COVID-19 and CLIA Expedited Certification

With COVID-19 clinical laboratory testing continuing to ramp up throughout the United States and worldwide, Clinical Laboratory Improvement Amendments (CLIA) applications for registration are continuing to increase. In response to the pandemic, the federal government is taking unprecedented action to ensure laboratories in the United States wishing to test for COVID-19 are expedited through the CLIA certificate application process.

On March 26, 2020, the Department of Health & Human Services Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality/Survey & Certification Group issued a memorandum reference number QSO-20-21-CLIA regarding CLIA Laboratory Guidance During COVID-19 Public Health Emergency.

The memorandum provides important guidance to surveyors and laboratories during the COVID-19 pandemic, including:

  • Enforcement discretion for remote pathology slide review
  • Ensuring laboratories in the United States wishing to perform COVID-19 testing that apply for CLIA certification are able to begin testing as quickly as possible
  • Laboratories with hospital/University Hospital Campus may hold a single certificate for sites at the same physical location
  • Enforcement discretion for Proficiency Testing
  • Alternate Specimen Collection Devices
  • Laboratory Developed Tests

In order for laboratories to successfully apply for certification, it is helpful to consider few initial questions in order for us to better assist in submitting the current state and federal documents.

  1. CA registration submittal option?
    1. State oversight only
    2. Approved organization accreditation (CAP, AABB, COLA, JC)
  2. Type of certificate?
    1. Certificate of Waiver
    2. Provider Performed Microscopy Procedure (PPM)
    3. Certificate of Compliance
    4. Certificate of Accreditation (choose one: CAP, AABB, COLA, JC, AAHHS/HFAP, ASHI, A2LA)
  3. Are there multiple testing locations?
  4. Are there mobile testing units?
  5. Has the volume of annual tests been estimated by specialty and accrediting organization?
  6. Does the Director have an affiliation(s) with other certified labs?
  7. Is there an existing quality management system in place?

If a CLIA identification number has already been obtained, what other kinds of services are you looking for? Freer Consulting Co provides additional services in the following areas:

  • Preparation for accreditation
  • Preparation for additional certificates
  • Training
  • Internal auditing
  • Quality Management System improvements
  • Operational efficiencies

Freer Consulting has extensive experience in all facets of accreditation, including providing all levels of support from a remote environment. If you’d like to learn more about how Freer can help you, contact us at (206) 285-9044 or at [email protected]