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FACT-JACIE International Inspection and Accreditation Workshop, Buenos Aires

posted 29 May 2017, 01:21 by Eoin McGrath   [ updated 29 May 2017, 01:22 ]

The first FACT-JACIE Accreditation Workshop held in Latin America took place at the NH City Hotel Buenos Aires, Argentina, on May 17, 2017. The event was the result of close collaboration between JACIE, FACT, and the Latin American Group for Blood and Marrow Transplantation (LABMT), and took place one day before the first Argentine Transplantation Congress and second LABMT congresses (www.gatmo.com.ar).
 
In terms of impact, our expectations were exceeded with 50 participants from six countries attending the event, filling the room to capacity.

The rich program was delivered mostly in Spanish and featured presentations on the accreditation process, the FACT-JACIE Standards, quality management basics including document management, and aspects of being an inspector. The attendees also heard first-hand the experience of 2 centers, one Mexican and one Brazilian, who have successfully achieved FACT accreditation in recent years. The program also included a regulator’s point-of-view with the presentation on behalf of INCUCAI, the Argentinian competent authority for transplantation.
 
The day concluded with clear signs of motivation and interest from the group in implementing quality in their day-to-day work and ultimately seeking international certification. It was also an excellent opportunity for the FACT and JACIE representatives to understand how transplantation is organized in the different countries, what their challenges are, and where we can help further in the future.
 
We are hopeful that a similar event can be held in the region in the future to capitalize on the momentum and the interest demonstrated by the group. In the meantime, we plan to continue with the well-received webinar series with the next one, about the SOP for SOPs, scheduled for June 22, 2017.  Meeting details and register online here
 
Sincere thanks to all of the participants, the invited speakers, the local organizers, and the LABMT for their support.
For further information, contact Carlos Bachier (carlos.bachier@hcahealthcare.com), Raquel Espada (raquel.espada@ebmt.org) or Sebastián Galeano (sgaleano.uy@gmail.com).
Workshop Participants by Country
Workshop Participants by Country

Draft 7th Edition FACT-JACIE Standards Available for Public Comment

posted 2 May 2017, 01:26 by Eoin McGrath   [ updated 2 May 2017, 01:27 ]

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) have published the draft 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment for a 90-day period.

Comments will be accepted from May 1, 2017 through July 30, 2017.

These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood, and administered by a FACT-accredited blood and marrow transplant team.
  1. Description and Instructions for FACT-JACIE Standards
  2. Draft FACT-JACIE Standards
  3. Draft FACT-JACIE Manual
To submit comments regarding the draft 7th edition FACT-JACIE Standards, follow the steps below. Comments will be accepted through July 30, 2017.

1.     Access the Comment Form at https://www.surveymonkey.com/r/FACT-JACIE.

2.     Type in your contact information and comments on the form. Fill in all fields so that the Standards Committee fully understands your position.

3.     Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

Jornada informativa sobre la Certificación JACIE y Fundación CAT, 20 abril

posted 12 Apr 2017, 02:45 by Eoin McGrath   [ updated 12 Apr 2017, 02:46 ]

JACIE y Fundación CAT organizan una jornada informativa sobre el nuevo proceso de certificación conjunta CAT-JACIE de programas de trasplante hematopoyético, que tendrá lugar en la sede de la SEHH (Calle Fortuny, 51, local 5, Madrid), el jueves 20 de abril de 2017, de 10:00 a 17:00 horas.

Más información

Quality @ EBMT2017 video

posted 31 Mar 2017, 05:46 by Eoin McGrath

Quality @ EBMT2017


BMT Special Report on JACIE published

posted 27 Mar 2017, 14:50 by Eoin McGrath   [ updated 31 Mar 2017, 02:16 ]

Advanced online publication in BMT today. "JACIE accreditation for blood and marrow transplantation: past, present and future directions of an international model for healthcare quality improvement". OPEN ACCESS.

New Accreditations Coordinator

posted 23 Mar 2017, 02:16 by Eoin McGrath   [ updated 23 Mar 2017, 02:17 ]

Eva Controle
Please welcome Eva Controle to the EBMT. Eva joined the Barcelona EBMT Executive Office as a JACIE Accreditations Coordinator in February 2017.
Eva is from France and received her Bachelor degree in Biotechnology in Paris. Her professional experience has been in Clinical Research. She worked in this field in Paris, London and most recently, Barcelona.
She speaks French, English and Spanish.

eva.controle@ebmt.org
+34 934538570

New interim standards to cover administration of immune effector cell products in bone marrow transplantation programmes

posted 2 Feb 2017, 01:41 by Eoin McGrath

FACT and JACIE have published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration.

The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others.
The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.

The new standards were initially developed by the FACT Immune Effector Cell Task Force and then JACIE experts were invited to contribute to the final version that is now incorporated into the FACT-JACIE Standards, edition 6.01.

The new editions of the Standards and Manual are attached here. They can also be downloaded from the JACIE website at www.jacie.org/document-centre in the Standards section.

If you are not utilizing any immune effector cell products, these standards do not apply to the transplant program, and you can complete the checklist as “NA” (not applicable) for the new standards.
If your haematopoietic cellular therapy (HCT) transplant program begins using immune effector cells, you must be in compliance with these standards as part of starting the new activity. These aspects will be assessed at the next on-site inspection.
Current accreditation awards do not include the administration of these products.

For any questions, please contact eoin.mcgrath@ebmt.org or telephone +34 93 453 8570 ext. 8101.

Application fees 2017

posted 27 Jan 2017, 05:51 by Eoin McGrath   [ updated 27 Jan 2017, 06:08 ]

Changes to the JACIE fees structure were approved by the EBMT Executive Committee on 09 January 2017 and presented to the EBMT Board on 14 January 2017. Effective from Monday 17 April 2017.
For applications received before 17 April 2017, please click here to see applicable fees.

This is the third JACIE fee increase since 1 January 2009. Since then inspections have increased from 23 in 2009 to 64 in 2016 with the associated increase in inspectors’ travel and other costs including the per diem payment introduced in 2014.

Apart from covering established costs, the increased fee income will be invested as follows:

  • The discount for active Inspectors has increased from 10% to 15%.
  • Increased training and education
  • Process improvement mainly focussed on electronic replacement for inspection checklist
  • Increased support from central office - additional Accreditation Coordinator
  • Increased per diem payment to inspectors (additional 1 day of per diem for travel)
  • Support development of outcome benchmarking mechanism to facilitate requirements under Standard B4.7.5. including statistical support
  • Support standards development
  • Development of 'First-Step' certification scheme for centres in Low- to Middle-Income Economies (LMIEs)
The difference in fees for EBMT and non-EBMT members is not new but has been displayed in a more concise format to better reflect the difference in rates.

For more information please go here.



Quality Management @ EBMT17

posted 10 Jan 2017, 09:02 by Eoin McGrath   [ updated 10 Jan 2017, 09:03 ]

The full programme for the Quality Management Day has been published on the meeting website at www.ebmt2017.org/quality-management.
We hope to see you by the Mediterranean in Marseilles in March!

logo

Training events 2017

posted 10 Jan 2017, 08:46 by Eoin McGrath

JACIE plans to run several events in 2017. These events will primarily be aimed at training new inspectors. If places remain, these will be open to other participants.
  • On 20-21 April, we expect to run an event in collaboration with Fundación CAT and ONT in Madrid, Spain. This event will be in Spanish within the framework of the agreement recently signed by the three organisations.
  • On 1-2 June, a second event will be held in Barcelona, Spain. This will be in English.
  • A third event is planned for 5-6 October 2017, again in Barcelona. This will be in English.
Registration and other details will be published shortly. If you are interested in receiving more information, please write to inspectors@ebmt.org.

If you are interested in hosting an event on JACIE in your country, please contact eoin.mcgrath@ebmt.org.

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