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Pre-inspection documents

Centres applying for accreditation 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.

The requested documentation includes:
  • Selection of key SOPs
  • Evidence of staff training and qualifications
  • Official facility licences and authorisations
  • Quality Management Manual or Handbook
  • Basic evidence that the QM system is functioning
  • Basic data on recent transplant activity
  • Consent forms and related information
  • Sample labels
  • Plans or maps of the centre
  • Sample agreements with third-party service providers

The documents are submitted in a pre-formatted .ZIP file that contains folders for the various types of documents. The file and instructions can be downloaded from the Document Centre under the "Pre-Inspection Documentation" section.

When do I have to send these documents?

 Applicant centres will be required to submit the Pre-audit documentation within 30 days from receipt of the service agreement signed by the centre’s representative. Where an applicant delays more than 30 days in submitting the pre-audit documentation, the accreditation process of the centre will be considered expired and the centre must restart the process

What about 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. 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 Accreditation 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 two cloud-based services for document storage and distribution: Redbooth (formerly Teambox) and Dropbox. Both systems are secured using industry-standard encryption combined with other measures to protect data. See below for their full security specifications.

While our strong preference is to use Redbooth to distribute files, there may be technical or other reasons that do not permit us to do so. In these cases, documents may also be distributed via email as attachments or on CD or USB memory sticks via regular postal or messenger services.

Important notice: The centre should consider if there are any documents that require special handling such as the MED-A forms or other files. 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.


Security specifications
www.redbooth.com/
The Redbooth (formerly Teambox) security specification can be read here.

Dropbox The Dropbox security specification can be read here.