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- Point in Time (31/01/2020)
- Original (As adopted by EU)
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance)
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that consent for the procurement has been obtained in accordance with Article 13 of Directive 2004/23/EC; and
how and by whom the donor has been reliably identified.
understood the information provided;
had an opportunity to ask questions and been provided with satisfactory responses;
confirmed that all the information provided is true to the best of his/her knowledge.
the medical records of the donor;
an interview with a person who knew the donor well, for deceased donors;
an interview with the treating physician;
an interview with the general practitioner;
the autopsy report.
the donor identification (first name, family name and date of birth — if a mother and child are involved in the donation, both the name and date of birth of the mother and the name, if known, and date of birth of the child);
age, sex, medical and behavioural history (the information collected must be sufficient to allow application of the exclusion criteria, where required);
outcome of body examination, where applicable;
haemodilution formula, where applicable;
the consent/authorisation form, where applicable;
clinical data, laboratory test results, and the results of other tests carried out;
if an autopsy was performed, the results must be included in the record (for tissues and cells that cannot be stored for extended periods, a preliminary verbal report of the autopsy must be recorded);
for haematopoietic progenitor cell donors, the donor’s suitability for the chosen recipient must be documented. For unrelated donations, when the organisation responsible for procurement has limited access to recipient data, the transplanting organisation must be provided with donor data relevant for confirming suitability.
the identification, name and address of the tissue establishment to receive the cells/tissues;
donor identification data (including how and by whom the donor was identified);
description and identification of procured tissues and cells (including samples for testing);
identification of the person who is responsible for the procurement session, including signing;
date, time (where relevant, start and end) and location of procurement and procedure (SOP) used, including any incidents that occurred; where relevant, environmental conditions at the procurement facility (description of the physical area where procurement took place);
for deceased donors, conditions under which the cadaver is kept: refrigerated (or not), time of start and end of refrigeration;
ID/batch numbers of reagents and transport solutions used.
The report must also contain the date and time of death where possible.
Where sperm is procured at home, the procurement report must state this and must contain only:
the name and address of the tissue establishment to receive the cells/tissues;
the donor identification.
The date and time of procurement may be included, where possible.
At the time of procurement, every package containing tissues and cells must be labelled. The primary tissue/cell container must indicate the donation identification or code and the type of tissues and cells. Where the size of the package permits, the following information must also be provided:
date (and time where possible) of donation;
hazard warnings;
nature of any additives (if used);
in the case of autologous donations, the label must state ‘for autologous use only’;
in the case of directed donations, the label must identify the intended recipient.
If any of the information under points (a) to (e) above cannot be included on the primary package label, it must be provided on a separate sheet accompanying the primary package.
When tissues/cells are shipped by an intermediary, every shipping container must be labelled at least with:
TISSUES AND CELLS and HANDLE WITH CARE;
the identification of the establishment from which the package is being transported (address and phone number) and a contact person in the event of problems;
the identification of the tissue establishment of destination (address and phone number) and the person to be contacted to take delivery of the container;
the date and time of the start of transportation;
specifications concerning conditions of transport relevant to the quality and safety of the tissues and cells;
in the case of all cellular products, the following indication: DO NOT IRRADIATE;
when a product is known to be positive for a relevant infectious disease marker, the following indication: BIOLOGICAL HAZARD;
in the case of autologous donors, the following indication: ‘FOR AUTOLOGOUS USE ONLY’;
specifications concerning storage conditions (such as DO NOT FREEZE).
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