National Reference Laboratory Network

The Competent Authority within each Member State is responsible for designating a National Reference Laboratory (NRL) for coordinating the diagnostic standards and methods for crustacean disease diagnosis in the Member State concerned. Details on the designation and responsibilities of NRLs, as detailed in Annex VI (Part II and III) of Directive 2006/88 are:

1. The national reference laboratories designated pursuant to Article 56 shall be responsible for coordinating the diagnostic standards and methods within their field of responsibility in the Member State concerned. These national reference laboratories shall:

(a) undertake to notify, without delay, the competent authority whenever the laboratory is aware of a suspicion of any of the diseases referred to in Annex IV;

(b) coordinate, in consultation with the relevant Community reference laboratory, the methods employed in Member States for diagnosing the diseases concerned under their responsibility;

(c) assist actively in the diagnosis of outbreaks of the relevant disease by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies;

(d) facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic techniques throughout the Member State;

(e) ensure confirmation of positive results of all outbreaks of exotic diseases listed in Part II of Annex IV, and of primary outbreaks of non-exotic diseases listed in that Annex;

(f) organise periodic comparative tests (ring tests) of diagnostic procedures at national level with the laboratories designated by the Member States in accordance with Article 57, in order to provide information on the methods of diagnosis used and the results of tests carried out in the Member State;

(g) cooperate with the Community reference laboratory referred to in Article 55 and participate in the comparative tests organised by the Community reference laboratories;

(h) ensure a regular and open dialogue with their national competent authorities;

(i) operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive:

(i) EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;

(ii) EN 45002 on ‘General criteria for the assessment of testing laboratories’;

(iii) EN 45003 on ‘Calibration and testing laboratory accreditation system —General requirements for operation and recognition’.

The accreditation and assessment of testing laboratories referred to in point 1(i) may relate to individual tests or groups of tests.

3. The Member States may designate national reference laboratories which do not comply with the requirements referred to in point 1(i)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided the laboratory operates under quality assurance in line with the guidelines in ISO 9001.

4. Member States may authorise a national reference laboratory situated on their territory to take advantage of the skills and capacity of other laboratories designated pursuant to Article 57, for one or more of the diseases under their responsibility, provided that these laboratories comply with the relevant requirements of this Part. However, the national reference laboratory shall remain the contact point for the central competent authority of the Member State, and for the Community reference laboratory.