CLSI Blog Articles

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

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.

It’s National Nurses Week

Join us in celebrating National Nurses Week as we acknowledge our appreciation and respect for the nursing professionals who work with laboratorians to deliver safe patient care. Nurses are often responsible for drawing patient blood samples that are delivered to the lab as well as performing point-of-care testing at the patient’s bedside. Laboratorians rely on nurses to perform testing that ultimately yields accurate results that contribute to good patient outcomes.

National Infant Immunization Week

National Infant Immunization Week (NIIW) is an observance that promotes the benefits of immunization for children two years old or younger. This year is the 25th anniversary of NIIW. Since 1994, organizations have worked together through NIIW to highlight the positive impact of vaccination on the lives of infants and children, and to call attention to immunization achievements.

Candida Auris Presents Global Health Threat

The Centers for Disease Control (CDC) is reporting that Candida auris, an emerging fungus that presents a serious global health threat, is causing severe illness in hospitalized patients in several countries, including the United States. Patients can remain colonized with C. auris for a long time and C. auris can persist on surfaces in health care environments. This can result in the spread of C. auris between patients in health care facilities.

The Importance of Laboratory Accreditation

An accredited laboratory inspires confidence in its customers. Laboratory accreditation is the internationally accepted framework for increasing test quality and reducing the frequency of laboratory errors. In order to pass accreditation, the laboratory must fulfill a set of requirements mandated by the accrediting body.

This Week We Celebrate National Public Health Week

During the first week of April, the American Public Health Association (APHA) brings together communities across the United States to observe National Public Health Week (NPHW) as a time to recognize the contributions of public health and highlight issues that are important to improving our nation. APHA creates new NPHW materials each year that can be used during and after NPHW to raise awareness about public health and prevention. You can visit the NPHW website for tools and tips and to learn how to get involved.

Accurate Patient Identification

Clinicians rely on the laboratory to provide accurate and reliable test results in order to treat the patient appropriately. Accurate patient identification is the first critical step to providing the right health care treatment for every patient. The consequences of an identification error can significantly impact an individual’s future health. In laboratory medicine, strict adherence to patient identification and specimen labeling requirements is necessary to maintain the unequivocal link between the accurately identified patient and the specimen throughout the path-of-workflow.