Healthcare Services (Blood Banking Service) Regulations 2021

  Table of Contents

  Enacting Formula

1 Citation and commencement

2 Definitions

3 Application of Regulations

3A Blood donation sites

4 Activities at approved permanent premises

5 Qualifications, skills and competencies of Clinical Governance Officer

6 Disqualifications for Clinical Governance Officer

7 Duties and responsibilities of Clinical Governance Officer

8 Quality management system

9 Personnel involved in evaluating donors and collecting blood and blood components

10 Facilities, equipment, supplies and processes — general

11 Facilities, equipment, supplies and processes — collection of blood and blood components

11A Safety programme

11B Licensee must ensure personnel comply with safety programme

11C Personal protective equipment must be provided

12 Recruitment and evaluation of donors

13 Collection of blood and blood components

14 Traceability of blood and blood components

15 Inventory system for blood and blood components

16 Processing and testing of blood and blood components

17 Requirements relating to storage, quarantine, distribution, etc., of blood and blood components

18 Distribution of blood and blood components to specified persons

19 Donor testing

19A Simple in vitro diagnostic tests

20 Documentation relating to donors and blood and blood components

21 Records

22 Outsourcing

23 Price transparency

24 Offence