Transcript Blood Transfusion - Safety, optimisation & new advances

Blood Transfusion - Safety,
optimisation & new advances
Dr Shubha Allard
Consultant Haematologist
Barts Health NHS Trust and NHS Blood
and Transplant
NHS Blood and
Transplant
• NHS Blood and Transplant (NHSBT) manages the national
voluntary donation system for blood, tissues, organs and stem
cells
• Supplies around 2 million units of blood a year
Blood safety/ Transfusion safety
SAFE
TRANSFUSION
PROCESS
SAFE BLOOD
COMPONENT
Blood Transfusion -Guidance and Regulations
• WHO recommendations
• safe and adequate blood supply
• also clinical transfusion process
–
–
–
–
–
–
Appropriate use of blood
Collection samples, patient ID
compatibility testing
Administration of blood
Adverse event reporting
Hospital transfusion committee
• ‘Better Blood Transfusion’
• EU Optimal Blood Use manual
• (www.optimalblooduse.eu)
• Council of Europe
• 47 member countries
European Union
Blood Directives
• Setting standards of quality and safety for collection, testing,
processing, storage and distribution of human blood and
blood components
• Blood Safety and Quality Regulations 2005
– Transposed into UK law
• Regulations affect the blood services (called blood
establishments) and hospital transfusion laboratories (hospital
blood banks)
• Competent Authority
– Medicines and Healthcare products Regulatory Agency (MHRA)
Blood safety and Quality Regulations
impact on hospitals in the UK
• Quality management system
•
•
•
•
Stringent requirements storage/distribution blood -‘cold chain’
standard operating procedures (SOPs)
Corrective and preventative action (CAPA)
Validation & change control
– Traceability
– Training and competency assessment
– Haemovigilance
• annual statement of compliance to MHRA
• ~60 hospitals inspected per year
– ‘Cease & desist’
– Critical non -compliances
Safety of the Blood
Supply
• Voluntary and non-remunerated donor
• Donor Health Questionnaire
• Council of Europe - Mandatory screening tests
– Hep B, Hep C, HIV 1 & 2
– Additional testing – Syphilis, HTLV
– Selective screening – Malaria, CMV
Infective risks - UK
Infection
Testing
started
Approximate risk of
infection per
unit of blood in UK
Hepatitis B
1975
1 in 1.06 million
HIV
1985
1 in 6 million
1991
&1998
1 in 72 million
Hepatitis C
(Anti HCV and NAT testing)
Health Protection Agency
Viral tests
in blood
donors
www.coe.int
Management chronic viral hepatitis in thalassemia:
recommendations of an international panel
Marco et al Blood 2010 116 2875
no.
Ref
AntiHCV+ %
13 2006
Iran
732
19.3
14 2006
Turkey
399
4.4
15 2003
Thailand 104
21.2
16 2002
Lebanon 395
14
17 2001
India
21
18
Malaysia 85
22.4
21 2006
Iraq
67.3
22
Pakistan 35
23
Italy
1481 85.2
24
Bahrain
242
20.5
25
Brazil
32
46.8
26
Hong Kong
99
34
27
UK
73
23.3
104
559
Hep C antibody in
thalassemia patients
Wonke B et al Clin
Pathol 1990;43:638
23.3% of 73 patients positive
Thompson et al 2011 Brit Journal of
Haematol, 153, 121–128 Thalassemia
Clinical Research Network Investigators:
169 of 697 Hep C Ab pos – 24%
60
1998
Cunningham et al 2004 Blood 104, 34
5% patients aged<16yrs
23% aged 16-24yrs;
70% aged 25yrs or older
West Nile Virus (WNV)
• Flavivirus
• Most cases asymptomatic
• very mild short term
symptoms (20% infections)
• 1% encephalitis/meningitis;
can be fatal
• First identified 1937 W Nile
area Uganda
• widely distributed Africa,
West Asia, Europe &
Australia; US since 1999
transmission may occur
as a result of blood
donation
WNV – blood donation
• EU Directive - deferral for 28 days - No provision for WNV
Nucleic acid testing (NAT) in place of deferral
• Since 2005 UK blood services have deferred travellers
– Concerns re impact on blood supply – planning 2012 Olympic s
– MHRA accepted WNV NAT testing rather than donor deferral
– May- Aug 2012 NHSBT has tested ~13,000 donations - so far all
negative
• West Nile Virus and Blood Safety Introduction to a
Preparedness Plan in Europe
– EU satellite meeting Working Group on Blood Safety; Jan 2011
– Surveillance, Risk assessment, Deferral criteria, NAT testing,
Impact on blood supply
Variant CJD
• First noted in 1996
• Distinct from sporadic CJD
• Median age at presentation 26 years
• Neuropsychiatric symptoms, ataxia,
dementia.
• Progression over 6 -40 months
same strain of prion disease as Bovine
Spongioform Encephalopathy (BSE)
• 173 cases in UK
• 4 transfusion related cases
• I case in Haemophilia patient
National Creutzfeldt-Jakob
Disease Survellance Unit
(NCJDSU)
www.cjd.ed.ac.uk
Impact of nVJD on processing Blood Components UK
Red Cells
Whole Blood
Platelets (also apheresis)
Plasma
(Universal leucodepletion
in UK since 1998)
Fresh Frozen Plasma
Cryoprecipitate
Paediatric FFP
Paediatric Cryo
Fractionation
Factor concentrates
egFVIII, FIXs
SD plasma
Immunoglobulin
Albumin, Anti D
(Non UK Plasma)
Blood processing – red
cells
• Most of the plasma is removed
• Optimal Additive Solution added SAGM in UK
•
•
•
•
Red Book Specifications
Vol = 280+ 60ml
WBC < 5 x 106 /unit
Hct 0.5 - 0.7
• 35 day shelf life
• For haemoglobinopathy
• Top up <14 days
• exchange (SCD) <7 days
• (washed red cells)
Serious Hazards
of Transfusion
(SHOT)
• UK-wide, established1996 confidential reporting
• evidence base to support
– blood safety policy decisions
– clinical guidelines & education
– improvements in transfusion practice
Trend in total reports and total deaths definitely due to transfusion
Special requirements
Haemoglobinopathy
• TIF Guidelines, UK Standards thalassaemia, Sickle Cell Disease
• British Committee Standards Haematology (www.bcsh.org)
• Red cells matched for Rh (D, C, c, E, e) and K antigens
• Antigen negative for current or historical red cell antibodies
that are clinically significant
• patient’s red cells phenotyped prior to transfusion or
molecular genotyping if transfused
– C, c, E, e, K, k, Jka, Jkb, Fya, Fyb, MNS
Special requirements
Haemoglobinopathy
• SHOT UK 2011 lessons - avoidable events
• Alloimmunisation SCD 20–35% or higher
• Risk haemolytic transfusion reactions
• Multiple & complex antibodies can result in
significant delays in sourcing blood
• Autoantibodies
• Thompson et al 2011 Brit J Haem 153, 121
– Red cell alloimmunization diverse popn of
transfused patients with thalassaemia
• 697 patients 16.5% allo and 5% auto abs
Thompson et al 2011 Brit J
Haematol 153, 121
Anti-E 22 (19%)
Anti-K 21 (18%)
Anti-C 11 (9%)
Anti-Kidd 9 (7%)
Anti-HLA 8 (6%)
Anti-c 7 (6%)
Anti-e 6 (5%)
Anti-Kpa 6 (5%)
Anti-Lewis 4 (3%)
Anti-D 4 (3%)
Anti-S 3 (2%)
Anti-V 2 (1%)
Anti-Duffy 2 (1%)
Anti-M 2 (1%)
Other* 9
NHSBT – a focus on improving care
for haemoglobinopathy patients
•
SP-ICE: Anti body Database
–
•
•
•
Frequency %

Sharing information
Increase in blood donations
from ethnically diverse groups
Rare blood units frozen
International Rare Donor
Panel, IBGRL, Bristol, UK worldwide collaboration 5000
donors, 28 countries




Blood
Caucasian
African
frequency
(%Blood group
Group
CaucasAfricanian
African
Rh



D
C
E
Kell
K
Kidd
Jka
Jkb



Duffy
Fya
Fyb


85
70
30
92
30
19
9
2
77
74
92
49
66
83
10
23
Molecular techniques Extended red cell matching
• Automated, high throughput testing platforms
– now available for molecular testing
• ?scope for extended donor testing and greater red cell antigen
matching with recipient
• NHS Blood and Transplant - Evaluation of chip based and Luminex
based genotyping platforms
– Panel of 1,000 DNA samples from donors with known phenotype
– Inter platform discrepancy very low (0.04%) across >20,000 blood
groupings
– Pilot H&I and RCI labs implementation patient testing
Red cells from stem cells
Harvey G. Klein. Brewing blood
Blood 2011 118, 5069
Standardised
well characterised,
readily available red cells?
Culture systems to generate
erythroid cells in laboratory from
• Somatic stem cells
• Embryonic stem cells
• Induced pluripotent stem cells
Ex vivo production of human red cells, the
Holy Grail of blood transfusion.
illustration by Debra T. Dartez.
Blood safety, optimisation and new advances
• Transfusion transmitted infections
– Reduced rates, never zero risk, emerging infections
• Adherence to guidelines
– avoidable alloimunisation
• Haemovigilance
– Essential for improving transfusion safety
– Highlights areas for action
• New advances
– e.g. IT, molecular techniques, pathogen activation