QC Planning References

Specific references are included at the end of the individual essays, lessons, and QC planning applications. A more comprehensive list is provided here to describe the body of work that is the basis for this course. These references are arranged in categories from broad to specific, beginning with how total quality management applies in a healthcare laboratory, how TQM influences analytical quality management and provides a focus on quality planning, how quality planning can be developed and supported using QC planning tools and technology for laboratories, and how those tools and new computer technology can be applied to laboratory testing processes. Also included are some earlier references concerning the performance characteristics of QC procedures and the evaluation of analytical methods that help complete the background for this approach to analytical quality management.

Total quality management

Westgard JO, Barry PL, Tomar RS. Implementing Total Quality Management in health care laboratories. CLMR 1991;5:353-370.
Westgard JO, Burnett RW, Bowers GN. Quality management science in clinical chemistry: A dynamic framework for continuous improvement. Clin Chem 1990;36:1712-16.
Westgard JO, Barry PL. Beyond quality assurance: Committing to quality improvement. Laboratory Medicine 1989;20:241-7.
Westgard JO, Barry PL. Total Quality Control: Evolution of quality systems in health care laboratories. Laboratory Medicine 1989;20:377-84.
Westgard JO. What is quality? Managing the quality of laboratory test results in a changing health care environment, l986 Institute on Critical Issues in Health Laboratory Practice, DuPont Company, Wilmington, DE, 1987.
Westgard JO. What is cost? Managing the quality of laboratory test results in a changing health care environment, 1986 Institute on Critical Issues in Health Laboratory Practice, DuPont Company, Wilmington, DE, 1987.
Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the quality and productivity of analytical processes. AACC Press, Washington, DC, 240 p, 1986 (chapter 1).

Analytical quality management

Westgard JO. Planning statistical QC procedures. Manual of Clinical Laboratory Immunology, 5th edition, Rose NR et al ed, ASM Press, Washington, DC, 1997, pp 1191-1200.
Westgard JO, QA: Are laboratories assuring, assessing, or assuming the quality of clinical testing today? Proceedings of the CDC 1995 Institute on Critical Issues in Health Laboratory Practice: Frontiers in Laboratory Practice Research. CDC, Atlanta, GA, 1996, pp 179-189.
Westgard JO, Klee GG. Quality Assurance. Chapter in Fundamentals of Clinical Chemistry, 2nd ed, Burtis K, ed., WB Saunders Company, Philadelphia, 1996, pp. 211-223.
Westgard JO. Strategies for Cost-Effective QC. Clin Lab News 1996;22(10): 8-9.
Westgard JO. A method evaluation decision chart (MEDx Chart) for judging method performance. Clin Lab Science. 1995;8:277-83.
Westgard JO. A QC planning process for selecting and validating statistical QC procedures. Reviews in Clinical Biochemistry 1994;15(iv):155-64.
Westgard JO, Klee GG. Quality Assurance. Chapter 2E in Textbook of Clinical Chemistry, 2nd edition. Burtis K, ed., WB Saunders Company, Philadelphia, 1994, pp 548-592.
Burnett RW, Westgard JO. Selection of measurement and control procedures to satisfy HCFA requirements and provide cost-effective operation. Arch Pathol Lab Med 1992;116:777-782.
Westgard JO. Analytical quality assurance through process planning and quality control. Arch Pathol Lab Med 1992;116:765-769.
Westgard JO, Burnett RW. Precision requirements for cost-effective operation of analytical processes. Clin Chem 1990;36:1629-32.
Westgard JO and Barry PL. Cost- Effective Quality Control. Japanese edition, 1989.
Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the quality and productivity of analytical processes. AACC Press, Washington, DC, 240 p, 1986 (chapters 2- 5).
Westgard JO, Groth T. A predictive value model for quality control: Effects of the prevalence of errors on the performance of control procedures. Am J Clin Pathol 1983;80:49-56.
deVerdier C-H, Groth T, Westgard JO. What is the quality of quality control procedures. Scand J Clin Lab Invest 1981;41:1-14.

QC planning tools and technology

Westgard JO, Stein B, Westgard SA, Kennedy R. QC Validator 2.0: a computer program for automatic selection of statistical QC procedures in healthcare laboratories. (accepted by Comput Method Program Biomed, expected publication fall 1997)
Westgard JO, Stein B. An automatic process for selecting statistical QC procedures to assure clinical or analytical quality requirements. Clin Chem 1997;43:400-403.
Westgard JO, Smith FA, Mountain PJ, Boss S. Design and assessment of average of normals (AON) patient data algorithms to maximize run lengths for automatic process control. Clin Chem 1996;42:1683-1688.
Westgard JO. Error budgets for quality management: Practical tools for planning and assuring the analytical quality of laboratory testing processes. Clin Lab Manag Review 1996;10:377- 403.
Westgard JO. OPSpecs Manual - Expanded Edition. Ogunquit, ME, Westgard QC, 1996, distributed by American Association for Clinical Chemistry, Americal Society for Clinical Laboratory Science, and Clinical Laboratory Management Association.
Westgard JO. A program for assessing statistical control procedures. Med Lab Observ 1994;26(2): 55-60.
Wiebe DA, Westgard JO. Cholesterol - a model system to relate medical needs with analytical performance. Clin Chem 1993;39:1504-1513.
Hyltoft Petersen P, Fraser CG, Westgard JO, Lytken Larsen M. Analytical goal-setting for monitoring patients when two analytical methods are used. Clin Chem 1992;38:2256-60.
Westgard JO. Charts of operational process specifications ("OPSpecs charts") for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing criteria. Clin Chem 1992;38:1226-33.
Westgard JO. Simulation and modeling for optimizing quality control and improving analytical quality assurance. Clin Chem 1992;38:175-8.
Westgard JO, Wiebe DA. Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing. Clin Chem 1991;37:1938-44.
Westgard JO, Hytoft Petersen P, Wiebe DA. Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program (NCEP). Clin Chem 1991:37:656- 661.
Westgard JO, Cembrowski GS. Relationship of quality goals and measurement performance to the selection of QC procedures for multi-test hematology analyzers. Eur J Hem 1990;45 suppl.53:14-18.
Westgard JO, Quam EF, Barry PL. QC selection grids for planning QC procedures. Clin Lab Sci 1990;3:271-8.
Westgard JO, Groth T. Design and evaluation of statistical control procedrues: Applications of a computer 'QC Simulator' program. Clin Chem 1981;27:1536-1545.
Groth T, Falk H, Westgard JO. An interactive computer simulation program for the design of statistical control procedures in clinical chemistry. Computer Programs in Biomedicine 1981;13:73-86.
Westgard JO, Groth T. Power functions for statistical control rules. Clin Chem 1979;25:863-69.

Quality planning applications

Fallest-Strobl PC, Olafsdottir E, Wiebe DA, Westgard JO. Comparison of NCEP performance specifications for triglycerides, HDL, and LDL cholesterol with operating specifications based on NCEP clinical and analytical goals. (accepted by Clin Chem, expected publication fall/winter 1997).
Green GA, Carey RN, Westgard JO, Carten T, Shablesky LA, Achord D, Page E, Van Le A. Quality control for qualitative assays: Design of a quantitative QC procedure to assure analytical quality for an ELISA for hepatitis B surface antigen. (accepted by Clin Chem, expected publication fall 1997).
Westgard JO, Bawa N, Ross JW, Lawson NS. Laboratory precision performance: State of the art versus operating specifications that assure the analytical quality required by proficiency testing criteria. Arch Path Lab Med 1996;120:621-625.
Olafsdottir E, Westgard JO, Ehrmeyer SS, Fallon KD. Matrix effects on the performance and selection of QC procedures to monitor PO2 in blood gas measurements. Clin Chem 1996;42:392-6.
Westgard JO, Haberzettl CA. QC for immunoassays. Diagnostic Endocrinology and Metabolism: An AACC Inservice Training & Continuing Education Program 1996;14:239- 243.
Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem 1994;40;1909-14.
Westgard JO, Seehafer JJ, Barry PL. European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by U.S. CLIA proficiency testing criteria. Clin Chem 1994;40:1228-32.
Mugan K, Carlson IH, Westgard JO. Planning QC procedures for immunoassays. J Clin Immunoassay 1994;17:216-22.
Westgard JO, Quam EF, Barry PL. Establishing and evaluating QC acceptability criteria. Med Lab Observ 1994;26(2):22-26.
Westgard JO, Oryall JJ, Koch DD. Predicting effects of QC practices on the cost-effective operation of a multitest analytical system. Clin Chem 1990;36:1760-64.
Koch DD, Oryall JJ, Quam EF, Felbruegge DH, Dowd DE, Barry PL, Westgard JO. Selection of medically useful QC procedures for individual tests on a multi-test analytical system. Clin Chem 1990;36:230-3.

QC procedures and performance characteristics

Carey RN, Tyvoll JL, Plaut DS, Hancock MS, Barry PL, Westgard JO. Performance characteristics of some statistical quality control rules for radioimmunoassay. J. Clin Immunoassay 1985;8:245-252.
Cembrowski GS, Westgard JO. Quality control of multichannel hematology analyzers: Evaluation of Bull's algorithm. Am J Clin Path 1985;83:337-345.
Cembrowski GS, Chandler EP, Westgard JO. Assessment of 'Average of Normals' quality control procedures and guidelines for implementation. Am J Clin Pathol 1984;81:492-499.
Bockelman HW, Cembrowski GS, Kurtyzc DFI, Garber CC, Westgard JO, Weisberg HF. Quality control of electrolyte analyzers: Evaluation of the anion gap average. Am J Clin Pathol 1984;81:219-223.
Cembrowski GS, Kurtycz DFI, Westgard JO. Use of anion gap for quality control of electrolyte analyzers. Am J Clin Pathol 1983;79:688-696.
Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981;27:493-501.
Westgard JO, Falk H, Groth T. Influence of a between run component of variation, choice of control limits, and shape of error distribution on the performance characteristics of rules for internal quality control. Clin Chem 1979;25:394-400.
Westgard JO, Groth T, Aronsson T, deVerdier C-H. Combined Shewhart-cusum control chart for improved quality control in clinical chemistry. Clin Chem 1977;23:1881-87.
Westgard JO, Groth T, Aronsson T, Falk H, deVerdier C-H. Performance characteristics of rules for internal quality control: Probabilities for false rejection and error detection. Clin Chem 1977;23:1857-67.

Method evaluation

Westgard JO. Precision and accuracy: Concepts and assessment by method evaluation testing. CRC Critical Reviews in Clinical Laboratory Sciences 1981;13:283-330.
Westgard JO, deVos DJ, Hunt MR, Quam EF, Carey RN, Garber CC. Method Evaluation, Japanese edition. Ishiyaku Publishers, Inc., Tokyo, Japan, 113 pages, 1981.
Garber CC, Westgard JO, Milz L, Larson FC. DuPont aca III performance as tested according to NCCLS guidelines. Clin Chem 1979;25:1730-38.
Cembrowski GS, Westgard JO, Conover WJ, Toren EC. Statistical analysis of method comparison data: Testing normality. Am J Clin Pathol 1979;72:21-26.
Westgard JO, deVos DJ, Hunt MR, Quam EF, Carey RN, Garber CC. Method Evaluation. American Society for Medical Technology, 75p, 1978.
Westgard JO, deVos D, Hunt MR, Quam EF, Carey RN, Garber CC. Concepts and practices in the evaluation of clinical chemistry methods. Part V. Applications. Am J Med Technol 1978;44:803-13.
Westgard JO, deVos D, Hunt MR, Quam EF, Carey RN, Garber CC. Concepts and practices in the evaluation of clinical chemistry methods. Part V. Decisions on acceptability. Am J Med Technol 1978;44:727-42.
Westgard JO, deVos D, Hunt MR, Quam EF, Carey RN, Garber CC. Concepts and practices in the evaluation of clinical chemistry methods. Part III. Statistics. Am J Med Technol 1978;44:552-70.
Westgard JO, deVos D, Hunt MR, Quam EF, Carey RN, Garber CC. Concepts and practices in the evaluation of clinical chemistry methods. Part II. Experimental procedures. Am J Med Technol 1978;44:420-430.
Westgard JO, deVos D, Hunt MR, Quam EF, Carey RN, Garber CC. Concepts and practices in the evaluation of clinical chemistry methods. Part I. Background and approach. Am J Med Technol 1978;44:290-300.
Westgard JO. The development of performance standards and criteria for testing the precision and accuracy of laboratory methods. 1976 Aspen Conference on Analytical Goals in Clinical Chemistry, Elevitch F, ed., College of American Pathologists, pp 105-114, 1977.
Westgard JO, Carey RN, Feldbruegge DH, Jenkins LM. Performance studies on the Technicon SMAC analyzer: Precision and comparison of values with methods in routine laboratory service. Clin Chem 1976;22:489-96.
Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem 1974;20:825-33.
Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method comparison studies. Clin Chem 1973;19:49-57.

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