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COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our COLA laboratories and affiliates. Below are links to the most recent messages about the new CMS Laboratory Quick Start Guide for CMS CLIA Certification, new CSTE Electronic Laboratory Reporting points of contact for COVID-19, and FDA SARS-CoV-2 Reference Panel Comparative Data updates.
CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification
The Centers for Medicare & Medicaid Services (CMS) has released a new Laboratory Quick Start Guide for CMS CLIA Certification. This resource outlines the necessary steps laboratories and testing sites must take in order to receive federal government certification to perform testing on human specimens. Any entity that performs tests for the purpose of providing information about the assessment or impairment of the health of human beings or the diagnosis, prevention or treatment of any disease is considered to be a laboratory under the Clinical Laboratory Improvement Amendments (CLIA) and must be certified by the CLIA program.
CSTE Posts New Electronic Laboratory Reporting Points of Contact for COVID-19
On Tuesday, September 29, 2020, the Council of State and Territorial Epidemiologists (CSTE) posted Electronic Laboratory Reporting (ELR) points of contact. This page lists the appropriate ELR contacts for each jurisdiction so that laboratories and other reporting facilities can connect with health department staff regarding ELR onboarding requests and issues.
FDA Updates the SARS-CoV-2 Reference Panel Comparative Data
On Tuesday, September 29, 2020, the U.S. Food and Drug Administration (FDA) updated its SARS-CoV-2 Reference Panel Comparative Data. Users can view a table that shows the sensitivity mean estimates of the EUA-authorized SARS-CoV-2 molecular diagnostic tests using the FDA SARS- CoV-2 reference panel.
