NCCLS Guidelines
NCCLS Guidelines
NCCLS Guidelines
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CLSI UPDATED February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
VOL 7 EP19-R 22 10 EP19-P JUNE<br />
2002<br />
VOL 13 HS11-A 25 30 HS11-P Dec<br />
2005<br />
VOL 2 HS1-A2 24 37 HS1-A Nov<br />
2004<br />
VOL 4 M35-A 22 18 M35-P SEP<br />
2002<br />
STATUS<br />
Approved by Board of<br />
Directors – MAY 2002<br />
Report Published –<br />
JUNE 2002<br />
Approved Guideline<br />
Approved Guideline<br />
– 2 nd Edition<br />
Approved Guideline<br />
TITLE<br />
A Framework for <strong>NCCLS</strong> evaluation protocols<br />
A Model for Managing Medical Device Alerts<br />
(Hazards and Recalls) for Healthcare Organizations<br />
A Quality Management System Model for Health Care<br />
Abbreviated Identification of Bacteria and Yeast<br />
VOL 7 D13-A 13 15 1993 Approved Guideline Agglutination analyses; antibody characterists,<br />
methodology, limitation and clinical validation<br />
VOL 7 M39-A2 25 28 M39-A Nov<br />
2005<br />
Approved Guideline<br />
2 nd Edition<br />
Analysis and Presentation of Cumulative<br />
Antimicrobial Susceptibility Test Data<br />
VOL 6 C40-A 21 9 C40-P Jun 2001 Approved Guideline Analytical Procedures for the Determination of Lead<br />
in Blood and Urine<br />
VOL 10 M33-A 24 7 M33-P FEB<br />
2004<br />
VOL 8 GP26-A3 24 36 GP26-A2 Nov<br />
2004<br />
VOL 11 HS10-A 24 24 HS10-P Aug<br />
2004<br />
VOL 8 HS5-A 22 24 HS5-P Nov<br />
2002<br />
VOL 5<br />
HS4-A 22 23 HS4-P Nov<br />
2002<br />
VOL 11 C48-A 24 22 C48-P JUL<br />
2004<br />
Approved Guideline<br />
Approved Guideline<br />
– 3 rd Edition<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Antiviral Susceptibility Testing Herpes Simplex Virus<br />
by Plaque Reduction Assay<br />
Application of a Quality Management System Model<br />
for Laboratory Services- Third Edition<br />
Application of a Quality System Model for Inpatient<br />
Medication Use<br />
Application of a Quality System Model for Medical<br />
Imaging Services<br />
Application of a Quality System Model for Respiratory<br />
Services<br />
Application of Biochemical Markers of Bone Turnover<br />
in the Assessment and Monitoring of Bone Diseases<br />
1
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
STATUS<br />
TITLE<br />
VOL 10 I/LA23-A 24 16 I/L23-P 5/04 Approved Guideline Assessing the Quality of Immunoassay System:<br />
Radioimmunoassays and Enzyme, Fluorescence, and<br />
Luminescence Immunoassays; Approved Guideline<br />
VOL 8 LA1-A2 14 17 LA1-A Dec<br />
1994<br />
VOL 5 GP-10A 15 19 GP10-T DEC<br />
1995<br />
VOL 7 GP29-A 22 26 GPA29-P Dec<br />
2002<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Assessing the Quality of Radioimmunoassay Systems<br />
– Second Edition<br />
Assessment of the Clinical Accuracy of Laboratory<br />
Tests Using Receiver Operating Characteristic<br />
(ROC)Plots<br />
Assessment of Laboratory Tests When Proficiency<br />
Testing is not Available<br />
VOL 3 GP11-A 18 14 GP11-T Nov-98 Approved Guideline Basic cost accounting for clinical services<br />
VOL 9 LA4-A4 23 21 LA3-A4 Jul 2003 Approved Standard –<br />
4 th Edition<br />
VOL 4 C46-A 21 14 C46-P Sep<br />
2001<br />
Approved Guideline<br />
Blood Collection on Filter Paper for Newborn<br />
Screening Programs<br />
Blood gas and pH analysis & related measurements<br />
VOL 13 H56-P 25 20 Aug 2005 Proposed Guideline Body Fluid Analysis for Cellular Composition<br />
VOL 3 H38-P 19 7 Apr-99 Proposed Standard Calibration and quality control of automated<br />
hematology analyzers<br />
VOL 9 H42-A 17 18 42-T Dec 1998 Approved Guideline Clinical Applications of Flow Cytometry: Quality<br />
Assurance and Immunophenotyping of Lymphocytes<br />
VOL 9 H43-A 17 18 43-P June<br />
1998<br />
Approved Guideline<br />
Clinical Applications of Flow Cytometry:<br />
Immunophenotyping of Leukemic Cells<br />
2
CLSI UPDATED February 8, 2006<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
VOL 2 I/LA 21-A 22 9 I/LA21-P June<br />
2002<br />
VOL 5 GP17-A2 24 13 GP17-A APRIL<br />
2004<br />
VOL 4 GP2-A4 22 5 GP2-A3 April<br />
2002<br />
VOL 7 GP5-A2 22 3 GP5-A March<br />
2002<br />
VOL 10 M36-A 24 6 M36-P FEB<br />
2004<br />
VOL 7 H21-A4 23 35 H21-A3 DEC<br />
2003<br />
VOL 12 MM13-A 25 31 MM13-P Dec<br />
2005<br />
VOL 4 GP22-A2 24 35 GP22-A Nov<br />
2004<br />
STATUS<br />
Approved<br />
Guideline<br />
Approved Guideline-<br />
2 ND Edition<br />
Approved Guideline<br />
4 th Edition<br />
Approved Guideline<br />
Second Edition<br />
Approved Guideline<br />
Approved Guideline<br />
– 4 th Edition<br />
Approved Guideline<br />
Approved Guideline<br />
– 2 nd Edition<br />
TITLE<br />
Clinical evaluation of immunoassays<br />
Clinical Laboratory Safety<br />
Clinical laboratory technical procedure manuals<br />
Clinical laboratory waste management<br />
Clinical Use and Interpretation of Serologic Tests for<br />
Toxoplasma gondii<br />
Collection, transport, and processing of blood specimens for<br />
coagulation testing plasma – based coagulation assays<br />
Collection, Transport, Preparation, and Storage of<br />
Specimens for Molecular Methods<br />
Continuous quality improvement; Integrating Five Key<br />
Quality System Components<br />
VOL 2 C 39-A 18 23 C39-P Oct-99 Approved<br />
Standard<br />
Designated comparison method for the measurement<br />
of ionized calcium in serum<br />
VOL 5 I/LA22-P 20 10 2000 Proposed Guideline Detection of Anticardiolipin Antibodies by ELISA<br />
VOL 8 H17-A 18 19 H17-P DEC<br />
1998<br />
Approved Standard<br />
Determination of Serum Ion, Total Iron-Binding<br />
Capacity and Percent Transferrin Saturation<br />
3
CLSI UPDATED February 8, 2006<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
VOL 1 M37-A2 22 7 M37-A May<br />
2002<br />
VOL 9 EP21-A 23 20 EP21-P April<br />
2003<br />
STATUS<br />
Approved<br />
Guideline<br />
2 nd Edition<br />
Approved<br />
Guideline<br />
TITLE<br />
Development of in vitro susceptibility testing criteria &<br />
QC parameters for vet antimicrobial agents<br />
Estimation of Total Analytical Error for Clinical<br />
Methods<br />
VOL 5 EP14-A2 25 1 EP14-A January<br />
2005<br />
Approved Guideline<br />
– 2 nd Edition<br />
Evaluation of Matrix Effects<br />
VOL 1 EP5-A2 24 25 EP5-A Aug<br />
2004<br />
VOL 6 EP6-A 23 16 EP6-P2 April<br />
2003<br />
VOL 5 H52-A 21 26 H52-P Dec<br />
2001<br />
Approved<br />
Guideline – 2 nd<br />
Edition<br />
Approved<br />
Guideline<br />
Approved Guideline<br />
Evaluation of Precision Performance of Quantitative<br />
Measurement Methods<br />
Evaluation of the Linearity of Quantitative Analytical<br />
Methods<br />
Fetal Red Cell Detection<br />
VOL 10 GP20-A2 23 27 GP20-A Oct 2003 Approved Guideline<br />
2 nd Edition<br />
Fine Needle Aspiration Biopsy (FNAB) Techniques<br />
VOL 11 I/LA24-A 24 26 I/LA24-P Aug<br />
2004<br />
VOL 9 MM7-A 24 5 MM7-P JAN<br />
2004<br />
VOL 6 C25-A 17 3 C25-T JAN<br />
1997<br />
VOL 5 C43-A 22 22 C43-P Nov<br />
2002<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Fluorescence Calibration and Quantitative<br />
Measurement of Fluorescence Intensity<br />
Fluorescence In Situ Hybridization (FISH) Methods for<br />
Medical Genetics<br />
Fractional Oxyhemoglobin, Oxygen Content and<br />
Saturation, and Related Quantities in Blood:<br />
Terminology, Measurement, and Reporting<br />
Gas Chromatography/Mass Spectometry (GC/MS)<br />
Confirmation of Drugs<br />
4
CLSI UPDATED February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
VOL 1 AST4-A2 25 12 AST4-A May<br />
2005<br />
VOL 8 C44-A 22 25 C44-P Dec<br />
2002<br />
STATUS<br />
Approved<br />
Guideline<br />
Approved Guideline<br />
TITLE<br />
Glucose Monitoring in Settings Without Laboratory<br />
Support<br />
Harmonization of Glycohemoglobin Measurements<br />
VOL 4 C28-A2 20 13 C28-A Jun 00 Approved Guideline<br />
2 nd Edition<br />
How to define and determine reference intervals in<br />
the clinical lab approved guideline.<br />
VOL 9 MM2-A2 22 12 MM2-A Aug<br />
2002<br />
Approved Guideline -<br />
2 nd Edition<br />
Immunoglobulin and T-Cell receptor gene<br />
rearrangement assays<br />
VOL 7 D12-A2 13 14 1993 Approved Guideline Immunoprecipitin analyses; Procedures for evaluating<br />
the performance of materials<br />
VOL 8 EP7-A2 25 27 EP7-A2 Nov<br />
2005<br />
Approved Guideline<br />
2 nd edition<br />
Interference Testing in Clinical Chemistry<br />
VOL 4 C31-A2 15 20 C31-A Jun 2001 Approved Guideline<br />
2 nd edition<br />
Ionized calcium determinations: Precollection<br />
variables, specimen choice, collection, & handling.<br />
VOL 1 AUTO2-A2 25 29 AUTO2-A Dec<br />
2005<br />
Approved Standard<br />
2 nd edition<br />
Lab automation: Barcodes for specimen container<br />
identification<br />
VOL 2 AUTO3-P 18 18 Dec-98 Lab automation: Communication with automated clinical<br />
laboratory systems instrument devices and information<br />
systems<br />
5
CLSI UPDATED February 8, 2006<br />
LOCATION Abbreviation Vol No Replaces Status<br />
Date<br />
STATUS<br />
TITLE<br />
VOL 2 AUTO5-P 19 23 Oct-99 Proposed Standard Lab automation electromechanical interfaces<br />
VOL 2 AUTO4-P 19 22 Oct-99 Proposed Standard Lab automation: Systems operational requirements,<br />
characteristics, & information elements<br />
VOL 4 M15-A 20 12 M15-T Jun 00 Approved Guideline Lab diagnosis of bloodborne parasitic diseases<br />
VOL 10 AUTO7-A 24 20 AUTO7-P June<br />
2004<br />
Approved Standard<br />
VOL 8 GP18-A 18 3 GP18-P APR 98 Approved Guideline Laboratory Design<br />
VOL 5 GP19-A2 23 4 GP19-A Feb<br />
2003<br />
Approved Guideline<br />
VOL 13 EP13-R 15 8 Aug<br />
1995<br />
VOL 12 I/LA25-A 24 39 I/LA25-P Dec<br />
2004<br />
Report<br />
Approved Standard<br />
Laboratory Automation: Data Content for Specimen<br />
Identification<br />
Laboratory Instruments and Data Management<br />
Systems: Design of Software User Interfaces and<br />
End-User Software Systems Validation, Operation and<br />
Monitoring<br />
Laboratory Statistics<br />
Maternal serum screening<br />
VOL 11 C45-A 24 31 C45-P Oct 2004 Approved Guideline Measurement of Free Thyroid Hormones<br />
VOL 10 ISO 15189 Jul 2003 Corrected Version Medical Laboratories – Particular requirements for<br />
quality and competence<br />
VOL 6 EP9-A2 22 19 EP9-A Sept<br />
2002<br />
Approved Guideline<br />
2 nd Edition<br />
Method comparison and bias estimation using patient<br />
samples<br />
VOL 10 M44-A 24 15 M44-P 5/04 Approved Guideline Method for Antifungal Disk Diffusion Susceptibility<br />
Testing of Yeasts; Approved Guideline<br />
6
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Status STATUS<br />
TITLE<br />
Date<br />
VOL 3 M21-A 19 17 M21-T Sep-99 Approved Guideline Methodology for the serum bactericidal test<br />
VOL 9 M42-R 23 19 April<br />
2003<br />
Report Published<br />
VOL 6 M11-A6 24 2 M11-A5 Jan<br />
2004<br />
VOL 3 M7-A7 26 2 M7-A6 Jan<br />
2006<br />
Approved Standard<br />
6 th Edition<br />
Approved Standard<br />
7 th Edition<br />
Methods for Antimicrobial Disk Susceptibility Testing<br />
of Bacteria Isolated from Aquatic Animals.<br />
Methods for Antimicrobial Susceptibility Testing of<br />
Anaerobic Bacteria<br />
Methods for Antimicrobial Susceptibility Tests for<br />
Bacteria That Grow Aerobically<br />
VOL 3 M26-A 19 18 M26-T Sep-99 Approved Guideline Methods for determining bactericidal activity of<br />
antimicrobial agents<br />
VOL 8 H44-A2 24 8 H44-A FEB<br />
2004<br />
VOL 10 GP28-A 25 7 GP28-P Feb<br />
2005<br />
Approved Guideline –<br />
2 ND Edition<br />
Approved Guideline<br />
Methods for Reticulocyte Counting ( Automated Blood<br />
Cell Counters, Flow Cytometry and Supravital Dyes)<br />
Microwave Device Used in the Clinical Laboratory<br />
VOL 5 MM1-A 20 7 MM1-P Apr Approved Guideline Molecular diagnostic methods for genetic diseases<br />
00<br />
VOL 8 MM3-A 15 22 MM3-P 1995 Approved Guideline Molecular Diagnostic Methods for Infectious Diseases<br />
VOL 3 GP23-A 19 14 GP23-P Aug-<br />
99<br />
VOL 12 MM9-A 24 40 MM9-P Dec<br />
2004<br />
Approved Guideline<br />
Approved Guideline<br />
Non gynecologic cytologic. specimens collection &<br />
cytoprepatory techniques<br />
Nucleic Acid Sequencing Methods in Diagnostic<br />
Laboratory Medicine<br />
VOL 9 MM5-A 23 17 MM5-P April<br />
2003<br />
VOL 7 H47-A 16 3 H28T &H29T JUN<br />
96<br />
VOL 7 GP15-A2 21 17 GP15-A Nov<br />
2001<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline –<br />
2 nd Edition<br />
Nucleic Acid Amplification Assays for Molecular<br />
Hematopathology<br />
One stage prothrombin time (PT) test and activated<br />
partial thromboplastin time (APTT)<br />
Papincolaou technique<br />
7
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Statu<br />
s<br />
Date<br />
VOL 5 H26-A 16 12 H26-P DEC<br />
96<br />
STATUS<br />
Approved Standard<br />
TITLE<br />
Performance Goals for the Internal Quality Control of<br />
Multichannel Hematology Analyzers<br />
VOL 11 I/LA26-A 24 29 I/LA26-P Oct<br />
2004<br />
Approved Guideline<br />
Performance of Single Cell Immune Response<br />
Assays<br />
VOL 12 H45-A2 25 15 H45-A June<br />
2005<br />
VOL 3 M31-A2 22 6 M31-A May<br />
2002<br />
VOL 5 M2-A9 26 1 M2-A8 Jan<br />
2006<br />
VOL 3 M100-S12 22 1 M100-S11 Jan<br />
2002<br />
VOL 6 M100-S6 15 14 M100-S5 Dec<br />
1995<br />
VOL 10 M100-S15 25 1 M100-S14 JAN<br />
2005<br />
VOL 13 M100-S16 26 3 M100-S15 Jan<br />
2006<br />
Approved Guideline – 2 nd<br />
Edition<br />
Approved Standard<br />
2 nd Edition<br />
Approved Standard<br />
9 th Edition<br />
12 th INFORMATIONAL<br />
SUPPLEMENT<br />
6 th Informational<br />
Supplement<br />
15 th Informational<br />
Supplement<br />
16 th Informational<br />
Supplement<br />
Performance of the Bleeding Time Test<br />
Performance standards for antimicrobial disk &<br />
dilution susceptibility tests for bacteria isolated from<br />
animals<br />
Performance Standards of Antimicrobial Disk<br />
Susceptibility Tests<br />
Performance standards for antimicrobial susceptibility<br />
testing<br />
Performance Standards for Antimicrobial Susceptibility<br />
Testing<br />
Performance Standards for Antimicrobial Susceptibility<br />
Testing – 15 th Informational Supplement<br />
Performance Standards for Antimicrobial Susceptibility<br />
Testing –16 th Informational Supplement<br />
CD Case I POCT1-A Approved Standard Point of care connectivity<br />
VOL 8 C30-A2 22 17 C30-A Aug Approved Guideline Point-of-Care Blood Glucose Testing in Acute and<br />
2002 2 nd Edition<br />
Chronic Care Facilities<br />
VOL 1 AST2-A 15 2 AST2-P Approved<br />
Point of care invitro diagnostic (IVD) testing<br />
Guideline<br />
VOL 11 H49-A 24 23 H49-P JUL<br />
2004<br />
Approved Guideline<br />
Point-of-Care Monitoring of Anticoagulation Therapy<br />
VOL 6 EP10-A2 18 6 EP10-A Dec<br />
2002<br />
Approved Guideline –<br />
2 nd Edition<br />
Preliminary Evaluation of Quantitative Clinical<br />
Laboratory Methods<br />
8
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Statu<br />
s<br />
Date<br />
VOL 5 C3-P4 25 13 C3-A3 June<br />
2005<br />
STATUS<br />
Proposed Guideline<br />
4 th Edition<br />
TITLE<br />
Preparation & testing of Reagent Water in the Clinical<br />
Laboratory<br />
VOL 3 C37-A 19 25 C37-P Nov-<br />
99<br />
Approved Guideline<br />
Preparation & validation of commutable frozen human<br />
serum pools as secondary reference materials for<br />
cholesterol measurement<br />
VOL 5 H7-A3 20 18 H7-A2 Approved Standard Procedure for Determining Packed Cell Volume by the<br />
Microhematocrit Method<br />
VOL 7 * H3-A5 23 32 H3-A4 DEC<br />
2003<br />
VOL 7 H30-A2 21 18 H30-A Nov<br />
2001<br />
Approved Standard –<br />
5 th Edition<br />
Approved Guideline – 2 nd<br />
Edition<br />
Procedure for the Collection of Diagnostic Blood<br />
Specimens by Venipuncture.<br />
Procedure for the determination of fibrinogen in<br />
plasma<br />
VOL 3 * H4-A4 19 16 Consolidates<br />
H4-A3 &<br />
H14-A2<br />
Sep-<br />
99<br />
VOL 13 H54-A 25 23 H54-P Aug<br />
2005<br />
Approved Standard<br />
Approved Guideline<br />
Procedures and devices for collection of diagnostic<br />
blood specimens by skin puncture<br />
Procedures for Validation of INR and Local Calibration of<br />
PT/INR Systems<br />
VOL 3 H11-A4 24 28 H11-A3 Sept<br />
2004<br />
VOL 2 H 18-A3 24 38 H18-A2 Nov<br />
2004<br />
VOL 12 M28-A2 25 16 M28-A June<br />
2005<br />
Approved Standard – 4 th<br />
Edition<br />
Approved Guideline –<br />
2 nd Edition<br />
Approved Guideline –<br />
2 nd Edition<br />
Procedures for the collection of arterial blood<br />
specimens<br />
Procedures for the handling and processing of blood<br />
specimens<br />
Procedures for the Recovery and Identification of<br />
Parasites from the Intestinal Tract<br />
VOL 11 MM14-A 25 24 MM14-P Aug<br />
2005<br />
Approved Guideline<br />
Proficiency Testing (External Quality Assessment) for<br />
Molecular Methods<br />
9
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Statu<br />
s<br />
Date<br />
VOL 6 M29-A3 25 10 M29-A2 March<br />
2005<br />
STATUS<br />
Approved Guideline<br />
- 3rd Edition<br />
TITLE<br />
Protection of laboratory workers from occupationally<br />
acquired infections<br />
VOL 11 EP17-A 24 34 EP17-P Oct<br />
2004<br />
Approved Guideline<br />
Protocols for Determination of Limits of Detection and<br />
Limits of Quantitation<br />
VOL 13 M6-A2 26 6 M6-A Jan<br />
2006<br />
Approved Standard -<br />
2 nd Edition<br />
Protocols for Evaluating Dehydrated Mueller-Hinton<br />
Agar<br />
VOL 6 HS2-A 23 5 HS2-P Feb<br />
2003<br />
VOL 12 HS3-A 25 5 HS3-P Jan<br />
2005<br />
Approved Guideline<br />
Approved Guideline<br />
Provider-Performed Microscopy Testing<br />
Pulse Oximetry<br />
VOL 5 M22-P2 23 22 M22-A Aug<br />
2003<br />
VOL 4 I/LA2-A 16 11 I/LA2-T Dec-<br />
96<br />
VOL 10 M40-A 23 34 M40-P Dec<br />
2003<br />
VOL 3 MM4-P 17 10 Dec<br />
99<br />
VOL 4 EP18-A 22 28 EP18-P Dec<br />
2002<br />
VOL 10 MM6-A 23 28 MM6-P Oct<br />
2003<br />
VOL 8 M38-A 22 16 M38-P AUG<br />
2002<br />
VOL 8 M27-A2 22 15 M27-A AUG<br />
2002<br />
Proposed Standard –<br />
2 nd Edition<br />
Approved Guideline<br />
Approved Standard<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
Approved Standard<br />
Approved Standard –<br />
2nd Edition<br />
Quality Assurance for Commercially Prepared<br />
Microbiological Culture Media<br />
Quality assurance for the indirect immunofluorescence<br />
test for autoantibodies to nuclear antigen(if-ana)<br />
Quality Control of Microbiological Transport Systems<br />
Quality for immunocytochemistry<br />
Quality management for unit-use testing<br />
Quantitative Molecular Methods for Infectious Diseases<br />
Reference Method for Broth Dilution Antifungal<br />
Susceptibility Testing of Filamentous Fungi<br />
Reference Method for Broth Dilution Antifungal Susceptibility<br />
Testing of Yeasts<br />
10
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
LOCATION Abbreviation Vol No Replaces Statu<br />
s<br />
Date<br />
11<br />
VOL 3 GP9-A 18 15 GP9-T Nov-<br />
98<br />
STATUS<br />
VOL 4 H2-A4 20 27 H2-A3<br />
Approved Standard –<br />
Dec0 4th Edition<br />
0<br />
VOL 4 H15-A3 20 28 H15-A2 Dec0 Approved Standard –<br />
0 3rd Edition<br />
Approved Guideline<br />
VOL 11 LIS2-A 24 33 LIS2-A Oct<br />
2004<br />
VOL 6 I/LA18-A2 21 15 I/LA18-A Sep<br />
2001<br />
Approved Standard –<br />
2nd Edition<br />
Approved Guideline<br />
TITLE<br />
Reference & selected procedure for the erythrocyte<br />
sedimentation rate (ESR) test<br />
Reference & selected procedures for the quantitative<br />
determination of hemoglobin in blood<br />
Selecting and evaluating a referral laboratory<br />
Specification for Transferring Information Between<br />
Clinical Laboratory Instruments and Information<br />
Systems<br />
Specifications for Immunological Testing for Infectious<br />
Diseases<br />
VOL 5 C29-A2 20 17 C29-A Approved Standard Standardization of Sodium & Potassium Ion-Selective<br />
Electrode Systems to the Flame Photometric<br />
Reference Method<br />
VOL 1 C24-A2 11 8 C24-A Feb-<br />
99<br />
VOL 11 HS6-A 24 32 HS6-P Oct<br />
2004<br />
VOL 4 C34-A2 20 14 C34-A Jun<br />
00<br />
VOL 7 M24-A 23 18 M24-T2 April<br />
2003<br />
Approved<br />
Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
2nd Edition<br />
Approved Standard<br />
Statistical Q.C. for quantitative measurements<br />
principles & definitions<br />
Studies to Evaluate Patient Outcomes<br />
Sweat testing sample collection & quantitative analysis<br />
Susceptibility Testing of Mycobacteria, Nocardia, and<br />
Other Aerobic Actinomycetes<br />
VOL 5 NRSCL13-A 20 21 NRSCL 13-P Approved Guideline The Reference System for the Clinical Laboratory:<br />
Criteria for Development and Credentialing of Methods<br />
and Materials for Harmonization of Results<br />
VOL 10 MM6-A 23 28 MM6-P Oct<br />
2003<br />
VOL 8 M38-A 22 16 M38-P AUG<br />
2002<br />
VOL 8 M27-A2 22 15 M27-A AUG<br />
2002<br />
Approved Guideline<br />
Approved Standard<br />
Approved Standard –<br />
2 nd Edition<br />
Quantitative Molecular Methods for Infectious<br />
Diseases<br />
Reference Method for Broth Dilution Antifungal<br />
Susceptibility Testing of Filamentous Fungi<br />
Reference Method for Broth Dilution Antifungal<br />
Susceptibility Testing of Yeasts
CLSI Updated February 8, 2006<br />
Alphabetical Listing<br />
VOL 4 H2-A4 20 27 H2-A3<br />
Approved Standard – Reference & selected procedure for the erythrocyte<br />
Dec0 4 th Edition<br />
sedimentation rate (ESR) test<br />
0<br />
LOCATION Abbreviation Vol No Replaces Statu STATUS<br />
TITLE<br />
s<br />
Date<br />
VOL 4 H15-A3 20 28 H15-A2 Dec0<br />
0<br />
VOL 3 GP9-A 18 15 GP9-T Nov-<br />
98<br />
VOL 11 LIS2-A 24 33 LIS2-A Oct<br />
2004<br />
VOL 6 I/LA18-A2 21 15 I/LA18-A Sep<br />
2001<br />
Approved Standard –<br />
3 rd Edition<br />
Approved Guideline<br />
Approved Standard –<br />
2 nd Edition<br />
Approved Guideline<br />
Reference & selected procedures for the quantitative<br />
determination of hemoglobin in blood<br />
Selecting and evaluating a referral laboratory<br />
Specification for Transferring Information Between<br />
Clinical Laboratory Instruments and Information<br />
Systems<br />
Specifications for Immunological Testing for Infectious<br />
Diseases<br />
VOL 5 C29-A2 20 17 C29-A Approved Standard Standardization of Sodium & Potassium Ion-Selective<br />
Electrode Systems to the Flame Photometric<br />
Reference Method<br />
VOL 1 C24-A2 11 8 C24-A Feb-<br />
99<br />
VOL 11 HS6-A 24 32 HS6-P Oct<br />
2004<br />
VOL 4 C34-A2 20 14 C34-A Jun<br />
00<br />
VOL 7 M24-A 23 18 M24-T2 April<br />
2003<br />
Approved<br />
Guideline<br />
Approved Guideline<br />
Approved Guideline<br />
2 nd Edition<br />
Approved Standard<br />
Statistical Q.C. for quantitative measurements<br />
principles & definitions<br />
Studies to Evaluate Patient Outcomes<br />
Sweat testing sample collection & quantitative analysis<br />
Susceptibility Testing of Mycobacteria, Nocardia, and<br />
Other Aerobic Actinomycetes<br />
VOL 5 NRSCL13-A 20 21 NRSCL 13-P Approved Guideline The Reference System for the Clinical Laboratory: Criteria<br />
for Development and Credentialing of Methods and Materials<br />
for Harmonization of Results<br />
VOL 5 GP21-A2 24 14 GP21-A APR<br />
2004<br />
Approved Guideline-2 nd<br />
Edition<br />
Training and Competence Assessment<br />
VOL 10 H1-A5 23 33 H1-A4 Dec<br />
2003<br />
Approved Standard –<br />
5 th Edition<br />
Tubes and Additives for Venous Blood Specimen<br />
Collection<br />
12
CLSI Updated February 8, 2006<br />
VOL 5<br />
Alphabetical Listing<br />
GP16-A2 15 15 GP16-A NOV<br />
2001<br />
Approved Guideline –<br />
2 ND EDITION<br />
Urinalysis and Collection, Transportation, and<br />
Preservation of Urine Specimens<br />
LOCATION Abbreviation Vol No Replaces Statu<br />
s<br />
Date<br />
VOL 1 T/DMB-A 19 6 T/DMB-P Feb<br />
99<br />
VOL 7 EP12-A 22 14 EP12-P Aug<br />
2002<br />
STATUS<br />
Approved<br />
Guideline<br />
Approved Guideline<br />
TITLE<br />
Urine drug testing in the clinical lab<br />
User protocol for evaluation of qualitative test<br />
performance<br />
VOL 7 EP15-A2 25 17 EP15-A June<br />
2005<br />
Approved Guideline-<br />
2 nd Edition<br />
User verification of Performance for Precision and<br />
Trueness<br />
VOL 1 GP27-A 19 15 GP22-P Aug<br />
99<br />
Approved<br />
Guideline<br />
Using proficiency test (PT) to improve the clinical<br />
laboratory<br />
VOL 5<br />
M34-A 20 20 M34-P Approved Guideline Western Blot Assay for Antibodies to Borrelia<br />
burgdorferi<br />
* Video is also available through CQI Office<br />
13
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