Washington, DC—The American Clinical Laboratory Association (ACLA) today announced its “full and strong support” for H.R. 6118, the Taking Essential Steps for Testing Act or TEST Act introduced by Rep. Michael Grimm (R-NY) in the House of Representatives.
The proposed legislation would address a lack of regulatory flexibility in the Clinical Laboratory Improvement Amendments (CLIA). The bill would grant the Centers for Medicare and Medicaid Services (CMS) much-needed discretion so that clinical laboratories would not have their CLIA certificates revoked for the unintentional referral of proficiency testing samples to other laboratories.
CMS maintains that the CLIA statute requires the agency to revoke the CLIA certificate for any laboratory that intentionally refers its proficiency testing samples to another laboratory for analysis. In several recent cases, laboratories’ CLIA certificates were revoked because they referred proficiency test specimens for an HIV test. But for HIV and certain other tests, the laboratory’s standard operating procedure is to refer all samples to another laboratory. For example, the HIV test involves both an initial screening test – called ELISA – as well as a confirmatory test – a Western Blot. However, many laboratories do not offer the Western Blot due to limited resources and, as a result, refer the confirmatory test to a lab that does offer it.
The proposed legislation would permit CMS to impose intermediate 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.
“As a result of this important statutory change, laboratories will no longer be unfairly punished when they follow the usual practice and refer a specimen to another laboratory,” said Alan Mertz, President of ACLA. “The TEST Act will prevent the wasteful time and expense that occurs when a laboratory’s CLIA certificate is revoked, and allow laboratories to continue providing vital services to patients,” Mertz continued.
ACLA is an association representing clinical laboratories throughout the country, including local, regional, and national laboratories.
The letter is available at www.acla.com.