POL:11:UP:008:03:NIBT PAGE 1 of 5. Document Title: BELFAST CORD BLOOD BANK POLICY FOR THE RETURN AND REISSUE OF BBMR AND DIRECTED CORD BLOOD UNITS

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1 POL:11:UP:008:03:NIBT PAGE 1 of 5 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:11:UP:008:03:NIBT Supersedes Number: POL:11:UP:008:02:NIBT No. of Appendices: NONE Document Title: BELFAST CORD BLOOD BANK POLICY FOR THE RETURN AND REISSUE OF BBMR AND DIRECTED CORD BLOOD UNITS ISSUE DATE: 12 DECEMBER 2014 EFFECTIVE DATE: 9 JANUARY 2015 Document Authorisation Written By: Dr Kieran Morris, Medical Director Signature: Date: Authorised By: Mr Mervyn Barkley, Chief Executive Signature: Date: CROSS REFERENCES This Policy refers to the following documents: Doc Type Doc. No. Title POL UP:005 Policy for discard and disposal of cord blood units SOP CB:077 Discard of unsuitable cord blood, its products and maternal samples.

2 POL:11:UP:008:03:NIBT PAGE 2 of 5 Key Change From Previous Revision: Change to equality screening statement to comply with current guidance. New arrangements for dedicated cord blood arrangements with NHSBT detailed. 1 STATEMENT This document sets out the general policies for return and reissue of both directed and unrelated/public cord blood units at Belfast Cord Blood Bank (BCBB), which shall be in keeping with the following Regulations and Best Practice Guidelines: The Human Tissue Act 2004 The Human Tissue (Quality and Safety for Human Application) Regulations, 2007 Human Tissue Authority Directions Human Tissue Authority Codes of Practice. Current Edition Guidelines for the Blood Transfusion Services in the United Kingdom. 2 OVERVIEW Belfast Cord Blood Bank (BCBB) issues both public (i.e. British Bone Marrow Registry, BBMR) cords and directed (family) cords for use in umbilical cord blood transplantation in Transplant Centres (TC) within the UK and internationally. These cords are issued to the TC under BCBB HTA Licence for distribution and exportation. As such, all transport conditions must comply with the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/2010. BCBB does not routinely accept returns of issued cord blood units but may in exceptional circumstances be asked by a TC to consider acceptance of a returned unit for banking and possible re-issue. This policy sets out the conditions under which return and re-banking of a unit may be considered by BCBB. 3 RESPONSIBILITY Medical Consultant /Designated Individual, Cord Blood Biomedical Scientists 4 POLICY 4.1 Recall: In general BCBB will not initiate recall of a unit. If information emerges which suggests that an issued cord should not be considered for clinical use, then this

3 POL:11:UP:008:03:NIBT PAGE 3 of 5 information will be provided to the TC and the TC will be asked to dispose of the cord according to their disposal policy. The TC will be required to provide BCBB with documentation to verify that the cord has been disposed of. This is required for full traceability of the unit, in keeping with Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/ Return of BBMR/Public bank cords: It may arise that a public bank cord is issued to a TC but the transplant does not go ahead. It is envisioned that in the majority of cases the cord will not be returned to BCBB but will stay with the TC who will be responsible for its storage (if the planned transplant is to go ahead at a later date), or its disposal if the transplant is cancelled. The TC will be required to provide BCBB with documentation to verify that the cord has been stored in their facility under conditions and temperatures which maintain the safety and quality of the cells, or has been disposed of. This is required for full traceability of the unit, in keeping with Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/2010. In exceptional circumstances, consideration may be given to return of a unit which is especially valuable by virtue of a particularly unusual HLA type /ethnic background or other rare attribute. Acceptance of return of such a unit will be at the discretion of the Designated Individual (DI) of the BCBB. The unit must be transported to the BCBB according to Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/2010 and the DI must assure her/himself that the necessary storage and transport conditions have been complied with prior to re-storage of the unit. Written documentation pertaining to transport, and risk assessment of the cord, must be entered into the cord blood chart for this unit. In the event of any adverse event or reaction the BCBB will inform the HTA within 24 hours of discovery of the incident. 4.3 Return of Directed cords: Occasionally a directed ( family ) cord may be issued to a TC but the transplant does not go ahead. In most circumstances the cord will not be returned to BCBB but will stay with the TC who will be responsible for its storage (if the planned transplant is to go ahead at a later date), or its disposal if the transplant is cancelled and the family are agreeable to disposal of the cord. The TC will be required to provide BCBB with documentation to verify that the cord has been stored in their facility or has been disposed of. This is required for full traceability of the unit. If the transplant is cancelled at that TC and the family wish the cord to be returned to BCBB for storage, the acceptance of return of such a unit will be at the discretion of the Designated Individual (DI) of the BCBB. The unit must be transported to the BCBB according to Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/2010 and the DI must assure her/himself that the necessary storage and transport conditions have been complied with prior to re-storage of the unit. Written documentation pertaining to transport and risk assessment of the cord must be entered into the cord blood chart for this unit. In the event of any adverse event or reaction the BCBB will inform the HTA within 24 hours of discovery of the incident.

4 POL:11:UP:008:03:NIBT PAGE 4 of 5 Dedicated cord blood donations will be collected under NIBTS HTA licence. Transport, testing, processing and storage will be under NHSBT HTA licence and this is covered by a letter of agreement. 4.4 Risk assessment and re-banking: Once a returned cord has been entered into storage at BCBB a full risk assessment of continued storage and clinical use of this cord must be undertaken. This risk assessment will take into consideration availability of reliable data on conditions of transport to and from the TC, and storage conditions at the TC. If significant doubt exists around these conditions and /or the suitability of the cord for future transplant use, then disposal of the cord will be considered. In the case of a directed cord, this should be in consultation with the family unless there are extenuating circumstances that would deem this inappropriate. The reason for disposal of a cord must be recorded and disposal must be in keeping with Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions 003/2010, and BCBB Policy for discard and disposal of cord blood units POL:UP:005, and SOP:CB:077, Discard of unsuitable cord blood, its products and maternal samples. 4.5 Reissue of cords: Returned cords may only be reissued when a satisfactory risk assessment has been performed and the cord is deemed suitable for reissue by the DI. Consideration may be given to performance of viability studies if a suitable sample is available for testing. In all circumstances the requesting TC should be informed at the earliest opportunity that the cord has been previously issued and returned to storage. 5 EQUALITY SCREENING OUTCOME This policy has been drawn up and reviewed in light of the statutory obligations contained within Section 75 of the Northern Ireland Act (1998). In line with the statutory duty of equality this policy has been screened against particular criteria. If at any stage of the life of the policy there are any issues within the policy which are perceived by any party as creating adverse impacts on any of the groups under Section 75 that party should bring these to the attention of the Head of HR& Corporate Services. The Northern Ireland Blood Transfusion Service is committed to the promotion of equality of opportunity for staff, donors and service users. We strive to ensure that everyone is treated fairly and that their rights are respected at all times. We believe it is important that our policy is understood by all those whose literacy is limited, those who do not speak English as a first language or those who face communication barriers due to a disability. On request it may be possible to make this policy available in alternative formats such as large print, Braille, disk, audio file, audio cassette, Easy Read or in minority languages to meet the needs of those not fluent in English.

5 POL:11:UP:008:03:NIBT PAGE 5 of 5 6 TRAINING REQUIREMENTS This policy should be read and understood by BCBB medical, nursing and biomedical scientist staff.