CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab industry that finds itself struggling just
Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accreditation, ISO 15189 accreditation, and CLIA requirements. In their statement about the benefits of the new arrangement, the
CEO SUMMARY: UnitedHealthcare’s ‘Laboratories of Choice’ network in Florida accepts only labs accredited by the College of American Pathologists and The Joint Commission. In March, COLA wrote to UnitedHealth to question this policy which excludes labs accredited by the five other accrediting bodies that hold deeming status from CMS. COLA has requested that UnitedHealthcare reconsider this program requirement, but UnitedHealthcare has not yet changed this policy.
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.
SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact
ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry since passage of the CLIA 1988 bill.
Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The recertification was obtained through the British Standards Institute. COLA earned its
Consolidation of private pathology group practices continues. On July 8, NeoGenomics of Fort Myers, Florida, announced that it had acquired Path Logic of Sacramento. Then, one day later, Incyte Diagnostics of Spokane, Washington, disclosed that it was buying Accupath Pathology Services, Inc., of Seattle, Washington. Path Logic was founded by Peter Kolbek, M.D., in 1999
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accreditation requirements of CLIA. Founded in 1978, A2LA is
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation.
It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the American Association for Laboratory Accreditation (A2LA). In addition to genomic testing, the company runs Caris
CEO SUMMARY: Spectra Laboratories, Inc., a renal-specific testing services company with labs in New Jersey and California, announced earlier this month that the American Association for Laboratory Accreditation awarded accreditation to ISO 1589 to its laboratory in Milpitas, California. It was in May 2010 when Spectra’s laboratory in Rockleigh, New Jersey, earned ISO 15189 accreditation.