134-603 / Inspection protocols for verification of compliance with the quality requirements to the Centers for procurement, processing, storage, distribution and implantation of human tissues and cells.

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
Healh Services Inspection
Andalusian Regional Ministry of Health and Social Welfare


Peer review
GOP Description
Implementation level
Clinical settings
Centers and Units for procurement, processing, storage, distribution and implantation of human tissues and cells in hospitals of Andalusia
Assess compliance with the requirements and the implementation of quality control measures required by RD 1301/2006, of 10 November on the premises or tissue banks, as well as obtaining Units and implant of cells and tissues of Andalusia.
This nationally RD transposes the following directives, including: 2004/23/EC, 2006/86/EC, 2006/17/EC, 2001/20/EC.
Users and practitioners of these types of centers.
RD 1301/2006, of 10 November, establishes standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Defines the tissue establishment (ET) as one where activities of processing, storage or distribution of tissue after collection and to use in humans. Center performs the collection and extraction of tissues or cells. And Implant Center, which has been operating as the application of human tissue in humans. Inspections of these centers can be extraordinary or scheduled, initial and periodic breaks, etc.. The RD provides a general inspection and initial full each ET and then every four years, every two years and subject to verification of reinspections rectify anomalies. 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:
– “protocol inspection of tissue establishments”,
– “inspection protocol for tissue procurement units” and “units calibration certificate tissue implant “.
They are designed to assess the activity of the same, in both public and private
Implementation cost
The implementation cost is restricted to the initial training courses of inspectors. In this case with a recommended duration of a week, the cost will depend on teachers fees and the number of professionals to be trained. These training activities are performed in public facilities that imply no extra expenses
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.
Is considered adequate if it meets these conditions:
– 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 was considered that the adaptation was conditional on the correction, or immediately after the implementation of a remedial plan to short notice, specifying if necessary, reinspection.
Were inspected in 2011, 7 tissue establishments and 32 units of production (16) and implant (16) eye tissue existing in 17 public hospitals and one private school. In 2012, 68 units were inspected for obtaining (28) and implant (40) of bone-tendon, located in 30 public hospitals and 9 private hospitals
Analysis of the results
The centers evaluated in 2011 (ET and procurement centers and ocular tissue implant) have obtained favorable inspection reports, considering that these have adaptation, despite having detected unfulfilled requirement, given that comply with a percentage higher than 80% applicable requirements and have not been detected critical deficiencies, and significant deficiencies detected in some center have been rectified immediately. Those evaluated in 2012, have obtained favorable inspection reports, except one center obtaining t. bone implantation and t 5. bone, for deficiencies related to the operating license and traceability.
Implementation barriers
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