Abstract
Every clinical laboratory must have a system in place to ensure accurate results are obtained and reported to the ordering clinician. In the case of the andrology laboratory, semen processing is performed in addition to semen analysis, and quality management extends to producing high-quality specimens that are free from contamination. Quality management involves developing and following standard operating procedures that cover every aspect of laboratory testing, including regular evaluation and maintenance of the facility, maintenance and function checks of equipment, ensuring the quality of supplies, controlling microbial contamination, evaluating the competency of personnel, and securing of data integrity. In addition, test methods must be established and verified, the performance specifications of each test determined, and the accuracy and precision of each test monitored. Quality management is an ongoing process designed not only to produce a quality product and reduce risk to patients and workers, but to improve the quality of performance over time through research and innovation. This chapter discusses the application of quality management techniques to the andrology laboratory.
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Muller CH. The andrology laboratory in an assisted reproductive technology program: quality assurance and laboratory methodology. J Androl. 1992;13:349–60.
Keel BA. Quality control, quality assurance, and proficiency testing in the andrology laboratory. Arch Androl. 2002;48:417–31.
Mortimer D. Technician training and quality control aspects. In: Practical laboratory andrology. Chapter 16. Oxford: Oxford University Press; 1994. pp. 337–348.
Mortimer D, Mortimer ST. Quality and risk management in the IVF laboratory. Cambridge: Cambridge University Press; 2005.
World Health Organization (WHO). Chapter 7. Quality assurance and quality control. In: WHO laboratory manual for the examination and processing of human semen. Geneva: World Health Organization; 2010.
Björndahl L, Mortimer D, Barratt CLR, Castilla JA, Menkveld R, Kvist U, Alvarez J, Haugen TB. Chapter 10. Quality management and accreditation. In: A practical guide to basic laboratory andrology. Cambridge: Cambridge University Press; 2010. pp. 227–48.
Bento F, Esteves S, Agarwal A, editors. Quality management in ART clinics: a practical guide. New York: Springer; 2013.
Dunphy BC, Kay R, Barratt CLR, Cooke ID. Quality control during the conventional analysis of semen, an essential exercise. J Androl. 1989;10:378–85.
Neuwinger J, Behre HM, Nieschlag E. External quality control in the andrology laboratory: an experimental multicenter trial. Fertil Steril. 1990;54:308–14.
Matson PL. Andrology: external quality assessment for semen analysis and sperm antibody detection: results of a pilot scheme. Hum Reprod. 1995;10:620–5.
Jørgensen N, Auger J, Giwercman A, Irvine DS, Jensen TK, Jouannet P, Keiding N, Le Bon C, MacDonald E, Pekur A-M, Scheike T, Simonsen M, Suominen J, Skakkebœk NE. Semen analysis performed by different laboratory teams: an intervariation study. Int J Androl. 1997;20:201–8.
Cooper TG, Atkinson AD, Nieschlag E. Experience with external quality control in spermatology. Hum Reprod. 1999;14:765–9.
Cooper TG, Björndahl L, Vreebrg J, Nieschlag E. Semen analysis and external quality control schemes for semen analysis need global standardization. Int J Androl. 2002;25:306–11.
Auger J, Eustach F, Ducot B, Blandin T, Daudin M, Diaz I, El Matribi S, Gony B, Keskes L, Kolbezen M, Lamart A, Lornage J, Nomal N, Pitaval G, Simon O, Virant-Klun I, Spira A, Jouannet P. Intra- and inter-individual variability in human sperm concentration, motility and vitality assessment during a workshop involving ten laboratories. Hum Reprod. 2000;11:2360–8.
Gandini L, Menditto A, Chiodo F, Lenzi A. Italian pilot study for an external quality control scheme in semen analysis and antisperm antibodies detection. Int J Androl. 2000;23:1–3.
Keel BA, Quinn P, Schmidt Jr CF, Serafy Jr NT, Serafy Sr NT, Schalue TK. Results of the American Association of Bioanalysts national proficiency testing programme in andrology. Hum Reprod. 2000;15:680–6.
Keel BA. How reliable are results from the semen analysis? Fertil Steril. 2004;82:41–4.
Álvarez C, Castilla JA, Vergara F, Yoldi A, Fernández A, Gaforio JJ. External quality control program for semen analysis: Spanish experience. J Assist Reprod Genet. 2005;22:379–87.
Mortimer D, Shu MA, Tan R. Standardization and quality control of sperm concentration and sperm motility counts in semen analysis. Hum Reprod. 1986;5:299–303.
Brazil C, Swan SH, Tollner CR, Treece C, Drobnis EZ, Wang C, Redmon JB, Overstreet JW. Quality control of laboratory methods for semen evaluation in a multicenter research study. J Androl. 2004;25:345–56.
Clements S, Cooke ID, Barratt CL. Implementing comprehensive quality control in the andrology laboratory. Hum Reprod. 1995;10:2096–106.
De Jonge C. Commentary: forging a partnership between total quality management and the andrology laboratory. J Androl. 2000;21:203–5.
Bielanski A, Bergeron H, Lau PCK, Devenish J. Microbial contamination of embryos and semen during long term banking in liquid nitrogen. Cryobiol. 2003;46:146–52.
Bielanski A. Experimental microbial contamination and disinfection of dry (vapour) shipper Dewars designed for short-term storage and transportation of cryopreserved germplasm and other biological specimens. Theriogenology. 2005;63:1946–57.
Morris GJ. The origin, ultrastructure, and microbiology of the sediment accumulating in liquid nitrogen storage vessels. Cryobiology. 2005;50:231–8.
Chen H-I, Tsai C-D, Wang H-T, Hwang S-M. Cryovial with partial membrane sealing can prevent liquid nitrogen penetration in submerged storage. Cryobiology. 2006;53:283–7.
Pomeroy KO, Harris S, Conaghan J, Papadakis M, Centola G, Basuray R, Battaglia D. Storage of cryopreserved reproductive tissues: evidence that cross-contamination of infectious agents is a negligible risk. Fertil Steril. 2009;94:1181–8.
Bielanski A, Vajta G. Risk of contamination of germplasm during cryopreservation and cryobanking in IVF units. Hum Reprod. 2009;24:2457–67.
Ombelet W, Bosmans E, Janssen M, Cox A, Vlasselaer J, Gyselaers W, Vandeput H, Gielen J, Pollet H, Maes M, Steeno O, Kruger T. Semen parameters in a fertile versus subfertile population: a need for change in the interpretation of semen testing. Hum Reprod. 1997;12:987–93.
Gunalp S, Onculoglu C, Gurgan T, Kruger TF, Lombard CJ. A study of semen parameters with emphasis on sperm morphology in a fertile population: an attempt to develop clinical thresholds. Hum Reprod. 2000;16:110–4.
Menkveld R, Wong WY, Lombard CJ, Wezels AMM, Thomas CMG, Merkus HMWM, Steegers-Theunissen PM. Semen parameters, including WHO and strict criteria morphology, in a fertile and subfertile population: an effort towards standardization of in-vivo thresholds. Hum Reprod. 2001;16:1165–71.
Sergerie M, Laforest G, Bujan L, Bissonnette F, Bleau G. Sperm DNA fragmentation: threshold value in male fertility. Hum Reprod. 2005;20:3446–51.
Simon L, Lutton D, McManus J, Lewis SEM. Sperm DNA damage measured by the alkaline Comet assay as an independent predictor of male infertility and in vitro fertilization success. Fertil Steril. 2011;95:652–7.
Venkatesh S, Singh A, Shamsi MB, Thilagavathi J, Kumar R, Mitra DK, Dada R. Clinical significance of sperm DNA damage threshold value in the assessment of male infertility. Reprod Sci. 2011;18:1005–13.
Ribas-Maynou J, Garcia-Peiro A, Fernandez-Encinas A, Abad C, Amengual MJ, Prada E, Navarro J, Benet J. Comprehensive analysis of sperm DNA fragmentation by five different assays: TUNEL assay, SCSA, SCD test and alkaline and neutral Comet assay. Andrology. 2013;1:715–22.
World Health Organization (WHO). WHO laboratory manual for the examination and processing of human semen. Geneva: World Health Organization; 2010.
Douglas-Hamilton DH, Smith NG, Duster CE, Vermeiden JPW, Althouse GC. Capillary-loaded particle fluid dynamics: effect on estimation of sperm concentration. J Androl. 2005;26:115–22.
Swan SH, Kruse RL, Liu F, Barr DB, Drobnis EZ, Redmon JB, Wang C, Brazil C, Overstreet JW. Semen quality in relation to biomarkers of pesticide exposure. Environ Health Perspect. 2003;111:1478–84.
Rothmann SA, Bort A-M, Quigley J, Pillow R. Sperm morphology classification: a rational method for schemes adopted by the World Health Organization. Methods Mol Biol. 2013;927:27–37.
Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol. 1950;20:1059–66.
Westgard JO, Ehrmeyer SS, Darcy TP. CLIA final rules for quality systems. Madison, WI: Westgard QC, Inc.; 2004.
Westgard JO, Basic QC. Practices. 2nd ed. Madison, WI: Westgard QC; 2002.
Knuth UA, Neuwinger J, Nieschlag E. Bias to routine semen analysis by uncontrolled changes in laboratory environment – detection by long-term sampling of monthly means for quality control. Int J Androl. 1989;12:375–83.
Walker RH. Pilot surveys for proficiency testing of semen analysis. Comparison of dry-ice vs. liquid nitrogen shipments. Arch Pathol Lab Med. 1992;116:423–4.
Johnson JE, Blackhurst DW, Boone WR. 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.
Cooper TG, Neuwinger J, Bahrs S, Nieschlag E. Internal quality control of semen analysis. Fertil Steril. 1992;58:172–8.
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Drobnis, E.Z. (2016). Quality Management in Andrology Laboratory. In: Agarwal, A., Gupta, S., Sharma, R. (eds) Andrological Evaluation of Male Infertility. Springer, Cham. https://doi.org/10.1007/978-3-319-26797-5_2
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DOI: https://doi.org/10.1007/978-3-319-26797-5_2
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