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

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Presentation on theme: "HEMOVIGILANCE SYSTEMS Pierre Robillard 1,2 MD 1 Québec Public Health Institute, Montréal, Canada 2 McGill University, Department of Epidemiology, Biostatistics."— Presentation transcript:


2 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

3 SCOPE Products –Blood components (mainly) –Plasma derivatives (in some countries) In many countries under pharmacovigilance (drug post-market surveillance) Donations –Donor safety Incidence of undesirable effects of donations in donors –Blood safety Prevalence of ID markers in first-time donors Incidence of ID markers in repeat donors Surveillance of donor exclusion factors

4 SCOPE….2 Transfusion process –Errors at blood center Blood center tracking systems MERS-TM system –Errors at the hospital Near-misses MERS-TM system, UK SHOT, Canadian TESS –Blood utilization –Traceability

5 SCOPE…3 Recipients –Identification of transfusion-transmitted infections Traceback and lookback activities Post-transfusion screening (low yield) Matching recipient database with reportable disease databases –Incidence of adverse transfusion events Serious onlyUK SHOT AllFrench Hemovigilance System –Identification of long term effects of transfusion Matching databases –Recipient with death registry –Recipient with tumour registry –Recipient with hospital discharge database

6 Modern Hemovigilance Recipient Process Donor AE ER NM ID AE Recipients Processes / Products Donors continuous improvement of transfusion safety collection / analysis of data Adapted from JC Faber, Luxembourg Red Cross

7 Local –Hospital Regional –Health District –State –Province National –Blood organizations –Public Health –Regulatory Agency –Professional bodies Supra national –Voluntary organizations EHN –Existing organizations ISBT WP Haemovigilance SETTINGS

8 Requirements 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 –Transfusion committee Multidisciplinary Review transfusion reactions Propose and evaluate preventive actions

9 Requirements….2 Regional or national level –STANDARDIZATION Data elements collected DEFINITION of data elements Reporting forms? –Centralized body for analysis Regular feedback to those who report –Mandatory or voluntary system?

10 Requirements….3 International –STANDARDIZATION Patience Commitment Leadership –Centralized analysis

11 10 TYPES OF GOVERNANCE FOR HAEMOVIGILANCE SYSTEMS Blood regulator –France, Switzerland, Germany Blood manufacturer –Singapore, Japan, South Africa, Denmark Professional organizations –Netherlands (TRIP), UK (SHOT) Public Health –Canada (TTISS) Public-private partnership –USA Biovigilance Network


13 12 EFS AFSSaPS Medical & nursing team Regional coordinator TSHC Haemovigilance officers (HO) Medical & nursing team

14 13 The local level Healthcare facility HO + EFS HO training transfusion safety committee various procedures traceability transfusion reactions information

15 14 training traceability transfusion reactions transfusion procedures organization of transfusion The local transfusion safety and hemovigilance committee information Management, HO, prescribers, nurses, regional coordinator

16 15 The regional level annual report traceability transfusion reactions organization of blood transfusion organization of haemovigilance information Local level National level

17 16 The national level  Hemovigilance unit – Afssaps  Hemovigilance unit – EFS  Hemovigilance unit - LFB  National Health Surveillance Institute - InVS  Regional coordinators’ national conference  National committee for the computerization of traceability  National commission for hemovigilance  French Society of Vigilance and Transfusion Therapeutics

18 17 Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS) The regulatory agency quality control Regional and local blood establishments Établissement Français du Sang (EFS) Centre de Transfusion Sanguine des Armées (CTSA) Ministry of Health European Commission Annual report adverse reactions Donor - Patient Healthcare establishments Regional coordinator Annual report InVS epidemiology of donors

19 18 Advantages  The centralization :  Definition and implementation of national policies  Development and use of standardized tools  Uniform standardized practice in adverse event reporting and traceability  Hemovigilance part of global healthcare risk management  Easier detection of rare events  The manpower :  Essential for good results  The multidisciplinary approach

20 19 Disadvantages  The centralization :  A top heavy organization, very dependent on political whim and public opinion  A vigilance system mostly concerned with blood components – what about transfusion practice ?  The manpower :  The cost : is the system cost-effective ?  What is the real place of clinical medical staff in the system ? Reporting to the regulator might prevent some institutions to report errors


22 21 Adverse reaction Physician Inform hospital blood bank/ Transfusion medical officer Report to Haemovigilance Program Coordinator Deputy Director / Director of Blood Center Transfusion reaction workup Evaluate and Manage Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore

23 22 Reporting Numbers Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore

24 23 Advantages: Supplier 1.Tighter feedback loop: Intimate knowledge of the transfusion process 2.“better qualified” to develop the system and to intepret and analyse the data 3.Regulators often come from a different perspective and mindset 4.Impetus for change stronger and quicker 5.Less fear of reprisals from hospitals due to accumulation of long term records of possible defects in care Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore

25 24 Diasdvantages: Supplier 1.One of the major participants in the transfusion process. What if analysis of data casts a spotlight on blood centre/provider’s deficiencies? 2.Pressure to highlight the achievements of the blood centre; disregarding the shortfalls. 3.Public perception on accuracy of data 4.Higher stakes: if something does emerge and doubts emerge from public on preservation of self interest from the supplier 5.Protection of data a more complex issue. Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore


27 26 Development of hemovigilance Board Medical Societies (Hospital associations, Sanquin) national TRIP office Hospitals blood Tx comm. Hospital laboratory clinicians Sanquin HV programme Sanquin blood bank Tx specialist QA manager side effects products recall products & look-back TRIP foundation created in 2001 Source: M. Schipperus, TRIP, Netherlands

28 27 TRIP (Transfusion Reactions In Patients) Hitherto ‘voluntary’ participation, –regarded as the norm by Inspectorate –professional standard in consensus guideline Reporting system what types, definitions, recommended further investigation how to report: paper / online Verification (expert review) Denominator data, statistical analysis Publication (transparency) Source: M. Schipperus, TRIP, Netherlands

29 28 Participation by hospitals Source: TRIP, English Newsletter 2008/1

30 29 Reports per year Source: M. Schipperus, TRIP, Netherlands

31 30 Advantages of the TRIP system scientifically validated data using agreed definitions user-friendly system stimulus for research strengthening of (international) scientific ties, learning from each other not just product focus, but chain-wide approach findings available to professionals in the transfusion and transplantation chains development of professional standards Source: M. Schipperus, TRIP, Netherlands

32 31 Weaknesses of TRIP system Dependent on willingness of professionals to report Late reporting (cold hemovigilance) Difficult to fund staff in the hospitals Simultaneous initiatives on the same subject possible (no official central steering) “Polder model”: many people decide. Democratic, effective but slow ! Source: M. Schipperus, TRIP, Netherlands


34 33 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)

35 34 Infrastructure for National TTISS Reporting National Transfusion Transmitted Injuries Surveillance System (TTISS) Public Health Agency of Canada Public Health Community Clinicians HOSPITALS Reportable Diseases Provincial/Territorial Blood Offices Adverse Events Acute Delayed Health Canada Regulatory Mandatory Reporting Death = 24 hrs Severe = 15 days Reportable Diseases Blood Manufacturers Plasma Manufacturers Volunteer Reporting

36 35 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

37 36 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

38 37 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

39 Disadvantages of Public Health Governance No prior knowledge of transfusion medicine in public health Lack of trust and credibility by the transfusion community at the outset No established network between public health and transfusion community Not perceived as a major public health issue within public health


41 Advantages of Public Health Governance Extensive knowledge in surveillance methodology Extensive experience in managing surveillance databases Extensive knowledge in analysing and interpreting surveillance data Some guarantee of sustainability once endorsed by public health


43 42 AABBBSIUS:CDC ABCCAPUS:CMS ARCUS:DHHSUS:FDA AABBARC CAP PPTA US:CDC AATBASH Publ Hlth Ag of Can Prov of Quebec US:CMS ABCASBMT ISBT Transfusion Alliance US:FDA AdvamedASH JCAHO UNOS US:HRSA AHABSI NMDP US:AHRQ US:NHLBI US:DHHS – Asst. Sec., OPHS Georges Andreu, MD (Fr) Mickey Koh, MD (SG) Simon Benson, MD (NZ) Mike Murphy, MD (UK) Emer Lawlor, MD (Irl)Paul Strengers, MD (ISBT) James AuBuchon, MD, chairNancy McCombie Neil Blumberg, MDBarbara Rabin-Fastman Jeannie Callum, MDPierre Robillard, MD Rodeina Davis Kent Sepkowitz, MD Anne Eder, MD, PhD Beth Shaz, MD Mark Fung, MD Tait Stevens, MD Linda Hahn Leon Su, MD Barbee Whitaker, PhD, staff The US Biovigilance Network Biovigilance Network Task Force Biovigilance Network Steering Committee Biovigilance Network Working Group PHASE I: Transfusion Service Operations Biovigilance Network International Correspondents “Moral support” Encouragement for participation Routes to ongoing funding Support for implementing changes Direction Review More encouragement for participation Make it happen! Critiques from experience

44 43 Biovigilance Through a Public-Private Partnership Governmental Agencies Charged with overseeing public health Concerned about “critical infrastructure” Offer epidemiologic expertise Private Entitities Generate the data Offer the field-specific expertise Need legal protection Need funding Can offer legal protection Can provide funding

45 44 The Public-Private Partnership CDC is providing: - Support for initial programming effort - Access to NHSN programmers and structure - Program managers - Support for AABB staff - Confidentiality and legal protections Blood Banking (through Task Force) is providing: - Technical expertise for system design - “Marketing” - Fundraising for ongoing operation - Data analysis through expert groups

46 45 USBVN Timeline Phase I: Transfusion Service Hemovigilance Terminology and definitions: Completed Design specifications: Completed Programming initiation: Winter 2008 Pilot trials: Spring, 2008 Opening of system: Fall, 2008 Phase II: Collection Center Hemovigilance Terminology and definitions: Underway Design specifications: Early 2008 Programming initiation: Contracted Phase III: Tissue Transplantation Biovigilance TTSN: Development underway (CDC/UNOS/AATB) (almost)

47 46. FranceSingaporeNetherlandsCanadaQuébec/ Canada Hemovigilance TRIPTTISSQHS 19942002 2000 Confidential AnonymousConfidential MandatoryVoluntary Non-punitive All reactions Only serious reactions All reactions Types of haemovigilance systems

48 Reporting in haemovigilance systems FRANCEQHS TRIP

49 48. Country/ region *Reports/ 1000 units What is reportable Type of system UK0.20Serious reactions + IBCT Voluntary Canada0.31Serious reactions not IBCT Voluntary Ireland1.22Serious reactions + IBCT Voluntary France2.83All reactionsMandatory Netherlands2.90All reactionsVoluntary Québec7.07All reactionsVoluntary Reporting in haemovigilance systems

50 49 Data utilization Setting priorities for transfusion safety Evaluation of implementation of preventive measures France: –Traceability –ABO mistransfusions –Bacterial contaminations UK –ABO mistransfusions –TRALI Québec –Bacterial contaminations –ABO mistransfusions

51 50 Traceability FRANCE

52 51 ABO mistransfusions FRANCE

53 52 Bacterial contaminations FRANCE

54 53 ABO incompatible red cell transfusions 1996 - 2005

55 54 Cases of TRALI with relevant donor antibody analysed by implicated component and by year 2003-2005

56 N ABO mistransfusions QUÉBEC

57 56 Frequencies and Ratios/100,000 BC - Platelet pools NRate Diversion pouch * Bacterial detection

58 57 Pre-post for diversion pouch WBDPC YearNRate 2000-2002181:2,655 2003-200411:27,737 Pre-post for diversion pouch + bacterial detection WBDPC X 2 =8.09, p = 0.0044 YearNRate 2000-2002181:2,655 2003-200611:40,662 X 2 = 12.68, p = 0.0003

59 58 The Canadian Transfusion Error Surveillance System (TESS) 2005-2006

60 59 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 will be used in USA biovigilance network

61 60 Methods Actual event vs. Near-miss Severity Description HighPotential for serious injury or death MediumPotential for minor harm LowNo realistic potential for harm TypeDescription 1Actual – harm 2Actual – no harm 3Near-miss – unplanned recovery 4Near-miss - planned recovery

62 61 Results Classification of hospital size by RBC Utilization SizeRBC Utilization per year No. Small<2,000 RBC transfusions/year3 Medium2,000 – 10,000 RBC transfusions/year5 Large>10,000 RBC transfusions/year3

63 62 Results 20,979 errors reported from 11 hospitals over 2 years  6.8% with the potential for patient harm (high severity)  0.2% with actual patient harm  74% detected within 48 hours of the error  85% occurred between 08:00-20:00  Weekday 31/day vs. weekend 25/day

64 63 Actions taken 3451Other 1650Events with products loss 3969Patient sample recollected 814Additional testing 7051Floor/clinic notified 5242Record corrected 300Product retrieved NAction

65 64 Products destroyed $232,241379Plasma derivatives N $CDN $668,294 $456,053 7,097 14,877 15,476 18,624 51,253 348,726 479FFP 146PLT 2355TOTAL 1976Total Components 47CRYO-SUP 27APH-PLT 194CRYO 1083RBC

66 65 Person Involved in Error Job DescriptionN% Nurse997247.6 Technologist757236.2 MD214910.3 Clerk2941.4 Lab Assistant2831.4 Supplier1970.9 Supervisor320.2 QA/TSO70.03 Other4362.1 TOTAL*20,942100% *37 (0.2%) not specified

67 66 Type of errors reported Clinical N% PR Product/Test Request 14877.1 SCSample Collection544425.9 SHSample Handling18328.7 RPRequest for Pick-up3221.5 UTUnit Transfusion429220.5 MSMiscellaneous1860.9 Subtotal1356364.7 Laboratory N% PCProduct Check-in11565.5 DCDonor Codes2041.0 SRSample Receipt11145.3 STSample Testing258812.3 USUnit Storage6363.0 AVAvailable for Issue1490.7 SEUnit Selection790.4 UMUnit Manipulation3551.7 UIUnit Issue11355.4 Subtotal741635.3

68 67 High Severity Top 5 List Event Type & DescriptionN% SC 01Sample labeled with incorrect name35626.9 SH 02Sample label and requisition do not match21616.3 SC 02Sample with no label18113.7 SC 07Other mislabeling997.5 RP 01Request for pick-up on wrong patient836.3 Subtotal93570.6

69 68 Rates for Event Codes per 100,000 n=436,223 products received; n=986,608 tests performed SAMPLE COLLECTION 1 IN 37 UNIT TRANSFUSION 1 IN 92 SAMPLE COLLECTION 1 IN 51 UNIT TRANSFUSION 1 IN 92

70 69 Rates for Sample Collection Errors 1:776 1:1615 1:12,623 1:2170 1:170 1:277 1:171 1:2620 1:1129 SC 01 SC 02 SC 03 SC 04 SC 06 SC 07 SC 08 SC 10 SC 99 SC 05 SC 09 1:2620 1:27,770

71 70 Error rates by location Sample Collection LocationRateDenominator Emergency1 in 1614,397 Operating room1 in 18749 Intensive care1 in 296,996 Medical/surgical ward1 in 3018,740 Out patient procedures1 in 829,054 Obstetrics1 in 24510,782 Outpatients1 in 28518,250 Denominator – 77,576 of 138,850 (55% of total)

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73 72 70% of transfusion activity in Canada

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81 80 CONCLUSION Hemovigilance is now an integral part of a quality system in transfusion Hemovigilance covers donors, processes and recipients Hemovigilance helps identify priorities for transfusion safety and monitors effects of preventive measures Hemovigilance works

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