This week, bipartisan legislation co-sponsored by U.S. Senator Rob Portman (R-Ohio) to protect hospitals and labs from budget-crushing regulations, the Taking Essential Steps for Testing Act (TEST Act), passed the Senate by unanimous consent on the Senate floor. A companion bill introduced by Rep. Michael Grimm (R-NY), H.R. 6118, passed the House of Representatives with unanimous support in June. This legislation improves the Clinical Laboratory Improvement Amendments (CLIA) in order to prevent labs that perform human specimen testing from losing their license, or CLIA certificate, when they unintentionally send out a test sample to another lab. This 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. This legislation allows for CMS to use greater discretion in determining whether to revoke a hospital or lab's CLIA certification.
"Ensuring that lab results are unaltered and reliable is critical to promoting the health of patients. However, burdensome, blanket regulations that penalize health care providers for innocent mistakes that do no harm to patients can jeopardize the future operation of the very services patients rely on to be there when they need them most," Portman said.
"Our legislation will protect hospitals and labs, such as our very own laboratory at the Ohio State University's Wexner Medical Center (OSUWMC), from losing funding by providing greater flexibility and discretion in determining whether to revoke a hospital or lab's CLIA certification."
CMS recently sanctioned the laboratory at the OSUWMC because of the accidental and unintentional referral of a limited number of proficiency testing samples to two other laboratories in violation of CMS regulations. The referral of these samples had no effect on any patients and was self-reported by the OSUWMC, which acknowledges the mistake as one made by accidental referral rather than malicious intent.
The Wexner Medical Center's laboratory performs 9.2 million tests per year for patients and is central Ohio's only fully automated hospital laboratory. The State of Ohio cannot afford for one of its most important medical institutions to lose its ability to conduct critical patient testing, and the TEST Act will help prevent that from happening.
The TEST Act allows for CMS to use judgment in order to determine when to suspend a hospital or lab's CLIA certificate. This prevents the mandatory revocation as required under the current statute and allows for the hospital to keep its license if CMS determines that the lab was acting in good faith. This legislation does not restrict the power of CMS to suspend a lab's certification when indicated, but instead it will allow CMS to exercise suspensions on a case-by-case basis. This bipartisan law will benefit many hospitals and patients around the country as well as in Ohio. It is important that the President moves to sign the TEST Act into law so that great hospitals like the Wexner Medical Center can continue to provide care to patients in Ohio and throughout the country.