Index of CLSI（NCCLS） Standards.doc

Alberta Laboratory Quality Enhancement Program CLSI Document Index of NCCLS StandardsPage 16 of 16Alberta Laboratory Quality Enhancement Program Index of CLSI/NCCLS Standards & GuidelinesALTERNATIVE SITE TESTING:CODEDOCUMENTDATEAST2-APoint-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline (Vol.19, No.9)June 1999AST3-AWellness Testing Using IVD Devices; Approved Guideline (Vol.19, No.4)February 1999AST4-A2Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition (Vol.25, No.12)May 2005C30-A2Point of Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Second Edition (Vol.22, No.17)September 2002GP14-ALabeling of Home-Use In Vitro Testing Products; Approved Guideline (Vol.16, No.2)June 1996POCT1-A2Point-of-Care Connectivity; Approved Standard Second Edition (Vol.26, No.28) (This is available as CD or printout in binder)July 2006POCT4-A2Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline Second Edition (Vol. 26, No. 30)August 2006POL1-T3Physicians Office Laboratory Guidelines Third Edition; Tentative Guideline (Vol.15, No.5)July 1995POL2-T3Physicians Office Laboratory Procedure Manual; Tentative Guideline (Vol.15, No.6)July 1995POL3-RCLIA/NCCLS POL Index (Vol.12, No.12)June 1992CLINICAL CHEMISTRY AND TOXICOLOGY:CODEDOCUMENTDATEC3-A4Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline Fourth Edition (Vol.24, No.22)June 2006C12-ADefinitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (Vol.14, No.11)September 1994C21-APerformance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples, Approved Standard (Vol.12, No.3)March 1992C24-A3Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline Third Edition (Vol.26, No.25)June 2006C25-AFractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (Vol.17, No.3)January 1997C27-ABlood Gas Pre-Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline (Vol.13, No.6)April 1993C28-A2How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline Second Edition (Vol.20, No.13)August 2000C29-A2Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard Second Edition (Vol.20, No.17)November 2000C31-AIonized Calcium Determinations: Precollection Variables, Specimen Choice, Collection and Handling; Approved Guideline (Vol.15, No.20)December 1995C32-PConsiderations in the Simultaneous Measurement of Blood Gases, Electrolytes and Related Analytes in Whole Blood; Proposed Guideline (Vol.13, No.17)November 1993C34-A2Sweat Testing: Sample Collection and Quantitative Analysis; Approved Guideline Second Edition (Vol.20, No.14)August 2000C37-APreparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline (Vol.19, No.25)November 1999C38-AControl of Preanalytical Variation in Trace Element Determinations; Approved Guideline (Vol.17, No.13)September 1997C39-AA Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (Vol.20, No.6)May 2000C40-PAnalytical Procedures for the Determination of Lead in Blood and Urine; Proposed Guideline (Vol.18, No.4)April 1998C42-AErythrocyte Protoporphyrin Testing; Approved Guideline (Vol.16, No.8)November 1996C43-AGas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Approved Guideline (Vol.22, No.22)January 2003C44-AHarmonization of Glycohemoglobin Measurements; Approved Guideline (Vol.22, No.25)January 2003C45-AMeasurement of Free Thyroid Hormones; Approved Guideline (Vol.24 No.31)October 2004C46-ABlood Gas and pH Analysis and Related Measurements; Approved Guideline (Vol.21, No.14)October 2001C48-AApplication of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases: Approve Guideline (Vol.24, No.22)July 2004C49-AAnalysis of Body Fluids in Clinical Chemistry; Approved Guideline (Vol.27, No.14)April 2007C52-A2Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline Second Edition (Vol.27, No.15)April 2007H11-A4Procedures for the Collection of Arterial Blood Specimens; Approved Standard Fourth Edition (Vol.24, No.28)September 2004H17-ADetermination of Serum Iron, Total Iron-Binding Capacity, and Percent Transferrin Saturation; Approved Standard (Vol.18, No.19)December 1998I2-A2Temperature Calibration of Water Baths, Instruments and Temperature Sensors Second Edition, Approved Standard (Vol.10, No.3)April 1990T/DM6-ABlood Alcohol Testing in the Clinical Laboratory; Approved Guideline (Vol.17, No.14)September 1997EVALUATION PROTOCOLS:CODEDOCUMENTDATEEP5-A2Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline Second Edition (Vol.24, No.25)August 2004EP6-AEvaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (Vol.23, No.16)April 2003EP7-A2Interference Testing in Clinical Chemistry; Approved Guideline Second Edition (Vol.25, No.27)November 2005EP9-A2Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second Edition (Vol.22, No.19)September 2002EP10-A3Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guidelines Third Edition (Vol.26, No.34)November 2006EP11-PUniformity of Claims For In Vitro Diagnostic Tests; Proposed Guideline (Vol.16, No.4)July 1996EP12-AUser Protocol for Evaluation of Qualitative Test Performance; Approved Guideline (Vol.22, No.14)September 2002EP13-RLaboratory Statistics Standard Deviation; A Report (Vol.15, No.8)August 1995EP14-A2Evaluation of Matrix Effects; Approved Guideline Second Edition (Vol.25, No.4)January 2005EP15-A2User Verification of Performance for Precision and Trueness; Approved Guideline Second Edition (Vol.25, No.17)June 2005EP17-AProtocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (Vol.24, No.34)October 2004EP18-AQuality Management for Unit-Use Testing; Approved Guideline (Vol.22, No.28)January 2003EP21-AEstimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (Vol.23 No.20)April 2003GENERAL LABORATORY PRACTICES:CODEDOCUMENTDATEGP2-A5Laboratory Documents: Development and Control; Approved GuidelineFifth Edition (Vol.26, No.12)March 2006GP2-A4CD Rom Toolkit: GP2-A4 TemplatesGP5-A2Clinical Laboratory Waste Management; Approved Guideline Second Edition (Vol.22, No.3)May 2002GP6-AInventory Control Systems for Laboratory Supplies; Approved Guideline (Vol.14, No.3)February 1994GP9-ASelecting and Evaluating a Referral Laboratory, Approved Guideline (Vol.18, No.15)November 1998GP10-AAssessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; Approved Guideline (Vol.15, No.19)December 1995GP11-ABasic Cost Accounting for Clinical Services; Approved Guideline (Vol.18, No.14)November 1998GP15-A2Papanicolaou Technique; Approved Guideline Second Edition (Vol.21, No.17)January 2002GP16-A2Urinalysis and Collection, Transportation and Preservation of Urine Specimens; Approved Guideline Second Edition (Vol.21, No.19)January 2002GP17-A2Clinical Laboratory Safety; Approved Guideline Second Edition (Vol.24, No.13)April 2004GP18-A2Laboratory Design; Approved Guideline Second Edition (Vol.27, No.7)February 2007GP19-A2Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation and Monitoring; Approved Guideline Second Edition (Vol.23, No.4)March 2003GP20-A2Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline Second Edition (Vol.23, No.27)October 2003GP21-A2Training and Competence Assessment; Approved Guideline Second Edition (Vol.24, No.14)April 2004GP22-A2Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline Second Edition(Vol.24, No.35)November 2004GP23-ANongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline (Vol.19, No.14)August 1999GP26-A3Application of a Quality Management System Model for Laboratory Services; Approved Guideline - Third Edition (Vol.24, No.36)November 2004GP27-A2Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline Second Edition (Vol.27, No.8)February 2007GP28-AMicrowave Device Use in the Histology Laboratory; Approved Guideline (Vol.25, No.7)February 2005GP29-AAssessment of Laboratory Tests When Proficiency Testing is Not Available; Approved Guideline (Vol.22, No.26)January 2003HS1-A2A Quality Management System Model for Health Care; Approved Guideline Second Edition (Vol.24, No.37)November 2004HS2-AProvider-Performed Microscopy Testing; Approved Guideline (Vol.23, No.5)March 2003HS3-APulse Oximetry; Approved Guideline (Vol.25, No.5)January 2005HS4-A2Application of a Quality Management System Model for Respiratory Services; Approved Guidelines Second Edition (Vol.22, No.23)May 2006HS5-A2Application of a Quality Management System Model for Medical Imaging Services; Approved Guidelines Second Edition (Vol.22, No.24)May 2006HS6-AStudies to Evaluate Patient Outcomes; Approved Guideline (Vol.24, No.32)October 2004HS10-A2Application of a Quality Management System Model for Inpatient Medication Use; Approved Guideline Second Edition (Vol.26, No.17)May 2006HS11-AA Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline (Vol.25, No.30)December 2005HEMATOLOGY:CODEDOCUMENTDATEH1-A5Tubes and Additives for Venous Blood Specimen Collection; Approved Standard Fifth Edition (Vol.23, No.33)December 2003H2-A4Reference and Selected Procedure for the Erythrocyte Sedimentation Rate (ESR) Test; Approved Standard Fourth Edition (Vol.20, No.27)March 2001H3-A5Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard Fifth Edition (Vol.23, No.32)December 2003H4-A5Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard Fifth Edition (Vol.24, No.21)June 2004H5-A3Procedures for the Handling and Transport of Diagnostic Specimens and Etiologic Agents Third Edition; Approved Standard (Vol.14, No.7)May 1994H7-A3Procedure for Determining Packed Cell Volume by the Microhematocrit Method Approved Standard Third Edition (Vol.20, No.18)November 2000H8-A2Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis Second Edition; Approved Standard (Vol.14, No.10)September 1994H9-AChromatographic (Microcolumn) Determination of Hemoglobin A2, Approved Standard (Vol.9, No.17)December 1989H10-A2Solubility Test to Confirm the Presence of Sickling Hemoglobins Second Edition; Approved Standard (Vol.15, No.7)August 1995H13-AQuantitative Measurement of Fetal Hemoglobin Using the Alkali Denaturation Method, Approved Guideline (Vol.9, No.18)December 1989H15-A3Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard Third Edition (Vol.20, No.28)March 2001H18-A3Procedures for the Handling and Processing of Blood Specimens, Approved Guideline Third Edition (Vol.24, No.38)November 2004H20-A2Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard Second Edition (Vol.27, No.4)January 2007H21-A4Collection, Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline Fourth Edition (Vol.23, No.35)December 2003H22-PHistochemical Method for Leukocyte Alkaline Phosphatase, Proposed Standard (Vol.4, No.14)October 1984H23-TCitrate Agar Electrophoresis for Confirming the Identification of Variant Hemoglobins, Tentative Guideline (Vol.8, No.6)September 1988H26-APerformance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard (Vol.16, No.12)December 1996H30-A2Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition (Vol.21, No.18)January 2002H31-PCollection Containers for Specimens for Toxicological Analysis, Proposed Guideline (Vol.6, No.4)July 1986H33-PAlgorithm for the Identification of Hemoglobin Variants; Proposed Guideline (Vol.17, No.8)May 1997H39-PDetermination of von Willebrand Factor Antigen; Proposed Guideline (Vol.13, No.29)December 1993H41-PAssay for Ristocetin Cofactor; Proposed Guideline (Vol.13, No.30)December 1993H42-A2Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline Second Edition (Vol.27, No.16)May 2007H43-A2Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline Second Edition (Vol.27, No.11)April 2007H44-A2Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline Second Edition (Vol.24, No.8)February 2004H45-A2Performance of the Bleeding Time Test; Approved Guideline Second Edition (Vol.25, No.15)June 2005H47-AOne-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (Vol.16, No.3)June 1996H48-ADetermination of Factor Coagulant Activities; Approved Guideline (Vol.17, No.4)April 1997H49-APoint-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline (Vol.24, No.23)July 2004H51-AAssays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline (Vol.22, No.20)September 2002H52-AFetal Red Cell Detection; Approved Guideline (Vol.21, No.26)March 2002H54-AProcedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline (Vol.25, No.23)August 2005H56-ABody Fluid Analysis for Cellular Composition; Approved Guideline (Vol.26, No.26)June 2006IMMUNOLOGY AND LIGAND ASSAY:CODEDOCUMENTDATEDI1-A2Glossary and Guidelines for Immunodiagnostic Procedures, Reagents and Reference Materials Second Edition, Approved Guideline (Vol.12, No.9)July 1992DI2-A2Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials Second Edition, Approved Guideline(Vol.13, No.14)October 1993DI3-AAgglutination Analyses: Antibody Characteristics, Methodology, Limitations, and Clinical Validation; Approved Guideline (Vol.13, No.15)October 1993DI4-TEnzyme and Fluorescence Immunoassays, Tentative Guideline (Vol.6, No.11)August 1986I/LA2-A2Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods: Approved GuidelineSecond EditionMarch 2006I/LA6-ADetection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling and Use of Test Products in the Clinical Laboratory; Approved Guideline (Vol.17, No.17)October 1997I/LA9-TA Candidate Reference Method for Serum Digoxin: A Model for Radioimmunoassay Reference Methods; Tentative Guideline(Vol.16, No.1)May 1996I/LA10-AChoriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (Vol.16, No.14)December 1996I/LA13-AHuman Immunodeficiency Virus Type 1 Reference Material Specifications, Approved Guideline (Vol.11, No.21)December 1991I/LA15-AApolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline (Vol.17, No.12)September 1997I/LA17-AAssessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Open Neural Tube Defects; Approved Guideline (Vol.17, No.5)April 1997I/LA18-A2Specifications for Immunological Testing for Infectious Diseases; Approved Guideline Second Edition (Vol.21, No.15)October 2001I/LA19-APrimary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (Vol.17, No.6)June 1997I/LA20-AEvaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (Vol.17, No.24)December 1997I/LA21-AClinical Evaluation of Immunoassays; Approved Guideline (Vol.22, No.9)June 2002I/LA23-AAssessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline (Vol.24, No.16)May 2004I/LA24-AFluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline (Vol.24, No.26)