Regulation 16

each instrument and equipment is installed, commissioned and used or operated properly, in accordance with the instructions of the manufacturer of the instrument or equipment;

each instrument and equipment is, and the supplies and reagents used or intended to be used are, effective to ensure the safety, and maintenance of the quality or viability, of every reproductive cell and embryo handled, processed or stored by the licensee;

every instrument or equipment is used in a manner that —

prevents the mix‑up, or contamination or cross‑contamination, of stored reproductive cells and embryos; and

ensures the safety, and maintenance of the quality or viability, of every reproductive cell and embryo handled, processed or stored by the licensee;

every refrigerator or storage tank undergoes periodic maintenance to ensure that there is no degradation in the quality and usability of the reproductive cells and embryos and reagents kept in the refrigerator or storage tank;

a procedure is put in place for monitoring, inspecting, sterilising and cleaning each piece of instrument or equipment used;

appropriate tests and procedures are carried out periodically to ensure that any instrument, equipment or reagent used by the licensee complies with the tolerance limits determined by the manufacturer of the instrument, equipment or reagent;

the following information about any supplies or reagent used in the collection, testing, processing and storage of any reproductive cell or embryo by the licensee is identified and recorded, where applicable:

the name of the supply or reagent;

the name of the manufacturer;

the lot number;

the date received;

the date opened;

the expiration date;

where any instrument, equipment, reagent or other material is sterilised — the instrument, equipment, reagent or other material is clearly labelled to indicate the date on which sterilisation took place and the expiry date of the sterilisation;

every laboratory chemical and reagent is labelled to indicate the date received, date opened, and shelf life, where applicable;

procedures are put in place to monitor and maintain the conditions in which each reproductive cell or embryo is stored, including the immediate notification of and response to temperature deviations outside acceptable ranges;

the carrying out of regular evaluation of suppliers of materials the use of which is likely to have a material impact on the safety, quality and viability of stored reproductive cells or embryos to ensure that the materials obtained from the suppliers are safe and effective;

adequate and stable electricity supply is provided for all equipment used in the embryology laboratory, including an adequate number of grounded electrical outlets and an emergency power supply for each piece of equipment that is essential for maintaining the safety, quality, viability and potency of stored reproductive cells or embryos.