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H.R. 6118 (112th): Taking Essential Steps for Testing Act of 2012
- Introduced:
- Jul 12, 2012 (112th Congress, 2011–2013)
- Sponsor:
- Rep. Michael Grimm [R-NY13]
- Status:
- Signed by the President
- Slip Law:
- This bill became Pub.L. 112-202.
The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.
- Full Title
To amend section 353 of the Public Health Service Act with respect to suspension, revocation, and limitation of laboratory certification.
- Summary
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No summaries available.
- Text
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Last updated Jan 01, 2012.
1 pages
- Primary Source
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View on THOMAS (The Library of Congress)
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- Citation
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Library of Congress Summary
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
12/4/2012--Public Law. (This measure has not been amended since it was introduced.
The summary of that version is repeated here.) Taking Essential Steps for Testing Act of 2012 - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by:
(1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and
(2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.
House Republican Conference Summary
The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.
This summary can be found at http://www.gop.gov/bill/112/2/hr6118.
Background
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). According to the Subcommittee on Health, labs are also required to do periodic proficiency testing (PT) in order to maintain their CLIA certification. PT testing requires a lab to adhere to CMS procedures for processing samples, share its testing results with CMS, and it is prohibited from intentionally referring that sample to any other lab. Currently, CMS is required to revoke the CLEA certificate of any laboratory that intentionally refers its proficiency testing samples to another laboratory for testing for a period of one year. In addition, any person who has owned or operated a laboratory which has had its CLIA certification revoked may not own or operate a laboratory for a period of two years following such revocation.
H.R. 6118 would allow CMS discretion to consider the circumstances under which a PT sample was referred to another lab and address the laboratory accordingly.
Summary
The Taking Essential Steps for Testing Act of 2012 would amend Section 353 of the Public Health Service Act to revise sanctions for clinical laboratories that unintentionally refer proficiency testing (PT) samples to other laboratories. The legislation would allow the Secretary of Health and Human Services (HHS) discretion to make the one-year certificate revocation for such a laboratory optional rather than mandatory, and the flexibility to levy intermediate sanctions instead of the two-year prohibition against ownership or operation of a lab.
Cost
There was no Congressional Budget Office (CBO) cost estimate available for this bill.
House Democratic Caucus Summary
The House Democratic Caucus does not provide summaries of bills.
So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.
We’ll be looking for a source of summaries from the other side in the meanwhile.
The bill contains the following citations to other parts of U.S. law:
United States Code
The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)
- Title 42: THE PUBLIC HEALTH AND WELFARE
- Chapter 6A: PUBLIC HEALTH SERVICE
- Subchapter II: GENERAL POWERS AND DUTIES
- Part F: Licensing of Biological Products and Clinical Laboratories
- Subpart 2: clinical laboratories
- Section 263a: Certification of laboratories