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