Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 laying down quality and safety standards for the collection, testing, processing, storage and distribution of blood In order to ensure a high level of protection of human health, it laid down the quality and safety standards for the extraction and verification of human blood and its components and for the purpose of ensuring a high level of human health protection. components whatever their destination, and for their treatment, storage and distribution when the destination is transfusion. Similarly, in order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of safety and quality, this directive required the establishment of quality systems in transfusion centres. In this regard, in its Article 11, the Commission had to develop and establish Community standards and specifications as regards the requirements for the quality and safety of blood and blood components.

Those rules and specifications are those set out in Commission Directive 2005 /62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards the Community standards and specifications relating to a quality system for blood establishments and whose transposition addresses this royal decree. In addition, as provided for in the directive itself, these standards and specifications should be interpreted in accordance with the best practice guidelines drawn up by the European Commission.

In the national legal order, it is Royal Decree 1088/2005 of 16 September, laying down the technical requirements and minimum conditions for the blood donation and transfusion centres and services, which Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 transposing Directive 2002/98/EC of 27 January 2003 on the obligation for establishments and services of transfusion to have a quality system in accordance with good practice practices, covering all the activities that determine its objectives and including the allocation of responsibilities. In particular, Article 32.2 of the Royal Decree provides for the Ministry of Health and Consumer Affairs to establish, in accordance with the guidelines laid down by the European Union, the minimum standards and specifications relating to the quality system of the institutions. and transfusion services. The main purpose and content of this royal decree is therefore to comply with this mandate on the basis of the contents of Commission Directive 2005 /62/EC of 30 September 2005.

Therefore, the internal rules faithfully transpose Community regulation in the specific field of the operation of transfusion centres and services, incorporating it in a manner consistent with the legal framework which structure of the activity of the National Health System according to the general principles of quality and safety. In this sense, article 59.2.a) of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, establishes that the infrastructure for the improvement of the quality of the National Health System will be constituted, among others, by quality and safety standards, which will contain the requirements that health centers and services must guide in order to be able to carry out an activity safely, so this royal decree is also specific development of the legal norm in How much it deals with basic technical issues that are essential and common aspects for the protection of the health and safety of persons, as provided for in Article 40 of Law 14/1986 of 25 April, General Health.

In its preparation, the sectors affected and consulted by the Autonomous Communities, the Interterritorial Council of the National Health System and the Scientific Committee for Transfusion Security have been heard. It has also been submitted to the previous favourable report of the Spanish Data Protection Agency.

This royal decree is issued under the protection of Article 149.1.16 of the Constitution, which attributes exclusive competence to the State in the field of bases and general coordination of health, and in accordance with the provisions of Article 40, Paragraphs 5, 6 and 7 of Law 14/1986 of 25 April, General of Health.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, with the prior approval of the Minister of Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the October 11, 2007,

DISPONGO:

Article 1. Object and scope of application.

1. This royal decree establishes the minimum requirements and specifications for the quality system of transfusion centers and services.

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

Article 2. Definitions.

For the purposes of this royal decree:

(a) Quality assurance: all activities carried out from the promotion of blood donation, to their distribution, whatever their destination, including the transfusion destination, in order to ensure that the blood and its components maintain the required quality.

(b) Good practice: each of the elements of the established practice which, together, ensure that the blood or the final blood components consistently meet the predefined specifications and conform to the rules defined.

c) Quality control: an element of the quality management programme, comprising the set of techniques and operational activities to determine the degree of compliance with the quality requirements.

d) Qualification: as part of the validation process, this is the check that the staff is working properly, and the premises, equipment or material work properly and produce the expected results.

e) Quarantine: physical isolation of blood components, materials and reagents over a variable time period, pending their acceptance, supply or rejection.

f) Specifications: description of the characteristics and criteria to be met by the blood components, and the activities of the transfusion centers and services, to achieve the required quality standard.

g) Quality management: a set of coordinated activities to manage and control an organisation in terms of quality at all levels of the blood transfusion centre, and to those of the services of transfusion.

h) Rules: requirements that serve as the basis for comparison.

i) Written procedure: a controlled document describing the chronological steps and requirements for the performance of a given activity which may influence the quality of the blood products and/or services provided.

j) Processing: each activity performed in the preparation of a blood component, between the extraction of blood and the supply of a blood component.

k) Tracing: process of investigating a post-transfusion adverse reaction notification in a recipient, in order to identify the potentially involved donor.

l) Quality system: organizational structure, responsibilities, procedures, processes and resources for the application of quality management.

m) computerised system: a system comprising the introduction of data, electronic processing and the production of information for use for the purposes of notification, automatic control or documentation.

n) Mobile unit: unit enabled for blood extraction and blood components, located outside the transfusion center, but under its control.

n) Validation: activity consisting in establishing and obtaining objective and documented evidence to demonstrate that the processes and/or equipment used will behave repeatedly as intended, to ensure their quality.

Article 3. General principles of the quality system.

1. The quality system of the transfusion centres and services shall ensure that all critical processes are specified in relevant instructions and are carried out in accordance with the minimum specifications set out in the Annexes of this royal decree.

2. The quality system of transfusion centres and services shall be reviewed on a regular basis in order to verify their effectiveness and to introduce corrective measures if they are deemed necessary. Staff working in the processes of the blood transfusion centre and the transfusion service will be responsible for the quality, and the management of these centres and services will ensure that a systematic search for quality is adopted and apply and maintain the quality system.

3. The quality system of the centres of transfusion must include: quality management, quality assurance and continuous improvement of quality, staff, premises, equipment and equipment, documentation, promotion of donation, selection of donors, extraction, verification and treatment, storage, conservation, distribution, quality control, withdrawal of blood components, contract management, external and internal audit, as well as self-inspection.

Article 4. Quality assurance.

1. In order to ensure quality assurance, all transfusion centres and services will have support, either internal or associated, to ensure that all quality issues can be addressed, and that they will be examined and approve all relevant documents relating to it.

2. All procedures, premises and equipment which have an influence on the quality and safety of blood and blood components shall be validated before being introduced and shall be revalidated periodically at intervals determined on the basis of activities.

Article 5. Importing blood and components.

Blood and blood components imported from third countries must comply, prior to their importation, with standards and specifications equivalent to those laid down in this royal decree.

Final disposition first. Incorporation of European Union law.

By this royal decree, Commission Directive 2005 /62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council on the application of Directive 2002/98/EC is incorporated into national law. refers to the Community rules and specifications relating to a quality system for blood establishments.

Final disposition second. Competence title.

This royal decree, which is of a basic standard, is dictated by the provisions of Article 149.1.16. of the Constitution, and in accordance with the provisions of Article 40 (5), (6) and (7) of Law 14/1986, of 25 April, General Health.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 11 October 2007.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

BERNAT SORIA ESCOMS

ANNEX I

Transfusion center quality system specifications and specifications

1. Staff and organization

1. The transfusion centres will have sufficient staff to carry out the activities related to the promotion of donation, the selection of donors, the extraction, verification, treatment, conservation and distribution of the blood and its components.

2. The transfusion centers will have the updated description of each job position that clearly specifies the tasks and responsibilities of their staff.

3. Staff shall receive training and advice for the competent exercise of their duties. To this end, initial and continuing training actions will be planned for the specific tasks, which will be duly documented and recorded. Training programmes including "good practice" will be introduced, as well.

4. The content of the training programmes shall be defined on a regular basis, and the competence of staff shall be assessed regularly.

5. Blood transfusion centers will assign responsibility for process management and quality assurance to different people, who will work independently.

There will be written instructions on health and hygiene adapted to the activities to be carried out and which must comply with the Law 31/1995 of 8 November, Prevention of Occupational Risks, to Royal Decree 39/1997, On 17 January the Regulation of the Prevention Services and Royal Decree 664/1997 of 12 May 1997 on the protection of workers from the risks related to exposure to biological agents during the course of the job.

2. Local

2.1 Generalities.

The premises, including mobile units, will be adapted and maintained in a way that is suitable for the activities to be performed. It will be possible to work on a logical sequence, in order to minimize the risk of occurrence of errors, as well as to allow easy cleaning and effective maintenance to minimize the risk of contamination.

2.2 Donor area.

A reserved area will be available to maintain confidential personal interviews with people and evaluate their possible admission as a donor. This area will be separate and differentiated from the rest of the areas of blood treatment.

2.3 Extraction area.

Extraction will be carried out in an area intended to safely collect blood from donors, it will be properly equipped for initial treatment of donors who have adverse reactions or injuries resulting from effects linked to donation, and organised in such a way as to ensure the safety of donors and staff, and avoid errors in the extraction procedure.

2.4 Blood Verification and Treatment Area.

There will be a laboratory area reserved for verification, separate from the donor area and the treatment of blood components, and access will be restricted to authorized personnel.

2.5 Storage Area:

1. Storage areas shall make safe and separate storage possible according to the different categories of blood and components and the materials, including the units in quarantine and the released units, as well as the units of blood or components extracted with special criteria (e.g. autologous donation).

2. Appropriate measures shall be provided in the event of failure of the electrical current equipment or cutting in the main installation of the area.

2.6 Waste disposal area.

An area shall be designated for the safe disposal of waste, the disposable material used for the extraction, verification and treatment, as well as for the blood or blood components rejected.

3. Equipment and equipment

1. All equipment shall be validated, calibrated and maintained in a manner that is appropriate for its function. The instructions for use will be available, and the corresponding records will be kept.

2. The equipment shall be selected in such a way as to minimise the risk to donors, staff and blood components.

3. Only reagents and materials from authorised suppliers, which comply with the documented requirements and specifications, shall be used. The critical material will be controlled by a qualified person to perform the task. Where appropriate, materials, reagents and equipment shall comply with the requirements laid down in Royal Decree 414/1996 of 1 March for the regulation of medical devices and in Royal Decree 1662/2000 of 29 September 2000 on products 'in vitro' diagnostic medical devices, or, in the case of extraction in other Community countries or in third countries, shall conform to equivalent standards.

4. The inventory records shall be kept for a period agreed and accepted by the competent authority.

5. Where computerised systems are used, the programmes, equipment and procedures for obtaining backup copies shall be regularly checked in order to ensure their reliability, to be validated prior to their use and to keep them in a state of good operation. Computer equipment and software shall be protected against any unauthorized use or change. The backup procedure will prevent data from being lost or damaged in expected or unexpected downtime or as a result of function failures.

4. Documentation and registration

1. Documents containing the specifications, procedures and records relating to each activity carried out by the blood transfusion centre shall be stored on the spot and kept up to date.

2. Records shall be legible and may be handwritten, transferred to another medium, such as microfilm, or documented in a computer system.

3. All significant changes to the content of the documents shall be implemented without delay, and shall be examined, dated and signed by a person authorised for that purpose.

5. Promotion of donation

5.1 The transfusion centre will have a plan of activities to promote the donation, subject to a periodic evaluation control that will measure its effectiveness.

5.2 The call files of donors will be protected to preserve their integrity in accordance with the provisions of the Organic Law 15/1999 of 13 December on the Protection of Personal Data. Such files shall be accessible only to authorised persons and used exclusively for the purposes authorised by the donor.

6. Selection of donors, extraction, verification and treatment of blood

6.1 Selection of donors.

1. Procedures for the safe identification of donors, the interview of suitability and the assessment of eligibility shall be maintained and maintained. They shall be carried out prior to each donation and shall comply with the requirements laid down in Annexes I and II to Royal Decree 1088/2005 of 16 September laying down the technical requirements and minimum conditions for hemodonation and centres and transfusion services.

2. The interview with the donor will be conducted in such a way as to ensure confidentiality.

3. The selection and final evaluation records of the donors will be signed by a qualified health professional.

6.2 Extraction of blood and blood components.

1. The blood draw procedure shall be designed to ensure that the identity of the donor is properly checked and recorded and that the relationship between the donor and the blood is clearly established. blood, and blood samples.

2. Sterile blood bag systems used for the removal of blood and blood components and their treatment shall bear the CE marking or comply with equivalent standards if blood and components were removed in other countries. Community or third countries. For each component it shall be possible to locate the batch number of the blood bag.

3. Blood extraction procedures will minimize the risk of microbial contamination.

4. At the time of donation, laboratory samples shall be taken, which shall be stored properly prior to the verification.

5. The procedure used to label the records, blood bags and laboratory samples with the donation numbers should avoid any risk of error and confusion of identification.

6. After the blood is removed, the bags will be handled in such a way as to maintain the quality of the blood, and during storage and transport they will be kept at a suitable temperature for further treatment requirements.

7. A system shall be in place to ensure traceability between each donation and the extraction and treatment system in which it was extracted or treated.

6.3 Laboratory verification.

1. All laboratory verification procedures shall be validated before they are used.

2. Each donation shall be verified in accordance with the requirements set out in Annex III to Royal Decree 1088/2005 of 16 September 2005.

3. Clearly defined procedures will be available to resolve the dissenting results and to ensure that blood and components in which a reactive result is repeatedly detected in a serological test for infection by the viruses referred to in Annex IV to Royal Decree 1088/2005 of 16 September 2005 are discarded for therapeutic use and stored separately in an environment specifically intended for that purpose. Appropriate confirmatory tests shall be carried out. In the event that the positive results are confirmed, appropriate attention shall be given to the donor, covering from the information to the monitoring procedures.

4. The data confirming the suitability of the laboratory reagents used for the verification of donor and blood component samples shall be available.

5. The quality of the verification in the laboratory shall be regularly evaluated by participation in a formal system of proficiency tests, such as those of an external quality assurance programme.

6. Tests for blood group determination will include procedures for specific donor groups (e.g., first-time donors and donors with a history of transfusion).

6.4 Treatment and validation.

1. All equipment and technical devices shall be used in accordance with validated procedures.

2. The treatment of blood components shall be carried out using appropriate and validated procedures and measures to avoid the risk of contamination and microbial proliferation in the prepared blood components.

6.5 Tagged.

1. At each stage of the process, all packages must be labelled with the relevant information about their identity. In the absence of a validated computerised system for monitoring the situation, the labelling shall clearly distinguish between the blood units and the compliant and non-compliant blood components.

2. The extracted blood labelling system, of the intermediate and finished blood components and of the samples, shall unequivocally identify the type of content, and shall comply with the labelling and traceability requirements laid down in this Regulation. Article 42 of Royal Decree 1088/2005 of 16 September 2005 and Articles 3 and 4 of Order SCO/322/2007 of 9 February 2007 laying down the requirements for the traceability and reporting of serious adverse reactions and reactions blood and blood components, respectively. The label of a final blood component shall comply with the requirements of Annex XI to Royal Decree 1088/2005 of 16 September 2005.

3. In the case of blood and autologous components, the label shall also comply with the requirements set out in Annex XI to Royal Decree 1088/2005 of 16 September 2005 and the additional requirements for autologous donations specified in Articles 21 to 26 of the aforementioned royal decree.

6.6 Conformity of blood and blood components.

1. There will be a safe system to prevent blood and blood components from receiving conformity if they do not meet all the mandatory requirements set out in this royal decree. Each blood transfusion centre must be able to demonstrate that blood or blood components have received the formal conformity of an authorised person. Records shall demonstrate that, before the conformity to a blood component, all the forms of declaration, relevant medical records and test results meet the acceptance requirements.

2. Before they are declared compliant, blood and blood components will be kept physically and administratively separate from the blood and blood components already approved. In the absence of a validated computer system to control the situation, the label of a blood unit or blood component shall identify the situation as to its conformity in accordance with paragraph 6.5.1.

3. In case the final component does not obtain conformity upon confirmation of the positive result of an infectious agent detection test, in accordance with the requirements set out in paragraphs 6.3.2 and 6.3.3, a check shall be carried out for ensure that other components of the same donation and prepared components of previous donations from the same donor are identified. The donor registry shall be updated immediately.

7. Storage and distribution

1. The quality system of the blood transfusion centre shall ensure that the requirements for the storage and distribution of blood and blood components for the manufacture of medicinal products comply with the provisions of the Royal Decree 1564/1992, of 18 December 1992, for the development and regulation of the system of authorization of pharmaceutical laboratories and importers of medicinal products and the guarantee of quality in their industrial manufacture.

2. The storage and distribution procedures will be validated to ensure the quality of blood and blood components throughout the storage period, and to exclude possible errors of blood components. All transport and storage actions, including reception and distribution, shall be defined by written specifications and procedures.

3. Autologous blood and blood components, as well as blood components extracted and prepared for specific purposes, shall be stored separately.

4. Adequate inventory and distribution records will be maintained.

5. The containers shall maintain the integrity and storage temperature of the blood or blood components during distribution and transport.

6. The return of blood and components to the inventory for later distribution will only be accepted if all the quality requirements and procedures established by the blood transfusion center are met to ensure the integrity of the blood. blood components.

8. Contract Management

Tasks that are performed externally will be defined in writing on a specific contract.

9. Non-compliance

9.1 Deviations.

Blood components that do not comply with the required standards set out in Annex V to Royal Decree 1088/2005 of 16 September shall only be declared as compliant for transfusion in exceptional circumstances, and with the registered agreement of the prescriber and doctor of the transfusion centre.

9.2 Claims.

All complaints and other information, including reactions and serious adverse events that may indicate that defective blood components have been distributed, will be documented and investigated. carefully to discover the causal factors of the defect. Where necessary, monitoring shall be carried out for the withdrawal of the same and for corrective measures to be taken to prevent their repetition. Procedures shall be provided to ensure that the competent authorities, as appropriate, are notified of serious adverse reactions or events in accordance with regulatory requirements.

9.3 Withdrawal from the blood.

1. The transfusion centre will have authorised staff to assess the need to remove blood and blood components and to initiate and coordinate the necessary measures.

2. There shall be an effective withdrawal procedure, as well as a description of the responsibilities and measures to be taken, including notification to the competent authority.

3. The measures shall be taken in pre-established time periods and shall include the monitoring of all relevant blood components and, where appropriate, include tracing to the donor. The aim of the research is to identify any donor who may have contributed to causing the reaction to transfusion and to recover their blood components, as well as to notify recipients and recipients of components extracted from the the same donor in case they may have been exposed to the risk.

9.4 Corrective and preventive measures.

1. There will be a system in place to ensure corrective and preventive measures on blood components, non-compliance and quality problems.

2. The data shall be regularly analysed for quality problems that may require corrective action or unfavourable trends that may require preventive measures.

3. All errors and accidents will be documented and investigated to detect and correct system problems.

10. Self-inspection, audits and improvements

1. Self-inspection or audit systems shall be available for all phases of operations in order to verify compliance with the rules laid down in this provision. Trained and competent persons shall apply them on a regular basis in an independent manner in accordance with approved procedures.

2. All results shall be documented, and appropriate corrective and preventive measures shall be taken in an effective and timely manner.

ANNEX II

Quality system specifications and specifications for transfusion services

1. Staff and organization

1. The transfusion services shall have sufficient staff to carry out the conservation activities, as well as the compatibility tests and the transfusion of blood and components.

2. Staff shall receive training and advice for the competent exercise of their tasks.

3. Descriptions of each updated job will be available, which clearly specify the tasks and responsibilities of the staff.

4. Staff will receive initial and continuing training appropriate to their tasks, as well as training programmes that include "good practice".

5. Written instructions on health and hygiene shall be available in accordance with the legislation in force.

2. Local

The premises will be adapted and maintained so that they are suitable for the activities to be carried out, while facilitating the work in such a way that the risk of occurrence of errors is minimised.

3. Equipment and equipment

1. The transfusion service shall have an up-to-date inventory of equipment, which shall be periodically validated and maintained in such a way as to be appropriate for its function.

2. Where computerised systems are used, the programmes, equipment and procedures for obtaining backup copies shall be regularly checked in order to ensure their reliability, to be validated prior to their use and to keep them in a state of good performance.

4. Documentation and registration

The documentation and records of the transfusion services shall be legible, and may be handwritten, transferred to another medium, or documented in a computer system.

5. Conservation

1. Transfusion services shall have written procedures for the reception and preservation of blood components.

2. Components extracted and prepared for specific receptors, autologous components, and 'non-compliant' components shall be kept in a clear and unambiguous manner.