council recommend june suitabl blood plasma donor screen donat blood european commun ec council european union regard treati establish european commun articl indent regard propos commiss regard opinion european parliament accord articl treati commun activ includ contribut attain high level health protect commiss commun decemb blood safeti suffici european commun identifi blood strategi order reinforc confid safeti blood transfus chain promot commun suffici respons commiss commun council adopt june resolut blood safeti suffici commun council adopt novemb resolut strategi blood safeti suffici european commun european parliament resolut blood safeti suffici european commun stress import ensur highest level safeti select donor test donat principl voluntari unpaid donat reiter continu support object commun suffici direct eec extend scope pharmaceut legisl guarante qualiti safeti efficaci proprietari industri prepar medicin product deriv human blood human plasma direct appli blood plasma blood cell human origin therapeut blood medicin product deriv human blood plasma contribut significantli save live yield consider benefit suffer long term blood disord spite signific therapeut blood blood compon blood plasma deriv potenti transmit infecti diseas avail blood plasma therapeut purpos start materi manufactur medicin product depend willing generos commun citizen prepar donat donat voluntari unpaid respect blood plasma start materi manufactur medicin product articl direct eec refer measur cover amend test requir refer articl direct member state prevent transmiss infecti diseas includ applic monograph european pharmacopoeia measur recommend council europ world health organis refer select test blood plasma donor promot commun suffici human blood human plasma encourag voluntari unpaid donat blood plasma time blood plasma collect donat manufactur transfus blood plasma therapeut purpos transfus manufactur industri prepar medicin product obtain individu health statu detriment effect state health ensu result donat risk transmiss infecti diseas minimis blood donat test accord rule provid assur measur safeguard health commun citizen recipi blood blood product blood transfus system member state exist serv citizen secur confid safeti system dispar polici practic member state select donor screen donat commun epidemiolog histor cultur reason ensur suffici suppli clinic purpos cooper member state essenti order overcom dispar build mutual confid aspect safeti blood transfus chain suitabl individu donat blood plasma essenti compon contribut safeti blood blood product inform sought potenti donor basi written questionnair vari member state member state aim identifi common risk behaviour diseas essenti measur safeguard health give blood plasma minimis hazard transmiss infecti diseas blood blood product converg practic commun accept donor screen donat record relev data contribut increas confid safeti blood plasma donat transfus process order bring converg practic measur requir commun level measur commun level account exist guidelin recommend standard area blood nation level intern level council europ accord principl subsidiar measur area fall exclus compet commun donor suitabl test donat commun reason scale effect propos action object propos action achiev commun member state commonli agre recommend donor suitabl test donat introduc order contribut safeti donat blood plasma health protect donor permit confid safeti transfus chain citizen move commun contribut attain commun suffici provid commun legisl member state remain free respect provis treati measur adopt thereund maintain introduc requir core criteria recommend recommend remain respons decis import export donat blood plasma accord principl proportion mean deploi commun level promot sound practic consist commun suitabl blood plasma donor screen donat blood proport object pursu recommend council pursuant articl treati mean commun level recommend congruent direct eec recommend donor suitabl test requir form part strategi enhanc safeti blood transfus chain element includ inspect accredit blood collect establish requir relat qualiti assur process involv optim blood blood product haemovigil public awar scientif advic commun relat safeti blood blood product precautionari principl prevail scientif evid direct ec european parliament council octob protect individu regard process person data free movement data lai special requir process data health recommend definit purpos recommend member state assign term list annex mean provis inform prospect donor member state ensur prospect donor blood plasma provid donor awar accur gener understand educ materi essenti natur blood product deriv import benefit patient blood plasma donat reason requir medic histori physic examin test donat inform risk infecti diseas transmit blood blood product sign symptom hiv aid hepat signific inform consent deferr temporari perman deferr reason donat detriment health reason donat put recipi risk unsaf sexual behaviour hiv aid hepat drug addict abus drug option chang mind donat prior proceed undu embarrass discomfort inform possibl withdraw defer time donat process opportun question time assur test result show evid patholog inform defer donat recommend annex ii safeti potenti recipi prospect donor object inform exclud donat process specif inform natur procedur involv donat process risk particip blood donat apheresi programm confidenti inform measur ensur confidenti health relat inform provid health personnel result test donat futur traceabl donat assur interview prospect donor carri confid option request confidenti deferr procedur blood plasma collect establish donat inform requir prospect donor member state ensur agreement willing proce donat blood plasma prospect donor provid blood plasma collect establish identif mean identif provid surnam addresss date birth altern mean allow donor uniqu identifi health histori inform health medic histori includ relev behaviour characterist assist identifi screen person donat present health risk risk transmit diseas written questionnair address criteria recommend annex ii person interview train health care staff member signatur alongsid health care staff member conduct interview donor questionnair signatur separ attest acknowledg educ materi provid read understood opportun question present satisfactori respons receiv give agreement blood plasma donat patient need transfus blood product countri donat made countri transfer accord provis legisl countri donat made regard destin donat inform consent proce donat process registr donor member state ensur establish donor identif registr system donor centr identif permit donat establish member state uniqu identifi donor identif record record inform identif prospect donor autom manual system verif time donat made provid keep record donor prospect donor ensur uniqu identif protect ident donor unauthoris access confidenti inform facilit futur traceabl donat inclus inform relat advers donor reaction donat reason prevent individu donat temporari perman basi ensur confidenti donor elig member state order ensur elig individu accept donor blood plasma ensur elig criteria accept donor blood donor compon apheresi gener criteria accept blood plasma donor publicis donat establish clear messag present donor import willing donat import accept criteria respons issu rais written questionnair person interview provid confid donat advers affect health futur recipi product deriv donat prospect donor meet physic requir criteria recommend annex ii order detriment effect health result donat prospect donor elig determin donat session practic replac donor phase respons physician written authoris accept prospect donor elig question deferr criteria donor blood donor compon apheresi show evid condit characterist list annex ii declar perman temporarili inelig donat blood plasma deferr record donat establish maintain record prospect donor deferr perman temporari includ reason data protect member state accord direct ec ensur confidenti sensit medic inform prospect donor ensur data secur measur place safeguard unauthoris data addit delet modif donor file deferr regist transfer inform ensur procedur place resolv data discrep prevent unauthoris disclosur inform ensur traceabl donat volum time interv protect health donor member state ensur volum blood plasma collect greater recommend annex iii time interv donat recommend annex iii medic attent donor event advers event relat donat test sampl donat blood member state order ensur safeti blood plasma donat ensur sampl donat blood plasma intend transfus purpos manufactur industri prepar medicin product test diseas transmiss blood plasma approv screen test elimin unit repeat reactiv ensur blood plasma donat found reactiv transmiss diseas marker list annex iv prior requir test blood sampl found reactiv initi screen test take account indic algorithm set annex addit measur member state ensur provis place donat establish counsel prospect donor defer encourag collect analysi evalu epidemiolog data donor donat view improv safeti blood transfus step dissemin recommend parti concern blood collect establish territori measur encourag voluntari unpaid donat blood plasma support effort council europ area account council europ definit voluntari remuner donat donat consid voluntari remuner person blood plasma cellular compon free receiv payment form cash kind consid substitut monei includ time work need donat travel small token refresh reimburs direct travel cost compat voluntari remuner donat invit commiss report applic recommend matter cover review order make propos revis updat involv nation expert member state prepar propos promot prioriti light scientif studi work potenti health effect depart maximum volum limit minimum time interv donat set annex iii order determin advers health effect result collect apheresi annual plasma volum higher recommend exist intern guidelin undertak work common volum frequenc limit type apheresi propos common terminolog purpos develop commun strategi blood safeti suffici examin close cooper member state aspect relat genom amplif technolog gat includ polymeras chain reaction pcr screen order prevent transmiss communic diseas blood transfus luxembourg june council presid cook oj oj oj oj oj oj oj council direct eec june extend scope direct eec eec approxim provis laid law regul administr action relat proprietari medicin product lai special provis medicin product deriv human blood human plasma oj oj annex gt tabl gt annex ii core criteria accept deferr blood plasma donor physic requir criteria accept blood plasma donor protect ag blood plasma donor year ag accept time donor ag discret respons physician repeat donor continu donat ag permiss respons physician annual blood donor ag legal classifi minor accept written consent requir applic law bodi weight donor weigh kg donat blood plasma blood pressur systol blood pressur exce mm mercuri diastol pressur exce mm mercuri puls puls regular beat minut prospect donor undergo intens sport train puls rate lower beat minut accept haemoglobin haemoglobin concentr determin time donat ml femal ml male equival valu express mmol haematocrit pack cell volum haematocrit determin time donat femal male apheresi plasma donor minimum plasmapheresi protein measur minimum litr deferr criteria blood plasma donor protect prospect donor histori qualifi physician blood collect establish declar perman temporarili inelig donat blood plasma protect health perman deferr auto immun diseas cardiovascular diseas central nervou system diseas malign diseas abnorm bleed tendenc faint spell syncop convuls sever chronic gastrointestin haematolog metabol respiratori renal diseas includ preced categori temporari deferr inelig month pregnanc deliveri abort inelig time frame variabl particip hazard sport employ problem shortli blood donat reason deferr criteria blood plasma donor protect recipi prospect donor histori qualifi physician blood collect establish declar perman temporarili inelig donat blood plasma protect potenti recipi perman deferr auto immun diseas infecti diseas person suffer suffer babesiosi hepat hbsag confirm posit hepat hepat infecti unexplain aetiolog hiv aid htlv ii leprosi kala azar leishmaniasi fever syphili trypanosoma cruzi chaga diseas malign diseas tse histori thereof genet famili alcohol chronic cornea dura mater transplant recipi diabet treat insulin intraven iv drug pituitari hormon human origin human growth hormon recipi sexual behaviour place high risk transmit infecti diseas includ person sex return monei drug temporari deferr inelig year tuberculosi declar cure toxoplasmosi recoveri absenc igm antibodi brucellosi full recoveri inelig year accident exposur blood blood contamin instrument acupunctur perform qualifi practition endoscop examin treatment involv cathet blood transfus major surgeri tissu cell transplant bodi pierc drug allergi allergi penicillin exposur tattoo close contact case hepat rabi vaccin post exposur inelig month infecti mononucleosi recoveri inelig week administr live attenu viral vaccin inelig week minor infecti diseas inelig week minor surgeri inelig hour administr vaccin desensitis inelig hour treatment dentist dental hygienist administr kill inactiv viral bacteri rickettsi vaccin rabi vaccin prophylact administr inelig time frame variabl hepat medicin malaria appli plasmapheresi donor tropic diseas addit reason exist temporari deferr donor protect recipi decis length time discret qualifi physician blood collect establish annex iii blood plasma donat gt tabl gt exist guidelin intern level area blood recommend litr maximum annual volum plasma collect autom plasmapheresi scientif evid advers health effect result higher volum collect area prioriti area scientif studi assess individu donat volum account physic characterist gender bodi weight annex iv core screen test blood sampl blood plasma donat gt tabl gt abo group rh type malaria travel endem area risk malaria transmiss dealt deferr period year travel treponema pallidum syphili proven blood group blood donor blood group previous determin verifi separ donat reliabl transfer label blood compon valid autom inform technolog system repeat determin abo rh group time blood donat case blood group blood donor period verifi requir apheresi plasma intend fraction annex indic algorithm interpret reactiv result screen test relat clinic donat reactiv result supplementari confirm test relat donor deferr gt refer film gt