Healthcare Services (Assisted Reproduction Service) Regulations 2023
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Application of Regulations
4 Specified services
5 Prohibited service delivery modes
6 Mandatory services
Part 2 GOVERNANCE OF SERVICE, CERTIFICATION AND PROCESSES
7 Qualifications, skills and competencies for Clinical Governance Officer
8 Additional duties and responsibilities of Clinical Governance Officer
9 Licensee must be certified
10 Quality management system
Part 3 REQUIREMENTS RELATING TO PERSONNEL
11 No employment or engagement of unqualified persons
12 Appointment of chief embryologist
13 Minimum staffing requirements
14 General requirements relating to personnel
Part 4 PREMISES, FACILITIES AND EQUIPMENT
15 Requirements relating to premises
16 Requirements relating to facilities and equipment
Part 5 ADMINISTRATION AND USE OF ANAESTHETICS
17 Definitions of this Part
18 Anaesthesia service
19 Procedural room
20 Specified anaesthetic must be suitable for patient
21 Safe provision of specified anaesthetics
22 Post-procedure care
23 Recovery and observation area
24 Discharge of patients
Part 6 REQUIREMENTS RELATING TO CONSENT
25 Written consent required for any procedure on patient
26 Instructions regarding stored oocytes or embryos
27 Written consent required from donors
28 Additional requirements where donor reproductive cells or embryos used
29 Other requirements relating to obtaining consent
30 Withdrawal of consent
Part 7 REQUIREMENTS RELATING TO PROVISION OF SERVICE
Division 1 Provision of service to patients
31 When assisted reproduction service may be provided
32 Assessment of patients above 45 years of age
33 Preventing ovarian hyperstimulation syndrome
34 Transfer of multiple embryos
35 No combination of certain assisted reproduction procedures
36 Prohibited practices
Division 2 Donors
37 When donor reproductive cells or embryos may be used
38 Restriction on the use of certain embryos
39 Evaluation of donors
40 Confidentiality of donor’s identity
41 Directed donations
Division 3 Storage and disposal requirements
42 Storage and disposal in accordance with terms of consent
43 Reproductive cells and embryos that may be stored
44 Storage of reproductive cells and embryos
Division 4 General requirements
45 Verification of identity when semen or seminal fluid submitted
46 Counterchecking procedures
47 Tests for specified pathogens
48 Conduct of ultrasound imaging
49 Testing of specimen
50 Conduct of simple in vitro diagnostic test
51 Instructions for self‑collection of specimens
52 Provision of life‑saving measures
53 Transfer of reproductive cells and embryos to and from other licensees, etc.
54 Requirements relating to transfer of reproductive cells and embryos
55 Requirements for remote provision
Part 8 EMBRYOLOGY LABORATORY
56 Requirements relating to embryology laboratory
57 Requirements relating to laboratory processes
58 Safety programme
Part 9 MISCELLANEOUS
59 Tests on persons must be conducted by licensed persons or accredited laboratories
60 Register of children conceived using assisted reproduction service
61 Notification of incidental findings
62 Keeping of records
63 Donor records
64 Continuity of operations
65 Price transparency
66 Disclosure of approved institution status
67 Financial counselling
68 Offences