Singapore legislation

Regulation 2

of Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021

Regulation 2

Definitions

Amended byS 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023S 417/2023 wef 26/06/2023

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;“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;“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);“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;“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;“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;“laboratory discipline” means any laboratory discipline set out in paragraph 1(a) of Part 1 of the Schedule;“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;“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;“radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007;“radiological service” has the meaning given by paragraph 2 of the First Schedule to the Act;“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;“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;[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;“specimen” has the meaning given by regulation 2 of the General Regulations;“temporary premises” means any premises other than permanent premises;“test” means an analysis or examination of a specimen conducted by a licensee in connection with the provision of a clinical laboratory service;“testing material” means any test kit, material, device, equipment, instrument or other article that is used to conduct a simple in vitro diagnostic test;“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.

Definition

“applicable service” means a clinical laboratory service or a radiological service, as the case may be;

Definition

“business name” has the meaning given by regulation 48(2) of the General Regulations;

Definition

“calendar day” includes Saturday, Sunday and every public holiday;

Amended byS 417/2023 wef 26/06/2023

Definition

“Clinical Governance Officer” means a Clinical Governance Officer appointed by a licensee under section 24(2) of the Act;

Definition

“clinical laboratory service” has the meaning given by paragraph 2 of the First Schedule to the Act;

Amended byS 417/2023 wef 26/06/2023

Definition

“clinical laboratory service licensee” means a person who holds a licence to provide a clinical laboratory service;

Definition

“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);

Amended byS 417/2023 wef 26/06/2023

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“laboratory discipline” means any laboratory discipline set out in paragraph 1(a) of Part 1 of the Schedule;

Amended byS 417/2023 wef 26/06/2023

Definition

“laboratory discipline” has the meaning given by regulation 4(4);

Definition

“licence” means a licence under the Act authorising the licensee to provide an applicable service;

Definition

“licensee” means a clinical laboratory service licensee or a radiological service licensee;

Definition

“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;

Definition

“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing the applicable service;

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“radioactive substance” has the meaning given by section 2(1) of the Radiation Protection Act 2007;

Amended byS 417/2023 wef 26/06/2023

Definition

“radiological service” has the meaning given by paragraph 2 of the First Schedule to the Act;

Amended byS 417/2023 wef 26/06/2023

Definition

“radiological service licensee” means a person who holds a licence to provide a radiological service;

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“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;

Amended byS 417/2023 wef 26/06/2023

Definition

“simple in vitro diagnostic test” has the meaning given by paragraph 2 of the First Schedule to the Act;

Amended byS 417/2023 wef 26/06/2023

Definition

“specimen” has the meaning given by regulation 2 of the General Regulations;

Amended byS 417/2023 wef 26/06/2023

Definition

“temporary premises” means any premises other than permanent premises;

Amended byS 417/2023 wef 26/06/2023

Definition

“test” means an analysis or examination of a specimen conducted by a licensee in connection with the provision of a clinical laboratory service;

Amended byS 417/2023 wef 26/06/2023

Definition

“testing material” means any test kit, material, device, equipment, instrument or other article that is used to conduct a simple in vitro diagnostic test;

Amended byS 417/2023 wef 26/06/2023

Definition

“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.

Amended byS 417/2023 wef 26/06/2023