Quality assurance of genetic analyses

(1) Genetic analyses carried out within the framework of genetic examinations to establish parentage may be performed only by institutions that have obtained accreditation to carry out genetic analyses from a body generally recognised for this purpose. For accreditation, the institution must in particular 1. carry out the genetic analyses in accordance with the generally recognised state of the art in science and technology and establish an internal quality-assurance system for this purpose, 2. have personnel qualified for the relevant activities, 3. comply with the requirements on the retention and destruction of the results of genetic analyses under section 12, and on the use and destruction of genetic samples under section 13, and take the necessary organisational and technical measures for this purpose, and 4. demonstrate successful participation in suitable external quality-assurance measures. Institutions are accredited for the types and methods of analysis specified in the accreditation application. Accreditation is limited to a maximum of five years.
(2) Institutions or persons that carry out genetic analyses for medical purposes within the framework of genetic examinations must satisfy the requirements referred to in subsection (1) sentence 2 numbers 1 to 4.