See also Events for training courses and other events of interest.
Quoted from EU Document released 1 October 2015:
1. Legal requirements
The Commission Directive (EU)2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells was published on 9 April 2015 (http://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L0565&from=EN).
The Directive introduces the obligation for tissue establishments to affix a "Single European Code” or “SEC” on tissues and cells distributed for clinical application in the EU. The Directive also sets out the requirements for its application (including exceptions) and general obligations of the tissue establishments, competent authorities and the European Commission.
The following situations are excluded from the application of the SEC:
(a) reproductive cells from partner donation;
(b) tissues and cells distributed directly for immediate transplantation to the recipient, as referred to in Article 6(5) of Directive 2004/23/EC;
(c) tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in Article 9(3)b of Directive 2004/23/EC.
The slides from the JACIE-related sessions at the EBMT 2015 Annual Meeting can be accessed here.
With the publication of the 6th edition of the FACT-JACIE Standards on 1 March 2015, JACIE Inspectors are now asked to complete the Inspector Exam. As with previous editions, the exam is designed to test inspectors' knowledge of the new standards and to offer explanations for why certain answers are incorrect or correct. By these means, the exam is considered to be an educational tool that helps to maintain and develop inspectors' skills and knowledge.
Who has to complete this exam?
All inspectors have to complete the exam. Failure to do so could result in being removed from the JACIE register of inspectors.
For non-inspectors - there is an open exam available to everyone to test their knowledge. Go here for more details.
The exam is divided into 2 parts. Part 1 must be completed by all inspectors and is an exam based on the JACIE Inspection Process and Common Standards. There are30 multiple choice questions in Part 1.
Part 2 consists of up to three exam(s) depending on the experience of each inspector. There are 20 questions in each exam. Please complete the exam for the area in which you quality to inspect. For instance, if you qualify to inspect only in the clinical setting, you should only complete the clinical exam. If you qualify to inspect processing and collection, then you should complete these two exams.
All inspectors will complete at minimum 2 exams and a maximum of 4.
With the online exam, you will be able to save your answers and return to the exam later if you wish. You will be asked to enter your email address and to create a password so that you can exit the exam and start again at a later date.
The next step is to enter your name and email so that we can easily identify who has completed the exam and also to complete the certificate that will be generated on passing the tests.
You should keep your password simple and easy to remember for future use.
The exams are separate and for this reason you are asked for your details for each exam.
A pass mark of 75% is required for each exam you complete. Note that marks are deducted for incorrect answers.
We calculate that you will need between 40-90 minutes in total. You will need to have the relevant documents at hand as the exams are open book, that is, you are expected to use the Standards, Manual, Comparison table of editions and the Inspection Guide. These documents are available on the exam page.
The deadline is 30 May 2015.
In order to start, go to www.jacie.org/inspectors/exam1. After you complete Part 1, you will be brought to another web page where there are 3 links to the remaining exams.
JACIE training in Barcelona in October 2015.
This course is designed to train JACIE inspectors. Anyone working in the transplant setting who is interested in JACIE but is not interested or is not qualified to become an inspector can also attend (a fee of €100 will be charged to non-inspector candidates to cover costs). Note that in the event of high demand, priority will be given to inspector candidates.
Documents should be in the language of the centre since JACIE would expect to assign inspectors that speak and understand the language. However, there may be exceptions to this:
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