This section provides you with information about WMDA accreditation. This page is relevant for the following registries:

• Registries that were accredited before January 1, 2012 and are applying for a renewal of their accreditation
• Registries that are WMDA qualified and are applying for WMDA accreditation

Introduction

The WMDA has established an accreditation programme for stem cell donor registries. Accreditation of individual registries by the World Marrow Donor Association (WMDA) is an indication that these registries are committed to follow WMDA standards. These standards promote the quality of procedures necessary to obtain, in the shortest possible time, the appropriate quality and quantity of hematopoietic stem cells of the best unrelated donor suitable for engrafting a patient while protecting the anonymity, health and well being of the volunteer donor.

Registries applying for WMDA accreditation follow a two step process:

• Document review based on all WMDA Standards
• Onsite inspection 

Six months before the expiration of your qualification/accreditation

In order to schedule work flow and to allow applications to be reviewed in a timely fashion, registries applying for WMDA accreditation 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 that 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.

• Letter of Intent for WMDA Accreditation

To prepare a package for WMDA accreditation

When the letter of intent is accepted the registry receives an application packet from the WMDA Office. The application packet includes:

• Current version of the WMDA Standards
• Evaluation table
• Signed Letter of Intent

The registry needs to provide an application package of documents, as described in the WMDA qualification section and in the policies and procedures document. In addition to the documentation, the onsite inspection needs to be prepared.

Onsite Inspection

To prepare for the onsite inspection the registry needs to submit six lists with the application:

1. Search requests in the last six (6) months
2. One donor file list from HPC donations that proceeded to transplant in a  time period covering a 6 month period from 4 years ago, to include both international and national patients, to include all stem cell sources supported through the registry.
3. Four donor file lists from the last six (6) months to include

• List 1: CT (verification typing) requests completed, to include both international and national patients
• List 2: CT (verification typing) requests that were not fulfilled, to include both international and national patients
• List 3: HPC donations that proceeded to work-up/collection, to include both international and national patients, to include all stem cell sources supported through the registry
• List 4: HPC donations that did not proceed to work-up/collection, to include both international and national patient

If the last 6 months do not include international patients, the registry should include international activities from the last 12 months as well as national activities from the last 6 months

Alternatively in place of donor file lists, a list of donor centers audited by the registry in the last two (2) years and percent of the total number of donor centers that this list represents may be submitted.

On-site inspection

An on-site inspection will only be performed if the review of the paper application has been judged by the review subcommittee as likely to meet WMDA requirements for accreditation. A date will be determined by the Office after discussion with the registry and the onsite-reviewers. The inspection takes 1.5 days. The reviewers select six donor files from each category and 10 search requests that will audited during the inspection. For the inspection the following checklists have been developed:

1. Audit Reports
2. Cord Blood
3. Search
4. Donor Verification (Confirmatory/Extended) Typing
5. Workup Collection
6. Quality Management
7. Donor Follow Up
8. Registry
9. Summary
10. Information Notes

If your registry is WMDA accredited

Annual Evaluation

Registries that have received the accreditation certificate are required to perform an annual self-evalution to be completed one month following the anniversary date.

• SOP for annual evaluation

• Annual evaluation form

Standard 1.03

WMDA Standard 1.03 describes that you need to inform the WMDA when some particular 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 the 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.

Related documents providing more information

• Accreditation policies and procedures

• Evaluation table

Questions?

If you have any questions about the WMDA accreditation you can contact the WMDA Office.