COVID–19 Testing Inventory Act

II 116TH CONGRESS 2D SESSION S. 3738 To require the Secretary of Health and Human Services to provide updated information about COVID–19 testing to the public, and for other purposes. 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 fol- lowing 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘COVID–19 Testing 4 Inventory Act’’. 5 VerDate Sep 11 2014 15:56 Jun 03, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3738.IS S3738 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3738 IS SEC. 2. PUBLIC INFORMATION ABOUT COVID–19 DIAG- 1 NOSTIC TESTS. 2 The Secretary of Health and Human Services, in con- 3 sultation with the Administrator of the Federal Emer- 4 gency Management Agency, the Commissioner of Food 5 and Drugs, the Director of the Indian Health Service, and 6 other Federal agencies, as appropriate, shall develop a 7 public-facing inventory, which shall be made available on 8 a single internet website, that provides real-time data and 9 information on in vitro diagnostic tests (as defined in sec- 10 tion 809.3 of title 21, Code of Federal Regulations (or 11 successor regulations)), for the detection of SARS–CoV– 12 2 or the diagnosis of the virus that causes COVID–19, 13 or for the detection of antibodies from COVID–19 (re- 14 ferred to in this section as ‘‘COVID–19 diagnostic tests’’), 15 including— 16 (1) the number and type of COVID–19 diag- 17 nostic tests that are available for use in each State, 18 territory, or Indian Tribe, by— 19 (A) county; 20 (B) sites of care where the tests are avail- 21 able for use; 22 (C) type of tests, including molecular, anti- 23 gen, and serological tests; and 24 (D) percentage of tests that deliver rapid 25 results at the point-of-care; 26 VerDate Sep 11 2014 15:56 Jun 03, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3738.IS S3738 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3738 IS (2) for each laboratory, hospital, or other health 1 care facility that receives COVID–19 diagnostic 2 tests, the number and type of COVID–19 diagnostic 3 tests received; 4 (3) each hospital or other health care facility 5 that has the capability, capacity, and testing-related 6 supplies to process COVID–19 diagnostic tests, in- 7 cluding test type and location by State, territory, or 8 Indian Tribe; 9 (4) each laboratory that has the capability, ca- 10 pacity, and testing-related supplies to process 11 COVID–19 diagnostic tests, including test type and 12 location by State, territory, or Indian Tribe; 13 (5) for each COVID–19 diagnostic test listed 14 under paragraph (1), the time required to receive 15 test results, including any time for processing and 16 shipping, measured in the smallest unit of measure- 17 ment reasonable for the particular test, whether 18 minutes, hours, or days; 19 (6) for each COVID–19 diagnostic test listed 20 under paragraph (1), the approximate time per em- 21 ployee required to run the test; 22 (7) for each COVID–19 diagnostic test listed 23 under paragraph (1), each test that the Secretary 24 has authorized, cleared, or approved under the Fed- 25 VerDate Sep 11 2014 15:56 Jun 03, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3738.IS S3738 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3738 IS eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 1 et seq.), or is marketed in accordance with applica- 2 ble guidance issued by the Secretary; 3 (8) a list of each laboratory, hospital, and other 4 health care facility that has reported a shortage of 5 testing-related supplies, and which such supplies re- 6 ported to be in shortage; 7 (9) for each COVID–19 test manufacturer— 8 (A) the number and type of COVID–19 di- 9 agnostic tests for which such manufacturer 10 has— 11 (i) current inventory and projected 12 production capacity for the next 180 days 13 for at least the 180-day period following 14 the date on which such information is sub- 15 mitted; and 16 (ii) received orders, including orders 17 they do not have capacity to deliver; and 18 (B) a description of materials that are in 19 shortage that are hindering production of 20 COVID–19 diagnostic tests by amount and type 21 of test; and 22 (10) for each laboratory, hospital, and other 23 health care facility that receives COVID–19 diag- 24 nostic tests, the number of samples collected per day 25 VerDate Sep 11 2014 15:56 Jun 03, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3738.IS S3738 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 3738 IS and the number of results transmitted to patients 1 (including results transmitted to health care pro- 2 viders for patients) per day. 3 Æ VerDate Sep 11 2014 15:56 Jun 03, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S3738.IS S3738 pamtmann on DSKBC07HB2PROD with BILLS