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Public Statements

Taking Essential Steps for Testing Act of 2012

Floor Speech

Location: Washington, DC


Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today to support H.R. 6118, the Taking Essential Steps for Testing Act of 2012.

H.R. 6118 would give the Centers for Medicare and Medicaid Services much needed regulatory flexibility to enforce prohibitions against improper referrals of proficiency testing under the clinical laboratory improvement amendments.

In order to operate as a business, laboratories must adhere to CMS procedures for processing samples, must share testing results with CMS periodically and are prohibited from intentionally referring testing samples to any other lab.

Currently the Centers for Medicare and Medicaid Services is required under statute to revoke the CLIA certificate of any laboratory that intentionally refers its proficiency testing samples to another laboratory for testing for a period of 1 year.

In addition, the statute requires that a person who has owned or operated a laboratory which has had its CLIA certification revoked, including those owning multiple labs, may not own or operate a laboratory for a period of 2 years following such revocation.

However, there have been instances where a hospital or independent laboratory has accidently referred a PT sample to another lab due to mistakes by employees or through automated systems. In such instances CMS is not allowed by law to consider the circumstances under which the test was accidently referred or if the lab acted in good faith to report and address the incident.

H.R. 6118 would address these issues by amending section 353 of the Public Health Service Act to allow the Secretary discretion to determine whether the 1-year ban on laboratories should be applied and the flexibility to levy immediate sanctions instead of the 2-year prohibition against ownership or operation of the lab.

The legislation enjoys bipartisan support among this body as well as numerous organizations, including the American Clinical Laboratory Association, the American Hospital Association, the College of American Pathologists, and the Clinical Laboratory Management Association, among others.

I would like to thank Congressman Grimm and Congressman Roskam for their work on this legislation, and I urge Members to support the bill.

I reserve the balance of my time.


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