The ‘quality’ of a product or service has been defined as a measure of how well the inherent characteristics of that product or service match all the requirements of it. When all the inherent characteristics meet the requirements the quality is said to be high but if the requirements are not meet quality is said to be low. Quality therefore depends not just on the inherent characteristics of a product or service but it also critically depends on the requirements and expectations of the product or service. Those requirements may be driven by customer or user expectation and/or they may be driven by legislation and regulatory requirements. The Quality Management System (QMS) describes the sum total of processes put in place by an Organisation to manage Quality. Key aspects of a laboratory Quality management system usually include a Quality Manual, Quality Policy, a set of Quality Objectives and a Quality Plan to achieve those objects, provision for sufficient Personnel, Document Control processes, provision of adequate Facilities, control of the Examination processes, control of Clinical Materials and Quality Review processes.
A quality manual documents a laboratory’s quality management system and includes the quality policy and arrangements for its implementation. It can be in paper or electronic form. A quality manual should define the scope of the quality management system, i.e. list what is included and what is specifically excluded. Certain external suppliers may for instance be excluded from the scope of the quality management system. Where exclusions are listed, they must be justified. The processes and procedures that are included e.g. document control, management review etc, must be listed or referenced if described elsewhere together with a description of how the processes interrelate. The quality manual must describe the human and other resources necessary to support the operations of the laboratory and to monitor the laboratory processes. The quality manual must also crucially describe the actions necessary to achieve planned results and continual process improvements. The ISO 9001 standard specifies a set of standard requirements for a quality management system for organisations and provides a good basis for a quality manual though care must be taken not to simply reproduce the standards.
The quality manual starts with a definition of the ‘quality policy’ of the laboratory or more likely, its parent organisation. This should be a clear statement of the organisations commitment to quality. The quality policy must be based on the principles of leadership from top management, a focus on users which in the context of H&I laboratories include patients, donors, clinicians and other colleagues, a commitment to involve staff in the maintenance of quality, a standard approach to processes and procedures and a commitment to continuous improvement.
The quality policy provides the basis for the laboratory to develop quality objectives. Quality objectives must be measurable and consistent with the quality policy of the parent organisation. They must meet or exceed user expectations and may even be developed with user input. Quality objectives must be updated periodically.
One means of itemising the quality objectives and monitoring progress to meet those objectives is to describe them in a ‘quality plan’. A quality plan specifies the objectives and describes the procedures and resources that will be needed to meet those objectives, including who will do what and when. It also describes the criteria by which success in achieving each of the objectives will be measured and provides a basis for regular review of the implementation of the quality management system including annual review of quality.
Another key feature of a quality management system is a description of the organisational structure and staffing levels, including staff training, required to meet the quality objectives. In the H&I laboratory context this means that the laboratory must be directed by an individual with the qualifications and experience to fulfil the responsibilities of the ‘Director’ of the laboratory. In the UK, the Director is usually a Consultant Clinical Scientist who holds the FRCPath (i.e. is a Fellow of the Royal College of Pathology).These, according to the current EFI standards, include an earned doctorial degree in a biological science or a medical qualification and in addition must have 4 – 5 years experience in H&I or Immunology (two or which must be in H&I in the case of the later). The laboratory must have an organogram describing its organisation and management and the place of the laboratory in any parent organisation. The quality management system must also specify the responsibilities, authority and interrelationships of all staff. A quality management system should require that staff undertaking any procedures which affect the quality of the service must be fully trained in those procedures. The quality management system should list or provide a reference to documentation which lists the competencies required by staff to undertake any processes and provide for training to take place for staff to achieve those competencies.
‘Document control’ is an essential part of the quality management system. A good quality management system requires that all key documents, including procedure descriptions and process documentation must be controlled. In the H&I laboratory context, these documents include amongst other, clinical policies, management process descriptions, standard operating procedures, information and datasheets, forms, records of processes and certain print outs from analysers. The quality management system must include the requirement that all documents be approved for use by authorised personnel prior to issue; that there must be a readily accessible master list of all documents which identifies the current revision status and distribution of all documents in order to prevent the use of invalid and/or obsolete documents; that all documents must contain a title, unique identifier, a review date and/or date of issue and/or revision version, the total number of pages and the name of the authoriser; that legible, readily identifiable documents must be available at points of use; and that all documents shall be regularly reviewed and updated as required. In addition, the quality management system must provide for the identification, secure storage for the legislated retention period, protection, retrieval and disposal of process documentation, test records, result reports and quality documentation.
A quality management system must provide for adequate premises, equipment and other resources to ensure that the work of the laboratory is performed safely and efficiently. This requires that the premises has sufficient space for separation of incompatible activities such as pre and post PCR activities and dedicated facilities for sample reception for instance. It also requires that the premises be secure from access by unauthorised personnel. There must be adequate storage for personal items away from laboratory items and sufficient storage for samples, reagents and records.
CPA and EFI define standards for examination processes such as sample reception, quality control of examinations, post examination processes such as handling reports and dealing with telephone requests for results. In the laboratory, the examination processes and their control forms a key aspect of the QMS.
In the H&I laboratory context, another key feature of a quality management system is the control of clinical materials. Clinical materials include all blood and tissue samples. The quality management system must describe how clinical material is uniquely labelled to allow identification and must describe how it is securely stored and retrieved as required and disposed of when no longer stored. These must be in compliance with current legislation, regulations and guidelines. Retained material must be stored in a manner which ensures the validity of a repeat examination.
Finally another key feature of a quality management system is provision for process improvement including regular ‘management quality reviews’. Ongoing evaluation and improvement processes are essential to ensure that the laboratory continues to meet the needs and requirements of its users. Methods for undertaking such evaluations include user surveys, vertical, horizontal and examination audits, monitoring the speed of dealing with non compliances from audits, monitoring the speed of dealing with complaints, monitoring of key performance indicators such as turnaround times, monitoring the status of preventative and corrective actions and monitoring the speed of follow up of actions from quality management reviews. All of these must be reviewed at regular intervals, no less than on an annual basis to ensure the continued suitability of the quality management system and to change and improve the system as required. The output from a management quality review must include decisions on what improvements can be made to the quality management system, what improvements can be made to the service and what resources are needed by the laboratory to continue to provide a high quality service that meets the needs of its users. The laboratory must have an identified individual whose role includes direct responsibility for quality. This individual has a responsibility to ensure that the quality management system is fully implemented and maintained and to report this back to the management of the laboratory.
In the UK, H&I laboratories are required to maintain Clinical Pathology Accreditation (CPA) in order to continue providing their services. In addition, most UK H&I laboratories choose to obtain and maintain European Federation for Immunogenetics (EFI) accreditation. Also, depending on the parent organisation the H&I laboratory is a part of, the laboratory may need to obtain and maintain the Medicines and Healthcare Regulatory Authority (MHRA) accreditation. Accreditation through all of these schemes requires that the laboratory meet the highest standards of quality, something which is facilitated by the implementation of a quality management system.
A quality management system contribute to H&I laboratory service provision by helping the lab to standardise and document its processes and train all staff to operate to that standard procedure thereby helping to improve process control. This ensures that the right tests are done on the right samples, using the right processes and the reports are sent to the right recipient. A quality management system facilitates staff training and helps reduce repeats and waste thereby lowering costs. Implementation of a quality management system helps reduce errors and potentially reduces the risk of litigation.
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