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CLSI
Product
Code
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Replaces
Approval Date
EP19-P
JUNE 2002
UPDATED October 2013
STATUS
Approved by Board of Directors MAY 2002
Report Published –
JUNE 2002
EP19-RE
22
10
A Model for Managing Medical Device Alerts QMS10-A
25
30 HS11-A(1)
DEC 2005
Approved Guideline
(Hazards and Recalls) for Healthcare
Organizations
A Quality Management System Model for
Health Care
HS1-A2
24
37
HS1-A
NOV 2004
Approved Guideline –
nd
2 Edition
M35-A2
22
18
M35-P
SEP 2002
Approved Guideline
A ccuracy in Patient and Sample
Identification
GP33-A
29 13
GP33-P
MAR 2010
Proposed Guideline
A gglutination analyses; antibody
D13-A
13
15
M39-A2
25
28
A nalysis of Body Fluids in Clinical Chemistry
C49-A
27
A nalytical Performance Characteristics and
Clinical Utility of Immunological Assays for
Human Immunoglobulin E (IgE)Antibodies
and Defined Allergen Specificities
A nalytical Procedures for the Determination
of Lead in Blood and Urine
I/LA20-A2
A Framework for NCCLS evaluation
protocols
A bbreviated Identification of Bacteria and
Yeast
1993
Approved Guideline
M39-A
NOV 2005
Approved Guideline
nd
2 Edition
14
C49-P
APR 2007
Approved Guideline
29
9
I/LA20-A
MAR 2009
Approved Guideline
nd
2 Edition
C40-A
21
9
C40-P
JUN 2001
Approved Guideline
M33-A
24
7
M33-P
FEB 2004
Approved Guideline
characterists, methodology, limitation and
1 clinical validation
A nalysis and Presentation of Cumulative
Antimicrobial Susceptibility Test Data
A ntiviral Susceptibility Testing Herpes
Page
1
Simplex Virus by Plaque Reduction Assay
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UPDATED October 2013
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nd
HS10-A2E 26
17
HS10-A
MAY 2006
Approved Guideline 2
HS5-A2E
26
16
HS5-A
May 2006
Approved Guideline – 2
nd
Edition
HS4-A2E
26
15
HS4-A
May 2006
Approved Guideline – 2
nd
Edition
C48-AE
24
22
C48-P
JUL 2004
Approved Guideline
I/LA23-A
24
16
I/L23-P
May 2004
Approved Guideline
LA1-A2
14
17
LA1-A
Dec 1994
Approved Guideline
A ssessment of the Clinical Accuracy of
Laboratory Tests Using Receiver Operating
Characteristic (ROC) Plots
GP-10A
15
19
GP10-T
DEC 1995
Approved Guideline
A ssessment of the Diagnostic Accuracy of
EP24-A2
31
23
GP10-A
November 2011
C58-A
31
20
GP29-A2
28
21
GP11-A
18
T/DM6-A
17
A pplication of a Quality Management
Edition
System Model for Inpatient Medication Use
A pplication of a Quality Management
System Model for Medical Imaging Services
A pplication of a Quality Management
System Model for Respiratory Services
A pplication of Biochemical Markers of Bone
nd
Approved Guideline – 2 . Edition
Laboratory Tests Using Receiver Operating
Characteristic Curves
Nov 2011
Approved Guideline
GPA29-A
Aug 2008
Approved Guideline – Second Edition
14
GP11-T
Nov-98
Approved Guideline
14
T/DM6-P
Sep 97
Approved Guideline
B lood Collection on Filter Paper for Newborn NBS01-AS 23 21
LA4-A4
Jul 2003
A ssessment of Fetal Lung Maturity by the
A ssessment of Laboratory Tests When
Proficiency Testing is not available
B asic cost accounting for clinical services
B lood Alcohol Testing in the Clinical
Laboratory
Screening Programs
2
Lamelar Body Count
th
Approved Standard – 4 Edition
Page
2
Turnover in the Assessment and monitoring
of Bone Diseases
A ssessing the Quality of Immunoassay
System: Radioimmunoassays and Enzyme,
Fluorescence and Luminescence
Immunoassays
A ssessing the Quality of Radioimmunoassay
Systems
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B lood gas and pH analysis & related
C46-A2
29
B ody fluid Analysis for Cellular Composition
H56-A
C alibration and quality control of automated
hematology analyzers
UPDATED October 2013
Replaces
Approval Date
STATUS
8
C46-A
Feb 2009
Approved Guideline-2
26
20
H56-P
June 2006
Approved Guideline
H38-P
19
7
April 1999
Proposed Standard
C linical Applications of Flow Cytometry:
H42-A
17
18
42-T
Dec 1998
Approved Guideline
Quality Assurance and Immunophenotyping
of Lymphocytes
C linical Applications of Flow Cytometry:
Immunophenotyping of Leukemic Cells
H43-A
17
18
43-P
June 1998
Approved Guideline
C linical evaluation of immunoassays
I/LA 21-A
22
9
I/LA21-P
June 2002
Approved
Guideline
C linical Laboratory Safety
GP17-A2
24 13
GP17-A
APRIL 2004
Approved Guideline-2
C linical laboratory waste management
GP5-A2
22
3
GP5-A
March 2002
Approved Guideline Second Edition
M36-A
24
6
M36-P
FEB 2004
Approved Guideline
C ollection, transport, and processing of
H21-A4
23 35
H21-A3
DEC 2003
Approved Guideline – 4 Edition
blood specimens for coagulation testing
plasma – based coagulation assays
C ollection, Transport, Preparation, and
Storage of Specimens for Molecular Methods
MM13-A
25 31
MM13-P
Dec
2005
C ontinuous quality improvement; Integrating
GP22-A2
24 35
GP22-A
Nov 2004
nd
Edition
measurements
3
C linical Use and Interpretation of Serologic
ND
Edition
Tests for Toxoplasma gondii
Approved Guideline – 2
nd
Edition
3
Approved Guideline
Page
Five Key Quality System Components
th
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D esignated comparison method for the
CLSI
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C 39-A
Vol No Replaces
I/LA22-P
20 10
H17-A
18 19
GP35-P
29 7
M23-A3
28 27
M23-A2
Oct
2008
M37-A3
28
M37-A2
Feb 2008
18
23
C39-P
Approval Date
STATUS
Oct-99
Approved
Standard
measurement of ionized calcium in serum
D etection of Anticardiolipin Antibodies by
UPDATED October 2013
2000
Proposed Guideline
DEC 1998
Approved Standard
February 2009
Proposed Guideline
ELISA
7
H17-P
rd
Approved Guideline-3 Edition
Approved
Guideline
3
nd
Edition
MM12-A
26 20
MM12-P
May 2006
Approved Guideline
E stablishing Molecular Testing in Clinical
Laboratory Environments
MM19-A
31 21
MM19-P
November 2011
Approved Guideline
E stimation of Total Analytical Error for
EP21-A
23 20
EP21-P
April 2003
Approved Guideline
E valuation of Matrix Effects
EP14-A2
25
1
EP14-A
January 2005
Approved Guideline – 2
E valuation of Precision Performance of
EP5-A2
24 25
EP5-A
Aug 2004
Approved Guideline – 2
EP6-A
23 16
EP6-P2
April 2003
Approved Guideline
Clinical Methods
E valuation of the Linearity of Quantitative
Analytical Methods
nd
Edition
Edition
4
Quantitative Measurement Methods
nd
Page
4
D etermination of Serum Ion, Total IronBinding Capacity and Percent Transferrin
Saturation
D evelopment and Use of Quality Indicators
for Process Improvement and Monitoring of
Laboratory Quality
D evelopment of In Vitro Susceptibility
Testing Criteria and Quality Control
Parameters
D evelopment of in vitro susceptibility testing
criteria & QC parameters for vet antimicrobial
agents
D iagnostic Nucleic Acid Microarrays
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E xpression of Measurement Uncertainty in
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CLSI
Product
Code
EP29-A
Vol No
UPDATED October 2013
Replaces
Approval Date
4
C51-A
January 2012
Approved Guideline
H52-A
21 26
H52-P
Dec 2001
Approved Guideline
GP20-A2
23 27
GP20-A
Oct 2003
Approved Guideline 2
32
STATUS
nd
Edition
Techniques
Fluorescence In Situ Hybridization Methods
MM07-A2
August 2013
Approved Guideline – 2
nd
Edition
for Clinical Laboratories
Genotyping for Infectious Diseases:
C25-A
17
3
C25-T
JAN 1997
Approved Guideline
C43-A
22 22
C43-P
Nov 2002
Approved Guideline
MM10-A
26
9
MM10-P
Feb 2006
Approved Guideline
AST4-A2
25 12
AST4-A
May 2005
Approved
Guideline
C44-A
22 25
C44-P
Dec 2002
Approved Guideline
C56-A
32 10
July 2012
Approved Guideline
Identification and Characterization
Glucose Monitoring in Settings Without
Laboratory Support
Harmonization of Glycohemoglobin
H emolysis, Icterus, and Lipemia/Turbidity
Indices as Indicators of Interference in
Clinical Laboratory Analysis
5
Measurements
Page
5
Fractional Oxyhemoglobin, Oxygen Content
and Saturation, and Related Quantities in
Blood: Terminology, Measurement, and
Reporting
Gas Chromatography/Mass Spectometry
(GC/MS) Confirmation of Drugs
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How to define and determine reference
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CLSI
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Code
C28-A2
Vol No
Replaces
Approval Date
STATUS
20 13
C28-A
Jun 2000
Approved Guideline 2
I/LA30-A
28
I/LA30-P
Feb 2008
Approved Guideline
MM2-A2
22 12
MM2-A
Aug 2002
Approved Guideline -2
D12-A2
13 14
nd
Edition
intervals in the clinical lab approved guideline.
Immunoassay Interference by Endogenous
6
Antibodies
Immunoglobulin and T-Cell receptor gene
nd
Edition
rearrangement assays
Immunoprecipitin analyses; Procedures for
1993
Approved Guideline
evaluating the performance of materials
22
4
Mar 2002
Published Report
nd
edition
nd
edition
nd
edition
EP7-A2
25 27
EP7-A2
Nov
2005
Interpretive Criteria for Identification of
Bacteria and Fungi by DNA Target
Sequencing
MM18-A
28 12
MM18-P
April 2008
Approved Guideline
Ionized calcium determinations: Precollection
C31-A2
15 20
C31-A
Jun 2001
Approved Guideline 2
AUTO2-A2
25 29
AUTO2-A
Dec
2005
Approved Standard 2
variables, specimen choice, collection, &
handling.
Lab automation: Barcodes for specimen
container identification
Lab automation: Communication with
AUTO3-P
18
18
Dec-98
automated clinical laboratory systems
instrument devices and information systems
Lab automation electromechanical interfaces
AUTO5-P
19
23
Oct-99
Approved Guideline 2
Proposed Standard
6
X3-R
Page
6
Implementing a Needlestick and Sharps
Injury Prevention Program in the Clinical
Laboratory
Interference Testing in Clinical Chemistry
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Lab automation: Systems operational
requirements, characteristics, & information
elements
Lab diagnosis of bloodborne parasitic
diseases
Laboratory Automation: Data Content for
CLSI
Product
Code
AUTO4-P
Vol No
M15-A
20 12
AUTO7-A
24 20
19
Replaces
22
Approval Date
UPDATED October 2013
STATUS
Oct-99
Proposed Standard
M15-T
Jun 00
Approved Guideline
AUTO7-P
June 2004
Approved Standard
GP18-P
APR 98
Approved Guideline
M48-P
May 2008
Specimen Identification
Laboratory Design
Laboratory Detection and Identification of
GP18-A
M48-A
18
3
28 17
Mycobacteria
7 Laboratory Documents: Development and
Approved
Guideline
GP2-A5
22
5
GP2-A4
March 2006
GP19-A2
23
4
GP19-A
Feb 2003
Approved Guideline
June
2007
Proposed Guideline
October 2011
Approved Guideline
Approved Guideline 5
th
Edition
Control
Laboratory Instruments and Data
Management Systems: Design of Software
User Interfaces and End-User Software
Systems Validation, Operation and Monitoring
Laboratory Instrument Implementation,
Verification, and Maintenance
L aboratory Quality Control Based on Risk
GP31-P
27 12
EP23-A
31 18
EP23-P
Management
EP23-A
Management: Implementation Workbook
A Practical Guide
S ample Worksheet form for Laboratory
Quality Control Based on Risk Management
EP23-A
Worksheet
Page
7
L aboratory Quality Control Based on Risk
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Laboratory Statistics
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Product
Code
EP13-R
Management of Nonconforming Laboratory
GP32-A
27 27
GP32-P
May
2007
Approved
Guideline
C50-A
27 24
C50-P
Oct
2007
Approved
Guideline
I/LA25-A
24 39
I/LA25-P
Dec 2004
Approved Standard
C45-A
24 31
C45-P
Oct 2004
Approved Guideline
Document Title
15
8
Aug 1995
Events
Mass Spectrometry in the Clinical
Laboratory: General Principles and Guidance
Maternal serum screening
Measurement of Free Thyroid Hormones
8 Measurement Procedure Comparison and
EP09-A3
Approval Date
UPDATED October 2013
33 11 EP09-A2-IR
August 2013
STATUS
Report
rd
Approved Guideline – 3 Edition
Bias Estimation Using Patient Samples
Medical Laboratories – requirements for
ISO 15189
Nov 2012
Third Edition
quality and competence
22 19
EP9-A
Sept 2002
Approved Guideline 2
M45-A
26
19
M45-P
May 2006
Approved Guideline
Method for Antifungal Disk Diffusion
M44-A
24
15
M44-P
5/04
Approved Guideline
Susceptibility Testing of Yeasts; Approved
Guideline
Methodology for the serum bactericidal test
M21-A
19
17
M21-T
Sep-99
Approved Guideline
Methods for Antimicrobial Disk Susceptibility
M42-A
26 23
M42-R
June 2006
Method comparison and bias estimation
EP9-A2
nd
Edition
using patient samples
Methods for Antimicrobial Dilution and Disk
Testing of Bacteria Isolated from Aquatic
Animals.
Approved Guideline
Page
8
Susceptibility Testing of Infrequently Isolated of
Fastidious Bacteria
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M ethods for Antimicrobial Susceptibility
CLSI
Product
Code
M11-A8
UPDATED October 2013
Vol No Replaces
Approval Date
STATUS
32
5
February 2012
Approved Standard 8 Edition
M43-A
31
19
M7-A9
32
2
M7-A8
Jan
2012
M49-A
26
24
M49-P
June 2006
Approved Guideline
M26-A
19
18
M26-T
Sep-99
Approved Guideline
H44-A2
24
8
H44-A
FEB 2004
Approved Guideline –
2ND Edition
GP28-A
25
7
GP28-P
Feb 2005
Approved Guideline
MM1-A2
26 27
MM1-A
June 2006
MM3-A2
26
8
MM3-A
Feb 2006
Approved Guideline – 2nd Edition
NBS02-A
26
18
I/LA27-P
May 2006
Approved Guideline
M11-A7
th
Testing of Anaerobic Bacteria
M ethods for Antimicrobial Susceptibility
October 2011
Approved Guideline
Testing for Human Mycoplasms
Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically
Methods for Broth Dilution Susceptibility
th
Approved Standard 9 Edition
Testing of Bacteria Isolated from Aquatic
9 Animals
Methods for determining bactericidal activity
of antimicrobial agents
Methods for Reticulocyte Counting (
Automated Blood Cell Counters, Flow
Cytometry and Supravital Dyes)
Microwave Device Used in the Clinical
Laboratory
Molecular diagnostic methods for genetic
Approved Guideline – 2
nd
Edition
Diseases
Newborn Screen Follow-up
Page
Molecular Diagnostic Methods for Infectious
9
diseases
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CLSI
Product
Code
NBS03-A
Vol No Replaces
28
34
I/LA31-P
Dec 2008
Proposed Guideline
NBS04-A
30
16
I/LA32-P
July 2010
Approved Guideline
Newborn Screening for Cystic Fibrosis
NBS05-A
31 22
Nov 2011
Approved Guideline
Non gynecologic cytologic. specimens
GP23-A
19
14
GP23-P
Aug-99
MM9-A
24 40
MM9-P
Dec 2004
Approved Guideline
MM5-A
23 17
MM5-P
April 2003
Approved Guideline
H47-A
16
3
H28T
&H29T
JUN 96
Approved Guideline
21 17
16 12
GP15-A
H26-P
Nov 2001
DEC 96
Approved Guideline – 2
Approved Standard
Document Title
Newborn Screening Guidelines for Premature
Approval Date
UPDATED October 2013
STATUS
and/or Sick Newborns
Newborn screening by tandem mass
spectrometry
Approved Guideline
collection & cytoprepatory techniques
Nucleic Acid Sequencing Methods in
Diagnostic Laboratory Medicine
Nucleic Acid Amplification Assays for
Molecular Hematopathology
10 One stage prothrombin time (PT) test and
activated partial thromboplastin time (APTT)
Papincolaou technique
Performance Goals for the Internal Quality
GP15-A2
H26-A
nd
Edition
Control of Multichannel Hematology
Analyzers
Performance of the Bleeding Time Test
H45-A2
25
15
H45-A
June 2005
Approved Guideline – 2nd Edition
P erformance Standards for Antimicrobial
M2-A11
32
1
M2-A10
January 2012
Approved Standard – 11th Edition
Page
10
Disk Susceptibility Tests
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Document Title
P erformance Standards for Antimicrobial
Disk and Dilution Susceptibility Tests for
Bacterial isolated from Animals
P erformance Standards for Antimicrobial
CLSI
Product
Code
VET01-A4
Vol No Replaces
Approval Date
July 2013
VET01-S2
July 2013
M100-S23
January 2013
Disk and Dilution Susceptibility Tests for
Bacterial isolated from Animals
P erformance Standards for Antimicrobial
UPDATED October 2013
STATUS
Fourth Edition – This document provides the
currently recommended techniques for
antimicrobial agent disk and dilution
susceptibility testing, criteria for quality
control testing, and interpretive criteria for
veterinary use.
Second Informational Supplement: This
document provides updated tables for the
CLSI antimicrobial susceptibility testing
standard VET01
Twenty Third Informational Supplement
Susceptibility Testing-23rd Informational
Supplement
P hysician and Nonphysician ProviderPerformed Microscopy Testing
POCT10-A2
31
24
HS02-A
Dec 2011
Approved Guideline – Second Edition
11 P oint-of-Care Monitoring of Anticoagulation
H49-A
24
23
H49-P
JUL 2004
Approved Guideline
Jan 2013
Approved
Therapy
P oint of Care Blood Glucose Testing in
POCT 12-A3
Acute and Chronic Care Facilities
P reliminary Evaluation of Quantitative
nd
EP10-A2
18
6
EP10-A
Dec 2002
Approved Guideline – 2
C3-A4
26
22
C3-P4
June 2006
Approved Guideline – 4 Edition
C37-A
19
25
C37-P
Nov-99
M47-A
27
17
M47-P
May 2007
Edition
Clinical Laboratory Methods
P reparation & testing of Reagent Water in
th
the Clinical Laboratory
11
frozen human serum pools as secondary
reference materials for cholesterol
measurement
P rinciples and Procedures for Blood
Cultures
Approved Guideline
Approved Guideline
Page
P reparation & validation of commutable
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P rinciples and Procedures for Detection of
Fungi in Clinical Specimens – Direct
Examination and Culture
Procedures and Devices for the Collection of
Diagnostic Capillary Blood specimens
P rocedure for Determining Packed Cell
CLSI
Product
Code
M54-A
Vol No Replaces
Approval Date
32
14
H04-A6
28
25
H04-A5
H7-A3
20
18
H7-A2
H3-A5
23
32
H3-A4
DEC 2003
H30-A2
21
18
H30-A
Nov 2001
H4-A4
19
16 Consolidates
H4-A3 &
H14-A2
H54-A
25
23
H11-A4
24
H 18-A3
24
UPDATED October 2013
STATUS
October 2012
Approved Guideline
Sept 2008
Approved Standard
Approved Standard
Volume by the Microhematocrit Method
P rocedure for the Collection of Diagnostic
th
Approved Standard – 5 Edition
Blood Specimens by Venipuncture.
P rocedure for the determination of
Approved Guideline – 2nd Edition
fibrinogen in plasma
12 P rocedures and devices for collection of
Sep-99
Approved Standard
H54-P
Aug 2005
Approved Guideline
28
H11-A3
Sept 2004
Approved Standard – 4th Edition
38
H18-A2
Nov 2004
Approved Guideline – 2
nd
Edition
M28-A2
25 16
M28-A
June 2005
Approved Guideline – 2
nd
Edition
X6-R
25 14
June 2005
Approved
diagnostic blood specimens by skin puncture
Procedures for Validation of INR and Local
Calibration of PT/INR Systems
Procedures for the collection of arterial blood
specimens
Procedures for the handling and processing
Identification of Parasites from the Intestinal
Tract
Proceedings From the QC for the Future
Workshop; A Report
Page
Procedures for the Recovery and
12
of blood specimens
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Approval Date
UPDATED October 2013
Document Title
CLSI
Product
Code
Vol No Replaces
STATUS
Proficiency Testing (External Quality Assessment)
MM14-A
25 24
MM14-P
Aug 2005
Approved Guideline
M29-A3
25 10
M29-A2
March 2005
Approved Guideline
- 3rd Edition
EP17-A
24 34
EP17-P
Oct 2004
Approved Guideline
M6-A2
26
6
M6-A
Jan
2006
HS2-A
23
5
HS2-P
Feb 2003
Approved Guideline
HS3-A
25
5
HS3-P
Jan 2005
Approved Guideline
M22-A3
24 19
M22-A2
June 2004
Approved Standard-3 Edition
I/LA2-A2
16 11
I/LA2-A
Mar 2006
Approved Guideline- 2
M40-A
23 34
M40-P
Dec 2003
Approved Standard
M50-A
28 23
M50-P
Aug 2008
Approved Guideline
for Molecular Methods
Protection of laboratory workers from
occupationally acquired infections
Protocols for Determination of Limits of
Detection and Limits of Quantitation
Protocols for Evaluating Dehydrated MuellerHinton Agar
Provider-Performed Microscopy Testing
13 Pulse Oximetry
Quality Assurance for commercially prepared
Approved Standard -2
nd
Edition
rd
microbiological culture media
Quality Control for Commercial Microbial
Edition
Identification Systems
Q uality Control MIC Limits for Mycobacterium
peregrinum and Staphylococcus aureus(When
Testing Rapidly Growing Mycobacteria)
M24-SI
Informational Supplement
13
Autoantibodies to Nuclear Antigens
(1)Indirect Fluorescence Assay for
Microscopy and (2) Microtiter Enzyme
Immunoassay Methods
Quality Control of Microbiological Transport
Systems
nd
Page
Quality assurance of Laboratory Tests for
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Document Title
Q uality Management for molecular genetic
CLSI
Product
Code
MM20-A2
Vol No
Replaces
32 15
Approval Date
UPDATED October 2013
STATUS
November 2012 Approved Guideline
testing
Q uality Management System: Equipment
QMS13-A
GP 37-A
Q uality Management System: leadership
QMA14-A
GP38-A
QMS14AES
GP38-AES
August 2011
Approved Guideline
December 2012 Approved Guideline
and Management Roles and Responsibilities
Q uality Management System: Leadership
and Management Roles and Responsibilities
– Executive Summary
Quality Management System: A Model for
GP26-A4
31 15
GP26-A3
JUN 2011
Laboratory services
Approved Guideline –
th
4 Edition
Approved Guideline
MM4-P
17
Quality management for unit-use testing
EP18-A
22 28
EP18-P
Dec 2002
Approved Guideline
Quantitative Molecular Methods for Infectious
MM6-A
23 28
MM6-P
Oct 2003
Approved Guideline
M38-A2
28 16
M38-A
AUG 2008
14 Quality for immunocytochemistry
10
Dec 99
Diseases
M27-S4E
M27-A2
Dec 2012
22 15
M27-A
AUG 2002
nd
Edition
Fourth Informational Supplement - This document
provides updated tables for the CLSI antimicrobial
susceptibility testing standard M27-A3
Approved Standard – 2nd Edition
14
Antifungal Susceptibility Testing of
Filamentous Fungi
R eference Method for Broth Dilution
th
Antifungal Susceptibility Testing of Yeasts; 4
Informational Supplement
Reference Method for Broth Dilution
Antifungal Susceptibility Testing of Yeasts
Approved Standard 2
Page
Reference Method for Broth Dilution
NOTE: THESE DOCUMENTS ARE PROTECTED BY COPYRIGHT LAWS
UPDATED October 2013
CLSI
Product
Code
H2-A4
Vol No
Replaces
Approval Date
20 27
H2-A3
Dec00
Approved Standard – 4th Edition
H15-A3
20 28
H15-A2
Dec00
Approved Standard – 3rd Edition
quantitative determination of hemoglobin in
blood
Remote Access to Clinical Laboratory
Diagnostic Devices via the Internet
AUTO9-A
26 11
AUTO9-p
March 2006
Risk Management Techniques to Identify and
EP18-P2
27 23
EP18-A
Aug 2007
GP9-A
18 15
GP9-T
Nov-98
LIS01-A2
28 13
LIS1-A
April 2008
Approved Standard 2
LIS2-A
24 33
LIS2-A
Oct 2004
Approved Standard – 2nd Edition
I/LA18-A2
21 15
I/LA18-A
Sep 2001
Approved Guideline
LIS3-A
23
C29-A2
20 17
Formerly
ASTM
E792-02
C29-A
C24-A3
26 25
C24-A2
June 2006
Approved
rd
Guideline- 3 Edition
HS6-A
24 32
HS6-P
Oct 2004
Approved Guideline
Document Title
Reference & selected procedure for the
STATUS
erythrocyte sedimentation rate (ESR) test
Reference & selected procedures for the
Approved Standard
Proposed Guideline – 2
nd
Edition
Control Laboratory Error Sources
Selecting and evaluating a referral laboratory
Specification for Low-Level Protocol to
Approved Guideline
nd
Edition
15 Transfer Messages Between Clinical
Selective Electrode Systems to the Flame
Photometric Reference Method
Statistical Quality Control for quantitative
measurement procedures: principles &
definitions
Studies to Evaluate Patient Outcomes
Publish Apr 2003 Published
Approved Standard
15
Standardization of Sodium & Potassium Ion-
9
Page
Laboratory Instruments and Computer
Systems.
Specification for Transferring Information
Between Clinical Laboratory Instruments and
Information Systems
Specifications for Immunological Testing for
Infectious Diseases
Standard Guide for Selection of a Clinical
Laboratory Information Management System
NOTE: THESE DOCUMENTS ARE PROTECTED BY COPYRIGHT LAWS
Document Title
Sweat testing sample collection &
CLSI
Product
Code
C34-A2
Vol No
Replaces
Approval Date
20 14
C34-A
Jun 00
M24-A
23 18
M24-T2
April 20.2003
UPDATED October 2013
STATUS
Approved Guideline 2nd Edition
quantitative analysis
Susceptibility Testing of Mycobacteria,
Approved Standard
Nocardia, and Other Aerobic Actinomycetes
The Reference System for the Clinical Laboratory: NRSCL13-A 20 21 NRSCL 13-
Approved Guideline
P
Criteria for Development and Credentialing of
Methods and Materials for Harmonization of
Results
Training and Competence Assessment
GP21-A2
24 14
GP21-A
APR 2004
Approved Guideline-2nd Edition
Tubes and Additives for Venous Blood
H1-A5
23 33
H1-A4
Dec 2003
Approved Standard – 5 Edition
GP16-A2
15 15
GP16-A
NOV 2001
Approved Guideline – 2
Urine drug testing in the clinical lab
T/DMB-A
19
6
T/DMB-P
Feb 99
Use of External RNA Controls in Gene
MM16-A
26 29
MM16-P
Aug 2006
Approved Guideline
EP12-A
22 14
EP12-P
Aug 2002
Approved Guideline
EP15-A2
25 17
EP15-A
April 2006
Approved Guideline-2
GP27-A2
27
GP22-A
Feb 2007
Approved
nd
Guideline-2 Edition
th
Specimen Collection
16 Urinalysis and Collection, Transportation, and
ND
EDITION
Preservation of Urine Specimens
Approved
Guideline
Expression Assays
User protocol for evaluation of qualitative test
performance
Using proficiency test (PT) to improve the
clinical laboratory
8
Edition – 2
nd
Printing
16
and Trueness
nd
Page
User verification of Performance for Precision
NOTE: THESE DOCUMENTS ARE PROTECTED BY COPYRIGHT LAWS
Document Title
Validation of Automated Devices for
Immunohematologic Testing Prior to
Implementation
V erification of Comparability of Patient
Results Within One Health Care System
Western Blot Assay for Antibodies to Borrelia
CLSI
Product
Code
I/LA33-A
Vol No
Replaces
EP31-A-IR
32 11
C
M34-A
20 20
M34-P
29 28 I/LA33-P
Approval Date
Dec 2009
August 2012
UPDATED October 2013
STATUS
Proposed Guideline
Approved Guideline (Interim Revision)
Approved Guideline
burgdorferi
Page
17
17