Regulation: The Key Players
The key participants in the quest for high quality laboratory tests have been the various Government regulatory and statutory bodies and the various professional bodies that represent scientific staff.
The scientists and doctors who work in laboratories must be registered professionals, who are appropriately qualified for the tasks they perform and who adhere to strict codes of conduct and ethics.
The appropriate statutory bodies require strict training and ethical standards for these staff to ensure proper conduct and competence to practice. Regulatory bodies conduct inspections of laboratory and/or its staff to ensure their standards are met Doctors working in laboratories, like all doctors, are registered with the General Medical Council and scientists are registered with the Health and Care Professions Council. The registration status of individual professionals can be checked via their websites.
Professional organisations such as the Association for Clinical Biochemistry and Laboratory Medicine (ACB) the Institute of Biomedical Science (IBMS) and the Royal College of Pathologists are also involved in improving pathology testing through the development and dissemination of standards, guidelines and best practices. They, along with the private health sector and the Department of Health, established Clinical Pathology Accreditation (CPA) to inspect Pathology Laboratories to ensure they meet the 47 CPA standards.
Statutory bodies include:
The Medicines and Health Care Products Regulatory Agency (MHRA) is a Government body which oversees the quality of medicines and devices used by the NHS, and also inspects Blood Transfusion Laboratories. It monitors adverse incidents and works with laboratory staff and industry to improve the quality of the service provided to patients.
The Human Tissue Authority (HTA) is a statutory body that has its own Codes of Practice setting out its legal framework for the storage and use of tissue from the living and for the removal, storage and the use of tissue and organs from the dead that conducts a bi-annual inspection of the processes and premises. It also requests details of any HTA related incidents, their subsequent investigation and learning points.
The Human Fertilisation and Embryology Authority (HEFA) ensure all human embryos outside the body are subject to regulation.
The Health and Safety Executive (HSE) have the right to inspect all laboratories at any time
Details of their specific role i.e. when they would inspect is available from the appropriate web site (see links and sources)