Table 1.
Glucose Meter Risk Managementa
| Potential sources of error | Control processes and risk mitigation strategies |
|---|---|
| Patient sources of error | |
| • Medications (i.e., maltose, xylose, galactose) | • Utilize alternate model of meter not subject to interference |
| • Hematocrit | • Education of acceptable hematocrit ranges |
| • Use a meter that measures and corrects for hematocrit effects | |
| • Disease contraindications (poor circulation, diabetic ketoacidosis, trauma) | • Education of meter limitations |
| Operator sources of error | |
| • Expired reagents | • Barcoded test strips that prevent use after expiration date |
| • Incorrect calibration | • Barcoded reagents that automatically calibrate meter with each test |
| • Reagent exposure from failure to recap bottles of test strips | • Use individually wrapped test strips |
| • Incorrect sample volume | • Use a meter that detects correct amount of blood or side-filling test strip |
| • Incorrect disinfection | • Match cleaning solution with manufacturer recommendations |
| • Inadvertent change of units from mg/dl to mmol/l | • Software administrative functions to prevent operator changing setting |
| • Untrained operator performing test | • Software operator IDb lockout, (checks operator against trained list) |
| • Failure to analyze controls or incorrectly interpret control pass/fail | • Software control lockout, (checks control performance passes at defined intervals) |
| • Wrong level control analyzed | • Use barcoded controls that automatically identify the level |
| • Incorrect patient identification | • Use meters with positive patient ID and barcoded patient wristbands |
| Environmental sources of error | |
| • Temperature extreme | • Internal meter checks that monitor temperature |
| • Analyze controls to verify test strip performance |
a
A sample of error sources encountered during the use of glucose meters and potential control processes that can reduce risk of specific errors. (Note, this list is not intended to be comprehensive, and sources of error will vary depending on meter model, institution, and medical use of the test result.)
b
(ID) identification