For Release: December 4, 2012
Contact: Jason DuBois, 202-637-9466
ACLA Applauds Enactment of Bill Increasing Flexibility of Regulations that Threaten Access to Clinical Lab Tests
WASHINGTON, DC — The American Clinical Laboratory Association (ACLA) today applauded President Barack Obama for signing into law the Taking Essential Steps for Testing Act (TEST Act), introduced in the House by Rep. Michael Grimm (R-NY) and in the Senate by Sen. Amy Klobuchar (D-MN). The House passed the bill (HR 6118) on September 19th and the Senate followed on November 14th. 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.
“ACLA is very pleased that President Obama has signed into law this important piece of legislation,” said Alan Mertz, President of ACLA. “The TEST Act will ensure that laboratories are not unfairly punished when they follow the usual practice and refer a specimen to another laboratory.”
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 – even though referring tests to other labs is 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.
ACLA is the leading association representing clinical laboratories throughout the country, including local, regional, and national laboratories. www.acla.com