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Recruitment and evaluation of donors

Healthcare Services (Blood Banking Service) Regulations 2021

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—(1) A licensee must, before collecting any blood or blood component from a potential donor (P), ensure that P —(a)is donating the blood or blood component voluntarily; and(b)is not donating the blood or blood component in contravention of any written law.(2) The licensee —(a)must provide or arrange for the provision of pre‑donation counselling to P by a qualified, trained and competent person in a manner that respects P’s privacy; and(b)must conduct or arrange for the conduct of adequate and appropriate assessment of P’s suitability to donate blood or blood components by a qualified, trained and competent person.(3) The licensee must provide accurate and relevant information on all of the following matters to P in the course of the pre‑donation counselling and assessment of P’s suitability mentioned in paragraph (2):(a)the nature and use of blood and blood components and the importance of maintaining a healthy lifestyle as a blood donor;(b)the importance of the donation of blood and blood components being voluntary and not being remunerated;(c)the purpose of the donor questionnaire administered to and pre‑donation health assessment of P, and the importance of P providing truthful responses and cooperating with the licensee’s measures to ensure the safety of all blood and blood components collected;(d)that P —(i)may withdraw from or defer the donation of blood or blood components at any time; and(ii)should inform the licensee if any blood or blood component that P donated is not safe for therapeutic transfusion to another individual for any reason;(e)the steps by which —(i)P may withdraw from or defer the donation of blood or blood components; and(ii)where P has donated blood or blood components — P may subsequently inform the licensee not to use any blood or blood component donated by P for therapeutic transfusion to another individual;(f)the donation process and possible adverse reactions (such as fainting and haematomas) that donors may encounter;(g)information on infectious diseases that are transmissible by the transfusion of blood and blood components, including —(i)the risk factors associated with all specified infectious diseases; and(ii)voluntary counselling and testing services (whether provided by the licensee or another person) that P may use to ascertain whether he or she has contracted any specified infectious disease;(h)that P should not donate blood or blood components for the sole or primary purpose of testing P’s blood for any infectious disease mentioned in sub‑paragraph (g);(i)the steps that the licensee may take in the event that any blood or blood component donated by P is found or suspected to be infected with any infectious disease mentioned in sub‑paragraph (g).(4) The licensee must ensure that the assessment of P’s suitability to donate blood or blood components mentioned in paragraph (2)(b) is clearly and accurately documented by the licensee.(5) The licensee must not prevent or dissuade P from withdrawing from or deferring the donation of blood or blood components in any manner that is intended to embarrass or humiliate P or coerce or pressure P to change his or her mind.(6) The licensee must implement and maintain a system —(a)to manage the deferral of the donation of blood and blood components by any potential donor who is assessed not to be suitable to donate blood or blood components; and(b)where any donor is unwell or for any other reason is of the opinion that the blood or blood component donated by the donor should not be used for therapeutic transfusion to another individual — to allow the donor to inform the licensee not to use the blood or blood component donated by the donor.

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