Setting up a medical laboratory – the basic needs

Privatisation of the NHS is an ongoing discussion in the UK and more and more entrepreneurs are keen to grab a slice of the healthcare pie. Whether public healthcare becomes privatised or not, a growing mistrust in the NHS has led to an increase in personal investment in private clinics, and as the British economy propels itself back towards stability this expenditure is only set to rise.

Whether you are a technician interested in launching your own clinic or a business manager looking to explore the realm of medicinal diagnostics, here is the low down on what you’ll need in order to set up a medical laboratory.

Laboratory Medical Research

Essential equipment

The plant and machinery required to operate the business will depend upon the type of testing you wish to undertake. You may wish to work in clinical microbiology (studying infectious diseases), clinical pathology (analysing tissue to determine disease) or, most commonly, clinical biochemistry (analysis of bodily fluids to, for example, determine genetics or substance abuse).

Regardless of laboratory type, you are likely to need a centrifuge, for processing samples, microscopes for visual analysis, autoclaves for sterilising equipment, safety equipment (including Personal Protective Equipment (PPE)), refrigeration and sample storage facilities, electrophoresis apparatus, basic laboratory equipment (including glass slides, petri dishes and pipettes), absorbent powder, hand sanitiser and sharps/biohazard containers – together with an appropriate protocol for disposing of such waste.

Qualified personnel

Lab technicians are usually degree- or NVQ-qualified. The NHS usually requires candidates to have a biomedical or life sciences degree in order to be accepted onto a scientist training programme although you may be working with people who have gone through the commercial track instead. You will also need clerical staff to deal with incoming samples, returning results and customer queries etc; a quality assurance manager to monitor the implementation of the company’s strategy and obligations; and an accounts manager to look after the organisation’s finances.

Accreditation

Medical lab accreditation in the UK is migrating from the CPA Standards to the new ISO 15189:2012 standard, with emphasis on auditing, traceability and equipment verification. The standard contains invaluable guidance for start-up laboratories and more information on this changeover can be obtained from UKAS’ website. Other certifications you may wish to pursue, if relevant, include ISO/IEC 17025 and AABB. If you aim to work in clinical biochemistry, in order for your laboratory’s paternity results to be admissible in a court of law you will need to seek accreditation from the Ministry of Justice under section 20 of the Family Law Reform Act 1969.