Physical Examination Updated Guidance: How does this affect my Org?
As businesses evolve, growth brings new challenges. In January 2024, the American Association of Tissue Banks (AATB) released Bulletin 24-1, specifically for the birth tissue industry, to consider new avenues in obtaining a robust Physical Examination (PE) as required by the Food and Drug Administration (FDA), AATB, and other state and international regulations. Through collaborative efforts of various members from AATB’s Birth Tissue Council(formerly Living Donor Council), three options of performing and documenting the PE were provided as guidance while maintaining compliance for donor screening and eligibility determination.
As defined by AATB 1 , a physical examination is “a recent documented evaluation of a living donor’s body to determine whether there is evidence of high-risk behavior and that determines overall general health of the donor. After a donor risk assessment interview is completed and if any history is suspect, the physical examination should also encompass a directed examination (of a body part or region)”.
Understanding standard prenatal care and the types of documents generated will assist in how an organization chooses the best method. If your organization contracts with birth tissue acquisition or recovery organizations who perform and obtain the PE, understanding the challenges that are faced by medical staff may point to a specific direction to better maximize the acquisition process. Here is a review of the options (example forms were provided in the Bulletin, tissue banks may develop their own forms):
Option A: Physical Examination Performed for the Purpose of Donation
1. The language in the Informed Consent and hospital contracts, where applicable, should encompass that the PE is performed for the purpose of donation and not part of the prenatal care or any exam during admission, and who completes the PE for the purpose of donation.
2. Providers (auxiliary medical professional) should be made aware there may be other documentation regarding an individual’s general health through the tissue donation process.
3. Documented training for those medical personnel performing this PE for the purpose of donation.
Option B: Attestation of the Physical Examination
1. PE already performed and member of birth mother’s OB care team reviews and signs the form confirming absence of any PE findings that would be a contraindication to donation.
2. Tissue banks would need to develop an SOP related to the attestation to address:
2.1. Information to be reviewed with or by the Physician or designee, as part of examination attestation.
2.2. Process of completing the attestation which may be obtained by the tissue bank representative when interviewing the Physician or designee, rather than signed by the Physician or designee themselves.
2.3. Whether the Physician/medial provider performing the exam or responsible tissue bank representative signs an attestation, the signatures attest there are no PE findings that would be contraindication to donation as listed on the attestation form.
2.4. Obtaining all available relevant records listed, with birth mother’s prenatal records to support the attestation.
Option C: Review of Relevant Medical Records Identifying Documented Physical Examinations by Medical Professionals Involved in the Birth Mother’s Care
1. Obtaining all relevant records generated from the beginning of a birth mother’s prenatal care through those generated during admission to delivery.
1.1. Tissue banks shall establish and define the records needed to enable a complete review and the review should contain the information needed to meet the PE requirements as defined by the tissue bank’s Medical Director.
1.2. If records do not contain the required information, then the SOPM should include this as an instance where a directed PE must be performed.
1.3. If a birth mother has not had continuous care or care later in pregnancy, the tissue bank should establish an acceptable length of time for prenatal care to ensure robust documentation.
Directed Physical Examination: Follow-up of Discordant Information
1. When information is obtained or discovered with discordant information about a body part/system that’s unavailable in existing records, a limited, directed PE may be required to resolve discrepancies or missing data.
2. SOPS should establish why and under what circumstances the directed PE is performed and documented, the PE must be performed by a responsible and trained person and the information must be verifiable through the directed PE or obtaining records post infection (treatment was successful, negative test of cure)
3. Directed PE should be performed when history or info about the birth mother from the DRAI is discordant with other relevant records, when the PE or medical record is lacking or inconclusive of the established requirements, or if the birth mother’s History & Physical examination is not performed or available at the time of delivery or is incomplete based on the pre-established requirements.
References:
1. American Association of Tissue Banks, Standards for Tissue Banking, 14 th Edition
2. Clinical Methods: The History, Physical, and Laboratory Examinations. 3 rd Edition. Walker HK,
Hall WD, Hurst JW, 1990, https://www.ncbi.nlm.nih.gov/books/NBK458/