July 9, 2018 Intelligence: Late Breaking Lab News

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Wake Forest Baptist Medical Center of Wake Forest, N.C., has been notified by the Centers for Medicare and Medicaid Services (CMS), in a letter dated June 15, that it is back in compliance with Medicare Conditions of Participation. Earlier this year, following inspection of the hospital and its anatomic pathology department, federal and state officials identified deficiencies that were an immediate threat to patient health and safety. As reported by local media and THE DARK REPORT, errors in pathology tests had caused some patients to get medically-unnecessary and life-changing surgeries and treatments. (See TDR, April 16, 2018.)

MORE ON: Wake Forest Medical Center

Following its inspection of Wake Forest Medical Center, on Feb. 8, CMS issued a 23-page list of deficiencies. Six weeks later, on March 26, CMS issued a revised list of deficiencies that identified the need for the medical center to review 9,291 pathology cases dating from June 2014 to August 2017. It was determined that at least 25 patients were affected by faulty pathology lab test results.


Here is a notable milestone. GeneDx, a division of BioReference Laboratories, Inc., reported that it has now done exome sequences on 100,000 unique individuals. It said this represents “one of the largest cohorts of sequenced exomes by an independent laboratory in the world.” The company says it has compound annual growth of 55% since its inception, demonstrating how the demand for clinical gene sequencing services continues to increase.


  • Konica Minolta appointed Kenneth Bloom, MD, to be the Chief Medical Officer of Advanced Pathology and Genomic Services at both Invicro and Ambry Genetics, each of which are divisions of Konica Minolta. Bloom previously held positions at Human Longevity, Clarient, and US Labs.
  • Michael Sullivan was selected as Chief Science Officer for Caris Life Sciences. Sullivan previously held executive positions at Roche Diagnostics, Ortho Clinical Diagnostics, IDEXX Laboratories, and Abbott Diagnostics.

That’s all the insider intelligence for this report.
Look for the next briefing on Monday, July 30, 2018.

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about …

…why UnitedHealth Group says 50% of seniors will enroll in Medicare Advantage plans within 10 years. That means there will be fewer fee-for-service patients in the Medical Part B Program for clinical labs to serve.

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