Blood Banking Service

When is a Blood Banking Service licence needed?

You will require a Blood Banking Service licence if you perform any or all of the following activities on blood or blood components (see exceptions below):

a. Collect,
b. Test,
c. Process,
d. Store,
e. Distribute

Currently, the Health Sciences Authority is the only licensed blood bank in Singapore.

You will not require a Blood Banking Service licence if you:

a. Provide selected blood banking activities as part of another licensable healthcare service.
b. Temporarily store blood or blood components when providing blood transfusion services as part of another licensable healthcare service.
c. Handle, process, test and distribute cord blood as cord blood banking is a separate licensable healthcare service under HCSA. (see Cord Blood Banking Service).

For the legal definition of a Blood Banking Service, please refer to the First Schedule of the Act.

Note: Although a Blood Banking Service licence may not be applicable for your service, your service may still be subject to regulation as another Licensable Healthcare Service under the Healthcare Services Act (HCSA) (e.g. transfusion medicine under a clinical laboratory service licence, blood transfusion under an acute hospital service licence). Please refer to the list of Licensable Healthcare Services for more information.

Applicable Specified Services and Mode of Service Delivery

Requirements to be a Clinical Governance Officer

An individual must be in good standing and fulfil all of the criteria below to be appointed as a Clinical Governance Officer (CGO).

1. For an individual to fulfil the requirements to be a CGO, he or she must:

a. Reside in Singapore during his or her appointment as a CGO,

b. Be a fully registered medical practitioner with SMC and holds a valid practising certificate 3. Be registered as a specialist in

c. Be registered as a specialist in - 

• Haematology; or
• Pathology with training in transfusion medicine

d. Have at least 5 years of work experience in Singapore in:

• Transfusion medicine in an acute hospital setting; or
• Any other area relevant to the provision of a Blood Banking Service in Singapore.

e. Not be subject to either a decision, or an order made under Part 7 of the Medical Registration Act 1997 by a Disciplinary Tribunal appointed under that Act, in the 3 years prior to the appointment.

For further details on the qualifications, skills and competencies of a CGO, please refer to Section 5 of the Blood Banking Service Regulations.

2. For an individual to fulfil the suitability qualifications to be a CGO, he or she must not:

a. Have any of the following convictions, unless it is a spent conviction:

i. An offence involving fraud or dishonesty

ii. An offence under the HCSA, the PHMCA or any applicable Acts listed in the Annex A of the Code of Practice;

iii. An offence specified in the Third Schedule to the Registration of Criminals Act; or

iv. Any other offence involving abuse, ill treatment, assault, or physical violence

b. Have a pending charge for an offence under 2a(iv).

c. Be an undischarged bankrupt,

d. Have had his or her healthcare professional registration(s) under MOH cancelled, removed, or suspended

e. Have been a director or manager of a healthcare services provider that had its registration or licence suspended, cancelled, or revoked

f. Have had his or her accreditation or approval to participate in MOH-administered public schemes revoked or suspended

g. Lack capacity within the meaning of the Mental Capacity Act 2008.

For further details on the suitability requirements for a Key Office Holder, please refer to the Code of Practice.