EDQM2013 report

ENG

The collection, testing and use of

BLOOD AND BLOOD COMPONENTS

in Europe

European Committee (Partial Agreement)

on Blood Transfusion CD-P-TS

L.R. van Hoeven1, M.P. Janssen1 and G. Rautmann2

1. Julius Center for Health Sciences and Primary Care, University Utrecht, Utrecht, Netherlands

2. European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France

The collection, testing and use of blood and blood components

in Europe

2013 report

Correspondence address

M.P. JanssenHP Str. 6.131P.O.-box 85.500NL-3508 GA UtrechtE-mail: m.p.janssen@umcutrecht.nlInternet: www.juliuscentrum.nl/tta

Visiting address

Stratenum 7.117Heidelberglaan 100

NL-3584 CX UtrechtTel: +31-(0)88-7553246

Fax: +31-(0)88-7555485

Prepared for

Department of Biological Standardisation, OMCL Network & HealthCare European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe 7 allée Kastner, CS 30026 F-67081 STRASBOURGFRANCEWebsite: www.edqm.eu

© Council of Europe, 2016

Cover illustration © Fotolia – Robert Kneschke

The collection, testing and use of blood and blood components in Europe is published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM).

All rights conferred by virtue of the International Copyright Convention are specifically reserved to the Council of Europe and any reproduction or translation requires the written consent of the Publisher.

Director of the Publication: Dr S. Keitel

Page layout and cover: EDQM

For further information concerning the work of the Council of Europe/EDQM in the area of blood transfusion please contact: Dr G. Rautmann Department of Biological Standardisation OMCL Network & HealthCare EDQM, Council of Europe 7 allée Kastner, CS 30026 F-67081 STRASBOURGFRANCEE-mail: guy.rautmann@edqm.eu

TABLE OF CONTENTS

Summary List of abbreviations Study methods Results References Tables

Table 1 - Donors, first time donors and inhabitants

Table 2.1 - Collection of whole blood, autologous blood and blood (apheresis) components

Table 2.2 – Profile of donations

Table 3 - Use of blood and blood components for transfusion

Table 4 - Plasma for fractionation into medicinal products

Table 5.1 - Special processing of blood components

Table 5.2 - Inactivation or quarantine of plasma

Table 6.1 - Donation testing strategy for infectious agents

Table 6.2 - Use of simple rapid tests

Table 7.1 - Confirmed seropositive donors

Table 7.2 - Prevalence and incidence calculated per 100,000 donors

Table 8.1 - Nucleic Acid Amplification Techniques (NAT) testing

Table 8.2 - NAT-only positive results

Table 9 - Bacterial screening

Table 10 - Organisation, registration and labelling

Table 11.1 - Quality Management-related issues (continued)

Table 11.2 - Quality Management-related issues

Table 12.1 - Haemovigilance system

Table 12.2 - Haemovigilance – number of serious adverse reactions

3

4

SUMMARY This report provides data on the donors, collection, testing, use and quality aspects of blood and blood components in Member States (MS) of the Council of Europe (CoE). Data were supplied by MS in response to a questionnaire requesting detailed information on donors, collections, testing, distribution and quality aspects of blood and blood components for the year 2013. In its present form it follows a series of similar reports which have assessed such data starting in 1989.

As of 2004, the format of the questionnaire was reviewed and re-designed by the authors and the CoE experts belonging to the Committee of Experts on Quality Assurance in Blood Transfusion Services (SP-GS) and the Committee of Experts on Blood Transfusion (SP-HM) bureau. In contrast to surveys for the year 2003 and earlier, the proportion of donations by voluntary non-remunerated and replacement donors was requested as of 2004. The European Commission (EC) has acknowledged the importance of this data in Directive 2002/98/EC.

In MS and in Blood Establishments (BE), data may be administered in different formats, and different definitions may be used. This could result in discrepancies or errors if the data is then reported in another format. Some data may not be available. It is anticipated that consistency and persistence with these CoE survey methods, together with the support of the EC, will result in adoption of uniform data collection by BE and MS, thereby generating better data and higher response rates among MS. In order to facilitate uniformity, definitions of the EC directives and CoE guidelines are used as far as possible (EC Council Recommendation 98/463/EC, Directive 2002/98/EC, Guide to the preparation, use and quality assurance of blood components, 17

th edition,

2013). In addition, it is to be welcomed that the European Medicines Agency employs the same definitions, especially on infectious disease epidemiology in donor populations (EMA Guideline on Epidemiological data on Blood Transmissible Infections and the EMA Guideline on the Scientific data requirements for a Plasma Master File). Uniformity of such definitions is of importance to the field, and circumvents unnecessary and costly repetitions in collating data. In total, 32 questionnaires were returned which reported annual data from 2013– a response rate of 70 % considering all MS of the Council of Europe. Note that in 2013 for the first time, Australia reported data and they are included in the tables. However, these data are not yet part of the summary statistics. The response rates for the 2011 and 2012 annual data surveys were 70 % and 65 %, respectively.

The average number of donors in relation to the general population was 24 per 1,000 inhabitants. On average, 24 % of the donor base consisted of first-time donors.

The number of Whole Blood (WB) collections was on average 36 per 1,000 inhabitants, and the average use of Red Blood Cells (RBC) was 33 per 1,000 inhabitants. On average, 4.2 litres (L) of plasmapheresis plasma per 1,000 inhabitants was collected.

Almost two thirds (63%) of the reporting MS indicated that the use of blood was expressed as units (U) distributed by BE; the remaining MS reported it as transfused units. The use of RBC

5

varied considerably (range 4-64) with a median of 35 U per 1,000 inhabitants. Four reporting MS (13 %) used less than 20 U per 1,000 inhabitants, most likely reflecting an insufficient supply. On average the Fresh Frozen Plasma (FFP)/RBC ratio was 0.41. In the respondent MS, on average 36 % of the total platelet volume was supplied by (random) single donor platelets by apheresis; in 8 countries (31 %), this volume amounted to more than 50 %.

The amount of plasma delivered for fractionation into medicinal products differed greatly among MS (range 0-54 L), with an average yield of 9.1 L of plasma for fractionation per 1,000 inhabitants. However, 7 % of the reporting MS delivered 20 L of plasma or more per 1,000 inhabitants. In Europe, on average, 71 % of the plasma for fractionation originates from recovered plasma.

In 46 % of the MS, all RBC components were leucocyte-depleted. Platelet concentrates were 100 % leucocyte-depleted in 57 % of MS and, in 41 % of the MS, all plasma for transfusion was leucocyte-depleted. In 52 % of the reporting MS nearly all (99 % or more) of the Fresh Frozen Plasma (FFP) was safeguarded by either quarantine or pathogen inactivation methods.

All donations were tested for anti-HIV-1/2, HBsAg and anti-HCV in all 32 reporting MS. All donations were tested for syphilis in 91 % of these MS. Anti-HTLV-I/II testing was performed on all donations in 16 %, and only on first-time donors in 9 % of reporting MS. Anti-HBc testing was performed on all donations in 30 % of reporting MS, and only on first-time donors in 13 %. Only three MS report implementation of HEV testing. Prevalence and incidences of infectious diseases varied greatly among MS, but highest incidence rates were found in the South/South-Eastern countries (Greece, Bulgaria, Moldova, Romania), and to a lesser degree in the Baltic States (i.e., Estonia and Latvia). The median prevalence amongst first-time tested donors was 4.9, 85 and 64 per 100,000 donors for HIV-1/2, HBV and HCV, respectively. The median incidence amongst repeat donors was 1.1, 0.9 and 1.9 per 100,000 donor years for HIV-1/2, HBV and HCV, respectively.

Nucleic Acid Testing (NAT) for HIV was performed on each donation in 62 % of reporting MS. HBV NAT and HCV NAT was performed on each donation in 57 % and 62 % of MS, respectively.

Bacterial screening was reported in 63 % of reporting MS. Screening of 80 % or more of platelet concentrates was performed in 30 % of MS. The median rate reported for confirmed-positive cultured platelet concentrates was 0.01 %.

All MS reported having legally binding national regulations for the collection, testing, processing, storage and distribution of blood and blood components. In 91 % of the reporting MS, a National Council or Expert Committee existed to advise the Ministry of Health on transfusion-related policy issues. In 89 % of MS, a national blood policy on the quality and safety of blood and blood components was in place.

In 88 % of MS, a Quality System (QS) had been established and was maintained in BE. Inspections were (partly) carried out by a national or other authority at least every 2 years in 94 % of the reporting MS. Labelling of donations according to either ISBT-128 or other procedures was performed by all MS for all donations. Labelling of all components by either ISBT or another system was also done by all reporting MS.

Ninety-one percent of all MS indicated that a national haemovigilance reporting system was

6

present. Taking the possibility of under-reporting and differences in national reporting systems into account, an overall incidence rate of 9.2 serious adverse reactions per 100,000 distributed blood components was calculated. This estimate is based on data provided by 28 MS. Anaphylaxis, TACO (Transfusion Associated Circulatory Overload) and haemolysis appeared to be the most frequent serious adverse reactions.

Acknowledgements

The EDQM and the authors are grateful to all colleagues and experts in MS who collated data at a national level and provided these for inclusion in this report.

The data collection, analysis and preparation of this manuscript was co-ordinated by Dr G. Rautmann (Scientific Officer, EDQM) supported by Ms I. Khraief-Zouari (Secretarial Assistant, EDQM). The report was prepared with the skilful assistance of Mr D. Crowe (Publication Unit, EDQM), Ms C. Knaup (Editorial Assistant, EDQM).

7

LIST OF ABBREVIATIONS Ag Antigen

BE Blood Establishments

CD-P-TS European Committee (Partial Agreement) on Blood Transfusion

CoE Council of Europe

CP Cryoprecipitate

CSP Cryosupernatant Plasma

EC European Commission

EDQM European Directorate for the Quality of Medicines and HealthCare

ELISA Enzyme-Linked Immunosorbent Assay

EU European Union

FFP Fresh Frozen Plasma

FVIII Factor VIII

GMP Good Manufacturing Practice

GTS Ad hoc working group on the guide to the preparation, use and quality assurance of blood components

HBc Hepatitis B core antigen

HBsAg Hepatitis B surface Antigen

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HIV Human Immunodeficiency Virus

HLA Human Leucocyte Antigen

HPA Human Platelet Antigen

HTLV Human T cell Lymphotropic Virus

IDM Infectious Disease Markers

ISBT International Society for Blood Transfusion

ISO International Organization for Standardization

IU International Unit

L Litres

MS Member States of the Council of Europe

NAT Nucleic Acid Amplification Techniques

8

PABD Pre-operative Autologous Blood Donation

QS Quality System

RBC Red Blood Cells

SP-GS Committee of Experts on Quality Assurance in Blood Transfusion Services

SP-HM Committee of Experts on Blood Transfusion

TACO Transfusion Associated Circulatory Overload

TTP Thrombotic Thrombocytopenic Purpura

U Unit

vCJD Variant Creutzfeldt-Jakob disease

WB Whole Blood

9

STUDY METHODS The methods applied in this survey were, in principle, the same as those used in the previous surveys. In brief, the EDQM circulated questionnaires to experts in MS in the form of a web-based application. The MS were requested to complete the questionnaire within a given timeframe with data collated during the year 2013. After the deadline, data tables were prepared and distributed for review by MS and corrected accordingly where necessary. Requests for additional information or clarifications from national experts were submitted by the authors where incomplete or incomprehensible data sets were returned. During the compilation of the data from the questionnaires, some of the data provided did not meet the necessary requirements and these have not been transcribed in the report, resulting in empty fields in some tables. The report was adopted by the CD-P-TS.

Trend analysis and incomplete data

Comparisons with results from the previous surveys and trend analyses are envisaged. The most recent report on trend analyses was published in 2015 and comprised questionnaire data from 2001 through to 2011 (http://www.edqm.eu/en/blood-transfusion-reports-70.html). Not all of the information requested in the questionnaire is included in the reported tables, but additional data are mentioned where justified. Occasionally, the end of row/column totals in the tables may not precisely match the sum of the contributing figures because of rounding. It was assumed that information was not available when it was not provided. The absence of a response (or data inconsistency) is represented by empty fields in the tables.

Remarks on the data collection process

It remains the responsibility of the individual MS to check the data reported in the questionnaires against the tables provided in the draft versions of this report.

With the launch of the web-based questionnaire, which was established for collecting the data for 2007 and subsequent surveys, the occurrence of errors was significantly reduced. In addition, the Julius Centre can, on request, provide MS with a spreadsheet tool to pre-collate the requested data from more than one BE if needed, so that the final data to be submitted can be combined using an automated procedure.

10

RESULTS Response rate

The MS of the CoE which have been asked to report their 2013 annual data are listed in a tabulated format and responses from 32 MS were received by the deadline; a response rate of 70 %. The response rates for 2011 and 2012 annual data surveys were 70 % and 65 %, respectively, which indicates that there is a stable MS response rate. In addition, Australia also reported data which are shown in the tables but not yet included in the summary statistics.

Donors, first-time donors and inhabitants: Table 1

The questionnaire requires data on donors ‘active during the year’, and must include only those donors who actually donated during the reporting year. In many establishments or countries, the query format on the donor database would thus need to be compliant. This may not yet always be the case. Therefore, it is not certain whether this requirement was always met in generating the data for this survey. Definitions have been largely addressed by the EC Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC).

The terms ‘regular and repeat donors’ are defined by EC Council Recommendation (98/463/EC) and these definitions apply to regular donors (i.e. donors whose last previous donation was less than 2 reporting years earlier) and for repeat donors (i.e. donors whose last previous donation was more than 2 reporting years earlier). The combined total of the two categories represents those donors who are known to the system or BE and, in many countries, form the basis and guarantee of continuity of the blood supply. These data are needed for the calculation of the prevalence of infectious diseases among new donors and the incidence of infectious diseases among repeat and regular donors (see Table 7). For European Union (EU) countries, the reporting of prevalence and incidence on these donor populations became mandatory in 2005 under Directive 2002/98/EC.

In this survey, the term ‘first-time tested donors’ includes all donors who are actually tested for the first time in the reporting year. ‘First-time donors’ includes all donors who donated for the first time in the reporting year. As some of these donors may also qualify as regular donors the total number of donors reported may be less than the sum of first time and regular and repeat donors. There are systems where ‘applicant donors’ (98/463/EC) are only tested and come back for a first donation later. They are known as ‘qualified donors’ when their applicant donor infectious disease tests are returned as negative. Only including ‘qualified donors’ in the report would generate a bias in reporting Infectious Disease Markers (IDM) (see Table 7). The term ‘new donors’ in EC Council Recommendation 98/463/EC does not specify this and allows for the exclusion of ‘non-qualified donors’. Therefore, in this survey, the term ‘first-time tested donors’ is used to include all donors who actually are tested for the first time in the reporting year, either at the time of donation or if they donate at a later stage.

It should be taken into account that ‘first-time donors’ are already a selected population and,

11

therefore, the prevalence of infectious disease markers in the general population of a given MS may be different. The ratio of first-time donors to the total number of donors in general reflects the annual donor recruitment or, more generally, the turn-over rate in the donor base. However, this figure may be influenced by recruitment programmes. The number of first-time donors, as compared to the total number of donors, becomes less meaningful in systems that only register donations and, even less so, only the (uniquely identifiable) donors.

Excluding MS where first-time donors and repeat plus regular donors were not reported separately, in 2013, 24 % (range 6-100 %) of the total donor base consisted of ‘first-time’ donors. It is known that first-time donors may have higher incidences of infectious diseases compared to regular or repeat donors (Schreiber et al., 2001).

The average number of donors in relation to the general population is 24 (range 3.0-56) per 1,000 inhabitants. This number may reflect the commitment of the population to donate blood in relation to demand. Differences exist but, in general terms, less than 10 donors per 1,000 inhabitants should really pose a problem with supply and around 30 donors per 1,000 inhabitants seems an achievable goal from the given data. Not surprisingly, there is a correlation between the number of donors per 1,000 inhabitants and the number of RBC units delivered to hospitals per 1,000 inhabitants (see Table 3). As stated before, some caution should be exercised in interpreting the number of ‘active’ donors, and ‘inactive’ donors may bias the database. However, maintaining ‘inactive’ donors in the database may be used as a strategy to ‘re-activate’ known donors.

Collection of Whole Blood, autologous blood and blood components: Tables 2.1 and 2.2

• Whole blood

Whole Blood (WB) collections are the basis of the blood supply in most countries; not only for the preparation of blood components, but also for the delivery of ‘recovered plasma’ as source material for the manufacture of medicinal products derived from human blood or plasma (see Table 4). The number of WB collections in the 32 MS reporting was, on average, 36 (range 4.2-66) per 1,000 inhabitants. Given the average use of RBC per 1,000 inhabitants (33 U, range 3.8-64 U, see Table 3), the number of WB donations collected appears to either conform to the demand for RBC components or determines their use in hospitals by limiting the supply.

• Autologous blood

Autologous donations are sometimes promoted as safer blood transfusions as they limit patients’ exposure to allogeneic blood and, also, as an enhancement of the blood supply. In general, enhancement of the blood supply does not appear to be substantial: in the 28 MS that reported data on autologous donations, they only contributed on average to around 0.2 % (range 0.0-2.7 %, median 0.01 %) of the WB donations. This is in agreement with the literature and previous reporting. However, it should be taken into account that surgery and anaesthesiology techniques, such as pre-operative haemodilution and intra-operative blood salvage, are not included in the data presented here. In this survey, only Pre-operative Autologous Blood Donations (PABD) were taken into account.

12

• Blood components (apheresis)

Plasmapheresis collections provide source plasma (including plasma with specific antibodies) for fractionation into medicinal products. In some countries plasma for transfusion (referred to as FFP) is also collected by apheresis donations. The volume of plasma collected by apheresis per 1,000 inhabitants reflects the volume of national plasmapheresis programmes. In the 30 reporting MS, on average 4.2 L (range 0.0-50 L, median 0.4 L) of plasma per 1,000 inhabitants was collected by plasmapheresis. The Czech Republic, Germany, Armenia and the Netherlands are prominent as countries with considerably more extensive plasmapheresis programmes, with 10 L or more of plasmapheresis plasma per 1,000 inhabitants per annum. Platelet apheresis may be aimed at Human Leucocyte Antigen (HLA) or Human Platelet Antigen (HPA) typed donations for refractory patients. It may also be used to replace the provision of platelets from pooled WB donations by apheresis platelets in order to reduce donor exposure in patients. The relative importance of platelet apheresis for the total supply of platelet components is given in Table 3. In the 26 reporting MS, on average 36 % (range 0.0-85 %, median 34 %) of the adult therapeutic doses of platelets were produced by apheresis. The vast range may reflect different blood management models, such as low access to HLA-typed platelet donors or MS striving towards 100 % platelet supply by apheresis.

RBC apheresis is a relatively new development and may be of particular interest for autologous programmes and for collections of RBC of rare blood types. It is primarily applied in Norway and Iceland with 1.7 %, 0.7% of all RBC collections respectively. Granulocyte apheresis donations are infrequent, as indications appear to be limited, with a maximum of 0.03% of all RBC collections in Sweden.

Use of blood and blood components for transfusion: Table 3

The term ‘the use of blood’ may be somewhat misleading as the reported data may not reflect the actual use of blood or blood components in the hospitals, but rather the number of blood components that have been distributed to hospitals by BE (see Directive 2002/98/EC for a definition). This depends on the source of the data and the national infrastructure. Data on actual use in hospitals is generally quite difficult to obtain in many MS; although in some countries, BE are hospital-based and the data provided can be related to actual transfusions issued. As component losses in hospitals are limited, the number of blood components delivered to hospitals represents an acceptable approximation of blood use estimates, and the heterogeneity of the given data may result in only minor deviations. Sixty-three percent (20/32) of the respondent MS indicated that the use of blood was expressed as the units distributed by BE, whereas 12 MS (38 %) reported it as transfused units.

WB “must be considered as a source material and has no, or only a very restricted, role in transfusion therapy” (Guide to the Preparation, Use and Quality Assurance of Blood and Blood Components, 17

th edition, 2013). However, in countries with limited resources, transfusion therapy

with WB may be needed when the infrastructure for blood component preparation is lacking. In 29 reporting MS, on average 4.2 % (range 0.0-100 %, median 0.01 %) of prescriptions of RBC transfusions by physicians were performed with WB. In Hungary WB accounted for 100 %, in

13

Montenegro for 13% and in Romania for 7% of the total volume of RBC components used.

The use of RBC per 1,000 inhabitants varied considerably. In 32 reporting MS, it averaged 33 RBC components per 1,000 inhabitants (range 3.8-64, median 35 units). Rejman (2000) suggested in his report on the 1997 survey that 40-60 WB donations per 1,000 inhabitants would be needed for optimal supply; a figure largely driven by the need for RBC for transfusion. Apparently, the use of RBC has been greatly reduced in the last decade. RBCs are mainly used in surgery, obstetrics, haematology and oncology care and, in some countries, programmes for ‘better use of blood’ or for ‘optimal use of blood’ have recently been installed in order to reduce unnecessary donor exposure to patients. Therefore, the use of 30 to 40 RBC U per 1,000 inhabitants could reflect the results of these programmes. In 4/32 (13 %) of the reporting MS, less than 20 RBC U per 1,000 inhabitants were used, which most likely reflects an insufficient blood supply or limited hospital care. A better benchmark may be achieved by including the number of hospital beds in a future survey and linking this figure to RBC use. The use of plasma for transfusion has been discouraged over the last decade, mainly because its clinical indications are limited and there is a greater need for plasma as a source material for fractionation into medicinal products. However, FFP transfusions are needed for multiple coagulation disorders, including Thrombotic Thrombocytopenic Purpura (TTP). In order to provide a benchmark, the use of plasma for transfusion can be related to the use of RBC transfusions (use of the FFP/RBC ratio). It should be taken into account that programmes for ‘better use of blood’ (e.g. RBC use) in some countries increased the FFP/RBC ratio by decreasing the rate of RBC use. On average, the FFP/RBC ratio was 0.41 (range 0.03-1.5, median 0.31, so almost one in three).

In Europe, platelets are generally recovered from 4-5 buffy-coats of WB donations. Discussions on blood safety in relation to Variant Creutzfeldt-Jakob disease (vCJD) have inspired programmes to enhance the use of random single-donor platelets by apheresis in order to reduce donor exposure to recipients. These programmes may have been influential in some MS where the use of apheresis platelets in relation to recovered platelets is relatively high. The extent to which donors are willing to undergo apheresis may be limited, as no supply reaches 100 % apheresis platelets. In the 26 reporting MS, on average 36 % (range 0.0-85 %, median 34 %) of the adult therapeutic doses of platelets were produced by single donor platelets by apheresis (Table 3). In 8 of 26 reporting countries (31 %), this volume amounted to more than 50 %.

Cryoprecipitate may incidentally be used for fibrinogen, Von Willebrand’s disease and complex coagulation disorders, though this component has largely been abandoned by most MS.

Plasma for fractionation: Tables 4.1 and 4.2

The total amount of plasma delivered for fractionation into medicinal products differed among MS. This variation was clearer when the figures were related to population size. In 29 of the reporting MS, there was an average yield of 9.1 L (range 0.0-54 L) per 1,000 inhabitants of plasma for fractionation into medicinal products. However, 2 of the 29 (6.9 %) reporting MS delivered 20 L or more plasma per 1,000 inhabitants.

In Europe, the main supply of plasma for fractionation was recovered plasma; in 11 reporting MS, on average, 71 % of the plasma for fractionation was from recovered plasma (range 11-

14

100 %, median 72 %).

Reporting on the use of medicinal products derived from human plasma was limited. The 17 MS that reported Factor VIII use indicated an average use of 34 x 106 IU (range 0.0 – 249 x 106 IU, median 4.0 x 106 IU). The average amount of polyvalent immunoglobulins used was 3,295 Kg (range 0.0-28,048 Kg, median 700 Kg) and the average amount of human albumin used was 5,088 Kg (range 0.0 – 35,379 Kg, median 1,139 Kg). In the 14 MS that manufactured immunoglobulins, for the 13 MS that reported the mode for usage, the average proportion of intravenous administration was 75% (range 0.0-100 %, median 87 %).

Special processing of blood components and pathogen reduction or quarantine of plasma: Tables 5.1 and 5.2

In 13/28 (46 %) of reporting MS, 100 % leucocyte-depletion of RBC components was carried out. This was the case for platelet concentrates in 16/28 (57 %) reporting MS. Complete (100 %) leucocyte-depletion was applied to plasma for transfusion in 9/22 (41 %) of the reporting MS.

Irradiation of blood components is carried out in order to prevent Graft Versus Host Disease (as a rule, this is relevant for blood components that may carry residual leucocytes) and for a selected group of recipients only. The numbers may reflect the extent of high clinical care; although, in many instances, irradiation is carried out in hospitals where it generally appears more difficult to obtain data.

FFP for transfusion, Cryosupernatant Plasma (CSP) and Cryoprecipitate (CP) may be additionally safeguarded against infectious diseases. One method is a quarantine step where the plasma is stored and only released if the donor is negative for IDM on a subsequent donation 4-6 months later. Another method is the application of ‘virus inactivation’ or ‘pathogen reduction’ by solvent detergent or methylene blue treatment. In 14/27 (52 %) of the reporting MS, nearly all FFP (>=99 %) were safeguarded by either method; in 7/25 (28 %) MS using mainly (>90 %) quarantine; in 4/26 (15 %) using mainly (>90 %) pathogen reduction technologies; and in 3/27 (11 %) using either method for the majority (>90%) of their products.

Screening for infectious markers and serological test methods: Tables 6.1 and 6.2

In all reporting MS, all donations were tested for anti-HIV-1/2, HBsAg and anti-HCV. In 29/32 (91 %) of these MS, all donations were tested for syphilis. Norway tests first time donations for syphilis only. It is still debated in the literature whether syphilis testing is necessary. Testing for anti-HTLV-I/II was performed on all donations in 5/32 (16 %) of the reporting MS, and only on first-time donors in 3/32 (9 %) MS.

Testing for anti-HBc was performed on all donations in 9/30 (30 %) reporting MS, and only on first-time donors in 4/30 (13 %) MS.

Testing of donations for HEV is only performed for the manufacture of plasma-derived medicinal products by France (structurally), the Netherlands (on indication) and Germany (optional). Confirmed seropositive donors and prevalence and incidence of infectious diseases: Tables 7.1 and 7.2

15

Given the limited positive predictive value of serological screening tests, donors who are found to be positive for IDM blood screening tests generally need to be ‘confirmed’ with another technique aimed at diagnosing infection. Confirmed positive donors are then notified and deferred from further donations. A typical flow-chart for confirmation is given in EC Council Recommendation 98/463/EC.

In Table 7.1, the absolute numbers of ‘confirmed positive’ donors reported among all first-time tested donors (see Table 1) and among all repeat tested donors (see Table 1) are given. Overall, 30 of 32 (94 %) MS that were able to provide the absolute numbers of positive donors provided confirmed positive infections for HIV, HBV and HCV, syphilis and/or HTLV-I/II (see Table 7.1).

• First-time tested donors

The frequency of ‘confirmed positive’ donors among all first-time tested donors yields the ‘prevalence’ of an IDM among first-time donors. This reflects the characteristics of the population from which first-time donors are recruited. It should be noted that the general population may have different rates of infectious diseases than blood donors. Even at the time of their first visit, blood donors are a selected population. The ‘prevalence’ of infectious diseases among first-time donors was calculated from Table 7.1 (number of confirmed positive donors) and Table 1 (number of first-time donors), and the ratio is given in Table 7.2.

The prevalence of infectious diseases per 100,000 first-time tested donors ranged from 0 to 240 for HIV-1/2, from 0 to 5,714 for HBV and 0 to 2,895 for HCV. Although considerable differences in the geographical distribution of these infections exist in Europe, it is questionable as to whether the extremely high frequencies in some countries reflect reliable data on actual ‘confirmed positive donors’ or, merely, represent repeat positive donors screened by Enzyme-Linked Immunosorbent Assay (ELISA) and, thereby, include many false positives. The geographical distribution of the high prevalence areas may coincide with low resources and a lack of confirmatory testing. Median prevalence estimates might be a more appropriate and robust reference for European prevalence of infectious diseases amongst first-time donors. The median prevalence amongst first time tested donors was 4.9, 85 and 64 per 100,000 donors for HIV-1/2, HBV and HCV, respectively.

• Repeat tested donors

The frequency of ‘confirmed positive’ donors (i.e. donors found to be positive for infectious diseases with confirmatory testing) among all repeat plus regular donors tested, yields the ‘incidence’ of an infectious disease among all ‘repeat tested donors’ (i.e. all donors who on a previous occasion had tested negative for an infectious disease). This ‘incidence’ accounts for the frequency with which repeat plus regular donors acquire a new infection. It is this frequency that directly relates to blood safety via the ‘window period’ of infectious disease testing (Schreiber et al., 1996, Guideline on Epidemiological data EMEA/CPMP/BWP/3794/03). The incidence of infectious diseases among repeat plus regular donors was calculated from the data in Table 7.1 (number of confirmed positive donors) and Table 1 (number of repeat plus regular donors), and is presented in Table 7.2. As with the data on prevalence for first-time tested donors, it cannot be completely excluded that extremely high incidence rates may refer only to repeat positive donors of ELISA screening instead of confirmed positive donors and, thereby, include many false positives. The geographical distribution of the high incidence areas coincides with high prevalence areas and

16

may be linked to low resources and a lack of confirmatory testing.

Notwithstanding the limitations of the data and the question as to whether all positive-screening test donors were submitted to confirmatory testing, the prevalence and incidence rates of infectious agents varied greatly among MS. Previous reports showed a Northwest-Southeast gradient in Europe, with HBV and HCV infections relatively infrequent in repeat donors in all North-Western countries. The 2013 data are in accordance with this gradient, although with no response from some of the mid-Eastern countries, they give a slightly different pattern. Highest incidence rates were found in the South/South-Eastern countries (Greece, Bulgaria, Moldova, Romania), and to a lesser degree in the Baltic States (i.e., Estonia and Latvia).

The incidence per 100,000 repeat tested donor years ranged from 0 to 13 for HIV-1/2, from 0 to 47 for HBV and 0 to 35 for HCV. The median incidence amongst repeat donors was 1.1, 0.9 and 1.9 per 100,000 donor years for HIV-1/2, HBV and HCV, respectively.

17

Nucleic Acid Amplification Techniques (NAT) testing and NAT-only confirmed positive donors: Tables 8.1 and 8.2

NAT testing for HIV was performed on each donation in 18/29 (62 %) of the reporting MS. NAT testing for HBV was performed on each donation in 16/28 (57 %) respondent MS. NAT testing for HCV was performed on each donation in 18/29 (62 %) of the MS. Although the cost-effectiveness (or ‘yield’) of NAT testing is expected to be higher in high incidence areas, especially in the MS with the highest incidence rates NAT testing is not implemented.

The ‘yield’ of NAT is defined as the identification of a NAT-positive donor, who is not found to be sero-positive for that virus in serological screening on the same donation, but is later shown to be a confirmed positive through detection from an additional NAT test on the same sample or by serology. The yield of NAT for HCV, HIV and HBV among first-time tested donors and among repeat donors is given in Table 8.2.

Bacterial screening: Table 9

Haemovigilance data have repeatedly shown the importance of bacterial safety of platelet concentrates. This is due to the fact that the storage temperature of platelets is around 22 oC, thus facilitating bacterial growth. Application of bacterial testing was reported by 20 MS (63 %). In 7/23 (30 %) reporting MS, bacterial culture was performed on 80 % or more of all platelets (concentrates recovered from both WB donations and apheresis platelets). Among the 18 MS that reported on the parameter, the average rate of confirmed positively-cultured platelet concentrates was 0.04 % (ranging from 0.0 to 0.26 %, median 0.01 %).

Organisation and registration: Table 10

All MS reported that there were legally-binding national regulations for the collection, testing, processing, storage and distribution of blood and blood components. In 29/32 (91 %) of the reporting MS, a National Council or Expert Committee advised the Ministry of Health on transfusion-related issues. In 28/32 (88 %) of the MS, there was a national policy on the quality and safety of blood and blood components. Of these 28 MS, 25 (89 %) had implemented the national blood policy or were in the process of doing so.

Quality management: Tables 11.1 and 11.2

In 28/32 (88 %) of the reporting MS, a QS was established and maintained by BE. In three MS, the implementation of such a system was planned, and one MS did not have or plan a QS. In 30/32 (94 %) reporting MS, inspections were performed at least every 2 years. The vast majority of these inspections (28/30, 93 %) were (partly) carried out by the national authority.

In 22/24 (92 %) of the reporting MS, all donations were covered by GMP. All MS reported that all donations were covered either by GMP, ISO 9000, local SOPs or other procedures. In six MS, donations were fully covered by both GMP and International Organization for Standardization (ISO) procedures. In total, 24/26 (92 %) reporting MS covered 100 % of donations by either of these procedures.

It is requested that labelling of donations and issued components is unique so as to allow full traceability. Labelling according to ISBT-128 for 100 % of the donation numbers was performed by

18

14/23 (61 %) of the respondent MS. In eleven MS, all donations were labelled under another system, but a combination of ISBT and other systems also occurred. Overall, labelling of all donations (either to ISBT standards or those of another system) was performed by all 29 reporting MS.

Labelling of the finished component code is more complex and, in general, lags behind in development as it includes implementation of automated applications in hospitals. ISBT-128 labelling of all issued components was performed by 11/21 (52 %) reporting MS. In 10/19 (53 %) MS, all components were coded using another system. Overall, all of the 24 reporting MS reported that all components were coded using either ISBT or another system.

Haemovigilance: Tables 12.1 and 12.2

Since 2004, this survey has presented data on haemovigilance, i.e. the reporting of serious adverse reactions. The format for data acquisition on haemovigilance was developed by CoE experts, submitted to the EC and adapted after slight modifications by the EC into Directive 2005/61/EC. Reporting of serious adverse reactions, as performed in haemovigilance programmes, can be considered as a high level of surveillance, as most of these serious reactions are not unexpected untoward effects but well-known complications of blood transfusion procedures from the medical literature and commonly indicated in the ‘information leaflets’ for physicians and patients. Most recipients of blood transfusions are very ill and have underlying pathology or medications that greatly influence the signs and symptoms of a possible transfusion reaction. A serious adverse reaction during or immediately after transfusion, even if it is most likely related to the transfusion procedure, may be restricted to the given recipient. Therefore, in this report, only those serious adverse reactions are presented that are probably or certainly (imputability grade 2 to 3, i.e. likely or certain) related to the transfusion of the blood component. The term ‘imputability’ includes the causal relationship to the component properties, but also to the transfusion itself (TACO) or to recipient properties (allergy). In contrast to the EC Directives 2002/98/EC and 2005/61/EC, haemovigilance data which may not be caused by blood component properties, such as TACO, are also reported here.

Of the reporting MS, 3/32 (9 %) indicated that they did not have a haemovigilance reporting system at a national level. In all but two of the MS that did have a reporting system, this system was associated with a national authority. Data on transfusion complications were provided by 28/32 MS (88 %). The incidence of serious adverse reactions with high imputability (level 2 to 3, i.e. likely or certain) can be calculated relative to the total number of blood components (whole blood + red blood cells + plasma + platelets) issued (or transfused). Taking the possibility of under-reporting and the differences in national reporting systems into account, an average incidence of 9.2 serious adverse reactions per 100,000 distributed blood components seems a reasonable estimate. The median estimate is 4.5 per 100,000 components distributed. Anaphylaxis, TACO and haemolysis were the most frequently reported serious adverse reactions.

19

REFERENCES • Council Recommendation 98/463/EC on the suitability of blood and plasma donors and the screening of donated blood in the European Community.

• Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

• Guide to the preparation, use and quality assurance of blood components, 17th edition, Council of Europe Publishing, Strasbourg, June 2013.

• Guideline on epidemiological data on blood transmissible infections, Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/BWP/548524/2008, April 2010.

• Guideline on Epidemiological data on Blood Transmissible Infections for inclusion in the Guideline on the Scientific data requirements for a Plasma Master File, Committee for Medicinal Products for Human Use (CHMP), EMEA/CPMP/BWP/3794/03, February 2004.

• Questionnaire on the collection, testing and use of blood and blood products in Europe, Council of Europe Publishing, Strasbourg, 22 May 2004, SP-HM (2002) 12.

• Rejman A. The collection and use of human blood and plasma in the non-European Union Council of Europe member states in 1997, Council of Europe Publishing, Strasbourg, 2000.

• Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion transmitted viral infections. The Retrovirus Epidemiology Study. N Engl J Med 1996; 334:1685-1690.

• Schreiber GB, Glynn SA, Busch MP, Sharma UK, Wright DJ, Kleinman SH. Retrovirus Epidemiology Donor Study. Incidence rates of viral infections among repeat donors: are frequent donors safer? Transfusion 2001;41:730-735.

• The Collection, Testing and Use of Blood and Blood Products in Europe in 2001, Council of Europe Publishing, Strasbourg, 2004.

20

TABLES List of countries that participated in the survey

Armenia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, Moldova, Montenegro, the Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, the United Kingdom, and Australia.

21

Qualitative report Survey 2013

Country Response questionnaires

Australia XAlbaniaAndorraArmenia XAustriaAzerbaijanBelgium XBosnia / HerzegovinaBulgaria XCroatia XCyprus XCzech Republic XDenmark XEstonia XFinland XFrance XFYR MacedoniaGeorgia XGermany XGreece XHungary XIceland XIreland XItaly XLatvia XLiechtensteinLithuaniaLuxembourg XMaltaMoldova XMontenegro XNetherlands XNorway XPoland XPortugal XRomania XRussian Federation XSan MarinoSerbiaSlovakia XSloveniaSpain XSweden XSwitzerland XTurkeyUkraineUnited Kingdom X

Response (excl. Australia) 32Response Rate 70%

22

Table 1Survey 2013

regular and repeat first time % first time % first time donors % first time donors total donors inhabitants donors perdonors donors donors donating tested only x 1,000 1,000 inhabitants

Australia 541 209 23 524 23,0AlbaniaAndorraArmenia 4 325 5 204 58,6 100 12 8 879 3 000 3,0AustriaAzerbaijanBelgium 234 411 52 891 18,4 100 0 287 302 11 150 25,8Bosnia / HerzegovinaBulgaria 125 757 34 643 21,6 100 0 160 400 7 246 22,1Croatia 86 136 14 092 14,1 100 100 228 4 285 23,4Cyprus 37 936 10 959 22,5 100 0 48 604 866 56,1Czech Republic 243 400 48 800 18,2 267 400 10 530 25,4Denmark 205 721 21 576 9,5 27 73 227 297 5 627 40,4Estonia 29 724 7 467 20,1 100 37 191 1 320 28,2Finland 131 976 14 221 9,7 100 0 146 197 5 451 26,8France 1 287 328 354 672 21,6 100 1 642 600 65 525 25,1FYR MacedoniaGeorgia 35 421 16 789 32,2 52 210 4 500 11,6Germany 2 381 385 484 892 16,9 83 17 2 866 277 80 767 35,5Greece 293 052 59 643 16,9 85 15 352 695 10 500 33,6Hungary 225 193 53 978 19,3 100 0 279 171 9 607 29,1Iceland 7 309 2 261 23,6 0 100 9 570 326 29,4Ireland 71 715 13 795 16,1 87 13 85 510 4 610 18,6Italy 1 442 715 374 576 20,6 73 27 1 817 291 59 685 30,4Latvia 33 276 9 148 27,5 100 364 33 276 2 000 16,6LiechtensteinLithuaniaLuxembourg 9 079 793 5,9 67 33 13 532 538 25,2MaltaMoldova 43 238 21 212 32,9 100 0 64 450 3 560 18,1Montenegro 8 601 5 234 37,8 100 13 835 626 22,1Netherlands 275 585 30 679 10,0 0 100 306 264 16 780 18,3Norway 97 825 15 593 15,9 0 100 97 825 5 109 19,1Poland 434 152 184 667 29,8 618 819 38 496 16,1Portugal 246 455 38 558 13,5 100 0 285 013 10 457 27,3Romania 105 423 100,0 100 19 528 5,4Russian Federation 1 036 167 566 848 35,4 1 603 015 143 116 11,2San MarinoSerbiaSlovakia 99 513 32 795 24,8 81 0 132 308 5 430 24,4SloveniaSpain 824 627 219 692 21,0 47 000 22,2Sweden 224 569 44 694 16,6 0 100 269 263 9 645 27,9Switzerland 194 773 28 067 12,6 100 0 222 840 8 140 27,4TurkeyUkraineUnited Kingdom 1 026 167 180 543 15,1 95 2 1 198 314 64 100 18,7

CountryAustraliaDenmark

Italy

PolandRomania empty fields: data not available

First time donors: 2013 numbers are exact. In previous years the numbers were not exact and may have included a number of persons that were registered as donors but never were bled

Donors, first time donors and inhabitants

Country

Comments

points 12 and 13: no data available on first time donors giving blood samples for testing only.

If the collection of data on donors is aimed at calculating prevalence and incidence rates, we would propose to collect data on "first-time tested" and "repeat-tested" donors, according to Plasma Master File procedures.

Information for questions 9-13 was not available at the time of submission

23

Table 2.1Survey 2013

whole blood whole blood per autologous % autologous plasma plasma in L per platelets RBC granulocytes multi-componentunits 1,000 inhabitants units whole blood units apheresis (L) 1,000 inhabitants apheresis (U) apheresis (U) apheresis (U) apheresis (U)

Australia 783 344 33,3 421 0,05 0 0 0 35 723AlbaniaAndorraArmenia 12 616 4,2 0 0,00 43 600 14,5 18AustriaAzerbaijanBelgium 496 288 44,5 36 0,01 62 349 5,6 12 558 1 698 94 17 009Bosnia / HerzegovinaBulgaria 166 912 23,0 96 0,06 233 0,0 1 323 0 0Croatia 180 411 42,1 270 0,15 684 0,2 3 277 3 277Cyprus 57 323 66,2 3 0,01 0 0,0 152 0 0 0Czech Republic 413 300 39,2 11 200 2,71 530 700 50,4 17 900 1 800Denmark 290 400 51,6 0 0,00 2 935 0,5 1 984 0 5 0Estonia 59 189 44,8 0 0,00 1 101 0,8 105 139 0 710Finland 222 831 40,9 0 0,00 2 422 0,4 939 0 0 0France 2 608 622 39,8 601 0,02 112 789 1,7 4 990 0 229 128 698FYR MacedoniaGeorgia 57 128 12,7 0 0,00 0 0,0 20 0Germany 4 631 290 57,3 9 428 0,20 1 952 829 24,2 195 347 14 705 616 25 090Greece 546 968 52,1 487 0,0 20 823 63 2 800Hungary 411 550 42,8 3 398 392Iceland 11 669 35,8 0 0,00 140 0,4 690 71 0 0Ireland 136 361 29,6 0 0,00 0 0,0 11 402 0 0 0Italy 2 633 175 44,1 50 852 1,93 233 260 3,9 10 666 571 258 84 731Latvia 52 015 26,0 0 0,00 0 0,0 1 887 0 0LiechtensteinLithuaniaLuxembourg 20 332 37,8 66 0,32 2 338 4,3 527 0 0 0MaltaMoldova 71 663 20,1 69 0,10 4 545 1,3 0 0 0 0Montenegro 16 603 26,5 0 0,00 0 0,0 0 0 0 0Netherlands 459 844 27,4 26 0,01 176 917 10,5 3 878 12 0 0Norway 193 812 37,9 9 0,00 3 137 0,6 5 622 3 220 0 501Poland 1 175 274 30,5 1 325 0,11 13 215 0,3 33 164 158 116Portugal 356 281 34,1 553 0,16 0 0,0 4 802 732 4Romania 428 140 21,9 8 612 0Russian Federation 2 212 901 15,5 345 565 2,4San MarinoSerbiaSlovakia 210 845 38,8 838 0,40 45 0,0 5 466 32 36SloveniaSpain 1 698 097 36,1 6 551 0,39 19 796 0,4 2 465 628 0 25 842Sweden 450 918 46,8 56 0,01 24 525 2,5 8 547 1 264 124Switzerland 324 024 39,8 1 116 0,34 1 156 0,1 17 224 323 0 7 667TurkeyUkraineUnited Kingdom 2 110 117 32,9 8 0,00 139 0,0 132 275 0 14 0

CountryAustralia

BelgiumCzech RepublicFrance

Georgia

GermanyMontenegroRomaniaSwitzerland

apheresis collectionsCollection of whole blood, autologous blood and blood (apheresis) components

whole blood collections

Comments

The data is kindly provided by Georgian National Centre of Disease Control (NCDC). The automated donor apheresis procedures did not exist in Georgia till 2014. Therefore, the number 20 in paragraph 31, might be incorrect. Probably, the facility reported to NCDC did not know the definition of "apheresis procedure". (Levan Avalishvili).

WB donations incl. "autologeous WB donations"multi-components donations are donations of platelets and plasma

Detail for question 34:103 854 Plasma/platelets2 738 Platelets/red cells22 106 Plasma/platelets/red cells

Question 18: Number of whole blood donations that commenced collection. Question 34: Number of apheresis donations collecting platelets and plasma. Information for questions 28 and 29 was not available at the time of submission.

the number given for plasma apheresis donations in liters is an estimate: the number of procedures is multiplicated with 360 ml (as units collected may vary between 120-600ml)empty fields: data not available

Country

Collection of blood and blood components by apheresi procedures are not performed in Montenegro during 2013.Family / Replacement donations are not allowed.

24

Table 2.2Survey 2013

plasmapheresis donations

platelet apheresis

Country% voluntary, non-

remunerated% from

replacement donors

% from autologous

donors

% voluntary, non-remunerated

% from autologous

donors

% voluntary, non-remunerated

% voluntary, non-remunerated

Australia 100 0 0,05 0 0AlbaniaAndorraArmenia 3 33 0,00AustriaAzerbaijanBelgium 100 0 0,01 100 0,00 100 100Bosnia / HerzegovinaBulgaria 28 72 0,06 0Croatia 100 0,15 100 100Cyprus 100 0,01 0 100Czech Republic 100 0 2,71Denmark 100 0 0,00 100 100 100Estonia 100 0 0,00 100 0,00 100 100Finland 100 0 0,00 0 100 100France 100 0 0,02 0 100FYR MacedoniaGeorgia 22 27 0,00Germany 100 0 0,20 100 7,45 100 100Greece 49 51 95 48 65Hungary 100 100 100Iceland 100 0 0,00 100 0,00 100 100Ireland 100 0 0,00 0 100Italy 100 0 1,93 100 7,53 100 100Latvia 100 0 0,00 0LiechtensteinLithuaniaLuxembourg 100 0 0,32 0 100 100MaltaMoldova 48 51 0,10 0 93 0Montenegro 33 67 0,00 0 0Netherlands 100 0 0,01 100 0,00 0 100Norway 100 0 0,00 100 0,00 100 100Poland 99 7 0,11 100 0,00 92 98Portugal 100 0 0,16 100 0,00 100Romania 100 100Russian Federation 96San MarinoSerbiaSlovakia 100 0 0,40 100 0,00 100 100SloveniaSpain 100 0 0,39 100 288,69 100 100Sweden 100 0 0,01 100 100 100Switzerland 100 0 0,34 100 0,62 100 100TurkeyUkraineUnited Kingdom 100 0 0,00 100 100 100

CountryAustralia

Czech RepublicFrance

Georgia

GermanyMontenegro Collection of blood and blood components by apheresi procedures are not performed in Montenegro during 2013.

The data is kindly provided by Georgian National Centre of Disease Control (NCDC). The automated donor apheresis procedures did not exist in Georgia till 2014. Therefore, the number 20 in paragraph 31, might be incorrect. Probably, the facility reported to NCDC did not know the definition of "apheresis procedure". (Levan Avalishvili).

Detail for question 34:103 854 Plasma/platelets2 738 Platelets/red cells22 106 Plasma/platelets/red cells

WB donations incl. "autologeous WB donations"

Profile of donations

whole blood donations red cell apheresis

Comments

Family / Replacement donations are not allowed.

Question 18: Number of whole blood donations that commenced collection. Question 34: Number of apheresis donations collecting platelets and plasma. Information for questions 28 and 29 was not available at the time of submission.

25

Table 3Survey 2013

Transfused or whole blood % whole blood red blood cell r.b.c. (U) per plasma for plasma for transfusion platelets platelets platelets % platelets by cryoprecipitatedistributed (U) of total RBCs concentrates (U) 1,000 inhabitants transfusion (U) per 1,000 inhabitants (U) total (U) recovered (U) apheresis (U) apheresis (10^6 IU FVIII)

Australia Distr. 0 0,00 703 358 29,9 132 228 5,6 130 598 80 504 50 094 38,4 90 236AlbaniaAndorraArmenia Trans. 0 0,00 11 387 3,8 11 056 3,7 2 065 2 047 18 0,9 680AustriaAzerbaijanBelgium Trans. 0 0,00 462 653 41,5 82 761 7,4 69 373 33 040 36 333 52,4 0Bosnia / HerzegovinaBulgaria Distr. 329 0,19 172 833 23,9 95 217 13,1 7 152 4 582 2 570 35,9 0Croatia Distr. 173 0,10 177 684 41,5 97 448 22,7Cyprus Distr. 0 0,00 55 235 63,8 20 032 23,1 4 947 4 412 152 3,1 0Czech Republic Trans. 637 0,17 368 367 35,9 165 092 15,7 36 049 8 614 27 435 76,1Denmark Trans. 0 0,00 269 696 47,9 55 158 9,8 34 370 33 051 1 319 3,8 1Estonia Distr. 49 0,08 57 860 43,9 22 515 17,1 7 430 5 863 1 567 21,1 1 602Finland Distr. 0 0,00 210 790 38,7 41 283 7,6 38 132 36 924 1 208 3,2 0France Distr. 0 0,00 2 498 328 38,1 398 918 6,1 306 242 158 173 148 069 48,4 0FYR MacedoniaGeorgia Distr. 50 795 11,3 49 800 11,1 8 208 20Germany Distr. 2 513 0,06 4 396 885 54,6 1 019 069 12,6 578 442 223 026 355 416 61,4 0Greece Distr. 403 482 38,4 188 846 18,0 116 378 20 823 0Hungary Distr. 418 854 99,78 908 43,7 90 196 9,4 90 196 184 083 3 398 3,8 0Iceland Trans. 0 0,00 10 822 33,2 4 146 12,7 2 098 891 1 207 57,5 0Ireland Distr. 4 0,00 128 973 28,0 19 099 4,1 22 626 3 473 19 153 84,7 167Italy Trans. 726 0,03 2 482 473 41,7 379 966 6,4 213 689 143 576 70 117 32,8 2 279Latvia Distr. 0 0,00 49 970 25,0 31 400 15,7 7 600 3 928 3 672 48,3 8 610LiechtensteinLithuaniaLuxembourg Distr. 0 0,00 19 721 36,8 5 957 11,1 2 481 1 816 674 27,2 0MaltaMoldova Trans. 90 0,21 41 914 11,8 61 176 17,2 0 8 193 0 11 012Montenegro Trans. 1 947 12,90 13 141 24,1 9 597 15,3 843 843 0 0,0 631Netherlands Distr. 88 0,02 452 819 27,0 67 772 4,0 57 501 52 199 5 302 9,2 0Norway Trans. 96 0,05 184 257 36,1 48 130 9,4 26 039 18 227 7 812 30,0Poland Distr. 61 0,01 1 132 466 29,4 359 662 9,3 106 327 64 867 41 460 39,0 18 156Portugal Trans. 0 0,00 338 621 32,4 9 627 0,9 39 523 34 112 5 411 13,7 1 190Romania Distr. 30 310 7,08 397 702 21,9 291 024 14,9 34 767 24 941 9 826 28,3 21 884Russian Federation Distr. 582 0,04 1 642 159 11,5 1 783 088 12,5 145 419San MarinoSerbiaSlovakia Distr. 448 0,23 192 050 35,6 86 914 16,0 17 937 6 661 11 276 62,9 0SloveniaSpain Trans. 122 0,01 1 586 811 33,8 187 842 4,0 200 923 1 901Sweden Trans. 0 0,00 464 466 48,2 69 265 7,2 52 604 33 667 18 937 36,0Switzerland Distr. 287 677 35,3 44 083 5,4 34 122 9 846 24 276 71,1 0TurkeyUkraineUnited Kingdom Distr. 5 0,00 2 020 300 31,5 269 658 4,2 314 263 59 663 254 630 81,0 164 364

CountryFrance

GeorgiaGermany

Ireland

NorwayPolandSwitzerlandUnited Kingdom

Country

494 lyophilised plasma units (Army Blood Transfusion Center only)229 apheresis granulocytes concentratesThe data regarding Whole Blood transfusions not available, though they took place. Usually, average 5% of all transfusions are WB transfusions each year. (Levan Avalishvili).Total number of whole blood units covers only autologous blood.Number of plasma units (plasma or FFP) for transfusion covers quarantined FFP and lyophilised plasma units, transfused SD-plasma units reported by users and autologous plasma units (0.7% autologous of total).Cryoprecipitate not in use.98.9% of plasma issued is SD-Plasma.167 single units of cryo issued. Most fibrinogen replacement is with fibrinogen concentrate:5095 fibrinogen concentrates(1 gm, Riastap) were issued

cryoprecipitate unitsQuestion # 45 incorrect automatic percentage calculation. No whole blood is used for allogenic transfusion.Question # 48 incorrect ratio calculationFigures given are for the number of units of clinical cryoprecipitate, either as single units or pools of 5.

Comments

Use of blood and blood components for transfusion

All plasma for transfusion is Octaplas 200 ml.

26

Table 4.1Survey 2013

plasma for plasma for fractionation volume fractionation Plasma for fractionation into FVIII % fractionation plasma % fractionation plasma plasma for transfusion plasma for transfusion /fractionation (L) per 1,000 inhabitants (L) plasma into FVIII recovered from whole blood

donations (litres)recovered from WB from plasmapheresis per 1,000 inhabitants (U) total red blood cell ratio

Australia 531 981 22,6 5,6 0,19AlbaniaAndorraArmenia 3,7 0,97AustriaAzerbaijanBelgium 175 884 15,8 174 186 113 535 65,2 34,8 7,4 0,18Bosnia / HerzegovinaBulgaria 14 655 2,0 0 13,1 0,55Croatia 18 715 4,4 22,7 0,55Cyprus 0 0,0 0 0 23,1 0,36Czech Republic 573 100 54,4 573 077 64 418 11,2 88,8 15,7 0,44Denmark 58 890 10,5 58 890 58 890 100,0 0,0 9,8 0,20Estonia 10 663 8,1 17,1 0,39Finland 60 370 11,1 0 0 7,6 0,20France 784 844 12,0 772 082 735 959 95,3 4,7 6,1 0,16FYR MacedoniaGeorgia 11,1 0,98Germany 3 022 599 37,4 3 002 993 1 120 441 37,3 62,7 12,6 0,23Greece 43 0,0 18,0 0,47Hungary 90 196 9,4 90 196 90 196 100,0 9,4 0,21Iceland 0 0,0 12,7 0,38Ireland 0 0,0 0 0 4,1 0,15Italy 768 920 12,9 701 295 505 725 72,1 27,9 6,4 0,15Latvia 3 800 1,9 15,7 0,63LiechtensteinLithuaniaLuxembourg 6 800 12,6 6 800 4 859 71,5 28,5 11,1 0,30MaltaMoldova 3 904 1,1 0 0 17,2 1,45Montenegro 15,3 0,64Netherlands 307 272 18,3 272 474 133 464 49,0 51,0 4,0 0,15Norway 54 000 10,6 9,4 0,26Poland 221 068 5,7 9,3 0,32Portugal 0 0,0 0 0 0,9 0,03Romania 0 0,0 0 0 14,9 0,68Russian Federation 148 011 1,0 12,5 1,09San MarinoSerbiaSlovakia 18 314 3,4 18 314 18 314 100,0 0,0 16,0 0,45SloveniaSpain 370 659 7,9 4,0 0,12Sweden 116 625 12,1 116 625 93 300 80,0 20,0 7,2 0,15Switzerland 94 748 11,6 0 0 5,4 0,15TurkeyUkraineUnited Kingdom 0 0,0 0 0 4,2 0,13

CountryAustraliaArmeniaCroatia

CyprusEstoniaGermany

Luxembourg

NorwayRomaniaSwitzerland

Plasma for fractionation into medicinal products

Country

The amount of plasma for different plasmaderivates is not appointedIn Cyprus we do not manufacture medicinal products from blood.

Plasma for fractionation was processed and freezed in between 24 and 72 hours of donation. All plasma was delivered to Institute of Immunology (Croatia, Zagreb). From that plasma Institute manufactured only albumin and immunoglobulines. In July 2013 Institute lost his Licence and all plasma fractionation in Croatia was stopped.

Mentioned data relate to plasma intended for preparation of anti D immunoglobulin

CommentsOther information not available at the time of submission.

the number given for plasma apheresis donations in liters is an estimate: the number of procedures is multiplicated with 360 ml (as units collected may vary between 120-600ml)No contract for plasma fractionationWe sell the plasma and do not know how it is used.

We sail all our plasma to Octapharma for:- the production of FFP A and O (toll manufacturing agreement)- The production of albumin and IG (contract between hospitals and Octapharma)

Data on the amount of plasma for fractionation of factor VIII are not collected separately. The number therefore indicates the amount of plasma delivered for manufacture of plasma derivatives except for plasma for manufacturing of specific immunoglobulines.Data not available to other component units.

27

Table 4.2Survey 2013

Polyvalent (kg) Intravenous (%) Subcutaneous plus intramuscular (%)

AustraliaAlbaniaAndorraArmeniaAustriaAzerbaijanBelgiumBosnia / HerzegovinaBulgariaCroatiaCyprus 0 0 0Czech Republic 32 327 83 17 1 139Denmark 31 652 60 40 1 761Estonia 4 18 50 50 253FinlandFrance 7 668 87 13FYR MacedoniaGeorgiaGermany 249 5 904 91 9 17 049Greece 0HungaryIceland 0IrelandItaly 133 4 073 91 9 35 379LatviaLiechtensteinLithuaniaLuxembourg 2 29 100 0 12MaltaMoldova 0 28 048 0 100 906MontenegroNetherlands 15 1 075 93 7 1 200Norway 5 362 71 29 886PolandPortugalRomaniaRussian FederationSan MarinoSerbiaSlovakia 34 249 93 7 935SloveniaSpain 69 2 573 12 267Sweden 3 1 001 63 37 2 581Switzerland 2 747 96 4 1 958TurkeyUkraineUnited Kingdom 0 0 0

CountryAustraliaArmeniaBulgariaCroatiaCyprus

Luxembourg

Moldova

NetherlandsNorwayPortugalRomaniaSwitzerlandUnited Kingdom

No data

These are estimated numbers.

Use of medicinal products derived from human plasma

CountryFVIII (excluding cryo and excluding recombinant)

(10^6 IU)

Human albumin (kg)

Immunoglobulins (kg)

We measure anti D immunoglobulin in doses. 1 dose contain 385IU active substance

Comments

The amount of immunoglobulin is indicated in doses.The amount of albumin is indicated in liters

The low quantity of albumin is the result of a negociation during several months for a contract between CTS/hospitals/Octapharma.FVIII recombinant: 1176000 UI

Because in Cyprus we do not produce medicinal products we import those needed. As a result the blood establishment and the blood banks are not informed on the kind and the amount of those used by the clinics.

Complete and accurate data are not available.

Information for questions 61-65 was not available at the time of submission.

No data. Supplied to hospitals directly from the manufacturer.Exact numbers for Factor VIII are 2 454 000 IU and for Albumin 1 957 955 gdata not availableInformation not availableThe hospital buys these products from the fractionator or the pharmacies.

28

Table 5.1Survey 2013

red blood cells plasma for transfusion plateletsleuco depleted % irradiated % leuco depleted % irradiated % leuco depleted % irradiated % path.inact. %

Australia 100 0 0 100 100 0AlbaniaAndorraArmeniaAustriaAzerbaijanBelgium 100 3 100 0 100 2 45Bosnia / HerzegovinaBulgaria 16 0 3 0 8 0 0Croatia 61 1 90 2Cyprus 100 10 7 0 100 18 0Czech Republic 30 6 0 1 95 42 0Denmark 100 4 1 0 100 25 0Estonia 9 4 0 0 69 29 2Finland 100 4 100 0 100 38 0France 100 100 100 8FYR MacedoniaGeorgiaGermany 100 5 0 100 41 0Greece 35 19 39 14 75 32 0Hungary 13 8 10 45Iceland 93 16 10 2 100 0 100Ireland 100 16 100 100 100 0Italy 32 5 2 0 18 61 4LatviaLiechtensteinLithuaniaLuxembourg 100 1 100 0 100 6 0MaltaMoldova 0 0 0 0 0 0 0MontenegroNetherlands 100 1 100 0 100 30 0Norway 100 4 100 41 12Poland 13 6 84 57 12Portugal 100 0 0 100 17Romania 3 28 0 0Russian Federation 32 1 22 38 4 8San MarinoSerbiaSlovakia 90 58 0SloveniaSpain 98 6 71 0 100 47 0Sweden 86 5 100 100 52 17Switzerland 100 2 100 0 100 0 100TurkeyUkraineUnited Kingdom 100 9 100 8 100 57 0

CountryCroatiaGeorgiaGermany

IrelandItalyLuxembourgMontenegroNorwayPolandRomaniaSwitzerlandUnited Kingdom

Lekocite depleted and irradiated RC and PLT are prepared in specific cases only.All the plasma for transfusion is FFP treated by solvant détergeant (Octaplas-LG)Plasma for transfusion pathogen reduced does not include S/D inactivated plasma (pharmaceutical)

Special processing of blood components

Country

most fibrinogen replacement is with fibrinogen concentate

Comments

Data on leukocyte depleted plasma for transfusion are not collected.Cryoprecipitate reduced plasma components and Cryoprecipitate: Not in use.

Paragraph 69: In 2013, there were 185 units of Leukocyte Depleted Red Cells produced. It's less than 1%. So, entry is not possible.In Croatia, there is no decision at national level for universal pre-storage leucodepletion of blood components.

Methylene Blue treated plasma and cryoprecipitate is imported.Quarentined Plasma 99.8% and Pathogen inactivated plasma is 0.02% - Your Survey does not allow comma useempty fields: data not availablePlasma distributed by Blood Establishments to hospitals and institutions All plasma for transfusion is Octaplas 200 ml.

29

Table 5.2Survey 2013

fresh frozen plasma cryoprecipitate reduced plasma cyroprecipitatequarantined % virus inactivated % quarantined % virus inactivated % quarantined % virus inactivated %

Australia 0 0 0 0 0 0AlbaniaAndorraArmenia 63 100AustriaAzerbaijanBelgium 0 100 0 0 0 0Bosnia / HerzegovinaBulgaria 100 0 0 0 0 0CroatiaCyprus 0 0 0 0 0 0Czech Republic 100 1Denmark 0 0 1 0 0 0Estonia 0 0 0 0 0 0Finland 0 100 0 0 0 0France 38 62FYR MacedoniaGeorgiaGermany 96 4 0 0 0 0Greece 23 8HungaryIceland 0 0 0 0 0 0Ireland 0 99 0 0 0 0Italy 4 11 0 0 0LatviaLiechtensteinLithuaniaLuxembourg 0 0 0 0 0 0MaltaMoldova 0 0 0 0 0 0MontenegroNetherlands 100 0 0 0 0 0Norway 100Poland 92 7 92 0Portugal 12 88 0 0 100 0Romania 0 0 0Russian Federation 93 7San MarinoSerbiaSlovakia 56 0 0 0 0 0SloveniaSpain 30 70 80 20 66 34Sweden 0 4Switzerland 99 0 0 0 0 0TurkeyUkraineUnited Kingdom 0 3 0 0 0 5

CountryCroatiaGeorgiaGermany

IrelandItalyLuxembourgMontenegroNorwayPolandRomaniaSwitzerlandUnited Kingdom

Inactivation or quarantine of plasma

Country

In Croatia, there is no decision at national level for universal pre-storage leucodepletion of blood components.Comments

Plasma for transfusion pathogen reduced does not include S/D inactivated plasma (pharmaceutical)most fibrinogen replacement is with fibrinogen concentate

Paragraph 69: In 2013, there were 185 units of Leukocyte Depleted Red Cells produced. It's less than 1%. So, entry is not possible.Data on leukocyte depleted plasma for transfusion are not collected.Cryoprecipitate reduced plasma components and Cryoprecipitate: Not in use.

Methylene Blue treated plasma and cryoprecipitate is imported.

All the plasma for transfusion is FFP treated by solvant détergeant (Octaplas-LG)

Quarentined Plasma 99.8% and Pathogen inactivated plasma is 0.02% - Your Survey does not allow comma useempty fields: data are not available for the % of quarantied plasma; with regards to incativation, no method is currently in use in ROPlasma distributed by Blood Establishments to hospitals and institutionsAll plasma for transfusion is Octaplas 200 ml.Lekocite depleted and irradiated RC and PLT are prepared in specific cases only.

30

Table 6.1Survey 2013

anti- HIVAg HBsAg Anti-HBc anti-HCV HCVAg anti- Syphilis Malaria Anti-HEV OtherHIV 1+2 HTLV I/II

Australia 100 0 100 100 0 100 100 8 0AlbaniaAndorraArmenia 100 100 100 100 100 0 0 100 0 0 Brucelliosis: Testing every donation. AustriaAzerbaijanBelgium 100 0 100 First 100 0 0 100 0Bosnia / HerzegovinaBulgaria 100 100 100 0 100 100 0 100 0 0Croatia 100 100 100 0 100 0 0 100 0 0Cyprus 100 100 100 0 100 100 0 100 0 0 : Testing 4%. Czech Republic 100 100 100 5 100 35 0 100 0 0Denmark 100 100 100 First 100 0 0 0 0Estonia 100 100 100 0 100 0 0 100 0 0Finland 100 100 100 0 100 0 0 100 0 0France 100 0 100 100 100 0 100 100 0FYR MacedoniaGeorgia 100 0 100 0 100 0 0 100 0 0Germany 100 100 100 100 0 0 100 0 0Greece 100 0 100 5 100 0 100 100 0Hungary 100 100 100 First 100 0 0 100 0 0Iceland 100 100 100 0 100 0 0 0 0Ireland 100 0 100 100 100 0 100 100 0 0 anti-CMV: Testing 80%. Italy 100 74 100 0 100 0 0 100 0 0Latvia 100 0 100 0 100 0 0 100 0 0LiechtensteinLithuaniaLuxembourg 100 100 100 100 100 0 4 100 7 0 anti-CMV IgG: Testing 1%. MaltaMoldova 100 100 100 100 100 0 0 100 0 0Montenegro 100 100 100 100 0 100 0 0Netherlands 100 0 100 100 100 0 First 100 0 0 Anti-Parvovirus B19 IgG: Testing 5%. Anti-CMV IgG:

Testing 0%. Norway 100 100 100 50 100 0 0 First 1 0Poland 100 100 0 100 0 0 100 0 0 Parvovirus B19 DNA: Testing 10%. RNA HAV:

Testing 10%. Portugal 100 100 100 100 0 First 100 3 0Romania 100 100 0 100 100 100 0 0 ALT: Testing every donation. Russian Federation 100 100 100 0 100 0 0 100 0 0 ALT: Testing every donation. San MarinoSerbiaSlovakia 100 100 100 100 100 0 0 100 0 0SloveniaSpain 100 0 100 0 100 0 30 100 1 0 Chagas disease: Testing 3%. Sweden 100 100 100 First 100 0 First 100 0 0Switzerland 100 100 100 100 0 100 0 NAT Parvo virus B19: Testing every donation. NAT

HAV: Testing every donation. TurkeyUkraineUnited Kingdom 100 100 100 1 100 0 100 100 1 0 Chagas' Disease: Testing 1%. Anti-CMV: Testing

30%.

Country

Type of test

Donation testing strategy for infectious agents

31

CountryAustralia

ArmeniaBelgiumCroatiaCzech RepublicDenmark

FinlandFrance

Germany

GreeceIcelandIrelandLuxembourg

MontenegroNetherlands

Norway

PolandRomaniaSpainSwitzerland

United Kingdom

anti-CMV: first time and previous CMV seronegative;Malaria: 37 tests, only if donor has travelled to malaria areas;Anti-HBc: Testing when required and in the investigation of Occult HBV; Malaria: Screening in less than 1% in the affected areas; WNV-RNA: In affected areas;

HIV Ag: No data. Antigen-Tests and Antibody-Antigen-Combitests for HIV-1/2 are used by some of the blood establishments.; HBsAg: Persons, tested positive for anti-HBc, can further donate blood if a sensitive assay for HBV-Genom results negative and if anti-HBs antibody-titer stays above 100 IU/l.; Anti-HTLV: Not mandatory. Anti-HTLV I/II screening tests are used by some of the blood establishments.; Syphilis: Not required for donations of plasma for fractionation.; HEV: Not mandatory. Anti-HEV screening tests are used by some of the blood establishments.;

Malaria: If necessary (Individuals who have lived in a malaria area or with history of undiagnosed febrile illness, visitors to endemic areas...); Chagas disease: If necessary (Individuals who have lived in a Chagas area or with history of Chagas disease or visitors to endemic areas, and mother of the donor born in endemic areas); Other tests can be added according to specific therapeutic indications: The tests listed above are the minimum laboratory tests required by the French regulation for blood donation. Other tests can be added according to specific therapeutic indications: detection of anti-CMV antibodies; Parvo B19 and HAV NAT for source plasma for fractionation...;

Anti-HBc: anti-HBc is a confirmatory assay for HBsAg or HBV-NAT positive; Malaria: Based on risk assesment (377 tests in 2013);

Anti-HBc: Anti-HBc screening of first time donors was implemented in Denmark in 2012; Anti-HTLV: Anti-HTLV I/II testing of first time donors was stopped by the end of 2011; Malaria: Only after stay in malaria area in 1) persons with fever during/after stay in a malaria area and 2) persons born/raised in a malaria area;

Malaria: In case of history of malaria or stay in endemic region; anti-CMV: very small % of red cells and platelets tested;We also do testing of Alaninaminotransferasa (ALT)

Comments

HIV Ag: HIV Ag/Ab combined test; Anti-HBc: few BEs screen first time donors; HCV Ag: some BEs use HCV Ag/Ab combined test;Anti-HIV: HIV testing is performed with HIV Ag/Ab Combo; HIV Ag: HIV testing is performed with HIV Ag/Ab Combo;

Syphilis: Treponema Pallidum Haemaglutination Assay; Malaria: Malarial antibody testing on donors who have travelled or resided in a malaria risk area, or have had a past malarial infection.; CMV: CMV testing on repeat donors;

Anti-HIV: Screened using HIV Ab/Ag combo assay for NHSBT, SNBTS and WBS; HIV Ag: Screened using HIV Ab/Ag combo assay for NHSBT, SNBTS and WBS; Anti-HBc: Donors that have had body piercing between 4 and 12 months ago; or history of jaundice or hepatitis; or contact with a person with hepatitis B; or a procedure involving flexible endoscopy 4-6 months ago; Malaria: Testing for donors who have been resident for 6 months in a malarial area and it is 6 months since their return. Ever had malaria diagnosed and 3 years since anti-malarial therapy completed and symptoms resolved. Ever had a fever which may have been malaria whilst in a malaria area or 6 months since return from the area. Between 6 and 12 months since return from a malarial endemic area.; Chagas' Disease: If at least 6 months following the date of last exposure (i.e stayed in rural south or central America fro >4 weeks, or received a transfusion there prior to 1980, or donor or their mother was born in south or central America) Accept if validated test for T .cruzi antibody is negative.;

HIV Ag: Not mandatory but all blood establishments use this screening test regularly using Ag-Ab combination tests. NAT HIV is tested at every donation,; Anti-HBc: Not mandatory but at least included in confirmatory testing and in unclear situations; HCV Ag: Not mandatory but some regional blood establishments use this screening test regularly using Ag-Ab combination tests. NAT HIV is tested at every donation,; Malaria: Donor at risk; Chagas: Donor at risk; CMV: Not mandatory, nevertheless tested in some regions for supply of immuno-deficient patients and neonates; NAT Parvo virus B19: Mandatory only for all plasma Units sent for fractionation.; NAT HAV: Mandatory only for all plasma Units sent for fractionation.; data on % of donations tested are not available for tests under "other testing strategy"

Anti-HTLV: Selective testing in most of blood Establishments; Malaria: Selective testing;

Anti-HBc: All blood donations were routinely tested for the presence of anti-HBc; donations positive for anti-HBc antibodies were then investigated for anti-HBs; donations showing anti-HBs levels <200 mIU/mL were not released for clinical or manufacturing use.; Anti-HTLV: As of July 2013, new donors only were tested for anti-HTLV I/II antibodies; until then, universal screening of all donated blood and blood components had been in place.; Malaria: Malaria antibody screening was performed for (re)entry purposes of blood donor candidates who gave a history of malaria and/or had lived in a malaria area for a continuous period of six months or more.; Anti-Parvovirus B19 IgG: Blood products from donors with detectable IgG antibodies to Parvovirus B19 in two separate blood samples, one taken at least six months after the other, were considered to be Parvovirus B19 safe; Parvovirus B19 safe cellular blood products were administered to specific groups of patients.; Anti-CMV IgG: On demand testing; blood components negative for anti-CMV IgG were provided at the request of treating experts for intra-uterine use or to administer to extremely premature babies.;

Anti-HBc: Anti HBc test is performed in cases of HBsAg reactivity only.; HCV Ag: Limited number of tests.;

HIV Ag: We have a combinated test Abott for AB and Ag P24; Anti-HTLV: Only first time donation; Malaria: Come back from endemic areas; anti-CMV IgG: Transfusion for no immuno competent patients;

Anti-HIV: Combo tests Ag-Ab anti-HIV are used; Anti-HCV: Combo tests Ag-Ab anti-HCV are used; Syphilis: Ab anti-TP; WNV: DURING THE SEASON, IF LARGE TOWN = AFFECTED HIV Ag: part of the Regional Blood Centers uses 3rd generation tests; Parvovirus B19 DNA: plasma for fractionation is tested; RNA HAV: plasma for fractionation is tested;

HIV Ag: Not a requirement, but combotest used.; Anti-HBc: First time donation and again every time it is more than 6 months since previous donation.; HCV Ag: Done by plasma fractionator; Malaria: Selected donors;

32

Table 6.2Survey 2013

anti- HBsAg anti- CommentsHIV 1+2 HCV

Australia 0 0 0AlbaniaAndorraArmenia 0 0 0AustriaAzerbaijanBelgium 0 0 0Bosnia / HerzegovinaBulgaria 0 0 0Croatia 0 0 0Cyprus 0 0 0Czech Republic 0 0 0Denmark 0 0 0Estonia 0 0 0Finland 0 0 0France 0 0 0FYR MacedoniaGeorgia The information is not available, though, in

some facilities, some amount of donations are still tested with Simple rapid tests.

Germany 0 0 0Greece 0 0 0Hungary 0 0 0Iceland 0 0 0Ireland 0 0 0Italy 0 0 0Latvia 0 0 0LiechtensteinLithuaniaLuxembourg 0 0 0MaltaMoldova 0 0 0Montenegro 0 0 0Netherlands 0 0 0Norway 0 0 0Poland 0 0 0Portugal 0 0 0Romania 0 0 0Russian FederationSan MarinoSerbiaSlovakia 0 0 0SloveniaSpain 0 0 0Sweden 0 0 0Switzerland 0 0 0TurkeyUkraineUnited Kingdom 0 0 0

Use of simple rapid tests

Type of test (% of donations)

Country

33

Table 7.1Survey 2013

first time repeat first time repeat first time repeat first time repeat first time repeat first time repeat first time repeat donors donors donors donors donors donors donors donors donors donors donors donors donors donors

Australia All 3 3AlbaniaAndorraArmenia NoneAustriaAzerbaijanBelgium All 2 8 45 4 13 4 29 14Bosnia / HerzegovinaBulgaria All 17 0 1 587 0 342 0Croatia All 2 2 12 3 9 5 1 7Cyprus All 1 2 10 1 11 2 12 10Czech Republic All 2 5 22 11 114 30 20 15Denmark All 0 1 9 1 2 0Estonia All 1 4 5 3 37 3 11 8Finland All 0 0 1 0 7 2 2 4 22 0France All 7 10 215 5 109 8 20 6 245 139FYR MacedoniaGeorgia All 19Germany All 28 72 486 34 295 48 204 123Greece All 34 9 415 138 139 34 4 2 89 17 0 0Hungary All 2 5 87 4 89 27 41 21Iceland All 1 0 1 0 1 0Ireland All 0 1 4 0 5 0 0 0 1 1Italy All 65 65 666 153 348 37 553 123Latvia All 14 0 39 116LiechtensteinLithuaniaLuxembourg All 0 1 0 0 0 0 0 0 0 7 0 0MaltaMoldova All 51 0 1 212 614 0 0 1 087 0 0 0 0 0Montenegro All 0 0 18 0 8 3 0 0 24 3 0 0 0 0Netherlands All 1 2 12 2 3 1 0 0 14 5 0 0Norway All 0 0 7 0 6 1 2 2 20Poland All 14 26 524 15 493 49Portugal All 16 23 49 6 27 10 0 5 83 404Romania All 41 13 2 357 15 470 9 25 0 1 299 112Russian Federation AllSan MarinoSerbiaSlovakia All 1 0 22 1 17 7 19 11SloveniaSpain All 58 91 299 136 186 31 28 0 497 331 153 0Sweden All 1 0 14 0 21 4 2 5 3Switzerland All 1 1 27 0 10 1 9 7TurkeyUkraineUnited Kingdom All 7 9 57 2 52 4 4 1 74 13 0 0 0 0

CountryBelgiumGeorgiaLuxembourg

Netherlands

NorwayRussian FederationSwitzerlandUnited Kingdom

CountryProportion

confirmatory testing (%)

Outcomes: Lines 145,146, 149, 150 153, 154, 161,162 are not correct because NAT only positive result are not added.Comments

Syphilis HEVConfirmed seropositive donors (absolute numbers)

MalariaHIV 1 / 2 HBV HCV HTLV-I/II

Testing: Donations from donors already demonstrated to have non-specific reactivity by the Reference Laboratory, when screen reactive on subsequent donations are then screened using an alternative assay and, if negative on that assay, are released.; Outcomes: Not applicable

Testing: The confirmation tests performed only for donations RR for HIV.

Outcomes: No data available for Malaria confirmatory testing.Outcomes: Confirmatory testing in repeated reactive donors is performing, but the existing official form of reporting does not allow separating the requested dataOutcomes: 20 donors tested positive for malaria out of 2355 tested donors. If any of these donors were first time donors is unknown

Testing: Barring anti-HBc, anti-Parvovirus B19, anti-CMV and malaria antibody reactive test results, all screening test repeatedly reactive donations were subject to confirmatory testing.; Outcomes: Malaria antibody reactive test results were not subject to confirmatory testing.

Testing: The biggest part is represented by regular donors of apheresis with TPHA testing + (syphilis); indeed, it's possible in Luxembourg, to give blood when the syphils is cured or when it's a false positive result

34

Table 7.2Survey 2013

prevalence incidence prevalence incidence prevalence incidence prevalence incidence prevalence incidence prevalence incidence prevalence incidenceper 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000 per 100,000first time repeat first time repeat first time repeat first time repeat first time repeat first time repeat first time repeat

tested donors donors tested donors donors tested donors donors tested donors donors tested donors donors tested donors donors tested donors donorsAustraliaAlbaniaAndorraArmeniaAustriaAzerbaijanBelgium 3,78 3,41 85,08 1,71 24,58 1,71 54,83 5,97Bosnia / HerzegovinaBulgaria 49,07 0,00 4581,01 0,00 987,21 0,00Croatia 14,19 2,32 85,15 3,48 63,87 5,80 7,10 8,13Cyprus 9,12 5,27 91,25 2,64 100,37 5,27 109,50 26,36Czech Republic 4,10 2,05 45,08 4,52 233,61 12,33 40,98 6,16Denmark 0,00 0,49 41,71 0,49 9,27 0,00Estonia 13,39 13,46 66,96 10,09 495,51 10,09 147,31 26,91Finland 0,00 0,00 7,03 0,00 49,22 1,52 14,06 3,03 154,70 0,00France 1,97 0,78 60,62 0,39 30,73 0,62 5,64 0,47 69,08 10,80FYR MacedoniaGeorgia 113,17Germany 5,77 3,02 100,23 1,43 60,84 2,02 42,07 5,17Greece 57,01 3,07 695,81 47,09 233,05 11,60 6,71 0,68 149,22 5,80 0,00 0,00Hungary 3,71 2,22 161,18 1,78 164,88 11,99 75,96 9,33Iceland 44,23 0,00 44,23 0,00 44,23 0,00Ireland 0,00 1,39 29,00 0,00 36,25 0,00 0,00 0,00 7,25 1,39Italy 17,35 4,51 177,80 10,61 92,91 2,56 147,63 8,53Latvia 153,04 0,00 426,32 1268,04LiechtensteinLithuaniaLuxembourg 0,00 11,01 0,00 0,00 0,00 0,00 0,00 0,00 0,00 77,10 0,00 0,00MaltaMoldova 240,43 0,00 5713,75 2894,59 0,00 0,00 5124,46 0,00 0,00 0,00 0,00 0,00Montenegro 0,00 0,00 343,91 0,00 152,85 34,88 0,00 0,00 458,54 34,88 0,00 0,00 0,00 0,00Netherlands 3,26 0,73 39,11 0,73 9,78 0,36 0,00 0,00 45,63 1,81 0,00 0,00Norway 0,00 0,00 44,89 0,00 38,48 1,02 12,83 2,04 20,44Poland 7,58 5,99 283,75 3,46 266,97 11,29Portugal 41,50 9,33 127,08 2,43 70,02 4,06 0,00 2,03 215,26 163,92Romania 38,89 2235,76 445,82 23,71 1232,18Russian FederationSan MarinoSerbiaSlovakia 3,05 0,00 67,08 1,00 51,84 7,03 57,94 11,05SloveniaSpain 26,40 11,04 136,10 16,49 84,66 3,76 12,75 0,00 226,23 40,14 69,64 0,00Sweden 2,24 0,00 31,32 0,00 46,99 1,78 4,47 11,19 1,34Switzerland 3,56 0,51 96,20 0,00 35,63 0,51 32,07 3,59TurkeyUkraineUnited Kingdom 3,88 0,88 31,57 0,19 28,80 0,39 2,22 0,10 40,99 1,27 0,00 0,00 0,00 0,00

Prevalence and incidence calculated per 100,000 donors

Country

HIV 1 / 2 HBV HEVHCV HTLV-I/II Syphilis Malaria

35

Table 8.1Survey 2013

which Size which Size which Size which Size which Sizedonations Minipool donations Minipool donations Minipool donations Minipool donations Minipool

Australia All 1 All 1 All 1 NoneAlbaniaAndorraArmenia None None None NoneAustriaAzerbaijanBelgium All 6 All 6 All 6 NoneBosnia / HerzegovinaBulgaria None None None NoneCroatia All All AllCyprus None None None NoneCzech RepublicDenmark All 1 All 1 All 1 NoneEstonia All 6 All 6 All 6 NoneFinland All All All None All HAV; All ParvoB16 16; 16France All All All 96FYR MacedoniaGeorgia None None None NoneGermany All 96 All 96Greece All All All WNV-RNAHungary None None None NoneIceland None None None NoneIreland All 1 All 1 All 1 West Nile virus* 1Italy All All All None WNV NATLatvia 24 24 24 NoneLiechtensteinLithuaniaLuxembourg All 96 All 96 All 96 None All PCR HAV; All PCR PARVOVIRUS B19; NONE 96; 96MaltaMoldova All 10 None All 10 NoneMontenegro None None None NoneNetherlands All 6 All 6 All 6 NoneNorway None None None NonePoland All All All None B19V DNA; HAV RNAPortugal All All All None All Multiplex HIV,HCV,HBV NAT Testing 6Romania None None None NoneRussian FederationSan MarinoSerbiaSlovakia None None None NoneSloveniaSpain All 1 All 1 All 1 NoneSweden None None None NoneSwitzerland All 6 All 6 All None Parvo Virus B 19; HAVTurkeyUkraineUnited Kingdom All 24 All 24 All 24 None West Nile Virus 6

Country

NAT testing

Other NAT tests (separated by ';')HIV NAT HBV NAT HCV NAT HEV NAT

36

CountryCroatia

Cyprus

Czech RepublicFinlandFrance

Germany

GreeceIreland

ItalyLatviaNetherlands

NorwayPoland

PortugalRussian FederationSpainSwitzerland

United Kingdom

Comments

HIV: A multiplex real-time PCR test was used to simultaneously screen donated blood for HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA.; HBV: A multiplex real-time PCR test was used to simultaneously screen donated blood for HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA.; HCV: A multiplex real-time PCR test was used to simultaneously screen donated blood for HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA.; In order to meet the requirements of the European Pharmacopeia and EMA guidelines, plasma for the manufacture of plasma-derived medicinal products was additionally screened by PCR for the presence of HAV RNA, HEV RNA and Parvovirus B19 DNA, if indicated.

HIV: seronegative samples are NAT tested; HBV: seronegative samples are NAT tested; HCV: seronegative samples are NAT tested;

HBV: ID NAT; WNV-RNA: Tested donors only in the affected areas plus some visitors (total of 26910 donors);

HBV: No Data. HBV NAT tests performed by blood donation service on a voluntary basis for more than 75% of all donations.; HEV: No Data. HEV NAT tests performed by blood donation service on a voluntary basis.;

HIV: ID NAT testing; HBV: ID NAT-testing; HCV: ID NAT-testing;HIV-HBV-HCV NAT testing is implemented in two BEs only (less then 5% of total donations). No "NAT-only pozitive donor" has been detected

It has already been decided by the Ministry of Health, that at the beginning of 2016 NAT testing will be implemented together with ELISA for the screening of blood donors on pacyprian base.

HIV: Triplex NAT assays by individual donation (ID-NAT) for HIV, HCV and HBV; HBV: Triplex NAT assays by individual donation (ID-NAT) for HIV, HCV and HBV.; HCV: Triplex NAT assays by individual donation (ID-NAT) for HIV, HCV and HBV; HEV: Triplex NAT assays by individual donation (ID-NAT) for HIV, HCV and HBV; ID-NAT testing was introduced at 01.03.2013. and by the end of the year 147.664 samples were tested. All samples were tested in Croatian Institute of Transfusion Medicine.

HIV: tested in IDT or MP6 (depends on country region); HBV: tested in IDT or MP6 (depends on country region); HCV: tested in IDT or MP6 (depends on country region); B19V DNA: MP16 (TMA) or MP96 (PCR) testing depending on country region, mainly repeat donors are tested; HAV RNA: MP16 (TMA) or MP96 (PCR) testing depending on country region, mainly repeat donors are tested;

NAT performed by plasma fractionator

HIV: Size of minipools : ID-NAT in 11 regions and minipools of 8 in 4 regions.; HBV: Size of minipools : ID-NAT in 11 regions and minipools of 8 in 4 regions.; HCV: Size of minipools : ID-NAT in 11 regions and minipools of 8 in 4 regions.; HEV: From 2013, implementation of HEV NAT for plasma units used for the manufacture of Solvent Detergent plasma.;

WNV NAT: Testing applied only in defined Summer periods in selected areas;

HBV: This was an occult HBV DNA positive i.e HBsAg Neg,anti-HBcore and anti-HBs positive; West Nile virus*: * WNV NAT was used instead of geographical deferral during European WNV season;

West Nile Virus: Discretionary testing if less than four weeks from a donor's return from a WNV endemic area.;

HIV: Size of minipools ranges from 1 to 6; HBV: Size of minipools ranges from 1 to 6; HCV: Size of minipools ranges from 1 to 6; Parvo Virus B 19: Is applied to donations from which plasma goes into fractionation; HAV: Is applied to donations from which plasma goes into fractionation;

HIV: Size of minipool: 1 - 6; HBV: Size of minipool: 1 - 6; HCV: Size of minipool: 1 - 6;NAT- test is not mandatory, but is performing by some blood establishments. Accurate data in frame of reporting is not availableHIV: We perform Multiplex HIV,HCV,HBV NAT Testing; HBV: We perform Multiplex HIV,HCV,HBV NAT Testing; HCV: We perform Multiplex HIV,HCV,HBV NAT Testing;

37

Table 8.2Survey 2013

first time repeat first time repeat first time repeat first time repeattested donor donor tested donor donor tested donor donor tested donor donor

AustraliaAlbaniaAndorraArmeniaAustriaAzerbaijanBelgium 0 1 1 0 0 1Bosnia / HerzegovinaBulgariaCroatiaCyprusCzech RepublicDenmark 0 0 1 1 0 0Estonia 0 0 0 0 0 0Finland 0 0 0 0 0 0France 0 1 5 0 0 0FYR MacedoniaGeorgiaGermany 0 5 1 3 2 10Greece 1 1 57 11 3 1HungaryIcelandIreland 0 0 1 0 0 0Italy 1 19 106 0 3Latvia 14 44 134LiechtensteinLithuaniaLuxembourg 0 1 0 0 0 0MaltaMoldova 0 0 0 0MontenegroNetherlands 0 0 1 0 0 0NorwayPoland 0 2 3 2 2 4PortugalRomaniaRussian FederationSan MarinoSerbiaSlovakiaSloveniaSpain 3 3 64 0 0 0SwedenSwitzerland 0 0 1 1 0 0TurkeyUkraineUnited Kingdom 0 0 1 3 0 3

NAT only positive results

Country

HBVHIV HEVHCV

38

Table 9Survey 2013

Total using culture-based methods

rapid detection methods

both methods

Total using culture-based methods

rapid detection methods

both methods

Australia 130 598 100 100 100 100 100AlbaniaAndorraArmenia 2 065 5AustriaAzerbaijanBelgium 69 373 61 61 0 0 49 49 0 0 55 0,06Bosnia / HerzegovinaBulgaria 7 152 1 100 0 0 1 100 0 0 1 0,00CroatiaCyprus 4 947 14 100 0 0 0 0 0 0 14 0,00Czech Republic 36 049 1 1 1 1 1 0,00Denmark 34 370 100 100 0 0 100 100 0 0 100 0,04Estonia 7 430 100 100 0 0 100 100 0 0 100 0,17Finland 38 132 8 8 0 0 7 7 0 0 8 0,10France 306 242 0FYR MacedoniaGeorgiaGermany 578 442GreeceHungary 90 196 3 100 0 0 100 5Iceland 2 098 0 0 0 0 0 0 0 0 0 0,00Ireland 22 626 100 100 0 0 100 100 0 0 100 0,07Italy 213 689 10 10 10Latvia 7 600LiechtensteinLithuaniaLuxembourg 2 481 4 4 0 0 6 6 0 0 5 0,00MaltaMoldova 0 24 24 0 0 0 0 0 0 24 0,00Montenegro 843Netherlands 57 501 100 100 0 0 100 100 0 0 100 0,26Norway 26 039 85 85 85 85 85 0,00Poland 106 327 0 0 0 0 0 0 0 0 0 0,00Portugal 39 523 100 100 0 0 100 100 0 0 100 0,02Romania 34 767 0 0 0 0Russian Federation 145 419San MarinoSerbiaSlovakia 17 937 1 100 1 100 1SloveniaSpain 200 923Sweden 52 604 41 0,05Switzerland 34 122 0 0 0 0 0 0 0 0 0 0,00TurkeyUkraineUnited Kingdom 314 263 100 100 0 0 100 100 0 0 100 0,03

CountryGermanyIcelandIrelandLuxembourgNetherlandsNorwayPolandRomaniaRussian FederationUnited Kingdom

Bacterial screeningTotal platelets

% screenedTotal platelets

% confirmed positive% adult doses screened for bacteria

Recovered platelets Apheresis platelets

Total platelets adult doses issued

0.03% confirmed positive . Northern Ireland - In the event of platelet shortage, platelets are not sampled and have a 5 day, instead of 7 day, shelf life assigned (approximately 160 components per year).

Country

Confirmatory testing and screening for the presence of bacteria in platelet preparations is performing, but the existing official form of reporting does not allow separating the requested data.EMPTY FIELDS: DATA NOT AVAILABLEPlatelet preparations are not screened routinely for presence of bacteria in platelet preparations95 platelet concentrates were culture positive.All platelet products were routinely cultured with the BacT/ALERT culturing system; products were released on a negative-to-date basis.

Comments

All these controls concerned expired products0.071% confirmed positive donations. 0.042% of tests as we do additional tests to extend shelf lifeNow using pathogen inactivationNo data. Microbiological control as a statistic process control 0.4 x the square root of N of each processing line per month and per processing plant at the end of shelf life.

39

Table 10Survey 2013

National Council or national regulationsExpert Committee on quality and safety implementing

Australia Yes Yes Yes YesAlbaniaAndorraArmenia Yes Yes Yes YesAustriaAzerbaijanBelgium Yes Yes Yes YesBosnia / HerzegovinaBulgaria Yes Yes Yes YesCroatia Yes No YesCyprus Yes Yes Yes YesCzech Republic Yes Yes Yes YesDenmark Yes Yes Yes YesEstonia Yes No No YesFinland No Yes Yes YesFrance Yes Yes Yes YesFYR MacedoniaGeorgia No Yes Yes YesGermany Yes Yes Yes YesGreece Yes Yes Yes YesHungary Yes Yes Yes YesIceland Yes No No YesIreland No No No YesItaly Yes Yes Yes YesLatvia Yes Yes No YesLiechtensteinLithuaniaLuxembourg Yes Yes No YesMaltaMoldova Yes Yes Yes YesMontenegro Yes Yes Yes YesNetherlands Yes Yes Yes YesNorway Yes Yes Yes YesPoland Yes Yes Yes YesPortugal Yes Yes Yes YesRomania Yes Yes Yes YesRussian Federation Yes Yes Yes YesSan MarinoSerbiaSlovakia Yes Yes No YesSloveniaSpain Yes Yes Yes YesSweden Yes Yes Yes YesSwitzerland Yes Yes Yes YesTurkeyUkraineUnited Kingdom Yes Yes Yes Yes

CountryFrance

Greece

Switzerland There are two expert committees available upon request

The national policy on the quality and safety of blood as well as the national guidelines are in compliance with the EDQM "Guide" and the EU legislation

Organisation, registration and labelling

national blood policy Country

The French National Agency for Medicines and Health Products Safety (ANSM), national competent authority for blood and blood components, advises the Ministry of Health. Expert working groups are created with this agency.

Comments

40

Table 11.1Survey 2013

Inspections every Description of the System of educ.GMP ISO 9000 Local SOP's Other Specification of 'Other' second year "Other" organisation/body and training

Australia Yes 100 100 National YesAlbaniaAndorraArmenia Planned 100 Regulations confirmed by

the MoHNo Yes

AustriaAzerbaijanBelgium Yes 100 95 100 National+Other When covered by ISO 9000 also inspection by ISO YesBosnia / HerzegovinaBulgaria Yes 100 National YesCroatia Yes 100 65 100 National YesCyprus No 0 0 100 0 National YesCzech Republic Yes 100 50 100 National State Institute for Drug Control (SUKL) YesDenmark Yes 100 National YesEstonia Yes 100 100 100 National NoFinland Yes 100 0 100 100 Management system

based on ISO 9001National+Other Internal audits and audits by international plasma fraction

companies and by FINASYes

France Yes 100 100 100 National National inspections of blood establishments by the ANSM, hospital blood banks inspections by the regional health agencies.

Yes

FYR MacedoniaGeorgia Planned No NoGermany Yes 100 National+Other Regional authorities in charge of GMP inspections. YesGreece Yes 83 27 92 National YesHungary Yes 100 National YesIceland Yes 100 100 100 National+Other BSI - British Standards Institution YesIreland Yes 100 0 100 0 National YesItaly Yes 40 100 national requirements National+Other Regional health authority + nationally qualified inspectors YesLatvia Yes 100 National NATIONAL DRUG AGENCY YesLiechtensteinLithuaniaLuxembourg Yes 100 100 100 100 ISO 9001, ISO 15189 National+Other Octapharma YesMaltaMoldova Yes 100 100 100 0 National YesMontenegro Planned National NoNetherlands Yes 100 0 100 0 National YesNorway Yes 100 67 100 National YesPoland Yes 100 0 100 0 Other Institute of Hematology and Transfusion Medicine YesPortugal Yes 100 100 100 0 National YesRomania Yes 100 National YesRussian Federation Yes National YesSan MarinoSerbiaSlovakia Yes 100 10 100 National YesSloveniaSpain Yes 100 100 Other Inspections conducted by regional authorities and

acreditations by scientific societiesYes

Sweden Yes 100 100 77 ISO/IEC 17025 or ISO/IEC 15189

National+Other SWEDAC Yes

Switzerland Yes 100 60 40 0 National+Other Blood establlishments engaging in any kind of collecting or manufacturing are inspected to get an establisment license and will subsequently be re-inspected every second year. This is perforded by the national authority. Applying analogous procedures, the cantonal authorities have regulatory oversight over hospital blood banks with activities restricted to storage and distribution of blood components.

Yes

TurkeyUkraineUnited Kingdom Yes 100 0 100 0 National Yes

CountryCroatia National IT transfusion system e-Delphyn was implemented in all 9 Blood Establishments.

Country % donations covered by

Quality Management related issues

QMS established and maintained

Comments

41

Table 11.2Survey 2013

CommentsISBT 128 another

systemISBT 128 another

systemAustralia 0 100 0 100AlbaniaAndorraArmenia 100AustriaAzerbaijanBelgium 95 5 95 5Bosnia / HerzegovinaBulgaria 100 100Croatia 100 100 CODE 128Cyprus 53 47 53 47Czech Republic 100 100 national system since 1996Denmark 100 100Estonia 100 0 0 100 we are using component codes of Estonian National Blood

Information SystemFinland 100 0 100 0France 0 100 0 100 Specific national coding system since 1994 for blood

establishments, blood donors, blood donations, blood and blood components, ABO donors grouping. ANSM is in charge

of this National coding system.FYR MacedoniaGeorgiaGermany Any unique code, mostly used is Eurocode.Greece 100Hungary 100Iceland 100 0 100 0Ireland 0 100 0 100 CodabarItaly 0 100 0 100 National regulation UNI 10529Latvia 100 100LiechtensteinLithuaniaLuxembourg 0 100 0 100 We have our own barcode systemMaltaMoldova 100 0 100 0Montenegro 100Netherlands 100 0 100 0Norway 100 100Poland 100 0 100 0Portugal 100 0 100 0Romania 0 100 0 100 NATIONAL; EYE READABLE DONATION CODES, NAME

OF BC AND OTHER INFORMATIONRussian FederationSan MarinoSerbiaSlovakia 75 25SloveniaSpain 63 37 63 37 CODABAR (76%), EUROCODE (18%), CODE39 (6%)Sweden 100 100Switzerland 100 100TurkeyUkraineUnited Kingdom 100 0 0 100 Codabar

Quality Management related issues

Country% donations labelled % components coded

42

Table 12.1Survey 2013

Available / organisation

Description of 'Other' organisation/body

Australia NationalAlbaniaAndorraArmenia NoAustriaAzerbaijanBelgium NationalBosnia / HerzegovinaBulgaria NationalCroatia National+Other Croatian Institute of Transfusion MedicineCyprus NationalCzech Republic National+Other State Institute for Drug Control + Society for Blood TransfusionDenmark National+Other State Serum Institute & Danish Society of Clin. ImmunologyEstonia NationalFinland National+Other Finnish Red Cross Blood ServiceFrance NationalFYR MacedoniaGeorgia NoGermany NationalGreece National Coordinating Haemovigilance CentreHungary Other Hungarian National Blood Transfusion ServiceIceland NationalIreland NationalItaly NationalLatvia NationalLiechtensteinLithuaniaLuxembourg NationalMaltaMoldova NationalMontenegro NoNetherlands National+Other TRIP FoundationNorway NationalPoland OtherPortugal NationalRomania NationalRussian Federation NationalSan MarinoSerbiaSlovakia NationalSloveniaSpain NationalSweden National+Other Swedish Society for Transfusion MedicineSwitzerland NationalTurkeyUkraineUnited Kingdom National+Other Serious Hazards of Transfusion (SHOT)

CountryCzech Republic

IrelandNetherlandsPolandSwitzerland

United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) [SABRE and SHOT]

annual Haemovigilabnce reports are available at: https://www.swissmedic.ch/marktueberwachung/00138/00188/index.html?lang=en

CountryHaemovigilance system

Institute of Hematology and Transfusion MedicineTRIP Foundation is the national hemovigilance office of the NetherlandsNational Haemovigilance Office

obligatory to national authority - severe adverse reactions / severe adverse eventson voluntary basis to medical society: all reactions / adverse events

Comments

43

Table 12.2Survey 2013

total number components transfused:

whole blood + RBC + FFP +

Platelets

Hem

olys

is A

BO

Hem

olys

is o

ther

allo

an

tibod

y

Non

imm

un. H

emol

.

PT P

urpu

ra

Anap

hyla

xis

TRAL

I

GVH

D

TA-H

BV

TA-H

CV

TA-H

IV

TA-O

ther

vira

l

TA-B

acte

rial

TA-M

alar

ia

TA-P

aras

itic

TA-T

ACO

TA-O

ther

ser

ious

AustraliaAlbaniaAndorraArmenia 24 508 0 0,0AustriaAzerbaijanBelgium 614 813 3 15 1 0 13 2 0 0 0 0 0 3 0 1 2 48 14,3Bosnia / HerzegovinaBulgaria 275 586 1 0,4Croatia 275 305 1 1 2 2 2 4 1 4,7Cyprus 80 217 0 0 0 0 28 0 0 0 0 0 0 0 0 0 0 6 42,4Czech Republic 579 171 1 0 0 0 10 0 0 0 0 0 0 0 0 0 1 0 2,1Denmark 359 224 0 5 0 1 2 1 0 0 0 0 0 0 0 0 7 0 4,5Estonia 87 854 4 3 3 11,4Finland 290 205 2 2 0 0 7 0 0 0 0 0 0 0 0 0 1 1 4,5France 3 204 160 0 4 2 0 31 7 0 0 0 0 0 3 0 0 32 9 2,7FYR MacedoniaGeorgiaGermany 6 003 890 16 13 0 0 1 10 0 0 0 0 2 4 0 0 9 1 0,9Greece 592 328 4 2 14 1 9 5,1Hungary 600 154 3 1 15 1 3,3IcelandIreland 170 702 0 8 0 0 30 0 0 0 0 0 0 0 0 3 10 29,9Italy 3 079 814 8 4 6 2 9 6 0 0 0 0 0 2 0 0 27 973 33,7Latvia 88 970 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0,0LiechtensteinLithuaniaLuxembourg 28 225 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0,0MaltaMoldova 103 249 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0,0MontenegroNetherlands 578 206 0 0 0 0 2 1 0 0 0 0 0 2 0 0 0 0 0,9Norway 258 531 2 2 0 0 11 3 0 0 0 0 0 0 0 0 10 0 10,8Poland 1 599 586 7 1 1 4 2 1 1,0Portugal 387 886 4 1 0 0 117 3 0 0 0 0 0 0 0 0 25 0 38,7Romania 753 803 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0,3Russian Federation 3 571 248 1 1 0,1San MarinoSerbiaSlovakia 298 006 35 1 68 34,9SloveniaSpain 1 978 511 7 9 1 1 60 14 1 2 35 6,6SwedenSwitzerland 365 884 11 4 11 541 155,0TurkeyUkraineUnited Kingdom 2 604 226 3 23 0 3 16 5 0 0 0 0 0 0 0 0 54 90 7,4Total 62 95 13 7 416 66 4 1 1 2 2 16 0 1 232 1749

Hemovigilance – number of serious adverse reactions

Imputability "likely, probable or certain" (level 2 or level 3) Incidence high imputability

serious adverse reactions per

100,000 components Country

44

45

The Council of Europe is the continent’s leading human rights organisation. It comprises 47 member states, 28 of which are members of the European Union. The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect public health.

www.edqm.eu

ENG