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Standards and Accreditation FAQs

What is the role of Standards & Accreditation?

AABB develops Standards that promote patient safety and quality in several different fields. AABB's Standards combine internationally accepted quality management system essentials with technical requirements appropriate for each discipline. These Standards then form the basis for AABB's Accreditation program. To become accredited, a facility must be in compliance with the current edition of Standards as well as the requirements in the Accreditation Information Manual. The AABB Accreditation program is internationally recognized as a symbol of quality, and facilities that have achieved AABB accreditation are known to provide quality products and services.

Why should my facility be accredited by AABB?

There are many reasons to be AABB accredited. By assessing the operational systems in place within a facility, the program strives to improve the safety of collecting, processing, testing, distributing and administering products. Facilities that have achieved AABB accreditation have demonstrated the highest level of quality and have systems in place to make continual improvements.

What is the process of getting accredited and how long does it take?

For more information on the process of getting accredited, click here for details. While the process typically takes 6-9 months, the estimated time to achieve accreditation depends upon the state of preparedness and adherence to Quality System requirements.

What are the different activities for which you can get accredited?

A list of activities is located here.

How much does it cost to become accredited?

The cost of Accreditation depends on several factors, including the activities for which your facility is being accredited and the volume/size of the facility. For more information on the specific costs of accreditation click here.

I know that I want to be accredited, but I have a lot of questions about the accreditation process and how it applies to my facility. How can I get these questions answered?

You can contact us at accreditation@aabb.org or by telephone at +1.301.215.6492. After starting the process by becoming an institutional member, AABB will assign you a technical specialist from the accreditation department who will help guide you through the Accreditation process. This personal assistance will help ensure that you understand what is expected of you at each step along the way.

What is a nonconformance?

A nonconformance is a failure to fulfill the requirements of a standard.

I'm not sure if my facility is meeting one of the standards. How do I find out if I'm meeting the intent of the standard before my assessment?

Contact us at accreditation@aabb.org or by telephone at +1.301.215.6492

What is a variance and how do I request one?

Variances are alternative methods that still achieve the intent of a standard while preserving quality and safety. Submitted variances are reviewed by the appropriate Standards Program Unit. Variance requests received from facilities located outside of the United States are reviewed by a separate committee, as US regulations often do not apply to these facilities. Click here to request a variance to a standard.

Does AABB provide a list of accredited facilities?

A complete list of accredited facilities may be found here.

Does AABB offer accreditation in collaboration with other organizations?

Yes, visit the Affiliated Accrediting Organizations page to learn more.   

When is the next edition of the standards effective and where can I find the significant changes?

The Standard Setting Activities website page provides links to the program page for each set of Standards for which AABB provides Accreditation. These individual program pages provide information and resources such as effective dates and links to a significant changes table, to purchase the Standards books, and to comment on a draft of the Standards (when available).

I have suggestions for changes to the next edition of standards. Where can I communicate these ideas?

AABB individual members may join our AABB HUB where they can post comments or suggestions for the next edition of standards or provide input to the draft edition of the standard that is available for public comment. Each edition of standards has its own thread.

How much do the Standards cost and where can I purchase them?

To purchase any set of standards, visit our Marketplace or call Membership at +1.866.222.2498.