The QC Applications This page contains a list of all the QC applications (45+) written for Westgard Web, dating back to 1996. You can access every public QC application by clicking the green button. To access a preview of an QC application, click the blue preview button.

Go read it!	Essay Title	Preview	Availability	Books you might also be interested in: NEW! Assuring the Right Quality Right Six Sigma, 2nd Edition! EZ Rules© 3 CLIA Final Rules Nothing but the Truth Basic Method Validation, SECOND EDITION! Basic QC Practices Manual SECOND EDITION!! Basic Planning for Quality manual
	Westgard Sigma Analysis: multiple POC glucose methods		Public
	Evaluating Quality Requirements for HbA1c on the Abbott Architect c8000		Public
	Westgard Sigma Analysis: Abbott Architect c16000 Chemistry Analyzer		Public
	Westgard Sigma Analysis: ADVIA 1800 Chemistry Analyzer		Public
	Westgard Sigma Analysis: Abbott Architect c16000 Chemistry Analyzer		Public
	Westgard Sigma Analysis: Sysmex XE 2100 Hematology Analyzer		Public
	Westgard Sigma Analysis: Beckman Coulter HMX Hematology Analyzer		Public
	Westgard Sigma Analysis: Sysmex XT 2000i Hematology Analyzer		Public
	Westgard Sigma Analysis: Sysmex 9500 Hematology Analyzer		Public
	Westgard Sigma Analysis: Roche Modular Chemistry Analyzer		Public
	Westgard Sigma Analysis: A Multitest Chemistry Analyzer - 16 years later		Public
	The Quality of ...The Quality of... Series Looking at the Proficiency Testing Data		Public
	Patient Data or "traditional" QC? Evaluating the options for QC and QC goals		Public
	Westgard Sigma Analysis: Beckman Coulter UniCel DxC 800 Synchron		Public
	Westgard Sigma Analysis: Vitros 5,1 FS Chemistry system		Public
	Westgard Sigma Analysis: WBC on a SE 9500		Public
	Sigma Estimates: Beckman Hematology Analyzers		Public
	Westgard Sigma Analysis: 4 POC Glucose Analyzers		Public
	Sigma Estimates: High Volume Hematology Analyzers		Public
	Westgard Sigma Analysis: Roche Integra 400+		Public
	Westgard Sigma analysis: A POC device		Public
	Six Sigma: A Project in Action!		Public
	Six Sigma: Real World Chemistry Data		Public
	Setting Method Specifications for Glycated Hemoglobin (GHb)		Public
	Choosing QC for Glycated Hemoglobin (GHb)		Public
	Six Sigma: Newborn Screening		Public
	Six Sigma: Patient Data for Assessing Performance and Stability		Public
	Six Sigma: Quality Design and Control Applications		Public
	Six Sigma: Medical Cutoffs as Tolerance Limits		Public
	MV - The Real World Applications		Public, MV
	Digoxin		Public
	Leukocyte Count		Public
	Hemoglobin		Public
	QC - The Practice		Public, BQC
	Using Biological Goals for cholesterol and glucose		Public
	Establishing QC Acceptability criteria for CLIA'88		Public
	QC for a POC glucose test		Public
	Cholesterol with clinical quality requirement		Public
	QC selection for multitest chemistry analyzer		Public
	Immunoassay QC with higher N multirules		Public
	Cholesterol with analytical quality requirement		Public
	Potassium		Public

Potassium

A simple example planning QC for potassium using power function and critical-error graphs. Read this QC Application Back to Top

Cholesterol with analytical quality requirement

An example planning QC for cholesterol using the CLIA proficiency testing criteria for acceptability as an analytical quality requirement. Read this QC Application Back to Top

Immunoassay QC with higher N multirules

Immunoassay methods often have higher CVs than observed for routine chemistry and hematology tests. Laboratory QC practices often involve analyzing 3 or 4 different levels of controls and sometimes analyzing these controls in duplicate. In planning QC for such applications, it is useful to assess the error detection and false rejections characteristics of higher N multirule QC procedures and see how they compare with the performance from more common QC procedures having Ns of 2 to 4. Read this QC Application Back to Top

QC selection for multitest chemistry analyzer

How do you select QC for 18 different tests on a multitest instrument? Dr. Westgard illustrates how it's done, using the critical-errors graphs, and also explains how it can save money. Read this QC Application Back to Top

Cholesterol with clinical quality requirement

This cholesterol example illustrates the use of a clinical quality requirement based on the National Cholesterol Education Program's guidelines for use and interpretation of a screening cholesterol test. OPSpecs charts designed for clinical quality requirements are used to plan QC for cholesterol based on these guidelines. Read this QC Application Back to Top

QC for a POC glucose test

Is the QC planning process appropriate for POC devices? You bet. See this example application that shows how to plan QC for a glucose device. Read this QC Application Back to Top

Establishing QC Accessbility criteria for CLIA'88

It's no revelation to say that there is a lack of clear and specific directions about quality control in government and literature. In up to 30% of laboratories, this has led to ill-defined QC practice. This QC application provides more specific directions on how to select appropriate "QC acceptability criteria" and a Total QC strategy that will satisfy CLIA requirements. Read this QC Application Back to Top

Using European Biological Goals for cholesterol and glucose

Recommendations on how to use the QC Validator program with the European biologic goals for imprecision and inaccuracy have been published, along with some example applications [1]. Two additional applications are illustrated here to facilitate comparisons between the European biologic goals, the CLIA analytical quality requirements for total error, and the clinical quality requirements for medically important changes. Read this QC Application Back to Top

QC - The Practice

This lesson provides a summary of the overall process of establishing and maintaining a statistical QC procedure. The objective of this lesson is to outline all the activities that are necessary -- QC Planning, QC Implementation, QC Operation, QC Documentation and Review -- without getting bogged down in the details of each of these activities. More detailed information is provided by links to other materials on this website. Read this QC Application Back to Top

Hemoglobin

A simple example planning QC for hemoglobin using OPSpecs charts. Read this QC Application Back to Top

Leukocyte Count

A simple example planning QC for hemoglobin using OPSpecs charts. Read this QC Application Back to Top

Digoxin

A simple example planning QC for hemoglobin using OPSpecs charts. Read this QC Application Back to Top

MV - The Real World Applications

A review of Method Validation to help provide you with the skills to establish your own method validation process. It is important to establish a systematic process that is tailored to the needs of your laboratory and to the characteristics of the methods being tested. Don't assume that method performance is okay just because you've purchased new instruments or new reagent kits! In the real world, methods still have real problems. Read this QC Application Back to Top

Six Sigma - Medical Cutoffs as Tolerance Limits

See how quality-planning can deliver World Class Quality for a POC device. This QC application makes use of medical cutoffs as tolerance limits for a cardiac marker POC device. Using Six Sigma techniques, Dr. Westgard shows how QC can be easy for difficult methods. Read this QC Application Back to Top

Six Sigma - Quality Design and Control Applications

Forget the theory and the hype about Six Sigma: What can do "in action"? It can help you to objectively assess the state of your current QC, determine the desirable CV and bias for your tests, specify the necessary QC procedures and/or needed improvements, compare all kinds of quality requirements to each other, and more. Combined with our Quality-Planning tools, Six Sigma can offer a "one-two" punch to any QC situation. Read this QC Application Back to Top

Six Sigma - Patient Data for Assessing Performance and Stability

Patient Data and Six Sigma together? Yes, the two most advanced QC techniques can work together. In fact, the two make a powerful combination. This application illustrates the use of both Sigma-metrics and Patient Data QC (also known as Average of Normals, AoN, Average of Patients). Patient Data QC uses patient test results to assess the performance of a laboratory testing process and to identify changes in process stability. This application strategy fits together with the strategy of multistage quality control, which employs multiple QC designs to accomplish specific objectives. Read this QC Application Back to Top

Six Sigma - Newborn Screening

Neonatal screening is one of the most important services the laboratory can provide. Yet it is also one of the more difficult testing areas -- hard to characterize, hard to standardize, hard to QC. However, even in this tough area, Six Sigma can provide crucial guidance for critical neonatal testing. See how it's done. Read this QC Application Back to Top

Choosing QC for Glycated Hemoglobin (GHb)

In the March 2002 issue of Clin Chem, the NACB published a 36 page report about the use of laboratory tests for patients with diabetes. It's probably the longest paper ever published by Clin Chem. Dr. Westgard examined the "evidence-based" recommendations, though, and found some poor Sigma values. Here, using EZ Rules software, Dr. Westgard demonstrates the process of choosing QC for GHb. Read this QC Application Back to Top

Six Sigma - Real World Chemistry Data

In the March 2002 issue of Clin Chem, the NACB published a 36 page report about the use of laboratory tests for patients with diabetes. It's probably the longest paper ever published by Clin Chem. Dr. Westgard examined the "evidence-based" recommendations, though, and found some poor Sigma values. Here, using Validator software, Dr. Westgard demonstrates how to set useful method specifications for GHb. Read this QC Application Back to Top

Six Sigma - Real World Chemistry Data

We recently received a set of data for a chemistry analyzer. An analysis of these numbers gives us an eye-opening glimpse of real-world performance. On some tests, there were Sigma-metrics higher than 20! And yet on one test, the Sigma metric was actually below 1.0!! See which tests were good, which ones were great, and which ones were just plain ugly. Read this QC Application Back to Top

Six Sigma - A Project in Action

Recently, the Charleston Area Medical Center in West Virginia embraced Six Sigma. Melda Brown, a Black Belt in training, is one of their staff bringing better quality control to healthcare. Ms. Brown has been extremely generous in allowing us a glimpse of her Six Sigma Project as it is being implemented. Here we present the Define and Measure phases of her project. Read this QC Application Back to Top

From MV to Six Sigma - A POC Chemistry Analyzer

Now that we know how to translate the manufacturer's performance claims into Six Sigma metrics, let's take a hard look at some real-world data. With a performance study supplied by a "near-patient" chemistry anlayzer, we find out just how good (and how bad) performance of tests are when they're at the POC. Read this QC Application Back to Top

From MV to Six Sigma - A Roche Integra 400+ Chemistry Analyzer

Continuing in our series on translating method validation studies into Six Sigma metrics, we examine a Roche Integra 400+ chemistry analyzer, with data provided by St. Joseph Hospital in Houston, Texas. The results are stunning. Read this QC Application Back to Top

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.