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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 - 

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 2002[
16].

    (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 - 

    (3) The restriction in paragraph (1) shall not apply to - 

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 - 

    (4) The information referred to in paragraph (4) is - 

    (5) The Secretary of State may - 

    (6) Where the Secretary of State grants an application for authorisation, he shall give notice in writing to the blood establishment specifying - 

    (7) Subject to the requirements of paragraph (8), the Secretary of State may at any time remove or vary any of the conditions referred to in paragraph (5)(b)(ii), or may impose additional conditions.

    (8) Where the Secretary of State removes or varies any condition or imposes any additional condition pursuant to paragraph (7), he shall serve a notice on the blood establishment in question which shall - 

    (9) A blood establishment may not make any substantial change in the activities which it undertakes without the prior written approval of the Secretary of State.

    (10) Any application for approval to make a substantial change in its activities shall be made in writing to the Secretary of State, and shall be accompanied by a fee of the amount prescribed in regulation 22(2)(b).

    (11) For the purpose of this regulation, a substantial change in a blood establishment's activities is any change - 

Suspension or revocation of authorisation
    
5.  - (1) The Secretary of State may suspend or revoke the authorisation of a blood establishment on one or more of the following grounds - 

    (2) Subject to paragraph (3), before suspending or revoking the authorisation of a blood establishment, the Secretary of State shall serve a notice on the blood establishment stating that he intends to suspend or revoke its authorisation with effect from the date specified in the notice, which date shall be not less than 7 days from the date on which the notice is served.

    (3) Where the Secretary of State considers that it is necessary in the interests of safety, he may, by a notice served on a blood establishment, suspend or revoke its authorisation with immediate effect.

    (4) Where - 

and the Secretary of State considers that the failure in question is not sufficiently serious to warrant suspension or revocation of the authorisation of the blood establishment in the first instance, he may serve a notice on the responsible person of the blood establishment in accordance with paragraph (5).

    (5) A notice served under this paragraph shall - 

    (6) If the blood establishment fails to comply with the requirements set out in the notice within the specified timescale, the Secretary of State may, by a notice served on the blood establishment, suspend or revoke the authorisation of the blood establishment.

    (7) A suspension or revocation pursuant to paragraph (6) shall take effect - 

    (8) Any suspension pursuant to paragraphs (1) or (6) shall be for such period as the Secretary of State shall consider necessary having regard to the reasons for the suspension.

    (9) The suspension or revocation of an authorisation under paragraph (1) or paragraph (6) may be total, or may be limited to a particular activity or to one or more activities carried out at a particular site or sites, or to a particular blood component.

The responsible person for a blood establishment
    
6.  - (1) A blood establishment shall designate a person who is responsible for the following tasks - 

    (2) A blood establishment shall not designate a person under paragraph (1) unless that person has - 

    (3) The Secretary of State shall from time to time publish details of courses recognised by him for the purpose of paragraph (2)(a)(ii).

    (4) The responsible person may delegate any of the tasks specified in paragraph (1) to other persons who shall be qualified by training and experience to perform them.

    (5) Blood establishments shall notify the Secretary of State of the name of any persons to whom tasks have been delegated by the responsible person under paragraph (4), and the specific tasks which have been delegated to such persons.

    (6) Where the responsible person or a person to whom tasks have been delegated under paragraph (4) is permanently or temporarily replaced, the blood establishment shall without delay provide the Secretary of State with the name of the replacement, details of his qualifications and the date on which the replacement began his duties.

    (7) If the Secretary of State considers that the responsible person does not meet the requirements of paragraph (2), he may serve a notice to that effect on the blood establishment.

    (8) If, within 14 days of receiving a notice in accordance with paragraph (7), a blood establishment is not able to demonstrate to the reasonable satisfaction of the Secretary of State that the responsible person does meet the requirements of paragraph (2), it shall, without delay - 

Blood establishment requirements
    
7.  - (1) A blood establishment shall - 

    (2) A blood establishment shall, in relation to the donation of blood - 

    (3) A blood establishment shall ensure that, in relation to the blood and blood components which it collects, processes, stores or distributes - 

    (4) A blood establishment shall, in relation to the activities specified in regulation 3(2) for which it is responsible, maintain records, for a minimum period of 15 years, of - 

    (5) The information specified in this paragraph is - 

    (6) The information specified in this paragraph is - 

    (7) The basic testing requirements with which blood establishments must ensure compliance pursuant to paragraph (3)(a)(i) are - 

    (8) The Secretary of State may issue guidance as to the additional tests referred to in paragraph (3)(a)(ii) which are necessary in relation to specific components, types of donor or epidemiological situations and blood establishments shall have regard to such guidance.

    (9) As soon as practicable after the end of the reporting year, each blood establishment shall provide to the Secretary of State a report specifying - 

Labelling of blood and blood components and traceability
    
8.  - (1) A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from outside the European Community, shall contain the following information - 

    (2) A blood establishment shall keep such records of the information referred to in paragraph (1) above and such additional records as are necessary - 

for a period of not less than 30 years.

Hospital blood bank requirements
    
9.  - (1) The person responsible for the management of a hospital blood bank shall - 

Requirement for hospital blood banks to provide information to the Secretary of State
    
10.  - (1) As soon as practicable after the end of the reporting year, the person responsible for management of a hospital blood bank shall submit an annual report to the Secretary of State, which shall - 

    (2) The person responsible for management of a hospital blood bank shall without delay notify the Secretary of State of any changes to the matters in respect of which evidence has been supplied pursuant to paragraph (1) which might affect compliance with the requirements of these Regulations.

Service of notices relating to hospital blood banks
    
11.  - (1) If the Secretary of State is of the opinion that - 

he may serve a notice on the person responsible for management of the hospital bank requiring that the hospital ceases to conduct any of the activities specified in the notice, or refrains from administering to patients any blood or blood components specified in the notice, until the requirements of paragraph (4) are met.

    (2) Subject to paragraph (3), any notice served by the Secretary of State pursuant to paragraph (1) shall specify the date from which the prohibition specified in the notice shall take effect, which shall be not less than 7 days from the date on which the notice is served.

    (3) Where the Secretary of State considers that it is necessary in the interests of safety, he may specify in the notice that the prohibition takes immediate effect.

    (4) The requirements of this paragraph are, as may be applicable in each case, that - 

Objections to suspensions, revocations etc
    
12.  - (1) A blood establishment or a person responsible for the management of a hospital blood bank who - 

may notify the Secretary of State of its desire to make written representations to, or be or appear before and be heard by, a person appointed by the Secretary of State for that purpose.

    (2) Any notification of an objection pursuant to paragraph 1 shall be made within 14 days of service on the blood establishment or the person responsible for the management of the hospital blood bank of the notice to which the notification pursuant to paragraph (1) relates.

    (3) Where the Secretary of State receives a notification pursuant to paragraph (1), he shall appoint a person to consider the matter.

    (4) The person appointed pursuant to paragraph (3) shall determine the procedure to be followed with respect to the consideration of any objection.

    (5) The person appointed pursuant to paragraph (3) shall consider any written or oral objections made by the blood establishment or the person responsible for management of the hospital blood bank in support of its objection, and shall make a recommendation to the Secretary of State.

    (6) A recommendation made pursuant to paragraph (5) shall be made in writing to the Secretary of State, and a copy of it shall be sent to the blood establishment or the person responsible for the management of the hospital blood bank concerned, or to its nominated representative.

    (7) The Secretary of State shall take into account any recommendation made pursuant to paragraph (5).

    (8) Within 14 days of receipt of any recommendation made pursuant to paragraph (5), the Secretary of State shall inform the blood establishment or the person responsible for the management of the hospital blood bank whether he accepts the recommendation and, if he does not accept it, of the reasons for his decision.

    (9) Where the Secretary of State is notified of an objection pursuant to paragraph (1)(a) before the date upon which the suspension or revocation or the notice is due to take effect, the suspension or revocation or notice in respect of which the objection is made shall not take effect until - 

    (10) Subject to paragraph (11), where the Secretary of State is notified of an objection pursuant to paragraph (1)(a), within the period specified in paragraph (2), to a suspension, revocation or other notice which has already taken effect on the date the notification was made, the suspension, revocation or notice in respect of which the objection is made shall cease to have effect until - 

    (11) Paragraph (10) shall not apply - 

Import of blood and blood components into the United Kingdom
    
13. No person shall import into the United Kingdom any blood or blood components (including blood or blood components intended for use as a starting material or raw material in the manufacture of medicinal products) from a country or territory outside the European Community which does not meet standards of quality and safety equivalent to those laid down in Part 5 of the Schedule.

Disclosure of information by blood establishments and hospital blood banks
    
14.  - (1) A blood establishment and the person responsible for management of a hospital blood bank shall ensure that all information which is collected for the purposes of these Regulations is held securely so that it is - 

    (2) The requirements of this paragraph are - 

    (3) Where a disclosure is made to an inspector pursuant to paragraph (2)(b), the inspector shall not further disclose the information received unless - 

    (4) Where a disclosure is made by an inspector to another officer of the Secretary of State pursuant to paragraph (3), that person shall not further disclose the information he receives other than in accordance with the requirements of that paragraph.

    (5) The responsible person of the blood establishment and the person responsible for management of the hospital blood bank shall ensure that they put in place a procedure to ensure that any discrepancies relating to data which are brought to their attention are resolved without delay.

Inspections, etc.
    
15.  - (1) The Secretary of State shall conduct a regular inspection of each site of a blood establishment, not less than once every two years, for the purpose of ensuring that - 

    (2) The Secretary of State may conduct such additional inspections of blood establishments sites as he considers necessary for the purpose of ensuring compliance with the requirements of these Regulations.

    (3) The Secretary of State may also serve a notice on a blood establishment requiring that it furnish him with such information concerning its compliance with these Regulations as shall be specified in the notice within such period as shall be specified in the notice.

    (4) Any blood establishment which receives a request or information in accordance with paragraph (3) shall provide the information requested within the period specified in the notice.

    (5) The Secretary of State may inspect hospital blood banks with a view to ensuring that - 

    (6) The Secretary of State may also serve a notice on the person responsible for managing a hospital blood bank requiring that he furnish him with such information concerning the compliance of the blood bank with these Regulations as shall be specified in the notice within such period shall be specified in the notice.

    (7) Any person responsible for management of a hospital blood bank who receives a request for information in accordance with paragraph (6) shall provide the information requested within the period specified in the notice.

    (8) In the event of any serious adverse event or any serious adverse reaction or suspicion thereof, the Secretary of State shall request such information or conduct such inspections in accordance with this regulation as he shall consider appropriate.

    (9) Any reference to an inspection of a site which the Secretary of State is required or empowered to conduct by virtue of this regulation, shall be construed so as to include an inspection of premises within the UK at which any of the activities listed in regulation 3(2) are carried out by any person on behalf of, and pursuant to a contractual arrangement with, a blood establishment or, as the case may be, a person responsible for management of a hospital blood bank.

    (10) The Secretary of State may appoint such persons to be inspectors as he thinks necessary for the proper discharge by them of his functions set out in these Regulations, and he may appoint such persons upon such terms and conditions (including conditions as to remuneration, benefits, allowances and reimbursement for expenses) as he thinks fit.

Records to be kept by the Secretary of State
    
16.  - (1) The Secretary of State shall keep such records of information which he receives from, or relating to, blood establishments as he considers appropriate and shall, in particular, keep records relating to - 

    (2) The Secretary of State shall keep such records of information which he receives from persons responsible for management of hospital blood banks, or otherwise or relating to hospital blood banks, as he considers appropriate and shall, in particular keep records relating to - 

Powers of entry, etc.
    
17.  - (1) For the purposes of enforcing compliance with these Regulations or conducting inspections pursuant to regulation 15, an inspector appointed in accordance with regulation 15(10) shall, upon production of evidence that he is so authorised, have the right - 

but nothing in this paragraph shall be taken to compel the production by any person of a document of which he would on grounds of legal professional privilege be entitled to withhold production on an order for disclosure in an action in the High Court or, as the case may be, on an order for production of documents in an action in the Court of Session.

    (2) If a justice of the peace is satisfied by any written information on oath that there are reasonable grounds for entry into any premises, other than premises used only as a private dwelling house, for any purpose mentioned in paragraph (1), and - 

the justice may, by warrant signed by him, which shall continue in force for a period of one month, authorise an inspector to enter the premises, if need be by force.

    (3) An inspector entering premises by virtue of paragraph (1) or of a warrant under paragraph (2) may take with him when he enters those premises such equipment as may appear to him necessary and any person who is authorised by the Secretary of State to accompany him on that visit.

    (4) On leaving any premises which an inspector is authorised to enter by a warrant under paragraph (2), he shall, if the premises are unoccupied, or the occupier is temporarily absent, leave the premises as effectively secured against trespassers as he found them.

    (5) Where, pursuant to paragraph (1)(e), an inspector takes possession of any article, substance, book, document, data or record, he shall leave at the premises with a responsible person, or if there is no such person present on the premises, leave in the premises in a prominent position, a statement giving particulars of the article, substance, book, document, data or record sufficient to identify it and stating that he has taken possession of it.

    (6) Where, pursuant to paragraph (1)(e) an inspector takes a sample for analysis, the Secretary of State may, subject to the requirements of paragraph (7), make such arrangements for analysis of that sample as he considers appropriate.

    (7) The requirements of this paragraph are - 

    (8) The requirements of this paragraph are - 

Criminal offences
    
18.  - (1) Any person who contravenes any of the following provisions - 

shall be guilty of an offence.

    (2) Any person who contravenes any of the following provisions - 

shall be guilty of an offence

    (3) Any person who fails to comply with a notice of suspension or revocation of his authorisation served pursuant to regulation 5, save where the operation of that notice has been suspended pursuant to regulation 12, or has been withdrawn or revoked by the Secretary of State, shall be guilty of an offence.

    (4) Any person who knowingly sells or supplies blood or any blood component which is not labelled in accordance with the requirements of regulation 8, shall be guilty of an offence.

    (5) Any person who contravenes the requirements of any notice served by the Secretary of State under regulation 11(1), shall be guilty of an offence.

    (6) Any person who - 

shall be guilty of an offence.

    (7) Subject to paragraph (5) - 


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