Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
necessary in response to continuing review. 56
The determination procedure includes both screening and testing
components. Donor screening establishes that the donor “[ i]s free from risk
factors for, and clinical evidence of, infection due to relevant communicable
disease agents and diseases [and] communicable disease risks associated
with xenotransplantation”; donor testing confirms that the donor is not
positive for “relevant communicable disease agents.” 57
The donor must provide available laboratory test results and other
records, medical or otherwise, which pertain to risk factors for relevant
communicable disease agents or diseases (RCDADs). 58 This process also
requires a “current donor medical history interview” (conducted in person
or by telephone, and verifies answers to any self-administered medical
questionnaire) 59 and physical examination of the donor. 60 The “current
medical history interview” is not, strictly speaking, “medical”; rather, it is a
“documented dialog about,” among other things, the donor’s “relevant
social behavior.” 61
Although it can affect whether a prospective donor is eligible to help a
woman start a family, FDA regulations do not specify what constitutes a
“relevant social behavior.” 62 21 C.F.R. Part 1271.3’s definition of “[d]onor
medical history interview” indicates “relevant social behavior” includes, but
56. 21 C.F.R § 1271.47 (2012).
57. 21 C.F.R § 1271.50 (2012).
58. Id. This includes “[r]ecords or other information received from any source pertaining
to risk factors for relevant communicable disease (e.g. social behavior, clinical signs and
symptoms of relevant communicable disease, and treatments related to medical conditions
suggestive of risk for relevant communicable disease).” For repeat donors, a bank may
perform an abbreviated screening if it has been six months or less since he completed a full
screening. An abbreviated screening requires only review and documentation of “any
changes in the donor’s medical history since the previous donation that would make the
donor ineligible, including relevant social behavior.” 21 C.F.R § 1271.75(e) (2012).
59. See 21 C.F.R. § 1271.75(a)( 1) (stating “if you are the establishment that performs
donor screening, you must screen a donor of cells or tissue by reviewing the donor’s relevant
medical records for . . . [r]isk factors for, and clinical evidence of, relevant communicable
disease agents and diseasesFalse” (emphasis added)); see 21 C.F.R. § 1271.3(s) (“Relevant
medical records means a collection of documents that includes a current donor medical
history interviewFalse” (emphasis added)).
60. 21 C.F.R. § 1271.75; Guidance for Industry: Eligible Determination for Doctors of
Human Cells, Tissues, and Cellular and Tissue-Based Products, U.S. FOOD & DRUG ADMIN.
(Apr. 19, 2012), http://www.fda.gov/BiologicsBloodVaccines/GuidanceCompliance
61. 21 C.F.R. § 1271.3(n) (“Donor medical history interview means a documented
dialog about the donor’s medical history and relevant social behavior, including activities,
behaviors, and descriptions considered to increase the donor’s relevant communicable
62. See 21 C.F.R. § 1271.3 (How does FDA define important terms in this part?); 21
C.F.R. § 1271.75 (How do I screen a donor?).