155. Regulation of the Federal Minister for Health, Family and Youth on haemovigilance (Hemovigilance-Ordinance 2007-HäVO 2007)

On the basis of Section 75d (4) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, and § 21 Z 3 of the Blood Safety Act 1999, BGBl. I n ° 44, as last amended by the Federal Laws BGBl. I No 107/2005 and BGBl. I n ° 6/2007, shall be arranged:

Scope

§ 1. This Regulation shall apply to reports of serious adverse reactions or serious incidents in connection with the collection, testing, transfusion, processing, storage or distribution of blood or blood components or in the Association with product-related defects in blood or blood components.

Definitions

§ 2. (1) A "serious adverse reaction" is an unintended response to the donor or donor or to the recipient/recipient in connection with the collection, testing or transfusion of blood or blood components which are fatal or is life-threatening, has a disability or has a loss of ability, leads to illness or The duration of the stay or the extension of a hospital stay is extended or extended.

(2) If the serious adverse reaction is indicated in the donor/donor, a distinction should be made between the following species:

1.		Nerve and vascular injuries,
2.		pathological reactions,
3.		cardio-vascular events,
4.		other complications related to apheresis,
5.		Death within seven days after the donation,
6.		other serious adverse reactions,
7.		serious adverse reactions related to apheresis, which require emergency medical care,
8.		serious adverse reactions associated with the apheresis requiring hospitalisation.

(3) In the case of the indication of the serious adverse reaction in the recipient/recipient, a distinction should be made between the following species:

1.		immunological haemolysis due to AB0 incompatibility,
2.		immunological haemolysis due to other isoantibodies,
3.		non-immunological haemolysis,
4.		delayed haemolytic transfusion reaction,
5.		bacterial infection transmitted by transfusion,
6.		anaphylaxis/hypersensitivity,
7.		transfusion-associated acute pulmonary disease (TRALI),
8.		virus infection transmitted by transfusion (HBV),
9.		virus infection transmitted by transfusion (HCV),
10.		virus infection transmitted by transfusion (HIV-1/ 2),
11.		other viral infection transmitted by transfusion,
12.		the parasitic infection (malaria) transmitted by transfusion,
13.		other parasitic infection transmitted by transfusion,
14.		Purpura post transfusionem (PTP),
15.		transfusion-associated Graft-versus-Host-Disease (GvHD),
16.		febrile not haemolytic transfusion reaction,
17.		non febrile non-haemolytic transfusion reaction,
18.		other allergic reactions,
19.		other serious adverse reactions.

(4) A "serious incident" means any undesirable event related to the collection, testing, processing, storage or distribution of blood or blood components that are of the quality or safety of blood or blood components , which could be fatal or life-threatening for donors or recipients/recipients, could lead to a disability or loss of ability, leads to diseases, or The duration of the stay or the extension of a hospital stay is extended or extended.

(5) A "mistransfusion" means any adverse event in which the recipient/recipient is not given the blood or blood components or parts thereof intended for him/her.

(6) A "blood donation facility" is any organizational unit for the production of blood or blood components according to § 5 Blood Safety Act 1999, BGBl. I n ° 44, as last amended by the Federal Laws BGBl. I No 107/2005 and BGBl. I No 6/2007.

(7) A "hospital blood depot" is a blood depot according to § 8f of the Federal Law on hospitals and health care institutions (KAKuG), BGBl. No. 1/1957, as last amended by the Federal Laws BGBl. I No 122/2006 and BGBl. I n ° 6/2007, as well as the implementation provisions adopted in each case.

Notifications of serious adverse reactions

§ 3. (1) Reporting requirements are

1.		the head of a hospital blood depot where such a hospital does not exist, the medical director of a hospital,
2.		The medical director of a blood donation facility.

(2) The head of a hospital blood depot where such a hospital does not exist, the medical director of a hospital, and the medical director of a blood donation establishment have the health Austria GmbH, Business Unit ÖBIG,

1.		suspected serious adverse reactions in the context of an apheresis pursuant to § 2 (2) (2) Z 3, 4, 7 and 8 immediately, and
2.		serious adverse reactions in accordance with § 2 (2) (1), (2), (5) and (6) for each type of donation and in accordance with § 2 (2) (2) (3) in the case of whole blood donations (non-apheresis donations) at the latest on the next working day after the announcement of the
to report.

(3) After the investigation of the suspected cases in accordance with paragraph 2 (1) (1), the notifiers pursuant to Section 2 of Public Health Austria GmbH, Business Unit ÖBIG, have to submit a confirmation message.

(4) The head of a hospital blood depot where such a hospital does not exist, the medical director of a hospital, has the health Österreich GmbH, Business Unit ÖBIG,

1.		any suspected serious adverse reaction pursuant to Section 2 (3) Z 5 without delay,
2.		serious adverse reactions, in accordance with Article 2 (3) (1) to (4) and (6) to (15) and (19), shall be made no later than the next working day following the notification
3.		serious adverse reactions according to § 2 (3) Z 16 to 18 per year
to report. At the same time, in the cases of Z 1 and 2, the reporting person shall have the person responsible for the holding, who has processed, stored or distributed the blood or blood components intended for transfusion, and the medical director/medical officer Head of the blood donation facility.

(5) After the investigation of the suspected cases in accordance with paragraph 4 (1) and (2), the notifying party pursuant to Section 4 of Public Health Austria GmbH, Business Unit ÖBIG, has to submit a confirmation message.

(6) In the event of the absence of the persons referred to in paragraph 1, the respective reporting obligation shall apply to the person who is responsible for the performance of the respective function.

Annual reports of serious adverse reactions

§ 4. Until 30 April of the following year of Health Austria GmbH, Business Unit ÖBIG, the reporting requirements pursuant to § 3 (1) shall have a full report on all serious adverse reactions pursuant to § 2 para. 3 and on all Transmission of mistransfusions as well as all conscious blood-group unequal transfusions of the previous year in their area.

Reports of serious incidents

§ 5. (1) Reporting requirements are

1.		the responsible person of a holding who processes, stores or distributes human blood or blood components, provided that they are intended for transfusion,
2.		the medical director of a blood donation system, and
3.		The head of a hospital blood depot, where there is no such person, the medical director of a hospital.

(2) The notifiers have suspected serious incidents attributable to faulty equipment, the health of Austria GmbH, the ÖBIG business unit, to report immediately.

(3) Reporting persons have suspected serious incidents attributable to human error or to donor-related causes or other causes, and to donors or recipients/recipients, except those directly addressed to , the person concerned may endanger the health of Austria GmbH, the ÖBIG business unit, at the latest on the next working day after the notification.

(4) Reporting persons have product-related defects in blood or blood components which may be related to a serious incident due to faulty equipment, human failure, or donor-related causes or other causes is to be reported immediately to Health Österreich GmbH, Business Unit ÖBIG. At the same time, the notifiable person in accordance with paragraph 1 (3) has the person in charge of the holding who has processed, stored or distributed the blood or blood components intended for transfusion, and the medical director of the holding who is responsible for the transfusion of blood or blood components. Blood donation facility.

(5) After the investigation of the suspected cases in accordance with para. 2 to 4, the Reporting Obligations of Health Austria GmbH, Business Unit ÖBIG, have to submit a confirmation message.

(6) In the event of the absence of the persons referred to in paragraph 1, the respective reporting obligation shall apply to the person who is responsible for the performance of the respective function.

Annual reports of serious incidents

§ 6. Up to 30 April of the following year of health Austria GmbH, ÖBIG business unit, the reporting requirements pursuant to § 5 (1) shall have a complete report on all serious serious cases occurring in the previous year. Any incidents that have affected the quality or safety of blood and blood components shall be transmitted. Die Gesundheit Österreich GmbH, Business Unit ÖBIG, has published a summary report of all reported serious incidents on its website.

Form of notifications

§ 7. (1) Notifications pursuant to this Regulation shall be made by means of notification forms, which are published on the website of the Federal Ministry of Health, Family and Youth.

(2) Personal data may not be included in the notification forms referred to in paragraph 1. This does not apply to information on reporting persons or institutions.

References to acts of the European Community

§ 8. This Regulation lays down Directive 2005 /61/EC on the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards requirements for traceability and notification of serious incidents and serious incidents Adverse reactions, OJ C 327, No. OJ L 256 of 1.10.2005 p.32.

Kdolsky