Saturday, September 19, 2020
Centers for Medicare and Medicaid Services Responds to Blaine COVID Response Testing Controversy
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Gail Severn has enlisted the sculptures outside her gallery in the fight to stop the spread of coronavirus.
   
Tuesday, August 25, 2020
 

BY KAREN BOSSICK

The Centers for Medicare & Medicaid Services (CMS) recently prepared a written statement for Eye on Sun Valley regarding the antibody testing being done by the Blaine Covid Response Group in Ketchum.

The group, which was conducting lateral flow testing to determine the prevalence of the coronavirus here, was recently issued a cease-and-desist order not to release the results of tests to participants or face a $23,000 fine.

Here is the statement:

“CMS is taking critical steps to ensure America’s clinical laboratories can respond to the threat of COVID-19 and other respiratory illnesses to ensure patient health and safety.

 “There are currently no SARS-CoV-2 antibody tests that have FDA EUA authorization to be used in a Certificate of Waiver laboratory.  Currently, the antibody tests authorized by the FDA must be performed in a CLIA certified laboratory that meets the requirements to perform moderate or high complexity testing.

 “When a test is authorized as “waived” by the FDA, it does not mean that the test does not need to be performed in a CLIA certified laboratory.  The waived authorization means that the test can be performed in a CLIA Certificate of Waiver laboratory, which has less requirements than other CLIA laboratory certificate types.  Any test currently authorized under FDA’s Emergency Use Authorization must be performed in a CLIA Certified laboratory if the results are going to be returned to individuals.

 “A group can test without a CLIA certificate for surveillance purposes only.  That means that the testing must be performed with de-identified specimens and individual results cannot be returned to the patient.  If the group intends to return patient specific SARS-CoV-2 antibody test results, it must obtain a CLIA Certificate and meet the requirements to perform moderate or high complexity testing, depending on the assay they are using.

“If the laboratory obtains a CLIA Certificate and meets the requirements to perform moderate or high complexity testing, depending on the assay they are using, they can release the results to the individuals who were tested.

“CMS CLIA regulations ensure that test results are reported in an accurate, reliable and timely manner.  The CLIA regulations focus on a laboratory’s overall performance, such as ensuring that laboratory personnel have the appropriate training, conduct the appropriate performance assessments, properly handle specimens, and report results in a timely manner to ensure the health and safety of the American public.

“The Idaho state agency is performing CLIA survey and certification activities on behalf of CMS pursuant to an agreement between the state and the Department of Health and Human Services to ensure accurate and reliable test results are available for individuals who seek COVID-19 testing.

 You can also find more information on CLIA in the May 2020, Medicare Learning Network brochure.”

IDAHO NUMBERS SCALING DOWN

Idaho passed the 30,000 mark on Monday with 217 new cases of coronavirus reported for a total of 30,070. But the daily count does seem to be improving from previous highs in the 500s, 600s and even 700s.

The death count is still giving health officials headaches, though. The state tallied eight new deaths on Monday for 314 total.

Blaine County reported one new case for a total of 595.

 

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