8.—(1) A licensee must ensure that every approved permanent premises is safe, secure, appropriate and adequate for the provision of the cord blood banking service.
[S 389/2023 wef 26/06/2023]
(2) Without limiting paragraph (1), the licensee must ensure all of the following:
(a)
access to the approved permanent premises is restricted to individuals authorised by a Clinical Governance Officer;
[S 389/2023 wef 26/06/2023]
(b)
the instruments and other equipment used or to be used in relation to the provision of the cord blood banking service are properly installed and commissioned for use;
(c)
every refrigerator or storage tank undergoes periodic maintenance to ensure the quality and usability of cord blood and reagents kept in the refrigerator or storage tank;
(d)
all refrigerators and storage tanks are used in a manner that —
(i)
prevents the mix-up, or contamination or cross‑contamination, of units of cord blood; and
(ii)
ensures the safety, quality, viability and potency of cord blood;
(e)
all instruments and other equipment, supplies and reagents used in the provision of the cord blood banking service are effective to ensure the safety, quality, viability and potency of cord blood;
(f)
a procedure is put in place for monitoring, inspecting, sterilising and cleaning each piece of equipment used in the provision of the cord blood banking service;
(g)
appropriate tests and procedures are carried out periodically to ensure that any equipment or reagent used in the provision of the cord blood banking service complies with at least the tolerance limits determined by the manufacturer of the equipment or reagent;
(h)
the suppliers of any materials, the use of which is likely to have a material impact on the safety, quality, viability or potency of cord blood, are selected and regularly evaluated to ensure that the materials obtained from the suppliers are safe and effective;
(i)
the following information about any supplies or reagent used in the collection, testing, processing and storage of cord blood by the licensee is identified and recorded:
(i)
the name of the supplies or reagent;
(ii)
the name of the manufacturer;
(iii)
the lot number;
(iv)
the expiration date;
(j)
all sterilised instruments, supplies and reagents are clearly labelled to indicate the date on which the sterilisation took place and the expiry date of the sterilisation;
(k)
procedures are put in place to monitor and maintain the conditions in which cord blood is stored, including the immediate notification of and response to temperature deviations outside acceptable ranges;
(l)
adequate, stable and appropriate electricity supply is provided for all laboratory equipment, including an adequate number of grounded electrical outlets and an emergency power supply for each piece of equipment that is essential for maintaining the safety, quality, viability and potency of cord blood;