The Blood Safety and Quality Regulations 2005

Extract

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The Blood Safety and Quality Regulations 2005

STATUTORY INSTRUMENTS

2005 No. 50

HEALTH AND SAFETY

The Blood Safety and Quality Regulations 2005

Made 13th January 2005

Laid before Parliament 18th January 2005

Coming into force

For all purposes other than regulation 25(1) 8th February 2005

For the purposes of regulation 25(1) 8th November 2005

The Secretary of State for Health, being a Minister designated[1] for the purposes of section 2(2) of the European Communities Act 1972[2] in relation to health protection measures regulating the use of material of human origin, in exercise of the powers conferred on him by the said section 2(2) and, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973[3], hereby makes the following Regulations: -

Citation, commencement and interpretation

1. - (1) These Regulations may be cited as the Blood Safety and Quality Regulations 2005.

(2) Except for regulation 25(1), which shall come into force on 8th November 2005, these Regulations shall come into force on 8th February 2005.

(3) In these Regulations -

"autologous transfusion" means a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood or blood components are used;

"blood" means whole human blood collected from a donor and processed either for transfusion or for further manufacturing;

"blood component" means a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods;

"blood component release" means a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;

"blood establishment" means any person, other than a person responsible for management of a hospital blood bank, which carries out any of the activities listed in regulation 3(2);

"blood product" means any therapeutic product derived from human blood or plasma;

"Commission" means the European Commission;

"deferral" means suspension of the eligibility of an individual to donate blood or blood components, such suspension being either permanent or temporary;

"the Directive" means Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components[4];

"distribution" means the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood products, other than the issuing of blood or blood components for transfusion;

"doctor" means a registered medical practitioner;

"donor carer" means a person who has passed both the written and practical examinations of the National Blood Authority[5], the Scottish National Blood Transfusion Service[6], the Northern Ireland Blood Transfusion Service[7] or the Welsh Blood Service[8] in the care of blood donors and who holds a current certificate of competence, awarded by that body, in the care of blood donors;

"health service hospital" has the same meaning as in section 128 of the National Health Service Act 1977[9];

"haemovigilance" means a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors;

"health service body" means -

(a) a Strategic Health Authority, Special Health Authority, Primary Care Trust or Local Health Board established under the National Health Service Act 1977,

(b) a Health Board or Special Health Board established under the National Health Service (Scotland) Act 1978,

(c) a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972[10],

(d) a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990[11],

(e) the Common Services Agency for the Scottish Health Service established under the National Health Service (Scotland) Act 1978,

(f) the Northern Ireland Central Services Agency for the Health and Social Services established under the Health and Personal Social Services (Northern Ireland) Order 1972,

(g) a National Health Service trust established under the National Health Service and Community Care Act 1990[12], or th...

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