Bulletin 24-1

Publication of AATB Guidance Document Physical Examination Birth Mothers

AATB’s Living Donor Council (LDC) is pleased to announce that the Guidance Document Physical Examination Birth Mothers has been published after a collaborative effort between the LDC and AATB’s Physicians Council and other stakeholders. 

The purpose of this document is to guide the birth tissue donation industry in establishing processes that meet the requirement for a current physical examination as part of the donor-eligibility determination, specifically focusing on assessing physical signs of communicable diseases and associated risk factors in birth mothers, by providing direction on various examination methods that satisfy regulatory requirements.

AATB and FDA require evaluation of the health and physical status of the birth mother and the newborn. The scope of this guidance is limited to the evaluation of the birth mother. The guidance document includes recommendations for 3 acceptable options to obtain a robust physical examination of a birth mother:

  1. Physical Examination Performed for the Purpose of Donation
  2. Attestation of Physical Examination
  3. Review of Relevant Medical Records Identifying Documented Physical Examinations by Medical Professionals Involved in the Birth Mother’s Care

The guidance document provides example forms that may be used to document each of the 3 acceptable methods.

If you have questions, please contact standards@aatb.org.