Recently Approved Documents
Precision (EP5-A2); Arterial Collection (H11-A4); Inpatient Medication Usage (HS10-A); Fluorescence Intensity (I/LA24-A) and Cellular Immune Functional Assays (I/LA26-A)

NCCLS is pleased to announce that the following documents have been approved by the Board of Directors for publication.  See the text following this list for information on options for member and nonmember organizations to obtain copies.

EP5-A2—Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition
This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers’ precision performance claims and determining when such comparisons are valid; as well as manufacturers’ guidelines for establishing claims.

H11-A4— Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition
This document provides principles for collecting, handling, and transporting arterial blood specimens to assist with reducing collection hazards and ensuring the integrity of the arterial specimen.

HS10-A—Application of a Quality System Model for Inpatient Medication Use; Approved Guideline
This document provides a model for providers of pharmacy services that will assist with implementation and maintenance of an effective quality system.

I/LA24-A—Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline
This guideline describes the basic principles, reference materials, and laboratory procedures upon which quantitative fluorescence calibration is based. 

I/LA26-A— Performance of Single Cell Immune Response Assays; Approved Guideline
This document contains methods of intracellular cytokine evaluation, major histo-compatibility complex (MHC) tetramer quantitation, and enzyme-linked immunospot (ELISPOT) technology.  This document provides basic aspects of specimen collection, transport, and preparation, in addition to quality assurance and test validation approaches.

-Second Notice-

EP14-A2— Evaluation of Matrix Effects; Approved Guideline—Second Edition
This document provides guidance for evaluating the bias in analyte measurements that is due to the sample matrix (physiological or artificial) when two measurement procedures are compared.

M29-A3— Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline—Third Edition
Based on U.S. regulations, this document provides guidance on the risk of transmission of hepatitis viruses and human immunodeficiency viruses in any laboratory setting; specific precautions for preventing the laboratory transmission of blood-borne infection from laboratory instruments and materials; and recommendations for the management of blood-borne exposure.

The NCCLS procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community which participates in the consensus process by carefully reviewing and commenting on the standard or guideline. The listed approved consensus documents are available for purchase.

You may automatically receive or select approved-level documents as a member benefit. For information on joining NCCLS, and viewing membership options and benefits, click here. [ return to top ]