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HEMOVIGILANCE SYSTEMS

HEMOVIGILANCE SYSTEMS. Pierre Robillard 1,2 MD 1 Québec Public Health Institute, Montréal, Canada 2 McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Canada. What is hemovigilance.

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HEMOVIGILANCE SYSTEMS

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  1. HEMOVIGILANCE SYSTEMS Pierre Robillard1,2 MD 1 Québec Public Health Institute, Montréal, Canada 2 McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Canada

  2. What is hemovigilance • A set of surveillance procedures on undesirable events/effects along the whole transfusion chain • Systematic data collection • Regular analyses of data • Interpretation of results • Dissemination of results

  3. What is hemovigilance • Objectives • Prevent occurrence or recurrence of those undesirable events/effects • Establish priorities for intervention • Evaluate preventive measures

  4. Scope of national hemovigilance • Products • Blood components (mainly) • Plasma derivatives (in some countries) • In many countries under pharmacovigilance (drug post-market surveillance)

  5. Scope of national hemovigilance • Donations • Donor safety • Undesirable effects of donations in donors • Blood safety • Surveillance of ID markers in donors • Surveillance of donor exclusion factors

  6. Scope of national hemovigilance • Surveillance of the transfusion process • Errors at blood center • Errors at the hospital • Traceability

  7. Scope of national hemovigilance • Recipients • Identification of transfusion-transmitted infections • Traceback and lookback activities • Matching recipient database with reportable disease databases

  8. Scope of national hemovigilance • Recipients • Surveillance of adverse transfusion events • Serious only • All reactions • Identification of long term effects of transfusion • Matching databases • Recipient with death registry • Recipient with tumour registry • Recipient with hospital discharge database

  9. Scope of national hemovigilance • Blood utilization • Patterns of use of blood components • Type of components • Diagnosis of recipients • Procedures performed on recipients • Appropriateness of use?

  10. TYPES OF GOVERNANCE FOR HEMOVIGILANCE SYSTEMS • Blood regulator • France, Switzerland, Germany • Blood manufacturer • Singapore, Japan, South Africa, Ireland • Professional organizations • Netherlands (TRIP), UK (SHOT) • Public Health • Canada (TTISS) • Public-private partnership • USA Biovigilance Network (CDC+AABB)

  11. Requirements for establishing a national hemovigilance system • Hospital • Personnel dedicated to blood safety • Transfusion safety officer • Blood bank director • Chief technologist • Role • Investigation and reporting of transfusion reactions and errors • Training • Oversee implementation of preventive measures

  12. Requirements for establishing haemovigilance • Hospital • Transfusion committee • Multidisciplinary • Review transfusion reactions • Propose and evaluate preventive actions • Guidelines for appropriate utiization

  13. Requirements for establishing a haemovigilance system • National level • Hospitals committed to participate • STANDARDIZATION • Data elements to be collected • DEFINITIONS of those data elements • Centralized body for analysis • Expertise in transfusion medicine • Expertise in surveillance • Regular feedback to those who report • Establish governance for the system

  14. Requirements for establishing a haemovigilance system • National level • Data validation is crucial • Cannot assume that definitions were followed • Needed for meaningful comparisons between institutions • Maybe unrealistic for all reactions but necessary for serious ones • Can be achieved through a validation committee • Single • Reaction specific

  15. QHS data validation

  16. HAEMOVIGILANCE SYSTEMMandatory or voluntary? . Year 2006

  17. TRIP Reporting in haemovigilancesystems FRANCE QHS

  18. Trends in reporting 5 centres tested short form report for error reporting 7 388 4671 4214 3905 2845 2874 1749 939

  19. Trends in reporting 19 756 36 centres used short form report for errors 3381 7388 4671 4214 3905 2845 2874 1749 939

  20. The Canadian Transfusion Transmitted Injuries Surveillance System(TTISS)

  21. Background • In collaboration with Canadian Provinces/Territories, Health Canada Regulatory and Canadian Blood Manufacturers, the Public Health Agency of Canada (PHAC) implemented a voluntary Transfusion Transmitted Injuries Surveillance System (TTISS) to monitor adverse transfusion events (ATEs)

  22. Infrastructure for National TTISS Reporting Reportable Diseases Reportable Diseases HOSPITALS Public Health Community Clinicians Volunteer Reporting Volunteer Reporting Plasma Manufacturers Blood Manufacturers • Provincial/Territorial Blood Offices • Adverse Events • Acute • Delayed Mandatory Reporting • Health Canada Regulatory • Death = 24 hrs • Severe = 15 days Volunteer Reporting National Transfusion Transmitted Injuries Surveillance System (TTISS) Public Health Agency of Canada

  23. National TTISS Working Group • Membership • All provinces/territories represented • Blood manufacturers • Health Canada regulators • Terms of Reference • Identify and address issues related to a national surveillance program to determine the risk of transmission of infections and injuries by blood transfusions • Recommend future directions, quality, efficacy and effectiveness of the TTISS as a national surveillance program

  24. National Data Review Group • Membership • Members are selected for their individual medical/scientific expertise in the fields of: • public health • infectious diseases • epidemiology • transfusion medicine • Ex-officio representatives are from PHAC, Health Canada, Canadian Blood Services and Héma-Québec • Terms of Reference • Reviewing and evaluating surveillance based epidemiological data concerning the risk of transmission of infections and injuries through blood, blood components and plasma derivatives • Develop research questions and hypotheses for investigation purposes • Identify signals or unusual events that should be further investigated

  25. Methods • Data on Adverse Events is collected at the hospitals/sites • Most sites voluntarily report the data to a provincial/territorial office • Few sites report directly to the Public Health Agency of Canada • Non-nominal data are transferred as per the provincial/federal TTISS agreement to the Public Health Agency of Canada

  26. Percentage of transfusions captured by TTISS(as of December 31, 2007) (2007 population/thousands) Proportion captured nationally: 82% YUKON 100% Pop 32.6 NORTHWEST TERRITORIES 100% Pop 43.5 NUNAVUT Pop 31.3 NEWFOUNDLAND & LABRADOR 93.4% Pop 506.5 BRITISH COLUMBIA 99.6% Pop 4,310.3 SASKAT- CHEWAN 92.2% Pop 999.7 MANITOBA 86.5% Pop 1,193.5 ALBERTA 43.3% Pop 3,510.9 QUEBEC 99.6% Pop 7,686.0 ONTARIO 63.0% Pop 12,793.6 PEI 100% Pop 138.1 NOVA SCOTIA 100% Pop 936.0 NEW BRUNSWICK 100% Pop 745.4 Note: Population estimates (in thousands) from Statistics Canada, as of July 1, 2007.

  27. ATEs reported to TTISS

  28. Canadian TTISS data validation

  29. Blood components involved in adverse transfusion events in 2007 (N=430)

  30. Percentage and number of ATEs by type of blood component and severity

  31. Adverse transfusion events involving bacterial contamination by relationship to transfusion, 2004-2007

  32. Transfusion-related fatalities 2007

  33. Transfusion Errors Surveillance System (TESS)Pilot Project – Data 2005-7

  34. Background • TESS is an abbreviated error tracking system designed for non-academic use • implement a tool for systematic capture of errors, including near-misses • Coding scheme comparable to what is now being used in USA biovigilance network

  35. Methods • Actual event vs. Near-miss • Severity

  36. Hospital sites’ size

  37. ERRORS REPORTED • TOTAL 31,989 • 2005 10,273 • 2006 9,918 • 2007 11,798 • No recovery-harm 23 (0.1%) • No recovery-no harm 919 (2.9%) • Near miss- unplanned rec. 742 (2.3%) • Near miss- planned rec. 30,305 (94.7%) Total: 31,989

  38. Errors by severity and site size 2005-2007 Chi-square: 3.37; p=0.067 comparing small vs medium+large * 3 severity not specified

  39. Figure 2. Point of detection of error in the transfusion process BEFORE ISSUE AFTER ISSUE 40.9% 54.6% Event did not involve a product (0.4%), Other (4.1%) are not shown

  40. Actions taken

  41. Delay between Occurrence and Discovery

  42. Person Involved in Error *3 not specified

  43. Occurrence Location 2005-2007

  44. Type of errors reported

  45. Type of errors reported

  46. Rates for General Event Codes PC PRSC SH SR ST SE US UM UI UT RP DC 1:353 1:257 1:48 1:180 1:333 1:371 1:6111 1:422 1:1027 1:327 1:132 1:1098 1:1488 2005-2007

  47. Rates for Product/Test Request PR 01 1:8786 PR 02 1:3681 PR 03 1:1325 1:2898 PR 04 PR 05 1:869 1:842 PR 06 1:13,968 PR 99 2005-2007

  48. Rates for Sample Collection Errors SC 01 1:1805 SC 02 1:1625 1:9098 SC 03 1:2357 SC 04 1:4026 SC 05 SC 06 1:152 SC 07 1:158 1:199 SC 08 1:3345 SC 09 1:26,758 SC 10 SC 11 1:30,326 SC 99 1:2861 2005-2007

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