Waived laboratories: are 'waived' from personnel requirements, proficiency testing and routine on-site inspections; shall follow manufacturer's instructions for test performance; and perform only those tests categorized as Waived for CLIA laboratories.

To Apply for a Certificate of Waiver

• Laboratories NOT located in Oregon: Link here to find your State Agency & mail forms there (pdf)
• Information regarding fees and submission of application (pdf)
• CLIA CMS-116 application form (pdf)
• Waived tests performed (pdf) 
• Approved waived test list - FDA cleared waived test list, inter-active document
• Tests Granted Waived Status under CLIA (pdf) - CMS/CLIA web document

Waived laboratory regulations and guidance

• CDC booklet 'Ready? Set? TEST!" (pdf) describes recommended practices for Certificate of Waiver laboratories
• Synopsis of CLIA regulations for waived laboratories (pdf)
• Clinical laboratory laws
• Oregon laboratory - requirements

Form to Notify Oregon's CLIA Office of changes affecting your CLIA Lab

• Notification Form

Free software to view, navigate and print Portable Document files (PDFs) can be downloaded from Adobe (go get Acrobat Reader)