Abstract
For fertility clinics to be successful, quality must be a priority. Quality is not just about ticking boxes, it is about ensuring jobs are completed to the best standard possible.
1 Introduction
For fertility clinics to be successful, quality must be a priority. Quality is not just about ticking boxes, it is about ensuring jobs are completed to the best standard possible. Quality is defined as:
the degree to which a set of inherent characteristics fulfils requirements
Quality can be considered as consistent conformance to patient expectations, and has also been referred to as a ‘journey where you never arrive’, since maintaining quality is a continuous process:
the race for quality has no finish line so technically it is more like a death march
Comparison to a death march is perhaps unfair! The process of achieving quality can be extremely rewarding, and is more like a ‘eureka moment’ when the people involved realise the benefits that quality brings to an organisation.
Achieving quality requires quality systems to be in place throughout the organisation. This enables troubleshooting via a cycle of continuous improvement, which enhances quality, leading to better patient satisfaction, alongside improved satisfaction of investors and staff.
1.1 Establishing a Quality Management System
The first step in achieving quality is to establish a quality management system (QMS). For the United Kingdom, the Human Fertilisation and Embryology Authority (HFEA) requires all licensed fertility clinics to have a QMS, stating:
The centre must put in place a QMS and implement this system to continually improve the quality and effectiveness of the service provided in accordance with the conditions of this licence and the guidance on good practice as set out in the HFEA’s Code of Practice.
The HFEA provides its own definition of a QMS as:
The organisational structure, defined responsibilities, procedures, processes and resources for implementing quality management (i.e. the co-ordinated activities to direct and control an organisation with regard to quality), including all activities which contribute to quality, directly or indirectly
The QMS requires regular review and needs to adapt to new legislation. For example, in 2004, the European Union Tissues and Cells Directive 2004/23/EC (EUTCD) established standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues. All HFEA-licensed fertility clinics had to revise their QMS to align themselves to the HFEA’s interpretation of the EUTCD.
1.2 External Standards
Many clinics consult external standards to establish a QMS, such as the International Organization for Standardization (ISO; www.iso.org), which provide sets of standards for a specific level of quality.
ISO standards that relate to assisted conception include:
ISO 9000:2000. Quality Management Systems: Fundamentals and vocabulary
ISO 9001:2008. Quality Management Systems: Requirements
ISO 15189:2012. Medical Laboratories: Requirements for Quality and Competence
Other approaches to QMS development originate from successful care manufacturing companies, and include ‘Lean & 5S’ and ‘Six Sigma’ (Figure 23.1). ‘Lean & 5S’ is an operating philosophy orginally developed by Toyota to help reduce costs and turnover time.
A systematic approach to identify and eliminate waste through continuous improvement by flowing the product only when the customer needs it in pursuit of perfection
Similarly, Motorola developed ‘Six Sigma’, a philosophy that reduces ‘variability’ to help solve problems. ‘Six Sigma’ solves all problems using a five-step DMAIC process: Define, Measure, Analyse, Improve, Control.
External standards tend to be short documents with wide-ranging statements to allow interpetation by different industries. For reproductive medicine, more specific organisations also need consideration, such as the HFEA, the Care Quality Commission, the NHS Litigation Agency and the UK Accreditation Service.
Whatever the approach, clinics with a well thought out QMS have the foundations for implementing effective quality management on a daily basis. All areas can be evaluated, from the way staff practice, to the actual treatment protocols and the results achieved.
The HFEA states:
The centre should:
a) identify the processes needed for quality management, for providing and managing resources and for assisted conception procedures, and
b) ensure these processes, including the interaction between them, are effective and continually improved.
In summary, the QMS provides a management framework to monitor and enhance performance. All activities that contribute to quality, either directly or indirectly, are considered. If quality is present, then the QMS ensures patients receive an agreed standard of care throughout their treatment, whilst the clinic works to continually improve the service delivered by achieving high standards and consistency throughout.
According to the HFEA, specific QMS documentation is needed:
The following documentation must form part of the QMS:
a. a quality manual
b. standard operating procedures (SOPs) for all activities authorised by this licence and other activities carried out in the course of providing treatment services that do not require a licence
c. guidelines
d. training and reference manuals, and
e. reporting forms.
This chapter will introduce and discuss the key steps and accountabilities within a QMS. This will take into account the elements mentioned in Guidance Note T33.
1.3 The Quality Manual
The Quality Manual is the backbone of the QMS. This document should consist of easily digestible sections for ease of reference. The introduction should briefly describe the clinic’s location, activities that take place and the legal entity. It is important to clarify the scope, to segregate any parts of the organisation excluded from the QMS, e.g. diagnostic hormone assays may be referred out to another organisation and therefore be beyond the clinic’s scope.
The Quality Manual should reference documented policies and procedures, describe how documents are controlled, how audits are conducted and how non-conformances (NCs) are addressed. When the benefits of quality are appreciated, then the Quality Manual becomes the Bible for a fertility clinic (alongside the HFEA Code of Practice in the United Kingdom).
1.4 Organisational Structure, Management and Responsibility
A clinic should have enough staff in place of sufficient grade and experience to perform the treatments to a required level of quality. All staff should comply with ethical conduct, which is usually covered by the codes of conduct from respective professional bodies, e.g. the Royal College of Nursing (RCN), the Royal College of Obstetrics and Gynecologists (RCOG) and the Royal College of Pathologists (RCPath). Laboratory staff additionally sign up to codes from the Health and Care Professions Council (HCPC), the Association of Clinical Embryologists (ACE) and the Association of Biomedical Andrologists (ABA).
A designated individual, or ‘Person Responsible’ (PR), should have overall responsibility for all licensable activity taking place. In the United Kingdom, the PR has to be approved by the HFEA. The PR and senior management of the different areas (medical, nursing, scientific and administration) form the management team to direct the organisational structure by assigning clear roles and responsibilities to all staff and ensuring they have everything they need to fulfill these roles. Consideration should also be given to other individuals (from other departments, other clinics, diagnostic laboratories and suppliers), with the patients at the heart of the organisation’s care.
The HFEA states that:
The centre must have an organisational chart which clearly defines accountability and reporting relationships
The organisational chart (Figure 23.2) requires periodic and timely reviews to ensure its effectiveness in supporting the clinic’s needs. For example, an increase in patient numbers may warrant an increase in the number of certain types of staff.
Fig. 23.2 An organisational chart for a fertility clinic
Each position within the organisation should be clearly defined by a job description specifying the requirements, e.g. appropriate education, skills, training and experience. Job descriptions can not only be used as part of the hiring process but also to develop staff to ensure they are sufficiently skilled to meet the clinic’s objectives. If employees are engaged they feel more valued, and this in turn benefits the clinic. A training system can cover training needs, with individuals having a personal training file, which includes evaluation of performance and competence, and an annual appraisal report from their line manager. If quality is present, individuals will competently perform their designated tasks in line with the SOPs to benefit the clinic.
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