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Article L6211-11 of the French Public Health Code

The biologist in charge of the medical biology laboratory to which the patient has referred retains responsibility for all phases of the medical biology examination, including when one of them, in the cases provided for in this Title, is performed, in whole or in part, by a medical biology laboratory other than the one in which he or she practises, or outside a medical biology laboratory.

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Article L6211-12 of the French Public Health Code

When the patient’s care pathway includes tests, collection and processing of biological signals for which a prescription has been issued and which require a measuring device, the medical biologist shall ensure, at the time of an examination, under conditions set by decree, that the data from the medical device or in vitro diagnostic medical device is consistent with the result of the medical biology examination that he carries out.

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Article L6211-13 of the French Public Health Code

When the sampling for a medical biology examination cannot be carried out in the medical biology laboratory within a timeframe compatible with the patient’s state of health, it may be carried out in a health establishment, in an army hospital, at the patient’s home or in places where this is possible, by an authorised health professional in accordance with procedures determined with the biologist in charge of the laboratory referred…

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Article L6211-14 of the French Public Health Code

When the test is not taken in a medical biology laboratory or a healthcare establishment, an agreement signed between the legal representative of the laboratory and the healthcare professional or, where applicable, between the legal representative of the laboratory and the legal representative of the structure in which the healthcare professional works, sets out the applicable procedures.

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Article L6211-15 of the French Public Health Code

When the test sample is taken outside the laboratory and in a health establishment to which the laboratory belongs, and the health professional who takes the sample does not belong to the laboratory but works in the health establishment, the applicable procedures are determined by the biologist in charge of the medical biology laboratory. The director of the establishment ensures that they are applied.

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Article L6211-16 of the French Public Health Code

A biological sample must be taken in one of the areas determined in application of b of 2° of Article L. 1434-9 where the medical biology laboratory is located, unless an exception is made for public health reasons and under conditions determined by decree in the Conseil d’Etat.

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Article L6211-18 of the French Public Health Code

I. – When the analytical phase of a medical biology examination cannot be carried out in a medical biology laboratory within a timeframe compatible with the patient’s state of health, it may be carried out : 1° Either in a health establishment or an element of the armed forces health service within the meaning of Article L. 6147-7 ; 2° Or, for reasons related to the patient’s state of health,…

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Article L6211-19 of the French Public Health Code

I. – When a medical biology laboratory is unable to carry out a medical biology examination, it shall transmit the biological samples to another medical biology laboratory for analysis and interpretation. These transmissions may not exceed, for a calendar year, a percentage set by regulation and between 10 and 20% of the total number of medical biology examinations carried out by the laboratory. By way of derogation from the previous…

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