The Blood Safety and Quality Regulations 2005
| Year | 2005 |
2005 No. 50
HEALTH AND SAFETY
The Blood Safety and Quality Regulations 2005
Made 13th January 2005
Laid before Parliament 18th January 2005
The Secretary of State for Health, being a Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in 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 19733, 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/ECof 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 components4;
“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 Authority5, the Scottish National Blood Transfusion Service6, the Northern Ireland Blood Transfusion Service7or the Welsh Blood Service8in 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 19779;
“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 197210,
(d) a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 199011,
(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 199012, or the National Health Service (Scotland) Act 1978,
(h) an NHS foundation trust within the meaning of section 1(1) of the Health and Social Care (Community Health and Standards) Act 200313, or
(i) a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 199114;
“hospital” means a health service hospital or an independent hospital;
“hospital blood bank” means any unit within a hospital which stores and distributes, and may perform compatibility tests on, blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities;
“independent hospital” has the same meaning as in section 2 of the Care Standards Act 200015;
“inspection” means formal and objective control to identify problems in accordance with standards adopted to assess compliance with these Regulations;
“inspector” means a person appointed by the Secretary of State to carry out inspections pursuant to regulation 15(10);
“nurse” means a registered nurse or registered midwife;
“person responsible for management of a hospital blood bank” means—
(a) in the case of hospital blood bank located in a hospital managed by a health service body, that body, and
(b) in the case of an independent hospital, the registered person;
“qualified health professional” means—
(a) a doctor;
(b) a nurse, or
(c) a donor carer;
“registered person” means the person registered as the manager of an independent hospital following an application to be registered as such pursuant to section 12(3) of the Care Standards Act 2000;
“reporting year” means the period of twelve months ending on 31st March;
“responsible person” in relation to a blood establishment means the person who has been designated pursuant to regulation 6 as the responsible person for that blood establishment,
“serious adverse event” means any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;
“serious adverse reaction” means an unintended response in a donor or in a patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling or incapacitating, or which results in or prolongs hospitalisation or morbidity;
“site”, in relation to a blood establishment, means any premises at which the blood establishment carries out any of the activities listed in regulation 3(2), but shall not include any premises not owned or managed by the blood establishment at which blood is collected, or any mobile blood collection unit;
“validation” means the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Designation of the competent authority and scope of the Regulations
2.—(1) The Secretary of State is designated the competent authority for the purpose of the Directive.
(2) Subject to the following paragraphs, the requirements of these Regulations apply to the collection and testing of blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when they are intended to be used for transfusion.
(3) These Regulations apply without prejudice to the Medical Devices Regulations 200216.
(4) These Regulations do not apply to blood stem cells.
Requirement for authorisation
3.—(1) Subject to paragraph (3), no person may carry on any of the activities listed in paragraph (2) otherwise than in accordance with an authorisation granted under regulation 4.
(2) The activities referred to in paragraph (1) are—
(a)
(a) the collection and testing of blood or blood components, whatever their intended purpose; and
(b)
(b) the processing, storage and distribution of blood and blood components when they are intended to be used for transfusion.
(3) The restriction in paragraph (1) shall not apply to—
(a)
(a) the storage and distribution of, and the performance of compatibility tests on, blood and blood components exclusively for use within hospital facilities, including transfusion activities where such activities are performed by a hospital blood bank; or
(b)
(b) any person carrying out any of the activities referred to in paragraph (2), where that person carries out that activity on behalf of, and pursuant to a contractual arrangement with—
(i) a blood establishment which is authorised under these regulations to carry out the activity in question; or
(ii) a person responsible for management of a hospital blood bank.
Authorisation of a blood establishment
4.—(1) The Secretary of State may grant an authorisation to a blood establishment to carry out any of the activities referred to in regulation 3(2).
(2) An application for authorisation under paragraph (1) shall be made to the Secretary of State.
(3) An application must—
(a)
(a) include the information set out in paragraph (4); and
(b)
(b) be accompanied by a fee of the amount prescribed in regulation 22(2)(a).
(4) The information referred to in paragraph (4) is—
(a)
(a) the name and address of the blood establishment and general information about its activities which shall include—
(i) details of each site at which it wishes to carry out any of the activities referred to in regulation 3(2),
(ii) a description of the activities which it wishes to carry out at each site,
(iii) where it has or intends...
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