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- What went Wrong with CLIA
- EQC = Eliminated QC
- 2008: Update on "Alternative QC"
- EQC, AQC, and FDA QC Clearance: From control to compliance; from compliant to complicit
- Equivocal QC: Coming Soon to a Laboratory Near You
- Quality versus the “No Lab Left Behind” Program
- Final Rule vs Final Word on Quality
- Testing Equivalent Quality: A Better Way
- CLIA QC and Q-less Compliance
- Final5 CLIA Rule 1/24/03
- CLIA QC Clearance Postponed Again & Again & Again & Again
- High Reliability
- "Housekeeping"
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- The New Westgard Web
- Quality: "I think I get it now!"
- WQC Y2K: Plans, Priorities, and Predicaments
- Education and Training in Analytical Quality Management, Part Four: Internet Tools for QC Training
- Education and Training in Analytical Quality Management, Part III: Basic QC Training
- Education and Training in Analytical Quality Management, Part Two: Developing Internet Courses
- Quality and Commerce
- Education and Training in Analytical Quality Management, Part One: Developing A "Lesson-Base"
- ISO
- W.o.W, part III: Intended Applications and Customers
- W.o.W., part II: Concepts and Terminology
- W.o.W., part I: Total Error vs. Trueness and Measurement Uncertainty
- Truthful Guidance about Trueness, Uncertainty and Quality
- Quality Management - the Gospel according to ISO
- ISO Says So: Recommendations for Validation of User QC
- To Be Uncertain or In Error?
- W.o.W. part IV: The Quality of Glycated Hemoglobin (Ghb)
- Links
- Links to Latin America 2010
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- Spotting Quality Internationally: The Antwerp Meetings
- Links to South Africa
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- Links to India, Part II: Clinical Quality and Analytical Quality Control
- Links to India, Part I: Best QC Practices and "Westgard Rules"
- Maryland General
- Blowing the Whistle
- The GAO Report Recommmendations: The Regulators, Accreditors and Inspectors Respond
- The GAO Report Recommmendations: The good, the bad, and the irrelevant
- The GAO Report on CMS - it's out
- Unannounced Inspections: Unlikely to Improve Quality
- Part V: A Few Bad Apples or the Tip of the Iceberg?
- Part IV. Inadequate Inspections
- Part III. Broken Windows at Maryland General Hospital
- Part II. Facts of the Maryland General Healthcare Scandal
- Part I. Cracks in the Healthcare Quality System?
- Method Validation
- Personal
- Ring in the New Year, Please
- March Madness: Out-of-control in North Dakota
- Announcement of 2003 NACB Alvin Dubin award
- Truthful claims may not be enough
- Global and Local Imperatives for US Healthcare
- Westgard Web: Why We Write
- Thank You...
- Rumors of my Retirement are somewhat exaggerated...
- Quality Contradictions: Hopeful Healthcare in a Fearful Society
- 100,000 miles to Quality: 2005 in Review
- QC: Not just a technicality!
- Bah, Humbug! Or, how I learned to stop worrying and love EQC
- Giving Thanks for 2003: Some Observations
- It's an Honor: Personal Reflections on being a Teacher
- QC Design
- Errors before the Laboratory
- The Meaning and Application of Total Error
- Test Quality vs. Method Performance: What's the Difference?
- $aving the Cost$ of Poor Quality
- Errors in Reasoning about Laboratory Errors
- QC Principles, Practices, and Planning
- From Rules and Tools to Technology and Training
- Electronic QC and the Total Testing Process
- Principles of QC Planning for Immunoassays
- Mapping the Road to Analytical Quality
- Tools and Technology for QC Planning
- Quality by Design
- Quality Goals, Requirements, and Specifications
- Assuring Quality through Total Quality Management
- Quality Requirements and Standards
- FDA hears concerns on Blood Glucose Meters
- HbA1c in 2010, Part X
- HbA1c in 2010, Part XI
- What's the Q of D? Vitamin D Performance Requirements
- Why Not Evidence-Based Method Specifications?
- Good Data Wanted - Bad Data Should Not Apply (The STARD Initiative)
- "The Truth, the Whole Truth, and Nothing but the Truth"
- Open Letter to CLSI
- What is the Laboratory's Core Competency?
- Good Laboratory Practices for Statistical QC, Part I:
- Good Laboratory Practices for Statistical QC, Part II:
- Need for a System of Quality Standards
- Quality Requirements: The Debate heats up!
- HbA1c for screening and diagnosis of diabetes?
- Quality of Laboratory Testing
- Part I: Myths and Metrics
- Part II: Touchstone Test Methodology
- Part III: The Quality of Cholesterol Testing
- Part IV: The Quality of Glucose Testing
- Part V: The Quality of Calcium Testing
- Part VI: The Quality of GHb Testing
- Part VII: The Quality of PSA Testing
- Part VIII: The Quality of Coag Testing
- Part IX: Variability of survey estimates
- Statistics
- Six Sigma
- Tools
- Trends
- AACC 2009: More interest in quality, but not QC
- Trends in Quality Management: Utilization and Outcomes
- Future Directions in Quality Control
- The Myth of Medical Decision Limits
- QC 2000: What changes are needed?
- The FDA-Abbott Consent Decree
- Sage Advice about New Approaches to Quality Control
- Who will care for quality tomorrow?
- Quality is Job 1 when the rubber meets the road
- 2001: Year of the Odyssey
- Has Quality been "Enronned"?
- Cooking the books: Does it happen in the laboratory?
- A momentous happening - A New Way to do QC!
- 2004 JCAHO Patient Safety Goals
- Taking Autoverification to the Next Level – up or down?
- Think straight, Talk straight
- Connecting the Dots to Find Common Causes
- Vioxx and Vaccines, Values and Votes
- Quality Indicators and Benchmarks
- Troubles with Tracking Tests
- CLSI faces the Challenge of Quality
- The Health of US Healthcare
- A Hopeful Year 2009
- Guest Essay
- Stability Testing and CLSI EP25-A
- Biologic Variation Database, the 2010 update
- Rilibak: Quality Goals the German way
- Are "Scientific Statements" the Scientific Truth?
- Sysmex Perspective on Sigma-metrics
- Time to engage in measurement uncertainty
- Quality of Proficiency Testing
- When Quality depends on the company you keep
- Waiting for the FDA
- Quality Requirements for Veterinary Labs
- Understanding Quality
- Approaches to Clinical Laboratory Utilization Art Eggert
- Tips on Managing the Quality of Immunoassays
- Defect Rates, Quality and Productivity
- What's New With CLIA'88, JCAHO & CAP
- European Approaches to Analytical Goal-Setting
- QC - The Regulations
- TQM for Labs: A European point of view
- Cost-Effective QC for Chemistry and Coagulation
- MV - The Regulations
- Biological Variation Data for setting Quality Specifications
- QC Validation in Veterinary Laboratories
- Report of the Norwegian EQA Validator Workshop
- Trueness and Uncertainty
- Good Laboratory Practice versus CLIA
- Biologic Variation and Desirable Specifications for QC
- CLS: Victims of our own success?
- Biologic Variation: Principles and Practice
- Pre-, Post- & Analytical Errors
- Biodatabase Update 2001
- Quality Requirements Update 2002
- Are Scientific Statements the Scientific Truth?
- Is GUM injurious? - Or just superfluous?
- It's not Rocket Science
- Biological / Desirable Specs for QC, 2004 update
- The latest on Reference Values and Reference Intervals
- The Nordic Reference Interval Project 2000 (NORIP)
- The Quality in the Spotlight Conference
- Quality Management Cocktail ISO, Lean, and Six Sigma
- What are the Risks of Risk Management?
- Biologic Variation and Desirable Specifications for QC, 2006 Update
- Multisite Validation that “Westgard Rules” are cost-efficient and effective
- Quality Goal Index
- Frequency of QC - Implications for Patient Safety
- Biological Variation and Desirable Specifications for QC, 2008 update
- The Skinny on QC Are Laboratory Quality Requirements "Lean"?
- QC Applications
- QC Design
- What's the TEa for D? Allowable Error for vitamin D
- Glucose, European Biologic Goal
- QC for Sysmex Hematology parameters
- Potassium
- Cholesterol, Analytical Quality Requirement
- Immunoassay QC with Higher N Rules
- Multitest Chemistry Analyzer
- Cholesterol, Clinical Quality Requirement
- POC Glucose Test
- Cholesterol, European Biologic Goal
- Hemoglobin
- Leukocyte Count
- Digoxin
- Glycated Hemoglobin
- Patient Data or Traditional QC? Evaluating the options for QC and QC goals
- Multitest Chemistry Analyzer - 16 Years Later
- Evaluating Quality Requirements for HbA1c
- Basic QC Practices
- Method Validation
- Six Sigma
- Sigma Metric Analysis
- Seven Vitamin D methods
- Two HbA1c POC methods
- Vitros 5600
- Sysmex XT 1800i hematology
- Four Glucose Methods
- Mid-Volume Chemistry analyzer 2009
- Real-World Chemistry Data
- A POC Chemistry Device
- Roche Integra 400+
- Sigma Estimates: High Volume Hematology
- WBC on a SE 9500
- Vitros 5.1
- Unicel DxC 800
- Roche Modular
- Sysmex SE 9500
- Sysmex XT 2000i
- Beckman Coulter HMX
- Sysmex XE 2100
- An Architect c16000
- ADVIA 1800
- Architect c16000
- Multiple POC Glucose Methods
- HbA1c on the cobas 6000
- POC Chemistry Instrument
- Roche cobas c311
- POC automated CBC analyzer
- Abbott ARCHITECT c8000
- A direct enzymatic assay for %HbA1c
- Six Hcy methods
- direct HbA1c method
- Quality Standards
- QC Design
- Lessons
- Basic QC Practices
- Pre-Analytical and Post-Analytical QC
- QC Practices for Molecular Testing
- QC - Proficiency Testing, EQC, and Peer Groups
- QC Calculation Problem Set - Answers
- QC Calculation Problem Set
- QC: Levey-Jennings: Answers
- QC - The Records
- QC - The Multirule Interpretation
- QC - The Out-of-Control Problem
- QC - The Chances of Rejection
- QC: The Levey-Jennings Control Chart
- QC - The Calculations
- QC - The Materials
- QC - The Idea
- Basic Planning for Quality
- QP-6: Adopting the OPSpecs Chart as Your Planning Tool
- QP-8: Implementing a manual process using Normalized OPSpecs charts
- QP-15: Frequently-Asked-Questions about Quality Planning
- QP-14: What's wrong with statistical quality control?
- QP-13: Coagulation Applications
- QP-12: Immunoassay Applications
- QP-11: Blood Gas Applications
- QP-10: Automated Chemistry Applications
- QP-9: Practice makes Proficient
- QP-7: Formulating a Total Quality Control Strategy
- QP 5: Defining Quality Requirements
- QP 4: Devising a Practical Process
- QP 3: Complying with Regulations, Standards, and Practice Guidelines
- QP 2: Assuring Quality Through Total Quality Management
- QP 1: A Wake-up call for Quality Management
- Basic Method Validation
- Determining Inaccuracy
- Reference Interval Transference
- The Detection Limit Experiment
- The Management of Quality
- Interference and Recovery Experiments
- The Linearity or Reportable Range Experiment
- The Decision On Method Performance
- The Data Analysis Tool Kit
- The Comparison of Methods Experiment
- The Replication Experiment
- The Experimental Plan for Method Validation
- Selecting a Method to Validate
- Z-Stats / Basic Statistics
- Z-14: Estimating Analytical Errors Using Regression Statistics
- Z-13: The Least Squares Regression Model
- Z-12: Correlation and Simple Least Squares Regression
- Z-11: Confidence Intervals
- Z-10: ANOVA
- Z-9: Truth or Consequences for a Statistical Test of Significance
- Z-8: Two-Sample and Directional Hypothesis Testing
- Z-7: Hypothesis Testing, Tests of Significance, and Confidence Intervals
- Z-6: Probability and the Standard Normal Distribution
- Z-5: Sum of Squares, Variance, and the Standard Error of the Mean
- Z-4: Mean, Standard Deviation, And Coefficient Of Variation
- Z-3: An Organizer Of Statistical Terms (Part II)
- Z-2: An Organizer Of Statistical Terms (Part I)
- Z-1: Aligning Attitudes Through Purpose
- Quality Management
- What about Bias?
- Quality Planning Models - The Math
- Assessing the time to rejection for QC procedures
- Area Under a Table
- Automatic QC Selection Engine
- QC Selection Grids
- Normalized OPSpecs Charts
- Total Quality Control Strategies
- Quality Planning Models
- OPSpecs Charts
- Critical-Error Graphs
- Power Function Graphs
- QC - The Planning Process
- What is QC Validator?
- Advanced Quality Management / Six Sigma
- Quality Goals, Systems, and Specifications
- Surpassing Six Sigma
- Translating Method Validation Data into Sigma Metrics
- From Precision Claims to Six Sigma Estimates
- Six Sigma Design and Error Budgets
- A Six Sigma Design Tool
- Thinking about Three Sigma
- Six Sigma: Quality Design and Control Processes
- Six Sigma Basics: Outcome Measurement of Process Performance
- Six Sigma Basics: Process improvement, goals and measurements
- "Westgard Rules"
- Patient Safety Concepts
- High Reliability
- ISO
- Basic QC Practices
- CLIA & Quality
- Quality Requirements
- Rilibak - German Guidelines for Quality
- Biological Variation in Patients with Disease
- CLIA Requirements for Analytical Quality
- Clinical Quality Requirements
- European Biologic Goals
- Biological Variation Database specifications
- Biological Variation Database references
- Biological Variation Database reference list
- RCPA (Australasian) Quality Requirements
- Quality Requirements for Dogs, Cats, and Horses?
- 1999 Stockholm Consensus Statement
- CLIA Final Rule
- Is this the end of EQC 1, 2, 3?
- "Equivalent" QC Option 4: Back to the future
- Analysis of the Rationale for "Equivalent" QC
- A Scientific Rationale for Equivalent QC?
- Part X: Lies, Damn Lies, and "Equivalent" QC
- Part IX: Appropriate QC Procedures
- Part VIII: The Interpretive Guidelines
- Part VII: "Equivalent" QC Procedures
- Part VI: Method Validation - Statistical Sense, Sensitivity, and Significance
- Part V: Method Validation Process and Procedures
- Part IV: The New Method Validation Regulations
- Part III: QC - Quality or Compliance?
- Part II: Perplexity about Complexity and Personnel
- Part I: Key Changes
- Quality Requirements
- Downloads
- Store
- Resources
- Basic QC Practices Extras page
- Normalized OPSpecs Chart, N=6, 50% AQA
- Normalized OPSpecs Chart, N=3, 50% AQA
- Normalized OPSpecs Chart, N=6, 90% AQA
- OPSpecs Chart N=3 90% AQA
- Order Form
- Six Sigma Table
- Medical Decision Levels
- Glossary of QC Terms
- List of QC References
- ISO Glossary
- Table of Areas beneath Normal Curve
- Basic Method Validation, 3rd Edition, extras
- Basic Method Validation, 3rd Edition, FAQs
- OPSpecs Chart N=2 50% AQA
- OPSpecs Chart N=2 90% AQA
- OPSpecs Chart N=4 50% AQA
- OPSpecs Chart N=4 90% AQA
- QC Selection Grid, Square 1
- QC Selection Grid, Square 2
- QC Selection Grid, Square 3
- QC Selection Grid, Square 4
- QC Selection Grid, Square 5
- QC Selection Grid, Square 6
- QC Selection Grid, Square 7
- QC Selection Grid, Square 8
- QC Selection Grid, square 9
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