Regulation, Licensing, and Accreditation of the ART Laboratory



Assisted reproductive technology (ART) laboratories are associated with assisted reproductive medical practices. These entities are unique in that they do not perform laboratory testing for purposes of diagnosis and treatment of disease but work with gametes and preembryos, performing interventions and treatments for infertility. These interventions and treatments vary among ART practices and extend from basic in vitro fertilization to highly complex and multifaceted genetic and molecular procedures. The level of education, training, and experience of the embryologists performing the work diverges as well, ranging from doctoral scientists specifically educated for the field to individuals trained on-site to perform procedures. Oversight of embryology and associated personnel may be by statute, regulation, guidelines, accreditation, licensure, or certification, or the field of embryology and embryologists may function without benefit of any type of scrutiny. Insufficient scrutiny, or inconsistent and confusing regulation of these ART interventions and treatments, as well as qualifications and oversight of the individuals performing the tasks, is of general concern. The procedures, which are often controversial, affect not only the infertile couple and any offspring that might result but also in cases of third-party reproduction multiple individuals who are involved, and because of associated medical, economic, scientific, ethical, religious, and legislative issues, ART has an effect on society as a whole. As a result, there is a movement to bring formal recognition and professional status to embryology. Members of the profession will then be able to petition for certification as an expectation for practice. Once embryology board certification is the standard, it will become a regulatory requirement, conferring embryologists parity with other medical and healthcare professionals. As well, members of the profession will be able to promote standardization for the field, have input into guidelines and development of quality standards for “laboratory” accreditation, and move toward self-regulation.


Accreditation Assisted reproductive technology ART interventions ART laboratory Certification Directive Embryologist Embryology Guideline Law Legal License Licensing body Mandate Oversight Standard Statute 


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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  1. 1.Reproductive Sciences, Center of Excellence in Reproductive SciencesUniversity of KentuckyLexingtonUSA

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