Singapore legislation

Regulation 56

of Healthcare Services (Assisted Reproduction Service) Regulations 2023

Regulation 56

Requirements relating to embryology laboratory

Subregulation 1

A licensee must ensure that all of the following requirements are satisfied in relation to the embryology laboratory in each approved permanent premises:

(a)

work in a wet laboratory is not performed in a manner that may adversely affect the handling, manipulation or quality of reproductive cells and embryos;

(b)

every work area where procedures involving the manipulation of reproductive cells or embryos are performed has a controlled environment to ensure the quality and safety of the assisted reproduction procedures;

(c)

entry to the embryology laboratory is restricted to persons authorised by the Clinical Governance Officer, to prevent tampering with any reproductive cell or embryo stored in the embryology laboratory;

(d)

the embryology laboratory is situated at a location that has low human traffic, and with convenient access to the room in which the assisted reproduction procedures are performed;

(e)

the maintenance manual for each laboratory equipment used in the embryology laboratory may be accessed by each personnel authorised to work in the embryology laboratory;

(f)

every procedure in the embryology laboratory is carried out using such equipment or facility that is —

(i)

designed for the purpose that it is used for; and

(ii)

checked and maintained to ensure that the equipment or facility is in good working order at all times.

Subregulation 2

A licensee must keep a record of all checks and maintenance work mentioned in paragraph (1)(f)(ii).