Singapore legislation

Regulation 34

of Healthcare Services (Nuclear Medicine Service) Regulations 2023

Regulation 34

Testing of specimens

Subregulation 1

Except as provided in this regulation, a licensee must not, in relation to the provision of a nuclear medicine service, test any specimen derived from a patient unless all of the following conditions are satisfied:

(a)

the testing of the specimen is incidental to the provision of the nuclear medicine service;

(b)

the testing of the specimen only involves the conduct of a simple in vitro diagnostic test;

(c)

a medical practitioner who is a personnel of the licensee orders the test for the patient.

Subregulation 2

A licensee may, in relation to the provision of a nuclear medicine service for an in vivo assay purpose, test any specimen derived from a patient if all of the following conditions are satisfied:

(a)

the specimen must not be subject to more than minimal manipulation;

(b)

the testing must be conducted using beta scintillation or gamma counting.

Subregulation 3

In paragraph (2), “minimal manipulation” —

(a)

includes all or any of the following:

(i)

measurement;

(ii)

separation;

(iii)

sterilisation;

(iv)

concentration;

(v)

purification; and

(b)

does not include any of the following:

(i)

cell culturing;

(ii)

cutting or sizing;

(iii)

grinding;

(iv)

shaping;

(v)

soaking in an antibiotic or antimicrobial solution;

(vi)

irradiation;

(vii)

lyophilisation;

(viii)

freezing;

(ix)

cryopreservation;

(x)

vitrification.

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