An 'SOA Registration' entity is one that:
1) Performs SOA screening tests on-site using easily portable simple hand-held manual methods; and
2) The screening tests are used for non-medical purposes only, including but not limited to employment, pre-employment, screening of students, testing for insurance eligibility or eligibility for plasmapheresis.
333-024-0365(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 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
Please be aware that the 2014 SOA Registration re-licensure form has changed. This change was developed to reduce submission errors and increase efficiencies making the best use of resources.
- Each laboratory will receive their new form showing the most recent information on file, as submitted by the lab.
- The lab reviews the information, and if needed notes any changes or additions on the lines provided.
- The lab then completes the remainder of the form, submitting as usual.
- All Current/Open SOA Registration labs will have their form mailed to them on or before November 15, 2013.
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.
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).
Free software to view, navigate and print Portable Document files (PDFs) can be downloaded from Adobe (go get Acrobat Reader)