Singapore legislation

Regulation 10

of Healthcare Services (Blood Banking Service) Regulations 2021

Regulation 10

Facilities, equipment, supplies and processes — general

Subregulation 1

A licensee must ensure that all facilities for the following activities are safe, secure, adequate and appropriate for the purposes for which the facilities are used:

(a)

the screening of donors prior to their donation of blood and blood components;

(b)

the collection of blood and blood components from donors;

(c)

the testing, processing, storage and distribution of blood and blood components.

Subregulation 2

The licensee must ensure that all operational processes and workflows for the activities mentioned in paragraph (1) are appropriate and effective in ensuring all of the following:

(a)

the safety and quality of blood and blood components;

(b)

the conduct of the activities mentioned in paragraph (1) in a safe and timely manner;

(c)

the timely resolution of any issue affecting the matters in sub‑paragraph (a) or (b).

Subregulation 3

The licensee must ensure that all equipment and supplies used in or in relation to the provision of the blood banking service are effective in ensuring —

(a)

the safety of donors; and

(b)

the safety of blood and blood components.

Subregulation 4

Without limiting paragraph (3), the licensee must ensure that —

(a)

all equipment —

(i)

is properly installed, tested, calibrated and maintained in accordance with the manufacturer’s specifications; and

(ii)

is repaired or replaced in a timely manner when necessary;

(b)

any equipment which is pending repair or replacement is not used in or in relation to the provision of the blood banking service;

(c)

all reagents and other supplies used in or in relation to the provision of the blood banking service are validated to ensure their suitability for their intended use;

(d)

all supplies that will come into contact with blood or blood components when used in the course of the provision of the blood banking service are single‑use, sterile and free of pyrogens;

(e)

all supplies that may be used in or in relation to the provision of the blood banking service are stored and used in accordance with the manufacturer’s specifications; and

(f)

appropriate and comprehensive policies and procedures for the evaluation, selection and regular review of the following are implemented and complied with:

(i)

the equipment, reagents and other supplies for use in or in relation to the provision of the blood banking service;

(ii)

the licensee’s suppliers of the equipment, reagents and other supplies mentioned in sub‑paragraph (i).

Read in full context — Healthcare Services (Blood Banking Service) Regulations 2021 →