Title I: Definitions and general principles

I.-Any prescription for a medical biology examination, together with the relevant clinical details, is sent to the medical biology laboratory prior to the sample being taken. The medical biologist shall indicate to the sampling healthcare professional the examinations to be carried out pursuant to the provisions of Articles L. 6211-8 and L. 6211-9 and the samples to be taken accordingly. When a medical biology laboratory information system or a clinical-biological…

When a medical biology test is carried out, each biological sample is identified as soon as it is taken, by computer or manually, by the following information: 1° Patient identification: surname, also known as birth name, first forename, date of birth, gender and identification number. This identification number, which is specific to each patient and distinct from the social security number, is known or allocated by the medical biology laboratory…

I.-The result of the medical biology examination is validated by a medical biologist before any communication. The surname and first name of the medical biologist appear in full on the communicated result of the examination. II – The contextual interpretation of results referred to in Articles L. 6211-2 and L. 6211-19 consists of writing down the biological significance of one or more results, taken individually or as a whole, in…

The medical biology examination report is structured in accordance with the interoperability reference framework known as the “medical biology examination report component”, adopted in application of the fourth paragraph of Article L. 1111-8. The medical biologist is identified and authenticated in accordance with the standards mentioned in the same paragraph. This structured report is produced, stored and exchanged electronically in accordance with the interoperability and security guidelines laid down by…

An order of the Minister for Health shall determine the nature of the samples to be kept after the analytical phase has been completed, as well as the duration and conditions of storage of these samples. In the event of transmission of a sample, the laboratory responsible for carrying out the patient’s examinations within the meaning of Article L. 6211-19 shall ensure that the laboratory carrying out the analytical phase…