168. Federal law, with which the Blood Safety Act 1999, the Medicines Act and the Federal Law on hospitals and hospitals are amended

The National Council has decided:

Article 1

Amendment of the Blood Safety Act 1999

The Blood Safety Act 1999, BGBl. I No 44/1999, as last amended by BGBl. I n ° 98/2002, shall be amended as follows:

1. § 1 reads:

" § 1. (1) This federal law regulates the collection and testing of human blood and blood components as well as the related safety measures in order to provide donors and patients with the best possible protection.

(2) In the production and testing of human blood or blood components, the status of medical science shall be complied with. "

2. § 2 (1) reads:

"(1) This federal law shall not apply to the collection and testing of blood or blood components of persons to whom blood or blood components are extracted for diagnostic purposes within the framework of their medical treatment."

3. In accordance with Article 2 (1), the following paragraph 1a is added:

"(1a) In the case of own blood donations, the provisions of this Federal Law shall be applied in accordance with a regulation of the Federal Minister for Health and Women in accordance with § 21."

4. § 2 (3) reads:

" (3) This federal law does not apply to the extraction of blood or blood components taken from the clinical trial than to the competent Ethics Committee (§ 41 of the German Drug Law, BGBl. No. 185/1983, § 58 Medical Devices Act, BGBl. No 657/1996, or which are to § 8c of the KAKuG, BGBl. No. 1/1957), all documents required for the assessment of the necessity of the deviation from the provisions of this Federal Law have been made available and the Ethics Committee has made this deviation in the sense of the protection of donors and test participants according to the state of the sciences is considered justified. "

5. According to Article 3 (6), the following paragraphs 7 and 8 are added:

" (7) A serious incident within the meaning of this Federal Law is any undesirable event related to the collection and testing of blood or blood components that is fatal or life-threatening, a disability or a Loss of capacity could lead to diseases or diseases. whose duration or hospitalisation is extended.

(8) The most serious adverse reaction is an unintended reaction in the donor or recipient in connection with the collection, testing or transfusion of blood or blood components that are fatal or life-threatening, a disability or a disability. it results in a loss of ability, leads to diseases, or whose duration or hospitalisation is extended. "

6. § 6 (2) reads:

" (2) Each blood donor shall have the personnel, spatial, operational and technical equipment required according to the state of medical science and technology in question. Staff must be brought to the latest scientific developments in good time and regularly by means of appropriate training. "

7. In § 6, paragraph 5 is deleted.

8. § 7 (3) reads:

" (3) The medical director and his deputy shall be required to:

1.		to the self-employed exercise of the medical profession in Austria,
2.		have specific knowledge and skills relevant to their tasks, and
3.		have completed at least two years of activity in a blood donation facility. "

9. § 10 (1) reads:

Each blood donation establishment shall provide a quality assurance system based on the principles of good manufacturing practice to ensure the quality of blood and blood components. The components of the quality assurance system, such as the quality assurance manual, the site master file, standard operating procedures (SOPs) and training manuals shall be at least once a year or at least once a year. Need to be up-to-date. "

10. § 11 (4), the following paragraphs 5 and 6 are added:

" (4) The documentation shall be made in writing or on a data medium, provided that it is ensured that the information referred to in paragraph 2 is available for the duration of the retention period.

(5) The documentation shall be for at least fifteen years-those parts which are indispensable for the complete traceability of the transfusion chain by at least thirty years-for the purpose of taking account of the provisions of this Federal Law at all times. competent control bodies.

(6) Each blood donation establishment shall be obliged to take any serious incident and serious adverse reaction in connection with the collection or testing of blood and blood components suspected of having an impact on the blood and blood components of the blood and blood components. The quality of the product or the safety of the recipient can be reported immediately to the Federal Ministry of Health and Women, or to a body commissioned by the Federal Ministry of Health and Women. "

11. In § 15, the point referred to in paragraph 1 Z 5 shall be replaced by a supplement and the following Z 6 shall be added:

" 6.		the blood donation establishment has a procedure with which blood or blood components, in respect of which a serious incident or serious adverse reactions in connection with the extraction or testing, are suspected, where there is a suspicion that: This influence on the quality of the product or the safety of the recipient has occurred, has occurred, is effectively and verifiably excluded from the distribution or can be withdrawn. "

Article 15 (3) reads as follows:

" (3) The following documents shall be attached to the request for the granting of the operating licence:

1.		the name and address of the advertiser,
2.		an operating description, including a list of essential medical equipment and other facilities,
3.		the necessary plans,
4.		a list of the staffing equipment envisaged, including the qualification and the organisation chart of the tasks and responsibilities of the staff;
4a.		a list of all mobile withdrawals envisaged, in particular as regards the selection criteria for the premises required, and a list of the essential medical devices used,
5.		the essential information relating to the quality system to be provided, including standard operating procedures (SOPs) for the recruitment of donors, the examination of donors, the processing and testing of the blood obtained, or the blood components, their storage and distribution, the recall of blood or blood components, documentation of serious adverse events and serious adverse reactions and their reporting, and
6.		a list of hospital blood depots to be supplied. "

13. § 18 (1) reads:

" (1) Monitoring of compliance with this federal law shall be the responsibility of the local district administrative authorities, with the assistance of a local doctor. In the case of mobile blood establishments, the local area of responsibility depends on the place of production of blood or blood components. The verifications shall be carried out at regular intervals of no more than two years. "

14. § 21 reads:

" § 21. The Federal Minister for Health and Women's Health and Women's Affairs may adopt detailed provisions on this subject,

1.		what needs a donor has to comply with in accordance with § 9, in particular with regard to his health protection, with regard to the flawless nature of the blood obtained and of the blood components obtained, which tests must be carried out and which test results are limited in time or permanently exclude health suitability as donors, in which amount and at what time intervals a donor blood and blood components may be removed and which Measures for the protection of privacy and with regard to the donors shall be subject to the obligation to provide care;
2.		in what form the donor is to be given information prior to donation;
3.		in what form the identity of the donor is to be documented, by whom, in what way and to what extent the collection, processing and transfer of the data, as well as the documentation and reporting obligation, must be carried out in accordance with § 11 and § 12;
4.		the requirements for the necessary spatial and technical equipment, as well as the hygiene standards to be complied with, a sufficient quality assurance system and an organisational plan;
5.		the minimum staffing level of a blood donation institution, the specific knowledge and skills of a head or his deputy, and the doctors and doctors employed in the production of blood or blood components, and the have otherwise been employed, and on which training, training and further education measures these persons must take part;
6.		how the blood obtained and the blood components obtained are to be labelled;
7.		what requirements should be complied with in respect of own blood donations;
8.		the content of the annual activity report of the blood donation system. "

15. According to § 28 the following § § 28a and 28b are inserted:

" § 28a. Persons who at the time of the entry into force of this Federal Law in the version of the Federal Law BGBl. I n ° 168/2004, the qualification of a head of a blood donation facility, shall be entitled to continue to exercise this function.

§ 28b. This federal law provides for Directive 2002/98/EC of the European Parliament and of the Council of 27. Jänner 2003, setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001 /83/EC and Directive 2004 /33/EC of the Commission for the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. "

Article 2

Amendment of the Medicines Act

The Drug Law, BGBl. No 185/1983, as last amended by BGBl. I n ° 35/2004, shall be amended as follows:

1. In accordance with § 62a the following § 62b is inserted:

" § 62b. (1) The Federal Minister for Health and Women may, in addition to the regulations referred to in § 62 and § 62a, enact more detailed rules for establishments which include human blood or blood components, provided that they are used for transfusion. are designed, processed, stored and distributed.

(2) The Regulation referred to in paragraph 1 shall, with a view to ensuring a high level of health protection for donors and recipients, address in particular the requirements relating to the staffing and quality and safety requirements. "

2. § 67 (2) first sentence reads:

The verifications shall be carried out at least once in three years, in the case of establishments which process, store or distribute human blood or blood components, provided that they are intended for transfusion, to be carried out once in two years ' time. "

3. In accordance with § 75a, the following § 75b together with the heading is inserted:

" Haemovigilance

§ 75b. (1) Any holding which processes, stores or distributes human blood or blood components, provided that they are intended for transfusion, is obliged to take serious incidents in connection with the processing, storage and distribution of blood or blood components that may affect quality and safety, the Federal Ministry of Health and Women, or a body commissioned by the Federal Ministry of Health and Women, to report immediately.

(2) Any holding which processes, stores or distributes human blood or blood components, provided that they are intended for transfusion, must have a procedure by means of which blood and blood components which are the subject of a notification as referred to in paragraph 1 of this Article must be provided. shall be able to be withdrawn from the distribution effectively and verifiably.

(3) The head of a blood depot within the meaning of Section 8f of the KAKuG (and the relevant implementing provisions respectively) or, where such a case does not exist, the medical director shall be obliged to take serious incidents which occurred during the storage or distribution of Blood and blood components may affect quality and safety, as well as serious adverse reactions that occur during or after transfusion and are attributed to the quality and safety of blood or blood components. , the Federal Ministry of Health and Women, or any of the Federal Ministry of Health and Women's Office to report immediately.

(4) The Federal Minister for Health and Women may, in so far as this is necessary in view of the uniformity and information content of the notifications, lay down detailed provisions on the content, scope and form of notifications in accordance with the provisions of paragraph 1 of this Article. 1 and 3.

(5) Where a notification in accordance with paragraph 1 relates to a specific blood donation facility, the Federal Minister for Health and Women shall inform the blood donation institution concerned about this. "

4. § 83 Z 10 reads:

10.		the obligation to notify pursuant to § 75, § 75a, § 75b, a regulation pursuant to § 75 (4), a regulation pursuant to 75a (6) or (7), or to Regulation (EEC) No 2309/93, Regulation (EC) No 726/2004 or Regulation (EC) No 540/95, intentionally infringed,

Article 3

Amendment of the Federal Act on hospitals and health care institutions

Federal law on hospitals and health care institutions, BGBl. No 1/1957, as last amended by BGBl. I n ° 35/2004, shall be amended as follows:

1. (Determination of the principles) According to § 8e, the following § 8f is inserted, together with the heading:

" Blood depot

§ 8f. (1) Each of the relevant bedside hospitals in accordance with the type and range of services concerned has to dispose of a blood depot. This is used for the storage and distribution of blood and blood components as well as for the performance of the compatibility tests for hospital-related purposes. It must be carried out by a specialist specialist and equipped with the personnel required to perform the tasks and qualified to carry out the tasks. The head and staff must be brought to the latest state of the art in a timely and regular manner by appropriate training measures.

(2) A quality system based on the principles of good manufacturing practice shall be introduced and operated for the storage and distribution of blood and blood components. The components of the quality assurance system, such as the quality assurance manual, standard operating procedures (SOPs) and training manuals shall be updated at least once a year or, where appropriate, to the latest status of the To bring science.

(3) The institution of the hospital shall ensure that each and every input and/or delivery, respectively Use of blood or blood components as part of the blood depot is documented. The documentation shall ensure full traceability of the transfusion chain, as far as this falls within the remit of the blood depot, in accordance with the state of the art. The documentation shall be kept for at least thirty years.

(4) Land legislation shall ensure that the storage and distribution of blood and blood components by blood depots is subject to the requirements laid down in Article 29e of Directive 2002/98/EC of the European Parliament and of the Council of 27 June 2002 on the protection of blood and blood components from the blood and blood components of the January 2003, in order to establish quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components. "

2. According to Article 65 (4), the following paragraph 4a is inserted:

" (4a) The national legislation has to enact the implementing provisions of § 8f within six months. In doing so, it is necessary to ensure that existing blood depots meet the requirements by 8 November 2005 at the latest. "

Section 65 (5) reads as follows:

"(5) The Federal Minister for Health and Women is entrusted with the exercise of the rights of the Federal Government in accordance with Article 15 (8) B-VG with regard to the First Part."

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