PART 1 | Citation and commencement |
| 1. These Regulations are the Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021 and come into operation on 3 January 2022. |
2. In these Regulations, unless the context otherwise requires —| “applicable service” means a clinical laboratory service or a radiological service, as the case may be; |
| “business name” has the meaning given by regulation 48(2) of the General Regulations; |
| “calendar day” includes Saturday, Sunday and every public holiday; [S 417/2023 wef 26/06/2023] |
| “Clinical Governance Officer” means a Clinical Governance Officer appointed by a licensee under section 24(2) of the Act; |
| “clinical laboratory service” has the meaning given by paragraph 2 of the First Schedule to the Act; [S 417/2023 wef 26/06/2023] |
| “clinical laboratory service licensee” means a person who holds a licence to provide a clinical laboratory service; |
| “collaborative prescribing practitioner” has the meaning given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023); [S 417/2023 wef 26/06/2023] |
“expiry date”, in relation to any reagent or testing material, means —| (a) | the date after which; or | | (b) | the month and year after the end of which, |
| as the case may be, the reagent or testing material should not be used; |
[S 417/2023 wef 26/06/2023] |
| “General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021); |
“imaging modality” means —| (a) | any imaging modality set out in paragraph 1(a) of Part 2 of the Schedule; | | (b) | bone densitometry; or | | (c) | ultrasound; |
[S 417/2023 wef 26/06/2023] |
“imaging service” means the use of ionising or non ionising radiation for any of the following purposes:| (a) | examination of the body, or any matter derived from the body, of an individual; | | (b) | assessment of the health or condition of an individual; | | (c) | observation and diagnosis of a condition, disability, disease, disorder or an injury of the body or mind of an individual; | | (d) | determining, predicting or providing a prognosis of the health or condition of an individual; |
[S 417/2023 wef 26/06/2023] |
| “laboratory discipline” means any laboratory discipline set out in paragraph 1(a) of Part 1 of the Schedule; [S 417/2023 wef 26/06/2023] |
| “laboratory discipline” has the meaning given by regulation 4(4); |
| “licence” means a licence under the Act authorising the licensee to provide an applicable service; |
| “licensee” means a clinical laboratory service licensee or a radiological service licensee; |
“patient” —| (a) | in relation to a clinical laboratory service licensee, means the individual from whose body a specimen is derived for testing by or on behalf of the licensee; or | | (b) | in relation to a radiological service licensee, means the individual for whom a radiological examination is performed by or on behalf of the licensee; |
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| “personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing the applicable service; |
“radioactive specimen” means any specimen —| (a) | on which a radioactive substance is applied for the purpose of a test or examination of the specimen; or | | (b) | that is derived, obtained or excreted from an individual who was administered a radiopharmaceutical for the purpose of testing or examining the specimen, whether or not the specimen contains any radioactive substance; |
[S 417/2023 wef 26/06/2023] |
| “radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007; [S 417/2023 wef 26/06/2023] |
| “radiological service” has the meaning given by paragraph 2 of the First Schedule to the Act; [S 417/2023 wef 26/06/2023] |
| “radiological service licensee” means a person who holds a licence to provide a radiological service; |
| “radiopharmaceutical” means any unsealed source (within the meaning given by regulation 2 of the Radiation Protection (Ionising Radiation) Regulations 2023 (G.N. No. S 85/2023)) that is administered to a patient as a diagnostic agent; [S 417/2023 wef 26/06/2023] |
“requestor”, in relation to a patient, means —| (a) | the medical practitioner, dentist or collaborative prescribing practitioner who ordered a test or radiological examination for the patient; or | | (b) | any person who is approved by the Director-General to request a licensee to conduct a test for the patient without a referral by a medical practitioner, dentist or collaborative prescribing practitioner; [S 417/2023 wef 26/06/2023] |
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| [Deleted by S 417/2023 wef 26/06/2023] |
| [Deleted by S 417/2023 wef 26/06/2023] |
| [Deleted by S 417/2023 wef 26/06/2023] |
| “simple in vitro diagnostic test” has the meaning given by paragraph 2 of the First Schedule to the Act; [S 417/2023 wef 26/06/2023] |
| “specimen” has the meaning given by regulation 2 of the General Regulations; [S 417/2023 wef 26/06/2023] |
| “temporary premises” means any premises other than permanent premises; [S 417/2023 wef 26/06/2023] |
| “test” means an analysis or examination of a specimen conducted by a licensee in connection with the provision of a clinical laboratory service; [S 417/2023 wef 26/06/2023] |
| “testing material” means any test kit, material, device, equipment, instrument or other article that is used to conduct a simple in vitro diagnostic test; [S 417/2023 wef 26/06/2023] |
“testing service” means the examination or testing of any matter derived, obtained or excreted from the body of any individual for the purpose of —| (a) | assessing the health or genetic predisposition of that individual or any other individual; | | (b) | predicting or providing a prognosis of the health condition of that individual or any other individual; | | (c) | diagnosing a condition, disability, disease, disorder or an injury of the body or mind of that individual or any other individual; | | (d) | determining the intervention to be taken, or the effect of any intervention taken, of a condition, disability, disease, disorder or an injury of the body or mind of an individual; | | (e) | ascertaining the result of a medical or surgical treatment given to that individual or any other individual; or | | (f) | 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 service. |
[S 417/2023 wef 26/06/2023] |
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| Application of Regulations |
3. Unless otherwise expressly provided in these Regulations —| (a) | the provisions of these Regulations apply in addition to the provisions of the General Regulations; and | | (b) | the provisions of these Regulations prevail if, and to the extent that, there is any inconsistency between these Regulations and the General Regulations insofar as the matter relates to a licensee. |
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4. For the purposes of section 9A(1) of the Act —| (a) | the services set out in Part 1 of the Schedule are specified services for a clinical laboratory service; and | | (b) | the services set out in Part 2 of the Schedule are specified services for a radiological service. |
[S 417/2023 wef 26/06/2023] |
| Notification of certain imaging modalities |
4A.—(1) For the purposes of section 10(2)(c)(viii) of the Act, an applicant for the grant or renewal of a licence to provide a radiological service must specify in the licence application whether the applicant provides, or intends to provide an imaging service by bone densitometry or ultrasound as part of that service.| (2) A radiological service licensee who, during the term of the licence, intends to provide an imaging service by bone densitometry or ultrasound as part of the radiological service must, no later than 2 months before the licensee intends to start providing the imaging service by that imaging modality, give written notice to the Director-General of the licensee’s intention. |
| (3) A radiological service licensee who, during the term of the licence, intends to stop providing an imaging service by bone densitometry or ultrasound as part of the radiological service must, no later than 10 calendar days before the licensee intends to stop providing the imaging service by that imaging modality, give written notice to the Director-General of the licensee’s intention. |
[S 417/2023 wef 26/06/2023] |
| Prohibited service delivery modes |
4B.—(1) A licensee must not provide a clinical laboratory service or radiological service by remote provision.(2) A clinical laboratory service licensee must not provide any of the following specified services using a conveyance or at temporary premises:| (a) | a testing service in a laboratory discipline specified in paragraph 1(a)(i), (iv), (v), (vii), (ix), (x) or (xi) of Part 1 of the Schedule; | | (b) | a test set out in paragraph 1(b)(iii), (iv) or (v) of Part 1 of the Schedule. |
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(3) A radiological service licensee must not provide any of the following specified services using a conveyance or at temporary premises:| (a) | an imaging service by an imaging modality specified in paragraph 1(a)(iii), (iv), (v) or (vi) of Part 2 of the Schedule; | | (b) | a procedure set out in paragraph 1(b) of Part 2 of the Schedule. |
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[S 417/2023 wef 26/06/2023] |
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