Proposal for a Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community
Date: 1997-11-17
Institutions: European Commission
Subjects: blood transfusion, data protection, disease prevention, product safety, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

•ir 

-tr 

Brussels, 17.11.1997 
C0M(97)  605 final 

97/0315 (CNS) 

PROPOSAL FOR A 

COUNCIL RECOMMENDATION 

on the suitability of blood and plasma donors and 

the screening of donated blood 

in the European Community 

(presented by the Commission) 

Explanatory Memorandum 

1.  INTRODUCTION 

in 

to  recommend, 

the  European  Commission 

1.  Continuing  concerns  about the quality,  safety  and efficacy  of blood  and blood  products  in the 
its 
European  Community  motivated 
Communication of December  1994 , the development of a Community blood strategy in order to 
improve confidence in the safety of the blood transfusion  chain and to promote Community  self-
sufficiency,  The Council in its Resolution of June  19952 invited the Commission to continue its 
efforts  to define  such  a  strategy  using  as a basis  the activities  it had proposed.  In November 
1996,  Council's  Resolution3  on a  Strategy  Towards  Blood  Safety  and Self-sufficiency  in the 
European Community further refined the constituent elements of the strategy by calling for a co 
ordinated approach to the safety of blood and blood products, and calling on the Commission to 
submit proposals as a matter of urgency, drawing upon the Conclusions and Recommendations 
of a Colloquium on blood safety and self-sufficiency  held in Adare, Ireland.  Responding to this 
invitation,  the  Commission  has been  pursuing  activities  to  advance  the  development  of  this 
strategy and as a first step has concentrated on the need for common requirements regarding the 
suitability of blood and plasma donors and the testing of their donations. Such requirements can 
make a significant  contribution to ensuring the quality and safety  of needed blood  and plasma, 
restoring  the  confidence  of  Community  citizens  in  the  blood  transfusion  system,  and 
contributing to the continuing efforts  to achieve Community  self-sufficiency  through  voluntary 
unpaid donations. 

2.  THE BLOOD TRANSFUSION  CHAIN 

2.  The  blood  transfusion  chain  comprises  an  extensive  number  of  complex  and  interrelated 
activities  extending  from  the  willingness  of  an  individual  to  provide  blood  or  plasma  for 
therapeutic  use; through the elaborate precautions taken in the preparation  of both  labile blood 
components  (red blood  cells, white  blood  cells, platelets  and plasma)  and stable  industrially-
prepared  derivatives  (e.g.  albumin,  clotting  factor  concentrates,  protease  inhibitors  and 
immunoglobulins);  to the administration  of any of these products  to a patient  and subsequent 
follow-up.  Each of these steps requires meticulous attention to safety. 

3.  One of the most  crucial  links  in  this  chain,  however,  are the requirements  for  ensuring  the 
acceptance of an individual as a blood or plasma donor and those for testing the donated  blood 
or  plasma  for  infectious  diseases.  As the Commission  noted  in its  1994 Communication,  the 
donor  selection  process  differs  across  the  Community  and  "it  would  be  beneficial  if  an 
agreement  is reached  as regards the rules and practices  for donor  selection,  including new and 
repeat donors as well as donors of whole blood, cellular components and plasma, to be applied 
across  the Community".  It  also  referred  to the differing  testing  requirements  that  exist  in the 

Communication  from  the  Commission  on  Blood  Safety  and  Self-sufficiency  in  the  European  Community. 
COM(94) 652 final.  21.12.1994. 23p. 
O.J. No C164. 30.6.95. p. 1 
O.J.NoC374.  11.12.96. p.l 
Department  of  Health,  Ireland.  Conclusions  and  Recommendations.  Colloquium  on Blood  Safety  and  Self-
sufficiency:  An Agenda for the European Community. Adare, County Limerick, Ireland. 4-6 September 1996. 
1 

Community  hindering  the  transfer  of  blood  and  the  free  movement  of  blood  products  and 
impeding  the  goal  of  self-sufficiency  in  blood  and  plasma  as  starting  material  used  for  the 
preparation  of  medicinal  products.  These existing  variations  among  the Member  States  of  the 
European Community contribute to a lack of confidence not only among patients but among the 
blood establishments themselves. 

4.  Donor  selection  and the  screening  of donations were  among the topics  discussed  at  the  Adare 
Colloquium by Member States experts who recommended, inter alia, that existing guidelines on 
donor selection be reviewed "with a view to making proposals for common criteria to be used in 
the European Community" and that "a minimal set of screening tests should apply in all Member 
States  for  the  testing  of  whole  blood  and  components  for  transfusion  as  well  as  plasma  for 
fractionation". Moreover, they stressed the need for criteria at Community level regarding donor 
identification  and  determining  the  core  elements  and risk behaviours  that  should  be  identified 
through a donor screening questionnaire. 

5.  In order to establish the basis for  common criteria, the Commission  in early  1997 conducted  a 
survey of the current regulations  and practices in the Member  States regarding the selection  of 
donors and the screening of their blood donations. This survey addressed the current  legislative 
requirements  in  the  Member  States  and  guidelines  of  the  Council  of  Europe  and  the  World 
Health Organization; the criteria for  the selection of whole blood  and plasma donors; elements 
covered  in  the  donor  questionnaire  and  physical  examination;  the  major  reasons  for  donor 
deferral  for  the  safety  of  recipients;  the  current  screening  tests  required  for  individual  whole 
blood  donations  and  plasma  obtained  through  apheresis;  and  the  interpretation  of  a  reactive 
result  in  the  initial  screening  test  for  infectious  agents  (e.g.  HIV,  HBV,  HCV,  syphilis)  in 
relation to the clinical use of the donation. The outcome of the survey, which was discussed  at a 
meeting  of  national  experts  in  June  1997,  and  the  deliberations  at  the  meeting  itself  clearly 
reflected  variations in regulations and practices in the-Member States. The results of the survey 
are being presented  in a working paper of the Commission  Services entitled "The suitability of 
blood and plasma donors and the screening of their donations: a  1997 survey of the regulations 
and practices in the Member States of the European Community". 

3.  EXISTING AND PROPOSED REQUIREMENTS 

6.  Directive  89/381 /EEC5  extended  the  scope  of  pharmaceutical  legislation  to  encompass  the 
quality,  safety  and  efficacy  requirements  for  industrially  prepared  medicinal  products  derived 
from blood and plasma but specifically  excluded whole blood, plasma and blood cells of human 
origin. In respect of measures covered by the modification  as to testing requirements, referred to 
in Article  6 of that Directive, to be taken by the Member  States to prevent  the transmission  of 
infectious  diseases  by  blood  and  plasma  used  as  a  starting  material  for  the  manufacture  of 
medicinal  products,  Article  3  refers  to  the  application  of  the  monographs  of  the  European 
Pharmacopoeia  and  to  recommendations  by  the  Council  of  Europe  and  the  World  Health 
Organization  as regards in particular the selection and testing of blood  and plasma donors. The 
Directive  makes  no  provision  for  adaptation  to  requirements  recommended  or  published  on 
donor  selection  that  may  have  arisen  after  its  adoption  in  1989 nor  to  scientific  and  technical 
progress.  Moreover,  since  Article  1(2)  of  the  Directive  specifically  excludes  whole  blood, 
plasma  or blood  cells of human origin from its scope, difficulties  may  arise in practice  when 
the final destination of the donation is not known. 

O.J. No  L181,  28.6.89,  p.44 

7.  Council Decision  94/358/EC6  accepted on behalf of the European  Community, the Convention 
on the elaboration of a European Pharmacopoeia which aims to harmonise quality  specifications 
for  active  substances  and  excipients  in  order  to  facilitate  the  free  circulation  of  medicinal 
products  in  the  countries  party  to  the  Pharmacopoeia.  This  harmonisation  simplifies 
pharmaceutical  and biological  testing requirements for marketing authorisations. The European 
Pharmacopoeia's  monograph  on 'Human Plasma for Fractionation'  makes only a reference to 
Council of Europe recommendations regarding the selection of donors which are therefore not 
mandatory. 

8.  Council  Directive  95/46/EC  addresses  the  protection  of  individuals  with  regard  to  the 
processing  of personal  data  and the free movement  of such data. This Directive  requires  that 
certain  sensitive  data  in  particular  that  related  to  the health  of  an  individual  be  subject  to 
reinforced  protection.  It  covers  only  personal  data  and not that  rendered  anonymous  so that 
the person  is no longer  identifiable.  Processing  of medical  data  is prohibited  unless  the data 
subject  gives  his  explicit  consent.  This  prohibition  is  not  applicable,  however,  if  the 
processing  of  the  data  is  for  the  purpose  of  preventive  medicine,  medical  diagnosis,  the 
provision  of  care  and  treatment  or  the  management  of  health  services,  and  the- data  are 
processed by a health professional  subject to the obligations of professional  secrecy. 

9.  At  the  level  of  the  Member  States,  the  Commission's  survey  highlighted  the  significant 
variations  in  legislative  requirements  regarding  the  selection  of  donors  and  the  testing  of 
donations.  These  range  from  extensive  and detailed  legislation  developed  in recent  years, to 
regulations  dating  to  1980, to  non-binding  national  guidelines.  Legislative  revisions  in the 
area  of  blood  are  currently  underway  in  two  Member  States.  These  variations  hinder  the 
transfer  of blood  (and plasma)  and the  free  movement  of blood  and plasma  products,  thus 
impeding the achievement of Community  self-sufficiency. 

lO.Therefore,  in keeping  with the goal of making  a contribution  towards  ensuring  a high  level of 
health  protection  to the citizens  of the Community,  and providing  for the attainment  of  self-
sufficiency  in  blood  and  plasma  through  voluntary  unpaid  donations,  and  in  view  of  the 
variations  both  in legislation  and practice  in the Member  States, the Commission  considers  it 
imperative  that  common  requirements  be  introduced  by all  Member  States  based  on  agreed 
recommendations.  These  should  be based on the outcome of its survey and the latest  scientific 
evidence  regarding  the  determination  of  the  suitability  of  donors  and the  screening  of  their 
donations. As stated in a recent  report by the Swedish National  Working Group on Blood  Self-
sufficiency8  "many  European  citizens  do not  trust  the quality  and  safety  of  blood  products 
originating from countries  other  than  their own.  Only by implementing  common  standards can 
we increase the trust between  Community Member States, enhance the free movement  of blood 
and  blood  products,  and reach  the  goal  of  Community  self-sufficiency".  These  requirements 
must, pursuant  to Article  129 of the EC Treaty, be based on Council  recommendations,  which 
should  aim at promoting  sound  practices  and consistency  throughout  the Community  without 
being disproportionate with regard to the overall objectives being pursued, namely the safety and 
sufficiency  in the Community  of blood and plasma and the health protection  of the donors. To 
that  end,  the  proposed  recommendations  should  address  donor  suitability  and  eligibility, 
volumes collected, and the screening of samples of donated blood, and should be congruent with 
the provisions of Directive 89/3 81 /EEC. 

O.J. No L158, 25.6.94, p.70. 
O.J. No L281. 23.11.95. p.31 
Swedish  National  Working  Group  on  Blood  Self-sufficiency.  European  self-sufficiency  in  blood  and  blood 
products: Balancing  supply  and demand.  Background  Paper  to the statement  by the Swedish  Minister  of Health 
and Social Affairs,  Margot Wallstrom, (Health) Council Meeting, Luxembourg, June 5 1997. 6p. 

3/H-

4.  DONOR SUITABILITY 

11 .Ascertaining  the  suitability  of  an  individual  who  has  offered  to  donate  blood  or  plasma  is 
essential in order to ensure that there are no detrimental effects  to the prospective donor's health 
and to protect that of future  recipients of the blood products emanating from that donation. The 
initial  step  in  this  process  is  the provision  of  accurate  and  understandable  information  to  the 
prospective  donor  about  the benefits  and  hazards, both  to  their  own  health  and  that  of  future 
recipients, associated with blood and plasma donation. Agreement by the prospective donor of a 
willingness to proceed should be followed by the identification  and registration of the donor, the 
recording  of  this  information  in  an  appropriate  data  file,  the  verification  of  certain  physical 
parameters, and the compilation  of a medical history to identify  and screen out those who may 
be at some health risk either to themselves or to recipients of their donation. 

12. Although the true effectiveness  of written questionnaires in screening out donors with high risk 
behaviours  has  not  yet  been  fully  demonstrated,  and  the  need  for  a  Community-wide 
comprehensive  and common questionnaire not established due especially to cultural  differences 
in  the Community,  it  is  essential  that  several  core  elements  and  risk  behaviours  be  addressed 
during the pre-donation process. These should be addressed in the written questionnaire, or the 
interview with a trained health care staff member, or both and should cover a number of diseases 
and  conditions,  as well  as certain  risk  factors,  on which there is  solid  scientific  consensus  for 
their inclusion. 

13.Acceptance  criteria  for  donors  of  whole  blood  and  apheresis  plasma  should  be  clearly 
established  to  ensure  that  there  are no  detrimental  effects  to  the  donor's  health  and  additional 
criteria need to be imposed for the protection of future  recipients of the blood products  deriving 
from their donation. Donors, who for one of many reasons may be deemed ineligible to  donate 
blood  either  temporarily  or  permanently  should  be  given  appropriate  counselling.  The 
discretion of the physician is paramount in the final determination of eligibility of a donor. 

5.  DONOR INELIGIBILITY 

14.A  prospective  donor  may  be  considered  ineligible  to  donate  blood  or  plasma,  either 
temporarily or permanently, at any time during the donation process. Such individuals are said 
to  be  "deferred"  and  the  period  of  time  during  which  they  are  considered  ineligible  varies 
according  to  different  factors.  It  is  important  that  appropriate  records  of  such  deferrals  are 
maintained  in  such  a  way  that  while  the  confidentiality  of  the  data  is  maintained,  the 
information  is accessible  to authorised  individuals whether at a donation  site or when  matters 
of  safety  are concerned.  Such  manual  or computerised  records  are  often  referred  to  as  donor 
deferral registers (DDR). 

15.The survey of the requirements  and practices in the Member States revealed  general  agreement 
regarding permanent  deferral  for particular situations such as HIV / AIDS, hepatitis C, syphilis, 
etc.. Temporary  deferral  showed both commonality  among Member  States for  some situations, 
and  considerable  variation  for  others.  For  example,  temporary  deferral  ranged  from  6 - 12 
months for tattoos; 2 -5  years after  recovery from tuberculosis;  1-2  years after  recovery from 
toxoplasmosis;  from  "each  service /  doctor has own  criteria" to  5 years  for  hepatitis  A.  These 
variations  appear  to  reflect  an  absence  of  conclusive  scientific  data  about  the  time  frame  for 
deferral  of donors  on which sound  decisions  can be made.  Supplementary  survey  information 
submitted  to the Commission  following  the meeting of experts also reflected  the variations  in 
practices. In order to arrive at suggested  common criteria, therefore,  a mean time frame of the, 

5 

responses  received  is  proposed.  The  scientific  basis  upon  which  these  deferral  periods  are 
made must be kept under review. 

16.1n those  situations  where  a donor  is deferred  temporarily,  provisions  must  be  made  to  allow 

him / her to be considered for donation again at the end of the deferral  period. 

6.  DATA PROTECTION 

17. Although  the measures  taken by Member  States  to  ensure  the protection  of  data  related  to  a 
blood  or plasma  donor were not  addressed  in the  Commission  survey, relevant  requirements 
are  laid  down  in  Directive  95/46/EC.  Measures  to  ensure  positive  donor  identification,  the 
verification  of  data,  safeguards  against  unauthorised  access  to  information,  data  additions, 
deletions  or  modifications,  data  irregularities  and  discrepancies  and  the  security  of 
confidential  data  all  need  to  be  taken  into  account.  This  is  particularly  applicable  in  cases 
where an individual is deferred. 

18.Article 8 of the Directive refers  to the processing  of special categories  of data including  that 
concerning health. According to this Article, the processing of such data shall be prohibited in 
the Member  States. It  establishes,  however,  certain  cases  in which  this  prohibition  shall  not 
apply  such  as when  the data  subject  has given his / her explicit  consent  to the processing  of 
those  data,  when  the  data  processing  is  required  for  the  purposes  of  preventive  medicine, 
medical  diagnosis,  the  provision  of  care  or  treatment  or  the  management  of  health  care 
services,  and  where  those  data  are processed  by  a health professional  subject  under  national 
law or rules established by national competent bodies to the obligation of professional  secrecy 
or by another person also subject to an equivalent obligation. The Article also establishes  that 
Member  States  may,  for  reasons  of  substantial  public  interest,  lay  down  exemptions  to  the 
prohibition with such measures notifiable to the Commission. 

7.  VOLUMES  COLLECTED 

19.The maximum amount of whole blood or plasma collected from a donor at any one sitting and 
over a  12 month period, the time interval between the donations, and the allowable  frequency 
over a given time period have been established  in order to prevent  any adverse  effects  to  the 
health of the donor as a consequence of the donation. For whole blood, the maximum  volume 
collected  during  an  individual  donation  (450  ml  ±  10%)  and  the  minimum  time  interval 
between  donations  (8  weeks)  are  practically  the  same  in  all  the  Member  States  and  are  in 
keeping  with  recommendations  of  the  Council  of  Europe  (1997)  and  the  World  Health 
Organization  (1994).  Two  Member  States  as  well  as  the  standards  of  the  American 
Association of Blood Banks (AABB), however, permit a higher volume (500- 525 ml). 

20.For apheresis plasma, the maximum volume collected during an individual donation and over 
a  12 month period varies among the Member  States - from 550 to 650 ml per donation; 0.5 to 
1 litre per week; and  10 to 25 litres per year. The frequency of donations varies between twice 
per week and twice a month  and the maximum number of donations varies between 4 and  50 
per year. This wide variation may be attributed  in part to the differences  between manual  and 
automated plasmapheresis. 

21. As a significant  volume of plasma and plasma products, sourced from donors who are paid, is 
imported  into  the  Community  from  the United  States  of America,  it has  to  be noted  that  the 
allowable maximum plasma volume per individual donation, and over a  12 month time frame, 

6 

are  higher  in  the  USA than  those  currently  permitted  in  several  Member  States.  The 
maximum  volume  of plasma  allowed per donation  in the USA depends  in practice  on the 
weight  of the donor:  625 ml for  donors  weighing  between  50-67  kg;  750 ml  for  donors 
weighing between 68-79 kg; and 800 ml for those weighing 80 kg or more. 

22.According  to  the  1997 report  of  the  Swedish  National  Working  Group  on  Blood  Self-
sufficiency,  "the volume of plasma collected is based mainly on theoretical calculations about 
how much fluid  can be lost without risk to the donor. In the US where the body size of the 
donor  is  used  to  determine  the  allowable  volume,  the  donor's  blood  status  has  been 
systematically monitored without detecting disturbances." 

23.In  view  of the Community's  goal  of self-sufficiency  and the lack  of progress  towards it, 
serious  consideration  has to be given  to  allowing  an increase  in the maximum  allowable 
volumes of plasma currently prevailing in the Member States. This would  contribute to the 
goal of self-sufficiency.  The view espoused by some that higher volumes are detrimental to 
the health  of the  donor  does not appear to be substantiated  by scientific  evidence.  On the 
contrary,  the United  States Department  of Health  and Human  Services  stated  in  1992 in a 
memo9  to  licensed  source  plasma  establishments  that  "An  analysis  based  on  comparison 
between the allowable volume of source plasma derived from whole blood  collected  during 
manual  plasmapheresis  and  the  experience  to  date  with  all  of  the  approved  equipment 
(automated plasma collection devices) indicates that there is no discernible impact on donor 
safety, or product quality with the use of the current limits in preference to any other". 

24.Until  scientific  evidence  is adduced  to show  that  permitting  an increase  in the volume of 
blood or plasma collected from a donor or reducing the time interval between donations has a 
detrimental  effect  on the donor's  health,  and in view  of the benefits  for  Community  self-
sufficiency,  it is proposed that increased volumes such as those accepted in the United States 
scheme be recommended for application by the Member States. Programmes using increased 
volumes should be monitored closely to ensure that no detrimental effects  accrue to the donor. 

8.  SCREENING OF SAMPLES OF DONATED BLOOD 

25.Whether it is a donation of whole blood or components intended for transfusion  purposes or 
plasma collected through apheresis and intended for transfusion  or further  manufacturing into 
medicinal  products,  sample  specimens  of the blood  taken  from the  donor  at  the  time of 
collecting  the  blood  and  plasma  should  be  tested  for  markers  of  infections  that  can be 
transmitted to recipients. In order that the citizens of the Community have the highest degree of 
confidence  in the safety  of the blood  and blood  products  administered  for therapy, Member 
States should apply the same screening tests to the common source for both whole blood and 
components used for transfusion,and plasma used for fractionation with one exception, namely 
when plasma is collected by plasmapheresis for the sole purpose of fractionation some tests may 
not be required because the virus is not transmitted by plasma-derived products. 

26.The survey showed that whether the donation is of whole blood or plasma, almost all Member 
States require a sample of the donor's blood to be tested for antibodies against the hepatitis C 
virus (anti-HCV), antibodies  against the human immunodeficiency  virus type  1 and 2 (anti-

Department  of  Health  and  Human  Services.  FDA. Memo  to  All  licensed  Source  Plasma  Establishments.  4 
November 1992. 

7 

this  reflects 

the  mandatory 

HIV  1 and  2),  the  surface  antigen  of  the  hepatitis  B  virus  (HBsAg),  and  syphilis.  With  the 
exception  of  syphilis, 
the  European 
Pharmacopoeia  monograph  on  'Human  Plasma  for  Fractionation'  for  all  blood  and  plasma 
donations  used  as source material  for  the preparation  of industrially  manufactured  medicinal 
products.  As  syphilis  is  not  transmissible  by  plasma-derived  products,  the  Biotechnology 
Working Party of the Committee for Proprietary Medicinal Products (CPMP) advised in  1995 
that this  test  is not  required  for  plasma  for  fractionation  . Only  one Member  State  does  not 
test for syphilis. 

requirements  of 

27.Requirements  for  other  tests  for  markers  of  various  diseases  transmissible  by  blood 
transfusion  vary  among  the Member  States. A malaria  test  is generally  not  required  but  five 
Member  States  allow  for  it  "when  required"  or  required  "for  travellers  to  endemic  areas". 
Testing for  antibodies to human T-cell lymphotropic virus (anti-HTLV  I and II) is carried  out 
in six Member  States with one indicating that it is carried out on first time donors and  another 
reporting  that  although  not  required  it  is  done. Testing  for  hepatitis  B  core  antibodies  (anti-
HBc)  is  carried  out  in  five  Member  States  for  whole blood  donations  with  three  requiring  it 
only  for  first  time donors. HIV p24  antigen  test  is not required  in any  of the Member  States 
but is a pilot project  in one. Only one Member State requires neopterin testing for whole blood 
donations. 

28.The  survey  substantiated  earlier  reports  regarding  tests  that  are  required  in  some  Member 
States  and  not  in  others  leading  to  impediments  on the utilisation  of  excess plasma,  the  free 
movement  of  plasma-derived  products,  and  therefore  to  a  lack  of  progress  towards 
Community  self-sufficiency.  This  difficulty  arises  particularly  with  reference  to  alanine 
aminotransferase  (ALT)  which  is  not  required  by  the  European  Pharmacopoeia.  Plasma 
collected by some Member States that has not undergone this test is rejected  for use by others. 
It  is noteworthy  that  an  expert  panel  at the National  Institute  of Health  of  the United  States 
recommended that its use be discontinued since, as shown by scientific  data, it had outlived  its 
usefulness  and was  of little value now  given the availability  of the HCV  test.  This view  was 
reiterated  by  the  experts  to  the  Adare  Colloquium  who  considered  that  ALT  screening  had 
become redundant because of the specific  screening for HBsAG and antibodies to hepatitis C. 

29.lt  follows  from 

the  above  that  a  set  of  scientifically-based  and  broadly-supported 
requirements,  as  well  as  a  procedure  for  making  decisions,  depending  on  the  results  of  the 
various  tests  that  donated  blood  undergoes,  should  be  established  based  on  agreed 
recommendations  for the Community. 

9.  COMMON  TERMINOLOGY 

the 

testing  of  donations 

30.A  fundamental  requirement  for  arriving  at common  criteria related  to the  suitability  of  donors 
and 
terminology.  Confusion  and 
misunderstandings  often  arise as a result of different  interpretations of the same terminology. In 
spite of the existence of several glossaries, there is still no consistent use of several terms in this 
sector  such  as  blood  products,  repeat  donors,  etc.  Therefore  common  terminology  for  use 
throughout the Community is proposed. 

the  use  of  common 

is 

10  DGIII/5941/94. "Selection  and screening of donors for blood / plasma as starting material for medicinal products. 
Position paper for  CPMP on harmonisation  of selection and screening  of donors/exclusion  criteria"  in"Inventory 
of Provisions  relating  to Medicinal  Products  Derived  from  Human  Blood  or Plasma",  Brussels, March  1995. 

10.  SCIENTIFIC COMMITTEE AND REPORTING 

31.The dynamic and rapidly-evolving environment of transfusion medicine, such as cytapheresis, 
total blood apheresis and cord blood collection as well as the questions posed by the availability 
or introduction of new technologies such as genome amplification technology (GAT) - a highly 
sensitive  technique  capable  of  detecting  viral  genomes  even  when  serological  tests  are 
negative  -  as  a  possible  screening  test,  demands  that  mechanisms  be  in  place  for  the 
Community to have ready access to scientific  and technical guidance and be able to respond 
quickly to changing technology and scientific information. Consideration will be given by the 
Commission  to  establishing  a Scientific  Committee  on blood  to  advise  it  on  these  and  the 
other matters covered in the proposed recommendation. 

32.Moreover, in order to ensure that all Member States are fully aware of developments that have 
implications at Community level and to keep the Council informed of the measures that have 
been  taken  towards  the  implementation  of  common  criteria  in  the  Community,  the 
Commission could prepare reports as appropriate. 

PROPOSAL FOR A 

COUNCIL RECOMMENDATION 

on the suitability of blood and plasma donors and 

the screening of donated blood 

in the European Community 

\p 

THE COUNCIL OF THE EUROPEAN UNION 

Having regard  to  the  Treaty  establishing  the European  Community,  and  in particular  Article  129 
thereof; 

Having regard to the proposal from the Commission ; 

Having regard to the opinion of the European Parliament, 

1.  Whereas  in  accordance  with  point  (o)  of  Article  3  of  the  Treaty,  Community  action  must 

include a contribution towards the attainment of a high level of health protection; 

2.  Whereas  the  Commission's  Communication  on  Blood  Safety  and  Self-sufficiency 

in  the 

European  Community  of December  1994 identified  the need  for  a blood  strategy  in  order  to 

reinforce  confidence  in the safety of the blood transfusion  chain and promote Community  self-

sufficiency; 

3.  Whereas  Council  in  its  Resolution  of  2  June  1995 ,  in  response  to  the  Commission's 

Communication, invited it to submit appropriate proposals in the framework of development of 

a blood strategy; 

4.  Whereas  Council  in its Resolution  of  12 November  1996  on a strategy  towards blood  safety 

and self-sufficiency  in the European  Community  invited  the  Commission  to  submit  proposals 

as  a  matter  of  urgency  with  the  view  to  encouraging  the  development  of  a  co-ordinated 

approach to the safety of blood and blood products; 

5.  Whereas the European Parliament in its resolutions on blood safety and self-sufficiency  through 

voluntary  unpaid  donations  in the European  Community 

has  stressed  the  importance  of 

ensuring the highest  level of safety  in the selection of donors and the testing  of donations  and 

has reiterated its continued support for the objective of Community  self-sufficiency; 

6.  Whereas  Council  Directive  89/381/EEC  extended  the  scope of pharmaceutical  legislation  to 

guarantee  the  quality,  safety,  and  efficacy  of  proprietary  industrially  prepared  medicinal 

products  derived  from  human  blood  or  human  plasma;  whereas  it  does  not  apply  to  whole 

blood, to plasma, or to blood cells of human origin; 

i 

.2 

3 

4 

5 

6 

7 

8 

9 

10 

O.J. 
O.J. 
COM (94)652 final. Brussels. 21.12.1994 
O.J. No C164, 30.6.95, p.l 
O.J.NoC374,  U. 12.96, p.l 
O.J.NoC268,  4.10.93, p.29 
O.J.NoC329,  6.12.93, p.268 
O.J. No C249, 25.9.95, p.231 
O.J.NoC141.  13 5.96. p.131 
O.J. No L181, 28.6.89, p.44 

It 

7.  Whereas  therapeutic  use  of  blood  and  medicinal  products  derived  from  human  blood  and 

plasma  contributes  significantly  to  saving  lives  and  yields  considerable  benefits  for  those 

suffering  from  long  term  blood  disorders;  whereas,  however,  in  spite  of  their  significant 

therapeutic  value,  blood,  blood  components,  and  blood  and  plasma  derivatives  have  the 

potential to transmit infectious diseases; 

8.  Whereas  the  availability  of  blood  and  plasma  used  for  therapeutic  purposes  and  as  starting 

material  for  the  manufacture  of  medicinal  products  is  dependent  on  the  willingness  and 

generosity of Community citizens who are prepared to donate; 

9.  Whereas donations should be voluntary and unpaid; 

10. Whereas in respect of blood or plasma as a starting material for the manufacture  of proprietary 

medicinal products, Article 3 of Council Directive  89/381/EEC refers  to measures: covered by 

the modification,  as to testing requirements, referred to in Article 6 of that Directive, to be taken 

by Member States to prevent the transmission of infectious diseases, comprising the application 

of the monographs of the European Pharmacopoeia and the recommendations of the Council of 

Europe and the World Health Organization as regards in particular  the selection and testing of 

blood  and  plasma  donors; to  promote  Community  self-sufficiency  in human  blood  or  human 

plasma; and to encourage voluntary unpaid donations of blood and plasma; 

11. Whereas  it  is  not  always  possible  to  know  at  the  time  of whole  blood  or  plasma  collection 

which donation may be used for further  manufacture  rather than used in  transfusion; 

12. Whereas  all blood  and plasma  used  for  therapeutic  purposes,  whether  for  transfusion  or  for 

further  manufacture  into  industrially-prepared  medicinal  products,  should  be  obtained  from 

individuals whose health status is such as to ensure that transmission of disease does not take 

place,  and  that  each  and  every  blood  donation  should  be  tested  in  accordance  with  rules 

which provide assurances that all necessary measures have been taken to safeguard  the health 

of Community citizens who are the recipients of blood and blood products; 

13. Whereas  given  that  the  blood  transfusion  systems  in  the  Member  States  of  the  European 

Community  exist to serve its citizens, it is necessary to secure their confidence  in the safety  of 

these systems; 

14. Whereas  disparities  in  policies  and  practices  among  the  Member  States  regarding  the 

selection  of  donors  and  the  screening  of  donations  within  the  Community  are  such  as  to 

undermine confidence  among its citizens as well as blood transfusion  services in the safety  of 

the blood and blood products and hinder the achievement of  self-sufficiency; 

12 

15. Whereas  the  goal  of  Community  self-sufficiency  can  only  be  achieved  through  co-operation 

among the Member States in order to overcome such disparities and build mutual confidence  in 

all aspects of safety of the blood transfusion  chain; 

16. Whereas the suitability of an individual to donate blood and plasma is an essential  component 

in contributing to the safety of blood and blood products and to the goal of  self-sufficiency; 

17. Whereas it is essential that all measures be taken to safeguard  the health of those who provide 

their blood  and plasma  and to minimise the hazard  of transmission  of infectious  diseases  by 

blood or blood products; 

18. Whereas  uniformity  and  consistency  throughout  the  Community  in the  acceptance  of  donors, 

the  screening  of  donations  and  the  recording  of  relevant  data  will  help  to  contribute  to  the 

achievement of self-sufficiency  and to increasing confidence  in the safety of blood and plasma 

donations  and  the  transfusion  process;  whereas  in  order  to  bring  about  such  uniformity  and 

consistency, and build confidence, measures are required at Community level; 

19. Whereas  measures  at  Community  level  should  take  into  account  existing  guidelines, 

recommendations and standards in the area of blood at both national and international levels; 

20. Whereas  in  accordance  with  the principle  of  subsidiarity,  any new  measure  taken  in  an  area 

which  does  not  fall  within  the  exclusive  competence  of  the  Community,  such  as  donor 

suitability and testing of donations, may be taken up by the Community only if, by reason of the 

scale  or  effects  of  the  proposed  action,  the  objectives  of  the  proposed  action  can  be  better 

achieved by the Community than by Member States; Whereas commonly  agreed  requirements 

on  donor  suitability  and  testing  of  donations  need,  therefore,  to  be  introduced  in  order  to 

contribute to the  safety  of donated blood and plasma and the health protection of donors  and 

to  permit  confidence  in  safety  of  the  transfusion  chain  among  citizens,  especially  as  they 

move  about  in  the  Community,  and  to  contribute  to  the  attainment  of  Community  self-

sufficiency  as provided  for in Community  legislation; 

21. Whereas  in  accordance  with  the  principle  of  proportionality,  the  means  to  be  deployed  at 

Community level for promoting sound practices and consistency throughout the Community  in 

the  suitability  of  blood  and  plasma  donors  and  the  screening  of  donated  blood  must  be  in 

proportion to the objective pursued; 

22. Whereas  recommendations  by the  Council, pursuant  to Article  129 of  the  EC  Treaty,  are  the 

appropriate  means  for  doing  so at  Community  level; whereas  such recommendations must  be 

congruent with the provisions of Directive 89/381/EEC; 

13 

23. Whereas recommendations on donor suitability and testing requirements form part of a strategy 

to  enhance  safety  of thé blood  transfusion  chain,  the other  elements  of  which  include  the 

inspection  and  accreditation  of  blood  collection  establishments,  requirements  related  to 

quality  assurance  of the processes  involved,  the optimal use of blood  and blood products, 

haemovigilance, and public awareness; 

24. Whereas it is necessary that the best possible scientific advice is available to the Community in 

relation to the safety of blood and blood products; 

25. Whereas Directive 95/46/ËC11 on the protection of individuals with regard to the processing 

of personal data and the free movement of such data lays down special requirements for the 

processing of data concerning health; 

HEREBY RECOMMENDS" THAT 

1.  DEFINITIONS 

For the purpose of this Recommendation, Member States assign to the terms listed in Annex  1  the 

meaning given to them therein; 

2.  PROVISION OF INFORMATION TO PROSPECTIVE DONORS 

Member States provide to all prospective donors of blood or plasma: 

2.1  For donor awareness 

a.  Accurate but generally understandable  educational materials about the essential nature of 

blood,  the products  derived from it,  and the  important benefits  to patients  of blood  and 

plasma donations; 

b.  The  reasons  for  requiring  a  medical  history,  physical  examination,  and  the  testing  of 

donations; information  on the risk of infectious diseases that may be transmitted by blood 

and blood products; the signs and symptoms of AIDS, and the significance  of  'informed 

consent', self-deferral,  and temporary and permanent deferral; 

c.  The reasons why they should not donate which may be detrimental to their own health; 

d.  The reasons why they should not donate which put recipients at risk, such as unsafe sexual 

behaviour, HIV /AIDS, hepatitis, drug addiction and the use and abuse of drugs; 

e.  The option of changing their mind about donating prior to proceeding further  without any 

undue embarrassment or discomfort; 

11  O.J. No L281, 23.11.95, p.31 

14 

f.  Information  on  the  possibility  of  withdrawing  or  self-deferring  at  any  time  during  the 

donation process; 

g.  The opportunity to ask questions at any time; 

h.  The undertaking that if test results shows evidence of any pathology, they will be contacted 

by the blood collection centre; 

i.  Specific  information  on the nature of the procedures  involved  in the donation process  and 

associated  risks  for  those  willing  to  participate  in  apheresis  programmes,  whether  for 

plasma or cellular components. 

2.2  Confidentiality 

a.  The measures taken to ensure the confidentiality  of:  any health-related  information  provided 

to the  authorised  health personnel, the results of the tests on their donations, as well  as any 

future traceability of their donation; 

b.  The assurance that all interviews with prospective donors are carried out in private; 

c.  The option of requesting the medical staff of the blood collection centre not to use his / her 

donation. 

3. 

INFORMATION REQUIRED FROM PROSPECTIVE  DONORS 

Member  States  ensure  that,  upon  agreement  of  a  willingness  to  proceed  to  donate  blood  or 

plasma,  all prospective donors (whether first time, new, repeat or regular) provide to the blood 

and plasma collection establishment: 

3.1 

Identification 

Identification,  supported by valid official  documentation providing name (first  and surname), 

address, and date of birth. 

3.2  Health  history 

a.  Information  on their health and medical history including any relevant social and behavioural 

characteristics that may assist in identifying  and screening out persons whose donation could 

present a higher risk of transmitting infections  as well as those who could have contracted  a 

recent infection that may not yet be detectable in the screening tests; 

b.  Answers  to  questions  about  their  health  and  medical  history  by  way  of  a  written 

questionnaire  and  a  personal  interview  with  a  trained  health  care  staff  member  which 

should address the elements and risk behaviours listed in Annex 2: 

c.  Their  signature  and that  of the health  care  staff  member  conducting  the  interviews  on  the 

donor questionnaire acknowledging that the educational materials provided have been read 

15 

and  understood,  the  opportunity  to  ask  questions  has  been  presented,  and  satisfactory 

responses have been received; 

3.3 

Informed  consent 

a.  Their informed  consent in writing that they wish to proceed with the donation process; 

b.  The prospective  donor's  agreement  that if their blood  or plasma donation  becomes  excess 

to the needs of their own Member State, it may be shared with another Member State of the 

Community that is in need ; 

4.  REGISTRATION OF DONOR 

Member  States,  in  order  to  facilitate  future  verification  of  repeat  and  regular  donors,  future 

tracing  of  donations,  and  future  exchanges  of  information*  establish  a  mutually  compatible 

donor identification  / registration system to: 

4.1  Donor centre  identification 

a.  Permit  every  donation  centre  in  each  Member  State  to  be  uniquely  identified,  by 

communicating  to all other Member States and to the Commission a list of centres and  their 

identification  comprising the country code and a suitable combination of letters and numbers 

at their discretion; 

4.2  Donor identification  and registry 

a.  Require  that  all  relevant  information  regarding  the  identification  of  prospective  donors  be 

recorded  in  an  automated  or  manual  system  for  new  and  first  time  donors  and  be  verified 

prior to each donation for repeat and regular donors; 

b.  Provide  for  the  keeping  of  records  on  donors  and  prospective  donors  in  such  a  way  as  to 

ensure  unique  identification,  protect  the  identity  of  the  donor  from  unauthorised  access  to 

confidential  information, but facilitate future traceability of any donation; 

c.  Allow  for  the  inclusion  of  information  related  to  adverse  donor  reaction  to  the  donation, 

reasons  for  preventing  an  individual  from  donating,  whether  on  a  temporary  or  permanent 

basis while ensuring  confidentiality. 

5.  DONOR SUITABILITY 

Member  States, in order to ensure the suitability of individuals to be accepted  as donors  of blood 

and plasma: 

5.1  Suitability criteria for the acceptance of whole blood and apheresis plasma donors 

a.  Ensure that general criteria for the acceptance of blood and plasma donors are clearly  spelt 

out  in  every  donation  centre  and  that  clear  messages  are  presented  to  donors  as  to  the 

importance of their willingness to donate but also the importance of the acceptance criteria; 

16 

b.  Ensure that the responses given to the issues raised in the written questionnaire  and / or the 

personal  interview,  as  presented  in  Annex  2,  provide  the  necessary  confidence  that  the 

donation will not adversely affect  the health of a future recipient of the products derived from 

that donation; 

c.  Ensure  that  the  prospective  donor  meets  the  physical  requirements  criteria  contained  in 

Annex 3 in order that there are no detrimental effects  to his / her own health as the result of 

the donation; 

d.  Ensure that the prospective donor's suitability is determined at each donation session; 

e.  Prohibit or phase out the practice of using'replacement donors'; 

f.  Require  the  responsible  physician  to  give  his  /  her  written  authorisation  as  to  the  final 

determination of the suitability of a prospective donor, when this may be questionable. 

6.  DONOR  INELIGIBILITY 

Member States, in order to ensure that the prospective donors do not cause harm to their own health 

nor that their donation present a risk of transmission of infectious diseases: 

6.1  Deferral  criteria for whole blood and apheresis plasma  donors 

a.  Ensure those who may show evidence of one of the characteristics  listed  in Annexes 4 and '  , 

5  should  be  rendered  either  permanently  or  temporarily  ineligible  to  donate  blood  and 

plasma; 

b.  Ensure  that  appropriate  provisions  are  in  place  in  the  donation  centre  for  counselling,  as 

appropriate, to prospective donors who are  deferred. 

6.2  Deferral  registers 

a.  Maintain  a  record  of  any  prospective  donor  deferral,  whether  permanent  or  temporary, 

including the reasons why; 

b.  Ensure  that  such  donor  deferral  registers  are  set  up  so  as  to  fully  respect  data 

confidentiality  requirements  but  be  available  for  consultation  by  authorised  personnel  of 

the  blood  collection  establishment  or  appropriate  authorities  when  matters  of  safety  are 

concerned. 

7.  DATA  PROTECTION 

Member  States,  in  order  to  ensure  the  confidentiality  of  sensitive  medical  information  about 

prospective donors: 

a.  Ensure  that  measures  are  in  place  for  prospective  donor  identification  and  accurate  data 

verification; 

17 

b.  Ensure that  data  security measures  are in place as well  as safeguards  against  unauthorised 

data additions, deletions or modifications  to donor files or deferral registers, and transfer  of 

information; 

c.  Ensure that procedures are in place to resolve data discrepancies; 

d.  Prevent the unauthorised  disclosure of such information,  while ensuring the traceability  of 

donations; 

e.  Pay  particular  attention  to  compliance  with  the  requirements  of  Directive  95/46/EC  in 

particular its Article 8, when processing data related to blood and plasma donors. 

8.  VOLUMES COLLECTED FOR SAFETY OF DONOR 

To protect the health of the donor, Member States: 

a.  Adhere  to the  maximum  volumes  of blood  and plasma  collected  at  a  single  donation  and 

over a 12 month period presented in Annex 6; 

b.  Adhere to the minimum time intervals between donations as presented in Annex 6; 

c.  Ensure  that  medical  attention  is  available  to  the  donor  in  the  event  of  an  adverse  event 

related to the donation. 

9. 

TESTING  SAMPLES OF DONATED BLOOD 

Member States, in order to ensure the safety of all blood and plasma donations: 

a.  Ensure  that  a  sample  of  all  donations  whether  intended  for  transfusion  purposes  or  for 

further  manufacturing  into  industrially  prepared  medicinal  products  is  tested  for  diseases 

transmissible  by  blood  using  licensed  screening  tests  to  eliminate  units  that  are  repeat 

reactive; 

b.  Ensure that all blood donations be found non-reactive for the transmissible disease markers 

listed in Annex 7; 

c.  Require re-testing  of the blood  samples  found  to be reactive  in  an  initial  screening  test  in 

accordance with the general algorithm set out in Annex 8; 

10. 

ADDITIONAL  MEASURES 

a.  Member States take the necessary steps for the dissemination of this recommendation to all 

parties concerned, and in particular to blood establishments in their territory; 

b.  Member States take all necessary measures to encourage the voluntary and unpaid  donation 

of blood or plasma; 

INVITES THE  COMMISSION 

To report on the application  of these recommendations  and keep the matters covered therein under 

review in order to take the necessary steps for revision and updating. 

Done  at Brussels 

g

F or  t he  Council 
The President 

 
ANNEX 1 

Common Terminology 

Blood 

Blood product 

Blood component 

Whole  blood  collected  from  a  single  donor  and  processed  either  for  transfusion  or 
further  manufacturing 

Any therapeutic product derived from human whole blood or plasma donations. 

Therapeutic  components of blood (red cells, white cells, plasma, platelets)  that can be 
prepared  by  centrifugation,  filtration,  and  freezing  using  conventional  blood  bank 
methodology. 

Plasma derivative 

Highly  purified  human  plasma  protein  prepared  under  licensed  pharmaceutical 
manufacturing conditions 

Cell-derivative 

Donor 

A therapeutic product derived from a blood  component  (as derived  from  leukocytes 
- interferon,  cytokines - or from outdated erythrocytes - haemoglobin solution) 

First time donor 

Someone who has never donated either blood or plasma. 

Deferred donor 

Someone who, for protection of their own health or that of potential recipients of blood 
products prepared from his / her donation, is not permitted to give blood or plasma. 

Lapsed donor 

New donor 

Someone who routinely had donated blood or plasma  (regular  donor)  and has  stopped 
presenting himself / herself to donate. 

Someone who has not donated blood or plasma within the last year or is not listed in 
the local donor registry. 

Prospective donor 

Someone  who  presents  himself  /  herself  at  a  blood  or  plasma  collection 
establishment and states his / her wish to give blood or plasma. 

Repeat donor 

Regular donor 

Someone  who  has  donated  before  and  within  the  last  year  in  the  same  donation 
centre. 

Someone  who  routinely  donates  their  blood  or  plasma  at  the  permissible  time 
intervals. 

Replacement donor 

Donors recruited by patients to enable them to undergo elective surgery. 

Medicinal product derived from blood or plasma 

Same meaning as in Directive 89/381/EEC 

Suitability 

Process by  which  an  acceptance  decision  of  a prospective  blood  or plasma  donor 

can be made. 

Personal data 

Any  information  relating  to  an  identified  or  identifiable  natural  person  who  can  be 
identified,  directly  or  indirectly,  in  particular  by  reference  to  an  identification 
number  or  to  one  or  more  factors  to  his  physical,  physiological,  mental,  economic, 
cultural or social identity. (Directive 95/46/EC) 

Voluntary, unpaid blood donation 

Same meaning as in Directive 89/3 81/EEC 

l9 

ANNEX2 

Common Elements to be Covered in a Donor Questionnaire 

Indication that the questionnaire is to be completed, signed and dated 

General health of the donor 

Whether prospective  donor 

has recently consulted a doctor 
is taking any medication 
has haemophilia or related blood clotting disorders 
participates in hazardous sports (e.g. motor racing) 
undertakes employment that might cause problems within 24 hours after blood  donation 
is pregnant or has delivered a child now under  1  year (for  women) 
has received growth hormone or pituitary extract treatment 
has received  a blood  transfusion 
has had a corneal or dura mater transplant 
has  undergone  tattooing,  acupuncture,  body  piercing  by  someone  other  than  qualified  and  /  or 
licensed  professional 
has been in recent contact (<3 weeks) with contagious infections, chicken pox, measles 
has recently received a vaccination(polio, tetanus, holiday vaccinations) 
has recently (<5 days) ingested aspirin (or other pain killers) 
is working as a prostitute 
is HIV positive 
has a spouse who is HIV positive 
has a family  history of Creutzfeldt-Jacob disease (CJD) 
self-injects  drugs 

Whether prospective  donor has / had 

Brucellosis 
Epilepsy 
Hepatitis 
Jaundice 
Major  surgery/serious  illness 
Malaria 

«  Whether prospective donor has travelled 

•  Outside Western Europe & North America 

•  Men who have sex with other men 

•  Sexual activity in  Africa 

•  Sexual activity in countries other than those in Africa:  (to specify  country) 

•  Self-exclusion  option 

The questionnaire  has to be given and completed at every visit. 

2o 

ANNEX3 

Common Acceptance Criteria for Blood and Plasma Donors 

Age 

Blood and plasma donors should be  18 - 65 years of age. Acceptance of first time donors age 60 -
65  is  at the  discretion  of the responsible  physician.  Repeat  donors  may  continue  to  donate  after 
the age of 65 with the permission of the responsible physician given annually. 
For  whole  blood,  donors  aged  17,  and  not  legally  classified  as  minors,  may  be  accepted; 
otherwise written consent should be required according to applicable law. 

Body weight 

Donors weighing no less than 50 kg may donate whole blood or plasma. 

Blood pressure 
The  systolic  blood  pressure  should  not  exceed  180  mm  of  mercury  and  the  diastolic  pressure 
should not exceed  100 mm of mercury. 

Pulse 
The pulse should be regular and between 50 -  110 beats per minute. Those prospective  donors who 
undergo  intensive  sport  training  and  have  a  pulse  rate  lower  than  50  beats  per  minute  may  be 
accepted. 

Haemoglobin 

The haemoglobin  concentration  should be determined prior to donation  and  shall be no  less  than 
12.5 g/100 ml  for  females  and  13.5 g/100 ml for males (or equivalent values expressed  in mmol / 
1). For apheresis plasma donors, the minimum shall be  12.5 g/100 ml for both males and  females. 

Haematocrit 

The packed cell volume (haematocrit)  should be determined prior to donation and shall be no less 
than  38%  for  females  and  40%  for  males.  For  apheresis  plasma  donors,  the  minimum  shall  be 
38%. 

Donation interval 

For whole blood, the time interval between donations should be greater than 8 weeks. 
For apheresis plasma, this interval should not be less than 72 hours. 

Donation  frequency 

For  whole  blood,  the  maximum  number  of times  allowable  for  donations  should  be  6 /  year  for 
men, 4 / year for women and 3 / year for pre-menopausal donors. 
For apheresis plasma, the maximum donation frequency  should be twice per week, 

Z\ 

ANNEX4 

Common Deferral Criteria for Blood and Plasma Donors 
(For protection of donor) 

1.  Permanent deferral 

Prospective  donors  with  any  or  a  history  of  any  of  the  following  should  be  declared  permanently 
ineligible to donate blood or plasma for the protection of their own health: 

•  Auto-immune diseases 

•  Cardiovascular diseases 

•  Central nervous system diseases 

•  Malignant diseases 

•  Abnormal bleeding tendency 

•  Fainting spells (syncope) or convulsions 

Permanent  deferral  in  cases  where  prospective  donors  have  or  have  had  a  severe  or  chronic 
gastrointestinal,  haematological,  metabolic, respiratory,  or renal  disease, not  included  in  the  preceding 
categories, should be determined by a qualified physician in the blood collection establishment. 

2. 

Temporary  deferral 

Ineligible for  1 year 
•  Abortion 

•  Pregnancy (after delivery) 

NOTE:  Additional reasons may exist for the temporary deferral of a donor for the protection of their own 
health.  A decision as to length of time is at the discretion of a qualified  physician in the blood 
collection establishment. 

IX 

ANNEX 5 

Common  Deferral  Criteria for Blood  and Plasma  Donors 
(For protection  of  recipient) 

1.  Permanent  deferral 

Prospective  donors  with  any,  or  a  history  of  any,  of 
ineligible to donate blood or plasma for the protection of potential recipients. 

the  following  should  be  declared  permanently 

•  Auto-immune  diseases 
• 

Infectious  diseases- persons suffering  or having suffered  from 

Babesiosis 
Brucellosis 
Creutzfeldt Jacob disease (CJD) (persons in whose family this has  occurred) 
Hepatitis B (HBsAg confirmed  positive) 
Hepatitis C 
Hepatitis, infectious  (of unexplained  aetiology) 
HIV/AIDS 
H T L V I / II 
Leprosy 
Kala Azar  (leishmaniasis) 
Q  fever 
Syphilis 
Trypanosoma  cruzi (Chagas'  disease) 

•  Malignant  diseases 

Alcoholic, chronic 
Cornea / dura mater transplantation recipient 
Intravenous (IV) drug use 
Males who have sex with other males 
Pituitary hormone of human origin (e.g. growth hormone) recipient 
Prostitutes (male and  female) 

2.  Temporary  deferral 

Prospective  donors with  any of the following  conditions  should be declared  ineligible  to donate blood  or 
plasma temporarily. The time interval for deferral  varies according to the condition. 

2.1 

Ineligible  for  3 years 

•  Tuberculosis  (after  recovery) 

2.2 

Ineligible  for  1 year 

Accidental exposure to blood or blood contaminated  instruments 
Acupuncture  (if not performed  by a qualified  physician) 
Blood transfusion  recipient 
Body piercing 
Drug allergy (after  last exposure) 
Tattoo 
Toxoplasmosis  (after  recovery) 
Individuals  who  have  had  sexual  relations  with  someone  infected  or  at  increased  risk  of 
infection  with HBV, HCV, HIV 

23 

2.3 

Ineligible for 6 months 

•  Mononucleosis infectiosa (after recovery) 
•  Surgery, major 

2.4 

Ineligible for 4 weeks 

•  Following administration of live attenuated viral vaccines 

2.5 

Ineligible for 48 hours 

•  Following administration of killed / inactivated viral / bacterial and rickettsial vaccines 
•  Following administration of vaccines (desensitising) 
•  Rabies vaccine (prophylactic administration) 

2.6 

Ineligible  (time frame variable) 
•  Hepatitis A 
•  Malaria (does not apply to plasmapheresis donors) 
•  Prescribed medicines 
•  Tropical diseases (other) 

NOTE:  Additional  reasons  may  exist  for  the  temporary  deferral  of  a  donor  for  the  protection  of  the 
recipient. A decision as to length of time is at the discretion of a qualified physician in the blood 
collection establishment. 

H 

ANNEX 6 

Common Volumes to be collected 
and time intervals 
for whole blood and plasma donations 

Whole Blood 

Maximum Volume 

per donation 

per consecutive 12 month period 

Minimum time interval between donations 

Maximum number of donations per 12 month period 

Automated  plasmapheresis 

Maximum Volume  per donation 

Donor Weight 

50-67 kg 
68-79 kg 
80 kg or more 

Minimum time interval between donations 

Maximum number of donations per 7 day period 

500 ml 

3 litres 

8 weeks 

6 (males) 
4 (females) 

(3 for pre-menopausal women) 

Volume Collected 
(excluding anticoagulant) 

625 ml 
750 ml 
800 ml 

72 hours 

2 

2s 

ANNEX 7 

Common Testing Requirements for all Blood Samples 
whether a whole blood or plasma donation 

For all blood and plasma  donations 

Antibodies to the Hepatitis C virus 

Anti-HCV 

Antibodies to the human immunodeficiency  virus 1 

Anti-HIV 1 

Antibodies to the human immunodeficiency  virus 2 

Anti-HIV 2 

Surface antigen of Hepatitis B 

HBsAg 

In  addition 

For all, excluding plasmapheresis intended only for  fractionation. 

ABO group 

Rhtype 

Malaria 

Treponema pallidum (syphilis) 

for travellers to endemic areas 

2& 

ANNEX 8 

Common Algorithm for 
Interpretation of reactive results in screening tests in relation to 
clinical use of donation and 
Reactive results in supplementary / confirmation  tests 
in relation to donor deferral 

blood sample 
1 x screening 
test 

screening test 
reactive/doubtful 

± 
± 

screening 
test 

\J/ 
unit/ 
donor 
cleared 

vr 

all tests negative 

donor cleared 

± 

all tests negative" 

| 

donor cleared 

^ 

negative 
donor and donation cleared 

2 repeats of the same test kit 

± 

screening 
test 
+  + 

± 

M/ 
screening 
test 
+  ? 

± 

eliminate unit 

± 

screening 
test 
+  /? 

± 

2 repeats of the screening test from another manufacturer 

v 
± 

one of tests doubtful or positive 

± 

in case of positive/doubtful or 
lacking result, plasma processing 
establishment 
to be informed about previous 
donations within 7 days 

^ 

2nd blood sample 

different screening tests 

X 
± doubtful 
± 

exclude/inform donor 

\k 

further clarification 

test positive 

± 
± 
± 

look back 

exclude/inform donor 

x\ 

FINANCIAL STATEMENT 

PROPOSAL  FOR A COUNCIL  RECOMMENDATION 
ON  THE  SUITABILITY  OF  BLOOD  AND  PLASMA 
DONORS  AND  THE  SCREENING  OF  DONATED 
BLOOD IN THE EUROPEAN COMMUNITY 

The proposal for a draft  Recommendation on the suitability of blood and plasma donors and the 
screening of donated blood  in the European  Community has no financial  impact  either  on the 
operational budget or on any human or administrative expenses. 

2& 

IMPACT ASSESSMENT FORM ON 
COMPETITIVENESS AND EMPLOYMENT 

PROPOSAL  FOR A COUNCIL  RECOMMENDATION 
ON  THE  SUITABILITY  OF  BLOOD  AND  PLASMA 
DONORS  AND  THE  SCREENING  OF  DONATED 
BLOOD IN THE EUROPEAN COMMUNITY 

The proposal for a draft  Recommendation on the suitability of blood and plasma donors and the 
screening of donated blood in the European Community has no impact on competitiveness and 
employment. 

l°l 

ISSN 0254-1475 

COM(97) 605  final 

DOCUMENTS 

EN 

05  15 

Catalogue number  :  CB-CO-97-617-EN-C 

ISBN  92-78-27583-2 

Office  for  Official  Publications  of the European  Communities 

L-2985  Luxembourg 

3D