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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
DRC Est. Publication Date
PRE05
1st Ed.
Urine Specimen Collection
2024-06-10
MM26
1st Ed.
Interpretive Framework for Laboratory Consultation for Cancer Genetics Testing (Somatic)
2024-06-11
EP10
4th Ed.
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
2024-07-01
EP30
2nd Ed.
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine
2024-08-21
QMS14
2nd Ed.
Quality Management System: Leadership and Management Roles and Responsibilities
2024-08-26
C38
2nd Ed.
Control of Preexamination Variation in Trace Element Determinations
2024-08-29
M64
1st Ed.
Implementation of Taxonomy Changes
2024-09-25
MM23
2nd Ed.
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
2024-10-04
AUTO11
3rd Ed.
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems
2024-10-08
EP37
2nd Ed.
Supplemental Tables for Interference Testing in Clinical Chemistry
2024-10-18
GP40
5th Ed.
Preparations and Testing of Reagent Water in the Medical Laboratory
2024-11-08
EP47
1st Ed.
Evaluation of Reagent Carryover
2024-11-18
PRE02
8th Ed.
Collection of Diagnostic Venous Blood Specimens
2024-11-22
QMS27
1st Ed.
Decontamination of Laboratory Instrumentation
2024-12-09
POCT16
1st Ed.
Emergency and Disaster Point-of-Care Testing
2024-12-13
QMS28
1st Ed.
Laboratory Safety Management
2025-01-09
C34
5th Ed.
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
2025-01-16
EP45
1st Ed.
Verifying Reference Intervals
2025-01-16
MM19
2nd Ed.
Establishing Molecular Testing in Medical Laboratory Environments
2025-02-10
EP32
2nd Ed.
Metrological Traceability and Its Implementation
2025-02-13
M67
1st Ed.
Verification of Laboratory Automation in Microbiology
2025-02-17
NBS13
1st Ed.
Newborn Screening for Spinal Muscular Atrophy
2025-02-21
POCT08
2nd Ed.
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers
2025-02-21
M100
35th Ed.
Performance Standards for Antimicrobial Susceptibility Testing
2025-02-26
EP46
1st Ed.
Determining Total Analytical Error Goals for Quantitative Medical Laboratory Test Methods
2025-03-03
EP35
2nd Ed.
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
2025-03-07
EP21
3rd Ed.
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
2025-03-11
EP31
2nd Ed.
Verification of Comparability of Patient Results Within One Health Care System
2025-03-12
PRE06
1st Ed.
Validation of External Transport Systems
2025-03-17
M23
2nd Ed.
Procedure for Optimizing Disk Contents (Potencies) for Disk Diffusion Testing of Antimicrobial Agents Using Harmonized CLSI and EUCAST Criteria
2025-03-24
MM27
1st Ed.
Molecular Diagnostic Methods for Hematologic Malignancies
2025-03-31
AUTO14
1st Ed.
Use of Two-Dimensional Bar Coding in Clinical and Anatomic Pathology Laboratories
2025-04-09
MM06
3rd Ed.
Quantitative Molecular Methods for Infectious Diseases
2025-04-16
M27
4th Ed.
Performance Standards for Antifungal Susceptibility Testing of Yeasts
2025-04-24
ILA20
4th Ed.
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
2025-04-25
M23
2nd Ed.
Process to Submit Disk Content (Potency) Data for Joint CLSI-EUCAST Working Group Review and Approval
2025-04-25
NBS11
1st Ed.
Newborn Screening for Congenital Adrenal Hyperplasia
2025-04-28
GP50
1st Ed.
Clinical Testing for Early Detection and Management of Sepsis
2025-05-14
M38
4th Ed.
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
2025-05-14
POCT09
2nd Ed.
Selection Criteria for Point-of-Care Testing Devices
2025-05-14
QMS06
4th Ed.
Quality Management System: Continual Improvement
2025-05-16
C46
3rd Ed.
Blood Gas and pH Analysis and Related Measurements
2025-05-23
M66
1st Ed.
Methods for Active Surveillance of Multidrug-Resistant Organisms
2025-06-11
NBS06
2nd Ed.
Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies
2025-06-11
M57
5th Ed.
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
2025-06-13
EP17
3rd Ed.
Evaluation of Detection Capability for Medical Laboratory Measurement Procedures
2025-06-27
H20
3rd Ed.
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
2025-06-27
EP44
1st Ed.
Establishing Reference Intervals
2025-07-01
C65
1st Ed.
Biochemical Tumor Marker Testing
2025-07-07
H42
3rd Ed.
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
2025-07-09
M45
4th Ed.
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
2025-07-16
MM14
3rd Ed.
Proficiency Testing (External Quality Assessment) for Molecular Methods
2025-07-17
NBS12
1st Ed.
Newborn Screening for Galactosemia
2025-07-21
M68
1st Ed.
Validation of Commercial Antimicrobial Susceptibility Test (AST) Breakpoints
2025-07-22
NBS14
1st Ed.
Newborn Screening for Lysosomal Diseases
2025-07-22
QMS13
2nd Ed.
Quality Management System: Equipment
2025-08-11
EP09
4th Ed.
Estimation of Systematic Difference Between Measurement Procedures
2025-08-12
PRE07
1st Ed.
Collection and Handling of Anterior Nares, Nasogastric, Nasopharyngeal, Mid-turbinate, Oropharyngeal, and Saliva Specimens
2025-08-12
M56
2nd Ed.
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
2025-08-20
H59
2nd Ed.
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
2025-08-21
MM28
1st Ed.
Liquid Biopsy Methods for Oncology
2025-08-21
GP34
2nd Ed.
Validation and Verification of Tubes for Venous and Capillary Blood Specimens
2025-08-25
MM25
1st Ed.
Sequencing Bioinformatics for Human Genetics and Oncology
2025-08-25
AUTO16
2nd Ed.
Next-Generation In Vitro Diagnostic Instrument Interface
2025-08-27
C62
3rd Ed.
Liquid Chromatography-Mass Spectrometry Methods
2025-08-27
EP05
4th Ed.
Evaluation of Precision of Quantitative Measurement Procedures
2025-08-29
M52
2nd Ed.
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
2025-09-03
EP24
3rd Ed.
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
2025-09-05
M63
1st Ed.
Principles and Procedures for the Gram Stain
2025-09-05
M35
3rd Ed
Abbreviated Identification of Bacteria and Yeast
2025-09-15
M58
2nd Ed.
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
2025-09-25
MM29
1st Ed.
Interpretive Framework Heritable Disorders
2025-10-13
POCT15
2nd Ed.
POCT for Infectious Diseases
2025-10-23
H26
3rd Ed.
Automated Hematology Analyzers
2025-10-24
H63
1st Ed.
CD34+ Hematopoietic Stem Cell Enumeration by Flow Cytometry
2025-10-27
VET03
3rd Ed.
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals
2025-10-29
M27
5th
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
2025-11-25
H43
3rd Ed.
Neoplastic Hematolymphoid Cells
2025-12-02
M69
1st Ed.
Principles of Serologic (Antibody and Antigen) Testing for Infectious Diseases
2025-12-16
POCT13
4th Ed.
Glucose Monitoring in Settings Without Laboratory Support
2025-12-22
VET06
2nd Ed.
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
2026-01-30
M38
4th Ed.
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
2026-02-02
AUTO18
1st Ed.
Data Collection Methods
2026-03-16
M70
1st Ed.
Laboratory Testing for Lyme Borreliosis
2026-04-09
I/LA28
3rd Ed.
Quality Assurance for Immunocytochemistry
2026-09-09