Laboratory Accreditation: What Is It And Why Is It Important?
Surveys conducted by IFCC have revealed that laboratory accreditation is considered to be important by the vast majority of Full and Affiliate Member Societies. Those surveys, and informal discussions with colleagues from IFCC Member societies, also reveal that achieving laboratory accreditation is perceived to be challenging, particularly in those countries where there is little or no experience or track record of laboratory accreditation.
The IFCC position is that it recommends that clinical laboratories should work towards and eventually achieve laboratory accreditation in line with the ISO 15189:2012 standard entitled ‘Medical laboratories – requirements for quality and competence’. As part of that commitment, IFCC has a memorandum of understanding with the International Laboratory Accreditation Cooperation (ILAC), which encourages the two organisations to collaborate in promoting laboratory accreditation.
The IFCC Strategic Plan (2015-2017) contains two actions that commit IFCC to practical support for laboratory accreditation:
- Establish at least one new project with ILAC that aims to improve the application of quality management and laboratory accreditation.
- In conjunction with others, develop a route to laboratory accreditation for countries with limited resources.
This article relates to the first of these action points. It has been prepared jointly by IFCC and ILAC and it seeks to provide answers to two key questions:
- What is laboratory accreditation?
- Why is laboratory accreditation important?
The article relies on material published in a series of ILAC brochures, including:
- ISO 15189 Medical Laboratory Accreditation
- Why become an Accredited Laboratory?
- The Advantages of being an Accredited Laboratory
These and other brochures, including translations into multiple languages, are available from:
What is Laboratory Accreditation?
A high proportion of clinical decisions are influenced by laboratory medicine results. This places laboratory medicine at the centre of modern healthcare, with influence over patient diagnosis, prognosis, therapy and long term management. Consequently, laboratory medicine specialists have a responsibility to ensure that the service they provide reaches high standards of quality and reliability. Increasingly, it is recognised that high quality in laboratory medicine includes what happens before the specimen reaches the laboratory (pre-analytical); what happens in the laboratory (analytical) and what happens once a result has been generated and reported (post-analytical).
Laboratory accreditation entails the independent assessment of the performance of a laboratory against an objective set of quality and competence standards. For medical laboratories (those that deliver laboratory medicine services) ISO 15189:2012 represents the current global best practise standard since it addresses quality management and technical performance across the pre-analytical, analytical and post-analytical phases of laboratory operation. This standard includes the qualifications and continuing professional development of staff; laboratory accommodation, equipment, reagents and supplies; and the considered opinion of users of the service.
The laboratory accreditation process requires the laboratory to submit an application to an accreditation body, usually in the same country. The accreditation body will preferably hold signatory status to the ILAC MRA (ILAC Mutual Recognition Arrangement) for the accreditation of medical laboratories using ISO 15189 or alternatively be a signatory to the mutual recognition arrangement of one of the regional cooperation bodies of ILAC. (Information on the ILAC MRA is available from http://ilac.org/ilac-mra-and-signatories/) The accreditation body will specify the information to be supplied by the laboratory and the requirements for accreditation, as well as a detailed outline of the assessment process. In preparing to submit an application the laboratory will conduct a series of internal audits against the requirements documents to determine its readiness for external assessment.
The formal assessment procedure will involve independent peer specialist scientific and clinical assessors, with expertise in the relevant discipline of practice, who conduct a thorough assessment of all factors in the laboratory that affect the production of test data. These will include:
- The quality management system
- The technical competence of staff
- The validity and appropriateness of test methods, including pre- and post-analytical elements such as sample collection and reporting
- Sample quality, including patient identification, handling and transport to maintain sample integrity
- A review of the history relating to previous patient results and any known clinical diagnoses
- Procedures relating to the use of “referral laboratories” such as specialised testing centres for specific diseases
- The traceability of measurements and calibrations to relevant standards
- The suitability, calibration and maintenance of test equipment
- The testing environment
- Quality assurance of test data
- Acceptable turnaround times
- The opinion of users of the service
- The application of appropriate ethical values
The laboratory is granted accreditation once it complies with the criteria set by the accreditation body. A certificate, or equivalent, is issued to confirm and demonstrate laboratory accreditation and the laboratory is then permitted to use an agreed endorsement to demonstrate that it has met the required standard. The laboratory should then use its quality management system to maintain and further improve its performance ahead of the next formal assessment, which will occur at regular intervals.
ILAC is the key international authority on laboratory accreditation, with a membership consisting of accreditation bodies and stakeholder organisations throughout the world. It is involved with the development of laboratory accreditation practices and procedures; the promotion of laboratory accreditation as a trade facilitation tool; and in the provision of services that promote an unpolluted environment, safe food, clean water and reliable health care services for the public benefit; the assistance of developing accreditation systems; and, the recognition of competent test and calibration facilities around the globe. ILAC actively cooperates with other relevant international bodies in pursuing these aims. Further information about ILAC may be obtained from www.ilac.org
Why is Laboratory Accreditation Important?
Laboratory accreditation is widely regarded as a benchmark of technical competence and high quality performance in the specialty of laboratory medicine. Accreditation is patient-focused, impartial and objective. Accreditation against a common global standard aids international recognition of the benchmark achievement.
Laboratory accreditation is important for several stakeholder groups:
Patients and the public:
The output from an accredited laboratory will provide patients and the public with confidence and reassurance about the quality and clinical relevance of their results. They will know that the results were obtained by trained and competent staff using up-to-date technologies and current best practice. As such, laboratory accreditation makes a significant contribution to patient safety.
Users of the laboratory:
Clinical users of an accredited laboratory will also have confidence in the quality and clinical relevance of the results that they receive. This will help them to plan patient investigations and management. There will be no need to duplicate testing and clinical practice guidelines will have greater relevance. Users will also know that they can contact laboratory staff to discuss interesting or difficult patient investigations. Overall, laboratory accreditation supports increased clinical effectiveness.
Employing authorities and regulators:
Laboratory accreditation provides independent assurance of the quality and safety of the laboratories overseen by employers and regulators. This establishes a high baseline of performance that provides a mechanism for measuring quality improvement and that encourages innovation. Therefore, laboratory accreditation is an important contributor to good clinical governance.
Laboratory management and staff:
Accreditation provides independent confirmation that a laboratory complies with best practice. As a result, laboratory management and staff have pride in their achievement and a determination to maintain and continually improve their performance. Accreditation enables employers and regulators to accept that the laboratory meets an international standard without the need for providing additional information or performance data. In marketing terms potential clients are more likely to use a laboratory if it is accredited, thereby opening up opportunities for innovation and collaborative research, including clinical trials.
Suggested Detailed Reading on Laboratory Accreditation:
ISO 15189:2012 Medical laboratories – requirements for quality and competence. Available from:
Burnett D. A practical guide to ISO 15189 in laboratory medicine. ACB Venture Publications 2013. ISBN 978-0-902429-49-9
Huisman W. European medical laboratory accreditation. Present situation and steps to harmonisation. Clin Chem Lab Med 2012; 50: 1147-52
Graham H Beastall (Past President of IFCC; firstname.lastname@example.org)
(Regina Robertson, ILAC AIC Chair - email@example.com)