Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 in order to ensure a high level of protection of human health laid down the quality and safety standards for extraction and verification of human blood and its components whatever its destination, and for its treatment, storage and distribution when the destination is the transfusion. Similarly, in order to prevent the transmission of diseases by blood and blood components, as well as to ensure an equivalent level of safety and quality, this directive required the establishment of traceability requirements, a the Community procedure for the notification of serious adverse reactions and effects, as well as a format for notification of common serious adverse reactions and adverse effects for all Member States. All of these forecasts have been set out in Commission Directive 2005 /61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and the notification of serious adverse reactions and effects. Royal Decree 1088/2005 of 16 September 2005 laying down the technical requirements and minimum conditions for blood donation and transfusion centres and services, for which Directive 2002/98/EC of the European Parliament was transposed and the Council of 27 January 2003 laying down quality and safety standards for the extraction, verification, processing, storage and distribution of human blood and blood components and amending the Directive 2001 /83/EC, requires the establishment of a system to ensure traceability by means of organised surveillance procedures which involve the unique and unequivocal identification of donations, the donor and the patient, as well as the establishment and maintenance of systems of registers, which in turn make it possible to evaluate the information. Article 43.3 of the aforementioned royal decree provides that the Ministry of Health and Consumer Affairs shall establish, in accordance with the guidelines laid down by the European Union, the minimum standards and specifications as regards traceability and notification of serious adverse reactions and effects. This provision incorporates into national law the Commission Directive 2005 /61/EC of 30 September 2005. The sectors concerned and the Autonomous Communities, the Interterritorial Council of the National Health System and the Scientific Committee for Transfusion Security have been heard in the process. This order is dictated by the provisions of Article 43.3 of Royal Decree 1088/2005 of 16 September 2005 and under the provisions of its second final provision. In its virtue, with the prior approval of the Minister of Public Administrations and in agreement with the State Council, I have:

Article 1. Object and scope of application.

1. This order lays down the minimum requirements and specifications for the traceability of blood and blood components, as well as the notification of serious adverse reactions and effects.

2. The provisions of this order shall apply throughout the national network of transfusion centres and services, as determined in Article 35 of Royal Decree 1088/2005 of 16 September 2005 laying down the technical requirements and conditions for the transfer of the minimum level of blood donation and transfusion centres and services.

Article 2. Definitions.

For the purposes of this order: a) Center: Hospitals, clinics, blood products manufacturers and biomedical research institutes to which blood or blood components may be supplied.

b) 'Reporting Centre' means the transfusion centre, hospital transfusion service or centre where the transfusion is carried out which, in each case, reports serious adverse reactions and reactions to the competent authorities. c) Transfusion Committee: Hospital structure consisting of a variable number of professionals according to the areas, size and degree of specialization of each hospital, and whose responsibility is to ensure the quality and safety of the transfusion exercise. (d) Distribution: Action to draw blood and components to other centres of transfusion, transfusion services or producers of blood and plasma products. It does not include sending blood or transfusion components to the recipient. (e) Serious adverse effect: Any adverse event linked to the extraction, verification, treatment, storage and distribution of blood and components, which may lead to the death of the patient or to states that may endanger his life, (a) a disability or a disability, or a stay in hospital or illness or, if any, extend them. (f) Hemosurveillance: A set of organised surveillance procedures for serious or unexpected effects or adverse reactions that may occur along the transfusion chain, from the extraction of blood and components to the monitoring of the recipients, all in order to prevent, and treat their occurrence or recurrence. (g) Imputability: The probability that a serious adverse reaction in a recipient can be attributed to the blood or the transfused component, or that a serious adverse effect on a donor can be attributed to the donation process. (h) Serious adverse reaction: A harmful and unexpected response in the donor or in the patient, in relation to the removal or transfusion of blood or blood components, and which is fatal, potentially fatal, resulting in disability or disability; or which results in hospitalization or illness or, where appropriate, prolongs. i) Receiver: Person who has received a transfusion of blood or blood components. (j) Provision: Release by a blood or blood transfusion centre or service for transfusion use. k) Traceability: The ability to track each unit of blood or component from the donor to its final destination (either to a recipient or a drug manufacturer), or its destruction and vice versa.

Article 3. Requirements and specifications relating to traceability.

1. Each transfusion service or centre, when supplying blood or components for transfusion, shall have a verification procedure that each unit supplied has been transfused to the recipient to whom it was intended, or to verify its subsequent destination in case of not being used for transfusion.

2. In all transfusion centres and services there shall be a system of registration of each unit of blood or components received, as well as of the final destination of each unit or component received, either transfused, removed or returned to the centre of Transfusion that distributed it. 3. In each transfusion centre there shall be a unique identifier, allowing for precise linking with each blood unit extracted and with each component made.

Article 4. Record of traceability data.

Transfusion centres, transfusion services or other centres involved shall keep the data set out in Annex I, in a period and form as set out in Article 42 of Royal Decree 1088/2005 of 16 September 2005.

Article 5. Reporting of serious adverse reactions.

1. Transfusion services shall have procedures to keep the record of all transfusions and to immediately notify the transfusion centres of any serious adverse reactions to the recipients, attributable to the quality and safety of blood or blood components.

2. The transfusion committee, set up in the centres with transfusion practice, will be the body responsible for carrying out the analysis and evaluation of the adverse reactions associated with transfusion. 3. For the purposes of notification, the reporting centres shall at least comply with the following specifications:

(a) Dispose of a system ensuring that all serious adverse reactions are communicated to the competent health authority by means of procedures including at least the data contained in the forms in the Annex II, Parts A and C.

(b) shall notify the competent health authority of all relevant information on serious adverse reactions classified at levels 2 or 3 of the imputability scale as set out in Part B of Annex II, to the quality and safety of the blood and components. (c) notify the competent health authority, as soon as it is confirmed, of any case of transmission of infectious agents by blood or components. (d) They shall notify the competent health authority of the actions undertaken in respect of other components involved which have been distributed for transfusion or for the subsequent manufacture of plasma derivatives. (e) Evaluate any serious adverse reactions in accordance with the imputability and gravity levels set out in Annex II, Part B. (f) After the completion of the investigation, they shall complete the relevant form and notify the serious adverse reactions, including at least the information set out in the form set out in Annex II, Part C. g, shall be submitted annually to the competent health authority by a complete report of the reactions serious adverse events, including at least the information contained in the form set out in Annex II, Part D.

Article 6. Reporting of serious side effects.

1. Transfusion centres and services shall have procedures in place to ensure that records of any serious adverse effects which may affect the quality or safety of blood and blood components are maintained.

2. For the purposes of the notification, the reporting centres shall at least comply with the following specifications:

(a) They shall have notification procedures to inform the competent health authority as soon as they are found of all relevant information on serious adverse effects which may endanger donors or recipients other than those directly involved in the particular case. This information shall contain at least the collection in the form of Annex III, Part A

b) Evaluate serious adverse effects in relation to the detection of preventable causes. (c) After the completion of the investigation, they shall complete the relevant form and notify the competent health authority of the serious adverse effects, including at least the information set out in the form set out in Annex III, Part B. (d) submit a full report of serious adverse effects to the competent health authority on an annual basis, including at least the information set out in the form in Annex III, Part C.

Article 7. Import of blood and components.

Blood and blood components imported from third countries, including those used as raw materials or as a starting material for the manufacture of medicinal products derived from human blood and plasma, must comply with and specifications equivalent to those laid down in this order, as regards traceability and the notification of serious adverse reactions and effects.

Article 8. Annual report and exchange of information.

1. For the purpose of the annual report to be submitted to the European Commission, the competent health authorities shall forward to the Ministry of Health and Consumer Affairs before 1 May each year the completed forms set out in Part D of the Annex II and Part C of Annex III, referring to serious adverse reactions and reactions occurring in the previous year.

2. Where the competent health authority receives information relating to serious reactions or effects which may endanger donors or recipients other than those directly involved in the particular case, it shall inform the competent health authority of the of the Ministry of Health and Consumer Affairs as quickly as possible. 3. Where a serious adverse effect or reaction is communicated which, at its origin, may pose a risk to more than one centre, region or country, the Ministry of Health and Consumer Affairs shall inform the authorities as soon as possible. (a) the competent authorities of the Member States, as well as the authorities of the Member States, in order to ensure that the defective elements are removed and disposed of.

Article 9. Data protection and confidentiality.

1. The treatment and communications of data of donors and recipients, resulting from compliance with the provisions of this order by the information centers, will be subject to the provisions of the Organic Law 15/1999, of 13 December, of Protection of Personal Data.

2. In any event, the security measures at a high level provided for in the Regulation on the security of automated files containing personal data, as set out in Royal Decree 994/1999, of 11 September 1999, shall be adopted. June.

Article 10. Infringements and sanctions.

In terms of infringements and penalties, the provisions of Articles 46 and 47 of Royal Decree 1088/2005 of 16 September 2005 will be followed.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2005 /61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards requirements is transposed into Spanish law. for traceability and for the reporting of serious adverse reactions and reactions.

Final disposition second. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 9 February 2007. -Minister for Health and Consumer Affairs, Elena Salgado Méndez.

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