French Public Health Code
In forceI. - When it is established that a medical biology laboratory has committed one or more of the offences listed in Article L. 6241-1, the Director General of the Regional Health Agency shall notify the legal representative of the laboratory, by any means that enables receipt to be acknowledged, of the facts of which the laboratory is accused and the penalties incurred, and shall ask it to make known, within one month, its written observations and the corrective measures adopted or envisaged. The person concerned has access to the file and may be assisted by counsel or represented by an agent of their choice.
II. - At the end of the period provided for in I, if the Director General of the Regional Health Agency does not acknowledge to the legal representative of the medical biology laboratory, in the light of his observations, that no infringement has been committed, he may within a period of two months :
1° Impose an administrative fine, the amount of which may not exceed, depending on the nature of the offence and the status of the offender, that set in 1° and 2° of I or in IV of Article L. 6241-2;
2° Give formal notice to the offender to take all necessary measures and to put a definitive end to the offences within a specified period that may not exceed fifteen days;
3° Add a daily penalty to the fine referred to in 1° if, by the end of the formal notice referred to in 2°, the legal representative of the laboratory has not taken all the necessary steps to put an end to the acts of which it is accused;
4° Approve, where appropriate, the corrective measures envisaged by the medical biology laboratory and ensure, within a time limit that it sets, that the legal representative of the medical biology laboratory has complied with its commitments.
To set the amount of the penalty referred to in 1°, the Director General of the Regional Health Agency shall take into account the circumstances and seriousness of the breach. The decision indicates the nature of the facts constituting the breach and specifies the deadline and procedures for payment of the fine, as well as the channels and deadlines for appeal.
The fine referred to in 3° begins to run from the expiry of the period referred to in 2° and ceases to run on the day the situation is rectified, if necessary by a new inspection.
III. - In the event of serious or repeated breaches as referred to in II of Article L. 6241-2, the Director General of the Regional Health Agency may order the temporary partial or total closure of the medical biology laboratory. The decision is notified to the medical biology laboratory, together with the findings and, where appropriate, an injunction to remedy the shortcomings within a specified period, which may not exceed fifteen days.
IV. - If, at the end of the formal notice referred to in 2° of II, it is found that the shortcomings have been remedied, the Director General of the Regional Agency takes note of the fact that the situation has been regularised. If this is not the case, the Director General of the Regional Agency may impose a daily penalty in addition to the administrative fine.
If, at the end of the injunction referred to in III, it is established that the shortcomings have been remedied, the Director General of the Regional Agency shall put an end to the temporary, partial or total closure of the medical biology laboratory and take note that the situation has been regularised. Otherwise, the Director General of the Regional Agency may close the laboratory definitively.
