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QUALITY
For the purpose of assuring compliance with CIBERES PBP objectives, the ISO 9001:2008 management and quality system was implemented in 2011, being certified in 2012 . In 2014, the organisational structure was modified as a result of the new CIBER structure and at the beginning of 2015 the certificate for the entire platform was renovated .
The quality management system forces establishing objective compliance indicators for each of the processes of the PBP . Figure 2 shows its most relevant activity:
100 91 94 93 82 84
80 67 69 75 60
% cases included with complete information
% cases included with the IC
% samples with anomalies/incidents
40 20 0
6
2011
2012 2013 2014
Figure 2. Percentage of newly registered cases in the PBP with complete clinical information (blue),with a record of the informed consent of the patient (in red) and since 2014 the number of samples with processing or storage incidents or anomalies is also evaluated (in green)
Its activity is registered in the National Biobank Registry in the ISCIII (B .0000471), overcoming yearly audits and external evaluations . All its functioning is consensual and is done by means of standard operating procedures, as well as its management board and advisory committee (External Scientific and External Ethical) that oversee all the activities of the platform .
The Steering Committee advises the director on the planning and decision making that affects the PBC as a whole, and the Advisory Committees are independent, advisory and interdisciplinary bodies formed by expert members of the implicated disciplines that are not linked to CIBERES, the basic function of which are to oversee the scientific suitability and quality in the use of samples managed by the PBC .
INTEGRATION WITH OTHER STRUCTURES AND ORGANISATIONS TO PERFORM SYNERGISTIC AND MUTUAL BENEFICIAL ACTIVITIES.
Several agreements have been signed with different entities for taking specific sample collections with specific pathologies:
• Creation of a prospective multicentre sample and data collection from patients with pulmonary thromboembolism, sponsored by the Integrated Pulmonary Thromboembolism Research Project of the Sociedad Española de Neumología y Cirugía Torácica (SEPAR) .
• Creation of a prospective and retrospective multicentre sample and data collection from patients in stages I and II of lung cancer, sponsored by the CIBERES Lung Cancer Corporate Research Programme and funded by SEPAR-FIS-CIBERES .
The incorporation of 20 more hospitals on a national level national for collecting blood products from patients who have suffered pulmonary thromboembolism and 2 hospitals for the prospective incorporation of lung cancer sample has been worked on in 2014 .
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