Healthcare Services (Cord Blood Banking Service) Regulations 2021

  Table of Contents

  Enacting Formula

1 Citation and commencement

2 Definitions

3 Application of Regulations

4 Qualifications, skills and competencies of Clinical Governance Officer

5 Quality management system

6 Personnel involved in providing cord blood banking service

7 Quality personnel

8 Facilities, equipment, supplies, etc.

8A Safety programme

8B Licensee must ensure personnel comply with safety programme

8C Personal protective equipment must be provided

9 Consent for donation and pre‑donation counselling

10 Evaluation and screening

11 Testing of infant donor or mother of infant donor

12 Collection of cord blood

13 Processing, testing and quarantine of cord blood

14 Suitability of recipient of cord blood

15 Storage of cord blood

16 Distribution of cord blood

17 Distribution of cord blood on exceptional grounds where infant donor or mother of infant donor suffers from infectious diseases

18 Import of processed cord blood

19 Re-identification and notification of infant donor and mother of infant donor — abnormal findings or incidental findings

20 Information about infant donor and mother of infant donor

21 Records

22 Provision of information relating to cord blood distributed for transplant

23 Continuity of operations

24 Outsourcing

25 Price transparency

26 Offence