Question: How does a laboratory obtain CLIA certification for COVID-19 testing?

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Biosafety and COVID-19
section_headers: Specimen Handling
How should the laboratory perform a risk assessment to identify and mitigate risks?
section_content: All laboratories should perform a site-specific and activity-specific risk
assessment to identify and mitigate risks and determine if enhanced biosafety
precautions are warranted based on situational needs, such as high testing
volumes, and the likelihood to generate infectious droplets and aerosols. Risk
assessments and mitigation measures are dependent on the procedures performed,
identification of the hazards involved in the process and/or procedures, the
competency level of the personnel who perform the procedures, the laboratory
equipment and facility, and the resources available.
The risk assessment should identify all potential scenarios of a particular
activity that could produce a negative outcome. The risk assessment should
prioritize those potential negative outcomes, or risks, based on an evaluation
of the likelihood and consequences of each of those identified risks. The risk
assessment should determine the most appropriate control measures, and how the
system will measure the effectiveness of those control measures.
For additional information, refer to the following:

Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV)pdf iconexternal icon
Risk Assessment Best Practicespdf iconexternal icon
World Health Organization Laboratory Biosafety Manual, 3rdpdf iconexternal icon


Reviewer feedback on this answer:
Discusses lab biosafety but doesn't explicitly address CLIA certification.
This answer does not answer the question nor is it on topic for the question.

Reviewer ratings:
Bad
Bad

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
My facility would like to begin SARS-CoV-2 testing. Do we need a Clinical Laboratory Improvement Amendments (CLIA) certificate? Can my facility be granted a waiver from the CLIA certification requirements so that I can begin testing immediately?
section_content: Before conducting SARS-CoV-2 viral testing, a laboratory must be CLIA-
certified and meet applicable regulatory requirements. The Centers for
Medicare and Medicaid Services (CMS) does not have the authority to grant
waivers of exceptions that are not established in a statute or regulation. For
additional information, please refer to the FAQs on the CMS website: CMS
Coronavirus Informationexternal icon.

Reviewer feedback on this answer:
Doesn't list the steps for obtaining CLIA certification, but does provide a link to them.
The answer does not give information on how to obtain CLIA certification.

Reviewer ratings:
Acceptable
Bad

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
How do I apply for a CLIA certificate so that my testing facility can perform SARS-CoV-2 testing?
section_content: The federal CLIA program contracts with states to carry out certain oversight
and recording functions of the CLIA program. The state in which the laboratory
is located processes applications for CLIA certificates. After the laboratory
has identified a qualified and certified laboratory directorexternal
icon and has
provided all required information on the CMS-116 application, a CLIA number
will be assigned and the laboratory can begin testing if applicable CLIA
requirements have been met. For additional information, please refer to the
FAQs on the CMS website: CMS Coronavirus Informationexternal
icon.

Reviewer feedback on this answer:
Gives a high-level overview of the certification process and links to detailed instructions.
This answer gives a vague understanding of the process in which labs can obtain CLIA certificates, while not helping labs understand how they can obtain it.

Reviewer ratings:
Excellent
Could be Improved