16.—(1) A licensee must ensure that the distribution of cord blood is carried out such that —
(a)
the biological and functional properties of the cord blood are preserved; and
(b)
the risk of contamination of the cord blood is minimised.
(2) Without limiting paragraph (1), the licensee must satisfy all of the following requirements:
(a)
the cord blood must be packaged and transported in a validated container;
(b)
the licensee must implement and maintain a system to prevent or control the spread of any communicable disease due to the contamination or infection of any cord blood in the licensee’s custody, including the traceability of all equipment and materials used in the processing of the cord blood;
(c)
the cord blood is distributed in appropriate conditions, including the storage of the cord blood during transport and the thawing of the cord blood before use;
(d)
the licensee must establish and implement written policies and procedures, where the suitability of any unit of cord blood for its intended use is or is believed to have been adversely affected for any reason (such as possible contamination or defects in the processing, testing or preparation of that unit of cord blood), for —
(i)
the recall of the unit of cord blood; and
(ii)
the notification of any person who receives or has received the unit of cord blood;
(e)
an instruction sheet which includes all of the following information must accompany every unit of cord blood distributed by the licensee:
(i)
the results of all screenings of the infant donor of the cord blood and the mother of that infant donor;
(ii)
the appropriate storage conditions for the cord blood prior to its transplant or other clinical use;
(iii)
any special requirement or measure that the medical practitioner using the cord blood must take to ensure the safe and effective use of the cord blood;
(iv)
the measures that must be taken if there is any evidence of damage to or mislabelling of the cord blood or its packaging.
(3) A licensee —
(a)
subject to paragraphs (4) and (5), must distribute any unit of cord blood only for a purpose for which the mother of the infant donor from whom that unit of cord blood was collected has given express written consent; and
(b)
must not distribute any unit of cord blood for any purpose except with the approval of a Clinical Governance Officer.
(4) A licensee must not distribute any unit of cord blood for the purpose of transplant except to an acute hospital service licensee.
[S 389/2023 wef 26/06/2023]
(5) Where any unit of cord blood is determined to be unsuitable for transplant or other clinical use, the licensee must ensure that the unit of cord blood is distributed in accordance with the requirements of these Regulations and other applicable written law.