Regulations & Guidelines

Engagement with JACIE a requirement for allogeneic transplant centres according to Arrêté du 3 avril 2009 relatif au contenu du document d’évaluation des activités de greffes d’organes et de greffes de cellules hématopoïétiques.

JACIE accreditation will be a legal requirement for transplantation centers (doing autologous and/or allogeneic transplantations) in Belgium for reimbursement by the social security according to C-2012/22474 Arrêté royal modifiant l'article 20, § 1er, a), de l'annexe à l'arrêté royal du 14 septembre 1984 published 21-12-2012.

Ordinance Pravilnik o uvjetima u pogledu prostora, stručnih radnika, medicinsko-tehničke opreme i sustava kvalitete za obavljanje djelatnosti prikupljanja, uzimanja, testiranja, obrade, očuvanja, pohrane i raspodjele ljudskih tkiva i stanicahaematopoietic. Art 35 (2) "progenitor cells bank must be accredited according to the JACIE standards" published 17-06-2013

Accreditation required to receive reimbursement from Social Insurance for treatments. Ordonnance du DFI sur les prestations dans l’assurance obligatoire des soins en cas de maladie (Ordonnance sur les prestations de l’assurance des soins, OPAS) 

Decreto Legislativo 25 gennaio 2010, n.16 implementing the European Directives on Tissues and Cells cites a 2003 agreement recognising JACIE

Accreditation required to receive authorisation to transplant from Ministry of Health

JACIE is a requirement according to NHS Commissioning Board: Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation (HSCT) (All Ages) (April 2013) Reference: NHSCB/B04/P/a

Reference to FACT-JACIE standards by The National Pathology Accreditation Advisory Council (NPAAC) in Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human, Haemopoietic Progenitor Cells, Fourth edition 2013

AVIS DU CONSEIL SUPERIEUR DE LA SANTE N° 9286 - Standards de qualité pour les divers types de matériel corporel humain destiné à une application chez l’homme : Cellules

ADVIES VAN DE HOGE GEZONDHEIDSRAAD nr 9286Kwaliteitsnormen voor verschillende types van menselijk lichaamsmateriaal dievoor toepassing op de mens bestemd zijn:Cellen. October 2016

German Standards for Unrelated Blood Stem Cell Donations

Draft Minimum Standards > Stem Cell Laboratory: Clinical Establishment Act Standards for Stem Cell Laboratory (Peripheral Blood Stem Cells And Umbilical Cord Cells) cites FACT-JACIE standards

Piano Oncologico Nazionale 2010-2012 cites JACIE accreditation

National Standards for stem cell transplantation: collection, processing, storage and infusion of haematopoietic stem cell and therapeutic cells (July 2009) Ministry Of Health Malaysia cite JACIE.

The Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-Based or Cellular Therapies in the Philippines cite the FACT-JACIE Standards.

South Africa Stem Cell Transplantation Society: Accreditation of Transplantation Centres in South Africa Discussion Document (2010)

JACIE cited in National Institute for Health and Clinical Excellence (NICE) guidelines 

• Manual for Cancer Services Haemato-oncology Cancer Measures Version 1.0 (2013)
• Improving Outcomes in Children and Young People with Cancer (2005)
• Haematological cancers: improving outcomes (2016)

The Future of Unrelated Donor Stem Cell Transplantation in the UK. A Report from the UK Stem Cell Strategic Forum (July 2010). NHSBT

JACIE cited in Specialised Services National Definitions Set (3rd edition) SSNDS Definition No.2, Specialised Services for Blood and Marrow Transplantation (all ages)

Welsh Health Specialised Services (WHSSC) Blood and  Marrow Transplantation Commissioning Policy

Guide to the quality & safety of tissues and cells for human application, 1st edition (2013)

Guide to the Safety and quality assurance for the transplantation of organs, tissues and cells, 4th edition (2010)

Common European Standards and Criteria for the Inspection of Blood Establishments. Audit / Inspection – Training Guide. Ed. 1.0.

First Global Consultation on Regulatory Requirements for Human Cells and Tissues for Transplantation 2004 

Aide-Mémoire on Key Safety Requirements for Essential Minimally Processed Human Cells and Tissues for Transplantation