Certificate of Waiver

Application Information and Resources: Waived Laboratories

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.

Please don’t send hard copies following a fax or email of a lab form. Double forms can cause duplication and extra work. You can verify receipt of your forms by calling 503-693-4125 or by e-mailing LC.info@odhsoha.oregon.gov.

To Apply for a Certificate of Waiver

• Labs NOT located in Oregon: Find your state agency and mail forms to them (pdf)
• Information regarding submission of application (pdf)
• CLIA CMS-116 application form (pdf)
  
• You can now pay your CLIA Fees online
• Pay CLIA Fees thru mail (pdf)
• Waived tests performed (pdf)
• Approved waived test list - FDA cleared waived test list, inter-active document
  

Waived Laboratory Regulations and Guidance

• Recommended practices publications and training for Certificate of Waiver laboratories
• Synopsis of CLIA regulations for waived laboratories (pdf)
• Clinical laboratory laws
• Oregon Laboratory Requirements
• Safety in the Laboratory

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