Thursday, April 28, 2005

A sustainable community process to improve availability of appropriate, verified quality control (QC) materials for genetic testing

Lisa Kalman, Bin Chen, Ira M. Lubin, and D. Joe Boone.

The expansion of molecular genetic testing in clinical and public health practice has increased the need for appropriate, verified quality control (QC) materials for quality assurance, test validation, proficiency testing (PT), and development of new genetic tests. However, despite the growing test volume and the rapidly increasing number of tests being offered, the necessary QC materials are not available for many tests.

To improve public availability of QC materials and facilitate information exchange and communication on QC materials development, contribution, verification, distribution, and needs assessment.

The Centers for Disease Control and Prevention (CDC) convened three working meetings in 2003/04 to identify specific areas of need, develop recommendations for practical approaches and establish a sustainable, collaborative process to make QC materials available to the genetic testing community.

Based on recommendations from meeting participants, the CDC established a QC Materials Coordination Program and designated a QC Materials Coordinator (QCMC) who will provide continuing support and coordination to improve QC material availability. The QCMC will 1) facilitate the identification, procurement, development, verification and distribution of needed QC materials; 2) facilitate exchange of QC-related information; and 3) explore collaborative efforts for ongoing needs monitoring and materials development. A QCMC website, currently under construction, will serve as an interactive communication tool to link users, providers, potential contributors, developers, and resources of QC materials and to inform the community about the availability of QC materials of clinical and public health interest.

These efforts will provide a sustainable, community-based process to make verified quality control materials available to the genetic testing community.

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