Transcript HAEMOVIGILANCE - Transfusion Medicine

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
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
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
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
• All
UK SHOT
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
Modern Hemovigilance
Recipient
AE
Recipients
Process
ER
Donor
NM
Processes / Products
ID
AE
Donors
collection / analysis of data
Adapted from
JC Faber,
Luxembourg
Red Cross
continuous improvement of transfusion safety
SETTINGS
• 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
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
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?
Requirements….3
• International
– STANDARDIZATION
• 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
Medical &
nursing team
EFS
AFSSaPS
Medical &
nursing team
TSHC
Haemovigilance
officers (HO)
Regional
coordinator
13
The local level
Healthcare facility HO + EFS HO
transfusion reactions
information
traceability
various procedures
transfusion safety committee
training
14
The local transfusion safety and
hemovigilance committee
Management, HO, prescribers, nurses,
regional coordinator
organization of transfusion
information
transfusion procedures
transfusion reactions
traceability
training
15
The regional level
National level
organization of haemovigilance
organization of blood transfusion
information
transfusion reactions
traceability
annual report
Local level
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






17
The regulatory agency
InVS
epidemiology of
donors
Agence Française de
Sécurité Sanitaire des
Produits de Santé
(AFSSaPS)
adverse
reactions
European Commission
Annual report
Ministry of Health
Établissement
Français du Sang
(EFS)
Donor - Patient
quality control
Annual report
Centre de
Transfusion
Sanguine des
Armées
(CTSA)
Regional and
local blood
establishments
Regional
coordinator
Healthcare
establishments
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
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
20
BLOOD MANUFACTURER
SINGAPORE
21
Adverse reaction
Evaluate and
Manage
Physician
Transfusion reaction
workup
Inform hospital blood bank/
Transfusion medical officer
Report to Haemovigilance
Program Coordinator
Source: Mickey Koh, Centre for
Transfusion Medicine, Health Sciences
Authority, Singapore
Deputy Director /
Director of Blood Center
22
Reporting Numbers
Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore
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
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
25
PROFESSIONAL
ORGANISATIONS
NETHERLANDS
26
Development of hemovigilance
TRIP foundation created in 2001
Board
Medical Societies
(Hospital associations, Sanquin)
Hospitals
blood Tx
comm.
national TRIP office
clinicians
HV
programme
Sanquin
Hospital
laboratory
Sanquin
side effects products
recall products & look-back
Source: M. Schipperus, TRIP, Netherlands
blood bank
Tx specialist
QA manager
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
Source: TRIP, English Newsletter 2008/1
29
Reports per year
2500
1984
2030
2005
2006
2000
1548
1500
1000
1267
862
500
0
2002
2003
2004
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)
34
Infrastructure for National TTISS Reporting
Reportable
Diseases
HOSPITALS
Reportable
Diseases
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
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
How to handle disadvantages
1. LISTEN TO THOSE WHO HAVE
EXPERTISE IN TRANSFUSION
MEDICINE
2. START WITH A PILOT PROJECT TO
ESTABLISH TRUST AND CREDIBILITY
3. PROVIDE REGULAR FEEDBACK TO
DATA PROVIDERS
4. HIRE PEOPLE WITH EXPERTISE TO
HELP BUILD THE SYSTEM
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
AABB
ARC
CAP
PPTA
US:CDC
“Moral
support”
AATB
ASH
Publ Hlth Ag of Can Prov of Quebec
US:CMS
Encouragement
for
participation
ABC
ASBMT ISBT
Transfusion Alliance US:FDA
Advamed
ASH
JCAHO
UNOS
US:HRSA
Routes
to
ongoing
funding
AHA
BSI
NMDP
US:AHRQ
US:NHLBI
Support for implementing changes
US:DHHS – Asst. Sec., OPHS
Biovigilance Network Steering Committee
AABB
BSI
Direction
ABC
CAP
Review US:DHHS
ARC
US:CDC
US:CMS
US:FDA
More encouragement for participation
Biovigilance Network Working Group
PHASE I: Transfusion Service Operations
James AuBuchon, MD, chair
Nancy McCombie
Make
it
happen!
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
Biovigilance Network
International Correspondents
Georges Andreu, MD (Fr) Mickey Koh, MD (SG)
Critiques from experience
Simon Benson, MD (NZ) Mike Murphy, MD (UK)
Emer Lawlor, MD (Irl)
Paul Strengers, MD (ISBT)
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 (almost)
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)
46
Types of haemovigilance systems
France
Singapore
Netherlands
Canada
Québec/
Canada
TRIP
TTISS
QHS
.
Hemovigilance Hemovigilance
1994
2002
2002
2002
2000
Confidential
Confidential
Confidential
Anonymous
Confidential
Mandatory
Voluntary
Voluntary
Voluntary
Voluntary
Non-punitive
Non-punitive
Non-punitive
Non-punitive
Non-punitive
All reactions
All reactions
All reactions
Only serious
reactions
All reactions
TRIP
2500
Reporting in
haemovigilance
systems
3,5
after closing date
3
2000
2,5
in report
1500
2
1000
1,5
reports /1000
1
500
0,5
0
Blood components
(1000s)
0
2002
2003
2004
FRANCE
2005
2006
QHS
2383
2500
2250
2358
1787
2000
10,00
8,00
1750
1500
1250
972
1000
750
7,07
5,54
6,00
4,00
4,65
568
500
250
7,13
1349
2,00
3,53
2,10
0
0,00
2000
2001
2002
2003
N
Rate
2004
2005
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
Voluntary
Ireland
1.22
Serious reactions
+ IBCT
Voluntary
France
2.83
All reactions
Mandatory
Netherlands
2.90
All reactions
Voluntary
Québec
7.07
All reactions
Voluntary
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
50
Traceability FRANCE
51
ABO mistransfusions FRANCE
52
Bacterial contaminations FRANCE
ABO incompatible red cell transfusions
1996 - 2005
600
500
IBCT cases
analysed
485
439
400
ABO
Incompatible
red cells
348
346
300
200
190
200
136
110
100
63
13
36
26
34
17
26
22
19
10
0
1996/97
1997/98
1998/99
1999/00
2000/01
2001/02
2003
2004
2005
53
Cases of TRALI with relevant donor antibody analysed
by implicated component and by year 2003-2005
2003
2004
2005
8
7
6
5
4
3
2
1
0
FFP
FFP+Other
Platelets
Cryoprecipitate
RBC OA
54
ABO mistransfusions QUÉBEC
N
14,4
15,0
12,5
11,5
10,5
9,5
10,0
7,5
7,9
7,2
6,3
2,5
6
4,9
5,0
8,5
8,4
4,9
3,1 3,4 3,0
2,1
2,4
2
0,0
ABO Inc
2000
AHTR
2001
2002
2003
DHTR
2004
2005
56
Frequencies and Ratios/100,000
BC - Platelet pools
N
Rate
8
50
7
7
43,8
44,1
7
6
5
45
Diversion pouch
40
35
Bacterial
detection
4
30
4
25
24,7
3
20
2
*
1
1
0
8,3
0
0
0
15
10
5
0
2000
2001
2002
2003
N
2004
Rate
2005
2006
57
Pre-post for diversion pouch WBDPC
Year
N
Rate
2000-2002
18
1:2,655
2003-2004
1
1:27,737
X2 =8.09, p = 0.0044
Pre-post for diversion pouch + bacterial detection
WBDPC
Year
N
Rate
2000-2002
18
1:2,655
2003-2006
1
1:40,662
X2 = 12.68, p = 0.0003
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
60
Methods
• Actual event vs. Near-miss
Type
Description
1
Actual – harm
2
Actual – no harm
3
Near-miss – unplanned recovery
4
Near-miss - planned recovery
• Severity
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
Size
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
3
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
Total Components
1976
$456,053
Plasma derivatives
379
$232,241
2355
$668,294
TOTAL
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
1.4
Supplier
197
0.9
32
0.2
7
0.03
436
2.1
20,942
100%
Supervisor
QA/TSO
Other
TOTAL*
*37 (0.2%) not specified
66
Type of errors reported
Clinical
N
%
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
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
US
Unit Storage
636
3.0
MS
Miscellaneous
186
0.9
AV
Available for Issue
149
0.7
13563
64.7
SE
Unit Selection
79
0.4
UM
Unit Manipulation
355
1.7
UI
Unit Issue
1135
5.4
Subtotal
7416
35.3
Subtotal
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
935
70.6
Subtotal
68
Rates for Event Codes per 100,000
n=436,223 products received; n=986,608 tests performed
SAMPLE COLLECTION
1 IN 37
2006
UNIT TRANSFUSION
1 IN 92
SAMPLE COLLECTION
1 IN 51
2005
UNIT TRANSFUSION
1 IN 92
0
500
1000
1500
2000
PC - Product Check-in
PR - Product/Test Request
SC - Sample Collection
SH - Sample Handling
SR - Sample Receipt
ST - Sample Testing
SE - Unit Selection
US - Unit Storage
UM - Unit Manipulation
UI - Unit Issue
UT - Unit Transfusion
RP - Request for Pick-Up
DC - Donor Codes
2500
3000
69
Rates for Sample Collection Errors
1:776
SC 01
SC 02 - Not labelled
SC 03 - Wrong patient collected
1:1615
SC 02
SC 01 - Sample labelled with wrongt patient name
SC 04 - Collected in wrong tube type
SC 05 - Sample with insufficient quantity
1:12,623
SC 03
SC 06 - Sample hemolyzed
SC 07 - Label incomplete/ illegible
SC 04
1:2170
SC 08 - Sample collected in error
SC 05
1:2620
SC 10 - Armband incorrect/ not available
SC 09 - Requisition without samples
SC 99 - Other
1:170
SC 06
1:277
SC 07
1:171
SC 08
1:2620
SC 09
1:27,770
SC 10
1:1129
SC 99
0
100
200
300
400
500
600
70
Error rates by location
Sample Collection
Location
Rate
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)
71
72
70% of transfusion
activity in Canada
73
74
75
76
77
78
79
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