Singapore legislation

Regulation 13

of Healthcare Services (Blood Banking Service) Regulations 2021

Regulation 13

Collection of blood and blood components

Subregulation 1

A licensee must ensure that the collection of blood and blood components is conducted by or under the supervision of one or more qualified, trained and competent personnel.

Subregulation 2

The licensee must ensure that the collection of blood and blood components is carried out in a manner that ensures the traceability, safety and suitability for use of the blood or blood components collected.

Subregulation 3

Without limiting paragraph (2), the licensee must —

(a)

before collecting any blood or blood component from a donor, verify the identity of the donor and match that identity to the record relating to that donor made and maintained by the licensee in accordance with these Regulations;

(b)

ensure that each unit of blood or blood component collected from the donor is labelled with the correct donation identification number at all times; and

(c)

ensure that aseptic techniques are used during the collection of blood or blood components from the donor.

Subregulation 4

The licensee must, in relation to each donor, ensure that —

(a)

the collection of blood or blood components from the donor is carried out in a manner that is safe and causes minimal discomfort to the donor; and

(b)

the donor is adequately monitored and managed by one or more personnel after the collection of blood or blood components, and is discharged only when it is safe for the donor.

Subregulation 5

The licensee must ensure that appropriate processes are implemented to ensure a swift and appropriate response to any injury sustained by any donor, or any incident affecting the safety or health of any donor or any personnel that occurs, in the course of the collection of blood and blood components, including the rapid activation of emergency medical services.

Subregulation 6

Where any blood or blood component is found to be infected by a specified infectious disease or any other infectious disease that is likely to adversely affect the health of the donor of the blood or blood component, the licensee —

(a)

must inform the donor of that fact in a timely manner, and provide the donor with appropriate information relating to the clinical follow‑up for that infectious disease; and

(b)

maintain accurate and complete records of all such donors.