CAUTION: Refer to the Document Library for the most recent version of this policy. Policy for the use of Cytomegalovirus (CMV) negative blood products

Transcription

1 Directorate Department Year Version Number Central Index Number Endorsing Committee Date Endorsed Approval Committee Date Approved Author Name and Job Title Key Words (for search purposes) Date Published on Document Library Review Date Target Audience Cancer & Diagnostics Pathology 2016 Version 3 C0661 Quality Governance Operational Committee 09/02/2016 Hospital Transfusion Committee 27/01/2016 Hospital Transfusion Team:- Dr M Sivakumaran, Consultant Haematologist Chris Jones, Transfusion Lab Manager Kaye Bowen, Transfusion Practitioner CMV; Blood products; Transfusion 10/02/ /02/2019 All staff involved in transfusion of blood and blood components Equality Impact Assessment Peterborough and Stamford Hospitals NHS Foundation Trust (PSHFT) strives to ensure quality of opportunity for all service users, local people and the workforce. As an employer and a provider of health care, PSHFT aims to ensure that none are placed at a disadvantage as a result of its policies. This policy has therefore been equality impact assessed to ensure fairness and consistency for all those covered by it regardless of their individuality. The results are shown in the Equality Impact Tool at Appendix 3 Central Index Number C0661 Version 3 Page 1 of 13

2 DOCUMENT VERSION CONTROL SCHEDULE Year and Version Number 2010 Version Version Version 3 Date Published on Document Library September /02/ /02/2016 Revisions from previous issue Original Document New advice from the Advisory committee on the Safety of Blood Tissues and Organs (SaBTO) regarding the use of CMV negative components- now only indicated for intrauterine transfusion and neonates (up to 28 days post expected date of delivery), and for transfusion during pregnancy. Reviewed by Hospital Transfusion Teamno changes in practice. NHSBT factsheet for healthcare professionals added to appendices Date of Endorsement September 2010 / Clinical Governance Committee October 2012 / Quality Governance Operational Committee 09/02/2016 / Quality Governance Operational Committee Central Index Number C0661 Version 3 Page 2 of 13

3 Key Points This policy applies to all staff with responsibility for prescribing and administering blood and blood components. This policy gives guidance on when and how to request CMV negative blood products. Central Index Number C0661 Version 3 Page 3 of 13

4 Contents Section Page Number 1 Introduction 5 2 Purpose 5 3 Scope 5 4 Definitions of terms 5 5 Duties and responsibilities 5 6 Indications for use of CMV negative blood products 6 7 How to request CMV negative blood products 6 8 Implementation of the policy 6 9 Endorsement 6 10 Distribution 7 11 References 7 12 Associated Documents 7 Appendices 1 NHSBT Factsheet CMV Negative components 8 2 Compliance Monitoring 10 3 Equality Impact Assessment 11 4 Quality Assurance Checklist 12 Central Index Number C0661 Version 3 Page 4 of 13

5 1. Introduction 2. Purpose 3. Scope Cytomegalovirus (CMV) is a member of the herpes virus group, which includes herpes simplex and varicella zoster. These share the ability to remain dormant within the body for long periods. CMV is transmissible by transfusion of blood products. Severe impairment of the immune system by medication or disease may reactivate the virus from its latent state to cause clinical disease which may be fatal. All blood products apart from granulocytes are now routinely leucocyte depleted which effectively reduces CMV transmission. As fresh frozen plasma (FFP) and cryoprecipitate contain very few cells, they are extremely unlikely to transmit CMV and thus CMV seronegative issues of these products are not manufactured. This policy only refers to red cells and platelets. The purpose of this policy is to ensure that CMV negative red cells and platelets are requested for and transfused to patients who require them. This document applies to all members of staff involved in transfusion, and all patients who are prescribed red cells and/or platelet transfusion. 4. Definitions of terms CMV Cytomegalovirus a member of the herpes virus group. SaBTO the Advisory Committee for the Safety of Blood Tissues and Organs. SOP Laboratory Standard Operational Procedure. DATIX Electronic Adverse event and near miss reporting form. SHOT Serious Hazards of Transfusion UK wide reporting system for adverse transfusion events and near misses. SABRE Serious Adverse Blood Reactions and Events. This system allows reporters to electronically submit reports of serious adverse events or serious adverse reactions directly to the Medicines and Healthcare Products Regulatory Agency (MHRA). 5. Duties and responsibilities 5.1 It is the responsibility of the prescriber to ensure that the indication for CMV negative components is noted on the prescription chart and the laboratory request form. 5.2 It is the responsibility of the member of staff administering the component to check the component is of the correct specification before administration. Central Index Number C0661 Version 3 Page 5 of 13

6 6. Indications for use of CMV negative blood products 6.1 CMV negative red cells and platelets should be provided for intrauterine transfusions and neonates (up to 28 days after expected date of delivery) CMV negative granulocytes should be provided for CMV seronegative recipients. 6.2 CMV negative red cells and platelets should be provided, where possible, for pregnant women. In an emergency, such as major haemorrhage, standard leucocyte depleted components should be given to avoid delay. 6.3 Standard pre-storage leucodepleted components are suitable for all other transfusion recipients, including haemopoietic stem cell transplant patients, organ transplant patients and immune deficient patients, including those with HIV. 6.4 For shared care patients (for example children under shared care with Great Ormond Street hospital), the transfusion lab will honour the request from the referring hospital for CMV negative products. 7. How to request CMV negative blood products 7.1 Using the Sunquest ICE requesting system, the requirement for CMV negative blood products should be indicated by clicking the yes button at the special requirement option screen. The transfusion laboratory must also be informed by telephone of the requirement for CMV negative blood products. 7.2 Once the requirement for CMV negative blood products has been communicated to the Transfusion Laboratory, all further blood products issued will be CMV negative until the Transfusion Laboratory is informed otherwise. 7.3 The requirement for CMV negative blood products must be noted in the Special Requirement box on the dedicated Blood and Blood Products prescription and Transfusion Record. 8. Monitoring of Compliance 8.1 The transfusion laboratory will maintain responsibility for ensuring CMV negative products are issued when requested appropriately, referring to laboratory SOP TRA-CC-TRA 001/09. This SOP is reviewed annually. 8.2 Compliance with the policy will be monitored each time a component is issued, as described in Appendix Endorsement The policy will be approved by the Hospital Transfusion Committee and endorsed by the Quality Governance Operational Committee. Central Index Number C0661 Version 3 Page 6 of 13

7 10. Distribution The policy will be available on share point, on the trust intranet. 11. References Department of Health Advisory Committee on Safety of Blood Tissues and Organs (SaBTO) position statement on Cytomegalovirus tested Blood Components Available yandguidance/dh_ [Accessed 29/01/2016] McClelland, DBL (ed) (2014) Handbook of Transfusion Medicine 5 th ed Available [Accessed 29/01/2016] NHS Blood and Transplant Service (2014) Portfolio of blood components and guidance for their clinical use. Available [Accessed 29/01/2016] 12. Associated Documents Blood Transfusion Policy (C0160). Policy for Assessment of Staff Handling Collecting and/or Administering Blood and Blood Components (C0175). Central Index Number C0661 Version 3 Page 7 of 13

8 Appendix 1 NHSBT Factsheet Cytomegalovirus (CMV) Negative Blood Components Information for Healthcare Professionals Central Index Number C0661 Version 3 Page 8 of 13

9 Central Index Number C0661 Version 3 Page 9 of 13

10 Appendix 2 Compliance Monitoring Policy Title: Author: Hospital Transfusion Team Page/Section of Key Document Key Control Checks to be carried out to confirm compliance with the policy How often the check will be carried out: Responsible for carrying out the check: Result of check reported to: (Responsible for also ensuring actions are developed to address any areas of non-compliance Frequency of reporting WHAT? HOW? WHEN? WHO? WHERE? WHEN? The supply of CMV negative components to appropriate patients The transfusion laboratory will check that when red cells and platelets are requested for pregnant women and neonates, the requirement for CMV negative blood products is indicated on the request form. Each time a request for components made. Transfusion Biomedical Scientist An incident form will be raised via DATIX, and the incident investigated by the transfusion operational management team and corrective and preventative actions implemented. If appropriate, a report will be made to SHOT and SABRE Monthly at TOMT Central Index Number C0661 Version 3 Page 10 of 13

11 Appendix 3 Central Index Number C0661 Version 3 Page 11 of 13

12 Quality Assurance Checklist - Version Number: 3 Appendix: 4 Y/N/ n/a 1 Title of document Policy for the use of Cytomegalovirus (CMV) negative blood products (C0661) 2 Type of document (e.g. policy, guidance) Policy COMMENTS (where necessary) Is the title clear and unambiguous? 3 Introduction Are reasons for the development of the document clearly stated? 4 Content Is there a standard front cover? Are the key points identified? Is the document in the correct format? Is the purpose of the document clear? Is the scope clearly stated? Are the definitions clearly explained? Are the roles and responsibilities clearly explained? 5 Evidence Base Is the type of evidence to support the document explicitly identified? Are key references cited? Are associated documents referenced? 6 Approval Route Does the document identify which committee/group will approve it? 7 Process to Monitor Compliance and Effectiveness Are there measureable standards or KPIs to support the monitoring of compliance with the effectiveness of the document? 8 Review Date Is the review date identified? 9 Equality and Diversity Is a completed Equality Impact Assessment attached? Central Index Number C0661 Version 3 Page 12 of 13

13 Compliance Team: 1. Date of Compliance Team approval 29/01/ Comments to author for any amendments 3. Name of compliance lead Jim Walker, Quality Governance & Policies Assistant Approval Committee: HTC If the committee/group is happy to approve this document would the chair please sign below and send the document and the minutes from the approval committee to the author. To aid distribution all documentation should be sent electronically wherever possible. Name Dr B Appadu Date 27/01/16 Signature Comments Endorsing Committee: QGOC If the committee/group is happy to endorse this document would the chair please sign below and send the document and the minutes from the endorsing committee to the author. To aid distribution all documentation should be sent electronically wherever possible. Name Date Signature If answers to any of the above questions is no, then this document is not ready for endorsement, it needs further review. Central Index Number C0661 Version 3 Page 13 of 13