血液管理辦法英文一、總則（一）目的本辦法旨在規(guī)范血液管理工作，確保血液質(zhì)量與安全，保障臨床用血需求，促進(jìn)無償獻(xiàn)血事業(yè)健康發(fā)展，依據(jù)相關(guān)法律法規(guī)及行業(yè)標(biāo)準(zhǔn)制定本辦法。英文表述為：ThisMeasuresaimstostandardizethemanagementofblood,ensurethequalityandsafetyofblood,guaranteetheclinicalblooduseneeds,andpromotethehealthydevelopmentoftheunpaidblooddonationcause.Thesemeasuresareformulatedinaccordancewithrelevantlaws,regulationsandindustrystandards.（二）適用范圍本辦法適用于在中華人民共和國境內(nèi)從事血液采集、檢測、儲存、運(yùn)輸、供應(yīng)等與血液管理相關(guān)活動的單位和個(gè)人。英文表述為：TheseMeasuresapplytounitsandindividualsengagedinactivitiesrelatedtobloodmanagementsuchasbloodcollection,testing,storage,transportation,supply,etc.withintheterritoryofthePeople'sRepublicofChina.（三）基本原則血液管理應(yīng)當(dāng)遵循自愿、無償、科學(xué)、安全的原則。鼓勵(lì)公民自愿無償獻(xiàn)血，確保血液來源合法、安全、可靠。嚴(yán)格執(zhí)行血液檢測標(biāo)準(zhǔn)，保障血液質(zhì)量符合國家規(guī)定。英文表述為：Bloodmanagementshallfollowtheprinciplesofvoluntariness,unpaid,scienceandsafety.Citizensareencouragedtodonatebloodvoluntarilytoensurethatthebloodsourceislegal,safeandreliable.Strictlyimplementbloodtestingstandardstoensurethatthebloodqualitymeetsnationalregulations.二、血液采集（一）獻(xiàn)血者招募1.設(shè)立專門的獻(xiàn)血者招募機(jī)構(gòu)或部門，通過多種渠道廣泛宣傳無償獻(xiàn)血知識和意義，提高公眾對無償獻(xiàn)血的認(rèn)知度和參與度。宣傳渠道可包括但不限于媒體廣告、社區(qū)宣傳、學(xué)校講座、網(wǎng)絡(luò)平臺推廣等。英文表述為：Establishspecialblooddonorrecruitmentagenciesordepartments,andwidelypublicizetheknowledgeandsignificanceofunpaidblooddonationthroughvariouschannelstoimprovethepublic'sawarenessandparticipationinunpaidblooddonation.Thepublicitychannelsmayincludebutarenotlimitedtomediaadvertisements,communitypublicity,schoollectures,onlineplatformpromotion,etc.2.對獻(xiàn)血者進(jìn)行健康征詢和體格檢查，確保獻(xiàn)血者身體狀況符合獻(xiàn)血要求。嚴(yán)格按照國家規(guī)定的獻(xiàn)血者健康標(biāo)準(zhǔn)進(jìn)行操作，不得采集不符合健康條件的血液。英文表述為：Conducthealthconsultationandphysicalexaminationonblooddonorstoensurethatthephysicalconditionsofblooddonorsmeettheblooddonationrequirements.Operatestrictlyinaccordancewiththenationalhealthstandardsforblooddonors,anddonotcollectbloodfromdonorswhodonotmeetthehealthconditions.3.建立獻(xiàn)血者信息管理系統(tǒng)，記錄獻(xiàn)血者的基本信息、獻(xiàn)血記錄、健康狀況等，以便對獻(xiàn)血者進(jìn)行跟蹤和管理。英文表述為：Establishablooddonorinformationmanagementsystemtorecordthebasicinformation,blooddonationrecords,healthconditions,etc.ofblooddonorsforthepurposeoftrackingandmanagingblooddonors.（二）采血操作1.采血機(jī)構(gòu)應(yīng)當(dāng)具備符合國家規(guī)定的采血場所、設(shè)備和人員。采血場所應(yīng)當(dāng)清潔、衛(wèi)生、安全，采血設(shè)備應(yīng)當(dāng)定期維護(hù)和校準(zhǔn)，確保正常運(yùn)行。采血人員應(yīng)當(dāng)經(jīng)過專業(yè)培訓(xùn)，取得相應(yīng)的資格證書。英文表述為：Bloodcollectioninstitutionsshallhavebloodcollectionsites,equipmentandpersonnelthatmeetnationalregulations.Thebloodcollectionsitesshallbeclean,hygienicandsafe.Thebloodcollectionequipmentshallberegularlymaintainedandcalibratedtoensurenormaloperation.Bloodcollectionpersonnelshallundergoprofessionaltrainingandobtaincorrespondingqualificationcertificates.2.嚴(yán)格按照無菌操作技術(shù)規(guī)范進(jìn)行采血，確保采血過程安全、衛(wèi)生。采血前應(yīng)當(dāng)對獻(xiàn)血者的穿刺部位進(jìn)行嚴(yán)格消毒，使用一次性采血器材，防止交叉感染。英文表述為：Strictlyfollowtheasepticoperationtechnicalspecificationsforbloodcollectiontoensurethesafetyandhygieneofthebloodcollectionprocess.Beforebloodcollection,thepuncturesiteoftheblooddonorshallbestrictlydisinfected,anddisposablebloodcollectionequipmentshallbeusedtopreventcrossinfection.3.控制采血速度和采血量，避免因采血不當(dāng)對獻(xiàn)血者造成傷害。采血量應(yīng)當(dāng)符合國家規(guī)定的標(biāo)準(zhǔn)，一般全血獻(xiàn)血量為200毫升、300毫升或400毫升。英文表述為：Controlthebloodcollectionspeedandvolumetoavoidharmtoblooddonorsduetoimproperbloodcollection.Thebloodcollectionvolumeshallmeetthenationalstandards.Generally,thewholeblooddonationvolumeis200ml,300mlor400ml.三、血液檢測（一）檢測機(jī)構(gòu)與人員1.血液檢測機(jī)構(gòu)應(yīng)當(dāng)具備相應(yīng)的資質(zhì)和條件，按照國家規(guī)定開展血液檢測工作。檢測機(jī)構(gòu)應(yīng)當(dāng)通過相關(guān)部門的認(rèn)證，確保檢測結(jié)果準(zhǔn)確、可靠。英文表述為：Bloodtestinginstitutionsshallhavecorrespondingqualificationsandconditionsandcarryoutbloodtestingworkinaccordancewithnationalregulations.Thetestinginstitutionsshallbecertifiedbyrelevantdepartmentstoensuretheaccuracyandreliabilityoftestresults.2.檢測人員應(yīng)當(dāng)經(jīng)過專業(yè)培訓(xùn)，熟悉血液檢測技術(shù)和標(biāo)準(zhǔn)，具備良好的職業(yè)道德。檢測人員應(yīng)當(dāng)嚴(yán)格遵守檢測操作規(guī)程，確保檢測過程規(guī)范、準(zhǔn)確。英文表述為：Testingpersonnelshallundergoprofessionaltraining,befamiliarwithbloodtestingtechniquesandstandards,andhavegoodprofessionalethics.Testingpersonnelshallstrictlyabidebythetestingoperationprocedurestoensurethestandardizationandaccuracyofthetestingprocess.（二）檢測項(xiàng)目與方法1.血液檢測項(xiàng)目應(yīng)當(dāng)包括國家規(guī)定的必檢項(xiàng)目和其他相關(guān)項(xiàng)目。必檢項(xiàng)目一般包括血型、血紅蛋白、轉(zhuǎn)氨酶、乙肝表面抗原、丙肝抗體、梅毒抗體、艾滋病病毒抗體等。英文表述為：Bloodtestingitemsshallincludemandatorytestingitemsstipulatedbythestateandotherrelevantitems.Mandatorytestingitemsgenerallyincludebloodtype,hemoglobin,transaminase,hepatitisBsurfaceantigen,hepatitisCantibody,syphilisantibody,HIVantibody,etc.2.采用先進(jìn)、可靠的檢測方法和技術(shù)，確保檢測結(jié)果的準(zhǔn)確性和及時(shí)性。檢測方法應(yīng)當(dāng)符合國家相關(guān)標(biāo)準(zhǔn)和規(guī)范，定期對檢測設(shè)備進(jìn)行校準(zhǔn)和維護(hù)。英文表述為：Adoptadvancedandreliabletestingmethodsandtechnologiestoensuretheaccuracyandtimelinessoftestresults.Thetestingmethodsshallcomplywithnationalrelevantstandardsandspecifications,andthetestingequipmentshallbecalibratedandmaintainedregularly.（三）檢測報(bào)告與結(jié)果處理1.檢測機(jī)構(gòu)應(yīng)當(dāng)及時(shí)、準(zhǔn)確地出具檢測報(bào)告，檢測報(bào)告應(yīng)當(dāng)包括檢測項(xiàng)目、檢測結(jié)果、檢測日期等信息。檢測報(bào)告應(yīng)當(dāng)加蓋檢測機(jī)構(gòu)公章，并由檢測人員簽字確認(rèn)。英文表述為：Testinginstitutionsshallissuetestreportspromptlyandaccurately.Thetestreportsshallincludeinformationsuchastestingitems,testresults,testdates,etc.Thetestreportsshallbestampedwiththeofficialsealofthetestinginstitutionandsignedbythetestingpersonnelforconfirmation.2.對檢測不合格的血液，應(yīng)當(dāng)按照國家規(guī)定進(jìn)行處理。處理方式包括報(bào)廢、隔離、追溯等，防止不合格血液流入臨床用血環(huán)節(jié)。英文表述為：Forbloodwithunqualifiedtestresults,itshallbehandledinaccordancewithnationalregulations.Thehandlingmethodsincludescrapping,isolation,traceability,etc.topreventunqualifiedbloodfromflowingintotheclinicalblooduselink.四、血液儲存（一）儲存設(shè)施與條件1.血液儲存機(jī)構(gòu)應(yīng)當(dāng)具備符合國家規(guī)定的儲存設(shè)施和條件，確保血液在儲存過程中的質(zhì)量安全。儲存設(shè)施應(yīng)當(dāng)包括冷藏庫、冷凍庫、溫度監(jiān)測設(shè)備等，能夠滿足不同血液成分的儲存要求。英文表述為：Bloodstorageinstitutionsshallhavestoragefacilitiesandconditionsthatmeetnationalregulationstoensurethequalityandsafetyofbloodduringstorage.Thestoragefacilitiesshallincludecoldstorage,freezer,temperaturemonitoringequipment,etc.,whichcanmeetthestoragerequirementsofdifferentbloodcomponents.2.儲存設(shè)施應(yīng)當(dāng)定期進(jìn)行維護(hù)和檢查，確保其正常運(yùn)行。溫度監(jiān)測設(shè)備應(yīng)當(dāng)實(shí)時(shí)監(jiān)測儲存溫度，并記錄溫度數(shù)據(jù)，以便及時(shí)發(fā)現(xiàn)溫度異常情況。英文表述為：Thestoragefacilitiesshallberegularlymaintainedandinspectedtoensuretheirnormaloperation.Thetemperaturemonitoringequipmentshallmonitorthestoragetemperatureinrealtimeandrecordthetemperaturedatatopromptlydetectabnormaltemperatureconditions.（二）儲存管理1.按照血液品種、血型、采血日期等進(jìn)行分類儲存，避免混淆。不同血液成分應(yīng)當(dāng)分別儲存于相應(yīng)的儲存設(shè)施中，確保儲存條件符合要求。英文表述為：Classifyandstoreaccordingtobloodtypes,bloodgroups,bloodcollectiondates,etc.toavoidconfusion.Differentbloodcomponentsshallbestoredincorrespondingstoragefacilitiesrespectivelytoensurethatthestorageconditionsmeettherequirements.2.建立庫存管理制度，定期盤點(diǎn)庫存血液，掌握庫存動態(tài)。及時(shí)補(bǔ)充庫存血液，確保臨床用血需求。英文表述為：Establishaninventorymanagementsystem,regularlychecktheinventoryofblood,andmastertheinventorydynamics.Timelyreplenishtheinventoryofbloodtoensuretheclinicalblooduseneeds.五、血液運(yùn)輸（一）運(yùn)輸要求1.血液運(yùn)輸應(yīng)當(dāng)采用符合國家規(guī)定的運(yùn)輸設(shè)備和包裝材料，確保血液在運(yùn)輸過程中的質(zhì)量安全。運(yùn)輸設(shè)備應(yīng)當(dāng)具備溫度控制功能，能夠保持血液所需的儲存溫度。英文表述為：Bloodtransportationshallusetransportationequipmentandpackagingmaterialsthatmeetnationalregulationstoensurethequalityandsafetyofbloodduringtransportation.Thetransportationequipmentshallhavetemperaturecontrolfunctionstomaintainthestoragetemperaturerequiredforblood.2.運(yùn)輸過程中應(yīng)當(dāng)采取必要的防護(hù)措施，防止血液受到污染、震蕩、擠壓等。確保運(yùn)輸過程平穩(wěn)、安全，避免因運(yùn)輸不當(dāng)導(dǎo)致血液質(zhì)量受損。英文表述為：Necessaryprotectivemeasuresshallbetakenduringtransportationtopreventbloodfrombeingcontaminated,shaken,squeezed,etc.Ensurethatthetransportationprocessisstableandsafetoavoiddamagetobloodqualityduetoimpropertransportation.（二）運(yùn)輸記錄1.建立血液運(yùn)輸記錄制度，記錄血液的運(yùn)輸起點(diǎn)、終點(diǎn)、運(yùn)輸時(shí)間、運(yùn)輸溫度等信息。運(yùn)輸記錄應(yīng)當(dāng)完整、準(zhǔn)確，保存期限應(yīng)當(dāng)符合國家規(guī)定。英文表述為：Establishabloodtransportationrecordsystemtorecordinformationsuchasthestartingpoint,destination,transportationtime,transportationtemperature,etc.ofbloodtransportation.Thetransportationrecordsshallbecompleteandaccurate,andthestorageperiodshallmeetnationalregulations.2.運(yùn)輸記錄應(yīng)當(dāng)便于查詢和追溯，以便在需要時(shí)能夠及時(shí)了解血液運(yùn)輸情況，確保血液質(zhì)量安全可追溯。英文表述為：Thetransportationrecordsshallbeconvenientforinquiryandtraceabilitysothatthebloodtransportationsituationcanbeunderstoodinatimelymannerwhenneededtoensurethetraceabilityofbloodqualityandsafety.六、血液供應(yīng)（一）供應(yīng)原則1.血液供應(yīng)應(yīng)當(dāng)遵循科學(xué)、合理、公平、及時(shí)的原則，根據(jù)臨床用血需求，合理安排血液供應(yīng)。優(yōu)先保障急救用血需求，兼顧常規(guī)用血需求。英文表述為：Bloodsupplyshallfollowtheprinciplesofscience,reasonableness,fairnessandtimeliness.Accordingtotheclinicalblooduseneeds,reasonablyarrangethebloodsupply.Giveprioritytoensuringtheemergencyblooduseneedsandtakeintoaccounttheroutineblooduseneeds.2.建立血液供應(yīng)協(xié)調(diào)機(jī)制，加強(qiáng)醫(yī)療機(jī)構(gòu)之間的溝通與協(xié)作，優(yōu)化血液調(diào)配流程，提高血液供應(yīng)效率。英文表述為：Establishabloodsupplycoordinationmechanism,strengthencommunicationandcooperationamongmedicalinstitutions,optimizethebloodallocationprocess,andimprovethebloodsupplyefficiency.（二）供應(yīng)流程1.醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)根據(jù)臨床用血需求，提前向血液供應(yīng)機(jī)構(gòu)提交用血申請。用血申請應(yīng)當(dāng)包括用血種類、用血量、用血時(shí)間等信息。英文表述為：Medicalinstitutionsshallsubmitblooduseapplicationstobloodsupplyinstitutionsinadvanceaccordingtoclinicalblooduseneeds.Theblooduseapplicationsshallincludeinformationsuchasbloodusetypes,bloodusevolumes,bloodusetimes,etc.2.血液供應(yīng)機(jī)構(gòu)應(yīng)當(dāng)對用血申請進(jìn)行審核，根據(jù)庫存情況和血液供應(yīng)計(jì)劃，合理安排血液供應(yīng)。對符合條件的用血申請，及時(shí)進(jìn)行配血、發(fā)血等操作，確保血液及時(shí)供應(yīng)到醫(yī)療機(jī)構(gòu)。英文表述為：Bloodsupplyinstitutionsshallreviewtheblooduseapplicationsandreasonablyarrangethebloodsupplyaccordingtotheinventorysituationandbloodsupplyplan.Foreligibleblooduseapplications,promptlyconductbloodmatching,bloodissuingandotheroperationstoensurethatbloodispromptlysuppliedtomedicalinstitutions.七、監(jiān)督管理（一）監(jiān)管部門職責(zé)1.衛(wèi)生健康行政部門負(fù)責(zé)本行政區(qū)域內(nèi)血液管理工作的監(jiān)督管理。制定血液管理相關(guān)政策、法規(guī)和標(biāo)準(zhǔn)，組織開展血液管理工作的監(jiān)督檢查，對違法行為進(jìn)行查處。英文表述為：Thehealthadministrativedepartmentisresponsibleforthesupervisionandmanagementofbloodmanagementworkwithinitsadministrativeregion.Formulaterelevantpolicies,regulationsandstandardsforbloodmanagement,organizeandcarryoutsupervisionandinspectionofbloodmanagementwork,andinvestigateandpunishillegalacts.2.其他相關(guān)部門按照各自職責(zé)，協(xié)同做好血液管理工作。如藥品監(jiān)督管理部門負(fù)責(zé)對血液檢測試劑、采血器材等進(jìn)行監(jiān)管，確保其質(zhì)量安全。英文表述為：Otherrelevantdepartmentsshall,inaccordancewiththeirrespectiveresponsibilities,cooperateindoingagoodjobinbloodmanagement.Forexample,thedrugregulatorydepartmentisresponsibleforthesupervisionofbloodtestingreagents,bloodcollectionequipment,etc.toensuretheirqualityandsafety.（二）監(jiān)督檢查內(nèi)容1.對血液采集、檢測、儲存、運(yùn)輸、供應(yīng)等環(huán)節(jié)進(jìn)行監(jiān)督檢查，檢查內(nèi)容包括機(jī)構(gòu)資質(zhì)、人員資質(zhì)、操作規(guī)范、質(zhì)量控制等方面。英文表述為：Conductsupervisionandinspectiononlinkssuchasbloodcollection,testing,storage,transportation,supply,etc.Theinspectioncontentsincludeaspectssuchasinstitutionalqualifications,personnelqualifications,operationspecifications,qualitycontrol,etc.2.對違反本辦法的行為，依法予以查處。對情節(jié)嚴(yán)重的違法行為，吊銷相關(guān)機(jī)構(gòu)或人員的資質(zhì)證書，并追究法律責(zé)任。英文表述為：InvestigateandpunishactsinviolationoftheseMeasuresaccordingtolaw.Forseriousille