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C39* A Designated Comparison Method for theMeasurement of Ionized Calcium in Serum,1st EditionItem Order Code: C39AEC40 Measurement Procedures for theDetermination of Lead Concentrations in Blood andUrine, 2nd EditionItem Order Code: C40A2C42* Erythrocyte Protoporphyrin Testing,1st EditionItem Order Code: C42AEC43* Gas Chromatography/Mass SpectrometryConfirmation of Drugs, 2nd EditionItem Order Code: C43A2EC45* Measurement of Free Thyroid Hormones,1st EditionItem Order Code: C45AEC46 Blood Gas and pH Analysis and RelatedMeasurements, 2nd EditionItem Order Code: C46A2C48* Application of Biochemical Markers of BoneTurnover in the Assessment and Monitoring of BoneDiseases, 1st EditionItem Order Code: C48AEC49 Analysis of Body Fluids in Clinical Chemistry,2nd EditionItem Order Code: C49Ed27 C50* Mass Spectrometry in the Clinical Laboratory:General Principles and Guidance, 1st EditionItem Order Code: C50AEC52 Toxicology and Drug Testing in the ClinicalLaboratory, 3rd EditionItem Order Code: C52Ed3C56* Hemolysis, Icterus, and Lipemia/TurbidityIndices as Indicators of Interference in ClinicalLaboratory Analysis, 1st EditionItem Order Code: C56AEC57 Mass Spectrometry for Androgen andEstrogen Measurements in Serum, 1st EditionItem Order Code: C57Ed1C58* Assessment of Fetal Lung Maturity by theLamellar Body Count, 1st EditionItem Order Code: C58AEC61* Determination of Serum Iron, Total IronBinding Capacity and Percent Transferrin Saturation,1st EditionItem Order Code: C61AEC62* Liquid Chromatography-Mass SpectrometryMethods, 1st EditionItem Order Code: C62AEC63 Laboratory Support for Pain ManagementPrograms, 1st EditionItem Order Code: C63Ed1ORDER TODAY: Toll Free (US): 877.447.1888 1.610.688.0100 www.clsi.org customerservice@clsi.org

General LaboratoryDocument PricingNonmembers: 180Level III Members: 90Level I Members: 54Individual Full Members: 135Level II Members: 72Individual Associate Members: 153* Available as PDF download only.Documents listed in gray are no longer being reviewed as part of our consensus process.Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.Featured DocumentsGP33 Accuracy in Patient and Sample Identification, 2nd Edition2nd EditionGP33Accuracy in Patient and SpecimenIdentificationThe processes required by regulatory bodies for ensuring accurate patient and specimenidentification are covered in GP33. Invaluable guidance on bar-code system implementationand user training is included.This standard specifies the processes required to ensure accuratepatient and specimen identification in manual and electronicsystems across the health care organization. Processes includesystem design considerations, differences in requirements forpatients with or without identification bands, and provisions forpatients with communication barriers.A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.1st EditionGP49Developing and Managing a MedicalLaboratory (Test) Utilization ManagementProgramGP49 Developing and Managing a Medical Laboratory (Test) Utilization ManagementProgram, 1st EditionEliminate unnecessary testing and focus on performing appropriate tests that improve qualityand outcomes. Learn about implementing a test utilization management program in your labwith GP49.This report provides guidance for initiating, developing, andmaintaining an effective test utilization program.A CLSI report for US application.GP05* Clinical Laboratory Waste Management,3rd EditionItem Order Code: GP05A3EGP20* Fine Needle Aspiration Biopsy (FNAB)Techniques, 2nd EditionItem Order Code: GP20A2EGP15* Cervicovaginal Cytology Based on thePapanicolaou Technique, 3rd EditionItem Order Code: GP15A3EGP23* Nongynecological Cytology Specimens:Preexamination, Examination, and PostexaminationProcesses, 2nd EditionItem Order Code: GP23A2EGP16 Urinalysis, 3rd EditionItem Order Code: GP16A3GP17 Clinical Laboratory Safety, 3rd EditionItem Order Code: GP17A3COVID-19 Related8 CLSI Catalog 2020GP33 Accuracy in Patient and SampleIdentification, 2nd EditionItem Order Code: GP33Ed2COVID-19 Related

GP34 Validation and Verification of Tubes forVenous and Capillary Blood Specimen Collection,1st EditionItem Order Code: GP34AGP44 Procedures for the Handling and Processingof Blood Specimens for Common Laboratory Tests,4th EditionItem Order Code: GP44A4COVID-19 RelatedGP36* Planning for Laboratory Operations During aDisaster, 1st EditionItem Order Code: GP36AECOVID-19 RelatedFree for a limited time.GP45* Studies to Evaluate Patient Outcomes,1st EditionItem Order Code: GP45AEGP39* Tubes and Additives for Venous andCapillary Blood Specimen Collection, 6th EditionItem Order Code: GP39A6EGP40 Preparation and Testing of Reagent Water inthe Clinical Laboratory, 4th EditionItem Order Code: GP40A4AMDGP41 Collection of Diagnostic Venous BloodSpecimens, 7th EditionItem Order Code: GP41Ed7COVID-19 RelatedGP47 Management of Critical- and Significant-RiskResults, 1st EditionItem Order Code: GP47Ed1GP48 Essential Elements of a Phlebotomy TrainingProgram, 1st EditionItem Order Code: GP48Ed1GP49 Developing and Managing a MedicalLaboratory (Test) Utilization Management Program,1st EditionItem Order Code: GP49Ed1GP42 Procedures and Devices for the Collection ofDiagnostic Capillary Blood Specimens, 6th EditionItem Order Code: GP42A6Did you know?Through our Partnerships program, CLSI provides international outreach servicesand hands-on support to laboratories throughout the world, helping them achievesustainable quality with systems to better diagnose and treat patients withinfectious diseases.See where we work and how we can help your laboratory at clsi.org/global-training.9 ORDER TODAY: Toll Free (US): 877.447.1888 1.610.688.0100 www.clsi.org customerservice@clsi.org

HematologyDocument PricingNonmembers: 180Level III Members: 90Level I Members: 54Individual Full Members: 135Level II Members: 72Individual Associate Members: 153* Available as PDF download only.Documents listed in gray are no longer being reviewed as part of our consensus process.Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.Featured Documents2nd EditionH48Determination of Coagulation FactorActivities Using the One-Stage Clotting AssayH48 Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2ndEditionQuantitative assays for measuring coagulant activity are important laboratory tools. Enhancethe precision and accuracy of patient clotting factor assay results with H48.This guideline provides recommendations regarding the propercollection and handling of specimens, reagents, controls,calibrators, and materials needed to optimize factor assay testing.It includes recommendations for good laboratory practices relatedto analyzer and reagent performance, reference intervals, lot-tolot validation, and quality control. Assay limitations and sources oferrors and variability are also included.A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.H52 Red Blood Cell Diagnostic Testing Using Flow Cytometry, 2nd EditionMarch 2014H52-A2Red Blood Cell Diagnostic TestingUsing Flow Cytometry; ApprovedGuideline—Second EditionThis guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescencebased assays on a flow cytometry platform. Points of validation and quality control, andcaveats of interpretation are also discussed.This guideline addresses the diagnostic red blood cell (RBC) assaysperformed as fluorescence-based assays on a flow cytometryplatform; including testing procedures for fetomaternal hemorrhagedetection, paroxysmal nocturnal hematuria screening, membranedefect anemia testing for hereditary spherocytosis, and nucleatedRBC counting. Points of validation and quality control, and caveats ofinterpretation are also discussed.A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.H02* Procedures for the ErythrocyteSedimentation Rate Test, 5th EditionItem Order Code: H02A5EH07* Procedure for Determining Packed CellVolume by the Microhematocrit Method, 3rd EditionItem Order Code: H07A3EH15* Reference and Selected Procedures for theQuantitative Determination of Hemoglobin inBlood, 3rd EditionItem Order Code: H15A3E10 CLSI Catalog 2020H20* Reference Leukocyte (WBC) DifferentialCount (Proportional) and Evaluation of InstrumentalMethods, 2nd EditionItem Order Code: H20A2EH21 Collection, Transport, and Processing of BloodSpecimens for Testing Plasma-Based CoagulationAssays and Molecular Hemostasis Assays,5th EditionItem Order Code: H21A5H26* Validation, Verification, and QualityAssurance of Automated Hematology Analyzers,2nd EditionItem Order Code: H26A2

H30* Procedure for the Determination ofFibrinogen in Plasma, 2nd EditionItem Order Code: H30A2EH56* Body Fluid Analysis for Cellular Composition,1st EditionItem Order Code: H56AEH42* Enumeration of Immunologically Defined CellPopulations by Flow Cytometry, 2nd EditionItem Order Code: H42A2EH57* Protocol for the Evaluation, Validation, andImplementation of Coagulometers, 1st EditionItem Order Code: H57AEH43* Clinical Flow Cytometric Analysis ofNeoplastic Hematolymphoid Cells, 2nd EditionItem Order Code: H43A2EH58* Platelet Function Testing by Aggregometry,1st EditionItem Order Code: H58AEH47* One-Stage Prothrombin Time (PT) Test andActivated Partial Thromboplastin Time (APTT) Test,2nd EditionItem Order Code: H47A2EH59 Quantitative D-dimer for the Exclusion ofVenous Thromboembolic Disease, 1st EditionItem Order Code: H59AH48 Determination of Coagulation FactorActivities Using the One-Stage Clotting Assay,2nd EditionItem Order Code: H48Ed2H60 Laboratory Testing for the LupusAnticoagulant, 1st EditionItem Order Code: H60AH52 Red Blood Cell Diagnostic Testing Using FlowCytometry, 2nd EditionItem Order Code: H52A2H54* Procedures for Validation of INR and LocalCalibration of PT/INR Systems, 1st EditionItem Order Code: H54AEDid you know you can create a custom solution packagefor your lab?Custom 5-Document PackageSelect Any 5 DocumentsNonmembers: 800Custom 10-Document PackageSelect Any 10 DocumentsNonmembers: 1,530Simply fill out our online form for a custom quote request or contact customerservice to order your custom document package today. Member rates apply.11 ORDER TODAY: Toll Free (US): 877.447.1888 1.610.688.0100 www.clsi.org customerservice@clsi.org

Immunology and Ligand AssayDocument PricingNonmembers: 180Level III Members: 90Level I Members: 54Individual Full Members: 135Level II Members: 72Individual Associate Members: 153* Available as PDF download only.Documents listed in gray are no longer being reviewed as part of our consensus process.Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.Featured Documents3rd EditionI/LA20Analytical Performance Characteristics,Quality Assurance, and Clinical Utilityof Immunological Assays for HumanImmunoglobulin E Antibodies of DefinedAllergen SpecificitiesI/LA20 Analytical Performance Characteristics, Quality Assurance, and Clinical Utilityof Immunological Assays for Human Immunoglobulin E Antibodies of Defined AllergenSpecificities, 3rd EditionGive your laboratory staff the guidance they need for the clinical application of laboratoryassays used in the measurement of human IgE.This report provides guidance for the design, analyticalperformance, standardization, quality assurance, and clinicalapplication of laboratory assays used in the measurementof human immunoglobulin E antibodies of defined allergenspecificity.A CLSI report for global application.I/LA26 Performance of Single Cell Immune Response Assays, 2nd EditionNovember 2013I/LA26-A2Performance of Single Cell Immune ResponseAssays; Approved Guideline—Second EditionLearn about methods for intracellular cytokine evaluation, major histocompatibility complexmultimer quantitation, and enzyme-linked immunospot technology for the assessment ofcellular proliferation with I/LA26.This document contains methods of intracellular cytokineevaluation, major histocompatibility complex multimerquantitation, enzyme-linked immunospot technology, andcarboxyfluorescein succinimidyl ester tracking dye staining forthe assessment of cellular proliferation. It also provides basicaspects of specimen collection, transport, and preparation;results interpretation; and quality assurance and test validationapproaches.A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.I/LA02* Quality Assurance of Laboratory Tests forAutoantibodies to Nuclear Antigens: (1) IndirectFluorescence Assay for Microscopy and (2) MicrotiterEnzyme Immunoassay Methods, 2nd EditionItem Order Code: ILA02A2EI/LA20 Analytical Performance Characteristics,Quality Assurance, and Clinical Utility ofImmunological Assays for Human ImmunoglobulinE Antibodies of Defined Allergen Specificities,3rd EditionItem Order Code: ILA20Ed312 CLSI Catalog 2020I/LA20S (I/LA37)* Analytical PerformanceCharacteristics and Clinical Utility of ImmunologicalAssays for Human Immunoglobulin E (IgE)Antibodies and Defined Allergen Specificities,1st EditionItem Order Code: ILA37Ed1EThis supplement is 80 for nonmembers.I/LA21* Clinical Evaluation of Immunoassays,2nd EditionItem Order Code: ILA21A2E

I/LA23* Assessing the Quality of ImmunoassaySystems: Radioimmunoassays and Enzyme,Fluorescence, and Luminescence Immunoassays,1st EditionItem Order Code: ILA23AEI/LA25* Maternal Serum Screening, 2nd EditionItem Order Code: ILA25A2EI/LA26 Performance of Single Cell ImmuneResponse Assays, 2nd EditionItem Order Code: ILA26A2I/LA28* Quality Assurance for Design Control andImplementation of Immunohistochemistry Assays,2nd EditionItem Order Code: ILA28A2EI/LA30* Immunoassay Interference by EndogenousAntibodies, 1st EditionItem Order Code: ILA30AEI/LA33* Validation of Automated Systemsfor Immunohematological Testing BeforeImplementation, 1st EditionItem Order Code: ILA33AEI/LA34* Design and Validation of Immunoassaysfor Assessment of Human Allergenicity of NewBiotherapeutic Drugs, 1st EditionItem Order Code: ILA34AECalling All VolunteersCLSI offers unmatched opportunity to maximize your voice in the global laboratoryand health care community. Work alongside colleagues and experts from diversesectors to improve patient care worldwide.Visit clsi.org/getinvolved for more information.13 ORDER TODAY: Toll Free (US): 877.447.1888 1.610.688.0100 www.clsi.org customerservice@clsi.org

Method EvaluationDocument PricingNonmembers: 180Level III Members: 90Level I Members: 54Individual Full Members: 135Level II Members: 72Individual Associate Members: 153* Available as PDF download only.Documents listed in gray are no longer being reviewed as part of our consensus process.Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.Featured Documents1st EditionEP34EP34 Establishing and Verifying an Extended Measuring Interval Through Specimen Dilutionand Spiking, 1st EditionEstablish, validate, or verify a dilution scheme that will provide an extended measuringinterval for specimens with concentrations above the analytical measuring interval of an invitro diagnostic measurement procedure.Establishing and Verifying an ExtendedMeasuring Interval Through SpecimenDilution and SpikingIt is often medically necessary to provide results for specimenswith concentrations above the analytical measuring interval ofan in vitro diagnostic measurement procedure. This guidelinehelps manufacturers and laboratory scientists with establishing,validating, or verifying a dilution scheme that will provide anextended measuring interval for such specimens.A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.1st EditionEP35Assessment of Equivalence or Suitabilityof Specimen Types for Medical LaboratoryMeasurement ProceduresThis guideline provides recommendations for assessing clinicallyequivalent performance for additional similar-matrix specimentypes and suitable performance for dissimilar-matrix specimentypes, such that the laboratory does not necessarily need torepeat the full measurement procedure validation for eachspecimen type. The recommendations in this guideline applyto both quantitative measurement procedures and qualitativeexaminations.EP35 Assessment of Equivalence or Suitability of Specimen Types for Medical LaboratoryMeasurement Procedures, 1st EditionThis guideline provides recommendations for assessing clinically equivalent performancefor additional similar-matrix specimen types and suitable performance for dissimilar-matrixspecimen types, such that the laboratory does not necessarily need to repeat the fullmeasurement procedure validation for each specimen type. The recommendations in thisguideline apply to both quantitative measurement procedures and qualitative examinations.A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.EP05 Evaluation of Precision of QuantitativeMeasurement Procedures, 3rd EditionItem Order Code: EP05A3COVID-19 RelatedEP06* Evaluation of the Linearity of QuantitativeMeasurement Procedures: A Statistical Approach,1st EditionItem Order Code: EP06AECOVID-19 RelatedEP07 Interference Testing in Clinical Chemistry,3rd EditionItem Order Code: EP07Ed3COVID-19 Related14 CLSI Catalog 2020EP07S (EP37)* Supplemental Tables for InterferenceTesting in Clinical Chemistry, 1st EditionItem Order Code: EP37Ed1EThis supplement is 80 for nonmembers.EP09 Measurement Procedure Comparison andBias Estimation Using Patient Samples, 3rd EditionItem Order Code: EP09Ed3cEP10 Preliminary Evaluation of Quantitative ClinicalLaboratory Measurement Procedures, 3rd EditionItem Order Code: EP10A3AMD

EP12 User Protocol for Evaluation of QualitativeTest Performance, 2nd EditionItem Order Code: EP12A2COVID-19 RelatedEP27* How to Construct and Interpret an Error Gridfor Quantitative Diagnostic Assays, 1st EditionItem Order Code: EP27AEEP14 Evaluation of Commutability of ProcessedSamples, 3rd EditionItem Order Code: EP14A3EP28 Defining, Establishing, and VerifyingReference Intervals in the Clinical Laboratory,3rd EditionItem Order Code: EP28A3CEP15 User Verification of Precision and Estimationof Bias, 3rd EditionItem Order Code: EP15A3EP17 Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures, 2nd EditionItem Order Code: EP17A2COVID-19 RelatedEP18 Risk Management Techniques to Identify andControl Laboratory Error Sources, 2nd EditionItem Order Code: EP18A2COVID-19 RelatedEP19* A Framework for Using CLSI Documentsto Evaluate Clinical Laboratory MeasurementProcedures, 2nd EditionIt

CLSI Catalog 2020 5 ORDER TODAY: Toll Free (US): 877.447.1888 1.610.688.0100 www.clsi.org customerservice@clsi.org AUTO08* Managing and Validating Laboratory Information Systems, 1st Edition Item Order Code: AUTO08AE AUTO09* Remote Access to Clinical Laboratory Diagnostic Devices via the Internet, 1st Edition Item Order Code: AUTO09AE AUTO10* Autoverification of Clinical Laboratory