OPSPECS MANUAL, EXPANDED EDITION
TABLE OF CONTENTS

Here's a glimpse of the chapters and sections contained in the OPSpecs Manual, Expanded Edition:

An Excerpt from the Forward:

This manual makes available a large number of OPSpecs^® charts to help select appropriate QC procedures. These charts describe the imprecision and inaccuracy that are allowable and the statistical quality control (QC) that is necessary to assure that a required level of analytical quality will be achieved in routine testing. The charts cover the full range of analytical quality requirements that have been published as CLIA-88 proficiency testing (PT) criteria, thus, this manual provides the tools needed to select QC procedures and validate QC performance to meet U.S. regulatory requirements.

OPSpecs charts are the simplest QC planning tool currently available. Application requires only that the imprecision and inaccuracy observed for the test method be plotted on the OPSpecs chart. No calculations are required, only visual inspection of the chart.

The OPSpecs approach evolved from earlier work on a structured QC design process[1] and a simplified selection process using QC Selection Grids[2]. These earlier approaches depended on the calculation of the critical-sized systematic error and the use of power function graphs to assess the performance of QC procedures. Some power function graphs are provided in the manual to demonstrate the performance characteristics of QC procedures and to help understand the OPSpecs chart. Once understood, the OPSpecs chart provides a simpler, more practical tool for busy service laboratories. The OPSpecs charts available in this expanded edition are applicable for commonly used single-rule procedures (1_3.5s, 1_3s, 1_2.5s, and 1_2s) and multi-rule procedures (1_3s/2_2s/R_4s/4_1s, 1_3s/2of3_2s/R_4s/3_1s/6_x) with 2 to 6 control measurements per run. More extensive applications are possible using the QC Validator^® computer program which can generate OPSpecs charts for other QC procedures and for clinical and analytical quality requirements. The charts included in this manual were prepared using QC Validator and users of that program should find this manual valuable for understanding the OPSpecs approach and utilizing the program's options.

References

1. Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes. Washington, DC: AACC Press, 1986.
2. Westgard JO, Quam EF, Barry PL. Selection grids for planning quality control procedures. Clin Lab Sci 1990;3:273-280.

Table of Contents for the OPSpecs Manual, Expanded Edition: