實(shí)驗(yàn)室認(rèn)可要求與室內(nèi)質(zhì)控規(guī)范

1、周之煒QSD Product Manager North China實(shí)驗(yàn)室認(rèn)可要求與室內(nèi)質(zhì)控標(biāo)準(zhǔn)CAP、ISO認(rèn)證和質(zhì)控的核心理念一切對病人樣本負(fù)責(zé)想說隨機(jī)誤差不容易不是單單做質(zhì)量控制，而是要做質(zhì)量管理持續(xù)質(zhì)量改進(jìn)分清責(zé)任注重解決方案一切都要評估質(zhì)量管理概覽QM分析前分析中分析后樣本采集樣本前處理樣本運(yùn)輸儀器狀態(tài)QC樣本保存報(bào)告發(fā)放臨床溝通CQI維護(hù)保養(yǎng)試劑管理耗材管理人員管理定標(biāo)、校準(zhǔn)定標(biāo)驗(yàn)證室內(nèi)質(zhì)控室間質(zhì)控方法學(xué)驗(yàn)證QA投訴處理質(zhì)控目的的新理解標(biāo)準(zhǔn)所有人，各取所需操作者主任檢察官病人臨床廠家很大程度上，質(zhì)控的目的是為了失控質(zhì)控品精密度評價(jià)室內(nèi)質(zhì)控(精密度控制)質(zhì)控品定標(biāo)(正確度控制)定標(biāo)液

2、（校準(zhǔn)品）標(biāo)準(zhǔn)品（標(biāo)準(zhǔn)物質(zhì)）正(準(zhǔn))確度評價(jià)室間質(zhì)評（比對計(jì)劃）第三方質(zhì)控品的特殊重要性總感覺第三方質(zhì)控品難做配套質(zhì)控品賦值的跟隨性掩蓋了問題其他質(zhì)控品賦值范圍過寬關(guān)于質(zhì)控品賦值方法為何質(zhì)控品給定的范圍只用作參考實(shí)驗(yàn)室需要自建質(zhì)控范圍免疫學(xué)的準(zhǔn)確度驗(yàn)證多為配套系統(tǒng)，室間比對為主不同系統(tǒng)間存在不可比，參考范圍需驗(yàn)證The need for independent laboratory quality control is fundamental! 最根本的是要獨(dú)立地進(jìn)行實(shí)驗(yàn)室質(zhì)控。Independent QC begins by having control materials that are

3、 independent of the calibration materials. 獨(dú)立質(zhì)控首先要求使用獨(dú)立于校準(zhǔn)品的質(zhì)控品(C24A3 7.3)。It is also good practice to have control materials that are made by a different manufacturer than the test system, as confirmed by FDAs recommendation for the use of quality control materials made by other companies to increa

4、se the assurance that these devices are performing successfully. 最好選擇不是由檢測系統(tǒng)廠家生產(chǎn)的質(zhì)控品，F(xiàn)DA對此也有類似的推薦“使用由其他廠家生產(chǎn)的質(zhì)控品提升該設(shè)備的性能保證Laboratories should establish their own means and standard deviations when implementing statistical QC procedures, rather than use bottle values provided by a manufacturer. 在應(yīng)用統(tǒng)計(jì)學(xué)

5、質(zhì)控程序時(shí)，實(shí)驗(yàn)室必須建立自己的均值和標(biāo)準(zhǔn)差，而不能使用廠家提供的定值。Laboratories should select appropriate control rules and numbers of control measurements on the basis of the quality required by the patients and physicians they serve and the imprecision and inaccuracy observed for their methods during routine operation in the la

6、boratory.實(shí)驗(yàn)室必須基于患者和醫(yī)生對檢測質(zhì)量的要求以及實(shí)驗(yàn)室實(shí)際的不精密度和不正確度水平，選擇恰當(dāng)?shù)馁|(zhì)控規(guī)那么和質(zhì)控次數(shù)獨(dú)立質(zhì)控EQASISO 17043ISO和CAP認(rèn)可我國CNAS也在互認(rèn)行列每月一次；每月回報(bào)；周年總結(jié)；雙份證書室內(nèi)質(zhì)控標(biāo)準(zhǔn)和操作建立質(zhì)控范圍的親民方案初次建立難以做到開20瓶難以在建立質(zhì)控范圍期間不發(fā)報(bào)告未考慮試劑批號和定標(biāo)影響由于上述及其他原因?qū)е聦?shí)踐中初期建立質(zhì)控范圍不能代表整個(gè)Lot親民的質(zhì)控范圍調(diào)整方案堅(jiān)持盡快向法規(guī)方案靠攏什么樣的質(zhì)控范圍是可用的？標(biāo)準(zhǔn)？親民方案10天20點(diǎn)；5天20點(diǎn)開12瓶1120d：使用前10d范圍控制2130d：使用前20d范圍控

7、制3160d：使用前30d范圍控制61d開始：使用前60d范圍控制建議36m確立本Lot最終范圍質(zhì)控更換LOT時(shí)的平行試驗(yàn)總要求重新建立質(zhì)控范圍建立時(shí)不影響常規(guī)工作一句話方案：當(dāng)樣本檢測特殊應(yīng)急老批號質(zhì)控品剩余有限質(zhì)控品本身效期有限新建質(zhì)控范圍不可用SD=mean*CV%質(zhì)量控制工作實(shí)例1質(zhì)控品的前處理儲存復(fù)溶、溶解時(shí)間、方法、試劑用水混勻的差異生化、血球、血凝非常規(guī)取樣分裝與凍融質(zhì)量控制工作實(shí)例2為何推薦至少檢測2水平質(zhì)控？兩點(diǎn)確定一條直線。何況是曲線！質(zhì)量控制工作實(shí)例3檢測結(jié)果和說明書賦值不符怎么辦？了解屬于何種不符并給出解釋：和均值不符，但在參考范圍內(nèi)沒有問題和均值不符，在參考范圍內(nèi)，但

8、接近上限/下限沒有問題和均值不符，超出參考范圍向我司索取全球報(bào)告，軟件用戶可自己下載全球報(bào)告或查閱室間比對報(bào)告假設(shè)報(bào)告顯示其他實(shí)驗(yàn)室也存在同樣問題，那么實(shí)驗(yàn)室的質(zhì)量沒有問題，需要排除質(zhì)控品的質(zhì)量問題，再確定是否是儀器/試劑的問題假設(shè)報(bào)告顯示其他實(shí)驗(yàn)室不存在同樣問題，同樣需要排除質(zhì)控品的質(zhì)量問題，才能確定是實(shí)驗(yàn)室的質(zhì)量問題質(zhì)控結(jié)果是否持續(xù)升高或下降？質(zhì)控結(jié)果是否忽高忽低？表現(xiàn)為瓶內(nèi)波動(dòng)還是瓶間差異？患者樣本的結(jié)果是否有同步表現(xiàn)？質(zhì)量控制工作實(shí)例4在控分析：什么是好的質(zhì)控圖Westgard 規(guī)那么警告失控：隨機(jī)誤差/新的系統(tǒng)誤差失控：系統(tǒng)誤差約0.3%約5%約0.1%約0.2%約0.1%約0.1%

9、5. Basic quality control at low cost5. 低本錢的根底質(zhì)量控制Quality control is essential under all circumstances. This chapter describes the necessity and low cost possibilities the internal and external quality control for medical laboratories.無論對興旺國家還是開展中國家，臨床實(shí)驗(yàn)室的質(zhì)量控制都非常重要。本章節(jié)描述了低本錢運(yùn)作的臨床實(shí)驗(yàn)室開展室內(nèi)質(zhì)量控制和室間質(zhì)量評價(jià)的必要

10、性和可行性。The laboratory should include for each kind of tests a minimum of one level QC at least once a day. However if the number of patients samples analyzed exceeds 25 per day then the laboratory should at least run 2 levels of Quality control. If the number of patients samples analyzed exceeds 75 per day, the laboratory should run two levels of QC at least twice a day. If the lab has a large work load then each run should carry a QC sample.每項(xiàng)測試實(shí)驗(yàn)室最少每天使用1個(gè)水平質(zhì)控品檢測1次。如果每天的患者標(biāo)本數(shù)超過25個(gè)，至少檢測2個(gè)水平的質(zhì)控品。假設(shè)每天的患者標(biāo)本數(shù)超過75個(gè)，實(shí)驗(yàn)室應(yīng)當(dāng)做2次質(zhì)控，每次檢測2個(gè)水