While to err is human, sometimes the cost of a mistake might be just too high. History knows many examples of situations when software flaws have caused billions of dollars in waste or even lead to casualties: from Starbucks coffee shops being forced to give away free drinks because of a register malfunction, to the F-35 military aircraft being unable to detect the targets correctly because of a radar failure.
A drawback of these advanced simulation strategies is that the outcomes are probably rather laboratory specific. Furthermore, advanced statistical modeling and/or software is required that is generally not available in medical laboratories, although the web-based application MA Generator has become available online . This application allows laboratories to use the MA optimization approach described by van Rossum et al. , using laboratory-specific data sets.
More recently, a more or less pragmatic MA approach was introduced. It comprises two web-based and freely available applications called the Percentiler and Flagger , . They are part of a larger empowerment project developed to enhance the communication on analytical performance of commercial test systems between laboratories and in vitro diagnostic manufacturers , , . The Percentiler database comprises instrument-specific daily medians calculated from outpatient results and sent by e-mail from all over the world. Data are peer grouped by platform/assay. Via a user interface, participants have access to the graphical presentation of the course of their moving medians in comparison with the peer group one. This allows inference of the mid- to long-term stability of analytical performance at the individual and peer group level, and/or occurrence of shifts/drifts , . The Flagger application is designed to monitor the stability of the percentage of results flagged when they exceed the cutoff points used by individual laboratories. From combining the Percentiler and Flagger observations, users can infer how the change in flagging rate in their laboratory is related to the analytical variation .
Implementation of MA QC can be divided into the following stages: (i) determination of the MA procedure settings (truncation limits, calculation algorithm, control limits); (ii) configuration of MA settings and MA management on the analyzer, middleware or other MA supporting software packages; and (iii) the design and implementation of laboratory protocols for MA alarms . Methods to optimize and validate MA procedures are described above.
Finally, when MA is setup in the MA management software, laboratory protocols for handling MA QC alarms should be designed and implemented. The design of these protocols also determines which errors detected by MA alarms will be acknowledged. For example, a case was reported in which sodium assay failure was detected by MA . However, at the time of QC measurement as part of the MA alarm workup, there was no sign of assay failure. Only reanalysis of the patient samples as part of the MA alarm workup was able to elucidate that the MA alarm detected temporary, clinically significant, assay failure . Because MA alarms can be due to causes other than analytical assay failure (e.g. preanalytical issues, a single patient with extreme results, or false MA alarms), follow-up of an MA alarm should (when possible) at least include internal QC analysis in order to confirm analytical error , .
CompuGroup Medical works closely with regulatory agencies to provide the required tools to assist with compliance. CGM LABDAQ has an established record of updating software to meet new regulations. Laboratory inspections require less preparation with the CGM LABDAQ Quality Control and Document Management options. User-defined rules ensure that laboratory procedures are followed.
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GL Spectrosoft is a modular, PC-based analytical software designed for laboratory applications, field work, production quality control and for general light assessment purposes. With a range of powerful add ons, Spectrosoft adds power, speed and efficiency to your GL spectrometer. Whether analyzing field measurements, comparing lighting scenarios, or supporting production quality control, this versatile software platform provides quick access to all important information. 153554b96e