|
On January 24, 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for
Medicare & Medicaid Services (CMS) published laboratory regulations (CLIA) that became effective April
24, 2003. A complete text of these regulations can be found on the Internet at
http://www.phppo.cdc.gov/CLIA/regs/toc.aspx.
These regulations now describe how and when calibration verification is to be performed for nonwaived
(moderate and high complexity) tests. A test system’s calibration must be checked once every six (6)
months and whenever any of the following occur:
• All of the reagents used for a test procedure are changed to new lot numbers.
• There is a major preventive maintenance or replacement of critical parts that may influence the test’s
performance.
• Control materials reflect an unusual trend or shift, or are outside of the lab’s acceptable limits.
• The lab has determined that the test system’s reportable range should be checked more often.
AUDIT® MicroControls™
Calibration Verification material designed to assist with your instrument’s revalidation. Five unique levels
of linearity material are provided with each product to allow for complete monitoring of that specific test
system’s reportable range, as defined by the manufacturer.
Our MicroCV™ Linearity Sets arrive as either liquid or freeze-dried material (dependent upon the
analytes involved). The liquid products are ready to use and testing can begin immediately upon opening
the vials. The freeze-dried products must be reconstituted with deionized or distilled water (see package
insert for details).
Each of the five levels provided in the linearity set are then run as you would normally run a patient’s
sample. CLIA regulations do not state the frequency of testing (duplicate, triplicate, etc.) as that should be
determined by your laboratory. Once the testing is completed and values are generated, our AUDITOR™assists your laboratory with the reduction of calibration verification data. Easily accessible
QC Program
via our website (www.auditmicro.com), you simply enter the raw data that you collect from your
instrument and AUDITOR™ does the rest! We instantly provide you with an on-line graph of your data,
which can either be printed for your records or stored in our secure on-line database for future reference.
For more information
further troubleshooting
|
