What Regulations for Preimplantation Genetic Diagnosis?
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Purpose: To discuss the qualifications of personnel involved in either (a) embryo biopsy/slide fixation, (b) performance of preimplantation genetic diagnosis-specific assays, or (c) interpretation of findings and results from such studies.
Methods: Illustrate similarities and differences between the qualifications and licensing requirements for personnel involved in high complexity testing in other laboratory specialities, such as microbiology or endocrinology.
Results: Parallels can in fact be drawn between specific personnel certification and licensing requirements for reporting test results following preimplantation genetic testing and those for other clinical specimens submitted for testing.
Conclusions: Assisted reproductive technology programs generally do not have personnel certified in cytotechnology or clinical genetics. Programs that perform the actual interpretation of specimens submitted for evaluation by fluorescent in situ hybridization will have to have supervisory personnel certified to perform such interpretations to ensure the level of quality control and assurance now afforded in centers for assisted reproductive technology.
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