Clinical Laboratory Service

When is a Clinical Laboratory Service licence needed?

You will require a Clinical Laboratory Service licence if you perform any of the following purposes:

1. Assessing the health or genetic predisposition of that individual or any other individual;
2. Predicting or providing a prognosis of the health condition of that individual or any other individual;
3. Diagnosing any condition, disability, disease, disorder or injury of that individual or any other individual;
4. Determining the intervention to be taken, or the effect of any intervention taken, of any condition, disability, disease, disorder or injury of an individual;
5. Ascertaining the result of a medical or surgical treatment given so that individual or any other individual;
6. Assessing the health, condition or suitability of any human biological material that is used, or is intended to be used, in relation to any healthcare services.

This includes the storage or distribution of any blood or blood component incidental to the examination or testing of the blood or blood component for a purpose specified under points (1) to (6) above.

You will not require a Clinical Laboratory Service licence if you:

1. Test any specimens using a simple in vitro diagnostic (IVD) test, where the testing is incidental to the care provided to your patients in your licensable healthcare service (e.g., point of care glucose or pregnancy testing in an Outpatient Medical Service or Radiological Service).
2. Examine a breath sample for its physical properties (e.g., volume or air flow rate as part of a pulmonary function test in an Outpatient Medical Service).
3. Examine or test any specimens for non-clinical purposes (e.g., research or epidemiology study purposes).
4. Collect and/or transport specimens only (e.g., phlebotomy services).
5. Test any blood for the purposes of ensuring its suitability for transfusion in a Blood Banking Service.
6. Test any cord blood for the purposes of ensuring its suitability for transplant or storage in a Cord Blood Banking Service. 

For the legal definition of a Clinical Laboratory Service, please refer to the First Schedule of the Act.

Note: Although a Clinical Laboratory 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). 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 hold a valid practising certificate

c. Be registered as a specialist in –

• Pathology; or
• Haematology, with the following qualifications –

i. A pass in the Fellowship of the Royal College of Pathology Part 1 and Part 2 examinations or other equivalent exit examinations from a professional board approved by the Director-General; and

ii. At least 5 years of work experience in a clinical laboratory licensed under the Private Hospitals and Medical Clinics Act 1980 or in the provision of a clinical laboratory service licensed under this Act, or another equivalent clinical laboratory outside of Singapore approved by the Director-General.

iii. For further details on the qualifications, skills and competencies of a CGO, please refer to Section 5 of the Clinical Laboratory 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.