WARNING: We do not support Internet Explorer. It is not secure and will not work correctly. Please come back using a newer web browser.


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.

Primary
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
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
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-A
Control of Preanalytical 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
 
 
 
 
 
 
 
 
 
 
 
 
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-A
Liquid Chromatography-Mass Spectrometry Methods
 
 
 
 
 
 
 
 
 
 
 
 
C63-Ed1
Laboratory Support for Pain Management Programs
 
 
 
 
 
 
 
 
 
 
 
 
EP05-A3
Evaluation of Precision of Quantitative Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
 
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach
 
 
 
 
 
 
 
 
 
 
 
 
 
EP07-Ed3
Interference Testing in Clinical Chemistry
 
 
 
 
 
 
 
 
 
 
 
 
EP09c-Ed3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
 
 
 
 
 
 
 
 
 
 
 
 
EP10-A3-AMD
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
 
 
 
 
 
 
 
 
 
 
 
EP12-A2
User Protocol for Evaluation of Qualitative Test Performance
 
 
 
 
 
 
 
 
 
 
 
 
 
EP14-A3
Evaluation of Commutability of Processed Samples
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
EP18-A2-EP23-A-WS
Laboratory Quality Control Based on Risk Management; Worksheet Template
 
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
EP23-A
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
 
 
 
 
 
 
 
 
 
 
 
 
 
EP24-A2
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
 
 
 
 
 
 
 
 
 
 
 
 
EP25-A
Evaluation of Stability of In Vitro Diagnostic Reagents
 
 
 
 
 
 
 
 
 
 
 
 
 
EP26-A
User Evaluation of Between-Reagent Lot Variation
 
 
 
 
 
 
 
 
 
 
 
 
 
EP27-A
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays
 
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
EP31-A-IR
Verification of Comparability of Patient Results Within One Health Care System
 
 
 
 
 
 
 
 
 
 
 
 
EP32-R
Metrological Traceability and Its Implementation
 
 
 
 
 
 
 
 
 
 
 
 
EP33-Ed1
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
 
 
 
 
 
 
 
 
 
 
 
 
EP36-Ed1
Harmonization of Symbology and Equations
 
 
 
 
 
 
 
 
 
 
EP37-Ed1
Supplemental Tables for Interference Testing in Clinical Chemistry
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
GP41-Ed7
Collection of Diagnostic Venous Blood Specimens
 
 
 
 
 
 
 
 
 
 
 
 
GP41-Ed7-QG
Quality Venipuncture Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
GP42-Ed7
Collection of Capillary Blood Specimens
 
 
 
 
 
 
 
 
 
 
 
 
GP42-A6-QGE
Technique for Skin Puncture in Adults and Older Children Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
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.
 
 
 
 
 
 
 
 
 
 
 
 
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-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
 
 
 
 
 
 
 
 
 
 
 
 
H47-A2
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-QG
Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant
 
 
 
 
 
 
 
 
 
 
 
 
 
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-A
Supplemental Data for Allergen Specificity for IgE Antibody Autoanalyzers
 
 
 
 
 
 
 
 
 
 
 
 
M02-Ed13
Performance Standards for Antimicrobial Disk Susceptibility Tests
 
 
 
 
 
 
 
 
 
 
 
 
M02QG-Ed1
Disk Diffusion Reading Guide
 
 
 
 
 
 
 
 
 
 
 
 
M07-Ed11
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
 
 
 
 
 
 
 
 
 
 
 
 
M100-Ed30
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
 
 
 
 
 
 
 
 
 
 
 
 
 
M24-Ed3
Susceptibility Testing of Mycobacteria, Nocardiae, 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
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
M39-A4
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
 
 
 
 
 
 
 
 
 
 
 
 
 
M39-A4-QG
Antibiograms: Developing Cumulative Reports for Your Clinicians
 
 
 
 
 
 
 
 
 
 
 
 
 
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-A
Principles and Procedures for Blood Cultures
 
 
 
 
 
 
 
 
 
 
 
 
 
M47-A-QG
Collection, Handling, and Transport for Blood Cultures Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
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-A
Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
M58-Ed1
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
 
 
 
 
 
 
 
 
 
 
 
 
M59-Ed2
Epidemiological Cutoff Values for Antifungal Susceptibility Testing
 
 
 
 
 
 
 
 
 
 
 
 
 
M60-Ed1
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
 
 
 
 
 
 
 
 
 
 
 
 
M61-Ed1
Performance Standards for Nondermatophyte Filamentous Fungi
 
 
 
 
 
 
 
 
 
 
 
 
M62-Ed1
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
 
 
 
 
 
 
 
 
 
 
 
 
MM01-A3
Molecular Methods for Clinical Genetics and Oncology Testing
 
 
 
 
 
 
 
 
 
 
 
 
 
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-A2
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine
 
 
 
 
 
 
 
 
 
 
 
 
 
MM11-A
Molecular Methods for Bacterial Strain Typing
 
 
 
 
 
 
 
 
 
 
 
 
MM12-A
Diagnostic Nucleic Acid Microarrays
 
 
 
 
 
 
 
 
 
 
 
 
MM13-A
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
 
 
 
 
 
 
 
 
 
 
 
 
 
MM13-A-QG
Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
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-A
Microarrays for Diagnosis and Monitoring of Infectious Diseases
 
 
 
 
 
 
 
 
 
 
 
 
MM23-Ed1
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
 
 
 
 
 
 
 
 
 
 
 
 
NBS01-A6
Blood Collection on Filter Paper for Newborn Screening Programs
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS01-A6-DVD
Making a Difference Through Newborn Screening: Blood Collection on Filter Paper
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS01-A6-QG
Specimen Collection and Sample Quality for Newborn Screening Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS02-A2
Newborn Screening Follow-up
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS02-A2-QG
Newborn Screening Follow-up Process Quick Guide
 
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS06-A-WC
Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period
 
 
 
 
 
 
 
 
 
 
 
 
 
NBS07-Ed1
Newborn Blood Spot Screening for Pompe Disease by Lysosomal Acid α-Glucosidase Activity Assays
 
 
 
 
 
 
 
 
 
 
 
 
NBS08-Ed1
Newborn Screening for Hemoglobinopathies
 
 
 
 
 
 
 
 
 
 
 
 
POCT01-A2
Point-of-Care Connectivity