• “health service hospital” means a hospital owned or managed by a health service body;

• “independent hospital”—

  1. a

     in England and Wales, has the same meaning as in section 2 of the Care Standards Act 20005,

  2. b

     in Scotland, has the same meaning as in section 2 of the Regulation of Care (Scotland) Act 20016, and

  3. c

     in Northern Ireland, has the same meaning as in article 2 of the Health and Personal Social Services (Quality, Improvement and Regulation)(Northern Ireland) Order 20037

• “registered person” means the person registered as the manager of an independent hospital, a care home or an independent clinic following an application to be registered as such pursuant to—

  1. a

     section 12(3) of the Care Standards Act 2000,

  2. b

     section 7(1) of the Regulation of Care (Scotland) Act 2001, or

  3. c

     article 13(1) of the Health and Personal Social Services (Quality, Improvement and Regulation)(Northern Ireland) Order 2003

• “biomedical research institution” means any body which carries out biomedical research;

• “care home”—

  1. a

     in England and Wales, has the same meaning as in section 3 of the Care Standards Act 2000,

  2. b

     in Scotland, has the same meaning as in section 2 of the Regulation of Care (Scotland) Act 2001, and

  3. c

     in Northern Ireland, has the same meaning as in article 2 of the Health and Personal Social Services (Quality, Improvement and Regulation)(Northern Ireland) Order 2003;

• “Commission Directive 2005/62/EC” means Commission Directive 2005/62/EC of 30th September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments8;

• “facility” means—

  1. a

     a hospital,

  2. b

     any other facility or service owned or managed by a health service body,

  3. c

     a care home,

  4. d

     an independent clinic,

  5. e

     a manufacturer, or

  6. f

     a biomedical research institute;

• “imputability” means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused, or that a serious adverse reaction in a donor can be attributed to the donation process;

• “independent clinic”—

  1. a

     in England and Wales, has the same meaning as in section 2 of the Care Standards Act 2000,

  2. b

     in Scotland, has the same meaning as in section 2 of the Regulation of Care (Scotland) Act 2001, and

  3. c

     in Northern Ireland, has the same meaning as in article 2 of the Health and Personal Social Services (Quality, Improvement and Regulations)(Northern Ireland) Order 2003;

• “issue” means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

• “manufacturer” means a person who—

  1. a

     holds a licence under section 8(2) of the Medicines Act 19689 to manufacture medicinal products;

  2. b

     holds an authorisation to manufacture an investigational medicinal product granted pursuant to regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 200410; or

  3. c

     falls within the definition of “manufacturer” in paragraph (1) of regulation 2 of the Medical Devices Regulations 200211;

• “person responsible for the management of a facility” means—

  1. a

     in the case of a hospital, facility or service which is owned or managed by an NHS body, that body,

  2. b

     in the case of an independent hospital, an independent clinic or a care home, the registered person,

  3. c

     in the case of a manufacturer or a biomedical research institution, the manufacturer or biomedical research institution;

• “person responsible for the management of a reporting establishment” means a blood establishment, the person responsible for the management of a facility or the person responsible for the management of a hospital blood bank;

• “recipient” means a person who has been transfused with blood or blood components;

• “reporting establishment” means the blood establishment, the hospital blood bank or the facility where the transfusion takes place;

• “third country” means any country other than a Member State; and

• “traceability” means the ability to trace each individual unit of blood or blood component from the donor to its final destination (whether this is a recipient, a manufacturer of medicinal products or disposal) and from its final destination back to the donor;