Traceability user manual - Irish Blood Transfusion Service
Contents
1. Hospital No Suitable for Transfusion Until Patient s Blood Group Component Comments Special Requirements Transfusion Protocol 1 ee er ee Donation Number re Once transfusion has been started you must send the completed section below back to the Hospital Transfusion Laboratory ae per lorna policy This te lagat ranuirement A x M kd a LR Ste es Donation Number DOB Component rm PRE ADMINISTRATION STEP 1 Check the component has been prescribed Check any special requirements e g irradiated Check if concomitant drugs prescribed e g diuretic STEP 2 Check and document baseline observations STEP 3 Check expiry date and time of component Check pack for leaks discolouration or clumping ADMINISTRATION STEP 1 Ask the patient to tell you their Surname Forename and Date of Birth Be especially vigilant with unconscious or compromised patients refer to your local hospital policy STEP 2 Check their Surname Forename and Date of Birth and Patient Identity Number against their wristband and the compatibility label STEP 3 Check that the information on the compatibility label matches the details on the blood component ie donation number blood group If there are any discrepancies DO NOT PROCEED contact your Hospital Transfusion Laboratory and HVO If you suspect a transfusion reaction STOP the transfusion immediately seek medical advice and c2. Hi 34333 Red cells in A S leucodepleted CPD SAGM BT 425 4 June 2014 10 4 4 2 Blood Component Issued Labelled as Emergency Stock Which has Been Transfused to a Patient On completion of pack inspection as per hospital procedure prior to commencing transfusion Practitioner 1 and Practitioner 2 sign the pink section of the compatibility traceability label Once the transfusion has commenced the pink section should be retained in the patient s chart as per hospital procedure The hospital returning the Compatibility Traceability Label will fill out a Traceability Form for Transfusion Confirmation of Non Assigned Blood Components IBTS DIAG SOP 0030 Att 6 1 containing the patient details of the patient to whom the blood component was transfused transfusion details and confirmation of transfusion The Traceability Form for Transfusion Confirmation of Non Assigned Blood Components will be returned to the IBTS with the Blue Section of the Compatibility Traceability Label BT 396 affixed to the designated section No patient practitioner details date or signature should be completed on the Blue Section If the staff member completing the Compatibility Traceability Form was not a witness to transfusion then prior to completing the Compatibility Traceability Form she he must have reviewed the patient chart to confirm transfusion to the named patient 4 5 Unlabelled Blood Component Issued in an Emergency Red c
3. explain why you corrected the data for example if you changed a piece of data Records should always be filled in at the time the operation is performed It is not good practice to fill in the paperwork or enter the data afterwards It is also important that records are kept on the official form Recording information on notepaper in order to fill in the official documents later is not acceptable as it could lead to transcription errors or omissions BT 425 4 June 2014 14 Appendix I Table of Frequently Issued Product Codes Please refer to current Product Master File for comprehensive list Provanc Text on Tag Text on Product Label Code 54481 RC LD in AS for NNU for first 5 days Red Cells Leucodepleted in additive solution suitable for neonatal use for 5 days after date drawn 04333 POS he ER RER Red Cells in Additive Solution Leucodepleted SAGM 04403 Red cells leucodepleted washed Red Cells Leucodepleted Washed 04236 Red cells in AS leucodepleted NNU Red Cells in Additive Solution Leucodepleted for Neonatal Use Primary unit 58235 Platelets apheresis LD NNU S1 Platelets Apheresis Leucodepleted for Neonatal Use Split 1 58236 Platelets Apheresis Leucodepleted for Neonatal Use Split 2 58237 Platelets Apheresis Leucodepleted for Neonatal Use Split 3 54388 Platelet Aph Ext Life NNU Platelets Apheresis Leucodepleted Extended Life for Neonatal Use 54389 Platelet Aph Ext Life NNU S1 Platelets Apheresis Leucodepleted Ext
4. GN MO accompanying the patient should complete the Pink Section and insert it in the hospital chart The Blue Section c should be completed and returned to the HVO in the hospital from which the patient was transferred by the RGN accompanying the patient to be sent on by the HVO to the Blood Bank from which the unit was issued crossmatched Transfusion Post Hospital Transfer On admission to the receiving hospital where transferred units are entered into Hospital inventory Stock and managed as per hospital practice traceability is the responsibility of the receiving hospital Blood Bank Confirmation of receipt of such components into hospital inventory should be sent to the relevant IBTS compatibility laboratory This service issue applies to the Munster Region only BT 425 4 June 2014 12 4 7 Rerouted Blood Components Where a red cell component is rerouted to CUH from a MRTC crossmatch facility under the approved re routing red cell optimisation scheme the BT 396 should be retained with the component on transfer CUH will confirm receipt of such components into CUH Hospital inventory and CUH will return the BT 396 directly to the compatibility laboratory at the Munster Regional Transfusion Centre This service issue applies to the Munster Region only 4 8 Unused Blood Components Where a blood component is issued from the IBTS blood bank with the traceability label attached BUT is not transfused used etc this should be
5. Irish Blood Transfusion Service D Seirbh s Fuilaistridchain na h ireann Document Detail BT DOC BT 0425 4 Title TRACEABILITY USER MANUAL Owner 1066 KATE FITZGERALD Status CURRENT Effective Date 07 Jul 2014 07 Jul 2016 Type Document No Expiration Date Review Review IBTS DOC REVIEW AND APPROVAL Level Owner Role Actor Sign off By 1 DIAGNOSTICS WRITER NBC MARY KEENAN MARY KEENAN 1 DIAGNOSTICS WRITER MRTC ORLA CROWLEY ORLA CROWLEY 2 QUALITY ASSURANCE REVIEWER NBC MARGARET KAVANAGH MARIE O CONNELL 2 QUALITY ASSURANCE REVIEWER MRTC COLIN JOHNS COLIN JOHNS 2 MEDICAL HEAD OF DEPT NBC WILLIAM MURPHY WILLIAM MURPHY 2 DIAGNOSTICS HEAD OF DEPT MRTC KEVIN SHEEHAN KEVIN SHEEHAN 2 MEDICAL HEAD OF DEPT MRTC JOAN POWER SMARTCOMM 2 MEDICAL HEAD OF DEPT MRTC JOAN POWER MARIE O CONNELL 2 MEDICAL HEAD OF DEPT MRTC WILLIAM MURPHY REBECCA WALDEN 2 DIAGNOSTICS HEAD OF DEPT NBC JOHN CRUMLISH JOHN CRUMLISH Change Orders Changes as described on Change Order Change Order No Change Orders Incorporated Changes as described on Change Order Change Order No IBTS CO 0135 14 Printing of this Document is Prohibited Printing of Forms is Allowed Official Copies Stamped in Red OFFICIAL COPY must be Issued through Document Control 1a IRISH BLOOD TRANSFUSION SERVICE TITLE TRACEABILITY USER MANUAL Supersedes Version 3 Change Order No IBTS CO 0135 14 This BT form may be printed directly from EQMS Internet fo
6. aceability Label should be retained with the component until disposal of the pack In the event of a patient adverse event the laboratory require this for pack inspection verification BT 425 4 June 2014 4 3 Blood Component Which was not Transfused to the Patient for Whom it was Originally Labelled but Transfused to a Different Patient On completion of pack inspection as per hospital procedure prior to commencing transfusion Practitioner 1 and Practitioner 2 sign the Pink Section of the Compatibility Traceability Label BT 396 Once transfusion has commenced the Pink Section should be retained in the patient s chart as per hospital procedure Where a blood component not transfused to the patient for whom it was originally labelled was transfused to a different patient The Traceability Form for Transfusion Confirmation of Non Assigned Blood Components IBTS DIAG SOP 0030 Att 6 1 should be completed with 1 The patient details of the patient to whom the blood component was transfused 2 Transfusion details 3 Confirmation of transfusion The Blue Section c of the Compatibility Traceability Label BT 396 should be affixed to the designated area NB No patient practitioner details date or signature should be completed in the blue section If the staff member completing the Traceability Form was not a witness to transfusion then prior to completing the Traceability Form she he must have reviewed the patient
7. aintenance and appropriate labelling Regulation 7 each blood bank should have a system in place for each blood unit or blood component received whether or not locally processed and the final destination of that unit whether transfused discarded or returned to the distributing blood establishment And in relation to verification Regulation 9 each blood establishment blood bank must have in place a procedure when it issues units of blood or blood components for transfusion to verify that each unit issued has been transfused to the intended recipient or if not transfused to verify subsequent disposition And Regulation 10 each blood establishment hospital blood bank and facility shall retain the data set in the first schedule here to for at least 30 years in an appropriate readable storage medium in order to ensure compatibility traceability Where the first schedule sets out requirement for facilities as blood component supplier unit identification or lot number transfusion recipient identification date of transfusion or disposition and for blood units not transfused confirmation of subsequent disposition 1 2 The IBTS Diagnostic services will comply by use of the Bag amp Tag compatibility traceability system This involves the tagging of a compatibility traceability label BT 396 to the component and the subsequent manual entry of the date of transfusion together with the confirmation of transfu
8. ell components of group O Rh D negative Emergency Stock may be issued in acute life threatening situations In such emergencies these units will be issued as emergency stock with traceability label on them Serological tests will not have been performed on these units prior to issue but will be done retrospectively BT 425 4 June 2014 11 4 6 Inter Hospital Transfer of Patient with Assigned Blood Components Transfusion Commenced Prior to Transfer Where transfusion is commenced prior to transfer management should be as for an assigned patient with Part C of the Compatibility Traceability Label BT 396 returned to the Crossmatch Laboratory by the hospital from which the patient is being transferred The Pink Section is to be completed and inserted in the hospital chart Transfusion during Inter Hospital Transfer Where a patient is transferred to another hospital with components the Compatibility Traceability label BT 396 is retained with the component on transfer Where transfusion is required for the patient in transit the RGN MO accompanying the patient should complete the Pink Section and insert it in the hospital chart The Blue Section c should be completed and returned to the HVO in the hospital from which the patient was transferred by the RGN accompanying the patient Where transfusion is required for the patient in the receiving hospital prior to transfused units being entered into hospital inventory stock the R
9. ended Life for Neonatal Use Split 1 54390 Platelet Aph Ext Life NNU S2 Platelets Apheresis Leucodepleted Extended Life for Neonatal Use Split 2 BT 425 4 June 2014
10. fe threatening emergency The following section details the appropriate management for each circumstance 4 2 Management of BT 396 Assigned Patient 1 Hospital procedures cover the issue of components for transfusion and management in the clinical area 2 On completion of independent identification checks and pack inspection as per hospital procedure Practitioner 1 and Practitioner 2 sign the Pink Section of the Compatibility Traceability Label BT 396 before commencing the transfusion Space is limited on the blue section of the Traceability Label Where a patient has lengthy forenames first and second forenames will be printed but a third is unlikely to be The complete name is present on the 6000 Report 3 Once the transfusion has commenced the completed peel off pink portion of the Compatibility Traceability Label signed by both practitioners is attached to the relevant place in the patient s medical notes 4 Once the transfusion is under way the practitioner signs the Blue Section c of the Compatibility Traceability Label The time given should be documented using the 24 hour time format with day ending at 23 59 and new day commencing at 00 00 This section must be returned to the Crossmatch Laboratory as per the procedures in hospitals for which the IBTS acts as a blood bank Remember the donor patient link must be made once the transfusion has commenced 5 The White Section of the Compatibility Tr
11. ontact the HVO and Transfusion Laboratory Under SI 547 of 2006 European Communities Human Blood and Blood Components Traceability Requirements and Notifications of Serious Adverse Reactions Regulations 2006 IT IS A LEGAL REQUIREMENT that this section of the label be completed and returned to the Transfusion Laboratory Irish Blood Transfusion Service BT396 2 The information will be printed by the laboratory or handwritten in the event of a technology failure BT 425 4 June 2014 3 Ties The Compatibility Traceability Label BT 396 is attached to the pack by way of a plastic tie as shown This should be received in your hospital with the tie uppermost as shown below at the open end of the overwrap and stored in this position This is to prevent the tie causing a pack tear from pressure on the pack BT 425 4 June 2014 7 4 Management of Compatibility Traceability Label BT 396 4 1 Overview The Crossmatch Laboratory may issue components e To assigned patients this may be transfused to the intended or an unintended recipient Such components could be transferred with a patient to another facility and within Cork City such components could be rerouted to CUH e Labelled as emergency stock to be held on hospital site non assigned Such components could be transferred with a patient to another facility and within Cork City such components could be rerouted to CUH e Unlabelled in case of li
12. r use BT 425 4 June 2014 BT 425 4 June 2014 INDEX 1 Introduction 2 Compatibility Traceability Label BT 396 3 Ties 4 Management of Compatibility Traceability Label 4 1 Overview 4 2 Assigned Patient 4 3 Blood Component Which was not Transfused to the Patient for Whom it was Originally Labelled but Transfused to a Different Patient 4 4 Blood Component issued labelled as Emergency Stock non assigned Blood Component 4 4 1 Compatibility Traceability BT 396 Labelled as Emergency Stock 4 4 2 Blood Component Issued Labelled as Emergency Stock Which has been Transfused to a Patient 4 5 Unlabelled Blood Component Issued in an Emergency 4 6 Inter Hospital Transfer of Patient with Assigned Blood Components 4 7 Rerouted Blood Components 4 8 Unused Blood Components 5 Records How to Write and Correct Your Data Appendix 1 Table of Frequently Issued Product Codes This service issue applies to the Munster Region only BT 425 4 June 2014 10 11 12 12 13 14 1 Introduction 1 1 SI 547 of 2006 requires that the IBTS where it acts as a Hospital Blood Bank has a system in place to trace the final fate of each and every unit of blood component supplied 100 This statutory instrument requires that inter alia Regulation 4 each blood establishment hospital blood bank and facility shall ensure the compatibility traceability of blood blood components with accurate identification procedure record m
13. returned to MRTC or the Dublin Centre Laboratory with the tag attached to ensure appropriate fating This applies to red cells platelets fresh frozen not solvent detergent plasma and cryoprecipitate BT 425 4 June 2014 13 5 Records How to Write and Correct Your Data Records are detailed written accounts of an operation We are required by our quality system to keep accurate records of all our activities We consider this to be a very important part of our practice If the records are not correct we cannot guarantee that the fating is correct There are forms provided for most activities These will ensure that you record all relevant information It is important that these forms are filled in correctly and accurately Black indelible pen should be used for all written records and forms Pencil is not acceptable Handwriting should be neat and clear Information should be recorded such that it could be read and understood by someone less familiar with the operation Care should be taken not to make mistakes when recording information However if you do make a mistake it should be corrected as follows e A single line should be marked through the incorrect information This cross out should not make the initial information illegible e g mistake e The correct information should be written beside the error e You should insert your initials and date beside the correction in some cases it may be necessary to
14. s chart to confirm transfusion to the named patient IBTS DIAG SOP 0030 Att 6 1 This service issue applies to the Munster Region only BT 425 4 June 2014 4 4 Blood Component Issued Labelled as Emergency Stock non assigned Blood Component 4 4 1 Compatibility Traceability Label BT 396 labelled as emergency stock STOP SEE BACK OF THIS TAG BEFORE TRANSFUSION Irish Blood NBC 014322800 Fax 01 4322930 Transfusion Service MRTC 0214807400 Fax 021 4323315 Seirbh s Fuilaistridchain Eireann BT396 2 Oct 13 Donation 4224159 HU Component 04333 Red cellsin Il AS leucodepleted 5 i _ CPDSAGM z _ Signature t Date Given Signature 2 Time Given Peel off label above and place in patient s Medical Records Surname Forename EMERGENCY STOCK SIVH Hospital South Infirmary Victoria Ward UNKNOWN Suitable for Transfusion Until Hospital No 18 06 2014 23 59 atient s Blood Group Component Comments O RhD Negative 04333 Red cells in AS leucodepleted CPD SAGM Special Requirements Transfusion Protocol Patient should receive C E K Rh Negative CMV Red Cells Once transfusion has been started you must send the completed section below back to the Hospital Transfusion Laboratory as per local policy This is a legal requirement Danation Number 4224159 Surname orename Donation Number ET TITI DOB l 4224159
15. sion or any part thereof recipient identification or other disposition other patient transferred re routed discarded on the eTraceline patient record from the information returned part C of BT 396 from the user hospital and the retention of a hard copy of part C of BT 396 for 30 years 1 3 The Traceability Programme was implemented to fulfil the requirements of SI 547 of 2006 European Community Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events Regulations 2006 The regulations require unambiguous traceability of all blood and blood components from donor to patient and documentation of final fate if not transfused 1 4 The intent is to identify all transfusion linked donors and patient therefore where a patient is exposed to any portion of a donor s blood component this link must be identified This includes where a few mls is transfused or indeed where the line has tissued BT 425 4 June 2014 4 1 5 The Compatibility Traceability Label BT 396 will be issued with all blood and blood components from the IBTS to patients in facilities where the IBTS acts as their blood bank in the provision of a routine compatibility service Return of the Compatibility Traceability Label BT 396 allows unambiguous traceability and the final fate of the blood component 1 6 Itis the responsibility of the Haemovigilance Officer Nominee to ensure the prompt return of fully comple
16. ted section C blue of the compatibility traceability labels 2 Compatibility Traceability Label BT 396 A Compatibility Traceability Label BT 396 is issued with all blood and blood components from the IBTS to patients in facilities where the IBTS acts as their blood bank in the provision of a routine compatibility service For exceptions to this see Section 4 5 Components include 1 Red Cell Preparations ii Platelets iii Plasma Components inc Fresh Frozen Plasma and Cryoprecipitate Solvent Detergent SD plasma is not within the scope of the regulation Care should be exercised when handling the unit to ensure that the label is not detached from the unit In the unlikely event that the label becomes detached from the unit it should not be transfused The Crossmatch Laboratory should be advised and the unit returned BT 425 4 June 2014 2 Compatibility Traceability Label BT 396 The compatibility traceability label BT 396 holds service related information on the face and instructions on the back as below STOP SEE BACK OF THIS TAG BEFORE TRANSFUSION Irish Blood NBC 014322800 Fax 01 4322930 Transfusion Service MRTC 021 4807400 Fax 021 4323315 Seirbh s Fuilaistri ch in Eireann BT396 2 Oct 13 Donation Component Signature 1 Date Given Signature 2 Time Giver Peel off label above and place in patient s Medical Records Surname Forename DOB Hospital Ward
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