Is the reaccreditation process different from the first time?
Q: What is the difference between reaccreditation and first-time accreditation?
A: In practical terms, there is no difference. At reaccreditation, the centre will be required to send the completed application form, provide the pre-inspection documentation, including the full checklist, and undergo a full on-site inspection. Inspectors may also be interested to check any issues that arose in the previous inspection. The applicant should take into account that at the time of reaccreditation, at least 4 years will have passed since the last on-site visit, which is considered sufficient time for significant changes to have occurred and thus warrants a full inspection.
Is it possible to separate allogeneic and autologous activity?
Q: In our programme, there are two teams - one performing allogeneic and the other autologous transplantation. Can we apply for accreditation just for the allogeneic team?
A: This is possible, although bear in mind that the accreditation will be limited to the allogeneic activity. The ideal would be where the full programme applies and is inspected together.
Cell collection performed in multiple locations
Q: If the collection facility team also perform collection procedures outside of their facility, should this be included in the scope of the accreditation?
A: Yes. The accreditation covers the activity, not just the site or facility, so the JACIE Office and Inspectors should be made aware of this service.
Printed copy of the Standards/Manual
Q: Can we request printed copies?
A: JACIE did not print copies of the 7th Edition due to costs. You can of course download and print a copy yourself.
Gene therapy products and JACIE inspection
Q: We carry out a small number of gene therapy procedures in this hospital using an authorised laboratory here in the hospital which is separate from our processing lab. Will this gene therapy lab have to be part of our JACIE inspection?
A: The use of gene-modified cells or tissues is expected to happen exclusively in the context of clinical research and not as standard care. JACIE inspectors will not be expected to inspect the gene therapy laboratory as such, only how it interfaces with the transplant programme and how it is reflected in the quality system. Where a centre indicates that gene therapy products are produced within the transplant programme, the following applies: Ask the centre if the gene-modified cells form part of the treatment pathway. If yes, then the inspectors should be notified of this. The centre should be asked to demonstrate to the inspectors all relevant authorisations for the facility. The centre should be able to show that the appropriate information has been given to the patient and that all due consents have been obtained This activity should be reflected in the Quality Manual. If it is an external laboratory, then a contract or agreement/SLA should be in place and be available for review by the inspectors on-site.
Q: Our centre has already undertaken a small number of cord blood transplants and we intend to do more in the future. What is the current JACIE position on this matter, which standards must we follow, and is there specific documentation required for the clinical use of cord blood?
A: The JACIE position in reference to cord blood transplantation is as follows:
Clinical Use of Cord Blood for Transplant
1. Section B of the FACT-JACIE Standards (seventh edition) covers the clinical use of cord blood along with any other type of HPC; currently you do not need any specific accreditation for the clinical use of cord blood. You would obviously need the same sort of policies and procedures for receipt of material, documenting infusion, tracking, etc. as for unrelated HPC-M or HPC-A.
2. Therefore, for clinical cord blood use, i.e. doing transplants with cord blood that has been collected somewhere else, the FACT-JACIE Standards apply.
Collection, Processing and Banking of Cord Blood
1. For the collection and banking of cord blood, the FACT-Netcord Standards and accreditation process should be applied.
2. However, for Processing Facilities that generally process HPC-M and HPC-A, but also process a low number of cord bloods for direct donation, this activity can be included as part of the general processing activity in the JACIE inspection, following the FACT-JACIE Standards (section B).
Q. Does JACIE conformance imply exceeding national legal requirements?
A. JACIE sometimes exceeds national legal requirements. When a JACIE requirement is forbidden by national laws or regulations, these national regulations will override the standards. When a JACIE requirement is not forbidden but simply not required by the law or regulations, the JACIE requirements apply.
For example, you cannot avoid testing for HIV as required by JACIE just because national law does not require you to do it. On the other hand, if there is a national law prohibiting HIV testing then JACIE cannot insist on it.
Q. What if my clinical programme is ready but the HLA laboratory does not have EFI accreditation yet?
A. A clinical programme will not be inspected until the HLA lab has at least applied for EFI accreditation. Evidence of this application should be submitted by the clinical programme at the time of applying for JACIE accreditation. A clinical programme may receive confirmation of compliance with all JACIE Standards except for satisfying standards concerning EFI, but cannot be accredited until the EFI cert has been submitted to the JACIE Office. Accreditation of the transplant programme will be effective from the date of receipt of the EFI certificate by JACIE.
Few cases of serious adverse events reported
Q. We implemented our quality management system just a couple of months ago so there are still very few reported serious adverse events. Can we apply for accreditation?
A. While a centre can apply for accreditation, SAE reporting is one of the areas that inspectors will want to see in operation. If the inspectors feel that the system is not fully up and running, a reinspection may be required after the initial inspection to see that the reporting system is fully operational. Therefore centres are recommended to wait until it can be easily demonstrated that the system is in full deployment.
Quality Activity Reports
Q: B/C/D188.8.131.52 The Clinical Program Director or designee shall report on quality management activities, at a minimum, quarterly. What does this mean?
A: QM activities shall be reported, at a minimum, quarterly to review the performance of the QM Plan. This is to determine whether the elements in the QM Plan are relevant and effective, and necessary actions are taken in a timely manner.
Quarterly reports can be based around minutes from the regular quality management meetings (if the frequency of the meetings is sufficient) and should summarize activities such as training performed, documents reviewed, audits performed, and procedures introduced or amended. It does not necessarily mean that audits must be performed quarterly.
External cell collection/processing service providers
Q: B1.2 / C1.4 / D1.3. As a clinical unit, up to now we have been using an external provider for cell collection and processing services. What are the implications for our accreditation if we change provider or use services from within our institution?
A: Where such a change occurs, the new collection and processing services - regardless of whether they are internal or external - must demonstrate compliance with the Standards, i.e. achieve accreditation. Particular attention should be given to the requirement for the minimum period of time that such units have been actively performing cell collection and/or cell processing (12 months minimum) prior to accreditation. Where units do not meet these standards, accreditation of the clinical unit may be suspended until such time as the new services are accredited.
If you are planning to change such services, it is recommended that you consult with the JACIE Office in advance.
In the Accreditation Manual, what does "chart" mean?
Q. What does "chart" refer to in the Manual e.g. p. 61 'The chart of a patient or donor where the cellular therapy product was contaminated provides evidence of how the Clinical Program managed the process. There must be evidence of integration and collaboration with the Collection and Processing Facilities.'
A. Chart refers to the patient or donor record/file.
What is an organigramme?
Q. What is an organigramme?
A. An organigramme is a graph showing the hierarchy and relationships of your organisation. It helps demonstrate who is responsible for what and who reports to whom. It should include the names and the roles of the people involved. An organigramme is also referred to as an organisational chart.
See wikipedia.org/wiki/Organizational_chart for more information.
Language of documents / translations
Q. Do I have to translate all of my documents?
A. Documents should be in the language of the centre since JACIE would expect to assign inspectors that speak and understand that language. However, there may be exceptions to this as follows:
- Centre is located in a country where no inspectors are available
- JACIE may not have inspectors anywhere that speak the centre’s language
- The transplant community in a given country has requested that only external inspectors be assigned to avoid conflicts of interest
In these cases, we must resort to other inspectors to perform the inspection. For these inspectors, one of the key parts of their preparation is reading documents made available in advance. Without this, it is very difficult for them to arrive on-site adequately prepared and this would clearly affect the quality of the inspection. In such cases, JACIE will ask the centre to translate a selection of the documents provided to the inspectors in advance of the inspection and will request the centre to provide local experts to facilitate interviews and understanding of documentation.
Please contact the Accreditations Coordinator at email@example.com if you have any doubts about this part of the process.