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Path of Workflow Crosswalk

A path of workflow is the description of the necessary processes to deliver the particular product or service that the organization or entity provides. A laboratory path of workflow consists of the sequential processes: preexamination, examination, and postexamination and their respective sequential subprocesses. All laboratories follow these processes to deliver their services, namely quality laboratory information.

To view each element of the path of workflow, click “Filter Off” and select from the dropdown options.

Product Code
Title
Examination ordering
Specimen collection
Specimen transport
Specimen receipt, accessioning, and processing
Examination method selection
Examination method performance
Results review and follow-up
Laboratory results interpretation
Comm. of alert values & issuance of prel. reports
Release of final reports
Specimen management
N/A
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
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
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-Ed3
Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
C56A-QG
Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
EP06-Ed2-IG
User Verification of Linearity Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP07-Ed3
Interference Testing in Clinical Chemistry
 
 
 
 
 
 
 
 
 
 
 
EP09-Ed3c
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
 
 
 
 
 
 
 
 
 
 
 
EP10-Ed4
Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
EP10-A3-AMD
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
EP10-Ed3-IG
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP10-Ed4-IG
Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP12-Ed3
Evaluation of Qualitative, Binary Output Examination Performance
 
 
 
 
 
 
 
 
 
 
 
EP12-Ed3-DS
 
 
 
 
 
 
 
 
 
 
 
 
 
EP12-Ed3-IG
Evaluation of Qualitative, Binary Output Examination Performance
 
 
 
 
 
 
 
 
 
 
 
 
EP14-Ed4
Evaluation of Commutability of Processed Samples
 
 
 
 
 
 
 
 
 
 
 
EP15-A3
User Verification of Precision and Estimation of Bias
 
 
 
 
 
 
 
 
 
 
 
EP15-Ed3-IG1
User Verification of Precision Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP15-Ed3-IG2
User Verification of Bias (Trueness) Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP17-Ed2-IG
Evaluation of Detection Capability Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources
 
 
 
 
 
 
 
 
 
 
 
EP18-Ed2-IG
Risk Management Techniques Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP18-Ed2-EP23-Ed2-WS
Laboratory Quality Control Based on Risk Management; Worksheet Template
 
 
 
 
 
 
 
 
 
 
 
 
EP18-A2-EP23-A-WS
Laboratory Quality Control Based on Risk Management; Worksheet Template
 
 
 
 
 
 
 
 
 
 
 
 
EP19-Ed3
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-Ed2-IG
Total Error Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP23-Ed2
Laboratory Quality Control Based on Risk Management
 
 
 
 
 
 
 
 
 
EP23-A-QG
EP23 Quick Reference Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP23-A-WB
Laboratory Quality Control Based on Risk Management; Workbook
 
 
 
 
 
 
 
 
 
 
 
 
EP23-A-WS
Laboratory Quality Control Based on Risk Management; Worksheet Template
 
 
 
 
 
 
 
 
 
 
 
 
EP23-Ed2-QG
EP23 Quick Reference Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP23-Ed2-WB
Laboratory Quality Control Based on Risk Management; Workbook
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
EP26-Ed2-IG
User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
EP28-Ed3-IG
Verification of Reference Intervals in the Medical Laboratory Implementation Guide
 
 
 
 
 
 
 
 
 
 
 
 
EP29-A
Expression of Measurement Uncertainty in Laboratory Medicine
 
 
 
 
 
 
 
 
 
 
 
EP30-Ed2
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine
 
 
 
 
 
 
 
 
 
 
 
EP30-A
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-Ed1-IG
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
 
 
 
 
 
 
 
 
 
 
 
EP34-Ed1-IG
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
 
 
 
 
 
 
 
 
 
 
 
EP36-Ed1
Harmonization of Symbology and Equations
 
 
 
 
 
 
 
 
 
EP37-Ed1
Supplemental Tables for Interference Testing in Clinical Chemistry
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
EP47-Ed1
Evaluation of Reagent Carryover Effects on Test Results
 
 
 
 
 
 
 
 
 
 
 
EPLDT-QG-Ed1
Validating Performance Claims for Laboratory-Developed Tests
 
 
 
 
 
 
 
 
 
 
 
 
MN
Method Navigator
 
 
 
 
 
 
 
 
 
 
 
 
MN v.2
Method Navigator
 
 
 
 
 
 
 
 
 
 
 
 
GP05-A3
Clinical Laboratory Waste Management
 
 
 
 
 
 
 
 
 
 
 
GP05-A3-CL
Waste Management Program – Audit Checklist
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
GP41-Ed7
Collection of Diagnostic Venous Blood Specimens
 
 
 
 
 
GP41-Ed7-QG
Quality Venipuncture Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
GP42-Ed7
Collection of Capillary Blood Specimens
 
 
 
 
 
 
 
 
GP42-A6-QG
Technique for Skin Puncture in Adults and Older Children Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
GP45-A
Studies to Evaluate Patient Outcomes
 
 
 
 
 
 
 
 
 
 
 
 
GP47-Ed1
Management of Critical- and Significant-Risk Results.
 
 
 
 
 
 
 
 
 
 
 
GP47-ES
Critical- and Significant-Risk Laboratory Results: Identification, Reporting, and Management; Executive Summary
 
 
 
 
 
 
 
 
 
 
 
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-Ed6
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays
 
 
 
 
 
H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
 
 
 
 
 
 
 
 
 
 
 
 
H21-A5-QG
H21-A5 Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
H60-A-QG1
Algorithmic Approach to Lupus Anticoagulant Testing
 
 
 
 
 
 
 
 
 
 
 
 
H60-A-QG2
Criteria for the Laboratory Diagnosis of 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/LA28-A2-QG
Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
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-Ed2 v2
Supplemental Data for Allergen Specificity for IgE Antibody Autoanalyzers
 
 
 
 
 
 
 
 
 
 
 
 
FR01-Ed1
Voriconazole Breakpoint for Aspergillus fumigatus
 
 
 
 
 
 
 
 
 
 
 
 
MR01-Ed2
Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.
 
 
 
 
 
 
 
 
 
 
 
MR02-Ed1
Fluoroquinolone Breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa
 
 
 
 
 
 
 
 
 
 
 
MR03-Ed1
Meropenem Breakpoints for Acinetobacter spp.
 
 
 
 
 
 
 
 
 
 
 
 
MR04-Ed1
Azithromycin Breakpoint for Neisseria gonorrhoeae
 
 
 
 
 
 
 
 
 
 
 
 
MR05-Ed1
Ceftaroline Breakpoints for Staphylococcus aureus
 
 
 
 
 
 
 
 
 
 
 
 
MR06-Ed1
Daptomycin Breakpoints for Enterococci
 
 
 
 
 
 
 
 
 
 
 
 
MR07-Ed1
Cefazolin Breakpoints for Enterobacterales for Systemic Infections
 
 
 
 
 
 
 
 
 
 
 
 
MR08-Ed1
Cefazolin Breakpoints for Enterobacterales for Uncomplicated Urinary Tract Infections
 
 
 
 
 
 
 
 
 
 
 
 
MR14-Ed1
Piperacillin-Tazobactam Breakpoints for Enterobacterales
 
 
 
 
 
 
 
 
 
 
 
 
MR15-Ed1
Piperacillin-Tazobactam and P. aeruginosa
 
 
 
 
 
 
 
 
 
 
 
 
BPI Toolkit
BPI Toolkit
 
 
 
 
 
 
 
 
 
 
 
 
M02-Ed14
Performance Standards for Antimicrobial Susceptibility Tests
 
 
 
 
 
 
 
M02-Ed14-QG
Disk Diffusion Reading Guide
 
 
 
 
 
 
 
 
 
 
 
M02QG
Disk Diffusion Reading Guide
 
 
 
 
 
 
 
 
 
 
 
M07-ED12-QG
Minimal Inhibitory Concentration Reading Guide
 
 
 
 
 
 
 
 
 
 
 
 
M07-Ed12
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
 
 
 
 
 
 
 
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-Ed6
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-ED5-S3-Ed1
Procedure for Confirming the Acceptability of Mueller-Hinton Agar Sources for Subsequent Use in CLSI and/or EUCAST Studies to Establish Disk Diffusion QC Ranges
 
 
 
 
 
 
 
 
 
 
 
M23S3-Ed1-WB
Data Collection Workbook for CLSI-EUCAST Mueller-Hinton Agar Acceptability Study
 
 
 
 
 
 
 
 
 
 
 
 
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-Ed2
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
 
 
 
 
 
 
 
M100-Ed34
Performance Standards for Antimicrobial Susceptibility Testing
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
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-Ed2
Microarrays for Diagnosis and Monitoring of Microbial Infections
 
 
 
 
 
 
 
 
MM22-A
Microarrays for Diagnosis and Monitoring of Infectious Diseases
 
 
 
 
 
 
 
MM23-Ed1
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
 
 
 
 
 
 
NBS01-Ed7-QG
Specimen Collection and Specimen Quality for Newborn Screening Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
NBS01OL
Making a Difference Through Newborn Screening: Blood Collection on Filter Paper
 
 
 
 
 
 
 
 
 
 
 
 
NBS02-A2-QG
Newborn Screening Follow-up Process Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
NBS02-Ed3
Newborn Screening Follow-up and Education
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
NBS06-A-QG1
Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
NBS06-A-QG2
Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
NBS10-Ed1
Newborn Screening for Congenital Hypothyroidism
 
 
 
 
 
 
 
 
 
 
 
 
POCT01-A2
Point-of-Care Connectivity
 
 
 
 
 
 
 
 
 
 
 
 
POCT01QG-Ed1
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
 
 
 
 
 
 
 
 
 
 
 
 
POCT08-A-QG1
Corrective Action Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
POCT08-A-QG2
Quality Control Troubleshooting Flow Chart
 
 
 
 
 
 
 
 
 
 
 
 
POCT08-A-QG3
Quality Control Log Sheet Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
POCT09-A
Selection Criteria for Point-of-Care Testing Devices
 
 
 
 
 
 
 
 
 
 
 
 
POCT09-A-WS
Instrument Selection Worksheet
 
 
 
 
 
 
 
 
 
 
 
 
POCT10-A2
Physician and Nonphysician Provider-Performed Microscopy Testing;
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
POCT17-Ed1
Use of Glucose Meters for Critically Ill Patients
 
 
 
 
 
 
 
 
 
 
 
 
POCT18-Ed1
Test Selection Process for CLIA-Waived Complexity Testing for SARS-CoV-2, Respiratory Syncytial Virus, and Influenza
 
 
 
 
 
 
 
 
 
 
 
 
PRE01-Ed1
Patient and Laboratory Specimen Identification Processes
 
 
 
 
 
 
 
 
 
 
 
 
PRE04-Ed1
Handling, Transport, Processing, and Storage of Blood Specimens for Routine Laboratory Examinations
 
 
 
 
 
 
 
 
 
 
 
 
PRE05-Ed1
Urine Specimen Collection
 
 
 
 
 
 
 
 
 
 
 
 
QMS01-Ed5
A Quality Management System Model for Laboratory Services
 
 
 
 
 
 
 
 
 
 
 
 
QMS01-CL
Gap Analysis Checklists, 1st Edition
 
 
 
 
 
 
 
 
 
 
 
 
QMS01-Ed5-es
Un Modelo de Sistema de Gestión de Calidad Para Servicios de Laboratorio
 
 
 
 
 
 
 
 
 
 
 
 
QMS02-Ed7
Quality Management System: Development and Management of Laboratory Documents
 
 
 
 
 
 
 
 
 
 
 
 
QMS02-A6
Quality Managment System: Development and Management of Laboratory Documents
 
 
 
 
 
 
 
 
 
 
 
 
QMS02-Ed7-QG
Quality Venipuncture Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
QMS15-Ed2
Assessments: Laboratory Internal Audit Program
 
 
 
 
 
 
 
 
 
 
 
 
QMS16-Ed1
Laboratory Personnel Management
 
 
 
 
 
 
 
 
 
 
 
 
QMS17-Ed2
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
 
 
 
 
 
 
 
 
 
 
 
 
QMS29-Ed1
Conducting Effective Management Reviews
 
 
 
 
 
 
 
 
 
 
 
 
QSRLDT
Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory
 
 
 
 
 
 
 
 
 
 
 
 
VET01-Ed6
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
 
 
 
 
 
 
 
 
 
 
 
 
VET01-Ed6-S-Ed7
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
 
 
 
 
 
 
 
 
 
 
 
 
VET06-Ed1
Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals
 
 
 
 
 
 
 
 
 
 
 
 
VET09-Ed2
Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings