Because POC testing is done sight unseen by the laboratory, there are two significant aspects to managing the quality of these results.

The first is the ability to hold selected results for review before sending to the LIMS/EMR. Instrument results from the central laboratory are first seen by the operator before uploading to the LIMS/EMR or held in the LIMS/EMR for review before release. With thousands of results coming from thousands of different POC devices where the results have already been released/acted upon, holding, and reviewing them would be a challenge. In QML, customers define rules for holding specific and sometimes suspect results based on any of the following:

• Flags received from devices,
• Internal ranges defined regardless of the device flag,
• Sample type/age/gender-defined reference ranges,
• Other information necessary to report with the result that is missing, or
• Invalid patient identification.

These rules can be defined by facility, or even down to a facility’s location, allowing for greater flexibility to meet different workflow requirements within each hospital or location. Follow-up is then limited to only those ‘flagged’ results along with electronic documentation of such actions while all other results are automatically sent to the LIMS/EMR.

The second is a review of the quality control results performed on each device to verify the device is performing within the manufacturer’s guidelines. Laboratory systems are very limited, if capable at all, in their ability to handle the thousands of quality control results generated daily by POC devices and generate applicable Levey Jennings/linearity charts for each device. The QML result exception process is for more than just patient results; it can also be used to hold QC results outside of the expected ranges.