Healthcare Services (Nuclear Medicine Assay Service and Nuclear Medicine Imaging Service) Regulations 2021
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Application of Regulations
4 Specific services provided under licence
Part 2 REQUIREMENTS RELATING TO PERSONNEL
5 Skills and competencies of Clinical Governance Officer for applicable licensee
6 Duties and responsibilities of Clinical Governance Officer
7 Appointment of section leader
8 Duties of section leader
9 General requirements relating to personnel
Part 3 PROCESSES, EQUIPMENT AND FITTINGS
10 Quality management system
11 Equipment and fittings
12 Referral, etc., needed before services provided to patients
Part 4 SAFETY REQUIREMENTS
13 Safety programme
14 Radiation safety programme
15 Chemical hygiene plan
16 Licensee must ensure personnel comply with safety plans and programmes
17 Personal protective equipment must be provided
Part 5 REQUIREMENTS SPECIFIC TO NUCLEAR MEDICINE ASSAY SERVICE
18 Specific personnel
19 Instructions for collection of specimens
20 Acceptance and rejection of specimens
21 Handling and transport of specimens
22 Tests must have clinical utility
23 Tests must be accurate
24 Standards for reagents
25 Documentation relating to tests
26 Quality control of tests
Part 6 REQUIREMENTS SPECIFIC TO NUCLEAR MEDICINE IMAGING SERVICE
27 Specific personnel
28 Facilities and equipment
29 Handling of images
30 General safeguards for examinations
31 Specific safeguards — use of contrast agent or radiopharmaceuticals
32 Specific safeguards — use of anaesthesia or sedation
33 Safety policies regarding pregnant women
Part 7 REPORTING OF RESULTS
34 Who is qualified person
35 Written reports of examinations must be issued
36 Contents of reports
37 Urgent notification of reports in emergency
38 Identification and review of incidental or abnormal findings
39 Notification of error
40 Processes to ensure prompt reporting
Part 8 MISCELLANEOUS
41 Outsourcing prohibited
42 Nuclear medicine assay licensee — records to be kept for each specimen
43 Nuclear medicine assay licensee — records to be kept for each test
44 Nuclear medicine imaging licensee — records to be kept for examinations
45 Keeping of other records
46 Price transparency
47 Display of charges
48 Offence