Section 1: Administrative penalties

The following constitute an offence subject to administrative sanction:

1° The performance, by a medical biology laboratory, of medical biology examinations with a view to establishing a prenatal diagnosis in disregard of the provisions of Article L. 6211-5 or of medical biology examinations constituting an examination of the genetic characteristics of a person or his identification by genetic fingerprints in disregard of the provisions of Article L. 6211-6 ;

1° bis Any failure by a medical biology laboratory to declare its activity in accordance with the conditions laid down in the last paragraph of I of Article L. 6211-19 or to make a false declaration;

2° A medical biology laboratory carrying out medical biology examinations without complying with the conditions and procedures laid down in Articles L. 6211-2, L. 6211-7 to L. 6211-9, L. 6211-11 to L. 6211-20 and L. 6211-22;

3° Invoicing, by a medical biology laboratory, for medical biology tests in breach of Article L. 6211-21 ;

4° The performance, by a medical biology laboratory or by a medical biologist, of medical biology examinations, biological activities of medically assisted procreation and pathological anatomy and cytology examinations which require special qualifications or which require the use of products presenting a particular danger in breach of article L. 6211-23;

5° The performance, by a medical biology laboratory, of medically assisted procreation activities in disregard of the provisions of the second paragraph of Article L. 6212-2;

6° The performance, by a medical biology laboratory, of pathological anatomy and cytology examinations in disregard of the provisions of the third paragraph of article L. 6212-2;

7° Failure by a medical biology laboratory to comply with its obligations to participate in the continuity of medical biology services and to carry out the tasks provided for in Article L. 6212-3;

8° Failure by a private medical biology laboratory, with the exception of laboratories operating as non-profit-making organisations, to comply with the operating rules laid down in Article L. 6213-9;

9° For a biologist-responsible, a biologist-co-responsible or a qualified specialist in pathological anatomy and cytology co-responsible to perform this function in several medical biology laboratories in disregard of Article L. 6213-10;

10° The performance of medical biology examinations by a medical biology laboratory that does not have the accreditation provided for in Article L. 6221-1, subject to the provisions of Article L. 6221-8, or the accreditation provided for in Articles L. 6221-3 and L. 6221-4, or the authorisation referred to in 3° of Article L. 6221-4 or that has not filed the declaration referred to in 1° and 2° of the same Article;

11° Failure by the biologist-responsible to make the declaration provided for in Article L. 6221-7 immediately ;

12° Any failure by a medical biology laboratory whose accreditation has been withdrawn or suspended to provide the information provided for in Article L. 6221-8 ;

13° Failure by a medical biology laboratory to carry out quality control of the results of the medical biology examinations it performs under the conditions provided for in Article L. 6221-9 or failure to submit to the national quality control of the results of medical biology examinations provided for in Article L. 6221-10;

14° Failure by a medical biology laboratory that carries out pathological anatomy and cytology examinations to comply with the requirements set out in Chapter I of Title II of this Book;

15° Failure by a medical biology laboratory to comply with one of the obligations to declare and communicate with the Regional Health Agency as provided for in Article L. 6222-1 ;

16° Failure by a medical biology laboratory to comply with the rules relating to the location of sites provided for in Article L. 6222-5;

17° Failure by a medical biology laboratory to comply with the rules governing the practice and work of medical biologists, as set out in article L. 6222-6;

18° Failure by a medical biology laboratory to comply with the obligations relating to patient information set out in Article L. 6222-7;

19° The carrying out, by a natural or legal person, of any form of direct or indirect advertising or promotion in favour of a medical biology laboratory in disregard of Article L. 6222-8;

20° Operating a private medical biology laboratory in a form other than those mentioned in Article L. 6223-1 ;

21° Any natural or legal person controlling a proportion of the medical biology supply in an area determined in application of b of 2° of Article L. 1434-9, in disregard of the rules laid down in Article L. 6223-4;

22° For any of the natural or legal persons referred to in Article L. 6223-5 to hold directly or indirectly a fraction of the share capital of a company operating a private medical biology laboratory, or for a company operating a private medical biology laboratory to be held directly or indirectly by any of the persons referred to in the same Article;

23° Failure by a company operating a private medical biology laboratory to comply with the rules laid down in Article L. 6223-6.