Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-23T08:52:27.826Z Has data issue: false hasContentIssue false

Chapter 12 - Quality Management and Accreditation

Published online by Cambridge University Press:  16 February 2022

David Mortimer ,
Lars Björndahl ,
Christopher L. R. Barratt ,
José Antonio Castilla ,
Roelof Menkveld ,
Ulrik Kvist ,
Juan G. Alvarez  and
Trine B. Haugen
David Mortimer
Affiliation:
Oozoa Biomedical Inc., Vancouver
Lars Björndahl
Affiliation:
Karolinska Institutet, Stockholm
Christopher L. R. Barratt
Affiliation:
University of Dundee
José Antonio Castilla
Affiliation:
HU Virgen de las Nieves, Granada
Roelof Menkveld
Affiliation:
Stellenbosch University, South Africa
Ulrik Kvist
Affiliation:
Karolinska Institutet, Stockholm
Juan G. Alvarez
Affiliation:
Centro ANDROGEN, La Coruña
Trine B. Haugen
Affiliation:
Oslo Metropolitan University
Get access

Summary

Following an overview of Quality Management concepts and the creation of a Quality Management System (QMS) there is a discussion of the principles of Accreditation and Accreditation schemes. The importance of training is emphasized, and the goal-orientated reiterative assessments apporach described, including defining criteria for competence as the endpoint of training. There are also discussion on quality control, measurement uncertainty, test method selection and comparison,laboratory equipment monitoring, and External Quality Assurance (EQA). A section on regulatory aspects includes a comparison between Standards (including the new ISO 23162) and guidelines. A final section describes a framework for validating new test methods.

Keywords

accreditationlicensingquality managementquality controlquality assuranceEQAISOvalidationtrainingcompetencyBland and Altman plot
Type
Chapter
Information
A Practical Guide to Basic Laboratory Andrology , pp. 262 - 289
Publisher: Cambridge University Press
Print publication year: 2022

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Tomlinson, MJ, Barratt, CL. Internal and external quality control in the andrology laboratory. In: Keel, BA, May, JV, De Jonge, CJ, eds. Handbook of the Assisted Reproduction Laboratory. Boca Raton: CRC Press, 2000, 269–77.Google Scholar
Zemlin, AE. Errors in the extra-analytical phases of clinical chemistry laboratory testing. Indian J Clin Biochem 2018; 33: 154–62.Google Scholar
Mortimer, ST, Mortimer, D. Quality and Risk Management in the IVF Laboratory, 2nd edn. Cambridge: Cambridge University Press, 2015.CrossRefGoogle Scholar
Bento, FC, Esteves, SC. Establishing a quality management system in a fertility center: experience with ISO 9001. Medical Express 2016; 3: M160302.CrossRefGoogle Scholar
Centola, GM. Quality control, quality assurance, and management of the cryopreservation laboratory. In: Keel, BA, May, JV, De Jonge, CJ, eds. Handbook of the Assisted Reproduction Laboratory. Boca Raton: CRC Press, 2000, 303–25.Google Scholar
International Standard Organization. ISO 9001:2015 Quality Management Systems – Requirements. Geneva: International Standards Organization, 2015.Google Scholar
Deming, WE. Out of the Crisis. Cambridge, MA: MIT Press, 1986.Google Scholar
Pereira, P. ISO series update, Part 1 – ISO 9001:2015 applied to medical laboratory scope. Madison: Westgard QC, 2017. www.westgard.com/iso-9001-2015-requirements.htm [last accessed 25 August 2021].Google Scholar
Gerteis, M, Edgman-Levitan, S, Daley, J, Delbanco, TL (eds.) Through the Patient’s Eyes: Understanding and Promoting Patient-Centered Care. San Francisco, CA: Jossey-Bass Inc Pub, 1993.Google Scholar
Guo, S, Duan, Y, Liu, X, Jiang, Y. Three-year customer satisfaction survey in laboratory medicine in a Chinese university hospital. Clin Chem Lab Med 201; 56: 755–63.CrossRefGoogle Scholar
van Empel, IW, Aarts, JW, Cohlen, BJ, et al. Measuring patient-centredness, the neglected outcome in fertility care: a random multicentre validation study. Hum Reprod 2010; 25: 2516–26.Google Scholar
Boivin, J, Takefman, J, Braverman, A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod 2011; 26: 2084–91.Google Scholar
Koh, YR, Kim, SY, Kim, IS, et al. Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level. Ann Lab Med 2014; 34: 380–5.Google Scholar
International Organization for Standardization. ISO 15189:2015 Medical Laboratories – Particular Requirements for Quality and Competence. Geneva: International Organization for Standardization, 2007.Google Scholar
Burnett, D. A Practical Guide to ISO 15189 in Laboratory Medicine. London: ABC Venture Publications, 2013.Google Scholar
Mourad, SM, Hermens, RP, Nelen, WL, et al. Guideline-based development of quality indicators for subfertility care. Hum Reprod 2007; 22: 2665–72.Google Scholar
Wollersheim, H, Hermens, R, Hulscher, M, et al. Clinical indicators: development and applications. Neth J Med 2007; 65: 15–22.Google Scholar
Castilla, JA, Hernandez, J, Cabello, Y, et al. Defining poor and optimum performance in an IVF programme. Hum Reprod 2008; 23: 85–90.Google Scholar
Sciacovelli, L, Panteghini, M, Lippi, G, et al. Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group ‘Laboratory Error and Patient Safety’ and EFLM Task and Finish Group ‘Performance specifications for the extra-analytical phases’. Clin Chem Lab Med 2017; 55: 1478–88.Google Scholar
Tsai, ER, Tintu, AN, Demirtas, D, et al. A critical review of laboratory performance indicators. Crit Rev Clin Lab Sci 2019; 56: 458–71.Google Scholar
Mainz, J. Defining and classifying clinical indicators for quality improvement. Int J Qual Health Care 2003; 15: 523–30.Google Scholar
American Society for Reproductive Medicine. Ten things physicians and patients should question. Available at: www.choosingwisely.org/wp-content/uploads/2015/02/ASRM-Choosing-Wisely-List.pdf [last accessed 25 August 2021].Google Scholar
Sánchez-Pozo, MC, Mendiola, J, Serrano, M, et al. Special Interest Group in Andrology of the European Society of Human Reproduction and Embryology. Proposal of guidelines for the appraisal of SEMen QUAlity studies (SEMQUA). Hum Reprod 2013; 28: 10–21.CrossRefGoogle Scholar
Husereau, D, Drummond, M, Petrou, S, et al. CHEERS Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Value Health 2013; 16: e1–5.CrossRefGoogle ScholarPubMed
Huysman, W, Horvath, AR, Burnett, D, et al. Accreditation of medical laboratories in the European Union. Clin Chem Lab Med 2007; 45: 268–75.Google Scholar
Mortimer, D. Practical Laboratory Andrology. New York: Oxford University Press, 1994.CrossRefGoogle Scholar
World Health Organization. WHO Laboratory Manual for the Examination and Processing of Human Semen, 5th edn. Geneva: World Health Organization, 2010.Google Scholar
World Health Organization. WHO Laboratory Manual for the Examination and Processing of Human Semen, 6th edn. Geneva: World Health Organization, 2021.Google Scholar
Björndahl, L, Barratt, CLR, Fraser, LR, et al. ESHRE basic semen analysis courses 1995–1999: immediate beneficial effects of standardized training. Hum Reprod 2002; 17: 1299–305.Google Scholar
Barratt, CLR, Björndahl, L, Menkveld, R, Mortimer, D. The ESHRE Special Interest Group for Andrology Basic Semen Analysis Course: a continued focus on accuracy, quality, efficiency and clinical relevance. Hum Reprod 2011; 26: 3207–12.CrossRefGoogle ScholarPubMed
Björndahl, L, Barratt, CLR, Mortimer, D, Jouannet, P. How to count sperm properly: checklist for acceptability of studies based on human semen analysis. Hum Reprod 2016; 31: 227–32.Google Scholar
Riddell, D, Pacey, A, Whittington, K. Lack of compliance by UK andrology laboratories with World Health Organization recommendations for sperm morphology assessment. Hum Reprod 2005; 12: 3441–5.Google Scholar
International Standards Organization. ISO 23162:2021 Basic Semen Examination – Specification and Test Methods. Geneva: International Standards Organization, 2021.Google Scholar
Keck, C, Fischer, R, Baukloh, V, et al. Staff management in the in vitro fertilization laboratory. Fertil Steril 2005; 84: 1786–8.Google Scholar
ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine. The Vienna consensus: report of an expert meeting on the development of ART laboratory performance indicators. Reprod Biomed Online 2017; 35: 494–510 and Hum Reprod Open 2017; hox011. https://doi.org/10.1093/hropen/hox011CrossRefGoogle Scholar
Aguilar, J, Alvarez, C, Morancho-Zaragoza, J, et al. Quality specifications for seminal parameters based on clinicians’ opinions. Scand J Clin Lab Invest 2008; 68: 68–76.Google Scholar
Toft, G, Rignell-Hydbom, A, Tyrkiel, E, et al. Quality control workshops in standardization of sperm concentration and motility assessment in multicentre studies. Int J Androl 2005; 28: 144–9.CrossRefGoogle ScholarPubMed
Auger, J, Eustache, F, Ducot, B, 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.Google Scholar
Björndahl, L, Tomlinson, M, Barratt, CLR. Raising standards in semen analysis: professional and personal responsibility. J Androl 2004; 25: 862–3.CrossRefGoogle ScholarPubMed
Viera, AJ, Garrett, JM. Understanding interobserver agreement: the Kappa statistic. Fam Med 2005; 37: 360–3.Google ScholarPubMed
Wongpakaran, N, Wongpakaran, T, Wedding, D, Gwet, KL. A comparison of Cohen’s Kappa and Gwet’s AC1 when calculating inter-rater reliability coefficients: a study conducted with personality disorder samples. BMC Med Res Methodol 2013; 13: 61.Google Scholar
Martínez-Granados, L, Serrano, M, González-Utor, A, et al. Special Interest Group in Quality of ASEBIR (Society for the Study of Reproductive Biology). Reliability and agreement on embryo assessment: 5 years of an external quality control programme. Reprod Biomed Online 2018; 36: 259–68.CrossRefGoogle Scholar
Petersen, PH, Stöckl, D, Blaabjerg, O, 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.Google Scholar
Menkveld, R, Stander, FSH, TJvW, Kotze, Kruger, TF, Van Zyl, JA. The evaluation of morphological characteristics of human spermatozoa according to stricter criteria. Human Reprod 1990; 5: 586–592.Google Scholar
Franken, DR, Menkveld, R, Kruger, TF, Sekadde-Kigondu, C, Lombard, C. Monitoring technologist reading skills in a sperm morphology quality control program. Fertil Steril 2003; 79: 1637–43.CrossRefGoogle Scholar
Alvarez, C, Castilla, JA, Martinez, L, et al. Biological variation of seminal parameters in healthy subjects. Hum Reprod 2003; 18: 2082–8.CrossRefGoogle ScholarPubMed
Johnson, JE, Blackhurt, 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.CrossRefGoogle ScholarPubMed
Clements, S, Cooke, ID, Barratt, CL. Implementing comprehensive quality control in the andrology laboratory. Hum Reprod 1995; 10: 2096–106.Google Scholar
Lu, JC, Xu, HR, Chen, F, et al. Standardization and quality control for the determination of alpha-glucosidase in seminal plasma. Arch Androl 2006; 52: 447–53.Google Scholar
Fearn, T, Thompson, M. A new test for ‘sufficient homogeneity’. Analyst 2001; 126: 1414–17.Google Scholar
International Organization for Standardization. ISO 13528:2015. Statistical Methods for Use in Proficiency Testing by Interlaboratory Comparisons. Geneva: International Standardization Organization, 2015.Google Scholar
Fraser, CG, Harris, EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989; 27: 409–37.Google Scholar
Sandberg, S, Fraser, CG, Horvath, AR, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015; 53: 833–5.Google Scholar
Ricos, C, Alvarez, V, Cava, F, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491–500.Google Scholar
Castilla, JA, Morancho-Zaragoza, J, Aguilar, J, et al. Quality specifications for seminal parameters based on the state of the art. Hum Reprod 2005; 20: 2573–8.Google Scholar
Jones, GR, Albarede, S, Kesseler, D, et al., for the EFLM Task Finish Group – Analytical Performance Specifications for EQAS (TFG-APSEQA). Analytical performance specifications for external quality assessment – definitions and descriptions. Clin Chem Lab Med 2017; 55: 949–55.CrossRefGoogle ScholarPubMed
Lopez-Regalado, ML, Martínez-Granados, L, González-Utor, A, et al. Special Interest Group in Quality of ASEBIR (Society for the Study of Reproductive Biology). Critical appraisal of the Vienna consensus: performance indicators for assisted reproductive technology laboratories. Reprod Biomed Online 2018; 37: 128–32.CrossRefGoogle Scholar
Westgard, JO. Use and interpretation of common statistical tests in method comparison studies. Clin Chem 2008; 54: 612.Google Scholar
Cooper, TG, Atkinson, AD, Nieschlag, E. Experience with external quality control in spermatology. Hum Reprod 1999; 14: 765–9.CrossRefGoogle ScholarPubMed
World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interactions, 4th edn. Cambridge: Cambridge University Press, 1999.Google Scholar
Bland, JM, Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; I: 307–10.Google Scholar
McCulloh, DH. Quality control and quality assurance. Record keeping and impact on ART performance and clinical outcome. In: May, JV, Diamond, MP, De Cherney, AH, eds. Infertility and Reproductive Medicine: Clinics of North America, 1998: 285–309.Google Scholar
Castilla, JA, Sanchez-Leon, M, Garrido, A, et al. Procedure control and acceptance sampling plans for donor sperm banks: a theoretical study. Cell Tissue Bank 2007; 8: 257–65.Google Scholar
Alvarez, C, Castilla, JA, Ramirez, JP, et al. External quality control program for semen analysis: Spanish experience. J Assist Reprod Genet 2005; 22: 379–87.Google Scholar
Strike, PW. Statistical Methods in Laboratory Medicine. Oxford: Butterworth Heinemann, 1991.Google Scholar
Jequier, AM, Ukombe, EB. Errors inherent in the performance of a routine semen analysis. Br J Urol 1983; 55: 434–6.Google Scholar
Neuwinger, J, Behre, HM, Nieschlag, E. External quality control in the andrology laboratory: an experimental multicenter trial. Fertil Steril 1990; 54: 308–14.CrossRefGoogle ScholarPubMed
Matson, PL. External quality assessment for semen analysis and sperm antibody detection: results of a pilot scheme. Hum Reprod 1995; 10: 620–5.Google Scholar
Keel, BA, Quinn, P, Schmidt, CF Jr, et al. Results of the American Association of Bioanalysts national proficiency testing program in andrology. Hum Reprod 2000; 15: 680–6.Google Scholar
Filimberti, E, Degl’Innocenti, S, Borsotti, M, et al. High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme. Andrology 2013; 1: 401–7.Google Scholar
Punjabi, U, Wyns, C, Mahmoud, A, et al. Fifteen years of Belgian experience with external quality assessment of semen analysis. Andrology 2016; 4: 1084–93.Google Scholar
Eliasson, R. Standards for investigation of human semen. Andrologie 1971; 3: 49–64.Google Scholar
Eliasson, R. Analysis of semen. In: Burger, H, de Kretser, D, eds. The Testis. New York: Raven Press, 1981.Google Scholar
Mortimer, D. Laboratory standards in routine clinical andrology. Reprod Med Rev 1994; 3: 97–111.CrossRefGoogle Scholar
Belsey, MA, Eliasson, R, Gallegos, AJ, et al. Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction. Singapore: Press Concern, 1980.Google Scholar
World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction, 2nd edn. Cambridge: Cambridge University Press, 1987.Google Scholar
World Health Organization. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction, 3rd edn. Cambridge: Cambridge University Press, 1992.Google Scholar
Yeung, CH, Cooper, TG, Nieschlag, E. A technique for standardization and quality control of subjective sperm motility assessments in semen analysis. Fertil Steril 1997; 67: 1156–8.CrossRefGoogle ScholarPubMed
ISO/IEC Guide 98-1:2009 Uncertainty of measurement - Part 1: Introduction to the expression of uncertainty in measurement. Geneva: International Organization for Standardization, 2009.Google Scholar
Cook, RR. Assessment of Uncertainties in Measurement for Calibration and Testing Laboratories. Sydney: National Association of Testing Authorities, 1999.Google Scholar
International Standards Organization. ISO/TS 20914:2019 Medical Laboratories – Practical Guidance for the Estimation of Measurement Uncertainty. Geneva: International Standards Organization, 2019.Google Scholar
Passing, H, Bablok, W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983; 21: 709–20.Google ScholarPubMed
Cooper, TG, Björndahl, L, Vreeburg, J, et al. Semen analysis and external quality control schemes for semen analysis need global standardization. Int J Androl 2002; 25: 306–11.Google Scholar
Palacios, ER, Clavero, A, Gonzalvo, MC, et al. Acceptable variability in external quality assessment programmes for basic semen analysis. Hum Reprod 2012; 27: 314–22.Google Scholar
Miller, WG, Jones, GR, Horowitz, GL, Weykamp, C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011; 57: 1670–80.CrossRefGoogle ScholarPubMed
Castilla, JA, Ruiz de Assin, R, Gonzalvo, MC, et al. External quality control for the embryology laboratory. Reprod Biomed Online 2010; 20: 68–74.Google Scholar
Martínez-Granados, L, Gonzalvo, MC, Clavero, A, et al. Application of a sperm survival test: results from an external quality control programme. Eur J Obstet Gynecol Reprod Biol 2018; 230: 55–9.CrossRefGoogle ScholarPubMed
Lippi, G, Banfi, G, Church, S, et al. European Federation for Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med 2015; 53: 357–70.Google Scholar
Vasikaran, S, Sikaris, K, Kilpatrick, E, et al. IFCC WG Harmonization of quality assessment of interpretative comments. Assuring the quality of interpretative comments in clinical chemistry. Clin Chem Lab Med 2016; 54: 1901–11.CrossRefGoogle ScholarPubMed
Mortimer, D. 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.Google Scholar
Hartshorne, GM. Challenges of the EU ‘tissues and cells’ directive. Reprod Biomed Online 2005; 11: 404–7.CrossRefGoogle ScholarPubMed
Saunders, D, Pope, A. Response to article – ‘A critical assessment of the impact of the European Union Tissues and Cell Directive (2004) on laboratory practices in assisted conception’ by David Mortimer. Reprod Biomed Online 2005; 11: 407–8.Google Scholar
EDQM (European Directorate for the Quality of Medicines & HealthCare of the Council of Europe). Guide to the quality and safety of tissues and cells for human application, 4º edn. Strasbourg: Council of Europe, 2019. https://register.edqm.eu/freepub [last accessed 25 August 2021].Google Scholar
European Commission EU Coding Platform – Reference Compendia for the Application of a single European Coding System for Tissues and Cells. https://webgate.ec.europa.eu/eucoding/reports/te/index.xhtml [last accessed 25 August 2021].Google Scholar
Carrell, DT, Cartmill, D. A brief review of current and proposed federal government regulation of assisted reproduction laboratories in the United States. J Androl 2006; 23: 611–17.Google Scholar
Sanders, D, Fensome-Rimmer, S, Woodward, B. Uncertainty of measurement in andrology: UK best practice guideline from the Association of Biomedical Andrologists. Br J Biomed Sci 2017; 74: 157–62.Google Scholar
Björndahl, L. What is normal semen quality? On the use and abuse of reference limits for the interpretation of semen analysis results. Hum Fertil 2011; 14: 179–86.CrossRefGoogle ScholarPubMed
Bailey, E, Fenning, N, Chamberlain, S, Devlin, L, Hopkissen, J, et al. Validation of sperm counting methods using limits of agreement. J Androl 2007; 28: 364–73.CrossRefGoogle ScholarPubMed

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×