Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.1. PERSONNEL

1. ‘Every tissue establishment shall designate a responsible person who shall at least fulfil the following conditions and have the following qualifications:

a) possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;

b) at least two years' practical experience in the relevant fields.

2. The person designated in paragraph 1 shall be responsible for:

a) ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with this Directive and with the laws in force in the Member State;

b) providing information to the competent authority or authorities as required in Article 6;

c) implementing the requirements of Articles 7, 10, 11, 15, 16 and 18 to 24 within the tissue establishment.

3. Tissue establishments shall inform the competent authority or authorities of the name of the responsible person referred to in paragraph 1. Where the responsible person is permanently or temporarily replaced, the tissue establishment shall immediately inform the competent authority of the name of the new responsible person and the date on which the duties of that person commence.3

4. Donor screening responsibilities should include, but not be limited to, the following functions:

a) To ensure the traceability of the donor during the screening process;

b) To guarantee that the established periods of time and circumstances have been kept from death to detection, donor refrigeration has been done until recovery and the analytical samples have been taken.

c) To ensure that the (family / personal/living donor) interview has been performed according to established requirements and to guarantee that there are no discrepancies with other evaluation reports;

d) To ensure communication with the competent judicial authority in case of unnatural or conspicuous causes of death;

e) To ensure that medical, social, physical and biological evaluations have been performed according to the established requirements;

f) To ensure that the absolute rejection criteria are met and the relative exclusion criteria are assessed against safety, quality and availability aspects of the tissue;

g) To establish the requirements for testing (parameters and methods) and to guarantee that the tests are carried out accordingly (quality agreement, audit visit, etc. when applicable);

h) To verify the identification, integrity and suitability of the test samples sent to the corresponding laboratory units and that these laboratory are authorised centres by the competent authorities;

i) To verify that, in case of suspicious and unexpected findings during donor evaluation, an adequate additional investigation is done;

j) To systematically check the donation dossier review process and adapt the processes when indicated;

k) To perform a process efficacy review, including an analysis of potential donors, real donors, causes to reject a potential donor and all the statistics considered helpful to improve the detection system and increase the donation efficacy;

l) To oversee and coordinate feedback with the hospitals or facilities that have reported the donor; 

m) To medically supervise the personnel involved in donor screening;

n) To guarantee that all legal and ethical aspects have been respected during every donor screening step (informed consent, death diagnosis, etc.).

o) To control, revise and update all the donor selection criteria documents affecting the donation. These responsibilities may be delegated to another authorized person.

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

a) Check donor identification;

b) Check medical-legal data of the donor documentation;

c) Donor physical exam (not required for living donors);

d) Donor preparation (preoperative disinfection and operative field setting) (not required

for living-donor tissue-recovery personnel);

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

f) Tissue packaging and identification;

g) Donor reconstruction (not required for living-donor tissue-recovery personnel);

h) Microbiological sampling;

i) Transport;

These responsibilities may be performed by a delegated person.

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

 a) Ensure that the tissues / cells for which that person is responsible have been processed, tested, stored and distributed in accordance with the corresponding approved procedures, specifications submitted to the competent authorities, the principles of the ‘European Good Tissue Practices’and the laws in force in the Member State;

b) Ensure that the tissues / cells imported from third countries have been processed and checked according to an equivalent quality system and standards respecting the requirements stated in the corresponding European Directives before they are distributed;

c) Providing information to the competent authority or authorities;

d) Implementing the requirements of Articles 7, 10, 11, 15, 16 and 18 to 24 (Directive 2004/23/EC) within the TE;

e) Approval of procedures, their updates and verification of their implementation;

f) The establishment of a quality assurance programme and verification of the entrusted quality and safety levels;

g) The release of tissues and cells, the distribution and dispensing of tissues and cells;

h) Ensure the independency between the quality control results assessment and the processing activities to guarantee the reliability and robustness of the release procedure. The individual(s) in charge of quality control results assessment are strongly recommended not to be involved in the conduct of the process being assured;

i) Relations with the TE or ORHAs (Organization Responsible for Human Application) and retrieval teams as well as with third subcontracted parties; 

These responsibilities may be performed by a delegated person.

7. Biovigilance responsibilities should include, but not be limited to, the following functions:

a) Report to their own Competent Authority and to any organisation in any country (TE / Recovery Unit) to whom the TE has supplied implicated tissues / cells, if this adverse event or reaction meets the  criteria for reporting to a CA (see below);

b) Where the implicated tissues or cells originated from an organisation (TE or Recovery Unit) in another EU Member State, (and the incident has / may have implications for them), also report to this organisation;

 

c) Where the implicated tissues or cells originated from an organisation (TE or Recovery Unit) outside the EU (and the incident has / may have implications for them), also report to this organisation which should take appropriate action in line with their own vigilance system;

d) Providing detailed information in appropriate language to the Recovery Unit, Transplant Centre, other relevant tissue and/or cells establishment using the tissues or cells, on how to report adverse events or reactions;

e) Co-ordination of the investigation and evaluation of any reported suspected adverse reaction, involving appropriate stakeholders. This should include allocating grades for Severity, Imputability and Impact Assessment;

f) Evaluation of any serious adverse event (SAE) in collaboration with appropriate stakeholders, including allocating an Impact score and reporting to the Competent Authority if the criteria are met;

g) Investigation of the cause and outcome of any serious adverse event or serious adverse reaction (SAE/SAR), collaborating as necessary with other organisations involved, and provision of the investigation report findings back to the Competent Authority;

h) Proposing a conclusion for each suspected adverse event or reaction and reporting this to the Competent Authority;

i) Implementation of any corrective or preventive actions arising, including initiation and coordination of recall or quarantine of associated tissues and cells, as appropriate;

j) Maintenance of records of SAE and SAR reported and investigated;

k) When tissues or cells are received with a defect in safety or quality from a TE or Recovery Unit, report it as an adverse event to the relevant TE or Recovery Unit;

l) When a report of an adverse reaction in a recipient is received, report it in accordance with the national requirements for biovigilance. Moreover, if this adverse reaction is suspected to have been caused by a defect of safety or quality in the tissues or cells, report it also to the supplying TE or Recovery Unit;

m) Initiation and co-ordination of recall or quarantine of associated tissues and cells, as appropriate;

 

These responsibilities may be performed by a delegated person.

8. ‘Tissue establishments shall inform the competent authority or authorities of the name of the responsible person referred to in paragraph 1. Where the responsible person is permanently or temporarily replaced, the tissue establishment shall immediately inform the competent authority of the name of the new responsible person and the date on which the duties of that person commence.4

Personnel directly involved in activities relating to the procurement, processing, preservation, storage and distribution of tissues and cells in a tissue establishment shall be qualified to perform such tasks and shall be provided with the training referred to in Article 28(c).5

9. The personnel in tissue establishments must be available in sufficient number and be qualified for the tasks they perform. The competency of the personnel must be evaluated at appropriate intervals specified in the quality system.

10. All personnel should have clear, documented and up-to-date job descriptions. Their tasks, responsibilities and accountability must be clearly documented and understood.

11. Personnel must be provided with initial/basic training, updated training as required when procedures change or scientific knowledge develops and adequate opportunities for relevant professional development. The training programme must ensure and document that each individual:

a) has demonstrated competence in the performance of their designated tasks;

b) has an adequate knowledge and understanding of the scientific/technical processes and principles relevant to their designated tasks; 25.10.2006 EN Official Journal of the European Union L 294/37;

c) understands the organisational framework, quality system and health and safety rules of the establishment in which they work; and

d) is adequately informed of the broader ethical, legal and regulatory context of their work.6

 

 

 

 

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