"
• Oregon Administrative Rule (OAR) governing "SOA Registration" testing (pdf)
• Synopsis of the Administrative Rule for "SOA Registration" entities (pdf)
• Ordering and Reporting Non-medical SOA Tests (pdf)
• Conforming Products List of Alcohol Screening Devices (external link)
  

Oregon Laws for Substance of Abuse Medical or Non-Medical Testing using Automated Methods

• Oregon Revised Statute (ORS) pertaining to medical and non-medical SOA testing (pdf)
• Full OAR for SOA testing in Oregon (pdf)
• SOA Laboratory Flow Chart (pdf)

Exceptions to the SOA Registration Requirement

Oregon law provides exceptions to the SOA Registration requirement. If you qualify for at least one of the following exceptions you need not apply for an SOA Registration:

1. Your lab has "Toxicology" listed on your Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance or Certificate of Accreditation (OAR 333-024-0315(4)(c); OR
2. Your lab is performing a combination of medical SOA testing and manual non-medical SOA screens. This implies you have a current CLIA Certificate for your medical SOA testing (OAR 333-024-0315(11).