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Monitoring Performance of Glucose Meters FAQs

Q&A from Webinar: Monitor Performance of Multiple Glucose Meters and Stay in Compliance

October 17, 2016

CAP Accreditation Program Proficiency Testing (PT) Requirements for Whole Blood Glucose Testing

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Beginning in 2017, PT for waived whole blood glucose on glucose meters will no longer be required for laboratories accredited by the CAP. Laboratories will be required to perform alternative performance assessment (APA).

Yes, PT requirements will only be discontinued for waived whole blood glucose by meter (strip). PT will still be required for other waived whole blood glucose methods such as iSTAT, Hemocue, and Piccolo.

While iSTAT uses a whole blood sample, it uses a blood cell separation microfluidic system and essentially tests plasma. Additionally, Hemocue and iSTAT are FDA approved for quantitative glucose measurement without restrictions, whereas meters do not have FDA approval for critical care use. The CAP offers a Quality Cross Check program (AQ4Q) for laboratories that want to verify the accuracy and perform comparability studies for additional iSTAT instruments.

The use of a waived whole blood glucose meter off label would classify it as a nonwaived method (high complexity); therefore, it would be subject to all the requirements for nonwaived methods in the CLIA regulations, including verifying the accuracy of the method twice per year. Quality Cross Check—Whole Blood Glucose (WBGQ) can be used to meet this requirement. In addition, laboratories can enroll in the Waived Test Combination (HCC2) to meet the requirement.

Alternative Performance Assessment (APA) for Whole Blood Glucose Testing Using Meters

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Semiannual APA options for waived whole blood glucose testing on glucose meters are as follows:

  • Participation in an external PT program or the Quality Cross Check—Whole Blood Glucose (WGBQ) program
  • Split sample analysis with reference or other laboratories
  • Split samples with an established in-house method (for example, Chemistry analyzer, iSTAT, etc)
  • Use of assayed materials (for example, blinded QC and/or linearity material
  • Other suitable and documented means

No, APA is required at the analyte level and is not required for each instrument/method. Similar to PT, a laboratory should rotate APA among glucose meters.

It is the responsibility of the laboratory director to define such alternative assessment procedures and the criteria for successful performance in accordance with good clinical and scientific laboratory practice.

APA review may be delegated, in writing, to other qualified individuals.

Quality Cross Check—Whole Blood Glucose (WBGQ)

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A single WBGQ kit may be used to test 30 meters, and laboratories may rotate meters between shipments. Alternatively, you may order multiple WBGQ kits to test additional meters.

No, the WBGQ kit is intended to test up to 30 meters. It contains three specimens each with a different level, and every meter used in testing will report a value for each of the three levels.

No, a laboratory should rotate testing among glucose meters and personnel.

Participant evaluations and a Participant Summary Report (PSR) will be available online at cap.org in e-LAB Solutions Suite. In addition, reports will be mailed to participating laboratories.

Quality Cross Check is not a form of proficiency testing, and as such will not be formally monitored by the CAP’s Laboratory Accreditation Program. Laboratories will be required to provide Quality Cross Check reports, evaluation of results, and any subsequent corrective actions performed during their on-site inspection.

Quality Cross Check is not a form proficiency testing, and it is important that laboratories distinguish PT from Quality Cross Check in their procedures. Similar to PT, the Quality Cross Check program provides an evaluation of results, and as such the written procedure can reflect a similar process to how laboratories evaluate graded PT.