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Chapter II: Conditions for opening and operating medical biology laboratories

Article R6222-2 of the French Public Health Code

A medical biologist present on each site in accordance with the provisions of the first sentence of Article L. 6222-6, or another biologist from the medical biology laboratory, is designated as responsible for this site within the meaning of this same article. He/she may not simultaneously assume this responsibility for several sites.

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Article R6222-3 of the French Public Health Code

On all professional titles and documents, in particular on all reports issued by the medical biology laboratory, the following information must be clearly displayed: 1° The name or business name of the medical biology laboratory and its form of operation; 2° The name of the biologist in charge of the medical biology laboratory and, where applicable, the names of the biologists in charge; 3° The accreditation number where full accreditation…

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Article R6222-4 of the French Public Health Code

When the Director General of a Regional Health Agency establishes that, in an area defined in b of 2° of Article L. 1434-9, the supply of medical biology does not meet the needs of the population, in particular because of geographical difficulties of access, he shall indicate in the regional health plan that, in this area, a medical biology laboratory established in a neighbouring area may open a site in…

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Article R6222-5 of the French Public Health Code

I.-When one or more medical biology laboratory sites created before the revision of the regional health plan or before the change in the delimitation of the zones defined in b of 2° of Article L. 1434-9 no longer meet the location conditions set by Article L. 6222-5 or to the forecasts for the location of sites indicated by the regional health plan in application of 4° of I of Article…

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Article D6222-6 of the French Public Health Code

I.-No later than eight months before the planned date of opening of the medical biology laboratory, the legal representative of the laboratory shall send the declaration provided for in the first paragraph of Article L. 6222-1, by any means that can be reliably dated, to the regional health agency or agencies concerned with the creation of the laboratory or site. This declaration includes the following documents or information 1° Identification…

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Article D6222-7 of the French Public Health Code

Within one month of receipt, the Regional Health Agency will send the person filing the declaration provided for in Article D. 6222-6 an acknowledgement of receipt. The application is deemed to be complete, with regard to I of article D. 6222-6 or, where applicable, II of the same article, if the Regional Health Agency does not notify the applicant, by the same deadline, of the list of missing documents. The…

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Article R6222-8 of the French Public Health Code

I.- Opposition to the opening of a medical biology laboratory or a new site or to the transfer of an existing site, pursuant to Article L. 6222-2, and opposition to the operations referred to in Article L. 6222-3 , shall be notified by reasoned decision of the General Director of the Regional Health Agency concerned, by any means capable of conferring a date certain on such notification, no later than…

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Article D6222-9 of the French Public Health Code

No later than two months before any change relating to the general organisation of the laboratory other than one of the site opening or transfer operations mentioned in the first paragraph of I and II of Article D. 6222-6 and any change in the biologist-in-charge or biologist-co-ordinator of the medical biology laboratory mentioned in Articles L. 6213-7 to L. 6213-10, the legal representative of the laboratory shall send the declaration…

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Article R6222-10 of the French Public Health Code

As soon as it is received, the laboratory’s legal representative shall forward to the regional health agency or agencies concerned the provisional attestation of satisfaction of the accreditation criteria referred to in the second paragraph of I of Article L. 6221-2, without which no medical biology laboratory may open to carry out examinations. The Regional Health Agency shall acknowledge receipt of this declaration within one month of receipt.

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