1. Blood Mattersbetter safer transfusion program Essential elements of the Serious Transfusion Incident Reporting system (STIR) –Part 1 Lisa Stevenson

2. Haemovigilance “A system of surveillance and alarm, which encompasses all steps of the transfusion process, from blood collection to the follow-up of recipients” Debeir J, Noel L, Aullen J, Frette C, Sari F, Mai MPV, Cosson A Vox Sang 1999; 77: 77-81

3. Introduction Serious Transfusion Incident Reporting System (STIR) • Statewide reporting system in private and public hospitals; links with sentinel events program • Collects serious adverse events and near misses • Measure and monitor practice • Make recommendations for better, safer practice • FRESH blood products (red blood cells, fresh frozen plasma, platelets and cryoprecipitate) • From volunteer or family donors or autologous collections

4. SHOT: The Serious Hazards of Transfusion Scheme • Launched in November 1996 UK • Voluntary, confidential, anonymous • Aims to capture data on major complications of transfusion

5. Total components issued 2.9 M The Issues in TransfusionData from the SHOT report 2007.

6. Near miss events – SHOT 2005 n=1358 Sample errors Request errors

7. STIR Notified adverse events 2006-07 Data 2006-07

8. Products Implicated *reported incidents involved more than one product unable to determine which product was involved #Issue data is Victoria and Tasmania (Data ref ARCBS 2006-2007)

9. Actual adverse events are only the tip of the iceberg, and are far outnumbered by near-miss events! Battles JB et al. Arch Pathol Lab Med 1998;122:231-238

10. ‘ Near Miss’ Events STIR • Definition Any incident, that had the potential to cause harm, but didn’t due to timely intervention and or luck or chance. For example any incident which is recognised before transfusion took place but which, if undetected, could have resulted in the determination of wrong blood group, or issue, collection, or administration of an incorrect, inappropriate or unsuitable component.

11. Wrong blood in tube (WBIT) • Definition A special category of near-miss event, where it is detected that the labelled blood sample has been collected from an incorrect patient, however the transfusion did not proceed

12. Recognising an event • The initial form (red/e form) has a summary of the main features and diagnostic tests. • Definitions are provided in the guide, pages 9 – 10; • Incorrect blood component transfused (IBCT) • Acute transfusion reaction: excludes acute reactions due to IBCT • Delayed transfusion reaction: occurring >24 hours post-trfn • Transfusion-Related Acute Lung Injury (TRALI) • Transfusion-Associated Graft-Versus-Host Disease (TA-GVHD) • Post-transfusion purpura (PTP) • Transfusion-transmitted infections (bacterial, viral, parasitic) • Near misses • Wrong blood in tube – a special category of near miss

13. Sentinel Events • if there is an event that fits within the sentinel event program • ABO incompatibility • other-catastrophic event • continue to report it through the sentinel event program, where a Root Cause Analysis is conducted • STIR are notified of the sentinel event from the sentinel event program and are asked to review the healthservice recommendations

14. Flowchart (initial red form) p.7 Step ActionResponsibilityof: Transfusion event reported on general hospital-wide incident form. See NOTE 1. Step 1 Clinical Staff Quality/Risk Manager will receive the report Step 2 Quality/Risk Manager BeST ‘Serious Transfusion Incident Report’ completed and forwarded to: 1. BeST Office (within 3 business days.) AND 2. Relevant hospital staff and committees. See NOTE 3 for sentinel events. Hospital Transfusion Contact Step 3 Step 4 Relevant hospital staff and committees. Also, ARCBSa notified if appropriate. Blood Matters central office AND

15. Flowchart – Second report (blue) Step ActionResponsibilityof: Blood Matters forwards relevant second layer of form (within one week) (for more detailed data). Step 5 BeST Completion of second layer form conducted/arranged by hospital transfusion contact and forwarded to Blood Matters (within four weeks). RCAb arranged if appropriate. Quality/Risk Manager Step 6 Incident data entered by Blood Matters into database. BeST Step 7 Data verified and collated by expert STIR group and reported back to hospitals on trends. BeST Step 8

16. Organisational readiness checklist • To be completed by the health service • The purpose is to ensure that systems are in place prior to commencement of the incident reporting scheme • Is included in the guide

17. Organisational readiness checklist • Includes: • senior management commitment • a hospital-wide incident reporting policy (that includes, transfusion incidents) • operational management aspects need to be in place (eg a transfusion committee or equivalent with clear reporting lines, clarity on roles and responsibilities) • Serious transfusion incident response (policy and procedures enable staff to identify an incident and know the reporting mechanism)

18. Notification Form both an e form and a paper based form are available via the Blood Matters website to notify of a serious transfusion incident to STIR

19. STIR: e form www.health.vic.gov.au/bloodmatters hospital code: aligned with the Victorian sentinel event program with nature of incident may enter one or more categories but must select suspected or confirmed for each category. reports can be entered by any clinician or manager, Quality department should be made aware of a report entered into STIR.

20. STIR –e form

21. Completing the Second form • This form will assist with your investigation of the adverse event at this stage this is a paper based system but with work in progress for an electronic form. • Timelines for this form is four weeks from date of receiving.

22. Completing the second form

23. Where to get help • Contact the Blood Matters-better safer transfusion program • Lisa.Stevenson@dhs.vic.gov.au 03 9096 0476 • Karen.Botting@dhs.vic.gov.au 03 9096 9037 • Stir@dhs.vic.gov.au • STIR guide – available on the website

24. Thankyou Acknowledgments and thanks to: STIR expert group Blood Matters-better safer transfusion program Department of Human Services and ARCBS and the reporting hospitals of Victoria and Tasmania.