1. WA Haemovigilance Reporting Office of the Chief Medical Officer Department of Health WA Version 1.0 July 2015

2. Section 1 – General Information  Topics covered in this section:  What is haemovigilance?  Haemovigilance reporting including clinical incident reporting  Importance of haemovigilance reporting  WA Haemovigilance reporting  Who is involved in haemovigilance?  Who can initiate a blood related adverse event report?

3. What is haemovigilance? “a set of surveillance procedures covering the whole transfusion chain … intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence” - International Haemovigilance Network

4. Importance of haemovigilance  Widely recognised as an integral part of safety in blood transfusion  Important role in improving effective and appropriate management of blood products as well as patient safety  Transfusion-related adverse events can include reactions to administered blood products as well as clinical incidents related to the delivery of health care

5. Importance of haemovigilance reporting  Identifying patterns of adverse transfusion events may improve:  Blood product transfusion practices  Policy  Error prevention  Blood product production  e.g.: leukoreduction of blood products based on decisions made from assessment of adverse outcomes  Information may be gathered at hospital, state, national and international levels

6. Haemovigilance requirements NSQHS Standard 7 requires hospitals and health services: 7.3Ensure blood and blood product adverse events are included in the incident management and investigation system 7.3.1Reporting on blood and blood product incidents is included in regular incident reports 7.3.2Adverse blood and blood product incidents are reported to and reviewed by the highest level of governance in the health service organisation 7.3.3Participate in relevant haemovigilance activities conducted by the organisation or at state or national level

7. WA Haemovigilance reporting  Haemovigilance should be undertaken at hospital level for hospital monitoring and review of blood related adverse events  WA Haemovigilance reporting process and tools developed to enable:  Collection of standardised data across hospitals  Department of Health WA to produce local (state level) reports  WA to contribute data to national reporting

8. WA Haemovigilance reporting  WA Haemovigilance reporting is an additional reporting activity to the reporting of clinical incidents involving blood products  Clinical incidents involving blood products must still be reported into Datix Clinical Incident Management System (CIMS) in line with relevant WA and hospital policy  Private hospitals record incidents in hospital clinical incident system and notify WA Health PSSU as required

9. Clinical Incident Reporting  A clinical incident (CI) is an event or circumstance resulting from health care which could have, or did lead to unintended and/or unnecessary harm to a patient/consumer  CIs include some transfusion related adverse events, for example:  transfusion transmitted infections  incorrect blood component transfused  allergic reactions but only if the allergy was previously known  Not all transfusion related adverse events are clinical incidents  CIs need to be reported into Datix CIMS which is a state-wide web based clinical incident management system. Licensed private health care facilities need to report CIs to PSSU  For further information refer to the Australian National Haemovigilance Data Dictionary 2015 and CIM Policy and contact your Safety and Quality team

10. WA Haemovigilance reporting scope  WA Haemovigilance reporting (for state and national reports) is currently confined to:  ‘fresh’ blood components  Red cells, platelets, fresh frozen plasma, cryoprecipitate and cryodepleted plasma  and includes  Reinfusion of blood from intraoperative and postoperative reinfusion devices (e.g. cell salvage)  Predonated autologous blood

11. WA Haemovigilance reporting scope  WA Haemovigilance reporting currently does not include:  manufactured plasma products (e.g. IVIg, albumin, clotting factor concentrates)  ‘near miss’ events  Note: clinical incidents involving manufactured plasma products or near miss events should be reported into Datix CIMS or other hospital clinical incident management systems (for private hospitals) in line with relevant policy

12. Who is involved in haemovigilance? Any healthcare professional involved in:  blood product handling (including in laboratories)  blood product transfusion  blood product ordering  phlebotomy for group and screen  monitoring of patients during blood transfusion  blood product / patient identification checks

13. Who can report a blood related adverse event?  Any healthcare professional involved with blood component  administration  handling  monitoring  ordering  delivery  or in any other capacity

14. How is this information going to be used?  May be used locally by hospital transfusion medicine as well as hospital Safety & Quality staff  De-identified information (no patient or clinician information) will be sent to Department of Health WA for use in state reporting  De-identified, aggregated information sent by state to National Blood Authority for inclusion in national reports (no patient, clinician or hospital identified)  Hospitals can keep on file to assist with meeting NSQHS Standard 7 requirements

15. What will participating hospitals receive?  Office of the Chief Medical Officer (OCMO) Department of Health WA will collate information from participating hospitals and report back to those hospitals  No hospitals other than the submitting (recipient) hospital will be identified in the individual return report

16. Section 2 – Data Entry  Topics covered in this section:  haemovigilance tool kit  use of data  examples  submission of data  contact information

17. Haemovigilance tool kit  Provided by Department of Health WA  ‘Tool Kit’ is an electronic folder containing the WA haemovigilance template reporting spreadsheet (Microsoft Excel file) plus accompanying files and documentation  Requires MS Excel 2007 or later

18. Haemovigilance tool kit  Contents include:  template reporting spreadsheet  WA Haemovigilance reporting guideline  frequently Asked Questions  transfusion reaction investigation form (optional)* - electronic form that links to template reporting spreadsheet  instruction sheet for transfusion reaction form  this template PowerPoint (optional)  Australian National Haemovigilance Data Dictionary 2015  WA Health Severity Assessment Codes

19. Template reporting spreadsheet  Preformatted Excel spreadsheet for entry of data for WA haemovigilance reporting  Collects information consistent with national minimum dataset (based on 2015 National Haemovigilance Data Dictionary)  Options in column headings and dropdown menus are locked to standardise data entered

20. Template reporting spreadsheet (cont.) Spreadsheet has three tabs: 1. Instructions and Links  Contains instructions for entry of data and links to supporting documentation 2. Data  Enter data for each transfusion related adverse event here 3. Import Transfusion Reaction  Use this to import data from the transfusion reaction form into the ‘data’ tab 1. Instructions and Links 2. Data 3. Import Transfusion Reaction

21. Template reporting spreadsheet  Columns A-E of the ‘data’ tab allow inclusion of identifying information to assist with data entry and validation  Information identifying patients (white columns) must be removed before data is sent to the Department of Health WA

22. Template reporting spreadsheet (cont.)  ‘Mouse’ over column headings to see definitions from the Australian National Haemovigilance Data Dictionary 2015  Hint: look for the red triangles

23. Template reporting spreadsheet (‘data’ tab) Example 1 - Dropdown menus  Most columns have dropdown menus for easy data entry  Click on the cell where the information is to be entered for the dropdown list to appear

24. Template reporting spreadsheet (‘data’ tab) These fields are removed when data is sent to Department of Health WA Fields to be completed by free text entry are:  date data entry completed  account number  UMRN  patient name (first name and surname)  date and time transfusion commenced – see next slide  comments on other contributory factors  comments/ notes

25. Template reporting spreadsheet (‘data’ tab) Example 2 – date and time transfusion commenced  Refer to the commencement of transfusion of the product unit involved in the adverse event  Enter Date as dd/mm/yyyy  Enter Time as hh:mm  HINT: the column is formatted as a 24 hour clock, so 4.30pm should be entered as 16:30

26. Where will details of information to be entered come from?  Data for entry in the WA Haemovigilance reporting spreadsheet may come from a number of sources, including:  clinical incident report/system (Datix CIMS or other)  transfusion reaction investigation form  patient chart notes  laboratory services event notes  Spreadsheet entry should be done when all the data are available-this may be during the investigation or at the end of the workup/analysis of a given event

27. Who is responsible for completing the template reporting spreadsheet?  It is recommended that each hospital determines the key staff member(s) responsible for the collection, entry and validation of haemovigilance data into the template reporting spreadsheet  Coordination between hospital staff may be required

28. How and when will data be sent to the Department of Health WA?  On a six monthly basis participating hospitals will provide haemovigilance data to the Office of the Chief Medical Officer (OCMO) at the Department of Health WA  Data provided will be:  validated – this will be undertaken at local (hospital or area health service) level prior to submission to OCMO  de-identified – no clinician or patient identifying information is included

29. How will data be submitted?  At completion of each six month reporting period  Hospitals copy (‘drag and drop’) information in columns F to AO on the ‘Data’ tab of the reporting spreadsheet into a new Excel spreadsheet  Only content in Columns F  AO should be provided  Information will be sent by secure file transfer  Hospitals retain master copy of reporting spreadsheet  for subsequent data entry (next reporting period)  as a record of events that have occurred

30. WA haemovigilance reporting process ((process flowchart to be inserted))

31. WA Haemovigilance Reporting Guideline  Outlines WA haemovigilance reporting  Background  Definitions  Process  Roles

32. FAQ document  Short answers to common questions about haemovigilance reporting in WA

33. Transfusion reaction form (optional)  Optional - not required to be used for WA haemovigilance reporting  Electronic form that links to WA haemovigilance reporting spreadsheet  Data entered can be exported into the template reporting spreadsheet  If hospitals do not wish to use this form information regarding the transfusion reaction event will require manual entry into the haemovigilance reporting spreadsheet

34. Transfusion reaction form (optional)  Two pages  Note: page two (laboratory use) is an optional working document for laboratory services  These data are not imported into the template reporting spreadsheet  Has option of being kept on file in the laboratory

35. Page 1 Page 2 Note: Information entered on this page is not imported into the template reporting spreadsheet Optional page for laboratory data

36. Completion of electronic transfusion reaction form  See instruction sheet  This is hyperlinked to the spreadsheet ‘Instructions’ tab  NOTE: to auto populate data the transfusion reaction form must be in the same folder as the reporting spreadsheet  Import of data should only occur when the reaction form is fully populated and data validated

37. Importing data to WA haemovigilance reporting spreadsheet - 1 ‘Write to Excel’ button: imports data from the form into the template reporting spreadsheet  Use ‘write to excel’ button to import data from the electronic form into the template reporting spreadsheet  Data import to a hidden tab in the spreadsheet where it remains until imported into the spreadsheet ‘Data’ tab

38. Importing data to WA haemovigilance reporting spreadsheet - 2 ‘Click to import’ button: imports data from the hidden tab in the spreadsheet to the main ‘Data’ tab  Use ‘click to import’ button on ‘Import Transfusion Reaction’ tab to import data into the Data tab  All entries will then be deleted from the hidden tab  If there is no data in the hidden tab to import a message box will tell the user that there is no data  NOTE: the excel spreadsheet must be closed before you import data from the transfusion reaction form

39. Australian National Haemovigilance Data Dictionary 2015  Definitions of all elements for the Australian National Haemovigilance Data Set  Produced by the National Blood Authority (NBA)  Available:  online at www.blood.gov.auwww.blood.gov.au  link in template reporting spreadsheet

40. How is WA haemovigilance reporting data going to be used and by whom?  Haemovigilance data provided by hospitals to the Department of Health WA will be used to:  provide summary reports to participating WA hospitals  contribute to national haemovigilance reporting  aggregated WA data will be sent to NBA for inclusion in national haemovigilance reports

41. Submission of haemovigilance data to Department of Health WA  Data should be sent by the nominated hospital contact (via the MyFT system) to bloodmanagement@health.wa.gov.au bloodmanagement@health.wa.gov.au  Data to be submitted at 6 monthly intervals:  For events 1 st Jan - 30 th Jun sent by 1 st Aug  For events 1 st Jul - 31 st Dec sent by 1 st Feb

42. What will be identified in the data sent to the Department of Health WA or the NBA  No patient or staff member will be identified in the data sent by hospitals to the Department of Health WA  No hospitals will be identified in the data sent to the National Blood Authority

43. Contact Information  Hospital Haemovigilance Contact (sites to fill in if required) Name: Position: Department: Phone: Fax: Email:

44. Contact Information  Department of Health WA Blood, Drugs and Technology Unit Office of the Chief Medical Officer Level 2, C Block, 189 Royal Street, East Perth WA 6004 T: (08) 9222 4370 F: (08) 9222 2130 E: bloodmanagement@health.wa.gov.aubloodmanagement@health.wa.gov.au