What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Author Information
Tara Cepull, MA
Tara Cepull, MA, earned a master's degree with high distinction in clinical psychology in 2009. She offered inpatient and outpatient psychological services for seven years prior to a career pivot that allowed her to gain nearly eight years of executive leadership experience in the recruiting and staffing industry with a particular focus on laboratory personnel, CLIA lab directors, and pathologists. She is now focusing her vocational energy on writing, editing, and content creation. In her free time, Tara enjoys hiking in Shenandoah National Park with her husband, playing video games, and curling up with a good book.
Posts by the Author
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
Using AI to Improve Reimbursement and Decrease Claim Denials
Though payers’ adoption of AI has made reimbursement more challenging for labs, providers can also use AI to address these issues
Private Payer Reimbursement for Genetic Testing Hinges on Clinical Utility
Two revenue cycle management experts offer tips for clinical labs to improve coverage decisions for genetic tests
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Considering the Impact of Digital Pathology on Recruitment Efforts
How might a modestly sized lab or pathology group harness technology to address their recruitment needs?
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
What the FTC’s New Noncompete Rule Means for Your Lab
The new rule, slated to go into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry
