135-603 / Inspection protocols for verification of compliance with the quality requirements for centers and transfusion services.

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
Healh Services Inspection

Andalusian Regional Ministry of Health and Social Welfare


Peer review
Blood / Blood products
GOP Description
Implementation level
Clinical settings
Regional transfusion centers and area.
Hospital transfusion services.
Assess compliance with the requirements and implementation of quality control measures required by RD 1088/2005,: technical requirements and minimum conditions and blood donation centers and transfusion services RD 1343/2007, by establishing standards and specifications for quality system of centers and transfusion services.
Incorporates the provisions of Directives 2002/98/EC and 2004/33/EC.
Users and practitioners of these types of centers.
Transfusion Centre is one where activities are carried out the collection and testing of human blood or blood components, and distribution when intended for transfusion. And transfusion service, to that linked to a transfusion center, and under the responsibility of a medical specialist in hematology and hemotherapy, which stores blood and blood components for transfusion, and where you can perform compatibility testing of blood and components .
Royal Decree 1088/2005 establishes the biennial inspection transfusion centers, so that has developed a specific program that includes inspection of compliance with the requirements applicable to such centers, with finding the unambiguous identification and traceability blood components. The methodology used is similar to that of an audit
Timeframe implementation
Six months, requires prior training of inspectors
Implementation tools available
As tools are used protocols and annexes (with rules and evidence) of the following: – “inspection protocol transfusion centers” and “inspection protocol transfusion service.” They are designed to assess the activity of the same, in both public and private.
Implementation cost
Cost of training of inspectors,
Method used to measure the results
After applying the protocol, a report is to be submitted to the center inspected, it may make submissions to it, and also to develop a remedial plan mandatory anomalies detected.
It is considered appropriate if:
– Meet more than 80% of the applicable requirements in the protocol.
– Does not breach any condition affecting critical processes.
– From detected some unfulfilled requirements for major deficiencies, but susceptible of correction, it is considered that the adaptation is contingent on the remedy, immediately or after implementation of a remedial plan to short notice, specifying where appropriate reinspection. Methodology used is similar to an audit
We have inspected the seven blood centers in Andalusia, in 2008, 2010 and 2012. In each evaluation, have been reduced by unfulfilled requirements rectify anomalies. Of these, the most important are those derived from failures that affect the organization and operation of the QMS.
In addition, we inspected 28 transfusion services of public hospitals and 18 private hospitals, analyzing the traceability of 575 units of blood and blood products in 2008, with follow-up in 83% of 575 units in 2010, up by 93% cases and 650 units in 2012, with follow-up in 94%.
Analysis of the results
Overall, transfusion centers evaluated in 2008, 2010 and 2012 have obtained favorable inspection reports, considering that they have adequate, despite detection of unfulfilled requirements since met with a percentage higher than 80% of the applicable requirements and not been found critical deficiencies and significant deficiencies detected in some center have been rectified immediately, or after implantation of a remedial action plan in the very short term, specifying if necessary, reinspection
Implementation barriers
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Other information
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