2020 04 14 ACIL Clinical Laboratory Improvement Amendments CLIA Certification Process Webinar

ACIL Clinical Laboratory Improvement Amendments (CLIA) Certification Process Webinar
Presented by Carlyn Brecht, A2LA Accreditation Officer
Learning Objectives:
 Briefly discuss COVID-19 testing and CLIA
 Briefly discuss the main differences between ISO/IEC 17025 and CLIA
 Discuss the application and accreditation process for CLIA
As part of its continued service to our member community, ACIL began FDA outreach early last month to offer the assistance of our laboratories with the national expansion of Covid-19 testing. As a result of those communications, ACIL undertook an informal survey of our Food Sciences laboratories (labs identified as holding the required Biosafety level and PCR units to conduct complex virus testing) to understand potential capacity for testing.
The result of that survey indicated that the responding laboratories possess approximately 179 PCRs with the capacity to run up to 40,000 tests per day. Our FSS Chair subsequently raised the issue of a required Clinical Laboratory Improvement Amendments (CLIA) certification necessary for labs conducting virus testing. Since many of our laboratories may not have this certification, A2LA has stepped up to provide us with more background on the CLIA certification process. Please join us for this informative webinar to explore your options for expanding your laboratory's certification and capabilities during this unprecedented time in our nation's history.
In response to the global pandemic, the demand for COVID-19 testing has increased. In order for a laboratory to perform COVD-19 testing, a laboratory must obtain a CLIA certificate through a Certificate of Compliance or a Certificate of Accreditation. During the course of this webinar, Carolyn Brecht of A2LA will provide a brief discussion about the main differences between ISO/IEC 17025 and CLIA as well as discuss the application and accreditation process for CLIA. During the discussion of the application and accreditation process for CLIA, A2LA will be discussing how to apply through CMS as well as the complete application process to receive A2LA accreditation.

[@myshisaiah]

How do you complete a wavier for a home health agency who wants to offer COVID testing and send it off to a laboratory for the results

[@sonilal2144]

Please stop drinking or eating in between the video. It is very annoying and diverting.

[@latrinakingsby]

So I have my Clia number, what’s the website to get accreditation?