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- Point in Time (08/04/2005)
- Original (As made)
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2.Designation of the competent authority and scope of the Regulations
10.Requirement for hospital blood banks to provide information to the Secretary of State
13.Import of blood and blood components into the United Kingdom
14.Disclosure of information by blood establishments and hospital blood banks
1.“Autologous donation” means blood and blood components collected from an...
2.“Allogeneic donation” means blood and blood components collected from an...
4.“Cryopreservation” means prolongation of the storage life of blood components...
5.“Plasma” means the liquid portion of the blood in which...
6.“Cryoprecipitate” means a plasma component prepared from plasma, fresh-frozen, by...
7.“Washed” means a process of removing plasma or storage medium...
9.“Red cells, buffy coat removed” means the red cells from...
10.“Red cells, leucocyte-depleted” means the red cells from a single...
11.“Red cells in additive solution” means the red cells from...
12.“Additive solution” means a solution specifically formulated to maintain beneficial...
13.“Red cells, buffy coat removed, in additive solution” means the...
14.“Buffy coat” means a blood component prepared by centrifugation of...
15.“Red cells, leucocyte-depleted, in additive solution” means the red cells...
16.“Red cells, apheresis” means the red cells from an apheresis...
17.“Apheresis” means a method of obtaining one or more blood...
18.“Platelets, apheresis” means a concentrated suspension of blood platelets obtained...
19.“Platelets, apheresis, leucocyte-depleted” means a concentrated suspension of blood platelets,...
20.“Platelets, recovered, pooled” means a concentrated suspension of blood platelets,...
21.“Platelets, recovered, pooled, leucocyte-depleted” means a concentrated suspension of blood...
22.“Platelets, recovered, single unit” means a concentrated suspension of blood...
23.“Platelets, recovered, single unit, leucocyte-depleted” means a concentrated suspension of...
24.“Plasma, fresh-frozen” means the supernatant plasma separated from a whole...
25.“Plasma, cryoprecipitate-depleted for transfusion” means a plasma component prepared from...
26.“Granulocytes, apheresis” means a concentrated suspension of granulocytes obtained by...
27.“Statistical process control” means a method of quality control of...
PART 2 INFORMATION REQUIREMENTS FOR DONORS
Part A – Information to be provided to prospective donors of blood or blood components
1.Accurate educational materials, which are written in terms which can...
2.For both allogeneic and autologous donations, the reasons for requiring...
3.For allogeneic donations, the criteria for self-deferral, and temporary and...
4.For autologous donations, the possibility of deferral and the reasons...
5.Information on the protection of personal data, including confirmation that...
6.The reasons why individuals are not to make donations which...
7.Specific information on the nature of the procedures involved either...
8.Information on the option for donors to change their mind...
10.Information on the responsibility of the blood establishment to inform...
11.Information as to why unused autologous blood and blood components...
12.Information that test results detecting markers for viruses, such as...
13.Information on the opportunity for donors to ask questions at...
Part B – Information to be obtained from donors by blood establishments at every donation
PART 3 ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS
1.Acceptance criteria for donors of whole blood and blood components
1.2.Haemoglobin levels in donor's blood Haemoglobin For females ≥ 125...
1.4.Platelet levels in donor's blood Platelets Platelet number greater than...
2.1.Deferral criteria for donors of whole blood and blood components
2.2.Temporary deferral criteria for donors of allogeneic donations
However, the following deferral periods shall apply for the infections...
2.2.2.Exposure to risk of acquiring a transfusion-transmissible infection — Endoscopic...
2.2.3.Vaccination Attenuated viruses or bacteria 4 weeks Inactivated/killed viruses, bacteria...
2.2.4.Other temporary deferrals Pregnancy 6 months after delivery or termination,...
2.3.Deferral for particular epidemiological situations Particular epidemiological situations (e.g. disease...
2.4.Deferral criteria for donors of autologous donations Serious cardiac disease...
PART 4 STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS
1.1.Liquid storage Component Temperature of storage Maximum storage time Red...
1.2.Cryopreservation Component Storage conditions and duration Red blood cells Up...
3.1.Autologous blood and blood components must be clearly identified as...
3.2.Autologous blood and blood components must be labelled as required...
PART 5 QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
1.THE BLOOD COMPONENTS 1. Red cell preparations The components listed...
2.QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
2.1.Blood and blood components must comply with the following technical...
2.2.Appropriate bacteriological control of the collection and manufacturing process must...
2.3.For autologous donations, the measures marked with an asterisk (*)...
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