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Presentation on theme: "HEMOVIGILANCE SYSTEMS"— Presentation transcript:

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

2 SCOPE Products Donations 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

3 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

4 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 only UK SHOT All French Hemovigilance System Identification of long term effects of transfusion Matching databases Recipient with death registry Recipient with tumour registry Recipient with hospital discharge database

5 collection / analysis of data
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

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

7 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

8 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?

9 Requirements….3 International STANDARDIZATION Centralized analysis
Patience Commitment Leadership Centralized analysis

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


12 EFS TSHC Medical & nursing team AFSSaPS Medical & nursing team
Regional coordinator TSHC Haemovigilance officers (HO) Here are the basics of the system. First of all, I should like to stress that there cannot be any haemovigilance without an active co-operation from all the medical and nursing staff in hospitals and the blood distribution service. All of haemovigilance depends, first of all, on those professionals who actually transfuse the patients. They are the ones who see what happens when a patient is transfused. They are the ones who can set off the whole system by declaring a transfusion related incident. Haemovigilance is now part of the care given to patients. To make the system work, you need people to look after this more specifically. These are the haemovigilance officers. There is supposed to be one in every hospital that uses blood components. There are also haemovigilance officers in the blood transfusion service distribution units. So, altogether, there are about 2200 haemovigilance officers. Haemovigilance officers alone cannot do all the work, which we will look into next. The hospital based “CSTH” - or transfusion safety and haemovigilance committees - were set-up to give all the actors involved, i.e. physicians who prescribe blood and its components, nurses, administrative staff who pay the bills and those who manage patient files, and the haemovigilance officers, a platform where all the problems associated with blood transfusion and haemovigilance can be discussed. Lastly, there are 24 regional co-ordinators for haemovigilance, who oversee the system, and represent a link between the local hospital and blood transfusion service level and the regional and national levels.

13 transfusion reactions transfusion safety committee
The local level Healthcare facility HO + EFS HO transfusion reactions information traceability transfusion safety committee various procedures training The whole system of haemovigilance, as for any surveillance system, is totally based on information. So, what information must the hospital based haemovigilance officer treat ? Of course, and first of all, comes the information concerning transfusion reactions. We’ll be looking at this in detail in a moment. Traceability of blood components is another major information which needs to be followed through. Nurses must inform the blood transfusion service that such and such a blood component has been transfused to such and such a patient. Spontaneously, only about 60 to 80% of information is given to the BTS distribution units. It is the hospital haemovigilance officer’s job to make sure the extra 40 to 20% information, that is missing, is in fact given. The haemovigilance officer is generally involved in the writing of various hospital procedures for transfusion and haemovigilance, procedures which are then approved by the transfusion safety committee. The hospital haemovigilance officer is usually the secretary of this committee. It is his task then to organise the meetings, and to prepare them. Not always an easy task : people in hospitals do not like committee meetings generally, finding them to be a waste of time. Last, but not least, they are involved in building in-service training programmes in blood transfusion for nurses, and if possible, for physicians ... well, in any case for juniors at least. All this work is done in co-operation with the haemovigilance officer from the distribution service which furnishes components for the hospital.

14 The local transfusion safety and hemovigilance committee
Management, HO, prescribers, nurses, regional coordinator organization of transfusion information transfusion procedures transfusion reactions training traceability We have already talked about some of the tasks of the transfusion safety and haemovigilance committees. They are responsible for organising blood transfusion within the hospital, i.e. by answering questions such as : how are blood components to be brought to the ward where they are needed? Who is to do that ? How can we bring down the number of packs that are wasted ? In the big hospitals, like teaching hospitals, the set-up is often quite complicated, because of the size of the institution, and of the numbers of people involved. Traceability is also a problem, as are using procedures. Assessment techniques, such as audits, can be used by haemovigilance officers to determine the degree of conformity with internal transfusion procedures.

15 The regional level organization of haemovigilance
information Local level National level organization of haemovigilance organization of blood transfusion transfusion reactions traceability annual report The regional co-ordinator must also treat information. But here, the objectives are somewhat different. His main job is to monitor the haemovigilance system. Are there haemovigilance officers everywhere there should be one ? Do they carry out their job properly ? In other words, is the regional haemovigilance system operative ? This monitoring also concerns the blood transfusion service, at least the distribution units. But this can go further, such as in the qualification units. The other big part of the work involves transfusion reaction reports. Each report is reviewed. Further enquiries can be asked for, or follow-up investigations can be decided on by the regional co-ordinator, in collaboration with the haemovigilance officers involved. Regional co-ordinators also monitor the levels of traceability in each hospital, the various procedures that are written by the haemovigilance officers and take part in various training and teaching actions.

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 Nationally, various bodies are involved in haemovigilance. First of all, the agency for health safety of medicinal products, the French equivalent to the FDA in the States. There is a haemovigilance unit, comprised of 6 people. They work together with other surveillance systems. These are the pharmacovigilance and “materiovigilance” units. Soon, there will be a “biovigilance” unit, dealing with organ and tissue grafts. The French Blood Establishment, the only blood transfusion service, also has a haemovigilance unit, which is in relation with all the haemovigilance officers of the blood distribution units. The regional co-ordinators meet together in a national conference, about six times a year. Moreover, because various haemovigilance officers and other staff involved in haemovigilance, whether on the hospital side or the blood transfusion service side, need to meet and discuss matters outside of a purely legal framework, a new scientific body was set up very recently. It is the French society for transfusion medicine and haemovigilance, which I have the honour of presiding.

17 Agence Française de Sécurité Sanitaire des Produits de Santé
The regulatory agency Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS) Ministry of Health European Commission Annual report InVS epidemiology of donors adverse reactions Donor - Patient Healthcare establishments Regional coordinator Annual report quality control Regional and local blood establishments Établissement Français du Sang (EFS) Centre de Transfusion Sanguine des Armées (CTSA) Let’s first look at the way blood transfusion is organised in France. You may know that this organisation has undergone several changes in the past years. The latest reorganisation occurred on the 1st of January this year. Ten years ago, there were 163 blood transfusion establishments in France. A first shake-up led to a reduction in the number to 43. There is only one establishment left now, which has 14 regional offices. There is one head office, in Paris for the moment, but which is likely to move to Lille. There are less regional offices than there are administrative regions in France. This is because most regional blood establishments cover more than one administrative region. In Rhône-Alpes, which is the region where I work, because it’s a big region - we’ll see some of the detail later on - there are two regional blood transfusion establishments, one of which covers another administrative region, Auvergne - the French volcano country. The whole system is overseen by the French agency for health safety of medicinal products, which of course include blood and its components and derivatives. This reorganisation aims at definitely removing the activities of inspection and control of the producer of blood and its components from the producer. I think you’ll agree with me in saying that this was not an ideal situation, when the producer could inspect itself. An external party is now involved. Another major aim of this reorganisation is economic, of course, as you might have guessed. Smaller units which treat larger volumes cost less.

18 Advantages The centralization : The manpower :
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

19 Disadvantages The centralization : The manpower :
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


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

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

23 Advantages: Supplier Tighter feedback loop: Intimate knowledge of the transfusion process “better qualified” to develop the system and to intepret and analyse the data Regulators often come from a different perspective and mindset Impetus for change stronger and quicker 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

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


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

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

28 Participation by hospitals
In 2006 hebben 6 ziekenhuizen online gemeld. Voor wat betreft 2006 hier een voorlopige aanduiding – een aantal ziekenhuizen heeft na de sluitingsdatum (eind maart want op 2 april was de bijeenkomst van het Expert committee) voor het rapport al meldingen ingestuurd bijvoorbeeld. Die komen in het rapport als ‘geen info’ en in de annex in het najaar uiteraard als participant. Inmiddels hebben 33 ziekenhuizen inlogcodes aangevraagd om online te gaan melden; zij hebben nog niet allemaal actief gemeld. Source: TRIP, English Newsletter 2008/1

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

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

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


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) As Justice Krever indicated in his report of the commission of inquiry on blood safety, a good surveillance system starts with good reporting (in this case from Hospital level).

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

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

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

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

38 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

39 How to handle disadvantages

40 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


42 The US Biovigilance Network
Biovigilance Network Task Force Biovigilance Network Steering Committee AABB ARC CAP PPTA US:CDC AATB ASH Publ Hlth Ag of Can Prov of Quebec US:CMS ABC ASBMT ISBT Transfusion Alliance US:FDA Advamed ASH JCAHO UNOS US:HRSA AHA BSI NMDP US:AHRQ US:NHLBI US:DHHS – Asst. Sec., OPHS “Moral support” Encouragement for participation Routes to ongoing funding Support for implementing changes Biovigilance Network Working Group PHASE I: Transfusion Service Operations AABB BSI US:CDC ABC CAP US:CMS ARC US:DHHS US:FDA Direction Review More encouragement for participation Biovigilance Network International Correspondents James AuBuchon, MD, chair Nancy McCombie Neil Blumberg, MD Barbara Rabin-Fastman Jeannie Callum, MD Pierre 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 Make it happen! Georges Andreu, MD (Fr) Mickey Koh, MD (SG) Simon Benson, MD (NZ) Mike Murphy, MD (UK) Emer Lawlor, MD (Irl) Paul Strengers, MD (ISBT) Critiques from experience

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

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

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 (almost) 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)

46 Types of haemovigilance systems
France Singapore Netherlands Canada Québec/ Hemovigilance TRIP TTISS QHS 1994 2002 2000 Confidential Anonymous Mandatory Voluntary Non-punitive All reactions Only serious reactions .

47 Reporting in haemovigilance systems
TRIP Reporting in haemovigilance systems FRANCE QHS

48 Reporting in haemovigilance systems
Country/ region *Reports/ 1000 units What is reportable Type of system UK 0.20 Serious reactions + IBCT Voluntary Canada 0.31 Serious reactions not IBCT Ireland 1.22 France 2.83 All reactions Mandatory Netherlands 2.90 Québec 7.07 .

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

50 Traceability FRANCE

51 ABO mistransfusions FRANCE

52 Bacterial contaminations FRANCE

53 ABO incompatible red cell transfusions

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

55 ABO mistransfusions QUÉBEC

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

57 Pre-post for diversion pouch WBDPC
Year N Rate 18 1:2,655 1 1:27,737 X2 =8.09, p = Pre-post for diversion pouch + bacterial detection WBDPC Year N Rate 18 1:2,655 1 1:40,662 X2 = 12.68, p =

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

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 To develop the Canadian System, we utilized the MERS-TM architecture and attributes to build the Canadian System. Where the MERS-TM is the Cadillac version and the Canadian system is the Volkswagon.

60 Methods Actual event vs. Near-miss Severity Type Description 1
Actual – harm 2 Actual – no harm 3 Near-miss – unplanned recovery 4 Near-miss - planned recovery Errors that could result in an ABO-incompatible error were hard coded as high severity to prevent hospitals from down grading an error. Severity Description High Potential for serious injury or death Medium Potential for minor harm Low No realistic potential for harm

61 Results Classification of hospital size by RBC Utilization
RBC Utilization per year No. Small <2,000 RBC transfusions/year 3 Medium 2,000 – 10,000 RBC transfusions/year 5 Large >10,000 RBC transfusions/year This classification scheme was chosen based on Jeanne Linden’s data from New York State published in 2000 documenting that hospitals with <2,000 RBC transfusions per year had the highest event rates.

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

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

64 Products destroyed N $CDN RBC 1083 348,726 FFP 479 51,253 CRYO 194
18,624 PLT 146 15,476 APH-PLT 27 14,877 CRYO-SUP 47 7,097 1 in 185 products received is discarded due to error 0.5% of National inventory is lost to preventable errors 850,000 red cells collected by CBS + 250,000 QB = 1,000,000 RBC to hospitals = over 10,000 RBC lost every year due to errors at the hospital level $35 per error Total Components 1976 $456,053 Plasma derivatives 379 $232,241 TOTAL 2355 $668,294

65 Person Involved in Error
Job Description N % Nurse 9972 47.6 Technologist 7572 36.2 MD 2149 10.3 Clerk 294 1.4 Lab Assistant 283 Supplier 197 0.9 Supervisor 32 0.2 QA/TSO 7 0.03 Other 436 2.1 TOTAL* 20,942 100% *37 (0.2%) not specified

66 Type of errors reported
Clinical N % PR Product/Test Request 1487 7.1 SC Sample Collection 5444 25.9 SH Sample Handling 1832 8.7 RP Request for Pick-up 322 1.5 UT Unit Transfusion 4292 20.5 MS Miscellaneous 186 0.9 Subtotal 13563 64.7 Laboratory N % PC Product Check-in 1156 5.5 DC Donor Codes 204 1.0 SR Sample Receipt 1114 5.3 ST Sample Testing 2588 12.3 US Unit Storage 636 3.0 AV Available for Issue 149 0.7 SE Unit Selection 79 0.4 UM Unit Manipulation 355 1.7 UI Unit Issue 1135 5.4 Subtotal 7416 35.3

67 High Severity Top 5 List Event Type & Description N % SC 01
Sample labeled with incorrect name 356 26.9 SH 02 Sample label and requisition do not match 216 16.3 SC 02 Sample with no label 181 13.7 SC 07 Other mislabeling 99 7.5 RP 01 Request for pick-up on wrong patient 83 6.3 Subtotal 935 70.6

68 Rates for Event Codes per 100,000 n=436,223 products received; n=986,608 tests performed

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

70 Error rates by location Sample Collection
Denominator Emergency 1 in 16 14,397 Operating room 1 in 18 749 Intensive care 1 in 29 6,996 Medical/surgical ward 1 in 30 18,740 Out patient procedures 1 in 82 9,054 Obstetrics 1 in 245 10,782 Outpatients 1 in 285 18,250 Denominator – 77,576 of 138,850 (55% of total)


72 70% of transfusion activity in Canada








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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