Bulletin 15-5

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Announcing Enforcement Discretion in Regard to Standard D2.400 Core Elements for Authorization​

Bulletin 15-5

March 17, 2015

The AATB has begun to exercise enforcement discretion at accreditation inspections in regard to standard D2.400 Core Elements for Authorization (access this standard here).

A few years ago, with assistance from Christina Strong, Esq., updates were made to AATB's Standards for Tissue Banking related to "consent" that aligned them with modern language and practices as well as the revised Uniform Anatomical Gift Act. At accreditation inspections occurring after the compliance date for these new standards, we have identified that language selected to meet the intent of the Core Elements may not meet expectations.

Due to the sensitive nature of the topic, we have again enlisted Ms. Strong to assist us with re-evaluating the Core Elements and, until these issues are resolved, the AATB will use enforcement discretion at inspections.

Ms. Strong will address this topic at AATB's Quality & Donor Suitability Workshop next month in Atlanta, Georgia and during an AATB webinar later this year. Other engagements with membership may also occur and we look forward to your participation and feedback. Updates will be announced and will allow ample time to come into compliance.

If you have any questions, please contact Scott Brubaker.