BLOOD COMPONENTS –
PROCESSING, QUALITY
ASSURANCE, STANDARDISATION
Vesna Libek MD, PhD
Blood transfusion specialist
Head of Blood Transfusion Service
Deputy manager CHC Zemun Belgrade
Lecturer in Blood transfusion education department at Belgrade Medical
University
SERBIA
Shenzhen, 2015
There is totally 81
million blood units
transfused all over
the world / per year
P.J.L Carson., Carless: The evidence base for red blood cell transfusions. ISBT Science Series (2013) 8,89-92
Over 20 million blood units are collected in Europe
from 13 million blood donors per year
Project DOMAINE ( Donor Managment in Europe)
Segmentation of blood donor population in blood
donor types
Veldhuizen I., Follea G., de Kort W.: Donor cycle and donor segmentation: new tools for
improving blood donor management Vox Sanguinis(2013) 105, 28-37
Production- blood
processing
Allogenic and autologous
whole blood donations
Collection of components
by apheresis
Voluntary nonremunerated blood donor
Fixed-site blood-collections
Mobile blood collection
Whole blood
donation
High-quality blood components meeting European
guidelines can be prepared by using automated
devices.
Think of Critical control points for the donation process:

Selection of blood donor

Collection of the donation

Handling and storage of the donation

Transport of the donation to the processing center

Distribution of blood component
Avoid them with new technologies that automate the critical control
points as far as possible
During this process, following Guide to
the preparation, use and quality
assurance of blood components, 17th
Edition is unavoidable
PRINCIPLES: up-to-date
useful information
STANDARDS: mainly
adherent to European
Pharmacopeia and
European Directives must be applied
Relevant legislative & regulatory references
 2001/83/EC “ community code relating to medicinal products for human use”
 2002/98/EC “standards of quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components
 2004/33/EC “Eligibility of donors ...Quality and safety requirements for blood
 2005/61/EC “…traceability requirements and notification of serious adverse reactions and
events”
 2005/62/EC “… Community standards and specifications relating to a quality system for blood
establishments”
 PE 005-3 PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS - 2007
 GOOD PRACTICE GUIDELINES FOR BLOOD ESTABLISHMENTS AND HOSPITALS BLOOD BANKS
required to comply with EU DE 2005/62 /CE - 15.11.2013
 EDQM Guide to the preparation, use and quality assurance of blood components.
Recommendation n. R(95)15. 17th Edition - 2013
 WHO guidelines on good manufacturing practices for blood establishments -Technical Report
Series, No. 961, 2011 Annex 4
 Feuropean Pharmacopeia 8th Ed.
Each blood establishment must develop
and maintain QS based on EU Directive
2003/94/EC Good Manufacturing Practices
(GMP) and complies with the requirements
identified in Directive 2005/62/EC and its
Annex.
QUALITY MEANS:
Quality system - organizational structure, responsibilities,
processes, procedures and resources required to maintain
high quality products and ⁄ or services.
In blood transfusion chain setting- quality system provides a
framework in a supply chain setting from a donor’s vein to a
patient’s vein through the collection, processing, testing,
distribution and administration of high quality, safe and
effective blood and blood products.\
Quality system considers:
 quality management,
 blood component recall,
 quality assurance,
 external and internal auditing and
issuance of blood components
 continuous quality improvement,
personnel, premises
 Control of equipment and
documentation, electronic data are
important part of QS.
 collection, processing, testing,
 release, storage, distribution,
 Non conformities and corrective and
preventive measures are included.
 Quality control testing of
components are done following the
recommended percent of all
produced components.
Strengers P.:ISBT Working Party on Quality Management. Transfusion Today, 96:4-5, 2013.
 A quality assurance programs - ensure that there are processes in place, to
control and monitor all critical steps
 the application of quality assurance to every part of the manufacturing
process from donor selection through to dispatch of the components to the
hospitals.
 quality assurance can ensure consistency of product, reliable results,
effective risk-based decision making and reduction in wastage through
minimization of errors.
 Quality assurance therefore provides a strong basis for donor, product and
staff safety.
QM considers:
Self inspection to
improve some field of
work as well as
Regulatory inspection
by Competitive
authorities or state
accreditation body
Seidl C.:Standards, criteria and trainig requirements for improving quality managment. Transfusion
Today, 96:6-7, 2013.
Quality policies
Quality procedures
SOPs
Records
Structure of controlled
document system
For all working procedures SOPs (Standard Operative
Procedures), which
represent the exact steps in
working process- need to
be written.
Effective, streamlined SOPs
based on principles of good
practice that comply with
relevant regulation.
European Project addressing the safety
of blood transfusion
 EU-Optimal Use of Blood Project
cofounded by the European Commission
 The EU-Q-Blood-SOP Project
cofounded by the European Commission
 The European Commission, Public Health Program
Blood Quality Project EQUAL
The main goal of the Project - “Good
Quality Management” (QM) in Blood
Transfusion Services
On the Basis of the Directive
2002/98/EC of Europian
Comission (Blood Directive)
Through the Project the Manual for
EU Standard Operating Procedures
was writen
www.equal-blood.eu
C. Seidl. European perspective of quality
management in blood establishments - The EuBIS
manual and training guide. XXXIth (ISBT) in joint cooperation
with the 43rd Congress of the DGTI, Berlin, 2010.

Continuously improving the quality of processing
procedures and the quality of final components

EDQM, WHO

Harmonization of definitions connected to QM

QM include human resources too
Strengers P.:ISBT Working Party on Quality
Managment. Transfusion Today, 96:4-5, 2013.
C. Seidl. The EUBIS standards and criteria for
the inspection of blood establishments Introduction and overview of the EuBIS
manual and training guide. XXXIth (ISBT) in joint
cooperation with the 43rd Congress of the DGTI, Berlin,
2010.
Equivalent recognition of inspections of
blood establishments among all
Member States through the
development and implementation of
commonly accepted criteria and
standards leading to comparable quality
systems and inspection procedures.
EUBIS:
 Enable that blood components are collected and prepared to
a consistently high standard of safety across Europe.
 Define requirements for the quality management system for blood
establishments based on the Directive 2005/62/EC
 Develop pan European standards and criteria for the inspection of
blood establishments (GMP guidelines, implementing the Directive
2002/98/EC and its technical annexes).
 Establish a common benchmark system for deviations and
improvements.
 Develop a training program for inspectors
Seidl C, Brixner V, Müller-Kuller T, Sireis W, Costello P, Cermakova Z, Delaney F, McMillan Douglas A, Nightingale M, van Galen JP ,
O’Connell M, Siegel W, Sobaga L, de Wit J, Seifried E. Levels of quality management of blood transfusion services in Europe. Vox
Sang 2008.; 3 (1) : 54-62
Project co-funded by the European Commission, DG Sanco
EUBIS - Standards and Criteria developed based on the European Blood legislation with cross-reference to common used European and
International standards defined by its survey in Annex I of the Grant Agreement (Vox Sanguinis, Science Series Vol (3), Seidl et al. 2008).
Project “Optimal USE of Blood”
- Improve safety for the donor reducing the unnecessary bleeding of
donors
- Improve safety for the patient improving the transfusion process,
reducing the unnecessary transfusion
of blood.
- Improve effectiveness of health
services -blood components to be used
in the most therapeutically beneficial
way for patients.
- Improve efficiency of health services reducing inefficient use of resources.
To summarize the current status in routine
preparation process of blood components
 Critical parameters during the
donation process and the period
before separation
 Temperature control
 Storage time and temperature
before separation
 Phagocytosis and self-sterilization
 Leucodepletion
 Red cell concentrates
 Platelet concentrates
 Additive solutions
 Agitation
 Storage lesion
 Cold storage of platelets
 Storage period of PCs
 Therapeutic plasma
 Pathogen inactivation
Production of cellular blood components from undifferentiated cells in vitro
Henschler R, Müller M.M, Pfeiffer H.U, Seifried E, Sireis W.: Production of standard blood components. ISBT Science
Series (2010) 5,190-195
Following standards for collection of blood
and blood components:
premises for donor sessions,
procedures and equipment used at blood donation sessions,
pre-donation checks,
labelling, venipuncture, bleeding and mixing,
handling of filled blood bags
following special requirements for Apheresis
Not less important is having the repository of archive samples.
Collection of blood,
Initial step in preparing standardized blood
components, proper mixing with the anticoagulant continuously
at all phases of the bleeding is important.
From blood donation through dividing
tubes and small pre donation bag, from
initial blood bag and then towards
producing different blood components in
everyday work, depends on well-chosen
equipment.
The plastic - need to be tolerant to temperatures required for blood steam
sterilization and plasma freezing
Clear - to allow visual assessment and processing
Strong enough - to tolerate centrifugal processing and
pressure infusion
Polyvinyl chloride (PVC) , plasticized with
di-2-ethylhexyl phthalate (DEHP) –safety?
The size, and thickness of platelet bags and the fracture resistance of plasma
bag
Plastic bags (DEHP free, PVC free) for platelet storage with better gas diffusion
capabilities are widely available.
Modern bags are also sized to prevent overdrawing
With the adoption of the ambient overnight hold of whole blood before
processing the importance of the plasticizer in the primary collection bag may
increase.
Prowse C.V., de Korte D., Hess J.R., van der Meer P.F.: Commercially available blood storage containers. Vox Sang 2014, 106:1-13.
Either to store whole blood (WB) units up to 24 h
before processing, the WB is actively chilled to
22±2ºC
Usually by placing the WB bags under cooling
plates filled with butane-1,4-diol
The WB is rapidly cooled from a post collection
temperature of about 34ºC to 22±2ºC within 2-3h
Thibault L., Beausejour A., Jacques A., Ducas E., Tremblay M.: Overnight storage of whole blood: cooling and
transporting blood at room temperature under extreme temperature conditions. Vox Sang 2014; 106: 127-136
Processing of blood
Blood components may be prepared either during collection of whole
blood with further processing through centrifugation or during collection
using apheresis technology.
Component separation after the initial centrifugation of whole
blood
Separation after initial filtration
T/B
Quadruple bag
Commonly used quality measures for fresh cellular components
Tests for platelet quality
Measuring platelet activation state
• CD62P expression
• Annexin V binding
• Extent of shape change
• Morphology score
• Swirl
Measuring platelet metabolic activity
 • Glucose
• Lactate
• pH
Tests of red cell concentrate quality
Measuring red cell metabolism
• 2,3- DPG
• ATP and other nucleotides
• Glucose
Measuring red cell integrity
• Osmotic fragility
• Potassium
• Morphology
• CD47 level
• Annexin V binding
• Per cent haemolysis at outdate
• The condition of centrifugation
determines the composition of the
desired component.
• The choice of initial separation step as
well as using initial filtration strongly
influences the choice of methods for
further processing.
• Together with methods of freezing
plasma, irradiation of blood
components, pathogen reduction
and different additive solution we
can also produce modified
components using appropriate
equipment.
Different factors influence the possible
stock period of components:
Composition of conservers, additive
solutions, post production manipulation
for instance- irradiation
Williamson L., Devine D.: Challenges in the management of the blood supply Lancet
2013 (381):1866-1875.
The separation of blood components
from whole blood collections can be
automated by a different devices
producing standardized blood
components, good quality control and
increased work efficiency.
Processing of blood components carried out
using appropriate and validated procedures
including measures to avoid risk of bacterial contamination.
 The labelling system for the collected blood, blood components and
samples must unmistakably identify the type of the content and must
be the link to obtain traceability of the donation.
There must be the safe system for realizing components after all
mandatory requirements priory being fulfilled.
Procedures for storage and distribution need to keep blood component
quality during whole storage period.
All processes for irradiation and leucodepletion must also be
standardized.
Red cell components can be processed like:
Red cells
RC buffy coat removed,
RC in additive solution,
RC buffy coat removed in additive solution,
RC leucocyte depleted,
RC leucocyte depleted in additive solution,
RC apheresis,
 RC washed and
RC cryopreserved.
Automatic separators allows even
simultaneously separation of two
blood units and whit the T/B
quadruple blood bags we came
closer to full automation with
shortening separation period.
Immediately transferred data to the
PC and stored in electronic form and
as printed copy, enables
haemovigilance.
The quality of samples from tubing segments is not
representative of the quality of the corresponding
RBC unit.
 Segments are not suitable surrogates with which to
assess RBC quality.
Segments from red blood cell units should not be used for quality testing
Jayme D.R. Kurach1,2,3, Adele L. Hansen1,2,3, Tracey R. Turner1,2,3,Craig Jenkins1,2,3, Jason P. Acker1,2,3,*
Transfusion Volume 54, Issue 2, pages 451–455, February 2014
QC of RBC components
RBCs without
BC
In additive
solution
RBCs
leucocytedepleted
RBCs
leucocytedepleted in AS
Red blood
cells
RBCs without BC
RBCs in
additive
solution
Volume
(mL)
280±50
250±50
Depends on AS
Depends on AS
To be defined for
the system used
To be defined for
the system used
Hematocrit
0,65-0,75
0,65-0,75
0,50-0,70
0,50-0,70
0,50-0,70
0,50-0,70
Hemoglobin
(g/unit)
≥ 45
≥ 43
≥ 45
≥ 43
≥ 40
≥ 40
Special
demands
-
Residual leucocyte
content / unit
<1,2x109 per unit
-
Residual leucocyte
content / unit
<1,2x109 per unit
Residual leucocyte
content / unit
<1 x106 per unit
Residual leucocyte
content / unit
<1 x106 per unit
Haemolysis at
the end of
storage(% of
RC mass
<0,8
<0,8
<0,8
<0,8
<0,8
<0,8
Volume
(mL)
Washed RBCs
RBCs cryopreserved
Apheresis RBCs
To be defined for the
system used
> 185 ml
To be defined by the
system used
Hematocrit
0,65-0,75
0,65-0,75
0,65-0,75
(0,50-0,70 with AS)
Hemoglobin
(g/unit)
≥ 40
≥ 36
≥ 40
Special demands
Protein content final
supernatant
< 0,5 g / unit
Residual leucocyte
content / unit
<1 x106 per unit
Haemolysis at the end
of storage(% of RC
mass
<0,8
Residual leucocyte
content / unit
<1 x109 per unit
Osmolarity < 340
mOsm/L
Sterile
Haemoglobin supernatant
< 0,2 g /per unit
<0,8
Improve product quality through
improved technology
 Gravitational separation of cells based on their
density
 Two methods for the ultimate preparation of
platelet concentrates
 PRP production ( soft spin
hard spin)
 “Buffy coat” production

(hard spin
several BC pooled
together
soft spin)
 Development of additive solutions
Devine D.V., Howe D. : Processing of whole blood into cellular blood components and plasma. ISBT Science Series
2010 (5):78-82.
Pooling BC by the system
Pooling BC by the chain
method
Transfusion medicine in Germany: Current Status and Perspectives.
Frankfurt 2010 (ISBT)
Platelet component can be prepared
 as single unit from PRP (platelet rich plasma) or from buffy coat.
 Platelets can be pooled, produced directly from whole blood derived buffy
coats or after pooling 4 to 6 single units of platelets.
 Platelets can be also produced as:
 pooled leucocyte depleted,
 pooled in additive solution,
 pooled leucocyte depleted in additive solution,
 or platelets pooled pathogen reduced and
 platelets donated by apheresis either leucocyte depleted, in additive solution,
or pathogen reduced.
 There are also platelets cryopreserved.
Pooled platelet concentrate
(from 4-6 blood units) –
240-360 X109 Plt in 250-300 ml of
plasma or additive solution
Apheresis platelets
200-400 X109 Plt in 200-300 ml of
plasma from one donor
Devine D.v.; Howe D.: Processing of whole blood into cellular components and plasma. ISBT Science
Series (2010)5,78-82
Many of activation
processes are calcium
dependent
Avoid Plt
activation
with introduction of
leucoreduction
filters
Plt activation
aggregates
Reduction of the ionized Ca++
level with citrate based
anticoagulants inhibited Plt
activation
Collection
and storage
of platelets
Preserving Plt
functional
capacity to
respond when
transfused
Preventive measures for aggregates
formation:
lowering pH
Resting period before further
processing
Van der Meer P.F.& al. Aggregates in platelet concentrates. Vox Sanguinis (2015)108,96-100.
Pathogen reduction treatment (PRT) leads to an increase
of platelet metabolism and activation independent of the
length of the initial rest times.
 PCs resuspended in autologous plasma - stored at
maximum up to day 5.
mixture of plasma and PAS improves pH and platelet
metabolism but not platelet activation. Prolonged shelf-life
for up to 7 days may be possible.
Janetzko K, Hinz K, Marschner S, Goodrich R, Klüter H: Evaluation of different preparations procedures of pathogen
reduction technology (Mirasol®) treated platelets collected by plateletpheresis. Transfus Med Hemother
2009;36:309-317.
Janetzko K, Hinz K, Marschner S, Goodrich R, Klüter H: Pathogen reduction technology (Mirasol®) treated single
donor platelets resuspended in a mixture of autologous plasma and PAS. Vox Sang 2009;97:234-239.
Pathogen inactivation
Increase the standard of care
Pooled product based on solvent detergent treatment
Single donor based on: methylene blue

amotosalen

riboflavin
Recent advances in blood component processing technology
Rebecca Cardigan (Jun 1, 2014; 53446)
Prolonged life time of Platelet
concentrates to 7 days in
some countries if they are
tested for bacterial
contamination or if they are
pathogen reduced
Williamson L., Devine D.: Challenges in the management of the blood supply Lancet 2013
(381):1866-1875.
Platelet concentrates in electrolytic medium
instead of plasma supernatant
Less post transfusion reactions
Better cell quality
Prolonged life time to 10 days on agitators in incubators
Additional additives for better PC quality: better energetic
metabolism, reduction of metabolic stress, increase the
stability of cells - post transfusion improve recovery
Heaton W.A. Costs and benefits of PAS platelets: A mix of science,quality, and value . TRANSFUSION 2013;53:25972602.
Leuco reduced Plt concentrates in small
volumes with 6% DMSO frozen and kept on
-80ºC
For alloimunised patients and for military
purposes
During frost–defrost procedures there is lost
of 23% Plt count
Hornsez et al. Freezing of buffy coat-derived, leucoreduced platelet concentrates in 6% dimethyl sulfoxide.
Transfusion (2008) 48:2508-2514.
QC of Plt components
Plt pooled
pathogen
reduced
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
Minimum 2 x1011
Minimum 2 x1011
Plt recovered
pooled
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
Minimum 2 x1011
Minimum 2 x1011
Per unit
Per unit
< 1 x106
per final unit
< 0,3 x109
per final unit
< 1 x106
per final unit
> 6,4
> 6,4
> 6,4
Platelet content
per final unit
pH measured
(+22ºC) at the
end of the
recommended
shelf-life
Plt recovered
pooled LD
In additive
solution
Plt recovered
single unit
Volume
(mL)
Residual
leucocytes per
final unit
a.
Prepared
from BC
b.
Prepared
from PRP
Plt recovered
pooled
In additive
solution
Plt recovered
pooled leucocyte
depleted
> 60 x109
a.
b.
< 0,05 x109
< 0,2x109
> 6,4
Minimum 2 x1011
< 1 x109
per final unit
(either BC pooled
or pooling of
single Plt units)
> 6,4
Per unit
< 1 x106
per final unit
> 6,4
Volume
(mL)
For use in
neonates and
infants:
Minimum
0,5 x1011
Per unit
pH measured
(+22ºC) at the
end of the
recommended
shelf-life
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
> 40 mL per
60 x109 of Plt
Standard unit:
Minimum 2 x1011
Standard unit:
Minimum 2 x1011
Standard unit:
Minimum 2 x1011
> 40 mL per
60 x109 of Plt
Per unit
Residual
leucocytes per
final unit
Plt apheresis LD
in AS
Plt apheresis
Standard unit:
Minimum 2 x1011
Platelet content
per final unit
Plt apheresis In
additive solution
Plt apheresis
pathogen
reduced
Plt apheresis
leucocyte depleted
< 0,3
x109
> 6,4
Per unit
Per unit
Per unit
For use in neonates
and infants:
Minimum
0,5 x1011
For use in neonates
and infants:
Minimum
0,5 x1011
For use in neonates
and infants:
Minimum
0,5 x1011
Per unit
Per unit
Per unit
Minimum 2 x1011
< 1 x106
per final unit
< 0,3 x109
per final unit
< 1 x106
per final unit
< 1 x106
per final unit
> 6,4
> 6,4
> 6,4
> 6,4
Plt
cryopreserved
50 – 200 mL
More than 40% of
the prefreeze
platelet content
Plasma, Fresh Frozen (FFP)
Plasma, Fresh Frozen is a component for
transfusion or for fractionation prepared either
from Whole Blood or by apheresis, frozen
within a period of time and to a temperature
that will adequately maintain the labile
coagulation factors in a functional state.
• Plasma, Fresh Frozen used as Human plasma
for fractionation must comply with the
specifications of the European
Pharmacopoeia monograph Human plasma
for fractionation (Ph. Eur. monograph 0853).
• Plasma, Fresh Frozen (FFP) used for clinical
transfusion must comply with the
specifications given in the monograph of the
R 95(15) Guide (Part D, Paragraph 1).
Preparation
a. From whole blood
•hard spin centrifugation,
•preferably within 6 hours (no > 18 hours if the unit is
refrigerated).
•Whithin 24 h if whole blood has been rapidly cooled between
+ 20 ºC and + 24 ºC
•Freezing must be completed within one hour to a
temperature below – 30 ºC.
The plasma core temperature reaches
-30°C within less than 1 hour.
b. By apheresis
•The freezing process must commence
within six hours of completion of the
procedure and completed within one hour
to a temperature below – 30 ºC.
•If plasma is maintained between + 20 °C
and + 24 °C immediately after collection
can be held at that temperature for up to
24 hours prior to freezing.
c. Quarantine FFP
• This FFP is released once the donor
has been retested, at least for HBsAg,
anti-HIV and anti-HCV, with negative
results after a defined period of time,
designed to exclude the risk
associated with the window period.
• A period of six months is generally
applied. This may be reduced if NAT
testing is performed.
QC of FFP
FFP pathogen
reduced.
Volume
(mL)
F VIII
Fibrinogen
Residual cells
Requirements
Stated volume ± 10%
Average not less than 50 IU
F VIII per 100 mL
Average (after freezing and
thawing):≥ 60% of the potency of
the freshly collected plasma unit
Red cells:< 6,0 x109 /L
Leucocytes: < 0.1 x109 /L
Platelets: < 50 x109 /L
If leucocyte depleted:
< 1 x106 /L
Frequency of control
All units
Every 3 months 10 units in the first month of
storage
Every 3 months 10 units in the first
month of storage
1% of, all units with a minimum of 4
units per month
1% of, all units with a minimum of
10 units per month
Leakage
No in any part of container
All units
Visual changes
No abnormal color or visible
clots.
All units
•
When there is
cryoprecipitate prepared,
then there is also
FFP cryoprecipitate
depleted produced.
Cryoprecipitat
Volume
(mL)
F VIII
Fibrinogen
Von Willebrand factor
Requirements
30 – 40 mL
≥ 70 IU per unit
≥ 140 mg per unit
> 100 IU per unit
Frequency of control
All units
Every 2 months :
a.
A pool of 6 units of mixed blood groups
during their first month of storage
b.
A pool of 6 units of mixed blood groups
during their last month of storage
1% of, all units with a minimum of 4 units per
month
Every 2 months :
a.
A pool of 6 units of mixed blood groups
during their first month of storage
b.
A pool of 6 units of mixed blood groups
during their last month of storage
LABELLING
ISBT 128 LABEL STANDARD
UNIT
(CDM: UNIQUE
WORLD NUMBER)
TYPE OF
PRODUCT
BLOOD GROUP
EXP.DATE
The computer system of blood establishment or
hospital blood bank includes:
 hardware, software, peripheral devices and documentation (e.g. SOPs, manuals).
 Such blood bank information system could consist of different parts, modules,
connected to donation process, filing process, production management and
laboratory part.
 These systems are the core of the supply chain management, which records and
monitors all processes from blood donation to post-transfusion follow-up in
adherence to international standards.
 It also consists of warning, guidance and decision support tools, which enables the
adoption of processes that meet international standards.
Production of blood components in EU










Production by BC method
High % of leucofiltration
Some countries doesn’t produce cell components of first time blood
donation
Quarantine FFP
Some countries use only man FFP or nulliparous FFP in therapy
High percentage of apheresis PC
NAT testing for HBV, HCV, HIV
Testing for bacterial contamination of PC
Some of member states use only virus inactivated FFP for all patients or
some group of patients
Blood components are typed in Rh system and Kell sistem
Production - statistic
 All WB (whole blood ) donations are separated in blood components: RBC
concentrates, plasma concentrates and BCs (buffy coats)
 20% of plasma used as therapeutic – FFP (after 4 months of quarantine
storage)
 80% of plasma for further fractionation
 Most apheresis procedures – double apheresis
 40% of collected BCs for manufacturing pooled random Plt concentrates
(comprised of 4 BCs)
 Since 2001, RC concentrates and Plt concentrates are 100% leukodepleted
 Irradiation for medical purpose individually for red cells and Plt concentrates
 Pathogen reduction (Plt concentrates, FFP)
 Washed erythrocyte concentrates in rare cases
Transfusion medicine in Germany: Current Status and Perspectives. Frankfurt 2010 (ISBT)
The administration of blood and blood components involves more than
70 steps and each of these may be subject to error.
 Standard protocols for the administration of blood are essential to
minimize the potential for error.
These protocols should be in place in each institution and should
conform to standard practice.
A quality management system should exist in each institution.
This should include an active transfusion committee, a process to
correct protocols and practice when deficiencies are identified,
participation in local and regional audit and in the national
haemovigilance program.
Biological variations between blood donors
influence the component production itself
Component processing can not completely
optimize the quality of products
Blood components are highly concentrated
but they are not completely free of other
blood elements
Williamson L., Devine D.: Challenges in the management of the blood supply Lancet 2013
(381):1866-1875.
Future steps
 To follow the influence of specific blood donor
characteristics on processed blood components
 The production of blood components from
hematopoietic steam cells in laboratory
1. Mountford J, Olivier E, Turner M. Prospect for the manufacture of red cells for transfusion. Br J Haematolog 2010; 149:22-34.
2. Reems JA, Pineault N, Sun S. In vitro megakaryocyte production and platelet biogenesis: state of the art. Transf Med Rev 2010;
24:33-43.
3. Giarratana MC, Rouard H, Dumont A, et al. Proof of principle for transfusion of in vitro-generated red blood cells. Blood 2011;118:
5071-79.
• Blood and blood
components are biological
products
• Automatisation = standardisation
vesna.libek@gmail.com
谢谢!