Istat Value Assignment Sheets

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The AMR must be at least every six months, at changes in major system components, and when a complete change in reagents for a procedure is introduced, unless the lab can demonstrate that changing reagent lot numbers does not affect the range used to report patient/client test results.

Routine reagent lot changes may not require AMR of the AMR.

In general, routine control materials are not suitable for calibration verification, except in situations where the material is specifically designated by the method manufacturer as suitable for verification of the method's calibration process.”¹ 1.

Yes, the use of the LGC Maine Standards products meets the requirements for AMR validation and also for calibration verification.

“Calibration verification means the assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results.” The CLIA regulations are located on the CDC internet site at the following location According to the CLIA regulation provided in 42 CFR 493 section 493.1255: "(b) Perform and document calibration verification procedures: (3) At least once every 6 months and whenever any of the following occur: (i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.(ii) There is a major preventive maintenance or replacement of critical parts that may influence test performance.(iii) Control material reflect an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.(iv) The laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.

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The definition is provided in 42 CFR 493 in section 493.2.A copy of this correspondence is available for download here.If laboratory users are interested in the position of the CAP on this matter, please feel free to contact CAP directly via e-mail ().LGC Maine Standards is confident that its products are uniquely suited to provide for linearity and calibration verification needs in today’s clinical laboratory.Please contact us with any questions you may have on this issue.Calibration verification can be accomplished in several ways.If the method manufacturer provides a calibration validation or verification process, it should be followed.The CAP checklist, and CLIA ’88 regulations, require three points for AMR validation: lowest, midpoint and highest values.“’We [in the committee] prefer at least five,’ says Dr.The requirements are specified in 42 CFR 493 in section 493.1253 "Standard: Establishment and verification of performance specifications".For a new unmodified, FDA-cleared or approved test system brought into the lab after April 24, 2003, the standard requires the following: "(b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (A) Accuracy.(B) Precision.(C) Reportable range of test results for the test system." LGC Maine Standards' VALIDATE® products are excellent for this testing and allow you to maximize your reportable range with no dilutions.

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