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
|
Product Category
|
|---|---|---|---|---|
|
M100
|
35th Ed.
|
Performance Standards for Antimicrobial Susceptibility Testing
|
2025-01-23
|
Supplemental Document
|
|
EP35
|
2nd Ed.
|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
|
2025-02-14
|
Standards and Guidelines
|
|
PRE02
|
8th Ed.
|
Collection of Diagnostic Venous Blood Specimens
|
2025-02-20
|
Standards and Guidelines
|
|
MM23
|
2nd Ed.
|
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
|
2025-02-24
|
Standards and Guidelines
|
|
EP32
|
2nd Ed.
|
Metrological Traceability and Its Implementation
|
2025-03-07
|
Standards and Guidelines
|
|
NBS13
|
1st Ed.
|
Newborn Screening for Spinal Muscular Atrophy
|
2025-03-28
|
Standards and Guidelines
|
|
EP21
|
3rd Ed.
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
|
2025-04-16
|
Standards and Guidelines
|
|
EP45
|
4th Ed.
|
Implementation of Reference Intervals in the Medical Laboratory
|
2025-04-16
|
Standards and Guidelines
|
|
EP46
|
1st Ed.
|
Determining Total Analytical Error Goals for Quantitative Medical Laboratory Test Methods
|
2025-04-16
|
Standards and Guidelines
|
|
NBS11
|
1st Ed.
|
Newborn Screening for Congenital Adrenal Hyperplasia
|
2025-04-22
|
Standards and Guidelines
|
|
MM19
|
2nd Ed.
|
Establishing Molecular Testing in Medical Laboratory Environments
|
2025-05-02
|
Standards and Guidelines
|
|
QMS06
|
4th Ed.
|
Quality Management System: Continual Improvement
|
2025-05-06
|
Standards and Guidelines
|
|
NBS12
|
1st Ed.
|
Newborn Screening for Galactosemia
|
2025-05-07
|
Standards and Guidelines
|
|
M67
|
1st Ed.
|
Verification of Laboratory Automation in Microbiology
|
2025-05-13
|
Standards and Guidelines
|
|
POCT16
|
1st Ed.
|
Emergency and Disaster Point-of-Care Testing
|
2025-05-29
|
Standards and Guidelines
|
|
EP31
|
2nd Ed.
|
Verification of Comparability of Patient Results Within One Health Care System
|
2025-06-04
|
Standards and Guidelines
|
|
AUTO14
|
1st Ed.
|
Use of Two-Dimensional Bar Coding in Clinical and Anatomic Pathology Laboratories
|
2025-06-10
|
Standards and Guidelines
|
|
MM06
|
3rd Ed.
|
Quantitative Molecular Methods for Infectious Diseases
|
2025-06-10
|
Standards and Guidelines
|
|
QMS28
|
1st Ed.
|
Laboratory Safety Management
|
2025-06-16
|
Standards and Guidelines
|
|
NBS06
|
2nd Ed.
|
Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies
|
2025-06-24
|
Standards and Guidelines
|
|
EP44
|
4th Ed.
|
Establishing Reference Intervals
|
2025-07-15
|
Standards and Guidelines
|
|
C65
|
1st Ed.
|
Biochemical Tumor Marker Testing
|
2025-07-21
|
Standards and Guidelines
|
|
EP05
|
4th Ed.
|
Evaluation of Precision of Quantitative Measurement Procedures
|
2025-07-21
|
Standards and Guidelines
|
|
M66
|
1st Ed.
|
Methods for Active Surveillance of Multidrug-Resistant Organisms
|
2025-07-29
|
Standards and Guidelines
|
|
MM14
|
3rd Ed.
|
Proficiency Testing (External Quality Assessment) for Molecular Methods
|
2025-08-01
|
Standards and Guidelines
|
|
H20
|
3rd Ed.
|
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
|
2025-08-20
|
Standards and Guidelines
|
|
AUTO16
|
2nd Ed.
|
Next-Generation In Vitro Diagnostic Instrument Interface
|
2025-08-25
|
Standards and Guidelines
|
|
QMS27
|
1st Ed.
|
Decontamination of Laboratory Instrumentation
|
2025-09-18
|
Standards and Guidelines
|
|
|
4th Ed.
|
User Verification of Precision and Estimation of Bias
|
2025-10-01
|
Standards and Guidelines
|
|
PRE06
|
1st Ed.
|
Validation of External Transport Systems
|
2025-10-17
|
Standards and Guidelines
|
|
C62
|
3rd Ed.
|
Liquid Chromatography-Mass Spectrometry Methods
|
2025-10-28
|
Standards and Guidelines
|
|
GP50
|
1st Ed.
|
Clinical Testing for Early Detection and Management of Sepsis
|
2025-10-29
|
Standards and Guidelines
|
|
M68
|
1st Ed.
|
Validation of Commercial Antimicrobial Susceptibility Test (AST) Breakpoints
|
2025-10-31
|
Standards and Guidelines
|
|
EP09
|
4th Ed.
|
Estimation of Systematic Difference Between Measurement Procedures
|
2025-11-05
|
Standards and Guidelines
|
|
POCT15
|
2nd Ed.
|
POCT for Infectious Diseases
|
2025-11-10
|
Reports and Other
|
|
MM27
|
1st Ed.
|
Molecular Diagnostic Methods for Hematologic Malignancies
|
2025-11-12
|
Standards and Guidelines
|
|
POCT08
|
2nd Ed.
|
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers
|
2025-11-25
|
Standards and Guidelines
|
|
POCT13
|
4th Ed.
|
Glucose Monitoring in Settings Without Laboratory Support
|
2025-12-05
|
Standards and Guidelines
|
|
NBS14
|
1st Ed.
|
Newborn Screening for Lysosomal Diseases
|
2025-12-11
|
Standards and Guidelines
|
|
C46
|
3rd Ed.
|
Blood Gas and pH Analysis and Related Measurements
|
2025-12-12
|
Standards and Guidelines
|
|
GP34
|
2nd Ed.
|
Validation and Verification of Tubes for Venous and Capillary Blood Specimens
|
2025-12-17
|
Standards and Guidelines
|
|
M45
|
4th Ed.
|
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
|
2025-12-23
|
Standards and Guidelines
|
|
M58
|
2nd Ed.
|
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
|
2025-12-23
|
Standards and Guidelines
|
|
ILA20
|
4th Ed.
|
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
|
2026-01-02
|
Standards and Guidelines
|
|
NBS15
|
1st Ed.
|
|
2026-01-15
|
Reports and Other
|
|
EP24
|
3rd Ed.
|
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
|
2026-01-27
|
Standards and Guidelines
|
|
M38
|
4th Ed.
|
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
|
2026-01-27
|
Supplemental Document
|
|
VET03
|
3rd Ed.
|
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals
|
2026-02-02
|
Standards and Guidelines
|
|
EP17
|
3rd Ed.
|
Evaluation of Detection Capability for Medical Laboratory Measurement Procedures
|
2026-02-05
|
Standards and Guidelines
|
|
POCT09
|
2nd Ed.
|
Selection Criteria for Point-of-Care Testing Devices
|
2026-02-09
|
Standards and Guidelines
|
|
QMS25
|
2nd Ed.
|
Handbook for Developing a Laboratory Quality Manual
|
2026-02-11
|
Reports and Other
|
|
AUTO12
|
2nd Ed.
|
Specimen Labels: Content and Location, Fonts, and Label Orientation
|
2026-02-12
|
Standards and Guidelines
|
|
H63
|
1st Ed.
|
CD34+ Hematopoietic Stem Cell Enumeration by Flow Cytometry
|
2026-02-12
|
Standards and Guidelines
|
|
MM28
|
1st Ed.
|
Liquid Biopsy Methods for Oncology
|
2026-02-12
|
Standards and Guidelines
|
|
M52
|
2nd Ed.
|
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
|
2026-02-17
|
Standards and Guidelines
|
|
MM25
|
1st Ed.
|
Sequencing Bioinformatics for Human Genetics and Oncology
|
2026-02-19
|
Standards and Guidelines
|
|
M35
|
3rd Ed.
|
Abbreviated Identification of Bacteria and Yeast
|
2026-02-20
|
Standards and Guidelines
|
|
H43
|
3rd Ed.
|
Neoplastic Hematolymphoid Cells
|
2026-02-24
|
Standards and Guidelines
|
|
H26
|
3rd Ed.
|
Automated Hematology Analyzers
|
2026-03-12
|
Standards and Guidelines
|
|
M27
|
4th Ed.
|
Performance Standards for Antifungal Susceptibility Testing of Yeasts
|
2026-03-16
|
Supplemental Document
|
|
MM29
|
1st Ed.
|
Interpretive Framework Heritable Disorders
|
2026-03-16
|
Standards and Guidelines
|
|
PRE07
|
1st Ed.
|
Collection and Handling of Anterior Nares, Nasogastric, Nasopharyngeal, Mid-turbinate, Oropharyngeal, and Saliva Specimens
|
2026-04-02
|
Standards and Guidelines
|
|
QMS13
|
2nd Ed.
|
Quality Management System: Equipment
|
2026-05-04
|
Standards and Guidelines
|
|
H42
|
3rd Ed.
|
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
|
2026-05-05
|
Standards and Guidelines
|
|
M69
|
1st Ed.
|
Principles of Serologic (Antibody and Antigen) Testing for Infectious Diseases
|
2026-05-06
|
Standards and Guidelines
|
|
M57
|
5th Ed.
|
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
|
2026-05-14
|
Supplemental Document
|
|
M27
|
5th Ed.
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
|
2026-05-21
|
Standards and Guidelines
|
|
EP49
|
1st Ed.
|
Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods
|
2026-05-29
|
Standards and Guidelines
|
|
VET06
|
2nd Ed.
|
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
|
2026-06-05
|
Standards and Guidelines
|
|
MM17
|
3rd Ed.
|
Verification and Validation of Multiplex Nucleic Acid Assays
|
2026-06-17
|
Standards and Guidelines
|
|
QMS23
|
3rd Ed.
|
General Laboratory Equipment Performance Qualification, Use, and Maintenance
|
2026-06-29
|
Standards and Guidelines
|
|
QMS01
|
6th Ed.
|
A Quality Management System Model for Laboratory Services
|
2026-07-01
|
Standards and Guidelines
|
|
M44
|
4th Ed.
|
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
|
2026-07-02
|
Standards and Guidelines
|
|
AUTO18
|
1st Ed.
|
Data Collection Methods
|
2026-07-06
|
Standards and Guidelines
|
|
M38
|
4th Ed.
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
|
2026-07-08
|
Standards and Guidelines
|
|
M56
|
2nd Ed.
|
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
|
2026-07-27
|
Standards and Guidelines
|
|
QMS11
|
3rd Ed.
|
Nonconforming Event Management
|
2026-07-29
|
Standards and Guidelines
|
|
GP36
|
2nd Ed.
|
Planning for Laboratory Operations During a Disaster
|
2026-08-04
|
Standards and Guidelines
|
|
QMS16
|
2nd Ed.
|
Laboratory Personnel Management
|
2026-08-24
|
Standards and Guidelines
|
|
M70
|
1st Ed.
|
Laboratory Testing for Lyme Borreliosis
|
2026-09-08
|
Standards and Guidelines
|
|
M63
|
1st Ed.
|
Principles and Procedures for the Gram Stain
|
2026-10-06
|
Standards and Guidelines
|
|
MM30
|
1st Ed.
|
Variant Monitoring for Infectious Diseases
|
2026-11-03
|
Standards and Guidelines
|
|
M29
|
5th Ed.
|
Protection of Laboratory Workers From Occupationally Acquired Infections
|
2027-02-12
|
Standards and Guidelines
|
|
QMS30
|
1st Ed.
|
|
2027-03-26
|
Standards and Guidelines
|
|
C66
|
1st Ed.
|
Vitamin D Testing in the Medical Laboratory
|
2027-04-06
|
Standards and Guidelines
|
|
M24
|
4th Ed.
|
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
|
2027-04-30
|
Standards and Guidelines
|
|
POCT12
|
4th Ed.
|
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
|
2027-05-11
|
Standards and Guidelines
|
|
I/LA28
|
3rd Ed.
|
Quality Assurance for Immunocytochemistry
|
2027-07-23
|
Standards and Guidelines
|
|
H59
|
2nd Ed.
|
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
|
2027-08-23
|
Standards and Guidelines
|