ASCP Works to Expand Coronavirus Testing Authority

ASCP has been working to expand the network of clinical laboratories that can test for the novel Coronavirus Disease-2019 (COVID-2019). On March 1, the Food and Drug Administration (FDA) released guidance authorizing certain clinical laboratories to develop and use their own molecular diagnostics.  ASCP has been in touch with the Administration to support the broadening of testing authority.  During the course of ASCP’s advocacy on this issue, FDA, in coordination with the U.S. Department of Health and Human Services, released policy, effective immediately, authorizing clinical laboratories outside the public health laboratory network to conduct testing for SARS-CoV-2, the virus responsible for the COVID-2019.  The FDA guidance policy will allow laboratories authorized to perform high complexity testing to develop and use their own diagnostics, once they have been validated in accordance with the Clinical Laboratory Improvement Amendments (CLIA). Once successfully validated, the developing laboratory will have 15 days to submit a EUA submission to FDA. In a letter to U.S. Secretary of Health and Human Services Alex Azar, ASCP supported expanded testing authorization, noting that this “will greatly expand the capacity of our nation’s clinical laboratories to provide diagnostic testing for SARS-CoV-2, which we believe will help expedite the detection of this disease and its containment.” 

ASCP further noted that “while the United States is fortunate to have an outstanding network of public health laboratories, the SARS-CoV-2 virus has the potential to overwhelm the capabilities of this diagnostic network to test patient samples in a timely fashion.  To effectively respond to COVID-19, rapid detection of cases and contacts as well as appropriate clinical management and infection control and implementation of community mitigation efforts are critical.”  A copy of ASCP’s letter can be accessed here.

In addition, FDA is soliciting comments on its policy to expand the network of laboratories that can test for the virus.  ASCP encourages its members to support the policy, which is already in effect.  Interested parties can comment here. For more information about COVID-19, visit CDC's COVID-19 Information for Laboratories webpage or the FDA's COVID-19 webpage.

Other articles in the March 2020 ePolicy News:

• ASCP Job Satisfaction, Wellness Surveys Released
• NSH Releases Histotechnology Workload Study
• Legislation to Address Surprise Billing Progressing in Congress
• ASCP Seeks Clarification on CLIA Personnel Standards
• CMS Responds to ASCP, AMA Concerns on Prior Authorization

To read more articles from ePolicy News click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.