title: Developing a sustainable process to provide quality control materials for genetic testing.
abstract: OBJECTIVE
  To provide a summary of the outcomes of two working conferences organized by the Centers for Disease Control and Prevention (CDC), to develop recommendations for practical, sustainable mechanisms to make quality control (QC) materials available to the genetic testing community.
  
  
  METHODS
  Participants were selected to include experts in genetic testing and molecular diagnostics from professional organizations, government agencies, industry, laboratories, academic institutions, cell repositories, and proficiency testing (PT)/external Quality Assessment (EQA) programs. Current efforts to develop QC materials for genetic tests were reviewed; key issues and areas of need were identified; and workgroups were formed to address each area of need and to formulate recommendations and next steps.
  
  
  RESULTS
  Recommendations were developed toward establishing a sustainable process to improve the availability of appropriate QC materials for genetic testing, with an emphasis on molecular genetic testing as an initial step.
  
  
  CONCLUSIONS
  Improving the availability of appropriate QC materials is of critical importance for assuring the quality of genetic testing, enhancing performance evaluation and PT/EQA programs, and facilitating new test development. To meet the needs of the rapidly expanding capacity of genetic testing in clinical and public health settings, a comprehensive, coordinated program should be developed. A Genetic Testing Quality Control Materials Program has therefore been established by CDC in March 2005 to serve these needs.
authors.affiliation: Quality Control Materials for Genetic Testing Group, Centers for Disease Control and Prevention, Atlanta, Georgia 30341, USA.
authors.forename: Bin
authors.initials: B
authors.lastname: Chen
authors.forename: Catherine D
authors.initials: CD
authors.lastname: O' Connell
authors.forename: D Joe
authors.initials: DJ
authors.lastname: Boone
authors.forename: Jean A
authors.initials: JA
authors.lastname: Amos
authors.forename: Jeanne C
authors.initials: JC
authors.lastname: Beck
authors.forename: Maria M
authors.initials: MM
authors.lastname: Chan
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Farkas
authors.forename: Roger V
authors.initials: RV
authors.lastname: Lebo
authors.forename: Carolyn Sue
authors.initials: CS
authors.lastname: Richards
authors.forename: Benjamin B
authors.initials: BB
authors.lastname: Roa
authors.forename: Lawrence M
authors.initials: LM
authors.lastname: Silverman
authors.forename: David E
authors.initials: DE
authors.lastname: Barton
authors.forename: Bassem A
authors.initials: BA
authors.lastname: Bejjani
authors.forename: Dorothy R
authors.initials: DR
authors.lastname: Belloni
authors.forename: Susan H
authors.initials: SH
authors.lastname: Bernacki
authors.forename: Michele
authors.initials: M
authors.lastname: Caggana
authors.forename: Patricia
authors.initials: P
authors.lastname: Charache
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Dequeker
authors.forename: Andrea
authors.initials: A
authors.lastname: Ferreira-Gonzalez
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Friedman
authors.forename: Carol L
authors.initials: CL
authors.lastname: Greene
authors.forename: Wayne W
authors.initials: WW
authors.lastname: Grody
authors.forename: William Edward
authors.initials: WE
authors.lastname: Highsmith
authors.forename: Cecelia S
authors.initials: CS
authors.lastname: Hinkel
authors.forename: Lisa V
authors.initials: LV
authors.lastname: Kalman
authors.forename: Ira M
authors.initials: IM
authors.lastname: Lubin
authors.forename: Elaine
authors.initials: E
authors.lastname: Lyon
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Payne
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Pratt
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Rohlfs
authors.forename: Clark A
authors.initials: CA
authors.lastname: Rundell
authors.forename: Erasmus
authors.initials: E
authors.lastname: Schneider
authors.forename: Ann M
authors.initials: AM
authors.lastname: Willey
authors.forename: Laurina O
authors.initials: LO
authors.lastname: Williams
authors.forename: James C
authors.initials: JC
authors.lastname: Willey
authors.forename: Emily S
authors.initials: ES
authors.lastname: Winn-Deen
authors.forename: Daynna J
authors.initials: DJ
authors.lastname: Wolff
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S.; D005820:Genetic Testing / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States