JACIE Certification Process

Complete your application form and submit it to jacie@ebmt.org. You may need to respond to requests for information or clarification. You can find the Application Form template in the Document Centre.

Once your application is approved, you must approve and sign the Quotation & Certification Agreement.

When both parties have signed the agreement you will also have 90 days to submit the pre-audit documentation.

Remember that if you are a first-time applicant you will have already provided the checklist when submitting the application.

Centres are required to submit documentation in advance of the inspection. This documentation is requested so that the inspectors can understand the centre's activity and organisation and also to check compliance with some of the standards before the on-site visit. 

You may find useful documents in the Document Centre.

Application Document FAQs

When do I have to send these documents?

Applicant centres will be required to submit the Pre-audit documentation within 90 days from receipt of the service agreement signed by the centre’s representative. Where an applicant delays more than 90 days in submitting the pre-audit documentation, the certification process of the centre will be considered expired and the centre must restart the process.

What if I send a document and then it is updated in our system?

Any revised documents should be sent to the JACIE Office before the inspection, clearly indicating what changes have been made and what document should be replaced.

What does JACIE do with these documents?

Firstly, staff at the JACIE Office check the folders' contents. Staff do not assess the quality of the documentation, only that a file or document is present. The inspectors assess the contents of the documents. If documents appear to be missing, the JACIE Office will contact the centre to ask for the documents. 

After this check, the documents are distributed to the Inspection Team members for their preparations. An inspector may request additional documents in advance of the inspection. 

The files are also stored electronically by the JACIE Office in the folders created for each centre after application. On occasion, these files may also be consulted by the Inspection Report Assessors when they review the Inspection Reports and by members of the Certification Committee. In the rare event of an appeal to the JACIE Committee, the Committee members may also be given access to these files if necessary.

In all cases, anyone given access to the files is reminded of their obligation to keep confidential any information contained therein. 

These files are maintained indefinitely. 

How does JACIE store and distribute these documents?

JACIE uses a cloud-based service for document storage and distribution: SharePoint. The system is secured using industry-standard encryption combined with other measures to protect data. 

Important notice: The centre should consider if there are any documents that require special handling. It is recommended that an internal discussion among the centre team be held before documents are submitted. Unless JACIE is told otherwise, we will assume that all documents can be stored and distributed using the above services. It is the responsibility of the centre to notify the JACIE Office if exceptions to this policy are required. In those cases, alternatives will be considered and discussed with the centre.

Before your inspection date arrives, be sure to complete all your preparations:

• Have a room booked for the inspectors to work from, and make catering arrangements (coffee breaks, lunches)
• Notify all key staff of inspection dates
• Gather relevant documentation (including paper copies of your pre-inspection documentation) and records in one location
• Prepare your patient notes for the onsite inspection. Identify the data points in advance for easy reference during the inspection. 

The Inspection Checklist you submitted is used by the Inspection Team to assess your centre's level of compliance with the standards. The Inspector will verify your answers using the documents submitted before the inspection and during the on-site visit, then indicate his/her assessment of the centre's level of compliance.

Usually the inspection lasts for 1.5 days, however this depends on the size of the center. It can be 1 or 2 days. It is a thorough examination of all aspects of the programme in accordance with the Certification Checklist, as well as a verification of the applicant's self-check. It will follow the Inspection Plan you were sent by JACIE to the greatest extent possible.

ALL members of staff can be interviewed by the inspectors.

Once the inspection is complete, you will need to fill out the Inspection Evaluation Survey and begin to respond to any deficiencies identified by the Inspection Team.
 
Where corrections are necessary, the applicant enters the appropriate information about changes and corrections into the same checklist, which again is assessed by the Inspectors. Meanwhile, the Inspectors will prepare the Summary Report of their findings during the inspection and submit it to the Certification Committee. 

Applicants will have to respond to any requests for clarification from JACIE, as well as submit corrections to the items noted to be Non-compliant/Partially Compliant in the Inspectors' report. The Certification Committee can decide to request evidence of corrections at its discretion. 

When all corrections and items have been deemed compliant by the inspectors and approved by JACIE Certification Committee, Certification will be awarded for a period of 4 years. Applicants will receive a letter of confirmation and a Certificate. Every certified centre has a number of responsibilities that they must attend to during the 4-year certification period.

Annual Report

Certified centres are no longer required to submit an annual report to JACIE. 

Changes in certified centres 

Where an certified centre makes substantial changes to key personnel, existing facilities and/or moves to new facilities/buildings, those shall be proactively communicated to the JACIE Office.

Large-scale improvements to an existing facility or a move to a new building or facility represent substantive changes to a certified programme. It is reasonable to expect that new or refurbished facilities represent improvements in service. However, JACIE must be satisfied that the centre continues to be compliant with the standards following the change.

When a change in a JACIE Certified programme is reported, the JACIE Certification Office shall consider and decide upon the appropriate action.

The JACIE Certified centres must notify the JACIE Certification Office of any changes to facilities and/or key personnel as soon as they are implemented by completing the Changes Affecting Certification Report (you will find it in the Document Centre).

Interim Audit

The interim audit takes place at the end of the second year of certification. The interim audit focuses primarily on the quality management system in the Clinical Units. Collection and Processing facilities must submit evidence that they are currently licenced/authorised by the appropriate regulatory authority(s). 

The interim audit will be carried out against the current edition of the FACT-JACIE Standards.

Note: see Frequently Asked Questions (FAQ) in the JACIE section of the EBMT's COVID19 response.

The process to apply for recertification is identical in practically all aspects to first-time applications. Your application form will give JACIE the necessary information to assess if your centre is eligible for recertification and to understand the structure of your centre or programme and relationships with other institutions.

We encourage you to submit recertification applications well in advance of the expiry date of your current certification. This will help avoid any gap between certifications. However, JACIE does not penalise centres for allowing their certification to lapse, because JACIE remains a voluntary programme. Where there are external requirements to be JACIE-Certified, the centre should assess for themselves the impact of any lapse between certifications.