統(tǒng)計(jì)質(zhì)控與分析目標(biāo)質(zhì)控方法在臨床化學(xué)檢驗(yàn)中的應(yīng)用--ppt課件

1、統(tǒng)計(jì)質(zhì)量控制和分析目的質(zhì)量控制方法在臨床化學(xué)檢驗(yàn)中的運(yùn)用廣東省中醫(yī)院檢驗(yàn)科黃憲章室內(nèi)質(zhì)量控制方法定性測(cè)定工程的室內(nèi)質(zhì)控利用患者數(shù)據(jù)質(zhì)控方法利用患者標(biāo)本質(zhì)控方法控制質(zhì)量控半定量測(cè)定工程的室內(nèi)質(zhì)控利用患者數(shù)據(jù)質(zhì)控方法利用患者標(biāo)本質(zhì)控方法控制質(zhì)量控定量測(cè)定工程的室內(nèi)質(zhì)控利用患者數(shù)據(jù)質(zhì)控方法患者結(jié)果均值法正態(tài)均值法，挪動(dòng)均值法差值檢查法Delta-核對(duì)法患者結(jié)果多參數(shù)核對(duì)法血型陰離子隙(Anion Gap)法酸堿平衡法臨床相關(guān)性研討利用患者標(biāo)本質(zhì)控方法患者樣本雙份分析保管患者樣本的檢測(cè)留樣再測(cè)患者樣本測(cè)定的方法學(xué)比較同一工程不同方法一樣方法不同檢測(cè)系統(tǒng)控制質(zhì)量控提 綱CNAS運(yùn)用闡明草案對(duì)室內(nèi)質(zhì)控的要

2、求統(tǒng)計(jì)質(zhì)量控制分析目的質(zhì)量控制室內(nèi)質(zhì)控?cái)?shù)據(jù)的管理CNAS運(yùn)用闡明草案對(duì)室內(nèi)質(zhì)控的要求臨床化學(xué)臨床免疫學(xué)臨床血液學(xué)臨床體液學(xué)臨床微生物學(xué)基因擴(kuò)增檢驗(yàn)臨床化學(xué)5.6.1實(shí)驗(yàn)室應(yīng)制定室內(nèi)質(zhì)量控制程序，可參照GB/T20468 -2006，內(nèi)容包括：運(yùn)用恰當(dāng)?shù)馁|(zhì)控規(guī)那么，檢查隨機(jī)誤差和系統(tǒng)誤差；質(zhì)控標(biāo)本的類型、濃度和檢測(cè)頻度；應(yīng)經(jīng)過(guò)實(shí)驗(yàn)室實(shí)踐檢測(cè)，確定精細(xì)度質(zhì)控品的均值和規(guī)范差；改換質(zhì)控品批號(hào)時(shí)，宜新舊批號(hào)平行測(cè)定，獲得20個(gè)以上數(shù)據(jù)后，重新確定新批號(hào)質(zhì)控品的均值；繪制室內(nèi)質(zhì)控圖，可運(yùn)用Levey-Jennings質(zhì)控圖和/或Z分?jǐn)?shù)圖。質(zhì)控圖應(yīng)包括質(zhì)控結(jié)果、質(zhì)控品稱號(hào)、濃度、批號(hào)和有效期、質(zhì)控圖的中心

3、線和控制界限、分析儀器稱號(hào)和獨(dú)一標(biāo)識(shí)、方法學(xué)稱號(hào)、檢驗(yàn)工程稱號(hào)、試劑和校準(zhǔn)品批號(hào)、每個(gè)數(shù)據(jù)點(diǎn)的日期和時(shí)間、干擾行為的記錄、質(zhì)控人員及審核人員的簽字、失控時(shí)的分析處置程序和糾正措施等。實(shí)驗(yàn)室應(yīng)檢查失控對(duì)之前檢驗(yàn)的影響。臨床免疫學(xué)5.6.1 實(shí)驗(yàn)室質(zhì)量控制程序應(yīng)符合如下要求：質(zhì)控標(biāo)本的類型宜選擇人血清基質(zhì)，防止工程菌或動(dòng)物源性等的基質(zhì)、濃度陽(yáng)性質(zhì)控物濃度宜2CUT OFF 值左右，陰性質(zhì)控物濃度宜0.5CUT OFF 值左右和位置不能固定而應(yīng)隨機(jī)放置、穩(wěn)定性宜選擇消費(fèi)者聲明在一定保管條件下如2-8或-20以下有效期為6個(gè)月以上、分析頻率的選擇應(yīng)滿足臨床要求的分析范圍的測(cè)定；用數(shù)值斷定結(jié)果的工程如E

4、LISA、發(fā)光技術(shù)等可運(yùn)用Levey-Jennings 質(zhì)控圖。質(zhì)控圖宜包括以下信息：分析儀器稱號(hào)和獨(dú)一標(biāo)識(shí)、方法學(xué)稱號(hào)、檢驗(yàn)工程稱號(hào)、試劑和校準(zhǔn)液批號(hào)、質(zhì)控品稱號(hào)、批號(hào)和有效期；橫坐標(biāo)X軸每個(gè)點(diǎn)闡明的是分析批或檢測(cè)日期，當(dāng)檢測(cè)日有多個(gè)批次時(shí)都應(yīng)標(biāo)出；縱坐標(biāo)Y軸用吸光度值或含量點(diǎn)圖，至少要引出中心線質(zhì)控物均值和上下失控限三條線；中心線為質(zhì)控物均值；利用cut off驗(yàn)證值可以直接確定上下失控限；陰、陽(yáng)性質(zhì)控物的測(cè)定值均應(yīng)在質(zhì)控圖中標(biāo)出。只需當(dāng)質(zhì)控物批號(hào)改動(dòng)時(shí)才重新繪制新的質(zhì)控圖，不能隨試劑批號(hào)的改動(dòng)而制造新質(zhì)控圖。根據(jù)滴度或稀釋度斷定陰陽(yáng)性的技術(shù)，如凝集實(shí)驗(yàn)，每檢測(cè)日或分析批，應(yīng)運(yùn)用弱陽(yáng)性和陰

5、性外對(duì)照作為質(zhì)控。實(shí)驗(yàn)室應(yīng)定義本人的質(zhì)控批長(zhǎng)度。陽(yáng)性質(zhì)控結(jié)果在均值上下一個(gè)滴度或稀釋度以及陰性質(zhì)控結(jié)果為陰性即為在控，否那么視為失控。純定性實(shí)驗(yàn)如金標(biāo)試紙、斑點(diǎn)滲濾等，檢測(cè)安裝的內(nèi)對(duì)照外，每檢測(cè)日或分析批，應(yīng)運(yùn)用弱陽(yáng)性和陰性外對(duì)照作為質(zhì)控。實(shí)驗(yàn)室應(yīng)定義本人的質(zhì)控批長(zhǎng)度。陰、陽(yáng)性質(zhì)控的檢測(cè)結(jié)果分別為陰性和陽(yáng)性即闡明在控，相反那么為失控。應(yīng)評(píng)價(jià)失控形狀下病人結(jié)果的影響。臨床血液學(xué)5.6.1室內(nèi)質(zhì)量控制應(yīng)符合如下要求：質(zhì)控品的選擇：引薦運(yùn)用配套質(zhì)控品，運(yùn)用非配套質(zhì)控品時(shí)應(yīng)評(píng)價(jià)其質(zhì)量和適用性；質(zhì)控品的濃度程度：至少運(yùn)用2個(gè)濃度程度正常和異常程度的質(zhì)控品；質(zhì)控工程：申報(bào)認(rèn)可的一切檢測(cè)工程均應(yīng)開(kāi)展室內(nèi)質(zhì)量

6、控制；質(zhì)控頻度：應(yīng)經(jīng)過(guò)檢測(cè)質(zhì)控物，檢查血常規(guī)檢驗(yàn)的精細(xì)性，應(yīng)根據(jù)實(shí)驗(yàn)室檢驗(yàn)標(biāo)本的數(shù)量定期實(shí)施，檢測(cè)當(dāng)天至少1次；質(zhì)控方法：應(yīng)運(yùn)用Levey-Jennings質(zhì)控圖；Levey-Jennings質(zhì)控圖或類似的質(zhì)量控制記錄應(yīng)包含以下信息：檢測(cè)質(zhì)控品的時(shí)間范圍、質(zhì)控圖的中心線和控制界限、儀器/方法稱號(hào)、質(zhì)控品的稱號(hào)、濃度程度、批號(hào)和有效期、試劑稱號(hào)和批號(hào)、每個(gè)數(shù)據(jù)點(diǎn)的日期、操作人員的記錄。質(zhì)控圖中心線確實(shí)定：血常規(guī)檢查的質(zhì)控品測(cè)定應(yīng)在每天的不同時(shí)段至少檢測(cè)3天，至少運(yùn)用10個(gè)檢測(cè)結(jié)果的均值為質(zhì)控圖的中心線；凝固實(shí)驗(yàn)的質(zhì)控品至少檢測(cè)10天，至少運(yùn)用20個(gè)檢測(cè)結(jié)果的均值為質(zhì)控圖的中心線；凝固實(shí)驗(yàn)改換新批

7、號(hào)試劑或儀器進(jìn)展重要調(diào)整時(shí)，應(yīng)重新確定質(zhì)控品的均值；每個(gè)新批號(hào)的質(zhì)控品在日常運(yùn)用前，應(yīng)由實(shí)驗(yàn)室經(jīng)過(guò)檢測(cè)確定質(zhì)控品均值，制造商規(guī)定的“規(guī)范值只能作為參考，通常實(shí)驗(yàn)室確定的質(zhì)控品均值宜在配套定值質(zhì)控品的允許范圍內(nèi)。質(zhì)控品均值的計(jì)算方法參見(jiàn)GB/T20468-2006。規(guī)范差確實(shí)定：經(jīng)過(guò)一段時(shí)間的反復(fù)檢測(cè)確定室內(nèi)質(zhì)量控制的規(guī)范差，規(guī)范差的計(jì)算方法參見(jiàn)GB/T20468-2006。失控的判別規(guī)那么：實(shí)驗(yàn)室應(yīng)有程序規(guī)定運(yùn)用的質(zhì)控規(guī)那么，至少運(yùn)用13s 規(guī)那么22s，多種質(zhì)量控制規(guī)那么的運(yùn)用可以提高誤差檢出概率。失控報(bào)告應(yīng)包括失控情況的描畫(huà)、核對(duì)方法、緣由分析、糾正措施及糾正效果的評(píng)價(jià)等內(nèi)容。質(zhì)控?cái)?shù)據(jù)的管

8、理：原那么上每月統(tǒng)計(jì)1次，至少保管二年。記錄的檢查：血液學(xué)檢驗(yàn)部門的擔(dān)任人或由擔(dān)任人指定的授權(quán)人應(yīng)至少每月對(duì)室內(nèi)質(zhì)量控制的記錄進(jìn)展檢查并簽字。臨床體液學(xué)5.6.1 尿有構(gòu)成份分析儀紅細(xì)胞、白細(xì)胞計(jì)數(shù)的室內(nèi)質(zhì)控，可參照GB/T 20468 -2006。應(yīng)至少運(yùn)用2 個(gè)濃度程度正常和異常程度的質(zhì)控品，每任務(wù)日至少1次。實(shí)驗(yàn)室應(yīng)至少運(yùn)用13s、22s失控規(guī)那么。對(duì)于定性體液學(xué)檢測(cè)工程的室內(nèi)質(zhì)控，應(yīng)至少運(yùn)用陰性和陽(yáng)性質(zhì)控品，檢測(cè)當(dāng)天至少1次，偏向不超越1個(gè)等級(jí)，且陰性不可為陽(yáng)性，陽(yáng)性不可為陰性。臨床微生物學(xué)5.6.1 實(shí)驗(yàn)室制定的內(nèi)部質(zhì)量控制程序應(yīng)包括整個(gè)實(shí)驗(yàn)操作過(guò)程，照實(shí)驗(yàn)分析前、中、后報(bào)告。細(xì)菌的

9、質(zhì)控應(yīng)滿足如下要求：運(yùn)用中的染色劑革蘭染色,特殊染色，熒光染色，至少每周用知陽(yáng)性和陰性適用時(shí)的質(zhì)控菌株檢測(cè)染色程序。凝固酶、過(guò)氧化氫酶、氧化酶、內(nèi)酰胺酶運(yùn)用時(shí)，每天應(yīng)做陰性和陽(yáng)性質(zhì)控，商業(yè)頭孢菌素試劑的內(nèi)酰胺酶實(shí)驗(yàn)可遵照制造商的建議。診斷性抗血清實(shí)驗(yàn)應(yīng)設(shè)陰性、陽(yáng)性對(duì)照。實(shí)驗(yàn)室常規(guī)采用的藥敏實(shí)驗(yàn)方法應(yīng)以參考菌株延續(xù)檢測(cè)2030天，每一組藥物/微生物超出參考范圍抑菌圈直徑或MIC的頻率需小于1/20或2/30。以后，應(yīng)每周運(yùn)用規(guī)范菌株對(duì)藥敏實(shí)驗(yàn)進(jìn)展質(zhì)控。應(yīng)保管抗菌藥物敏感性實(shí)驗(yàn)資料，并至少每年向臨床醫(yī)師報(bào)告。厭氧菌應(yīng)以有效的方法檢測(cè)厭氧培育環(huán)境如以亞甲蘭試條、厭氧菌或適當(dāng)?shù)某绦驒z測(cè)厭氧系統(tǒng)的厭氧條

10、件。分枝桿菌抗酸染色應(yīng)在實(shí)驗(yàn)的每天用適當(dāng)?shù)年?yáng)性和陰性質(zhì)控驗(yàn)證；熒光染色應(yīng)每次以陰性和陽(yáng)性對(duì)照驗(yàn)證。真菌直接染色如：抗酸染色，PAS，吉姆薩染色，墨汁染色檢查患者標(biāo)本時(shí)，應(yīng)每天做陰性和陽(yáng)性質(zhì)控某些染色如吉姆薩染色，玻片本身作為陰性質(zhì)控。KOH制備的玻片不需求質(zhì)控。病毒延續(xù)細(xì)胞傳代時(shí)應(yīng)定期監(jiān)測(cè)支原體污染宜監(jiān)測(cè)陰性未傳代的質(zhì)控株，而不是培育支原體；應(yīng)監(jiān)測(cè)用于細(xì)胞生長(zhǎng)培育液的動(dòng)物血清的細(xì)胞毒性；應(yīng)具備相應(yīng)的細(xì)胞株用于病毒培育。基因擴(kuò)增檢驗(yàn)實(shí)驗(yàn)室應(yīng)制定室內(nèi)質(zhì)量控制程序，可參照GB/T 20468 -2006。質(zhì)控圖應(yīng)包括質(zhì)控結(jié)果、質(zhì)控品稱號(hào)、濃度、批號(hào)和有效期、質(zhì)控圖的中心線和控制界限、分析儀器稱號(hào)和獨(dú)

11、一標(biāo)識(shí)、方法學(xué)稱號(hào)、檢驗(yàn)工程稱號(hào)、試劑和校準(zhǔn)品批號(hào)、每個(gè)數(shù)據(jù)點(diǎn)的日期和時(shí)間、干擾行為的記錄、質(zhì)控人員及審核人員的簽字、失控時(shí)的分析處置程序和糾正措施等。對(duì)于定性檢測(cè)工程，每次實(shí)驗(yàn)應(yīng)設(shè)置陰性、弱陽(yáng)性和陽(yáng)性質(zhì)控。質(zhì)控規(guī)那么應(yīng)確保實(shí)驗(yàn)的穩(wěn)定性和檢驗(yàn)結(jié)果的可靠性。實(shí)驗(yàn)室應(yīng)檢查失控對(duì)之前檢驗(yàn)的影響。統(tǒng)計(jì)質(zhì)量控制控制品控制圖均值與規(guī)范差控制規(guī)那么質(zhì)控頻率失控后的處置控制品正確度控制品正確度控制品Trueness Control不同于普通的控制品。在定值要求上等同于校準(zhǔn)品的定值。公用于核實(shí)、確認(rèn)、證明檢測(cè)系統(tǒng)能否真實(shí)地實(shí)現(xiàn)了溯源性。公用性廠商能否有才干提供“正確控制品，是衡量廠商提供的檢測(cè)系統(tǒng)產(chǎn)品能否可以使

12、實(shí)驗(yàn)室每天的患者標(biāo)本檢驗(yàn)結(jié)果具有溯源性的重要標(biāo)志。Trueness (measurement) closeness of agreement between the average of an infinite number of replicate measured quantity values and a reference quantity value(JCGM 200:2021); NOTE:Trueness is usually expressed numerically by the statistical bias, which is inversely related to

13、trueness.trueness control material a reference material with measurand value assigned by a procedure traceable to a higher order reference system and with commutability properties suitable for use to assess the bias of measurement of a specified measurement procedure(modified from ISO 17511).Truenes

14、s Controls Target values may also be assigned to reference (or QC sample)materials by reference measurement laboratories using certified primary reference measurement procedures . These control samples may be used to verify the trueness of a laboratorys measuring system, as long as their commutabili

15、ty with patient samples has been validated for a given measurement procedure. Trueness controls should also have product labeling that starts the materials are intended for trueness of measurement, and identifies the measuring systems for which the commutability was validated.Trueness ControlsTruene

16、ss controls are generally too expensive for routine use in QC, but they are invaluable for verifying that a measuring system is properly calibrated when it is first implemented or periodically thereafter. Trueness controls are also useful for routine verification of calibration or troubleshooting wh

17、en the accuracy of patient results is suspect. 控制品定值控制血清定量控制品是在曾經(jīng)確認(rèn)了多家穩(wěn)定的檢測(cè)系統(tǒng)有的可溯源的前提下對(duì)控制品進(jìn)展定值。定量控制品只需在一樣穩(wěn)定檢測(cè)系統(tǒng)上運(yùn)用才具有估計(jì)結(jié)果可靠性的參考價(jià)值，也僅僅是參考價(jià)值。在其它檢測(cè)系統(tǒng)上，這個(gè)定值沒(méi)有參考價(jià)值！更不可運(yùn)用定值控制品為校準(zhǔn)品！Control Materials with Assigned ValuesControl Materials with Assigned Values (Assayed Quality Control Samples)Measuring system

18、 specific values can also be assigned to QC samples as target values. such materials are often called “assayed controls , and the values are assigned by the QC material manufacturer or by laboratories in a value assignment program using a given measuring system . These material are intended to give

19、individual laboratories a means of determining whether their performance is as expected for a given measuring system. The usefulness of these system-specific values depends on the traceability and uncertainty of the assigned values.復(fù)溶過(guò)程中多種要素對(duì)干粉質(zhì)控品檢測(cè)結(jié)果的影響評(píng)價(jià)資料干粉質(zhì)控品：邁瑞正常值批號(hào)QMN295和病理值干粉質(zhì)控品(批號(hào)QMP296)，規(guī)格為

20、5/ml瓶。儀器：BS-800全自動(dòng)生化分析儀深圳邁瑞公司，Microlab 500稀釋配液儀美國(guó)HAMILTON公司，QB208型自動(dòng)混勻器(海門其林倍爾公司)。檢測(cè)試劑：ALB，ALP，ALT，AMY,AST, Ca，CK，Cl，CREA，DBIL， Glu， K，LDH，Mg，Na，P，TBIL，TC，TG，TP，UA, UREA， HBDH，GGT為邁瑞公司原裝試劑。復(fù)溶過(guò)程中多種要素對(duì)干粉質(zhì)控品檢測(cè)結(jié)果的影響評(píng)價(jià)結(jié)論實(shí)驗(yàn)人員復(fù)溶操作過(guò)程對(duì)干粉質(zhì)控品的檢測(cè)結(jié)果有影響復(fù)溶時(shí)的溫度以室溫242水質(zhì)選用電導(dǎo)率1 s/cm的純水為宜控制圖控制圖L-J控制圖Z值圖Youden圖均值和規(guī)范差的設(shè)置

21、均值和規(guī)范差的統(tǒng)計(jì)固定均值和規(guī)范差固定均值和SD:每月恒定的均值3SD范圍設(shè)定質(zhì)控圖的均值和控制限各實(shí)驗(yàn)室應(yīng)運(yùn)用本室現(xiàn)行的檢測(cè)系統(tǒng)，對(duì)新批號(hào)的控制品的各個(gè)測(cè)定工程自行確定均值和控制限?？刂葡尥ǔＳ靡?guī)范差的倍數(shù)來(lái)表示，臨床實(shí)驗(yàn)室不同定量測(cè)定工程的控制限要根據(jù)其采用的控制規(guī)那么來(lái)決議。設(shè)定質(zhì)控圖的均值和控制限 穩(wěn)定性較長(zhǎng)的控制品做法1第三版全國(guó)臨床檢驗(yàn)操作規(guī)程：對(duì)新批號(hào)的控制品進(jìn)展測(cè)定，根據(jù)20或更多批獲得的質(zhì)控測(cè)定結(jié)果，進(jìn)展離群值檢驗(yàn)剔除超越3s外的數(shù)據(jù)，計(jì)算出平均數(shù)和規(guī)范差，作為暫定均值和暫定規(guī)范差。以此暫定均值和規(guī)范差作為下一月室內(nèi)質(zhì)控圖的均值和規(guī)范差進(jìn)展室內(nèi)質(zhì)控。設(shè)定質(zhì)控圖的均值和控制限穩(wěn)

22、定性較長(zhǎng)的控制品做法1第三版全國(guó)臨床檢驗(yàn)操作規(guī)程：一個(gè)月終了后，將該月的在控結(jié)果與前20個(gè)質(zhì)控測(cè)定結(jié)果聚集在一同，計(jì)算累積平均數(shù)和累積規(guī)范差第一個(gè)月，以此累積的平均數(shù)和規(guī)范差作為下一個(gè)月質(zhì)控圖的均值和規(guī)范差。反復(fù)上述操作過(guò)程，延續(xù)3至5個(gè)月，以最初20個(gè)數(shù)據(jù)和3至5個(gè)月在控?cái)?shù)據(jù)聚集的一切數(shù)據(jù)計(jì)算累積平均數(shù)和規(guī)范差，以此作為該控制品有效期內(nèi)的常用均值和常用規(guī)范差。設(shè)定質(zhì)控圖的均值和控制限 穩(wěn)定性較長(zhǎng)的控制品做法2：對(duì)新批號(hào)的控制品進(jìn)展測(cè)定，根據(jù)20或更多批獲得的質(zhì)控測(cè)定結(jié)果，進(jìn)展離群值檢驗(yàn)剔除超越3s外的數(shù)據(jù)，計(jì)算出平均數(shù)和規(guī)范差，作為暫定均值和暫定規(guī)范差。以此暫定均值和規(guī)范差作為下一月室內(nèi)質(zhì)控

23、圖的均值和規(guī)范差進(jìn)展室內(nèi)質(zhì)控。設(shè)定質(zhì)控圖的均值和控制限穩(wěn)定性較長(zhǎng)的控制品做法2：一個(gè)月終了后，將該月剔除人為錯(cuò)誤數(shù)據(jù)、超越3s外數(shù)據(jù)后一切結(jié)果與前20個(gè)質(zhì)控測(cè)定結(jié)果聚集在一同，計(jì)算累積平均數(shù)和累積規(guī)范差第一個(gè)月，以此累積的平均數(shù)和規(guī)范差作為下一個(gè)月質(zhì)控圖的均值和規(guī)范差。反復(fù)上述操作過(guò)程，延續(xù)3至5個(gè)月，以最初20個(gè)數(shù)據(jù)和3至5個(gè)月剔除人為錯(cuò)誤數(shù)據(jù)、超越3s外數(shù)據(jù)后一切數(shù)據(jù)聚集，計(jì)算累積平均數(shù)和規(guī)范差，以此作為該控制品有效期內(nèi)的常用均值和常用規(guī)范差。設(shè)定質(zhì)控圖的均值和控制限 穩(wěn)定性較長(zhǎng)的控制品做法3：對(duì)新批號(hào)的控制品進(jìn)展測(cè)定，根據(jù)20或更多批獲得的質(zhì)控測(cè)定結(jié)果，進(jìn)展離群值檢驗(yàn)剔除超越3s外的數(shù)據(jù)

24、，計(jì)算出平均數(shù)和規(guī)范差，作為暫定均值和暫定規(guī)范差。以此暫定均值和規(guī)范差作為下一月室內(nèi)質(zhì)控圖的均值和規(guī)范差進(jìn)展室內(nèi)質(zhì)控。設(shè)定質(zhì)控圖的均值和控制限穩(wěn)定性較長(zhǎng)的控制品做法3：一個(gè)月終了后：將該月剔除人為錯(cuò)誤數(shù)據(jù)、超越3s外數(shù)據(jù)后一切結(jié)果與前20個(gè)質(zhì)控測(cè)定結(jié)果聚集在一同，計(jì)算累積平均數(shù)X1和累積規(guī)范差(S1)第一個(gè)月；將該月的在控結(jié)果與前20個(gè)質(zhì)控測(cè)定結(jié)果聚集在一同，計(jì)算累積平均數(shù)X2和累積規(guī)范差(S2) 第一個(gè)月；以X2和S1作為下一個(gè)月質(zhì)控圖的均值和規(guī)范差。反復(fù)上述操作過(guò)程，延續(xù)3至5個(gè)月：以最初20個(gè)數(shù)據(jù)和3至5個(gè)月剔除人為錯(cuò)誤數(shù)據(jù)、超越3s外數(shù)據(jù)后一切數(shù)據(jù)聚集，計(jì)算累積平均數(shù)X3和規(guī)范差S3;

25、以最初20個(gè)數(shù)據(jù)和3至5個(gè)月在控?cái)?shù)據(jù)聚集的一切數(shù)據(jù)計(jì)算累積平均數(shù)X4和規(guī)范差S4；以X4和S3作為該控制品有效期內(nèi)的常用均值和常用規(guī)范差。設(shè)定質(zhì)控圖的均值和控制限能否必需對(duì)“定值控制品建立均值和范圍？CLIA 只需靶值，只適用于運(yùn)用的方法和儀器。必需經(jīng)過(guò)反復(fù)檢測(cè)確定均值與規(guī)范差。CLSI 定值僅供參考，必需經(jīng)過(guò)反復(fù)檢測(cè)建立本人的值。臨床實(shí)驗(yàn)室定量測(cè)定室內(nèi)質(zhì)量控制指南 假設(shè)運(yùn)用定值質(zhì)控品，運(yùn)用闡明書(shū)上的原有標(biāo)定值只能作參考。必需由實(shí)驗(yàn)室作反復(fù)測(cè)定來(lái)確定實(shí)踐的均值和規(guī)范差。設(shè)定質(zhì)控圖的均值和控制限 穩(wěn)定性較短的控制品在至少3至4天內(nèi)，每天分析每程度控制品3至4瓶，每瓶進(jìn)展2至3次反復(fù)。搜集數(shù)據(jù)后，

26、計(jì)算平均數(shù)、規(guī)范差和變異系數(shù)。對(duì)數(shù)據(jù)進(jìn)展離群值檢驗(yàn)剔除超越3S的數(shù)據(jù)。假設(shè)發(fā)現(xiàn)離群值，需重新計(jì)算余下數(shù)據(jù)的平均數(shù)和規(guī)范差。以此均值作為質(zhì)控圖的均值。對(duì)于穩(wěn)定性較短的控制品，應(yīng)采用以前變異系數(shù)CV%來(lái)估計(jì)新的規(guī)范差，即規(guī)范差等于平均數(shù)乘以變異系數(shù)CV%。 改換控制物改換新批號(hào)控制物時(shí)，應(yīng)在“舊批號(hào)控制物運(yùn)用終了前，將新批號(hào)控制物與“舊批號(hào)控制物同時(shí)進(jìn)展測(cè)定。反復(fù)上面過(guò)程，設(shè)立新的X、SD。改換質(zhì)控品，對(duì)新批號(hào)的控制品進(jìn)展測(cè)定，根據(jù)20或更多批獲得的質(zhì)控測(cè)定結(jié)果。改換質(zhì)控品，假設(shè)無(wú)法從20天內(nèi)得到20個(gè)數(shù)值，至少在5天內(nèi)，每天作不少于4次反復(fù)檢測(cè)來(lái)獲得。即刻性質(zhì)控法 對(duì)于某些不是每天開(kāi)展的工程或試

27、劑盒有效期較短的工程可采用即刻性質(zhì)控方法，只需延續(xù)測(cè)定3次，即可對(duì)第三次及以后的檢驗(yàn)結(jié)果進(jìn)展控制。即刻性質(zhì)控法評(píng)價(jià)適用性：正態(tài)分布或近似正態(tài)分布，檢測(cè)頻次低的定量檢驗(yàn)工程或定性實(shí)驗(yàn)缺陷：結(jié)果易受前3個(gè)質(zhì)控?cái)?shù)據(jù)的影響，在統(tǒng)計(jì)學(xué)中樣本量少時(shí)容易出現(xiàn)抽樣誤差，Grubbs檢驗(yàn)法要求樣本數(shù)據(jù)不可少于6個(gè)?；叵胄允Э貦z出：遲后異常值就是某一測(cè)定值當(dāng)天用Grubbs檢驗(yàn)法判別為極值，在控，但隨著數(shù)據(jù)的添加，后來(lái)判別為異常值，屬于“警告或“失控。浮動(dòng)均值和浮動(dòng)規(guī)范差的設(shè)置浮動(dòng)均值和規(guī)范差浮動(dòng)均值和SD:恒定Z=3ALB、Na+、C1-、Ca CREA、URIC、Na+、 C1- GLU、TBIL、CREA、

28、URIC ALB FSH2程度浮動(dòng)變異系數(shù)CV與值時(shí)間浮動(dòng)cv偏倚值SE性能質(zhì)控規(guī)則NPedPfr1月31日3.566.195.283.63良好13S,22S,R4S,41S,10X210.0132月15日4.446.194.282.63良好13S,22S,R4S,41S,10X20.920.0122月28日4.396.194.282.63良好13S,22S,R4S,41S,10X20.9910.0133月15日4.736.193.982.33良好13S,22S,R4S,41S,10X20.9070.0133月31日5.066.193.722.07良好13S,22S,R4S,41S,10X20

29、.9150.0134月15日5.876.193.21.55良好13S,22S,R4S,41S,10X20.6770.0134月30日6.266.1931.35良好13S,22S,R4S,41S,10X20.5280.0135月15日6.26.193.131.38良好13S,22S,R4S,41S,10X20.5280.0135月31日6.226.193.021.37良好13S,22S,R4S,41S,10X20.5280.0136月15日6.276.1931.35良好13S,22S,R4S,41S,10X20.5280.0136月30日6.496.192.91.25合格13S,22S,R4S,

30、41S,10X20.450.0137月15日6.656.192.831.18差13S,22S,R4S,41S,10X20.3720.0137月31日6.686.192.821.17差13S,22S,R4S,41S,10X20.3720.0138月15日6.616.192.851.2差13S,22S,R4S,41S,10X20.3720.0138月31日6.46.192.941.29合格13S,22S,R4S,41S,10X20.5060.01915個(gè)化學(xué)發(fā)光工程8個(gè)月每月監(jiān)測(cè)兩次質(zhì)控結(jié)果浮動(dòng)CV評(píng)價(jià)21個(gè)常規(guī)生化工程延續(xù)20次質(zhì)控結(jié)果浮動(dòng)CV%評(píng)價(jià) C24-A3 Statistical Qua

31、lity Control for Quantitative Measurements8.6.5 Cumulative Values Estimates of the standard deviation (and to a lesser extent the mean) from monthly control data are often subject to considerable variation from month to month, due to an insufficient number of measurements(e.g., with 20 measurements,

32、 the estimate of the standard deviation might vary up to 30% from the true standard deviation;even with 100 measurements, the estimate may vary by as much as 10%). More representative estimates can be obtained by calculating cumulative values based on control data from longer periods of time (e.g.,

33、combining control data from a consecutive six-month period to provide a cumulative estimate of the standard deviation of the measurement procedure). This cumulative value will provide a more robust representation of the effects of factors such as recalibration, reagent lot change,calibrator lot chan

34、ge, maintenance cycles,and environmental factors including temperature and humidity.Care should be taken to ensure that the method has been stable and the mean is not drifting consistently lower or consistently higher over the six-month periods being combined, for example due to degradation of the c

35、alibrator or control material.浮動(dòng)均值和浮動(dòng)規(guī)范差控制圖控制圖L-J控制圖(固定/浮動(dòng))Z值圖(固定/浮動(dòng))Youden圖(固定/浮動(dòng))控制規(guī)那么Westgard多規(guī)那么質(zhì)控方法修正的Westgard多規(guī)那么質(zhì)控方法SPC規(guī)那么Westgard多規(guī)那么質(zhì)控方法修正的Westgard多規(guī)那么質(zhì)控方法測(cè)定次數(shù)和控制規(guī)那么的選擇操作過(guò)程規(guī)范圖(OPSpecs圖):測(cè)定次數(shù)N和控制規(guī)那么的選擇應(yīng)盡量采用測(cè)定次數(shù)N=2或N=3,能檢出90%的系統(tǒng)誤差,同時(shí)維持盡能夠5%的假失控率。對(duì)于方法性能“差的工程，有必要重新進(jìn)展方法學(xué)評(píng)價(jià)，重新選擇分析方法或不同廠家試劑盒。對(duì)于測(cè)定方

36、法的偏向過(guò)大，導(dǎo)致達(dá)不到臨床質(zhì)量要求。OPSpecs圖OPSpecs圖TEa的設(shè)置：CLIA，生物學(xué)變異，自定CV的設(shè)置：累計(jì)CVBias%設(shè)置相近濃度的室間質(zhì)評(píng)Bias%控制品室間比對(duì)的對(duì)等組或一樣方法組的Bias%室間比對(duì)的Bias%當(dāng)前檢測(cè)系統(tǒng)測(cè)定互通性好的參考物質(zhì)與靶值的Bias%新穎標(biāo)本當(dāng)前檢測(cè)系統(tǒng)測(cè)定值與參考方法賦值的Bias%例如(Alb實(shí)踐CV和BIAS)例如Alb實(shí)踐CV,BIAS(1/3TEa)例如Alb實(shí)踐CV,BIAS(1/2TEa)例如AlbCV(1/4TEa),BIAS(1/3TEa)例如Alb-CV(1/3TEa),BIAS(1/2TEa)例如AlbCV(1/3T

37、Ea),BIAS(1/3TEa)例如AlbCV(1/4TEa),BIAS(1/2TEa)質(zhì)控頻率-C24-A3 Frequency of controlmeasurementsQuality control samples must be analyzed at least once during each user-defined analytical run length. Manufacturers of analytical systems or reagents may recommend the number of quality specimens and their locat

38、ion within the run. However,manufacturers recommendations should be used as guidelines and frequency of QC measurement should be established by the laboratory considering the factors outlined in section 7.2. The frequency and location of control samples should reflect actual test system performance

39、and application at the site of testing. The user may need additonal control specimens and a different location in order to meet different laboratory circumstances. 質(zhì)控頻率-EP23-A lab Qulity Control Based on Risk Management 5.1.6 Frequency of Quality Control Sample TestingThe optimal frequency of perfor

40、ming QC sample procedures depends on built-in and other controls for a given measuring system, the stability of that measuring system, and conditions in the laboratory identified through risk assessment that could affect the reliability of testing such as staff turnover, and the clinical risk of har

41、m to a patient if an erroneous result is reported and acted on. The frequency of control procedures should also conform to applicable regulatory and accreditatlbn requirements. Monitoring the measuring system at shorter intervals increases the likelihood that systematic errors are detected before in

42、correct results are reported, or decreases the time before alerting the health care provider who may have received incorrect results. For example, a laboratory that evaluates the examination (analytical) process every eight hours will identity a systematic error condition much earlier than a laborat

43、ory that monitors the examination process every 24 hours. However, the total number of specimens tested in a time interval may also influence the frequency of monitoring. For example, a laboratory that tests 2000 samples in one 24-hour period might perform control procedures several times a day, whe

44、reas a laboratory that tests 50 samples in an eight-hour shift might perform control procedures at the beginning and end of a shift. The complex relationship between the frequency of QC sample testing, frequency of false rejection,and the quality of patient results has been explored by Parvin and co

45、lleagues.EP23-A:6.3.3 Frequency of Patient TestingThe QCP should take into account the frequency with which patient testing is performed. Operators may be less familiar with the details of a procedure performed infrequently, thereby increasing the probability of use errors and erroneous result. Freq

46、uent repetition of the steps of a measuring system leads to operator competency. Consequently, when a test is not performed often in a laboratory, consider the need for more frequent QC sample testing. Give consideration to the simplicity/complexity of the procedure and whether the procedure is full

47、y automated, semiautomated, or manual. Dilutions, extractions, calculations, and maintenance of measuring systems and support equipment(refrigerators, centrifuges, balances), for example, can be challenging to operators. Manual steps typically pose more risks than automated processes owing to the li

48、kelihood of use errors. 我院的質(zhì)控頻率與控制檔次置分析批：一段時(shí)間的區(qū)間，或是一組病人標(biāo)本量的大小，統(tǒng)計(jì)過(guò)程確定控制形狀的對(duì)象。CLIA88規(guī)定，臨床化學(xué)檢驗(yàn)最大批的時(shí)間為24小時(shí)，血液學(xué)檢驗(yàn)為8小時(shí)。我科的做法：門診PPI常規(guī)化學(xué)每天3次，上午7：30左右兩程度Biorad質(zhì)控物，與標(biāo)本同時(shí)進(jìn)展；中午10:30 11:00左右做1個(gè)程度正常值配套質(zhì)控物；下午4時(shí)左右儀器保養(yǎng)終了，加試劑后做1個(gè)程度病理值配套質(zhì)控物。門診化學(xué)法光Centaur每天3次，上午7：30一程度Biorad正常值質(zhì)控物，與標(biāo)本同時(shí)進(jìn)展；中午10:30 11:00左右大部分標(biāo)本快終了時(shí)做1個(gè)程度病

49、理值Biorad質(zhì)控物；下午4時(shí)左右儀器保養(yǎng)終了，加試劑后做1個(gè)程度正常值Biorad質(zhì)控物。門診化學(xué)法光601每天2次，上午7：30做1個(gè)程度正常值Biorad質(zhì)控物，與標(biāo)本同時(shí)進(jìn)展；中午11:30左右大部分標(biāo)本快終了時(shí)做1個(gè)程度病理值Biorad質(zhì)控物。我院的質(zhì)控頻率與控制檔次置病房PPI常規(guī)化學(xué)每天3次，上午7：30左右兩程度配套質(zhì)控物，在控后檢測(cè)標(biāo)本；中午10:3011:00左右做兩個(gè)程度Biorad質(zhì)控物。病房干化學(xué)上午8時(shí)左右做兩程度配套質(zhì)控物。下午2：30左右做兩程度Biorad質(zhì)控物，24小時(shí)檢測(cè)標(biāo)本。病房特種蛋白每天一次，每次兩個(gè)程度配套質(zhì)控物，在控后檢測(cè)標(biāo)本。病房糖化血紅蛋

50、白每天一次，每次兩個(gè)程度，兩程度配套質(zhì)控物或兩程度Biorad質(zhì)控物交替進(jìn)展，在控后檢測(cè)標(biāo)本。病房化學(xué)法光上午8時(shí)左右做兩程度Biorad質(zhì)控物，24小時(shí)檢測(cè)標(biāo)本。病房血?dú)夥治雒刻?次，每次一個(gè)程度，配套質(zhì)控物和Biorad質(zhì)控物，交替進(jìn)展，24小時(shí)檢測(cè)標(biāo)本。失控后的處置失控后的不當(dāng)做法預(yù)防性質(zhì)控失控緣由分析失控后的處置分析目的質(zhì)量控制提高檢驗(yàn)質(zhì)量統(tǒng)計(jì)質(zhì)量控制方法分析目的質(zhì)量控制方法累積均值和規(guī)范差浮動(dòng)均值和規(guī)范差不精細(xì)度-生物學(xué)變異總誤差-生物學(xué)變異當(dāng)前技術(shù)程度醫(yī)學(xué)相關(guān)性常用研討很少少用分析目的質(zhì)量控制當(dāng)前技術(shù)程度：根據(jù)當(dāng)前可以到達(dá)的檢測(cè)不精細(xì)度，將測(cè)試不精細(xì)度控制在目的范圍內(nèi)。 不精細(xì)度-生物學(xué)變異：根據(jù)生物學(xué)變異數(shù)據(jù)制定實(shí)驗(yàn)室本人的性能目的。 總誤差-生物學(xué)變異：根據(jù)由生物學(xué)變異確定的總允許誤差制定檢測(cè)性能的上下控制限。醫(yī)學(xué)相關(guān)性：根據(jù)臨床規(guī)范制定分析過(guò)程的總允許誤差。CV很小，假失控率太高，浪費(fèi)人力物力。如TE =10%，CV = 1%統(tǒng)計(jì)質(zhì)量控制存在的問(wèn)題CV很大，失控檢出率會(huì)很低。如TE=10%， CV=7%統(tǒng)計(jì)質(zhì)量控制存在的