Insights Blog

Inspection and accreditation doesn't have to be stressful. Using CLSI standards streamlines the process and has your laboratory inspection ready, and prepared to achieve accreditation with ease.

Through the power of translation, access to CLSI standards is advancing around the world, helping to create harmonization across the medical laboratory industry.

The CLSI Expert Panel on Method Evaluation is leading a strategic initiative to restructure CLSI EP documents, using a modular, purpose‑driven framework. This approach maintains scientific rigor while improving usability and navigation. This initiative marks a significant evolution in how EP guidance is organized and delivered to better support its consistent and effective application in practice.

CLSI EP49 brings together best practices for clinical performance evaluation, supporting more consistent and aligned laboratory approaches worldwide.

In an era of instant answers and AI-generated content, it’s tempting to believe that a quick search or chatbot response can replace the depth of expert consensus.

The table provided maps specific Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol (EP) documents that cover the Verification Phase of the Test Life Phases Model to assist medical laboratories verifying performance claims for both laboratory-developed tests and regulatory cleared or approved test methods.

CLSI has published a white paper, EP43—Implementing a Laboratory Test Under Emergency Use Conditions. EP43 covers public health emergencies (PHEs) in general, the ways in which emergency use authorizations (EUAs) may be used, and the ramifications of EUAs for medical laboratories and other testing sites.

Medical laboratory tests are essential to the clinical management of patients. It is important to express numerical results with additional properties, such as linearity.

Most laboratories use methods such as QC, equipment calibration measurement, QA measurements of process performance, and more recently, implementation of a quality management system, to determine the quality of examination results and laboratory services.

CLSI’s GHP team will be hosting a workshop on February 9-11th at the Medlab Middle East exhibition in Dubai. Participants will learn how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement.