News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Clinical Pathology Laboratories Get a New CLIA Accreditation Choice as CMS Grants Deeming Status to A2LA

NEWS UPDATE: American Association of Laboratory Accreditation (A2LA) is given four-year authority to accredit clinical laboratories to CLIA requirements for all specialty and subspecialty lab test areas

There’s a new Centers for Medicare and Medicaid Services-approved (CMS) accrediting organization for clinical laboratories. Medicare officials granted deeming status for Clinical Laboratory Improvement Amendments (CLIA) to the American Association for Laboratory Accreditation (A2LA). The approval marks the first time in two decades that CMS has added a new organization to accredit medical laboratories under CLIA.

CMS announced the approval in a notice published March 25 in the Federal Register. CMS approved A2LA’s application as an accreditation organization for clinical laboratories under CLIA for all specialty and subspecialty areas for four years. “We have determined that the A2LA meets or exceeds the applicable CLIA requirements,” stated the CMS announcement. (more…)

Clinical Laboratories in United States Show More Interest in ISO 15189 Accreditation

It may be a small number of 15189-accredited medical laboratories, but these are prominent lab organizations and their ranks are growing

One by one, a small number of innovative clinical laboratory organizations are taking steps to earn accreditation to either ISO 15189 or CAP 15189. This is a quiet trend and one that has yet to attract widespread notice across the world of medical laboratory and pathology testing.

It is a trend that touches clinical lab organizations of all sizes. For example, many lab executives may be surprised to learn that multibillion-dollar Laboratory Corporation of America (NYSE: LH) has five different clinical laboratory locations that have earned accreditation to CAP 15189. (more…)

Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189

A2LA, CAP, and QMP-LS to Participate in an Informational Event on January 20th

 

 

ISO 15189 is gaining a foothold among laboratories in the United States. Since the first clinical pathology laboratory in the U.S. earned accreditation to “ISO 15189:2007 Medical Laboratories” in 2008, there has been a steady increase in the number of clinical laboratories that have embarked on their own path to accreditation.

This fall, The Dark Report and Dark Daily invited all three of the organizations in North America that offer accreditation services for ISO 15189 to speak at the fourth annual Lab Quality Confab, which took place in San Antonio, Texas, on November 2-3, 2010. It marked the first time that all three of these ISO-accrediting organizations spoke in public at one time and in one place. (more…)

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