commiss direct ec septemb implement direct ec european parliament council commun standard specif relat qualiti system blood establish text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon amend direct ec point paragraph articl thereof direct ec lai standard qualiti safeti collect test human blood blood compon intend purpos process storag distribut intend transfus ensur high level human health protect order prevent transmiss diseas blood blood compon ensur equival level qualiti safeti direct ec call establish specif technic requir includ commun standard specif regard qualiti system blood establish qualiti system blood establish embrac principl qualiti manag qualiti assur continu qualiti improv includ personnel premis equip document collect test process storag distribut contract manag conform inspect qualiti control blood compon recal extern intern audit direct lai technic requir account council recommend ec june suitabl blood plasma donor screen donat blood european commun direct ec european parliament council novemb commun code relat medicin product human commiss direct ec octob lai principl guidelin good manufactur practic respect medicin product human investig medicin product human commiss direct ec march implement direct ec european parliament council technic requir blood blood compon recommend council europ monograph european pharmacopoeia respect blood blood compon start materi manufactur proprietari medicin product recommend world health organis intern experi field order ensur highest qualiti safeti blood blood compon guidanc good practic develop support qualiti system requir blood establish take fulli account detail guidelin refer articl direct ec ensur standard requir medicin product maintain blood blood compon import countri includ start materi raw materi manufactur medicin product deriv human blood human plasma intend distribut commun meet equival commun standard specif relat qualiti system blood establish set direct qualiti system appli blood blood compon circul commun member state ensur blood blood compon come countri qualiti system place blood establish stage preced import equival qualiti system provid direct determin common definit technic terminolog order ensur consist implement direct ec measur provid direct accord opinion committe set direct ec adopt direct articl definit purpos direct definit appli quot standard quot mean requir serv basi comparison quot specif quot mean descript criteria fulfil order achiev requir qualiti standard quot qualiti system quot mean organis structur respons procedur process resourc implement qualiti manag quot qualiti manag quot mean ordin activ direct control organis regard qualiti level blood establish quot qualiti control quot mean part qualiti system focuss fulfil qualiti requir quot qualiti assur quot mean activ blood collect distribut made object ensur blood blood compon qualiti requir intend quot trace back quot mean process investig report suspect transfus advers reaction recipi order identifi potenti implic donor quot written procedur quot mean control document describ oper carri quot mobil site quot mean temporari movabl place collect blood blood compon locat control blood establish quot process quot mean step prepar blood compon carri collect blood issu blood compon quot good practic quot mean element establish practic collect lead final blood blood compon consist meet predefin specif complianc defin regul quot quarantin quot mean physic isol blood compon incom materi reagent variabl period time await accept issuanc reject blood compon incom materi reagent quot valid quot mean establish document object evid pre defin requir specif procedur process consist fulfil quot qualif quot part valid mean action verifi personnel premis equip materi work correctli deliv expect result quot computeris system quot mean system includ input data electron process output inform report automat control document articl qualiti system standard specif member state ensur qualiti system place blood establish compli commun standard specif set annex direct good practic guidelin develop commiss accord articl direct ec interpret commun standard specif refer paragraph develop guidelin commiss fulli account detail principl guidelin good manufactur practic refer articl direct ec member state ensur blood blood compon import countri intend distribut commun qualiti system blood establish stage preced import equival qualiti system provid articl articl transposit prejudic articl direct ec member state bring forc law regul administr provis compli direct august latest forthwith commun commiss text provis correl tabl provis direct member state adopt provis refer direct accompani refer occas offici public member state determin refer made member state commun commiss text main provis nation law adopt field cover direct articl entri forc direct enter forc dai public offici journal european union articl addresse direct address member state brussel septemb commiss marko kyprian member commiss oj oj oj direct amend direct ec oj oj oj annex qualiti system standard specif introduct gener principl qualiti system qualiti recognis respons person involv process blood establish manag ensur systemat approach qualiti implement mainten qualiti system qualiti system encompass qualiti manag qualiti assur continu qualiti improv personnel premis equip document collect test process storag distribut qualiti control blood compon recal extern intern audit contract manag conform inspect qualiti system ensur critic process instruct carri accord standard specif set annex manag review system regular interv verifi effect introduc correct measur deem qualiti assur blood establish hospit blood bank support qualiti assur function intern relat fulfil qualiti assur function involv qualiti relat matter review approv qualiti relat document procedur premis equip influenc qualiti safeti blood blood compon valid prior introduct valid regular interv determin result activ personnel organis personnel blood establish suffici number carri activ relat collect test process storag distribut blood blood compon train assess compet perform task personnel blood establish date job descript set task respons blood establish assign respons process manag qualiti assur individu function independ personnel blood establish receiv initi continu train specif task train record maintain train programm place includ good practic content train programm period assess compet personnel evalu regularli written safeti hygien instruct place adapt activ carri complianc council direct eec direct ec european parliament council premis gener premis includ mobil site adapt maintain suit activ carri enabl work proce logic sequenc minimis risk error effect clean mainten order minimis risk contamin blood donor area area confidenti person interview assess individu assess elig donat area separ process area blood collect area blood collect carri area intend safe withdraw blood donor appropri equip initi treatment donor experienc advers reaction injuri event blood donat organis ensur safeti donor personnel avoid error collect procedur blood test process area dedic laboratori area test separ blood donor blood compon process area access restrict authoris personnel storag area storag area provid properli secur segreg storag categori blood blood compon materi includ quarantin releas materi unit blood blood compon collect special criteria autolog donat provis place event equip power failur main storag facil wast dispos area area design safe dispos wast dispos item collect test process reject blood blood compon equip materi equip valid calibr maintain suit intend purpos oper instruct record equip select minimis hazard donor personnel blood compon reagent materi approv supplier meet document requir specif critic materi releas person qualifi perform task relev materi reagent equip meet requir council direct eec medic devic direct ec european parliament council vitro diagnost medic devic compli equival standard case collect countri inventori record retain period accept agre compet author computeris system softwar hardwar back procedur check regularli ensur reliabl valid maintain valid state hardwar softwar protect unauthoris unauthoris back procedur prevent loss damag data expect unexpect time function failur document document set specif procedur record cover activ perform blood establish place date record legibl handwritten transfer medium microfilm document computeris system signific document act promptli review date sign person authoris perform task blood collect test process donor elig procedur safe donor identif suitabl interview elig assess implement maintain place donat compli requir set annex ii annex iii direct ec donor interview conduct ensur confidenti donor suitabl record final assess sign qualifi health profession collect blood blood compon blood collect procedur design ensur ident donor verifi secur record link donor blood blood compon blood sampl establish steril blood bag system collect blood blood compon process ce mark compli equival standard blood blood compon collect countri batch number blood bag traceabl blood compon blood collect procedur minimis risk microbi contamin laboratori sampl time donat appropri store prior test procedur label record blood bag laboratori sampl donat number design avoid risk identif error mix blood collect blood bag handl maintain qualiti blood storag transport temperatur process requir system place ensur donat link collect process system collect process laboratori test laboratori test procedur valid donat test conform requir laid annex iv direct ec defin procedur resolv discrep result ensur blood blood compon repeatedli reactiv result serolog screen test infect virus mention annex iv direct ec exclud therapeut store separ dedic environ confirmatori test place case confirm posit result donor manag place includ provis inform donor follow procedur data confirm suitabl laboratori reagent test donor sampl blood compon sampl qualiti laboratori test regularli assess particip formal system profici test extern qualiti assur programm blood group serolog test includ procedur test specif group donor time donor donor histori transfus process valid equip technic devic accord valid procedur process blood compon carri valid procedur includ measur avoid risk contamin microbi growth prepar blood compon label stage contain label relev inform ident absenc valid computeris system statu control label distinguish releas releas unit blood blood compon label system collect blood intermedi finish blood compon sampl unmistak identifi type content compli label traceabl requir refer articl direct ec commiss direct ec label final blood compon compli requir annex iii direct ec autolog blood blood compon label compli articl direct ec addit requir autolog donat annex iv direct releas blood blood compon safe secur system prevent singl blood blood compon releas mandatori requir set direct fulfil blood establish demonstr blood blood compon formal releas authoris person record demonstr blood compon releas current declar form relev medic record test result meet accept criteria releas blood blood compon administr physic segreg releas blood blood compon absenc valid computeris system statu control label unit blood blood compon identifi releas statu accord event final compon fail releas due confirm posit infect test result conform requir set section check made ensur compon donat compon prepar previou donat donor identifi updat donor record storag distribut qualiti system blood establish ensur blood blood compon intend manufactur medicin product storag distribut requir compli direct ec procedur storag distribut valid ensur blood blood compon qualiti entir storag period exclud mix up blood compon transport storag action includ receipt distribut defin written procedur specif autolog blood blood compon blood compon collect prepar specif purpos store separ record inventori distribut packag maintain integr storag temperatur blood blood compon distribut transport return blood blood compon inventori subsequ reissu accept qualiti requir procedur laid blood establish ensur blood compon integr fulfil contract manag task perform extern defin specif written contract conform deviat blood compon deviat requir standard set annex direct ec releas transfus except circumst record agreement prescrib physician blood establish physician complaint complaint inform includ advers reaction advers event suggest defect blood compon issu document carefulli investig caus factor defect recal implement correct action prevent recurr procedur place ensur compet author notifi advers reaction advers event accord regulatori requir recal personnel authoris blood establish assess blood blood compon recal initi coordin action effect recal procedur place includ descript respons action includ notif compet author action pre defin period time includ trace relev blood compon applic includ trace back purpos investig identifi donor contribut caus transfus reaction retriev blood compon donor notifi consigne recipi compon collect donor event put risk correct prevent action system ensur correct prevent action blood compon conform qualiti problem place data routin analys identifi qualiti problem requir correct action identifi unfavour trend requir prevent action error accid document investig order identifi system problem correct inspect audit improv inspect audit system place part oper verifi complianc standard set annex carri regularli train compet person independ approv procedur result document correct prevent action time effect manner oj oj oj direct amend regul ec european parliament council oj oj direct amend regul ec page offici journal