Inter-laboratory performance monitoring system

A system for providing quality control ratings for a plurality of instruments which are operated on a periodic basis to produce control data from the same lot of control materials for all instruments comprising a peer group, the system comprising, in combination:

• an electronic communication interface for automatically receiving from all instruments in the peer group the control data on a periodic basis;
• a data storage module for storing the control data received on a periodic basis from all of the instruments in the peer group, the data storage module storing said control data along with an identification of the instrument and an identification of the period for which the control data was produced;
• a status memory identifying a subset of the peer group as a golden peer group operating at a high standard of accuracy and precision;
• a target module operating in conjunction with the status memory for determining from the golden peer group a set of periodic moving targets, the target module including means for automatically producing horizontal robustness across periods and vertical robustness across instruments in the golden peer group so as to automatically minimize, without human editing, the effect of outliers and erroneous data;
• a correlation comparator comprising means for comparing the periodic control data from the data storage module with the periodic targets for a given interval comprising a number of periods to produce a CCC rating for said interval for each instrument in the peer group;
• a CCC evaluator for determining the distribution of the CCC's of all of the instruments in the peer group and rating the CCC of each instrument against said distribution;
• and
• means responsive to the CCC evaluator for selecting the golden peer group from the peer group, and for updating the status memory with the golden peer group identification.

A method for quality control monitoring of a plurality of widely geographically dispersed instruments which are operated periodically to produce control data from common control samples, the method comprising the steps of:

• electronically communicating the control data from each instrument to a central station on a periodic basis and automatically receiving and storing the control data at the central station, maintaining with the stored control data an identification of each instrument which produced it and the date on which it was produced;
• producing a moving median periodic output for each instrument in a way which provides horizontal robustness by monitoring n periods and selecting for each new period median control data values for the new period which minimize the effect of outliers and erroneous data;
• determining moving control targets for each period from the moving median periodic outputs by selecting a subset of the peer group comprising a golden peer group of good performing instruments and averaging the control data for each period across the golden peer group in a way which assures vertical robustness;
• performing a concordance correlation comparison to produce a CCC for each instrument measuring its accuracy and precision with respect to the moving targets from the golden peer group over an interval comprising a number of periods;
• determining the distribution of the CCC's for all instruments in the peer group;
• rating the CCC of each instrument for the interval against the distribution for all instruments in the peer group;
• and
• selecting the golden peer group from the instruments near the center of the distribution.

A method of performing laboratory analyses on samples to produce results on a standardized scale, the scale being calibrated by periodically performing the analysis on known calibration samples, the method comprising the steps of obtaining a plurality of patient samples to be tested, performing the analysis on each of the plurality of patient samples to produce analytical reports for those samples, periodically performing the analysis on calibration samples to produce control data for the control samples and using the control data to validate the analytical reports, electronically reporting the control data to a central station along with like control data from all other laboratories making up a peer group which perform the same test and use the same control materials, at the central station:

• storing all of the control data for a plurality of periods for the peer group;
• selecting from the peer group a golden peer group of good performing laboratories;
• setting control data targets against which to evaluate the laboratory control data, the control data targets being selected from only the golden peer group, and being selected in such a way as to assure horizontal and vertical robustness while automatically eliminating the effect of outliers and erroneous data;
• for a given interval comprising a number of periods, comparing the control data from each laboratory against the targets determined from the golden peer group to produce a CCC for the interval for each laboratory;
• combining the CCC's from all of the laboratories in the peer group to determine the CCC distribution for the peer group;
• rating each laboratory by the fit of its CCC into the distribution;
• and
• utilizing the CCC evaluation to select the golden peer group.