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Chapter 9 - Quality Management in the IVF Laboratory

Published online by Cambridge University Press:  24 December 2019

Kay Elder
Affiliation:
Bourn Hall Clinic, Cambridge
Brian Dale
Affiliation:
Centre for Assisted Reproduction, Naples
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Summary

From the beginning of the twenty-first century onwards, laboratories that offer human ART treatment or are involved in the handling of human gametes and/or tissue became subject to increasing demands and precepts set down by regulatory and legislative authorities. The regulations differ from country to country, and some directives (e.g., the EuropeanTissue Directive 2004/23/EC-2006/86/EC) are subject to interpretation according to legislation or guidelines set down by national authorities in individual countries. In many countries, it has become necessary to obtain accreditation and/or certification by a national or international body that will carry out in-depth assessments and inspections to ensure that all aspects of facilities and treatment meet a required standard.

Type
Chapter
Information
In-Vitro Fertilization , pp. 180 - 193
Publisher: Cambridge University Press
Print publication year: 2020

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References

Bento, F, Esteves, S, Agarwal, A, eds. (2013) Quality Management in ART Clinics: A Practical Guide. Springer, New York.CrossRefGoogle Scholar
Carson, B, Alper, M, Keck, C (2005) Quality Management Systems for Assisted Reproductive Technology. Taylor & Francis, London.Google Scholar
Elder, KT, Baker, D, Ribes, J (2005) Infections, Infertility and Assisted Reproduction. Cambridge University Press, Cambridge, UK.Google Scholar
Elder, K, Van den Bergh, M, Woodward, B (2015).Troubleshooting and Problem-Solving in the IVF Laboratory. Cambridge University Press, Cambridge, UK.CrossRefGoogle Scholar
Keel, BA, May, JV, De Jonge, CJ (eds.) (2000) Handbook of the Assisted Reproduction Laboratory. CRC Press, Boca Raton, FL.CrossRefGoogle Scholar
Mortimer, ST, Mortimer, D (2015) Quality and Risk Management in the IVF Laboratory, 2nd edn. Cambridge University Press, Cambridge, UK.CrossRefGoogle Scholar
Association of Clinical Embryologists: www.embryologists.org.uk
College of American Pathologists, Accreditation and Laboratory Improvement: www.cap.org/laboratory-improvement/accreditation
Health and Safety: www.hse.gov.uk
Human Fertilisation and Embryology Authority: www.hfea.gov.uk
Human Fertilisation and Embryology Code of Practice 9th edition, 2019: www.hfea.gov.uk/media/2793/2019-01-03-code-of-practice-9th-edition-v2.pdf
International Organization for Standardization (ISO): www.iso.org
Joint Commission International (JCI): www.jointcommissioninternational.org/
Department of Health: www.dh.gov.uk
The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology (2014) Recommended practices for the management of human embryology, andrology and endocrinology laboratories: a committee opinion. Fertility and Sterility 102(4): 00150284.
de los Santos, MJ, Apter, S, Coticchio, G, et al. (2016) Revised guidelines for good practice in IVF laboratories. Human Reproduction 31(4): 685686.Google ScholarPubMed
Magli, MC, Van den Abbeel, E, Lundin, K, et al. (2008) Revised guidelines for good practice in IVF laboratories. Human Reproduction 23(6): 12531262.CrossRefGoogle ScholarPubMed
Alper, MA (2013) Experience with ISO quality control in assisted reproductive technology. Fertility and Sterility 100(6): 15031508.CrossRefGoogle ScholarPubMed
Blechová, R, Pivodová, D (2001) LAL test – an alternative method of detection of bacterial endotoxins. Acta Veterinaria 70: 291296.CrossRefGoogle Scholar
Butler, JM, Johnson, J, Boone, WR (2013) The heat is on: room temperature affects laboratory equipment; an observational study. Journal of Assisted Reproduction and Genetics 30(10): 13891393.CrossRefGoogle ScholarPubMed
Cohen, J, Gilligan, A, Esposito, W, Schimmel, T, Dale, B (1997) Ambient air and its potential effects on conception in vitro. Human Reproduction 12: 17421749.CrossRefGoogle ScholarPubMed
Critchlow, JD, Matson, PL, Newman, MC, et al. (1989) Quality control in an in vitro fertilisation laboratory: use of human sperm survival studies. Human Reproduction 4: 545549.CrossRefGoogle Scholar
Cutting, R, Pritchard, J, Clarke, H, Martin, K (2004) Establishing quality control in the new IVF laboratory. Human Fertility 7(2): 119125.CrossRefGoogle ScholarPubMed
Gilling-Smith, C, Emiliani, S, Almeida, P, Liesnard, C, Englert, Y (2005) Laboratory safety during assisted reproduction in patients with blood-borne viruses. Human Reproduction 20: 14331438.CrossRefGoogle ScholarPubMed
Imai, M (1997) Gemba Kaizen: A Commonsense, Low-Cost Approach to Management. McGraw Hill, New York.Google Scholar
Kastrop, PM (2003) Quality management in the ART laboratory. Reproductive BioMedicine Online 7(6): 691694.CrossRefGoogle ScholarPubMed
Meintjes, M, Chantilis, SJ, Douglas, JD, et al. (2009) A controlled, randomized trial evaluating the effect of lowered incubator oxygen tension on live births in a predominantly blastocyst transfer program. Human Reproduction 24(2): 300307.CrossRefGoogle Scholar
Nijs, M, Franssen, K, Cox, A, et al. (2009) Reprotoxicity of intrauterine insemination and in vitro fertilization – embryo transfer disposables and products: a 4-year survey. Fertility and Sterility 92(2): 527535.CrossRefGoogle ScholarPubMed
Painter, RB (1978) DNA synthesis inhibition in HeLa cells as a simple test for agents that damage human DNA. Journal of Environmental Pathology and Toxicology 2(1): 6578.Google ScholarPubMed
Phillips, KP, Leveille, MC, Klaman, P, Baltz, JM (2000) Intracellular pH regulation in preimplantation embryos. Human Reproduction 15: 896904.CrossRefGoogle ScholarPubMed
Pool, T (2004) Optimising pH in clinical embryology. Clinical Embryologist 7(3): 117.Google Scholar
Rinehart, JS, Bavister, BD, Gerrity, M (1988) Quality control in the in vitro fertilization laboratory: comparison of bioassay systems for water quality. Journal of In Vitro Fertilization and Embryo Transfer 5: 335425.CrossRefGoogle ScholarPubMed
Swain, JE (2012) Is there an optimal pH for culture media used in clinical IVF? Human Reproduction Update 18: 333339.CrossRefGoogle ScholarPubMed
Swain, JE, Cabrera, L, Smith, GD (2012) Microdrop preparation factors influence culture media osmolality which can impair mouse preimplantation embryo development. Reproductive BioMedicine Online 2012; 24(2): 142147.CrossRefGoogle Scholar
Tedder, RS, Zuckerman, MA, Goldstone, AH, et al. (1995) Hepatitis B transmission from contaminated cryopreservation tank. Lancet 346: 137140.CrossRefGoogle ScholarPubMed
Tomlinson, M (2005) Managing risks associated with cryopreservation. Human Reproduction 20: 14331438.CrossRefGoogle ScholarPubMed
Bento, F, Esteves, S, Agarwal, A, eds. (2013) Quality Management in ART Clinics: A Practical Guide. Springer, New York.CrossRefGoogle Scholar
Carson, B, Alper, M, Keck, C (2005) Quality Management Systems for Assisted Reproductive Technology. Taylor & Francis, London.Google Scholar
Elder, KT, Baker, D, Ribes, J (2005) Infections, Infertility and Assisted Reproduction. Cambridge University Press, Cambridge, UK.Google Scholar
Elder, K, Van den Bergh, M, Woodward, B (2015).Troubleshooting and Problem-Solving in the IVF Laboratory. Cambridge University Press, Cambridge, UK.CrossRefGoogle Scholar
Keel, BA, May, JV, De Jonge, CJ (eds.) (2000) Handbook of the Assisted Reproduction Laboratory. CRC Press, Boca Raton, FL.CrossRefGoogle Scholar
Mortimer, ST, Mortimer, D (2015) Quality and Risk Management in the IVF Laboratory, 2nd edn. Cambridge University Press, Cambridge, UK.CrossRefGoogle Scholar
Association of Clinical Embryologists: www.embryologists.org.uk
College of American Pathologists, Accreditation and Laboratory Improvement: www.cap.org/laboratory-improvement/accreditation
Health and Safety: www.hse.gov.uk
Human Fertilisation and Embryology Authority: www.hfea.gov.uk
Human Fertilisation and Embryology Code of Practice 9th edition, 2019: www.hfea.gov.uk/media/2793/2019-01-03-code-of-practice-9th-edition-v2.pdf
International Organization for Standardization (ISO): www.iso.org
Joint Commission International (JCI): www.jointcommissioninternational.org/
Department of Health: www.dh.gov.uk
The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology (2014) Recommended practices for the management of human embryology, andrology and endocrinology laboratories: a committee opinion. Fertility and Sterility 102(4): 00150284.
de los Santos, MJ, Apter, S, Coticchio, G, et al. (2016) Revised guidelines for good practice in IVF laboratories. Human Reproduction 31(4): 685686.Google ScholarPubMed
Magli, MC, Van den Abbeel, E, Lundin, K, et al. (2008) Revised guidelines for good practice in IVF laboratories. Human Reproduction 23(6): 12531262.CrossRefGoogle ScholarPubMed
Alper, MA (2013) Experience with ISO quality control in assisted reproductive technology. Fertility and Sterility 100(6): 15031508.CrossRefGoogle ScholarPubMed
Blechová, R, Pivodová, D (2001) LAL test – an alternative method of detection of bacterial endotoxins. Acta Veterinaria 70: 291296.CrossRefGoogle Scholar
Butler, JM, Johnson, J, Boone, WR (2013) The heat is on: room temperature affects laboratory equipment; an observational study. Journal of Assisted Reproduction and Genetics 30(10): 13891393.CrossRefGoogle ScholarPubMed
Cohen, J, Gilligan, A, Esposito, W, Schimmel, T, Dale, B (1997) Ambient air and its potential effects on conception in vitro. Human Reproduction 12: 17421749.CrossRefGoogle ScholarPubMed
Critchlow, JD, Matson, PL, Newman, MC, et al. (1989) Quality control in an in vitro fertilisation laboratory: use of human sperm survival studies. Human Reproduction 4: 545549.CrossRefGoogle Scholar
Cutting, R, Pritchard, J, Clarke, H, Martin, K (2004) Establishing quality control in the new IVF laboratory. Human Fertility 7(2): 119125.CrossRefGoogle ScholarPubMed
Gilling-Smith, C, Emiliani, S, Almeida, P, Liesnard, C, Englert, Y (2005) Laboratory safety during assisted reproduction in patients with blood-borne viruses. Human Reproduction 20: 14331438.CrossRefGoogle ScholarPubMed
Imai, M (1997) Gemba Kaizen: A Commonsense, Low-Cost Approach to Management. McGraw Hill, New York.Google Scholar
Kastrop, PM (2003) Quality management in the ART laboratory. Reproductive BioMedicine Online 7(6): 691694.CrossRefGoogle ScholarPubMed
Meintjes, M, Chantilis, SJ, Douglas, JD, et al. (2009) A controlled, randomized trial evaluating the effect of lowered incubator oxygen tension on live births in a predominantly blastocyst transfer program. Human Reproduction 24(2): 300307.CrossRefGoogle Scholar
Nijs, M, Franssen, K, Cox, A, et al. (2009) Reprotoxicity of intrauterine insemination and in vitro fertilization – embryo transfer disposables and products: a 4-year survey. Fertility and Sterility 92(2): 527535.CrossRefGoogle ScholarPubMed
Painter, RB (1978) DNA synthesis inhibition in HeLa cells as a simple test for agents that damage human DNA. Journal of Environmental Pathology and Toxicology 2(1): 6578.Google ScholarPubMed
Phillips, KP, Leveille, MC, Klaman, P, Baltz, JM (2000) Intracellular pH regulation in preimplantation embryos. Human Reproduction 15: 896904.CrossRefGoogle ScholarPubMed
Pool, T (2004) Optimising pH in clinical embryology. Clinical Embryologist 7(3): 117.Google Scholar
Rinehart, JS, Bavister, BD, Gerrity, M (1988) Quality control in the in vitro fertilization laboratory: comparison of bioassay systems for water quality. Journal of In Vitro Fertilization and Embryo Transfer 5: 335425.CrossRefGoogle ScholarPubMed
Swain, JE (2012) Is there an optimal pH for culture media used in clinical IVF? Human Reproduction Update 18: 333339.CrossRefGoogle ScholarPubMed
Swain, JE, Cabrera, L, Smith, GD (2012) Microdrop preparation factors influence culture media osmolality which can impair mouse preimplantation embryo development. Reproductive BioMedicine Online 2012; 24(2): 142147.CrossRefGoogle Scholar
Tedder, RS, Zuckerman, MA, Goldstone, AH, et al. (1995) Hepatitis B transmission from contaminated cryopreservation tank. Lancet 346: 137140.CrossRefGoogle ScholarPubMed
Tomlinson, M (2005) Managing risks associated with cryopreservation. Human Reproduction 20: 14331438.CrossRefGoogle ScholarPubMed

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