COVID–19 Testing Inventory Act

Bill: 116-s-3738
Sponsor: full_name: Sen. Smith, Tina [D-MN]
Introduced: 2020-05-14
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Emergency medical services and trauma care

Government information and archives

Health facilities and institutions

Health information and medical records

Health technology, devices, supplies

Infectious and parasitic diseases

Manufacturing

Medical tests and diagnostic methods
Latest action: action_date: 2020-05-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2020-05-14
action_desc: Introduced in Senate
text: <p><strong>COVID-19 Testing Inventory Act</strong></p> <p>This bill requires the Department of Health and Human Services to share information on a public website about tests to diagnose COVID-19 (i.e., coronavirus disease 2019) or detect the virus that causes the disease. The website must include, among other information,&nbsp;a list of testing sites and the number and type of diagnostic tests available for use in each state, territory, or tribe. </p>

tv_txt: II 116th CONGRESS 2d Session S. 3738 IN THE SENATE OF THE UNITED STATES May 14, 2020 Ms. Smith (for herself, Ms. Warren , Mr. Blumenthal , Mrs. Gillibrand , Mrs. Shaheen , Mr. Markey , Mr. Merkley , Mr. Peters , Ms. Harris , Ms. Klobuchar , Mrs. Murray , and Ms. Hirono ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Secretary of Health and Human Services to provide updated information about COVID–19 testing to the public, and for other purposes.

1. Short title This Act may be cited as the COVID–19 Testing Inventory Act . 2. Public information about COVID–19 diagnostic tests The Secretary of Health and Human Services, in consultation with the Administrator of the Federal Emergency Management Agency, the Commissioner of Food and Drugs, the Director of the Indian Health Service, and other Federal agencies, as appropriate, shall develop a public-facing inventory, which shall be made available on a single internet website, that provides real-time data and information on in vitro diagnostic tests (as defined in section 809.3 of title 21, Code of Federal Regulations (or successor regulations)), for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, or for the detection of antibodies from COVID–19 (referred to in this section as COVID–19 diagnostic tests ), including— (1) the number and type of COVID–19 diagnostic tests that are available for use in each State, territory, or Indian Tribe, by— (A) county; (B) sites of care where the tests are available for use; (C) type of tests, including molecular, antigen, and serological tests; and (D) percentage of tests that deliver rapid results at the point-of-care; (2) for each laboratory, hospital, or other health care facility that receives COVID–19 diagnostic tests, the number and type of COVID–19 diagnostic tests received; (3) each hospital or other health care facility that has the capability, capacity, and testing-related supplies to process COVID–19 diagnostic tests, including test type and location by State, territory, or Indian Tribe; (4) each laboratory that has the capability, capacity, and testing-related supplies to process COVID–19 diagnostic tests, including test type and location by State, territory, or Indian Tribe; (5) for each COVID–19 diagnostic test listed under paragraph (1), the time required to receive test results, including any time for processing and shipping, measured in the smallest unit of measurement reasonable for the particular test, whether minutes, hours, or days; (6) for each COVID–19 diagnostic test listed under paragraph (1), the approximate time per employee required to run the test; (7) for each COVID–19 diagnostic test listed under paragraph (1), each test that the Secretary has authorized, cleared, or approved under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), or is marketed in accordance with applicable guidance issued by the Secretary; (8) a list of each laboratory, hospital, and other health care facility that has reported a shortage of testing-related supplies, and which such supplies reported to be in shortage; (9) for each COVID–19 test manufacturer— (A) the number and type of COVID–19 diagnostic tests for which such manufacturer has— (i) current inventory and projected production capacity for the next 180 days for at least the 180-day period following the date on which such information is submitted; and (ii) received orders, including orders they do not have capacity to deliver; and (B) a description of materials that are in shortage that are hindering production of COVID–19 diagnostic tests by amount and type of test; and (10) for each laboratory, hospital, and other health care facility that receives COVID–19 diagnostic tests, the number of samples collected per day and the number of results transmitted to patients (including results transmitted to health care providers for patients) per day.