Laboratory Accreditation: the basis for confidence

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 (GMC) and scientists are registered with the Health and Care Professions Council (HCPC). 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 required standards. In 2009 CPA became a subsidiary of United Kingdom Accreditation Service (UKAS) as part of a strategy to contribute to the modernisation of pathology services in the UK.

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)

Accreditation

CPA UK Ltd was originally formed by the main UK organisations of laboratory professionals to operate a scheme of voluntary accreditation for laboratories. In 2009 CPA became a subsidiary of United Kingdom Accreditation Service (UKAS) as part of a strategy to contribute to the modernisation of pathology services in the UK. As part of this modernisation and development UKAS is currently managing the transition of all CPA accredited laboratories to UKAS accreditation to the internationally recognised standard ISO 15189:2012, Medical Laboratories – particular requirements for quality, competence and the transition of CPA accredited External Quality Assurance Providers (EQA) to ISO/IEC 17043:2010, Conformity Assessment – General requirements for proficiency testing.

Laboratories are currently assessed every 2 years and have to renew their registration every year, confirming that they are continuing to operate in compliance with a set of defined standards. Although the scheme is voluntary, the majority of UK clinical laboratories are currently accredited by the scheme, and the phrase 'UKAS/CPA accredited laboratory' is a guarantee that the laboratory has been assessed and approved as a provider of results which meet accepted standards. More details can be found on the UKAS website, which lists all currently accredited laboratories.

Four particularly important areas for inspection are external quality assessment, internal quality control, standard operating procedures and personnel training/competence assessment.

External quality assessment:

Laboratories performing tests on clinical samples participate in External Quality Assessment (EQA) programmes. In these programmes, an outside organisation checks on the accuracy of a laboratory's test results by sending test specimens to be analysed. The outside organisation knows the results of the tests- the cholesterol concentration, for example - but the laboratory does not. The laboratory must test these specimens in the same way it would test specimens normally and return their result to the EQA co-ordinators. The outside organisation uses these programmes to assess the laboratory’s ability to deliver consistently accurate results, and laboratories with performance problems will receive advice and help to rectify any difficulties. UKAS assessors verify that the laboratory shows acceptable performance in approved EQA schemes.

Internal quality control:

To ensure that the results being issued by the laboratory are correct, 24 hours a day, 7 days a week, clinical laboratories test 'control' specimens alongside specimens from patients. The laboratories know the result of the control specimens which act as a built-in check on the process of analysis, which in many cases is carried out on automated equipment. The control specimens contain both high and low values of the test being measured, to make sure that the analyser or procedure is operating correctly across the range of concentrations the patient specimens may contain. If the control results differ from the known, expected result, laboratory staff will immediately know that there is a problem and take action to resolve, before patient results are released. Laboratory assessors also examine these records as part of their evaluations to ensure the action of the laboratory scientists is appropriate.

Standard Operating Procedures:

Every test or process carried out in a laboratory must have a Standard Operating Procedure, which is a defined way of performing a specific course of action. Standard Operating Procedures help to ensure that every process is carried out consistently and accurately each time.  Assessors ensure that all Standard Operating Procedures are accessible, regularly reviewed and up-to-date.

Education and Training:

There are many roles to fulfil in a laboratory, and both the professional organisations and the statutory bodies which undertake registration spell out the requirements for education, fitness to practice and training of laboratory personnel.

Your Role

Assessment creates a "level playing field" in which accredited laboratories must meet appropriate standards of competence. But the quality of service may vary between laboratories, and to ensure that you are receiving the best quality service, there are some simple steps that you can take for yourself.

• Observe the collection process for the specimen. Were you asked to identify yourself? Was the specimen properly labelled? Were you given clear and adequate instructions if you collected the specimen yourself?
• Ask where the tests are going to be performed. Some tests are performed in the GP surgery or in the ward or clinic, others will be sent to a hospital or commercial laboratory. Ask your doctor if he knows whether the laboratory is properly accredited for the tests he wants them to do. You can check laboratory CPA accreditation for yourself at http://www.ukas.com/services/accreditation-services/clinical-pathology-accreditation/.

If the test is being carried out on the spot by a doctor or nurse, ask them to explain the procedures for ensuring that the results are correct e.g. what training the person undertaking the test received. Ask whether an accredited laboratory looks after the equipment that is being used, and ensures that it is performing correctly.

Links & Sources

To check the registration of an individual laboratory professional, visit www.gmc-uk.org for doctors and www.hpc-uk.org for scientists (clinical scientists and biomedical scientists - there are separate registers for each group).

To check the accreditation status of a laboratory, or to find out more about laboratory assessments by UKAS, visit http://www.ukas.com/services/accreditation-services/clinical-pathology-accreditation/

To find out more about the various laboratory External Quality Assessment Schemes, go to www.ukneqas.org.uk, www.riqas.com or www.weqas.co.uk.

Further information on the Human Tissue Authority at http://www.hta.gov.uk/

Details about the Human Fertilisation and Embryonic Authority may be found at http://guide.hfea.gov.uk/guide/

Also see: A practical guide to ISO15189 in laboratory medicine. David Burnett, ACB Venture Publications, 2013.