Documentation relating to donors and blood and blood components
20.—(1)  A licensee must, in respect of each donor of blood or blood component, maintain accurate records of all of the following:
(a)information about the donor’s suitability to donate (such as the donor’s haemoglobin level at the time of donation), including the criteria used to assess the donor’s suitability and the outcome of the applicable licensee’s assessment of the donor in relation to each criterion used;
(b)the donor’s express written consent for the donation of blood or blood component, as the case may be;
(c)the occurrence and clinical management of any adverse reaction affecting or reported by the donor;
(d)the occurrence and particulars of —
(i)any event that adversely affects the safety and health of the donor or the safety or traceability of any blood or blood component collected from the donor; or
(ii)any finding or observation that has or may have an adverse effect on the safety or health of the donor;
(e)the measures taken by the licensee to address and prevent the recurrence of the event, finding or observation mentioned in sub‑paragraph (d);
(f)where any blood or blood component collected from the donor is found not to be suitable for clinical use — the distribution of that blood or blood component in accordance with regulation 18.
(2)  The licensee must, in respect of every unit of blood or blood component in the possession or under the control of the licensee, maintain accurate records of the following:
(a)information identifying, and relating to the characteristics, source and use of, the unit of blood or blood component, as the case may be;
(b)information relating to the collection, testing, processing, storage, transportation and delivery or disposal of the unit of blood or blood component, as the case may be.
(3)  The licensee must keep every record mentioned in paragraph (1) confidential and ensure that —
(a)the confidentiality, integrity and security of every such record are maintained at all times; and
(b)every personnel handling any such record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the record.
[S 388/2023 wef 26/06/2023]
(4)  In addition, where any information in a record mentioned in paragraph (1) 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.
[S 388/2023 wef 26/06/2023]
(5)  The licensee must —
(a)implement adequate safeguards and appropriate protocols and processes to protect all applicable records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification;
(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; and
(c)take reasonable care in the disposal or destruction of the applicable records so as to prevent unauthorised access to the records.
[S 388/2023 wef 26/06/2023]
(6)  In paragraph (5), “applicable record” means any record mentioned in paragraph (1) or (2).
[S 388/2023 wef 26/06/2023]