Question: Are laboratories allowed by CMS to use temporary testing sites for remote review and reporting of laboratory data?

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
Can laboratories use specimen collection devices other than those listed in the manufacturer’s instructions or EUA (e.g., swabs) for SARS-CoV-2 testing?
section_content: According to FDA, when one entity establishes equivalent performance between
parallel testing of the same specimens with the new and original components
(including viral transport media [VTM]), and FDA’s review of the validation
data indicates that it could be applicable to modifications of other tests
with an authorized EUA, FDA will post this information on its website so that
other laboratories can refer to the validation for their testing. Then, other
laboratories do not need to conduct their own bridging study for the same
modification. For additional information regarding FDA’s policy for
modification, see FDA’s frequently asked questionsexternal
icon website.

Reviewer feedback on this answer:
Refers to cross-validation of testing. Doesn't discuss temporary testing sites.
The answer tangentially relates to testing and including validation and review of testing methods which may or may not be in play in a temporary testing site. However, it does not say anything about CMS allowing temporary testing sites.

Reviewer ratings:
Bad
Could be Improved

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
Are pathologists able to sign out cases remotely during the COVID-19 public health emergency?
section_content: CMS has indicated that it will allow laboratories to use temporary testing
sites for remote review and reporting of laboratory data, slides, and images
if specific criteria are met. Please refer to this CMS Memorandumexternal
icon for additional information.

Reviewer feedback on this answer:
Clearly says that temporary testing sites are acceptable. Fully on-topic.
Within the first line the answer is given that yes, CMS will allow labs to use temporary testing sites for remote review and reporting of data. There is also a link given with additional information.

Reviewer ratings:
Excellent
Excellent

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
Can a pooling strategy be used to expand nucleic acid testing for SARS-CoV-2?
section_content: In areas with low COVID-19 prevalence, a two-stage specimen pooling approach
can help preserve testing reagents and resources. In the first stage, several
patients’ specimens are combined before extraction, and then tested all at
once. If the test comes back negative, then all of those patients can be
cleared with one test. If the test comes back positive, then all of those
specimens need to be extracted and re-tested individually.
The lower the prevalence of the disease, the larger the optimal pool size can
be. A recent studyexternal
icon from the
Nebraska Public Health Laboratory found that polymerase chain reaction (PCR)
tests for SARS-CoV-2 reliably return a positive result when one positive
sample is mixed with four negatives. Researchers in Germany and Israel have
had similar results.
A pooling strategy is not efficient when the prevalence of COVID-19 is
high. People with symptoms and people who have been exposed to someone with a
confirmed SARS-CoV-2 infection should still be tested individually.
Before using a pooling strategy, the laboratory must have the proper
regulatory approvals. If the manufacturer’s guidelines and the emergency use
authorization (EUA) for that SARS-CoV-2 test do not stipulate pooling,
laboratories that use authorized nucleic acid devices can still bridge to
alternative components, including extraction methods, PCR instruments,
software versions, etc., under Section IV. A. 4. of FDA’s Policy for COVID-19
Tests During the Public Health Emergencyexternal
icon. These component changes can be achieved through evaluation
and verification of the performance of the component with the test, without a
new EUA or an amendment to the original EUA. Additional detail and suggested
studies are discussed in FDA’s policy. The process used for such changes must
also comply with Clinical Laboratory Improvement Amendments
(CLIA) guidelines.

Reviewer feedback on this answer:
Answer relates to "pooling" strategies and says nothing about temporary testing sites which is what is in question.
Focuses on pooling test samples. Doesn't mention temporary testing sites.

Reviewer ratings:
Bad
Bad