POL:02:UP:001:06:NIBT PAGE 1 of 6 ISSUE DATE: 6 JULY 2012 EFFECTIVE DATE: 20 JULY 2012

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1 POL:02:UP:001:06:NIBT PAGE 1 of 6 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:02:UP:001:06:NIBT Supersedes Number: 02:05:UP:001:NIBT No. of Appendices: NONE Document Title: POLICIES FOR CORD BLOOD BANKING ISSUE DATE: 6 JULY 2012 EFFECTIVE DATE: 20 JULY 2012 Document Authorisation Written By: Dr Joanne Murdock, Medical Director Signature: Date: Authorised By: Geoffrey Geddis, Quality Manager Signature: Date: Authorised By: Dr Kieran Morris, Chief Executive Signature: Date: CROSS REFERENCES This Policy refers to the following documents: Doc Type Doc. No. Title SOP QA:092 Reporting of Serious Adverse Events and Reactions to the Human Tissue Authority FORM DD:841 Cord Blood Complaints Leaflet

2 POL:02:UP:001:06:NIBT PAGE 2 of 6 Key Change From Previous Revision: Policy in new format Regulation and guideline details updated Organisational chart updated Reference to SOP:QA:092 (Reporting of SAERs) added Minor typographical errors corrected. 1 STATEMENT This document sets out the general policies for cord blood banking 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. Current UKBTS/NIBSC Tissue Donor Selection Guidelines.

3 POL:02:UP:001:06:NIBT PAGE 3 of 6 2 OVERVIEW Belfast Cord Blood Bank Organisational chart: Catherine Ferguson Laboratory Manager Dr Joanne Murdock Consultant Haematologist & Designated Individual Geoffrey Geddis Quality Manager Pauline Gowdy Cord Blood Bank Manager Heather Dickson Cord Blood Nurse Coordinator Heather Kinghan, Pat Davidson Quality Control Staff Tina Bannon Cord Blood BMS Brenda Rush Cord Blood Nurse John McCormick, Shirley McPeake Medical Laboratory Assistants

4 POL:02:UP:001:06:NIBT PAGE 4 of 6 3 RESPONSIBILITY 3.1 All BCBB Staff: Medical, Nursing, Biomedical Scientist And Medical Laboratory Assistants, Quality Staff. 4 POLICY 4.1 Quality Management All aspects of the cord blood bank operations will be covered by the NIBTS Quality Management System. This covers document control, change management including validation, regular internal audit and quality incident reporting. There is general oversight of the QM System by the NIBTS Clinical Governance & Risk Management Committee, which also oversees training arrangements, clinical audit, Health and Safety and Risk Management. 4.2 Procedures Written policies and procedures will cover all operations including the recruitment and medical assessment of donors, consent procedures, collection, transport, processing, labelling, testing (of mother and cord), storage and release procedures. There are separate policies and procedures covering cord blood units collected for directed use. All procedures will be subject to regular review by the medical consultant, head of laboratory or nurse coordinator as appropriate, in conjunction with the Quality Manager. 4.3 Release Procedures Release for banking All relevant records, including medical assessment of mother, baby and donation, test results on mother and cord blood, processing and storage records and post-processing quality control tests must be reviewed and signed off by the Quality Manager and NIBTS medical consultant prior to release for banking and inclusion on the British Bone Marrow Donor Registry Release for clinical use (transplantation) 4.4 Registry Prior to release, the NIBTS medical consultant will carry out additional review of records. This will be carried out in conjunction with the requesting consultant from the transplant centre. The Belfast Cord Bank is linked with the British Bone Marrow Registry (BBMR). Cord blood donation data will be forwarded to the BBMR following completion of release sign off (see above).

5 POL:02:UP:001:06:NIBT PAGE 5 of Third Party Agreements and Service Level Agreements Third Party and Service level agreements will be in place with all relevant third parties including participating maternity hospitals and testing laboratories (e.g. tissue typing, microbiology, special functional assays). 4.6 External Quality Assessment All laboratory facilities performing tests for cord blood (internal or third party) will participate in available NEQAS schemes. 4.7 Facilities All facilities will conform to required standards as set down by HTA Directions 003/2010 and UK Guidelines (Guidelines for the Blood Transfusion Services of the United Kingdom, current edition: 7 th edition, 2005) 4.8 Training Staff training will be provided covering all procedures and such training will be documented and regularly updated in keeping with NIBTS training policies and procedures. 4.9 Health and Safety All procedures will be carried out in keeping with NIBTS Health and Safety Policies and procedures Adverse Incidents General NIBTS policies and procedures will be applied and cover the detection, reporting, investigation, documentation and corrective actions in relation to all errors, adverse events and reactions which may affect the quality of product (for potential recipient) or donors. The Designated Individual will be responsible for ensuring that adverse events are reported to the Human Tissue Authority as appropriate. The procedure is described in SOP:QA:092, Reporting of Serious Adverse Events and Reactions to the Human Tissue Authority Complaints The NIBTS complaints policy and procedure apply to all issues, comments or complaints received in relation to staff, users, visitors, services or product. All complaints will be copied to the Complaints Coordinator and dealt with within defined timescales. Regular review will be carried out to monitor the Agency s performance in dealing with complaints. BCBB has a complaints leaflet, DD:841 for patient/client use.

6 POL:02:UP:001:06:NIBT PAGE 6 of Research Use of cord blood for research purposes will conform to HTA Directions 003/2010 and NIBTS research governance policies and procedures Records Management Procedures will be in keeping with HTA Directions 003/2010 and NIBTS policies on Information Governance and Records Management Risk Management and Contingency Planning Policies and procedures will be developed in keeping with HTA Directions 003/2010 and the NIBTS Risk Management Strategy and Business Continuity Planning Policies. 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 this 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. 6 TRAINING REQUIREMENTS All Belfast Cord Blood Bank staff should have read and understood this policy.