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.

In recent years, reliable aseptic closed vitrification systems have been accepted instead of open devices and have changed the ART-cryopreservation landscape in the combat against any microbiological exposure. Still, misunderstanding on the balances in a vitrification method and inappropriate implementations expose IVF laboratories to inconsistent survival and pregnancy outcomes. The present set-up and training of a microdroplet vitrification model for human blastocysts takes into account some important quality-control factors to minimize technical variation with consistent good laboratory practice. A uniform approach of the physical environment at 37 °C was validated with a ready-to-use DMSO free vitrification kit plus Ssucrose warming kit and a closed storage device with a hole carrier, based on optimal visualization, simplicity of loading/recovery, consistent volumes and ionomeric-resin straws with secured seals. The microdroplet closed vitrification model offers safety, reliability, consistency with successful results towards benchmark survival / transfer rates (>95%) and promising day 5 vitrified blastocyst live birth rates (>30%).

The purpose of the human sperm survival assay (HSSA) is to test disposables, media and reagents for potential sources of cytotoxicity in a human assisted reproductive technology (ART) laboratories before their use in in vitro fertilization (IVF)/andrology procedures. The contact bioassay is a cornerstone of a successful and safe ART laboratory, and in many countries, the use of a contact bioassay is required by law. When using a bioassay in the laboratory, it must be useful rather than just fulfilling a legal requirement. This means that the assay should be able to detect very subtle levels of toxicity consistently without any false-negative or false-positive results. Several alternative contact bioassays have been described that may fulfil these requirements, but they are not all equally affordable, accessible and practical to execute. The use of human sperm in a contact bioassay is inexpensive and convenient, as well as invaluable for consistent quality assurance in ART laboratories. If used appropriately, the HSSA is sensitive, repeatable, readily available and each sample acts as its own control.

Ensuring proper quality control (QC) in the laboratory is critical to the success of any in vitro fertilization (IVF) programme, as the environment of the laboratory can alter the quality of the embryos produced. The ultimate role of the embryology laboratory is to maintain the inherent viability of the gametes and embryos in an environment outside the female reproductive tract. There is a need for objective, sensitive and reproducible methods and assays for testing materials for embryo toxicity as well as growth promoting and inhibiting factors. The manufacturers test commercially available IVF media and plastic ware and provide the results of their testing with the shipment of supplies. It may be advisable to test media and supplies upon arrival to confirm that nothing occurred during shipping. The suitability of various reagents and materials for use in human IVF can be tested using a range of bioassays. While the most used bioassays for QC in IVF laboratories are the human sperm survival assay and the mouse embryo bioassay (MEA), the one-cell MEA has been consistently shown to be the most sensitive.

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.

High-quality data are necessary for drawing valid research conclusions, yet errors can occur during data collection and processing. These errors can compromise the validity and generalizability of findings. To achieve high data quality, one must approach data collection and management anticipating the errors that can occur and establishing procedures to address errors. This chapter presents best practices for data cleaning to minimize errors during data collection and to identify and address errors in the resulting data sets. Data cleaning begins during the early stages of study design, when data quality procedures are set in place. During data collection, the focus is on preventing errors. When entering, managing, and analyzing data, it is important to be vigilant in identifying and reconciling errors. During manuscript development, reporting, and presentation of results, all data cleaning steps taken should be documented and reported. With these steps, we can ensure the validity, reliability, and representative nature of the results of our research.

This chapter argues that Early Career Researchers (ECRs) can contribute to the IPCC in two major ways. First, ECRs can contribute unique skills and competences to the assessment process. Second, ECRs can share the workload with senior researchers and thus enhance the quality of the assessment. By reviewing the IPCC’s Scholarship Programme and the role of Chapter Scientists, this chapter explores the potentials and challenges of introducing ECRs into the IPCC, and for the Panel to engage in capacity building to enhance the quality of the assessment. The review shows how the organisational setup of the Scholarship Programme and the Chapter Scientist role allows the IPCC to informally engage in capacity building without diverting from its mandate that does not include capacity building. Even so, ECRs remains an untapped source of expertise that, through active and strategic work, can contribute to the future development of the IPCC.

Chapter 15 focuses on legal issues surrounding the licensing of trademarks, brands, designs, trade dress and characters. It covers the historical development of the naked licensing and abandonment doctrines (Dawn Donut) and explores the issue of quality control through BarcAmerica v. Tyfield Importers and different examples of quality control clauses. It next addresses the related issue of trademark usage guidelines. It concludes with a discussion of franchising agreements, a special category of trademark licenses that often include stringent business format requirements and are regulated under state law. Franchise disputes are illustrated with IHOP Restaurants v Moeni.

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 provides an overview of the ADEPT planning system that applies the previously discussed principles of effective plan-development, implementation, and evaluation.

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.

Trepanning of the bone is one of the oldest known procedures carried out by man and the use of the modern trephine biopsy has a venerable history. Parapia has published an admirable summary of the history of the topic and this should be consulted for the excellent illustrations of historical instruments [1]. The history is briefly summarized here [1]. Trepanning of the skull is the oldest known surgical procedure in humans and evidence of this practice has been found in Europe, North Africa, South America, Asia and New Zealand. In Peru, where the procedure is likely to have been carried out to treat headache, mental illness and to relieve intracranial pressure, sharp knives of obsidian, stone and bronze were used for trephination. Celsus, the Roman physician, described a modiolus – an iron instrument with a serrated cylinder that was rotated over a central pin by means of a strap. The early interventions were therapeutic and the first diagnostic biopsy was undertaken in Pianese in Italy in 1903. In 1922, Morris and Falconer used a drill-like instrument to biopsy the tibia, producing similar specimens to modern biopsies and, in the same year, Seyfarth developed a puncture needle for open biopsy of the sternum, producing smears, touch preparations and blocks for sectioning. The modern era probably began in 1958 when McFarland and Dameshek described a technique for biopsy of the right posterior iliac crest using a Silverman needle, which had been described in 1938. Further improvements followed, with modified instruments described by Jamshidi in 1971 and an electric drill technique by Burkhardt in 1971. Recent developments are described later in the chapter.