Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

November 2021

VALID Act vs. VITAL Act: Day of Reckoning for LDTs

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests. One bill is called the Verifying Accurate Leading-Edge IVCT …

VALID Act vs. VITAL Act: Day of Reckoning for LDTs Read More »

To access this post, you must purchase The Dark Report.

Congress May Soon Act on LDT, IVCT Regulation

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tests under CLIA while calling …

Congress May Soon Act on LDT, IVCT Regulation Read More »

To access this post, you must purchase The Dark Report.

Florida Laboratory Owner Gets 82-Month Jail Term

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who violate the federal anti-kickback statute. Morever, this case is …

Florida Laboratory Owner Gets 82-Month Jail Term Read More »

To access this post, you must purchase The Dark Report.

In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys questioned four of Theranos’ former lab directors about inaccurate test results and failures to comply …

In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role Read More »

To access this post, you must purchase The Dark Report.

Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility

Laboratory Compliance / By Robert Michel

MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab? This question is being asked after the California Department of Public Health (CDPH) finally made public the CLIA inspection report by state officials after they visited the state-owned Valencia Branch Laboratory last winter. ‘Scathing …

Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility Read More »

To access this post, you must purchase The Dark Report.

November 29, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Pathologists interested in ways to automate the various manual steps in the histology laboratory may want to watch the progress of an emerging company. Clarapath of Hawthorne, N.Y., says it is “automating processes around the way tissue is processed onto glass slides via ‘sectioning,’ or cutting a cross-section of the tissue specimen.” The company just …

November 29, 2021 Intelligence: Late-Breaking Lab News Read More »

To access this post, you must purchase The Dark Report.

Congress May Soon Act on IVCT, LDT Regulation

TDR Insider / By Robert Michel

This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on laboratory-developed tests (LDT) regulation and that of other in vitro clinical tests (IVCTs). The VALID …

Congress May Soon Act on IVCT, LDT Regulation Read More »

To access this post, you must purchase The Dark Report.

Physician Salary Survey Ranks Pathology Income at Number 14

TDR Insider / By Robert Michel

This is an excerpt of a 1,488-word article in the November 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In its 28th Annual Physician Compensation Survey, Modern Healthcare put pathology income at number 14 of 23 medical specialties. It reported the …

Physician Salary Survey Ranks Pathology Income at Number 14 Read More »

To access this post, you must purchase The Dark Report.

It’s Flu Season and COVID-19 Cases Continue

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years. Meanwhile, the next influenza season has commenced. Since Oct. …

It’s Flu Season and COVID-19 Cases Continue Read More »

To access this post, you must purchase The Dark Report.

New Lab, Pathology Trends at Executive War College 2021

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Hundreds of lab leaders traveled to San Antonio last week for the 27th annual Executive War College on Laboratory and Pathology Management. After almost two years of virtual conference and meetings using Zoom, attendees were ready to gather for a live event, complete with speakers, networking, meals, and receptions. Speakers addressed the need …

New Lab, Pathology Trends at Executive War College 2021 Read More »

To access this post, you must purchase The Dark Report.

;