Healthcare Services (Nuclear Medicine Service) Regulations 2023
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Application of Regulations
4 Notification of addition or removal of purposes for which nuclear medicine service provided
5 Specified services
6 Prohibited service delivery modes
Part 2 REQUIREMENTS RELATING TO PERSONNEL
7 Qualifications, skills and competencies of Clinical Governance Officer
8 Duties and responsibilities of Clinical Governance Officer
9 Appointment of section leader
10 Duties of section leader
11 General requirements relating to personnel
12 Specific personnel
Part 3 PROCESSES, EQUIPMENT AND FITTINGS
13 Quality management system
14 Equipment and fittings
Part 4 SAFETY REQUIREMENTS
15 Safety programme
16 Radiation safety programme
17 Licensee must ensure personnel comply with safety plans and programmes
18 Personal protective equipment must be provided
19 Administration and use of radiopharmaceuticals
20 Pregnant women
21 Patients 12 years of age or younger
22 Adjunctive measures
23 Essential life-saving measures must be available
Part 5 ADMINISTRATION AND USE OF ANAESTHETICS AND SEDATIVES
24 Definitions of this Part
25 General requirements on administration and use of anaesthetics or sedatives
26 Anaesthesia service
27 Specified anaesthetic must be suitable for patient
28 Nursing services
29 Essential life-saving measures
30 Post-procedure care
31 Recovery and observation area
32 Discharge of patients
33 Post-discharge follow-up
Part 6 TESTING OF SPECIMENS AND ULTRASOUND IMAGING
34 Testing of specimens
35 Instructions for self-collection of specimens by patient
36 Conduct of simple in vitro diagnostic tests
37 Testing material for simple in vitro diagnostic tests
38 Conduct of ultrasound imaging
Part 7 ADDITIONAL REQUIREMENTS FOR PROVISION OF NUCLEAR MEDICINE SERVICE FOR IMAGING PURPOSE
39 Application of this Part
Division 1 — Provision of nuclear medicine service for imaging purpose
40 Handling of images
41 General safeguards for examinations
42 Referral required before service provided to patients
43 Administration and use of contrast agents
44 Records — examinations
Division 2 — Reporting of results or findings of examinations
45 Definition of this Division
46 Written imaging reports
47 Contents of imaging reports
48 Urgent notification of results or findings in emergency
49 Identification and review of incidental or abnormal findings
50 Notification of errors
51 Processes to ensure prompt reporting
Part 8 ADDITIONAL REQUIREMENTS FOR PROVISION OF NUCLEAR MEDICINE SERVICE FOR IN VIVO ASSAY PURPOSE
52 Definition of this Part
Division 1 — Provision of nuclear medicine service for in vivo assay purpose
53 Referral needed before service provided to patients
54 Acceptance and rejection of specimens
55 Handling and transport of specimens
56 Applicable tests must be accurate
57 Standards for reagents
58 Documentation relating to applicable tests
59 Quality control of applicable tests
60 Records — specimens
61 Records — applicable tests
Division 2 — Reporting of results
62 Definitions of this Division
63 Written clinical laboratory reports
64 Contents of reports
65 Urgent notification of results or findings in emergency
66 Identification and review of incidental or abnormal findings
67 Notification of errors
68 Processes to ensure prompt reporting
Part 9 ADDITIONAL REQUIREMENTS FOR PROVISION OF NUCLEAR MEDICINE SERVICE FOR THERAPY PURPOSE
69 Application of this Part
70 Pre-treatment counselling and assessment
71 Post-treatment protocols
Part 10 MISCELLANEOUS
72 Outsourcing prohibited
73 Records — conduct of examinations, performance of in vivo assay procedures and provision of treatment
74 Records — other matters
75 Price transparency
76 Display of charges
77 Disclosure of approved institution status
78 Financial counselling
79 Offences
80 Revocation