Clinical and Laboratory Standards Institute (CLSI)

February 28 is Rare Disease Day, a day dedicated to promoting awareness about rare diseases and how they impact patients' lives. Today, and every day, it's important to acknowledge the vital role testing and the work of laboratory and healthcare professionals play in helping to uncover and diagnose rare diseases. Learn more about #RareDiseaseDay here >> https://hubs.la/Q037Qs9x0.

Are you ready for Regulatory Approval? Join CLSI’s half-day virtual event for expert-led insights on compliance, testing protocols, and quality system implementation. What You’ll Gain: Keynotes & panels with top industry experts Hands-on learning labs & real-world case studies Critical updates on evolving regulatory oversight Register by March 16 for the lowest price >> https://hubs.la/Q038g8-J0. #ldt #clsi #CLSIRegulatoryReady

Check out this article that succinctly summarizes the regulatory requirements (as of now) for LDTs in the U.S. CLSI volunteers Shannon Bennett, MS, MBA, CMQOE (ASQ) and Benjamin Uphoff, MLS(ASCP) are among the contributors. The article explains the interrelationship of CLIA, ISO, NYS, and FDA, focusing on test validation and regulation. Read more here >> https://hubs.la/Q0382Ckc0.

Draw with efficiency. Prepare your lab with procedures for venous blood specimens, collection and identification processes. Ensuring accurate, safe, and efficient blood collection is critical for patient care. CLSI has two essential resources to help you and your team maintain best practices in venipuncture procedures, #CLSI #PRE02 & CLSI PRE02 Quick Guide. Get both here >> https://hubs.la/Q037nflV0. CLSI PRE02 was formerly sold under code: #GP41.

Get prepped for implementing #CLSI #M100 in your lab! Download your PDF copy of CLSI M100 if you haven't yet before Wednesday's webinar here >> https://hubs.la/Q037nfjX0.

Here are some highlights from our Committee's Week last month: Committees upholding standards, future educational products, vital decisions on antimicrobial testing, spotlight on C. Auris and anti fungal development, dynamic location, and excellent networking opportunities. #CLSIMeets Learn more about CLSI Committees Weeks: https://hubs.la/Q037k9P00

Make sure your lab is fully equipped! Participate as a team! Join the CLSI #M100 Updates Webinar highlighting new changes to breakpoints and performance standards. Package options for documents and group webinar registrations are available. More here >> https://hubs.la/Q037nflR0

We're excited to announce Eva Temkin with Arnold & Porter as the keynote speaker at our upcoming event, Testing with Confidence: Evaluation Protocols and Strategies for Compliance in an Evolving Regulatory Environment, on 29 April 2025. Secure your spot before the early bird special ends March 16 here >> https://hubs.la/Q037lhHV0 #ldt #ivd #clsi

#CLSI #MM23: Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd Edition is available for download. CLSI MM23 covers the current state of #molecular diagnostic methods intended for characterization of solid tumors and covers a range of clinical applications, including diagnosis, prognosis, therapeutic response prediction for available drugs and drugs still in clinical trials, monitoring, and presymptomatic and predisposition testing. Get it here >> https://hubs.la/Q03773zX0.

Calling all CLSI Members! Make an impact through volunteering to help develop CLSI M24: Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 4th Edition. Apply to serve on the committee here >> https://hubs.la/Q036Gsx00.