Healthcare Services (Human Tissue Banking 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 Notification of handling, processing, etc., of additional types of human tissue
6 Prohibited service delivery modes
Part 2 REQUIREMENTS RELATING TO PERSONNEL AND PROCESSES
7 Qualifications, skills and competencies of Clinical Governance Officer
8 Appointment of advising specialist
9 General requirements relating to personnel
10 Quality management system
Part 3 PREMISES AND EQUIPMENT
11 Requirements relating to permanent premises
12 Requirements relating to equipment and materials
Part 4 SAFETY REQUIREMENTS
13 Safety programme
14 Licensee must ensure personnel comply with safety programme
15 Personal protective equipment must be provided
Part 5 COLLECTION, STORAGE, DISTRIBUTION AND RETURN OF HUMAN TISSUE
16 Written consent required for collection and use
17 Evaluation and screening of donors
18 Collection of human tissue
19 Processing, testing and quarantine of human tissue
20 Storage of human tissue
21 Suitability of human tissue for distribution
22 Restrictions on distribution of human tissue
23 Distribution of human tissue must be carried out in safe manner
24 Approval of distribution by Clinical Governance Officer
25 Provision of information relating to human tissue distributed for transplant
26 Return of human tissue
27 Preventing spread of communicable disease
28 Withdrawal of consent
Part 6 MISCELLANEOUS
29 Import of processed human tissue
30 Notification of abnormal or incidental findings
31 Keeping of records — enabling identification of donor
32 Keeping of records — general requirements
33 Continuity of operations
34 Transfer of human tissue to another human tissue bank
35 Tests on persons must be conducted by licensed persons or accredited laboratories
36 Outsourcing
37 Price transparency
38 Offences