Requirements for how regulated activity is performed
12.—(1) An approved test provider must take such measures to ensure that —
(a)
any relevant sampling activity removing a respiratory specimen for testing using a test product specified in the first column of the Schedule; or
(b)
any relevant sampling activity performed by an individual on himself or herself for the purpose of removing a respiratory specimen for testing using a test product specified in the first column of the Schedule,
is performed in accordance with the method specified opposite the test product in the second column of that Schedule.
[S 591/2021 wef 10/08/2021]
(1A) Where an approved test provider provides any service which involves in-person supervision of a self-administered test, the duty of the approved test provider is to take measures to ensure that the self-administered test is performed by the supervised subject only when the supervised subject is in the presence of a self-administered test supervisor who is a qualified self-administered test supervisor mentioned in regulation 10(3).
[S 38/2022 wef 21/01/2022]
(2) Where an approved test provider provides any service which involves remote supervision of a self-administered test, it is the duty of the approved test provider to take measures to ensure compliance with all the following:
(a)
a self-administered test supervisor is, at all times during the self-administered test for a supervised subject, located in a room or an enclosed place which is designed or constructed such that the following information cannot be seen or heard by anyone who is not involved (directly or indirectly) with remote supervision of self-administered tests:
(i)
the identity of the supervised subject performing the self-administered test;
(ii)
the results of the self-administered test;
(iii)
any other medical information pertaining to the supervised subject in connection with the self-administered test;
(b)
a self-administered test supervisor ascertains and records accurately all of the following in order for the approved test provider to satisfy regulation 14:
(i)
the particulars of identity of every supervised subject the self-administered test supervisor has performed a remote supervision of a self-administered test;
(ii)
the date and time every such self-administered test started and ended;
(iii)
the results of every self-administered test supervised but not if sub-paragraph (d) was not or cannot be complied with in respect of any such test;
(c)
a self-administered test supervisor must, immediately before the start of a self-administered test by a supervised subject —
(i)
require the supervised subject to show the self-administered test supervisor that the packaging of the test product to be used by the supervised subject for the self-administered test is undamaged or otherwise satisfy the self-administered test supervisor that the test product is new and has not been earlier opened; and
(ii)
be satisfied that the supervised subject will be performing the self-administered test using a stable and flat surface on which the test product and all its components may be placed throughout the test;
(d)
a self-administered test supervisor has and maintains an unobstructed line of sight of —
(i)
the test product used by the supervised subject for the self-administered test and all its components, from the start to the end of a self-administered test by a supervised subject;
(ii)
the face of the supervised subject, from the start of the supervised subject undergoing the relevant sampling activity to the end of the relevant testing activity;
(iii)
the supervised subject when performing the relevant testing activity; and
(iv)
the results of the self-administered test in order to ascertain those results for the relevant assessment activity.
[S 38/2022 wef 21/01/2022]
(3) It is the duty of every approved test provider to ensure that any test product that is used in the performance of any regulated activity provided, or caused or allowed to be provided, by the approved test provider in the course of business, is used in a manner that is in conformity with the directions of the manufacturer of the test product.
[S 38/2022 wef 21/01/2022]
(2) [Deleted by S 767/2021 wef 11/10/2021]
(3) [Deleted by S 767/2021 wef 11/10/2021]
(3A) [Deleted by S 767/2021 wef 11/10/2021]
(3B) [Deleted by S 767/2021 wef 11/10/2021]
(4) An approved test provider commits an offence if the approved test provider intentionally or negligently contravenes any duty imposed on the approved test provider under paragraph (1), (1A), (2) or (3), and shall be liable on conviction of the offence to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 3 months or to both.