WQC ARCHIVES

More than 300 Essays, Guest Essays, QC Applications, Lessons, and Questions are archived here! At this time, most articles are available to the public. 

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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 The Quality of Glycohemoglobin Testing The Quality of PSA Testing Solutions for a Taxing Problem The Quality of Coagulation Testing The Quality of PT Sigma metrics Links to India, Part I Method Performance and Test Quality: Same Thing? Links to India, Part II QC: Not just a technicality 100,000 miles to quality: 2005 in review Unannounced Inspections: Unlikely to improve quality Hopeful Healthcare in a Fearful Society Quality Indicators and Benchmarks Trouble with Tracking Tests Open Letter to CLSI What's the Laboratory's Core Competency? Update on Quality Design Tools GAO Report on CMS - it's out GAO Report Recommendations: the good, the bad, and the irrelevant GAO Report: The agencies respond Rumors of my Retirement are somewhat exaggerated... Thank you 2006: Links to Argentina 2006: Links to Spain GLP for Lab QC: Part I GLP for Lab QC: Part II 2006: Links to South Africa Why We Write Global and Local Imperatives for US healthcare In 2007, Method Validation skills are still vital Truthful Claims may not be enough Truthful Guidances about Trueness, Uncertainty and Quality Spotting Quality Internationally The meaning and application of Total Error CLSI faces the challenge of Quality The Health of US Healthcare Errors before the Laboratory "But is it really out?" Doing the Wrong QC Wrong A War of Words in Laboratory Terminology? A War of Words in Laboratory Terminology? Part II A War of Words in Laboratory Terminology? Part III Equivocal QC: Coming to a Lab near you The Quality of Glycated Hemoglobin (GHb) 2008: The year of EQC, AQC, or no QC at all?

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 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 (See also: QC Applications for Specific Case Studies)

Downloads:  See also the Demo Page EZ Rules 3 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 Six Sigma Metrics: A POC Chemistry Analyzer Six Sigma Metrics: A Roche Integra 400+ Chemistry Analyzer Six Sigma Metrics: High Volume Hematology Analyzers Six Sigma Metrics: Glucose POC Six Sigma Metrics: A user-submitted hematology example Six Sigma Metrics: Vitros 5.1 FS Chemistry System Six Sigma Metrics: UniCel DxC Synchron 800 Patient Data or "traditional QC"? Evaluating options for QC and QC Goals Designing QC for a multitest chemistry analyzer: an update 16 years later Six Sigma Metrics: Roche Modular system Six Sigma Metrics: Sysmex 9500 Hematology Analyzer Six Sigma Metrics: Sysmex XT 2000i Hematology Analyzer Six Sigma Metrics: Beckman Coulter HMX Hematology Analyzer Six Sigma Metrics: Sysmex XE 2100 Hematology Analyzer Six Sigma Metrics: Abbott Architect c16000 Chemistry Analyzer Six Sigma Metrics: Bayer ADVIA 1800 Chemistry Analyzer Six Sigma Metrics: Site Evaluation of Abbott Architect c16000 Evaluating Quality Requirements for HbA1c on the Abbott Architect c8000 Evaluating multiple POC glucose methods Six Sigma Metrics: HbA1c on the Roche cobas 6000 Six Sigma Metrics: Site Evaluation of a POC Critical Care Analyzer

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 Ten ways to do the Wrong QC Wrong