Istat Value Assignment Sheets

Istat Value Assignment Sheets-25
“Reportable range means the span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response.” This definition is very similar to the definition of Analytical Measurement Range (AMR) used by CAP.

“Reportable range means the span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response.” This definition is very similar to the definition of Analytical Measurement Range (AMR) used by CAP.Use of the LGC Maine Standards products meets the requirements for reportable range validation and calibration verification.The CAP checklist, and CLIA ’88 regulations, require three points for AMR validation: lowest, midpoint and highest values.

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“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.

The definition is provided in 42 CFR 493 in section 493.2.

CAP uses two terms – calibration verification and AMR validation – to identify the two distinct processes required. Per the article below, AMR must be at least every six months.

From March 2003 CAP Today, “Analytical measurement range validation: The process of confirming that the assay system will correctly recover the concentration or activity of the over 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.

, ‘but CLIA says three,’ so the checklist question specifies three.”¹ LGC Maine Standards provides five levels and has multiple product configurations available to get as close as possible to the lowest and highest values for the many instrument systems available to maximize the AMR with no dilutions. No, the CAP does not require mandatory use of the CAP LN Survey materials in order to satisfy the CAP accreditation program.

In May of 2006, LGC Maine Standards received written confirmation from the CAP regarding this matter.

Other techniques include (1) assay of the current method calibration materials as unknown specimens and determination that the correct target values are recovered, and (2) assay of matrix-appropriate materials with accurate target values that are specific for the method.

Materials for calibration verification must have a matrix appropriate for the clinical specimens assayed by that method and target values appropriate for the measurement system.

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