Regulatory News

Late Breaking News and Information on SARS-CoV-2 From Regulators and Accreditors

CMS Releases FAQs for CLIA Certificates and University Laboratories

September 21, 2020 No Comments

Three essential points pertaining to university laboratories planning for SARS-CoV-2 surveillance testing.

CMS Releases New COVID-19 Testing and Reporting Requirements

September 15, 2020 No Comments

Guidance released Sept. 8 provides simplified details on nursing home testing that should be performed, also identifies three circumstances related to COVID-19 testing triggers.

FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing

September 11, 2020 No Comments

Four key points from the FDA’s September 2020 update to initial COVID-19 convalescent plasma guidelines.

FDA Issues New EUA for Multiplex SARS-CoV-2, Flu Test

September 7, 2020 No Comments

Combination coronavirus flu tests readying for flu season.

HHS Invokes Defense Production Act to Speed SARS-CoV-2 Antigen Test Production

September 3, 2020 No Comments

Details fall into place for invoking the Defense Production Act for SARS-CoV-2 antigen test production.

CMS Releases New and Modified CLIA Requirements and Penalties for Noncompliance

August 31, 2020 No Comments

Points of interest from CMS-3401-IFC and CLIA requirements modified in August 2020.

HHS Finds that FDA Does Not Have the Authority to Regulate Laboratory Developed Tests

August 26, 2020 No Comments

New guidance for those seeking approval or clearance of, or an EUA for, an LDT, and for those opting to use LDTs in their laboratories without FDA premarket review or authorization.

FDA Issues Four New Warning Letters for Adulterated and Misbranded COVID-19 Tests

August 25, 2020 No Comments

The four companies implicated in recent FDA warning letters over unauthorized COVID-19 tests. What did these tests have in common?

FDA Issues EUA for Third Diagnostic SARS-CoV-2 POC Antigen Test

August 19, 2020 No Comments

Update on emergency use authorization for third SARS-CoV-2 POC antigen test.

China-Based Autobio Diagnostics Becomes the Second Company to Have SARS-CoV-2 Serology Test EUA Revoked

August 19, 2020 No Comments

What the National Cancer Institute (NCI) found toward the revocation of Autobio Diagnostics’ antibody test EUA.

FDA Issues First EUAs for SARS-CoV-2 Serology Tests that Provide Quantitative Information About COVID-19 Antibodies

August 16, 2020 No Comments

New developments in measuring SARS-CoV-2 antibodies.

CMS Releases Answers to Frequently Asked Questions About Nursing Home SARS-CoV-2 Antigen Test Distribution

August 14, 2020 No Comments

Overview of new CMS resource for understanding SARS-CoV-2 antigen test distribution to nursing homes.

FDA Announces New EUA Template for At-Home and Over-the-Counter SARS-CoV-2 Diagnostic Tests

August 10, 2020 No Comments

FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing. The US Food and Drug Administration (FDA) issued

FDA Issues First EUA for SARS-CoV-2 Diagnostic Testing Intended to Test Asymptomatic Individuals

August 3, 2020 No Comments

New EUA opens the door for increased availability of COVID-19 testing for asymptomatic individuals.

FDA updates direction on alternative COVID-19 testing supplies

FDA Releases Update of Test Substitution Tool Identifying Validated Supply Alternatives for SARS-CoV-2 Testing

July 28, 2020 No Comments

The FDA recently updated its interactive tool designed to assist in identifying COVID-19 testing supply alternatives.

DOT Issues Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples

July 27, 2020 No Comments

Shipping guidelines for SARS-CoV-2 specimens emphasized as many clinical laboratories are not shipping specimens correctly.

FDA Issues First EUA for Pooled SARS-CoV-2 Diagnostic Testing

July 24, 2020 No Comments

Pooled SARS-CoV-2 diagnostic testing is now available after FDA issues first EUA for this testing method.

Clinical laboratories must abide by federal SARS-CoV-2 test reporting requirements.

HHS Releases New COVID-19 Reporting Requirements for In-House Clinical Laboratories

July 17, 2020 No Comments

A look at new COVID-19 test data reporting requirements for in-house clinical laboratories of critical access hospitals, children’s hospitals, general hospitals (including acute, trauma, and teaching hospitals), long-term acute care hospitals, military hospitals, oncology hospitals, orthopedic hospitals, pediatric long-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, surgical hospitals, Veterans Administration hospitals, women’s hospitals, and women’s and children’s hospitals, according to HHS.

FDA Announces Three EUAs Issued for SARS-CoV-2 and Influenza Combination Testing

July 17, 2020 No Comments

Overview of detection detailed in combination SARS-CoV-2 and flu testing EUAs.

CMS Answers Frequently Asked Questions for SARS-CoV-2 Surveillance Testing

July 13, 2020 No Comments

Interest is increasing in pooled sampling for SARS-CoV-2 surveillance testing. CMS addressed three primary questions in a recent FAQ.

insurance coverage issues with covid-19 testing

Federal Agencies Answer Frequently Asked Questions About Implementation of Health Coverage Issues Related to COVID-19

July 8, 2020 No Comments

Five points of interest to clinical laboratory leaders, gleaned from an over 8,000-word payer guidance document jointly developed by federal agencies.

Antigen SARS-CoV-2 Diagnostic Test EUA Update

July 8, 2020 No Comments

This point-of-care test can potentially scale up to test millions, according to FDA Commissioner Stephen Hahn, MD.

FDA Issues Warning Letter to KBMO Diagnostics for Advertising Unauthorized At-Home SARS-CoV-2 Testing

July 6, 2020 No Comments

Explanation of warnings issued to KBMO Diagnostics related to at-home COVID-19 testing.

FDA Announces First EUA for SARS-CoV-2 Testing Using Next-Generation Sequencing Technology

July 1, 2020 No Comments

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.

FDA Releases EUA Templates for Clinical Laboratories and Manufacturers Creating Tests for the Broad Screening of Asymptomatic Individuals

June 24, 2020 No Comments

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.

CDC Provides Additional Supporting Information on New Data Reporting Requirements for Clinical Laboratories

June 22, 2020 No Comments

Four important statements from a June 8 CDC clinical laboratory call covering COVID-19 test data reporting requirements.

Clinical laboratory testing supplies, such as primers and probes, master mix, collection and media, and general reagents. Photo snaps source FDA supply tool.

FDA Announces New Tool for Clinical Laboratories to Identify Validated Supply Alternatives for SARS-CoV-2 Testing

June 17, 2020 No Comments

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.

FDA Releases SARS-CoV-2 Reference Panel for Laboratory and Commercial Test Developers

June 9, 2020 No Comments

The FDA addresses concerns of unreliable tests by providing a new tool to support their evaluation of SARS-CoV-2 diagnostic tests.

HHS Announces New Guidance for SARS-CoV-2 Testing Reporting by Clinical Laboratories

June 5, 2020 No Comments

SARS-CoV-2 test reporting requirements just multiplied. Clinical laboratories are on a deadline now.

FDA-serology-test-removed-not-for-distribution

FDA Issues List of SARS-CoV-2 Antibody Tests That Have Been Removed from the FDA’s Notification List

June 5, 2020 No Comments

Introduction to commercially manufactured SARS-CoV-2 serology tests listed with the status of “Removed – Should Not Be Distributed.”

3 Frequently Asked Questions About COVID-19 Price Transparency Requirements

June 3, 2020 No Comments

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.

Centers for Medicare & Medicaid Services

SARS-CoV-2 Serology Reimbursement Rates Posted

May 31, 2020 No Comments

Multiple-step methods versus single-step methods differentiated.

Update to COVID-19 Molecular Diagnostics Specimen Requirements

May 26, 2020 No Comments

As the number of COVID-19 cases in the United States has increased, the availability of real COVID-19 positive specimens has also increased.

Overview of CMS Rule Changes Allowing Flexibility for COVID-19 Testing, Telehealth, and Hospital Operations

May 23, 2020 No Comments

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.

7 Highlights of the FDA EUA Policy Issued May 11

May 18, 2020 No Comments

Major highlights of the FDA’s revised COVID-19 testing policy issued May 11, 2020.

CMS Releases New Guidance on CLIA Certifications and Requirements to Perform SARS-CoV-2 Testing

May 13, 2020 No Comments

Compare SARS-CoV-2 testing requirements for clinical laboratories and other facilities based on new 20-06-CLIA memo issued April 30, 2020.

Regulatory Agencies Are Investigating and Prosecuting COVID-19 Related Fraud and Waste

May 1, 2020 No Comments

Clinical laboratory directors may reduce their risk of fraud and waste by familiarizing themselves with these four areas of recent focus.

HIPAA Enforcement Relaxed to Allow More Information Flow in Response to COVID-19 Pandemic

April 30, 2020 No Comments

Impact of relaxing HIPAA enforcement during COVID-19 pandemic.

Regulatory News

CMS Releases FAQs for CLIA Certificates and University Laboratories

Three essential points pertaining to university laboratories planning for SARS-CoV-2 surveillance testing.

September 21, 2020 No Comments

Regulatory News

CMS Releases New COVID-19 Testing and Reporting Requirements

Guidance released Sept. 8 provides simplified details on nursing home testing that should be performed, also identifies three circumstances related to COVID-19 testing triggers.

September 15, 2020 No Comments

Regulatory News

FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing

Four key points from the FDA’s September 2020 update to initial COVID-19 convalescent plasma guidelines.

September 11, 2020 No Comments

Regulatory News

FDA Issues New EUA for Multiplex SARS-CoV-2, Flu Test

Combination coronavirus flu tests readying for flu season.

September 7, 2020 No Comments

Regulatory News

HHS Invokes Defense Production Act to Speed SARS-CoV-2 Antigen Test Production

Details fall into place for invoking the Defense Production Act for SARS-CoV-2 antigen test production.

September 3, 2020 No Comments

Regulatory News

CMS Releases New and Modified CLIA Requirements and Penalties for Noncompliance

Points of interest from CMS-3401-IFC and CLIA requirements modified in August 2020.

August 31, 2020 No Comments

Regulatory News

CMS Releases FAQs for CLIA Certificates and University Laboratories

Three essential points pertaining to university laboratories planning for SARS-CoV-2 surveillance testing.

September 21, 2020 No Comments

Regulatory News

CMS Releases New COVID-19 Testing and Reporting Requirements

Guidance released Sept. 8 provides simplified details on nursing home testing that should be performed, also identifies three circumstances related to COVID-19 testing triggers.

September 15, 2020 No Comments

Regulatory News

FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing

Four key points from the FDA’s September 2020 update to initial COVID-19 convalescent plasma guidelines.

September 11, 2020 No Comments

Regulatory News

FDA Issues New EUA for Multiplex SARS-CoV-2, Flu Test

Combination coronavirus flu tests readying for flu season.

September 7, 2020 No Comments

Regulatory News

HHS Invokes Defense Production Act to Speed SARS-CoV-2 Antigen Test Production

Details fall into place for invoking the Defense Production Act for SARS-CoV-2 antigen test production.

September 3, 2020 No Comments

Regulatory News

CMS Releases New and Modified CLIA Requirements and Penalties for Noncompliance

Points of interest from CMS-3401-IFC and CLIA requirements modified in August 2020.

August 31, 2020 No Comments

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

Regulatory News

Late Breaking News and Information on SARS-CoV-2 From Regulators and Accreditors

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times