Quality System Essentials
CLSI subscribes to a quality management system (QMS) approach in the development of standards and guidelines that facilitates project management, defines a document structure using a template, and provides a process to identify needed documents. The QMS approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide.
To view each QSE, click "Filter Off" and select from the dropdown options.
|
Product Code
|
Title
|
OR
|
CS
|
FS
|
PE
|
SI
|
EQ
|
PM
|
DR
|
IM
|
NC
|
AS
|
CI
|
N/A
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUTO01-A
|
Laboratory Automation: Specimen Container/Specimen Carrier
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO02-A2
|
Laboratory Automation: Bar Codes for Specimen Container Identification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO03-A2
|
Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO04-A
|
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO05-A
|
Laboratory Automation: Electromechanical Interfaces, 1st Edition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO07-A
|
Laboratory Automation: Data Content for Specimen Identification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO08-A
|
Managing and Validating Laboratory Information Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO09-A
|
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO10-A
|
Autoverification of Clinical Laboratory Test Results
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO11-A2
|
IT Security of In Vitro Diagnostic Instruments and Software Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO11-Ed3
|
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO12-A
|
Specimen Labels: Content and Location, Fonts, and Label Orientation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO13-A2
|
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO15-Ed1
|
Autoverification of Medical Laboratory Results for Specific Disciplines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO16-Ed1
|
Next-Generation In Vitro Diagnostic Instrument Interface
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO17-Ed1
|
Semantic Interoperability for In Vitro Diagnostic Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C24-Ed4
|
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C29-A2
|
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C31-A2
|
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C34-Ed4
|
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C34-Ed5
|
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C37-A
|
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C38-A
|
Control of Preanalytical Variation in Trace Element Determinations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C38-Ed2
|
Control of Preexamination Variation in Trace Element Determinations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C39-A
|
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C40-A2
|
Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C42-A
|
Erythrocyte Protoporphyrin Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C43-A2
|
Gas Chromatography/Mass Spectrometry Confirmation of Drugs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C45-A
|
Measurement of Free Thyroid Hormones
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C46-A2
|
Blood Gas and pH Analysis and Related Measurements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C48-A
|
Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C49-Ed2
|
Analysis of Body Fluids in Clinical Chemistry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C50-A
|
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C52-Ed3
|
Toxicology and Drug Testing in the Clinical Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C56-A
|
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C57-Ed1
|
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C58-A
|
Assessment of Fetal Lung Maturity by the Lamellar Body Count
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C61-A
|
Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C62-Ed2
|
Liquid Chromatography-Mass Spectrometry Methods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C63-Ed1
|
Laboratory Support for Pain Management Programs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C64-Ed1
|
Quantitative Measurement of Proteins and Peptides by Mass Spectrometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP05-A3
|
Evaluation of Precision of Quantitative Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP06-Ed2
|
Evaluation of Linearity of Quantitative Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP06-Ed2-EG
|
Developer Validation of Linearity Establishment Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP07-Ed3
|
Interference Testing in Clinical Chemistry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP09-Ed3c
|
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP10-A3-AMD
|
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP10-Ed4
|
Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP10-Ed4-IG
|
Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures Implementation Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP12-Ed3
|
Evaluation of Qualitative, Binary Output Examination Performance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP14-Ed4
|
Evaluation of Commutability of Processed Samples
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP14-Ed4-G
|
Evaluation of Commutability of Processed Samples Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP15-A3
|
User Verification of Precision and Estimation of Bias
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP17-A2
|
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP18-A2
|
Risk Management Techniques to Identify and Control Laboratory Error Sources
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP19-Ed2
|
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP21-Ed2
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP21-Ed3
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP21-Ed3-QG
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures Quick Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP23-A
|
Laboratory Quality Control Based on Risk Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP24-A2
|
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP25-Ed2
|
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP26-Ed2
|
User Evaluation of Acceptability of a Reagent Lot Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP27-Ed2
|
How to Construct and Interpret an Error Grid for Quantitative Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP28-A3c
|
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP29-A
|
Expression of Measurement Uncertainty in Laboratory Medicine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP30-A
|
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP30-Ed2
|
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP31-A-IR
|
Verification of Comparability of Patient Results Within One Health Care System
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP31-Ed2
|
Verification of Comparability of Patient Results Within One Health Care System
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP32-Ed2
|
Implementation of Metrological Traceability in Laboratory Medicine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP31-Ed2-G
|
Verification of Comparability of Patient Results Within One Health Care System
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP32-R
|
Metrological Traceability and Its Implementation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP33-Ed2
|
Use of Delta Checks in the Medical Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP34-Ed1
|
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP35-Ed1
|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP35-Ed2
|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP36-Ed1
|
Harmonization of Symbology and Equations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP37-Ed1
|
Supplemental Tables for Interference Testing in Clinical Chemistry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP37-Ed2
|
Supplemental Tables for Interference Testing in Clinical Chemistry v2.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP39-Ed1
|
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP43-Ed1
|
Implementing a Laboratory Test Under Emergency Use Conditions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP46-Ed1
|
Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP46-Ed1-QG
|
Determining Error Goals and Limits Quick Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP47-Ed1
|
Evaluation of Reagent Carryover Effects on Test Results
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FR02-Ed1
|
Isavuconazole for A. fumagatis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP05-A3
|
Clinical Laboratory Waste Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP15-A3
|
Cervicovaginal Cytology Based on the Papanicolaou Technique
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP16-A3
|
Urinalysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP17-A3
|
Clinical Laboratory Safety
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP20-A2
|
Fine Needle Aspiration Biopsy (FNAB) Techniques
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP23-A2
|
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Technique
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP33-Ed2
|
Accuracy in Patient and Specimen Identification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP34-A
|
Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP36-A
|
Planning for Laboratory Operations During a Disaster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP39-A6
|
Tubes and Additives for Venous and Capillary Blood Specimen Collection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP40-A4-AMD
|
Preparations and Testing of Reagent Water in the Clinical Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP40-Ed5
|
Preparations and Testing of Reagent Water in the Medical Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP41-Ed7
|
Collection of Diagnostic Venous Blood Specimens
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP42-Ed7
|
Collection of Capillary Blood Specimens
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP44-A4
|
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP45-A
|
Studies to Evaluate Patient Outcomes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP47-Ed1
|
Management of Critical- and Significant-Risk Results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP48-Ed1
|
Essential Elements of a Phlebotomy Training Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP49-Ed1
|
Developing and Managing a Medical Laboratory (Test) Utilization Management Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H02-A5
|
Procedures for the Erythrocyte Sedimentation Rate Test
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H07-A3
|
Procedure for Determining Packed Cell Volume by the Microhematocrit Method
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H15-A3
|
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H20-A2
|
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H21-A5
|
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H21-Ed6-QG
|
Quick Guide for Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H26-A2
|
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H30-A2
|
Procedure for the Determination of Fibrinogen in Plasma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H42-A2
|
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H43-A2
|
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H44-A2
|
Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H47-Ed3
|
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H48-Ed2
|
Determination of Factor Coagulant Activities Using the One-stage Clotting Assay
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H52-A2
|
Red Blood Cell Diagnostic Testing Using Flow Cytometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H54-A
|
Procedures for Validation of INR and Local Calibration of PT/INR Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H56-A
|
Body Fluid Analysis for Cellular Composition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H57-A
|
Protocol for the Evaluation, Validation, and Implementation of Coagulometers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H58-A
|
Platelet Function Testing by Aggregometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H59-A
|
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H60-A
|
Laboratory Testing for the Lupus Anticoagulant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H62-Ed1
|
Validation of Assays Performed by Flow Cytometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA02-A2
|
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA20-Ed3
|
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA21-A2
|
Clinical Evaluation of Immunoassays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA23-A
|
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA25-A2
|
Maternal Serum Screening
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA26-A2
|
Performance of Single Cell Immune Response Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA28-A2
|
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA30-A
|
Immunoassay Interference by Endogenous Antibodies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA33-A
|
Validation of Automated Systems for Immunohematological Testing Before Implementation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA34-A
|
Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA37-A
|
Supplemental Data for Allergen Specificity for IgE Antibody Autoanalyzers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIS01-A2
|
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIS02-A2
|
Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M02-Ed13
|
Performance Standards for Antimicrobial Disk Susceptibility Tests
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M02QG
|
Disk Diffusion Reading Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M07-Ed11
|
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M100-Ed33
|
Performance Standards for Antimicrobial Susceptibility Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M100-Ed35
|
Performance Standards for Antimicrobial Susceptibility Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M11-Ed9
|
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M15-A
|
Laboratory Diagnosis of Blood-borne Parasitic Diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M22-A3
|
Quality Control for Commercially Prepared Microbiological Culture Media
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5
|
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5-S-Ed1
|
Procedure for Optimizing Disk Contents (Potencies) for Disk Diffusion Testing of Antimicrobial Agents Using Harmonized CLSI and EUCAST Criteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5-S2-Ed1
|
Process to Submit Disk Content (Potency) Data for Joint CLSI-EUCAST Working Group Review and Approval
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed6
|
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed6-S-Ed2
|
Procedure for Optimizing Disk Contents (Potencies) for Disk Diffusion Testing of Antimicrobial Agents Using Harmonized CLSI and EUCAST Criteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed6-S2-Ed2
|
Process to Submit Disk Content (Potency) Data for Joint CLSI-EUCAST Working Group Review and Approval
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M24-Ed3
|
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M24S-Ed2
|
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M26-A
|
Methods for Determining Bactericidal Activity of Antimicrobial Agents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M27-Ed4
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M27-M44-S-Ed3
|
Performance Standards for Antifungal Susceptibility Testing of Yeasts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M28-A2
|
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M29-A4
|
Protection of Laboratory Workers From Occupationally Acquired Infections
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M34-A
|
Western Blot Assay for Antibodies to Borrelia burgdorferi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M35-A2
|
Abbreviated Identification of Bacteria and Yeast
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M36-A
|
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M38-Ed3
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M38-M51-S-Ed3
|
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M39-Ed5
|
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M40-A2
|
Quality Control of Microbiological Transport Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M41-A
|
Viral Culture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M43-A
|
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M44-Ed3
|
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M45-Ed3
|
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M47-Ed2
|
Principles and Procedures for Blood Cultures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M48-Ed2
|
Laboratory Detection and Identification of Mycobacteria; Approved Guideline
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M50-A
|
Quality Control for Commercial Microbial Identification Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M51-A
|
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M52-Ed1
|
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M53-A
|
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M54-Ed2
|
Principles and Procedures for Detection and Culture of Fungi in Clinical Specimens
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M56-A
|
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M57-Ed1
|
Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal Susceptibility Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M57-S-Ed4
|
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M58-Ed1
|
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M59-Ed3
|
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M60-Ed2
|
Performance Standards for Antifungal Susceptibility Testing of Yeasts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M61-Ed2
|
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M62-Ed1
|
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M64-Ed1
|
Implementation of Taxonomy Nomenclature Changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM01-Ed4
|
Molecular Testing for Heritable Genetics and Specimen Identification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM03-Ed3
|
Molecular Diagnostic Methods for Infectious Diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM05-A2
|
Nucleic Acid Amplification Assays for Molecular Hematopathology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM06-A2
|
Quantitative Molecular Methods for Infectious Diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM07-A2
|
Fluorescence In Situ Hybridization Methods for Medical Genetics
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM09-Ed3
|
Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM11-A
|
Molecular Methods for Bacterial Strain Typing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM12-A
|
Diagnostic Nucleic Acid Microarrays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM13-Ed2
|
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM14-A2
|
Design of Molecular Proficiency Testing/External Quality Assessment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM14-Ed3
|
Design of Molecular Proficiency Testing/External Quality Assessment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM17-Ed2
|
Verification and Validation of Multiplex Nucleic Acid Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM18-Ed2
|
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM19-A
|
Establishing Molecular Testing in Clinical Laboratory Environments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM20-A
|
Quality Management for Molecular Genetic Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM21-Ed1
|
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM22-A
|
Microarrays for Diagnosis and Monitoring of Infectious Diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM23-Ed1
|
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM23-Ed2
|
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM24-Ed1
|
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM26-Ed1
|
Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS01-Ed7
|
Blood Collection on Filter Paper for Newborn Screening Programs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS03-Ed2
|
Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS04-Ed2
|
Newborn Screening by Tandem Mass Spectrometry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS05-Ed2
|
Newborn Screening for Cystic Fibrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS06-A
|
NBS for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS07-Ed1
|
Newborn Blood Spot Screening for Pompe Disease by Lysosomal Acid α-Glucosidase Activity Assays
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS08-Ed1
|
Newborn Screening for Hemoglobinopathies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS09-Ed1
|
Newborn Screening for X-Linked Adrenoleukodystrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS11-Ed1
|
Newborn Screening for Congenital Adrenal Hyperplasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS13-Ed1
|
Newborn Screening for Spinal Muscular Atrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT01-A2
|
Point-of-Care Connectivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT01-QG-Ed2
|
CLSI Vendor Code Registry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT02-A
|
Implementation Guide of POCT01 for Healthcare Providers; Approved Guideline
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT04-Ed3
|
Essential Tools for Implementation and Management of a Point-of-Care Testing Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT05-Ed2
|
Performance Metrics for Continuous Interstitial Glucose Monitoring
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT06-Ed1
|
Effects of Different Sample Types on Glucose Measurements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT07-A
|
Quality Management: Approaches to Reducing Errors at the Point of Care
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT08-A
|
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT09-A
|
Selection Criteria for Point-of-Care Testing Devices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT10-Ed2
|
Physician and Nonphysician Provider-Performed Microscopy Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT10-Ed2-QG
|
Provider-Performed Microscopy Training Quick Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT10-Ed2-CL1
|
Provider-Performed Microscopy Competency Assessment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT10-Ed2-CL2
|
Provider-Performed Microscopy Training Checklist
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT12-A3
|
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT13-Ed3c
|
Glucose Monitoring in Settings Without Laboratory Support
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT14-Ed2
|
Point-of-Care Coagulation Testing and Anticoagulation Monitoring
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT15-Ed1
|
POCT for Infectious Diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT16-Ed1
|
Emergency and Disaster Point-of-Care Testing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT17-Ed1
|
Use of Glucose Meters for Critically Ill Patients
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRE02-Ed8
|
Collection of Diagnostic Venous Blood Specimens
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRE02-Ed8-QG
|
Collection of Diagnostic Venous Blood Specimens Quick Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRE05-Ed1
|
Urine Specimen Collection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS01-Ed5
|
A Quality Management System Model for Laboratory Services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS02-A6
|
Quality Managment System: Development and Management of Laboratory Documents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS03-Ed4
|
Training and Competence Assessment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS04-Ed3
|
Laboratory Design
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS05-Ed3
|
Qualifying, Selecting, and Evaluating a Referral Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS06-A3
|
Quality Management System: Continual Improvement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS06-Ed4
|
Quality Management System: Continual Improvement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS11-Ed2
|
Nonconforming Event Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS12-Ed2
|
Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS13-A
|
Quality Management System: Equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS14-A
|
Quality Management System: Leadership and Management Roles and Responsibilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS14-Ed2
|
Quality Management System: Leadership and Management Roles and Responsibilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS15-Ed2
|
Assessments: Laboratory Internal Audit Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS16-Ed1
|
Laboratory Personnel Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS17-Ed1
|
External Assessments, Audits, and Inspections of the Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS18-Ed2
|
Process Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS19-Ed1
|
Customer Focus in a Quality Management System
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS20-Ed2
|
The Cost of Quality in Medical Laboratories
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS21-Ed1
|
Purchasing and Inventory Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS22-Ed1
|
Management of Paper-based and Electronic Laboratory Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS23-Ed2
|
General Laboratory Equipment Performance Qualification, Use, and Maintenance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS24-Ed3
|
Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS25-Ed1
|
Handbook for Developing a Laboratory Quality Manual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS26-Ed1
|
Managing Laboratory Records
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS28-Ed1
|
Laboratory Safety Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QSRLDT-Ed2
|
Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET01-Ed5
|
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET01-Ed5-S-Ed6
|
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET02-Ed4
|
Development of Quality Control Ranges, Breakpoints, and Interpretive Categories for Antimicrobial Agents Used in Veterinary Medicine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET03-Ed2
|
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET04-Ed3
|
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET05-R
|
Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET06-Ed1
|
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET09-Ed1
|
Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET09-Ed2
|
Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings
|
|
|
|
|
|
|
|
|
|
|
|
|
|