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Quality and safety of organs intended for transplantation 2010/53/EU

This document describes the aeras for which Scandiatransplant supports the quality and safety requirements outlined in: DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

Article 7: Organ and donor characterisation
Characterised of donor/organs before transplantation are done through the collection of the information listed  in the attached Excel sheet, which lists most of the variables that are included in the deceased donor registration in YASWA (Deceased_donor.xls).

The specific Scandiatransplant requirements for HLA typing on deceased donors has been decided by the Scandiatransplant Tissue Typers Group and they are outlined in this document.
When organs are exchanged between Member States, the organ and donor characterisation information is avaliable to the relevant transplant centers though YASWA.

Article 8: Transport of organs:
Shipping containers used for transporting organs are labelled with one of the following information labels Addresses for icebox - ORGAN
The organs transported are accompained by a standard report form on the organ and donor characterisation Deceased Donor Organ Form .
The report is either filled out by the coordiantors by hand or printed directly from YASWA. 
To secure that the container has not been comprimised under transportation a Scandiatransplant security seal is placed on the shipping container.

Article 9: Transplantation centres
Not in the scope of the Scandiatransplant office

Article 10: Traceability:
All organ donors and recipients within Scandiatransplant are registered and linked together in YASWA. This registration and storage in electronic form ensures traceability at all stages of the chain from donation to transplantation. 

Article 11: Reporting system and management concerning serious adverse events and reactions:
1st of January 2018 a system for reporting SAE/SAR was introduced in YASWA. Definitions and examples of SAE/SAR are available on the Scandiatransplant homepage and through the data entry form in YASWA.
All competent authorities are automatically informed when a SAE/SAR is reported. Scandiatransplant office makes a complete report once a year for the competent authority which they can report to EU. 

Article 12: Healthcare personnel + Article 13: Principles governing organ donation + Article 14: Consent requirements
Not in the scope of the Scandiatransplant office

Article 15: Quality and safety aspects of living donation:
In the secure YASWA framework basic information is registered and kept on all Living Donors, further information can be registered in the Living Kidney Donor Registry
Data in the registry is registered and kept in order to identify, report and manage any event potentially relating to the quality and safety of the donated organ, and hence of the safety of the recipient.
Any serious adverse reaction in the living donor that may result from the donation is reported through the SAE/SAR reporting system in YASWA.

Article 16: Protection of personal data, confidentiality and security of processing
The implementation of the Scandiatransplant IT-system complies with GDPR the REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
Documentation to support this is found on the homepage in an overview document and in relation with relevant ISO27001 elements (Through the ISO27001 link elements that are public can be reach by the menu to the left).

Article 17: Designation and tasks of competent authorities
Not in the scope of the Scandiatransplant office

Article 18: Records and reports concerning procurement organisations and transplantation centres:
Scandiatransplant office provides quarterly donation, waiting list and transplantation figures and an annual report this to keep a record of the activities of procurement organisations and transplantation centres, including aggregated numbers of living and deceased donors, and the types and quantities of organs procured and transplanted.
Both quarterly and annual reports a publicly accessible.

Article 19: Exchange of information
Not in the scope of the Scandiatransplant office

Article 20: Organ exchange with third countries
Agreements on organ exchange with third countries is found on the Scandiatransplant homepage here. Registration of donors and recipients follows the framework set up in YASWA, thus is secures the traceability.

The rest of the directive is not in the scope of the Scandiatransplant office