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Senate Approval of Taking Essential Steps for Testing (TEST) Act of 2012
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CLMA Applauds Senate Approval of Taking Essential Steps for Testing (TEST) Act of 2012

The Clinical Laboratory Management Association (CLMA) applauds the U.S. Senate for yesterday’s passage of the Taking Essential Steps for Testing (TEST) Act , introduced in the House by Rep. Michael Grimm (R-NY). The House passed the bill (H.R. 6118) on September 19. The TEST Act addresses a lack of regulatory flexibility in the Clinical Laboratory Improvement Amendments (CLIA) that threatens patient access to tests from some labs.

The bill grants the Centers for Medicare and Medicaid Services (CMS) much-needed discretion so that clinical laboratories will not have their CLIA certificates revoked for the unintentional referral of proficiency testing samples to other laboratories. Until now, CMS has maintained that the current CLIA statute requires the agency to revoke the certificate for any laboratory that refers its proficiency testing samples to another laboratory for analysis, a routine practice designed to best match lab expertise with patient and physician needs. The legislation permits CMS to impose alternative sanctions prior to revoking a laboratory’s CLIA certificate in cases where a proficiency-testing sample was referred to another laboratory for confirmatory testing or because the laboratory does not offer a specific test.

President Obama is expected to sign the bill into law.

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