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): 
 

FDA

FDA FAQs on Testing for SARs-CoV-2 (Covid-19 Testing)  

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FDA

FDA’s stand on Serology testing  

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