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
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).
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