Quality management system
5.—(1)  A licensee must establish and maintain an effective quality management system for the cord blood banking service provided by the licensee relating to —
(a)the safety of infant donors, the mothers of infant donors and recipients;
(b)the safety, quality, potency and viability of cord blood collected, tested, processed, stored and distributed by the licensee; and
(c)the proper collection, testing, processing, storage and distribution of cord blood.
[S 389/2023 wef 26/06/2023]
(2)  The quality management system mentioned in paragraph (1) must provide for all of the following:
(a)the investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the cord blood banking service;
(b)the identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub‑paragraph (a) and prevent a recurrence;
(c)measures to ensure that the provision of the cord blood banking service complies with the Act, these Regulations and any other regulations made under the Act and any other applicable written law;
(d)the implementation of quality control measures for all cord blood collected, tested, processed, stored and distributed by the licensee, including measures pertaining to the safety, quality, potency and viability of the cord blood in relation to —
(i)the recruitment of infant donors and the mothers of infant donors;
(ii)the collection and transport of the cord blood;
(iii)the processing of the cord blood;
(iv)the testing and quarantine of the cord blood; and
(v)the storage and distribution of the cord blood;
(e)the implementation of appropriate and effective measures to ensure the safety or health of infant donors and the mothers of infant donors in relation to the collection of cord blood, including the detection and management of any finding or observation that has or may have an adverse effect on the safety or health of the infant donors or mothers;
(f)the maintenance of adequate and appropriate documentation on the clinical outcomes of the transplant or other clinical use of all cord blood distributed by the licensee, including documentation relating to any event, finding or observation that —
(i)adversely affects or may adversely affect the safety or health of any recipient; and
(ii)relates to or is the result of the collection, testing, processing, storage or distribution of cord blood by the licensee;
(g)quality control measures for tests performed and equipment used in the provision of the cord blood banking service, including acceptance testing, quality control tests and regular monitoring of equipment performance;
(h)a system to ensure the appropriate and adequate documentation of the licensee’s policies and processes, including —
(i)creating, reviewing and updating documentation for the licensee’s quality assurance measures and all personnel’s compliance with those measures; and
(ii)ensuring proper document control of all such documentation;
(i)regular participation in relevant external quality assessment programmes for each test performed for product qualification;
(j)[Deleted by S 389/2023 wef 26/06/2023]
(k)the implementation of a system for appropriate accountability, roles and responsibilities of and continuing educational programmes for all personnel;
(l)identification of key performance indicators for assessing performance outcomes of the cord blood banking service, including mechanisms for periodic monitoring and evaluation of these indicators;
(m)the conduct of regular risk assessments of every activity conducted as part of the provision of the cord blood banking service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments.
(3)  A licensee must —
(a)conduct regular reviews of the quality management system mentioned in paragraph (1);
(b)make and maintain accurate reports of all reviews conducted under sub-paragraph (a);
[S 389/2023 wef 26/06/2023]
(c)update the quality management system as may be necessary, including in response to the findings of any review conducted under sub-paragraph (a); and
[S 389/2023 wef 26/06/2023]
(d)implement appropriate and effective actions to address any weakness or inadequacy in the provision of the cord blood banking service.
[S 389/2023 wef 26/06/2023]
(4)  A second or subsequent review of the quality management system mentioned in paragraph (1) must be conducted during the twelfth month after the month in which the licensee conducted the immediately preceding review.