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.
Following the landmark achievement of the first in vitro fertilisation (IVF) birth in 1978 major advances in the clinical and laboratory techniques in assisted conception practice have widened the scope and efficacy of treatment. These included the refinement of ovarian stimulation protocols, ultrasound guided oocyte retrieval, cryopreservation of surplus embryos, egg donation, surrogacy, intracytoplasmic sperm injection (ICSI), surgical sperm retrieval, in vitro maturation of oocytes, preimplantation genetic testing of embryos and the use of gonadotropin-releasing hormone antagonists.
In the United Kingdom, these advances took place within a regulatory framework administered by the Human Fertilisation and Embryology Authority (HFEA) empowered through an Act of Parliament. Oversight and regulation within the burgeoning sector were further moderated by the European Tissues and Cells Directive (EUTCD) in 2004. Continued progress in specific areas such as ovarian tissue cryopreservation and transplantation, preimplantation genetic diagnosis and screening and somatic cell nuclear transfer were complemented by a revision of the 1990 Human Fertilisation and Embryology (HFE) Act in 2008.
More recently, elective single embryo transfer, the individualisation of stimulation regimes to maximise outcomes through ovarian reserve testing, the advent of vitrification of eggs and embryos, fertility preservation for young women facing potentially sterilising medical or surgical treatment of cancer and other conditions have expanded the scope of assisted reproductive technologies in the reproductive health care. In the United Kingdom, some 2% of all births are attributable to the use of IVF, with nearly 70,000 treatment cycles across 80 licensed centres. Responding to major laboratory and clinical advances has been a requirement for clinics in an increasingly competitive environment where the client group has high expectations. In the United Kingdom, all licensed IVF centres are required by the HFEA Code of Practice to have a quality management system to ensure a uniform standard of excellence.
This quality-based approach to the delivery of assisted reproductive technology (ART) services has become an integral part of the management of the infertile couple. It underpins a patient-centred approach from first contact, through assessment and diagnostic pathways, first-line treatment and ultimately assisted conception.
This chapter seeks to give an overview of the place of Quality Management in contemporary fertility practice.
Providing the best care for patients lies at the heart of good medicine. However, as this book shows, there are many stages in the pathway of fertility treatment, with many stakeholders involved. It is important to establish agreement between patients and professionals on factors which are perceived to be critical in defining the quality of care.
The World Health Organization suggests that a health system should seek to ensure that the following dimensions of quality are considered in the organisation of services:
Care should be effective, predicated on sound evidence, resulting in improved health outcomes addressing the needs of service users.
Care should be efficient, maximising use of resources and avoiding waste.
Care should be accessible, that is, deliverable at an appropriate time in the care pathway and in a place where skills and resources are available to meet the medical need.
The preferences of users of services should be taken account of in accordance with patient-centred principles of care.
The quality of care should be available on an equitable basis, without prejudice relevant to issues such as gender, race, ethnicity, sexual orientation or socio-economic status.
Safe delivery of care minimising risks and harm to users of services is essential.
Service delivery in line with these principles utilises a number of tools to monitor performance against agreed upon standards and these will be considered in more detail.
Quality Management, quality assurance, quality control are quality improvement are terms which are commonly used in this context. It is useful to compare and contrast the meanings of these terms to better understand how they are related.
Quality Management describes the establishment of a system which enables an organisation, in this case a clinic, to provide a standard of service which leads to a consistent level of excellence. This is provided within a culture of continual monitoring of performance and effort to improve the quality and effectiveness of the service. A commonly used resource to facilitate the introduction of quality management is the Quality Management Systems – Requirements ISO 9001:2015.
Quality assurance sets out to maintain a high level of quality by monitoring and recording every stage in a process of care thereby facilitating identification of specific problems associated with an overall reduction in performance. An example of this might be a fall in the expected number of cleavage stage embryos which might develop from normally fertilised eggs within the incubator. The consequence of this could be a reduction in the number of pregnancies and live births resultant from treatment within the centre.
Quality control is the mechanism whereby a clinic monitors specific elements within the process of care which may directly or indirectly impact on the quality of outcome for the patient engaging with the clinical service. This might, for example, include the use of specific equipment to assess the temperature and pH within an incubator used to culture embryos. Problems with either of these variables may be the cause of the embryo cleavage issues alluded to earlier.
Quality improvement describes the responsibility of a clinic to set in place actions with the aim of enhancing outcomes. The clinic might, in response to problems with embryo cleavage, choose to introduce changes in the culture media used in the embryo incubator. Monitoring systems to assess the impact of any change should be in place to provide objective evidence that the adaptation to the protocols used have led to the desired improvement.
14.3 Using a Process Model in the Organisation of Services
The goal in quality management is to enable the provision of a high-quality clinical service, underpinned by evidence, at a standard which is consistent for all patients and customers.
An assessment of the functional needs of the clinic is best achieved through a process model approach (Figure 14.1). This encompasses the three elements of encounter with any organisation: an input, a process and an output. In fertility care, the patient is at the heart of every process.
To demonstrate how this applies in a fertility clinic setting it is best to consider the input in this situation to be the patients referred to the clinic. This might be from general practitioners or hospital colleagues, while some users of the service may self-refer.
Receipt of the referral triggers a process of care. This process should be mapped carefully such that each stage may be considered individually and in the context of the overall pathway. A referral would normally encompass consultation, assessment, investigation and treatment by highly trained and adequately equipped staff. A trained multidisciplinary team will be involved in the delivery of care whose members will require access to and possession of facilities, materials and good levels of internal/external communication; they need to provide relevant and understandable information for users of services, and utilise sound clinical methods encompassing knowledge and procedure specific skills. Care must be provided in facilities which are fit for purpose and respect the privacy and dignity of patients. Each element of the clinic/patient interaction in a care pathway should be defined and described clearly in Standard Operating Procedures (see Section 14.4.4).
The output of the service will include some patients who will have become pregnant, and many who will not. All will have degrees of satisfaction in relation to their experience of the service. Analysis of the process of care at its various stages should identify areas of deficiency allowing corrective and preventative actions to be instituted enabling improved performance at all levels for the benefit of patients/users of services.
14.4 Quality Management in Practice
The Quality Management System (QMS) should define the requirements of those seeking assistance, identify what the clinical service can offer, define and record the processes involved in the provision of the clinical service and establish quality objectives for the organisation. These will be aligned to the key issues of patient safety, clinical effectiveness, patient experience and regulatory compliance alluded to earlier.
The quality policy for the fertility service should clearly define the corporate and shared vision of those who work there. It should include the views and aspirations of all stakeholders. The quality policy might for example be a statement along the lines that
This clinic aims to provide rational, efficient and effective treatment delivered in a compassionate manner to all our patients in accordance with UK regulatory requirements within an environment which is sensitive to the needs of patients and the staff who work within the Centre.
Managers in all areas of a clinical service should have input into the development of the Quality Policy. The QMS requires demonstration that standards related to the agreed Policy are met, for example, an aspiration to provide compassionate care will require supportive evidence of that being achieved most likely through patient feedback systematically researched through questionnaires.
There are a number of components which contribute to a quality management system within a fertility centre (Figure 14.2). Individually and collectively these ensure that services are provided in a consistent and effective way. These will be examined in detail.
The quality policy provides the framework upon which the clinic can build its quality objectives. These set out for the centre the principles upon which the quality policy aspirations will be realised. All should be patient focused and be inclusive of elements which support patients’ emotional as well as physical needs in undertaking treatment. The acronym SMART is helpful in defining criteria in the setting of objectives. A Specific area should be targeted for improvement. The objective should be Measurable to allow a determination as to whether progress is being made. Any aspirational target set should be Achievable and Realistic, with improvement expected to occur within a defined Timeframe.
Examples of objectives which a clinic might set could include
Improving live birth rates
○ This might be achieved through adjustments to clinical or laboratory protocols.
Enhancing the patient experience
○ This might be achieved through a response to patient feedback on an element of care in a survey or by enhancing information provision.
Increasing the numbers of patients being seen
○ This might be achieved through adjustment to clinic schedules or referral pathways.
Increasing staff satisfaction within the workplace
○ This might require adjustment to training policies, enhancing access to continuous professional development sessions, improving in-house communication pathways.
Implementation of the QMS requires a sound organisational and management structure. A team of leaders in a fertility centre, whether administrative, clinical or laboratory based, are vital to the delivery of a quality-based service. While quality is a responsibility for all, appointment of an individual with lead responsibility for oversight of the QMS is essential. The Quality Manager (QM) is a key appointment within any organisation and is tasked to ensure that the QMS is functioning appropriately and effectively. This appointment is a regulatory requirement for treatment centres in the United Kingdom as dictated by the HFEA Code of Practice. Beyond that, it is also a regulatory requirement that laboratories undertaking diagnostic semen analysis should be certified to the ISO 15189:2012 standard, which also explicitly requires implementation of a QMS.
The QM should be an individual with effective communication skills and possessing high-level organisational skills. The QM should either be part of the management team or be able to report to management on how the QMS works and how effective it is. The QM needs to engage with all staff within the centre, encouraging co-operation with the principles of quality management and opening lines of communication both horizontally and vertically within and between all professional disciplines in the centre. The QM must institute and manage a robust document control system and ensure that the components of audit, performance review and continual improvement integral to the QMS are delivered. It is not expected that the QM carries out all these functions on their own but they, together with senior management, need to ensure that tasks in relation to these components are covered and delegated appropriately.