NCCLS eNews - 8 December 2004 (Plain Text Version)

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News
Executive Vice President’s Message
NCCLS’s Name Will Change, But our Mission and Values Remain the Same
Press Releases
Standards Status
Notice of Vote and Comment Deadline for Consensus Document
Recently Approved Documents
Recently Published ISO Standards
Focus on Global Terminology
Seeking Expert Opinions and Volunteer Participation – Call for Nominations
Events and Exhibits
Meeting Calendar
Upcoming Events and Exhibits
Membership
Join Us
New and Sustaining Members
Update Your Subscriptions

Recently Approved Documents

Limits of Detection and Limits of Quantitation (EP17-A); Continuous Quality Improvement (GP22-A2); Laboratory Quality Management Systems (GP26-A3); Handling and Processing of Blood Specimens (H18-A3); Quality Management System for Health Care (HS1-A2); Maternal Serum Screening (I/LA25-A); Transfer Information Between Clinical Instruments and Computer Systems (LIS2-A2); Nucleic Acid Sequencing (MM9-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.

I/LA25-A—Maternal Serum Screening; Approved Standard
This document addresses the steps required to provide reliable screening and reporting using examples of serum markers currently in common use (AFP, hCG, uE3, DIA). Outcome evaluation, information management, and calculation of risk are also emphasized in this standard.

MM9-A—Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline
This document addresses automated, PCR-based, dideoxy-terminator, and primer extension sequencing done on gel- or capillary-based sequencers. Topics covered include specimen collection and handling; isolation of nucleic acid; amplification and sequencing of nucleic acids; interpretation and reporting of results; and quality control/assessment considerations as appropriate.

-Second Notice-

EP17-A—Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline
This guideline provides protocols for determining the lower limits of detection of clinical laboratory methods, for verifying claimed limits, and for the proper use and interpretation of these limits.

GP22-A2— Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline—Second Edition
This guideline considers continuous quality improvement (CQI) as integrated quality system components, which include Quality Planning, Quality Teamwork, Quality Monitoring, Quality Improvement, and Quality Review.

GP26-A3—Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition
This guideline describes the clinical laboratory’s path of workflow and provides information for laboratory operations that will assist the laboratory in improving its processes and meeting government and accreditation requirements.

H18-A3 — Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition
This document includes criteria for preparing an optimal serum or plasma sample and for the devices used to process blood specimens.

HS1-A2—A Quality Management System Model for Health Care; Approved Guideline—Second Edition
This document provides a model for providers of healthcare services that will assist with implementation and maintenance of effective quality management systems.

LIS2-A2—Specification for Transferring Information Between Clinical Instruments and Computer Systems: Approved Standard—Second Edition
This specification covers the two-way digital transmission of remote requests and results between clinical laboratory instruments and information systems. It enables any two such systems to establish a logical link for communicating text to send result, request, or demographic information in a standard and interpretable form.

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.