Crosswalk of Documents Referenced Within CAP Accreditation Checklists
Numerous CLSI documents are referenced in the College of American Pathologists (CAP) Accreditation Checklists and serve as key resources in satisfying regulatory requirements. CAP Accreditation Checklists are updated regularly to include CLSI’s standards, guidelines, and other documents as references. This crosswalk was last updated June 2021.
To view each checklist area, click "Filter Off" and select from the dropdown options.
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Product Code
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Title
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Former Code
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ANP
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BAP
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CBG
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CHM
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COM
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CYG
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CYP
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DRA
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FDT
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FLO
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GEN
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HEM
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HSC
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IMM
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LSV
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MIC
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MOL
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POC
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RLM
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TRM
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URN
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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AUTO01-A
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Specimen Container and Carrier
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AUTO02-A2
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Specimen ID
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AUTO03-A2
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Communication for Automated Systems
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AUTO04-A
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System Status
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AUTO05-A
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Electromechanical Interfaces
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AUTO07-A
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Barcode Data Content
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AUTO08-A
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LIS Validation
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AUTO09-A
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Remote Access to IVD Instruments
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AUTO10-A
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Autoverification of Test Results
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AUTO11-A2
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IT Security for IVD Instruments
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AUTO12-A
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Specimen Labels
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AUTO13-A2
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Lab Instrument Data Management
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GP19
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AUTO15-Ed1
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Autoverification for Specific Laboratory Departments
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AUTO16-Ed1
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IVD Instrument Interface
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LIS01-A2
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Low-Level Message Transfer Protocol
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LIS02-A2
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Information Transfer Between Instruments and LIS
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C24-Ed4
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Statistical Quality Control
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C29-A2
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Sodium and Potassium Reference Method
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I09
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C31-A2
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Ionized Calcium Testing
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C34-Ed4
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Sweat Testing
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C37-A
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Cholesterol Reference Materials
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C38-A
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Trace Element Preanalytical Variation
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C39-A
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Ionized Calcium Comparison Method
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C40-A2
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Lead Testing
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C42-A
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Erythrocyte Protoporphyrin Testing
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T/DM09
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C43-A2
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GCMS Drug Confirmation Testing
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T/DM10
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C45-A
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Free Thyroid Hormones Testing
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C46-A2
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Blood Gas and pH Testing
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C48-A
|
Biochemical Markers of Bone Turnover
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C49-Ed2
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Analysis of Body Fluids
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C50-A
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Mass Spectrometry
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C52-Ed3
|
Toxicology and Drug Testing
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T/DM8
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C56-A
|
HIL Indices
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C56A-QG
|
Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide
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C57-Ed1
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MS for Androgen and Estrogen
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C58-A
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Fetal Lung Maturity
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C61-A
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Iron/TIBC Determination
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H17A
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C62-A
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LC-MS Methods
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C50A
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C63-Ed1
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Laboratory Support of Pain Management
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C61A
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C64-Ed1
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Proteins and Peptides by MS
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EP05-A3
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Evaluation of Precision
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EP06-Ed2
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Evaluation of Linearity
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EP07-Ed3
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Interference Testing
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EP09-Ed3
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Measurement Procedure Comparison
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EP10-A3-AMD
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Preliminary Evaluation of Quantitative Tests
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EP12-A2
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Qualitative Test Performance
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EP14-A3
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Commutability of Processed Samples
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EP15-A3
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User Verification of Precision and Bias
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EP17-A2
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Evaluation of Detection Capability
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EP18-A2
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Risk Management Techniques
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EP18-A2-EP23-A-WS
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Laboratory Quality Control Based on Risk Management; Worksheet Template
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EP19-Ed2
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Using CLSI EP Documents
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EP21-Ed2
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Total Analytical Error
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EP23-A
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Laboratory QC Based on Risk Management
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EP23-A-QG
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EP23 Quick Reference Guide
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EP23-A-WB
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Laboratory Quality Control Based on Risk Management; Workbook
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EP23-A-WS
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Laboratory Quality Control Based on Risk Management; Worksheet Template
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EP24-A2
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Diagnostic Accuracy Using ROC Curves
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GP10
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EP25-A
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Reagent Stability
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EP26-A
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Between-Reagent Lot Variation
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EP27-A
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Constructing Error Grids
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EP28-A3c
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Reference Intervals
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C28
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EP29-A
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Measurement Uncertainty
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C51
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EP30-A
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Commutable Reference Materials
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C53
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EP31-A-IR
|
Comparability of Patient Results
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C54-A
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EP32-R
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Metrological Traceability
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X05, C59
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EP33-Ed1
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Implementing Delta Checks
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EP34-Ed1
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Dilution and Spiking for Extended Measuring Interval
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EP35-Ed1
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Equivalency of Specimen Types
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EP36-Ed1
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Symbology and Equations
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EP37-Ed1
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Interference Testing Database
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GP05-A3
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Waste Management
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GP05-A3-CL
|
Waste Management Program – Audit Checklist
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GP15-A3
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Pap Smear
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GP16-A3
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Urinalysis
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GP17-A3
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Laboratory Safety
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GP20-A2
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Fine Needle Biopsy
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GP23-A2
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NonGyn Collection
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GP33-Ed2
|
Patient and Specimen ID
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GP34-A
|
Blood Tubes Validation and Verification
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GP36-A
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Disaster Planning
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GP39-A6
|
Tubes and Additives
|
H01-A6
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GP40-A4-AMD
|
Reagent Water
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C03-A4
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GP41-Ed7
|
Venous BloodCollecion
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H03
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GP41-Ed7-QG
|
Quality Venipuncture Quick Guide
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GP42-A6
|
Capillary Blood Collection
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GP42-A6-QGE
|
#INVALID VALUE
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#INVALID VALUE
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#INVALID VALUE
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#INVALID VALUE
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#INVALID VALUE
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#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
|
GP44-A4
|
Handling and Processing Specimens
|
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GP45-A
|
Patient Outcomes
|
HS06
|
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GP47-Ed1
|
Managing Critical Results
|
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GP47-ES
|
Critical Results Executive Summary
|
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GP48-Ed1
|
Phlebotomy Training Program
|
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GP49-Ed1
|
Test Utilization Program
|
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H02-A5
|
Erythrocyte Sedimentation Rate
|
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H07-A3
|
Microhematocrit Method
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H15-A3
|
Hemoglobin Quantitation
|
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H20-A2
|
Leukocyte Differential Count
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H21-A5
|
Coagulation Assay Specimen
|
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H21-A5-QG
|
H21-A5 Quick Guide
|
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H26-A2
|
Automated Hematology Analyzers
|
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H30-A2
|
Determination of Plasma Fibrinogen
|
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H42-A2
|
Lymphocyte Flow Cytometry
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H43-A2
|
Neoplastic Hematolymphoid Cells
|
N
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H47-A2
|
PT and APTT
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H48-Ed2
|
One-stage Clotting Assay
|
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H52-A2
|
Erythrocyte Flow Cytometry
|
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H54-A
|
PT/INR Systems
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H56-A
|
Body Fluid Cell Composition
|
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H57-A
|
Coagulometer Validation / Implementation
|
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H58-A
|
Platelet Function Aggregometry
|
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H59-A
|
Quantitative D-dimer
|
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H60-A
|
Lupus Anticoagulant
|
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H60-A-QG1
|
Algorithmic Approach to Lupus Anticoagulant Testing
|
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H60-A-QG2
|
Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant
|
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I/LA02-A2
|
Autoantibodies to Nuclear Antigens
|
DI10
|
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I/LA20-Ed3
|
Assays for IgE Antibodies
|
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I/LA21-A2
|
Evaluation of Immunoassays
|
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I/LA23-A
|
Assessing Immunoassay Systems
|
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I/LA25-A2
|
Maternal Serum Screening
|
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I/LA26-A2
|
Single Cell Immune Response
|
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I/LA28-A2
|
QA Immunohistochemistry Assays
|
MM04
|
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I/LA28-A2-QG
|
QA Immunohistochemistry Assays Quick Guide
|
|
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I/LA30-A
|
Immunoassay Interference
|
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I/LA33-A
|
Automated Systems for Immunohematological Testing
|
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I/LA34-A
|
Validation of Immunoassays
|
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I/LA37-A
|
IgE Antibody Database
|
I/LA20S
|
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|
M02-Ed13
|
AST Disk Susceptibility
|
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|
M02QG-Ed2
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
|
M07-Ed11
|
Dilution AST for Aerobes
|
|
|
|
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|
|
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|
M100-Ed31
|
AST Performance Standards
|
|
|
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|
M11-Ed9
|
AST Methods for Anaerobes
|
|
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|
M15-A
|
Blood-borne Parasites
|
|
|
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|
M22-A3
|
QC of Media
|
|
|
|
|
|
|
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|
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|
|
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|
M23-Ed5
|
Susceptibility Testing Criteria and QC
|
|
|
|
|
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|
|
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|
M24-Ed3
|
Mycobacteria and Other Actinomycetes
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
M26-A
|
Determining Bactericidal Activity
|
|
|
|
|
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|
M27-Ed4
|
Yeast Broth Dilution
|
|
|
|
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|
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|
M28-A2
|
Intestinal Parasites Recovery and ID
|
|
|
|
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|
M29-A4
|
Protection of Laboratory Workers
|
|
|
|
|
|
|
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|
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|
M34-A
|
B. burgdorferi by Western Blot
|
|
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|
M35-A2
|
Abbreviated ID
|
|
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|
M36-A
|
T. gondii Serology
|
|
|
|
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|
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|
M38-Ed3
|
Mould Broth Dilution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
M39-A4
|
AST Data Analysis and Presentation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M39-A4-QG
|
Antibiograms: Developing Cumulative Reports for Your Clinicians
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
M40-A2
|
Microbiological Transport Systems
|
|
|
|
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|
|
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|
|
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|
M41-A
|
Viral Culture
|
|
|
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|
M43-A
|
AST for Mycoplasmas
|
|
|
|
|
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|
M44-Ed3
|
Yeast Disk Diffusion
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
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|
|
M45-Ed3
|
AST of Infrequently Isolated Bacteria
|
|
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|
|
|
|
|
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|
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|
M47-Ed2
|
Blood Cultures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M48-Ed2
|
Detection and Identification of Mycobacteria
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
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|
M50-A
|
Commercial Microbial ID Systems
|
|
|
|
|
|
|
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|
M51-A
|
Mould Disk Diffusion
|
|
|
|
|
|
|
|
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|
M52-Ed1
|
Verifying ID/AST Systems
|
|
|
|
|
|
|
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|
M53-A
|
HIV
|
|
|
|
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|
|
|
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|
M54-Ed2
|
Detecting Fungi
|
|
|
|
|
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|
|
|
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|
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|
|
|
|
|
|
|
M56-A
|
Detecting Anaerobes
|
M55
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
M57-Ed1
|
Developing Fungal ECVs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
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|
|
M58-Ed1
|
MALDI-TOF MS
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
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|
|
M59-Ed2
|
Interpreting Fungal ECVs
|
M57-S
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
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|
M60-Ed1
|
Interpreting Yeast AST
|
M27-S
|
|
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|
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|
M61-Ed1
|
Interpreting Mould AST
|
M51-S
|
|
|
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|
|
|
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|
|
|
|
|
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|
|
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|
M62-Ed1
|
Aerobic Actinomycetes
|
M24-S
|
|
|
|
|
|
|
|
|
|
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|
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|
MM01-A3
|
Molecular Genetics/Oncology
|
|
|
|
|
|
|
|
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|
|
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|
MM03-Ed3
|
Qualitative Molecular InfDis
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
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|
MM05-A2
|
Molecular Hematopathology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
MM06-A2
|
Quantitative Molecular InfDis
|
|
|
|
|
|
|
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|
MM07-A2
|
FISH
|
|
|
|
|
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|
MM09-A2
|
DNA Sequencing
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
MM11-A
|
Bacterial Strain Typing
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
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|
|
MM12-A
|
Microarrays
|
M51
|
|
|
|
|
|
|
|
|
|
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|
MM13-A
|
Molecular Specimen Management
|
|
|
|
|
|
|
|
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|
|
|
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|
|
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|
|
MM13-A-QG
|
Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide
|
|
|
|
|
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MM14-A2
|
Molecular PT
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MM17-Ed2
|
Molecular Multiplex Validation
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MM18-Ed2
|
Interpreting Microbial Sequencing
|
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MM19-A
|
Molecular Testing Implementation
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MM20-A
|
QMS Molecular Genetics
|
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MM21-Ed1
|
Genetic/Oncology Microarrays
|
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MM22-A
|
Infectious Disease Microarrays
|
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MM23-Ed1
|
Molecular Testing Tumors
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NBS01-Ed7
|
NBS Specimen Collection
|
LA04
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NBS01-A6-DVD
|
Making a Difference Through Newborn Screening: Blood Collection on Filter Paper
|
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NBS01-A6-QG
|
Specimen Collection and Sample Quality for Newborn Screening Quick Guide
|
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NBS02-A2
|
NBS Follow-up
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NBS02-A2-QG
|
Newborn Screening Follow-up Process Quick Guide
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NBS03-Ed2
|
NBS Preterm and Sick
|
ILA31
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NBS04-Ed2
|
NBS Tandem Mass Spec
|
ILA32
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NBS05-Ed2
|
NBS Cystic Fibrosis
|
ILA35
|
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NBS06-A
|
NBS SCID
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NBS06-A-QG1
|
Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide
|
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NBS06-A-QG2
|
Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide
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NBS06-A-WC
|
Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period
|
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NBS07-Ed1
|
NBS Pompe Disease
|
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NBS08-Ed1
|
NBS Hemoglobinopathies
|
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POCT01-A2
|
Point-of-Care Connectivity
|
AUTO06
|
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POCT01QG-Ed1
|
POCT01 Vendor Code List
|
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POCT02-A
|
POCT01 Implementation Guide
|
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|
POCT04-Ed3
|
Essential Tools for POCT
|
AST02
|
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POCT05-Ed2
|
Continuous Glucose Monitoring
|
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POCT06-Ed1
|
Glucose Measurement of Different Sample Types
|
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POCT07-A
|
Reducing Errors at POCT
|
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|
POCT07-A-RG
|
Addressing Errors in Point-of-Care Testing Reference Guide
|
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POCT08-A
|
Quality Practices for Noninstrumented POCT
|
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POCT08-A-QG1
|
Corrective Action Quick Guide
|
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POCT08-A-QG2
|
Quality Control Troubleshooting Flow Chart
|
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|
POCT08-A-QG3
|
Quality Control Log Sheet Quick Guide
|
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|
POCT09-A
|
Selection Criteria for POCT
|
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|
POCT09-A-WS
|
Instrument Selection Worksheet
|
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|
POCT10-A2
|
Provider-Performed Microscopy Testing
|
AST05, HS02
|
|
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|
POCT12-A3
|
Glucose Testing in Acute Care
|
C30
|
|
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|
POCT13-Ed3c
|
Glucose Testing Without Laboratory Support
|
AST04
|
|
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|
POCT14-A
|
Point-of-Care Coagulation Testing
|
|
|
|
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|
POCT15-Ed1
|
POCT for Infectious Diseases
|
POCT14
|
|
|
|
|
|
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|
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|
POCT17-Ed1
|
Use of Glucose Meters for Critically Ill
|
|
|
|
|
|
|
|
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|
|
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|
|
|
QMS01-Ed5
|
Quality Management System
|
GP26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS01-CL
|
Gap Analysis Checklists, 1st Edition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
QMS02-A6
|
Laboratory Documents
|
GP02
|
|
|
|
|
|
|
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|
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|
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|
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|
QMS02-A6-QG
|
Ten Rules for Laboratory Document Management Quick Guide
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
QMS03-Ed4
|
Training and Competence Assessment
|
GP21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS04-Ed3
|
Laboratory Design
|
GP18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS05-Ed3
|
Referral Laboratories
|
GP09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS06-A3
|
Continual Improvement
|
GP22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
QMS11-Ed2
|
Nonconforming Events
|
GP32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS12-Ed2
|
Quality Indicators
|
GP35
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
QMS13-A
|
Equipment
|
GP35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS14-A
|
Leadership/Management Roles and Responsibilities
|
GP37
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS14-ES
|
Leadership/Management Executive Summary
|
GP38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
QMS15-A
|
Internal Audit Program
|
|
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|
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|
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|
|
|
|
|
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|
|
|
QMS16-Ed1
|
Personnel Management
|
GP39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS17-Ed1
|
System: Quality Management Systems
|
GP40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
QMS18-Ed1
|
Process Management
|
GP43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS19-Ed1
|
Customer Focus
|
|
|
|
|
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|
|
|
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|
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|
|
|
|
|
|
|
|
|
QMS20-Ed2
|
Cost of Quality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS21-Ed1
|
Purchasing and Inventory
|
|
|
|
|
|
|
|
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|
|
|
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|
|
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|
|
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|
QMS22-Ed1
|
Laboratory Information Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS23-Ed2
|
Laboratory Instruments
|
GP31A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS24-Ed3
|
Using PT/EQA
|
GP27, GP29
(merged)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
QMS25-Ed1
|
Quality Manual
|
QMH
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
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|
|
QSRLDT
|
Laboratory-Developed Tests
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET01-Ed5
|
VET AST Methods Standard
|
M31, VET08-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET02-Ed4
|
VET AST Breakpoint-Setting Requirements
|
M37
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET03-Ed2
|
Aquaculture AST Methods
|
M42, M49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET04-Ed3
|
Aquaculture Methods – MICs
|
VET03/VET04-S2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET05-R
|
VET AST Data Presentations
|
X08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET06-Ed1
|
VET AST Breakpoints Fastidious Guidelines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET08-Ed4
|
VET AST Breakpoints Standard
|
VET01-S;
M31-S
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VET09-Ed1
|
Understanding AST Data in Veterinary Settings
|
|
|
|
|
|
|
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|
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