From the 1980s, globalization produced conditions that demanded tough decisions in a complex set of fluctuating economic circumstances. This required more decision-makers, who discarded almost all virtue but success. Chapter 8 shows that to this new managerial elite, the moral character of the professionals was at best an old-fashioned affectation, at worst the sanctimonious preaching of the old establishment, bleating over their loss of prestige. Managers began to treat those merely applying their expertise as plug-and-play professionals, able to be manoeuvred in and out of place according to flexible strategies. These were applied under a new cliché: ‘work smarter, not harder’, where the ‘smarter’ referred mainly to managerial innovation. Under this managerial regime, success was the only virtue that mattered, while traditional aspects of professional virtue, still needed for professional work to succeed, were embedded into systems for quality and risk management, launching a process of moral deskilling. In this context, professionals turned to a more generic ‘effectiveness’ into which they could pour their personal professional values. This kept them investing relentlessly in their own human capital, reducing the kind of virtue that sought a better world into a category of virtuous consumption.

Optimization of procedures routinely performed in a clinical human in vitro fertilization (IVF) laboratory have become increasingly important due to the increase in complexity of procedures now performed in the laboratory. The addition of new technologies requiring more oversight has increased dramatically within the last decade. As a result of incorporating these new technologies, safe and efficient operation of the IVF laboratory has become increasingly complex and requires a substantial understanding of processes within the laboratory. In today’s modern IVF laboratory, the amount of staff time to perform every increasingly complicated case has more than doubled. Similarly, the amount required time to prepare for these cases has increased dramatically as well. In many instances, the increase in complexity of laboratory procedures has not translated into hiring of new staff but the creation of challenges to improve efficiency within the laboratory. The current guidelines for allocation of staff are based upon cycle numbers performed on an annual basis, not complexity of cases performed.

Concurrently, IVF has become more complex due to the adoption of highly technological laboratory procedures, including cryopreservation of eggs and embryos, micromanipulation and pre-implantation genetic screening. In addition, the patient population being treated has broadened and often includes not only the intended parents but also gamete donors or gestational surrogates. It is critical therefore for IVF laboratories to implement and maintain the highest standards of quality. Quality can be an elusive concept and is often in the eye of the beholder. In an IVF laboratory it is frequently defined by a clinic’s success rates or the results of inspections by regulatory agencies such as the College of American Pathologists (CAP) or a laboratory’s ability to offer the latest technology. While these attributes are very important and a vital part of a high-quality laboratory, quality comprises many other elements that are often overlooked. This chapter has been written to guide laboratory directors and embryologists in this endeavour.

Cryobanking is a major component of today’s assisted reproductive technologies (ART). As Reproductive Biologists and Cryogenic Specialists, we are not only burdened with the accurate labelling, witnessing and use of cryopreserved specimens (the subject of other chapters in this text), we must ensure their safe and secure long-term storage. Based on a heightened awareness of actual and experimental tank failures, we will outline and discuss the critical components of effective quality management for cryostorage.

The performance of the embryology laboratory is of imperative importance for the successful outcome of an assisted reproductive technology (ART) cycle. The development and viability of gametes and embryos can be compromised by small fluctuations in their environment, so it is crucial to establish optimal culture conditions at which gametes and embryos are attained and maintained. Having a robust control of culture conditions means that it is not necessary to search for a needle in a haystack when trouble-shooting. In order to ensure and maintain these very specific conditions, quality control (QC) routines need to be established with quality specifications for each quality parameter. These parameters are assessed on a daily, weekly, monthly or annual basis to determine whether they meet certain specifications, followed by any necessary fine-tuning to bring the levels back within the acceptable limits of uncertainty of measurement.

Even though Japan has a largely Westernized system of education, it is worth remembering that this country has a strong hierarchical Confucian tradition of master–student relationships. This relationship is underlined by the literal meaning of sensei, “the one born before,” as the honorific given to all teachers and professors. University lecturers enjoy significant autonomy, and there are no particular barriers to faculty integrating undergraduate research (UR) into the curriculum. It can be argued that the STEM areas in which Japan excels have historically created more opportunities for research, and that UR is already undertaken there, whether formally recognized or not. In the arts, humanities, and social sciences, students are required to write a graduation thesis or report under the guidance of their instructor.

Many parameters are associated with IHC testing assays. With so many variables, it is quite easy to accumulate errors within the system. To make things more manageable, these considerations are categorized into three main groups. Pre-analytic aspects occur before the assay, analytic factors are concerned with the staining protocol and post-analytic elements relate to interpreting of results. It has also come to reason that any one variable can impact the reliability and consistency of the overall IHC assay. In this regard, standardization requirements have been enlisted to assist laboratories achieve optimal results. In addition, monitoring proficiency testing regimens and various organizations are in place to ensure high levels of standards are attained. All these endeavours are known as quality assurance and quality control measures. They are arranged under the overall umbrella of a facility’s quality management system.

The basic princples of cryobiology are described for both slow freezing and vitrification of spermatozoa. Specific aspects of cryopreserving human spermatozoa are discussed in detail, incluidng the formulation of cryopreservation media and their proper use. Alternative packaging devices are discussed in relation to the achievement of correct cooling and warming curves as well as effective biocontainment. High security straws are recommended as the best method to use from both perspectives, and a standard operating procedure (SOP) for easy use at the bench is provided. SOPs for human sperm vitrification techniques are also gven. Quality control and risk management aspects of sperm freezing and for cryobank organzation are described. Finally, there is a section on sperm donation.

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.

This chapter seeks to give an overview of the place of Quality Management (QM) in contemporary fertility practice. It provides the reader with an understanding of the terminology used in QM and explores the definition of quality and success in fertility care. An examination of process modelling in the organisation of services is outlined and an analysis in practical terms as to how QM is applied in practice is provided, covering key issues such as document control, organisational structure and the role of the quality manager. Audit as a tool for improving quality is a fundamental tool and its use within a clinical governance framework including risk management/assessment, and other key responsibilities is detailed. Measuring what we do, analysing performance and setting targets to improve should be fundamental to how we approach our work in contemporary clinical practice.

Medical registries are frequently used to generate quality measures with the objective of improving the provision of medical care. Assisted reproductive technology (ART) registries can be used in this manner even if they were initially created for other purposes. Aggregate registry outcomes can be used for internal benchmarking purposes by individual programs. This data can also be used for external Quality Assurance purposes to identify programs that are outliers (low success rates or high multiple gestation rates). Collection of detailed cycle specific information allows benchmarking of process measures that can allow easy identification of specific areas for improvement. Ongoing, daily collection and reporting of key performance indicators (e.g. fertilization rates, embryo development rates) can be used to produce Shewart type control charts to promptly identify and remediate issues that could ultimately result in low birth rates or high risk of multiple gestation.