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Newsletter 11-2016

posted 17 Nov 2016, 01:07 by Eoin McGrath   [ updated 17 Nov 2016, 01:13 ]

See the JACIE section of the latest EBMT Newsletter.

Includes:
  • Inspector Training Courses- recent and upcoming
  • Updated Quality Management Inspectors Criteria
  • Transplant Procedures Update for Physicians and Nurses operating in JACIE accredited transplant centers
  • New JACIE inspectors
  • Third Party Agreements

Access previous editions here.

EBMT 2017 - Quality Management - invite to present cases - deadline extended!

posted 17 Oct 2016, 03:25 by Eoin McGrath   [ updated 1 Dec 2016, 03:35 ]

9th Meeting of the Quality Management Group - case study submission

The programme for the EBMT 2017 Annual Meeting is being prepared with a draft programme now online at www.ebmt2017.org/program. For the Meeting of the Quality Management Group, there will be a new format based on real-life cases presented by centres.
Case will be presented in two workshops under two topics:
  • Workshop 1 - Corrective and Preventive Actions - 4 cases of CAPAs in bone marrow transplant programme
  • Workshop 2 - Outcome analysis - 4 cases of outcome analysis - how you perform this, what tools do you use and what were the findings?
A third workshop later in the day will summarise the findings and lessons learned with facilties for audience participation.
 
The selected case studies will be added to the final program and each speaker will make a 10-minute presentation. The speakers will receive free registration for the congress as well as travel and accomodation for 2 nights.

Anyone interested should send an abstract of 250 words maximum to ebmt2017-qm@ebmt.org.
The JACIE Quality Managers Committee will make the selection.
 
Don’t hesitate to make the most of this opportunity to share your experience with an international audience.

Deadline for submission: EXTENDED TO Monday 12/12/2016

Single European Coding system for tissues & cells

posted 10 Oct 2016, 01:45 by Eoin McGrath   [ updated 10 Oct 2016, 01:46 ]

The long-awaited Single European Coding (SEC) system for tissues and cells is closer to being fully implemented. EU Member States are required to transpose the provisions of Directive (EU) 2015/565 into their national legislation by 29 October 2016 and then should apply the requirements on the SEC from 29 April 2017.

The ICCBBA, the organisation behind ISBT128, has prepared a guide "Simultaneous Implementation of the Single European Code and ISBT 128".

To support the SEC, the EU Commission has launched the EU Coding platform. The platform will allow public, free of charge access to the EU Tissue Establishments Compendium and the EU Tissue and Cell Product Compendium.

The link to the EU Coding Platform is available here: https://webgate.ec.europa.eu/eucoding/.




JACIE introduces a new version of the Checklist which reflects QM inspector inclusion in the inspection teams

posted 28 Jul 2016, 23:49 by Raquel Espada   [ updated 24 Aug 2016, 07:03 by Eoin McGrath ]

From September 1st, 2016, centres submitting applications for accreditation or re-accreditation will be required to submit version 9 of the checklist (CH-001-09-Inspection Checklist). The contents of the checklist have not been modified since the publication of the 6th edition of the Standards. In this new version, QM Standards have been separated into individual sections of the Checklist to better manage the inclusion of the QM inspector into the inspection teams.
 
This version replaces all previous versions and older versions of the checklist will not be accepted after August 31st, 2016. Given that the contents of the checklist remain without change and have only been reorganized, if needed it should not be difficult to transfer the information from an older version of the checklist into the current one. Centers that might have started working on an older version are kindly requested to transfer the information to the current version.

Please note that the checklist includes an Instructions section. A brief tutorial for the current version of the Checklist will be available in the Fall. In the meantime, if you have any questions regarding the checklist please do not please do not hesitate to contact the JACIE Office.
The checklist entitled 'CH-001-09-Inspection Checklist' can be accessed in the 'Document Centre' in the 'Checklist' section.
Also by clicking HERE.

ECDC guide on Zika virus and safety of substances of human origin

posted 15 Jul 2016, 07:29 by Eoin McGrath   [ updated 15 Jul 2016, 07:30 ]

The ECDC has published a guide on Zika virus preparedness. The objective of the document is to guide the preparation and implementation of national preparedness plans for the safety of substances of human origin during outbreaks of Zika virus infection, both in affected and non-affected areas.
ECDC Guide on Zika

The document includes key elements to be considered in the risk-based decision-making process of mitigating the threats to the safety of substances of human origin posed by Zika virus. It also identifies supporting tools and information sources available at the EU level, either from ECDC or the European Commission’s Directorate-General for Health and Food Safety.
Access the guide at /ecdc.europa.eu/en/publications

EU testing requirements for tissues and cells donors

posted 13 Jul 2016, 06:41 by Eoin McGrath   [ updated 13 Jul 2016, 06:41 ]

Mapping of More Stringent Tissues and Cells Donor Testing Requirements - Mapping Exercise 2015

Directive 2004/23/EC defines the mandatory tests that must be performed on tissues and cells donors each time they donate. The legal basis of this legislation allows Member States to adopt more stringent measures on a national basis. Implementation surveys have indicated that many Member States have done this, in some cases in response to local epidemiological risks and in some other cases because they consider that a higher level of safety can be ensured with these more stringent provisions. The more stringent measures are either adopted in national legislation and/or they are defined by national standards organisations to be taken into consideration by authorities in their regular inspections.
More

New mechanism to establish equivalence to doctoral degrees for processing facility directors

posted 7 Oct 2015, 03:03 by Eoin McGrath   [ updated 7 Oct 2015, 03:04 ]

The FACT-JACIE Standards, 6th edition, describe the academic requirements for the position of Processing Facility Director (PFD):

D3.1.1 There shall be a Processing Facility Director with a medical degree, doctoral degree, or equivalent degree in a relevant science, qualified by a minimum of two (2) years training and experience for the scope of activities carried out in the Processing Facility.

A doctoral degree including a medical degree is considered as the ‘gold standard’ of scientific and medical achievement. However, the term doctoral degree is not applied in a uniform fashion in all countries. The Guidance to Standard D3.1.1, 6th edition FACT-JACIE Standards reads:

Some regions of the world may have degrees that are equivalent to the doctoral degree. If a Processing Facility Director has such a degree, significant and compelling information regarding the degree requirements must be submitted to demonstrate equivalency (p.325).

JACIE has developed a points system to be applied in those cases where the PFD does not hold a doctoral degree but has other qualifications combined with experience. This system is described in this document (also available below this text or on request to jacie@ebmt.org).

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