Laboratory Regulators Offer Updated Covid-19 Guidelines

Monday, March 23rd the CDC hosted the first of a new series of weekly calls for clinical laboratories to discuss the Covid-19 crisis. The calls feature speakers from relevant agencies such as the FDA, CLIA, and CDC answering questions from the medical professionals on the front lines. Questions are related to testing implementation, safety concerns, and new guidelines for validation during this emergency. These meetings are conducted through Zoom and are open to all laboratory professionals. You can find call in info here.

On the first call on the 23rd, Wendi Kuhnert-Tallman, of the virus’s CDC laboratory task force, provided an update on the state of testing in the United States. Though testing is still not widely available, it has been streamlined to the point where there are sites now open in all 50 states as well as US territories. These state and public health labs are no longer being required to go through confirmatory testing at the CDC as part of new FDA guidelines. States now may take responsibility for tests developed and used by laboratories in their states. If the state does not have a program for this however, they will still go through the FDA. Meanwhile, commercial testing has also become available, but all sites are facing supply challenges for reagents, including extraction kits.

As part of attempts to speed the availability of testing, on March 26th CMS released a memo addressing other exceptions to standard processes for accreditation. Laboratories must still be CLIA certified in order to perform the COVID-19 testing, however CLIA announced that it would be expediting applications for certificates. Once a location has identified a laboratory director and provided all the information required on the CMS-116 application, a CLIA number will be assigned. Once a location receives a number they can begin testing (as opposed to waiting for the issuance of the paper certificate).

This same memo also offered updated regulations for digital pathology that will allow some pathologists to work from home. Normally, sites would need to have a certificate for every testing site, however this order has been waived for temporary sites, provided that the primary site, or home base of the laboratory, has a certificate. All work performed at the temporary site must still fall within what the laboratory was already certified to be doing. Temporary site is defined as “where, at various intervals of time, an entity that is not at a fixed or permanent location performs laboratory testing. Such a temporary testing site may be the pathologist’s home.”

The second of the CDC clinical laboratory calls on March 30th provided information released in the previously mentioned CMS memo, as well as CDC priorities for testing, which were updated on March 24th.

Tier 1: Hospitalized patients and symptomatic health care workers

Tier 2: People at high risk of complications who have symptoms, including people in long-term care facilities, people age 65 and older, people with underlying conditions, and first responders

Tier 3: Critical infrastructure workers with symptoms, healthcare workers and first responders without symptoms, people with mild symptoms in communities with high COVID-19 hospitalizations, and others with symptoms

Tier 4: People without symptoms

The next CDC laboratory professionals call will be held on Monday, April 6th. You can find more information such as recommended laboratory decontamination procedures and updated news on NSH's Covid-19 page.

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