CLSI Projects in Progress
The projects below are currently in progress and are listed with their projected publication dates. Interested in volunteering your expertise for one of these projects? Contact us.
Please note, the publication dates are subject to change based on document development activities.
|
Product Number
|
Edition
|
Title
|
Est. Publication Date
|
|---|---|---|---|
|
AUTO11
|
3rd Ed.
|
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems
|
2024-09-26
|
|
EP37
|
2nd Ed.
|
Supplemental Tables for Interference Testing in Clinical Chemistry
|
2024-10-10
|
|
QMS14
|
2nd Ed.
|
Quality Management System: Leadership and Management Roles and Responsibilities
|
2024-10-15
|
|
C34
|
5th Ed.
|
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
|
2024-11-04
|
|
M64
|
1st Ed.
|
Implementation of Taxonomy Changes
|
2024-11-14
|
|
MM23
|
2nd Ed.
|
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
|
2024-11-21
|
|
M23
|
2nd Ed.
|
Procedure for Optimizing Disk Contents (Potencies) for Disk Diffusion Testing of Antimicrobial Agents Using Harmonized CLSI and EUCAST Criteria
|
2024-11-22
|
|
GP40
|
5th Ed.
|
Preparations and Testing of Reagent Water in the Medical Laboratory
|
2025-01-07
|
|
M23
|
2nd Ed.
|
Process to Submit Disk Content (Potency) Data for Joint CLSI-EUCAST Working Group Review and Approval
|
2025-01-09
|
|
M100
|
35th Ed.
|
Performance Standards for Antimicrobial Susceptibility Testing
|
2025-01-23
|
|
EP32
|
2nd Ed.
|
Metrological Traceability and Its Implementation
|
2025-02-04
|
|
EP35
|
2nd Ed.
|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
|
2025-02-07
|
|
NBS13
|
1st Ed.
|
Newborn Screening for Spinal Muscular Atrophy
|
2025-02-11
|
|
EP21
|
3rd Ed.
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
|
2025-03-04
|
|
EP46
|
1st Ed.
|
Determining Total Analytical Error Goals for Quantitative Medical Laboratory Test Methods
|
2025-03-04
|
|
EP45
|
4th Ed.
|
Implementation of Reference Intervals in the Medical Laboratory
|
2025-03-11
|
|
MM19
|
2nd Ed.
|
Establishing Molecular Testing in Medical Laboratory Environments
|
2025-03-17
|
|
M67
|
1st Ed.
|
Verification of Laboratory Automation in Microbiology
|
2025-03-21
|
|
PRE02
|
8th Ed.
|
Collection of Diagnostic Venous Blood Specimens
|
2025-03-21
|
|
POCT16
|
1st Ed.
|
Emergency and Disaster Point-of-Care Testing
|
2025-03-24
|
|
AUTO14
|
1st Ed.
|
Use of Two-Dimensional Bar Coding in Clinical and Anatomic Pathology Laboratories
|
2025-03-25
|
|
QMS27
|
1st Ed.
|
Decontamination of Laboratory Instrumentation
|
2025-03-28
|
|
POCT15
|
2nd Ed.
|
POCT for Infectious Diseases
|
2025-04-02
|
|
NBS11
|
1st Ed.
|
Newborn Screening for Congenital Adrenal Hyperplasia
|
2025-04-21
|
|
NBS12
|
1st Ed.
|
Newborn Screening for Galactosemia
|
2025-04-25
|
|
QMS28
|
1st Ed.
|
Laboratory Safety Management
|
2025-04-28
|
|
QMS06
|
4th Ed.
|
Quality Management System: Continual Improvement
|
2025-05-06
|
|
EP31
|
2nd Ed.
|
Verification of Comparability of Patient Results Within One Health Care System
|
2025-05-08
|
|
M66
|
1st Ed.
|
Methods for Active Surveillance of Multidrug-Resistant Organisms
|
2025-05-20
|
|
EP05
|
4th Ed.
|
Evaluation of Precision of Quantitative Measurement Procedures
|
2025-05-23
|
|
C65
|
1st Ed.
|
Biochemical Tumor Marker Testing
|
2025-05-29
|
|
EP44
|
4th Ed.
|
Establishing Reference Intervals
|
2025-06-04
|
|
MM06
|
3rd Ed.
|
Quantitative Molecular Methods for Infectious Diseases
|
2025-06-18
|
|
NBS06
|
2nd Ed.
|
Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies
|
2025-06-26
|
|
AUTO16
|
2nd Ed.
|
Next-Generation In Vitro Diagnostic Instrument Interface
|
2025-06-27
|
|
MM14
|
3rd Ed.
|
Proficiency Testing (External Quality Assessment) for Molecular Methods
|
2025-07-01
|
|
MM27
|
1st Ed.
|
Molecular Diagnostic Methods for Hematologic Malignancies
|
2025-07-25
|
|
H20
|
3rd Ed.
|
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
|
2025-08-04
|
|
GP50
|
1st Ed.
|
Clinical Testing for Early Detection and Management of Sepsis
|
2025-08-18
|
|
C46
|
3rd Ed.
|
Blood Gas and pH Analysis and Related Measurements
|
2025-08-20
|
|
C62
|
3rd Ed.
|
Liquid Chromatography-Mass Spectrometry Methods
|
2025-08-25
|
|
EP09
|
4th Ed.
|
Estimation of Systematic Difference Between Measurement Procedures
|
2025-09-12
|
|
|
4th Ed.
|
User Verification of Precision and Estimation of Bias
|
2025-09-12
|
|
PRE06
|
1st Ed.
|
Validation of External Transport Systems
|
2025-09-23
|
|
POCT13
|
4th Ed.
|
Glucose Monitoring in Settings Without Laboratory Support
|
2025-10-07
|
|
M68
|
1st Ed.
|
Validation of Commercial Antimicrobial Susceptibility Test (AST) Breakpoints
|
2025-10-08
|
|
EP17
|
3rd Ed.
|
Evaluation of Detection Capability for Medical Laboratory Measurement Procedures
|
2025-10-16
|
|
M45
|
4th Ed.
|
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
|
2025-10-17
|
|
M52
|
2nd Ed.
|
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
|
2025-10-24
|
|
POCT09
|
2nd Ed.
|
Selection Criteria for Point-of-Care Testing Devices
|
2025-10-28
|
|
QMS13
|
2nd Ed.
|
Quality Management System: Equipment
|
2025-11-05
|
|
EP24
|
3rd Ed.
|
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
|
2025-11-06
|
|
ILA20
|
4th Ed.
|
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
|
2025-11-17
|
|
H26
|
3rd Ed.
|
Automated Hematology Analyzers
|
2025-11-18
|
|
MM25
|
1st Ed.
|
Sequencing Bioinformatics for Human Genetics and Oncology
|
2025-12-15
|
|
NBS14
|
1st Ed.
|
Newborn Screening for Lysosomal Diseases
|
2025-12-16
|
|
H42
|
3rd Ed.
|
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
|
2026-01-05
|
|
M56
|
2nd Ed.
|
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
|
2026-01-12
|
|
VET06
|
2nd Ed.
|
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
|
2026-01-12
|
|
PRE07
|
1st Ed.
|
Collection and Handling of Anterior Nares, Nasogastric, Nasopharyngeal, Mid-turbinate, Oropharyngeal, and Saliva Specimens
|
2026-01-15
|
|
MM28
|
1st Ed.
|
Liquid Biopsy Methods for Oncology
|
2026-01-16
|
|
POCT08
|
2nd Ed.
|
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers
|
2026-01-23
|
|
M38
|
4th Ed.
|
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
|
2026-01-28
|
|
GP34
|
2nd Ed.
|
Validation and Verification of Tubes for Venous and Capillary Blood Specimens
|
2026-02-02
|
|
H43
|
3rd Ed.
|
Neoplastic Hematolymphoid Cells
|
2026-02-02
|
|
M58
|
2nd Ed.
|
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
|
2026-02-11
|
|
M27
|
4th Ed.
|
Performance Standards for Antifungal Susceptibility Testing of Yeasts
|
2026-02-26
|
|
M35
|
3rd Ed
|
Abbreviated Identification of Bacteria and Yeast
|
2026-03-11
|
|
M69
|
1st Ed.
|
Principles of Serologic (Antibody and Antigen) Testing for Infectious Diseases
|
2026-03-25
|
|
MM29
|
1st Ed.
|
Interpretive Framework Heritable Disorders
|
2026-04-20
|
|
M57
|
5th Ed.
|
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
|
2026-04-23
|
|
H63
|
1st Ed.
|
CD34+ Hematopoietic Stem Cell Enumeration by Flow Cytometry
|
2026-04-24
|
|
VET03
|
3rd Ed.
|
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals
|
2026-05-18
|
|
M27
|
5th Ed.
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
|
2026-05-21
|
|
M63
|
1st Ed.
|
Principles and Procedures for the Gram Stain
|
2026-06-03
|
|
AUTO18
|
1st Ed.
|
Data Collection Methods
|
2026-07-06
|
|
M38
|
4th Ed.
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
|
2026-07-08
|
|
M70
|
1st Ed.
|
Laboratory Testing for Lyme Borreliosis
|
2026-09-08
|
|
MM30
|
1st Ed.
|
Variant Monitoring for Infectious Diseases
|
2026-11-03
|
|
H59
|
2nd Ed.
|
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
|
2027-04-29
|