9780521516358book.pdf

Closely allied to the process of clinical audit is that ofaccreditation. However, whereas

clinical audit is carried out primarily for the local benefit of the laboratory and its staff and

ultimately for the patient, accreditation is a public and national recognition of the profes-

sional quality and status of the laboratory and its personnel. The accreditation process

and assessment is the responsibility of either a recognised public professional body or a

government department or agency. Different models operate in different countries. In the

UK, accreditation of clinical biochemistry laboratories is required by government bodies

and is carried out by either Clinical Pathology Accreditation (UK) Ltd (CPA) or less

commonly the United Kingdom Accreditation Service (UKAS). In the USA accreditation

is mandatory and may be carried out by one of a number of ‘deemed authorities’ such as the

College of American Pathologists. Accreditation organisations also exist for non-clinical

analytical laboratories. Examples in the UK include the National Measurement Accredit-

ation Service (NAMAS) and the British Standards Institution (BSI). The International

Accreditation Co-operation (ILAC), the European Co-operation for Accreditation (EA)

and the Asia-Pacific Laboratory Accreditation Co-operation (APLAC) are three of many

international fora for the harmonisation of national standards of accreditation for

analytical laboratories.

Assessors appointed by the accreditation body assess the compliance by the laboratory

with standards set by the accreditation body. The standards cover a wide range of issues

such as those of accuracy and precision, timeliness of results, clinical relevance of the

tests performed, competence to carry out the tests as judged by the training and qualifi-

cations of the laboratory staff, health and safety, the quality of administrative and

technical support systems and the quality of the laboratory management systems and

document control. The successful outcome of an assessment is the national recognition

Glucose (mmol/L)

No. of laboratories

14.2

0

50

100

150

200

15.1 16.0 16.9 17.8

All methods

Hexokinase + G6PD

Olympus reagents [150L]

Fig.16.3Histogram of UK NEQAS quality assessment data for serum glucose based on data in Table 16.2.

The arrow indicates the location of the value submitted by the participating laboratory. (Reproduced by

permission of UK NEQAS, Wolfson EQA Laboratory, Birmingham, UK.)

639 16.2 Clinical measurements and quality control