Recently Approved Documents
Free Hormones (C45-A); Limits of Detection (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); Patient Outcomes (HS6-A); Transfer Information Between Clinical Instruments and Computer Systems (LIS2-A2)

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.

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.

-Second Notice-

C45-A—Measurement of Free Thyroid Hormones; Approved Guideline
This document addresses analytical and clinical validation of free (nonprotein-bound) thyroid hormone (FTH) measurement procedures.

HS6-A—Studies to Evaluate Patient Outcomes; Approved Guideline
This guideline describes the essential issues in planning outcomes research, including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan, including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.

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 ]