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Inspection checklist

The Checklist is fundamental to the accreditation process. The Checklist is first completed by the applicant as part of the self-check or audit. The definitive list is then submitted to JACIE at the time of application. First-time applications must be accompanied by the completed Checklist. Reaccreditation applications can be accepted without the Checklist which can be submitted later along with the pre-inspection documents.
Th Checklist is then used by the Inspection Team to assess the level of compliance with the standards. The inspector completes his/her part of the checklist, enters remarks or comments supporting findings and these in turn are considered by the Accreditation Committee. 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. 

The checklist can be downloaded from the Document Centre > Checklist.

Instructions

The checklist is to be completed by centres applying for JACIE accreditation (initial or reaccreditation) and must be submitted along with the Application Form in the case of first-time applications. Reaccreditation applications can be accepted without the Checklist which can be submitted later along with the pre-inspection documents.

The checklist is divided into 8 sections:
  1. Clinical
  2. Cell Collection (Bone Marrow)
  3. Cell Collection (Apheresis)
  4. Processing
  5. Donors
  6. MED-A data
  7. Label
  8. Shipping labels
The checklist repeats the Standards and the applicant should indicate their level of compliance from the pull-down menu of answers. The available answers are:
  • Compliant (where all aspects of the standard are met)
  • Partially compliant (where some but not all aspects are met)
  • Uncompliant (where none of the aspects are met)
  • Not applicable (where the standard is not applicable to specific activity in the applicant facility or programme. NOTE: this should not be used to answer for something that is not compliant).
Alongside the 'Applicant's Self-Assessment' column, there is space for the applicant to add information supporting their answer. It is VERY important that the applicant provides as much relevant information as possible. Examples of this information include the reference of the applicable SOP, the name of the responsible person or the explanation for achieving only partial compliance or uncompliant.
Where 'Partially compliant' or 'Uncompliant' are used, the Applicant should explain why or what remains to be done to achieve comliance.

In addition, a set of Basic Questions has been added to the top of each checklist. Depending on the Applicant's answers to these questions, specific sections of the checklist wil appear as shaded out when these are non-applicable. In these cases, the questions do not have to be answered. Examples include whether the Clinical Program performs autologous transplants only, allogeneic only or both. If autologous only, questions related to allogeneic patients/donors will be excluded from the checklist (they will remain visible).

Standards that are related to these Basic Questions are indicated by a YELLOW cell.

The Inspector will verify the Applicant's answers using the documents submitted before the inspection and during the on-site visit. The Inspector will indicate his/her assessement of the level of compliance using the same pull-down menu options and entered remarks into the adjoining column where necessary. In addition, the answers will be colour-coded with 'Compliant' being GREEN; 'Partially Compliant' being ORANGE, 'Uncompliant' being RED; and 'Not applicable' showing as WHITE.

Items noted as Partially Compliant will not in most cases require the Applicant to submit documentary evidence of corrections after the inspection although the Applicant must indicate what steps will be taken to achieve full compliance. The Accreditation Committee can decide to request evidence of corrections at its discretion.

Notes
  • B/CM/C 6 Allogeneic and Autologous Donor Selection, Evaluation, and Management standards are now on a separate worksheet. The Collection Inspector will assess these standards for all facilities involved. Where only a Clinical Unit is being inspected, the Clinical Inspector will assess these standards.
  • CM/C/D 7 Coding and Labeling of Cellular Therapy Products are grouped on 2 separate worksheets: 'All Labels Content' and 'Shipping Labels'. Labels will be assessed by the Processing Inspector for all facilities involved. Where only a Collection Unit is being inspected, the Collection Inspector will assess these standards.
  • The reference numbers have been modifed from "1, 2, 3..." to "01, 02, 03..." to allow for the list to be sorted.
  • Guidance from the Accreditation Manual has been include as Comments in the Standards column. Cells with comments will show a small red triangle in the top right corner. They are accessible by holding the mouse pointer over the cell. Note not all Standards have additional Guidance in this checklist. Readers are strongly recommended to refer to all of the Guidance in the Manual.
  • Post-inspection: The checklist now also incorporates the post-inspection corrections phase.