The FACT-JACIE Standard
The FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration represent the gold standard for quality and safety in stem cell transplantation. Developed jointly by the Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE), these standards provide a comprehensive framework that covers all aspects of the transplant process.
The standards encompass clinical care, donor management, cell collection (bone marrow, peripheral blood, and cord blood), cell processing and storage, quality management systems, and facility requirements. Compliance ensures that transplant centres deliver the highest level of patient safety and treatment efficacy, while also enabling participation in international clinical trials and collaborative research networks.
The FACT-JACIE accreditation is increasingly recognized by national health authorities and insurance bodies as a prerequisite for performing hematopoietic stem cell transplantation, making it an essential credential for any serious transplant program.
Our Services
ICMED S.r.l. provides a comprehensive suite of consulting services tailored to the specific needs of each transplant centre:
- Transplant program start-up: complete guidance for new programs, from organizational design to regulatory compliance
- Quality management system development: design and implementation of a robust QMS aligned with FACT-JACIE requirements, including document control, SOPs, work instructions, and forms
- Gap analysis and readiness assessment: thorough evaluation of current practices against FACT-JACIE standards to identify areas requiring improvement
- Staff training programs: structured education and competency assessment for clinical, collection, and processing personnel on accreditation requirements
- Inspection preparation: mock inspections, document review, and coaching to ensure readiness for the official FACT-JACIE inspection
- Internal audit execution: systematic audits designed to verify ongoing compliance and identify opportunities for continuous improvement
- Quality system maintenance: ongoing support for Management Review, indicator monitoring, CAPA management, and periodic performance evaluation
- Re-accreditation support: preparation for the renewal cycle, including updated gap analysis and remediation of any new standard requirements
Methodology
Our methodology is built on decades of hands-on experience and has been refined through engagements with over 100 transplant centres worldwide. We follow a structured, phased approach:
Phase 1 — Assessment: We conduct a comprehensive gap analysis comparing the centre's current state against all applicable FACT-JACIE standard requirements. This produces a detailed action plan with prioritized recommendations and realistic timelines.
Phase 2 — Implementation: We work alongside your team to develop and implement all required documentation, processes, and training programs. This includes creating the quality manual, SOPs, competency frameworks, and data collection systems.
Phase 3 — Verification: Before the official inspection, we conduct thorough internal audits and mock inspections that simulate the actual FACT-JACIE inspection process. We identify and resolve any remaining gaps.
Phase 4 — Continuous Improvement: After accreditation, we provide ongoing support to maintain compliance, implement corrective actions from inspection findings, and prepare for re-accreditation cycles.
Throughout the entire process, we transfer knowledge to your team, ensuring long-term self-sufficiency in quality management.
Who We Work With
ICMED has successfully supported a diverse range of institutions across three continents:
- University hospitals and academic medical centres establishing or expanding their transplant programs
- Public and private healthcare facilities seeking initial FACT-JACIE accreditation
- Established transplant centres preparing for re-accreditation or upgrading their quality systems
- National health ministries and regulatory bodies developing transplant program frameworks
- Cell processing and storage facilities requiring compliance with international standards
Our client portfolio spans Europe, Africa, and the Middle East, giving us unique insight into the challenges of implementing international standards across different healthcare systems, regulatory environments, and cultural contexts. This cross-cultural experience allows us to adapt our approach to the specific realities of each institution while maintaining rigorous adherence to FACT-JACIE requirements.
Why Choose ICMED
ICMED stands apart in the field of FACT-JACIE consulting for several compelling reasons:
- Consulting expertise: Vincenzo Iaconianni, ICMED.s founder and CEO, is a FACT-JACIE consultant with direct, firsthand knowledge of what inspectors look for and how to prepare effectively.
- Proven track record: With over 100 centres supported and more than 20 years of continuous activity in the field, our success rate speaks for itself.
- International reach: Our experience spans multiple countries, healthcare systems, and regulatory frameworks across Europe, Africa, and the Middle East.
- End-to-end service: From initial gap analysis through accreditation and beyond, we provide comprehensive support at every stage of the accreditation journey.
- Knowledge transfer: We do not create dependency. Our goal is to build your team's capability to independently manage and maintain the quality system.
- Scientific network: As part of the ICMED ecosystem, clients gain access to our scientific publications, training events, and international research collaborations in the field of cellular therapy.
When you partner with ICMED, you are working with a team that has lived and breathed FACT-JACIE accreditation for over two decades — not as distant advisors, but as active participants in the global transplant quality community.
Scientific Insights & Magazine
ICMED Magazine (ISSN 3103-1943) — the scientific journal dedicated to quality and innovation in healthcare
