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Chapter 2 - Quality control, certification, and accreditation

Published online by Cambridge University Press:  05 July 2015

Kay Elder
Affiliation:
Bourn Hall Clinic, Cambridge
Marc Van den Bergh
Affiliation:
Fertility Laboratory, Kantonsspital Baden
Bryan Woodward
Affiliation:
IVF Consultancy Services, Leicester
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Publisher: Cambridge University Press
Print publication year: 2015

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References

Further reading

Association of Clinical Embryologists – www.embryologists.org.uk

ASRM Guidelines

The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology (2008). “Revised guidelines for human embryology and andrology laboratories.” Fertil Steril, 90:S45S59.CrossRefGoogle Scholar
Boone, WR, Higdon, HL III (2012). Quality control management. In: Practical Manual of In Vitro Fertilization, Advanced Methods and Novel Devices. Nagy, ZP, Varghese, AC, & Agarwal, A (eds), SpringerNY, pp. 33–9.Google Scholar
Carson, B, Alper, M, Keck, C (2005). Quality Management Systems for Assisted Reproductive Technology ISO 9001: 2000. Taylor Francis.Google Scholar
College of American Pathologists, Accreditation and Laboratory Improvementhttp://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditationGoogle Scholar
Cutting, R, Pritchard, J, Clarke, H, Martin, K (2004). Establishing quality control in the new IVF laboratory. Hum Fertil, 7(2), 119–25.CrossRefGoogle ScholarPubMed
Department of Healthwww.dh.gov.uk.Google Scholar
Edwards, RG, Purdy, JM (1982). Human Conception In Vitro; Proceedings of the First Bourn Hall Meeting, Edwards, RG & Purdy, JM (eds.) Academic Press, London.Google Scholar
Elder, K, Dale, B, In Vitro Fertilization, 3rd edition; Cambridge University Press, 2010 Joint Commission International (JCI). http://www.jointcommissioninternational.org/.CrossRefGoogle Scholar
Hreinsson, J, Sjøblom, P (2012). Regulation, licensing and accreditation of the ART laboratory in Europe. In: Practical Manual of In Vitro Fertilization, Advanced Methods and Novel Devices, Nagy, ZP, Varghese, AC, & Agarwal, A (eds), SpringerNY, pp. 611–18.Google Scholar
Hughes, C (2012). Association of Clinical Embryologists – Guidelines on Good Clinical Practice in Clinical Embryology Laboratories. Hum Fertil (Camb), 15 (4), 174–89.Google Scholar
International Organisation for Standardisation (ISO) (www.iso.org).Google Scholar
Keel, BA, May, JV, De Jonge, CJ, (eds.) (2000). Handbook of the Assisted Reproduction Laboratory, CRC Press.CrossRefGoogle Scholar
Lane, M, Mitchell, M, Cashman, KS, Feil, D, Wakefield, S, Zander-Fox, DL (2008). To QC or not to QC: the key to a consistent laboratory? Reprod, Fertil, Devel, 20, 2332.CrossRefGoogle ScholarPubMed
Magli, MC, Van den Abbeel, E, Lundin, K, Royere, D, Cen der Elst, J, Gianaroli, L (2008). ESHRE Guidelines. Revised guidelines for good practice in IVF laboratories. Hum Reprod 23(6) ESHRE pp. 1253–62.CrossRefGoogle ScholarPubMed
Mortimer, D, Mortimer, S (2007). Quality and Risk Management in the IVF Laboratory; Cambridge University Press.Google Scholar

References

Bertheussen, K, Holst, N, Forsdahl, F, Høie, KE (1989). A new cell culture assay for quality control in IVF. Hum Reprod, 4(5), 531–5.CrossRefGoogle ScholarPubMed
Critchlow, JD, Matson, PL, Newman, MC, Horne, G, Troup, SA, Lieberman, BA (1989). Quality control in an in vitro fertilisation laboratory: use of human sperm survival studies. Hum Reprod, 4, 545–9.CrossRefGoogle Scholar
Elder, K, Johnson, MH (2015c). The Oldham Notebooks: an analysis of the development of IVF 1969–1978. III. Variations in procedures. Reprod Biomed and Society, in press.CrossRefGoogle Scholar
George, MA, Braude, PR, Johnson, MH, Sweetnam, DG (1989). Quality control in the IVF laboratory: in-vitro and in-vivo development of mouse embryos is unaffected by the quality of water used in culture media. Hum Reprod, 4, 826–31.CrossRefGoogle ScholarPubMed
Gilligan, A, Schimmel, T, Esposito, B Jr., Cohen, J (2008). Release of volatile organic compounds such as styrene by sterile petri dishes and flasks used for in-vitro fertilization. IVF Online newsletter article: http://www.ivfonline.com/User/Newsstand/Release.aspx.Google Scholar
Hall, J, Gillian, A, Schimmel, T, Cecchi, M, Cohen, J (1998). The origin, effects and control of air pollution in laboratories used for human embryo culture. Hum Reprod, 13 (Suppl 4), 146–55.CrossRefGoogle ScholarPubMed
Holyoak, GR, Wang, S, Liu, S, Bunch, TD (1996). Toxic effects of ethylene oxide residues on bovine embryos in vitro. Toxicology, 108, 33–8.CrossRefGoogle ScholarPubMed
Imai, M (1997). Genba Kaizen: A Commonsense Low-cost Approach to Management. New York: McGraw-Hill Professional. p. 13.Google Scholar
ISO/IEC 17025 (2005). General requirements for the competence of testing and calibration laboratories.Google Scholar
ISO 9001 (2008). Quality Management Systems.Google Scholar
ISO15189 (2012). Medical Laboratories – Requirements for Quality and Competence.Google Scholar
Johnson, MH, Franklin, SB, Cottingham, M, Hopwood, N (2010). Why the Medical Research Council refused Robert Edwards and Patrick Steptoe support for research on human conception in 1971. Hum Reprod, 25 (9), 2157–74.CrossRefGoogle Scholar
Kastrop, PM (2003). Quality management in the ART laboratory. Reprod Biomed Online, 7(6), 691–4.CrossRefGoogle ScholarPubMed
Leandro, G, Rolando, N, Gallus, G, Rolles, K, Burroughs, AK (2005). Monitoring surgical and medical outcomes: the Bernoulli cumulative SUM chart. A novel application to assess clinical interventions. Postgrad Med J, 81, 647–52.CrossRefGoogle Scholar
Nijs, M, Franssen, K, Cox, A, Wissmann, D, Ruis, H, Ombelet, W (2009). Reprotoxicity of intrauterine insemination and in vitro fertilization – embryo transfer disposables and products: a 4-year survey. Fertil Steril, 92(2), 527–35.CrossRefGoogle ScholarPubMed
Purdy, JM (1982). Methods for fertilization and embryo culture in vitro. In: Human Conception In Vitro; Proceedings of the First Bourn Hall Meeting, Edwards, RG & Purdy, JM (eds.), Academic Press, London, p.135.Google Scholar
Rinehart, JS, Bavister, BD, Gerrity, M (1988). Quality control in the in vitro fertilization laboratory: comparison of bioassay systems for water quality. J In Vitro Fertili Embryo Transfer, 5, 335425.CrossRefGoogle ScholarPubMed
Van den Bergh, M, Baszo, I, Biramane, Jet al. (1996). Quality control in IVF with mouse bioassay: a four years experience. J Assist Reprod Genet, 13, 733–8.CrossRefGoogle ScholarPubMed

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