September 10, 2008 10:45 ET

CLSI Publishes Guideline for Assessment of Laboratory Tests

WAYNE, PA--(Marketwire - September 10, 2008) - Proficiency testing (PT) is an important part of quality management in the clinical laboratory. PT complements internal quality control (QC) to help ensure patient test results are valid. Clinical and Laboratory Standards Institute (CLSI) recently published an updated document, "Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline -- Second Edition (GP29-A2)," which offers methods to assess test performance when formal PT programs are not available.

Stephen J. Sarewitz, MD, Valley Medical Center, working group chairholder, says, "If PT is not available, laboratories should use alternative methods to periodically assess testing, because errors in the testing process can develop that may not be readily detected by routine QC. This document offers several methods that can be used to assess test performance when PT is not available."

The document addresses a variety of tests, including quantitative analyses of blood, microbiological cultures, morphologic analyses, and in vivo tests.

Validating ongoing performance is important for all laboratory tests. GP29-A2 offers guidelines for assessing test performance when PT is not available and includes information to:

--  Determine accuracy of analysis under some circumstances;
--  Compare performance against other laboratories using similar
    methods/reagents/instruments; and
--  Integrate quality elements for good laboratory practice.

This document is a revision of GP29-A, which was published in 2002, and includes the following updates:

--  revised/harmonized terminology;
--  updated examples of tests for which PT is not available; and
--  examples of government comparison programs.

The document is written for managers, supervisors, and laboratory personnel in traditional laboratories, as well as personnel performing point-of-care and bedside testing.

For additional information on CLSI or for further information regarding this release, visit or call +610.688.0100.

CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.

Contact Information

  • Contact:
    Amanda Holm
    Marketing Manager
    Phone: +610.688.0100 ext. 129
    E-mail: Email Contact