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Public Statements

Taking Essential Steps for Testing Act of 2012

Floor Speech

Location: Washington, DC


Mr. GRIMM. Thank you for yielding me time.

Today, I rise in strong support of this legislation, H.R. 6118, the Taking Essential Steps for Testing Act. I would like to thank Chairman Upton for his leadership, Ranking Member Waxman, as well as the Health Subcommittee and their entire staff for their support and dedication to this important bill.

The TEST Act is a bipartisan and bicameral solution to an issue that threatens Americans' access to health care. Under the Clinical Laboratory Improvement Amendments, CLIA, any lab that conducts human specimen testing must have a CLIA certificate and comply with the law's proficient testing, or PT, requirements. CLIA requires labs to treat PT samples as it would a patient sample. However, the law explicitly prohibits a lab from referring a PT sample to another laboratory, although this may be normal for patient procedures. The purpose of this prohibition is to ensure labs submit their own results for PT samples. I believe that this does clearly promote continued patient safety, accurate results, and that a lab is not getting reimbursed for tests it does not or cannot perform.

The concern is that labs which have accidentally referred a PT sample to another lab and self-reported this mistake are being told by CMS that CLIA does not provide any flexibility and therefore their certificates must be revoked. As a result, labs that make a mistake and proactively try to correct it are treated identically to labs that knowingly and in bad faith violate the law.

Without a CLIA certificate, as we have heard, labs are unable to conduct any human specimen testing. For hospitals, this could mean choosing between shutting down essentially all services such as the ER and the operating room or paying millions of dollars to bring in an outside lab for 2 years. Both of these options result in reduced access to health care and other related services for patients.

The TEST Act gives CMS discretion to not revoke a CLIA certificate for a PT referral if it is determined that the lab was acting in good faith. And for labs which are bad actors, the TEST Act does nothing to alter CMS's ability to punish those labs and revoke their certificate. H.R. 6118 also gives CMS the discretion to not apply the revocation to an entire hospital network or other owner-operators based on the facts of a particular case.

In determining whether or not to revoke a CLIA certificate, I urge CMS to consider factors such as the nature of the violation, the lab's history of compliance and past PT experience, whether or not the lab voluntarily reported the referral, any remedial actions taken by the lab, and any recommendations made by the State or applicable accrediting organization.

I would like to end by saying thank you to all of my colleagues that helped support this legislation and urge all my colleagues to vote in favor of H.R. 6118. It's commonsense legislation that ultimately puts patients first.


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