This section provides information for registries who are interested in becoming WMDA Qualified. Tips and tools how to prepare an application and FAQ.
The WMDA accreditation programme for registries has been established since 2003. The first step to become a WMDA accredited registry is to become a WMDA qualified registry. To become WMDA qualified a registry needs to meet all benchmarked WMDA Standards. The review will focus on the registry operations, how your registry has organized its processes.
The structure of a registry can vary from country to country. In some registries, the activities of a registry may be performed by more than one organization. For example, one organization may recruit donors while another organization oversees the donor database and the search algorithm. Regardless of the structure of the registry, the application for WMDA accreditation must cover all organizations that contribute to the operation of a registry. The operation of a registry includes recruitment and counseling of donors, maintenance of the donor database and the search algorithm, facilitation of requests for donor samples and data, facilitation of the donation and transport of the stem cells to the patient, and follow-up of the donor post-donation.
Information on the registry must be submitted to the WMDA annual report. The registry should be able to complete the annual questionnaire and respond to all questions. Inability to obtain the information required by the questionnaire suggests that the registry may need to review its ability to track and monitor its progress prior to applying for WMDA accreditation.
Criteria that a registry must meet before sending a letter of intent
Registries that apply for WMDA qualification must meet the following criteria:
- WMDA registry member in good standing
- Must contribute to the WMDA Annual Report
- Must have a specified level of activity for each of the following to be based on data from last three annual reports:
- Searchable donor file of minimum size: 500 donors and/or 100 cord blood units
- Access to donors/cord blood units for further testing: search requests received for international patients, additional HLA testing performed on request of transplant centres, donor samples shipped
- Access to donors/cord blood units for transplantation: minimum of 6 donations/cord blood shipments within the last three years with 2 of the 6 for international patients
To apply for WMDA qualification
In order to schedule work flow and to allow applications to be reviewed in a timely fashion, registries applying for WMDA qualification must first submit a letter of intent indicating when they plan to submit an application. The letter of intent should be submitted no more than six (6) months before the requested submission date. After the receiving the letter of intent, the WMDA Office will confirm the date the application can be submitted to the WMDA Office. Applications can only be accepted with a letter of intent signed by the Chair of the Accreditation Steering Committee.
To prepare a package for WMDA qualification
When the letter of intent is accepted the registry receives an application packet from the WMDA Office. The application packet includes:
Submit in time!
Once a letter of intent is accepted, the registry must submit the application by the assigned date. There is a penalty for delayed submission: the subsequent letter of intent cannot be submitted until one year has passed from the date of the missed submission.
Translate your documents into English!
Each registry submitting an application must submit their application in English. Critical portions of the registry’s procedure manual and other documents that relate to WMDA Standards must be provided in English. Any translator (e.g. a member of the registry) may be used for the preparation of the packet. The registry should designate an individual who will be able to assist the Review Subcommittee in translation of documents after submission of the application packet. This individual must not be an employee of the registry.
The originals of all translated materials in the native language of the country must be submitted in the application. This includes documents that were altered during the review process; the revision and its translation must be submitted. Other documents in the native language of the registry may be submitted in the application packet.
As a minimum the following must be submitted in English:
- Key documents on policies and procedures;
- Operations manual with key sections related to WMDA Standards.
- Donor consent documents and donor information material;
- Key sections of any service level agreements or other documents describing interactions between the registry and other entities (donor centres, transplant centres, collection centres) that perform registry functions;
- Key sections of all documents that relate to compliance with WMDA Standards and with accreditation requirements of national/international organizations.
It will be appreciated by the reviewers if each original language document is accompanied by a short explanation of its content translated into English. We suggest that you create the SOPs in English if that will work with your staff being able to understand them. Documents for the volunteer donors will have to be in the language of the country and you need to provide a translation when you submit your application.
Creating SOPs in English might also make it easier to set up affiliations with other registries around the world-outside of the WMDA accreditation activities.
Paper-based application or digital application?
Some registries submit a paper package; others decided to submit an electronic application. On the following link you will find some guidelines.
Tools to prepare an application
The WMDA Accreditation Committee has developed guidance to help registries prepare their application for qualification. This document is based on the new WMDA standards.
If your registry is WMDA Qualified
From Qualification to Accreditation
After you have celebrated the WMDA qualification with your colleagues in the registry. You have to start working on the next step. The WMDA qualification is based on the benchmarked standards. The next time you submit an application it must comply on the full set of the WMDA Standards.
The next step will not only be a document review, but will also include an onsite inspection.
Registries that have received WMDA qualification are required to perform an annual self-evaluation to be completed one month following the anniversary date.
WMDA Standard 1.03 requires that you need to inform the WMDA when critical changes occur in your organisation. For example:
- the registry changes its legal status; for example, from a private structure to a public one;
- the national organization of the registry or of its related entities changes;
- the registry moves its headquarters to a new location;
- the registry appoints a new official who authorizes all official documents related to WMDA accreditation;
- the registry changes its Director or key personnel for whom CV and basic knowledge were submitted previously in the accreditation application;
- due to national regulations the registry can no longer comply with a WMDA benchmark standard.
In these and similar cases your organisation must have a mechanism to bring the registry’s significant changes to the attention of the WMDA Office.
If you have any questions about the WMDA qualification you can contact the WMDA Office.
Last update: 14:42 20/12 2012