See also Events for training courses and other events of interest.

Single European Code (SEC) for Tissues and Cells - EU Update

posted 1 Oct 2015, 10:33 by Eoin McGrath   [ updated 1 Oct 2015, 10:33 ]

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 (

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.

July 2015 Newsletter

posted 23 Jul 2015, 05:02 by Eoin McGrath   [ updated 23 Jul 2015, 05:03 ]

You can access the latest newsletter here

Slides from Istanbul 2015

posted 17 Jun 2015, 00:40 by Eoin McGrath   [ updated 17 Jun 2015, 00:40 ]

The slides from the JACIE-related sessions at the EBMT 2015 Annual Meeting can be accessed here.

Inspectors - exam on 6th edition now open

posted 24 Apr 2015, 02:57 by Eoin McGrath   [ updated 24 Apr 2015, 02:58 ]

With the publication of the 6th edition of the FACT-JACIE Standards on 1 March 2015, JACIE 
examInspectors 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.

Pass mark
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 After you complete Part 1, you will be brought to another web page where there are 3 links to the remaining exams.

Good luck!
JACIE Office

Inspection Checklist, 6th ed. now available

posted 8 Apr 2015, 09:18 by Eoin McGrath   [ updated 20 Apr 2015, 04:40 ]

The Inspection Checklist is now available from the Document Centre or from the 6th edition pages. You can also download it from the recent email announcement.

JACIE Training Course, 1-2 October 2015

posted 16 Dec 2013, 03:40 by Eoin McGrath   [ updated 31 Jul 2015, 07:58 ]

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.


Zenit Borrell

Translation of centre's documents

posted 3 May 2013, 08:02 by Eoin McGrath   [ updated 14 May 2013, 09:15 ]

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:
  • Centre is located in a country where no inspectors are available
  • JACIE may not have inspectors anywhere that speak the centre’s language
  • The transplant community in a given country has requested that only external inspectors be assigned to avoid conflicts of interest


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