Facilities, equipment, supplies and processes — collection of blood and blood components
11.—(1) A licensee must ensure that every blood donation site is set up to ensure —
(a)
the proper, safe and hygienic collection of blood and blood components from donors; and
(b)
the privacy of donors.
(2) Without limiting paragraph (1), the licensee must ensure that every blood donation site satisfies all of the following:
(a)
any part of the blood donation site that is to be used —
(i)
for the collection, storage or disposal of biohazardous waste; or
(ii)
as a sluice,
must be segregated from the rest of the blood donation site;
(b)
the phlebotomy area of the blood donation site must be segregated from the rest of the blood donation site, and access to the phlebotomy area is restricted to individuals who have been screened and determined to be eligible to donate blood or blood components and any authorised personnel;
(c)
the furniture, flooring and walls of the blood donation site are non‑absorbent;
(d)
the furniture, flooring and walls of, and equipment at, the blood donation site allow for effective cleaning using appropriate disinfectants;
(e)
security measures must be implemented to prevent unauthorised access to any part of the blood donation site that is used for —
(i)
the screening of donors;
(ii)
the storage of blood and blood components collected from donors; or
(iii)
the storage of medical supplies and equipment;
(f)
there is ready access to clean running water;
(g)
there are adequate quantities of appropriate medical supplies and equipment for the safe management of donors, including emergency medication, medical supplies and equipment.
(3) Without affecting regulation 10(2), the licensee must implement operational processes and workflows to ensure that all screenings of donors are carried out accurately and in a safe and timely manner.