1、CS與凝血標(biāo)準(zhǔn)化操作主要內(nèi)容CS5100、CS2000介紹凝血標(biāo)準(zhǔn)化操作文件解讀3CS-2000i 、CS5100優(yōu)勢最多方法學(xué)提供完整止血血栓方案免疫比濁法發(fā)色底物法聚集法凝固法International Business Management4CS-5100 設(shè)計理念提供優(yōu)越性能，滿足高端客戶的需求綜合處理能力最快PT 400 TEST/H,PT/APTT 400 TEST/H,DD 202 TEST/H凝血5項/6項/7項的檢測速度均為200TEST/小時左右相比CA-7000提高30-50%成本控制 最好試劑艙10 設(shè)計，提高試劑的機上穩(wěn)定性，節(jié)省試劑花費試劑艙斜坡設(shè)計，減少死腔量，節(jié)

2、省試劑花費多波長檢測技術(shù)，減少重測，節(jié)省試劑花費10批號定標(biāo)曲線儲存，減少定標(biāo)次數(shù)，節(jié)省試劑花費 質(zhì)量保證 最優(yōu)閉蓋穿刺采樣功能樣本質(zhì)量監(jiān)控功能，異常結(jié)果給出客觀評價樣本量監(jiān)測功能，提示抗凝比例的差異HEM.20020 Is there a documented procedure(s) describing methods for patient identification, patient preparation, specimen collection and labeling, specimen preservation, and conditions for transportat

3、ion, and storage before testing, consistent with good laboratory practice?導(dǎo)讀：本條款要求檢驗科要有文件規(guī)定，病人的身份信息、病人采集樣本前的準(zhǔn)備、標(biāo)本的采集方法和標(biāo)本標(biāo)簽、樣本的前處理、樣本運輸條件、測試前的儲存等內(nèi)容。參考CLSI H21-5AHEM.22707Is there a documented policy regarding clearing (flushing) of the volume of intravenous lines before drawing samples for hemostasi

4、s testing?導(dǎo)讀：原則上不能通過靜脈留置導(dǎo)管采集凝血樣本，如果要通過靜脈留置導(dǎo)管采集的話，先用生理鹽水沖洗導(dǎo)管以避免肝素污染，然后抽取5ml或6倍導(dǎo)管體積的血液丟棄，之后再采集凝血樣本。HEM.22748Are all coagulation specimens collected into 3.2% buffered sodium citrate?導(dǎo)讀：推薦使用枸櫞酸鈉質(zhì)量濃度為3.2%的抗凝劑來采集凝血樣本，如果不能使用質(zhì)量濃度3.2%的抗凝劑，應(yīng)當(dāng)有實驗數(shù)據(jù)說明其他濃度抗凝劑不影響結(jié)果。CLSI H21-A規(guī)定如果醫(yī)院要換抗凝管，需要驗證抗凝管對凝血檢測結(jié)果的影響，如果有影響還需

5、要重新建立參考范圍HEM.22789Are there documented guidelines for rejection of under- or overfilled collection tubes?導(dǎo)讀：檢驗科要有文件規(guī)定，拒收采樣量不足或過量的樣本。CS可以監(jiān)控樣本量，如果樣本量不正確，儀器會自動提示，同時具備HIL樣本檢測功能（自動識別黃疸溶血、乳糜的樣本）標(biāo)準(zhǔn)高度樣本量多樣本量正常樣本量少9提示當(dāng)前樣本量體積異常，會導(dǎo)致抗凝比例不當(dāng)，可能對檢測結(jié)果帶來影響102、溶血、黃疸、脂血樣本對檢測結(jié)果的影響 CS-5100 HIL功能監(jiān)測評估 1 2 3 4 5 61、正常樣本2、黃

6、疸樣本3、正常樣本4、溶血樣本5、正常樣本6、脂血樣本CS-5100對流程的改善：HIL樣本檢測功能1112HEM.22830Are there documented guidelines for detection and special handling of specimens with elevated hematocrits?導(dǎo)讀：采集樣本時要根據(jù)HCT調(diào)整抗凝劑的用量調(diào)整公式：X = (100 - PCV)/(595 - PCV)，X為每毫升抗凝標(biāo)本所用抗凝劑的量，PCV為紅細(xì)胞壓積，單位為%HEM.22871Are coagulation specimens checked fo

7、r clots (visual, applicator sticks, or by analysis of testing results) before testing or reporting results?導(dǎo)讀：樣本分析前要檢查樣本有無凝塊?；蚍治龊箨P(guān)注四項凝固時間均延長的樣本。HEM.22912Are coagulation tests promptly performed on fresh plasma, or is the platelet-poor plasma frozen until testing can be performed?導(dǎo)讀：要求凝血樣本的保存時間和條件。樣本

8、的保存時間的限制常常如果被忽略，例如TT，有用戶將常溫保存的樣本在上午和下午做TT實驗，比較上下午的TT結(jié)果是否可比，顯然這是不符合要求的。參考H21-A5HEM.23000Are reference intervals (normal ranges) established or verified by the laboratory for the population tested?導(dǎo)讀：介紹了在參考范圍的使用方面的要求。HEM.23150Are routine and STAT results available within a reasonable time?導(dǎo)讀：常規(guī)樣本4 - 8

9、小時出結(jié)果，急診樣本1小時出結(jié)果。CS5100 目前世界上綜合處理速度最快滿足急診快速發(fā)報告的要求:PT 400 test/h PT and APTT 400 test/hDD202 test/h19CS-5100 速度（組合項目速度最快）CS-5100A 儀器B 儀器PT400360300PT/APTT400330300D-Dimer20213065隨著特殊項目的開展，樣本量增加，臨床對實驗室的要求越來越高，如果越是特殊項目開展多，CS5100檢測速度優(yōu)勢越來越明顯。HEM.23220For PT, is there documentation that the ISI is appropr

10、iate to the particular PT reagent and instrumentation used?導(dǎo)讀：ISI值要與使用的試劑和儀器相適應(yīng)。每換一個批號都要更換ISI值。CS通過批號管理功能，強制操作者，更換不同批號PT試劑的時候，更換ISI值HEM.23290Is the calculation of the INR appropriately adjusted for every new lot of PT reagent, changes in types of reagent, or change in instrumentation?導(dǎo)讀：更換PT試劑批號，要重新

11、調(diào)整INR值。CS通過批號管理功能，強制操作者，更換不同批號PT試劑的時候，更換ISI值和MNPT，以調(diào)整INRHEM.23360Is the appropriate geometric mean of the PT reference interval used in the INR calculation?導(dǎo)讀：計算PT-INR的MNPT值是正常人群PT的幾何均值HEM.23453Is there documentation that the aPTT-based heparin therapeutic range is established and subsequently valid

12、ated when appropriate?導(dǎo)讀：需要建立肝素安全治療的APTT監(jiān)測范圍，不同批號的APTT試劑監(jiān)測肝素安全治療的范圍可能不同。每個批號的APTT試劑都需要驗證監(jiān)測肝素安全治療的范圍。HEM.23476Is there documentation that the aPTT-based heparin therapeutic range is established and validated using an appropriate technique?導(dǎo)讀：建立肝素安全治療的APTT監(jiān)測范圍要有文件明確的方法和技術(shù)。有兩種方法建立和驗證監(jiān)測范圍，（1）用肝素試劑盒建立，（2

13、）新批號的APTT試劑與已經(jīng)建立過監(jiān)測范圍的APTT試劑比較，從而建立監(jiān)測范圍。HEM.23500Are reference intervals for PT and aPTT current for the reagent or lot number, and have they been appropriately determined?導(dǎo)讀：由于不同類型、甚至不同批號的PT和APTT試劑有差異，因此實驗室在更換試劑時，需要重新確認(rèn)或建立新?lián)Q試劑相應(yīng)的參考范圍。HEM.24000Are reagents and solutions properly labeled, as applicab

14、le and appropriate, with the following elements?1. Content and quantity, concentration or titer2. Storage requirements3. Date prepared or reconstituted by the laboratory4. Expiration date導(dǎo)讀：實驗室必須文件記錄（不僅僅在試劑容器上），試劑內(nèi)容物的成分和數(shù)量、濃度或滴度、儲存的要求、制備的日期、有效截止日期。HEM.24100Are all reagents used within their indicate

15、d expiration date?導(dǎo)讀：所有的試劑必須在有效截至日期內(nèi)使用。CS試劑管理功能自動提示過有效期的試劑：如OVB（緩沖液） 超過8小時不會再使用試劑狀態(tài)實時監(jiān)控Reagent Screen 實時試劑量 機上穩(wěn)定時間HEM.24150Are reagents for functional clotting assays (e.g., PT, aPTT, fibrinogen) prepared, stored, and discarded as recommended by the manufacturer?導(dǎo)讀：PT/APTT/FIB試劑的制備、儲存、廢棄必須按照廠家的要求去做。

16、HEM.25150Are pipettors and dilutors (fixed volume or adjustable) checked at specific defined intervals for accuracy and reproducibility, (gravimetric, colorimetric or other verification procedure), and results recorded?導(dǎo)讀：定期檢查吸樣和稀釋裝置的準(zhǔn)確性和精密度。HEM.37050Are tests for common coagulation problems availab

17、le?導(dǎo)讀：為急診醫(yī)療服務(wù)的實驗室，必須提供足夠的實驗項目用于診斷常見的凝血異常，例如：血小板計數(shù)、PT、APTT、纖維蛋白原、FDP或D二聚體，以及血小板功能檢查。Sysmex凝血注冊項目最全HEM.37150Are tests for defining or monitoring disseminated intravascular coagulation (DIC) problems available, if applicable to the patient population served?導(dǎo)讀：如果有DIC發(fā)生的人群，需要提供診斷和監(jiān)測DIC的檢查項目。HEM.37175Is

18、there a system to periodically measure the actual platelet concentration of the usual platelet poor plasma used for many coagulation tests?導(dǎo)讀：乏血小板血漿對于LA和凍存后的分析很重要。其血小板數(shù)應(yīng)該低于10 X 109/L。因為血小板的促凝表面會加速凝血時間，引起假性凝血時間縮短。LA與血小板表面磷脂結(jié)合，被分離出血漿，使得本來存在的LA檢測不出來，引起LA的假陰性。XN的低值血小板通道可以定期監(jiān)測乏血小板血漿中血小板的的濃度HEM.37216If th

19、e laboratory has more than one instrument (same or different makes/models) for performing the same coagulation assays, are the instruments/reagents checked against each other at least twice a year for correlation of patient results?導(dǎo)讀：不同的儀器/試劑系統(tǒng)檢測同一個項目的時候，需要對不同的分析系統(tǒng)進行病人的樣本比對，每年至少兩次。以其中一臺檢測系統(tǒng)為準(zhǔn)，調(diào)整其它的

20、檢測系統(tǒng)。HEM.37232 Are there defined tolerance limits for results agreement of interinstrument assays?導(dǎo)讀：實驗室需要建立不同系統(tǒng)之間項目檢測結(jié)果的允許偏差。HEM.37300Is the photo-optical coagulation testing system (for PT, aPTT, etc.) checked with 2 different levels of control material during each 8 hours of patient testing, and

21、each time there is a change in reagents?導(dǎo)讀：PT和APTT等項目每8個小時或每次更換試劑，都要做質(zhì)控檢查。CS自動質(zhì)控功能，可以設(shè)定定期自動執(zhí)行質(zhì)控和更換試劑自動執(zhí)行質(zhì)控HEM.37400Are guidelines established for determining when alternative procedures should be performed (e.g., lipemia, hyperbilirubinemia, turbidity, etc.)?導(dǎo)讀：對于有干擾（溶血、脂血、黃疸）的樣本，需建立備選的檢測程序。CS的HIL功能

22、可以有效篩選出干擾標(biāo)本，多波長轉(zhuǎn)換功能作為備選檢測程序，無需多消耗試劑HEM.37930 If a D-dimer test is used for exclusion of deep vein thrombosis and/or pulmonary embolism, does the laboratory report the cutoff value for exclusion of venous thromboembolism, as well as the reference range?導(dǎo)讀：如果實驗室將D二聚體用于DVT/PE的排除診斷，應(yīng)該將cutoff和參考范圍一樣，與病人的

23、D二聚體結(jié)果一起報告給臨床。HEM.37935 If a D-dimer test is not used for exclusion of deep vein thrombosis and/or pulmonary embolism, does the laboratory inform clinicians that the test should not be used to exclude deep vein thrombosis or pulmonary embolism?導(dǎo)讀：如果某D二聚體不是用于DVT/PE排除診斷的，實驗室應(yīng)該告知臨床。例如日系的D二聚體試劑，主要用于DIC的篩查HEM.37940 For coagulation end point-based factor assays, are three or