Start doing a self-assessment. The Inspection Checklist is fundamental to the Accreditation process. Download it and perform a self-audit against the standards to determine which areas of your centre require attention.
The definitive list will be submitted later, along with your pre-audit documents. This will be requested by the JACIE office a month after the approval of your application.
If you are a first time applicant the checklist will be requested when you submit the application form. You can also download the Inspection Guide for an overview of the entire process.
Determine the National Representative for your country. Your National Representative will be able to assist you with any specific national issues. Determine if there are any JACIE Inspectors in your country, as they may be willing to assist you with a mock inspection. If you do approach an inspector and they conduct a mock inspection, you must inform the JACIE Office. This inspector will not be considered for participation in the actual inspection.
Step 1: Submit the Application
Complete your application form and submit it to email@example.com. You may need to respond to requests for information or clarification.
Once your application is approved, you must approve and sign the Quotation & Accreditation Agreement and pay your invoice within 30 days of its receipt.
When both parties have signed the agreement you will also have 30 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.
Step 2: Prepare Pre-inspection Documents
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.
The documents are submitted in a pre-formatted .ZIP file that contains folders for the various types of documents to firstname.lastname@example.org. The file and instructions can be downloaded below.
Application Document FAQs
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 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 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 a cloud-based service for document storage and distribution: Dropbox. The system is secured using industry-standard encryption combined with other measures to protect data. See below for full security specifications.
While our strong preference is to use Dropbox 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.
Step 3: The On-site Inspection
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 Accreditation 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.
Step 4: Clarifications, Corrections & the Inspection Report
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. Items noted as Partially Compliant on the Inspection Checklist will not in most cases require the Applicant to submit documentary evidence of corrections, although the Applicant must indicate what steps will be taken to achieve full compliance.
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 Accreditation 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 in the Inspectors' report. The Accreditation Committee can decide to request evidence of corrections at its discretion.
Step 5: Receive Accreditation
When all corrections and items have been deemed compliant by the inspectors and approved by JACIE Accreditation Committee, Accreditation will be awarded for a period of 4 years. Applicants will receive a letter of confirmation and a Certificate of Accreditation. Every accredited centre has a number of responsibilities that they must attend to during the 4-year accreditation period.
Step 6: Maintain Accreditation
Accredited centres are no longer required to submit an annual report to JACIE.
Changes in accredited centres
Where an accredited 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 an accredited 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 Accredited programme is reported, the JACIE Accreditation Office shall consider and decide upon the appropriate action.
The JACIE Accredited centres must notify the JACIE Accreditation Office of any changes to facilities and/or key personnel as soon as they are implemented by completing the Changes Affecting Accreditation Report (please download below).
The interim audit takes place at the end of the second year of accreditation. 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 based on the same edition of the Standards used for the preceding accreditation of the centre.
A detailed description of the Interim Audit is available below, as well as the Checklist, a .zip file containing the Interim Audit documents, and a template for the Interim Audit Report so that you can understand what aspects of your centre the inspectors will focus on.
Step 7: Renew your Application
The process to apply for reaccreditation 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 reaccreditation and to understand the structure of your centre or programme and relationships with other institutions.
We encourage you to submit reaccreditation applications well in advance of the expiry date of your current accreditation. This will help avoid any gap between accreditations. However, JACIE does not penalise centres for allowing their accreditation to lapse, because JACIE remains a voluntary programme. Where there are external requirements to be JACIE-accredited, the centre should assess for themselves the impact of any lapse between accreditations.