The House on Wednesday passed a bill introduced by GOP Rep. Michael Grimm that protects medical labs that do human specimen testing from losing their licenses when they accidentally send a test sample out to another lab.
The bill, known as the TEST Act, passed the House by unanimous voice vote.
According to Grimm (R-Staten Island/Brooklyn), there have been cases when an "honest mistake" that causes no threat to patients has resulted in hospitals and labs losing their license or Clinical Laboratory Improvement Amendments (CLIA) certificate for two years.
Without a CLIA certificate, labs are unable to conduct any human specimen testing. Grimm said that could lead to hospitals choosing between shutting down services like the emergency or operating room or paying millions of dollars to bring in an outside lab for two years.
"The TEST Act tweaks a well-intended law and rids it of the unintended negative consequences imposed by an overzealous regulation," said Grimm. "While the current regulation was well-intended to ensure reliable lab results from the most basic test to the most life-threatening, it can turn an honest mistake into a disaster for our healthcare providers."
Grimm's bill changes the mandatory revocation of the CLIA certificate to allow the Centers for Medicare and Medicaid Services (CMS) to revoke on a case-by-case basis.
It is Grimm's seventh bill to pass the House since he became a member in 2011. He has passed more bills than any House freshman.
Any lab that conducts human specimen testing must have a CLIA certificate and comply with the law's proficient testing (PT) requirements. The law explicitly prohibits a lab from referring a PT sample to another lab.
Grimm said that the bill addresses the concern that labs which have accidentally referred a PT sample to another lab and self-reported the mistake are being told by CMS that their CLIA certificate must be revoked.
As a result, labs that make a mistake and try to correct it are treated identically to labs which knowingly violate the law.