Title: To direct the Comptroller General of the United States to submit a report describing the response of certain entities to the COVID-19 pandemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests.
Policy area: Health

Summary:
This bill requires the Government Accountability Office (GAO) to report on diagnostic tests to diagnose COVID-19 (i.e., coronavirus disease 2019) or detect the virus that causes the disease. Specifically, the report must describe the response of, among others, laboratories, diagnostic test manufacturers, and government entities with respect to the development, regulatory evaluation, and deployment of diagnostic tests. The GAO must also assess standards, guidance, clinical processes, and intergovernmental coordination related to COVID-19 testing.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6839 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 6839

  To direct the Comptroller General of the United States to submit a 
  report describing the response of certain entities to the COVID-19 
 pandemic with respect to the development, regulatory evaluation, and 
                    deployment of diagnostic tests.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 12, 2020

 Ms. Spanberger (for herself and Mr. Gonzalez of Ohio) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
  To direct the Comptroller General of the United States to submit a 
  report describing the response of certain entities to the COVID-19 
 pandemic with respect to the development, regulatory evaluation, and 
                    deployment of diagnostic tests.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. GAO REPORT ON DIAGNOSTIC TESTS.

    (a) GAO Study.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor and 
Pensions of the Senate a report describing the response of entities 
described in subsection (b) to the COVID-19 pandemic with respect to 
the development, regulatory evaluation, and deployment of diagnostic 
tests.
    (b) Entities Described.--Entities described in this subsection 
include--
            (1) laboratories, including public health, academic, 
        clinical, and commercial laboratories;
            (2) diagnostic test manufacturers;
            (3) State, local, Tribal, and territorial governments; and
            (4) the Food and Drug Administration, the Centers for 
        Disease Control and Prevention, the Centers for Medicare & 
        Medicaid Services, the National Institutes of Health, and other 
        relevant Federal agencies, as appropriate.
    (c) Contents.--The report under subsection (a) shall include--
            (1) a description of actions taken by entities described in 
        subsection (b) to develop, evaluate, and deploy diagnostic 
        tests;
            (2) an assessment of the coordination of Federal agencies 
        in the development, regulatory evaluation, and deployment of 
        diagnostic tests;
            (3) an assessment of the standards used by the Food and 
        Drug Administration to evaluate diagnostic tests;
            (4) an assessment of the clarity of Federal agency guidance 
        related to testing, including the ability for individuals 
        without medical training to understand which diagnostic tests 
        had been evaluated by the Food and Drug Administration;
            (5) a description of--
                    (A) actions taken and clinical processes employed 
                by States and territories that have authorized 
                laboratories to develop and perform diagnostic tests 
                not authorized, approved, or cleared by the Food and 
                Drug Administration, including actions of such States 
                and territories to evaluate the accuracy and 
                sensitivity of such tests; and
                    (B) the standards used by States and territories 
                when deciding when to authorize laboratories to develop 
                or perform diagnostic tests;
            (6) an assessment of the steps taken by laboratories and 
        diagnostic test manufacturers to validate diagnostic tests, as 
        well as the evidence collected by such entities to support 
        validation; and
            (7) based on available reports, an assessment of the 
        accuracy and sensitivity of a representative sample of 
        available diagnostic tests.
    (d) Definition.--In this section, the term ``diagnostic test'' 
means an in vitro diagnostic product (as defined in section 809.3(a) of 
title 21, Code of Federal Regulations) for--
            (1) the detection of SARS-CoV-2;
            (2) the diagnosis of the virus that causes COVID-19; or
            (3) the detection of antibodies specific to SARS-CoV-2, 
        such as a serological test.
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