1、ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007Alberta Laboratory Quality Enhancement Program Index of CLSI/NCCLS Standards Approved Guideline (Vol. 19, No. 9) June 1999AST3-A Wellness Testing Using IVD Devices; Approved Guideline (Vol. 19, No. 4) Februa
2、ry 1999AST4-A2 Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition (Vol. 25, No. 12) May 2005C30-A2 Point of Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Second Edition (Vol. 22, No. 17) September 2002GP14-A Labeling of
3、Home-Use In Vitro Testing Products; Approved Guideline (Vol. 16, No. 2) June 1996POCT1-A2 Point-of-Care Connectivity; Approved Standard Second Edition (Vol. 26, No. 28) (This is available as CD or printout in binder) July 2006POCT4-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideli
4、ne Second Edition (Vol. 26, No. 30) August 2006POL1-T3 Physicians Office Laboratory Guidelines Third Edition; Tentative Guideline (Vol. 15, No. 5) July 1995POL2-T3 Physicians Office Laboratory Procedure Manual; Tentative Guideline (Vol. 15, No. 6) July 1995POL3-R CLIA/NCCLS POL Index (Vol. 12, No. 1
5、2) June 1992Alberta Laboratory Quality Enhancement Program CLSI Document Index of NCCLS Standards Page 2 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007CLINICAL CHEMISTRY AND TOXICOLOGY:CODE DOCUMENT DATEC3-A4 Preparation and Testing of Reagent Wate
6、r in the Clinical Laboratory; Approved Guideline Fourth Edition (Vol. 24, No. 22) June 2006C12-A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (Vol. 14, No. 11) September 1994C21-A Performance Characteristics for Devices Measuring PO2 and PCO2 in B
7、lood Samples, Approved Standard (Vol. 12, No. 3) March 1992C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline Third Edition (Vol. 26, No. 25)June 2006C25-A Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Qua
8、ntities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (Vol. 17, No. 3)January 1997C27-A Blood Gas Pre-Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline (Vol. 13, No. 6) April 1993C28-A2 How to Define and Determine Reference Intervals
9、 in the Clinical Laboratory; Approved Guideline Second Edition (Vol. 20, No. 13)August 2000C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard Second Edition (Vol. 20, No. 17)November 2000C31-A Ionized Calcium De
10、terminations: Precollection Variables, Specimen Choice, Collection and Handling; Approved Guideline (Vol. 15, No. 20)December 1995C32-P Considerations in the Simultaneous Measurement of Blood Gases, Electrolytes and Related Analytes in Whole Blood; Proposed Guideline (Vol. 13, No. 17)November 1993C3
11、4-A2 Sweat Testing: Sample Collection and Quantitative Analysis; Approved Guideline Second Edition (Vol. 20, No. 14) August 2000C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline (Vol. 19
12、, No. 25)November 1999C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline (Vol. 17, No. 13) September 1997C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (Vol. 20, No. 6) May 2000Alberta Laboratory Quali
13、ty Enhancement Program CLSI Document Index of NCCLS Standards Page 3 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007CLINICAL CHEMISTRY AND TOXICOLOGY:CODE DOCUMENT DATEC40-P Analytical Procedures for the Determination of Lead in Blood and Urine; Pro
14、posed Guideline (Vol. 18, No. 4) April 1998C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline (Vol. 16, No. 8) November 1996C43-A Gas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Approved Guideline (Vol.22, No. 22) January 2003C44-A Harmonization of Glycohemoglobin Measu
15、rements; Approved Guideline (Vol. 22, No. 25) January 2003C45-A Measurement of Free Thyroid Hormones; Approved Guideline (Vol. 24 No.31) October 2004C46-A Blood Gas and pH Analysis and Related Measurements; Approved Guideline (Vol. 21, No. 14) October 2001C48-A Application of Biochemical Markers of
16、Bone Turnover in the Assessment and Monitoring of Bone Diseases: Approve Guideline (Vol. 24, No. 22)July 2004C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline (Vol. 27, No. 14) April 2007C52-A2 Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline Second Ed
17、ition (Vol. 27, No. 15) April 2007H11-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard Fourth Edition (Vol. 24, No. 28) September 2004H17-A Determination of Serum Iron, Total Iron-Binding Capacity, and Percent Transferrin Saturation; Approved Standard (Vol. 18, No. 19)
18、December 1998I2-A2 Temperature Calibration of Water Baths, Instruments and Temperature Sensors Second Edition, Approved Standard (Vol. 10, No. 3)April 1990T/DM6-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (Vol. 17, No.14) September 1997Alberta Laboratory Quality Enhancemen
19、t Program CLSI Document Index of NCCLS Standards Page 4 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007EVALUATION PROTOCOLS:CODE DOCUMENT DATEEP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline Second E
20、dition (Vol. 24, No. 25)August 2004EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (Vol. 23, No. 16) April 2003EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline Second Edition (Vol. 25, No. 27) November 2005EP9-
21、A2 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second Edition (Vol. 22, No. 19) September 2002EP10-A3 Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guidelines Third Edition (Vol. 26, No. 34)November 2006EP11-P Uniformi
22、ty of Claims For In Vitro Diagnostic Tests; Proposed Guideline (Vol. 16, No. 4) July 1996EP12-A User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline (Vol. 22, No. 14) September 2002EP13-R Laboratory Statistics Standard Deviation; A Report (Vol. 15, No. 8) August 1995EP14-
23、A2 Evaluation of Matrix Effects; Approved Guideline Second Edition (Vol. 25, No. 4) January 2005EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline Second Edition (Vol. 25, No. 17) June 2005EP17-A Protocols for Determination of Limits of Detection and Limits of Qu
24、antitation; Approved Guideline (Vol. 24, No. 34) October 2004EP18-A Quality Management for Unit-Use Testing; Approved Guideline (Vol. 22, No. 28) January 2003EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (Vol. 23 No. 20) April 2003Alberta Laboratory
25、Quality Enhancement Program CLSI Document Index of NCCLS Standards Page 5 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007GENERAL LABORATORY PRACTICES:CODE DOCUMENT DATEGP2-A5 Laboratory Documents: Development and Control; Approved GuidelineFifth Edi
26、tion (Vol. 26, No. 12) March 2006GP2-A4 CD Rom Toolkit: GP2-A4 TemplatesGP5-A2 Clinical Laboratory Waste Management; Approved Guideline Second Edition (Vol. 22, No. 3) May 2002GP6-A Inventory Control Systems for Laboratory Supplies; Approved Guideline (Vol. 14, No. 3) February 1994GP9-A Selecting an
27、d Evaluating a Referral Laboratory, Approved Guideline (Vol. 18, No. 15) November 1998GP10-A Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; Approved Guideline (Vol. 15, No. 19)December 1995GP11-A Basic Cost Accounting for Clinical Servic
28、es; Approved Guideline (Vol. 18, No. 14) November 1998GP15-A2 Papanicolaou Technique; Approved Guideline Second Edition (Vol. 21, No. 17) January 2002GP16-A2 Urinalysis and Collection, Transportation and Preservation of Urine Specimens; Approved Guideline Second Edition (Vol. 21, No. 19)January 2002
29、GP17-A2 Clinical Laboratory Safety; Approved Guideline Second Edition (Vol. 24, No. 13) April 2004GP18-A2 Laboratory Design; Approved Guideline Second Edition (Vol. 27, No. 7) February 2007GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Sof
30、tware Systems Validation, Operation and Monitoring; Approved Guideline Second Edition (Vol. 23, No. 4)March 2003GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline Second Edition (Vol. 23, No. 27) October 2003GP21-A2 Training and Competence Assessment; Approved Guideline Seco
31、nd Edition (Vol. 24, No. 14) April 2004GP22-A2 Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline Second Edition(Vol. 24, No. 35)November 2004GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline (Vol.
32、 19, No. 14) August 1999Alberta Laboratory Quality Enhancement Program CLSI Document Index of NCCLS Standards Page 6 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007GENERAL LABORATORY PRACTICES:CODE DOCUMENT DATEGP26-A3 Application of a Quality Manag
33、ement System Model for Laboratory Services; Approved Guideline - Third Edition (Vol. 24, No. 36) November 2004GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline Second Edition (Vol. 27, No. 8) February 2007GP28-A Microwave Device Use in the Histology Laboratory;
34、 Approved Guideline (Vol. 25, No. 7) February 2005GP29-A Assessment of Laboratory Tests When Proficiency Testing is Not Available; Approved Guideline (Vol. 22, No. 26) January 2003HS1-A2 A Quality Management System Model for Health Care; Approved Guideline Second Edition (Vol. 24, No. 37) November 2
35、004HS2-A Provider-Performed Microscopy Testing; Approved Guideline (Vol. 23, No. 5) March 2003HS3-A Pulse Oximetry; Approved Guideline (Vol. 25, No. 5) January 2005HS4-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guidelines Second Edition (Vol. 22, No. 23)Ma
36、y 2006HS5-A2 Application of a Quality Management System Model for Medical Imaging Services; Approved Guidelines Second Edition (Vol. 22, No. 24)May 2006HS6-A Studies to Evaluate Patient Outcomes; Approved Guideline (Vol. 24, No. 32) October 2004HS10-A2 Application of a Quality Management System Mode
37、l for Inpatient Medication Use; Approved Guideline Second Edition (Vol. 26, No. 17)May 2006HS11-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline (Vol. 25, No. 30)December 2005Alberta Laboratory Quality Enhancement Program CLSI Docume
38、nt Index of NCCLS Standards Page 7 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007HEMATOLOGY:CODE DOCUMENT DATEH1-A5 Tubes and Additives for Venous Blood Specimen Collection; Approved Standard Fifth Edition (Vol. 23, No. 33) December 2003H2-A4 Refer
39、ence and Selected Procedure for the Erythrocyte Sedimentation Rate (ESR) Test; Approved Standard Fourth Edition (Vol. 20, No. 27)March 2001H3-A5 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard Fifth Edition (Vol. 23, No. 32)December 2003H4-A5 Procedures
40、 and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard Fifth Edition (Vol. 24, No. 21)June 2004H5-A3 Procedures for the Handling and Transport of Diagnostic Specimens and Etiologic Agents Third Edition; Approved Standard (Vol. 14, No. 7)May 1994H7-A3 Procedure for
41、 Determining Packed Cell Volume by the Microhematocrit Method Approved Standard Third Edition (Vol. 20, No. 18)November 2000H8-A2 Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis Second Edition; Approved Standard (Vol. 14, No. 10)September 1994H9-A Chromatographic (Microcolum
42、n) Determination of Hemoglobin A2, Approved Standard (Vol. 9, No. 17) December 1989H10-A2 Solubility Test to Confirm the Presence of Sickling Hemoglobins Second Edition; Approved Standard (Vol. 15, No. 7) August 1995H13-A Quantitative Measurement of Fetal Hemoglobin Using the Alkali Denaturation Met
43、hod, Approved Guideline (Vol. 9, No. 18) December 1989H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard Third Edition (Vol. 20, No. 28)March 2001H18-A3 Procedures for the Handling and Processing of Blood Specimens, Approved Guidelin
44、e Third Edition (Vol. 24, No. 38) November 2004H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard Second Edition (Vol. 27, No. 4)January 2007H21-A4 Collection, Transport and Processing of Blood Specimens for Testing Plasma-Bas
45、ed Coagulation Assays; Approved Guideline Fourth Edition (Vol. 23, No. 35)December 2003Alberta Laboratory Quality Enhancement Program CLSI Document Index of NCCLS Standards Page 8 of 16ALQEP CLSI Document Index of NCCLS Standards CPSA: November 19, 2007Replaces: August 22, 2007HEMATOLOGY:CODE DOCUME
46、NT DATEH22-P Histochemical Method for Leukocyte Alkaline Phosphatase, Proposed Standard (Vol. 4, No. 14) October 1984H23-T Citrate Agar Electrophoresis for Confirming the Identification of Variant Hemoglobins, Tentative Guideline (Vol. 8, No. 6) September 1988H26-A Performance Goals for the Internal
47、 Quality Control of Multichannel Hematology Analyzers; Approved Standard (Vol. 16, No. 12) December 1996H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition (Vol. 21, No. 18) January 2002H31-P Collection Containers for Specimens for Toxicological Analysis
48、, Proposed Guideline (Vol. 6, No. 4) July 1986H33-P Algorithm for the Identification of Hemoglobin Variants; Proposed Guideline (Vol. 17, No. 8) May 1997H39-P Determination of von Willebrand Factor Antigen; Proposed Guideline (Vol. 13, No. 29) December 1993H41-P Assay for Ristocetin Cofactor; Propos
49、ed Guideline (Vol. 13, No. 30) December 1993H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline Second Edition (Vol. 27, No. 16)May 2007H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline Second Edition (Vol. 27, No. 11) April 2007H44-A2 Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline Second Edition (Vol. 24, N
