Inspections, Compliance, Enforcement, and Criminal Investigations

CPG 230.130- Adequate Space for Determination of Donor Suitability

BACKGROUND:

21 CFR 606.40(a)(1) requires that facilities for interviewing donors provide adequate space for private and accurate examinations of individuals to determine their suitability as [] donors. []

The Agency views privacy to include any type of arrangement that would allow the donor to answer questions without being overheard by staff and other donors. This can be accomplished in a variety of ways, e.g., special donor screening booths, partitions, or simply by using an isolated area such as the corner of the room.

POLICY:

It is not the intent of 21 CFR 606.40(a)(1) to require donor screening booths and partitions, but rather to assure that there is an arrangement whereby other donors and staff will not unavoidably overhear responses during donor suitability determinations.

[] Indicates material has been deleted

Issued: 4/8/80 as 7134.13
Revised: 10/1/80, 3/95

Page Last Updated: 03/20/2015
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