A.6.4. DOCUMENTATION AND RELEASE
1. The TE or ORHA must develop a system to maintain a record of each step of donation, donor selection, collection, control, preparation, storage and distribution of tissues and cells. The decision to release (validation for human use) is taken on the basis of data contained in this dossier.
2. The records and documents must be completed in a legibly and indelibly manner.
3. The dossier and any other documentation can also be saved on a reliable system such as a digital or microfilm system. When data is managed by tissue bank personnel, a declaration must be made to the Competent Institution for personal data protection according to current regulations.
4. The recording of relevant data in the dossier must allow identification of the author and the date of these entries.
5. Data security and confidentiality must be guaranteed.
1. The items indicated in the Storing and Distribution File Contents should be required for the release or rejection of the tissues / cells and thus should be documented. The tissue / cells recovered dossier should include the contents showed in the Recovery File Contents section.
A.6.4.3. Storing and Distribution File Contents
1. The organisation performing the procurement must prepare a procurement report, which is passed on to the tissue establishment. This report must contain at least:
a) Reception records for tissues/cells;
b) Release statements of the corresponding responsible persons;
c) Conditions under which the tissues or cells are kept (conditions and time);
d) Shipping records with the name and address of the tissue establishment to receive the cells/tissues;
e) Date of issuance or distribution or destruction.
1. The tissue bank sets up a procedure to ensure the registration of the following information to guarantee traceability of tissues and cells and to report incidents or serious adverse reactions;
a) Identification of the recipient (name and date of birth);
b) Identification of the surgeon in charge of implantation;
c) Place and date of implantation;
d) Clinical follow-up (initial results, complications and remarks);
e) Description of the tissues and cells (such as quantitative data, morphological data, functional data);
f) Recommendations of interim storage, if any;
g) Instructions for use (such as opening instructions, thawing and / or reconstitution, handling, etc.);
h) Conditions and the maximum period of storage after deconditioning. This dossier also includes a form to be completed by the surgeon after implantation and be returned to the TE. It will contain relevant information related to possible SAEs and/or SARs that may occur during implantation.
Access to registers and data must be restricted to persons authorised. This file must be kept for a minimum of 30 years after clinical use.
A.6.4.4. Availability for inspection
The records must be accessible at any times for inspections conducted by the Competent Authority. Access to the donor's identity and data related is limited to persons responsible for the TE or ORHA, but must, if necessary, be allowed to inspectors.
1. The TE or ORHA should be able to assure the traceability of the donor.
2. The traceability requirement applies to all relevant data related to the donor, critical products and materials coming into contact with the donor.
3. Corrections, changes or amendments made to a file should be carried out according to a written change control management procedure.
4. When electronic data is affected any critical change should be recorded and available through an audit trail.