【专题讲座一】：问题的提出
临床 临床检验结果准确、可靠是临床检验工作的首要前提。那么如何才能知道检验结果是对的呢？因此，我们做临床检验和实验，首先要了解如下方面的内容：
临床 1. 怎样去选择和评估使用的仪器、试剂、校准品和检测方法（综合起来即为检测系统）；
临床 2. 怎样去判断公司提供的产品的分析性能是否符合临床要求；
临床 3. 有了好的检测检测系统，在日常检测病人标本中，怎样用质量控制方法去揭示和控制发生的不可预料的误差？应该怎样正确使用。
临床 美国国家临床实验室标准委员会(National Committee for Clinical Laboratory Standards, NCCLS)为全球检验医学的标准化作出了卓越的贡献。从2005年1月NCCLS已正式更名为临床和实验室标准协会（Clinical and Laboratory Standards Institute, CLSI）。他们提出了一系列的标准，为上述问题提供了咨询和参考。
AST
AST2-A Point-of-Care in Vitro Diagnostic (IVD) Testing (1999.6)
AST3-A Wellness Testing Using IVD Devices (1999.2)
AST4-A Blood Glucose Testing in Settings Without Laboratory Support (1999.6)
C
C3-A3 Preparation and Testing of Reagent Water in the Clinical Laboratory (1997.10)
C24-A2 Statistical Quality Control for Quantitative Measurements: Principle and Definitions
(1999.2)
C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory (2000.6)
C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the
Flame Photometric Reference Method (2000.10)
C30-A2 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities (2002.8)
C31-A2* Ionized Calcium Determinations: Precollection Variables, Specimen Choice,
Collection, and Handling (2001.6)
C34-A2 Sweat Testing: Sample Collection and Quantitative Analysis (2000.6)
C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures (1999.11)
C38-A Control of Preparation Variation in Trace Element Determinations (1997.9)
C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum
(2000.4)
C40-A Analytical Procedures for the Determination of Lead in Blood and Urine (2001.6)
C42-A Erythrocyte Protoporphyrin Testing (1996.11)
C43-A Gas Chromatography/mass Spectrometry (GC/MS) Confirmation of Drugs (2002.11)
C44-A Harmonization of Glycohemoglobin Measurements (2002.12)
C46-A Blood Gas and pH Analysis and Related Measurememnts (2001.9)
DI
DI2-A2 Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials.
(1993.10)
DI3-A Agglutination Assayses: Antibody Characteristics,Methodology, Limitations,and
Clinical Validation (1993.10)
EP
EP5-A2 Evaluation of Precision Performance of Quantative measurement methods;
Approved Guideline-Second Edition (2004.08)
EP6-A Evaluation of the Linearity of Quantative Analytical Methods (2003.4)
EP7-A Interference Testing in Clinical Chemistry (2002.12)
EP9-A2 Method Comparison and Bias Estimation Using Patient Samples (2002.9)
EP10-A2 Preliminary Evaluation of Quantitative Clinical Laboratory Methods (2002.12)
EP12-A User Protocol for Evaluation of Qualitative Test Performance (2002.8)
EP13-R Laboratory Statistics-Standard Deviation.(1995.8)
EP14-A* Evaluation of Matrix Effects (2001.3)
EP15-A* User Demonstration of Performance for Precision and Accuracy (2001.12)
EP18-A Quality Management for Unit-Use Testing (2002.12)
EP19-R A Framework for NCCLS Evaluation Protocols. (2002.6)
EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods (2003.4)
G
GP2-A4* Clinical Laboratory Technical Procedure Manuals (2002.4)
GP5-A2 Clinical Laboratory Waste Management (2002.4)
GP6-A Inventory Control Systems for Laboratory Supplies.(1994.2)
GP9-A Selecting and Evaluating a Referral Laboratory (1998.11)
GP10-A Assessment of the Clinical accuracy of Laboratory Tests Using Receiver Operating
Characteristics (ROC) Plots (1995.12)
GP11-A Basic Cost Accounting in the Clinical Services (1998.11)
GP14-A Labeling of Home-Use In Vitro Testing products.(1996.6)
GP15-A2* Papanicolaou Technique (2001.11)
GP16-A2* Urinalysis and Collection, Transportation, and Preservation of Urine Specimens
(2001.11)
GP17-A Clinical Laboratory Safety.(1996.12)
GP18-A Laboratory Design (1998.4)
GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User
Interface and End-User Software Systems Validation, Operation, and Monitoring
(2003.2)
GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques (2003.10)
GP21-A Traning Verification for Laboratory Personnel.(1995.12)
GP22-A Continuous Quality Improvement: Essential Management Approaches (1999.8)
GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques
(1999.8)
GP26-A2 Application of a Quality System Model to Laboratory Services (2003.2)
GP27-A Using Proficiency Testing (PT) to Improve the Clinical Laboratory (1999.8)
GP29-A Validation of Laboratory Tests When Proficiency Testing is Not Available (2002.12)
H
H1-A5 Evacuated Tubes and Additives for Blood Specimen Collection—4th Edition (2003.12)
H2-A4 Reference and selected procedure for the Erythrocyte Sedimentation Rate(ESR) Test
(2000.12)
H3-A5 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture
(2003.12)
H4- A4 Procedures and Devices for the Collection of Diagnostic Blood Specimen by Skin
Puncture (1999.9)
H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method
(2000.12)
H11-A3 Procedures for the Collection of Arterial Blood Specimens (1999.5)
H15-A3 Reference and Selected Procedures for the quantitative Determination of Hemoglobin
in Blood (2000.12)
H17-A Determination of Serum Iron, Total Iron-Binding Capacity6 and Percent Transferrin
Saturation (1998.12)
H18-A2 Procedures for the Handling and Processing of Blood Specimens (1999.10)
H20-A Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental
Methods (1992.3)
H21-A4 Collection, Tranport, and Processing of Blood Specimens for Coagulation testing and
General performance of Coagulation Assays (2003.12)
H26-A Performance Goals for the Internal Quality Control of Multichannel Hemotology
Analyzers (1996.12)
H30-A2* Procedure for the Determination of Fibrinogen in Plasma (2001.12)
H42-A Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping
of Lymphocytes (1998.12)
H43-A Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells
(1998.6)
H44-A Methods for Reticulocyte Counting( Flow Cytometry, and Supravital Dyes) (1997.10)
H45-A Performance of the Bleeding Time Test (1998.6)
H47-A One-Stage prothrombin Time (PT) Test and Activated Partial Thromboplastin Time
(APTT) Test. (1996.6)
H51-A Assays of von Willebrend Factor Antigen and Ristocetin Cofactor Activity (2002.9)
H52-A* Fetal Red Cell Detection (2001.12)
HS
HS1-A A Quality System Model for Health Care (2002.8)
HS2-A Provider-Performed Microscopy Testing (2003.2)
HS4-A Application of a Quality System Model to Respiratory Services (2002.11)
HS5-A Application of a Quality System Model for Medical Imaging Services (2002.11)
I/LA
I/LA-2A Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to
Nuclear Antigen(IF-ANA);(1996.12)
I/LA6-A Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance
Criteria for muleiple Component Test Product and Specimen Handling and Use of
Test Products in the Clinical Laboratory (1997.10)
I/LA10-A Choriogonadotropin Testing:Nomenclature,Reference Preparations,Assay
Performance,and Clinical Application (1996.12)
I/LA15-P Apolipoprotein Immunoassays: Development and Recommended Performance
Characteristics (1997.9)
I/LA17-A Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used
in Prenatal Screening and Diagnosis of Open neural Tube Defects (1997.4)
I/LA18-A2* Specifications for Immunological Testiong for Infectious Diseases (2001.9)
I/LA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical
Assays for serum Prostate specific antigen (PSA) (1997.6)
I/LA20-A Evaluation Methods and Analytical Performance Characteristics of Immunological
Assays for Human Immunoglobulin E (Ig E) Antibodies of Defined Allegen
Specificities (1997.12)
I/LA21-A* Clinical Evaluation of Immunoassays (2002.6)
LA
LA1-A2 Assessing the Quality of Radioimmunoassay System（1994.12）
LA4-A4 Blood Collection on Filter Paper for Neonatal Screening Programs (2003.7)
M
M2-A8 Performance Standards for Antimicrobial Disk Susceptibility Tests (2003.1)
M6-A Protocols for Evaluating Dehydrated Muller-Hinton Agar (1996.12)
M7-A6 Methods for Dilution Antimicrobial Suswceptibility Tests for Bacteria That Grow
Aerobically (2003.1)
M11-A6 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria (2004.1)
M15-A Laboratory Diagnosis of Blood-Borne Parasitic Diseases (2000.6)
M21-A Methodology for the Serum Bactericidal Test (1999.9)
M22-A2 Quality Assurance for Commercially Prepared Microbiological Culture
Media-Second (1996.12)
M23-A2* Development of In Vitro Susceptibility Testing Criteria and Quality Control
Parameters (2001.5)
M24-A Susceptibility Testing of Mycobacteria,Nocariae,and Other Aerobic Actinomycetes
(2003.4)
M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents (1999.9)
M27-A2 Reference Method for Broth Diloution Antifungal Susceptibility Testing of Yeasts
(2002.8)
M28-A Procedures for the Recovery and Identification of Parasites from the Intestinal
Tract (1997.12)
M29-A2* Protection of Laboratory Workers from Occupationally Acquired Infections (2001.12)
M100-S14* Performance Standards for Antimicrobial susceptibility Testing (2004.1)
临床 为提高整个检验版块的整体水平，从今天起，我将陆续提供CLSI的EP文件，同时提供我们科室全体人员的中文翻译内容，这些文件得之不易，翻译更是科室同事的辛勤劳动的结晶，内容涉及检测系统的六大基本性能精密度、准确度、可报告范围、灵敏度、特异性的评价方法，望大家珍惜宝贵资源。同时希望各位同行参与评议和讨论共同提高我们的理论和实践水平。
我是可爱的分割线
临床 今天提供第一部分：精密度的评价方法
EP5-A2.part1.rar (292.97k)
好样的
谢谢!!!
我很想要这样的资料，但我看不到这份资料，能不能帮忙发一份到我邮箱。邮箱xzyhz720615@126.com 在这里先谢谢了！！
非常感谢，期待其他ＥＰ文件
中文翻译正在进行校对！大家慢慢等候！
wacsd999 wrote:
中文翻译正在进行校对！大家慢慢等候！
期待中..........,这些文件对临床实验室确实有帮助!
期待分享中！
【专题知识二】： CLSI替代NCCLS的介绍
临床众所周知, (美国)国家临床实验室标准委员会(National Committee for Clinical Laboratory Standards, NCCLS)为全球检验医学的标准化作出了卓越的贡献。从2005年1月NCCLS已正式更名为临床和实验室标准协会（Clinical and Laboratory Standards Institute, CLSI）。为帮助大家进一步了解CLSI，现将有关情况简介如下。
临床NCCLS至1967年成立以来，致力于“改善我们为病人所做”和为“使检验结果具有一致性”建立标准。迄今为止，NCCLS为临床实验室已提供超过160份标准和指南，涉及到当今检验医学发展的方方面面，包括保健服务（Healthcare Services）、自动化和信息学（Automation and Informatics）、临床化学和毒理学（Clinical Chemistry and Toxicology）、血液学（Hematology）、免疫学和配体分析（Immunology and Ligand Assay）、微生物学（Microbiology）、分子生物学（Molecular Biology）、床旁检测（Point-of-Care Testing）、临床实验室国家参考系统（National Reference System for the Clinical Laboratory）等。同时，NCCLS与世界相关的权威机构如国际标准化组织（ISO）、国际临床化学协会（IFCC）、国际血液学标准化委员会（ICSH）等机构密切合作，为全球的检验医学和卫生技术标准的一致性做出了不懈努力。例如，NCCLS一直参与管理ISO的临床实验室检测技术委员会（ISO Technical Committee on Clinical Laboratory Testing）和体外诊断实验系统（in vitro diagnostic test systems）（其被官方命名为ISO/TC212），并参与其标准的制定。
临床随着所建立的标准和指南越来越多，NCCLS对全球检验医学的影响日益增大，其已被全球检验医学界所接受，现已拥有会员组织超过2000家。为了让NCCLS发挥更大、更好和更全面的作用，2004年3月有关机构和权威人士就正式提案将NCCLS更名为CLSI，随后便成立了CLSI；并在2005年1月由CLSI正式替代NCCLS发布标准和指南。成立CLSI的目的是扩大和增强NCCLS的服务范围，通过建立和传播具有一致性的标准和指南以加强检验医学在医疗保健服务中的价值。同时将CLSI定义为一个全球性、非赢利、致力于标准建立和开发的组织。CLSI基于大家认同的一致性标准具有效率高、成本低的原则，促进医疗保健团体自愿使用具有一致性的标准和指南，以改善对病人的检测和服务。
一、 CLSI的主要服务范围
1. 标准和指南的建立：其仍是CLSI的主要工作。在建立标准方面，CLSI除继续从事原有检验医学各领域的标准建立外，还将其服务范围扩展如下：（1）建立保健服务指南，如2004年10月建立的标准HS 1-A2：保健质量管理系统模式（A Quality Management System Model for Health Care）；（2）临床服务标准，如2004年10月建立的指南HS 6-A：病人（治疗）结果评估的研究（Studies to Evaluate Patient Outcomes）； (3)临床和实验室服务标准，如2004年7月建立的标准 H 49A：抗凝治疗的床旁监测（Point-of-Care Monitoring of Anticoagulation Therapy）等。CLSI希望通过标准和指南的建立，达到以下目的：（1）改善保健服务机构、医学检验、临床和其他实验室的工作质量；（2）有益于公共卫生、安全和福利；（3）促进保健服务机构、医学检验、临床和其他实验室的相互交流和理解。
2. 与其他国际组织的合作： CLSI通过与其他国际权威机构一起合作，制定保健服务机构、医学检验、临床和其他实验室的相关标准和指南；并促进已建立的标准和指南的使用；评价其在实践过程中的有效性。同时我们注意到，在以CLSI批准2005年生效的标准和指南中，将以前NCCLS的四类标准—通过标准（Approved, A）、提议标准（Proposed, P）、暂定标准（Tentative, T）和报告（Report, R）中A的一部分标准以FDA（美国食品与药物管理局）进行标识，表明该类标准已通过FDA的认可；另有一些标准是以“星条旗”标识，表明该类标准正在申请美国国家标准，使其更具权威性。
3．提供一种机制：即发现标准与指南在使用过程中所出现的问题，并予以解决，以维持和促进公共卫生与社会需要的一致性。
二、 CLSI的组织机构（图1）
三、联系方式
临床为了保持NCCLS更名为CLSI后的延续性，CLSI的网址目前仍用原来NCCLS的网址hppt://www.nccls.org；但是，CLSI的咨询邮箱和执行办公室的邮箱已分别变为info@clsi.org 和exoffice@clsi.org 。同时，CLSI仍用原来的NCCLS的办公地址，即940 West Valley Road, Suite 1400 Wayne, PA 19087, USA。
我是可爱的分割线
图1 CLSI的组织结构
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应广大同行和...er要求提供上面三个实验室认可的标准蓝皮书，分别为ISO15189 、ISO17511、ISO18153的中文译本，均加密10分，初级DXYER不要通过EMAIL向我索取，对不起，请大家努力做出贡献争分！10分其实很容易！
[您无权限看这个帖子，您的积分需要大于 8]
针对另一贴里的战友提出的问题-----
>
在此处贴出NCCLS的标准文件GP29：GP29－Validation of Laboratory Tests When Proficiency Testing is Not Available (2002.12)，望大家仔细阅读，参与讨论，另希望版主将战友那一帖的内容转到本精华贴来以节省资源！谢谢！由于标准文件来之不易，依然在下贴加密3分！大家谅解，多多参与讨论获得积分！
.pdf_fn=document-frame.htm&f=templates&2.part1.rar (292.97k)
精彩，顶。
海豚您好,看了山东省临检中心主页,看了你们的论坛,知道你们省实施了通过了室间质评的医疗单位可进行检验结果的互认,我个人认为这是件好事,但我认为其间还有很长一段路要走,这要求在行业内建立一个通用的标准,这样才可以真正实现检验结果的互认,我们就是在近年来尝试探索这些问题,所以发动了很多医院的检验科参与这项NCCLS的标准执行计划,目前只是在翻译和学习阶段,希望您能加入到我们中来,参与到我们的讨论以及探索工作中!我们将不胜感激!
真着急啊，以前的号被盗了，看不到这么精彩的内容，先上传些资料，望获得加分，谢谢
如何做好质量控制.ppt (283.5k)
