Document Number Document Title Date Note Old Document No.

Automation and Informatics

AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard 2000.12 electric file AUTO1-A
AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard 2005.12 electric file AUTO2-A2
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information
AUTO03-A2 2009.09 electric file AUTO03-A2
Systems; Approved Standard-Second Edition
AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard 2001.03 electric file AUTO4-A
AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard 2001.03 electric file AUTO5-A
AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard 2004.06 electric file AUTO7-A
AUTO8-A Managing and Validation Laboratory Information Systems; Approved Guideline 2006.12 紙本 AUTO8-A
AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard 2006.03 紙本 AUTO9-A
AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideling 2006.10 紙本 AUTO10-A
AUTO11-A IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard 2006.10 紙本 AUTO11-A
AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard 2011.04 electric file AUTO12-A
AUTO13-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Va 2003.02 electric file GP19-A2
LIS1-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer S 2003.04 electric file LIS1-A
LIS2-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-S 2004.10 electric file LIS2-A2
LIS3-A Standard Guide for Selection of a Clinical Laboratory Information Management System 2003.04 electric file LIS3-A
LIS4-A Standard Guide for Documentation of Clinical Laboratory Computer Systems 2003.04 electric file LIS4-A
LIS5-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems 2003.04 electric file LIS5-A
LIS6-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems 2003.04 electric file LIS6-A
LIS7-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory 2003.04 electric file LIS7-A
LIS8-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems 2003.04 electric file LIS8-A
LIS9-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked2003.04
Architectures
electric file LIS9-A
Clinical Chemistry and Toxicology
C24 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, Fourth Edition 2016.09 electric file C24-A3
C29-A2 Standardization of Sodium and Potassium Ion-selective Electrode Systems to the Flame Photometric Reference Method; Approv 2000.10 electric file C29-A2
C30-A2 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline —Second Edition 2002.08 electric file C30-A2
C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline.--Se 2001.06 electric file C31-A2
C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition 2009.12 electric file C34-A3
C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Meas 1999.11 electric file C37-A
C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline 1997.09 electric file C38-A
C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard 2000.04 electric file C39-A
C40-A Analytical Procedures for the Determination of Lead in Blood and Urine; Approved Guideline 2001.06 electric file C40-A
C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline 1996.11 electric file C42-A
C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline-Second Edition 2010.03 electric file C43-A2
C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline 2002.12 electric file C44-A
C45-A Measurement of Free Thyroid Hormones; - Approved Guideline 2004.10 electric file C45-A
C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline-Second Edition 2009.02 electric file C46-A2
C48-A Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guidelin 2004.07 electric file C48-A
C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guide 2012.07 electric file C56-A
 C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guildeline 2011.11 electric file C58-A
C59-A Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline 1997.09 electric file ILA15-A
C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline 1997.09 electric file TDM6-A
C61-A Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard 1998.12 electric file H17-A
TDM8-A Urine Drug Testing in the Clinical Laboratory; Approved Guideline 1999.02 electric file TDM8-A
General Laboratory
GP5-A3 Clinical Laboratory Waste Management; Approved Guideline-Third Edition 2011.01 electric file GP5-A3
GP6-A Inventory Control Systems for Laboratory Supplies; Approved Guideline 1994.02 electric file GP6-A
GP10-A Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guide 1995.12 electric file GP10-A
GP11-A Basic Cost Accounting for Clinical Services; Approved Guideline 1998.11 electric file GP11-A
GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline 1996.06 electric file GP14-A
GP15-A3 Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline-Third Edition 2008.11 electric file GP15-A3
GP16-A3 Urinalysis; Approved Guideline-Third Edition 2009.02 electric file GP16-A3
GP17-A3 Clinical Laboratory Safety; Approved Guideline-Third Edition 2012.06 electric file GP17-A3
GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition 2003.10 electric file GP20-A2
GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline 1999.08 electric file GP23-A
GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline- Second Edition 2007.02 紙本 GP27-A2
GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline 2005.02 electric file GP28-A
GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline-Second Edition 2008.08 electric file GP29-A2
GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline 2009.04 electric file GP31-P
GP33-A Accuracy in Patient and Sample Identification; Approved Guideline 2010.03 electric file GP33-A
GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline 2010.12 electric file GP34-A
GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline 2014.12 electric file
GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition 2010.12 electric file H01-A6
GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline-Fourth Edition 2006.06 紙本 C3-A4
GP41 Collection of Diagnostic Venous Blood Specimens, Seventh Edition 2017.04 electric file GP41-A6
GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard-Sixth Edition 2008.09 electric file H04-A6
GP43-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard-Fourth Edition 2004.09 electric file H11-A4
GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline - Fourth Ed 2010.05 electric file H18-A4
GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline 2004.10 electric file HS6-A
GP46-R Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report 2003.10 electric file X4-R
Hematology
H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard-Fifth Edition 2011.05 electric file H02-A5
H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method-Third Edition; Approved Standard 2000.10 electric file H7-A3
H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Editi 2000.12 electric file H15-A3
H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard- Se 2007.01 紙本 H20-A2
H21-A4 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline - 2003.12 electric file H21-A4
H22-P Histochemical Method for Leukocyte Alkaline Phosphatase 1984.10 electric file H22-P
H26-A2 Validation, Verification, and Quality Assurance fo Automated Hematology Analyzers; Approved Standard - Second Edition 2010.06 electric file H26-A2
H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline-Second Edition 2001.11 electric file H30-A2
H38-P Calibration and Quality Control of Automated Hematology Analyzers; Proposed Standard 1999.04 electric file H38-P
 H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline-Second Edition 2007.05 紙本 H42-A2
H43-A Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells; Approved Guideline 1998.06 electric file H43-A
H44-A2 Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guidelin 2004.02 electric file H44-A2
H45-A2 Performance of the Bleeding Time Test; Approved Guideline 2005.06 electric file H45-A2
H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline-Second Ed 2008.05 electric file H47-A2
H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline 2002.09 electric file H51-A
H52-A Fetal Red Cell Detection; Approved Guideline 2001.12 electric file H52-A
H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline 2005.08 electric file H54-A
H56-A Studies to Evaluate Patient Outcomes; Approved Guideline 2004.10 electric file H56-A
H58-A Platelet Function Testing by Aggregometry; Approved Guideline 2008.11 electric file H58-A
H59-P Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Propose Guideline 2010.06 electric file H59-P
H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline 2011.03 electric file H59-A
Immunology and Ligand Assay
I/LA2-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flucorescence Assay for Microsc 2006.03 紙本 I/LA2-A2
ILA6-A Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Product 1997.10 electric file ILA6-A
ILA18-A2 Specifications for Immunological Testing for Infectious Diseases; Approved Guideline - Second Edition 2001.09 electric file ILA18-A2
ILA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antig 1997.06 electric file ILA19-A
I/LA20-A2 Analytical Performance Characteristics and Clinical Utlilty of Immunological Assays for Human Immunoglobulin E (IgE) Antibo 2009.03 electric file I/LA20-A2
I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline-Second Edition 2008.08 electric file I/LA21-A2
ILA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoas 2004.05 electric file ILA23-A
ILA24-A Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline 2004.08 electric file ILA24-A
ILA25-A2 Maternal Serum Screening; Approved Standard-Second Edition 2011.04 electric file ILA25-A2
ILA26-A Performance of Single Cell Immune Response Assays; Approved Guideline 2004.10 electric file ILA26-A
I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Editi 2011.01 electric file I/LA28-A2
I/LA29-A Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline 2008.08 electric file I/LA29-A
I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline 2009.12 electric file I/LA33-A
I/LA34-A Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guidel 2011.06 electric file I/LA34-A
MM4-A Quality Assurance for Immunocytochemistry; Approved Guideline 1999.12 electric file MM4-A
Method Evaluation
EP5-A2 Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline-Second Edition 2004.08 electric file EP5-A2
EP6-A Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline 2003.04 electric file EP6-A
EP7-A2 Interference Testing in Clinical Chemistry; Proposed Guideline 2005.11 electric file EP7-A2
EP9-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Third Edition 2013.08 electric file EP9-A2-IR
EP10-A2 Preliminary Evaluation of Quantitative Clinical Laboratory Methods - Approved Guideline-Second Edition 2002.12 electric file EP10-A2
EP12-A User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline 2002.08 electric file EP12-A
EP13-R Laboratory Statistics - Standard Deviation; A Report 1995.08 electric file EP13-R
EP14-A2 Evaluation of Matrix Effects; Approved Guideline 2005.01 electric file EP14-A2
EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition 2012.06 electric file EP17-A2
EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline-Second Edition 2009.11 electric file EP18-A2
EP19-R A Framework for NCCLS Evaluation Protocols; A Report 2002.06 electric file EP19-R
EP19, 2nd ed. A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures 2015.01 electric file
EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline 2003.04 electric file EP21-A
 EP22-P Presentation of a Manufacturer's Risk Mitigation Information for Users of In Vitro Diagnostic Devices; Proposed Guideline 2010.04 electric file EP22-P
EP23-A Laboratory Quality Control Based on Risk Managemant; Approved Guideline 2011.10 electric file EP23-A
EP23-A-WB A Practical Guide for Laboratory Quality Control Based on Risk Management 2011.10 electric file
EP23-A-WS A Sample form for Laboratory Quality Control Based on Risk Management 2011.10 electric file
EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideli 2011.11 electric file EP24-A2
EP25-P Evaluation of Stability of In Vitro Diagnostic Method Products; Proposed Guideline 2008.12 electric file EP25-P
EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline 2012.09 electric file EP27-A
EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guiedline-Third Edition 2010.10 electric file C28-A3c
EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline 2012.01 electric file C51-A
EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline 2010.05 electric file C53-A
EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline（Interim Revision） 2012.08 electric file C54-A-IR
EP32-R Metrological Traceabikity and Its Implementation; A Report we don't have X05-R
EP36, 1st ed. Harmonixation of Symbology and Equations 2015.06 electric file
Microbiology
M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Twelfth Edition 2015.01 electric file M02-A12
M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard-Second Edition 2006.01 紙本 M6-A2
M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerbically; Approved Standard-Tenth Edition 2015.01 electric file M07-A10
M11-A8 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition 2012.02 electric file M11-A8
M11-S1 Performance Standards for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Informational Supplement 2009.12 electric file M11-S1
M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline 2000.06 electric file M15-A
M21-A Methodology for the Serum Bactericidal Test; Approved Guideline 1999.09 electric file M21-A
M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition 2004.06 electric file M22-A3
M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline-Third Edition 2008.10 electric file M23-A3
M24-A2 Susceptibility Testing of Mycobacteria, Nocardia, and Other Aerobic Actinomycetes; Approved Standard-Second Edition 2011.03 electric file M24-A2
M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline 1999.09 electric file M26-A
M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Third Edition 2008.04 electric file M27-A3
M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement 2012.12 electric file M27-S4
M28-A2 Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline 2005.06 electric file M28-A2
M29-A4 Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Fourth Edition 2014.05 electric file
M32-P Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline 2001.12 electric file M32-P
M33-A Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard 2004.02 electric file M33-A
M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline 2000.10 electric file M34-A
M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline-Second Edition 2008.11 electric file M35-A2
M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline 2004.02 electric file M36-A
M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard-Second Editio 2008.04 electric file M38-A2
M39-A3 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline-Third Edition 2009.02 electric file M39-A3
M40-A Quality Control of Microbiological Transport Systems; Approved Standard 2003.12 electric file M40-A
M43-A Methods for Antimicrobial Susceptibility Testing for Hurman Mycoplasmas; Approved Guideline 2011.10 electric file M43-A
M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition 2009.08 electric file M44-A2
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and
M44-S3 2009.12 electric file M44-S3
Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved G 2010.08 electric file M45-A2
 M47-A Principles and Procedures for Blood Cultures; Approved Guideline 2007.05 紙本 M47-A
M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline 2008.05 electric file M48-A
M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline 2008.08 electric file M50-A
M51-A Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline 2010.05 electric file M51-A
M51-S1 Performance Standards for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Informat 2010.05 electric file M51-S1
M53-A Criteria for Laboratory Testing and Diagnosis of Human ImmunodeficiencyVirus Infection; Approved Guideline 2011.06 electric file M53-A
M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens- Direct Examination and Culture; Approved Guideline 2012.10 electric file M54-A
M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement 2015.01 electric file M100-S25
LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; A 2008.04 electric file LIS01-A2
M100-S27 Performance Standards for Antimicrobial Susceptibility Testing; Twenty Seventh Edition 2017.02 electric file M100-S27
Molecular Methods
MM1-A3 Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline-Third Edition 2012.05 electric file MM1-A3
MM2-A2 Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays; Approved Guideline—Second Edition 2002.08 electric file MM2-A2
MM3-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideling-Second Edition 2006.02 紙本 MM3-A2
MM5-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline-Second Edition 2012.03 electric file MM5-A2
MM6-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline-Second Edition 2010.11 electric file MM6-A2
MM7-A Fluorescence In Situ Hybridization (FISH) Methods for Medical Genetics; Approved Guideline 2004.01 electric file MM7-A
MM9-A Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 2004.12 electric file MM9-A
MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline 2006.02 紙本 MM10-A
MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline 2006.05 紙本 MM12-A
MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular methods; Approved Guideline 2005.12 electric file MM13-A
MM14-A Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline 2005.08 electric file MM14-A
MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline 2006.08 紙本 MM16-A
MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline 2008.04 electric file MM18-A
MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline 2011.11 electric file MM19-A
Newborn Screening
NBS01-A5 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard-Fifth Edition 2007.07 紙本 LA4-A5
NBS02-A5 Newborn Screening Follow-up; Approved Guideline 2006.05 紙本 I/LA27-A
NBS03-A Newborn Screening Guidelines for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline 2009.10 electric file I/LA31-A
NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline 2010.07 electric file I/LA32-A
NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline 2011.11 electric file I/LA35-A
NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; 2014.04 electric file
Point-of-Care Testing
AST2-A Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline 1999.06 electric file AST2-A
AST3-A Wellness Testing Using IVD Devices; Approved Guideline 1999.02 electric file AST3-A
POCT1-A Point-of-Care Connectivity; Approved Standard 2001.12 electric file POCT1-A
POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline 2008.05 electric file POCT02-A
POCT4 Essential Tools for Implementation and Management of a Point-of-Care Testing Program, Third Edition 2016.06 electric file POCT4-A2
POCT05-A Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline 2008.12 electric file POCT05-P
POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline 2010.10 electric file POCT07-P
POCT08-P Quality Practices in Noninstrumented Nearpatient Testing : An Instructional Manual and Resources for Health Care Workers; Pr 2009.10 electric file POCT08-P
 POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing : An Instructional Manual and Resources for Health Care Workers; 2010.12 electric file POCT08-A
POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline 2010.04 electric file POCT09-P
POCT10-A2 Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline-Second Edition 2011.12 electric file POCT10-A2
POCT11-A2 Pulse Oximetry; Approved Guideline-Second Edition 2011.04 electric file POCT11-A2
POCT12-A3 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline —Third Edition 2013.01 electric file POCT12-A3
POCT13-A2 Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline 2005.05 electric file AST4-A2
POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline 2004.07 electric file H49-A
Quality Management Systems
QMS01-A4 Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition 2011.06 electric file GP26-A4
QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline-Sixth Edition 2013.02 electric file QMS02-A6
QMS03 Training and Competence Assessment; Approved Guideline, Fourth Edition 2016.11 electric file QMS03-A3
QMS04-A2 Laboratory Design; Approved Guideling - Second Edition 2007.02 紙本 GP18-A2
QMS05-A2 Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory; Approved Guideline-Second Edition 2012.09 electric file GP09-A2
QMS06-A3 Quality Management System: Continual Improvement; Approved Guideline-Third Edition 2011.06 electric file GP22-A3
QMS07-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guideline-Second Edition 2006.05 紙本 HS4-A2
QMS08-A2 Application of a Quality Management System Model for Medical Imaging Services; Approved Guideling-Second Edition 2006.05 紙本 HS5-A2
QMS09-A2 Application of a Quality Management System Model for Inpatient Medication Use; Approved Guideline-Second Edition 2006.05 紙本 HS10-A2
QMS10-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline 2005.12 electric file HS11-A
QMS12-A Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Approved Guidelin 2010.12 electric file GP35-A
QMS13-A Quality Management System: Equipment; Approved Guideline 2011.08 electric file GP37-A
QMS14-A Quality Management System: Leadership and Management Roles and Responsibilities; Approved Quideline 2012.12 electric file GP38-A
QMS14-AES Quality Management System: Leadership and Management Roles and Responsibilities; Executive Summary 2013.01 electric file GP38-AES
QMS15-A Assessments : Laboratory Internal Audit Program; Approved Guideline 2013.12 electric file
Veterinary Medicine
VET-A2 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved 2002.05 electric file M31-A2
M31-S1 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Informatio 2004.05 electric file M31-S1
VET02-A2 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; A 2002.05 electric file M37-A2
VET03/VET04-S1 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; First Informational 2010.06 electric file M42/M49-S1
VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guidline 2006.06 紙本 M42-A
VET04-A Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideling 2006.06 紙本 M49-A
No.
Volume Number Page (ASCP LABMEDICINE) Title
40 5 257-320 Role of the Genomics Revolution in Pharmaceutics
40 6 321-384 Utility of Serum Free Light Chain Analysis When Screening for Lymphoproliferative Disorder
40 7 385-488 Developing a Standard Protocol for the Introduction of New Testing Into a Clinical Laborator
40 8 449-512 Is it Necessary to Repeat Critical Values in the Laboratory?
40 9 513-576 Use of Laboratory Robots for Transport and Delivery of Blood Products
40 10 577-640 An Example of How Rural Clinical Laboratories Can Introduce HIV Testing Cost Effectively
40 11 641-704 Cartilage Oligomeric Metrix Protein, Monoclonal Antibody Drugs, and Rheumatoid Arthritis
Evaluation of the Performance of the Sysmex XT-2000i Hematology Analyzer With Whole
40 12 705-768 Blood Specimens Stored at Room Temperature
41 1 1-64 The Novel H1N1 Outbreak: Lessons Learned
41 2 65-128 Isolation of a Novel Nanobody Against HER-2/ neu
41 3 129-192 Measuring Protein Expression in Tissue
41 4 193-256 Anaerobic Adenosine-Triphosphate and Chronic Lymphocytic Leukemia
41 5 257-320 Artefactually Low Hemoglobin A1c in a Patient with Hemolytic Anemia
Progression of a Recurrent Community-Acquired Methicillin-Resistant Staphylococcus
41 6 321-384 aureus (MRSA) Infection
41 7 385-448 Heterogeneous Muscular Involvement in Inclusion Body Myositis
41 8 449-512 Is Dextromethorphan a Concern for Causing a False Positive During Urine Drug Screening?
41 9 513-576 Molecular diagnostics of Human Papillomavirus
41 10 577-640 Intestinal Helminthes in Dewormed and Non-Dewormed Students
41 11 641-704 A Review of Acinetobacter baumannii as a Highly Successful Pathogen in Times of War
41 12 705-768 Unique Profile of Adenoid Cystic Carcinoma: A Triple Negative Breast Tumor With Paradoxic
42 2 65-128 Using N-Terminal-Pro-B-Type Natriuretic Peptide to Identify Pediatric Patients with Congenit
42 3 129-192 American Society for Clinical Pathology's 2010 Wage Survey of U.S. Clinical Laboratories
42 4 193-256 American Society for Clinical Pathology's 2011 Vacancy Survey of U.S. Clinical Laboratories
42 5 257-320 Molecular Diagnostics and Active Screening for Health Care-Associated Infections: Steppin
42 6 321-384 Absolute Quantitation of Different Genotypes of Hepatitis C Virus RNA in Clinical Sample
42 7 385-448 Gaining Efficiency in the Laboratory-Automated Body Fluid Cell Counts
42 9 513-576 Third-Generation HIV Antibody Assays and Fourth-Generation Abbott HIV Ag/Ab Combo Te
42 10 577-640 Digital Pathology: A Regulatory Overview
42 11 641-703 New Contrast Stain for the Rapid Diagnosis of Dermatophytosis and Pityriasis Versicolor
42 12 705-768 Setting Up a Processing Laboratory to Support Multi-center HIV/AIDS Vaccine and Interventi
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