Blood Banking Service

Regulatory requirements

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):

1. Collect

2. Test

3. Process

4. Store

5. 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:

• Provide selected blood banking activities as part of another Licensable Healthcare Service.

• Temporarily store blood or blood components when providing blood transfusion services as part of another Licensable Healthcare Service.

• 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.

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:

   • Reside in Singapore during his or her appointment as a CGO

   • Be a fully registered medical practitioner with the Singapore Medical Council (SMC) and hold a valid practising certificate

   • Be registered as a specialist in haematology or pathology with training in transfusion medicine

   • 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.

   • 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.

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

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

     • An offence involving fraud or dishonesty;

     • An offence under the HCSA, the PHMCA or any applicable Acts listed in the Annex A of the Code of Practice [PDF, 439KB];

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

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

   • Have a pending charge for an offence involving abuse, ill treatment, assault or physical violence

   • Be an undischarged bankrupt

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

   • Have been a director or manager of a healthcare service provider that had its registration or licence suspended, cancelled, or revoked

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

   • 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 [PDF, 439KB].

Licence fee

For Blood Banking Service, the applicable licence fee is determined by the total number of sites (whether offered via permanent premises or conveyances) held by the licensee.

• $7,300 (more than 10 sites)

• $5,500 (10 or fewer sites)