PART 3
OPERATING REQUIREMENTS
Only trained personnel may perform regulated activity
10.—(1)  An approved test provider must ensure that any individual employed or engaged by the approved test provider to perform any relevant sampling activity or any relevant testing activity for an approved test —
(a)is a legally qualified medical practitioner;
(b)is a qualified nurse; or
(c)has undergone training to perform the relevant sampling activity or relevant testing activity for the approved test, conducted by a specified training provider or any person mentioned in sub‑paragraph (a) or (b).
(2)  An approved test provider must ensure that any individual employed or engaged by the approved test provider to perform a relevant assessment activity for an approved test —
(a)is a legally qualified medical practitioner;
(b)is a qualified nurse;
(c)has obtained any of the following qualifications and has, after obtaining his or her qualifications, acquired at least 3 continuous years of practical experience in clinical laboratory work in Singapore:
(i)a degree in Biomedical Science;
(ii)a degree or diploma in Medical Laboratory Science; or
(d)has undergone training to perform the relevant assessment activity for the approved test, conducted by a specified training provider or any person mentioned in sub‑paragraph (a), (b) or (c).
(3)  An approved test provider must ensure that any individual employed or engaged by the approved test provider to supervise another individual performing any self-administered test is a qualified self-administered test supervisor.
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Qualified person to act as supervisor
11.—(1)  The qualified person who endorses the risk assessment mentioned in regulation 5(2)(h)(i) for any premises must supervise the performing of the regulated activity at those premises.
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(2)  Where for any reason the qualified person mentioned in regulation 5(2)(h)(i) or a qualified person appointed under this paragraph ceases to be employed or engaged by the approved test provider, the approved test provider must not perform, or cause or allow to be performed, any regulated activity before the approved test provider appoints another qualified person to replace the firstmentioned qualified person.
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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.
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(1A)  Where an approved test provider provides any service which involves supervising an individual performing a self-administered test, the approved test provider must take such measures to ensure that the self-administered test is performed by an individual only when in the presence of another individual who is a qualified self-administered test supervisor mentioned in regulation 10(3).
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(2)  Subject to regulation 13, where the result of an approved test performed by an approved test provider for an individual is uncertain or invalid (called in this regulation the first result), the approved test provider must —
(a)where sufficient respiratory specimen was removed to perform the relevant testing activity again — perform the relevant testing activity immediately after the first result is ascertained; or
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(b)in any other case —
(i)without delay and in no case more than 2 hours after the first result is available, request the individual to undergo another approved test, within 24 hours after the first result is available; and
(ii)where the individual consents to undergoing another approved test, perform another relevant sampling activity in respect of the individual for the purposes of performing another relevant testing activity, within 24 hours after the first result is available.
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(3)  Where an individual mentioned in paragraph (2) does not consent to undergoing another approved test within 24 hours after the first result is available, the approved test provider must notify the Director immediately upon the expiry of those 24 hours.
(3A)  Subject to regulation 13, where an approved test provider provides any service which involves supervising an individual performing a self-administered test and the result of the self-administered test is uncertain or invalid (called in this regulation the first self-administered test result), the approved test provider must —
(a)where sufficient respiratory specimen was removed for the individual to perform the relevant testing activity again — request the individual to perform the relevant testing activity immediately after the first self-administered test result is ascertained; or
(b)in any other case —
(i)without delay and in no case more than 2 hours after the first self-administered test result is ascertained, request the individual to perform another self-administered test within 24 hours after the first self-administered test result is ascertained; and
(ii)where the individual agrees to perform another self-administered test, supervise the performing by the individual of the self-administered test within 24 hours after the first self-administered test result is ascertained.
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(3B)  Where an individual mentioned in paragraph (3A) does not agree to or does not perform another self-administered test within the period of 24 hours mentioned in paragraph (3A)(b)(i), the approved test provider must notify the Director immediately after the end of that period.
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(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) or (1A), 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.
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Approved test not allowed in certain circumstances
13.—(1)  An approved test provider must not intentionally perform, or intentionally cause or allow to be performed, a regulated activity in respect of an individual whom the approved test provider knows or has reason to suspect —
(a)has at any time —
(i)undergone an approved test or a polymerase chain reaction test in respect of which the last test result is positive for SARS‑CoV‑2;
(ii)undergone 2 or more approved tests in respect of which the test result is uncertain or invalid for 2 consecutive tests; or
(iii)undergone an approved test performed by another approved test provider, or performed a self-administered test supervised by another approved test provider, in respect of which the test result is uncertain or invalid; and
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(b)has not, at any time after sub‑paragraph (a)(i), (ii) or (iii) has occurred —
(i)undergone a polymerase chain reaction test in respect of which the last test result is negative for SARS‑CoV‑2; or
(ii)recovered from a COVID‑19 infection and been certified as having so recovered by a legally qualified medical practitioner in Singapore approved by and in the form specified by the Director.
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(2)  An approved test provider who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 3 months or to both.
Submission of test results to Director
14.—(1)  Where an approved test provider performs a relevant assessment activity, the approved test provider must, no later than 30 minutes after completing the relevant assessment activity and in the manner the Director specifies in accordance with paragraph (2), submit the following information to the Director:
(a)the name of the individual, nationality and other identifying particulars required by the Director;
(b)the date and time that the relevant sampling activity was performed;
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(c)the type of approved test applied to the respiratory specimen;
(d)the results of the approved test.
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(2)  The Director must specify the manner of submitting the information for the purposes of paragraph (1) in a notice to approved test providers and publish (or cause to be published) the notice in such a way the Director considers will bring the notice to the attention of every approved test provider.
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(3)  An approved test provider who is subject to a requirement under paragraph (1) to submit any information to the Director commits an offence if the approved test provider intentionally or negligently submits the information not within the time delimited under that paragraph, and shall be liable on conviction of the offence to a fine not exceeding $3,000.
(4)  An approved test provider who is subject to a requirement under paragraph (1) to submit any information to the Director commits an offence if the approved test provider —
(a)intentionally or negligently contravenes the requirement under paragraph (1); or
(b)intentionally alters, suppresses or destroys any information which the approved test provider is required under paragraph (1) to give,
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.
Informing test subject of results
15.—(1)  An approved test provider providing a service involving the performing of a regulated activity must ensure that the individual from whom a respiratory specimen is removed for an approved test to be applied in the course of that service is given, without delay and in no case more than 2 hours after the approved test result is available, the test result.
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(2)  Where the test result of an approved test performed on an individual by an approved test provider shows the presence of SARS‑CoV‑2 in that individual, the approved test provider must, without delay and in no case more than 24 hours after the approved test result is available, issue the prescribed notice to the individual.
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(3)  Where the test result of an approved test performed on an individual by an approved test provider is uncertain or invalid and the approved test provider knows or has reason to suspect that the individual had undergone another approved test earlier in respect of which the test result is also uncertain or invalid, the approved test provider must, without delay and in no case more than 24 hours after the approved test result is available, issue the prescribed notice to the individual.
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(4)  Where the approved test provider, for any reason, fails to or is unable to issue the prescribed notice to the individual under paragraph (2) or (3), the approved test provider must notify the Director immediately upon the expiry of 24 hours after the approved test result is available.
(5)  In this regulation, a reference to an individual includes a reference to —
(a)where the individual is a minor, the individual’s parent or guardian; or
(b)where the individual is under the care of another person, the person who has such care.
Safety systems
16.  An approved test provider must establish and maintain a safety system consisting of the following:
(a)safety policy and objectives:
(i)the approved test provider’s commitment to safety;
(ii)the responsibilities of trained personnel employed or engaged by the approved test provider, and their safety accountability;
(iii)the documentation of the safety system;
(b)safety risk assessment:
(i)the identification of hazards;
(ii)the safety risk assessment and mitigation;
(c)safety assurance:
(i)the measuring and monitoring of safety performance;
(ii)the continuous improvement of the safety system;
(d)safety promotion:
(i)the training and education regarding safety management;
(ii)the communication on safety.
Use of reagents and other materials
17.—(1)  An approved test provider must ensure that reagents (including quality control materials) that are used in the course of providing a service involving approved tests are —
(a)registered or provisionally approved by the Health Sciences Authority under the Health Products Act (Cap. 122D);
(b)stored and used under the conditions specified by the manufacturer;
(c)handled in a manner that minimises deterioration or exposure to the environment;
(d)not used beyond the shelf life or expiry date, whichever is earlier; and
(e)labelled with the date of opening and shelf life once opened for use.
(2)  For each reagent that is used, the approved test provider must ensure that the following information is recorded and retained for a period of 2 years after the date it is first opened for use:
(a)the lot number;
(b)the expiry date;
(c)the personnel who prepared the reagent.