191. Regulation of the Federal Minister for Health, Family and Youth on the setting of standards for the production of human cells and tissues for use in human beings (tissue removal device ordinance-GEEVO)

On the basis of § 7 tissue safety law, BGBl. I n ° 49/2008, shall be ordered:

Scope

§ 1. (1) This Regulation shall apply to the operation of removal devices according to § 2 Z 14 of the tissue safety law (GSG), BGBl. N ° 49/2008.

(2) The definitions of § 2 Tissue Safety Act (GSG), BGBl. I n ° 49/2008, shall also apply to this Regulation.

Staff

§ 2. (1) Pick-up facilities shall ensure that any cell or tissue recovery is carried out by persons who have successfully completed a training programme from a clinical team with a view to the removal of the tissue from the tissue. The type of tissue has sufficient clinical experience, as specified in the state of science and technology.

(2) Pick-up facilities shall keep records of all training measures.

Selection criteria for donors

§ 3. (1) The selection criteria for donors shall be based on a risk analysis in relation to the use of the specific type of cell or tissue. The signs of such risks shall be determined by physical examination, anamnesis, laboratory tests, post-mortem examination, where appropriate, and any other appropriate studies.

(2) If the donation is not justified on the basis of a documented risk assessment carried out by a responsible person in accordance with § 9 GSG, donors are also only one of the following reasons from the donation. excluding:

1.		Disease of unknown aetiology in prehistory,
2.		the existence or history of a malignant disease, except where there is no risk to the recipient, according to the state of the scientific community;
3.		Risk of disease transmission by prions; this risk exists in the case of
a)			Persons who have been diagnosed with Creutzfeldt-Jakob Disease or the new variant of Creutzfeldt-Jakob disease or who have a non-iatrogenic Creutzfeldt-Jakob disease in the family history,
b)			Persons with a rapidly progressing dementia or a degenerative neurological disease, including such unknown cause,
c)			Recipients of hormones obtained from the human pituitary gland (such as growth hormones), recipients of transplants from Cornea, Sklera or Dura mater, as well as persons who have undergone undocumented neurological operations (at which may have been used by Dura mater),
4.		Systemic infection, which is not under control at the time of donation, including bacterial infections, systemic viral, fungal or parasitic infections, or significant local infection in the tissues to be donated, or Cells; donors with bacterial sepsis can be assessed for a corneal end and considered when the corneas are stored in a medium that allows the detection of possible bacterial contamination of the tissue,
5.		anamnestically raised HIV infection, transmission risk of acute or chronic hepatitis B, hepatitis C and HTLV I/II, or signs of risk factors for these infections, detected clinically or by confirmed laboratory tests,
6.		Chronic, systemic autoimmune disease, which may have an adverse effect on the tissue to be removed or the recipient,
7.		Signs of invalid test results of donor blood samples
a)			Haemodilution, if no pretransfusion sample is available, or
b)			Treatment with immunosuppressive agents,
8.		Evidence of other risk factors for infectious diseases based on a risk assessment, taking into account the travel and exposure history of the donor and the local prevalence of infectious diseases,
9.		physical signs on the body of the donor, which suggest an infectious disease risk,
10.		exposure to or exposure to a substance which could be transferred to the recipient at a dose harmful to health,
11.		vaccination with live vaccine within the last four weeks at which a risk of transmission is considered possible; and
12.		Recipient of a xenotransplant.

(3) In the event of an unknown cause of death, deceased donors shall be excluded from donation, provided that the cause of death is not determined after the removal by an autopsy.

(4) Allogenic living donors shall be selected on the basis of their state of health and their history, collected in accordance with paragraph 2, by means of a questionnaire and a personal interview by a physician. This examination shall include relevant factors which may contribute to the identification and exclusion of persons whose donation is at risk of health for themselves or for others, such as: For example, the risk of disease transmission may be associated with the risk of disease transmission. In the event of no donation, the withdrawal process may involve a serious risk to the life or health of the donor, and the withdrawal process may influence or impair the medical care of the donor. At the donation of umbilical cord blood or amniotic membrane this applies both to the mother and to the child.

(5) The selection criteria for allogeneic living donors shall be defined and documented by the tissue bank, or in the case of direct use by the user, on the basis of the specific cells or tissues to be donated, together with the the physical condition of the donor, the history of the donor and the results of the clinical examinations and laboratory tests for the determination of the health of the donor. Depending on the type of tissue or cells to be donated, the supplement may be necessary for further specific exclusion criteria.

(6) In the case of autologous living donors, the same selection criteria and minimum requirements for laboratory testing shall be satisfied as with an allogeneic living donor. In the case of positive test results, the tissues can be Cells or products derived therefrom are stored, processed and reimplanted, provided that suitable isolated storage facilities are present, in order to avoid any risk of cross-contamination with other transplants and/or contamination with Adventiv agents and/or confusion should be avoided.

Laboratory tests

§ 4. (1) Each living donor of cells or tissues shall be subject to the following laboratory tests:

1.		AIDS/HIV infection: HIV antibody determination in accordance with the regulation on quality control and quality assurance in HIV diagnostics and the procedure to be followed in the taking of HIV tests, BGBl. No 772/1994, as last amended by BGBl. II No 221/2004,
2.		Hepatitis B: Anti-HBc and HBsAg,
3.		Hepatitis C: Anti-HCV-Ab and
4.		Syphilis: Test according to paragraph 5.
The same test requirements apply to autologous donors.

(2) In the case of deceased donors, a determination to be carried out on HIV, HBV and HCV genomes by means of NAT and a syphilis test in accordance with paragraph 5 shall be carried out.

(3) HTLV-I antibody tests should be carried out in donors who live in or come from areas of high incidence or whose sexual partners or parents come from such areas.

(4) If the anti-HBc test is positive and the HBsAg negative, further risk assessment studies are required in order to determine clinical usability.

(5) In order to exclude an infection with Treponema Pallidum, either a determination on Treponema Pallidum-Genome can be used by means of NAT or a validated test algorithm. A specific or non-specific non-reactive test may result in the release of the tissue or tissue. Allow cells. If a non-specific test is carried out, a reactive test result is not precluding the removal or release, provided that a specific test for confirmation of Treponema is non-reactive. A donor whose sample reacts to a specific Treponema test shall be subject to a risk assessment in order to determine clinical usability.

(6) Depending on the previous history of the donor and the characteristics of the donated tissue, Cells may require additional laboratory tests on the basis of a risk assessment.

(7) The laboratory tests shall be carried out by a laboratory, if any, using test kits with CE marking. The type of test to be used shall be validated, provided that this is indicated in the state of the sciences and technology with regard to the intended use.

(8) The laboratory tests shall in principle be carried out on the serum or plasma of the donor; in other fluids or tissues only if this is done specifically by the use of a test validated for such a fluid or tissue is justified.

(9) If potential donors have lost blood and have received shortly before donated blood, blood components, colloids or crystalloids, an algorithm shall be used to assess the degree of hemodilution:

1.		Premortal blood sampling: if a dose of blood, blood components and/or colloids or a crystalloid infusion has taken place within 48 hours of taking blood samples, blood components and/or colloids, or within one hour before the sampling of blood,
2.		Post-mortem blood sampling: if there has been a dose of blood, blood components and/or colloids within 48 hours before death or an infusion of crystalloids within one hour before death.
Tissues and cells of donors with more than 50% plasma dilution may only be used if the test methods used for such plasma are validated or if a pretransfusion sample is present.

(10) In the case of deceased donors, blood samples must be taken immediately after death, if this is not possible, as soon as possible and not later than 24 hours after death, unless immediate prior to the death of the donor, a Blood sample was taken.

(11) In the case of live donors, excluding allogeneic donors of bone marrow stem cells and peripheral blood stem cells, blood samples shall be taken at the time of donation or, if this is not possible, within seven days before or after the date of donation. Donation (this is the "Spendenprobe").

(12) If the tissues and cells can be stored in the long term, a new sampling and a repeat test shall be carried out in allogeneic living donors after 180 days. If the test is repeated, the donor sample can be taken up to 30 days before and seven days after the donation.

(13) If tissues and cells of allogeneic living donors cannot be stored in the long term and therefore no repetition is possible, paragraph 14 shall apply.

(14) In the case of a living donor (excluding donors of bone marrow stem cells and peripheral blood stem cells), the "donation sample", as defined in paragraph 11, is additionally tested for HIV, HBV and HCV by means of nucleic acid amplification methods (NAT), The test of a repeat blood sample may be omitted. The repeat test may also be omitted if the processing involves a deactivation step which has been validated for the viruses concerned.

(15) In the withdrawal of bone marrow and peripheral blood stem cells, the blood samples are to be taken within 30 days before the donation to the test.

(16) If the donor is a newborn, the biological donor test should be carried out on the mother, provided that this can avoid unnecessary intervention on the new-born child.

(17) The samples taken from all samples taken are to be set in sufficient quantity so that at least a two-fold repetition of the laboratory tests relevant to the release of the release can be carried out. The reset patterns are to be transmitted to the respective tissue bank.

Donation and removal procedures

§ 5. (1) Prior to the removal of cells or tissues, the consent of the donor and its identification must be confirmed and documented.

(2) The doctor responsible for the anamnesis has to ensure that the donor has understood the information given, has had the opportunity to ask questions and has confirmed to have made all the information to the best of knowledge and conscience.

(3) In the case of deceased donors, the request shall be documented in the case of the opposition register held by health Austria GmbH and the negative result thereof.

(4) In order to collect the relevant information on the donor, all relevant sources shall be used, provided that the donor is a living donor, and in any event, a survey shall be held.

(5) In addition, in the case of the deceased donor and, where justified, a physical examination is to be carried out in the case of the living donor in order to identify any signs which alone are sufficient for the exclusion of the donor or which are based on the following: of the medical and personal history of the donor.

(6) The entire donor file shall be reviewed and evaluated by a physician on the suitability of the donor.

(7) The removal procedures must be carried out with regard to the donor and the donated tissues or tissues, respectively. cells are appropriate. The procedures must ensure the safety of the living donor.

(8) The removal methods must be those of the tissues or tissues. Cells which are necessary for their eventual clinical use and at the same time minimise the risk of microbial contamination during the process, in particular if the tissues and cells do not subsequently The process of inactivation and sterilisation is carried out.

(9) In the case of deceased donors, access to the place of withdrawal shall be restricted. At the removal point on the body of the dispenser, a local sterile area with sterile cloths is to be used. The personnel carrying out the withdrawal must be dressed in accordance with the type of withdrawal (sterile clothing and gloves, face masks) and properly disinfected.

(10) In the case of deceased donors, the sampling point must be documented and the period elapsed between the death and the removal must be indicated in order to ensure that the necessary biological and/or physical properties of the tissues or tissues are required. Cells are preserved.

(11) Any incident occurring during the withdrawal which has caused or may have caused damage to a living donor, as well as the result of any investigation to determine the appropriate cause, shall be recorded and checked.

(12) Procedures and SOPs must be present to present the risk of contamination of the tissues or tissues. Cells may be excluded or reduced to the non-exclusive minimum by a staff which may be infected with a communicable disease.

(13) For the tissues and/or Cell removal is to use sterile instruments and pick-up cutlery. The instruments and tapping cutlery are to be qualified or specially certified as well as regularly for the removal of tissues and/or tissues. To maintain cells.

(14) If reusable instruments are used, a validated cleaning and sterilisation process must be available for the removal of infectious agents.

(15) For all activities, the specifications of all critical inputs and reagents, as well as specifications for the packaging material, shall be defined. Critical equipment and reagents must comply with documented requirements and specifications and, if necessary, comply with the requirements of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, Council Directive 93 /42/EEC of 14 June 1993 on medical devices and Directive 98 /79/EC of the European Parliament and of the Council of 27 June 1993 on medical devices and on medical devices. The European Parliament and the Council of the European Union, the European Parliament and the Council of 27 October 1998 on in-vitro diagnostic medical devices or, in the case of procurement All personnel involved shall be trained in the appropriate manner in dealing with critical resources and reagents.

Documentation

§ 6. (1) For each donor, a donor documentation shall be provided with the following information:

1.		donor identity (first name, surname and date of birth; mother and child are involved in the donation, both the mother's name and date of birth and the name, where known, and the date of birth of the child),
2.		Age, gender, medical and behavioural history (the information collected must be sufficient to enable the exclusion criteria to be applied if necessary),
3.		where appropriate, the physical examination,
4.		where appropriate, hemodilusive formula,
5.		where appropriate, consent, including in relation to the purpose and/or the purposes for which the tissues and/or Cells are allowed to be used (d. h. for therapy and/or research purposes) as well as other specific instructions for disposal, if the tissues or cells are not used for the purpose for which consent has been given,
6.		where appropriate, the negative result of a request for the opposition register,
7.		clinical data, results of laboratory tests and other tests carried out, including the time of sampling,
8.		where an autopsy has been made, their results shall be included in the documentation (in the case of tissues and cells which cannot be stored in the long term, a preliminary oral autopsy report shall be recorded),
9.		in the case of donors of haematopoietic progenitor cells, the suitability of the donor for the selected recipient must be documented. If the donor and the recipient are not genetically related and the organisation responsible for the removal has limited access to the recipient data, the transplant body shall be required to obtain the donor data useful for the purpose of confirming the suitability of the donor data. shall be made available.

(2) A removal report shall be drawn up for each removal, which shall contain at least:

1.		the identification, name and address of the tissue bank; of the user in the case of direct use, which is the tissue or cells are to be preserved,
2.		information on donor identity (including information on how and by whom the donor has been identified) and the history of the anamnesis,
3.		Description and identification of the removed tissue or tissue. cells (including cells taken to test),
4.		the identity of the person responsible for such removal, including the signature thereof,
5.		Date, time (if appropriate, beginning and end), location of the collection and the method used (SOP), including any incidents, if appropriate, environmental conditions in the removal device (description of the area where the removal is carried out) ),
6.		in the case of deceased donors, description of the conditions under which the corpse is stored: chilled (or not), the time of commencement and the end of the cooling,
7.		Identification/batch numbers of the reagents used and transport solutions and
8.		in the case of cell cultures for autologous use, also the possibility of drug allergies of the recipient.

(3) The removal report as well as the documentation contents according to paragraphs 1 Z 3, 4, 5, 6, 7 and 8 shall be transmitted to the respective tissue bank.

(4) The records of the donation required for full traceability shall be kept at least 30 years after clinical use or expiry date in a suitable manner. All records must be clear and identifiable throughout the specified retention period, protected from unauthorised alteration, kept in this condition and easily accessible.

Packaging

§ 7. (1) After removal, all the tissues or tissues obtained are: Packing cells in such a way that the risk of contamination is minimized. They are to be stored at temperatures where their characteristics and biological functions are preserved. The packaging must also be used to contaminate the packaging and transport of the tissues or tissues, respectively. Avoid cells responsible.

(2) The packaged tissue or Cells are to be transported in a container that is suitable for the transport of biological material and which is responsible for the safety and quality of the tissue or tissues contained therein. Cells are guaranteed.

(3) Any attached tissue or blood samples intended for testing shall be clearly identified in order to ensure the identification of the donor. In addition, they must bear information about the place and time of sampling.

Marking

§ 8. (1) Any tissue or Cells containing cells are to be labelled at the time of removal. The primary packaging for tissues and/or Cells must have the donor code in accordance with § 5 (6) GSG and information on the type of tissue and/or tissue. Cells.

(2) If the package is large enough, it must also bear the following information in addition to the information referred to in paragraph 1:

1.		the date (and time) of the donation,
2.		Warning of hazard potential,
3.		Type of additives used,
4.		in the case of autologous donations, the inscription "Only for autologous use",
5.		in the case of direct ends, the recipient code shall be mentioned.
If any of these information cannot be indicated on the primary packaging, it shall be indicated on a separate sheet which shall be inseparably attached to the primary packaging.

Transport container marking

§ 9. (1) If the tissues or cells, each transport container shall bear at least the following information:

1.		"CAUTION" and "TISSUE AND CELLS",
2.		Identity of the device from which the package is transported (address and telephone number) and contact person for problem cases,
3.		Identity of the destination bank or of the user for direct use (address and telephone number) and the contact person for the delivery of the container,
4.		the date and time of the start of transport,
5.		Information on the conditions of transport for the quality and safety of the tissues or tissues, cells are relevant,
6.		for all cell products to add: "DO NOT IRRADIATE",
7.		If a product is known to produce a positive test result for a marker of a relevant infectious disease, it should be added: "BIOLOGICAL HAZARD",
8.		in the case of autologous donors, "ONLY FOR AUTOLOGOUS USE",
9.		Data on storage conditions (such as B. "DO NOT FREEZE").

(2) For all labeling operations, the removal device must have SOPs.

Default Work Instructions (SOPs)

§ 10. (1) Each sampling device has standard operating instructions (SOPs) for

1.		the review of donor identity,
2.		the details of the consent,
3.		the evaluation of the selection criteria for donors listed in § 3, and
4.		the evaluation of the laboratory tests prescribed for donors
shall be available.

(2) The removal device must also be used by SOPs for the removal, packaging, labelling and transfer of tissues and cells to the tissue bank or, in the case of the direct use of tissues and cells, to the person responsible for their use. clinical team or, in the case of tissue or Cell samples, to the laboratory for carrying out the test.

Selection criteria for the donors of germ cells

§ 11. (1) The selection criteria in accordance with § 3 and laboratory tests in accordance with § 4 shall not apply to donors at the partner donation of germ cells for direct use.

(2) In the case of partner donations not intended for direct use, the conditions laid down in paragraphs 3 to 7 must be fulfilled.

(3) The doctor responsible for the donor must decide on the basis of the history and therapeutic indications and shall document whether the donation justifies the donation and its safety for the recipient and the child or child who may be born. the children are guaranteed.

(4) The following laboratory tests shall be carried out in order 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.
In the case of sperm which is processed and not stored for the intrauterine semen transfer, and provided that the tissue bank can demonstrate that the risk of cross-contamination and the exposure of the staff is met by the use of validated procedures , the laboratory examination is not required.

(5) If the results of the tests on HIV 1 and 2, hepatitis B or hepatitis C are positive or if there are no results or if a risk of infection of the donor is known, the donation must be stored separately.

(6) HTLV-I antibody tests should be carried out in donors who live in or from areas of high incidence, or whose sexual partners or parents come from such areas.

(7) Depending on the previous history of the donor and the characteristics of the donated tissue, carry out additional tests on the basis of a risk assessment.

(8) The use of germ cells for other than partner donations must meet the following requirements:

1.		The donors must be selected on the basis of their age, state of health and their history, which will be collected by a doctor by means of a questionnaire and a personal interview. This examination shall include relevant factors which may contribute to the identification and exclusion of persons whose donation is at risk of health to others, such as a possible disease transmission or to a health risk to them. could be self-connected.
2.		The serum or plasma samples of donors must react negatively to HIV 1 and 2, HCV, HBV and syphilis in the test in accordance with § 4 para. 1; the urine samples of sperm donors must also be used in the test on chlamydia by means of Nucleic acid amplification methods (NAT) react negatively.
3.		HTLV-I-antibody tests are to be carried out in donors who live in areas of high incidence or come from such areas or whose sexual partners or parents originate from such areas.
4.		Depending on the history of the donor and the characteristics of the donated tissue and/or the characteristics of the donated tissue, Cells must be subjected to additional tests on the basis of a risk assessment.

(9) In the case of autologous donors, the requirements of paragraph 8 shall apply if the tissues or cells taken are to be stored or cultivated; positive test results do not necessarily indicate that the tissues or cells have been removed from the tissue or cells, respectively. Cells or products derived therefrom are stored, processed and reimplanted, provided that suitable isolated storage facilities are present, in order to avoid any risk of cross-contamination with other transplants and/or contamination with Adventiv agents and/or confusion should be avoided.

References to acts of the European Community

§ 12. This Regulation repeals Commission Directive 2006 /17/EC of 8 February 2006 on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards technical requirements for donation, procurement and testing of human tissues and cells, OJ C No. OJ L 38 of 9 February 2006 S 40.

Kdolsky