CMS Amends CLIA Enforcement Policies in Response to the COVID-19 Public Health Emergency
December 19, 2022
The Centers for Medicare & Medicaid Services (CMS) took a big step on Thursday (March 26) by releasing important guidelines for laboratories to follow while combating the spread of the novel coronavirus here in the U.S.
In its memo to state survey agencies, CMS addressed how CLIA enforcement policies have been amended to help ramp up COVID-19 testing and mitigate the spread of the virus.
Here is a review of the memo’s key points:
- Authorization for pathologists to review slides remotely, including at home, subject to certain conditions, including compliance with HIPAA, applicable state laws, and requirements of accrediting organizations.
- Permitting COVID-19 testing to be performed in parking lots and other designated overflow locations outside the laboratory facility, so long as the arrangement complies with applicable CLIA and state law requirements.
- Expedited review of applications from laboratories applying for a CLIA certificate to perform COVID-19 testing, permitting such labs to start testing upon CMS’ assignment of a CLIA number to the lab.
- Procedures for requesting postponement, suspension or cancellation of a proficiency testing (PT) event, and addressing situations where a laboratory is required to temporarily suspend the performance of a particular test.
- The potential use of certain alternate collection devices and specimen transport media permitted by the FDA, subject to the laboratory director’s decision related to the need for validation studies.
- Clarifying that labs performing laboratory-developed tests (LCDs) as provided for in FDA guidance are required to be CLIA-certified and to satisfy requirements to perform high complexity testing.
At LigoLab, we welcome these much-needed amendments. All health experts agree that the only way to get a handle on the spread of the virus is to test, test, test. That will allow us to flatten the curve and lessen the strain on our country’s health system during the pandemic.
These amendments will keep all pathologists and clinicians safe and while at the same time providing the infrastructure needed to test on a large scale.
It’s been inspiring to see so many people in our industry come together for the good of all during this crisis, and we want to be counted among those making a difference.
If your laboratory needs help with COVID-19 testing, please book a time HERE to discuss your needs with us.
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