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

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;

a test set out in paragraph 1(b)(iii), (iv) or (v) of Part 1 of the Schedule.

an imaging service by an imaging modality specified in paragraph 1(a)(iii), (iv), (v) or (vi) of Part 2 of the Schedule;

a procedure set out in paragraph 1(b) of Part 2 of the Schedule.

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

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

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

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

implement and oversee the safety programme mentioned in regulation 14.

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

implement and oversee the safety programme mentioned in regulation 14.

who resides in Singapore;

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

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

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

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

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

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;

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

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:

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

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

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.

the Clinical Governance Officer or the relevant section leader;

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

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.

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

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;

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

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

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;

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

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

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

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

the regular testing of the quality and safety of the radioactive substances;

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

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

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

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

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

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

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

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

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;

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

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

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

regular creation, review and updating of the documentation;

document control procedures;

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

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

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.

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;

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

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.

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

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

the storage space provided is adequately secured; and

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;

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;

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

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

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

adequate space is provided at every approved permanent premises; and

the space provided is secure and access to the space is controlled;

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;

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.

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

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

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

at any temporary premises.

electrical safety and safety of water supply and outlets;

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

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

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

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

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

waste management;

spills management;

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

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

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

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

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

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

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

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

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

where the licensee is a radiological service licensee —

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

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

clear criteria for the acceptance and rejection of specimens for traceability, quality and safety reasons;

how rejected specimens are to be handled;

documentation of the reason or reasons for rejecting a specimen.

the rejected specimen is not returned to the requestor except in the circumstances specified in the policy; and

the requestor is informed of the rejection of a specimen and the reasons for the rejection.

with a description of the general nature of the transported item; and

with a warning that the transported item contains biohazardous or radioactive material.

a test result for a patient deviates substantially from those earlier reported in respect of the patient; or

there is reason to suspect that it is inaccurate given the patient’s clinical presentation,the licensee must investigate the reason for the deviation or the suspected inaccuracy and take appropriate remedial action if applicable.

any specified procedure must be conducted by a medical practitioner who is registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of diagnostic radiology;

a sonographer must not conduct any radiological examination other than an ultrasound scan;

a dentist must not conduct any radiological examination other than for dental imaging.

every radiological examination is conducted on the correct patient; and

for any patient, the radiological examination is conducted at the part of the body or the site of the body part in accordance with the prescription of a medical practitioner or dentist.

there are protocols in place to ensure that the patient’s exposure to radiation is kept to a minimum; and

there are appropriate safety measures in place to protect any other person against exposure to radiation.

the administration and use of the anaesthesia or sedative is in accordance with safety protocols implemented by the licensee, including a protocol requiring the minimal use of any anaesthesia or sedative for patients who are 12 years of age or younger;

appropriate equipment is provided to sedate patients before the radiological examination;

an appropriate device to monitor the patient’s vital signs is available for use during and after the administration of the anaesthesia or sedative to the patient;

the patient’s vital signs are monitored during and after the administration of the anaesthesia or sedative and for an appropriate period after such administration;

there are in place at any approved permanent premises, approved conveyance or temporary premises where the radiological service is provided resuscitation measures to be taken immediately for the patient (if required), including ensuring that —

resuscitation equipment and resuscitation drugs are available for emergency use at the approved permanent premises, approved conveyance or temporary premises; and

one or more competent personnel of the licensee are present at the approved permanent premises, approved conveyance or temporary premises to carry out resuscitation on the patient;

the licensee keeps a record of the administration of the anaesthesia or sedative to the patient;

the patient is discharged from the licensee’s care in accordance with the licensee’s policy on when a patient can be discharged after anaesthesia or sedation.

using testing material in respect of which —

the expiry date has not passed; and

the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and

in accordance with the instructions specified by the manufacturer of the testing material.

in relation to a test — a Clinical Governance Officer or a person who is suitably qualified to certify and interpret the test results and appointed by a Clinical Governance Officer to do so;

in relation to any radiological examination —

a medical practitioner registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of diagnostic radiology; or

a medical practitioner who is —

a diagnostic radiology resident; and

a member of the Fellowship of the Royal College of Radiologists or any equivalent professional association of radiologists; and

in addition to paragraph (b) —

in relation to a fetal ultrasound — a medical practitioner registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of obstetrics and gynaecology;

in relation to a dental radiological examination — a dentist; (iii)in relation to a plain radiography image — a person who —

is duly authorised or registered to practise as a medical practitioner in a state or territory other than Singapore by a foreign authority having the function conferred by law of authorising or registering persons to practise as a medical practitioner in that state or territory;

has a degree of Bachelor of Medicine, Bachelor of Surgery or equivalent; and

is a member of the Fellowship of the Royal College of Radiologists or any equivalent professional association of radiologists; and

in relation to a plain radiography image — a medical practitioner who —

is a diagnostic radiology resident; and

has passed the National Plain Film Test administered by the College of Radiologists, Singapore.

issue a written clinical laboratory report for every test requested for a patient; and

without undue delay, give the report to the requestor (or another medical practitioner, dentist or collaborative prescribing practitioner designated by the requestor to receive the report).

appoint a qualified person to interpret and report the findings of any radiological examination;

ensure that a written radiological report is issued for every radiological examination conducted for a patient for diagnostic purpose; and

without undue delay, give the report to the requestor (or another medical practitioner, dentist or collaborative prescribing practitioner designated by the requestor to receive the report).

the following information about the licensee issuing the report:

the licensee’s name and the business name (if different from the licensee’s name) by which the licensee provides the applicable service;

the licensee’s address;

all of the following identifying information:

the patient’s name;

the patient’s identification number or passport number;

where the information in sub‑paragraphs (i) and (ii) is not known to the licensee — other information identifying the patient;

subject to paragraph (1A), the address of the premises at which or the vehicle number of the approved conveyance in which the test or radiological examination is conducted;

the date the test or radiological examination is conducted;

the name of the requestor;

the description and findings of the test or radiological examination;

for a clinical laboratory report —

where the information is known to the clinical laboratory service licensee — the date and time the specimen was derived from the patient;

[Deleted by S 417/2023 wef 26/06/2023](iii)for a tissue specimen — the anatomical site of the specimen; and

any other necessary information for the interpretation of results, including the established norms and ranges applicable to the test results;

the date the report is issued;

the name and signature (including an electronic signature) of the qualified person certifying the test results or interpreting and reporting the findings of the radiological examination.

A’s name;

the address of the premises in which the test or radiological examination (as the case may be) was performed;

the original clinical laboratory report or radiological report (as the case may be) issued by A, if any.

ensure that the qualified person mentioned in regulation 35(1)(i) states in the clinical laboratory report or radiological report all incidental findings that are potentially clinically significant and abnormal findings; and

bring the incidental or abnormal findings to the attention of the requestor.

any other person who holds a clinical laboratory service licence under the Act;

a person who operates a clinical laboratory outside Singapore that is accredited by an accreditation body approved by the Director-General;

where none of the persons mentioned in sub‑paragraph (a) or (b) is willing or able to conduct the test, a person who operates a clinical laboratory that is approved by the Director-General.

the date, time and type of radiological examination;

where the radiological examination was conducted at temporary premises that are residential premises — the address of those residential premises;

the name of the person who conducted the radiological examination;

the name of the person who reported and issued the radiological report;

each radiological image obtained from the radiological examination;

in relation to the examination —

information about the site of the anatomic site imaged; and

where any images are provided by the licensee directly to another person together with the radiological report —

the person to whom the images were provided; and

the mode by which the images were provided to that person;

in relation to any contrast agent administered to a patient during the examination —

the name and dose of the contrast agent;

the route and rate of administration of the contrast agent; and

any adverse reaction experienced by the patient following or associated with the administration of the contrast agent;

where the radiological examination involves the administration of any anaesthetic or sedative to the patient —

information relating to the anaesthetic or sedative administered; and

information relating to the safety of patients and personnel, including information relating to —

any adverse reaction experienced by any patient following or associated with the administration of any anaesthetic or sedative, including any investigation into the cause of the adverse reaction; and

any incident occurring in the course of or in relation to the examination of any patient that affected or potentially affected the safety of the patient or any personnel, including any investigation and follow-up action taken.

the qualifications and competencies (including training and competency assessments) of each personnel, that are relevant to the provision of the applicable service;

the quality management activities and measures taken by the licensee in connection with the provision of the applicable service (called in this regulation a quality record);

every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under that programme, policy, system, measure, protocol or process.

information relating to the quality management system mentioned in regulation 11;

a master list of the initials and signatures of each personnel;

the job descriptions, training and competency assessments for each personnel;

all information and documents related to the review of policies and processes implemented under regulation 11, and documentation of changes made to different versions of those documents;

details regarding the maintenance and calibration of each piece of equipment and instrument used in the provision of the applicable service;

quality control measures for each test, piece of equipment and instrument used in the provision of the applicable service; and

for a clinical laboratory service licensee —

validation of every test method used in the provision of the clinical laboratory service; and

proficiency testing and external quality assurance programme performance.

the amount of each fee (including any administrative fee) that the clinical laboratory service licensee charges, or intends to charge, for any test or test panel;

in the case of a test panel, the tests that are included in that test panel.

imaging procedures, including consumables;

contrast fees;

sedation procedures, if applicable.

to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both; and

in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.