87. Regulation of the Federal Minister for health, modifies the tissue collection device regulation and the regulation of tissue bank
On the basis of articles 7 and 30 of the tissue safety law - GSG, Federal Law Gazette I no. 49/2008, in the version of Federal Law Gazette I is no. 162/2013, prescribed:
Tissue extraction facility regulation
The tissue collection device regulation - GEEVO, Federal Law Gazette II No. 191/2008, is amended as follows:
1. paragraph 1 together with the heading:
'Scope of application and definitions
1. (1) this Regulation shall apply to the operation of extraction facilities according to § 2 Z 14 of the tissue safety law (GSG), Federal Law Gazette I no. 49/2008, in the applicable version.
(2) the definitions in section 2 of the tissue Safety Act apply to this regulation.
(3) in addition, mean:
1. direct use: any procedure, be donated the cells and used without recorded in a tissue bank;
2. germ cells: all tissues and cells that are intended for the use of medically assisted procreation;
3. viable cells: fertilized oocytes and cells from it developed;
4. partner donation: the donation of reproductive cells from persons of different sex, living in a marriage or cohabitation;
"5. standard operating procedures (SOP): a written statement describing the steps in a specific process, including the materials to be used and methods, as well as the expected end product."
2. paragraph 2 together with the heading:
2. (1) the extraction facilities have to ensure that each generation of cells or tissues by persons takes place which sufficient clinical experience and have successfully completed a training program, which has been specified according to the level of science and technology by a collection team which has, with regard to the tissue type to be taken about sufficient clinical experience.
(2) the sampling equipment have all training measures to keep records, where in particular date, duration, place, content as well as all speakers and participants are listed. Each training event is to confirm the signature of the presenter and the participants/participants."
3. § 4 para 1 subpara 1 is:
"1. AIDS/HIV infection: HIV-antibody determination in accordance with the regulation on quality control and quality assurance in the diagnosis of the HIV and the to be followed when making any HIV testing procedure, BGBl. No. 772/1994, in its up-to-date version" 4. pursuant to article 4 paragraph 2 is a added the following paragraph 2a:
"(2a) of the sampling device taking into account recognized scientific principles and requirements in writing set, for which donations which microbiological tests are required is based on a written risk assessment."
5. in the section 4, paragraph 3, the word "Incidence" is replaced by the word "Prevalence".
6 paragraph 4 section 15:
"(15) in the case of the removal of bone marrow and peripheral blood stem cells 30 days before the donation for testing blood samples can be found, and the test result before the donation to be."
7 paragraph 4 section 17:
"(17) any sampling device has to define, whether and in what quantity samples of suitable body fluids or tissues and cells of the donor are to be to ensure that at least twice repeat of sharing relevant laboratory tests is possible in advance - based on a risk evaluation. The retain samples have to submit to the respective tissue bank."
8 § 6 par. 2 No. 6 is:
"6. for deceased donors/donors place and time of death and the description of the conditions under which the body kept: refrigerated (or not), time of commencement and end of cooling," 9. At the end of article 6 par. 2 Z 7 is the word 'and' replaced by a comma; at the end of article 6 par. 2 Z 8 is the point by the word "and" replaced and following Z 9 shall be added:
"9 are derived sperm outside a sampling device, this is in the procurement report to specify; This has to include date and time of donation in this case."
10. in section 10 para 2, the phrase "clinical team responsible for their use to the" is replaced by the phrase "responsible/managers on the use user/users".
11 paragraph 11 paragraph 2:
"(2) in the case of partner donation not for direct use the conditions referred to in paragraph 3 to 9 must be met. § 4 section 17 does not apply."
12 paragraph 11 paragraph 4 to 9:
"(4) the following laboratory tests must be carried out to determine whether there is a risk of cross-contamination:"
1. HIV 1 and 2: anti-HIV-1,2, 2. hepatitis B: HBsAg and anti-HBc, 3. hepatitis c anti-HCV-AB and 4. syphilis.
In addition, urine samples have to respond negatively to donors/donors of reproductive cells in the test for Chlamydia using nucleic acid amplification technique (NAT).
(5) HTLV I antibody tests are to make donors, who live in areas with high prevalence or originating from those areas or with sexual partners originating from those areas or where the donor's parents originate from those areas.
(6) depending on the donor's history and the characteristics of donated tissues or cells, additional tests are based on a risk assessment for donors.
(7) the blood sample for testing can be found with the test result before the donation to be three months before the first-time donation. More blood samples to carry out the laboratory tests referred to in paragraph 4 shall no later than 24 months after the previous sampling.
(8) in the case of sperm, which to the intrauterine insemination processed and are not stored, and provided that prove the tissue establishment can, that the use of validated methods has been addressed through the risk of cross contamination and staff exposure, a laboratory examination is not required.
(9) if the results of the laboratory tests referred to in paragraph 4 are positive, no results are available or a risk of infection of the donor is known, the donation must be stored separately, to avoid any risk of cross-contamination with other grafts and/or a contamination with adventitious agents and/or confusion."
13. in paragraph 11, the previous paragraph 8 receives the sales designation (10), "Incidence" is replaced by the word "Prevalence" in no. 3 of this paragraph and is attached following Z 5:
"5. the serum or plasma samples can be found at the time of each donation."
14. pursuant to section 11, the following Article 11a is inserted:
'Article 11a. "Applies to dealing with viable cells § 9 of the reproductive medicine Act (Fortpflanzungsmedizingesetz), Federal Law Gazette No. 275/1992, in the current version."
15 paragraph 12 together with the heading:
"Referring to acts of the European Union
§ 12. Following legal acts of the European Union are implemented by this Regulation:
1. the directive 2006/17/EC implementing Directive 2004/23/EC as regards technical requirements for the donation, procurement and testing of human tissues and cells OJ No. L 38 of the 09.02.2006 p. 40, 2. the 2012/39/CE directive amending Directive 2006/17/EC as regards certain technical provisions for the testing of human tissues and cells OJ "No. L 327 from the 26.11.2012 S. 24."
Tissue bank regulation
The tissue bank regulation - GBVO, Federal Law Gazette II No. 192/2008, is amended as follows:
1. paragraph 1 para 3:
"(3) the definitions in section 2 of the tissue safety law (GSG), Federal Law Gazette I no. 49/2008, and § 1 of the tissue collection device regulation, BGBl. II Nr 191/2008, each as amended, see also this regulation application."
2. paragraph 3 section 2:
"(2) the staff must be trained prior to commencement of activities and change of procedures or new scientific evidence and receive sufficient opportunities to the appropriate professional development. Training programs must ensure that all staff performing the tasks assigned to them have proved competent, sufficient knowledge and understanding of the scientific and technical procedures and principles have, which for the assigned tasks are relevant to them, understand the organisational framework, quality system and the health and safety regulations of the institution in which they work and are sufficiently informed of the wider ethical and legal context of their work. On the training measures are records to lead, with in particular date, duration, place and content as well as all speakers and participants are required to. Each training event is to confirm the signature of the presenter and the participants/participants. The expertise of staff is regularly within the framework of the quality system to evaluate."
3. paragraph 9 paragraph 5:
"(5) samples of the donors/donor are to retain for that period, which was set by the tissue bank based on a risk assessment."