ACLA Applauds House Passage of Bill that Increases Flexibility of Regulations which Threaten Access to Clinical Lab Tests

September 20, 2012 Categories: ACLA News, All News, ACLA Press Releases, Regulatory Issues

For Release: Sept. 20, 2012
Contact: Jason DuBois, 202-637-9466

ACLA Applauds House Passage of Bill that Increases Flexibility of Regulations which Threaten Access to Clinical Lab Tests

WASHINGTON, DC—The American Clinical Laboratory Association (ACLA) today applauded the U.S. House of Representatives for yesterday’s passage of H.R. 6118, the Taking Essential Steps for Testing Act (TEST Act), introduced by Rep. Michael Grimm (R-NY). A Senate companion bill (S. 3391) was also approved yesterday by the Senate Health, Education, Labor, and Pensions Committee. 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 applauds the House for making this important statutory change,” said Alan Mertz, President of ACLA. “It is our hope that the full Senate also recognizes that 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.

In several recent cases, however, CMS revoked laboratory CLIA certificates because the labs referred proficiency test specimens for an HIV test to another lab. This occurred even though, for HIV and certain other tests, the standard operating procedure of many laboratories is to refer samples to a different lab. For example, the HIV test involves both an initial screening test, called ELISA – as well as a confirmatory test, known as a Western Blot. Many laboratories do not offer the Western Blot due to limited resources and, as a result, they refer the confirmatory test to one that does offer it.

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.

“The TEST Act prevents the wasteful time and expense that occurs when a laboratory’s CLIA certificate is revoked under these circumstances,” Mertz continued. “It allows laboratories to continue providing vital services to patients.”

ACLA is the leading association representing clinical laboratories throughout the country, including local, regional, and national laboratories.

Print page / Save as PDF