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The Role of Standards and Accreditation

The main purpose for having standards and accreditation is to establish a uniform level of practice dedicated to supporting patient safety. AABB has been designated as a Patient Safety Organization by the U.S. Department of Health and Human Services.

What are standards?

AABB publishes voluntary Standards for Cellular Therapy Services that are regularly updated by a committee of experts in the field to ensure that the Standards address the dynamic nature of the field and maintain the highest level of quality to support patient safety. These Standards augment any national, federal or state requirements. The Standards describe the minimum acceptable requirements for facilities providing these services and may or may not be more stringent than local requirements. The Standards cover all aspects of operation from donor selection and testing to product processing, storage, clinical administration, and patient outcomes. The Standards require written policies, processes and procedures. Except in a few cases, the Standards do not specifically prescribe how each of these may be done but rather whether the objective is reached.

What does AABB accreditation mean?

The AABB Accreditation program is internationally recognized as a symbol of quality. The accreditation program and the Assessor Training program are accredited by the International Society for Quality in Healthcare (ISQua) — giving the program credibility on a global scale.

Facilities seek AABB accreditation for recognition of their ability to meet or exceed the Standards set by AABB in providing quality products and services. The accreditation process ensures the facilities meet the applicable Standards for the services it provides.

Generally, when a facility believes it complies with the Standards, it applies for accreditation. The facility is assessed by an objective team with experience in the field. Any evidence the team finds of non-conformance with the Standards is brought to the attention of the applying facility, and corrective action must be taken before accreditation is granted. Once a facility is found to be in conformance with AABB Standards, accreditation is granted for two years. AABB tracks customer complaints and follows up on any reported non-conformances. Only facilities with a current accreditation have permission to use the AABB logo, and AABB investigates reports of misrepresentation or fraudulent use once the misuse is brought to its attention.

Accreditation against other standards

Because AABB is internationally recognized as a global leader in quality systems, other organizations may partner with the association for accreditation services. AABB may determine that collaboration is in the best interest of patient safety and resource utilization. In these cases, AABB may perform an assessment against another organization's standards using AABB policies, procedures, and tools to assess compliance to these other standards. AABB is one of the recognized accreditation bodies with the Health Resources and Services Administration, or HRSA, for cord blood banks who are contractors for the U.S. National Cord Blood Inventory. Such decisions are made prudently and with a focus on patient safety and quality.