Singapore legislation

Regulation 17

of Healthcare Services (Blood Banking Service) Regulations 2021

Regulation 17

Requirements relating to storage, quarantine, distribution, etc., of blood and blood components

Subregulation 1

The licensee must have in place proper and appropriate equipment and processes for the secure storage of blood and blood components, starting from the time the blood or blood component is collected from a donor and ending at the time the blood or blood component is delivered to a specified person or is otherwise disposed of.

Subregulation 2

Without limiting paragraph (1), the licensee must implement and maintain a quarantine and storage system that segregates blood and blood components that have not been tested for their suitability for clinical use from any other blood and blood components in the possession or under the control of the licensee.

Subregulation 3

The licensee must ensure that all blood and blood components are handled, stored and transported in a manner that preserves their integrity and quality for safe and effective clinical use.

Subregulation 4

Without limiting paragraph (3), the licensee must take all reasonable steps to ensure —

(a)

the cold chain for the transportation of the blood or blood component is maintained at all times; and

(b)

any person engaged by the licensee to transport the blood or blood component is trained and competent to handle biohazardous substances.

Subregulation 5

The licensee must implement and maintain appropriate processes for the purposes of compliance with the requirements under this regulation.