POL:08:LP:003:03:NIBT PAGE : 1 of 5. Document Title: NIBTS POLICY FOR RETURN AND RE-ISSUE OF BLOOD AND BLOOD COMPONENTS

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1 POL:08:LP:003:03:NIBT PAGE : 1 of 5 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:08:LP:003:03:NIBT Supersedes Number: 08:02:LP:003:NIBT No. of Appendices: NONE Document Title: NIBTS POLICY FOR RETURN AND RE-ISSUE OF BLOOD AND BLOOD COMPONENTS ISSUE DATE: 26 NOVEMBER 2014 EFFECTIVE DATE: 24 DECEMBER 2014 Document Authorisation: Written By: Pauline Gowdy, Hospital Services Manager Signature: Date: Authorised By: Catherine Ferguson, Laboratory Manager 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 FORM DD:046 Recall Notification And Component Fate Form FORM DD:062 NIBTS Blood component or Blood product returns Form SOP QA:002 Blood Component Recall Procedure SOP BI:044 Return of in date components which may be re-issued FORM DD:1142 NIBTS component returns for re-issue form FORM DD:1040 Recall record form

2 POL:08:LP:003:03:NIBT PAGE : 2 of 5 Key Change from Previous Revision: Inclusion of SOP:BI:044 and FORM:DD:1142 when returning blood for re-issue. Amend Equality Statement 1 STATEMENT It is a fundamental requirement of the NIBTS Quality Management System that all components which are considered to pose a risk to patients are withdrawn from use. A recall may be initiated for many reasons, including the following: Donation(s) found to have been collected from donor(s) who did not meet standard acceptance criteria, e.g. following post donation notifications/potentially infective donation Problems identified with donation testing. Problems identified with quality of raw materials e.g. blood bag faults/faulty labels. Adverse post transfusion reactions requiring the recall of other implicated components. Hospital no longer requires components or notifies NIBTS that the incorrect product was received. Note: Recall in this instance can only be initiated after approval from the Regulatory Affairs and Compliance Manager/Deputy during normal working hours or the NIBTS Consultant On Call outside normal working hours. Issued component is found to be suitable HLA match for a patient in a different hospital. For an incident in which the quality or safety of products may be compromised. A recall may be initiated from an internal or external source. It is not NIBTS policy to routinely accept returns of issued blood and re-issue of blood / blood components after recall must comply with strict conditions, to ensure the safety of the patient. This policy has been developed to outline the circumstances, which will permit staff to accept and reissue returned blood and blood components.

3 POL:08:LP:003:03:NIBT PAGE : 3 of 5 2 OVERVIEW The NIBTS Agency does not routinely accept returns of issued blood components from hospitals. However, returns can infrequently be requested by NIBTS for a variety of reasons. Some of these reasons may include: a failure in the quality of the product, new donor information coming to light, the return of components for the subsequent reissue to a different location e.g. specific phenotyped blood or HLA matched components. This policy attempts to give guidance to staff for the re-issue of blood components after recall. 3 RESPONSIBILITY Regulatory Affairs and Compliance Manager or Approved Deputy is responsible for approving the re-issue of blood / blood components during normal working hours. The Consultant on call is responsible for approving the re-issue of blood / blood components outside normal working hours. Hospital Services staff are responsible for recall / re-issue during normal working hours. On-Call staff are responsible for recall / re-issue outside normal working hours. 4 POLICY 4.1 RECALL Recall is instigated in accordance with NIBTS recall procedure SOP:QA:002 and recorded using FORM:DD:1040. Please also refer to SOP:BI:044 Return of in date components which may be re-issued. Completed documentation must be received from the recall location before NIBTS can consider reissue of blood products or components. The return of components to stock with the intention of re-issue must be approved by the Regulatory Affairs & Compliance Manager or Deputy during normal working hours or the Medical Consultant out of Hours. 4.2 RETURNS All blood components and products must be returned to Pulse Donor Management System whether or not they are for re-issue. This is to ensure a complete audit trail is maintained. Product which has been recalled for reasons of inferior quality must not be re-issued to another clinical location. 4.3 RECALL OF PRODUCTS SUITABLE FOR REISSUE Products/components may be recalled for re-issue for a variety of reasons. Some are detailed below but this list is not exhaustive.

4 POL:08:LP:003:03:NIBT PAGE : 4 of Issued components found subsequently to be a suitable HLA match for a specific patient and no other suitable units are available at NIBTS Phenotyped red cells when insufficient are available at NIBTS and request for transfusion is urgent Low stock at NIBTS of particular blood components or products Inadvertent over ordering by hospitals in response to an emergency Error in issue by NIBTS where wrong product is dispatched. 4.4 REISSUE Products may only be re-issued if the following criteria are established Recall form FORM:DD:046 and storage FORM:DD:062 are returned from hospital Returning hospitals must be MHRA compliant FORM:DD:062 and FORM:DD:1142 must be completed with all required information The blood or components have not been outside temperature monitored storage The blood components or products must not have been issued from hospital blood banks to wards or theatres Any further situations not documented here but which the Hospital Services Manager and Regulatory Affairs and Compliance Manager have considered and deemed not to be a risk. 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 this 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 that 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 because of a disability. On request it may be possible to make this policy

5 POL:08:LP:003:03:NIBT PAGE : 5 of 5 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. 6 TRAINING REQUIREMENTS The following staff must read and understand the policy RAC Manager or approved deputy Consultant on call Hospital Services Manager / Deputy All Hospital Services staff All On Call staff All rotational laboratory staff