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

Search Results for: COVID-19

December 20, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

In Europe, Switzerland-based Unilabs will be acquired by a Danish company. Unilabs owns laboratories in at least 11 European countries and posted revenue of €2 billion euros (US $2.26 billion) in the financial year ending September. The seller is Apax Partners, a private equity company in the United Kingdom. The buyer is A.P. Moller Holding, which …

December 20, 2021 Intelligence: Late-Breaking Lab News 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.

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.

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.

Post-COVID: Repurposing Excess PCR Instruments

Laboratory Equipment / By Robert Michel

CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could perform. Today, with the demand for COVID-19 PCR tests dropping steadily, these same …

Post-COVID: Repurposing Excess PCR Instruments Read More »

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

November 8, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Last week, the state of California auto-renewed its controversial COVID-19 testing contract with PerkinElmer to run the Valencia Branch Laboratory. Designed, built, and operated by PerkinElmer, the lab began SARS-CoV-2 testing in the fall of 2020 and immediately was in the news for a range of issues. The original award was a no-bid contract worth …

November 8, 2021 Intelligence: Late-Breaking Lab News Read More »

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

UnitedHealth’s Lab Test Registry Implementation Delayed Again

Managed Care Contracts / By Robert Michel

ANOTHER DELAY WAS ANNOUNCED FOR IMPLEMENTATION of UnitedHealthcare’s Laboratory Test Registry Protocol, which requires clinical laboratories to register each of their tests with the health insurer. This latest delay likely is the result of operational issues on behalf of the managed care company and does not spell an end to the test registry altogether. “It’s …

UnitedHealth’s Lab Test Registry Implementation Delayed Again Read More »

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

SUNY Hospital Uses Drones to Move COVID Test Kits

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: One healthcare trend accelerated by the SARS-CoV-2 pandemic is the use of drones to move COVID-19 test kits, specimens, and medical supplies. Earlier this year, the SUNY Upstate Medical University Hospital in Syracuse tested the reliability of drones to move unused COVID-19 test kits between locations on its campus. In Scotland and Ghana, …

SUNY Hospital Uses Drones to Move COVID Test Kits Read More »

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

;