CLIA, Regulatory, & Accreditation

|2 min read

FDA Predetermined Change Control Plans May Aid LDT Modifications

A new PCCP draft guidance outlines what elements the agency expects in these plans

byKarin Hughes, PhD

ISO standards shown in a schematic drawing design

|1 min read

A2LA Accredits First Clinical Laboratory in US to New Version of ISO 15189

ADL Health meets requirements of ISO 15189:2022, the latest version of the standard

byA2LA

Image of the lobby of the OneLab VR facility.

|3 min read

Laboratory Training Goes Virtual

The CDC’s OneLab VR lab environment offers an expanding suite of lab training scenarios in real-time from around the world

byJoe Rothschild

Updated |2 min read

Webinar Recap: LDT Compliance Requirements for FDA Final Rule

Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance

byChristine P. Bump

Available on Demand

Loper Bright and the Potential Impact on the Laboratory Industry

Join Today's Clinical Lab, G2 Intelligence and Christine P. Bump to learn about Loper Bright and the Potential Impact on the Laboratory Industry

byChristine P. Bump

Sponsored by

Photo of the letters F, D, and A, representing the US FDA, on wooden blocks with pills in the background.

|2 min read

Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation

Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures

byAssociation for Molecular Pathology

|3 min read

The Quiet Brilliance of Efficient Water Purification

Impeccable Water Purification Systems Power the Lab With Minimal Staff Interaction

byELGA

Sponsored by

|1 min read

Tips for Improving Your Lab's Sustainability Practices

Learn actionable strategies to reduce waste, conserve energy, and optimize water use in your lab

byELGA

Sponsored by

An illustration of the chemical fingerprinting process at work on a common pesticide. Each peak in the graph indicates a different combination of carbon isotopes bonded to fluorine, as measured by the NMR instrument. The pattern gives the molecule its fingerprint.

Updated |3 min read

Forever Chemical Pollution Can Now Be Tracked via Carbon Fingerprinting

The new method could help authorities trace forever chemicals to their source after they end up in aquifers, waterways, or soil

byUniversity of Texas at Austin

Updated |1 min read

A Clinical Lab Manager’s Guide to Antimicrobial Stewardship

Explore the latest strategies and essential elements for effective antimicrobial stewardship in health care settings

byBiomerieux

Sponsored by

Photo of the word “regulation” in bold capital letters on the side of a file folder.

|3 min read

FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions

Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition

by Julie Ballard