CMS Releases New Guidance on CLIA Certifications and Requirements to Perform SARS-CoV-2 Testing
Compare SARS-CoV-2 testing requirements for clinical laboratories and other facilities based on new 20-06-CLIA memo issued April 30, 2020.
Northwell Health Labs Uses Mobile Phlebotomy App to Better Serve Patients, Increase Test Volume and Revenue During COVID-19 Outbreak
Christopher Zavala of Northwell Health Labs explains use of Northwell’s mobile collections services app for blood draws, before and during the COVID-19 pandemic.
FDA Seeks Path Forward for How It Regulates the Development of COVID-19 Clinical Laboratory Tests
Roger D. Klein, MD, JD, explains how federal regulation around clinical laboratory developed tests (LDTs) has evolved during the COVID-19 pandemic.
DOJ Indicts Individual for COVID-19 Test Bribes Under Anti-Kickback
Understand how the anti-kickback law connects to the Erik Santos COVID-19 test bribe case, plus EKRA.
Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests
This complimentary program features leading clinical laboratory thought leaders James O. Westgard, PhD, Sten Westgard and The Dark Report founder Robert L. Michel, as they discuss how labs can navigate the risks and pitfalls of COVID-19 serology testing. Learn what you should look for to ensure that the tests will produce accurate, reproducible test results.
Regulatory Agencies Are Investigating and Prosecuting COVID-19 Related Fraud and Waste
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
Impact of relaxing HIPAA enforcement during COVID-19 pandemic.
Antibody Studies in Three Cities Hint at Greater Magnitude of COVID-19 Exposure
Review three briefs about first COVID-19 antibody studies in three cities, and what these studies suggest about demand for serology testing.
Hospital-based Clinical Laboratories Need to Submit Daily Reports on COVID-19 Test Activity to Federal Government
Explanation and discussion of federal guideline for daily clinical laboratory COVID-19 test reporting to FEMA.
3 Essentials for Setting Up COVID-19 Serology Testing in the Lab
An exclusive interview and podcast with Frederick (Fritz) Kiechle, MD, PhD, explores what actions clinical laboratories can take to implement reliable antibody tests and benefit from potential serology testing reimbursement.