|Organisation sharing the GOP||
Related practices from PaSQ database
|Directorade of Quality, Research, Development and Innovation. Scientific Management of Biobank. Andalusian Regional Ministry of Health and Social Welfare.||
|Blood / Blood products
|It is a common ethical framework, with a unique organizational structure and a decentralized activity that integrates all blood banks and tissues for therapeutic purposes, as well as research biobanks and other existing units within the Andalusian Public Health System.|
|To unify systems of procurement, processing, custody, release of tissue samples and biological substances of human origin, whatever their destination (care, teaching, research or industrial use).
-To sort and coordinating the banks and the sample collections of the APHS.
– To strength connections and cooperation programs nationally and internationally.
|The organizational model will be equipped with three different areas, marked by their expertise and regulatory framework for action:
• Blood. Blood derivatives
• Tissues, anatomical parts, chemicals and biological samples for clinical use.
• Tissues, chemicals and biological samples for research.The organization of the Biobank is developed on the following basis:
– Public Control (guarantor to the citizen).
– Tendency to autonomy. New management models more agile, integrated within Public Health Administration.
– The purpose is self-financing from the billing of costs of production, processing and distribution conservation.
– Services to agencies and public and private entities within and outside Andalusia
– Ensure the quality, safety and traceability of data and stored samples and procedures associated with the operation of the biobank.
– Answering of inquiries or complaints may be addressed to the biobank.
|Implementation tools available|
|a) Instalaciones and equipment
– Biosecurity plan: sample transport logistics, Signage
– Preservation and traceability of samples: precoded tubes, printers, freezers
– Conditioning spaces
– Sample Processing
b) Quality management system. It has a strategic plan that includes goals, mission, values and service portfolio in the Biobank network. It will include strategic, operational and support processes.
c) Information management system:
Widespread use of Bio-and tool-Bank and Sacilab-Saciweb
Transfering of the Bio-e-Bank tool server
Changes in the tool-and Bio-Bank
Design of new plans and sample and procedures processing
Definition of new activities
Defining new units, sources of samples.
d) Training and dissemination activities
|Although the initial budget for 2012 was € 1776121 in current expenditure and € 640000 in investments by 2012, the Biobank of APHS, far from being a new expense, substantially reduce the current cost, increasing the quality of the process and improving the results.|
|Method used to measure the results|
|The approach focuses on the integration and optimization of the various systems responsible of the collection, handling, processing and supply of tissues and biological samples, increasing the process quality and improving the results.
Specifically, measures like:
Sample integrity Control
|a) The integration and streamlining management structures have resulted in annual savings of 300000 euros.
b) The unification of systems of procurement, processing, custody of hover substance and tissue samples: 3 million euros of potential savings.
c) Unification of information systems: 100000 euros.
d) Improving the management model, with measures such as centralized purchasing of consumables, concentration processing activities: 1 million euros per year.
e) Introduction of quality criteria in the storage of samples: 1 million euros per year and transport of 300000 euros a year.
|Analysis of the results|
|The scope of our project includes all types of products: Blood and derivatives, umbilical cord blood, tissues (including the reproductive one), biologicals, biological samples for research, embryonic cell lines, reprogrammed cells and other precursor and not precursor cell lines. It also affects all processes of procurement, processing and distribution, regardless of origin and destination and the type of processing or preservation applied. All of them will follow the same systematic biohazard control, track and trace, in a common framework of biomonitoring.|
|Did you find implementation barriers?|
|Please describe implementation barriers|
|There is no specified text here|
|Describe the strategies used to overcome the barriers (If needed)|
|There is no specified text here|
|Other information about the GOP that you would like to add (Link or attached document)|
|Despite finding implementation barriers, it has been an opportunity to involve professionals in an integrated quality system. Undoubtedly, it has posed a challenge to coordinate these activities and to structure directing to user needs, and even anticipating them, in order to eliminate inefficiencies. For its part, to involve donor unit of blood, organs and tissues in the project has provided an opportunity to integrate teams. The aim has been to avoid duplication and identify synergies, seek unification of criteria, quality control systems, as well as to connect these units and activities devoted to obtain, maintain and manage samples for clinical units and research centers within the APHS. Donation and conservation units, care teams and research groups provide a service and mutual benefit in a clear example of the exercise of translational medicine.|