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全面质量控制需要的文件目录
[ 2008-10-20 21:56:00 | By: 小猪 ]
 

AST
AST2-A Point-of-Care in Vitro Diagnostic (IVD) Testing (1999.6)
AST3-A Wellness Testing Using IVD Devices (1999.2)
AST4-A Blood Glucose Testing in Settings Without Laboratory Support (1999.6)

C
C3-A3 Preparation and Testing of Reagent Water in the Clinical Laboratory (1997.10)
C24-A2 Statistical Quality Control for Quantitative Measurements: Principle and Definitions
(1999.2)
C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory (2000.6)
C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the
Flame Photometric Reference Method (2000.10)
C30-A2 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities (2002.8)
C31-A2* Ionized Calcium Determinations: Precollection Variables, Specimen Choice,
Collection, and Handling (2001.6)
C34-A2 Sweat Testing: Sample Collection and Quantitative Analysis (2000.6)
C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures (1999.11)
C38-A Control of Preparation Variation in Trace Element Determinations (1997.9)
C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum
(2000.4)
C40-A Analytical Procedures for the Determination of Lead in Blood and Urine (2001.6)
C42-A Erythrocyte Protoporphyrin Testing (1996.11)
C43-A Gas Chromatography/mass Spectrometry (GC/MS) Confirmation of Drugs (2002.11)
C44-A Harmonization of Glycohemoglobin Measurements (2002.12)
C46-A Blood Gas and pH Analysis and Related Measurememnts (2001.9)

DI
DI2-A2 Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials.
(1993.10)
DI3-A Agglutination Assayses: Antibody Characteristics,Methodology, Limitations,and
Clinical Validation (1993.10)

EP
EP5-A2 Evaluation of Precision Performance of Quantative measurement methods;
Approved Guideline-Second Edition (2004.08)
EP6-A Evaluation of the Linearity of Quantative Analytical Methods (2003.4)
EP7-A Interference Testing in Clinical Chemistry (2002.12)
EP9-A2 Method Comparison and Bias Estimation Using Patient Samples (2002.9)
EP10-A2 Preliminary Evaluation of Quantitative Clinical Laboratory Methods (2002.12)
EP12-A User Protocol for Evaluation of Qualitative Test Performance (2002.8)
EP13-R Laboratory Statistics-Standard Deviation.(1995.8)
EP14-A* Evaluation of Matrix Effects (2001.3)
EP15-A* User Demonstration of Performance for Precision and Accuracy (2001.12)
EP18-A Quality Management for Unit-Use Testing (2002.12)
EP19-R A Framework for NCCLS Evaluation Protocols. (2002.6)
EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods (2003.4)

G
GP2-A4* Clinical Laboratory Technical Procedure Manuals (2002.4)
GP5-A2 Clinical Laboratory Waste Management (2002.4)
GP6-A Inventory Control Systems for Laboratory Supplies.(1994.2)
GP9-A Selecting and Evaluating a Referral Laboratory (1998.11)
GP10-A Assessment of the Clinical accuracy of Laboratory Tests Using Receiver Operating
Characteristics (ROC) Plots (1995.12)
GP11-A Basic Cost Accounting in the Clinical Services (1998.11)
GP14-A Labeling of Home-Use In Vitro Testing products.(1996.6)
GP15-A2* Papanicolaou Technique (2001.11)
GP16-A2* Urinalysis and Collection, Transportation, and Preservation of Urine Specimens
(2001.11)
GP17-A Clinical Laboratory Safety.(1996.12)
GP18-A Laboratory Design (1998.4)
GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User
Interface and End-User Software Systems Validation, Operation, and Monitoring
(2003.2)
GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques (2003.10)
GP21-A Traning Verification for Laboratory Personnel.(1995.12)
GP22-A Continuous Quality Improvement: Essential Management Approaches (1999.8)
GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques
(1999.8)
GP26-A2 Application of a Quality System Model to Laboratory Services (2003.2)
GP27-A Using Proficiency Testing (PT) to Improve the Clinical Laboratory (1999.8)
GP29-A Validation of Laboratory Tests When Proficiency Testing is Not Available (2002.12)

H
H1-A5 Evacuated Tubes and Additives for Blood Specimen Collection—4th Edition (2003.12)
H2-A4 Reference and selected procedure for the Erythrocyte Sedimentation Rate(ESR) Test
(2000.12)
H3-A5 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture
(2003.12)
H4- A4 Procedures and Devices for the Collection of Diagnostic Blood Specimen by Skin
Puncture (1999.9)
H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method
(2000.12)
H11-A3 Procedures for the Collection of Arterial Blood Specimens (1999.5)
H15-A3 Reference and Selected Procedures for the quantitative Determination of Hemoglobin
in Blood (2000.12)
H17-A Determination of Serum Iron, Total Iron-Binding Capacity6 and Percent Transferrin
Saturation (1998.12)
H18-A2 Procedures for the Handling and Processing of Blood Specimens (1999.10)
H20-A Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental
Methods (1992.3)
H21-A4 Collection, Tranport, and Processing of Blood Specimens for Coagulation testing and
General performance of Coagulation Assays (2003.12)
H26-A Performance Goals for the Internal Quality Control of Multichannel Hemotology
Analyzers (1996.12)
H30-A2* Procedure for the Determination of Fibrinogen in Plasma (2001.12)
H42-A Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping
of Lymphocytes (1998.12)
H43-A Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells
(1998.6)
H44-A Methods for Reticulocyte Counting( Flow Cytometry, and Supravital Dyes) (1997.10)
H45-A Performance of the Bleeding Time Test (1998.6)
H47-A One-Stage prothrombin Time (PT) Test and Activated Partial Thromboplastin Time
(APTT) Test. (1996.6)
H51-A Assays of von Willebrend Factor Antigen and Ristocetin Cofactor Activity (2002.9)
H52-A* Fetal Red Cell Detection (2001.12)

HS
HS1-A A Quality System Model for Health Care (2002.8)
HS2-A Provider-Performed Microscopy Testing (2003.2)
HS4-A Application of a Quality System Model to Respiratory Services (2002.11)
HS5-A Application of a Quality System Model for Medical Imaging Services (2002.11)

I/LA
I/LA-2A Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to
Nuclear Antigen(IF-ANA);(1996.12)
I/LA6-A Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance
Criteria for muleiple Component Test Product and Specimen Handling and Use of
Test Products in the Clinical Laboratory (1997.10)
I/LA10-A Choriogonadotropin Testing:Nomenclature,Reference Preparations,Assay
Performance,and Clinical Application (1996.12)
I/LA15-P Apolipoprotein Immunoassays: Development and Recommended Performance
Characteristics (1997.9)
I/LA17-A Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used
in Prenatal Screening and Diagnosis of Open neural Tube Defects (1997.4)
I/LA18-A2* Specifications for Immunological Testiong for Infectious Diseases (2001.9)
I/LA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical
Assays for serum Prostate specific antigen (PSA) (1997.6)
I/LA20-A Evaluation Methods and Analytical Performance Characteristics of Immunological
Assays for Human Immunoglobulin E (Ig E) Antibodies of Defined Allegen
Specificities (1997.12)
I/LA21-A* Clinical Evaluation of Immunoassays (2002.6)

LA
LA1-A2 Assessing the Quality of Radioimmunoassay System(1994.12)
LA4-A4 Blood Collection on Filter Paper for Neonatal Screening Programs (2003.7)

M
M2-A8 Performance Standards for Antimicrobial Disk Susceptibility Tests (2003.1)
M6-A Protocols for Evaluating Dehydrated Muller-Hinton Agar (1996.12)
M7-A6 Methods for Dilution Antimicrobial Suswceptibility Tests for Bacteria That Grow
Aerobically (2003.1)
M11-A6 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria (2004.1)
M15-A Laboratory Diagnosis of Blood-Borne Parasitic Diseases (2000.6)
M21-A Methodology for the Serum Bactericidal Test (1999.9)
M22-A2 Quality Assurance for Commercially Prepared Microbiological Culture
Media-Second (1996.12)
M23-A2* Development of In Vitro Susceptibility Testing Criteria and Quality Control
Parameters (2001.5)
M24-A Susceptibility Testing of Mycobacteria,Nocariae,and Other Aerobic Actinomycetes
(2003.4)
M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents (1999.9)
M27-A2 Reference Method for Broth Diloution Antifungal Susceptibility Testing of Yeasts
(2002.8)
M28-A Procedures for the Recovery and Identification of Parasites from the Intestinal
Tract (1997.12)
M29-A2* Protection of Laboratory Workers from Occupationally Acquired Infections (2001.12)
M100-S14* Performance Standards for Antimicrobial susceptibility Testing (2004.1)
 
 
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