Procedure control and acceptance sampling plans for donor sperm banks: a theoretical study Jose Antonio Castilla Æ Maria Sa ´nchez-Leo ´n Æ Antonio Garrido Æ Juan P. Ramirez Æ Ana Clavero Æ Luis Martı ´nez Received: 16 January 2007 / Accepted: 22 March 2007 / Published online: 13 April 2007 Ó Springer Science+Business Media B.V. 2007 Abstract The publication of European Directive 2004/23/EC in the European Parliament and in the European Council on 31 March 2004 concerning the setting of standards of quality and safety for the donation, procurement, testing, processing, preser- vation, storage and distribution of human cells and tissues made it obligatory for sperm banks to set up quality control systems to ensure, among other goals, the satisfactory control of all procedures carried out. The objective of the present study is to set out guidelines that will make it possible to ensure the quality of the donors and frozen speci- mens accepted and the homogeneity of the samples supplied by a sperm bank. For this purpose, we shall describe clear-cut criteria for the acceptance of donors and frozen sperm, taking into account both analytic variability and the biological variations to be expected in semen parameters. Furthermore, we shall show how the evaluation of the results of a frozen semen specimen, on the basis of analysing a single straw after such freezing, does not guarantee the homogeneity of all the straws. Therefore, we must design a sampling plan to take into consider- ation all the straws obtained from a donor. This kind of plan will depend on different parameters, such as acceptable levels of quality and the tolerable rate of straws with defective semen, and will involve certain risks, both for the sperm bank and for the client. The establishment of these acceptance control criteria for frozen specimens and for donors could be of practical use for the control of the procedures applied in the operation of a sperm bank. Keywords Sperm bank  Freezing  Quality control  Sperm donors  Acceptance sampling plans  Semen Introduction At present, the use of sperm from donors is common practice in assisted reproduction, and since the late 1980s it has been obligatory for sperm from donors to be frozen in order to allow time for repeat testing and therefore reduce the risk of AIDS transmission. Globally, it is estimated that 30,000 births every year result from inseminations carried out with frozen semen from donors (Mortimer 2004). There is some controversy as to the results of this technique (Scott et al. 1990). One of the reasons for this could be the differing quality of the semen samples that are used. Large differences have been described in the results of cryopreservation of semen specimens from the same donor (Yogev et al. 2004; Centola et al. 1992; J. A. Castilla (&)  M. Sa ´nchez-Leo ´n  A. Garrido  A. Clavero  L. Martı ´nez Unidad Reproduccio ´n, HU ‘‘Virgen de las Nieves’’, Avda Coronel Munoz s/n, 181014 Granada, Spain e-mail: josea.castilla.sspa@juntadeandalucia.es J. P. Ramirez Laboratorio CEIFER, Granada, Spain 123 Cell Tissue Banking (2007) 8:257–265 DOI 10.1007/s10561-007-9041-4