By Robert Michel, from the Volume XXVI No. 13 – September 23, 2019 issue
Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis International Airport and the Memphis world hub operated by FedEx Corporation. The
By Joseph Burns, from the Volume XXIV, No. 13 – September 18, 2017 issue
CEO SUMMARY: In the latest chapter of an explosive case at the University of Kansas Medical Center that includes claims of a cancer misdiagnosis, an unnecessary surgery, and a cover-up that involves the former chair of pathology, the patient has sued for fraud, negligence, and civil conspiracy. After a whistle-blowing pathologist filed an earlier lawsuit,
By Joseph Burns, from the Volume XXIV, No. 4 – March 13, 2017 issue
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acceptable evidence that their genetic test is accurate and that it produces information
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. 2 - February 8, 2016 issue
CEO SUMMARY: To date, a bill to restrict how health insurers use lab benefit management systems such as UnitedHealthcare’s BeaconLBS, has been favorably received in the Florida Senate. But the bill may face opposition when presented to the Senate’s Appropriations Committee. In a report, the state Office of Insurance Regulation said that restricting the use
By Robert Michel, from the Volume XXII NO. 17 - December 7, 2015 issue
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
By Robert Michel, from the Volume XXII NO. 5 - March 30, 2015 issue
Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation systems. Located in a new building of 162,378 square feet, it will be home to more than 350 lab employees.
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. 15 - November 3, 2014 issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased
