Is semiannual calibration verification required if the laboratory is performing calibration at least once every six months? Effective 6/2004
Joint Commission on Accreditation of Healthcare Organizations
Q: Is semiannual calibration verification required if the laboratory is performing calibration at least once every six months?
A: Semiannual calibration verification is not required when the laboratory performs a calibration protocol using 3 or more levels of calibration materials that include a low, mid, and high value at least once every 6 months. After calibration, quality control should be performed and documented to verify the calibration protocol was successful.
Issue 4, 2006 Lab Focus
Megan Sawchuk, MT (ASCP), associate director
Standards Interpretation Group
Q. Does the Joint Commission require semiannual “linearity studies?” Are there less expensive acceptable alternatives?
A. Joint Commission standards require semiannual calibration verification, not specifically linearity studies. The requirements are in Standard QC.1.170: The laboratory maintains and evaluates data on the routine precision of test results and performs calibration verification and recalibration as required.
The purpose of calibration verification is to verify both the reportable range and the linearity of an instrument’s results. Laboratories have the option to use a variety of materials with known values such as national reference standards, calibrators (used to establish a “set point” for an instrument), proficiency testing results, or quality control materials (different lots than routinely used). Verification using these materials is typically less expensive and more convenient than purchased linearity kits because you use information that is already on hand. The laboratory must simply aggregate the data on a semiannual basis and demonstrate the linear performance and reportable range of the instrument. Verifying linear performance requires documentation of at least three known samples including a low, middle, and high value that span the reportable range.
Calibration verification using purchased commercial linearity kits typically exceeds what is required by the Joint Commission or CLIA regulations. Linearity kits often include at least five levels of testing which are performed in duplicate. The results are then submitted to the vendor for aggregation and analysis.
For waived tests, such as bedside glucose testing, neither linearity studies nor calibration verification are required. A basic validation of the reportable range should be done prior to implementation of the waived instrument. Running several quality control samples (at least the high and low range) or known patient samples would be sufficient.