JACIE Inspection Checklist 6th edition Highlights
Warning on versions of Excel and operating systems • The checklist has been created in MS Excel 2013. There are known incompatibilities with older versions of Excel up to the 2007 edition. • Experience with the 5th edition checklist has also shown that the Excel file can behave differently on Apple devices although use with a Mac version of MS Excel should make the file compatible. • Please email
[email protected] if you have any problems with this file.
INSTRUCTIONS
The checklist is divided into 10 sections to be completed: • 4 parts of the FACT-JACIE Standards • Donors • MED-A data • Labels (3) worksheets • Snapshot
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Snapshot Provides an overview of the main activities. The cells in blue should be completed by the Applicant. Cells that are not applicable will appear as shaded e.g. if Adults only, the Paediatrics cells will appear as shaded
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Dashboard Displays the aggragated information from the different checklists and shows percentages completed as: • Compliant • Partially compliant • Non-compliant • Not applicable • Uncompleted
The information helps show how well a centre is progressing during preparations and then compares the inspectors’ findings with the applicant’s assessment. Here
Checklists As in the previous edition of the checklist, the applicant completes the checklist chosing from the 4 options. The cell will change color depending on which answer was selected.
The column ‘Source of evidence and explanatory text’ is precompleted as “No evidence”. This should be changed by the applicant to indicate how a standard has been met or what the situation is e.g. reference to the SOP, person responsible etc. Here
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MED-A data The Applicant must complete this worksheetwith the patient identifiers. The entered identifiers then automatically appear in the worksheets below to be completed by the Inspector
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All Processing labels are combinedin a single Collection labels worksheet
Bone Marrow and Apheresis Labels are combined in a single Collection labels worksheet
Inspectors The checklistsall now include an option for the Inspector to complete all of his/her sections as “Compliant” in one click. By selecting or typing “Yes”, all of the cells below in the ‘Inspectors Assessment’ column will show as “Compliant”. Note that you can always change the answers in individual cells but once this is done, those cells will not change automatically again in response to the “Yes/No” question. In effect, they become disconnected from that action after being edited.
Note the warning message: “Please note that by selecting “Yes” you are confirming that all ítems on this checklist were found by you to be compliant with the Standards”
Links Relevant sections of the checklist use links within the Excel file to jump back and forth. For instance, there is a link to the labelling worksheets from the Collection and Processing checklists. All worksheets have a link to the Dashboard view. The Checklist also incorporates the Appendices from the Standards and these are linked to the other checklists where relevant for easy quick reference.
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