Hum. Reprod. Advance Access originally published online on March 28, 2008
Human Reproduction 2008 23(6):1253-1262; doi:10.1093/humrep/den068
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Revised guidelines for good practice in IVF laboratories
Laarbeeklaan 101, Brussels 1090, Belgium
* Correspondence address. UZ Brussel, Centre for Reproductive Medicine, Laarbeeklaan 101, 1090 Brussels, Belgium. E-mail: etienne.vandenabbeel{at}uzbrussel.be
The ‘ESHRE Guidelines for Good Practice in IVF Laboratories’ were drawn up by the Special Interest Group (SIG) in Embryology and published in the year 2000, and since then they constitute the minimal requirements for any laboratory offering assisted reproduction techniques (ART). In the understanding that the embryologist has a responsibility for the correct and justified application of ART in the laboratory, the implementation of these guidelines requires a quality management programme to be in place that encompasses and integrates the operative units, the processes and procedures that represent the core of ART clinics.
In March 2004, the European Parliament issued the Directive 2004/23/EC ‘On setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells’. The Directive applies to human tissues and cells, including fresh or frozen reproductive cells for application to the human body, and is mainly concerned with increasing quality and safety through the implementation of a quality management system.
Therefore, the European Society of Human Reproduction and Embryology (ESHRE) undertook a series of initiatives aiming to promote assurance of good laboratory practice and to define the concept of qualified embryologists. One ESHRE initiative was to revise the guidelines for good practice in IVF laboratories, not only in response to the need of embryologists for support and guidance in their duties, but also as a complement to the requirements issued by the Tissue and Cell Directive.
The SIG in Embryology hopes that this document may assist the laboratory staff to operate according to the requirements of harmonization, implementation, inspection and certification that are now common to all European member states.
Key words: assisted reproduction techniques/European Union Tissue and Cell Directive/laboratory safety/quality assurance/quality control
Submitted on January 9, 2008; resubmitted on February 5, 2008; accepted on February 12, 2008.
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