REGULATORY
CDPH
CLIA and Covid 19 Testing - serological or RT-PCR (molecular) testing need to have CLIA certification as well as a California clinical lab license
CDPH
Testing personnel performing high-complexity SARS-CoV-2 tests must meet CLIA requirements for high-complexity testing personnel as set out in
42 CFR 493.1489
CDPH
Positive test results must be reported, within one hour, to the
local health officer for the jurisdiction where the patient resides, by telephone and through the Electronic Laboratory Reporting system (ELR:
CDPH
Coronavirus Disease 2019 (COVID-19) Mitigation Plan Recommendations for Testing of Health Care Personnel (HCP) and Residents at Skilled Nursing Facilities (SNF)
CMS
OPENING UP AMERICA AGAIN
Centers for Medicare & Medicaid Services (CMS) Recommendations
Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I
CDC
CDC provides guidance on how the specimens can be
handled/shipped (including preparing viral transport medium (VTM):
CDC
For those who are involved directly with the suspected COVID-19 patients, they need to follow these rules:
CDC
For those who are not involved directly with such patients but
handling the specimens for analysis, they need to follow standard precautions (e.g. hand hygiene and the use of personal protective equipment
(PPE) such as laboratory coats or gowns, gloves, and eye protection). More
CDC
Packing/shipping of the specimens are subject to the International Air Transport Association (IATA) regulations (suspected or confirmed
SARS-CoV-2 patient specimens are UN 3373 Biological Substance, Category B):
