title: Provision and quality assurance of preimplantation genetic diagnosis in Europe.
abstract: Preimplantation genetic diagnosis (PGD) is now well established and provided in many European countries. However, regulations, professional standards and accreditation requirements can differ notably. Furthermore, no comprehensive independent data exist either about practice and provision in Europe or about the quality assurance practices and procedures designed to optimize the quality of the results. Consequently, a study was launched to obtain knowledge, currently lacking, of the provision and quality assurance of PGD services and cross-border activities in Europe. An online questionnaire was developed and sent to PGD providers, and expert opinions were obtained through interviews with professionals in specific countries. Information was gathered from 53 centres offering PGD in 17 European countries. There is a diverse array of tests available, with a trend for custom-made services. Although half of the centres have a designated quality manager, just 33% have achieved or are preparing for accreditation or certification. About 66% of the centres responded that they did not participate in external quality assessment, a problem exacerbated by the lack of existing PGD-specific schemes. Approximately 19% of the centres do not keep data on accuracy and 9% do not even follow up until birth. PGD is an expanding activity with an increasing international flow that accounts for approximately one-third of the activity reported. The survey highlights a significant need for improvement in quality assurance in PGD centres. On the positive side, important improvements in the quality management of these services are expected with the European Tissue Directive entering into force.
authors: Department for Human Genetics, University of Leuven, Leuven, Belgium.
authors: Anniek
authors: A
authors: Corveleyn
authors: Michael A
authors: MA
authors: Morris
authors: Elisabeth
authors: E
authors: Dequeker
authors: Karen
authors: K
authors: Sermon
authors: James Lawford
authors: JL
authors: Davies
authors: Guillermo
authors: G
authors: Antiñolo
authors: Andreas
authors: A
authors: Schmutzler
authors: Jiri
authors: J
authors: Vanecek
authors: Nick
authors: N
authors: Nagels
authors: Eleni
authors: E
authors: Zika
authors: Francesc
authors: F
authors: Palau
authors: Dolores
authors: D
authors: Ibarreta
mesh_terms: D005060:Europe; D030342:Genetic Diseases, Inborn / Q000175:diagnosis* / Q000235:genetics; D005820:Genetic Testing / Q000379:methods*; D006801:Humans; D019836:Preimplantation Diagnosis