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  • Cited by 2
  • Online publication date: May 2010

Chapter 10 - Quality management and accreditation

References

1. TomlinsonMJ, BarratCL. Internal and external quality control in the andrology laboratory. In: KeelBA, MayJV, De JongeCJ, eds. Handbook of the Assisted Reproduction Laboratory. Boca Raton: CRC Press 2000: 269–77.
2. CentolaGM. Quality control, quality assurance, and management of the cryopreservation laboratory. In: KeelBA, MayJV, De JongeCJ, eds. Handbook of the Assisted Reproduction Laboratory. Boca Raton: CRC Press 2000: 303–25.
3. Deming, WE. Out of the Crisis. Cambridge, MA: MIT Press 1986.
4. MortimerD, MortimerST. Quality and Risk Management in the IVF Laboratory. Cambridge: Cambridge University Press 2005.
5. McCullohDH. Quality control and quality assurance. Obstet Gynecol Clin N Am 1998; 9: 285–309.
6. HuysmanW, HorvathAR, BurnettD, et al. Accreditation of medical laboratories in the European Union. Clin Chem Lab Med 2007; 45: 268–75.
7. BurnettD. A Practical Guide to Accreditation in Laboratory Medicine. London: ABC Venture Publications 2002.
8. CastillaJA, HernandezJ, CabelloY, et al. Defining poor and optimum performance in an IVF programme. Hum Reprod 2008; 23: 85–90.
9. RiddellD, PaceyA, WhittingtonK. Lack of compliance by UK andrology laboratories with World Health Organization recommendations for sperm morphology assessment. Hum Reprod 2005; 12: 3441–5.
10. BjörndahlL, BarrattCLR, FraserLR, et al. ESHRE basic semen analysis courses 1995–1999: immediate beneficial effects of standardized training. Hum Reprod 2002; 17: 1299–305.
11. MouradSM, HermensRP, NelenWL, et al. Guideline-based development of quality indicators for subfertility care. Hum Reprod 2007; 22: 2665–72.
12. WollersheimH, HermensR, HulscherM, et al. Clinical indicators: development and applications. Neth J Med 2007; 65: 15–22.
13. KeckC, FischerR, BauklohV, et al. Staff management in the in vitro fertilization laboratory. Fertil Steril 2005; 84: 1786–8.
14. AguilarJ, AlvarezC, Morancho-ZaragozaJ, et al. Quality specifications for seminal parameters based on clinicians’ opinions. Scand J Clin Lab Invest 2008; 68: 68–76.
15. ToftG, Rignell-HydbomA, TyrkielE, et al. Quality control workshops in standardization of sperm concentration and motility assessment in multicentre studies. Int J Androl 2005; 28: 144–9.
16. AugerJ, EustacheF, DucotB, et al. Intra- and inter-individuality variability in human sperm concentration, motility and vitality assessment during a workshop involving ten laboratories. Hum Reprod 2000; 15: 2360–8.
17. BjörndahlL, TomlinsonM, BarrattCLR. Raising standards in semen analysis: Professional and personal responsibility. J Androl 2004; 25: 862–3.
18. VieraAJ, GarrettJM. Understanding interobserver agreement: The kappa statistic. Fam Med 2005; 37: 360–3.
19. PetersenPH, StöcklD, BlaabjergO, et al. Graphical interpretation of analytical data from comparison of a field method with reference method by use of difference plots. Clin Chem 1997; 43: 2039–46.
20. MortimerD. Technician training and quality control aspects. In: Practical Laboratory Andrology. Oxford: Oxford University Press 1994: 337–347.
21. MenkveldR, StanderFSH, KotzeTJvW, KrugerTF, Van ZylJA. The evaluation of morphological characteristics of human spermatozoa according to stricter criteria. Hum Reprod 1990; 5: 586–92.
22. KrugerTF, AcostaAA, SimmonsKF, SwansonRJ, MattaJF, OehningerS. Predictive value of abnormal sperm morphology in in vitro fertilization. Fertil Steril 1988; 49: 112–7.
23. FrankenDR, MenkveldR, KrugerTF, Sekadde-KigonduC, LombardC. Monitoring technologist reading skills in a sperm morphology quality control program. Fertil Steril 2003; 79: 1637–43.
24. AlvarezC, CastillaJA, MartinezL, et al. Biological variation of seminal parameters in healthy subjects. Hum Reprod 2003; 18: 2082–8.
25. JohnsonJE, BlackhurtDW, BooneWR. Can Westgard Quality Control Rules determine the suitability of frozen sperm pellets as a control material for computer assisted semen analyzers?J Assist Reprod Genet 2003; 20: 38–45.
26. ClementsS, CookeID, BarrattCL. Implementing comprehensive quality control in the andrology laboratory. Hum Reprod 1995; 10: 2096–106.
27. LuJC, XuHR, ChenF, et al. Standardization and quality control for the determination of alpha-glucosidase in seminal plasma. Arch Androl 2006; 52: 447–53.
28. FearnT, ThompsonM. A new test for ‘sufficient homogeneity’. Analyst 2001; 126: 1414–7.
29. ISO. ISO13528. Statistical Methods for Use in Proficiency Testing by Interlaboratory Comparisons. Geneva, Switzerland: International Standardization Organization 2005.
30. FraserCG, HarrisEK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989; 27: 409–37.
31. FraserCG, KallnerA, KennyD, PetersenPH. Introduction: strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999; 59: 477–8.
32. RicosC, AlvarezV, CavaF, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491–500.
33. CastillaJA, Morancho-ZaragozaJ, AguilarJ, et al. Quality specifications for seminal parameters based on the state of the art. Hum Reprod 2005; 20: 2573–8
34. WestgardJO. Use and interpretation of common statistical tests in method comparison studies. Clin Chem 2008; 54: 612.
35. CooperTG, AtkinsonAD, NieschlagE. Experience with external quality control in spermatology. Hum Reprod 1999; 14: 765–9.
36. World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. 4th edn. Cambridge, UK: Cambridge University Press 1999.
37. BlandJM, AltmanDG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; i: 307–10.
38. McCullohDH. Quality Control and Quality Assurance. Record Keeping and Impact on ART Performance and Clinical Outcome. In: MayJV, DiamondMP, De CherneyAH, eds. Infertility and Reproductive Medicine: Clinics of North America 1998: 285–309.
39. CastillaJA, Sanchez-LeonM, GarridoA, et al. Procedure control and acceptance sampling plans for donor sperm banks: a theoretical study. Cell Tissue Bank 2007; 8(4): 257–65.
40. AlvarezC, CastillaJA, RamirezJP, et al. External quality control program for semen analysis: Spanish experience. J Assist Reprod Genet 2005; 22: 379–87.
41. StrikePW. Statistical Methods in Laboratory Medicine. Oxford: Butterworth Heinemann 1991.
42. JequierAM, UkombeEB. Errors inherent in the performance of a routine semen analysis. Br J Urol 1983; 55: 434–6.
43. NeuwingerJ, BehreHM, NieschlagE. External quality control in the andrology laboratory: an experimental multicenter trail. Fertil Steril 1990; 54: 308–14.
44. MatsonPL. External quality assessment for semen analysis and sperm antibody detection: results of a pilot scheme. Hum Reprod 1995; 10: 620–5.
45. KeelBA, QuinnP, SchmidtCF Jr., et al. Results of the American Association of Bioanalysts national proficiency testing program in andrology. Hum Reprod 2000; 15: 680–6.
46. EliassonR. Standards for investigation of human semen. Andrologie 1971; 3: 49–64.
47. EliassonR. Analysis of semen. In: BurgerH, de KretserD, eds. The Testis. New York: Raven Press 1981: 381–99.
48. Mortimer, D. Laboratory standards in routine clinical andrology. Reprod Med Rev 1994; 3: 97–111.
49. BelseyMA, EliassonR, GallegosAJ, et al. Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction. Singapore: Press Concern 1980.
50. World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction. 2nd edn. Cambridge: Cambridge University Press 1987.
51. World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. 3rd edn. Cambridge: Cambridge University Press 1992.
52. YeungCH, CooperTG, NieschlagE. A technique for standardization and quality control of subjective sperm motility assessments in semen analysis. Fertil Steril 1997; 67: 1156–8.
53. International Standard ISO 15189. Medical laboratories – Particular Requirements for Quality and Competence. Geneva: International Organization for Standardization 2007.
54. ISO. Guide to the Expression of Uncertainty in Measurement. Geneva: International Organization for Standardization 1993.
55. CookRR. Assessment of Uncertainties in Measurement for Calibration and Testing Laboratories. Sydney: National Association of Testing Authorities 1999.
56. MatsonPL. External quality assessment for semen analysis and sperm antibody detection: Results of a pilot scheme. Hum Reprod 1995; 10: 620–5.
57. CooperTG, BjörndahlL, VreeburgJ, et al. Semen analysis and external quality control schemes for semen analysis need global standardization. Int J Androl 2002; 25: 306–11.
58. MortimerD. A critical assessment of the impact of the European Union Tissues and Cells Directive (2004) on laboratory practices in assisted conception. Reprod Biomed Online 2005; 11: 162–76.
59. HartshorneGM. Challenges of the EU ‘tissues and cells’ directive. Reprod Biomed Online 2005; 11: 404–7.
60. European Society of Human Reproduction and Embryology. ESHRE position paper on the EU Tissues and Cells Directive EC/2204/23, November 2007. http://www.eshre.com/emc.asp?pageId=685 (viewed 01/08/2008).
61. CarrellDT, CartmillD. A brief review of current and proposed federal government regulation of assisted reproduction laboratories in the United States. J Androl 2006; 23: 611–7.