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The court denied a petition for review of the revocation filed by Wade Pediatrics in Muskogee, Okla., after the sanction was upheld in administrative hearings within the U.S. Department of Health and Human Services.
Though the lab said it was only checking the accuracy of its work, the appeals court for the Tenth Circuit found that the lab had violated the plain language of the CLIA statute. While consultation between labs may be permissible in other circumstances before and after a proficiency test, asking an outsider for help during a test corrupts the process and defeats its purpose, the court ruled. In fact, this type of double-checking is exactly what Congress sought to prevent [in the CLIA statute].
In the case presented to the court, Wade Pediatrics failed parts of two rounds of proficiency tests in 2005, and acting on the advice of a field investigator for the Centers for Medicare and Medicaid Services (CMS), turned to another certified lab, at Muskogee Regional Medical Center, for training and comparison testing of its equipment. In PT rounds during 2006, a technician from Wade took samples to the medical center and tested them on its equipment, ostensibly to double-check Wades results. When CMS found out, it revoked Wades CLIA certificate for one year, the penalty required by the CLIA statute.
The appeals court concluded that even if Wade did not intend to violate the statute but only to improve its work, it did knowingly and willfully send its PT results to the medical center.
The court also rejected the labs argument that it was relying on advice from CMS. Under the statute, Wade might have been free to work with another lab to train its personnel and fix its equipment, but its a very different thing to compare results during the testing process.
The case is Wade Pediatrics v. HHS, 10th Cir., No. 08-9529 (6/2/09).
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