Information about infant donor and mother of infant donor
20.—(1) A licensee must —
(a)
collect all information that ensures the linkage of all cord blood units collected from an infant donor and the mother of that infant donor; and
(b)
keep and maintain accurate records of all information mentioned in sub‑paragraph (a).
(2) The licensee must keep every record mentioned in paragraph (1)(b) (called an applicable record) confidential and ensure that —
(a)
the confidentiality, integrity and security of every applicable record are maintained at all times; and
(b)
every personnel handling any applicable record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the applicable record.
(3) In addition, where any information in an applicable record is in the form of an extract or aggregated compilation, the licensee must ensure that the confidentiality, integrity and security of the information in the extract or aggregated compilation are maintained at all times.
(4) The licensee must —
(a)
implement adequate safeguards and appropriate protocols and processes to protect the applicable records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification; and
(b)
periodically monitor and evaluate the safeguards, protocols and processes mentioned in sub‑paragraph (a) to ensure that they are effective and being complied with by the staff involved in handling the applicable records.