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More than 200 Essays, Guest Essays, QC Applications, Lessons, and Questions are available for viewing!
 

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WQC Online Courses: See also WQC Training

"Westgard Rules" Minicourse 

Basic QC Course 

Basic MV Course 

MT  520 Course 
Pathology Resident Course 

 
Essays: 
Myths of Quality
Putting Quality into Quality Control 
Assuring Quality through Total Quality Management 
Trends in Quality management: Utilization and Outcomes 
Quality Goals, Requirements, & Specifications 
Future Directions in Quality Control 
The Myth of Medical Decision Limits 
Quality by Design 
Tools and Technology for QC Training 
Education and Training for Analytical Quality Management, Part I
Mapping the Road to Analytical Quality with Charts of Operating Specifications 
QC - Back to Basics 
Quality and Commerce 
Method Validation: The Inner, Hidden, Deeper Secret Meaning  
Principles of QC Planning for Immunoassays
Education and Training for Analytical Quality Management, Part III
Electronic QC and the Total Testing Process
From Rules and Tools to Technology and Training

The Beijing Abstract
Points of Care in using Statistics in Method-Comparison Studies

Quality Requirements: The Debate Heats Up!
Z-Stats: Those #$%!@ Statistics
The Need for a System of Quality Standards

What's wrong with traditional Quality Control?
To be Uncertain or In Error? That is the question
Quality Control 2000: What changes are needed?

Education & Training for Analytical Quality Managerment, Part IV:
Internet Tools for Training
The Do's and Don'ts of Quality Control
The Abbott Consent Decree: A Wake-Up Call for Laboratories
WQC Y2K: Plans, Predictions & Predicaments
Sage advice on New Approaches to QC
EZ Rules for easier operation

Who will care for quality tomorrow?
Quality is Job 1 when the Rubber meets the Road
Errors in Reasoning about Laboratory Errors
Six Sigma Quality Management

Six Sigma and Requisite Laboratory QC
2001: Year of the Odyssey
EZ Runs Preview
CLIA Postponed again and again and again
Repeated, repeated, got lucky!
Six Sigma Staffing Strategies
Technology for Implementing QC Right
$aving the Cost$ of Poor Quality (Six Sigma)
Has Quality been "Enronned"?
Why not Evidence-Based Method Specifications?

Quality: "I think I got it!"
Cooking the Books: Does it happen in the lab?
A momentous happening - CLIA QC clearance
Signs of Six Sigma
Good Data Wanted - Bad Data Need Not Apply
The Final, final, final, final , final CLIA Rule
The truth, the whole truth, and nothing but the truth
It's an Honor: Personal Reflection on being a Teacher
2004 JCAHO Patient Safety Goals: What they mean
ISO Says So: NCCLS recommendations for Validation of User QC
Medical Errors: Complexity and its solutions
Giving Thanks to 2003: Some Observations on the State of Quality Management
Autoverification: Taking QC to the next level - is that up or down?
Think Straight, Talk Straight
Quality Management - the Gospel according to ISO
More on CLIA and "Quality-Less Compliance"
Testing Equivalent Quality: A Better Way
The Final Word on the Final Rule?
Maryland General Hospital, Part I: Cracks in the System
Maryland General Hospital, Part II: Facts of the Scandal
Maryland General Hospital, Part III: Broken Windows
Connecting the Dots
Maryland General, Part IV: Inadequate Inspections?
Maryland General, Part V: Tip of the Iceberg?
The Quality of Laboratory Testing, Part I
Remarks at the G2 Conference: "No Lab Left Behind"
Vioxx and Values, Vaccines and Votes
The Quality of Laboratory Testing, Part II: Methodology
The Quality of Cholesterol Testing
Bah, Humbug! A Look Back at 2004
The Quality of Glucose Testing
The Quality of Calcium Testing
Blowing the Whistle on the Tip of the Iceberg

Six Sigma lessons: 
Six Sigma Basics
Six Sigma Quality Management
Six Sigma and Requisite Laboratory QC
Six Sigma: Outcome Measurement of Process Performance
Six Sigma: Quality Design and Control Processes
Six Sigma: General attributes of the OPSpecs Design Tool
(See also: QC Applications)
Interview with a Black Belt: Quest Diagnostics
Interview with a Black Belt: CAMC & GE Medical Systems
Interview: Process Metrics "Un-belted"

Six Sigma Calculator!
Signs of Six Sigma
From Method Performance Claims to Six Sigma Metrics
From Precision Claims to Six Sigma Metrics
 Downloads:  See also the Demo Page
EZ Rules(r) 3 demos
QC Validator(r) 2.0 tutorials and demos
Quality Planning worksheets
Normalized OPSpecs charts

"Westgard Rules" worksheet
Six Sigma Method Decision Chart

Basic QC Practices lessons: 
QC - The Idea 
QC - The Levey-Jennings Chart 
QC - The Materials 
QC - The Calculations 
QC - The Chances of Rejection 
QC - The Out-of-Control Problem 
QC - The Multirule Intrepretation 
QC - The Reports
"Westgard Rules": Abuses, misuses and "In-excuses"

"Westgard Rules" Best Practices 
 Basic Method Validation lessons: 
MV - Selecting a Method to Validate
MV - The Experimental Plan
MV - The Replication Experiment
MV - The Comparison of Methods Experiment
MV - The Data Analysis Tool Kit
MV - The Decision on Method Performance
MV - The Linearity or Reportable Range Experiment
MV - The Interference & Recovery Experiments

MV - The Need for Standard Processes and Standards of Quality
MV - The Detection Limit
MV - Reference Interval Transference

QC Planning lessons: 
QP 1: A Wake-Up Call for Quality Management
QP 2: Assuring Quality through TQM
QP 3: Complying with Regulations, Standards, and Practices Guidelines
QP 4: Devising a Practical Process
QP 5: Defining Quality Requirements
QP 6: Using OPSpecs Charts to Plan Quality

QP 7: Formulating a Total Quality Control Strategy
QP 8: Using Normalized OPSpecs to Plan Quality
QP 9: Practice makes Proficient
QP 10:Automated Chemistry applications
QP 11: Blood Gas applications
QP 12: Immunoassay applications
QP 13: Coagulations applications
QP 14: What's wrong with quality control?
QP 15: FAQ's about quality planning
Other Lessons:
What is QC Validator? 
Starting a QC Planning Process 
Power Function Graphs 
Critical-Error Graphs 
OPSpecs Charts 
Quality Planning Models 
Total Quality Control (TQC) Strategies 
Normalized OPSpecs Charts 
QC Selection Grids 
The Automatic QC Selection Engine
The Area Under a Table
It's About Time!

 

Z-Stats (Basic Statistics) lessons: 
Z-1: Aligning attitudes through purpose
Z-2: An organizer of statistical terms, part I

Z-3: An organizer of statistical terms, part II
Z-4: Mean, standard deviation and coefficient of variation
Z-5: Sum of squares, variance, and the standard error of the mean
Z-6: Probability and the standard error of the mean
Z-7: Hypothesis testing, tests of significance, and confidence intervals
Z-8: Two-Sample and Directional Hypothesis Testing
Z-9: Truth or consequences for a statistical test of significance
Z-10: ANOVA - The analysis of variance
Z-11: Confidence Intervals
Z-12: Correlation and least squares analysis

Z-13: Least-squares regression model
Z-14: Estimating analytical errors using regression statistics

 CLIA Final[5] Rule: 
Part I: Key Changes
Part II: Perplexity about Complexity and Personnel
Part III: QC - Compliance or Quality?
Part VI: The New Method Validation Regulations
Part V: Method Validation Process & Procedures
Part VI: Statistical Sense, Sensitivity and Significance
Part VII: "Equivalent" QC Procedures
Part VIII: Interpretive Guidelines
Part IX: Appropriate QC Procedures
Part X: Lies, Damn Lies, and "Equivalent QC" Practices

CLIA analytical quality requirements

More on CLIA and "Quality-Less Compliance"
Testing Equivalent Quality: A Better Way
The Final Word on the Final Rule?
Hearings on Untruth and Unquality, Part I: Cracks

The Scientific Rationale for "Equivalent QC" from CMS?
Challenging the CMS Scientific Rationale

QC Applications: 
Potassium 
Cholesterol with analytical requirement 
Immunoassay QC with higher N multirules 
QC selection for multitest chemistry analyzer 
Cholesterol with clinical requirement 
QC for a POC glucose test 
Establishing QC Acceptability criteria for CLIA'88 
Using Biological Goals for cholesterol and glucose 
QC - The Practice 
Hemoglobin 
Leukocyte Count
Digoxin
MV - The Real World Applications
 
Six Sigma: Medical Cutoffs as Tolerance Limits
Six Sigma: Quality Design and Control Applications
Six Sigma: Patient Data for Assessing Performance and Stability
Six Sigma: Newborn Screening
Choosing QC for Glycated Hemoglobin (GHb)
Setting Method Specs for Glycated Hemoglobin (GHb)

Six Sigma: Real World Chemistry Data
Six Sigma: A Project in Action
From Method Performance Claims to Six Sigma Metrics: A POC Chemistry Analyzer
From Method Performance Claims to Six Sigma Metrics: A Roche Integra 400+ Chemistry Analyzer
From Precision Claims to Six Sigma Metrics: High Volume Hematology Analyzers
Questions: 
Using Mean/Range charts 
FAQ's about QC Validator 
FAQ's about Multirule QC; Immunoassay QC 
FAQ's about Power Functions and Critical-Error Graphs 
FAQ's about OPSpecs Charts 
Multirules and Validator; What's a Run? 
FAQ's about CLIA'88, JCAHO & CAP 
FAQ's about Basic QC practices
1998 Round-up of Q&A
FAQ's about Method Validation
Basic Method Validation class questions

1999 Round-up of Q&A
AACC Expert Access Online Q&A - Six Sigma
Quintiles and Quality? What to do with hs-CRP

Guest Essays: 
Understanding Quality -- Jerry Ehrmeyer 
Approaches to Clinical Laboratory Utilization -- Art Eggert, Ph.D. 
Tips on managing the quality of immunoassays -- R. Neill Carey, Ph.D. 
Defect rates, quality and productivity -- Robert Burnett, Ph.D. 
What's New with CLIA'88, JCAHO & CAP -- Sharon Ehrmeyer, Ph.D. 
European Approaches to Analytical Goal-Setting -- Per Hyltoft Petersen 
QC - The Regulations -- Sharon Ehrmeyer, Ph.D.  
Total Quality Management for Medical Laboratories: A European point of view -- Dr. Pharm. J.C. Libeer, Ph.D., Ph.D.
MV - The Regulations -- Sharon Ehrmeyer, Ph.D.
Biological variation data for setting quality specifications -- Callum G. Fraser, Ph.D.
QC Validation in Veterinary Laboratories -- Kathleen P. Freeman, DVM, MS, Ph.D.
Report of the Norwegian EQA Validator Workshop, Dr. Heidi Steensland
Trueness and Uncertainty,
Dr Xavier Fuentes Arderiu Ph.D. Pharm.D.
Good Laboratory Practice versus CLIA
Janine Denis Cook, Ph.D.
Biologic Variation and desirable specifications for quality control
Dr. Carmen Ricos

CLS: Victims of our own Success?
Diana Mass M.A., CLS(NCA)
Biologic Variation: Principles & Practice
Callum Fraser Ph.D.

Pre-,Post- & Analytical Errors, David Plaut
Biological Database Update, Dr. Carmen Ricos et al
Quality Requirements Update, Sharon Ehrmeyer, Ph.D.
Are "Scientific Statements" the Scientific Truth?, Callum G. Fraser, Ph.D.
Is GUM Injurious? or just superfluous?, Per Hyltoft Petersen et al.
It's Not Rocket Science: Lessons from the Columbia and Challenger Disasters, Sten Westgard and James O. Westgard, Ph.D.  
Reference Material 
CLIA analytical quality requirements 
Clinical quality requirements 
European Biologic Goals and calculated allowable total errors 
Medical Decision Levels 
QC Planning Course outline 
Glossary of QC Terms 
List of QC Planning References
The Original Multirule Paper (PDF) 
MEDx Charts (PDF)
MEDx Excel Spreadsheet
 
Use and Interpretation of common statistical tests in method-comparison studies (PDF) 
Multichemistry papers (& Cost savings!) (PDF)
Global Quality Requirements: consensus draft
Multirule/"Westgard Rules" Worksheet (PDF)

ISO Glossary of Metrological Terms
Table of Areas beneath a Standard Normal Curve
Quality Planning Worksheet (PDF)

Normalized OPSpecs Charts (PDF)
Biologic Variation database
IQC paper (PDF)
Portuguese Translations (ZIP, PDF)

WQC Biographies 
James O. Westgard, Ph.D. 
Bernie Stein. 
Sten Westgard.
WQC Web Tools 
Normalized OPSpecs Chart Calculator 
QC Selection Grids 
Control Limit Calculator 
QC Calculators 
  The Replication Experiment Calculator
The Linearity or Reportable Range Calculator
Method Validation data analysis tools
QC Plotter, Simulator, Checker, Trainer
QC Planner, Method Planner
Six Sigma Calculator!

2005 WQC Products Catalog 

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