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Euro GTP Guidance - Euro GTPs

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e) To ensure that medical, social, physical and biological evaluations have been<br />

performed according to the established requirements;<br />

f) To ensure that the absolute rejection criteria are met and the relative exclusion criteria<br />

are assessed against safety, quality and availability aspects of the tissue;<br />

g) To establish the requirements for testing (parameters and methods) and to guarantee<br />

that the tests are carried out accordingly (quality agreement, audit visit, etc. when<br />

applicable);<br />

h) To verify the identification, integrity and suitability of the test samples sent to the<br />

corresponding laboratory units and that these laboratory are authorised centres by the<br />

competent authorities;<br />

i) To verify that, in case of suspicious and unexpected findings during donor evaluation,<br />

an adequate additional investigation is done;<br />

j) To systematically check the donation dossier review process and adapt the processes<br />

when indicated;<br />

k) To perform a process efficacy review, including an analysis of potential donors, real<br />

donors, causes to reject a potential donor and all the statistics considered helpful to<br />

improve the detection system and increase the donation efficacy;<br />

l) To oversee and coordinate feedback with the hospitals or facilities that have reported<br />

the donor;<br />

m) To medically supervise the personnel involved in donor screening;<br />

n) To guarantee that all legal and ethical aspects have been respected during every donor<br />

screening step (informed consent, death diagnosis, etc.).<br />

o) To control, revise and update all the donor selection criteria documents affecting the<br />

donation. These responsibilities may be delegated to another authorized person.<br />

5. Recovery responsibilities should include, but not be limited to, the following functions:<br />

a) Check donor identification;<br />

b) Check medical-legal data of the donor documentation;<br />

c) Donor physical exam (not required for living donors);<br />

d) Donor preparation (preoperative disinfection and operative field setting) (not required<br />

for living-donor tissue-recovery personnel);<br />

e) Recovery process and inspection of the cavities (thorax, abdomen) during recovery;<br />

f) Tissue packaging and identification;<br />

g) Donor reconstruction (not required for living-donor tissue-recovery personnel);<br />

h) Microbiological sampling;<br />

i) Transport;<br />

These responsibilities may be performed by a delegated person.<br />

6. Processing responsibilities should include, but not be limited to, the following functions:<br />

4

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