keep and maintain complete and accurate records of the licensee’s policies, procedures and programmes in relation to the cord blood banking service;
(b)
ensure proper document control of all documents relating to the cord blood banking service; and
(c)
take all reasonable steps to ensure the confidentiality and security of all records mentioned in sub‑paragraph (a).
(2) Without limiting paragraph (1), the licensee must ensure that all of the following requirements are satisfied:
(a)
the licensee must establish and implement a process to ensure proper document control of all documents relating to the cord blood banking service by one or more appropriate personnel;
(b)
the licensee’s procedures and practices for the cord blood banking service must be set out in one or more procedure manuals;
(c)
a Clinical Governance Officer must approve, sign and date each procedure manual mentioned in sub‑paragraph (b);
(d)
the procedure manuals mentioned in sub‑paragraph (b) must be made available at all times to all personnel and regularly updated;
(e)
accurate records must be kept and maintained of the time at which every unit of cord blood is accepted into the processing facility of every approved permanent premises of the licensee;
[S 389/2023 wef 26/06/2023]
(f)
where any cord blood is to be transferred to another licensee or a person outside Singapore that is licensed, registered, approved or otherwise allowed to carry on the activities of a cord blood bank under the laws of the foreign jurisdiction — there must be a written agreement setting out the terms of the transfer of the cord blood;
(g)
the licensee must document and validate any change to the licensee’s procedures or processes or any equipment or system used in relation to the provision of the cord blood banking service before the change is implemented.
(3) The licensee must keep and maintain complete and accurate records of the approval given by a Clinical Governance Officer under regulation 16(3)(b) or 17(2) for the distribution of every unit of cord blood.