21 Apr 2017
(Commonwealth Healthcare Corp.) — More than three years after the Centers for Medicare and Medicaid Services or CMS lifted its suspension on the Commonwealth Health Center laboratory unit, Dr. Philip Dauterman, lab director, was pleased to receive word that the unit’s certification has been renewed for another two years.
The new certificate of compliance doesn’t expire until April of 2019.
“After years of hard work to get the lab back into good shape from where we were in 2012, I’m very proud of our unit for continuing to hold good standing with CMS,” added Dr. Dauterman.
CMS regulates laboratories through what’s known as “CLIA,” which stands for Clinical Laboratory Improvement Amendments. CLIA was passed by Congress in 1988 to establish standards for all non-research laboratory testing.
As a “non-CLIA waived” medical laboratory, the CHC laboratory performs tests of greater complexity than the simple “waived” tests, and therefore must meet higher and stricter standards for compliance.
Waived tests such as pregnancy tests, some urine tests, and fecal occult blood tests are those tests that are so simple and accurate, that they carry little risk of error when performed correctly.
As the only full service CMS certified non-CLIA waived medical laboratory in the CNMI, the CHC lab performed 1,987,868 tests in the last year.