BS EN 14136:2004

What is BS EN 14136 - External quality assessment schemes for in-vitro diagnostic examination procedures about?

BS EN 14136 is a European standard that discusses the performance of in vitro diagnostic examination procedures. BS EN 14136 outlines the external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs).

BS EN 14136 sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:

• Scheme design and organisation
• Identification of procedures (IVD MDs) used by the participant
• Classification and evaluation of data

Note 1: External quality assessment data generated according to these criteria assists manufacturers, users, or competent authorities to monitor independently the post-marketing performance of IVD MDs.

Note 2: BS EN 14136 does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

Who is BS EN 14136 - External quality assessment schemes for in-vitro diagnostic examination procedures for?

BS EN 14136 on the external quality assessment schemes for in-vitro diagnostic examination procedures is useful for:

• In-vitro diagnostic centres
• Medical laboratories
• Regulatory authorities

Why should you use BS EN 14136 - External quality assessment schemes for in-vitro diagnostic examination procedures?

External quality assessment schemes (EQAS) are an essential feature of mechanisms designed to maintain and improve the analytical quality and medical appropriateness of clinical laboratory data. EQAS are most highly developed in fields in which mostly quantitative, numerical data are generated notably in clinical chemistry, haematology, immunology, etc. However, EQAS can also be extended to qualitative or more subjective investigations such as in microbiology and parasitology, as well as in cytopathology.

BS EN 14136 guideline assists you with requirements on design for EQAS, requirements organisations conducting EQAS, assessment of analytical examination procedures, assessment procedure for quantitative results on ratio or difference scales, assessment of qualitative results on nominal scales or quantitative results on ordinal scales, using results to identify possible deficiencies, archiving documents, and confidentiality.

This assists in the assessment of the performance of in vitro diagnostic examination procedures and taking appropriate decisions for enhancing its performance.

With obedience and compliance to BS EN 14136, you can achieve an acceptable level of performance on in vitro diagnostic procedures.