一、醫學(xue)實驗室的認可起源(yuan)和定義
1947年(nian)(nian),澳大利亞成立了世(shi)界(jie)上第一個國(guo)(guo)家(jia)(jia)(jia)實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)機構即澳大利亞國(guo)(guo)家(jia)(jia)(jia)檢(jian)測(ce)機構協會(NATA)。自(zi)20世(shi)紀60年(nian)(nian)代，英(ying)國(guo)(guo)、美國(guo)(guo)、新西蘭、中國(guo)(guo)以及(ji)東(dong)南(nan)亞諸國(guo)(guo)家(jia)(jia)(jia)相繼成立了國(guo)(guo)家(jia)(jia)(jia)實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)機構。亞太實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)合(he)(he)(he)作(zuo)(zuo)組(zu)(zu)織(APLAC)、歐洲(zhou)(zhou)實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)合(he)(he)(he)作(zuo)(zuo)組(zu)(zu)織(EAL,1998年(nian)(nian)改為(wei)(wei)(wei)(wei)EA) 也相繼成立,國(guo)(guo)際實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)大會也完成了向(xiang)國(guo)(guo)際實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)合(he)(he)(he)作(zuo)(zuo)組(zu)(zu)織(ILAC)的(de)(de)轉變,加(jia)之美洲(zhou)(zhou)認可(ke)(ke)合(he)(he)(he)作(zuo)(zuo)組(zu)(zu)織(IAAC)和南(nan)部非洲(zhou)(zhou)認可(ke)(ke)發展合(he)(he)(he)作(zuo)(zuo)組(zu)(zu)織(SADCA)的(de)(de)成立,形成了在(zai)ILAC下的(de)(de)四大實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)區域組(zu)(zu)織。1999年(nian)(nian)12月(yue)，ISO 和IEC共同發表了ISO/ IEC17025《檢(jian)測(ce)和校準實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)能力的(de)(de)通用要(yao)求》作(zuo)(zuo)為(wei)(wei)(wei)(wei)《實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)準則(ze)》，包括醫學實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)在(zai)內的(de)(de)各(ge)行(xing)業(ye)的(de)(de)實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)開始了實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)的(de)(de)認可(ke)(ke)工(gong)作(zuo)(zuo)。2003年(nian)(nian)2月(yue)，ISO又發布了ISO15189《醫學實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)質量和能力的(de)(de)專(zhuan)用要(yao)求》，成為(wei)(wei)(wei)(wei)醫學實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)的(de)(de)專(zhuan)用準則(ze)。原中國(guo)(guo)實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)國(guo)(guo)家(jia)(jia)(jia)認可(ke)(ke)委(wei)員會（2006年(nian)(nian)3月(yue)更名為(wei)(wei)(wei)(wei)中國(guo)(guo)合(he)(he)(he)格評定國(guo)(guo)家(jia)(jia)(jia)認可(ke)(ke)委(wei)員會）于2004年(nian)(nian)5月(yue)發布公告，IS0/IEC17025和ISO15189均可(ke)(ke)作(zuo)(zuo)為(wei)(wei)(wei)(wei)醫學實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)認可(ke)(ke)的(de)(de)準則(ze)，由申(shen)請(qing)認可(ke)(ke)的(de)(de)單位根據客戶(hu)的(de)(de)要(yao)求和自(zi)身的(de)(de)需要(yao)決(jue)定，已通過IS0/IEC17025認可(ke)(ke)的(de)(de)醫學實(shi)(shi)(shi)(shi)驗(yan)室(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)，也可(ke)(ke)以轉化為(wei)(wei)(wei)(wei)ISO15189的(de)(de)認可(ke)(ke)，但(dan)要(yao)符合(he)(he)(he)ISO15189的(de)(de)要(yao)求。
二、醫學實驗(yan)室(shi)認(ren)可的依(yi)據
CNAS根據國際要(yao)(yao)(yao)(yao)求(qiu)(qiu)將ISO/ IEC17025《檢測(ce)和(he)校準實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)能力(li)的通用(yong)(yong)要(yao)(yao)(yao)(yao)求(qiu)(qiu)》作為(wei)(wei)《實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)認(ren)(ren)可準則》，是適用(yong)(yong)于(yu)所有(you)類(lei)型實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)的通用(yong)(yong)要(yao)(yao)(yao)(yao)求(qiu)(qiu)。2003年(nian)(nian)2月(yue),ISO又發(fa)布(bu)(bu)了(le)(le)ISO15189《醫(yi)學(xue)(xue)實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)質量和(he)能力(li)的專用(yong)(yong)要(yao)(yao)(yao)(yao)求(qiu)(qiu)》。在ISO15189沒有(you)正(zheng)式(shi)(shi)發(fa)布(bu)(bu)前(qian),CNAS就已經使(shi)用(yong)(yong)ISO/IEC17025認(ren)(ren)可了(le)(le)一些醫(yi)學(xue)(xue)領域的實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi),目(mu)前(qian),CNAS已決定將這兩個標準作為(wei)(wei)對(dui)醫(yi)學(xue)(xue)實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)認(ren)(ren)可的準則,醫(yi)學(xue)(xue)類(lei)實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)可根據其自身(shen)工作特(te)點(dian)及管(guan)(guan)理(li)部門和(he)用(yong)(yong)戶的要(yao)(yao)(yao)(yao)求(qiu)(qiu),選擇使(shi)用(yong)(yong)。ISO15189從管(guan)(guan)理(li)要(yao)(yao)(yao)(yao)求(qiu)(qiu)和(he)技(ji)術(shu)要(yao)(yao)(yao)(yao)求(qiu)(qiu)兩大方面(mian)提出了(le)(le)醫(yi)學(xue)(xue)實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)應遵守的要(yao)(yao)(yao)(yao)求(qiu)(qiu)。在管(guan)(guan)理(li)方面(mian),描述了(le)(le)實(shi)(shi)(shi)驗(yan)(yan)(yan)(yan)室(shi)組織和(he)管(guan)(guan)理(li)以(yi)及質量管(guan)(guan)理(li)體系、服務活動要(yao)(yao)(yao)(yao)素(su)等(deng)方面(mian)的要(yao)(yao)(yao)(yao)求(qiu)(qiu);在技(ji)術(shu)要(yao)(yao)(yao)(yao)素(su)上,則對(dui)人員(yuan)、設備、設施等(deng)要(yao)(yao)(yao)(yao)素(su)以(yi)及檢驗(yan)(yan)(yan)(yan)程序和(he)結(jie)果報告等(deng)要(yao)(yao)(yao)(yao)點(dian)做出了(le)(le)規(gui)定。為(wei)(wei)更加(jia)有(you)效符合醫(yi)學(xue)(xue)行業的特(te)點(dian)，ISO于(yu)2007年(nian)(nian)開始制訂ISO15189：2007版(ban)，并于(yu)2008年(nian)(nian)11月(yue)14日正(zheng)式(shi)(shi)發(fa)布(bu)(bu)，2008年(nian)(nian)12月(yue)1日正(zheng)式(shi)(shi)實(shi)(shi)(shi)施。
三、醫學實驗室認可的(de)條(tiao)件
根據CNAS的(de)(de)要(yao)求，申(shen)請認(ren)可(ke)的(de)(de)檢測(ce)(ce)/校準實(shi)驗室必須滿足的(de)(de)條件包(bao)括(kuo)：具(ju)有(you)明確的(de)(de)法律地位，即(ji)實(shi)驗室或(huo)所(suo)(suo)在母體應(ying)(ying)是一個(ge)能夠獨立(li)承擔法律責任的(de)(de)實(shi)體；按(an)認(ren)可(ke)準則及其(qi)應(ying)(ying)用說明建立(li)質(zhi)量管理體系，且各要(yao)素（過程）都(dou)已(yi)運行(xing)并有(you)相應(ying)(ying)記錄(lu)，包(bao)括(kuo)完整(zheng)的(de)(de)內部(bu)審核和管理評審；質(zhi)量管理體系運行(xing)至少六個(ge)月；在申(shen)請后三個(ge)月內可(ke)接受CNAS的(de)(de)現場(chang)評審；具(ju)有(you)申(shen)請認(ren)可(ke)范圍(wei)內的(de)(de)檢測(ce)(ce)/校準能力(li)，并在可(ke)能時至少參加過一次CNAS或(huo)其(qi)承認(ren)的(de)(de)能力(li)驗證活動(dong)；具(ju)有(you)支配所(suo)(suo)需資源的(de)(de)權(quan)力(li)；遵(zun)守CNAS認(ren)可(ke)規則、認(ren)可(ke)政(zheng)策等有(you)關規定，包(bao)括(kuo)支付認(ren)可(ke)費(fei)用，履行(xing)相關義務。
四、醫學實驗室認可的意義
- 通過醫學實驗(yan)(yan)(yan)室(shi)(shi)(shi)的(de)認(ren)可(ke)，可(ke)以提(ti)(ti)高(gao)醫學實驗(yan)(yan)(yan)室(shi)(shi)(shi)的(de)質(zhi)量(liang)管理(li)水平，減少可(ke)能(neng)出現的(de)質(zhi)量(liang)風險和實驗(yan)(yan)(yan)室(shi)(shi)(shi)的(de)責任(ren)，平衡實驗(yan)(yan)(yan)室(shi)(shi)(shi)與患者(zhe)之(zhi)間的(de)利益，提(ti)(ti)高(gao)社會對(dui)認(ren)可(ke)實驗(yan)(yan)(yan)室(shi)(shi)(shi)的(de)信任(ren)度(du)(du)。ISO/IEC 15189其實質(zhi)是醫學實驗(yan)(yan)(yan)室(shi)(shi)(shi)檢(jian)驗(yan)(yan)(yan)/校準質(zhi)量(liang)風險的(de)控制要(yao)求。嚴格持久地按照這些要(yao)求去做(zuo)，實驗(yan)(yan)(yan)室(shi)(shi)(shi)的(de)檢(jian)驗(yan)(yan)(yan)/校準質(zhi)量(liang)就得(de)到了保(bao)證，從而達(da)到提(ti)(ti)高(gao)實驗(yan)(yan)(yan)室(shi)(shi)(shi)社會信任(ren)度(du)(du)的(de)目的(de)。
- 通(tong)(tong)過(guo)醫(yi)學實(shi)(shi)驗(yan)(yan)(yan)室的認(ren)(ren)可，可以不斷提(ti)高醫(yi)學實(shi)(shi)驗(yan)(yan)(yan)室的信譽(yu)，增強患(huan)者及(ji)(ji)醫(yi)務人員對實(shi)(shi)驗(yan)(yan)(yan)室的信任。醫(yi)療(liao)(liao)單位通(tong)(tong)過(guo)了ISO-9000質(zhi)量體系認(ren)(ren)證，這僅是證明醫(yi)療(liao)(liao)過(guo)程得(de)到了保證，而并不能(neng)證明檢驗(yan)(yan)(yan)結(jie)果(guo)(guo)的合格。而經過(guo)ISO15189認(ren)(ren)可的醫(yi)學實(shi)(shi)驗(yan)(yan)(yan)室通(tong)(tong)過(guo)其完善(shan)的管(guan)理，能(neng)夠向患(huan)者以及(ji)(ji)醫(yi)護人員提(ti)供準(zhun)確的檢驗(yan)(yan)(yan)結(jie)果(guo)(guo)。
- 通過醫學實(shi)驗(yan)(yan)室(shi)的(de)(de)認(ren)可，可以(yi)消除國(guo)際交(jiao)流中(zhong)的(de)(de)技術壁壘(lei)，互認(ren)檢(jian)測結果。我國(guo)認(ren)可的(de)(de)實(shi)驗(yan)(yan)室(shi)出具的(de)(de)檢(jian)驗(yan)(yan)/校準數據能夠得到國(guo)際社(she)會的(de)(de)承認(ren)，表明實(shi)驗(yan)(yan)室(shi)具備(bei)了(le)按國(guo)際認(ren)可準則開(kai)展(zhan)檢(jian)測的(de)(de)技術能力，在認(ren)可范圍內使用“中(zhong)國(guo)實(shi)驗(yan)(yan)室(shi)國(guo)家認(ren)可”標志列入(ru)《國(guo)家認(ren)可實(shi)驗(yan)(yan)室(shi)目(mu)錄》，提高知名度。
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