For medical devices and in vitro diagnostic medical devices other than those mentioned in article D. 6211-9, the inspection is carried out, where applicable, in accordance with the procedures set out in the instruction leaflet for the device concerned.
The derogation provided for, on public health grounds, in Article L. 6211-16, under which the taking of a biological sample is carried out in one of the health territories in which the medical biology laboratory is located, applies to the following cases: 1° (Repealed) ; 2° To the taking of a biological sample for a periodic health examination mentioned in articles L. 321-3 and R. 321-5 of the Social Security…
For the application of Articles L. 6211-19, L. 6222-2, L. 6222-3 and L. 6223-4, the total number of medical biology examinations is obtained, for each laboratory, by adding together the number of unit examinations for which the result derives from an analytical phase, whether or not these unit examinations are subject to reimbursement. For examinations listed in the nomenclature of medical biology procedures drawn up in application of articles L….
Before 31 March each year, each medical biology laboratory shall declare electronically to the regional health agency within whose jurisdiction it is established, the total number of medical biology examinations, as defined in Article D. 6211-13, that it has performed during the previous calendar year. This declaration distinguishes : 1° The number of tests performed on samples that it has taken or that were taken under its responsibility and for…
For the application of articles L. 6211-19, L. 6222-2, L. 6222-3 and L. 6223-4, the percentages are calculated on the basis of the previous calendar year and, in the absence of a full calendar year of activity of the laboratory, on the basis of the completed days of activity.
For the application of article L. 6222-2, the supply of medical biology examinations for a zone defined in b of 2° of article L. 1434-9 corresponds to the total number of examinations mentioned in 1° and 2° of article D. 6211-14, the sampling of which was carried out in this same health territory. The needs of the population in the zone mentioned in the same article are those set out…
The examinations mentioned in Article D. 6211-16, the analysis of which was carried out in medical biology laboratories under the authority of the Minister for Defence and not included in the list provided for in II of Article L. 6147-7, are not taken into account in the total number of examinations.
The number of medical biology examinations performed on samples transmitted by a medical biology laboratory pursuant to Article L. 6211-19 may not exceed 15% of the total number of medical biology examinations performed in whole or in part by the transmitting laboratory. The total number of tests is obtained by adding together the medical biology tests covered by 1°, 2° and 3° of Article D. 6211-14 , with the exception…
Without prejudice to the provisions of Articles L. 1413-3 and L. 1413-8, a reference medical biology laboratory for specific medical biology tests or for specific pathologies, within the meaning of paragraph III of Article L. 6211-19, is a medical biology laboratory which, designated under the conditions defined in Article D. 6211-19, meets the following conditions: 1° Demonstrates a high level of competence in the three pre-analytical, analytical and post-analytical phases…
I.-Reference medical biology laboratories are designated for a period of five years. For the designation of reference medical biology laboratories, a call for applications is launched by the Minister for Health at least eight months before the expected date of publication of the order establishing the list of reference medical biology laboratories provided for inArticle L. 6211-19 of the Public Health Code. This call for applications is made on the…
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