The "Genetic Diagnostics Act" (GenDG) has been in force since February 1st, 2010
It regulates the handling of examinations of the properties of human chromosomes or DNA or genes, insofar as they are inherited or were acquired before birth. However, it also applies to the investigation of gene products if the aim of the investigation involves gaining knowledge about a genetic makeup.
Specifically, this means that this law is used for epigenetic investigations, DNA adducts and SOD profiles.
Although the legislature does not expressly name these, it also makes its intention with epigenetics clear and thus these parameters are subject to the GenDG.
The physician's reservation applies to all genetic diagnostics and especially to epigenetic parameters (see above) and requirements. In the case of predictive examinations, the requesting physician must even have a special qualification, e.g. can be acquired in special courses of the medical associations and the KVen.
No analysis without the patient's declaration of consent. A mandatory requirement for any genetic diagnostic examination in the laboratory is the patient's declaration of consent, signed by the physician and patient, stating about:
- the subject or scope of the investigation
- Consent for sampling and examination
- Acknowledgment of the test result or destruction of the same and the decision about the whereabouts of the sample after the analysis
Prior to the declaration of consent, the "responsible" doctor, i.e. the primary ordering physician, must provide and document an explanation of the nature, scope and implications of the examination. Use the corresponding form (consent form). You can also request it in the laboratory. In the case of persons who are not capable of giving consent (children, incapacitated), the legal representative signs.
If the consent form is not provided, the analysis may not be performed by the laboratory at all; it is not permissible to perform the analysis and only withhold the result.
Unless otherwise instructed/consented to by the patient, the specimen must be discarded immediately upon completion of the analysis.
If the sample is still available due to a given instruction from the patient, subsequent requests for further genetic diagnostic tests may only be performed if covered by the patient's written consent. Otherwise, a new consent is required.
The patient can withdraw from his declaration of consent at any time, also by telephone, but only to the responsible doctor. This must then be documented accordingly.
Results that have not yet been communicated must then be destroyed immediately.
Results that have already been communicated, on the other hand, are not discarded but blocked.
The result of a genetic diagnostic test may only be communicated by the laboratory to the physician placing the order, but not to the patient or to any other person! Disclosure to third parties (including other physicians) may only be made by the responsible physician and only with the written consent of the patient.
The results must be automatically destroyed after 10 years, unless the patient requests a longer retention period or a blocking of the results. Blocking has the effect of extending the retention period by 10 years from that date.
All examinations for which the patient's declaration of consent is required according to the GenDG are marked with a "§" in the analysis directory, as well as on the order form.