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CMS Sanctioned Three Houston Hospitals, Labs

By Joseph Burns | From the Volume XXVI No. 10 – July 22, 2019 Issue

CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process …

Houston Errors Are Every Clinical Pathologist’s Fear

By R. Lewis Dark | From the Volume XXVI No. 10 – July 22, 2019 Issue

Due to medical errors, three patients died in three Houston hospitals in a short period of time. Each adverse event led to inspections by the federal Centers for Medicare and Medicaid Services (CMS) and sanctions as tough as revocation of deemed status for participation in the Medica…

Attorney Explains Risks from New ‘Support Act’

By Joseph Burns | From the Volume XXV No. 17 – December 3, 2018 Issue

CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the …

FDA Issues Response to Draft Legislation to Regulate LDTs

By Joseph Burns | From the Volume XXV No. 12 – August 20, 2018 Issue

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…

Dartmouth-Hitchcock Builds Strong Lab Outreach Business

By Joseph Burns | From the Volume XXV No. 10 – July 9, 2018 Issue

CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach …

In Lawsuit Against HHS, ACLA Has Strong Positions

By Joseph Burns | From the Volume XXV No. 9 – June 18, 2018 Issue

CEO SUMMARY: Rulings from Judge Amy Berman Jackson of the U.S. District Court in Washington, D.C., are expected soon in the ACLA’s lawsuit against HHS concerning the PAMA final rule that set the course for the new Medicare CLFS rates implemented in January 2018. One lawyer following the…

WSJ Reporter Tells All About Downfall of Troubled Theranos

By Joseph Burns | From the Volume XXV No. 8 – May 29, 2018 Issue

CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical…

How Many Patients Were Harmed at Theranos?

By Joseph Burns | From the Volume XXV No. 8 – May 29, 2018 Issue

CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the …

Wake Forest Baptist Lab’s Path Errors Teach Lessons

By Joseph Burns | From the Volume XXV No. 7 – May 7, 2018 Issue

CEO SUMMARY: For medical directors and pathologists interested in improving their labs’ compliance with CLIA regulations, a report from federal and state inspectors of an inspection of the pathology lab at the Wake Forest Baptist Medical Center offers insights into what issues caught th…

Wake Forest Baptist Hospital Reviewing Path Lab Deficiencies

By R. Lewis Dark | From the Volume XXV No. 6 – April 16, 2018 Issue

CEO SUMMARY: In response to information the staff provided to Wake Forest Baptist Hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, CMS describes deficiencies found as “an immediate jeopardy to the health and …

Volume XXVII No. 8 – June 1, 2020

THE DARK REPORT brings news that the national media has overlooked: Lab revenues, cut precipitously during the coronavirus pandemic, will leave many labs without the resources to continue operation in the near future. As calculated by THE DARK REPORT, the nation’s clinical lab industry had lost $6.8 billion in revenue by week 12 of the crisis. Also reported is that in many cases, the culprit is a frustrating lack of supplies that would allow labs to replace lost routine testing with new COVID-19 testing.

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