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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
GP40
5th Ed.
Preparations and Testing of Reagent Water in the Medical Laboratory
2024-12-11
Standards and Guidelines
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
2025-02-03
Standards and Guidelines
MM23
2nd Ed.
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
2025-02-05
Standards and Guidelines
EP32
2nd Ed.
Metrological Traceability and Its Implementation
2025-02-14
Standards and Guidelines
PRE02
8th Ed.
Collection of Diagnostic Venous Blood Specimens
2025-02-24
Standards and Guidelines
EP45
4th Ed.
Implementation of Reference Intervals in the Medical Laboratory
2025-03-19
Standards and Guidelines
EP21
3rd Ed.
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
2025-03-28
Standards and Guidelines
EP46
1st Ed.
Determining Total Analytical Error Goals for Quantitative Medical Laboratory Test Methods
2025-03-28
Standards and Guidelines
NBS13
1st Ed.
Newborn Screening for Spinal Muscular Atrophy
2025-03-31
Standards and Guidelines
NBS11
1st Ed.
Newborn Screening for Congenital Adrenal Hyperplasia
2025-04-15
Standards and Guidelines
MM19
2nd Ed.
Establishing Molecular Testing in Medical Laboratory Environments
2025-04-16
Standards and Guidelines
QMS06
4th Ed.
Quality Management System: Continual Improvement
2025-05-05
Standards and Guidelines
POCT16
1st Ed.
Emergency and Disaster Point-of-Care Testing
2025-05-12
Standards and Guidelines
AUTO14
1st Ed.
Use of Two-Dimensional Bar Coding in Clinical and Anatomic Pathology Laboratories
2025-05-14
Standards and Guidelines
NBS12
1st Ed.
Newborn Screening for Galactosemia
2025-05-15
Standards and Guidelines
M67
1st Ed.
Verification of Laboratory Automation in Microbiology
2025-05-19
Standards and Guidelines
MM06
3rd Ed.
Quantitative Molecular Methods for Infectious Diseases
2025-05-23
Standards and Guidelines
QMS28
1st Ed.
Laboratory Safety Management
2025-06-02
Standards and Guidelines
EP31
2nd Ed.
Verification of Comparability of Patient Results Within One Health Care System
2025-06-04
Standards and Guidelines
MM27
1st Ed.
Molecular Diagnostic Methods for Hematologic Malignancies
2025-06-18
Standards and Guidelines
C65
1st Ed.
Biochemical Tumor Marker Testing
2025-06-24
Standards and Guidelines
NBS06
2nd Ed.
Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies
2025-06-30
Standards and Guidelines
MM14
3rd Ed.
Proficiency Testing (External Quality Assessment) for Molecular Methods
2025-07-14
Standards and Guidelines
EP44
4th Ed.
Establishing Reference Intervals
2025-07-15
Standards and Guidelines
POCT15
2nd Ed.
POCT for Infectious Diseases
2025-07-25
Reports and Other
M66
1st Ed.
Methods for Active Surveillance of Multidrug-Resistant Organisms
2025-07-29
Standards and Guidelines
EP05
4th Ed.
Evaluation of Precision of Quantitative Measurement Procedures
2025-08-01
Standards and Guidelines
AUTO16
2nd Ed.
Next-Generation In Vitro Diagnostic Instrument Interface
2025-08-07
Standards and Guidelines
H20
3rd Ed.
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
2025-08-20
Standards and Guidelines
 
4th Ed.
User Verification of Precision and Estimation of Bias
2025-09-05
Standards and Guidelines
QMS27
1st Ed.
Decontamination of Laboratory Instrumentation
2025-09-18
Standards and Guidelines
GP50
1st Ed.
Clinical Testing for Early Detection and Management of Sepsis
2025-10-03
Standards and Guidelines
PRE06
1st Ed.
Validation of External Transport Systems
2025-10-03
Standards and Guidelines
C46
3rd Ed.
Blood Gas and pH Analysis and Related Measurements
2025-10-13
Standards and Guidelines
C62
3rd Ed.
Liquid Chromatography-Mass Spectrometry Methods
2025-10-17
Standards and Guidelines
EP09
4th Ed.
Estimation of Systematic Difference Between Measurement Procedures
2025-10-20
Standards and Guidelines
M68
1st Ed.
Validation of Commercial Antimicrobial Susceptibility Test (AST) Breakpoints
2025-10-31
Standards and Guidelines
POCT13
4th Ed.
Glucose Monitoring in Settings Without Laboratory Support
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
NBS14
1st Ed.
Newborn Screening for Lysosomal Diseases
2025-12-08
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
2025-12-09
Standards and Guidelines
GP34
2nd Ed.
Validation and Verification of Tubes for Venous and Capillary Blood Specimens
2025-12-10
Standards and Guidelines
POCT09
2nd Ed.
Selection Criteria for Point-of-Care Testing Devices
2025-12-10
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
EP24
3rd Ed.
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
2025-12-26
Standards and Guidelines
M52
2nd Ed.
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
2026-01-05
Standards and Guidelines
NBS15
1st Ed.
 
2026-01-07
Reports and Other
M58
2nd Ed.
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
2026-01-08
Standards and Guidelines
M38
4th Ed.
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
2026-01-28
Supplemental Document
EP17
3rd Ed.
Evaluation of Detection Capability for Medical Laboratory Measurement Procedures
2026-01-29
Standards and Guidelines
MM25
1st Ed.
Sequencing Bioinformatics for Human Genetics and Oncology
2026-01-29
Standards and Guidelines
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
H63
1st Ed.
CD34+ Hematopoietic Stem Cell Enumeration by Flow Cytometry
2026-02-06
Standards and Guidelines
AUTO12
2nd Ed.
Specimen Labels: Content and Location, Fonts, and Label Orientation
2026-02-12
Standards and Guidelines
QMS25
2nd Ed.
Handbook for Developing a Laboratory Quality Manual
2026-02-12
Reports and Other
VET06
2nd Ed.
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
2026-02-12
Standards and Guidelines
MM28
1st Ed.
Liquid Biopsy Methods for 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
2026-03-03
Standards and Guidelines
M27
4th Ed.
Performance Standards for Antifungal Susceptibility Testing of Yeasts
2026-03-17
Supplemental Document
MM29
1st Ed.
Interpretive Framework Heritable Disorders
2026-04-06
Standards and Guidelines
M56
2nd Ed.
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
2026-04-07
Standards and Guidelines
PRE07
1st Ed.
Collection and Handling of Anterior Nares, Nasogastric, Nasopharyngeal, Mid-turbinate, Oropharyngeal, and Saliva Specimens
2026-04-30
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
2026-05-15
Supplemental Document
M27
5th Ed.
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
2026-05-21
Standards and Guidelines
QMS23
3rd Ed.
General Laboratory Equipment Performance Qualification, Use, and Maintenance
2026-05-27
Standards and Guidelines
EP49
1st Ed.
Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods
2026-05-29
Standards and Guidelines
GP36
2nd Ed.
Planning for Laboratory Operations During a Disaster
2026-06-03
Standards and Guidelines
MM17
3rd Ed.
Verification and Validation of Multiplex Nucleic Acid Assays
2026-06-04
Standards and Guidelines
QMS01
6th Ed.
A Quality Management System Model for Laboratory Services
2026-06-12
Standards and Guidelines
QMS16
2nd Ed.
Laboratory Personnel Management
2026-06-16
Standards and Guidelines
M44
4th Ed.
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
2026-07-02
Standards and Guidelines
QMS11
3rd Ed.
Nonconforming Event Management
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
M63
1st Ed.
Principles and Procedures for the Gram Stain
2026-08-27
Standards and Guidelines
M70
1st Ed.
Laboratory Testing for Lyme Borreliosis
2026-09-08
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
2027-02-11
Standards and Guidelines
POCT12
4th Ed.
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
2027-03-03
Standards and Guidelines
QMS30
1st Ed.
 
2027-03-09
Standards and Guidelines
C66
1st Ed.
Vitamin D Testing in the Medical Laboratory
2027-04-06
Standards and Guidelines
H59
2nd Ed.
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
2027-06-29
Standards and Guidelines
I/LA28
3rd Ed.
Quality Assurance for Immunocytochemistry
2027-07-23
Standards and Guidelines