Index of CLSI（NCCLS） ，Standards & Guidelines----2007

Alberta Laboratory Quality Enhancement Program CLSI Document Index of NCCLS Standards Page 4 of 16 Alberta Laboratory Quality Enhancement Program Index of CLSI/NCCLS Standards & Guidelines ALTERNATIVE SITE TESTING: CODE DOCUMENT DATE AST2-A Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline (Vol. 19, No. 9) June 1999 AST3-A Wellness Testing Using IVD Devices; Approved Guideline (Vol. 19, No. 4) February 1999 AST4-A2 Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline – Second Edition (Vol. 25, No. 12) May 2005 C30-A2 Point of Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline – Second Edition (Vol. 22, No. 17) September 2002 GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline (Vol. 16, No. 2) June 1996 POCT1-A2 Point-of-Care Connectivity; Approved Standard – Second Edition (Vol. 26, No. 28) (This is available as CD or printout in binder) July 2006 POCT4-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline – Second Edition (Vol. 26, No. 30) August 2006 POL1-T3 Physician’s Office Laboratory Guidelines – Third Edition; Tentative Guideline (Vol. 15, No. 5) July 1995 POL2-T3 Physician’s Office Laboratory Procedure Manual; Tentative Guideline (Vol. 15, No. 6) July 1995 POL3-R CLIA/NCCLS POL Index (Vol. 12, No. 12) June 1992 CLINICAL CHEMISTRY AND TOXICOLOGY: CODE DOCUMENT DATE C3-A4 Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline – Fourth Edition (Vol. 24, No. 22) June 2006 C12-A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (Vol. 14, No. 11) September 1994 C21-A Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples, Approved Standard (Vol. 12, No. 3) March 1992 C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline – Third Edition (Vol. 26, No. 25) June 2006 C25-A Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (Vol. 17, No. 3) January 1997 C27-A Blood Gas Pre-Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline (Vol. 13, No. 6) April 1993 C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline – Second Edition (Vol. 20, No. 13) August 2000 C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard – Second Edition (Vol. 20, No. 17) November 2000 C31-A Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection and Handling; Approved Guideline (Vol. 15, No. 20) December 1995 C32-P Considerations in the Simultaneous Measurement of Blood Gases, Electrolytes and Related Analytes in Whole Blood; Proposed Guideline (Vol. 13, No. 17) November 1993 C34-A2 Sweat Testing: Sample Collection and Quantitative Analysis; Approved Guideline –Second Edition (Vol. 20, No. 14) August 2000 C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline (Vol. 19, No. 25) November 1999 C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline (Vol. 17, No. 13) September 1997 C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (Vol. 20, No. 6) May 2000 C40-P Analytical Procedures for the Determination of Lead in Blood and Urine; Proposed Guideline (Vol. 18, No. 4) April 1998 C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline (Vol. 16, No. 8) November 1996 C43-A Gas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Approved Guideline (Vol.22, No. 22) January 2003 C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline (Vol. 22, No. 25) January 2003 C45-A Measurement of Free Thyroid Hormones; Approved Guideline (Vol. 24 No.31) October 2004 C46-A Blood Gas and pH Analysis and Related Measurements; Approved Guideline (Vol. 21, No. 14) October 2001 C48-A Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases: Approve Guideline (Vol. 24, No. 22) July 2004 C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline (Vol. 27, No. 14) April 2007 C52-A2 Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline – Second Edition (Vol. 27, No. 15) April 2007 H11-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard – Fourth Edition (Vol. 24, No. 28) September 2004 H17-A Determination of Serum Iron, Total Iron-Binding Capacity, and Percent Transferrin Saturation; Approved Standard (Vol. 18, No. 19) December 1998 I2-A2 Temperature Calibration of Water Baths, Instruments and Temperature Sensors – Second Edition, Approved Standard (Vol. 10, No. 3) April 1990 T/DM6-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (Vol. 17, No.14) September 1997 EVALUATION PROTOCOLS: CODE DOCUMENT DATE EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition (Vol. 24, No. 25) August 2004 EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (Vol. 23, No. 16) April 2003 EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition (Vol. 25, No. 27) November 2005 EP9-A2 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition (Vol. 22, No. 19) September 2002 EP10-A3 Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guidelines – Third Edition (Vol. 26, No. 34) November 2006 EP11-P Uniformity of Claims For In Vitro Diagnostic Tests; Proposed Guideline (Vol. 16, No. 4) July 1996 EP12-A User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline (Vol. 22, No. 14) September 2002 EP13-R Laboratory Statistics – Standard Deviation; A Report (Vol. 15, No. 8) August 1995 EP14-A2 Evaluation of Matrix Effects; Approved Guideline – Second Edition (Vol. 25, No. 4) January 2005 EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline – Second Edition (Vol. 25, No. 17) June 2005 EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (Vol. 24, No. 34) October 2004 EP18-A Quality Management for Unit-Use Testing; Approved Guideline (Vol. 22, No. 28) January 2003 EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (Vol. 23 No. 20) April 2003 GENERAL LABORATORY PRACTICES: CODE DOCUMENT DATE GP2-A5 Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition (Vol. 26, No. 12) March 2006 GP2-A4 CD Rom Toolkit: GP2-A4 Templates GP5-A2 Clinical Laboratory Waste Management; Approved Guideline – Second Edition (Vol. 22, No. 3) May 2002 GP6-A Inventory Control Systems for Laboratory Supplies; Approved Guideline (Vol. 14, No. 3) February 1994 GP9-A Selecting and Evaluating a Referral Laboratory, Approved Guideline (Vol. 18, No. 15) November 1998 GP10-A Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; Approved Guideline (Vol. 15, No. 19) December 1995 GP11-A Basic Cost Accounting for Clinical Services; Approved Guideline (Vol. 18, No. 14) November 1998 GP15-A2 Papanicolaou Technique; Approved Guideline – Second Edition (Vol. 21, No. 17) January 2002 GP16-A2 Urinalysis and Collection, Transportation and Preservation of Urine Specimens; Approved Guideline – Second Edition (Vol. 21, No. 19) January 2002 GP17-A2 Clinical Laboratory Safety; Approved Guideline – Second Edition (Vol. 24, No. 13) April 2004 GP18-A2 Laboratory Design; Approved Guideline – Second Edition (Vol. 27, No. 7) February 2007 GP19-A2 Laboratory 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 2003 GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline – Second Edition (Vol. 23, No. 27) October 2003 GP21-A2 Training and Competence Assessment; Approved Guideline – Second Edition (Vol. 24, No. 14) April 2004 GP22-A2 Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline – Second Edition (Vol. 24, No. 35) November 2004 GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline (Vol. 19, No. 14) August 1999 GP26-A3 Application of a Quality Management System Model for Laboratory Services; Approved Guideline - Third Edition (Vol. 24, No. 36) November 2004 GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline – Second Edition (Vol. 27, No. 8) February 2007 GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline (Vol. 25, No. 7) February 2005 GP29-A Assessment of Laboratory Tests When Proficiency Testing is Not Available; Approved Guideline (Vol. 22, No. 26) January 2003 HS1-A2 A Quality Management System Model for Health Care; Approved Guideline – Second Edition (Vol. 24, No. 37) November 2004 HS2-A Provider-Performed Microscopy Testing; Approved Guideline (Vol. 23, No. 5) March 2003 HS3-A Pulse Oximetry; Approved Guideline (Vol. 25, No. 5) January 2005 HS4-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guidelines – Second Edition (Vol. 22, No. 23) May 2006 HS5-A2 Application of a Quality Management System Model for Medical Imaging Services; Approved Guidelines – Second Edition (Vol. 22, No. 24) May 2006 HS6-A Studies to Evaluate Patient Outcomes; Approved Guideline (Vol. 24, No. 32) October 2004 HS10-A2 Application of a Quality Management System Model for Inpatient Medication Use; Approved Guideline – Second Edition (Vol. 26, No. 17) May 2006 HS11-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline (Vol. 25, No. 30) December 2005 HEMATOLOGY: CODE DOCUMENT DATE H1-A5 Tubes and Additives for Venous Blood Specimen Collection; Approved Standard – Fifth Edition (Vol. 23, No. 33) December 2003 H2-A4 Reference and Selected Procedure for the Erythrocyte Sedimentation Rate (ESR) Test; Approved Standard – Fourth Edition (Vol. 20, No. 27) March 2001 H3-A5 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Fifth Edition (Vol. 23, No. 32) December 2003 H4-A5 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard – Fifth Edition (Vol. 24, No. 21) June 2004 H5-A3 Procedures for the Handling and Transport of Diagnostic Specimens and Etiologic Agents – Third Edition; Approved Standard (Vol. 14, No. 7) May 1994 H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method – Approved Standard – Third Edition (Vol. 20, No. 18) November 2000 H8-A2 Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis – Second Edition; Approved Standard (Vol. 14, No. 10) September 1994 H9-A Chromatographic (Microcolumn) Determination of Hemoglobin A2, Approved Standard (Vol. 9, No. 17) December 1989 H10-A2 Solubility Test to Confirm the Presence of Sickling Hemoglobins – Second Edition; Approved Standard (Vol. 15, No. 7) August 1995 H13-A Quantitative Measurement of Fetal Hemoglobin Using the Alkali Denaturation Method, Approved Guideline (Vol. 9, No. 18) December 1989 H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition (Vol. 20, No. 28) March 2001 H18-A3 Procedures for the Handling and Processing of Blood Specimens, Approved Guideline – Third Edition (Vol. 24, No. 38) November 2004 H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard – Second Edition (Vol. 27, No. 4) January 2007 H21-A4 Collection, Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline – Fourth Edition (Vol. 23, No. 35) December 2003 H22-P Histochemical Method for Leukocyte Alkaline Phosphatase, Proposed Standard (Vol. 4, No. 14) October 1984 H23-T Citrate Agar Electrophoresis for Confirming the Identification of Variant Hemoglobins, Tentative Guideline (Vol. 8, No. 6) September 1988 H26-A Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard (Vol. 16, No. 12) December 1996 H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline – Second Edition (Vol. 21, No. 18) January 2002 H31-P Collection Containers for Specimens for Toxicological Analysis, Proposed Guideline (Vol. 6, No. 4) July 1986 H33-P Algorithm for the Identification of Hemoglobin Variants; Proposed Guideline (Vol. 17, No. 8) May 1997 H39-P Determination of von Willebrand Factor Antigen; Proposed Guideline (Vol. 13, No. 29) December 1993 H41-P Assay for Ristocetin Cofactor; Proposed Guideline (Vol. 13, No. 30) December 1993 H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline – Second Edition (Vol. 27, No. 16) May 2007 H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline – Second Edition (Vol. 27, No. 11) April 2007 H44-A2 Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition (Vol. 24, No. 8) February 2004 H45-A2 Performance of the Bleeding Time Test; Approved Guideline – Second Edition (Vol. 25, No. 15) June 2005 H47-A One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (Vol. 16, No. 3) June 1996 H48-A Determination of Factor Coagulant Activities; Approved Guideline (Vol. 17, No. 4) April 1997 H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline (Vol. 24, No. 23) July 2004 H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline (Vol. 22, No. 20) September 2002 H52-A Fetal Red Cell Detection; Approved Guideline (Vol. 21, No. 26) March 2002 H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline (Vol. 25, No. 23) August 2005 H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline (Vol. 26, No. 26) June 2006 IMMUNOLOGY AND LIGAND ASSAY: CODE DOCUMENT DATE DI1-A2 Glossary and Guidelines for Immunodiagnostic Procedures, Reagents and Reference Materials – Second Edition, Approved Guideline (Vol. 12, No. 9) July 1992 DI2-A2 Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials – Second Edition, Approved Guideline (Vol. 13, No. 14) October 1993 DI3-A Agglutination Analyses: Antibody Characteristics, Methodology, Limitations, and Clinical Validation; Approved Guideline (Vol. 13, No. 15) October 1993 DI4-T Enzyme and Fluorescence Immunoassays, Tentative Guideline (Vol. 6, No. 11) August 1986 I/LA2-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods: Approved Guideline—Second Edition March 2006 I/LA6-A Detection 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 1997 I/LA9-T A Candidate Reference Method for Serum Digoxin: A Model for Radioimmunoassay Reference Methods; Tentative Guideline (Vol. 16, No. 1) May 1996 I/LA10-A Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (Vol. 16, No. 14) December 1996 I/LA13-A Human Immunodeficiency Virus Type 1 Reference Material Specifications, Approved Guideline (Vol. 11, No. 21) December 1991 I/LA15-A Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline (Vol. 17, No. 12) September 1997 I/LA17-A Assessing 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 1997 I/LA18-A2 Specifications for Immunological Testing for Infectious Diseases; Approved Guideline – Second Edition (Vol. 21, No. 15) October 2001 I/LA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (Vol. 17, No. 6) June 1997 I/LA20-A Evaluation 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 1997 I/LA21-A Clinical Evaluation of Immunoassays; Approved Guideline (Vol. 22, No. 9) June 2002 I/LA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline (Vol. 24, No. 16) May 2004 I/LA24-A Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline (Vol. 24, No. 26) August 2004 I/LA25-A Maternal Serum Screening; Approved Standard (Vol. 24, No. 39) December 2004 I/LA26-A Performance of Single Cell Immune Response Assays; Approved Guideline (Vol. 24, No. 29) October 2004 I/LA27-A Newborn Screening Follow-up; Approved Guideline (Vol. 26, No. 18) May 2006 I8-P Determining Performance of Volumetric Equipment, Proposed Guideline (Vol. 4, No. 6) May 1984 LA1-A2 Assessing the Quality of Radioimmunoassay Systems – Second Edition; Approved Guideline (Vol. 14, No. 17) December 1994 LA4-A5 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard – Fifth Edition (Vol. 27, No. 20) July 2007 Laboratory Information Systems CODE DOCUMENT DATE LIS1-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems (Vol. 23, No. 7) April 2003 LIS2-A2 Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard – Second Edition (Vol. 24, No. 33) October 2004 LIS3-A Standard Guide for Selection of a Clinical Laboratory Information Management System (Vol. 23, No. 9) April 2003 LIS4-A Standard Guide for Documentation of Clinical Laboratory Computer Systems (Vol. 23, No. 10) April 2003 LIS5-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems (Vol. 23, No. 11) April 2003 LIS6-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems (Vol. 23, No.12) April 2003 LIS7-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory (Vol. 23, No. 13) April 2003 LIS8-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (Vol. 23, No. 14) April 2003 LIS9-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures (Vol. 23, No. 15) April 2003 MICROBIOLOGY CODE DOCUMENT DATE M2-A9 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Ninth Edition (Vol. 23, No. 1) January 2006 M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition (Vol. 26, No. 6) January 2006 M7-A7 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Seventh Edition (Vol. 26, No. 2) January 2006 M11-A7 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Seventh Edition (Vol. 27, No. 2) January 2007 M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline (Vol. 20, No.12) June 2000 M21-A Methodology for the Serum Bactericidal Test; Approved Guideline (Vol. 19, No. 17) September 1999 M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard – Third Edition (Vol. 24, No. 19) June 2004 M23-T3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Tentative Guideline – Third Edition (Vol. 18, No. 5) April 1998 M24-T Antimycobacterial Susceptibility Testing for Mycobacterium tuberculosis; Tentative Standard (Vol. 15, No. 16) December 1995 M24-A Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard (Vol. 23 No. 18) April 2003 M25-A Fetal Bovine Serum; Approved Guideline (Vol. 15, No. 9) October 1995 M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline (Vol. 19, No. 18) September 1999 M27-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard – Second Edition (Vol. 22, No. 15) September 2002 M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline – Second Edition (Vol. 25, No. 16) June 2005 M29-A3 Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition (Vol. 25, No. 10) March 2005 Video Preventing Bloodborne Pathogen Infection: Improved Practice Means Protection (Based on M29-A2) January 2003 M31-A2 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard – Second Edition (Vol. 22, No. 6) May 2002 M33-A Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard (Vol. 24, No. 7) February 2004 M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline (Vol. 20, No. 20) January 2001 M35-A Abbreviated Identification of Bacteria and Yeast; Approved Guideline (Vol. 22, No. 18) September 2002 M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline (Vol. 24, No. 6) February 2004 M37-A2 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline - Second Edition (Vol. 22, No. 7) May 2002 M38-A Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard (Vol. 22, No. 16) Sept 2002 M39-A2 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline – Second Edition (Vol. 25, No. 28) November 2005 M40-A Quality Control of Microbiological Transport Systems; Approved Standard (Vol. 23, No. 34) December 2003 M41-A Viral Culture; Approved Guideline November 2006 M42-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guidelines (Vol. 26, No. 23) June 2006 M44-A Method for Antifungal disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline (Vol. 24, No. 15) May 2004 M45-A Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline (Vol. 26, No. 19) May 2006 M47-A Principles and Procedures for Blood Cultures; Approved Guideline (Vol. 27, No. 17) May 2007 M49-A Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guideline (Vol. 26, No. 24) June 2006 M100-S17 Performance Standards for Antimicrobial Susceptibility Testing; Seventeenth Informational Supplement (Vol. 27, No. 1) January 2007 MOLECULAR METHODS: CODE DOCUMENT DATE MM1-A2 Molecular Diagnostic Methods for Genetic Diseases; Approved Guidelines – Second Edition (Vol. 26, No. 27) June 2006 MM2-A2 Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays; Approved Guideline – Second Edition (Vol. 22, No. 12) September 2002 MM3-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition (Vol. 26, No. 8) February 2006 MM4-A Quality Assurance for Immunocytochemistry; Approved Guideline (Vol. 19, No. 26) December 1999 MM5-A Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline (Vol. 23, No. 17) April 2003 MM6-A Quantitative Molecular Methods for Infectious Diseases; Approved Guideline (Vol. 23, No. 28) October 2003 MM7-A Fluorescence In Situ Hybridization (FISH) Methods for Medical Genetics; Approved Guideline (Vol. 24, No.5) January 2004 MM9-A Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (Vol. 24, No. 40) December 2004 MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline (Vol. 26, No. 9) February 2006 MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guidelines (Vol. 27, No. 10) April 2007 MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline (Vol. 26, No. 20) May 2006 MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline (Vol. 25, No. 31) December 2005 MM14-A Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline (Vol. 25, No. 27) August 2005 MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline (Vol. 26, No. 29) August 2006 NATIONAL REFERENCE SYSTEM FOR THE CLINICAL LABORATORY: CODE DOCUMENT DATE NRSCL8-A Terminology and Definitions For Use in NCCLS Documents; Approved Standard (Vol. 18, No. 16) November 1998 NRSCL12-P Sourcebook of Reference Methods, Materials and Related Information for the Clinical Laboratory; Proposed Guideline (Vol. 14, No. 1) January 1994 NRSCL13-A The Reference System for the Clinical Laboratory: Criteria for Development and Credentialing of Methods and Materials for Harmonization of Results; Approved Guideline (Vol. 20, No. 21) January 2001 Transfusion Medicine / Blood Banks CODE DOCUMENT DATE AABB 1-24 AABB Guidelines: Standards for Blood Banks and Transfusion Services, 1-24th Editions (Compact Disc) 2006 I16-T Temperature Monitoring and Recording in Blood Banks (Vol. 6, No. 19) November 1986 Miscellaneous: CODE DOCUMENT DATE AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard – Second Edition (Vol. 25, No. 29) December 2005 AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard (Vol. 24, No. 20) June 2004 AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline (Vol. 26, No. 36) December 2006 AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (Vol. 26, No. 11) March 2006 AUTO 10-A Autoverification of Clinical Laboratory Test Results; Approved Guidelines (Vol. 26, No. 32) October 2006 AUTO 11-A IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (Vol. 26, No. 33) October 2006 X3-R Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical Laboratory; A Report (Vol. 22, No. 4) March 2002 X4-R Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report (Vol. 23 No. 29) October 2003 ALQEP – CLSI Document Index of NCCLS Standards CPSA: November 19, 2007 Replaces: August 22, 2007 ALQEP – CLSI Document Index of NCCLS Standards CPSA: November 19, 2007 Replaces: August 22, 2007