COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration
Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.
Where to start when working on a laboratory developed test using next generation sequencing (NGS) technology for diagnosing SARS-CoV-2, according to Timothy Stenzel, MD, PhD.
Selected quotes from Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health at the FDA on the June 16, 2020, updates to EUA templates.
Four important statements from a June 8 CDC clinical laboratory call covering COVID-19 test data reporting requirements.
As of June 12, 2020, the FDA had authorized 135 COVID-19 tests under emergency use authorization (EUA), which include 114 molecular tests, 20 antibody tests, and 1 antigen test. The FDA has also released a new interactive tool designed to assist in identifying COVID-19 testing supply deficiencies and alternatives.
The FDA addresses concerns of unreliable tests by providing a new tool to support their evaluation of SARS-CoV-2 diagnostic tests.
SARS-CoV-2 test reporting requirements just multiplied. Clinical laboratories are on a deadline now.
Introduction to commercially manufactured SARS-CoV-2 serology tests listed with the status of “Removed – Should Not Be Distributed.”
While not specifically addressed by CMS, the U.S. Department of Health and Human Services (HHS) may fine non-compliant institutions up to $300 per day.
Multiple-step methods versus single-step methods differentiated.
As the number of COVID-19 cases in the United States has increased, the availability of real COVID-19 positive specimens has also increased.
Segmented highlights from interim final rule CMS-5531-IFC, which was released with a 60-day comment period, effective May 8, 2020. Recent changes are intended to increase the COVID-19 response capabilities of providers and hospitals.
Major highlights of the FDA’s revised COVID-19 testing policy issued May 11, 2020.
Compare SARS-CoV-2 testing requirements for clinical laboratories and other facilities based on new 20-06-CLIA memo issued April 30, 2020.
Clinical laboratory directors may reduce their risk of fraud and waste by familiarizing themselves with these four areas of recent focus.
Impact of relaxing HIPAA enforcement during COVID-19 pandemic.
Where to start when working on a laboratory developed test using next generation sequencing (NGS) technology for diagnosing SARS-CoV-2, according to Timothy Stenzel, MD, PhD.
Selected quotes from Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health at the FDA on the June 16, 2020, updates to EUA templates.
Four important statements from a June 8 CDC clinical laboratory call covering COVID-19 test data reporting requirements.
As of June 12, 2020, the FDA had authorized 135 COVID-19 tests under emergency use authorization (EUA), which include 114 molecular tests, 20 antibody tests, and 1 antigen test. The FDA has also released a new interactive tool designed to assist in identifying COVID-19 testing supply deficiencies and alternatives.
The FDA addresses concerns of unreliable tests by providing a new tool to support their evaluation of SARS-CoV-2 diagnostic tests.
SARS-CoV-2 test reporting requirements just multiplied. Clinical laboratories are on a deadline now.
Where to start when working on a laboratory developed test using next generation sequencing (NGS) technology for diagnosing SARS-CoV-2, according to Timothy Stenzel, MD, PhD.
Selected quotes from Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health at the FDA on the June 16, 2020, updates to EUA templates.
Four important statements from a June 8 CDC clinical laboratory call covering COVID-19 test data reporting requirements.
As of June 12, 2020, the FDA had authorized 135 COVID-19 tests under emergency use authorization (EUA), which include 114 molecular tests, 20 antibody tests, and 1 antigen test. The FDA has also released a new interactive tool designed to assist in identifying COVID-19 testing supply deficiencies and alternatives.
The FDA addresses concerns of unreliable tests by providing a new tool to support their evaluation of SARS-CoV-2 diagnostic tests.
SARS-CoV-2 test reporting requirements just multiplied. Clinical laboratories are on a deadline now.
Dear Colleague,
In these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.
We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.
Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.
Sincerely,
Robert L. Michel
President, Founder
The Dark Intelligence Group
