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Quality cannot be taken for granted, especially in the laboratory. Yet many healthcare organizations are operating without well-defined or even documented policies, processes, and procedures. Now CLSI is announcing a solution available in January 2007. Called The Key to Quality, it includes all of the fundamentals for implementing a quality system in the clinical laboratory. The Key to Quality is a comprehensive portfolio that covers 12 quality system essentials, the building blocks for a quality management system. The portfolio includes tabs for easy reference; an overview of policies, processes, and procedures for each of the 12 quality system essentials; as well as examples and checklists. There’s also a CD-ROM with additional examples and a PowerPoint presentation to get you started. The Key to Quality is universal and can be applied to any operation from simple to complex and regardless of where you reside on the quality spectrum. Using the guidelines and tools in The Key to Quality you can establish a quality management system or a methodology for continuous improvement with the following outcomes:
Streamline laboratory processes
Enhance employee potential
Meet accreditation requirements
Reduce risk of medical errors

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Body Fluid Analysis for Cellular Composition; Approved Guideline (H56-A)
NEWLY PUBLISHED
Provides recommendations for standardizing collection and transport of body fluids; numeration and identification of cellular components; and guidance for qualitative and quantitative assessment for the characterization of inflammatory, infectious, neoplastic, and immune alterations.
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition (H20-A2)
AVAILABLE in NOVEMBER
Evaluates automated and semiautomated hematology instruments for their capability to perform an acceptable leukocyte (WBC) differential count.

COMING in DECEMBER!
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition (H42-A2)
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition (H43-A2)

Order NowCall +610.688.0100 or toll free at +877.447.1888Fax +610.688.0700Visit our web site at www.clsi.org Contact customerservice@clsi.org

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X5-R was recently published to help resolve confusion surrounding the best practical approach to metrological traceability, ensuring comparable results regardless of location or device. Metrological traceability is facilitated by expressing results in common units, producing a measurement system that supports shared reference intervals and decision limits. Results from a harmonized measurement system support the establishment of common reference intervals and decision limits, whic allows for global application of clinical study findings. However, much confusion exists about how to implement the traceability scheme on a practical level. X5-R can help by:
providing guidance for establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the requirements for in vitro diagnostic (IVD) medical devices in ISO 17511 and ISO 15183, as well as the requirements for traceability in the IVD Directive;
explaining the basics of traceability; and
defining a reference measurement system that includes reference materials, measurement procedures, reference laboratories, and laboratory networks

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