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. 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

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

11. BLOOD REGULATOR
FRANCE

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

20. BLOOD MANUFACTURER
SINGAPORE

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

25. PROFESSIONAL ORGANISATIONS
NETHERLANDS

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

32. PUBLIC HEALTH
CANADA

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
LISTEN TO THOSE WHO HAVE EXPERTISE IN TRANSFUSION MEDICINE
START WITH A PILOT PROJECT TO ESTABLISH TRUST AND CREDIBILITY
PROVIDE REGULAR FEEDBACK TO DATA PROVIDERS
HIRE PEOPLE WITH EXPERTISE TO HELP BUILD THE SYSTEM

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

41. PUBLIC-PRIVATE PARTNERSHIP
USA

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
SAMPLE COLLECTION
1 IN 37
UNIT TRANSFUSION
1 IN 92
SAMPLE COLLECTION
1 IN 51
UNIT TRANSFUSION
1 IN 92

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