The FACT-JACIE Standard
The FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration are an international reference 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 supports patient safety and treatment quality in transplant centres, and can also support 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 structured in phases and adapted to each centre. 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, to support your team's autonomy 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
We have worked in healthcare settings in Europe, Africa and the Middle East, adapting our approach to the regulatory and organisational context of each institution.
How We Work
Elements that characterise our work on transplant programmes:
- Specialisation: we work on accreditation and compliance for transplant programmes and cell therapies.
- Tailored approach: every project starts with an assessment and is calibrated to the size and complexity of the centre.
- Continuity: from the project to maintenance, with an optional support service.
Who it is for
- Hospital management and heads of haematopoietic stem cell (HPC) transplant programmes
- Quality managers, programme coordinators, heads of processing laboratories and collection units
- Centres starting a programme or preparing for their first FACT-JACIE inspection or for renewal
Common critical points
- A documentation system that is incomplete or not aligned with real clinical practice
- Staff roles, responsibilities and competences that are not formalised
- Internal audits and indicators that do not feed the management review
- Coordination between the clinical programme, collection and the processing laboratory
- Preparing the team for the inspection and handling findings
What ICMED does
- Gap analysis against the applicable FACT-JACIE standards
- Design of the quality system and its documents: procedures, forms, indicators
- Staff training on accreditation requirements
- Internal audits and mock inspection
- Support in handling findings and corrective actions
- Support for maintenance: management review and indicator monitoring
CNT/CNS scope: national requirements
Transplant programmes may also be subject to requirements and checks set by national authorities (in the transplant and blood fields, including the Italian National Transplant Centre and National Blood Centre), which are distinct from voluntary FACT-JACIE accreditation. ICMED addresses the two scopes separately and points out where requirements overlap.
- Mapping of the national requirements applicable to the programme, to be confirmed case by case, against the existing quality system
- Document management and traceability consistent with the applicable national obligations
- Preparation for checks by the competent authorities, where provided for
- Coordination with the FACT-JACIE path to avoid duplicate documents
Collaboration path
- Assessment — analysis of existing processes and documents against the requirements
- Work plan — priorities, responsibilities, timing and resources agreed with management
- Implementation — document development, staff training, putting processes into routine use
- Audit and verification — internal audits, mock inspection and corrective actions
- Maintenance — management review, indicators and periodic audits, if requested
Indicative deliverables
- Assessment report listing gaps and priorities
- Work plan with responsibilities and timing
- Document set (procedures, forms, indicators) adapted to the centre
- Internal audit and mock inspection report, with a corrective action plan
- Evidence of the training delivered
Actual content depends on the centre and the agreed scope.
Related services and resources
Each ICMED service can be chosen on its own: consulting does not require adopting IAAPP or enrolling in training courses.
Specialist consulting
CAR-T, IEC and cell and gene therapies
Additional requirements for Immune Effector Cells.
Specialist consulting
Cord blood banks (FACT-NetCord)
Accreditation of cord blood banks.
Specialist consulting
Continuous support
Follow-up service after the project.
ICMED method
ICMED methodology
The seven steps of our working method.
IAAPP
ICMED's software platform for documents, audits and non-conformities. Not required for consulting.
ECM training
ECM training
Courses for staff, if useful to the project.
Research
Scientific evidence
Publications and scientific contributions.
Specialist consulting
The ICMED method in practice
Three composite, anonymised scenarios that illustrate the method.
Path and deliverables are indicative: they are defined after the assessment, based on your facility. The outcome of accreditations, authorisations, certifications or inspections depends on the decisions of the competent bodies and cannot be promised by ICMED. The rules and standards mentioned are not an exhaustive list of the applicable requirements.
Preliminary assessment for your transplant programme
Tell us where you are starting from: we will outline how we could work together.
Request an assessment
