CLSI Blog Articles

Read the latest articles about CLSI and laboratory standards in the official CLSI Blog. Browse our most recent blog articles below.

NBS03, Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition

Each year millions of newborns are born prematurely, of low birth weight or with serious birth defects. The effects of these conditions, and the treatments these newborns receive greatly complicate the ability to obtain reliable and timely newborn screening results for the dozens of diseases screened.

AACC is Coming Up Soon!

The 71st AACC Annual Scientific Meeting & Clinical Lab Expo will take place in Anaheim, California at the Anaheim Marriott from August 4th through the 8th. The 71st AACC Annual Scientific Meeting & Clinical Lab Expo “showcases the cutting edge science and technology shaping the future of laboratory medicine.” The conference will be hosting over 300 exciting scientific and educational sessions to keep you informed about advances in laboratory medicine technology.

New Laboratory Equipment Performance Qualification Document

Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment. This is essential to ensuring the achievement of accurate and reproducible examination results.

CLSI’s Training Partnership in Tanzania

CLSI’s Joanne Christopher sat down with her colleague, Emily Anderson, who is a program manager with CLSI’s Global Health Partnerships working with our partners in laboratories in Tanzania. She wanted to find out more about how CLSI works with laboratories in Tanzania to help them improve patient care and achieve their accreditation goals.

New Next-Generation In Vitro Diagnostic Instrument Interface Standard

CLSI’s Next-Generation In Vitro Diagnostic Instrument Interface—AUTO16 applies to the exchange of analytical testing data between in vitro diagnostic instruments and health care informatics systems. The document discusses connectivity challenges present in medical laboratories. AUTO16 leverages the work of the IVD Industry Connectivity Consortium and Integrating the Healthcare Enterprise (IHE) organizations through the use of the Laboratory Analytical Workflow (LAW) Profile.

National Safety Month and Laboratory Safety

Observed annually in June, National Safety Month focuses on reducing leading causes of injury and death at work, on the road, and in homes and communities. The National Safety Council provides downloadable resources highlighting a different safety topic for each week in June. Topics for 2019 are Hazard Recognition, Slips, Trips and Falls, Fatigue, and Impairment. NSC remains focused on saving lives and preventing injuries, including raising public awareness of the opioid epidemic, helping to reduce motor vehicle crashes, and improving safety practices in workplaces across the country.

Clinical Laboratory Testing Interference

Interference in clinical laboratory testing can create discrepancies in test results which can lead to patient harm. In clinical chemistry, interference is defined as a cause of medically significant difference in the measurand test result due to another component or property of the sample. Although performance is monitored by internal QC and external quality assessment procedures, laboratories can’t easily detect error caused by interferents.

Next-Generation In Vitro Diagnostic Instrument Interface—AUTO16

CLSI’s AUTO16 (and its analog the IICC/IHE Laboratory Analytical Workflow (LAW) Profile) defines plug-n-play connectivity between instruments, middleware, and laboratory information systems in the clinical laboratory. More specifically, it defines the physical connection, transfer security, message definitions, and workflow definitions that standardize the data flow of IVD patient and QC test work order steps and results.

Learn About CLSI’s Free AST Rationale Documents

Understanding how CLSI’s antimicrobial susceptibility testing (AST) breakpoints and interpretive categories are determined is important for medical laboratories, drug and device manufacturers, and regulatory and accreditation organizations. To answer this question, CLSI publishes rationale documents that provide the scientific reasons behind the decisions related to breakpoint and interpretive categories, along with documentation of the standardized data and methods used to determine breakpoints.

General Laboratory Equipment Performance Qualification

Most examination results reported by laboratories are generated by methods that use common general laboratory equipment. Understanding what is needed to begin using and then maintaining the equipment can often be challenging. Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance is designed as a toolkit for general laboratory equipment. It provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment that is essential in ensuring the achievement of accurate and reproducible examination results.