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

No. S 1036

Healthcare Services Act 2020

(ACT 3 OF 2020)

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

In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:

PART 1

PRELIMINARY

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.

Definitions

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;

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“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);

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“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;

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“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;

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“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;

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

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“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;

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

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

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“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;

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“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;

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

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

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

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

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

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“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.

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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.

Specified services

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.

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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.

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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.

(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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PART 2

REQUIREMENTS RELATING TO PERSONNEL

Skills and competencies of Clinical Governance Officer for clinical laboratory service

5.  For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed a Clinical Governance Officer for a clinical laboratory service if the individual has —

(a) all of the following skills and competencies:

(i) registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;

(ii) registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of pathology; or

(b) all of the following skills and competencies:

(i) registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;

(ii) registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of haematology;

(iii) a pass in the Fellowship of the Royal College of Pathology Part 1 and Part 2 examinations or other equivalent exit examinations from a professional board approved by the Director-General;

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(iv) at least 5 years of work experience in a clinical laboratory licensed under the repealed Act or in the provision of a clinical laboratory service licensed under this Act, or another equivalent clinical laboratory outside of Singapore approved by the Director-General.

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[S 842/2023 wef 18/12/2023]

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Skills and competencies of Clinical Governance Officer for radiological service

6.—(1)  For the purposes of section 24(3)(b) of the Act and subject to paragraph (2), an individual who has all of the following skills and competencies is suitably qualified to be appointed a Clinical Governance Officer for a radiological service:

(a) registration under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;

(b) registration under section 22 of the Medical Registration Act 1997 as a specialist in the branch of diagnostic radiology;

(c) at least 5 years of work experience after obtaining the qualification mentioned in sub‑paragraph (b), in providing a radiological service.

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(2)  Where a licensee provides a radiological service only for dental purposes, the licensee may appoint a person registered under section 14 of the Dental Registration Act 1999 as a Clinical Governance Officer for the radiological service.

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Additional duties and responsibilities of Clinical Governance Officer

7.—(1)  In addition to regulation 14 of the General Regulations, a Clinical Governance Officer appointed by a clinical laboratory service must —

(a) before the provision of any test or implementation of any test method, evaluate whether the test or test method performs in accordance with the manufacturer’s specifications (if any) and produces accurate results; and

(b) implement and oversee the safety programme mentioned in regulation 14.

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(2)  In addition to regulation 14 of the General Regulations, a Clinical Governance Officer appointed by a radiological service must —

(a) before the provision of an imaging modality as part of the service, evaluate whether the imaging modality produces images of diagnostic quality; and

(b) implement and oversee the safety programme mentioned in regulation 14.

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Licensee must appoint section leader

8.—(1)  A clinical laboratory service licensee must, in relation to each specified service provided by the licensee, appoint as the section leader, a person who resides in Singapore.

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(2)  A radiological service licensee must, in relation to each imaging modality or specified service provided by the licensee, appoint as the section leader a radiographer —

(a) who resides in Singapore;

(b) who is registered under section 16 of the Allied Health Professions Act 2011; and

(c) who has at least 3 years of work experience in providing a radiological service in the imaging modality or specified service.

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(3)  A person may be appointed as a section leader —

(a) in relation to a clinical laboratory service — for more than one specified service; or

(b) in relation to a radiological service — for more than one imaging modality or specified service.

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(4)  A Clinical Governance Officer may be appointed as a section leader.

Duties of section leader

9.  A licensee must ensure that every section leader appointed under regulation 8 does all of the following in relation to the imaging modality or specified service for which the section leader is appointed:

(a) assist the relevant Clinical Governance Officer in the day‑to‑day technical management of the imaging modality or specified service;

(b) supervise, train and guide each personnel under the charge of the section leader in conducting tests or radiological examinations under that imaging modality or specified service;

(c) assess and ensure the competency of each personnel deployed to perform tasks for that imaging modality or specified service;

(d) evaluate any test or equipment before it is used in the provision of the applicable service;

(e) monitor the performance of all tests or radiological procedures carried out under the imaging modality or specified service that the section leader is appointed for, including ensuring the implementation of quality control measures;

(f) establish and review policy and procedures for the safe and effective performance of all tests or radiological procedures carried out under the imaging modality or specified service for which the section leader is appointed;

(g) resolve any technical issues that arise from the performance of all tests or radiological procedures carried out under the imaging modality or specified service that the section leader is appointed for;

(h) review all service records in relation to the tests or radiological procedures carried out under the imaging modality or specified service for which the section leader is appointed.

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General requirements relating to personnel

10.—(1)  A licensee must ensure all of the following in relation to each personnel:

(a) each personnel is adequately trained for the work performed by the personnel and attends regular training in accordance with a continuing training programme;

(b) each personnel has the relevant awareness and knowledge of, and attends regular training on, clinical laboratory safety measures or radiation safety, as the case may be;

(c) each personnel is assessed periodically on the personnel’s competencies and work performance;

(d) each of the following personnel is supervised by an experienced person when performing any task or providing any service in relation to the applicable service:

(i) for a clinical laboratory service licensee — any personnel with less than 2 years of work experience in providing a clinical laboratory service;

(ii) for a radiological service licensee — any personnel with less than one year of work experience in providing a radiological service;

(iii) any personnel who has not been assessed by the relevant section leader or Clinical Governance Officer to be able to perform the task or provide the service competently without supervision.

(2)  In this regulation, “experienced person” means —

(a) the Clinical Governance Officer or the relevant section leader;

(b) for a clinical laboratory service licensee — another of the licensee’s personnel with at least 5 years of relevant work experience and who is designated by the Clinical Governance Officer or the relevant section leader to provide supervision; or

(c) for a radiological service licensee — another of the licensee’s personnel with at least 3 years of relevant work experience and who is designated by the Clinical Governance Officer or the relevant section leader to provide supervision.

PART 3

PROCESSES, EQUIPMENT AND FITTINGS

Quality management system

11.—(1)  A licensee must establish and implement a quality management system in accordance with this regulation for the purposes of quality assessment and assurance of the clinical laboratory service or radiological service provided by the licensee.

(2)  Without limiting paragraph (1), the quality management system mentioned in paragraph (1) must provide for all of the following:

(a) implementation of a system for appropriate accountability, roles, responsibilities and continuing educational programmes;

(b) measures to ensure that the provision of the service complies with any written law governing the service and licence conditions imposed under section 13(1) of the Act;

(c) implementation of protocols to ensure compliance with Parts 4 to 6 and for the physical safety of the licensee’s personnel, patients and visitors;

(d) identification of key performance indicators for assessing performance outcomes of the applicable service, including mechanisms for periodic monitoring and evaluation of these indicators;

(e) quality control measures for equipment used in the provision of the applicable service, including acceptance testing, quality control tests and regular monitoring of equipment performance;

(f) quality control measures for all specimens or radiological images kept or tested by the licensee, as the case may be;

(fa) where the licensee provides any testing service on radioactive specimens —

(i) quality control measures for all radioactive substances kept and used by the licensee, including measures pertaining to —

(A) the acceptance, or rejection for quality or safety reasons, of all radioactive substances supplied to the licensee;

(B) the safe and proper preparation, handling, transport and use of the radioactive substances; and

(C) the regular testing of the quality and safety of the radioactive substances;

(ii) the maintenance of adequate and accurate documentation on the licensee’s use of radioactive substances;

(iii) the conduct of regular holistic analysis and reviews of all information relating to —

(A) the quality and safety of all radioactive substances kept and used by the licensee; and

(B) the applicable licensee’s use of all radioactive substances; and

(iv) the testing and monitoring of the radiation levels in every approved permanent premises to ensure the safety of personnel, patients and visitors;

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(g) systems and processes to ensure that regulation 32 is complied with;

(h) the investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the service;

(i) the identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub‑paragraph (h) and prevent a recurrence;

(j) the conduct of regular risk assessments of every activity conducted as part of the provision of the applicable service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments;

(k) validation of test methods and imaging procedures, as the case may be;

(l) validation of all processes relating to the performance of a test or radiological examination, as the case may be;

(m) a system to ensure the appropriate and adequate documentation of all quality assurance measures, policies and processes, which includes all of the following features:

(i) regular creation, review and updating of the documentation;

(ii) document control procedures;

(iii) processes to ensure that each personnel complies with sub‑paragraphs (i) and (ii).

(3)  A licensee must review the effectiveness of the quality management system for the applicable service on an annual basis and ensure that the quality management system is updated periodically.

(4)  In addition, a clinical laboratory service licensee must —

(a) participate in and perform satisfactorily for the relevant external quality assessment programme for every test provided by the licensee; and

(b) ensure that the Clinical Governance Officer or such other suitably qualified personnel designated by the Clinical Governance Officer reviews the results of the quality assessment programmes mentioned in sub‑paragraph (a) and implements appropriate and effective actions to address any weakness or inadequacy in the provision of the clinical laboratory service.

Equipment and fittings

12.—(1)  A licensee must ensure that —

(a) every approved permanent premises, approved conveyance and temporary premises where the applicable service is provided has adequate space for the licensee to carry out the applicable service in a safe manner;

(b) every approved permanent premises or approved conveyance is adequately secured to prevent unauthorised access to the approved permanent premises or approved conveyance; and

(c) every temporary premises (other than any residential premises) at which the applicable service is provided is adequately secured to prevent unauthorised access to the premises.

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(2)  A licensee must ensure that all of the following requirements are satisfied:

(a) in relation to the storage of reagents, specimens or other materials and supplies used the provision of the applicable service —

(i) adequate storage space at every approved permanent premises, approved conveyance or temporary premises where the applicable service is provided;

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(ii) the storage space provided is adequately secured; and

(iii) effective measures are in place to prevent any damage to, deterioration of, or unauthorised access to and use of, the reagents, specimens and other materials and supplies;

(b) adequate decontamination equipment is provided at every approved permanent premises, approved conveyance or temporary premises where the applicable service is provided to ensure the safety of all personnel, patients and visitors, and prevent any contamination of specimens;

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(c) appropriate safety equipment is provided in every approved permanent premises, approved conveyance or temporary premises where the applicable service is provided;

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(d) an adequate number of first-aid kits for emergency use that are readily accessible to all personnel.

(3)  Where a licensee provides any testing service on radioactive specimens, the licensee must also ensure that all of the following requirements are satisfied:

(a) in relation to the receipt, use, preparation, storage and disposal of radioactive substances —

(i) adequate space is provided at every approved permanent premises; and

(ii) the space provided is secure and access to the space is controlled;

(b) appropriate radiation shielding is provided at any part of every approved permanent premises where procedures involving the handling and use of radioactive substances are performed;

(c) every approved permanent premises complies with the requirements of, and is approved for use in accordance with, any written law relating to the preparation, storage, possession, use and disposal of radioactive substances.

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Additional requirements where applicable service provided using approved conveyances or at temporary premises

12A.—(1)  This regulation applies to a licensee that is approved to provide an applicable service using an approved conveyance or at temporary premises.

(2)  The licensee must establish a post-relocation commissioning process to ensure the following:

(a) that each piece of equipment used in every approved conveyance or temporary premises is adequate, functional and effective by recalibrating the equipment;

(b) that any reagent used for the provision of the applicable service remains safe, suitable and effective for use.

(3)  A licensee must implement the post-relocation commissioning process mentioned in paragraph (2) each time before a licensee first provides the applicable service —

(a) after the approved conveyance is moved to a new location; or

(b) at any temporary premises.

(4)  The licensee must establish and implement protocols for the management of any hazardous materials or waste, that are specific to each approved conveyance or temporary premises.

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Services may be provided to patients only where ordered by requestor

13.  In the provision of an applicable service, a licensee must not —

(a) conduct a test for a patient who resides in Singapore; or

(b) conduct a radiological examination in Singapore for a patient,

unless a requestor orders the test or radiological examination for the patient.

PART 4

SAFETY REQUIREMENTS

Safety programme

14.—(1)  A licensee must develop and ensure the implementation of a safety programme setting out appropriate and effective safety measures to prevent the occurrence of any adverse incident and reduce any hazard at any approved permanent premises, approved conveyance or temporary premises where an applicable service is provided.

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(2)  Without limiting paragraph (1), a safety programme must contain appropriate and effective measures for —

(a) electrical safety and safety of water supply and outlets;

(b) where any radioactive substance or irradiating apparatus is used in the provision of the service —

(i) radiation safety to ensure the safety of personnel and patients and other individuals within or in the vicinity of any premises used by the licensee for the provision of the service, including the proper handling, use and disposal of radioactive substances; and

(ii) compliance with any written law governing the preparation, storage, possession, use and disposal of radioactive substances and irradiating apparatus;

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(c) the handling and disposal of sharp apparatus and objects that can readily puncture or cut human skin when encountered;

(d) the safety of all personnel and patients during the conduct of any test or radiological examination;

(e) waste management;

(f) spills management;

(g) ensuring that there is adequate space, ventilation and lighting for every personnel to perform work safely;

(h) ensuring that patients are not exposed to unsafe levels of noise when undergoing any test or radiological examination;

(i) ensuring that all safety or emergency equipment are kept in good working order and there is an adequate stock of materials required for the handling of any medical emergency or adverse incident; and

(j) ensuring the cleanliness of any approved permanent premises, approved conveyance or temporary premises where an applicable service is provided.

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(2A)  The safety programme mentioned in paragraph (1) must also include the following:

(a) where the licensee is a clinical laboratory service licensee who provides any testing service on radioactive specimens —

(i) policies to protect any personnel who is pregnant against radiation exposure in the course of work and at every approved permanent premises, approved conveyance and temporary premises where the applicable service is provided; and

(ii) measures to ensure that an adequate number of the following are available for use by all personnel:

(A) suitable radiation monitoring devices, including dose calibrators and radiation survey meters;

(B) suitable radiation shields and primary and second containers for transportation of radioactive substances within and outside the approved permanent premises;

(b) where the licensee is a radiological service licensee —

(i) policies to protect any personnel who is pregnant against radiation exposure in the course of work and at every approved permanent premises, approved conveyance and temporary premises where the applicable service is provided; and

(ii) policies on the performance of ionising radiological procedures on pregnant women or women suspected to be pregnant.

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(3)  A licensee must keep up‑to‑date documentation of the policies and processes of the safety programme mentioned in paragraph (1) and make such documentation available to every personnel.

Licensee must ensure personnel comply with safety plans

15.—(1)  A licensee must ensure that every personnel complies with the measures set out in the safety programme mentioned in regulation 14.

(2)  In addition, a clinical laboratory service licensee must ensure that every personnel complies with the chemical hygiene plan mentioned in regulation 23.

Personal protective equipment must be provided

16.  A licensee must provide each personnel performing any work in any approved permanent premises, approved conveyance or temporary premises where an applicable service is provided with personal protective equipment appropriate for the work performed.

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Made on 28 December 2021.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/19 Vol. 1]