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Commission Directive 2006/17/ECShow full title

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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Changes over time for: Division 1.4.

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1.4.Donor documentationU.K.+E.U.

1.4.1.For each donor, there must be a record containing:U.K.+E.U.
(a)

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);

(b)

age, sex, medical and behavioural history (the information collected must be sufficient to allow application of the exclusion criteria, where required);

(c)

outcome of body examination, where applicable;

(d)

haemodilution formula, where applicable;

(e)

the consent/authorisation form, where applicable;

(f)

clinical data, laboratory test results, and the results of other tests carried out;

(g)

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);

(h)

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.

1.4.2.The organisation performing the procurement must produce a procurement report, which is passed on to the tissue establishment. This report must contain at least:U.K.+E.U.
(a)

the identification, name and address of the tissue establishment to receive the cells/tissues;

(b)

donor identification data (including how and by whom the donor was identified);

(c)

description and identification of procured tissues and cells (including samples for testing);

(d)

identification of the person who is responsible for the procurement session, including signing;

(e)

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);

(f)

for deceased donors, conditions under which the cadaver is kept: refrigerated (or not), time of start and end of refrigeration;

(g)

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:

(a)

the name and address of the tissue establishment to receive the cells/tissues;

(b)

the donor identification.

The date and time of procurement may be included, where possible.

1.4.3.All the records must be clear and readable, protected from unauthorised amendment and retained and readily retrieved in this condition throughout their specified retention period in compliance with data protection legislation.U.K.+E.U.
1.4.4.Donor records required for full traceability must be kept for a minimum of 30 years after clinical use, or the expiry date, in an appropriate archive acceptable to the competent authority.U.K.+E.U.

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