BLOOD FACILITY DECLARATION FORM

FOR REPORTING PERIOD 1ST APRIL 2018 to 31ST MARCH 2019

Blood Facility Name

Trust / Private Healthcare Organisation Name (where applicable)

Address

Town / City

Post Code

Name of supplying Hospital Blood Bank

Facility details above completed by:

Signed: Date:
(Signature)

Name: Position:
(BLOCK CAPITALS) (see note below *)

Telephone: _____________________________ Email: __________________________

DECLARATION

To the best of my knowledge and belief the particulars given in this form are correct and complete.
(The provision of this information is a requirement under regulation 15 (Section 15(6) and 15(7)) of the
Blood Safety and Quality Regulations 2005 (as amended). Contravention of the requirements of a
notice served under regulation 15(7) would be a criminal offence under regulation 18(2) of the
Regulations.)
By signing this form, I declare that:
- The blood facility operates in compliance with the Blood Safety and Quality Regulations 2005
(as amended)
- The blood facility operates a quality system based on the principles of good practice
- The facility has named personnel with overall responsibility for quality within the blood facility
that have read and understood Regulations 12A, 12B, 15, 17, & 22 of the Blood Safety and
Quality Regulations (as amended), and the Annex to Commission Directive 2005/62/EC

”:
The person responsible for management of the facility

Signed: Date:
(SIGNATURE)

Name: Position:
(BLOCK CAPITALS) (see note below *)

Third Party service provider declaration (where applicable)

Name of Third Party:

Signed: Date:
(SIGNATURE)

Name: Position:
(BLOCK CAPITALS) (see note below *)

* Signatories should include the person completing the form and the "person responsible for
management of a facility", as defined by Regulation 1 of the Blood Safety and Quality Regulations, SI
2005 No. 50 (as amended), which in the case of a hospital, facility or service which is owned or
managed by an NHS body, that body; or in the case of an independent hospital, an independent clinic
or a care home, the registered person; or in the case of a manufacturer or a biomedical research
institution, the manufacturer or bio-medical research institution. Where the provision of services is
outsourced to a third party (e.g. private company or other legal entity such as a pathology partnership),
the Chief Executive of the outsourced service provider should also declare that to the best of their
knowledge and belief the particulars given in this form are correct and complete.

When complete please return the signed declaration form electronically to:
BCRBF@mhra.gov.uk email subject heading ‘Full facility name – DEC2019’.