Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.25 · sl/458.25 (S.L. 458.25)

S.L. 458.25 Art. 11Provision of facilities and services.

In KraftAmtlicher Text

(1) The licensee shall ensure that there is sufficient space, equipment and facilities for the proper performance, within the medical laboratory, of the required volume of work to ensure that a high standard of accuracy, precision, efficiency and safety is always maintained to the satisfaction of the Minister.

(2) Without prejudice to the generality of subregulation (1), the licensee, having regard to the category of tests performed at the laboratory, shall -

(a) provide adequate professional, technical, ancillary and other supporting staff;

(b) provide and maintain adequate laboratory facilities in accordance with good laboratory practice;

(c) maintain all parts of the building in a good structural state of repair, and, in particular, provide adequate lighting and ventilation, and all necessary safety;

(d) maintain a high degree of cleanliness and hygiene in all parts of the building;

(e) take established precautions against the risk of fire and make established arrangements for detecting, containing and extinguishing fires and for the evacuation of staff in the event of such fire. In particular the licensee shall comply with such instructions as may be given by the Commissioner of Police in this respect;

(g) take all the necessary precautions to ensure the safety, both physical and biological, of all staff on the premises. Moreover, he shall provide and maintain adequate means of protection against occupational hazards, and ensure that all staff is making use of the protection provided.

(3) The licensee shall make available, when so required by the Minister or by any authorised officer, the following written codes of practice and procedures:

(a) the laboratory’s policy for quality control on a daily basis, including accreditation of its tests from an authority that is recognised by the Minister to be appropriate and reliable, with inter-laboratory calibration exercises forming part of this accreditation;

(b) the laboratory’s policy on instrument function checks and preventive maintenance of instruments;

(c) the laboratory’s safety policies to the workers, the patients and the public in general:

Provided that the Minister may from time to time require these codes to be amended and updated as he may deem appropriate.

(4) The licensee shall ensure that the codes referred to in subregulation (3) are strictly adhered to by all persons working in the laboratory.