September 23, 2019 Intelligence: Late Breaking Lab News

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 Intern…

Read More

---

Pathologist’s Error and Hospital’s Cover-up Lead to CMS Investigation

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 consp…

Read More

---

Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

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 acc…

Read More

---

Much Disruption for Labs In 2016’s Top 10 Stories

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 indust…

Read More

---

Lab Benefit Management Bill Advances in FL Senate

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 repor…

Read More

---

December 7, 2015 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXII, Number 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 accredit…

Read More

---

March 30, 2015 Intelligence: Late Breaking Lab News

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 system…

Read More

---

Achieving CLIA, ISO 15189 at Same Time with A2LA

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 America…

Read More

---

Top 10 2014 Biggest News Stories

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 s…

Read More

---

Public Comment Started on FDA LDT Regulations

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 bureaucrat…

Read More

---