Regulation 57

establish policies and processes for the processing, testing and quarantine of any reproductive cell or embryo in the licensee’s custody in order to prevent the mix‑up of reproductive cells and embryos, and ensure the safety, quality and viability of the reproductive cell or embryo for clinical use; and

take measures to ensure that the policies and processes mentioned in sub‑paragraph (a) are implemented.

ensure that the environment within which reproductive cells or embryos is processed, tested and quarantined is appropriate to ensure the safety, quality and viability of the reproductive cells and embryos, and the safety of the licensee’s personnel handling the reproductive cells and embryos;

ensure that —

each reproductive cell is collected or cryopreserved; and

each embryo is cryopreserved,within the appropriate time period for the reproductive cell or embryo to retain the biological functions compatible with the intended use of the reproductive cell or embryo;

a reproductive cell collected from, or an embryo created using a reproductive cell collected from, an individual is not mixed with or placed together in the same straw, vitrification device or cryo vial as a reproductive cell collected from, or an embryo created using a reproductive cell collected from, another individual;

take all reasonable steps to minimise the risk of contamination of each reproductive cell and embryo in the licensee’s custody;

use validated methods and appropriate protocols for the processing (including cryopreservation) and testing of each reproductive cell and embryo to maintain the safety, quality and viability of the reproductive cell and embryo and retain the clinical properties of the reproductive cell and embryo that are consistent with the intended use of the reproductive cell or embryo, as the case may be;

maintain the traceability of all materials and equipment by keeping records of each material or equipment used to process each reproductive cell and embryo such that the specific material or equipment used to process the reproductive cell or embryo is known;

ensure that every specimen is labelled with the full name of the patient to whom the specimen relates;

implement a labelling system in the embryology laboratory to ensure identification and traceability of reproductive cells and embryos from their collection to storage, transfer, freezing, thawing and distribution or disposal;

ensure that aseptic techniques are used for any laboratory procedure involving the handling of any reproductive cell or embryo;

ensure that none of the following are used in the embryology laboratory:

toxic chemicals or radioisotopes, including in cleaning materials;

aerosol or pest control substances;

implement measures to minimise interruptions and distractions within the embryology laboratory when any laboratory procedure is being carried out;

ensure each processing cabinet or workstation is, at any time, used only to process —

except where sub‑paragraph (ii) applies — reproductive cells collected from one person;

oocytes collected from one woman and sperm collected from one man, for the purpose of performing IVF or ICSI; or

embryos created using oocytes collected from one woman and sperm collected from one man.

each procedure undertaken in the embryology laboratory for the provision of the assisted reproduction service is documented;

each document mentioned in sub‑paragraph (a) is available in the embryology laboratory; and

the maintenance manual for each piece of laboratory equipment in the embryology laboratory is available in the embryology laboratory.