By Robert Michel, from the Volume XXIII No. 17 – December 19, 2016 issue
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
By Joseph Burns, from the Volume XXIII No. 13 – September 26, 2016 issue
CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15189 to help lab staff to raise the quality of lab services.
By Joseph Burns, from the Volume XXII NO. 6 - April 20, 2015 issue
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.
By Joseph Burns, from the Volume XXII NO. 3 - February 17, 2015 issue
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.
See additional Dark Daily coverge on CLIA and A2LA certification
By Robert Michel, from the Volume XXI NO. 17 - December 15, 2014 issue
Story no.1
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.
Congress used
By Joseph Burns, from the Volume XXI NO. 5 – April 7, 2014 issue
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
By Robert Michel, from the Volume XV No. 3 - March 3, 2008 issue
CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologists’ (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global convergence of laboratory operations. Also, a growing number
